CN106727415A - A kind of capsule composition containing C14H25N4NaO11P2 and preparation method thereof - Google Patents
A kind of capsule composition containing C14H25N4NaO11P2 and preparation method thereof Download PDFInfo
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Abstract
Description
技术领域technical field
本发明属于医药制备领域，具体涉及一种含有胞磷胆碱钠的胶囊组合物及其制备方法。The invention belongs to the field of medicine preparation, and in particular relates to a capsule composition containing citicoline sodium and a preparation method thereof.
背景技术Background technique
胞磷胆碱钠(Citicoline Sodium)，为胆碱胞嘧啶核苷二磷酸酯的单钠盐，是核苷衍生物，干燥品中胞磷胆碱钠不少于98％。胞磷胆碱钠可以通过降低脑血管阻力，增加脑血流来促进脑物质代谢，改善脑循环。也可增强脑干上行网状激活系统的机能，增强椎体系统的功能，改善运动麻痹，故对促进大脑功能的恢复和促进苏醒有一定作用。注入胞磷胆碱钠注射液后可迅速进入血液，有部分通过血脑屏障进入脑组织，胆碱部分在体内成为良好的甲基化供体，可对多种化合物有转甲基化作用，约1％的胆碱从尿排出。胞磷胆碱钠主要用于急性颅脑外伤和脑手术后意识障碍，对脑中风所致的偏瘫可逐渐恢复四肢的功能，也可用于其他中枢神经系统急性损伤引起的功能和意识障碍，也用于缺血性脑血管病和血管性痴呆。Citicoline Sodium (Citicoline Sodium), the monosodium salt of choline cytosine nucleoside diphosphate, is a nucleoside derivative, and the dry product contains no less than 98% of Citicoline Sodium. Citicoline sodium can promote brain substance metabolism and improve cerebral circulation by reducing cerebrovascular resistance and increasing cerebral blood flow. It can also enhance the function of the ascending reticular activation system of the brain stem, enhance the function of the vertebral system, and improve motor paralysis, so it has a certain effect on promoting the recovery of brain function and waking up. After injection of citicoline sodium injection, it can quickly enter the blood, and part of it enters the brain tissue through the blood-brain barrier. The choline part becomes a good methylation donor in the body, and can transmethylate a variety of compounds. About 1% of choline is excreted in urine. Citicoline Sodium is mainly used for disturbance of consciousness after acute craniocerebral trauma and brain surgery. It can gradually restore the function of limbs for hemiplegia caused by cerebral apoplexy. For ischemic cerebrovascular disease and vascular dementia.
胞磷胆碱钠易吸湿，在胞磷胆碱钠胶囊填充过程中过度暴露于空气中容易吸潮，造成粘冲或影响填充；并且胶囊剂在放置过程中，胶囊壳中的水分容易被囊壳内的胞磷胆碱颗粒吸收，导致胶囊壳变脆；经包装后，如采用铝塑包装，颗粒容易吸湿，导致水分增加，并且，本发明需要解决如下两个问题：Citicoline sodium is easy to absorb moisture, and it is easy to absorb moisture when it is excessively exposed to the air during the filling process of citicoline sodium capsules, causing stickiness or affecting filling; and during the capsule placement process, the moisture in the capsule shell is easily absorbed The citicoline particles in the shell are absorbed, causing the capsule shell to become brittle; after packaging, if aluminum-plastic packaging is used, the particles are easy to absorb moisture, resulting in an increase in moisture, and the present invention needs to solve the following two problems:
1、稳定性与市售产品一致：根据本专利制备的样品0天样品有关物质低于市售制剂产品，质量更优；长期24月和加速6月条件下稳定性未发生改变；其余检测指标亦合格，未出现显著变化；1. The stability is consistent with that of commercially available products: the sample prepared according to this patent at day 0 has lower related substances than commercially available preparation products, and the quality is better; the stability does not change under long-term 24-month and accelerated 6-month conditions; other detection indicators Also qualified, no significant changes;
2、生产成本：为解决胞磷胆碱钠吸湿性强导致吸收胶囊壳水分，使得胶囊壳变脆的问题，本专利选择常规的干粉混合直灌胶囊，选择双层铝塑材料进行包装。2. Production cost: In order to solve the problem that citicoline sodium absorbs moisture from the capsule shell due to its strong hygroscopicity and makes the capsule shell brittle, this patent selects conventional dry powder mixed direct filling capsules and double-layer aluminum-plastic materials for packaging.
