CN106511292A - Production method for improving stability of vitamin ingredients in preparation - Google Patents
Production method for improving stability of vitamin ingredients in preparation Download PDFInfo
- Publication number
- CN106511292A CN106511292A CN201611122849.1A CN201611122849A CN106511292A CN 106511292 A CN106511292 A CN 106511292A CN 201611122849 A CN201611122849 A CN 201611122849A CN 106511292 A CN106511292 A CN 106511292A
- Authority
- CN
- China
- Prior art keywords
- vitaminss
- vitamin
- preparation
- production method
- stability
- 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.)
- Pending
Links
- 235000013343 vitamin Nutrition 0.000 title claims abstract description 50
- 238000002360 preparation method Methods 0.000 title claims abstract description 36
- 239000004615 ingredient Substances 0.000 title claims abstract description 19
- 229940088594 vitamin Drugs 0.000 title claims abstract description 16
- 229930003231 vitamin Natural products 0.000 title claims abstract description 16
- 239000011782 vitamin Substances 0.000 title claims abstract description 16
- 150000003722 vitamin derivatives Chemical class 0.000 title claims abstract description 16
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 14
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims abstract description 41
- 239000000203 mixture Substances 0.000 claims abstract description 27
- 238000000576 coating method Methods 0.000 claims abstract description 25
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 22
- 239000011248 coating agent Substances 0.000 claims abstract description 21
- 229910052500 inorganic mineral Inorganic materials 0.000 claims abstract description 20
- 239000011707 mineral Substances 0.000 claims abstract description 20
- 239000000463 material Substances 0.000 claims abstract description 15
- 239000011230 binding agent Substances 0.000 claims abstract description 14
- 229910052742 iron Inorganic materials 0.000 claims abstract description 12
- 238000005469 granulation Methods 0.000 claims abstract description 11
- 230000003179 granulation Effects 0.000 claims abstract description 11
- 238000001035 drying Methods 0.000 claims abstract description 7
- 239000008157 edible vegetable oil Substances 0.000 claims abstract description 7
- 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 31
- 235000010755 mineral Nutrition 0.000 claims description 18
- 239000000243 solution Substances 0.000 claims description 17
- 239000002671 adjuvant Substances 0.000 claims description 13
- 239000008187 granular material Substances 0.000 claims description 13
- 239000010409 thin film Substances 0.000 claims description 12
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 claims description 11
- 229930003268 Vitamin C Natural products 0.000 claims description 11
- 238000000034 method Methods 0.000 claims description 11
- 235000019154 vitamin C Nutrition 0.000 claims description 11
- 239000011718 vitamin C Substances 0.000 claims description 11
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 9
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 9
- 238000002156 mixing Methods 0.000 claims description 9
- 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 8
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 8
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 8
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 8
- 239000004925 Acrylic resin Substances 0.000 claims description 6
- 229920000178 Acrylic resin Polymers 0.000 claims description 6
- 239000007787 solid Substances 0.000 claims description 6
- 239000012467 final product Substances 0.000 claims description 5
- 239000003921 oil Substances 0.000 claims description 5
- 235000019198 oils Nutrition 0.000 claims description 5
- 229930003427 Vitamin E Natural products 0.000 claims description 4
- 235000013305 food Nutrition 0.000 claims description 4
- 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 4
- -1 polyethylene Polymers 0.000 claims description 4
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 4
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 4
- 239000011709 vitamin E Substances 0.000 claims description 4
- 235000019165 vitamin E Nutrition 0.000 claims description 4
- 229940046009 vitamin E Drugs 0.000 claims description 4
