CN1053744A - 一种制备改进的释放二甲苯氧庚酸组合物的方法 - Google Patents
一种制备改进的释放二甲苯氧庚酸组合物的方法 Download PDFInfo
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Abstract
一种制备能提供即时释和缓释二甲苯氧庚酸的
可崩解组合物的方法,包括将第一颗粒和第二颗粒以
及能使其在胃中部分或完全崩解的崩解赋形剂的混
合物压制成片剂,上述第一颗粒包括用至少一种纤维
素衍生物制粒的细微粉末的纯二甲苯氧庚酸和第二
颗粒包括用药用的水溶性或水不溶性聚合物与纯二
甲苯氧庚酸一起制粒的细微颗粒,并且在与第一颗粒
混合之前先用药用的(meth)丙烯酸酯共聚物均匀地
包衣。在制成的组合物中,第一颗粒和第二颗粒比例
从约10∶1到约1∶10。
Description
本发明涉及改进的释放二甲苯氧庚酸的组合物。
二甲苯氧庚酸即5-(2,5-二甲苯氧基)-2,2-二甲基戊酸,是一种广泛地作为抗高脂蛋白血症的药剂。虽然似乎在整个肠胃道中被吸收,但最大的吸收作用似乎出现在上胃肠道,尽管该药在酸性pH值时溶解度很差。
先前研制持续释药组合物的努力,如贮存系统,一直未获得相当的成功,产生的组合物或者生物利用率不好,或者释放曲线不能令人接受。自相矛盾的是,似乎要想得到持久释放的组合物,必须要在胃中崩解或溶蚀。
英国专利申请2,179,254公开了一些先用甲基丙烯酸-丙烯酸共聚物包衣,然后用甲基丙烯酸酯共聚物包衣,最后用多乙氧基醚80和羟丙基甲基纤维素的混合物包衣的止痛的丙酸衍生物(如异丁苯丙酸)的组合物。
EPO-A 8600802公开了聚乙烯乙二醇和两亲化合物的缓释组合物。
法国专利申请2,554,717公开的缓释组合物,使用乙烯基吡咯烷酮-乙烯基醋酸酯共聚物和用聚烯丙基蔗糖交联的丙烯酸聚合物作为基质(也可参见比利时申请901007)。
美国专利4,132,753公开了可控的释药颗粒,其中药物粉末被加热以陷入到很细的腊类材料中。
美国专利4,195,084公开了一种用于降低高血胆甾醇的细微的妥尔油谷甾醇的液体混悬剂。
美国专利4,263,272公开了逐渐释药或分两个阶段释药的胆汁酸的三组分组合物。
美国专利4,291,016公开了具有用羟丙基甲基纤维素包裹的基质芯的药物组合物。
美国专利4,533,562公开了用成膜聚合物如羟丙基甲基纤维素和一种液体增塑剂,如聚乙二醇包衣的片剂。
美国专利4,661,162公开了一种肠溶性组合物,它含有肠溶聚合物,如(m)丙烯酸乙酯/甲基丙烯酸酯共聚物和多阴离子聚合物如藻酸及其盐类的混合物。
本发明涉及一种能提供即时和缓释的二甲苯氧庚酸的可崩解组合物。具体地说,本发明包含一种片剂,它由(ⅰ)如下文所述的第一颗粒,(ⅱ)如下文所述第二颗粒和(ⅲ)能使该片剂在胃中部分或完全崩解的合适的崩解赋形剂。
第一颗粒包括纯的二甲苯氧庚酸的细微粒子,或二甲苯氧庚酸和赋形剂的粉末混合物,用至少一种粘合剂,如纤维素衍生物、蔗糖或聚乙烯吡咯烷酮制成颗粒,合适的纤维素衍生物包括微晶纤维素、水溶性羟烷基纤维素,如羟乙基纤维素、羟丙基纤维素和羟丙基甲基纤维素。纤维素衍生物的混合物特别好。
第二颗粒包括纯二甲苯氧庚酸的细微粒子,或二甲苯氧庚酸与赋形剂的粉末混合物,采用药用的水溶性的或不溶性的聚合物制粒,然后在与所述第一颗粒混合前,先均匀地用药用的缓释材料,如(meth)丙烯酸酯共聚物和1或2基纤维素包衣。
用于第二颗粒的缓释聚合组份含有至少一种水不溶性聚合物,如(meth)丙烯酸共聚物,使用括号中的“meth”作为词头表明该聚合物分子是由丙烯酸或甲基丙烯酸类之一或两者得到的。因此,共聚物可由丙烯酸甲酯与乙酯和甲基丙烯酸甲酯和乙酯获得。其它常规共聚用单体可以存在于共聚物中,只要它们无损于本发明系统中共聚物的使用性,特别有用的是Eudragit E30D,一种特性基于聚-(meth)丙烯酸酯中性共聚物的聚合分散体,平均分子量大约为800,000。其它有用的聚合物包括具有更低水溶性的纤维素衍生物,例如乙基纤维素和醋酸纤维素(以Aquacoat和Surelease商品名出售的水分散体)。
第一和第二组分的制粒分别完成。每种情况,都使用少量水和表面活性剂按湿法制粒技术进行。
第二颗粒依次用一种水不溶性聚合物如上述类型的(meth)丙烯酸共聚物,单独地或与其它聚合物如乙基纤维素结合使用进行包衣。
然后第一和第二颗粒按彼此之比分别从10∶1到1∶10的比例混合。不难看出,该比例可以依所要求的释放曲线而变化。将这些颗粒与一种或多种能使片剂在胃中实现部分或完全崩解的崩解赋形剂混合,部分崩解意指片剂成分的部分分离或片剂的溶蚀,留下能继续崩解或释放活性成分二甲苯氧庚酸的可辨认的基质。适当的崩解和溶蚀赋形剂包括一种或多种可水分散的纤维素衍生物,如微晶纤维素、水溶性羟烷基纤维素、如羟乙基纤维素、羟丙基纤维素、羟丙基甲基纤维素、交联羧甲基纤维素钠、聚乙二醇、蔗糖和聚乙烯吡咯烷酮。
