CN106619128B - sealing composition for capsules and sealing method thereof - Google Patents
sealing composition for capsules and sealing method thereof Download PDFInfo
- Publication number
- CN106619128B CN106619128B CN201510742615.6A CN201510742615A CN106619128B CN 106619128 B CN106619128 B CN 106619128B CN 201510742615 A CN201510742615 A CN 201510742615A CN 106619128 B CN106619128 B CN 106619128B
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- CN
- China
- Prior art keywords
- capsule
- solute
- composition
- aqueous solution
- solution
- 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.)
- Expired - Fee Related
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- 239000002775 capsule Substances 0.000 title claims abstract description 175
- 238000007789 sealing Methods 0.000 title claims abstract description 68
- 239000000203 mixture Substances 0.000 title claims abstract description 57
- 238000000034 method Methods 0.000 title claims abstract description 36
- 239000002904 solvent Substances 0.000 claims abstract description 36
- 230000002378 acidificating effect Effects 0.000 claims abstract 7
- 108010010803 Gelatin Proteins 0.000 claims description 21
- 239000008273 gelatin Substances 0.000 claims description 21
- 229920000159 gelatin Polymers 0.000 claims description 21
- 235000019322 gelatine Nutrition 0.000 claims description 21
- 235000011852 gelatine desserts Nutrition 0.000 claims description 21
- 239000007864 aqueous solution Substances 0.000 claims description 19
- 239000000243 solution Substances 0.000 claims description 16
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 15
- 238000011049 filling Methods 0.000 claims description 14
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 14
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 13
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 13
- DNIAPMSPPWPWGF-UHFFFAOYSA-N monopropylene glycol Natural products CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 12
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 10
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 9
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical group OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 9
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 9
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 9
- 239000012047 saturated solution Substances 0.000 claims description 9
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 8
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims description 8
- 239000000463 material Substances 0.000 claims description 8
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical group [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims description 7
- 229960004063 propylene glycol Drugs 0.000 claims description 7
- 229920002907 Guar gum Polymers 0.000 claims description 6
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 claims description 6
- 239000000665 guar gum Substances 0.000 claims description 6
- 235000010417 guar gum Nutrition 0.000 claims description 6
- 229960002154 guar gum Drugs 0.000 claims description 6
- 239000007788 liquid Substances 0.000 claims description 6
- 239000004014 plasticizer Substances 0.000 claims description 6
- 235000013772 propylene glycol Nutrition 0.000 claims description 6
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 5
- 230000009471 action Effects 0.000 claims description 5
- 239000012670 alkaline solution Substances 0.000 claims description 5
- 239000003605 opacifier Substances 0.000 claims description 5
- 150000007524 organic acids Chemical class 0.000 claims description 5
- 239000000843 powder Substances 0.000 claims description 5
- 239000000600 sorbitol Substances 0.000 claims description 5
- DNIAPMSPPWPWGF-GSVOUGTGSA-N (R)-(-)-Propylene glycol Chemical compound C[C@@H](O)CO DNIAPMSPPWPWGF-GSVOUGTGSA-N 0.000 claims description 4
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 4
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 claims description 4
- 239000003929 acidic solution Substances 0.000 claims description 4
- 229910000272 alkali metal oxide Inorganic materials 0.000 claims description 4
- 239000000451 gelidium spp. gum Substances 0.000 claims description 4
- 235000011187 glycerol Nutrition 0.000 claims description 4
- 150000007522 mineralic acids Chemical class 0.000 claims description 4
- 229920001282 polysaccharide Polymers 0.000 claims description 4
- 239000005017 polysaccharide Substances 0.000 claims description 4
- 230000008569 process Effects 0.000 claims description 4
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims description 3
- MIDXCONKKJTLDX-UHFFFAOYSA-N 3,5-dimethylcyclopentane-1,2-dione Chemical compound CC1CC(C)C(=O)C1=O MIDXCONKKJTLDX-UHFFFAOYSA-N 0.000 claims description 3
- 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 3
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 3
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 3
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims description 3
- 229930195725 Mannitol Natural products 0.000 claims description 3
- 239000002202 Polyethylene glycol Substances 0.000 claims description 3
- 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 3
- 229930006000 Sucrose Natural products 0.000 claims description 3
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 3
