WO2023272694A1 - 一种维生素c加锌缓控释片及其制备方法 - Google Patents
一种维生素c加锌缓控释片及其制备方法 Download PDFInfo
- Publication number
- WO2023272694A1 WO2023272694A1 PCT/CN2021/104052 CN2021104052W WO2023272694A1 WO 2023272694 A1 WO2023272694 A1 WO 2023272694A1 CN 2021104052 W CN2021104052 W CN 2021104052W WO 2023272694 A1 WO2023272694 A1 WO 2023272694A1
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- WIPO (PCT)
- Prior art keywords
- parts
- vitamin
- zinc
- sustained
- agent
- Prior art date
Links
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 title claims abstract description 129
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 title claims abstract description 39
- 239000011701 zinc Substances 0.000 title claims abstract description 39
- 229910052725 zinc Inorganic materials 0.000 title claims abstract description 39
- 239000007939 sustained release tablet Substances 0.000 title claims abstract description 15
- 238000002360 preparation method Methods 0.000 title claims abstract description 10
- 229960005070 ascorbic acid Drugs 0.000 title 1
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 claims abstract description 64
- 229930003268 Vitamin C Natural products 0.000 claims abstract description 64
- 239000011718 vitamin C Substances 0.000 claims abstract description 64
- 235000019154 vitamin C Nutrition 0.000 claims abstract description 64
- 239000011248 coating agent Substances 0.000 claims abstract description 51
- 238000000576 coating method Methods 0.000 claims abstract description 51
- 238000013268 sustained release Methods 0.000 claims abstract description 39
- 239000003826 tablet Substances 0.000 claims abstract description 35
- 229940079593 drug Drugs 0.000 claims abstract description 33
- 239000003814 drug Substances 0.000 claims abstract description 33
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 30
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 25
- 239000012730 sustained-release form Substances 0.000 claims abstract description 20
- 239000000126 substance Substances 0.000 claims abstract description 17
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 15
- PTFCDOFLOPIGGS-UHFFFAOYSA-N Zinc dication Chemical compound [Zn+2] PTFCDOFLOPIGGS-UHFFFAOYSA-N 0.000 claims abstract description 14
- 229920000881 Modified starch Polymers 0.000 claims abstract description 13
- 239000012745 toughening agent Substances 0.000 claims abstract description 13
- 239000003086 colorant Substances 0.000 claims abstract description 12
- 239000012752 auxiliary agent Substances 0.000 claims abstract description 9
- 238000003756 stirring Methods 0.000 claims description 23
- 238000013270 controlled release Methods 0.000 claims description 20
- 230000002459 sustained effect Effects 0.000 claims description 19
- 239000002994 raw material Substances 0.000 claims description 16
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 12
- 239000002981 blocking agent Substances 0.000 claims description 12
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 11
- 239000004014 plasticizer Substances 0.000 claims description 11
- 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 claims description 10
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 10
- 239000000203 mixture Substances 0.000 claims description 8
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 claims description 6
- 238000004898 kneading Methods 0.000 claims description 6
- 239000000843 powder Substances 0.000 claims description 6
- 239000004408 titanium dioxide Substances 0.000 claims description 6
- 235000019483 Peanut oil Nutrition 0.000 claims description 5
- 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 claims description 5
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 5
- 235000019359 magnesium stearate Nutrition 0.000 claims description 5
- 235000010355 mannitol Nutrition 0.000 claims description 5
- 239000000312 peanut oil Substances 0.000 claims description 5
- 239000000377 silicon dioxide Substances 0.000 claims description 5
- 235000012239 silicon dioxide Nutrition 0.000 claims description 5
- 229960000306 zinc gluconate Drugs 0.000 claims description 5
- 235000011478 zinc gluconate Nutrition 0.000 claims description 5
- 239000011670 zinc gluconate Substances 0.000 claims description 5
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 4
- 229930006000 Sucrose Natural products 0.000 claims description 4
- 239000000796 flavoring agent Substances 0.000 claims description 4
- 235000013355 food flavoring agent Nutrition 0.000 claims description 4
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 4
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 4
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 4
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 4
- JEIPFZHSYJVQDO-UHFFFAOYSA-N iron(III) oxide Inorganic materials O=[Fe]O[Fe]=O JEIPFZHSYJVQDO-UHFFFAOYSA-N 0.000 claims description 4
- 239000000314 lubricant Substances 0.000 claims description 4
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims description 2
- 241000196324 Embryophyta Species 0.000 claims description 2
