CN121197307B - Pharmaceutical composition with heat-clearing and detoxifying effects and preparation method and application thereof - Google Patents
Pharmaceutical composition with heat-clearing and detoxifying effects and preparation method and application thereofInfo
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Abstract
The application relates to the technical field of traditional Chinese medicine preparations, in particular to a pharmaceutical composition with the effects of clearing heat and removing toxicity, and a preparation method and application thereof. The preparation method of the pharmaceutical composition comprises adding the fermented traditional Chinese medicine components into the decocted traditional Chinese medicine components, uniformly stirring, adding excipient, preparing into soft material, molding and drying to obtain the pharmaceutical composition with the effects of clearing heat and detoxicating. The pharmaceutical composition with the heat-clearing and detoxifying effects, which is prepared by the application, combines fermentation and ultrasonic-decoction synergistic extraction, the fermentation can decompose Chinese medicinal macromolecules to promote the dissolution of active ingredients, the ultrasonic energy enhances the extraction efficiency, the ingredient retention and the extraction effect are both considered, and the heat-clearing and detoxifying effects are excellent.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a pharmaceutical composition with the effects of clearing heat and detoxicating and regulating immunity, and a preparation process and clinical application of the composition, which can be widely applied to the treatment of human infectious diseases and disease prevention and control scenes.
Background
The traditional Chinese medicine composition for clearing heat and detoxicating is a core means for preventing and treating heat toxin syndrome in traditional Chinese medicine, and is widely applied to the fields of prevention and control of human infectious diseases and livestock epidemic diseases. Symptoms such as fever, sore throat, carbuncle, swelling and sore toxin and the like caused by accumulation of heat toxin aggravate treatment difficulty due to drug resistance in modern environments, and the Western antibiotics and chemical drugs have the limitations of obvious side effects, easy drug resistance generation and the like, so that the traditional Chinese medicine composition becomes a research hotspot.
In the prior art, the traditional Chinese medicine composition for clearing heat and detoxicating has a multi-element development pattern, such as a compound preparation which takes houttuynia cordata as a main medicine and is matched with mulberry leaves, chrysanthemum and the like, has the effects of dispelling wind and clearing heat, or an oral liquid for clearing plague and detoxicating which takes radix isatidis and radix scutellariae as core components, has wide application in prevention and control of fowl epidemic diseases, and has a simplified formula compounded by radix isatidis and dandelion, and is used for detoxifying and relieving sore throat. However, the technology still has obvious defects that the quality control of the complex formula is difficult and the dosage is large, while the curative effect is single with the simple formula, and the heat clearing and the strengthening are difficult to be achieved. The traditional decoction method has the problems of low dissolution rate of active ingredients, high loss rate of thermosensitive ingredients, high energy consumption and the like. In the application aspect, the long-term use of a single preparation leads to the enhancement of pathogenic drug resistance, and most of the compositions lack of regulation effect on the immune function of organisms, and easily cause side effects of bitter and cold injury. Therefore, there is a need to develop a traditional Chinese medicine composition with simple formula, controllable quality, high extraction efficiency and heat-clearing and detoxicating and immunoregulation functions, and optimize the existing preparation process to reduce energy consumption and component loss, so that the traditional Chinese medicine composition becomes an urgent need for solving the difficult problem of heat toxin prevention in the clinical and cultivation fields.
Disclosure of Invention
In order to solve the technical problems in the background art, the application provides a pharmaceutical composition with the effects of clearing heat and detoxicating, and a preparation method and application thereof.
The application provides a pharmaceutical composition with the effects of clearing heat and detoxicating, which adopts the following technical scheme:
A pharmaceutical composition with heat-clearing and detoxicating effects comprises fermented traditional Chinese medicine components and decoction traditional Chinese medicine components, wherein the mass ratio of the fermented traditional Chinese medicine components to the decoction traditional Chinese medicine components is 5-8:10-12.
Preferably, the fermented traditional Chinese medicine comprises astragalus, poria cocos, chinese yam and liquorice.
Preferably, the Chinese medicinal decoction comprises herba Houttuyniae, radix Isatidis, scutellariae radix and herba Taraxaci.
Preferably, the preparation method of the fermented traditional Chinese medicine component comprises the following preparation steps of;
Step 1, mixing astragalus, poria cocos, chinese yam and liquorice according to a mass ratio, crushing the mixture to 60-80 meshes to obtain a fermentation raw material, adding 5-8 times of purified water into the fermentation raw material, and uniformly stirring the mixture to obtain a fermentation substrate;
Step 2, inoculating a composite fermentation strain into the fermentation substrate, and performing sealed fermentation for 48-60 hours to obtain a fermented material;
And 3, boiling the fermented material, steaming for 20-30min, drying in the shade until the water content is 30-40%, repeating the steaming-drying in the shade for 2-3 times, drying, crushing and sieving to obtain the fermented traditional Chinese medicine component.
Preferably, in the step 1, the mass ratio of the astragalus, the poria cocos, the Chinese yam and the liquorice is 20-30:15-25:15-25:5-15.
Preferably, the inoculation amount of the composite fermentation strain in the step 2 is 3-5% of the mass of the fermentation substrate.