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 3
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 3
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims description 3
- 235000013736 caramel Nutrition 0.000 claims description 3
- 229940014259 gelatin Drugs 0.000 claims description 3
- 239000008103 glucose Substances 0.000 claims description 3
- 239000008187 granular material Substances 0.000 claims description 3
- 229960003943 hypromellose Drugs 0.000 claims description 3
- 239000000594 mannitol Substances 0.000 claims description 3
- 235000010355 mannitol Nutrition 0.000 claims description 3
- 229960001855 mannitol Drugs 0.000 claims description 3
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 3
- 239000006072 paste Substances 0.000 claims description 3
- 229920001223 polyethylene glycol Polymers 0.000 claims description 3
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 claims description 3
- 239000005720 sucrose Substances 0.000 claims description 3
- 229960004793 sucrose Drugs 0.000 claims description 3
- 239000000725 suspension Substances 0.000 claims description 3
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 claims description 3
- 239000000811 xylitol Substances 0.000 claims description 3
- 229960002675 xylitol Drugs 0.000 claims description 3
- 235000010447 xylitol Nutrition 0.000 claims description 3
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 3
- 229910000287 alkaline earth metal oxide Inorganic materials 0.000 claims description 2
- 238000007865 diluting Methods 0.000 claims description 2
- 235000013402 health food Nutrition 0.000 claims description 2
- 239000008194 pharmaceutical composition Substances 0.000 claims description 2
- 238000005538 encapsulation Methods 0.000 claims 2
- 150000004676 glycans Chemical class 0.000 claims 1
- 230000009919 sequestration Effects 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 12
- 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 description 10
- 239000002994 raw material Substances 0.000 description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 7
- 229940079593 drug Drugs 0.000 description 6
- 239000007902 hard capsule Substances 0.000 description 6
- 239000007901 soft capsule Substances 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 5
- 239000000654 additive Substances 0.000 description 4
- 239000003513 alkali Substances 0.000 description 4
- 239000000126 substance Substances 0.000 description 4
- 102000008186 Collagen Human genes 0.000 description 3
- 108010035532 Collagen Proteins 0.000 description 3
- 239000002253 acid Substances 0.000 description 3
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- 239000011248 coating agent Substances 0.000 description 3
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- 239000000825 pharmaceutical preparation Substances 0.000 description 3
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- 150000004804 polysaccharides Chemical class 0.000 description 3
- 241000283690 Bos taurus Species 0.000 description 2
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 229920002472 Starch Polymers 0.000 description 2
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- 238000006243 chemical reaction Methods 0.000 description 2
- NEHMKBQYUWJMIP-UHFFFAOYSA-N chloromethane Chemical compound ClC NEHMKBQYUWJMIP-UHFFFAOYSA-N 0.000 description 2
- 239000002552 dosage form Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 235000013305 food Nutrition 0.000 description 2
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- 239000008107 starch Substances 0.000 description 2
- 235000019698 starch Nutrition 0.000 description 2
- FCGXLCNBWYIEAA-UHFFFAOYSA-N 1,3-benzothiazol-6-ylmethanamine Chemical compound NCC1=CC=C2N=CSC2=C1 FCGXLCNBWYIEAA-UHFFFAOYSA-N 0.000 description 1
- 229920001817 Agar Polymers 0.000 description 1
- 241001474374 Blennius Species 0.000 description 1
- 235000008733 Citrus aurantifolia Nutrition 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- 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 1
- 229920000881 Modified starch Polymers 0.000 description 1
- GOOHAUXETOMSMM-UHFFFAOYSA-N Propylene oxide Chemical compound CC1CO1 GOOHAUXETOMSMM-UHFFFAOYSA-N 0.000 description 1
- 241000282887 Suidae Species 0.000 description 1
- 235000011941 Tilia x europaea Nutrition 0.000 description 1
- 229920001938 Vegetable gum Polymers 0.000 description 1
- 238000007259 addition reaction Methods 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
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- 235000010419 agar Nutrition 0.000 description 1
- 150000001298 alcohols Chemical class 0.000 description 1
- 229920000615 alginic acid Polymers 0.000 description 1
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- 125000002947 alkylene group Chemical group 0.000 description 1
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- MZNDIOURMFYZLE-UHFFFAOYSA-N butan-1-ol Chemical compound CCCCO.CCCCO MZNDIOURMFYZLE-UHFFFAOYSA-N 0.000 description 1
- OVYQSRKFHNKIBM-UHFFFAOYSA-N butanedioic acid Chemical compound OC(=O)CCC(O)=O.OC(=O)CCC(O)=O OVYQSRKFHNKIBM-UHFFFAOYSA-N 0.000 description 1
- 239000000496 cardiotonic agent Substances 0.000 description 1
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- 230000005595 deprotonation Effects 0.000 description 1