- 239000001856 Ethyl cellulose Substances 0.000 claims description 2
- 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 claims description 2
- 229920002774 Maltodextrin Polymers 0.000 claims description 2
- 239000005913 Maltodextrin Substances 0.000 claims description 2
- 235000019482 Palm oil Nutrition 0.000 claims description 2
- 239000002202 Polyethylene glycol Substances 0.000 claims description 2
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 2
- 239000004373 Pullulan Substances 0.000 claims description 2
- 229920001218 Pullulan Polymers 0.000 claims description 2
- 235000019484 Rapeseed oil Nutrition 0.000 claims description 2
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 2
- 235000019486 Sunflower oil Nutrition 0.000 claims description 2
- 235000019498 Walnut oil Nutrition 0.000 claims description 2
- 239000006229 carbon black Substances 0.000 claims description 2
- 235000019868 cocoa butter Nutrition 0.000 claims description 2
- 229940110456 cocoa butter Drugs 0.000 claims description 2
- 235000020186 condensed milk Nutrition 0.000 claims description 2
- 235000005687 corn oil Nutrition 0.000 claims description 2
- 239000002285 corn oil Substances 0.000 claims description 2
- 235000021552 granulated sugar Nutrition 0.000 claims description 2
- WTFXARWRTYJXII-UHFFFAOYSA-N iron(2+);iron(3+);oxygen(2-) Chemical compound [O-2].[O-2].[O-2].[O-2].[Fe+2].[Fe+3].[Fe+3] WTFXARWRTYJXII-UHFFFAOYSA-N 0.000 claims description 2
- SZVJSHCCFOBDDC-UHFFFAOYSA-N iron(II,III) oxide Inorganic materials O=[Fe]O[Fe]O[Fe]=O SZVJSHCCFOBDDC-UHFFFAOYSA-N 0.000 claims description 2
- 239000000832 lactitol Substances 0.000 claims description 2
- 235000010448 lactitol Nutrition 0.000 claims description 2
- VQHSOMBJVWLPSR-JVCRWLNRSA-N lactitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-JVCRWLNRSA-N 0.000 claims description 2
- 229960003451 lactitol Drugs 0.000 claims description 2
- 239000000845 maltitol Substances 0.000 claims description 2
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims description 2
- 235000010449 maltitol Nutrition 0.000 claims description 2
- 229940035436 maltitol Drugs 0.000 claims description 2
- 229940035034 maltodextrin Drugs 0.000 claims description 2
- 229920000609 methyl cellulose Polymers 0.000 claims description 2
- 239000001923 methylcellulose Substances 0.000 claims description 2
- 235000010981 methylcellulose Nutrition 0.000 claims description 2
- 239000004006 olive oil Substances 0.000 claims description 2
- 235000008390 olive oil Nutrition 0.000 claims description 2
- 239000002540 palm oil Substances 0.000 claims description 2
- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 2
- 229940068984 polyvinyl alcohol Drugs 0.000 claims description 2
- 235000019422 polyvinyl alcohol Nutrition 0.000 claims description 2
- 235000019423 pullulan Nutrition 0.000 claims description 2
- 239000008159 sesame oil Substances 0.000 claims description 2
- 235000011803 sesame oil Nutrition 0.000 claims description 2
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 2
- OKODKVMXHLUQSW-JITBQSAISA-M sodium;(e)-4-hydroxy-4-oxobut-2-enoate;octadecanoic acid Chemical compound [Na+].OC(=O)\C=C\C([O-])=O.CCCCCCCCCCCCCCCCCC(O)=O OKODKVMXHLUQSW-JITBQSAISA-M 0.000 claims description 2
- 239000003549 soybean oil Substances 0.000 claims description 2
- 235000012424 soybean oil Nutrition 0.000 claims description 2
- 239000005720 sucrose Substances 0.000 claims description 2
- 239000002600 sunflower oil Substances 0.000 claims description 2
- 239000008170 walnut oil Substances 0.000 claims description 2
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 claims description 2
- NWONKYPBYAMBJT-UHFFFAOYSA-L zinc sulfate Chemical compound [Zn+2].[O-]S([O-])(=O)=O NWONKYPBYAMBJT-UHFFFAOYSA-L 0.000 claims description 2
- 229960001763 zinc sulfate Drugs 0.000 claims description 2
- 229910000368 zinc sulfate Inorganic materials 0.000 claims description 2
- 239000003361 porogen Substances 0.000 claims 3
- NPYPAHLBTDXSSS-UHFFFAOYSA-N Potassium ion Chemical compound [K+] NPYPAHLBTDXSSS-UHFFFAOYSA-N 0.000 claims 1
- 235000010944 ethyl methyl cellulose Nutrition 0.000 claims 1
- 235000003891 ferrous sulphate Nutrition 0.000 claims 1
- 239000011790 ferrous sulphate Substances 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
- 229920003087 methylethyl cellulose Polymers 0.000 claims 1
- 239000008188 pellet Substances 0.000 claims 1
- 229910001414 potassium ion Inorganic materials 0.000 claims 1
- 229910052814 silicon oxide Inorganic materials 0.000 claims 1
- 239000000454 talc Substances 0.000 claims 1
- 235000012222 talc Nutrition 0.000 claims 1
- 229910052623 talc Inorganic materials 0.000 claims 1
- 235000010215 titanium dioxide Nutrition 0.000 claims 1
- 238000010521 absorption reaction Methods 0.000 abstract description 7
- 238000006911 enzymatic reaction Methods 0.000 abstract description 4
- 102000014914 Carrier Proteins Human genes 0.000 abstract description 3
- 108010078791 Carrier Proteins Proteins 0.000 abstract description 3