而CN102525997B专利时通过挤出滚圆工艺制备胞磷胆碱钠微丸或者颗粒，再对微丸或者颗粒进行包衣达到防潮的目的。两个防潮目的一致，但是本专利优点是工艺简单，生产周期短，成本低于CN102525997B专利；CN102525997B专利公布的工艺需额外采用特殊设备挤出滚圆设备和流化床，本专利设备无需专用设备。And during CN102525997B patent, citicoline sodium pellets or granules were prepared by extrusion and spheronization process, and then the pellets or granules were coated to achieve the moisture-proof purpose. The two moisture-proof purposes are the same, but the advantage of this patent is that the process is simple, the production cycle is short, and the cost is lower than that of the CN102525997B patent; the process disclosed by the CN102525997B patent requires additional special equipment for extrusion spheronization equipment and a fluidized bed, and the patented equipment does not need special equipment.
发明内容Contents of the invention
发明目的：本发明提供一种含有胞磷胆碱钠的胶囊组合物及其制备方法。Purpose of the invention: the present invention provides a capsule composition containing citicoline sodium and a preparation method thereof.
技术方案：一种含有胞磷胆碱钠的胶囊组合物，所述的含有胞磷胆碱钠的胶囊组合物包括胞磷胆碱钠、乳糖、微晶纤维素Avicel PH102、微粉硅胶和硬脂酸镁，所述胞磷胆碱钠与乳糖的质量比为1：0.1-5，所述胞磷胆碱钠与微晶纤维素Avicel PH102的质量比为1：0.1-3，所述胞磷胆碱钠与微粉硅胶的质量比为5-50：1，所述胞磷胆碱钠与硬脂酸镁的质量比为10-100：1。Technical solution: a capsule composition containing citicoline sodium, said capsule composition containing citicoline sodium comprising citicoline sodium, lactose, microcrystalline cellulose Avicel PH102, micropowder silica gel and stearin Magnesium acid, the mass ratio of citicoline sodium to lactose is 1:0.1-5, the mass ratio of citicoline sodium to microcrystalline cellulose Avicel PH102 is 1:0.1-3, and the citicoline sodium The mass ratio of sodium choline to micronized silica gel is 5-50:1, and the mass ratio of citicoline sodium to magnesium stearate is 10-100:1.
一种根据所述的含有胞磷胆碱钠的胶囊组合物的制备方法，包括如下步骤：A preparation method according to the capsule composition containing citicoline sodium, comprising the steps of:
(1)过筛：取胞磷胆碱钠过60目筛；取乳糖和微晶纤维素Avicel PH102分别过60目筛；(1) Sieving: take citicoline sodium and pass through a 60-mesh sieve; take lactose and microcrystalline cellulose Avicel PH102 and pass through a 60-mesh sieve respectively;
(2)一次混合：称取处方量50％的胞磷胆碱钠加入多维混合机内，投入经过处理的乳糖和微晶纤维素Avicel PH102，混合速度为15～20rpm，混合时间为5～10min；将剩余的胞磷胆碱钠加入多维混合机内，继续混合15～20min；(2) One-time mixing: Weigh 50% of the prescription amount of citicoline sodium into the multidimensional mixer, put in the processed lactose and microcrystalline cellulose Avicel PH102, the mixing speed is 15-20rpm, and the mixing time is 5-10min ; Add the remaining citicoline sodium into the multidimensional mixer and continue mixing for 15-20 minutes;
(3)二次混合：加入处方量微粉硅胶混合均匀，混合速度15～20rpm，混合时间15～20min；(3) Secondary mixing: add the prescribed amount of micro-powder silica gel and mix evenly, the mixing speed is 15-20rpm, and the mixing time is 15-20min;
(4)三次混合：加入处方量硬脂酸镁混合均匀，混合速度20rpm，混合时间15min；(4) Mix three times: add the prescribed amount of magnesium stearate and mix evenly, the mixing speed is 20rpm, and the mixing time is 15min;
(5)灌装：测定颗粒含量，胶囊灌装，PVC/PVDC40涂层铝塑包装。(5) Filling: determination of particle content, capsule filling, PVC/PVDC40 coated aluminum-plastic packaging.
