CN104784206A - Multi-vitamin dispersible tablet - Google Patents
Multi-vitamin dispersible tablet Download PDFInfo
- Publication number
- CN104784206A CN104784206A CN201510114483.2A CN201510114483A CN104784206A CN 104784206 A CN104784206 A CN 104784206A CN 201510114483 A CN201510114483 A CN 201510114483A CN 104784206 A CN104784206 A CN 104784206A
- Authority
- CN
- China
- Prior art keywords
- vitamin
- tablet
- pvp
- dispersible tablet
- coating
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000007919 dispersible tablet Substances 0.000 title claims abstract description 22
- 229940088594 vitamin Drugs 0.000 title abstract description 20
- 239000011782 vitamin Substances 0.000 title abstract description 20
- 239000000463 material Substances 0.000 claims abstract description 47
- AUNGANRZJHBGPY-UHFFFAOYSA-N D-Lyxoflavin Natural products OCC(O)C(O)C(O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-UHFFFAOYSA-N 0.000 claims abstract description 10
- AUNGANRZJHBGPY-SCRDCRAPSA-N Riboflavin Chemical compound OC[C@@H](O)[C@@H](O)[C@@H](O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-SCRDCRAPSA-N 0.000 claims abstract description 10
- 229930003451 Vitamin B1 Natural products 0.000 claims abstract description 10
- 229930003471 Vitamin B2 Natural products 0.000 claims abstract description 10
- 229960002477 riboflavin Drugs 0.000 claims abstract description 10
- 229960003495 thiamine Drugs 0.000 claims abstract description 10
- DPJRMOMPQZCRJU-UHFFFAOYSA-M thiamine hydrochloride Chemical compound Cl.[Cl-].CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N DPJRMOMPQZCRJU-UHFFFAOYSA-M 0.000 claims abstract description 10
- 235000010374 vitamin B1 Nutrition 0.000 claims abstract description 10
- 239000011691 vitamin B1 Substances 0.000 claims abstract description 10
- 235000019164 vitamin B2 Nutrition 0.000 claims abstract description 10
- 239000011716 vitamin B2 Substances 0.000 claims abstract description 10
- 229920001661 Chitosan Polymers 0.000 claims description 44
- 239000011248 coating agent Substances 0.000 claims description 38
- 238000000576 coating method Methods 0.000 claims description 38
- 229910052500 inorganic mineral Inorganic materials 0.000 claims description 35
- 235000010755 mineral Nutrition 0.000 claims description 35
- 239000011707 mineral Substances 0.000 claims description 35
- 239000008187 granular material Substances 0.000 claims description 27
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 26
- 229920003081 Povidone K 30 Polymers 0.000 claims description 26
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 20
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 20
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- 239000011734 sodium Substances 0.000 claims description 20
- 229910052708 sodium Inorganic materials 0.000 claims description 20
- NLKNQRATVPKPDG-UHFFFAOYSA-M potassium iodide Chemical compound [K+].[I-] NLKNQRATVPKPDG-UHFFFAOYSA-M 0.000 claims description 18
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- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims description 16
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 16
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 16
- LXNHXLLTXMVWPM-UHFFFAOYSA-N pyridoxine Chemical compound CC1=NC=C(CO)C(CO)=C1O LXNHXLLTXMVWPM-UHFFFAOYSA-N 0.000 claims description 16
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- XLOMVQKBTHCTTD-UHFFFAOYSA-N Zinc monoxide Chemical compound [Zn]=O XLOMVQKBTHCTTD-UHFFFAOYSA-N 0.000 claims description 12
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- 239000005751 Copper oxide Substances 0.000 claims description 8
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 claims description 8
- PMVSDNDAUGGCCE-TYYBGVCCSA-L Ferrous fumarate Chemical compound [Fe+2].[O-]C(=O)\C=C\C([O-])=O PMVSDNDAUGGCCE-TYYBGVCCSA-L 0.000 claims description 8
- SQUHHTBVTRBESD-UHFFFAOYSA-N Hexa-Ac-myo-Inositol Natural products CC(=O)OC1C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C1OC(C)=O SQUHHTBVTRBESD-UHFFFAOYSA-N 0.000 claims description 8
- 229930003268 Vitamin C Natural products 0.000 claims description 8
- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 claims description 8
- 229930003427 Vitamin E Natural products 0.000 claims description 8
- FAPWYRCQGJNNSJ-UBKPKTQASA-L calcium D-pantothenic acid Chemical compound [Ca+2].OCC(C)(C)[C@@H](O)C(=O)NCCC([O-])=O.OCC(C)(C)[C@@H](O)C(=O)NCCC([O-])=O FAPWYRCQGJNNSJ-UBKPKTQASA-L 0.000 claims description 8
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- 229960000225 ferrous fumarate Drugs 0.000 claims description 8
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims description 8
- CDAISMWEOUEBRE-GPIVLXJGSA-N inositol Chemical compound O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](O)[C@@H]1O CDAISMWEOUEBRE-GPIVLXJGSA-N 0.000 claims description 8
- 229960000367 inositol Drugs 0.000 claims description 8
- 235000019359 magnesium stearate Nutrition 0.000 claims description 8
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 8
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 claims description 8
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 8
- OTYBMLCTZGSZBG-UHFFFAOYSA-L potassium sulfate Chemical compound [K+].[K+].[O-]S([O-])(=O)=O OTYBMLCTZGSZBG-UHFFFAOYSA-L 0.000 claims description 8
