CN106619128A - Sealed storage composition for capsule and sealed storage method thereof - Google Patents
Sealed storage composition for capsule and sealed storage method thereof Download PDFInfo
- Publication number
- CN106619128A CN106619128A CN201510742615.6A CN201510742615A CN106619128A CN 106619128 A CN106619128 A CN 106619128A CN 201510742615 A CN201510742615 A CN 201510742615A CN 106619128 A CN106619128 A CN 106619128A
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- Prior art keywords
- capsule
- safekeeping
- compositionss
- seal
- solute
- Prior art date
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- 239000002775 capsule Substances 0.000 title claims abstract description 164
- 238000000034 method Methods 0.000 title claims abstract description 41
- 239000000203 mixture Substances 0.000 title claims abstract description 8
- 239000002904 solvent Substances 0.000 claims abstract description 35
- 230000002378 acidificating effect Effects 0.000 claims abstract 2
- 108010010803 Gelatin Proteins 0.000 claims description 22
- 239000008273 gelatin Substances 0.000 claims description 22
- 229920000159 gelatin Polymers 0.000 claims description 22
- 235000019322 gelatine Nutrition 0.000 claims description 22
- 235000011852 gelatine desserts Nutrition 0.000 claims description 22
- 238000007789 sealing Methods 0.000 claims description 22
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 17
- 239000000243 solution Substances 0.000 claims description 17
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 16
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 14
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 12
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 10
- 239000007864 aqueous solution Substances 0.000 claims description 10
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 9
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 9
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical group OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 9
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-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
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 8
- 239000002253 acid Substances 0.000 claims description 8
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical group [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims description 7
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 claims description 7
- 229920002907 Guar gum Polymers 0.000 claims description 6
- 239000012670 alkaline solution Substances 0.000 claims description 6
- 235000010417 guar gum Nutrition 0.000 claims description 6
- 239000000665 guar gum Substances 0.000 claims description 6
- 229960002154 guar gum Drugs 0.000 claims description 6
- 239000007788 liquid Substances 0.000 claims description 6
- 239000003605 opacifier Substances 0.000 claims description 6
- 239000004014 plasticizer Substances 0.000 claims description 6
- 239000000654 additive Substances 0.000 claims description 5
- 150000007524 organic acids Chemical class 0.000 claims description 5
- 239000000843 powder Substances 0.000 claims description 5
- 230000008569 process Effects 0.000 claims description 5
- 239000012047 saturated solution Substances 0.000 claims description 5
- 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 4
- 241001428166 Eucheuma Species 0.000 claims description 4
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims description 4
- 229910000272 alkali metal oxide Inorganic materials 0.000 claims description 4
- 239000003292 glue Substances 0.000 claims description 4
- 229960003943 hypromellose Drugs 0.000 claims description 4
- 239000007943 implant Substances 0.000 claims description 4
- 229920001282 polysaccharide Polymers 0.000 claims description 4
- 239000005017 polysaccharide Substances 0.000 claims description 4
- 229960004063 propylene glycol Drugs 0.000 claims description 4
- 239000000600 sorbitol Substances 0.000 claims description 4
- 239000001117 sulphuric acid Substances 0.000 claims description 4
- 235000011149 sulphuric acid Nutrition 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
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-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
- 230000000996 additive effect Effects 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
- 239000008103 glucose Substances 0.000 claims description 3
- 235000013402 health food Nutrition 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
- 150000007522 mineralic acids Chemical class 0.000 claims description 3
- 235000011837 pasties Nutrition 0.000 claims description 3
- 229920001223 polyethylene glycol Polymers 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
- 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
- 235000010447 xylitol Nutrition 0.000 claims description 3
- 229960002675 xylitol Drugs 0.000 claims description 3
- 229910000287 alkaline earth metal oxide Inorganic materials 0.000 claims description 2
- 238000004090 dissolution Methods 0.000 claims description 2
- 229940014259 gelatin Drugs 0.000 claims description 2
- 150000004676 glycans Chemical class 0.000 claims 1
