CN1774179A - Multi-vitamin and mineral supplement for pregnant women - Google Patents

Multi-vitamin and mineral supplement for pregnant women Download PDF

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Publication number
CN1774179A
CN1774179A CNA2004800101967A CN200480010196A CN1774179A CN 1774179 A CN1774179 A CN 1774179A CN A2004800101967 A CNA2004800101967 A CN A2004800101967A CN 200480010196 A CN200480010196 A CN 200480010196A CN 1774179 A CN1774179 A CN 1774179A
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vitamin
medicinal
milligrams
cobastab
edible composition
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费比奥·索尔达蒂
拉腊·安布罗塞蒂-朱迪西
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Boehringer Ingelheim International GmbH
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/04Sulfur, selenium or tellurium; Compounds thereof
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12Fatty acids or derivatives thereof
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15Vitamins
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15Vitamins
    • A23L33/155Vitamins A or D
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16Inorganic salts, minerals or trace elements
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/32Manganese; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/34Copper; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Polymers & Plastics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Mycology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Obesity (AREA)
  • Pediatric Medicine (AREA)
  • Diabetes (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The invention relates to pharmaceutical or dietary unit dosage form, which can be swallowed easily, consisting essentially of vitamins, minerals and trace elements recommended for consumption by pregnant women, lactating women or women of childbearing potential that are attempting to become pregnant, DHA and a pharmaceutically or dietetically suitable carrier.

Description

Multivitamin that pregnant women is used and mineral supplement
Invention field
The invention relates to a kind of medicinal or edible unit dosage forms preparation, it is easy to swallow, and is made up of vitamin, mineral matter and trace element, DHA and the suitable medicinal or edible carrier of recommending pregnant woman, nursing women or want conceived women to use by fecundity basically.
Background technology
Vitamin and mineral preparations generally are the usefulness that is used for the treatment of specific medical conditions or the general nutriment of conduct.Recently the important physiological action that vitamin and mineral matter are brought into play has been illustrated in research, and established that these nutritional labelings lack or not enough and some disease cause of disease of the mankind between existing correlation, for example referring to, Diplock, " Antioxidant Nutrients and Disease Prevention:AnOverview; " Am.J.Clin.Nutr., 53:189-193 (1991); Documenta Geigy ScientificTables, 457-497, (Diem and Cemtuer eds., 7th ed., 1975).
Confirmed further that different crowd needs different amounts and dissimilar vitamin and mineral matters, with prevention or palliate a disease and keep the normal health state.For example, people know that the pregnant woman generally need be with the iron therapy with prevention or treatment hypoferric anemia.Many in the past patents are devoted to improve the effect of period of gestation with the iron complementary goods.For example, US 4,994, and 283 have disclosed and comprise with citrate or tartrate, ascorbate and fructose and unite the iron of use and the trophism mineral supplement of calcium compound.It is said that these compositions can weaken the tendency of calcium to the bioavilability inhibition of iron, so uniting of these two kinds of mineral matters improved bioavilability.
US 4,431, and 634 owing to maintain 300 or be less than 300 milligrams and magnesium compound amount 75 or be less than 75 milligrams with calcium compound amount in the iron in prenatal iron of per unit formulation, and make the bioavilability of iron in this iron in prenatal iron reach maximum.
US 4,752, and 479 find the another kind of solution of same problem, wherein provide multivitamin and mineral matter dietary supplement, and it comprises (a) one or more divalence dietary minerals compositions (as calcium or magnesium); And (b) the available ferrous components of a kind of biology, it is to exist and can discharge at intestines and stomach in a controlled manner with the controlled release form.
US 4,710, and 387 announcements are a kind of to be the nutritional supplementation preparation that pregnant woman and nursing women use, its contained albumen weight ratio is 10-20%, fat weight ratio is 16-28%, and the carbon compound weight ratio is 43-65%, and moisture, mineral matter, trace element and vitamin weight ratio mostly are 3.5% most.This patent is not pointed out DHA, and also not mentioning this complementary goods is capsule or the tablet of easily swallowing.
International Patent Application WO 99/53777 disclose water-based beverage that a kind of pregnant women or nursing women use or cereal be pressed into piece alimentation composition, it comprises non-milk protein source, dietary fiber, comprises polyunsaturated fatty acid source, mineral matter and the vitamin of DHA.Not disclosing said composition is a kind of capsule or tablet, dripping pill or lozenge.