Preferably, the composite fermentation strain in the step2 consists of aspergillus niger, candida utilis and lactobacillus plantarum with the effective viable count ratio of 10-12:4-6:2-3.
Preferably, the preparation method of the decocted traditional Chinese medicine component comprises the following preparation steps:
Mixing herba Houttuyniae, radix Isatidis, scutellariae radix and herba Taraxaci at a mass ratio, pulverizing to 40-60 mesh to obtain decoction raw materials, adding 10-15 times of purified water into the decoction raw materials, soaking for 20-30min, extracting for 2-3 times by ultrasonic-decoction for 40-50min each time, mixing extractive solutions, concentrating the mixed extractive solutions under reduced pressure to obtain decoction traditional Chinese medicine components.
Preferably, the mass ratio of the cordate houttuynia, the radix isatidis, the radix scutellariae and the dandelion is 30-45:25-35:20-30:15-25.
The application also provides a preparation method of the pharmaceutical composition with the effects of clearing heat and detoxicating, which adopts the following technical scheme:
Adding the fermented traditional Chinese medicine components into the decocted traditional Chinese medicine components, stirring uniformly, adding excipients, preparing soft materials, and performing molding and drying treatment to obtain the pharmaceutical composition with the effects of clearing heat and detoxicating.
Preferably, the excipient is dextrin or corn starch, when the excipient is dextrin, the adding amount is 12-14% of the total weight, and when the excipient is corn starch, the adding amount is 13-15% of the total weight.
In summary, the application has the following beneficial effects:
The astragalus membranaceus in the fermentation components of the application has the effects of tonifying qi and yang, the poria cocos has the effects of invigorating spleen and promoting diuresis, the Chinese yam has the effects of tonifying spleen and stomach, and the liquorice has the effects of harmonizing all the medicines, the four are all the tonifying traditional Chinese medicines, the dissolution and absorption of active ingredients of the traditional Chinese medicines can be enhanced after fermentation, so that the effect of strengthening the body resistance can be better exerted, the foundation is laid for the body to resist exogenous evils, the cordate houttuynia in the decoction components has the effects of clearing heat and detoxicating, the radix isatidis has the effects of cooling blood and relieving sore throat, the radix scutellariae has the effects of clearing heat and drying dampness, and the dandelion has the effects of relieving swelling and resolving masses, and the four are all the heat-clearing traditional Chinese medicines, and the water-soluble heat and detoxifying ingredients of the traditional Chinese medicines can be fully extracted after decoction, so that the effect of eliminating evil is realized. The division mode of strengthening body resistance component fermentation and eliminating evil component decoction is adopted, and the effective components are reserved to the maximum extent and the drug effect synergy is realized according to the accurate matching technology of the characteristics of medicinal materials. The four medicines such as astragalus root, poria cocos and the like are rich in macromolecules such as starch and polysaccharide, hydrolytic enzymes secreted by strains can decompose the macromolecules into micromolecular active substances during fermentation, the dissolution rate of effective components is remarkably improved compared with that of direct decoction, the glycyrrhizic acid and the like can be converted into mild components, the temperature compensation property is balanced, and the spleen and stomach injury during heat clearing is avoided. The four medicines of houttuynia cordata and radix isatidis have the advantages that the heat-clearing components are mostly water-soluble, the houttuynia cordata contains volatile decanoyl acetaldehyde, the cell wall can be destroyed by ultrasonic cavitation effect in the synergistic extraction of ultrasonic and decoction, and the impurity dissolution of tannins and the like is obviously reduced compared with the simple decoction in low-temperature decoction, so that the purity of the components is improved. The two processes respectively activate the healthy energy strengthening effect of the warming and tonifying medicinal materials and the pathogenic factor eliminating effect of the heat clearing medicinal materials, so that a synergistic effect of clearing heat without hurting healthy energy is formed, and the heat clearing and detoxifying effects and safety are ensured.
The application utilizes three strains of aspergillus niger, candida utilis and lactobacillus plantarum to cooperatively ferment, and constructs a complete fermentation chain through functional complementation, thereby not only solving the problem of short efficiency board of single strain fermentation, but also realizing dual upgrading of drug effect and safety, and particularly adapting to the processing requirements of isothermal tonic medicinal materials of astragalus and poria cocos. From the viewpoint of component conversion, the aspergillus niger can secrete amylase and cellulase, starch and cellulose in medicinal materials can be decomposed into small molecular sugar, the small molecular sugar can be used as a carbon source of candida utilis, so that the active peptide, B vitamins and other new substances are synthesized, the strengthening effect of astragalus is more remarkable, meanwhile, lactic acid produced by lactobacillus plantarum can regulate the pH value of a fermentation system, not only can activate the enzyme activity of the aspergillus niger and accelerate the decomposition of macromolecules, but also can avoid the breeding of mixed bacteria, solve the problem of easy pollution of single strain fermentation, and finally improve the dissolution rate of the effective components of the medicinal materials compared with single strain fermentation. From the aspects of drug effect and safety, the three can be cooperated to balance the properties of the warming and tonifying drug, namely lactobacillus plantarum can reduce trace irritant substances generated in the fermentation process, reduce discomfort of gastrointestinal tracts after taking, and metabolites of candida utilis can be cooperated with active ingredients decomposed by aspergillus niger to enhance anti-inflammatory and immunoregulation effects and avoid the problem of single drug effect of single strain fermentation. In addition, the synergistic fermentation can lead the batch difference of the products to be smaller, and the repeated steaming and drying in the shade can remove trace impurities generated by the fermentation, simultaneously lead the components to be more stable and provide more reliable raw material guarantee for the subsequent preparation of the medicines.
