CN101716156B - 乌苯美司分散片组合物 - Google Patents
乌苯美司分散片组合物 Download PDFInfo
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- CN101716156B CN101716156B CN2010100280466A CN201010028046A CN101716156B CN 101716156 B CN101716156 B CN 101716156B CN 2010100280466 A CN2010100280466 A CN 2010100280466A CN 201010028046 A CN201010028046 A CN 201010028046A CN 101716156 B CN101716156 B CN 101716156B
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- ubenimex
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- VGGGPCQERPFHOB-MCIONIFRSA-N Bestatin Chemical compound CC(C)C[C@H](C(O)=O)NC(=O)[C@@H](O)[C@H](N)CC1=CC=CC=C1 VGGGPCQERPFHOB-MCIONIFRSA-N 0.000 title claims abstract description 72
- 229950009811 ubenimex Drugs 0.000 title claims abstract description 72
- 239000007916 tablet composition Substances 0.000 title description 3
- 229930006000 Sucrose Natural products 0.000 claims abstract description 24
- 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 abstract description 24
- 239000005720 sucrose Substances 0.000 claims abstract description 24
- 239000002994 raw material Substances 0.000 claims abstract description 22
- 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 18
- 239000008101 lactose Substances 0.000 claims abstract description 18
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 17
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 17
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 17
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 17
- 238000002360 preparation method Methods 0.000 claims abstract description 15
- 238000000034 method Methods 0.000 claims abstract description 14
- 229960000540 polacrilin potassium Drugs 0.000 claims abstract description 14
- WVWZXTJUCNEUAE-UHFFFAOYSA-M potassium;1,2-bis(ethenyl)benzene;2-methylprop-2-enoate Chemical compound [K+].CC(=C)C([O-])=O.C=CC1=CC=CC=C1C=C WVWZXTJUCNEUAE-UHFFFAOYSA-M 0.000 claims abstract description 14
- 239000003826 tablet Substances 0.000 claims description 50
- 239000006185 dispersion Substances 0.000 claims description 37
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 claims description 18
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 18
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 18
- 239000007919 dispersible tablet Substances 0.000 claims description 11
- 239000000203 mixture Substances 0.000 claims description 9
- 239000011812 mixed powder Substances 0.000 claims description 3
- 239000003814 drug Substances 0.000 abstract description 10
- 239000002775 capsule Substances 0.000 abstract description 9
- 239000008187 granular material Substances 0.000 abstract description 4
- 210000004369 blood Anatomy 0.000 abstract description 3
- 239000008280 blood Substances 0.000 abstract description 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 abstract description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 abstract description 2
- 230000008569 process Effects 0.000 abstract description 2
- 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 abstract 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract 1
- 230000009286 beneficial effect Effects 0.000 abstract 1
- 238000004132 cross linking Methods 0.000 abstract 1
- 230000000857 drug effect Effects 0.000 abstract 1
- 229960001375 lactose Drugs 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 229940069328 povidone Drugs 0.000 abstract 1
- 229960004793 sucrose Drugs 0.000 abstract 1
- 238000004458 analytical method Methods 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 4
- 210000004881 tumor cell Anatomy 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 208000019505 Deglutition disease Diseases 0.000 description 3
- 206010028980 Neoplasm Diseases 0.000 description 3
- 239000007963 capsule composition Substances 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
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- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 2
- 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 description 2
- 239000002671 adjuvant Substances 0.000 description 2
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- 238000006243 chemical reaction Methods 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 230000036541 health Effects 0.000 description 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 2
- 229950005770 hyprolose Drugs 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 239000011734 sodium Substances 0.000 description 2
- 229910052708 sodium Inorganic materials 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- NWUYHJFMYQTDRP-UHFFFAOYSA-N 1,2-bis(ethenyl)benzene;1-ethenyl-2-ethylbenzene;styrene Chemical compound C=CC1=CC=CC=C1.CCC1=CC=CC=C1C=C.C=CC1=CC=CC=C1C=C NWUYHJFMYQTDRP-UHFFFAOYSA-N 0.000 description 1
- 102000005606 Activins Human genes 0.000 description 1
- 108010059616 Activins Proteins 0.000 description 1
- 208000031261 Acute myeloid leukaemia Diseases 0.000 description 1
- 208000032791 BCR-ABL1 positive chronic myelogenous leukemia Diseases 0.000 description 1
- 208000010833 Chronic myeloid leukaemia Diseases 0.000 description 1
- 102000007644 Colony-Stimulating Factors Human genes 0.000 description 1
- 108010071942 Colony-Stimulating Factors Proteins 0.000 description 1
- 102000004127 Cytokines Human genes 0.000 description 1
- 108090000695 Cytokines Proteins 0.000 description 1
- 108010016626 Dipeptides Proteins 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- 206010061598 Immunodeficiency Diseases 0.000 description 1