The alimentation composition that International Patent Application WO 00/66133 discloses before a kind of pregnancy and period of gestation is used, it comprises a certain amount of Cobastab 6, folic acid, magnesium and calcium optionally and DHA.With the exception of this, wherein the composition of all announcements all contains the calcium of extra a large amount, therefore causes the formulation volume relatively large, is difficult to swallow.
International application WO 01/87070 discloses a kind of nutriment that comprises vitamin and minerals and comprise the powdery fish oil particle of eicosapentaenoic acid (EPA) and DHA.Therefore and wherein the composition of all announcements all contains the calcium of a large amount, and what cause containing about 20 milligrams of DHA is a kind of 1000 milligrams or formulation of volume more, and its volume is difficult to swallow, and the weight ratio that contains DHA has only 2%.
The food that is pressed into piece that U.S. Patent application US 2002/0102330A1 provides the pregnant woman to use, it contains one or more vitamins and/or mineral matter, and the preparation of one or more anti-constipation and maintenance defecation rule, and it can contain DHA in addition.
U.S. patent application case US 2003/0050341A1 has disclosed a kind of composition that is used for replenishing diet, and it comprises and is higher than 100 milligrams DHA.Yet, do not disclose said composition and contain trace element chromium, copper, molybdenum and selenium.And all compositions all disclose the calcium that wherein contains extra a large amount, and cause the formulation volume relatively large, are difficult to swallow.
Although before making great efforts to improve vitamin and the mineral supplement that the pregnant woman uses, yet traditional antenatal complementary goods shows several shortcomings always.Significant problem is to make the formulation volume become bigger owing to the calcium of a large amount and the vitamin of relative a large amount, is difficult to swallow, especially for the pregnant woman.
Morning sickness generally can cause poor appetite and the sense of feeling sick, and quite a lot of pregnant woman all has experience.Because they experienced morning sickness, and because contain the pill of antenatal vitamin that high dose recommend to use and mineral matter and/or be pressed into the food of piece, general volume is bigger, many pregnant woman often be unwilling to swallow so antenatal vitamin and mineral matter pill or be pressed into the food of piece.And, during they take these pills or are pressed into the food of piece, often do not continue to use them because of being difficult to swallow.Therefore, with patient's compliance (taking vitamin and mineral supplement every day), keep or improve pregnant woman health, and emerge in an endless stream with the vitamin of normal fetus developmental phase pass and the problem of mineral matter uptake.
In addition, during the morning sickness, compare with the edible food that is pressed into piece, the pregnant woman more is ready swallowable capsule, pill or tablet.Owing to need chew the food that is pressed into piece and could take in; And the women feels to have a kind of taste when chewing the food that is pressed into piece, and this usually can be to nauseating the having a negative impact that is caused by morning sickness.
The morning sickness generally first trimester occurrence frequency in pregnancy is the highest.The defective (spina bifida) of growing fetal neural tube also takes place at the first trimester of pregnancy, and for example gestation first month women does not recognize during oneself progestational this section as yet.These defectives are known relevant with the folic acid insufficiency of intake.As everyone knows, folic acid can prevent NTD.Therefore, the women of child-bearing age should take in the folic acid of capacity.Folic acid also demonstrates has useful effect to heart, and can reduce the danger of dysplasia of cervix.
In addition, up to the present, vitamin that existing pregnant women uses and mineral preparations do not provide any active component that promotes that fetal brain and vision health are grown.
Therefore wishing to provide a kind of antenatal multivitamin and mineral supplement that can overcome above-mentioned prior art deficiency.
Summary of the invention
Be surprised to find a kind of being easy at present and swallowed, the medicinal or edible composition that is fit to capsule that medicinal or edible carriers form or tablet, dripping pill or lozenge form by the mineral matter of (a) one or more vitamins, (b) one or more chosen from Fe, zinc and magnesium, (c) one or more trace element, (d) DHA, (e) that are selected from chromium, copper, iodine, molybdenum and selenium has overcome the known multivitamin that above-mentioned pregnant woman uses and the shortcoming of mineral supplement basically.
Therefore, the invention relates to the medicinal or edible composition of a kind of capsule or tablet, dripping pill or lozenge form, it is easy to swallow, basically by the mineral matter of (a) one or more vitamins, (b) one or more chosen from Fe, zinc, magnesium, (c) one or more be selected from chromium, copper, iodine, molybdenum and selenium trace element, (d) DHA, and (e) be fit to medicinal or edible carrier and formed.
