CN1241566C - 西洛他唑固体分散体及其片剂制备方法 - Google Patents
西洛他唑固体分散体及其片剂制备方法 Download PDFInfo
- Publication number
- CN1241566C CN1241566C CN 200410026503 CN200410026503A CN1241566C CN 1241566 C CN1241566 C CN 1241566C CN 200410026503 CN200410026503 CN 200410026503 CN 200410026503 A CN200410026503 A CN 200410026503A CN 1241566 C CN1241566 C CN 1241566C
- Authority
- CN
- China
- Prior art keywords
- cilostazol
- tablet
- solid dispersion
- weight ratio
- crospolyvinylpyrrolidone
- 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 - Lifetime
Links
- 229960004588 cilostazol Drugs 0.000 title claims abstract description 94
- RRGUKTPIGVIEKM-UHFFFAOYSA-N cilostazol Chemical compound C=1C=C2NC(=O)CCC2=CC=1OCCCCC1=NN=NN1C1CCCCC1 RRGUKTPIGVIEKM-UHFFFAOYSA-N 0.000 title claims abstract description 93
- 239000007962 solid dispersion Substances 0.000 title claims abstract description 66
- 238000000034 method Methods 0.000 title claims abstract description 32
- 239000000203 mixture Substances 0.000 claims abstract description 41
- 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 claims abstract description 24
- 239000008101 lactose Substances 0.000 claims abstract description 24
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 20
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 20
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 20
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 20
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 17
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims abstract description 17
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims abstract description 11
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound 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 GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims abstract description 6
- 238000007908 dry granulation Methods 0.000 claims abstract description 6
- 238000007907 direct compression Methods 0.000 claims abstract description 5
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims abstract description 4
- 229920000858 Cyclodextrin Polymers 0.000 claims abstract description 3
- 239000004480 active ingredient Substances 0.000 claims abstract description 3
- 239000002270 dispersing agent Substances 0.000 claims abstract description 3
- 229940093429 polyethylene glycol 6000 Drugs 0.000 claims abstract description 3
- 238000005498 polishing Methods 0.000 claims abstract 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 48
- 238000002360 preparation method Methods 0.000 claims description 37
- 239000008187 granular material Substances 0.000 claims description 29
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical group [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 27
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 27
- 239000004141 Sodium laurylsulphate Substances 0.000 claims description 25
- 235000019359 magnesium stearate Nutrition 0.000 claims description 24
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 claims description 14
- 238000005303 weighing Methods 0.000 claims description 14
- 239000003795 chemical substances by application Substances 0.000 claims description 12
- 239000007779 soft material Substances 0.000 claims description 12
- 238000000227 grinding Methods 0.000 claims description 11
- 239000000314 lubricant Substances 0.000 claims description 11
- 238000002156 mixing Methods 0.000 claims description 10
- 239000002245 particle Substances 0.000 claims description 10
- 239000011230 binding agent Substances 0.000 claims description 9
- 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 7
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 7
- 239000012876 carrier material Substances 0.000 claims description 7
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 7
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 7
- 229920000881 Modified starch Polymers 0.000 claims description 6
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 6