- 229910052939 potassium sulfate Inorganic materials 0.000 claims description 8
- 235000011151 potassium sulphates Nutrition 0.000 claims description 8
- RADKZDMFGJYCBB-UHFFFAOYSA-N pyridoxal hydrochloride Natural products CC1=NC=C(CO)C(C=O)=C1O RADKZDMFGJYCBB-UHFFFAOYSA-N 0.000 claims description 8
- 229960000342 retinol acetate Drugs 0.000 claims description 8
- QGNJRVVDBSJHIZ-QHLGVNSISA-N retinyl acetate Chemical compound CC(=O)OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C QGNJRVVDBSJHIZ-QHLGVNSISA-N 0.000 claims description 8
- 235000019173 retinyl acetate Nutrition 0.000 claims description 8
- 239000011770 retinyl acetate Substances 0.000 claims description 8
- CDAISMWEOUEBRE-UHFFFAOYSA-N scyllo-inosotol Natural products OC1C(O)C(O)C(O)C(O)C1O CDAISMWEOUEBRE-UHFFFAOYSA-N 0.000 claims description 8
- 235000019158 vitamin B6 Nutrition 0.000 claims description 8
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- 239000011718 vitamin C Substances 0.000 claims description 8
- QYSXJUFSXHHAJI-YRZJJWOYSA-N vitamin D3 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-YRZJJWOYSA-N 0.000 claims description 8
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- 235000019165 vitamin E Nutrition 0.000 claims description 8
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- BVHLGVCQOALMSV-JEDNCBNOSA-N L-lysine hydrochloride Chemical compound Cl.NCCCC[C@H](N)C(O)=O BVHLGVCQOALMSV-JEDNCBNOSA-N 0.000 claims description 6
- 229930003779 Vitamin B12 Natural products 0.000 claims description 6
- FDJOLVPMNUYSCM-WZHZPDAFSA-L cobalt(3+);[(2r,3s,4r,5s)-5-(5,6-dimethylbenzimidazol-1-yl)-4-hydroxy-2-(hydroxymethyl)oxolan-3-yl] [(2r)-1-[3-[(1r,2r,3r,4z,7s,9z,12s,13s,14z,17s,18s,19r)-2,13,18-tris(2-amino-2-oxoethyl)-7,12,17-tris(3-amino-3-oxopropyl)-3,5,8,8,13,15,18,19-octamethyl-2 Chemical compound [Co+3].N#[C-].N([C@@H]([C@]1(C)[N-]\C([C@H]([C@@]1(CC(N)=O)C)CCC(N)=O)=C(\C)/C1=N/C([C@H]([C@@]1(CC(N)=O)C)CCC(N)=O)=C\C1=N\C([C@H](C1(C)C)CCC(N)=O)=C/1C)[C@@H]2CC(N)=O)=C\1[C@]2(C)CCC(=O)NC[C@@H](C)OP([O-])(=O)O[C@H]1[C@@H](O)[C@@H](N2C3=CC(C)=C(C)C=C3N=C2)O[C@@H]1CO FDJOLVPMNUYSCM-WZHZPDAFSA-L 0.000 claims description 6
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Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a multi-vitamin dispersible tablet. Best amounts of auxiliary materials are screened through afresh design of a prescription, and an advanced dry granulation, tabletting and film coated tablet production technology is adopted to main the content of various vitamins unchanged to prepare the domestic advanced dispersible tablet dosage form. Compared with common tablets, the tablet disclosed in the invention can be easily dissolved out and released in vivo, and can be easily absorbed by human body; the dispersion uniformity is increased, so the multi-vitamin dispersible tablet can be dissolved within 3min and passes through a No.2 sieve; and the dissolution rates of vitamin B1, vitamin B2 and nicotinamide in every tablet are preciously determined through adopting high-performance liquid chromatography, are above 98% of labeled amounts, and the qualitative detection disintegration time limit of a common sheet is shorter than 30min, so the quality of the multi-vitamin dispersible tablet is obviously improved. The multi-vitamin dispersible tablet can be cooperatively used in treatment of the stomach cancer, can alleviate symptoms, and enhances the body immunity.
Description
Technical field
The invention belongs to health care medicine technical field, particularly relate to a kind of Muhivitamin Formula With Minerals dispersible tablet and preparation method thereof.
Background technology
Along with the raising of people's living standard and the enhancing of health care consciousness, and the change of people's dietary habit and dietary structure, as certain nutrient shortage that fat, too high, the vegetable of refined sugar intake and fruit intake deficiency, imbalance diet etc. cause people to take in.Quite a few crowd custom daily some supplementarys.Nutrient prime replenisher is for the purpose of supplementary needed by human body nutrient, is the product that raw material is made by one or several through chemosynthesis or the nutrient that extracts from natural animal-plant.Supplementing the Muhivitamin Formula With Minerals class supplementary into main purpose with vitamin and trace element, is the important kind of nutrient prime replenisher.The composite dosage form that multivitamin and minerals tablet (multivitamin tablet) is various vitamin, mineral synthesizes according to doses ratio, the major part in the vitamin containing human body Minimum requirements every day amount, mineral or whole.Its main uses comprises medical application (for preventing vitamin, the mineral deficiency because meals imbalance causes) and sport-utility (vitamin, mineral disappearance for preventing prolonged exercise or training to cause).Compound vitamin various brands content is different, also finds in its application, except using as supplementary, also can produce synergism with other class medicines, play better curative effect.As multivitamin and minerals tablet, compound Zinc glycyrrhetate granules treatment recurrent oral ulceration, achieve good clinical efficacy.