Detailed Description
The present application will be described in further detail with reference to examples.
Aspergillus niger (cat# B94857), candida utilis (cat# B81627) and Lactobacillus plantarum (cat# B94828) used in the examples and comparative examples of the application were all purchased from Ningbo biotechnology Co.
Examples 1-3 provide a pharmaceutical composition with the effects of clearing away heat and toxic materials, and a preparation method and application thereof.
Example 1
A pharmaceutical composition with heat-clearing and detoxicating effects comprises fermented traditional Chinese medicine components and decoction traditional Chinese medicine components, wherein the mass ratio of the fermented traditional Chinese medicine components to the decoction traditional Chinese medicine components is 5:10.
The preparation method of the fermented traditional Chinese medicine component comprises the following preparation steps:
Step 1, mixing astragalus, poria cocos, chinese yam and liquorice according to a mass ratio of 20:15:15:5, crushing, sieving with a 60-mesh sieve to obtain a fermentation raw material, adding 5 times of purified water into the fermentation raw material, stirring for 20min at a stirring rotating speed of 200rpm, and uniformly stirring to obtain a fermentation substrate;
step 2, inoculating a composite fermentation strain into a fermentation substrate, and performing sealed fermentation for 48 hours at the temperature of 32 ℃ to obtain a fermented material, wherein the inoculum size of the composite fermentation strain is 3% of the mass of the fermentation substrate, and the composite fermentation strain consists of aspergillus niger, candida utilis and lactobacillus plantarum with the effective viable count ratio of 10:4:2;
and 3, boiling the fermented material, steaming for 20min, drying in the shade until the water content is 30%, repeating the steaming-drying in the shade for 2 times, drying at 40 ℃ until the water content is 5%, crushing and sieving with a 40-mesh sieve to obtain the fermented traditional Chinese medicine component.
The preparation method of the decocted traditional Chinese medicine component comprises the following preparation steps:
Mixing herba Houttuyniae, radix Isatidis, scutellariae radix and herba Taraxaci at a mass ratio of 30:25:20:15, pulverizing, sieving with 40 mesh sieve to obtain decoction raw materials, adding 10 times of purified water into the decoction raw materials, soaking for 20min, extracting for 2 times by ultrasonic-decoction, wherein ultrasonic power is 300W, ultrasonic frequency is 40kHz, decocting temperature is 60 deg.C, each time is 40min, mixing extractive solutions, concentrating the mixed extractive solution under reduced pressure to relative density of 1.15, and obtaining decoction traditional Chinese medicine component.
A preparation method of a pharmaceutical composition with the effects of clearing heat and detoxicating comprises the following preparation steps:
adding the fermented traditional Chinese medicine components into the decocted traditional Chinese medicine components, stirring for 20min at the stirring speed of 50rpm, adding dextrin accounting for 12% of the total weight after stirring uniformly to prepare a soft material, and then carrying out molding and 60 ℃ drying treatment to obtain the pharmaceutical composition with the effects of clearing heat and detoxicating.
Example 2
A pharmaceutical composition with heat-clearing and detoxicating effects comprises a fermented traditional Chinese medicine component and a decocted traditional Chinese medicine component, wherein the mass ratio of the fermented traditional Chinese medicine component to the decocted traditional Chinese medicine component is 7:11.
The preparation method of the fermented traditional Chinese medicine component comprises the following preparation steps:
Step 1, mixing astragalus, poria cocos, chinese yam and liquorice according to a mass ratio of 25:20:20:10, crushing, sieving with a 70-mesh sieve to obtain a fermentation raw material, adding 7 times of purified water into the fermentation raw material, stirring for 25min at a stirring rotating speed of 300rpm, and uniformly stirring to obtain a fermentation substrate;
Step 2, inoculating a composite fermentation strain into a fermentation substrate, and performing sealed fermentation for 54 hours at the temperature of 34 ℃ to obtain a fermented material, wherein the inoculation amount of the composite fermentation strain is 4% of the mass of the fermentation substrate, and the composite fermentation strain consists of aspergillus niger, candida utilis and lactobacillus plantarum with the effective viable count ratio of 11:5:2.5;
And 3, boiling the fermented material, steaming for 25min, drying in the shade until the water content is 35%, repeating the steaming-drying in the shade for 3 times, drying at 50 ℃ until the water content is 3%, crushing and sieving with a 50-mesh sieve to obtain the fermented traditional Chinese medicine component.