- 239000000654 additive Substances 0.000 claims description 6
- 230000000996 additive effect Effects 0.000 claims description 6
- 230000008569 process Effects 0.000 claims description 6
- 239000000741 silica gel Substances 0.000 claims description 6
- 229910002027 silica gel Inorganic materials 0.000 claims description 6
- 239000004094 surface-active agent Substances 0.000 claims description 6
- 238000004132 cross linking Methods 0.000 claims description 5
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 5
- 229920002472 Starch Polymers 0.000 claims description 4
- 239000003085 diluting agent Substances 0.000 claims description 4
- 239000008107 starch Substances 0.000 claims description 4
- 235000019698 starch Nutrition 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 3
- 229930195725 Mannitol Natural products 0.000 claims description 3
- 239000002202 Polyethylene glycol Substances 0.000 claims description 3
- 239000000594 mannitol Substances 0.000 claims description 3
- 235000010355 mannitol Nutrition 0.000 claims description 3
- 229920001223 polyethylene glycol Polymers 0.000 claims description 3
- 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 2
- 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 2
- 241001597008 Nomeidae Species 0.000 claims description 2
- 235000021355 Stearic acid Nutrition 0.000 claims description 2
- 239000000853 adhesive Substances 0.000 claims description 2
- 230000001070 adhesive effect Effects 0.000 claims description 2
- 239000000783 alginic acid Substances 0.000 claims description 2
- 235000010443 alginic acid Nutrition 0.000 claims description 2
- 229920000615 alginic acid Polymers 0.000 claims description 2
- 229960001126 alginic acid Drugs 0.000 claims description 2
- 150000004781 alginic acids Chemical class 0.000 claims description 2
- 159000000007 calcium salts Chemical class 0.000 claims description 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims description 2
- 239000008116 calcium stearate Substances 0.000 claims description 2
- 235000013539 calcium stearate Nutrition 0.000 claims description 2
- GXGAKHNRMVGRPK-UHFFFAOYSA-N dimagnesium;dioxido-bis[[oxido(oxo)silyl]oxy]silane Chemical compound [Mg+2].[Mg+2].[O-][Si](=O)O[Si]([O-])([O-])O[Si]([O-])=O GXGAKHNRMVGRPK-UHFFFAOYSA-N 0.000 claims description 2
- 239000008172 hydrogenated vegetable oil Substances 0.000 claims description 2
- -1 hydroxypropyl Chemical group 0.000 claims description 2
- 239000000391 magnesium silicate Substances 0.000 claims description 2
- 229940099273 magnesium trisilicate Drugs 0.000 claims description 2
- 229910000386 magnesium trisilicate Inorganic materials 0.000 claims description 2
- 235000019793 magnesium trisilicate Nutrition 0.000 claims description 2
- TZBAVQKIEKDGFH-UHFFFAOYSA-N n-[2-(diethylamino)ethyl]-1-benzothiophene-2-carboxamide;hydrochloride Chemical compound [Cl-].C1=CC=C2SC(C(=O)NCC[NH+](CC)CC)=CC2=C1 TZBAVQKIEKDGFH-UHFFFAOYSA-N 0.000 claims description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical group 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
- 239000002002 slurry Substances 0.000 claims description 2
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 claims description 2
- 239000000600 sorbitol Substances 0.000 claims description 2
- 235000010356 sorbitol Nutrition 0.000 claims description 2
- 239000008117 stearic acid Substances 0.000 claims description 2
- 239000002671 adjuvant Substances 0.000 claims 6
- 239000006185 dispersion Substances 0.000 claims 2
- 239000003814 drug Substances 0.000 abstract description 23
- 238000004090 dissolution Methods 0.000 abstract description 7
- 238000005550 wet granulation Methods 0.000 abstract description 4
- 238000007906 compression Methods 0.000 abstract description 3
- 230000006835 compression Effects 0.000 abstract description 3
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract 4
- 229960000913 crospovidone Drugs 0.000 abstract 4