- 238000010537 deprotonation reaction Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000002934 diuretic Substances 0.000 description 1
- 229940030606 diuretics Drugs 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 239000003995 emulsifying agent Substances 0.000 description 1
- 210000002615 epidermis Anatomy 0.000 description 1
- 239000003172 expectorant agent Substances 0.000 description 1
- 229940066493 expectorants Drugs 0.000 description 1
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- 239000000576 food coloring agent Substances 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
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- 239000002874 hemostatic agent Substances 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
- 229940088597 hormone Drugs 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- SYJRVVFAAIUVDH-UHFFFAOYSA-N ipa isopropanol Chemical compound CC(C)O.CC(C)O SYJRVVFAAIUVDH-UHFFFAOYSA-N 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 239000004571 lime Substances 0.000 description 1
- YLGXILFCIXHCMC-JHGZEJCSSA-N methyl cellulose Chemical compound COC1C(OC)C(OC)C(COC)O[C@H]1O[C@H]1C(OC)C(OC)C(OC)OC1COC YLGXILFCIXHCMC-JHGZEJCSSA-N 0.000 description 1
- 229940050176 methyl chloride Drugs 0.000 description 1
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- 235000019426 modified starch Nutrition 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- ZFACJPAPCXRZMQ-UHFFFAOYSA-N phthalic acid Chemical compound OC(=O)C1=CC=CC=C1C(O)=O.OC(=O)C1=CC=CC=C1C(O)=O ZFACJPAPCXRZMQ-UHFFFAOYSA-N 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
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- USGIERNETOEMNR-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO.CCCO USGIERNETOEMNR-UHFFFAOYSA-N 0.000 description 1
- 239000004065 semiconductor Substances 0.000 description 1
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- 238000003860 storage Methods 0.000 description 1
- 239000000516 sunscreening agent Substances 0.000 description 1
- 239000000375 suspending agent Substances 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 239000000814 tuberculostatic agent Substances 0.000 description 1
- 229940124549 vasodilator Drugs 0.000 description 1
- 239000003071 vasodilator agent Substances 0.000 description 1
- 235000013311 vegetables Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
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- 235000013343 vitamin Nutrition 0.000 description 1
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
- A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
- A61J3/072—Sealing capsules, e.g. rendering them tamper-proof
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4883—Capsule finishing, e.g. dyeing, aromatising, polishing
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
The invention discloses a capsule sealing composition and a sealing method thereof, wherein the sealing composition comprises an acidic or alkaline solute and a volatile solvent; the sealing method is characterized in that the capillary phenomenon and the characteristic of volatile solvent are utilized to dissolve and seal the joint part of the upper cover of the capsule and the capsule body, the capsule can become a sealed capsule, and the medicine in the capsule is not easy to leak.
Description
[ technical field ] A method for producing a semiconductor device
The present invention relates to a composition for sealing capsules and a method for sealing capsules using the composition, and more particularly, to a sealing method for sealing capsules using a volatile solvent and utilizing capillary phenomenon.
[ background of the invention ]
The capsule is a pharmaceutical dosage form which is developed rapidly, has the thickness of about 0.07 mm to 0.7 mm, is widely applied to oral drugs such as medicines and health-care foods, has the advantages of convenient storage, accurate dosage, controllable drug release and the like, can cover the unpleasant odor of active ingredients of the drugs and maintain the activity of the drugs, and is easy to accept by users. The capsule dosage form can seal the medicine inside the capsule, and due to the sealing characteristic, the medicine in the capsule can avoid the activity reduction or the moisture exposure caused by the contact with the outside air and moisture, thereby keeping the stability for a long time.
Commercially available capsules are classified into hard capsules and soft capsules according to their appearance. The hard capsule is a two-piece assembly comprising a capsule body and an upper cover, but it is not easy to be completely sealed. In view of the above characteristics, liquid drugs are generally coated with soft capsules. The production method of the soft capsule is that the coating and the filling are carried out simultaneously, and the thickness of the capsule needs to be adjusted and thickened in order to avoid the breakage of the soft capsule in the manufacturing process. If the capsule shell is too thick, the capsule may not be easily absorbed after taking the capsule, and even the content may not be effectively released from the capsule, resulting in ineffectiveness or discomfort. Therefore, if the hard capsule can be manufactured in a more compact way to replace the disadvantage of too thick soft capsule, the medical and health care purpose of consumers is more ensured!