- 230000009056 active transport Effects 0.000 abstract description 3
- 210000000170 cell membrane Anatomy 0.000 abstract description 3
- 230000001502 supplementing effect Effects 0.000 abstract description 3
- 230000002035 prolonged effect Effects 0.000 abstract 3
- 230000032258 transport Effects 0.000 abstract 1
- 241000282414 Homo sapiens Species 0.000 description 8
- 239000000654 additive Substances 0.000 description 5
- 230000007774 longterm Effects 0.000 description 4
- 102000008186 Collagen Human genes 0.000 description 3
- 108010035532 Collagen Proteins 0.000 description 3
- 210000000988 bone and bone Anatomy 0.000 description 3
- 229920001436 collagen Polymers 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 208000032843 Hemorrhage Diseases 0.000 description 2
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 208000034158 bleeding Diseases 0.000 description 2
- 230000000740 bleeding effect Effects 0.000 description 2
- 210000004204 blood vessel Anatomy 0.000 description 2
- 230000036039 immunity Effects 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 210000000515 tooth Anatomy 0.000 description 2
- 239000011573 trace mineral Substances 0.000 description 2
- 235000013619 trace mineral Nutrition 0.000 description 2
- 239000002699 waste material Substances 0.000 description 2
- 241000282412 Homo Species 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- IOVCWXUNBOPUCH-UHFFFAOYSA-M Nitrite anion Chemical compound [O-]N=O IOVCWXUNBOPUCH-UHFFFAOYSA-M 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000000840 anti-viral effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 231100000357 carcinogen Toxicity 0.000 description 1
- 239000003183 carcinogenic agent Substances 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000002925 chemical effect Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 238000001784 detoxification Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229920001249 ethyl cellulose Polymers 0.000 description 1
- 235000019325 ethyl cellulose Nutrition 0.000 description 1
- 229910052742 iron Inorganic materials 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 238000003760 magnetic stirring Methods 0.000 description 1
- 210000004995 male reproductive system Anatomy 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 230000033116 oxidation-reduction process Effects 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 150000003335 secondary amines Chemical class 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 230000009469 supplementation Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 230000029663 wound healing Effects 0.000 description 1
Classifications
-
- 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
- A61K33/30—Zinc; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
Definitions
- the invention relates to the technical field of vitamin C sustained release, in particular to a vitamin C plus zinc sustained and controlled release tablet and a preparation method thereof.
- Vitamin C is one of the indispensable substances for human beings. It assists various enzyme reactions in the body. Vitamin C plays an important role in the formation of collagen. Collagen is an important substance for the development and repair of human tissue cells, gums, blood vessels, bones, and teeth; it helps the body absorb iron; it accelerates the consumption of vitamin C in a state of tension. Vitamin C participates in the oxidation-reduction process in the body, promotes the growth and development of the human body, enhances the body's resistance to diseases, promotes the formation of collagen in the intercellular substance, maintains the normal functions of teeth, bones, blood vessels and muscles, and enhances the detoxification ability of the liver.
- vitamin C can prevent nitrite and secondary amines from combining in the stomach to form carcinogens - deamines, thereby reducing the incidence of cancer. Humans cannot synthesize it by themselves and need to ingest it from the outside world. In addition to daily vitamin C intake, oral vitamin C tablets are a good way to supplement vitamin C. However, vitamin C is prone to chemical effects during long-term storage and transportation. Changes, the rapid release of a large amount of vitamin C in the human body will also cause unnecessary waste of drugs.
- the object of the present invention is to provide a vitamin C plus zinc slow-release tablet and its preparation method, vitamin C and zinc are mixed together, vitamin C plus zinc is prepared into a slow-release tablet, and vitamin C is supplemented orally while supplementing trace elements
- Zinc is conducive to the smooth progress of various enzyme reactions in the human body. It has good toughness and wear resistance. It can be released at a long-term and uniform rate through the slow-release coating. The absorption of zinc requires the active transport of carrier proteins on the cell membrane, and the longer Longer release time can avoid short-term carrier saturation, and longer release time and carrier transit time can improve absorption utilization.