Because multivitamin and minerals tablet main constituent is many, part principal agent is unstable under heat, wet condition, therefore prepares the rapid and stable tablet of release and have larger difficulty.Dry granulation powder material is directly made the granular product meeting user and require, after pelletize, bulk density significantly increases, can reach not only Control pollution, but also reduce powder waste, improve material outward appearance and mobility, be convenient to storage and transport, the objects such as dissolubility, porosity and specific surface area can be controlled.Dry granulation process technology in a lot of comparatively wet granulation technology have some superiority, suitably can adjust the consumption producing adjuvant in prescription, therefore application is more extensive simultaneously.Compressing dry granulation is exactly that the granule of dry granulation is carried out tabletting, and be usually used in heat sensitive material, meet the labile medicine of water, method is simple, saving of work and time.Dry granulation tabletting preparation technology, compared with wet granule compression tablet preparation technology, has the features such as cost is low, technique is simple, easy to operate, is conducive to serialization and the automatization of tablet manufacturing, suitable to wet heat-labile medicine, has vast potential for future development.
The present inventor is intended to redesign through prescription filter out adjuvant optimum amount, adopt advanced dry granulation, tabletting, film coating sheet production technology, keep various vitamin content constant, be prepared into the tablet formulation of domestic advanced person, compared with common multivitamin and minerals tablet: more easily stripping in vivo, drug release being absorbed by the body, and in the treatment of gastric cancer, there is the effect of collaborative enhancing immunity.
Summary of the invention
Object of the present invention can be achieved through the following technical solutions:
The present invention adopts brand-new advanced dosage form, adjusts each constituent content, and quality is significantly improved, its easily stripping in vivo, drug release being absorbed by the body, and in the treatment of gastric cancer, has the effect coordinating enhancing immunity.The nonprescription drugs that Muhivitamin Formula With Minerals dispersible tablet of the present invention is made up of 21 kinds of vitamin and minerals, for prevention and therapy because of the various diseases caused by vitamin and mineral deficiency.Vitamin and mineral are ties up special body homergy and healthy requisite important substance, and the two is the important composition forming multiple coenzyme and hormone, can cause dysbolismus and cause various diseases during shortage.Be applicable to each age group crowd use, taking convenience, drug safety.
The present invention is on multivitamin and minerals tablet original prescription basis, redesign through prescription and filter out adjuvant optimum amount, adopt advanced dry granulation, tabletting, film coating sheet production technology, keep various vitamin content constant, be prepared into the tablet formulation of domestic advanced person, compared with ordinary tablet: more easily stripping in vivo, drug release being absorbed by the body; Add dispersing uniformity, product can leach and by No. 2 sieves in 3 minutes; And adopt the dissolution of the vitamin such as the every sheet vitamin B1 of high performance liquid chromatography micrometric measurement, vitamin B2, nicotiamide, be more than 98% of labelled amount, and an ordinary tablet qualitative detection is less than 30 minutes disintegration, product quality significantly improves.
Chitosan has amino, as the oligosaccharide with clean positive charge that occurring in nature is unique, has very unique biochemical functions.The physiological function of chitosan mainly contains: improve body's immunity, antitumor, antibacterial and bacteriostasis, eliminating heavy metal ion, blood fat reducing, conciliation blood glucose comprehensively, regulate blood pressure, promote intestinal beneficial flora propagation, improve digestive function, reconcile acid-base value, maintain acid-base balance, the scavenging free radicals of body, activate the activity of antioxidase, thus improve the healing of lipid oxidation resistance, promotion fracture ..., etc.(being called as life the 6th key element).Chitosan is the oligosaccharide with amino, be called as " amino-oligosaccharide (amino-oligosaccharin); as a kind of inducer (elicitor) of oligosaccharide kind; can the expression of inducing plant defensin gene group; thus improve disease-resistant crops ability, coordinate plant growth.(oligosaccharide is called as the key opening plant gene)
Chitosan is at medicine, and food, agricultural, the numerous areas such as light industry have application prospect widely.The function of chitosan and the degree of polymerization (DP) of chitosan closely related: many Physiology and biochemistries of chitosan are active closely related with the degree of polymerization distribution scope of chitosan, as in enhancing immunity, the report degree of polymerization is had to be 6-8 (or 4-7, chitosan 5-7) has good antibacterial, enhancing immunity, anti-tumor activity, wherein six sugar [chitin six sugar (GlcNAc) 6 and shell six sugar (GlcN) 6] show higher antitumor activity; In inducing plant disease resistance, have the report degree of polymerization to be that the chitosan of 4-6 can the generation of regulating plant root nodule bacteria, the chitosan of degree of polymerization 4-11 effectively can resist the ability of pathogenic microorganism by activated plant; In adjustment blood glucose, there are some researches show that the chitosan of molecular weight about 1700 is applicable to hyperlipemia sugar patient, hypoglycemia ﹑ raising oxidation resistance can be fallen and play a role in health care; In bacteria resistance function, there is the chitosan of report mean molecule quantity 610 (3 sugar) to have certain fungistatic effect to raw milk, obvious inhibitory action etc. is served to the rear acidify of Yoghourt.Therefore the molecular weight of chitosan and degree of polymerization distribution scope are the important indicators of reflection chitosan product quality.