The capsule material may be gelatin (gelatin), sorbitol (sorbitol), hydroxypropyl methylcellulose (HPMC), and optional additives such as opaque food coloring, opalescent, glycerin, or other additives for shaping or changing the appearance color.
The traditional capsule is prepared from gelatin (gelatin), which is protein or peptide extracted from animal epidermis, bone or connective tissue, and collagen (collagen), and is boiled in water to obtain hydrophilic yellowish protein layer, i.e. gelatin.
In addition, the capsule material used frequently may be hydroxypropyl methylcellulose (hydroxypropyl methylcellulose, abbreviated as HPMC), which is a viscous polymer and is often used as a substitute for excipients, emulsifiers, thickeners, suspending agents or gelatin in oral drugs. After cellulose is treated by alkali, the alkylene oxide anions generated by deprotonation of hydroxyl can perform addition reaction on propylene oxide to generate hydroxypropyl cellulose ether; or with methyl chloride to form methyl cellulose ether. Hydroxypropyl methylcellulose is produced when both reactions are carried out simultaneously.
In addition, there are many substitutes for capsule raw materials, including seaweed extract, i.e. polysaccharide colloid, as a substitute raw material, vegetable raw materials can avoid cross-linking reaction with animal protein contained in the capsule, and can maintain the strength of capsule body of the capsule, and because of the recent prevalence of mad cow disease in the united states, the raw material for improving soft capsules is receiving increasing attention. Other alternative raw materials, such as agar gum, water-soluble etherified starch derivatives, HPMC, i.e. carrageenan, etc., are also increasingly in market proportion.
The hard capsule consists of an upper shell and a lower shell, wherein the upper shell is generally called an upper cover, and the lower shell is generally called a capsule body; the capsule is filled with the contents by preparing the capsule in advance, the capsule body and the upper cover are respectively placed when the contents are filled, the capsule body is placed on the specific hole die in an opening-up mode, the substance to be filled is filled into the capsule body through the transmission pipe, the upper cover and the capsule body are combined by applying proper pressure, and the capsule sealing procedure is completed.
In the packaging of the medicinal powder, solid particulate medicament, medicinal solution, or auxiliary material using the above method, dry powder having a low moisture content such as starch, lactose, oily adjuvant, etc. is required, and it is not suitable for coating water in the capsule because the capsule is melted and broken by water and water easily escapes from the capsule shell.
Chinese patent CN1182842C discloses that since some pharmaceutically active substances must be administered in the form of a complex carrier medium, 1, 2-propylene glycol or isosorbide dimethyl ether is mostly used as a solvent for the carrier medium. However, solvents such as 1, 2-propanediol tend to migrate from the capsule into the capsule shell, causing softening of the capsule, and the mixing of gelatin with 1, 2-propanediol is highly and unnecessarily viscous.
US4756902A discloses that the method of encapsulating the shell of a capsule is carried out by applying an aqueous alcohol solution to the junction between the upper lid of the capsule and the body of the capsule, heating the capsule to about 100 c to bring the junction to a semi-dissolved state, and then covering the junction with a layer of gelatin. In addition, european patent EP0152517B also discloses applying an aqueous alcohol solution to the capsule joint and applying heat energy to fuse the joint. However, the above methods have disadvantages including the aqueous solution being prone to moisture distortion or shrinkage of the capsule shell.
Due to the above limitations, the use of alcohols (including ethanol, propanol, or propylene glycol) in encapsulating capsules has disadvantages that the capsule sealing method needs to be improved, and the existing capsule sealing method is prone to deformation of the capsule or leakage of the drug in the capsule, which increases the defects in capsule manufacturing and the manufacturing cost. If the capsule shell raw materials such as gelatin, HPMC and the like are in a semi-dissolved state, heat is usually applied or a low-concentration aqueous solution is used for dissolving, and the inventor tests that if a proper amount of the capsule connecting part is dissolved, a trace amount of solvent is used, and a precise position can be sealed without damaging the capsule shell.
[ summary of the invention ]
In order to solve the problems of the capsule deformation and the leakage of the filling material caused by the characteristics of the sealing solution during the sealing process of the capsule, the present invention provides a novel capsule sealing composition and a sealing method thereof, which are used for improving the sealing method of the capsule.
