CN1069408A - 球状药用制剂 - Google Patents
球状药用制剂 Download PDFInfo
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Abstract
一种受控释放组合物,包括由硫氮酮或其药学
上可接受的盐和可选的成球剂组成的球状核,所述核
被一种受控释放材料涂覆。如果加入成球剂的话,最
好选用微晶纤维素。乙基纤维素是优选的受控释放
涂层。受控释放涂层最好包含增塑剂、表面活性剂和
胶粘改性剂。
Description
本发明所用的适当的药学上可接受的盐包括药学上可接受的酸加成盐。特别优选盐酸盐。
本发明的受控释放药用组合物能够在较长时间内缓慢释放药物,并且在该时间内延长药物作用时间以达到常规药物传送的效果。
“球状”一词是药学领域的常用词,它是指直径为0.1mm~2.5mm;尤其是0.5mm~2mm的球状粒子。
成球剂可以是任何适当的药学上可接受的材料。它可以与活性成分一起成球以形成球状核。优选的成球剂是微晶纤维素,所用的微晶纤维素可以是,例如阿维塞尔PH107或阿维塞尔PH102(商品名,FMC公司)。一般来说,当存在成球剂时,它占球状核的1%~60%(重量),最好药15%~40%(重量)。
球状核还可含有其它药学上可接受赋形剂和稀释剂。使之易于成球,例如用糖(如蔗糖、右旋糖、麦芽糖或乳糖)或糖醇(例如甘露醇、木糖醇或山梨糖醇)。在球状核中还可含有着色剂。
球状核最好是涂覆允许硫氮
酮在水性介质中控制速率释放的膜,适宜的涂膜材料可包括水不溶蜡和聚合物,例如聚甲基丙烯酸酯(例如商标为Eudragit的聚合物)或优选水不溶纤维素,特别是乙基纤维素。这膜涂层还可含水溶性聚合物,例如聚乙烯吡咯烷酮或最好是水溶性纤维素,例如羟丙基甲基纤维素和羟丙基纤维素。应当理解,水不溶材料与水溶性材料的比率取决于所要求的释放速度和所选村料的溶解度,水溶性聚合物与水不溶聚合物的比率以1∶20至1∶2为佳。受控释放涂层优选包括一种或多种本领域的常规增塑剂,例如酞酸二乙酯,但最好是癸二酸二丁酯;表面活性剂,例如山梨聚糖三油酸酯、山梨聚糖单月桂酸酯或优选多乙氧基醚80(商标为Tween80)和胶粘改性剂,例如滑石粉或优选胶质无水硅石。
当存在增塑剂时,其含量将取决于所选的特定增塑剂,一般,增塑剂的量为受控释放膜涂层的1%至25%(重量)。当存在表面活性剂时,其适宜存在量为受控膜涂层的1%至25%(重量)当存在胶粘改性剂时,其存在量也以受控释放膜涂层的1%至25%(重量)为宜。
优选的受控释放膜涂层包括50%至95%乙基纤维素,5%至15%胶质无水硅石,5%至15%癸二酸二丁酯和5%至15%多乙氧基醚80(商标为Tween 80)。
采用传统涂覆方法例如流化床或槽式涂覆,可在含硫氮
酮的球状核的表面形成受控释放涂膜层。该涂层材料可应用溶液或悬浮液,适宜的溶剂系统包括水、二氯甲烷、乙醇、甲醇、异丙醇和丙酮及其混合物。涂覆溶液或悬浮液优选含2%至60%(重量)、最好含2%至20%(重量)涂覆材料。
受控释放涂覆材料的用量取决于所要求的释放速率,但是一般为受控释放涂覆球体的1%至25%(重量),最好为2%至8%(重量)。
(b)挤压成粒混合物,得到挤出物;
(c)将挤出物成球,直至形成球状核;
(d)干燥球状核;并且
(e)膜涂覆球状核。
采用传统制药技术可将本发明组合物填充制成胶囊或压制成片剂。
为了更好地理解本发明,给出下述实施例,仅为说明而已。
实施例1
制备了具有下述配方的胶囊
材料 毫克
微晶纤维素E.P(Avicel PH 101) 30.0
蒸馏水E.P 适量
150
受控释放膜涂层
材料 毫克
乙基纤维素N10 U.S.N.F 7.38
胶质无水硅石E.P.(Aerosil 130) 0.988
癸二酸二丁酯U.S.N.F. 0.742
多乙氧基醚80 E.P.(Tween80) 0.791
二氯甲烷BS 1994 适量
甲醇B.P.1973 适量
160
胶囊制剂 mg
硬酯酸镁 EP 0.480
明胶囊壳3号(Size 3)
将受控释放涂膜成分分散在二氯甲烷/甲醇溶剂体系中,应用到流化床涂敷器内的硫氮
酮球状核上,得到的涂膜球体过筛,然后,在流化床涂覆器中,将含硫氮
酮受控释放球体用双氢氯噻嗪和羟丙基甲基纤维素的分散体涂膜。
通过EP篮式装置(100转/分),用PH4.5EP磷酸盐缓冲液测定所得产品的溶解度。所得结果如下:
硫氮
酮溶解度
时间(小时) 硫氮
酮受控释放
球状体
1 9
2 23
3 37
4 48
5 57
6 63
8 72
10 77
12 81
15 86
20 90
Claims (12)
3、按照权利要求2的组合物,其中,球状核包含70%~85%(重量)的硫氮
酮或其药学上可接受的盐。
4、接照权利要求1至3的组合物,其中,成球剂的含量为球状核重量的15%~40%。
5、按照权利要求4的组合物,其中,成球剂包括微晶纤维素。
6、按照权利要求1至5任一项的组合物,其中,受控释放涂覆材料包括水不溶性聚合物。
7、按照权利要求6的组合物,其中,涂覆材料包括乙基纤维素。
8、按照权利要求1至7任一项的组合物,其中,受控释放涂覆材料还包括一种或多种增塑剂、表面活性剂和胶粘改性剂。
9、按照权利要求8的组合物,其中,受控释放涂层包括50%~95%乙基纤维素、5%~15%胶状无水硅石、5%~15%癸二酸二丁酯和5%~15%多乙氧基醚80。
10、按照权利要求1至9任一项的组合物,其中,受控释放涂覆材料的用量为组合物重量的2%~8%。
11、一种胶囊,它包含权利要求1至10任一项的受控释放涂覆的球状核。
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB919117361A GB9117361D0 (en) | 1991-08-12 | 1991-08-12 | Oral dosage form |
GB9117361.7 | 1991-08-12 | ||
GB919122967A GB9122967D0 (en) | 1991-10-29 | 1991-10-29 | Pharmaceutical composition |
GB9122967.4 | 1991-10-29 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1069408A true CN1069408A (zh) | 1993-03-03 |
CN1052398C CN1052398C (zh) | 2000-05-17 |
Family
ID=26299395