The present invention is by countless experiments, specific formula and ratio are verified, select the chitosan of specified molecular weight and content, especially the chitosan of 1300-1600 molecular weight, the Muhivitamin Formula With Minerals dispersible tablet of index excellence can be prepared, it not only has physiological function, also affects the dispersive property of dispersible tablet.And especially, in curing gastric cancer, collaborative use, can significantly improve immunity.It has been generally acknowledged that, the degree of polymerization is 6-8 (or 4-7, chitosan 5-7) has enhancing immunity, anti-tumor activity, but the present inventor surprisingly finds, the chitosan of 1300-1600 molecular weight water soluble, in this component, effect is best, disintegration, dissolution, improve immunity effect all fine, effect is better than degree of polymerization 6-8's on the contrary.
Technical solution of the present invention is as follows:
A kind of preparation method of Muhivitamin Formula With Minerals dispersible tablet:
(1) raw material is prepared:
Described raw material is prepared into 1000;
(2) prepare granule: above-mentioned raw materials is divided into A, B, C material, obtain granule after A, B, C material carries out premixing respectively with dry granulating machine, then A, B, C are expected that granule adds magnesium stearate, PVP K30, polyvinylpolypyrrolidone mix homogeneously are granulated;
Described A material is: vitamin A acetate powder, vitamin E powder, vitamin D3, vitamin B2, vitamin B12, vitamin B1, vitamin B6, magnesium oxide, potassium sulfate, manganese sulfate, zinc oxide, calcium hydrogen phosphate, microcrystalline Cellulose 13-20g, pregelatinized Starch, low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, PVP K30;
Described B material is: vitamin C, nicotiamide, adipokinetic hormone, lysine hydrochloride, calcium pantothenate, inositol, calcium hydrogen phosphate, water-soluble chitosan, microcrystalline Cellulose, pregelatinized Starch, low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, PVP K30;
Described C material is: potassium iodide, copper oxide, ferrous fumarate, microcrystalline Cellulose, pregelatinized Starch, carboxymethylstach sodium, PVP K30;
The technique of described dry granulating machine is: nip pressure 60-80bar, roll rotational speed 45-50r/min, material transfer rate are 10-20r/min;
(3) tabletting: qualified granule carries out tabletting on request;
(4) peplos: the Opadry Y-1-7000 selecting water solublity coating material Ka Lekang, coating solution mass fraction is 18%, adopts high-efficiency coating machine turnadle pan coating;
The molecular weight of described chitosan is 1300-1600;
Coating controlled condition is as follows: inlet temperature is 60-70 DEG C, and atomizing pressure is 0.3-0.4MPa, and spouting velocity is 160g/mL, carries out coating to obtained label, increases quality 2-3%
Multivitamin and minerals tablet of the present invention, also unexpected discovery assists use in the treatment of the intestines and stomach cancer, can help relief of symptoms, improve immunity of organisms.
Usefulness of the present invention is:
(1) many multivitamin and minerals tablets are had on the market, but most of disintegration time is long, dissolution is low, and bioavailability is not high, and adjuvant materials are many, unstable, multivitamin and minerals tablet disintegrate of the present invention is fast, and product can leach in 3 minutes and by No. 2 sieves, dissolution is high, bioavailability is high, and definite effect is stablized.
(2) multivitamin and minerals tablet of the present invention selects the chitosan of specified molecular weight, has synergism, not only improves the dispersive property of dispersible tablet, in the treatment of the intestines and stomach cancer, can also can alleviate its symptom, the effect of enhancing human body immunity power.
(3) multivitamin and minerals tablet processing technology of the present invention is simple, and quality is high, has good market prospect.
Detailed description of the invention
The unique component of composition is defaulted as use whole amount, and the component repeatedly occurred gives at every turn concrete consumption.
Embodiment 1:
German Alexanders Co. Ltd. is selected to manufacture WP50N/75 type calender;
The water-soluble chitosan of the present embodiment, purchased from the red trade Co., Ltd of Guangzhou sheng, also can be prepared according to prior art voluntarily, and the molecular weight of described chitosan is 1300-1600.