To achieve the above object, the present invention provides a method for sealing a capsule, comprising the steps of:
diluting the solute with a solvent to a concentration at which the solute does not harm the capsule;
The concentration of solute in the solution is gradually increased in the process that the solvent volatilizes to the space by utilizing the volatility and the capillary action of the solvent, and meanwhile, the solution which is not volatilized is guided to the top end of an included angle formed by the capsule body and the capsule upper cover by utilizing the capillary action of the solution; and
Until the solvent is completely volatilized, the solute concentration of the solution is enough to locally dissolve the contact surface of the capsule, and the upper cover of the capsule and the capsule body of the capsule are dissolved into a whole.
To achieve the above objects, the sealing composition of the present invention comprises a solute and a volatile solvent, wherein the solute comprises an acidic solution or an alkaline solution, and the solute can be replaced by water.
Further, the above-mentioned sealing composition of the present invention, wherein the ratio of the solute to the volatile solvent is 1 to 15.
Further, the above-mentioned sealing composition of the present invention, wherein the preferable ratio of the solute to the volatile solvent is 1: 4 to 1: 6.
Further, the above-mentioned sealing composition of the present invention, wherein the alkaline solution is an aqueous solution of an alkali metal oxide or an alkaline earth metal oxide, the alkali metal oxide may be potassium hydroxide or sodium hydroxide, and the concentration of the above-mentioned solution is 0.1 mol/l to a saturated solution.
further, the sealing composition of the present invention, wherein the acidic solution is an aqueous solution of an organic acid or an inorganic acid, the organic acid is citric acid or acetic acid, the inorganic acid is hydrochloric acid or sulfuric acid, and the concentration of the above solution is 0.1 mol/l to a saturated solution.
Further, the above-mentioned sealing composition of the present invention, wherein the volatile solvent is methanol, ethanol, propanol, isopropanol, or butanol.
Further, the sealing composition of the present invention may further comprise gelatin, hypromellose, guar gum, or agar gum, and pharmaceutically acceptable additives such as plasticizer and opacifier.
Further, the above-mentioned sealing composition of the present invention, wherein the plasticizer is selected from the group consisting of: glycerol, sorbitol, maltose, glucose, polysaccharides, sucrose, xylitol, mannitol, 1, 2-propanediol, and polyethylene glycol.
Further, the above-described sealing composition of the present invention, wherein the sunscreen agent may be selected from the group consisting of: caramel, titanium oxide, and iron oxide.
To achieve the above object, the method for sealing a capsule of the present invention comprises the following steps:
Combining the upper cover of the capsule with the capsule body of the capsule;
Attaching the sealing composition between one side or two sides of the inner side of the upper cover of the capsule and the outer side of the capsule body of the capsule;
when the volatile solvent is filled between the inner side of the upper cover of the capsule and the outer side of the capsule body of the capsule through capillary phenomenon and the concentration of the solute of the sealing composition is increased along with the volatilization of the solvent, the concentration of the solute is enough to integrate the contacted part of the capsule into a whole, and then the capsule can be sealed;
the capsule is a sealed capsule.
Furthermore, the filling of the capsule prepared by the sealing method of the present invention may be a pharmaceutical composition or health food in the form of liquid, suspension, paste, powder, granule, etc.
The specific techniques employed in the present invention will be further illustrated by the following examples and accompanying drawings.
[ description of the drawings ]
Fig. 1 is a schematic view of a capsule used in a capsule sealing method according to a preferred embodiment of the present invention.
FIG. 2 is another schematic view of a capsule used in the capsule sealing method according to the preferred embodiment of the present invention.
FIG. 3 is a schematic view of the applied sealing composition of the capsule used in the capsule sealing method according to the preferred embodiment of the present invention.
fig. 4 is a schematic view of the sealing of the capsule used in the capsule sealing method according to the preferred embodiment of the present invention.
description of the main component symbols:
1 Capsule upper cover
2 capsule body
3 filling the space
4 sealing composition
5 fusion part
[ detailed description ] embodiments
All technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this specification belongs unless defined otherwise. The present invention is illustrated by the following examples, but the present invention is not limited by the following examples. The materials used in the present invention are readily available commercially and the following are merely exemplary of the available conduits.
the invention provides a capsule sealing composition, which comprises a solute and a carrier, wherein the solute can be an acid solution or an alkaline solution, and the carrier is a volatile solvent.
the invention also provides a capsule sealing method, which is to apply the capsule sealing composition at the joint of the upper cover and the capsule body, and dissolve the surface of the capsule shell when the composition permeates between the upper cover and the capsule body due to capillary capacity, thereby forming a sealing ring.