- 235000005985 organic acids Nutrition 0.000 claims 1
- 239000003814 drug Substances 0.000 abstract description 20
- 229940079593 drug Drugs 0.000 abstract description 7
- 238000012856 packing Methods 0.000 description 10
- 239000002994 raw material Substances 0.000 description 10
- 239000000463 material Substances 0.000 description 7
- 239000007902 hard capsule Substances 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 6
- 239000007901 soft capsule Substances 0.000 description 6
- 238000011049 filling Methods 0.000 description 5
- 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 5
- 238000010586 diagram Methods 0.000 description 4
- XNGIFLGASWRNHJ-UHFFFAOYSA-N phthalic acid Chemical compound OC(=O)C1=CC=CC=C1C(O)=O XNGIFLGASWRNHJ-UHFFFAOYSA-N 0.000 description 4
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 4
- 102000008186 Collagen Human genes 0.000 description 3
- 108010035532 Collagen Proteins 0.000 description 3
- 239000003513 alkali Substances 0.000 description 3
- 238000007385 chemical modification Methods 0.000 description 3
- 238000006243 chemical reaction Methods 0.000 description 3
- 150000004804 polysaccharides Chemical class 0.000 description 3
- 230000002441 reversible effect Effects 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
- ATUOYWHBWRKTHZ-UHFFFAOYSA-N Propane Chemical compound CCC ATUOYWHBWRKTHZ-UHFFFAOYSA-N 0.000 description 2
- 229920002472 Starch Polymers 0.000 description 2
- 238000010306 acid treatment Methods 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 150000001298 alcohols Chemical class 0.000 description 2
- 210000000988 bone and bone Anatomy 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 229920001436 collagen Polymers 0.000 description 2
- 239000000499 gel Substances 0.000 description 2
- 230000003301 hydrolyzing effect Effects 0.000 description 2
- -1 opalizer Substances 0.000 description 2
- 235000018102 proteins Nutrition 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 239000008107 starch Substances 0.000 description 2
- 235000019698 starch Nutrition 0.000 description 2
- 239000001384 succinic acid Substances 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
- ODINCKMPIJJUCX-UHFFFAOYSA-N Calcium oxide Chemical compound [Ca]=O ODINCKMPIJJUCX-UHFFFAOYSA-N 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 206010015866 Extravasation Diseases 0.000 description 1
- 208000032843 Hemorrhage Diseases 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
- 241000195474 Sargassum Species 0.000 description 1
- 230000009102 absorption Effects 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 235000010443 alginic acid Nutrition 0.000 description 1
- 239000000783 alginic acid Substances 0.000 description 1
- 229920000615 alginic acid Polymers 0.000 description 1
- 229960001126 alginic acid Drugs 0.000 description 1
- 150000004781 alginic acids Chemical class 0.000 description 1
- 125000003368 amide group Chemical group 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
- 229940035676 analgesics Drugs 0.000 description 1
- 230000033115 angiogenesis Effects 0.000 description 1
- 235000021120 animal protein Nutrition 0.000 description 1
- 150000001450 anions Chemical class 0.000 description 1
- 230000000954 anitussive effect Effects 0.000 description 1
- 239000000730 antalgic agent Substances 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 230000000843 anti-fungal effect Effects 0.000 description 1
- 230000003276 anti-hypertensive effect Effects 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000001754 anti-pyretic effect Effects 0.000 description 1
- 239000000043 antiallergic agent Substances 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 239000003429 antifungal agent Substances 0.000 description 1
- 229940121375 antifungal agent Drugs 0.000 description 1
- 239000002246 antineoplastic agent Substances 0.000 description 1
- 239000002221 antipyretic Substances 0.000 description 1
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- 230000008901 benefit Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 239000007963 capsule composition Substances 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- 235000010418 carrageenan Nutrition 0.000 description 1
- 229920001525 carrageenan Polymers 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- NEHMKBQYUWJMIP-UHFFFAOYSA-N chloromethane Chemical class ClC NEHMKBQYUWJMIP-UHFFFAOYSA-N 0.000 description 1
- 238000005253 cladding Methods 0.000 description 1
- 239000000084 colloidal system Substances 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 210000002808 connective tissue Anatomy 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 230000001186 cumulative effect Effects 0.000 description 1
- 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
- 239000002552 dosage form Substances 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 239000003995 emulsifying agent Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000003172 expectorant agent Substances 0.000 description 1
- 229940066493 expectorants Drugs 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 230000036251 extravasation Effects 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 239000000576 food coloring agent Substances 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 239000005556 hormone Substances 0.000 description 1
