CN104224739A - 一种以恩替卡韦为主药成分的口服固体组合物 - Google Patents
一种以恩替卡韦为主药成分的口服固体组合物 Download PDFInfo
- Publication number
- CN104224739A CN104224739A CN201410479622.7A CN201410479622A CN104224739A CN 104224739 A CN104224739 A CN 104224739A CN 201410479622 A CN201410479622 A CN 201410479622A CN 104224739 A CN104224739 A CN 104224739A
- Authority
- CN
- China
- Prior art keywords
- entecavir
- gained
- coating
- monohydrate
- film coating
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- YXPVEXCTPGULBZ-WQYNNSOESA-N entecavir hydrate Chemical compound O.C1=NC=2C(=O)NC(N)=NC=2N1[C@H]1C[C@H](O)[C@@H](CO)C1=C YXPVEXCTPGULBZ-WQYNNSOESA-N 0.000 title claims abstract description 91
- 229960000980 entecavir Drugs 0.000 title claims abstract description 71
- 239000008247 solid mixture Substances 0.000 title abstract description 8
- 239000002075 main ingredient Substances 0.000 title abstract 2
- 239000003814 drug Substances 0.000 claims abstract description 34
- 229940079593 drug Drugs 0.000 claims abstract description 21
- 238000002360 preparation method Methods 0.000 claims abstract description 19
- 239000007941 film coated tablet Substances 0.000 claims abstract description 7
- 239000003826 tablet Substances 0.000 claims description 40
- 239000000203 mixture Substances 0.000 claims description 35
- 239000007888 film coating Substances 0.000 claims description 29
- 238000009501 film coating Methods 0.000 claims description 29
- 239000003795 chemical substances by application Substances 0.000 claims description 23
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 22
- 229950010614 entecavir monohydrate Drugs 0.000 claims description 20
- 239000011248 coating agent Substances 0.000 claims description 19
- 238000000576 coating method Methods 0.000 claims description 19
- 239000008187 granular material Substances 0.000 claims description 15
- 239000000463 material Substances 0.000 claims description 15
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims description 14
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 14
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 14
- 229960001021 lactose monohydrate Drugs 0.000 claims description 14
- 238000000034 method Methods 0.000 claims description 14
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 14
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 14
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 14
- 239000011230 binding agent Substances 0.000 claims description 13
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 12
- 235000019359 magnesium stearate Nutrition 0.000 claims description 11
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 claims description 11
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 11
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 11
- 239000000945 filler Substances 0.000 claims description 10
- 239000004322 Butylated hydroxytoluene Substances 0.000 claims description 9
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 claims description 9
- 235000010354 butylated hydroxytoluene Nutrition 0.000 claims description 9
- 229940095259 butylated hydroxytoluene Drugs 0.000 claims description 9
- 239000000314 lubricant Substances 0.000 claims description 9
- 239000003963 antioxidant agent Substances 0.000 claims description 8
- 230000003078 antioxidant effect Effects 0.000 claims description 8
- 239000008213 purified water Substances 0.000 claims description 8
- 239000007779 soft material Substances 0.000 claims description 8
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 7
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 7
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims description 6
- 229920001214 Polysorbate 60 Polymers 0.000 claims description 6
- 238000013019 agitation Methods 0.000 claims description 6
- JLFNLZLINWHATN-UHFFFAOYSA-N pentaethylene glycol Chemical compound OCCOCCOCCOCCOCCO JLFNLZLINWHATN-UHFFFAOYSA-N 0.000 claims description 6