The preparation method of the decocted traditional Chinese medicine component comprises the following preparation steps:
Mixing herba Houttuyniae, radix Isatidis, scutellariae radix and herba Taraxaci at a mass ratio of 38:30:25:20, pulverizing, sieving with 50 mesh sieve to obtain decoction raw materials, adding 12 times of purified water into the decoction raw materials, soaking for 25min, performing ultrasonic-decoction synergistic extraction for 3 times, wherein ultrasonic power is 350W, ultrasonic frequency is 50kHz, decoction temperature is 65 deg.C, each time is 45min, mixing extractive solutions, concentrating the mixed extractive solution under reduced pressure to relative density of 1.21, and obtaining decoction traditional Chinese medicine component.
A preparation method of a pharmaceutical composition with the effects of clearing heat and detoxicating comprises the following preparation steps:
Adding the fermented traditional Chinese medicine components into the decocted traditional Chinese medicine components, stirring for 25min at the stirring speed of 80rpm, adding corn starch accounting for 13% of the total weight after stirring uniformly, preparing into a soft material, and then carrying out molding and drying at 62 ℃ to obtain the pharmaceutical composition with the effects of clearing heat and detoxicating.
Example 3
A pharmaceutical composition with heat-clearing and detoxicating effects comprises fermented traditional Chinese medicine components and decoction traditional Chinese medicine components, wherein the mass ratio of the fermented traditional Chinese medicine components to the decoction traditional Chinese medicine components is 8:12.
The preparation method of the fermented traditional Chinese medicine component comprises the following preparation steps:
Step 1, mixing astragalus, poria cocos, chinese yam and liquorice according to a mass ratio of 30:25:25:15, crushing, sieving with a 80-mesh sieve to obtain a fermentation raw material, adding 8 times of purified water into the fermentation raw material, stirring for 30min at a stirring rotating speed of 400rpm, and uniformly stirring to obtain a fermentation substrate;
step 2, inoculating a composite fermentation strain into a fermentation substrate, and performing sealed fermentation for 60 hours at the temperature of 35 ℃ to obtain a fermented material, wherein the inoculum size of the composite fermentation strain is 5% of the mass of the fermentation substrate, and the composite fermentation strain consists of aspergillus niger, candida utilis and lactobacillus plantarum with the effective viable count ratio of 12:6:3;
And 3, boiling the fermented material, steaming for 30min, drying in the shade until the water content is 40%, repeating the steaming-drying in the shade for 3 times, drying at 60 ℃ until the water content is 4%, crushing and sieving with a 60-mesh sieve to obtain the fermented traditional Chinese medicine component.
The preparation method of the decocted traditional Chinese medicine component comprises the following preparation steps:
mixing herba Houttuyniae, radix Isatidis, scutellariae radix and herba Taraxaci at a mass ratio of 45:35:30:25, pulverizing, sieving with 60 mesh sieve to obtain decoction raw materials, adding 15 times of purified water into the decoction raw materials, soaking for 30min, extracting for 3 times by ultrasonic-decoction, wherein the ultrasonic power is 400W, the ultrasonic frequency is 60kHz, the decoction temperature is 70 deg.C, each time for 50min, mixing the extractive solutions, concentrating the mixed extractive solution under reduced pressure to relative density of 1.25, and obtaining the decoction traditional Chinese medicine component.
A preparation method of a pharmaceutical composition with the effects of clearing heat and detoxicating comprises the following preparation steps:
Adding the fermented traditional Chinese medicine components into the decocted traditional Chinese medicine components, stirring for 30min at a stirring speed of 100rpm, adding dextrin accounting for 14% of the total weight after stirring uniformly to prepare a soft material, and then carrying out molding and drying treatment at 65 ℃ to obtain the pharmaceutical composition with the effects of clearing heat and detoxicating.
Comparative example 1
A pharmaceutical composition with heat-clearing and detoxicating effects comprises fermented traditional Chinese medicine components and decoction traditional Chinese medicine components, wherein the mass ratio of the fermented traditional Chinese medicine components to the decoction traditional Chinese medicine components is 5:10.
The preparation method of the fermented traditional Chinese medicine component comprises the following preparation steps:
Step 1, mixing houttuynia cordata, radix isatidis, radix scutellariae and dandelion according to a mass ratio of 30:25:20:15, crushing, sieving with a 60-mesh sieve to obtain a fermentation raw material, adding 5 times of purified water into the fermentation raw material, stirring for 20min at a stirring rotating speed of 200rpm, and uniformly stirring to obtain a fermentation substrate;
step 2, inoculating a composite fermentation strain into a fermentation substrate, and performing sealed fermentation for 48 hours at the temperature of 32 ℃ to obtain a fermented material, wherein the inoculum size of the composite fermentation strain is 3% of the mass of the fermentation substrate, and the composite fermentation strain consists of aspergillus niger, candida utilis and lactobacillus plantarum with the effective viable count ratio of 10:4:2;
and 3, boiling the fermented material, steaming for 20min, drying in the shade until the water content is 30%, repeating the steaming-drying in the shade for 2 times, drying at 40 ℃ until the water content is 5%, crushing and sieving with a 40-mesh sieve to obtain the fermented traditional Chinese medicine component.