A kind of preparation method of Muhivitamin Formula With Minerals dispersible tablet:
Following raw material is prepared into 1000;
Prepare granule: above-mentioned raw materials is divided into A, B, C material, obtain granule after A, B, C material carries out premixing respectively with dry granulating machine, then A, B, C are expected that granule adds magnesium stearate, PVP K30 6g, polyvinylpolypyrrolidone mix homogeneously are granulated;
Described A material is: vitamin A acetate powder, vitamin E powder, vitamin D3, vitamin B2, vitamin B12, vitamin B1, vitamin B6, magnesium oxide, potassium sulfate, manganese sulfate, zinc oxide, calcium hydrogen phosphate, microcrystalline Cellulose 13g, pregelatinized Starch 20g, low-substituted hydroxypropyl cellulose 3g, carboxymethylstach sodium 4g, PVP K30 7g;
Described B material is: vitamin C, nicotiamide, adipokinetic hormone, lysine hydrochloride, calcium pantothenate, inositol, calcium hydrogen phosphate, water-soluble chitosan, microcrystalline Cellulose 11g, pregelatinized Starch 12g, low-substituted hydroxypropyl cellulose 2g, carboxymethylstach sodium 3g, PVP K30 6g;
Described C material is: potassium iodide, copper oxide, ferrous fumarate, microcrystalline Cellulose 11g, pregelatinized Starch 18g, carboxymethylstach sodium 3g, PVP K30 6g;
The technique of described dry granulating machine is: nip pressure 60-80bar, roll rotational speed 45-50r/min, material transfer rate are 10-20r/min;
On request tabletting is carried out to qualified granule;
Select the Opadry Y-1-7000 of water solublity coating material Ka Lekang, coating solution mass fraction is 18%, adopts high-efficiency coating machine turnadle pan coating; Coating controlled condition is as follows: inlet temperature is 70 DEG C, and atomizing pressure is 0.4MPa, and spouting velocity is 160g/mL, carries out coating to obtained label, increases quality 3%.
Embodiment 2:
German Alexanders Co. Ltd. is selected to manufacture WP50N/75 type calender;
The water-soluble chitosan of the present embodiment, purchased from the red trade Co., Ltd of Guangzhou sheng, also can be prepared according to prior art voluntarily, and the molecular weight of described chitosan is 1300-1600.
A kind of preparation method of Muhivitamin Formula With Minerals dispersible tablet:
Following raw material is prepared into 1000;
Prepare granule: above-mentioned raw materials is divided into A, B, C material, obtain granule after A, B, C material carries out premixing respectively with dry granulating machine, then A, B, C are expected that granule adds magnesium stearate, PVP K30 7.25g, polyvinylpolypyrrolidone mix homogeneously are granulated;
Described A material is: vitamin A acetate powder, vitamin E powder, vitamin D3, vitamin B2, vitamin B12, vitamin B1, vitamin B6, magnesium oxide, potassium sulfate, manganese sulfate, zinc oxide, calcium hydrogen phosphate, microcrystalline Cellulose 14.5g, pregelatinized Starch 20g, low-substituted hydroxypropyl cellulose 4g, carboxymethylstach sodium 4.5g, PVP K30 8g;
Described B material is: vitamin C, nicotiamide, adipokinetic hormone, lysine hydrochloride, calcium pantothenate, inositol, calcium hydrogen phosphate, water-soluble chitosan, microcrystalline Cellulose 13g, pregelatinized Starch 20g, low-substituted hydroxypropyl cellulose 4g, carboxymethylstach sodium 3g, PVP K30 5g;
Described C material is: potassium iodide, copper oxide, ferrous fumarate, microcrystalline Cellulose 11g, pregelatinized Starch 20g, carboxymethylstach sodium 3g, PVP K30 5g;
The technique of described dry granulating machine is: nip pressure 60-80bar, roll rotational speed 45-50r/min, material transfer rate are 10-20r/min;
On request tabletting is carried out to qualified granule;
Select the Opadry Y-1-7000 of water solublity coating material Ka Lekang, coating solution mass fraction is 18%, adopts high-efficiency coating machine turnadle pan coating; Coating controlled condition is as follows: inlet temperature is 60 DEG C, and atomizing pressure is 0.3MPa, and spouting velocity is 160g/mL, carries out coating to obtained label, increases quality 2%.
Embodiment 3:
German Alexanders Co. Ltd. is selected to manufacture WP50N/75 type calender;
The water-soluble chitosan of the present embodiment, purchased from the red trade Co., Ltd of Guangzhou sheng, also can be prepared according to prior art voluntarily, and the molecular weight of described chitosan is 1300-1600.
A kind of preparation method of Muhivitamin Formula With Minerals dispersible tablet:
Following raw material is prepared into 1000;
Prepare granule: above-mentioned raw materials is divided into A, B, C material, obtain granule after A, B, C material carries out premixing respectively with dry granulating machine, then A, B, C are expected that granule adds magnesium stearate, PVP K30 5g, polyvinylpolypyrrolidone mix homogeneously are granulated;
Described A material is: vitamin A acetate powder, vitamin E powder, vitamin D3, vitamin B2, vitamin B12, vitamin B1, vitamin B6, magnesium oxide, potassium sulfate, manganese sulfate, zinc oxide, calcium hydrogen phosphate, microcrystalline Cellulose 15g, pregelatinized Starch 20g, low-substituted hydroxypropyl cellulose 3g, carboxymethylstach sodium 5g, PVP K30 5g;
Described B material is: vitamin C, nicotiamide, adipokinetic hormone, lysine hydrochloride, calcium pantothenate, inositol, calcium hydrogen phosphate, water-soluble chitosan, microcrystalline Cellulose 15g, pregelatinized Starch 18g, low-substituted hydroxypropyl cellulose 3g, carboxymethylstach sodium 5g, PVP K30 5g;
Described C material is: potassium iodide, copper oxide, ferrous fumarate, microcrystalline Cellulose 15g, pregelatinized Starch 17g, carboxymethylstach sodium 4g, PVP K30 5g;
The technique of described dry granulating machine is: nip pressure 60-80bar, roll rotational speed 45-50r/min, material transfer rate are 10-20r/min;
On request tabletting is carried out to qualified granule;
Select the Opadry Y-1-7000 of water solublity coating material Ka Lekang, coating solution mass fraction is 18%, adopts high-efficiency coating machine turnadle pan coating; Coating controlled condition is as follows: inlet temperature is 65 DEG C, and atomizing pressure is 0.4MPa, and spouting velocity is 160g/mL, carries out coating to obtained label, increases quality 3%.