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- 239000010903 husk Substances 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
- 230000006872 improvement Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000002609 medium 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
- 239000011707 mineral Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 235000019426 modified starch Nutrition 0.000 description 1
- 239000012120 mounting media Substances 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 229940126701 oral medication Drugs 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 239000001294 propane Substances 0.000 description 1
- 235000013772 propylene glycol Nutrition 0.000 description 1
- 230000009103 reabsorption Effects 0.000 description 1
- 230000001603 reducing effect Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
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- 239000000375 suspending agent Substances 0.000 description 1
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- 230000024883 vasodilation Effects 0.000 description 1
- 235000013311 vegetables Nutrition 0.000 description 1
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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 sealed storage composition for a capsule and a sealed storage method thereof. The sealed storage composition contains an acidic or alkaline solute and a volatile solvent. According to the sealed storage method, a capillary phenomenon and characteristics of the volatile solvent are utilized to an upper capsule cover and a connecting portion of a capsule body dissolved and sealed, the capsule can become a sealed capsule, and medicines in the capsule are not likely to be leaked out.
Description
【Technical field】
The present invention is a kind of and method for sealing capsule up for safekeeping using compositionss with regard to compositionss for sealing capsule up for safekeeping, and particularly one kind is using effumability solvent and utilizes capillarity, makes the method for seal of capsule sealing.
【Background technology】
Capsule is a kind of pharmaceutical dosage form for quickly growing, about slightly 0.07 millimeter to 0.7 millimeter of thickness, it is widely applied to the endo-medicines such as medicine, health food, have the advantages that convenient preservation, dosage are accurate, can control drug release, and the bad smell of active constituents of medicine can be covered, pharmaceutically active is maintained, therefore user is easy to receive.Capsule formulation can seal medicine in capsule up for safekeeping, and due to the feature that it is sealed, capsule medicine therein can be avoided because reducing activity with outside air, contact with moisture or making moist, therefore is maintained a long-term stability.
Commercially available capsule can divide into hard capsule and soft capsule according to external form.Hard capsule is two-piece combination, comprising utricule and upper lid, but its be difficult it is completely closely sealed.Consider above-mentioned characteristic, liquid drug is usually used soft capsule cladding.The mode of production of soft capsule is coated with filling while carrying out, to avoid soft capsule from rupturing in manufacturing process, the manufacturing process is needed to adjust, thickeies capsule thickness.If capsule shell is blocked up, it is likely that cause to take and be difficult after capsule absorption, or even content cannot effectively disengage capsule and cause invalid or discomfort.If therefore hard capsule can be manufactured with more adhesion method, with the shortcoming for replacing soft capsule blocked up, the medicine of consumer and the purpose of health care are more protected!
Capsule raw material can be gelatin(gelatin), Sorbitol(sorbital), hydroxypropyl methyl cellulose(HPMC is made in hydroxypropyl methylcellulose, abbreviation), and non-essential additive, such as opaque food coloring, opalizer, glycerol or other additives to plastotype or change appearance color.
Conventional capsules manufacture raw material is gelatin(gelatin), it is the protein or victory peptide extracted from animal cuticle, bone or connective tissue, include collagen(collagen), the flaxen protein layer of hydrophilic, as gelatin can be obtained after boiling in water.
Another commonly used capsule raw material can be hydroxypropyl methyl cellulose, also have simplification to make hypromellose(HPMC is made in hydroxypropyl methylcellulose, abbreviation), it is a kind of polymer with stickiness, often in the succedaneum for serving as excipient, emulsifying agent, thickening agent, suspending agent or gelatin in oral drugs.After cellulose alkali process, the alcoxyl anion that hydroxyl deprotonation is generated can carry out addition to expoxy propane, generate hydroxypropylcelluloether ether;Can also be condensed with chloromethanes, generate methyl cellulose ether.Two kinds of reactions will produce hydroxypropyl methyl cellulose when carrying out simultaneously.