- 239000000725 suspension Substances 0.000 claims description 6
- 239000002245 particle Substances 0.000 claims description 5
- 239000007787 solid Substances 0.000 claims description 5
- 206010008909 Chronic Hepatitis Diseases 0.000 claims description 4
- 229920002261 Corn starch Polymers 0.000 claims description 4
- 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 4
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 4
- 229930195725 Mannitol Natural products 0.000 claims description 4
- 229920002472 Starch Polymers 0.000 claims description 4
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 4
- -1 basifier Substances 0.000 claims description 4
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 4
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 4
- 239000008120 corn starch Substances 0.000 claims description 4
- 229940099112 cornstarch Drugs 0.000 claims description 4
- 238000004132 cross linking Methods 0.000 claims description 4
- 208000006454 hepatitis Diseases 0.000 claims description 4
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 4
- 239000000594 mannitol Substances 0.000 claims description 4
- 235000010355 mannitol Nutrition 0.000 claims description 4
- 229960001855 mannitol Drugs 0.000 claims description 4
- 239000000843 powder Substances 0.000 claims description 4
- 229910052708 sodium Inorganic materials 0.000 claims description 4
- 239000011734 sodium Substances 0.000 claims description 4
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 4
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 4
- 239000008107 starch Substances 0.000 claims description 4
- 235000019698 starch Nutrition 0.000 claims description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 3
- 239000005030 aluminium foil Substances 0.000 claims description 3
- 229960000935 dehydrated alcohol Drugs 0.000 claims description 3
- GRPACOKKYPLPHM-UHFFFAOYSA-N ethanol;phenylmethanol Chemical class CCO.OCC1=CC=CC=C1 GRPACOKKYPLPHM-UHFFFAOYSA-N 0.000 claims description 3
- 229940031705 hydroxypropyl methylcellulose 2910 Drugs 0.000 claims description 3
- 238000010298 pulverizing process Methods 0.000 claims description 3
- 238000003756 stirring Methods 0.000 claims description 3
- 239000004408 titanium dioxide Substances 0.000 claims description 3
- 230000004584 weight gain Effects 0.000 claims description 3
- 235000019786 weight gain Nutrition 0.000 claims description 3
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 claims description 2
- 239000004255 Butylated hydroxyanisole Substances 0.000 claims description 2
- 206010013786 Dry skin Diseases 0.000 claims description 2
- 235000021355 Stearic acid Nutrition 0.000 claims description 2
- 229910000288 alkali metal carbonate Inorganic materials 0.000 claims description 2
- 150000008041 alkali metal carbonates Chemical class 0.000 claims description 2
- 150000008064 anhydrides Chemical class 0.000 claims description 2
- 235000019282 butylated hydroxyanisole Nutrition 0.000 claims description 2
- CZBZUDVBLSSABA-UHFFFAOYSA-N butylated hydroxyanisole Chemical compound COC1=CC=C(O)C(C(C)(C)C)=C1.COC1=CC=C(O)C=C1C(C)(C)C CZBZUDVBLSSABA-UHFFFAOYSA-N 0.000 claims description 2
- 229940043253 butylated hydroxyanisole Drugs 0.000 claims description 2
- 238000001035 drying Methods 0.000 claims description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 2
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 2
- 239000003605 opacifier Substances 0.000 claims description 2
- 239000004014 plasticizer Substances 0.000 claims description 2
- 239000008117 stearic acid Substances 0.000 claims description 2
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 abstract description 5
- 230000001590 oxidative effect Effects 0.000 abstract description 5
- 238000011160 research Methods 0.000 abstract description 5