有益效果：本发明提供的胞磷胆碱钠胶囊组合物采用干粉混合的工艺，直接灌装胶囊，选用PVC/PVDC40涂层铝塑包装，能确保良好防潮功能和崩解时限，在长期24个月稳定性考察中，水分无明显增加，胶囊壳无变脆现象，产品稳定、储藏时间长。Beneficial effects: the citicoline sodium capsule composition provided by the present invention adopts the technology of dry powder mixing, directly fills the capsules, and uses PVC/PVDC40 coated aluminum-plastic packaging, which can ensure good moisture-proof function and disintegration time limit, and can be used for 24 hours in a long-term During the monthly stability inspection, there was no significant increase in moisture, no brittleness of the capsule shell, and the product was stable and had a long storage time.
具体实施方式detailed description
下面结合具体实施例对本发明进行详细阐述。The present invention will be described in detail below in conjunction with specific embodiments.
综述如下：一种含有胞磷胆碱钠的胶囊组合物，所述的含有胞磷胆碱钠的胶囊组合物包括胞磷胆碱钠、乳糖、微晶纤维素Avicel PH102、微粉硅胶和硬脂酸镁，所述胞磷胆碱钠与乳糖的质量比为1：0.1-5，所述胞磷胆碱钠与微晶纤维素Avicel PH102的质量比为1：0.1-3，所述胞磷胆碱钠与微粉硅胶的质量比为5-50：1，所述胞磷胆碱钠与硬脂酸镁的质量比为10-100：1。A summary is as follows: a capsule composition containing citicoline sodium, said capsule composition containing citicoline sodium comprising citicoline sodium, lactose, microcrystalline cellulose Avicel PH102, micronized silica gel and stearin Magnesium acid, the mass ratio of citicoline sodium to lactose is 1:0.1-5, the mass ratio of citicoline sodium to microcrystalline cellulose Avicel PH102 is 1:0.1-3, and the citicoline sodium The mass ratio of sodium choline to micronized silica gel is 5-50:1, and the mass ratio of citicoline sodium to magnesium stearate is 10-100:1.
一种根据所述的含有胞磷胆碱钠的胶囊组合物的制备方法，包括如下步骤：A preparation method according to the capsule composition containing citicoline sodium, comprising the steps of:
(1)过筛：取胞磷胆碱钠过60目筛；取乳糖和微晶纤维素Avicel PH102分别过60目筛；(1) Sieving: take citicoline sodium and pass through a 60-mesh sieve; take lactose and microcrystalline cellulose Avicel PH102 and pass through a 60-mesh sieve respectively;
(2)一次混合：称取处方量50％的胞磷胆碱钠加入多维混合机内，投入经过处理的乳糖和微晶纤维素Avicel PH102，混合速度为15～20rpm，混合时间为5～10min；将剩余的胞磷胆碱钠加入多维混合机内，继续混合15～20min；(2) One-time mixing: Weigh 50% of the prescription amount of citicoline sodium into the multidimensional mixer, put in the processed lactose and microcrystalline cellulose Avicel PH102, the mixing speed is 15-20rpm, and the mixing time is 5-10min ; Add the remaining citicoline sodium into the multidimensional mixer and continue mixing for 15-20 minutes;
(3)二次混合：加入处方量微粉硅胶混合均匀，混合速度15～20rpm，混合时间15～20min；(3) Secondary mixing: add the prescribed amount of micro-powder silica gel and mix evenly, the mixing speed is 15-20rpm, and the mixing time is 15-20min;
(4)三次混合：加入处方量硬脂酸镁混合均匀，混合速度20rpm，混合时间15min；(4) Mix three times: add the prescribed amount of magnesium stearate and mix evenly, the mixing speed is 20rpm, and the mixing time is 15min;
(5)灌装：测定颗粒含量，胶囊灌装，PVC/PVDC40涂层铝塑包装。(5) Filling: determination of particle content, capsule filling, PVC/PVDC40 coated aluminum-plastic packaging.