Separately there is the substitute of various capsule raw materials, it is that polysaccharide colloid is alternative materials including the extract of Sargassum, vegetable raw material can avoid crosslinking reaction with the animal protein that capsule is included, the intensity of capsule utricule can be maintained, and because in recent years the prevalence of U.S.'s mad cow disease gradually rises, improvement soft capsule raw material is gradually taken seriously.Other alternative materials, such as agaropectin, water solublity etherificate starch derivatives, HPMC, i.e. carrageenin, also gradually with city account for rate.
Hard capsule is made up of upper lower casing, and upper casing is commonly referred to as lid, and lower casing is commonly referred to as utricule;And made in advance in case filling before filling content, filling content when first by utricule with it is upper lid place respectively, utricule is placed on specific casement in opening upwards mode, it is intended to filler Jing transfer tubes and is packed into utricule, upper lid and utricule are applied into appropriate pressure combines it, and capsule hold account procedure is completed.
Need to be with dried powder such as starch, Lactose, oil adjuvant etc. of low moisture content medicated powder, solid particulate medicament, drug solution or secondary material etc. is packed using said method, and be not suitable for coat moisture in capsule, because meeting water capsule will be caused to melt and rupture, and moisture is easily from capsule shell loss.
Chinese patent CN1182842C is disclosed, because some active medicinal matters must be administered in the form of composite support medium, wherein it is many using 1,2-PD or isosorbide dimethyl ether as solvent, for mounting medium.But 1,2-PD equal solvent easily migrates into capsule shell from capsule, the softening of capsule is caused, and gelatin has height and unnecessary stickiness with the mixing of 1,2-PD.
United States Patent (USP) US4756902A is disclosed, and the method for seal of capsule shell can be by being applied on capsule the joint covered with utricule by alcohol water blend, and heat capsule makes joint become half dissolved state to about 100 DEG C, and then at joint one layer of gelatin is covered.Separately, European patent EP 0152517B is also disclosed, and alcohol water blend is applied to into capsule joint, and applies heat energy makes to merge at this.But said method has its shortcoming, including aqueous solution easily makes capsule shells make moist deformation or shrinkage.
Due to above-mentioned restriction, alcohols is used when capsule is encapsulated(Comprising ethanol, propanol or Propylene Glycol), still with the presence of its shortcoming, make capsule method of seal need to be improved, and now capsule method of seal easily causes medicine in capsule deformation or capsule and leaks, and increases the flaw and manufacturing cost of capsule manufacture.And if capsule husk as raw material to be made such as gelatin, HPMC etc. are presented half dissolved state, often need to grant heat or with low concentration aqueous solution's dissolving, Jing inventor's test, to make capsule weld the appropriate dissolving in part, should be with micro solvent, accurately position can be only achieved sealing and not destroy capsule shells.
【The content of the invention】
To solve afore mentioned capsule during sealing up for safekeeping, because the characteristic for sealing solution up for safekeeping produces capsule deformation, and implant is caused to leak outside, the purpose of the present invention provides a novel capsule and seals compositionss and its method of seal up for safekeeping, to improved capsule method of seal.
It is, up to aforementioned purpose, the method for seal of the capsule of the present invention, to comprise the following steps:
Solute is diluted to into the concentration that solute does not injure capsule using solvent;
And using the volatility and capillarity of solvent, in solvent the concentration of solute in solution is gradually increased to the process that space is volatilized, while the solution for not yet volatilizing is guided to capsule utricule and capsule into the formed angle top of lid by the capillarity of solution;And
Until solvent volatilization is completed, solution's solute concentration be enough to local dissolution capsule contact surface, and make to cover be integrated molten with capsule utricule on capsule.
It is that, up to aforementioned purpose, the present invention's seals compositionss up for safekeeping including a solute and an effumability solvent, and solute can be substituted containing acid solution or alkaline solution, solute with water.