The preparation method of the decocted traditional Chinese medicine component comprises the following preparation steps:
Mixing radix astragali, poria, rhizoma Dioscoreae and Glycyrrhrizae radix at mass ratio of 20:15:15:5, pulverizing, sieving with 40 mesh sieve to obtain decoction raw material, adding 10 times of purified water into the decoction raw material, soaking for 20min, extracting for 2 times by ultrasonic-decoction, wherein ultrasonic power is 300W, ultrasonic frequency is 40kHz, decoction temperature is 60 deg.C, each time for 40min, mixing extractive solutions, concentrating the mixed extractive solution under reduced pressure to relative density of 1.15, and obtaining decoction traditional Chinese medicine component.
A preparation method of a pharmaceutical composition with the effects of clearing heat and detoxicating comprises the following preparation steps:
adding the fermented traditional Chinese medicine components into the decocted traditional Chinese medicine components, stirring for 20min at the stirring speed of 50rpm, adding dextrin accounting for 12% of the total weight after stirring uniformly to prepare a soft material, and then carrying out molding and 60 ℃ drying treatment to obtain the pharmaceutical composition with the effects of clearing heat and detoxicating.
Comparative example 2
A pharmaceutical composition with heat-clearing and detoxicating effects comprises fermented traditional Chinese medicine components and decoction traditional Chinese medicine components, wherein the mass ratio of the fermented traditional Chinese medicine components to the decoction traditional Chinese medicine components is 5:10.
The preparation method of the fermented traditional Chinese medicine component comprises the following preparation steps:
Step 1, mixing astragalus, poria cocos, chinese yam and liquorice according to a mass ratio of 20:15:15:5, crushing, sieving with a 60-mesh sieve to obtain a fermentation raw material, adding 5 times of purified water into the fermentation raw material, stirring for 20min at a stirring rotating speed of 200rpm, and uniformly stirring to obtain a fermentation substrate;
Step 2, inoculating a composite fermentation strain into a fermentation substrate, and performing sealed fermentation for 48 hours at the temperature of 32 ℃ to obtain a fermented material, wherein the inoculation amount of the composite fermentation strain is 3% of the mass of the fermentation substrate, and the composite fermentation strain consists of candida utilis and lactobacillus plantarum with the effective viable count ratio of 4:2;
and 3, boiling the fermented material, steaming for 20min, drying in the shade until the water content is 30%, repeating the steaming-drying in the shade for 2 times, drying at 40 ℃ until the water content is 5%, crushing and sieving with a 40-mesh sieve to obtain the fermented traditional Chinese medicine component.
The preparation method of the decocted traditional Chinese medicine component comprises the following preparation steps:
Mixing herba Houttuyniae, radix Isatidis, scutellariae radix and herba Taraxaci at a mass ratio of 30:25:20:15, pulverizing, sieving with 40 mesh sieve to obtain decoction raw materials, adding 10 times of purified water into the decoction raw materials, soaking for 20min, extracting for 2 times by ultrasonic-decoction, wherein ultrasonic power is 300W, ultrasonic frequency is 40kHz, decocting temperature is 60 deg.C, each time is 40min, mixing extractive solutions, concentrating the mixed extractive solution under reduced pressure to relative density of 1.15, and obtaining decoction traditional Chinese medicine component.
A preparation method of a pharmaceutical composition with the effects of clearing heat and detoxicating comprises the following preparation steps:
adding the fermented traditional Chinese medicine components into the decocted traditional Chinese medicine components, stirring for 20min at the stirring speed of 50rpm, adding dextrin accounting for 12% of the total weight after stirring uniformly to prepare a soft material, and then carrying out molding and 60 ℃ drying treatment to obtain the pharmaceutical composition with the effects of clearing heat and detoxicating.
Comparative example 3
A pharmaceutical composition with heat-clearing and detoxicating effects comprises fermented traditional Chinese medicine components and decoction traditional Chinese medicine components, wherein the mass ratio of the fermented traditional Chinese medicine components to the decoction traditional Chinese medicine components is 5:10.
The preparation method of the fermented traditional Chinese medicine component comprises the following preparation steps:
Step 1, mixing astragalus, poria cocos, chinese yam and liquorice according to a mass ratio of 20:15:15:5, crushing, sieving with a 60-mesh sieve to obtain a fermentation raw material, adding 5 times of purified water into the fermentation raw material, stirring for 20min at a stirring rotating speed of 200rpm, and uniformly stirring to obtain a fermentation substrate;
Step 2, inoculating a composite fermentation strain into a fermentation substrate, and performing sealed fermentation for 48 hours at the temperature of 32 ℃ to obtain a fermented material, wherein the inoculation amount of the composite fermentation strain is 3% of the mass of the fermentation substrate, and the composite fermentation strain consists of aspergillus niger and lactobacillus plantarum with the effective viable count ratio of 10:2;
and 3, boiling the fermented material, steaming for 20min, drying in the shade until the water content is 30%, repeating the steaming-drying in the shade for 2 times, drying at 40 ℃ until the water content is 5%, crushing and sieving with a 40-mesh sieve to obtain the fermented traditional Chinese medicine component.