- the present invention provides the following technical solutions:
- a vitamin C plus zinc sustained and controlled release tablet which is composed of a tablet-shaped drug core and a sustained-release coating, and the tablet-shaped drug core includes the following raw materials in parts by weight:
- the sustained-release coating comprises the following raw materials in parts by weight:
- a vitamin C plus zinc sustained and controlled release tablet is composed of a sheet-shaped drug core and a sustained-release coating
- the sheet-shaped drug core includes the following raw materials in parts by weight: 12 to 14 parts of vitamin C; substances containing zinc ions 12-14 parts; water balance;
- the slow-release coating includes the following raw materials in parts by weight: 30-60 parts of main film-forming agent; 12-18 parts of pregelatinized starch; 7-13 parts of toughening agent; 5-7 parts of adhesive; 3-5 parts of plasticizer; 2-4 parts of colorant; 2-4 parts of auxiliary agent; the balance of ethanol.
- the zinc ion-containing substance is one or both of zinc sulfate and zinc gluconate.
- the main film-forming agent is one or more of methylcellulose, ethylcellulose, and hydroxypropylmethylcellulose.
- the toughening agent is one or more of rapeseed oil, soybean oil, olive oil, walnut oil, peanut oil, cocoa butter, sunflower oil, condensed milk, sesame oil, palm oil, and corn oil.
- the plasticizer is one or more of D-mannitol, polyvinyl alcohol, maltitol, lactitol and polyethylene glycol.
- the colorant is one or more of plant carbon black, black iron oxide, red iron oxide, and yellow iron oxide; the ethanol is absolute ethanol with a volume fraction of 95%.
- the auxiliary agent includes one or more of flavoring agent, pore forming agent and lubricant.
- the flavoring agent includes one or more of sucrose, white granulated sugar, maltodextrin, soft white sugar, and pullulan; the pore-forming agent is a soluble pore-forming agent; the lubricant is magnesium stearate, One or more of zinc stearate, sodium lauryl sulfate, and sodium stearate fumarate.
- a vitamin C plus zinc sustained and controlled release tablet is composed of a sheet-shaped drug core and a sustained-release coating
- the sheet-shaped drug core includes the following raw materials in parts by weight: vitamin C 10-15 parts; zinc gluconate 10-15 parts; water balance;
- the slow-release coating includes the following raw materials in parts by weight: 20-80 parts of hydroxypropyl methylcellulose; 10-20 parts of pregelatinized starch; 5-15 parts of peanut oil; 3-8 parts of anti-blocking agent; 2-6 parts of D-mannitol; 1-5 parts of red iron oxide; 1-5 parts of magnesium stearate; the balance of ethanol.
- the preparation method of the vitamin C plus zinc sustained and controlled release tablet comprises the following steps:
- step (3) Put the sheet drug core obtained in step (1) into a coating machine, add the slow-release coating solution obtained in step (2), adjust temperature, pressure, coating speed, and coat the sheet drug core Clothes, get sustained-release tablets.
- Vitamin C and zinc are mixed together.
- the trace element zinc is supplemented, which is not only conducive to the smooth progress of various enzyme reactions in the human body, but also promotes children's intellectual development and improves immunity.
- zinc supplementation also has a nutritional effect on the male reproductive system, especially to improve antiviral immunity.
- the functional film-forming agent increases the wear resistance of the coating
- the addition of toughening agents and other additives increases the toughness of the coating, which is conducive to the preservation of vitamin C, so that it will not occur during long-term storage. Deterioration due to chemical reactions such as oxidation; the coating has the function of slow and controlled release, which makes the drug release slowly for a long time, which is beneficial to the slow absorption of vitamin C and zinc, and will not cause waste due to rapid release.
- the addition of various additives can control the release rate of the drug from the coating, adjust the color and taste of the coating, etc., so that the oral administration of vitamin C and zinc is more in line with human taste, etc., and avoid conflicts caused by oral administration.
- Sustained-release tablets are prepared by adding vitamin C and zinc. Long-term and uniform release can be achieved through slow-release coating, which can reduce production costs, and the release time can be longer than that of matrix sustained-release tablets. In addition, the absorption of zinc requires active transport of the carrier protein on the cell membrane. A longer release time can avoid short-term carrier saturation, and a longer release time and carrier transit time can improve the absorption utilization rate.
- Vitamin C plus zinc sustained and controlled release tablet is composed of a tablet core and a sustained release coating.
- the tablet core includes the following raw materials in parts by weight: 10 parts of vitamin C, 10 parts of zinc ion-containing substances, and the balance of water ;
- the sustained-release coating includes the following raw materials in parts by weight: 20 parts of main film-forming agent, 10 parts of pregelatinized starch, 5 parts of toughening agent, 3 parts of anti-blocking agent, 2 parts of plasticizer, 1 part of coloring agent part, 1 part of additive, and the balance of ethanol.