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN92105698A Expired - Lifetime CN1052398C (zh) | 1991-08-12 | 1992-08-12 | 球状药用制剂 |
Country Status (14)
Country | Link |
---|---|
US (2) | US5670172A (zh) |
EP (1) | EP0527637B1 (zh) |
JP (1) | JP3019235B2 (zh) |
KR (1) | KR100221695B1 (zh) |
CN (1) | CN1052398C (zh) |
AT (1) | ATE165513T1 (zh) |
AU (1) | AU651715B2 (zh) |
CA (1) | CA2075356A1 (zh) |
DE (1) | DE69225278D1 (zh) |
ES (1) | ES2115643T3 (zh) |
FI (1) | FI923582A (zh) |
IL (1) | IL102778A (zh) |
NO (1) | NO304406B1 (zh) |
PH (1) | PH31288A (zh) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN100411611C (zh) * | 2002-04-05 | 2008-08-20 | 欧洲凯尔蒂克公司 | 用于持续,不变且独立释放活性化合物的基质 |
CN1489455B (zh) * | 2000-10-13 | 2010-05-26 | 欧洲凯尔特公司 | 延释药物制剂 |
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- 1992-08-05 CA CA002075356A patent/CA2075356A1/en not_active Abandoned
- 1992-08-06 AU AU20880/92A patent/AU651715B2/en not_active Expired
- 1992-08-10 PH PH44791A patent/PH31288A/en unknown
- 1992-08-10 IL IL10277892A patent/IL102778A/en not_active IP Right Cessation
- 1992-08-10 JP JP4234295A patent/JP3019235B2/ja not_active Expired - Lifetime
- 1992-08-11 DE DE69225278T patent/DE69225278D1/de not_active Expired - Lifetime
- 1992-08-11 EP EP92307333A patent/EP0527637B1/en not_active Expired - Lifetime
- 1992-08-11 ES ES92307333T patent/ES2115643T3/es not_active Expired - Lifetime
- 1992-08-11 FI FI923582A patent/FI923582A/fi unknown
- 1992-08-11 NO NO923128A patent/NO304406B1/no not_active IP Right Cessation
- 1992-08-11 AT AT92307333T patent/ATE165513T1/de active
- 1992-08-12 CN CN92105698A patent/CN1052398C/zh not_active Expired - Lifetime
-
1995
- 1995-04-21 US US08/426,065 patent/US5670172A/en not_active Expired - Lifetime
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1996
- 1996-06-18 US US08/666,636 patent/US5601845A/en not_active Expired - Lifetime
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1489455B (zh) * | 2000-10-13 | 2010-05-26 | 欧洲凯尔特公司 | 延释药物制剂 |
CN100411611C (zh) * | 2002-04-05 | 2008-08-20 | 欧洲凯尔蒂克公司 | 用于持续,不变且独立释放活性化合物的基质 |
Also Published As
Publication number | Publication date |
---|---|
EP0527637B1 (en) | 1998-04-29 |
AU651715B2 (en) | 1994-07-28 |
AU2088092A (en) | 1993-02-18 |
FI923582A (fi) | 1993-02-13 |
FI923582A0 (fi) | 1992-08-11 |
JPH05201867A (ja) | 1993-08-10 |
ATE165513T1 (de) | 1998-05-15 |
PH31288A (en) | 1998-07-06 |
ES2115643T3 (es) | 1998-07-01 |
US5601845A (en) | 1997-02-11 |
IL102778A (en) | 1999-05-09 |
NO923128L (no) | 1993-02-15 |
NO923128D0 (no) | 1992-08-11 |
KR930003906A (ko) | 1993-03-22 |
JP3019235B2 (ja) | 2000-03-13 |
CN1052398C (zh) | 2000-05-17 |
CA2075356A1 (en) | 1993-02-13 |
NO304406B1 (no) | 1998-12-14 |
IL102778A0 (en) | 1993-01-31 |
DE69225278D1 (de) | 1998-06-04 |
KR100221695B1 (ko) | 1999-09-15 |
US5670172A (en) | 1997-09-23 |
EP0527637A1 (en) | 1993-02-17 |
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