The preparation method of the decocted traditional Chinese medicine component comprises the following preparation steps:
Mixing herba Houttuyniae, radix Isatidis, scutellariae radix and herba Taraxaci at a mass ratio of 30:25:20:15, pulverizing, sieving with 40 mesh sieve to obtain decoction raw materials, adding 10 times of purified water into the decoction raw materials, soaking for 20min, extracting for 2 times by ultrasonic-decoction, wherein ultrasonic power is 300W, ultrasonic frequency is 40kHz, decocting temperature is 60 deg.C, each time is 40min, mixing extractive solutions, concentrating the mixed extractive solution under reduced pressure to relative density of 1.15, and obtaining decoction traditional Chinese medicine component.
A preparation method of a pharmaceutical composition with the effects of clearing heat and detoxicating comprises the following preparation steps:
adding the fermented traditional Chinese medicine components into the decocted traditional Chinese medicine components, stirring for 20min at the stirring speed of 50rpm, adding dextrin accounting for 12% of the total weight after stirring uniformly to prepare a soft material, and then carrying out molding and 60 ℃ drying treatment to obtain the pharmaceutical composition with the effects of clearing heat and detoxicating.
Comparative example 4
A pharmaceutical composition with heat-clearing and detoxicating effects comprises fermented traditional Chinese medicine components and decoction traditional Chinese medicine components, wherein the mass ratio of the fermented traditional Chinese medicine components to the decoction traditional Chinese medicine components is 5:10.
The preparation method of the fermented traditional Chinese medicine component comprises the following preparation steps:
Step 1, mixing astragalus, poria cocos, chinese yam and liquorice according to a mass ratio of 20:15:15:5, crushing, sieving with a 60-mesh sieve to obtain a fermentation raw material, adding 5 times of purified water into the fermentation raw material, stirring for 20min at a stirring rotating speed of 200rpm, and uniformly stirring to obtain a fermentation substrate;
step 2, inoculating a composite fermentation strain into a fermentation substrate, and performing sealed fermentation for 48 hours at the temperature of 32 ℃ to obtain a fermented material, wherein the inoculation amount of the composite fermentation strain is 3% of the mass of the fermentation substrate, and the composite fermentation strain consists of aspergillus niger and candida utilis with the effective viable count ratio of 10:4;
and 3, boiling the fermented material, steaming for 20min, drying in the shade until the water content is 30%, repeating the steaming-drying in the shade for 2 times, drying at 40 ℃ until the water content is 5%, crushing and sieving with a 40-mesh sieve to obtain the fermented traditional Chinese medicine component.
The preparation method of the decocted traditional Chinese medicine component comprises the following preparation steps:
Mixing herba Houttuyniae, radix Isatidis, scutellariae radix and herba Taraxaci at a mass ratio of 30:25:20:15, pulverizing, sieving with 40 mesh sieve to obtain decoction raw materials, adding 10 times of purified water into the decoction raw materials, soaking for 20min, extracting for 2 times by ultrasonic-decoction, wherein ultrasonic power is 300W, ultrasonic frequency is 40kHz, decocting temperature is 60 deg.C, each time is 40min, mixing extractive solutions, concentrating the mixed extractive solution under reduced pressure to relative density of 1.15, and obtaining decoction traditional Chinese medicine component.
A preparation method of a pharmaceutical composition with the effects of clearing heat and detoxicating comprises the following preparation steps:
adding the fermented traditional Chinese medicine components into the decocted traditional Chinese medicine components, stirring for 20min at the stirring speed of 50rpm, adding dextrin accounting for 12% of the total weight after stirring uniformly to prepare a soft material, and then carrying out molding and 60 ℃ drying treatment to obtain the pharmaceutical composition with the effects of clearing heat and detoxicating.
Comparative example 5
A pharmaceutical composition with heat-clearing and detoxicating effects comprises fermented traditional Chinese medicine components and decoction traditional Chinese medicine components, wherein the mass ratio of the fermented traditional Chinese medicine components to the decoction traditional Chinese medicine components is 5:10.
The preparation method of the fermented traditional Chinese medicine component comprises the following preparation steps:
Step 1, mixing astragalus, poria cocos, chinese yam and liquorice according to a mass ratio of 20:15:15:5, crushing, sieving with a 60-mesh sieve to obtain a fermentation raw material, adding 5 times of purified water into the fermentation raw material, stirring for 20min at a stirring rotating speed of 200rpm, and uniformly stirring to obtain a fermentation substrate;
step 2, inoculating a composite fermentation strain into a fermentation substrate, and performing sealed fermentation for 48 hours at the temperature of 32 ℃ to obtain a fermented material, wherein the inoculum size of the composite fermentation strain is 3% of the mass of the fermentation substrate, and the composite fermentation strain consists of aspergillus niger, candida utilis and lactobacillus plantarum with the effective viable count ratio of 10:4:2;
And 3, boiling the fermented material, steaming for 20min, drying in the shade until the water content is 30%, drying at 40 ℃ until the water content is 5%, crushing and sieving with a 40-mesh sieve to obtain the fermented traditional Chinese medicine component.