With the exception of this, the invention relates to a kind of additional pregnant woman, nursing women or have fecundity to want the method for conceived women's diet desired nutritional, this method comprises this medicinal or edible composition of taking the diet magnitude of recruitment to these women.
And, the invention relates to this application medicinal or edible composition, be used to prepare and replenish pregnant woman, nursing women or have fecundity to want the medicinal or edible composition of conceived women's diet desired nutritional.
Below by to the preferred embodiment for the present invention be described in detail and embodiment can be more readily understood the present invention.
Here used " Pharmaceutical composition " this term is meant so a kind of composition, and it meets prescription and the requirement of OTC medicament, and its can from doctor acquisition in the herbal medicine shop or pharmacy just available.
Here used " edible composition " this term is meant so a kind of composition, it replenishes regular diet with the additional nutrient key element and improves quality of the life, and said composition can be in the shop or the supermarket freely buy and need not prescription, be not only just available in pharmacy.
This medicinal or edible composition can be mixed with capsule, tablet, dripping pill or lozenge form, is preferably soft shell capsule or tablet.
The composition that the present invention contains vitamin (a), mineral matter (b), trace element (c) and the DHA (d) of pre-selected amount preferably wraps into it in soft gelatin capsule that contains ox-hide matter, pigskin matter, plant and succinyl group gelatin shell.Preferably, this soft gelatin shell is transparent basically, can increase the exterior quality of capsule thus.Soft gelatin shell of the present invention in principle comprises following neccessary composition and inessential composition.
Gelatin is the neccessary composition of soft gelatin shell of the present invention.The gelatin raw material of producing soft capsule is to obtain after collagen-based materials (as skin, white connective tissue or the animal skeleton) partial hydrolysis.Gelatin materials can be divided into category-A gelatin (it is obtained by the acid treatment pigskin, and isoelectric point is between pH 7 and 9) and category-B gelatin (it is that alkali treatment bone and animal (ox) skin obtain, and isoelectric point is between pH value 4.7 and 5.2).With the category-A gelatin with can be used to produce a kind of gelatin of necessary viscosity and breaking down intensity (bloom strength) characteristic when having capsule manufacture after the category-B gelatin mixes.The gelatin that is suitable for producing capsule can be available from sigma (Sigma) chemical company, St. Louis, Montana State.See the Pharmaceuticai Sciences of Remington ' s about the summary of gelatin and gelatin-based capsules, 16th ed., MackPublishing Company, Easton, Pa. (1980), 1245 pages and 1576-1582 page or leaf; Reach people such as Borkan, the US 4,935,243 that announce July 19 nineteen ninety; These two pieces of lists of references quote in full at this.
The soft gelatin shell of the capsule of the present invention of initial preparation comprises about 20% to about 60% gelatin, and preferred about 25% to about 50% gelatin, and most preferably from about 40% to about 50% gelatin.This gelatin can be that category-A can also be a category-B, or the mixture of the two, between its breaking down intensity (bloom strength) number range about 60 to about 300.
Plasticizer is an another kind of composition in the soft gelatin shell of the present invention.One or more plasticizer can be added in the production soft gelatin shell.The soft gelatin that obtains like this has as the essential flexible nature of envelope wafer.The present invention can with plasticizer comprise glycerine, sorbitan, D-sorbite, or similar low molecular weight polyols, and composition thereof.
The shell of the present invention of initial preparation generally comprises about 10% to about 35% plasticizer, and preferred person about 10% is to about 25% plasticizer, and most preferably from about 10% to about 20% plasticizer.Being applied to preferred plasticizer of the present invention is glycerine.
Soft gelatin shell of the present invention also comprises water.If there is not bound by theory, water dissolves fast when being considered to help soft gelatin shell to touch in the body gastro-intestinal Fluid or breaks.
The shell of the present invention of initial preparation generally comprises about 15% to about 50% water, and more preferably from about 25% to about 40% water, most preferably from about 30% to 40% water.
Other inessential compositions that can add this soft capsule shell comprise colouring agent, flavor enhancement, anticorrisive agent, antioxidant, the essence pigment of coloured coating, and other make the more beautiful composition of outward appearance.