In the above method, the size of the capsule used is not particularly limited, and the content may be adjusted to a range of about 1 mg to 10 g.
in the above method, the capillary ability refers to a phenomenon in which a liquid rises inside a minute space against gravity due to a difference between cohesive force and adhesive force.
the capsule material of the present invention is a substance having reversible gelling properties even after drying. The substance is formed of an intra-colloidal substance such as HPMC, gelatin, agar, starch, alginic acid, guar gum (guar gum) or the like, and preferably comprises gelatin or HPMC and a plasticizer as a raw material for a capsule. In addition, the capsule raw material may contain additives such as opacifier, etc. as necessary.
as the gelatin, those obtained by extracting collagen from animals such as cattle and pigs by hydrolysis can be used. The gelatin having the reversible gel property includes alkali-treated, acid-treated, chemically modified gelatin, and the like. Acid-treated gelatin is obtained by using hydrochloric acid or sulfuric acid as a hydrolytic agent; alkali such as lime is used as the hydrolytic agent of alkali-treated gelatin; chemically modified gelatin is obtained by reacting an amine group of gelatin with an organic acid such as succinic acid (succinic acid) or phthalic acid (phthalic acid).
As for the foregoing plasticizer, glycerin, sorbitol, maltose, glucose, polysaccharides, sucrose, xylitol, mannitol, propylene glycol, polyethylene glycol, and the like may be included, but not limited thereto.
with respect to the foregoing opacifiers, caramel, titanium oxide, iron oxide, and the like may be included, but not limited thereto.
The form of the capsule filling material to which the present invention is applied is not limited, and may be liquid, suspension, paste, powder, granule, or the like.
The hard capsule of the present invention has a thickness of 0.01 to 5 millimeters (mm), preferably 0.05 to 1mm, though it is not particularly limited as long as it can exert the function of the capsule.
The capsule of the present invention can be used in pharmaceutical products, quasi-pharmaceutical products, foods, cosmetics, etc., depending on the composition of the filler.
The pharmaceutical agent and quasi-pharmaceutical agent are not particularly limited as long as the active ingredient contained in the capsule of the present invention does not impair the function of the capsule. The pharmaceutical products include, but are not limited to, vitamins, antipyretics, analgesics, anti-inflammatory agents, antiulcers, cardiotonics, anticoagulants, hemostatic agents, antiresorptive agents, angiogenesis inhibitors, antidepressants, antitumor agents, antitussive and expectorant agents, muscle-retardation agents, antiepileptics, antiallergic agents, arrhythmia remedies, vasodilators, blood pressure-lowering diuretics, diabetes remedies, antituberculosis agents, hormone preparations, analgesics, antibacterial agents, antifungal agents, antiviral agents, and the like, which are listed below, but are not limited to the aforementioned group of pharmacological actions, and include all the pharmaceutical active ingredients having poor solubility in water, which are the subject of the hard capsules of the present invention. Active substances which are poorly soluble are preferred.
The preferred embodiment of the present invention will be described in detail with reference to fig. 1 to 4.
The shape of the capsule used in the sealing method of the present invention is shown in fig. 1, but is not limited thereto, and the shape of the capsule which can achieve the sealing method provided by the present invention is suitable for the present invention.
The capsule used by the sealing method of the invention is shaped as shown in figure 1, the diameter (b) of the outer edge of the capsule upper cover (1) needs to be larger than the diameter (a) of the outer edge of the capsule body (2), the diameter (a) of one position of the inner ring of the capsule upper cover (1) is similar to the diameter (a) of the outer edge of the capsule body (2), the capsule body (2) and the capsule upper cover (1) are combined as shown in figure 2, the inner edge of the capsule upper cover (1) is not airtight with the capsule body (2), a filling space (3) is arranged between the capsule body (2) and the capsule upper cover (1), the filling space (3) is an included angle formed by the capsule body (2) and the capsule upper cover (1), and the filling space (3) is used for coating or injecting the sealing composition.
