伏格列波糖口溶膜剂的制备及质量评价

陈 芳,夏怡然,侯惠民

主办:上海医药工业研究院
   中国药学会
   中国化学制药工业协会
ISSN 1001-8255   CN 31-1243/R   ZYGZEA
中国医药工业杂志 ›› 2013, Vol. 44 ›› Issue (10) : 989-992.
药物制剂 Pharmaceutics

伏格列波糖口溶膜剂的制备及质量评价

作者信息 +

Preparation and Quality Evaluation of Voglibose Oral Dissolvable Films

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History +

摘要

采用热熔挤出法制备伏格列波糖口溶膜剂,以拉伸性能和溶化时间为指标,筛选优化处方。结果以聚氧乙烯N10为成膜材料、5%甘油为增塑剂的膜剂可在20 s 内溶化,体外溶出行为与已在日本上市的膜剂相似。对正常大鼠蔗糖负荷后高血糖的体内试验表明,自制膜剂与国外膜剂以及国内上市的分散片的降血糖效果相当。

Abstract

The voglibose oral dissolvable films were prepared by hot melt extrusion method. The formulation was optimized with the tensile properties and the dissolvable time as the evaluation parameters. The optimal product with polyoxyethylene N10 as carrier and 5% glycerol as plasticizer could dissolve within 20 s and showed a similar dissolution behavior to the voglibose OD Film 0.2?QQ? marketed in Japan. The in vivo experiment on postprandial hyperglycemia
in normal rats demonstrated that the voglibose oral dissolvable films had equivalent hypoglycemic effect with the commercial voglibose films in Japanese market and its dispersible tablets in domestic market.

关键词

伏格列波糖 / 口溶膜剂 / 热熔挤出 / 溶出 / 降血糖

Key words

voglibose; / oral dissolvable film / hot melt extrusion / dissolution / hypoglycemic effect

引用本文

导出引用
陈 芳,夏怡然,侯惠民. 伏格列波糖口溶膜剂的制备及质量评价. 中国医药工业杂志. 2013, 44(10): 989-992
CHEN Fang, XIA Yiran, HOU Huimin. Preparation and Quality Evaluation of Voglibose Oral Dissolvable Films. Chinese Journal of Pharmaceuticals. 2013, 44(10): 989-992

参考文献

[1] Barnhart SD, Sloboda MS. The future of dissolvable films [J]. Drug Deliv Technol, 2007, 7(2): 34-37.

[2] 中华医学会糖尿病学分会. 中国2 型糖尿病防治指南(2010 年版)[J]. 中国糖尿病杂志, 2012, 20(1): S1-S37.

[3] 四川美康医药软件研究开发有限公司. 药物临床信息参考[M]. 四川: 四川科学技术出版社, 2006: 1169-1170.

[4] 陈 芳, 夏怡然, 侯惠民. 口腔膜剂的研发及应用[J]. 中国医药工业杂志, 2012, 43(6): 484-489.

[5] 陈 芳, 夏怡然, 张惠平, 等. 流延法制备口溶膜剂及其质量评价[J]. 中国医药工业杂志, 2013, 44(9): 938-942.

[6] 侯惠民, 付 民, 张惠平, 等. 膜剂用溶出度漏槽式测定装置: 中国, 201749117U [P]. 2011-02-16.

[7] Odaka H. Effect of AO-128 alone or in combination with sulfonylurea on fasting blood glucose and postprandial hyperglycemia in normal and diabetic rats [J]. Jpn Pharmacol

Ther, 1994, 22(6): 221-229.

[8] 平賀興吾. AO-128 の薬物動態および糖代謝に及ぼす影響 健康成人における検討 [J]. 基礎と臨床, 1992, 26(1): 283-294.

[9] Maeshiba Y. Metabolic fate of AO-128, a new a-glucosidase inhibitor, in rats and dogs [J]. Jpn Pharmacol Ther, 1991, 19(9): 247-257.

基金

国家“重大新药创制”科技重大专项(2011ZX0940-403-3)

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