- the preparation method of the vitamin C plus zinc sustained and controlled release tablet comprises the following steps:
- step (3) Put the sheet drug core obtained in step (1) into a coating machine, add the slow-release coating solution obtained in step (2), adjust temperature, pressure, coating speed, and coat the sheet drug core Clothes, get sustained-release tablets.
- Vitamin C plus zinc sustained and controlled release tablet is composed of a tablet core and a sustained release coating.
- the tablet core includes the following raw materials in parts by weight: 15 parts of vitamin C, 15 parts of zinc ion-containing substances, and the balance of water ;
- the sustained-release coating includes the following raw materials in parts by weight: 80 parts of main film-forming agent, 20 parts of pregelatinized starch, 15 parts of toughening agent, 8 parts of anti-blocking agent, 6 parts of plasticizer, 5 parts of colorant parts, 5 parts of additives, and the balance of ethanol.
- the preparation method of the vitamin C plus zinc sustained and controlled release tablet comprises the following steps:
- step (3) Put the sheet drug core obtained in step (1) into a coating machine, add the slow-release coating solution obtained in step (2), adjust temperature, pressure, coating speed, and coat the sheet drug core Clothes, get sustained-release tablets.
- Vitamin C plus zinc sustained and controlled release tablet is composed of a tablet core and a sustained release coating.
- the tablet core includes the following raw materials in parts by weight: 13 parts of vitamin C, 13 parts of zinc ion-containing substances, and the balance of water ;
- the sustained-release coating includes the following raw materials in parts by weight: 60 parts of main film-forming agent, 15 parts of pregelatinized starch, 10 parts of toughening agent, 5 parts of anti-blocking agent, 4 parts of plasticizer, 3 parts of colorant parts, 3 parts of additives, and the balance of ethanol.
- the preparation method of the vitamin C plus zinc sustained and controlled release tablet comprises the following steps:
- step (3) Put the sheet drug core obtained in step (1) into a coating machine, add the slow-release coating solution obtained in step (2), adjust temperature, pressure, coating speed, and coat the sheet drug core Clothes, get sustained-release tablets.