- PMVSDNDAUGGCCE-TYYBGVCCSA-L Ferrous fumarate Chemical compound [Fe+2].[O-]C(=O)\C=C\C([O-])=O PMVSDNDAUGGCCE-TYYBGVCCSA-L 0.000 claims description 3
- 230000001476 alcoholic effect Effects 0.000 claims description 3
- 239000002775 capsule Substances 0.000 claims description 3
- 239000011773 ferrous fumarate Substances 0.000 claims description 3
- 235000002332 ferrous fumarate Nutrition 0.000 claims description 3
- 229960000225 ferrous fumarate Drugs 0.000 claims description 3
- 239000004222 ferrous gluconate Substances 0.000 claims description 3
- 235000013924 ferrous gluconate Nutrition 0.000 claims description 3
- 229960001645 ferrous gluconate Drugs 0.000 claims description 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 3
- VRIVJOXICYMTAG-IYEMJOQQSA-L iron(ii) gluconate Chemical compound [Fe+2].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O VRIVJOXICYMTAG-IYEMJOQQSA-L 0.000 claims description 3
- 239000004006 olive oil Substances 0.000 claims description 3
- 235000008390 olive oil Nutrition 0.000 claims description 3
- 210000000582 semen Anatomy 0.000 claims description 3
- 150000003700 vitamin C derivatives Chemical class 0.000 claims description 3
- GDSOZVZXVXTJMI-SNAWJCMRSA-N (e)-1-methylbut-1-ene-1,2,4-tricarboxylic acid Chemical compound OC(=O)C(/C)=C(C(O)=O)\CCC(O)=O GDSOZVZXVXTJMI-SNAWJCMRSA-N 0.000 claims description 2
- ZEMPKEQAKRGZGQ-AAKVHIHISA-N 2,3-bis[[(z)-12-hydroxyoctadec-9-enoyl]oxy]propyl (z)-12-hydroxyoctadec-9-enoate Chemical compound CCCCCCC(O)C\C=C/CCCCCCCC(=O)OCC(OC(=O)CCCCCCC\C=C/CC(O)CCCCCC)COC(=O)CCCCCCC\C=C/CC(O)CCCCCC ZEMPKEQAKRGZGQ-AAKVHIHISA-N 0.000 claims description 2
- 241000218236 Cannabis Species 0.000 claims description 2
- 235000003935 Hippophae Nutrition 0.000 claims description 2
- 241000229143 Hippophae Species 0.000 claims description 2
- QAQJMLQRFWZOBN-LAUBAEHRSA-N L-ascorbyl-6-palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](O)[C@H]1OC(=O)C(O)=C1O QAQJMLQRFWZOBN-LAUBAEHRSA-N 0.000 claims description 2
- 239000011786 L-ascorbyl-6-palmitate Substances 0.000 claims description 2
- 239000004698 Polyethylene Substances 0.000 claims description 2
- DHKHKXVYLBGOIT-UHFFFAOYSA-N acetaldehyde Diethyl Acetal Natural products CCOC(C)OCC DHKHKXVYLBGOIT-UHFFFAOYSA-N 0.000 claims description 2
- 239000007864 aqueous solution Substances 0.000 claims description 2
- 235000010323 ascorbic acid Nutrition 0.000 claims description 2
- 239000011668 ascorbic acid Substances 0.000 claims description 2
- 229960005070 ascorbic acid Drugs 0.000 claims description 2
- 235000010385 ascorbyl palmitate Nutrition 0.000 claims description 2
- MDXRFOWKIZPNTA-UHFFFAOYSA-L butanedioate;iron(2+) Chemical compound [Fe+2].[O-]C(=O)CCC([O-])=O MDXRFOWKIZPNTA-UHFFFAOYSA-L 0.000 claims description 2
- HJMZMZRCABDKKV-UHFFFAOYSA-N carbonocyanidic acid Chemical compound OC(=O)C#N HJMZMZRCABDKKV-UHFFFAOYSA-N 0.000 claims description 2
- 125000004177 diethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 claims description 2
- 229960001604 ferrous succinate Drugs 0.000 claims description 2
- 229960003943 hypromellose Drugs 0.000 claims description 2
- 235000015091 medicinal tea Nutrition 0.000 claims description 2
- 238000000465 moulding Methods 0.000 claims description 2
- 229940060184 oil ingredients Drugs 0.000 claims description 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 2
- 239000011772 phylloquinone Substances 0.000 claims description 2
- 229920000573 polyethylene Polymers 0.000 claims description 2
- 235000010378 sodium ascorbate Nutrition 0.000 claims description 2
- PPASLZSBLFJQEF-RKJRWTFHSA-M sodium ascorbate Substances [Na+].OC[C@@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RKJRWTFHSA-M 0.000 claims description 2
- 229960005055 sodium ascorbate Drugs 0.000 claims description 2
- PPASLZSBLFJQEF-RXSVEWSESA-M sodium-L-ascorbate Chemical compound [Na+].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RXSVEWSESA-M 0.000 claims description 2
- 239000003826 tablet Substances 0.000 claims description 2
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- 239000002700 tablet coating Substances 0.000 claims description 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims 1
- 125000002777 acetyl group Chemical class [H]C([H])([H])C(*)=O 0.000 claims 1
- 239000011575 calcium Substances 0.000 claims 1
- 229910052791 calcium Inorganic materials 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