The present composition can be enclosed in any traditional soft gelatin shell that still can contain said composition in the quite a while basically.Preparing soft gelatin shell of the present invention need merge an amount of gelatin, water, plasticizer and any inessential composition, and it is put in the suitable vessel, mixes and is heated to about 65 ℃ when shaking and/or stirring, until obtaining a kind of homogeneous solution.The application standard encapsulating method is sealed the filling component of aequum with this soft gelatin shell preparation then, thereby produces the soft gelatin capsule of a sealing.This gelatine capsule can be made into predetermined shape of being convenient to swallow and size.Soft gelatin capsule size of the present invention is suitable for swallowing, and typical capsule contains has an appointment 100 milligrams to about 2000 milligrams active compound.People such as P.K.Wilkinson are seen in the description of soft gelatin capsule and encapsulating method, " Softgels:Manufacturing Considerations ", Drugs and the PharmaceuticalSciences, 41 (certain drug transfer systems), P.Tyle, Ed. (Marcel Dekker Inc., New York, 1990) pp.409-449; People such as F.S.Horn, " Capsules, Soft ", Encyclopedia ofPharmaceutical Technology, vol.2, J.Swarbrick and J.C.Boylan, eds. (MarcelDekker Inc., New York, 1990) pp.269-284; People such as M.S.Patel, " Advances inSoftgel Formulation Technology ", Manufacturing Chemist, vol.60, no.7, pp.26-28 (in July, 1989); People such as M.S.Patel, " Softgel Technology ", ManufacturingChemist, vol.60, no.8, pp.47-49 (in August, 1989); R.F.Jimerson, " Softgel (SoftGelatin Capsule) Update ", Drug Development and Industrial (Interphex ' 86 meetings), vol.12, no.8 ﹠amp; 9, pp.1133-1144 (1986); And W.R.Ebert, " Soft ElasticGelatin Capsules:A Unique Dosage Form ", Pharmaceutical Technology, vol.1, no.5, pp.44-50 (1977); These documents are introduced among the application as a reference in full.The soft gelatin capsule water soluble and the gastro-intestinal Fluid of gained.When swallowable capsule, this gelatin shell can be dissolved or break in intestines and stomach at once, therefore its pharmacologically active can be caused physiological system from liquid core.
This capsule is preferably ellipse, so that swallow.Contain at a capsule under the situation of 300 to 700 milligrams of associativity active components, an oval capsule is about 10-28 millimeters long (preferred 20-26 millimeter, particularly about 25 millimeters), and diameter is about 5 to 11 millimeters (preferred 6-10 millimeters, particularly 8-9 millimeter).
Tablet of the present invention generally contains the medicinal or edible acceptable excipient that at least a tradition is used for this technology solid dosage.
The appropriate excipients that can add comprises lubricant (for example dolomol and stearic acid); Disintegrant (for example fiber is a derivative); Starch; Binder (as modified starch, polyvinylpyrrolidone and cellulose derivative); Slip agents (for example colloid silicon); Compression aid (for example cellulose derivative); Reach and the anticorrisive agent, suspending agent, wetting agent, flavor enhancement, swelling agent, binder, colouring agent, the sweetener that are suitable for moulding.
When composition was tablet, said composition still can comprise film coating, for example hydroxypropyl methylcellulose (HPMC).Although also can use non-transparent film dressing (can by thin film coating material and nontransparent dose or pigment such as titanium dioxide, color lake or dye combinations are obtained), yet only film coating still is the transparent membrane dressing.Advantageously, the variable color that has been found that when the inclusion body of non-transparent film dressing can be with long preservation tablet that may the variable color degree that minimizes.Colouring agent added in the tablet cores also can avoid variable color.If purpose is to wish attractive in appearance and/or wish that it helps to swallow, then to make film coating tablet comparatively suitable for this tablet.
Active component that adds and the mixed with excipients in the tablet cores, and with suitable tablet press machine compressing tablet.
Required compression force depended on the shape and the size of used stamping tool when production had suitable resistance to fracture and the tablet of the pressurized time that requires thereof.The scope of compression force serves as preferred with 2-20 thousand newton.Higher compression forces may cause active material in the tablet (i) extremely (iv) to postpone to disengage.Low compression force may be produced the unsettled tablet of mechanical property.Tablet cores can have difformity; Preferred shape is circular biplane or biconvex and oval or ellipse.
Film forming agent mixed in water with coloured material and plasticizer can prepare coating solution.Using a suitable coating pan is coated to the solution of coating membrane on the tablet cores.