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 abstract 4
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 abstract 4
- 239000000969 carrier Substances 0.000 abstract 2
- 238000010521 absorption reaction Methods 0.000 abstract 1
- 239000000463 material Substances 0.000 abstract 1
- 229940057838 polyethylene glycol 4000 Drugs 0.000 abstract 1
- 239000003826 tablet Substances 0.000 description 39
- 239000000843 powder Substances 0.000 description 11
- 239000004615 ingredient Substances 0.000 description 9
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 6
- 239000000047 product Substances 0.000 description 6
- 206010013786 Dry skin Diseases 0.000 description 5
- 238000001035 drying Methods 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 239000007864 aqueous solution Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 210000003414 extremity Anatomy 0.000 description 4
- 239000002904 solvent Substances 0.000 description 4
- 208000024891 symptom Diseases 0.000 description 4
- 210000001367 artery Anatomy 0.000 description 3
- 238000011978 dissolution method Methods 0.000 description 3
- 229940079593 drug Drugs 0.000 description 3
- BSYNRYMUTXBXSQ-UHFFFAOYSA-N Aspirin Chemical compound CC(=O)OC1=CC=CC=C1C(O)=O BSYNRYMUTXBXSQ-UHFFFAOYSA-N 0.000 description 2
- 206010017577 Gait disturbance Diseases 0.000 description 2
- 206010022562 Intermittent claudication Diseases 0.000 description 2
- 208000007536 Thrombosis Diseases 0.000 description 2
- 229960001138 acetylsalicylic acid Drugs 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000000706 filtrate Substances 0.000 description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 2
- 230000005764 inhibitory process Effects 0.000 description 2
- 208000021156 intermittent vascular claudication Diseases 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 238000007500 overflow downdraw method Methods 0.000 description 2
- 230000002093 peripheral effect Effects 0.000 description 2
- 208000010110 spontaneous platelet aggregation Diseases 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 239000000080 wetting agent Substances 0.000 description 2
- UCTWMZQNUQWSLP-VIFPVBQESA-N (R)-adrenaline Chemical compound CNC[C@H](O)C1=CC=C(O)C(O)=C1 UCTWMZQNUQWSLP-VIFPVBQESA-N 0.000 description 1
- 229930182837 (R)-adrenaline Natural products 0.000 description 1
- IRFSXVIRXMYULF-UHFFFAOYSA-N 1,2-dihydroquinoline Chemical compound C1=CC=C2C=CCNC2=C1 IRFSXVIRXMYULF-UHFFFAOYSA-N 0.000 description 1
- 208000037260 Atherosclerotic Plaque Diseases 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- 206010010904 Convulsion Diseases 0.000 description 1
- 208000005189 Embolism Diseases 0.000 description 1
- 208000032843 Hemorrhage Diseases 0.000 description 1
- 208000000112 Myalgia Diseases 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 208000031481 Pathologic Constriction Diseases 0.000 description 1
- 102000004861 Phosphoric Diester Hydrolases Human genes 0.000 description 1
- 108090001050 Phosphoric Diester Hydrolases Proteins 0.000 description 1
- 208000001435 Thromboembolism Diseases 0.000 description 1
- 208000025865 Ulcer Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000006502 antiplatelets effects Effects 0.000 description 1
- 229940027991 antiseptic and disinfectant quinoline derivative Drugs 0.000 description 1
- 230000003143 atherosclerotic effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 125000004106 butoxy group Chemical group [*]OC([H])([H])C([H])([H])C(C([H])([H])[H])([H])[H] 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 229940034205 cilostazol oral tablet Drugs 0.000 description 1
- 229920001436 collagen Polymers 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000036461 convulsion Effects 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 229960005139 epinephrine Drugs 0.000 description 1
- 229960001123 epoprostenol Drugs 0.000 description 1