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- 239000011790 ferrous sulphate Substances 0.000 claims 1
- 235000003891 ferrous sulphate Nutrition 0.000 claims 1
- BAUYGSIQEAFULO-UHFFFAOYSA-L iron(2+) sulfate (anhydrous) Chemical compound [Fe+2].[O-]S([O-])(=O)=O BAUYGSIQEAFULO-UHFFFAOYSA-L 0.000 claims 1
- 229910000359 iron(II) sulfate Inorganic materials 0.000 claims 1
- 235000014655 lactic acid Nutrition 0.000 claims 1
- 239000004310 lactic acid Substances 0.000 claims 1
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- 230000000694 effects Effects 0.000 abstract description 3
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- 239000000843 powder Substances 0.000 description 13
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- 238000002845 discoloration Methods 0.000 description 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 6
- 239000005720 sucrose Substances 0.000 description 6
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 5
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- 239000001856 Ethyl cellulose Substances 0.000 description 4
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 4
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- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 3
- CWYNVVGOOAEACU-UHFFFAOYSA-N Fe2+ Chemical compound [Fe+2] CWYNVVGOOAEACU-UHFFFAOYSA-N 0.000 description 3
- DKKCQDROTDCQOR-UHFFFAOYSA-L Ferrous lactate Chemical compound [Fe+2].CC(O)C([O-])=O.CC(O)C([O-])=O DKKCQDROTDCQOR-UHFFFAOYSA-L 0.000 description 3
- 229930195725 Mannitol Natural products 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 230000008859 change Effects 0.000 description 3
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- 239000008120 corn starch Substances 0.000 description 3
- 230000007423 decrease Effects 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 235000013925 ferrous lactate Nutrition 0.000 description 3
- 239000004225 ferrous lactate Substances 0.000 description 3
- 229940037907 ferrous lactate Drugs 0.000 description 3
- 235000019359 magnesium stearate Nutrition 0.000 description 3
- 239000000594 mannitol Substances 0.000 description 3
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- 238000003860 storage Methods 0.000 description 3
- 235000015112 vegetable and seed oil Nutrition 0.000 description 3
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- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- IHBCFWWEZXPPLG-UHFFFAOYSA-N [Ca].[Zn] Chemical compound [Ca].[Zn] IHBCFWWEZXPPLG-UHFFFAOYSA-N 0.000 description 2
- 230000003064 anti-oxidating effect Effects 0.000 description 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 2
- 235000010376 calcium ascorbate Nutrition 0.000 description 2
- 229940047036 calcium ascorbate Drugs 0.000 description 2
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- BLORRZQTHNGFTI-ZZMNMWMASA-L calcium-L-ascorbate Chemical compound [Ca+2].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] BLORRZQTHNGFTI-ZZMNMWMASA-L 0.000 description 2
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- 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 description 1
- ABSPRNADVQNDOU-UHFFFAOYSA-N Menaquinone 1 Natural products C1=CC=C2C(=O)C(CC=C(C)C)=C(C)C(=O)C2=C1 ABSPRNADVQNDOU-UHFFFAOYSA-N 0.000 description 1
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 description 1
- 244000269722 Thea sinensis Species 0.000 description 1
- WHMDKBIGKVEYHS-IYEMJOQQSA-L Zinc gluconate Chemical compound [Zn+2].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O WHMDKBIGKVEYHS-IYEMJOQQSA-L 0.000 description 1
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- 239000004227 calcium gluconate Substances 0.000 description 1
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- 229960004494 calcium gluconate Drugs 0.000 description 1
- NEEHYRZPVYRGPP-UHFFFAOYSA-L calcium;2,3,4,5,6-pentahydroxyhexanoate Chemical compound [Ca+2].OCC(O)C(O)C(O)C(O)C([O-])=O.OCC(O)C(O)C(O)C(O)C([O-])=O NEEHYRZPVYRGPP-UHFFFAOYSA-L 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- BVTBRVFYZUCAKH-UHFFFAOYSA-L disodium selenite Chemical compound [Na+].[Na+].[O-][Se]([O-])=O BVTBRVFYZUCAKH-UHFFFAOYSA-L 0.000 description 1
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- 150000002500 ions Chemical class 0.000 description 1