For ease of swallowing, tablet appearance is preferably ellipse.In the film coating tablet that contains 300-700 milligram associativity active component, oval tablet is about the 10-20 millimeter, wide about 5-10 millimeter.
Because the oily characteristic of DHA, the amount of the contained DHA of tablet (d) is lower than capsule according to the present invention usually.
But pregnant women, nursing women or the various vitamins, mineral matter and the trace element that have fecundity to want conceived women to use safely also can various dose be applied in the formulation of the present invention.These vitamins, mineral matter and trace element comprise, for example, and vitamin A or beta carotene, Cobastab 1(as thiamine or single nitric acid thiamines), Cobastab 2(as riboflavin), Cobastab 3(as nicotinic acid), Cobastab 6(as pyridoxine or pyridoxine hydrochloride), Cobastab 9(as folic acid), Cobastab 12(as cyanocobalamin), biotin (biotin), vitamin C (ascorbic acid), vitamin D, vitamin E (as d1-α-tocopherol acetate), vitamin K, folic acid, niacinamide, iron (as Ferrous Fumarate), phosphorus, pantothenic acid (as calcium pantothenate), iodine (as KI), magnesium (as magnesia), zinc (as zinc oxide), selenium (as sodium selenate), copper (as cupric oxide), manganese (as manganese sulfate), chromium (as chromium chloride), molybdenum (as sodium molybdate), choline, fluoride, chloride, potassium, sodium and composition thereof.These vitamins, mineral matter and trace element can be available from sources well known by persons skilled in the art, such as Hoffmann-LaRoche Inc. (Nutley, N.J.).
Preferably, the present composition contains at least a beta carotene, the Cobastab of being selected from 1, Cobastab 2, Cobastab 6, Cobastab 12, vitamin C, vitamin D 3, vitamin E, folic acid, biotin and niacinamide vitamin, concrete multivitamin mixture is by beta carotene, Cobastab in this class formulation 1, Cobastab 2, Cobastab 6, Cobastab 12, vitamin C, vitamin D 3, vitamin E, folic acid, biotin and niacinamide form.
Preferably, DHA (d) and at least a vitamin D that is selected from 3With the weight ratio of the vitamin of biotin be 500: 1 to 100,000: 1, be preferably 3,000: 1 to 30,000: 1.
Preferably so in addition a kind of composition, i.e. wherein folic acid and Cobastab 6Weight ratio be 1: 1 to 1: 8, be preferably 1: 1.5 to 1: 7.5, particularly about 1: 3.
Also preferred in addition so a kind of composition, promptly wherein the weight ratio of iron and magnesium is 10: 1 to 1: 2, especially 5: 1 to 1: 1, most preferably is about 2.7: 1.
The present composition contains the mineral matter of at least two kinds of chosen from Fe, zinc and magnesium, and at least two kinds of trace elements that are selected from chromium, copper, iodine, molybdenum and selenium, preferred compositions comprises molybdenum and/or selenium at least, especially for containing the mineral matter be made up of iron, zinc, magnesium, chromium, copper, iodine, molybdenum and selenium and the composition of trace element mixture.
Contain and recommend pregnant woman, nursing women and have fecundity to want use and the thing that is pre-mixed that contains vitamin and mineral matter that be used for production formulation of the present invention of conceived women, can be available from the Watson Foods Co. of Watson CodeWT-6061A branch company, Inc.
With above-mentioned any medicinal vitamin and/or mineral matter (comprising its salt) preparation formulation of the present invention of accepting form well-known to those skilled in the art, for example, useful medicinal acceptable magnesium compound comprises dolomol, magnesium carbonate, magnesia, magnesium hydroxide and magnesium sulfate.Medicinal acceptable iron compound comprises any known ferrous iron (ferrous) or ferric iron (positive iron) fill-in,, ferrous lactate ferrous such as ferrous sulfate, iron chloride, glucose, ferrous tartrate, saccharide carboxylic acids iron complexes, Ferrous Fumarate, ferrous succinate, GLU are ferrous, ferrous citrate, ferrous pyrophosphate, ferrous, the ferrous carbonate of choline citrate, and analog.
Preparing used vitamin of formulation of the present invention and/or mineral matter can make microcapsules in the coating of grease, micro-crystalline cellulose or similar material, under multiple situation degradation takes place to prevent it.