Example one
the present invention provides a capsule sealing composition for sealing a capsule, which comprises (A) a solute and (B) a volatile solvent component. The solute can be acidic solution such as hydrochloric acid, citric acid, acetic acid, sulfuric acid, etc., or alkaline solution such as sodium hydroxide solution, potassium hydroxide solution, etc., and the solute can be replaced by water; the volatile solvent may be alcohol, including methanol, ethanol, propanol (1-propanol), isopropanol (2-propanol), butanol (1-butanol), etc. The aforementioned composition may comprise a solute and a volatile solvent in a ratio of 1 to 15; the aforementioned composition preferably comprises the solute and the volatile solvent in a ratio of 1 to 3 to 1 to 10; the aforementioned composition preferably comprises the solute and the volatile solvent in a ratio of 1 to 4 to 1 to 6; the concentration of the solute can be 1 mol/L to the saturated solution. The aforementioned composition may also comprise gelatin or a vegetable gum, such as Hypromellose (HPMC), guar gum (guar gum), or agar gum.
After the upper capsule cover (1) is sleeved with the capsule body (2) (figure 2), a filling space (3) is arranged between the upper capsule cover (1) and the capsule body (2), wherein the same purpose can be achieved by applying, injecting, spraying, or other means, so that the sealing composition (4) adheres to the overlapping space (figure 3) inside the capsule lid (1) and outside the capsule body (2), then the sealing composition (4) is attached to the capsule, and the sealing composition (4) has the liquid capillary phenomenon, the attached sealing composition (4) can be loaded to the contact part of the upper cover (1) of the capsule and the capsule body (2) of the capsule along the surface of the capsule, namely, the area where the inner circle of the capsule upper cover (1) with the diameter a is contacted with the outer circle of the capsule body (2) with the diameter a, so that the sealed composition (4) is positioned at the original filling space (3). Furthermore, since the sealing composition (4) contains a volatile solvent, the solvent is increased with time and volatilized from the open surface, and the concentration of the solute is increased due to the reduction of the amount of the solvent and the constant amount of the solute in the volatilization process; the solute concentration is increased to dissolve the capsule surface, forming a fused portion (5) in the original filling space (3).
After the fusion part (5) is formed, the capsule can be sealed, and because only trace solute exists, namely the sealing composition (4) can rise to the top end of the filling space (3) due to capillary phenomenon, and because the sealing composition (4) only has trace solute, the shell of the capsule which can dissolve the filling space (3) can not deform the capsule, so that the medicine in the capsule leaks out; and the air in the outside is blocked, so that the medicine is prevented from being deteriorated due to the contact with the air.
Although the present invention has been described with reference to particular embodiments, it will be understood by those skilled in the art that various changes in form, construction, features and quantities may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.
Claims (14)
1. A method for the containment of capsules, characterized in that it comprises the following steps:
Diluting a solute with a solvent to a concentration at which the solute does not harm the capsule, the ratio of the solute to the solvent being from 1 to 15, the solute being an acidic aqueous solution or an alkaline aqueous solution, the acidic aqueous solution having a concentration of 0.1 mol/l to a saturated solution, the alkaline aqueous solution having a concentration of 0.1 mol/l to a saturated solution;
Gradually increasing the concentration of the solute in the solution in the process of volatilizing the solvent to the space by utilizing the volatility and the capillary action of the solvent, and guiding the solution which is not volatilized to the top end of an included angle formed by the capsule body and the capsule upper cover by means of the capillary action of the solution; and
Until the solvent is completely volatilized, the solute concentration of the solution is enough to locally dissolve the contact surface of the capsule, and the upper cover of the capsule and the body of the capsule are dissolved into a whole.
2. An encapsulating composition for capsules, said encapsulating composition comprising:
a solute; and
a volatile solvent;
The ratio of the solute to the volatile solvent is from 1 to 15;
the solute is an acidic aqueous solution or a basic aqueous solution;
The concentration of the acidic aqueous solution is 0.1 mol/L to a saturated solution;
the concentration of the alkaline aqueous solution is 0.1 mol/L to a saturated solution.
3. the encapsulating composition for capsules according to claim 2, wherein the ratio of said solute to said volatile solvent is from 1 to 4 to 1 to 6.
4. The sealing composition for capsules according to claim 2, wherein said alkaline solution is an aqueous solution of an alkali metal oxide or an alkaline earth metal oxide.
5. The sealing composition for capsules according to claim 4, wherein said alkali metal oxide is potassium hydroxide or sodium hydroxide.
6. The sealing composition for capsules according to claim 2, wherein said acidic solution is an aqueous solution of an organic acid or an inorganic acid.
7. the sealing composition for capsules according to claim 6, wherein said aqueous organic acid is citric acid or acetic acid.