- 101100489867 Mus musculus Got2 gene Proteins 0.000 description 1
- 208000033761 Myelogenous Chronic BCR-ABL Positive Leukemia Diseases 0.000 description 1
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- 208000002454 Nasopharyngeal Carcinoma Diseases 0.000 description 1
- 206010061306 Nasopharyngeal cancer Diseases 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 241000187747 Streptomyces Species 0.000 description 1
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- 230000001093 anti-cancer Effects 0.000 description 1
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- 239000003729 cation exchange resin Substances 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
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- 230000001413 cellular effect Effects 0.000 description 1
- 238000002512 chemotherapy Methods 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 238000005354 coacervation Methods 0.000 description 1
- 238000000748 compression moulding Methods 0.000 description 1
- 239000012531 culture fluid Substances 0.000 description 1
- 238000013461 design Methods 0.000 description 1
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- 239000012738 dissolution medium Substances 0.000 description 1
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- 239000002552 dosage form Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000036737 immune function Effects 0.000 description 1
- 229960001438 immunostimulant agent Drugs 0.000 description 1
- 239000003022 immunostimulating agent Substances 0.000 description 1
- 230000003308 immunostimulating effect Effects 0.000 description 1
- 238000001294 liquid chromatography-tandem mass spectrometry Methods 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
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- 201000011216 nasopharynx carcinoma Diseases 0.000 description 1
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- -1 onset is rapid Substances 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 210000002381 plasma Anatomy 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
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- 238000011127 radiochemotherapy Methods 0.000 description 1
- 238000001959 radiotherapy Methods 0.000 description 1
- 230000008929 regeneration Effects 0.000 description 1
- 238000011069 regeneration method Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 229910021487 silica fume Inorganic materials 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 230000004936 stimulating effect Effects 0.000 description 1
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- 239000000375 suspending agent Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
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- 208000024891 symptom Diseases 0.000 description 1
- 239000007885 tablet disintegrant Substances 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
Description
参数 | 乌苯美司分散片 | 乌苯美司胶囊 |
Cmax(ng/ml) | 848±221 | 764±175 |
Tmax(hr) | 0.64±0.29 | 9.93±0.44 |
AUC0-t(ng·h/ml) | 1135±149 | 1159±179 |
AUC0-∞(ng·h/ml) | 1144±152 | 1174±186 |
t1/2(hr) | 1.27±0.28 | 1.35±0.46 |
F(%) | 98.6±9.7 |
原料 | 实施例2 | 实施例3 | 实施例4 | 实施例5 | 实施例6 | 实施例7 |
乌苯美司 | 10 | 10 | 20 | 21 | 30 | 30 |
交联聚维酮 | 10 | 3 | 5 | 4 | 10 | 10 |
波拉克林钾 | 0 | 5 | 2 | 1 | 3 | 0 |
乳糖 | 30 | 20 | 30 | 22 | 27 | 30 |
微晶纤维素 | 90 | 100 | 95 | 92 | 94 | 90 |
可压性蔗糖 | 0 | 1 | 1 | 0 | 1 | 0 |
蔗糖 | 0 | 0 | 0 | 1 | 0 | 0 |
编号 | 实施例2 | 实施例3 | 实施例4 | 实施例5 | 实施例6 | 实施例7 |
分散均匀性测定结果 | 45秒 | 1分02秒 | 54秒 | 1分00秒 | 40秒 | 39秒 |
Claims (4)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN2010100280466A CN101716156B (zh) | 2010-01-08 | 2010-01-08 | 乌苯美司分散片组合物 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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CN2010100280466A CN101716156B (zh) | 2010-01-08 | 2010-01-08 | 乌苯美司分散片组合物 |
Publications (2)
Publication Number | Publication Date |
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CN101716156A CN101716156A (zh) | 2010-06-02 |
CN101716156B true CN101716156B (zh) | 2011-06-22 |
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CN2010100280466A Active CN101716156B (zh) | 2010-01-08 | 2010-01-08 | 乌苯美司分散片组合物 |
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CN (1) | CN101716156B (zh) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103142544B (zh) * | 2013-02-28 | 2014-01-08 | 成都苑东药业有限公司 | 乌苯美司胶囊组合物及其制备方法 |
CN103610663B (zh) * | 2013-12-10 | 2015-05-06 | 成都苑东药业有限公司 | 一种乌苯美司胶囊药物组合物及其制备方法 |
CN104784239B (zh) * | 2015-04-28 | 2017-12-26 | 新乡医学院第一附属医院 | 一种快速溶出的珍菊降压片及其制备工艺 |
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Date | Code | Title | Description |
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C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Sichuan Sunheal Technology Co., Ltd. Assignor: Chengdu Easton Pharmaceutical Co., Ltd. Contract record no.: 2011510000147 Denomination of invention: Ubenimex dispersive tablet composition Granted publication date: 20110622 License type: Exclusive License Open date: 20100602 Record date: 20110812 |
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C56 | Change in the name or address of the patentee | ||
CP01 | Change in the name or title of a patent holder |
Address after: 611731 Chengdu province high tech Zone, west of the source road, No. 8, No. Patentee after: CHENGDU EASTON BIOPHARMACEUTICALS CO., LTD. Address before: 611731 Chengdu province high tech Zone, west of the source road, No. 8, No. Patentee before: Chengdu Easton Pharmaceutical Co., Ltd. |