Vitamin that formulation of the present invention is used and/or mineral matter are vitamin and/or the mineral matters of recommending pregnant woman, nursing women or having fecundity to want conceived women to use.The consumption of these vitamins and mineral matter be for can effectively increase pregnant woman, nursing women or to have fecundity to want the amount of pregnant woman's nutrition, or increase grow in fetus or brephotrophic amount.This consumption can change according to selected concrete vitamin and/or mineral matter, but usually excursion be account for the formulation gross weight about 25% to about 95% weight, be preferably about 30% to about 90% weight, most preferably from about 80% weight.
Every kind of formulation can contain one or more above-mentioned vitamins, mineral matter and/or trace element, its content is for to pregnant woman, nursing women or to have fecundity to want conceived women be safe any amount (that is this content can to the women of the food of edible this class formulation or it grows fetus or breast-fed babies work the mischief).Set forth hereinafter pregnant women, nursing women or fecundity is arranged and want the approximate preferable range (from a kind of dosage to another kind of dosage) of various vitamins that conceived women uses and mineral matter consumption every day and preferable range and optimum amount.These consumptions generally are to use a kind of formulation (or using more than one formulations in a day).
Every kind of most preferred dosage form of the present invention is to contain one or more above-mentioned vitamins, mineral matter and/or trace element, and its content is equivalent to the pregnant woman and advises that using dosage approximately absolutely every day.
DHA (DHA) is a kind of children's brain and the necessary LCFA of eye development, it is contained in pregnant women, nursing women in the formulation of the present invention or has fecundity to want content range about 10 that conceived women uses to about 300 milligrams, preferred about 100 to 200 milligrams, most preferably from about 150 milligrams.
Many kind fat and grease can be used as the carrier of DHA.These fat or grease comprise for example olive oil, rapeseed oil, palm oil, coconut oil, sunflower oil, peanut oil, vegetable oil, lecithin, fish oil, cotton seed oil, soybean oil, lard, glyceryl monoacetate, diglyceride, butter, margarine, with other animals, plant and ocean grease, reach butterfat, wax (such as beeswax), these fat or grease and composition thereof can be available from sources well known by persons skilled in the art.Vegetable oil is the preferred grease of food that the present invention is used to be pressed into piece.
The particularly preferred formulation of the present invention is to be grouped into by following one-tenth basically:
(a) by beta carotene, Cobastab 1, Cobastab 2, Cobastab 6, Cobastab 12, vitamin C, vitamin D 3, the multivitamin mixture formed of vitamin E, folic acid, biotin and niacinamide;
(b) mineral mixture of forming by iron, zinc and magnesium;
(c) mixture of the trace element of forming by chromium, copper, iodine, molybdenum and selenium;
(d) DHA; And
(e) be fit to medicinal or edible carrier.
Preferred formulation is to be grouped into by following one-tenth basically according to the present invention:
(a) 100 to 160 milligrams by beta carotene, Cobastab 1, Cobastab 2, Cobastab 6, Cobastab 12, vitamin C, vitamin D 3, the multivitamin mixture formed of vitamin E, folic acid, biotin and niacinamide;
(b) 60 to 120 milligrams of mineral mixtures of forming by iron, zinc and magnesium;
(c) trace element mixture formed by chromium, copper, iodine, molybdenum and selenium of 100 to 1500 micrograms;
(d) 100 to 200 milligrams DHA; And
(e) be fit to medicinal or edible carrier.
Most preferred formulation is to be grouped into by following one-tenth basically according to the present invention:
(a) by 1.5 to 2.5 milligrams of beta carotenes, 1.0 to 1.8 milligrams of Cobastabs 1, 1.0 to 1.8 milligrams of Cobastabs 2, 1.5 to 2.5 milligrams of Cobastabs 6, 1.0 to 5.0 microgram Cobastabs 12, 60 to 110 milligrams of vitamin Cs, 2.0 to 200 micrograms, particularly 2.5 to 10 microgram vitamin Ds 3, 15 to 30 milligrams of vitamin E, 200 to 1000 microgram folic acid, 10 to 100 microgram biotins and 10 to 40 milligrams of multivitamin mixtures that niacinamide is formed;
(b) by 10 to 50 milligrams of iron, 5 to 20 milligrams of zinc and 1 to 100 milligram of mineral mixture that magnesium is formed;
(c) by 10 to 50 microgram chromium, 0.5 to 1.5 milligram of trace element mixture that copper, 50 to 500 microgram iodine, 10 to 100 microgram molybdenums and 10 to 100 microgram selenium are formed;
(d) 100 to 200 milligrams, particularly about 150 milligrams DHA; And
(e) be fit to medicinal or edible carrier.