将颗粒和崩解赋形剂混合压制成片剂。操作助剂如分散剂、增塑剂、稳定剂、润滑剂等,都按较小量加入。适用的分散或抗粘结剂包括高岭土、滑石粉、三硅酸镁、二氧化硅、碳酸钙等,滑石粉最好;润滑剂包括硬脂酸镁、硬脂酸钙、硬脂酸锌、胶体二氧化硅、硬脂酸,以及聚乙烯乙二醇也有助于组合物。
可以选择的另一种方法是,将两种独立配制的颗粒采用两层冲压机压制成二层片剂。首先压制由第一颗粒组成的第一层和再将第二颗粒组成的第二层压制在第一层上。
然后对片剂包衣。包衣材料具有的溶解度特性使包衣在口腔中不溶解,而在胃中胃液的酸性环境下迅速溶解。为了易于操作和包装,最好包衣材料是聚合物性质的。然而,其它类型的包衣材料也能全部或部分代替聚合物包衣。
下述实例起进一步说明本发明性质的作用,但不应解释成对本发明范围的限制。本发明的范围仅由权利要求书限定。
例1
第一颗粒
由下列组分制备第一颗粒
成分 重量份数
二甲苯氧庚酸 255.5
微晶纤维素 25.5
羟丙基纤维素 6.4
聚乙氧基醚80 2.6
纯水 20.0
上述成分经混合并制备:
第二颗粒
由下列组分独立地制备第二颗粒。
成分 重量份数
二甲苯氧庚酸 344.5
Eudragit E30D 137.8
聚乙氧基醚80 2.8
纯水 6.0
该颗粒用下列组合物包衣:
成分 重量份数
Eudragit E30D 349.70
乙基纤维素(30%水分散体) 103.40
将上述颗粒组合成三种具有如下组分的不同的配方。
成分 重量份数
(Ⅰ) (Ⅱ) (Ⅲ)
颗粒1 290.0 149.9 60.0
颗粒2 524.6 712.4 833.0
微晶纤维素 219.4 171.7 141.0
交联羧甲基纤维素钠 50.0 50.0 50.0
滑石粉 8.0 8.0 8.0
硬脂酸钙 8.0 8.0 8.0
上述三种组合物经体外释药分析,产生下列释药特性:
时间(小时) 释药%
组合物(Ⅰ) (Ⅱ) (Ⅲ)
1 66.0 50.9 38.5
2 79.1 68.2 57.8
4 89.6 85.1 77.1
6 94.6 90.4 85.7
8 97.2 95.3 90.9
10 99.1 98.2 94.3
12 100.0 100.0 96.7
Claims (11)
1、一种制备二甲苯氧庚酸可即时释放和缓释的可崩解的组合物的方法,包括将(ⅰ)第一颗粒,(ⅱ)第二颗粒和(ⅲ)能使其在胃中完全或部分崩解的崩解赋形剂的混合物压制成片剂,所述第一颗粒和第二颗粒分别以各自对另外一种颗粒的比例约为10∶1-1∶10存在,所述第一颗粒包括用至少一种纤维素衍生物制粒的细微颗粒的纯二甲苯氧庚酸,而所述第二颗粒包括用药用的水溶性或水不溶性聚合物制粒的细微粉末纯二甲苯氧庚酸,所述第二颗粒在与所述第一颗粒混合前用水不溶性物质均匀地包衣。
2、如权利要求1的制备方法,其中所述的第一颗粒的所说的纤维素衍生物至少包括微晶纤维素、水溶性羟(基)烷基纤维素和交联羧甲基纤维素中的一种。
3、如权利要求2所述的方法,其中水溶性羟烷基纤维素是羟乙基纤维素、羟丙基纤维素和羟丙基甲基纤维素。
4、如权利要求1所述的制备方法,其中所述的第一颗粒的纤维素衍生物包括微晶纤维素和羟丙基纤维素。
5、如权利要求1所述的制备方法,其中所述第二颗粒的所述药用水溶性或水不溶性聚合物是一种药用(meth)丙烯酸酯共聚物。
6、如权利要求5所述的方法,其中所述(meth)丙烯酸酯共聚物是一种由丙烯酸甲酯和乙酯与甲基丙烯酸甲酯和乙酯产生的平均分子量约为800,000的共聚物。
7、如权利要求6所述的方法,其中所述的第二颗粒由药用的(meth)丙烯酸酯共聚物包衣。
8、所权利要求7所述的方法,其中所述(meth)丙烯酸酯共聚物是从丙烯酸甲酯和乙酯与甲基丙烯酸甲酯和乙酯衍生的,平均分子量约为800,000。
9、如权利要求1-8中任一项所述的方法,其中所述崩解赋形剂包括一种或多种可水分散的纤维素衍生物。
10、如权利要求9所述的方法,其中所述崩解赋形剂选自由微晶纤维素、羟乙基纤维素、羟丙基纤维素、羟丙基甲基纤维素和交联羧甲基纤维素钠组成的组中的一种。
11、如权利要求10所述的方法,其中所述崩解赋形剂是微晶纤维素和交联羧甲基纤维素钠。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US305,082 | 1989-02-02 | ||