Further, the invention described above seals compositionss up for safekeeping, and wherein the ratio of solute and effumability solvent is 1 to 1 to 1 to 15.
Further, the invention described above seals compositionss up for safekeeping, and wherein solute and the preferred proportion of effumability solvent are 1 to 4 to 1 to 6.
Further, the invention described above seals compositionss up for safekeeping, and wherein alkaline solution is alkali metal oxide or alkaline earth oxide aqueous solution, alkali metal oxide can be potassium hydroxide or sodium hydroxide, and previous solu concentration is 0.1 mole/litre to saturated solution.
Further, the invention described above seals compositionss up for safekeeping, and wherein acid solution is organic acid or inorganic acid aqueous solution, organic acid can be citric acid or acetic acid, and mineral acid can be hydrochloric acid or sulphuric acid, and previous solu concentration is 0.1 mole/litre to saturated solution.
Further, the invention described above seals compositionss up for safekeeping, and wherein effumability solvent is methanol, ethanol, propanol, isopropanol or butanol.
Further, the invention described above seals compositionss up for safekeeping, wherein sealing compositionss up for safekeeping can further include gelatin, hypromellose, guar gum or Eucheuma gelatinosum glue, and the additive such as pharmaceutically acceptable plasticizer, opacifier.
Further, the invention described above seals compositionss up for safekeeping, and wherein plasticizer may be selected from following constituted group:Glycerol, Sorbitol, maltose, glucose, polysaccharide, sucrose, xylitol, mannitol, 1,2- Propylene Glycol and Polyethylene Glycol.
Further, the invention described above seals compositionss up for safekeeping, and wherein opacifier may be selected from following constituted group:Caramel, titanium oxide and ferrum oxide.
It is, up to aforementioned purpose, the method for sealing capsule up for safekeeping of the present invention, to comprise the following steps:
With reference to lid on capsule and capsule utricule;
Make it is aforesaid seal compositionss up for safekeeping, be attached on capsule between lid inner side and capsule utricule outside between side or two sides;
Treat that effumability solvent Jing capillarity is filled on capsule between lid inner side and capsule utricule outside and makes to seal the rising of compositionss solute concentration up for safekeeping with solvent volatilization, its concentration is enough integrated contacted capsule local i.e. salable;
Capsule is seal capsule.
Further, wherein with capsule made by the method for seal of the invention described above, its implant can be the medical composition or health food of the kenels such as liquid, suspension, pasty state, powder, graininess.
Particular technique of the present invention, attached will be further described by below example and in schema.
【Description of the drawings】
Fig. 1 is used the schematic diagram of capsule by the capsule method of seal of better embodiment of the present invention.
Fig. 2 is used another schematic diagram of capsule by the capsule method of seal of better embodiment of the present invention.
Fig. 3 be the capsule method of seal of better embodiment of the present invention using capsule the schematic diagram of sealing compositionss up for safekeeping smeared.
Fig. 4 is used the sealing schematic diagram of capsule by the capsule method of seal of better embodiment of the present invention.
Primary clustering symbol description:
Cover on 1 capsule
2 capsule utricules
3 packing spaces
4 seal compositionss up for safekeeping
5 fused portions
【Specific embodiment】
All technical and scientific terminology described in this specification, unless defined in addition, is all the meaning that there is art usual those skilled in the art can understand jointly.The present invention gives demonstration and illustrates with the following examples, but the present invention is not limited by following embodiments.Material used by the present invention is all commercially available to be easy to obtain, following merely illustrative obtainable pipeline.
The present invention provides a capsule and seals compositionss up for safekeeping, and capsule seals compositionss up for safekeeping comprising solute and carrier, and solute can be acid solution or alkaline solution, and carrier is effumability solvent.
Of the invention another to provide a capsule method of seal, capsule method of seal is to smear afore mentioned capsule and seal compositionss up for safekeeping cover on capsule and utricule joint, and thing to be combined is penetrated between lid and utricule because of wicking capacity, dissolves capsule shell surface, and then formation sealing ring.