- Vitamin C plus zinc sustained and controlled release tablet is composed of a sheet-shaped drug core and a sustained-release coating.
- the sheet-shaped drug core includes the following raw materials in parts by weight: 15 parts of vitamin C; 15 parts of zinc gluconate; the balance of water;
- the sustained-release coating includes the following raw materials in parts by weight: 50 parts of hydroxypropyl methylcellulose; 15 parts of pregelatinized starch; 10 parts of peanut oil; 5 parts of anti-blocking agent; 4 parts of D-mannitol; 3 parts of iron oxide; 3 parts of magnesium stearate; balance of ethanol.
- the preparation method of the vitamin C plus zinc sustained and controlled release tablet comprises the following steps:
- step (3) Put the sheet drug core obtained in step (1) into a coating machine, add the slow-release coating solution obtained in step (2), adjust temperature, pressure, coating speed, and coat the sheet drug core Clothes, get sustained-release tablets.
- Embodiment 1-4 sustained and controlled-release tablets are measured for release according to the method stipulated in "Chinese Pharmacopoeia” 2010, and the results are as follows in Table 1:
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Abstract
本发明涉及维生素C缓释技术领域，具体涉及一种维生素C加锌缓控释片及其制备方法。由片状药芯与缓释包衣组成，片状药芯包括原料是维生素C 10～15份，含锌离子物质10～15份，水余量；缓释包衣包括原料是主成膜剂20～80份，预胶化淀粉10～20份，增韧剂5～15份，抗粘连剂3～8份，增塑剂2～6份，着色剂1～5份，助剂1～5份，乙醇余量。维生素C与锌混合，在补充维生素C同时，补充微量元素锌，有利于人体内多种酶反应的顺利进行，具有很好的韧性、耐磨性，通过缓控释包衣实现长效匀速释放，锌的吸收要细胞膜上载体蛋白进行主动转运，更长的释放时间，可避免短期载体饱和，更长释放时间和载体转运时间，提高吸收利用率。
Description
本发明涉及维生素C缓释技术领域，具体涉及一种维生素C加锌缓控释片及其制备方法。
维生素C是人类不可或缺的物质之一，辅助体内多种酶反应，维生素C在胶原质的形成上扮演很重要的角色。胶原质对于人体的组织细胞、牙龈、血管、骨骼、牙齿的发育和修复是一种重要的物质；帮助人体内铁的吸收；在紧张状态时，会加速维生素C的消耗。维生素C参加体内的氧化还原过程，促进人体的生长发育，增强人体对疾病的抵抗能力，促进细胞间质中胶原的形成，维持牙齿、骨骼、血管和肌肉的正常功能，增强肝脏的解毒能力。当人体中缺少维生素C时，就会出现牙龈出血、牙齿松动、骨骼脆弱、粘膜及皮下易出血、伤口不易愈合等症状。近年来，科学家们还发现，维生素C能阻止亚硝酸盐和仲胺在胃内结合成致癌物质——亚脱胺，从而减低癌的发病率。人类不能自身合成，需要从外界摄取，在日常的维生素C摄入外，口服维生素C片是维生素C补充的一个很好的途径，但维生素C在长期保存和运输过程中，易产生化学效应，发生变化，人体内大量维生素C的快速释放同样会造成药物不必要的浪费。
发明内容
本发明的目的是提供一种维生素C加锌缓控释片及其制备方法，维生素C与锌共同混合，生素C加锌制备成缓释片，在口服补充维生素C的同时，补充微量元素锌，有利于人体内多种酶反应的顺利进行，具有很好的韧性、耐磨性， 通过缓控释包衣实现长效匀速释放，锌的吸收需要细胞膜上载体蛋白进行主动转运，更长的释放时间，可以避免短期载体饱和，更长的释放时间和载体转运时间，可以提高吸收利用率。
为了达到上述目的，本发明提供如下技术方案：