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- SHUZOJHMOBOZST-UHFFFAOYSA-N phylloquinone Natural products CC(C)CCCCC(C)CCC(C)CCCC(=CCC1=C(C)C(=O)c2ccccc2C1=O)C SHUZOJHMOBOZST-UHFFFAOYSA-N 0.000 description 1
- MBWXNTAXLNYFJB-NKFFZRIASA-N phylloquinone Chemical compound C1=CC=C2C(=O)C(C/C=C(C)/CCC[C@H](C)CCC[C@H](C)CCCC(C)C)=C(C)C(=O)C2=C1 MBWXNTAXLNYFJB-NKFFZRIASA-N 0.000 description 1
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/26—Iron; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Landscapes
- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
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Abstract
The invention discloses a production method for improving the stability of vitamin ingredients in a preparation. According to the production method, an iron-containing mineral material is mixed with a certain proportion of auxiliary materials and is dispersed uniformly, a mixture is wrapped with a binder solution capable of forming a film for granulation, and drying is conducted; the vitamin ingredients are wet with edible oil firstly, mixed with a certain proportion of the auxiliary materials and dispersed uniformly, the mixture is wrapped with the binder ethyl alcohol solution capable of forming the film for granulation, and low-temperature drying is conducted at the temperature of 10-50 DEG C. According to the production method, the dried iron-containing mineral material particles and the particles containing the vitamin ingredients are mixed with a certain proportion of the auxiliary materials, then tabletting or not tabletting is conducted, coating of tablets or not coating of the tablets is conducted, and the preparation which contains the vitamin ingredients and is good in stability is obtained. The prepared preparation product is good in stability, long in effective period and good in use effect.
Description
Technical field
The present invention relates to vitaminss ingredient stability in food, field of pharmaceutical technology, more particularly to a kind of raising preparation
Method.
Background technology
In the solid preparations such as tablet, granule in the market containing mineral such as ferrum, vitaminss composition is because straight
The mineral ions such as ferrum are touched, or during storage, are affected by humidity, illumination etc., be susceptible to aoxidize, change colour,
There is content decline, discoloration, piebaldism, the phenomenon such as oozes out in the preparation for resulting in, and causes that keeping life is short, conforming product rate
It is low, the problems such as product is apt to deteriorate.
(international medical and health Leaders, 2004,10 (14)) such as tight principal columns although by changing coating material and coating method,
Film coating is greatly improved the quality of pill.But from for the angle for formulating effect duration, still need in film-coated moisture resistance
Can on further explored.
Liu's equality (Chinese food health magazine, 2011,23 (2)), supplements in health food and the nutrient of various dosage forms
In agent, sample composition and packaging are the principal elements for affecting Vitamin C Stability.
Sun Peixiong (applications for a patent for invention number：2011102356924) and prior art coating in actual applications also
Shortcomings, the easy moisture absorption of medicine, this directly affects the stability of medicine and storage period, and coating color and luster is unstable, easily by oxygen
Change and the character of impact medicine, coating dispersion heterogeneity.And the preparation raw material of its coatings is water solublity coating solution, preparing
In dry run, the decomposition and loss of vitamin are easily caused.
The content of the invention
There is content decline, discoloration, piebaldism, the phenomenon such as ooze out to solve existing vitamin preparation, cause product to have
The problems such as effect phase is short, conforming product rate is low, product is apt to deteriorate, it is an object of the invention to propose dimension life in a kind of raising preparation
The production method of plain constituents stability, prevents the oxidation of vitaminss composition, discoloration, piebaldism, the phenomenon such as oozes out, it is ensured that preparation is produced
The stability of product and effectiveness.