具体实施案例1：最佳Specific implementation case 1: best
胞磷胆碱钠胶囊的制备处方(以1000片计)：The preparation prescription of citicoline sodium capsule (in 1000 tablets):
制备过程：Preparation Process:
(1)取胞磷胆碱钠过60目筛；取乳糖和微晶纤维素Avicel PH102分别过60目筛。(1) Take citicoline sodium and pass through a 60-mesh sieve; take lactose and microcrystalline cellulose Avicel PH102 and pass through a 60-mesh sieve respectively.
(2)称取处方量50％的胞磷胆碱钠加入多维混合机内，投入经过处理的乳糖和微晶纤维素Avicel PH102，混合速度20rpm，混合时间5min；将剩余的胞磷胆碱钠加入多维混合机内，继续混合15min。(2) Take by weighing 50% of the prescription amount of citicoline sodium and add it into the multidimensional mixer, drop into the processed lactose and microcrystalline cellulose Avicel PH102, the mixing speed is 20rpm, and the mixing time is 5min; the remaining citicoline sodium Add it into the multidimensional mixer and continue mixing for 15 minutes.
(3)加入处方量微粉硅胶混合均匀，混合速度20rpm，混合时间15min。(3) Add the prescribed amount of micro-powder silica gel and mix evenly, the mixing speed is 20rpm, and the mixing time is 15min.
(4)加入处方量硬脂酸镁混合均匀，混合速度20rpm，混合时间15min。(4) Add the prescribed amount of magnesium stearate and mix well, the mixing speed is 20rpm, and the mixing time is 15min.
(5)测定颗粒含量。胶囊灌装，PVC/PVDC40涂层铝塑包装。(5) Determination of particle content. Capsule filling, PVC/PVDC40 coated aluminum-plastic packaging.
具体实施案例2：包材选择不合适Specific implementation case 2: Inappropriate selection of packaging materials
胞磷胆碱钠胶囊的制备处方(以1000片计)：The preparation prescription of citicoline sodium capsule (in 1000 tablets):
制备过程：Preparation Process:
(1)取胞磷胆碱钠过60目筛；取乳糖和微晶纤维素Avicel PH102分别过60目筛。(1) Take citicoline sodium and pass through a 60-mesh sieve; take lactose and microcrystalline cellulose Avicel PH102 and pass through a 60-mesh sieve respectively.
(2)称取处方量50％的胞磷胆碱钠加入多维混合机内，投入经过处理的乳糖和微晶纤维素Avicel PH102，混合速度20rpm，混合时间5min；将剩余的胞磷胆碱钠加入多维混合机内，继续混合15min。(2) Take by weighing 50% of the prescription amount of citicoline sodium and add it into the multidimensional mixer, drop into the processed lactose and microcrystalline cellulose Avicel PH102, the mixing speed is 20rpm, and the mixing time is 5min; the remaining citicoline sodium Add it into the multidimensional mixer and continue mixing for 15 minutes.
(3)加入处方量微粉硅胶混合均匀，混合速度20rpm，混合时间15min。(3) Add the prescribed amount of micro-powder silica gel and mix evenly, the mixing speed is 20rpm, and the mixing time is 15min.
(4)加入处方量硬脂酸镁混合均匀，混合速度20rpm，混合时间15min。(4) Add the prescribed amount of magnesium stearate and mix well, the mixing speed is 20rpm, and the mixing time is 15min.
(5)测定颗粒含量。胶囊灌装，PVC涂层铝塑包装。(5) Determination of particle content. Capsule filling, PVC coated aluminum plastic packaging.