一种维生素C加锌缓控释片，由片状药芯与缓释包衣组成，所述片状药芯包括以下重量份数的原料：
维生素C 10～15份；
含锌离子物质 10～15份；
水 余量；
所述缓释包衣包括以下重量份数的原料：
优选，一种维生素C加锌缓控释片，由片状药芯与缓释包衣组成，所述片状药芯包括以下重量份数的原料：维生素C 12～14份；含锌离子物质12～14份；水余量；所述缓释包衣包括以下重量份数的原料：主成膜剂30～60份；预胶化淀粉12～18份；增韧剂7～13份；抗粘连剂5～7份；增塑剂3～5份；着色剂2～4份；助剂2～4份；乙醇余量。
所述含锌离子物质为硫酸锌、葡萄糖酸锌中的一种或两种。
所述主成膜剂为甲基纤维素、乙基纤维素、羟丙基甲基纤维素的一种或多种。
所述增韧剂为菜籽油、大豆油、橄榄油、核桃油、花生油、可可脂、葵花籽油、炼乳、芝麻油、棕榈油、玉米油中的一种或多种。
所述抗粘连剂为二氧化硅、二氧化钛、滑石粉混合，二氧化硅：二氧化钛：滑石粉的重量比例为二氧化硅：二氧化钛：滑石粉＝1:3:2。
所述增塑剂为D-甘露糖醇、聚乙烯醇、麦芽糖醇、乳糖醇、聚乙二醇中的一种或多种。
所述着色剂为植物炭黑、黑氧化铁、红氧化铁、黄氧化铁的一种或多种；所述乙醇为体积分数为95％的无水乙醇。
所述助剂包括调味剂、致孔剂、润滑剂中的一种或多种。
所述调味剂包括蔗糖、白砂糖、麦芽糊精、绵白糖、普鲁兰多糖中的一种或多种；所述致孔剂为可溶性致孔剂；所述润滑剂为硬脂酸镁、硬脂酸锌、十二烷基硫酸钠、硬脂酸富马酸钠中的一种或多种。
进一步方案，一种维生素C加锌缓控释片，由片状药芯与缓释包衣组成，所述片状药芯包括以下重量份数的原料：维生素C 10～15份；葡萄糖酸锌10～15份；水余量；所述缓释包衣包括以下重量份数的原料：羟丙基甲基纤维素20～80份；预胶化淀粉10～20份；花生油5～15份；抗粘连剂3～8份；D-甘露糖醇2～6份；红氧化铁1～5份；硬脂酸镁1～5份；乙醇余量。
所述的维生素C加锌缓控释片，制备方法包括以下步骤：
(1)称取重量份数的维生素C粉碎成粉，加入重量份数的含锌离子物质，搅拌混合均匀后，加入水，持续搅拌，使其成粘稠状，放入捏片机中，进行片状药芯的捏制；
(2)用重量份数的乙醇溶解重量份数的主成膜剂，磁力搅拌2h后，过100目筛，除去不溶物，依次加入重量份数的预胶化淀粉、增韧剂、抗粘连剂、增塑剂、着色剂、助剂，继续搅拌2h，得到缓释包衣液；
(3)将步骤(1)得到的片状药芯放入包衣机中，加入步骤(2)得到的缓释包衣液，调节温度、压力、包衣速度，对片状药芯进行包衣，得缓控释片。
与现有技术相比，本发明的优点：
1、维生素C与锌共同混合，在口服补充维生素C的同时，补充微量元素锌，不仅有利于人体内多种酶反应的顺利进行，而且促进儿童智力发育，提高免疫力。此外，锌元素的补充，对男性生殖系统也有营养作用，尤其是可以提高抗病毒免疫力。
2、缓释包衣的应用，功能成膜剂增加包衣的耐磨性，增韧剂等助剂的加入增加包衣的韧性，有利于维生素C的保存，使得在长期保存时不会发生氧化等化学反应而变质；包衣具有缓控释放的作用，使得药物在长时间缓慢释放，有利于维生素C和锌的缓慢吸收，不会因快速释放造成浪费。
3、各种助剂的加入，控制包衣对药物释放的速度，调节包衣的颜色，口味等，使得维生素C和锌的口服更加符合人的口味等，避免口服时引起的抵触等。
4、维生素C加锌制备成缓释片，通过缓控释包衣实现长效匀速释放，可降低生产成本低，且释放时间可以比骨架缓释片释放时间更长。此外，锌的吸收需要细胞膜上载体蛋白进行主动转运，更长的释放时间，可以避免短期载体饱和，更长的释放时间和载体转运时间，可以提高吸收利用率。
下面结合实施例对本发明做进一步的说明，以下所述，仅是对本发明的较佳实施例而已，并非对本发明做其他形式的限制，任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为同等变化的等效实施例。凡是未脱离本发明方案内容，依据本发明的技术实质对以上实施例所做的任何简单修改、等同变化与改型，均落在本发明的保护范围内。
实施例1
维生素C加锌缓控释片，由片状药芯与缓释包衣组成，所述片状药芯包括 以下重量份数的原料：维生素C 10份，含锌离子物质10份，水余量；所述缓释包衣包括以下重量份数的原料：主成膜剂20份，预胶化淀粉10份，增韧剂5份，抗粘连剂3份，增塑剂2份，着色剂1份，助剂1份，乙醇余量。
所述的维生素C加锌缓控释片，制备方法包括以下步骤：
(1)称取重量份数的维生素C粉碎成粉，加入重量份数的含锌离子物质，搅拌混合均匀后，加入水，持续搅拌，使其成粘稠状，放入捏片机中，进行片状药芯的捏制；
(2)用重量份数的乙醇溶解重量份数的主成膜剂，磁力搅拌2h后，过100目筛，除去不溶物，依次加入重量份数的预胶化淀粉、增韧剂、抗粘连剂、增塑剂、着色剂、助剂，继续搅拌2h，得到缓释包衣液；
(3)将步骤(1)得到的片状药芯放入包衣机中，加入步骤(2)得到的缓释包衣液，调节温度、压力、包衣速度，对片状药芯进行包衣，得缓控释片。
实施例2
维生素C加锌缓控释片，由片状药芯与缓释包衣组成，所述片状药芯包括以下重量份数的原料：维生素C 15份，含锌离子物质15份，水余量；所述缓释包衣包括以下重量份数的原料：主成膜剂80份，预胶化淀粉20份，增韧剂15份，抗粘连剂8份，增塑剂6份，着色剂5份，助剂5份，乙醇余量。
所述的维生素C加锌缓控释片，制备方法包括以下步骤：