With regard to aforesaid method, though its capsule size for using is not particularly limited, content amount is adjusted to about 1 milligram to 10 grams of scope.
With regard to aforesaid method, wicking capacity refers to liquid on the inside of fine spatial, the difference, the phenomenon that overcomes gravity and rise due to cohesiveness and adhesive force.
Even if after the capsule raw material of the present invention is for a kind of drying, still with reversible gel(reversible gelling)The material of property.This material, such as by HPMC, gelatin, Eucheuma gelatinosum, starch, alginic acid, guar gum(guar
gum)Formed Deng material in glue, be to come preferable as the raw material of capsule to include gelatin or HPMC and plasticizer person.Additionally, capsule raw material can include the additives such as opacifier in response to needs.
With regard to aforementioned gelatin, can use by acquired in the animals such as cattle, pig, go out collagen protein Jing hydrolysis extractions, and the gelatin for obtaining.Also, as the gelatin with aforesaid reversible gel property, including alkali process, acid treatment or chemical modification(chemical
modification)Gelatin etc..Acid treatment gelatin is that hydrolytic reagent uses the acid person such as hydrochloric acid or sulphuric acid;Alkali treated gelatin is that hydrolytic reagent uses the bases such as Calx;Chemical modification gelatin is by the amido and succinic acid of gelatin(succinic
acid)Or phthalic acid(phthalic acid)Deng organic acid reaction gained person.
With regard to aforementioned plasticizer, glycerol, Sorbitol, maltose, glucose, polysaccharide, sucrose, xylitol, mannitol, Propylene Glycol, Polyethylene Glycol etc. can be included but are not only restricted to.
With regard to aforementioned opacifier, caramel, titanium oxide, ferrum oxide etc. can be included but are not only restricted to.
The present invention is suitable for the kenel of capsule filling and does not limit, and can be liquid, suspension, pasty state, powder, graininess etc..
The thickness of the hard capsule of the present invention only needs that the function of capsule can be played, and there is no particular restriction, but with 0.01-5 millimeters(mm)Thickness is preferred, and preferred thickness is 0.05-1mm.
The present invention capsule can be used on the purposes such as pharmaceuticals, quasi- pharmaceuticals, food, cosmetics, can be according to the composition of implant depending on.
With regard to aforementioned pharmaceuticals, quasi- pharmaceuticals, if the active ingredient for being filled in the capsule of the present invention does not undermine capsule function person, it is not particularly limited.The vitaminss that drug class is including but not limited to exemplified below, antipyretic, analgesics, antiinflammatory, antiulcer agent, cardiac tonic, anticoagulant, hemorrhage, anti- bone reabsorption agent, angiogenesis inhibiting agent, it is anti-strongly fragrant dose, antitumor agent, antitussive stops expectorant agent, slow dose of muscle, Anti-epilepticses, anti-allergic agent, arrhythmia therapeutic agent, vasodilation, antihypertensive diuretic agent, Remedies for diabetes, tuberculosiss, hormone preparation, analgesic, antibacterial agent, antifungal and antiviral agent etc., but not it is limited to aforesaid pharmacological action group, the object of hard capsule of the present invention is comprising all active ingredient poor to water relative solubility.The preferably active substance of insoluble.
Fig. 1 to Fig. 4 is hereby coordinated to describe in detail preferred embodiments of the present invention as follows.
The capsule external form that used of method of seal of the present invention as shown in figure 1, but be not limited to the external form, the capsule external form that may achieve method of seal provided by the present invention is applied to the present invention.
The capsule external form that the method for seal of the present invention is used on capsule as shown in figure 1, cover(1)External profile diameter(b)Capsule utricule need to be more than(2)External profile diameter(a), and cover on capsule(1)Diameter at inner ring one(a)With capsule utricule(2)External profile diameter(a)It is close, capsule utricule(2)Cover with capsule(1)As shown in Fig. 2 covering on capsule after combination(1)Inner edge not with capsule utricule(2)It is airtight, and capsule utricule(2)Cover with capsule(1)Between there is a packing space(3), packing space(3)It is the presence of a capsule utricule(2)Cover with capsule(1)The angle for being formed, and packing space(3)Compositionss are sealed up for safekeeping for smearing or injecting.