US07/305,082 US4927639A (en) | 1989-02-02 | 1989-02-02 | Modified release gemfibrozil composition |
Publications (1)
Publication Number | Publication Date |
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CN1053744A true CN1053744A (zh) | 1991-08-14 |
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ID=23179253
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Application Number | Title | Priority Date | Filing Date |
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CN90100781A Pending CN1053744A (zh) | 1989-02-02 | 1990-02-02 | 一种制备改进的释放二甲苯氧庚酸组合物的方法 |
Country Status (21)
Country | Link |
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US (1) | US4927639A (zh) |
EP (1) | EP0381219B1 (zh) |
JP (1) | JPH02240017A (zh) |
KR (1) | KR0137268B1 (zh) |
CN (1) | CN1053744A (zh) |
AT (1) | ATE88889T1 (zh) |
AU (1) | AU622751B2 (zh) |
CA (1) | CA2009135A1 (zh) |
DE (1) | DE69001488T2 (zh) |
DK (1) | DK0381219T3 (zh) |
ES (1) | ES2055177T3 (zh) |
FI (1) | FI900491A0 (zh) |
HU (1) | HU204192B (zh) |
IE (1) | IE900371L (zh) |
IL (1) | IL92994A (zh) |
MY (1) | MY104898A (zh) |
NO (1) | NO900484L (zh) |
NZ (1) | NZ232321A (zh) |
PH (1) | PH26317A (zh) |
PT (1) | PT93029A (zh) |
ZA (1) | ZA90776B (zh) |
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-
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- 1989-02-02 US US07/305,082 patent/US4927639A/en not_active Expired - Fee Related
-
1990
- 1990-01-08 IL IL9299490A patent/IL92994A/en not_active IP Right Cessation
- 1990-01-12 MY MYPI90000054A patent/MY104898A/en unknown
- 1990-01-30 PH PH39966A patent/PH26317A/en unknown
- 1990-01-31 NZ NZ232321A patent/NZ232321A/xx unknown
- 1990-01-31 FI FI900491A patent/FI900491A0/fi not_active Application Discontinuation
- 1990-02-01 JP JP2020552A patent/JPH02240017A/ja active Pending
- 1990-02-01 KR KR1019900001170A patent/KR0137268B1/ko not_active IP Right Cessation
- 1990-02-01 AU AU48992/90A patent/AU622751B2/en not_active Ceased
- 1990-02-01 CA CA002009135A patent/CA2009135A1/en not_active Abandoned