8. The sealing composition for capsules according to claim 6, wherein the aqueous solution of inorganic acid is hydrochloric acid or sulfuric acid.
9. The sealing composition for capsules according to claim 2, wherein said volatile solvent is methanol, ethanol, propanol, isopropanol, or butanol.
10. The encapsulation composition of claim 2, wherein the encapsulation composition further comprises gelatin, hypromellose, guar gum, or agar gum, and a pharmaceutically acceptable plasticizer, an opacifier.
11. The encapsulating composition for capsules according to claim 10, wherein said plasticizer is selected from the group consisting of: glycerol, sorbitol, maltose, glucose, polysaccharides, sucrose, xylitol, mannitol, 1, 2-propanediol, and polyethylene glycol.
12. The encapsulating composition of claim 10, wherein the opacifier is selected from the group consisting of: caramel, titanium oxide, and iron oxide.
13. A method of encapsulating capsules using the encapsulating composition of any of claims 2 to 12, wherein the method of encapsulating capsules with the encapsulating composition comprises the steps of:
Combining the upper cover of the capsule with the capsule body of the capsule;
Attaching the sequestration composition of any one of claims 2-12 between the inside of the capsule lid and the outside of the capsule body; and
when the volatile solvent is filled between the inner side of the upper cover of the capsule and the outer side of the capsule body through capillary phenomenon and volatilizes along with the volatile solvent, the concentration of the solute of the sealing composition is increased, the concentration of the solute is enough to dissolve the contacted capsule into a whole locally, and the sealing composition can be sealed, wherein the solute is an acidic aqueous solution or an alkaline aqueous solution, the concentration of the acidic aqueous solution is 0.1 mol/L to a saturated solution, and the concentration of the alkaline aqueous solution is 0.1 mol/L to a saturated solution;
The capsule is a sealed capsule.
14. The method for sealing a capsule with a composition according to claim 13, wherein the filling material of the capsule is a pharmaceutical composition or health food in the form of liquid, suspension, paste, powder, or granule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201510742615.6A CN106619128B (en) | 2015-11-04 | 2015-11-04 | sealing composition for capsules and sealing method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510742615.6A CN106619128B (en) | 2015-11-04 | 2015-11-04 | sealing composition for capsules and sealing method thereof |
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| CN106619128B true CN106619128B (en) | 2019-12-06 |
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| CN111346069A (en) * | 2020-03-12 | 2020-06-30 | 澳美制药厂有限公司 | Hollow capsule enteric-coated sealing ring composition, preparation method and application thereof |
| PL4225276T3 (en) * | 2020-12-14 | 2024-05-20 | Capsugel Belgium Nv | Sealing fluid for sealing capsules |
| CN115869283A (en) * | 2022-12-21 | 2023-03-31 | 山东赫尔希胶囊有限公司 | Enteric sealing glue for hollow capsules and preparation method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3159546A (en) * | 1962-10-12 | 1964-12-01 | F G Okie Inc | Capsule sealing composition |
| US3394983A (en) * | 1963-06-14 | 1968-07-30 | American Cyanamid Co | Dip-dyeing capsules |
| US4539060A (en) * | 1983-02-18 | 1985-09-03 | Warner-Lambert Company | Apparatus and method of sealing capsules |
| EP0180543B1 (en) * | 1984-10-25 | 1991-04-24 | Warner-Lambert Company | Method for sealing capsules and capsule |
| CN1365268A (en) * | 1999-07-30 | 2002-08-21 | 沃纳-兰伯特公司 | Method and apparatus for sealing capsules and capsules suitable for use in said method and apparatus |
-
2015
- 2015-11-04 CN CN201510742615.6A patent/CN106619128B/en not_active Expired - Fee Related
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3159546A (en) * | 1962-10-12 | 1964-12-01 | F G Okie Inc | Capsule sealing composition |
| US3394983A (en) * | 1963-06-14 | 1968-07-30 | American Cyanamid Co | Dip-dyeing capsules |
| US4539060A (en) * | 1983-02-18 | 1985-09-03 | Warner-Lambert Company | Apparatus and method of sealing capsules |
| EP0180543B1 (en) * | 1984-10-25 | 1991-04-24 | Warner-Lambert Company | Method for sealing capsules and capsule |
| CN1365268A (en) * | 1999-07-30 | 2002-08-21 | 沃纳-兰伯特公司 | Method and apparatus for sealing capsules and capsules suitable for use in said method and apparatus |
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