Embodiment 4:
German Alexanders Co. Ltd. is selected to manufacture WP50N/75 type calender;
The water-soluble chitosan of the present embodiment, purchased from the red trade Co., Ltd of Guangzhou sheng, also can be prepared according to prior art voluntarily, and the molecular weight of described chitosan is 1300-1600.
A kind of preparation method of Muhivitamin Formula With Minerals dispersible tablet:
Following raw material is prepared into 1000;
Prepare granule: above-mentioned raw materials is divided into A, B, C material, obtain granule after A, B, C material carries out premixing respectively with dry granulating machine, then A, B, C are expected that granule adds magnesium stearate, PVP K30 2g, polyvinylpolypyrrolidone mix homogeneously are granulated;
Described A material is: vitamin A acetate powder, vitamin E powder, vitamin D3, vitamin B2, vitamin B12, vitamin B1, vitamin B6, magnesium oxide, potassium sulfate, manganese sulfate, zinc oxide, calcium hydrogen phosphate, microcrystalline Cellulose 22g, pregelatinized Starch 18g, low-substituted hydroxypropyl cellulose 4g, carboxymethylstach sodium 10g, PVP K30 3g;
Described B material is: vitamin C, nicotiamide, adipokinetic hormone, lysine hydrochloride, calcium pantothenate, inositol, calcium hydrogen phosphate, water-soluble chitosan, microcrystalline Cellulose 18g, pregelatinized Starch 19g, low-substituted hydroxypropyl cellulose 3g, carboxymethylstach sodium 8g, PVP K30 3g;
Described C material is: potassium iodide, copper oxide, ferrous fumarate, microcrystalline Cellulose 15g, pregelatinized Starch 20g, carboxymethylstach sodium 7g, PVP K30 2g;
The technique of described dry granulating machine is: nip pressure 60-80bar, roll rotational speed 45-50r/min, material transfer rate are 10-20r/min;
On request tabletting is carried out to qualified granule;
Select the Opadry Y-1-7000 of water solublity coating material Ka Lekang, coating solution mass fraction is 18%, adopts high-efficiency coating machine turnadle pan coating; Coating controlled condition is as follows: inlet temperature is 61 DEG C, and atomizing pressure is 0.3MPa, and spouting velocity is 160g/mL, carries out coating to obtained label, increases quality 3%.
Embodiment 5:
Contrast experiment:
German Alexanders Co. Ltd. is selected to manufacture WP50N/75 type calender;
The water-soluble chitosan of the present embodiment, purchased from the red trade Co., Ltd of Guangzhou sheng, also can be prepared according to prior art voluntarily, and the molecular weight of described chitosan is 1300-1600.
Every 1000 adjuvants used are:
Coating controlled condition is as follows: inlet temperature is 75 DEG C, and atomizing pressure is 0.5MPa, and spouting velocity is 180g/mL, carries out coating to obtained label, increases quality 1.5%.
Other parameters are all identical with embodiment 1.
Embodiment 6: effect is tested and assessed
(1) to disintegration and the hardness of the multivitamin and minerals tablet of embodiment 1-5, dissolution, stability measures, and result is as shown in table 1.
Apparatus selection: LC-20AT high performance liquid chromatograph (Japanese Shimadzu), ZB-1B Intelligent disintegration tester, 101A-5 type electric heating blast dry oven (Nanjing circle in the air dry refrigeration plant factory).
Table 1
The product of embodiment 1-4 all can leach in 3 minutes and by No. 2 sieves, the contrast test disintegration rate of embodiment 5 is 8min, is obviously inferior to disintegration rate of the present invention.
Under the condition of Packing Sound, put 40 DEG C ± 2 DEG C, place 10 months under the accelerated test condition of RH75% ± 5%, embodiment 1-4 disintegration is unchanged, and the disintegration of embodiment 5 became 20 minutes by 8 minutes, significantly declined; After embodiment 1-5 disintegrate various vitamin relative to the percentage composition of labelled amount without significant change.
As can be seen here, the disintegrate of this product is very fast, the 30min of conventional multivitamin and minerals tablet on market, and dissolution is high, and stability also improves greatly.Especially the disintegration rate of embodiment 2 is only 2 minutes, and dissolution is also all very high, is preferred forms of the present invention.
The successful of embodiment 1-4 is better than the control experiment of embodiment 5, and the selection of adjuvant is described, the molecular weight of chitosan serves beyond thought synergism all in the present invention, and the ratio of each raw material is also very crucial, all can produce larger impact to result.Can judge in the preparation of described multidimensional sheet, to there is beyond thought synergy time the molecular weight of chitosan is 1300-1600.