The present invention is adopted the technical scheme that：
In the raising preparation of the present invention, the production method of vitaminss ingredient stability comprises the following steps that：
(1) will be the Mineral feedstocks such as iron content sameAdjuvant mixing be uniformly dispersed, using can be molten into the binding agent of thin film
Liquid carries out parcel granulation, is dried；
(2) vitaminss composition first uses edible oils moistening, togetherAdjuvant mixing be uniformly dispersed, then with can be into
The binder solution of thin film carries out parcel granulation, cold drying (10～50 DEG C)；
(3) by the Mineral feedstock granule and ingredient granules containing vitaminss of above-mentioned dried iron content with remaining adjuvant
After mixing, tabletting or not tabletting, tablet coating or not coating obtain final product a kind of system containing vitaminss composition having good stability
Agent.
In step (1), the Mineral feedstock such as described iron content refers to carbonyl iron, ferrous fumarate, Ferrous gluconate, sulfur
One or more combinations in sour ferrous iron, ferrous lactate, ferrous succinate, alternatively ferrum is with other edible Mineral feedstocks
Combination.
In step (1), described adjuvant refers to food or pharmaceutic adjuvant conventional and that be conducive to solid preparation molding, to possess
The adjuvant of certain non-oxidizability is excellent.
In step (1), described can be edible hypromellose (HPMC), hydroxypropyl fiber into the binding agent of thin film
Plain (HPC), acrylic resin IV, polyvinylpyrrolidone (PVP), polyethylene acetal diethyl nitrilo acetic acid (AEA) etc. can be into
One or more combination in the binding agent or coating materials of thin film is used, aqueous solution of its solution for 0.05%-25% mass ratioes
Or ethanol solution, can be into the binding agent of thin film and its alcoholic solution as excellent with alcohol-soluble.
In step (2), described vitaminss composition is referred to containing vitamin C in vitamin C compounds (ascorbic acid), is resisted
Bad hematic acid sodium, calcium ascorbate, one or more combination of L-AA -6- palmitates (ascorbyl palmitate),
Various dimensions lifes that alternatively vitamin C compounds are combined into one or more vitaminss in needed by human body other vitamin
Plain premix material.The vitaminss composition can be the not form such as coating, coating or micropill, with coating or micropill form as excellent.
In step (2), described edible oils refer to edible Oleum Arachidis hypogaeae semen, Oleum Ricini, olive oil, Fructus Cannabis oil,
The oily vitamin such as the vegetable oil such as Semen Fructus Hippophae oil or Vitamin E, vitamin K1, is waved with possessing certain non-oxidizability, mobility, nothing
The arbitrary proportion of one or two edible oils of the property sent out is mixed into excellent.
In step (3), the described preparation containing vitaminss composition having good stability is with other ore deposits containing ferrum or ferrum
The combination of material charge and vitamin C or vitamin C are with one or more the vitaminss groups in needed by human body other vitamin
Close the solid preparations such as made tablet, granule, capsule, medicinal tea.
One of preferred technical scheme：The inventive method prepare the component preparation containing vitaminss having good stability be by
The raw material of following weight portion is made：
The two of preferred technical scheme：The inventive method prepare the component preparation containing vitaminss having good stability be by
The raw material of following weight portion is made：
The three of preferred technical scheme：The inventive method prepare the component preparation containing vitaminss having good stability be by
The raw material of following weight portion is made：
The positive effect of the present invention is as follows：
It is an advantage of the invention that can be by iron content, the tablet of iron content and other edible mineral, granule, capsule, tea
In the solid preparations such as agent, by adjuvant dilution, the Mineral feedstocks such as ferrum can be wrapped up into the binding agent of thin film, form buffer action；
By the vegetable oil moistening vitaminss composition for possessing certain antioxidant, vitamin anti-oxidation protection sealing coat is formed, then is led to
Cross adjuvant dilution and film-coat sealing coat can be wrapped to form into the binding agent of thin film.Vitaminss composition is isolated by adjuvant,
Vegetable oil anti-oxidation protection sealing coat and 2 layer film clothing sealing coats, will not directly contact the metal ions such as ferrum, and isolate oxygen
And moisture, during storage, affected very little by moisture content, illumination etc., vitaminss ingredient stability is good, will not occur oxidation,
Discoloration etc., the preparation of formation are not in content declines, discoloration, piebaldism, the phenomenon such as ooze out, the stability of formulation products with it is effective
Property is good, greatly improves economic benefit.