- 1990-02-01 PT PT93029A patent/PT93029A/pt unknown
- 1990-02-01 DK DK90102022.2T patent/DK0381219T3/da active
- 1990-02-01 EP EP90102022A patent/EP0381219B1/en not_active Expired - Lifetime
- 1990-02-01 NO NO90900484A patent/NO900484L/no unknown
- 1990-02-01 AT AT90102022T patent/ATE88889T1/de active
- 1990-02-01 ZA ZA90776A patent/ZA90776B/xx unknown
- 1990-02-01 DE DE9090102022T patent/DE69001488T2/de not_active Expired - Fee Related
- 1990-02-01 IE IE900371A patent/IE900371L/xx unknown
- 1990-02-01 ES ES90102022T patent/ES2055177T3/es not_active Expired - Lifetime
- 1990-02-01 HU HU90638A patent/HU204192B/hu not_active IP Right Cessation
- 1990-02-02 CN CN90100781A patent/CN1053744A/zh active Pending
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN1325053C (zh) * | 2002-06-17 | 2007-07-11 | 兴和株式会社 | 控释医药组合物 |
CN106463873A (zh) * | 2014-09-22 | 2017-02-22 | 安芬诺尔互连系统股份有限公司 | 插入器组件和方法 |
CN106463873B (zh) * | 2014-09-22 | 2019-06-28 | 安芬诺尔互连系统股份有限公司 | 插入器组件和方法 |
Also Published As
Publication number | Publication date |
---|---|
EP0381219A3 (en) | 1990-12-05 |
AU4899290A (en) | 1990-08-09 |
HUT52950A (en) | 1990-09-28 |
DK0381219T3 (da) | 1993-06-01 |
IL92994A (en) | 1994-04-12 |
ATE88889T1 (de) | 1993-05-15 |
NO900484D0 (no) | 1990-02-01 |
DE69001488D1 (de) | 1993-06-09 |
EP0381219B1 (en) | 1993-05-05 |
FI900491A0 (fi) | 1990-01-31 |
DE69001488T2 (de) | 1993-08-26 |
JPH02240017A (ja) | 1990-09-25 |
EP0381219A2 (en) | 1990-08-08 |
US4927639A (en) | 1990-05-22 |
ZA90776B (en) | 1991-10-30 |
HU900638D0 (en) | 1990-04-28 |
MY104898A (en) | 1994-06-30 |
NO900484L (no) | 1990-08-03 |
CA2009135A1 (en) | 1990-08-02 |
IL92994A0 (en) | 1990-09-17 |
PT93029A (pt) | 1990-08-31 |
PH26317A (en) | 1992-04-29 |
KR0137268B1 (ko) | 1998-04-25 |
KR900012604A (ko) | 1990-09-01 |
IE900371L (en) | 1990-08-02 |
HU204192B (en) | 1991-12-30 |
NZ232321A (en) | 1991-02-26 |
ES2055177T3 (es) | 1994-08-16 |
AU622751B2 (en) | 1992-04-16 |
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