The preparation method of the decocted traditional Chinese medicine component comprises the following preparation steps:
Mixing herba Houttuyniae, radix Isatidis, scutellariae radix and herba Taraxaci at a mass ratio of 30:25:20:15, pulverizing, sieving with 40 mesh sieve to obtain decoction raw materials, adding 10 times of purified water into the decoction raw materials, soaking for 20min, extracting for 2 times by ultrasonic-decoction, wherein ultrasonic power is 300W, ultrasonic frequency is 40kHz, decocting temperature is 60 deg.C, each time is 40min, mixing extractive solutions, concentrating the mixed extractive solution under reduced pressure to relative density of 1.15, and obtaining decoction traditional Chinese medicine component.
A preparation method of a pharmaceutical composition with the effects of clearing heat and detoxicating comprises the following preparation steps:
adding the fermented traditional Chinese medicine components into the decocted traditional Chinese medicine components, stirring for 20min at the stirring speed of 50rpm, adding dextrin accounting for 12% of the total weight after stirring uniformly to prepare a soft material, and then carrying out molding and 60 ℃ drying treatment to obtain the pharmaceutical composition with the effects of clearing heat and detoxicating.
Comparative example 6
A pharmaceutical composition with heat-clearing and detoxicating effects comprises fermented traditional Chinese medicine components and decoction traditional Chinese medicine components, wherein the mass ratio of the fermented traditional Chinese medicine components to the decoction traditional Chinese medicine components is 10:5.
The preparation method of the fermented traditional Chinese medicine component comprises the following preparation steps:
Step 1, mixing astragalus, poria cocos, chinese yam and liquorice according to a mass ratio of 20:15:15:5, crushing, sieving with a 60-mesh sieve to obtain a fermentation raw material, adding 5 times of purified water into the fermentation raw material, stirring for 20min at a stirring rotating speed of 200rpm, and uniformly stirring to obtain a fermentation substrate;
step 2, inoculating a composite fermentation strain into a fermentation substrate, and performing sealed fermentation for 48 hours at the temperature of 32 ℃ to obtain a fermented material, wherein the inoculum size of the composite fermentation strain is 3% of the mass of the fermentation substrate, and the composite fermentation strain consists of aspergillus niger, candida utilis and lactobacillus plantarum with the effective viable count ratio of 10:4:2;
and 3, boiling the fermented material, steaming for 20min, drying in the shade until the water content is 30%, repeating the steaming-drying in the shade for 2 times, drying at 40 ℃ until the water content is 5%, crushing and sieving with a 40-mesh sieve to obtain the fermented traditional Chinese medicine component.
The preparation method of the decocted traditional Chinese medicine component comprises the following preparation steps:
Mixing herba Houttuyniae, radix Isatidis, scutellariae radix and herba Taraxaci at a mass ratio of 30:25:20:15, pulverizing, sieving with 40 mesh sieve to obtain decoction raw materials, adding 10 times of purified water into the decoction raw materials, soaking for 20min, extracting for 2 times by ultrasonic-decoction, wherein ultrasonic power is 300W, ultrasonic frequency is 40kHz, decocting temperature is 60 deg.C, each time is 40min, mixing extractive solutions, concentrating the mixed extractive solution under reduced pressure to relative density of 1.15, and obtaining decoction traditional Chinese medicine component.
A preparation method of a pharmaceutical composition with the effects of clearing heat and detoxicating comprises the following preparation steps:
adding the fermented traditional Chinese medicine components into the decocted traditional Chinese medicine components, stirring for 20min at the stirring speed of 50rpm, adding dextrin accounting for 12% of the total weight after stirring uniformly to prepare a soft material, and then carrying out molding and 60 ℃ drying treatment to obtain the pharmaceutical composition with the effects of clearing heat and detoxicating.
Performance testing
The pharmaceutical compositions with heat-clearing and detoxifying effects prepared in examples 1 to 3 and comparative examples 1 to 6 of the present application were subjected to heat-clearing efficacy tests, specifically as follows:
The test animals are healthy white rabbits with the weight of 5-6 jin, the male and female animals are not limited, and the disease is confirmed to be free before the test, and the mental state is good;
Test article the pharmaceutical compositions with heat-clearing and detoxicating effects prepared in examples 1-3 and comparative examples 1-6 and compound honeysuckle flower granules (the pharmaceutical compositions with heat-clearing and detoxicating effects prepared in examples 1-3 and comparative examples 1-6 and compound honeysuckle flower granules are prepared into gastric juice of 0.5 g/mL);
The reagent and instrument are bacterial endotoxin, physiological saline, a disposable syringe, an electronic thermometer, an electronic balance, a timer and the like, wherein the bacterial endotoxin is required to meet the medicinal standard, and the physiological saline is prepared for use at present.