Description of the drawings
Fig. 1 is that one product of patent Example of the present invention accelerates 6 months design sketchs.
Fig. 2 is that traditional handicraft ferrum VITAMIN C TABLET accelerates 6 months design sketchs.
Fig. 3 is that two product of patent Example of the present invention accelerates 6 months design sketchs.
Fig. 4 is that traditional handicraft ferrum zinc calcium VITAMIN C TABLET accelerates 6 months design sketchs.
Fig. 5 is that three product of patent Example of the present invention accelerates 6 months design sketchs.
Fig. 6 is that traditional handicraft several mineral materials VITAMIN C TABLET accelerates 6 months design sketchs.
By Fig. 1 and Fig. 2, Fig. 3 and Fig. 4, the contrast between Fig. 5 and Fig. 6, it can be clearly seen that prepared by the method for the present invention
Preparation in vitaminss ingredient stability it is good, will not aoxidize, change colour, be not in content decline, discoloration, piebaldism,
The phenomenon such as ooze out, the stability of formulation products and effectiveness are good, greatly improve economic benefit.
Specific embodiment
The following examples are that the present invention is described in further detail.
Embodiment one:
Preparation technology：
(1) ethyl cellulose 75g is taken, plus 95% ethanol 425g stirring and dissolving is completely, makes 15% ethyl cellulose second
Alcoholic solution.
(2) sucrose of ferrous fumarate powder same 1/3,1/3 Mannitol, 1/3 maltodextrin powder press equal increments
Method mix homogeneously, is bonded with 35g15% ethyl celluloses ethanol solution, is crossed the granulation of 24 mesh, is dried at 70 DEG C, and moisture Control exists
Less than 5%.
(3) vitamin C (ascorbic acid) powder first use 25g Vitamin E moistenings, with 1/3 sucrose, 1/3 Mannitol, 1/
3 maltodextrin powder is uniformly dispersed by equal increments method mixing, then is wrapped with 28g10% ethyl cellulose ethanol solution
Wrap up in, the granulation of 24 mesh, 40 DEG C of cold drying, moisture Control is below 5%.
(4) by above-mentioned dried ferrous mineral material particles and containing vitamin C granules with remaining 1/3 sucrose,
After 1/3 Mannitol, 1/3 maltodextrin, hydroxypropyl methyl cellulose powder mix homogeneously, magnesium stearate is added, mixing is equal
Even, tabletted, with remaining 15% ethyl cellulose ethanol solution coating, coating weight gain is 2.5%, obtains final product a kind of stability good
Good ferrum VITAMIN C TABLET.
Embodiment two:
Preparation technology：
(1) 10.0gHPMC and 40g HPC are taken, plus 95% ethanol 425g stirring and dissolving is completely, makes 2.0%HPMC+
8.0%HPC alcohol mixed solutions.
(2) Calcium Carbonate, Ferrous gluconate, ferrous lactate, zinc gluconate powder are pasted with 1/3 Lactose, 1/3 Fructus Hordei Germinatus
Essence, 1/3 sucrose powder press equal increments method mix homogeneously, are bonded with 65g2.0%HPMC+8.0%HPC alcohol mixeding liquids, mistake
30 mesh are pelletized, and are dried at 70 DEG C, and moisture Control is below 6%.
(3) vitamin C (sodium ascorbate, calcium ascorbate) first use 30.0g Oleum Arachidis hypogaeae semen moistenings, with 1/3 Lactose, 1/3
Maltodextrin, 1/3 sucrose powder be uniformly dispersed by equal increments method mixing, then with 50g 2.0%HPMC+8.0%HPC second
Alcohol mixed liquor is bonded, the granulation of 30 mesh, 40 DEG C of cold drying, and moisture Control is below 5%.