Embodiment one
The capsule that the present invention is provided seals compositionss up for safekeeping for making capsule closely sealed, and compositionss are included(A)Solute and(B)Effumability solvent binary.Aforementioned solute can be acid solution, such as hydrochloric acid, citric acid, acetic acid, sulphuric acid, also can be alkaline solution, such as sodium hydroxide solution, potassium hydroxide solution, and solute can be substituted with water;Aforementioned effumability solvent can be alcohols, including methanol, ethanol, propanol(1-propanol), isopropanol(2-propanol), butanol(1-butanol)Deng.The solute and effumability solvent ratios that foregoing is included can be 1 to 1 to 1 to 15;The solute and effumability solvent ratios that foregoing is included is preferably 1 to 3 to 1 to 10;The solute and effumability solvent ratios that foregoing is included is preferably 1 to 4 to 1 to 6;The concentration of another aforementioned solute can be 1 mole/rise to saturated solution.Foregoing can simultaneously comprising gelatin or plant gum, such as hypromellose(Hydroxypropyl methylcellulose, HPMC), guar gum(guar gum)Or Eucheuma gelatinosum glue.
Cover on capsule(1)With capsule utricule(2)After fit(Fig. 2), with a packing space(3), this packing space is covered on capsule(1)With capsule utricule(2)Between, wherein can smear, inject, spraying or method that other reach identical purpose, make to seal compositionss up for safekeeping(4)It is attached on capsule and covers(1)Inner side and capsule utricule(2)The overlapping space in outside(Fig. 3), then seal compositionss up for safekeeping(4)Due to being attached to capsule, and because sealing compositionss up for safekeeping(4)Capillarity with liquid, can along capsule surface by attachment after seal compositionss up for safekeeping(4)It is loaded onto on capsule and covers(1)With capsule utricule(2)Contact part, i.e., cover on capsule(1)Inner ring with diameter a and capsule utricule(2)The region of the contact of the outer rim with a diameters, makes to seal compositionss up for safekeeping(4)Position is in former packing space(3)Part.Furthermore, due to sealing compositionss up for safekeeping(4)Comprising an effumability solvent, this solvent increases with the time, is volatilized by open surface, and because quantity of solvent reduction, solute amount are constant in volatilization process, solute concentration is cumulative;After solute concentration increases, it is sufficient to the contacted capsule surface of dissolving, in former packing space(3)Part forms a fused portion(5).
Form fused portion(5)Afterwards, capsule is salable, and because only micro solute, that is, seals compositionss up for safekeeping(4)Packing space can be risen to because of capillarity(3)Top, simultaneously as sealing compositionss up for safekeeping(4)It is only micro, can dissolve packing space(3)Capsule shell but do not make capsule deformation, cause drug extravasation in capsule;And block outside air entrance, it is to avoid medicament contact air and go bad.
Although embodiments of the invention are disclosed above described; so it is not limited to the present invention; it is any to be familiar with relevant art; without departing from the spirit and scope of the present invention; such as working as according to the shape described in the present patent application scope, construction, feature and quantity can do a little change, therefore the scope of patent protection of the present invention must be defined depending on this specification scope of the appended claims person of defining.
Claims (17)
1. a kind of method of seal of capsule, it is characterised in that the method for seal of the capsule is comprised the following steps:
Solute is diluted to into the concentration that the solute does not injure capsule using solvent;
And using the volatility and capillarity of the solvent, gradually increase the concentration of solute described in solution to the process that space is volatilized in the solvent, while the solution for not yet volatilizing is guided to capsule utricule and capsule into the formed angle top of lid by the capillarity of the solution;And
Until solvent volatilization is completed, the solution's solute concentration be enough to local dissolution capsule contact surface, and make to cover be integrated molten with the capsule utricule on the capsule.
2. a kind of capsule seals compositionss up for safekeeping, it is characterised in that the compositionss of sealing up for safekeeping of the capsule include:
One solute;And
One effumability solvent;
The solute is acidic aqueous solution, alkaline aqueous solution or water.