- 230000007935 neutral effect Effects 0.000 abstract description 3
- 230000008901 benefit Effects 0.000 abstract description 2
- 230000002378 acidificating effect Effects 0.000 abstract 1
- 208000002672 hepatitis B Diseases 0.000 description 13
- 239000000243 solution Substances 0.000 description 12
- 241000700721 Hepatitis B virus Species 0.000 description 10
- 230000000694 effects Effects 0.000 description 9
- 239000007962 solid dispersion Substances 0.000 description 8
- 238000004090 dissolution Methods 0.000 description 7
- 239000002671 adjuvant Substances 0.000 description 6
- 230000001684 chronic effect Effects 0.000 description 6
- 238000005516 engineering process Methods 0.000 description 6
- 208000019425 cirrhosis of liver Diseases 0.000 description 5
- 238000002474 experimental method Methods 0.000 description 5
- 239000008194 pharmaceutical composition Substances 0.000 description 5
- 239000000758 substrate Substances 0.000 description 5
- 208000000419 Chronic Hepatitis B Diseases 0.000 description 4
- 239000002253 acid Substances 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 239000012535 impurity Substances 0.000 description 3
- 208000015181 infectious disease Diseases 0.000 description 3
- 239000002777 nucleoside Substances 0.000 description 3
- 150000003833 nucleoside derivatives Chemical class 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 239000000047 product Substances 0.000 description 3
- YKBGVTZYEHREMT-KVQBGUIXSA-N 2'-deoxyguanosine Chemical compound C1=NC=2C(=O)NC(N)=NC=2N1[C@H]1C[C@H](O)[C@@H](CO)O1 YKBGVTZYEHREMT-KVQBGUIXSA-N 0.000 description 2
- 206010016654 Fibrosis Diseases 0.000 description 2
- 108700024845 Hepatitis B virus P Proteins 0.000 description 2
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 description 2
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 2
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000003513 alkali Substances 0.000 description 2
- 230000033228 biological regulation Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 239000000969 carrier Substances 0.000 description 2
- 230000007882 cirrhosis Effects 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 230000004060 metabolic process Effects 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 239000003960 organic solvent Substances 0.000 description 2
- 229960000502 poloxamer Drugs 0.000 description 2
- 229920001983 poloxamer Polymers 0.000 description 2
- 238000005070 sampling Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- YKBGVTZYEHREMT-UHFFFAOYSA-N 2-amino-9-[4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-3h-purin-6-one Chemical compound C1=2NC(N)=NC(=O)C=2N=CN1C1CC(O)C(CO)O1 YKBGVTZYEHREMT-UHFFFAOYSA-N 0.000 description 1
- 102000004506 Blood Proteins Human genes 0.000 description 1
- 108010017384 Blood Proteins Proteins 0.000 description 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 102000016680 Dioxygenases Human genes 0.000 description 1
- 108010028143 Dioxygenases Proteins 0.000 description 1
- 206010019663 Hepatic failure Diseases 0.000 description 1
- 206010019799 Hepatitis viral Diseases 0.000 description 1
- 208000009889 Herpes Simplex Diseases 0.000 description 1
- 102100034343 Integrase Human genes 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 108010092799 RNA-directed DNA polymerase Proteins 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 229940002637 baraclude Drugs 0.000 description 1
- 230000006399 behavior Effects 0.000 description 1
- 239000008366 buffered solution Substances 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000012512 characterization method Methods 0.000 description 1
- 230000001447 compensatory effect Effects 0.000 description 1