- KAQKFAOMNZTLHT-VVUHWYTRSA-N epoprostenol Chemical compound O1C(=CCCCC(O)=O)C[C@@H]2[C@@H](/C=C/[C@@H](O)CCCCC)[C@H](O)C[C@@H]21 KAQKFAOMNZTLHT-VVUHWYTRSA-N 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 201000002818 limb ischemia Diseases 0.000 description 1
- 210000003141 lower extremity Anatomy 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 208000013465 muscle pain Diseases 0.000 description 1
- 210000002464 muscle smooth vascular Anatomy 0.000 description 1
- 230000000414 obstructive effect Effects 0.000 description 1
- 229940096978 oral tablet Drugs 0.000 description 1
- 239000007935 oral tablet Substances 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 231100000915 pathological change Toxicity 0.000 description 1
- 230000036285 pathological change Effects 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- 229940093430 polyethylene glycol 1500 Drugs 0.000 description 1
- 125000002943 quinolinyl group Chemical class N1=C(C=CC2=CC=CC=C12)* 0.000 description 1
- 239000013558 reference substance Substances 0.000 description 1
- 230000000630 rising effect Effects 0.000 description 1
- 210000002460 smooth muscle Anatomy 0.000 description 1
- 230000036262 stenosis Effects 0.000 description 1
- 208000037804 stenosis Diseases 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
- 210000003556 vascular endothelial cell Anatomy 0.000 description 1
- 230000001196 vasorelaxation Effects 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
样本 | 市售样品 | 实施例1 | 实施例2 | 实施例3 | 实施例4 | 实施例5 | 实施例6 | 实施例7 | 实施例8 | 实施例9 |
溶出度(%) | 89.69 | 99.64 | 93.88 | 98.89 | 99.71 | 91.13 | 94.22 | 98.56 | 95.45 | 96.67 |
Claims (17)
Priority Applications (1)
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CN 200410026503 CN1241566C (zh) | 2004-03-15 | 2004-03-15 | 西洛他唑固体分散体及其片剂制备方法 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN 200410026503 CN1241566C (zh) | 2004-03-15 | 2004-03-15 | 西洛他唑固体分散体及其片剂制备方法 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1562018A CN1562018A (zh) | 2005-01-12 |
CN1241566C true CN1241566C (zh) | 2006-02-15 |
Family
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Family Applications (1)
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CN 200410026503 Expired - Lifetime CN1241566C (zh) | 2004-03-15 | 2004-03-15 | 西洛他唑固体分散体及其片剂制备方法 |
Country Status (1)
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CN (1) | CN1241566C (zh) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1883493B (zh) * | 2005-06-24 | 2010-05-05 | 云南白药集团股份有限公司 | 偏诺皂苷类化合物固态分子分散制剂 |
TW200848041A (en) * | 2007-03-30 | 2008-12-16 | Otsuka Pharma Co Ltd | A medicament for treating schizophrenia comprising cilostazol |
CN101298502B (zh) * | 2007-04-30 | 2010-08-11 | 福建省医学科学研究所 | 一种增加壳聚糖水溶性的方法 |
CN101081213B (zh) * | 2007-06-26 | 2010-10-06 | 中山大学 | 丁二酸(5-雄甾烯-17-酮-3β-羟基)二酯固体分散体及其制备方法与应用 |
CN102133188B (zh) * | 2011-03-18 | 2012-02-15 | 海南美兰史克制药有限公司 | 一种西洛他唑脂质体固体制剂 |
CN103018190B (zh) * | 2011-09-22 | 2016-02-10 | 北京美迪康信医药科技有限公司 | 一种药物制剂及其溶出度测定方法 |
CN103099790B (zh) * | 2011-11-11 | 2015-09-02 | 山东新时代药业有限公司 | 一种含依维莫司的片剂及其制备方法 |
TWI615157B (zh) * | 2013-02-06 | 2018-02-21 | 大塚製藥股份有限公司 | 包括不定形西洛他唑的固體分散劑 |
CN103705485B (zh) * | 2013-12-31 | 2015-07-22 | 广州帝奇医药技术有限公司 | 一种用于治疗骨髓增生异常综合症的组合物及其制备方法 |
CN105232489B (zh) * | 2014-07-01 | 2019-06-11 | 深圳信立泰药业股份有限公司 | 一种阿利沙坦酯固体分散体及含有该固体分散体的药物组合物 |
CN109157516A (zh) * | 2018-11-05 | 2019-01-08 | 天津双硕医药科技有限公司 | 一种西洛他唑口服固体药物组合物 |
-
2004
- 2004-03-15 CN CN 200410026503 patent/CN1241566C/zh not_active Expired - Lifetime
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Application publication date: 20050112 Assignee: HANGZHOU NEPTUNUS BIOENGINEERING Co.,Ltd. Assignor: SHENZHEN NEPTUNUS PHARMACEUTICAL Co.,Ltd. Contract record no.: 2010330000330 Denomination of invention: Cilostazol solid dispersion and its method for preparing tablet Granted publication date: 20060215 License type: Exclusive License Record date: 20100326 |
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