(2) auxiliary treatment gastric cancer measure of merit:
Muhivitamin Formula With Minerals dispersible tablet of the present invention can not only supplement necessary vitamin, can also regulate human immunity, find there is good effect to auxiliary treatment gastric cancer in practice.
Gastric cancer is to current existing chemotherapeutics relative insensitivity, and its offer limited effectiveness, and elder patients with gastric cancer is older, body tolerance is poor.In Muhivitamin Formula With Minerals dispersible tablet of the present invention clinical combined with chemotherapy treatment gastric cancer, improving life in patients, improving the aspects such as immunity of organisms and achieve good therapeutic effect.Immunology Today research shows, the generation of tumor, development and treatment all with immunosuppressant and immunodeficiency closely related, when body immune system lack of proper care or hypofunction time, when tumor growth exceedes immune surveillance control, tumor cell continued growth also forms tumor.Cellular immunization plays prior effect in body Graft Versus Tumor, lymphocyte subgroup plays an important role to the immunne response regulation and control of body and immune the stablizing of maintenance, cell is dominant response cell in immunne response, cell can produce cell mediated cytotoxicity to target cell, have modulability inhibitory action to cell, ratio can directly reflect Immune Function state simultaneously.Therefore detection peripheral blood cells subgroup plays an important role to the cellular immune function understood in tumor host body.In treatment neoplastic process, cellular immune function and the direct killing tumor cell of enhancing body have identical important effect.
Select sufferer 150 example, men and women is 78 examples and 72 examples respectively, all meet " up-to-date domestic surgery disease treatment standard " relevant criterion, are diagnosed as gastric cancer, are divided into 3 groups at random, no significant difference between 3 groups, have statistics comparability.
Patient all gives conventional improvement chemotherapy regimen.Treatment group gives multivitamin and minerals tablet of the present invention simultaneously, each 2, once a day, takes 2 months continuously.Matched group 1 only carries out chemotherapy, and matched group 2 takes the multivitamin and minerals tablet of embodiment 5, each 2, once a day, takes 2 months continuously.
Adopt flow cytometry to carry out the detection of lymphocyte subgroup and natural killer cell activity before and after treatment, observe the change of Cellular Immunologic Function In Patients.Also can find the change of lymphocyte subgroup and cytoactive, the CD3 for the treatment of group, CD4, CD8 are all apparently higher than matched group, and NK is less than matched group.Result is as shown in table 2.
The change of table 2 lymphocyte subgroup and cytoactive
| Group | CD3 | CD4 | CD8 | NK(％) |
| Before matched group 1 is treated | 62.9 | 42.8 | 35.3 | 22.8 |
| After matched group 1 is treated | 52.3 | 32.2 | 49.5 | 18.1 |
| Before matched group 2 is treated | 62.6 | 42.7 | 35.7 | 22.9 |
| After matched group 2 is treated | 62.1 | 41.1 | 29.7 | 22.1 |
| Before treatment group treatment | 62.8 | 43.5 | 34.8 | 22.4 |
| After treatment group treatment | 69.5 | 48.1 | 25.3 | 28.5 |
This shows that multivitamin and minerals tablet of the present invention is in the chemotherapeutic treatment of gastric cancer, can significantly improve the immunne response ability to body and immune surveillance function thereof, improve immunity of organisms further, has the untoward reaction of significantly prevention and reparation chemotherapy.The control experiment of embodiment 5, successful is lower than the effect of embodiment 1-4, and this should be component of the present invention, ratio, formula, and technique serves synergism, especially to the selection of chitosan molecule amount and molecular weight distribution.
The above; be only the present invention's preferably detailed description of the invention; but protection scope of the present invention is not limited thereto; anyly be familiar with those skilled in the art in the technical scope that the present invention discloses; be equal to according to technical scheme of the present invention and inventive concept thereof and replace or change, all should be encompassed within protection scope of the present invention.
Claims (3)
1. a Muhivitamin Formula With Minerals dispersible tablet, is characterized in that it is made up of following raw material:
Vitamin A acetate powder 2,500,000 unit, in vitamin A
Vitamin E powder 5g
Vitamin B2 2.5g
Vitamin B12 0.5mg
Nicotiamide 7.5g
Adipokinetic hormone 25g
Ferrous fumarate 5g, in ferrum
Copper oxide 0.5g, in copper
Magnesium oxide 0.5g, in magnesium
Potassium iodide 50mg, in iodine
Lysine hydrochloride 12.5g
Vitamin D3 200,000 unit
Vitamin B1 2.5g
Vitamin B6 0.25g
Vitamin C 25g
Calcium pantothenate 2.5g
Inositol 25g
Potassium sulfate 5g, in potassium
Manganese sulfate 0.5g, in manganese
Zinc oxide 0.25g, in zinc
Calcium hydrogen phosphate 279g
Water-soluble chitosan 5-8g
Pregelatinized Starch 50-60g
Low-substituted hydroxypropyl cellulose 5-8g
Microcrystalline Cellulose 35-55g
Polyvinylpolypyrrolidone 8-10g
PVP K30 10-25.25g
Carboxymethylstach sodium 10-25g
Magnesium stearate 2-5.21g
The molecular weight of described chitosan is 1300-1600;
Described raw material is prepared into 1000.