- 239000000470 constituent Substances 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 230000034994 death Effects 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 239000007919 dispersible tablet Substances 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 238000011978 dissolution method Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- QDGZDCVAUDNJFG-FXQIFTODSA-N entecavir (anhydrous) Chemical compound C1=2NC(N)=NC(=O)C=2N=CN1[C@H]1C[C@H](O)[C@@H](CO)C1=C QDGZDCVAUDNJFG-FXQIFTODSA-N 0.000 description 1
- 230000029142 excretion Effects 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000012494 forced degradation Methods 0.000 description 1
- 229930182480 glucuronide Natural products 0.000 description 1
- 150000008134 glucuronides Chemical class 0.000 description 1
- 239000007902 hard capsule Substances 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 208000019423 liver disease Diseases 0.000 description 1
- 208000007903 liver failure Diseases 0.000 description 1
- 231100000835 liver failure Toxicity 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000001050 lubricating effect Effects 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 108020004999 messenger RNA Proteins 0.000 description 1
- 239000002207 metabolite Substances 0.000 description 1
- OKKJLVBELUTLKV-UHFFFAOYSA-N methanol Natural products OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 1
- 150000004682 monohydrates Chemical class 0.000 description 1
- 239000006225 natural substrate Substances 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 230000005180 public health Effects 0.000 description 1
- 238000010839 reverse transcription Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000002002 slurry Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 150000003467 sulfuric acid derivatives Chemical class 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 238000004885 tandem mass spectrometry Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 229940126680 traditional chinese medicines Drugs 0.000 description 1
- 238000001890 transfection Methods 0.000 description 1
- 229940048102 triphosphoric acid Drugs 0.000 description 1
- UNXRWKVEANCORM-UHFFFAOYSA-N triphosphoric acid Chemical compound OP(O)(=O)OP(O)(=O)OP(O)(O)=O UNXRWKVEANCORM-UHFFFAOYSA-N 0.000 description 1
- 241001529453 unidentified herpesvirus Species 0.000 description 1
- 238000001291 vacuum drying Methods 0.000 description 1
- 230000029812 viral genome replication Effects 0.000 description 1
- 201000001862 viral hepatitis Diseases 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
规格 | 10min | 20min | 30min | 45min | 60min |
0.5mg | 95.2% | 96.4% | 96.5% | 97.2% | 99.4% |
1.0mg | 92.5% | 93.4% | 94.6% | 95.6% | 97.8% |
Claims (9)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201410479622.7A CN104224739B (zh) | 2014-09-18 | 2014-09-18 | 一种以恩替卡韦为主药成分的口服固体组合物 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201410479622.7A CN104224739B (zh) | 2014-09-18 | 2014-09-18 | 一种以恩替卡韦为主药成分的口服固体组合物 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN104224739A true CN104224739A (zh) | 2014-12-24 |
CN104224739B CN104224739B (zh) | 2017-02-15 |
Family
ID=52214224
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201410479622.7A Active CN104224739B (zh) | 2014-09-18 | 2014-09-18 | 一种以恩替卡韦为主药成分的口服固体组合物 |
Country Status (1)
Country | Link |
---|---|
CN (1) | CN104224739B (zh) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110585148A (zh) * | 2019-09-19 | 2019-12-20 | 苏州扬厉医药科技有限公司 | 一种恩替卡韦片及其制备方法 |
CN113730367A (zh) * | 2021-09-28 | 2021-12-03 | 海南海灵化学制药有限公司 | 一种恩替卡韦片的制备工艺 |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101371841A (zh) * | 2007-08-23 | 2009-02-25 | 浙江医药股份有限公司新昌制药厂 | 结晶型恩替卡韦制剂及其制备方法和应用 |
CN102552920A (zh) * | 2012-02-20 | 2012-07-11 | 北京协和药厂 | 一种含恩替卡韦的药物组合物及其制备方法 |
EP2508172A1 (en) * | 2011-04-06 | 2012-10-10 | Zentiva, a.s. | Stable and uniform formulations of entecavir and preparation method thereof |
WO2013114389A1 (en) * | 2011-12-21 | 2013-08-08 | Mylan Laboratories Limited. | Process for preparing solid oral formulations comprising low dose of entecavir |