具体实施案例3：湿法制粒工艺Specific implementation case 3: Wet granulation process
胞磷胆碱钠胶囊的制备处方(以1000片计)：The preparation prescription of citicoline sodium capsule (in 1000 tablets):
制备过程：Preparation Process:
(1)取胞磷胆碱钠粉碎过60目筛；取预胶化淀粉、微晶纤维素和羧甲基淀粉钠，分别过60目筛，备用。(1) Take citicoline sodium and grind it through a 60-mesh sieve; take pregelatinized starch, microcrystalline cellulose and sodium carboxymethyl starch, pass it through a 60-mesh sieve respectively, and set aside.
(2)将处方量胞磷胆碱钠与预胶化淀粉、微晶纤维素和羧甲基淀粉钠置湿法制粒机中混匀，搅拌速率不低于40Hz，混合时间不低于5min；配制8％PVP K30水溶液用于湿法制粒，边加浆液边开启搅拌，搅拌速率30～35Hz，浆液在30秒内加入湿法制粒机锅内；同时开启制粒转子，调节制粒转速30Hz～32Hz，继续制粒220秒～250秒。用18目筛将湿颗粒整粒，95℃-105℃干燥将水分控制在5％以内。用20目筛将干颗粒整粒，根据干颗粒重量加入处方量折算后硬脂酸镁量，于二维混合机中混合均匀15min。(2) Mix the prescription amount of citicoline sodium with pregelatinized starch, microcrystalline cellulose and sodium carboxymethyl starch in a wet granulator, the stirring speed is not lower than 40Hz, and the mixing time is not lower than 5min; Prepare 8% PVP K30 aqueous solution for wet granulation, start stirring while adding slurry, the stirring rate is 30-35Hz, and add the slurry into the pot of the wet granulator within 30 seconds; at the same time, open the granulation rotor and adjust the granulation speed to 30Hz～ 32Hz, continue to granulate for 220 seconds to 250 seconds. Sizing the wet granules with 18-mesh sieve and drying at 95°C-105°C to control the moisture within 5%. The dry granules were sized with a 20-mesh sieve, and the amount of magnesium stearate converted from the prescription amount was added according to the weight of the dry granules, and mixed uniformly in a two-dimensional mixer for 15 minutes.
(3)测定颗粒含量。胶囊灌装，PVC/PVDC40涂层铝塑包装。(3) Determination of particle content. Capsule filling, PVC/PVDC40 coated aluminum-plastic packaging.
具体实施案例1各项性能表Specific implementation case 1 performance table
具体实施案例2各项性能表Specific implementation case 2 various performance tables
具体实施案例3各项性能表Specific implementation case 3 various performance tables
通过上述3组具体实施案例各项性能表的对比，可得出如下结论：Through the comparison of the performance tables of the above three groups of specific implementation cases, the following conclusions can be drawn:
1、具体实施案例1只有选对合理的赋形剂种类用量和包装材料，才能制备出质量可靠、成本低廉的产品供应患者。1. Specific implementation case 1 Only by choosing a reasonable amount of excipients and packaging materials can products with reliable quality and low cost be prepared and supplied to patients.
2、具体实施案例2选择不合适的包材，导致长期放置过程中吸潮，水分增加，囊壳变脆，产品质量亦有所下降。2. Specific implementation case 2. The selection of inappropriate packaging materials will lead to moisture absorption during long-term storage, increased moisture, brittle capsule shells, and a decline in product quality.
3、具体实施案例3中选用常规的湿法制粒，产品质量劣于具体实施案例1。3. In the specific implementation case 3, the conventional wet granulation method is used, and the product quality is inferior to that of the specific implementation case 1.
本发明不局限于上述最佳实施方式，任何人在本发明的启示下都可得出其他各种形式的产品，但不论在其形状或结构上作任何变化，凡是具有与本申请相同或相近似的技术方案，均落在本发明的保护范围之内。The present invention is not limited to the above-mentioned best implementation mode, anyone can draw other various forms of products under the inspiration of the present invention, but no matter make any changes in its shape or structure, all those with the same or similar features as the present application Approximate technical solutions all fall within the protection scope of the present invention.
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