(4) by the Mineral feedstock granules such as above-mentioned dried iron content and containing vitamin C granules with remaining 1/3 breast
After sugar, 1/3 maltodextrin, 1/3 sucrose powder mix homogeneously, magnesium stearate is added, mix homogeneously is tabletted, used
2.0%HPMC+8.0%HPC alcohol mixeding liquid coatings, coating weight gain is 2.1%, obtains final product a kind of ferrum zinc calcium dimension having good stability
Raw element C pieces.
Embodiment three:
Preparation technology：
(1) 25g is taken, plus 95% ethanol 475g stirring and dissolving is completely, makes 5% acrylic resin IV solution.
(2) calcium gluconate, ferrous lactate, sodium selenite powder with 1/3 corn starch, 1/3 beta-schardinger dextrin-, 1/3
Lactose powder press equal increments method mix homogeneously, with 5% acrylic resin IV solution of 40g bond, cross 20 mesh granulation, in
It is dried at 70 DEG C, moisture Control is below 6%.
(3) vitamin D3Be put in olive oil, Vitamin E mixed solution, stir, with 1/3 corn starch, 1/3
Beta-schardinger dextrin-, 1/3 lactose powder be uniformly dispersed by equal increments method mixing, it is then molten with 5% acrylic resins of 33g IV
Liquid is bonded, the granulation of 20 mesh, 50 DEG C of cold drying, and moisture Control is below 5%.
(4) by above-mentioned dried ferrous mineral granule and containing vitamin C granules with remaining 1/3 corn starch,
After 1/3 beta-schardinger dextrin-, 1/3 Lactose and 385.0g milk powder mix homogeneously, magnesium stearate is added, mix homogeneously is tabletted,
With 5% acrylic resin IV solution coatings, coating weight gain is 3.0%, obtains final product a kind of several mineral materials dimension having good stability
Raw element C pieces.
Although an embodiment of the present invention has been shown and described, for the ordinary skill in the art, can be with
Understanding can carry out various changes, modification, replacement to these embodiments without departing from the principles and spirit of the present invention
And modification, the scope of the present invention be defined by the appended.
Claims (7)
1. it is a kind of improve preparation in vitaminss ingredient stability production method, it is characterised in that：The concrete step of methods described
It is rapid as follows：
(1) will be the Mineral feedstocks such as iron content sameAdjuvant mixing be uniformly dispersed, using can enter into the binder solution of thin film
Row parcel granulation, is dried；
(2) vitaminss composition first uses edible oils moistening, togetherAdjuvant mixing be uniformly dispersed, then with can be into thin film
Binder solution carries out parcel granulation, cold drying；
(3) the Mineral feedstock granule and ingredient granules containing vitaminss of above-mentioned dried iron content are mixed with remaining adjuvant
Afterwards, tabletting or not tabletting, tablet coating or not coating obtain final product a kind of preparation containing vitaminss composition having good stability.
2. the production method of vitaminss ingredient stability in preparation is improved as claimed in claim 1, it is characterised in that：Step
(1), in, the Mineral feedstock of the iron content refers to that carbonyl iron, ferrous fumarate, Ferrous gluconate, ferrous sulfate, lactic acid are sub-
One or more combinations in ferrum, ferrous succinate, alternatively ferrum or iron containing compoundses are with other edible Mineral feedstocks
Combination.
3. the production method of vitaminss ingredient stability in preparation is improved as claimed in claim 1, it is characterised in that：It is described
Adjuvant refer to food or pharmaceutic adjuvant conventional and that be conducive to solid preparation molding, with the adjuvant for possessing certain non-oxidizability be
It is excellent.
4. the production method of vitaminss ingredient stability in preparation is improved as claimed in claim 1, it is characterised in that：It is described
Can be edible hypromellose (HPMC), hydroxypropylcellulose (HPC), acrylic resin IV into the binding agent of thin film
Number, polyvinylpyrrolidone (PVP), polyethylene acetal diethyl nitrilo acetic acid (AEA) etc. can be into the binding agent of thin film or coating materials
In be applied in combination for one or more, aqueous solution or ethanol solution of its solution for 0.05%-25% mass ratioes, with alcohol-soluble
Can be excellent into the binding agent of thin film and its alcoholic solution.