-
2014
- 2014-09-18 CN CN201410479622.7A patent/CN104224739B/zh active Active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101371841A (zh) * | 2007-08-23 | 2009-02-25 | 浙江医药股份有限公司新昌制药厂 | 结晶型恩替卡韦制剂及其制备方法和应用 |
EP2508172A1 (en) * | 2011-04-06 | 2012-10-10 | Zentiva, a.s. | Stable and uniform formulations of entecavir and preparation method thereof |
WO2013114389A1 (en) * | 2011-12-21 | 2013-08-08 | Mylan Laboratories Limited. | Process for preparing solid oral formulations comprising low dose of entecavir |
CN102552920A (zh) * | 2012-02-20 | 2012-07-11 | 北京协和药厂 | 一种含恩替卡韦的药物组合物及其制备方法 |
Non-Patent Citations (1)
Title |
---|
THIPPANI RAMESH 等: "LC-MS/MS method for the characterization of the forced degradation products of entecavir", 《JOURNAL OF SEPARATION SCIENCE》 * |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN110585148A (zh) * | 2019-09-19 | 2019-12-20 | 苏州扬厉医药科技有限公司 | 一种恩替卡韦片及其制备方法 |
CN113730367A (zh) * | 2021-09-28 | 2021-12-03 | 海南海灵化学制药有限公司 | 一种恩替卡韦片的制备工艺 |
CN113730367B (zh) * | 2021-09-28 | 2022-12-02 | 海南海灵化学制药有限公司 | 一种恩替卡韦片的制备工艺 |
Also Published As
Publication number | Publication date |
---|---|
CN104224739B (zh) | 2017-02-15 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
JP5775464B2 (ja) | 非晶質cddo−meを含有する遅延放出性経口投薬組成物 | |
CN102631347B (zh) | 一种吉非替尼药物组合物及其制备方法 | |
WO2010017432A1 (en) | Pharmaceutical formulations of an hcv protease inhibitor in a solid molecular dispersion | |
CN106102716A (zh) | 雄激素受体拮抗剂的固体药物组合物 | |
CN1682719B (zh) | 一种含有石杉碱甲的肠溶包衣缓释片剂及制备方法 | |
CN104434805A (zh) | 一种替格瑞洛固体分散体及其制备方法 | |
Visser et al. | Inulin solid dispersion technology to improve the absorption of the BCS Class IV drug TMC240 | |
US20230190732A1 (en) | Pharmaceutical composition containing nitroxoline prodrug, and preparation method and application therefor | |
CN104844600A (zh) | 一种他达拉非化合物、及其组合物 | |
CN104622836B (zh) | 索非布韦包衣片剂及其制备方法 | |
CN104146978A (zh) | 一种双硫仑肠溶片剂及其制备方法 | |
CN107913256A (zh) | 一种治疗肺动脉高压的马西替坦口腔崩解片及其制备方法 | |
CN104586799A (zh) | 依托考昔分散片及其制备方法 | |
CN104224739A (zh) | 一种以恩替卡韦为主药成分的口服固体组合物 | |
CN101816640B (zh) | 普拉格雷脂质体固体制剂 | |
CN105902507A (zh) | 一种乙磺酸尼达尼布制剂及其应用 | |
CN104800184A (zh) | 琥珀酸呋罗曲坦缓释剂片 | |
CN105828827A (zh) | 一种含他克莫司的药物组合物及其制备方法 | |
CN105001223B (zh) | 一种恩替卡韦晶体化合物及其胶囊制剂 | |
CN102008525B (zh) | 芹菜籽提取物的微丸及其制备方法 | |
CN104884050A (zh) | 用于治疗hiv感染的药物组合物 | |
CN105412027A (zh) | 一种盐酸决奈达隆片剂的制备方法 | |
CN101590051B (zh) | 含有烟酸、HMG-CoA还原酶抑制剂和α-糖苷酶抑制剂的药物组合物 | |
Zhao et al. | Formulation and characterization of tadalafil-loaded orodispersible films with enhanced dissolution rate and membrane permeability | |
CN103751109A (zh) | 替格瑞洛干混悬剂及其制备方法 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
CB02 | Change of applicant information |
Inventor after: Liu Chong Inventor after: Zhao Jiamin Inventor before: The inventor has waived the right to be mentioned |
|
CB03 | Change of inventor or designer information | ||
TA01 | Transfer of patent application right |
Effective date of registration: 20161223 Address after: North Street house 261000 Shandong city of Weifang province Kuiwei District No. 264 Applicant after: Liu Chong Address before: 301700 Tianjin Guangyuan Wuqing Development Zone Wuqing Road on the south side of the Swan Garden District Building 8 Room 703 Applicant before: Li Baoqi |
|
TA01 | Transfer of patent application right | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
TR01 | Transfer of patent right |
Effective date of registration: 20180612 Address after: 226500 No. 999 Wanshou South Road, Chengnan street, Rugao City, Nantong, Jiangsu (room 3A08-26, 8 building, Rugao hi tech Zone) Patentee after: Jiangsu hundred sword Pharmaceutical Technology Co., Ltd. Address before: 261000 264 North Palace Street, Kuiwei District, Weifang, Shandong. Patentee before: Liu Chong |
|
TR01 | Transfer of patent right |