3. capsule according to claim 2 seals compositionss up for safekeeping, it is characterised in that the ratio of the solute and the effumability solvent is 1 to 1 to 1 to 15.
4. capsule according to claim 3 seals compositionss up for safekeeping, it is characterised in that the ratio of the solute and the effumability solvent is 1 to 4 to 1 to 6.
5. capsule according to claim 2 seals compositionss up for safekeeping, it is characterised in that the alkaline solution is alkali metal oxide or alkaline earth oxide aqueous solution.
6. capsule according to claim 5 seals compositionss up for safekeeping, it is characterised in that the alkali metal oxide is potassium hydroxide or sodium hydroxide.
7. capsule according to claim 5 seals compositionss up for safekeeping, it is characterised in that the alkaline solution concentration is 0.1 mole/litre to saturated solution.
8. capsule according to claim 2 seals compositionss up for safekeeping, it is characterised in that the acid solution is organic acid or inorganic acid aqueous solution.
9. capsule according to claim 8 seals compositionss up for safekeeping, it is characterised in that the aqueous solutions of organic acids can be citric acid or acetic acid.
10. capsule according to claim 8 seals compositionss up for safekeeping, it is characterised in that the inorganic acid aqueous solution can be hydrochloric acid or sulphuric acid.
11. capsules according to claim 8 seal compositionss up for safekeeping, it is characterised in that the acid solution concentration is 0.1 mole/litre to saturated solution.
12. capsules according to claim 2 seal compositionss up for safekeeping, it is characterised in that the effumability solvent is methanol, ethanol, propanol, isopropanol or butanol.
13. capsules according to claim 2 seal compositionss up for safekeeping, it is characterised in that the compositionss of sealing up for safekeeping can further include gelatin, hypromellose, guar gum or Eucheuma gelatinosum glue, and the additive such as pharmaceutically acceptable plasticizer, opacifier.
14. capsules according to claim 13 seal compositionss up for safekeeping, it is characterised in that the plasticizer may be selected from following constituted group:Glycerol, Sorbitol, maltose, glucose, polysaccharide, sucrose, xylitol, mannitol, 1,2- Propylene Glycol and Polyethylene Glycol.
15. capsules according to claim 13 seal compositionss up for safekeeping, it is characterised in that the opacifier may be selected from following constituted group:Caramel, titanium oxide and ferrum oxide.
A kind of 16. usage rights require the method for sealing capsule up for safekeeping for sealing compositionss up for safekeeping of 2-15, it is characterised in that the method for sealing capsule up for safekeeping for sealing compositionss up for safekeeping is comprised the following steps:
With reference to lid on capsule and capsule utricule;
Make the described of claim 2-15 seal compositionss up for safekeeping, be attached on the capsule between lid inner side and capsule utricule outside;And
Treat that the effumability solvent Jing capillarity is riddled on the capsule between lid inner side and capsule utricule outside and the compositionss solute concentration of sealing up for safekeeping is increased with effumability solvent volatilization, its concentration enough by contact capsule locally it is molten be integrated it is i.e. salable;
The capsule is seal capsule.
17. methods for sealing capsule up for safekeeping according to claim 16, it is characterised in that the implant of the capsule can be the medical composition or health food of the kenels such as liquid, suspension, pasty state, powder, graininess.
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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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 |
WO2022128905A1 (en) * | 2020-12-14 | 2022-06-23 | Capsugel France SAS | 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 |
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Cited By (3)
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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 |
WO2022128905A1 (en) * | 2020-12-14 | 2022-06-23 | Capsugel France SAS | 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 |
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Effective date of registration: 20201012 Address after: Room B8, 3 / F, No.1 Lixing 1st Road, East District, Hsinchu, Taiwan, China Patentee after: Yongda medical materials Co.,Ltd. Address before: 19222 Tranbage Street, Roland Hill, California, USA Patentee before: Cao Ronghua Patentee before: Cao Zhengzhong Patentee before: Wang Tinghua |
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