(1)称取重量份数的维生素C粉碎成粉，加入重量份数的含锌离子物质，搅拌混合均匀后，加入水，持续搅拌，使其成粘稠状，放入捏片机中，进行片状药芯的捏制；
(2)用重量份数的乙醇溶解重量份数的主成膜剂，磁力搅拌2h后，过100目筛，除去不溶物，依次加入重量份数的预胶化淀粉、增韧剂、抗粘连剂、增塑剂、着色剂、助剂，继续搅拌2h，得到缓释包衣液；
(3)将步骤(1)得到的片状药芯放入包衣机中，加入步骤(2)得到的缓释包衣液，调节温度、压力、包衣速度，对片状药芯进行包衣，得缓控释片。
实施例3
维生素C加锌缓控释片，由片状药芯与缓释包衣组成，所述片状药芯包括以下重量份数的原料：维生素C 13份，含锌离子物质13份，水余量；所述缓释包衣包括以下重量份数的原料：主成膜剂60份，预胶化淀粉15份，增韧剂10份，抗粘连剂5份，增塑剂4份，着色剂3份，助剂3份，乙醇余量。
所述的维生素C加锌缓控释片，制备方法包括以下步骤：
(1)称取重量份数的维生素C粉碎成粉，加入重量份数的含锌离子物质，搅拌混合均匀后，加入水，持续搅拌，使其成粘稠状，放入捏片机中，进行片状药芯的捏制；
(2)用重量份数的乙醇溶解重量份数的主成膜剂，磁力搅拌2h后，过100目筛，除去不溶物，依次加入重量份数的预胶化淀粉、增韧剂、抗粘连剂、增塑剂、着色剂、助剂，继续搅拌2h，得到缓释包衣液；
(3)将步骤(1)得到的片状药芯放入包衣机中，加入步骤(2)得到的缓释包衣液，调节温度、压力、包衣速度，对片状药芯进行包衣，得缓控释片。
实施例4
维生素C加锌缓控释片，由片状药芯与缓释包衣组成，所述片状药芯包括以下重量份数的原料：维生素C 15份；葡萄糖酸锌15份；水余量；所述缓释包衣包括以下重量份数的原料：羟丙基甲基纤维素50份；预胶化淀粉15份；花生油10份；抗粘连剂5份；D-甘露糖醇4份；红氧化铁3份；硬脂酸镁3份；乙醇余量。
所述的维生素C加锌缓控释片，制备方法包括以下步骤：
(1)称取重量份数的维生素C粉碎成粉，加入重量份数的葡萄糖酸锌，搅拌混合均匀后，加入水，持续搅拌，使其成粘稠状，放入捏片机中，进行片状药芯的捏制；
(2)用重量份数的乙醇溶解重量份数的主成膜剂，磁力搅拌2h后，过100目筛，除去不溶物，依次加入重量份数的预胶化淀粉、花生油、抗粘连剂、D- 甘露糖醇、红氧化铁、硬脂酸镁，继续搅拌2h，得到缓释包衣液；
(3)将步骤(1)得到的片状药芯放入包衣机中，加入步骤(2)得到的缓释包衣液，调节温度、压力、包衣速度，对片状药芯进行包衣，得缓控释片。
将实施例1-4缓控释片按《中国药典》2010中规定的方法对释放度进行测定，测定结果如下表1：
表1
由表1可以看出，由实施例1-4提供的维生素C加锌缓控释片在不同的环境中均具有较好的释放性能，且均匀缓慢释放。
以上所述，仅为本发明的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应所述以权利要求的保护范围为准。
Claims (10)
- 一种维生素C加锌缓控释片，由片状药芯与缓释包衣组成，其特征在于，所述片状药芯包括以下重量份数的原料：维生素C 10～15份；含锌离子物质 10～15份；水 余量；所述缓释包衣包括以下重量份数的原料：
- 根据权利要求1所述的维生素C加锌缓控释片，其特征在于：所述含锌离子物质为硫酸锌、葡萄糖酸锌中的一种或两种。
- 根据权利要求1所述的维生素C加锌缓控释片，其特征在于：所述主成膜剂为甲基纤维素、乙基纤维素、羟丙基甲基纤维素的一种或多种。
- 根据权利要求1所述的维生素C加锌缓控释片，其特征在于：所述增韧剂为菜籽油、大豆油、橄榄油、核桃油、花生油、可可脂、葵花籽油、炼乳、芝麻油、棕榈油、玉米油中的一种或多种。
- 根据权利要求1所述的维生素C硫酸亚铁缓控释片，其特征在于：所述抗粘连剂为二氧化硅、二氧化钛、滑石粉混合，二氧化硅：二氧化钛：滑石粉的重量比例为二氧化硅：二氧化钛：滑石粉＝1:3:2。
- 根据权利要求1所述的维生素C加锌缓控释片，其特征在于：所述增塑剂为D-甘露糖醇、聚乙烯醇、麦芽糖醇、乳糖醇、聚乙二醇中的一种或多种。
- 根据权利要求1所述的钾离子缓释微丸，其特征在于，所述着色剂为植物炭黑、黑氧化铁、红氧化铁、黄氧化铁的一种或多种；所述乙醇为体积分数为95％的无水乙醇。
- 根据权利要求1所述的一种维生素C加锌缓控释片，其特征在于：所述助剂包括调味剂、致孔剂、润滑剂中的一种或多种。
- 根据权利要求8所述的维生素C加锌缓控释片，所述调味剂包括蔗糖、白砂糖、麦芽糊精、绵白糖、普鲁兰多糖中的一种或多种；所述致孔剂为可溶性致孔剂；所述润滑剂为硬脂酸镁、硬脂酸锌、十二烷基硫酸钠、硬脂酸富马酸钠中的一种或多种。
- 根据权利要求1-9任意一项所述的维生素C加锌缓控释片，其特征在于，制备方法包括以下步骤：(1)称取重量份数的维生素C粉碎成粉，加入重量份数的含锌离子物质，搅拌混合均匀后，加入水，持续搅拌，使其成粘稠状，放入捏片机中，进行片状药芯的捏制；(2)用重量份数的乙醇溶解重量份数的主成膜剂，磁力搅拌2h后，过100目筛，除去不溶物，依次加入重量份数的预胶化淀粉、增韧剂、抗粘连剂、增塑剂、着色剂、助剂，继续搅拌2h，得到缓释包衣液；(3)将步骤(1)得到的片状药芯放入包衣机中，加入步骤(2)得到的缓释包衣液，调节温度、压力、包衣速度，对片状药芯进行包衣，得缓控释片。
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