2. a preparation method for Muhivitamin Formula With Minerals dispersible tablet, is characterized in that its step is as follows:
(1) raw material is prepared:
Vitamin A acetate powder 2,500,000 unit, in vitamin A
Vitamin E powder 5g
Vitamin B2 2.5g
Vitamin B12 0.5mg
Nicotiamide 7.5g
Adipokinetic hormone 25g
Ferrous fumarate 5g, in ferrum
Copper oxide 0.5g, in copper
Magnesium oxide 0.5g, in magnesium
Potassium iodide 50mg, in iodine
Lysine hydrochloride 12.5g
Vitamin D3 200,000 unit
Vitamin B1 2.5g
Vitamin B6 0.25g
Vitamin C 25g
Calcium pantothenate 2.5g
Inositol 25g
Potassium sulfate 5g, in potassium
Manganese sulfate 0.5g, in manganese
Zinc oxide 0.25g, in zinc
Calcium hydrogen phosphate 279g
Water-soluble chitosan 5-8g
Pregelatinized Starch 50-60g
Low-substituted hydroxypropyl cellulose 5-8g
Microcrystalline Cellulose 35-55g
Polyvinylpolypyrrolidone 8-10g
PVP K30 10-25.25g
Carboxymethylstach sodium 10-25g
Magnesium stearate 2-5.21g
Described raw material is prepared into 1000;
The molecular weight of described chitosan is 1300-1600;
(2) prepare granule: above-mentioned raw materials is divided into A, B, C material, obtain granule after A, B, C material carries out premixing respectively with dry granulating machine, then A, B, C are expected that granule adds magnesium stearate, PVP K30, polyvinylpolypyrrolidone mix homogeneously are granulated;
Described A material is: vitamin A acetate powder, vitamin E powder, vitamin D3, vitamin B2, vitamin B12, vitamin B1, vitamin B6, magnesium oxide, potassium sulfate, manganese sulfate, zinc oxide, calcium hydrogen phosphate, microcrystalline Cellulose, pregelatinized Starch, low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, PVP K30;
Described B material is: vitamin C, nicotiamide, adipokinetic hormone, lysine hydrochloride, calcium pantothenate, inositol, calcium hydrogen phosphate, water-soluble chitosan, microcrystalline Cellulose, pregelatinized Starch, low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, PVP K30;
Described C material is: potassium iodide, copper oxide, ferrous fumarate, microcrystalline Cellulose, pregelatinized Starch, carboxymethylstach sodium, PVP K30;
The technique of described dry granulating machine is: nip pressure 60-80 bar, roll rotational speed 45-50 r/min, material transfer rate are 10-20r/min;
(3) tabletting: qualified granule carries out tabletting on request;
(4) peplos: the Opadry Y-1-7000 selecting water solublity coating material Ka Lekang, coating solution mass fraction is 18%, adopts high-efficiency coating machine turnadle pan coating;
Coating controlled condition is as follows: inlet temperature is 60-70 DEG C, and atomizing pressure is 0.3-0.4 MPa, and spouting velocity is 160g/mL, carries out coating to obtained label, increases quality 2-3%.
3. the Muhivitamin Formula With Minerals dispersible tablet for preparing of method according to claim 2.
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Cited By (3)
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| CN107772478A (en) * | 2016-08-24 | 2018-03-09 | 南京逐陆医药科技有限公司 | A kind of multivitamin tablet and preparation method thereof |
| CN108347990A (en) * | 2015-10-16 | 2018-07-31 | 诺维克斯科学私人有限公司 | The stabilization composition of vitamin C and zinc metal sheet agent |
| CN112655969A (en) * | 2021-03-15 | 2021-04-16 | 江苏艾兰得营养品有限公司 | Choline bitartrate granules, tablets containing same and preparation method |
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| CN101401809A (en) * | 2008-11-12 | 2009-04-08 | 杭州民生药业集团有限公司 | Preparation for composition of vitamin and mineral matter |
| CN101926801A (en) * | 2009-06-23 | 2010-12-29 | 胡晓阳 | Medicinal composition |
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| WO2004058257A1 (en) * | 2002-12-30 | 2004-07-15 | Centurion, Inc. | Controlled release formulation comprising benzimidazole derivatives or pharmaceutically acceptable salts thereof with increased stability and method for preparing the same |
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| CN108347990A (en) * | 2015-10-16 | 2018-07-31 | 诺维克斯科学私人有限公司 | The stabilization composition of vitamin C and zinc metal sheet agent |
| CN107772478A (en) * | 2016-08-24 | 2018-03-09 | 南京逐陆医药科技有限公司 | A kind of multivitamin tablet and preparation method thereof |
| CN112655969A (en) * | 2021-03-15 | 2021-04-16 | 江苏艾兰得营养品有限公司 | Choline bitartrate granules, tablets containing same and preparation method |
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| CN104784206B (en) | 2017-07-14 |
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Denomination of invention: A multidimensional element dispersion tablet Effective date of registration: 20231101 Granted publication date: 20170714 Pledgee: Zhejiang Deqing Rural Commercial Bank Co.,Ltd. Dixin Green Branch Pledgor: ZHEJIANG SUBKOM PHARMACEUTICAL CO.,LTD. Registration number: Y2023980063249 |