3. Animal screening and adaptation test, placing white rabbits in a feeding room with the ambient temperature of 22-25 ℃ and the relative humidity of 50-60% for 7 days, and freely feeding water. The body temperature is measured 3 times every 2 hours 1 day before the test, the body temperature is ensured to be within the range of 38-39.4 ℃ and the temperature fluctuation in the day is not more than 0.4 ℃, the rabbits meeting the conditions are screened for standby, and the base body temperature (marked as T0) before the molding of each rabbit is measured firstly on the day of the heating model building test. The bacterial endotoxin physiological saline solution was then intravenously injected from the auricle white rabbit at a dose of 1mL/kg. The method comprises the steps of continuously observing body temperature change after injection, measuring the body temperature again after 1 hour (marked as T1), selecting rabbits with body temperature rising above 0.5 ℃ (namely T1-T0 is more than 0.5 ℃) as qualified fever model animals, randomly dividing the qualified fever model rabbits into 11 groups of 12 animals per group by grouping and administration, wherein the specific grouping is as follows, a blank control group is not administered with normal saline, a positive control group is filled with gastric equal volume, the positive control group is filled with commercially available compound honeysuckle particles, and the pharmaceutical compositions with heat-clearing and detoxifying effects prepared by the examples 1-3 and the comparative examples 1-6 are filled with gastric administration, namely, after the administration of body temperature monitoring, the body temperature change is continuously observed, the body temperature data are recorded once every 1 hour, and are continuously recorded for 3 hours.
The test results are shown in Table 1.
TABLE 1 Heat clearing and detoxifying effects of pharmaceutical compositions prepared in examples 1-3 and comparative examples 1-6
As can be seen from Table 1, the pharmaceutical composition prepared by the present application has outstanding advantages. In the process, fermentation and ultrasonic-decoction synergistic extraction are combined, the fermentation can decompose Chinese medicinal macromolecules to promote dissolution of active ingredients, ultrasonic energy enhances extraction efficiency, and gives consideration to ingredient retention and extraction effects, and the Chinese medicinal preparation has the advantages of excellent heat clearing effect, good practicality, good quality stability, guaranteed effective period, good formability of a soft material prepared by assisting an excipient, convenience in taking, ensured efficacy, improved use experience and remarkable comprehensive advantages.
The present embodiment is only for explanation of the present application and is not to be construed as limiting the present application, and modifications to the present embodiment, which may not creatively contribute to the present application as required by those skilled in the art after reading the present specification, are all protected by patent laws within the scope of claims of the present application.
Claims (3)
1. The pharmaceutical composition with the effects of clearing heat and detoxicating is characterized by comprising a fermented traditional Chinese medicine component and a decocted traditional Chinese medicine component, wherein the mass ratio of the fermented traditional Chinese medicine component to the decocted traditional Chinese medicine component is 5-8:10-12;
The fermented traditional Chinese medicine comprises astragalus, poria cocos, chinese yam and liquorice;
The Chinese medicinal decoction comprises herba Houttuyniae, radix Isatidis, scutellariae radix and herba Taraxaci;
The preparation method of the fermented traditional Chinese medicine component comprises the following preparation steps of;
Step 1, mixing astragalus, poria cocos, chinese yam and liquorice according to a mass ratio, crushing the mixture to 60-80 meshes to obtain a fermentation raw material, adding 5-8 times of purified water into the fermentation raw material, and uniformly stirring the mixture to obtain a fermentation substrate;
Step 2, inoculating a composite fermentation strain into the fermentation substrate, and performing sealed fermentation for 48-60 hours to obtain a fermented material;
Step 3, boiling the fermented material, steaming for 20-30min, drying in the shade until the water content is 30-40%, repeating the steaming-drying in the shade for 2-3 times, drying, crushing and sieving to obtain a fermented traditional Chinese medicine component;
In the step 1, the mass ratio of the astragalus, the poria cocos, the Chinese yam and the liquorice is 20-30:15-25:15-25:5-15;
The inoculation amount of the composite fermentation strain in the step 2 is 3-5% of the mass of the fermentation substrate;
The composite fermentation strain in the step 2 consists of aspergillus niger, candida utilis and lactobacillus plantarum with the effective viable count ratio of 10-12:4-6:2-3;
The preparation method of the decocted traditional Chinese medicine component comprises the following preparation steps:
Mixing herba Houttuyniae, radix Isatidis, scutellariae radix and herba Taraxaci at a mass ratio, pulverizing to 40-60 mesh to obtain decoction raw materials, adding 10-15 times of purified water into the decoction raw materials, soaking for 20-30min, extracting for 2-3 times by ultrasonic-decoction for 40-50min each time, mixing extractive solutions, concentrating the mixed extractive solutions under reduced pressure to obtain decoction traditional Chinese medicine components;
The mass ratio of the cordate houttuynia, the radix isatidis, the radix scutellariae and the dandelion is 30-45:25-35:20-30:15-25.
2. A method for preparing the pharmaceutical composition with the efficacy of clearing heat and detoxicating according to claim 1, which comprises the following preparation steps:
Adding the fermented traditional Chinese medicine components into the decocted traditional Chinese medicine components, stirring uniformly, adding excipients, preparing soft materials, and performing molding and drying treatment to obtain the pharmaceutical composition with the effects of clearing heat and detoxicating.
3. The method for preparing a pharmaceutical composition with heat and toxic materials clearing away effect according to claim 2, wherein the excipient is dextrin or corn starch, the adding amount is 12-14% of the total weight when the excipient is dextrin, and the adding amount is 13-15% of the total weight when the excipient is corn starch.
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