5. the production method of vitaminss ingredient stability in preparation is improved as claimed in claim 1, it is characterised in that：Step
(2), in, described vitaminss composition is referred to containing vitamin C in vitamin C compounds (ascorbic acid), sodium ascorbate, is resisted
One or more combination of bad hematic acid calcium, L-AA -6- palmitates (ascorbyl palmitate), alternatively vitamin
The multivitamin premix material that C compounds are combined into one or more vitaminss in needed by human body other vitamin.Institute
It can be the not form such as coating, coating or micropill to state vitaminss composition, with coating or micropill form as excellent.
6. the production method of vitaminss ingredient stability in preparation is improved as claimed in claim 1, it is characterised in that：Step
(2), in, described edible oils refers to that edible Oleum Arachidis hypogaeae semen, Oleum Ricini, olive oil, Fructus Cannabis oil, Semen Fructus Hippophae oil etc. are planted
Thing oil or Vitamin E, vitamin K1Deng oily vitamin, with possess certain non-oxidizability, mobility, one kind of non-volatility or
The arbitrary proportion of various edible oils is mixed into excellent.
7. the production method of vitaminss ingredient stability in preparation is improved as claimed in claim 1, it is characterised in that：Step
(3), in, the described preparation containing vitaminss composition having good stability is with other edible minerals containing ferrum or ferrum
The combination of material and vitamin C or vitamin C are made with one or more vitamin combinations in needed by human body other vitamin
Tablet, granule, capsule, the solid preparation such as medicinal tea.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108969527A (en) * | 2017-05-31 | 2018-12-11 | 上海通用药业股份有限公司 | A kind of pharmaceutical preparation and its preparation method and application |
| CN109528679A (en) * | 2019-01-15 | 2019-03-29 | 南宁富莱欣生物科技有限公司 | One kind includes multivitamin soft capsule and its production method |
| CN109874744A (en) * | 2019-04-08 | 2019-06-14 | 大连洪家畜牧有限公司 | A kind of production method of pregnant woman wet nurse's richness trace nutrient fresh hen egg |
| CN110327303A (en) * | 2019-08-15 | 2019-10-15 | 威海百合生物技术股份有限公司 | A kind of iron vitamin C tablet and preparation method thereof |
| CN111194925A (en) * | 2018-11-19 | 2020-05-26 | 临沂山松药业有限公司 | Total-nutrient special medical application formula food containing soybean peptide and preparation method thereof |
| CN113180245A (en) * | 2021-06-07 | 2021-07-30 | 湖北人缘堂医药生物工程有限公司 | Production method of multi-vitamin mineral tablets |
| CN115067522A (en) * | 2022-07-14 | 2022-09-20 | 养生堂药业有限公司 | Choline-containing multivitamin and mineral composition and preparation method and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108969527A (en) * | 2017-05-31 | 2018-12-11 | 上海通用药业股份有限公司 | A kind of pharmaceutical preparation and its preparation method and application |
| CN108969527B (en) * | 2017-05-31 | 2021-05-11 | 上海通用药业股份有限公司 | Medicinal preparation and its preparing method and use |
| CN111194925A (en) * | 2018-11-19 | 2020-05-26 | 临沂山松药业有限公司 | Total-nutrient special medical application formula food containing soybean peptide and preparation method thereof |
| CN109528679A (en) * | 2019-01-15 | 2019-03-29 | 南宁富莱欣生物科技有限公司 | One kind includes multivitamin soft capsule and its production method |
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| CN109874744A (en) * | 2019-04-08 | 2019-06-14 | 大连洪家畜牧有限公司 | A kind of production method of pregnant woman wet nurse's richness trace nutrient fresh hen egg |
| CN110327303A (en) * | 2019-08-15 | 2019-10-15 | 威海百合生物技术股份有限公司 | A kind of iron vitamin C tablet and preparation method thereof |
| CN113180245A (en) * | 2021-06-07 | 2021-07-30 | 湖北人缘堂医药生物工程有限公司 | Production method of multi-vitamin mineral tablets |
| CN115067522A (en) * | 2022-07-14 | 2022-09-20 | 养生堂药业有限公司 | Choline-containing multivitamin and mineral composition and preparation method and application thereof |
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