The most preferably weight of active component in the unit dosage forms of thing combined according to the invention (a) to (d) is 150 to 700 milligrams, particularly 200 to 600 milligrams, and most preferably from about 300 to 400 milligrams.
Preferably take a unit dosage forms of the present composition every day.
Embodiment
Following examples are more specifically described the preparation process of formulation of the present invention.These embodiment just are illustrated in greater detail, rather than are used for limiting the present invention.
Embodiment 1
Soft capsule
Preparation contains the soft capsule of following active ingredients:
Composition Effective content/capsule
Active componentBeta carotene is as 30% suspending agent single nitric acid thiamines (Cobastab 1) riboflavin (Cobastab 2) pyridoxine hydrochloride (Cobastab 6) Cobastab 12As contain 0.1% Cobastab of sweet mellow wine 12Ascorbic acid (vitamin C) cholecalciferol (vitamin D 3) d; Plain niacinamide (nicotinic acid, the nicotinic acid) chromium of 1-α-tocopherol acetate (vitamin E) folic acid biological such as chromium chloride hexahydrate copper such as anhydrous cupric sulfate (II) iron such as fumaric acid iron iodine 2.8 27.0 milligrams of 82.14 milligrams of 200 micrograms of milligram 9.338 milligrams of 1.75 milligrams 1.68 milligrams 2.09 milligrams 3.25 milligrams of 114.75 milligrams of 5.75 micrograms of 3.25 micrograms (230 international unit), 24.59 milligram of 720 microgram, 31.5 micrograms, 18.9 milligram of 30 microgram, 153.6 microgram 1000 micrograms, 2512 micrograms
Such as KI molybdenum such as sodium molybdate dihydrate selenium such as anhydrous sodium sodium selenate zinc such as zinc sulfate monohydrate magnesium such as anhydrous magnesium sulfate DHA such as 50%DHA oil 261.6 11 milligrams 30.25 milligrams 10 milligrams 71.0 milligrams 150 milligrams 300 milligrams of microgram 50 micrograms 126.1 micrograms 60 micrograms 133.2 micrograms
Mix these compositions and also enclose in the capsule of making by gelatin, water and plasticizer, have the oval soft gelatin capsule of following size with formation:
Diameter: 7 to 11 millimeters, be preferably 8 to 9 millimeters;
Length: 21 to 26 millimeters, be preferably about 25 millimeters.

Claims (15)

1. the medicinal or edible composition of a capsule that is easy to swallow or tablet, dripping pill or lozenge form, by the mineral matter of (a) one or more vitamins, (b) one or more chosen from Fe, zinc and magnesium, (c) one or more be selected from chromium, copper, iodine, molybdenum and selenium trace element, (d) DHA, and (e) be fit to medicinal or edible carrier and formed.
2. according to the medicinal or edible composition of claim 1, wherein vitamin (a) is selected from beta carotene, Cobastab 1, Cobastab 2, Cobastab 6, Cobastab 12, vitamin C, vitamin D 3, vitamin E, folic acid, biotin and niacinamide.
3. according to the medicinal or edible composition of claim 1 or 2, wherein DHA (d) and at least a vitamin D that is selected from 3With the weight ratio of the vitamin (a) of biotin be 500: 1 to 100,000: 1.
4. according to the medicinal or edible composition of the arbitrary claim in front, wherein folic acid and Cobastab 6Weight ratio be 1: 1 to 1: 8.
5. according to the medicinal or edible composition of the arbitrary claim in front, wherein the weight ratio of iron and magnesium is 10: 1 to 1: 2.
6. according to the medicinal or edible composition of the arbitrary claim in front, wherein DHA (d) and at least a weight ratio that is selected from the trace element (c) of chromium, molybdenum and selenium be 500: 1 to 20,000: 1.
7. according to the medicinal or edible composition of the arbitrary claim in front, it is grouped into by following one-tenth basically:
(a) by beta carotene, Cobastab 1, Cobastab 2, Cobastab 6, Cobastab 12, vitamin C, vitamin D 3, the multivitamin mixture formed of vitamin E, folic acid, biotin and niacinamide;
(b) mineral mixture of forming by iron, zinc and magnesium;
(c) trace element mixture of forming by chromium, copper, iodine, molybdenum and selenium;
(d) DHA; And
(e) be fit to medicinal or edible carrier.
8. according to the medicinal or edible composition of the arbitrary claim in front, wherein the weight of active component (a) to (d) is 150 to 700 milligrams in the unit dosage forms.
9. according to the medicinal or edible composition of the arbitrary claim in front, be grouped into by following one-tenth basically:
(a) 100 to 160 milligrams by beta carotene, Cobastab 1, Cobastab 2, Cobastab 6, Cobastab 12, vitamin C, vitamin D 3, the multivitamin mixture formed of vitamin E, folic acid, biotin and niacinamide;
(b) 60 to 120 milligrams of mineral mixtures of forming by iron, zinc and magnesium;
(c) trace element mixture formed by chromium, copper, iodine, molybdenum and selenium of 100 to 5000 micrograms;
(d) 100 to 200 milligrams DHA; And
(e) be fit to medicinal or edible carrier.
10. according to the medicinal or edible composition of the arbitrary claim in front, it is to be grouped into by following one-tenth basically:
(a) by 1.5 to 3.5 milligrams of beta carotenes, 1.0 to 1.8 milligrams of Cobastabs 1, 1.0 to 1.8 milligrams of Cobastabs 2, 1.5 to 2.5 milligrams of Cobastabs 6, 1.0 to 5.0 microgram Cobastabs 12, 60 to 150 milligrams of vitamin Cs, 2.0 to 200 microgram vitamin Ds 3, 15 to 30 milligrams of vitamin E, 200 to 1000 microgram folic acid, 10 to 100 microgram biotins and 10 to 40 milligrams of multivitamin mixtures that niacinamide is formed;
(b) by 10 to 50 milligrams of iron, 5 to 20 milligrams of zinc and 1 to 100 milligram of mineral mixture that magnesium is formed;
(c) by 10 to 50 microgram chromium, 0.5 to 1.5 milligram of trace element mixture that copper, 50 to 500 microgram iodine, 10 to 100 microgram molybdenums and 10 to 100 microgram selenium are formed;
(d) 100 to 200 milligrams of DHA; And
(e) be fit to medicinal or edible carrier.
11. according to the medicinal or edible composition of the arbitrary claim in front, it is the oval gelatine capsule form with following size:
Diameter: 7 to 11 millimeters; And
Length: 21 to 26 millimeters.
12. pregnant woman, women breast-feeding their children or have fecundity to want the compensation process of the conceived daily desired nutritional of women, described method comprises the medicinal or edible composition of taking the arbitrary claim in front of diet magnitude of recruitment to this women.
13., wherein give the medicinal or edible composition that has this women who needs to take a unit dosage forms every day according to claim 1-11 according to the method for claim 12.
14. the purposes according to the medicinal or edible composition of arbitrary claim among the 1-11 of front is used to be prepared as and replenishes pregnant woman, women breast-feeding their children or have fecundity to want the preparation of the medicinal or edible unit dosage forms of the conceived daily desired nutritional of women.
15. according to the purposes of claim 14, be used to prepare the preparation of single medicinal or edible unit dosage forms, but this formulation is taken once every day.
CNA2004800101967A 2003-04-17 2004-04-14 Multi-vitamin and mineral supplement for pregnant women Pending CN1774179A (en)

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CN104970372A (en) * 2014-10-27 2015-10-14 上海妈咪宝贝生物科技有限公司 Vitamin and mineral tablets for pregnant woman and wet nurse
WO2019192174A1 (en) * 2018-04-03 2019-10-10 中国科学院上海硅酸盐研究所 Ion reagent capable of treating myocardial infarction, and preparation method therefor and application thereof

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CN1929824B (en) * 2004-02-13 2011-03-23 狄洛特医药有限公司 Soft gelatin capsule comprising omega-3-polyunsaturated fatty acid
CN104970372A (en) * 2014-10-27 2015-10-14 上海妈咪宝贝生物科技有限公司 Vitamin and mineral tablets for pregnant woman and wet nurse
WO2019192174A1 (en) * 2018-04-03 2019-10-10 中国科学院上海硅酸盐研究所 Ion reagent capable of treating myocardial infarction, and preparation method therefor and application thereof

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EP1617734A1 (en) 2006-01-25
AU2004229165A1 (en) 2004-10-28
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PE20040963A1 (en) 2005-01-05
ZA200506794B (en) 2006-04-26

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