目的 建立阿苯达唑片有区分能力的溶出曲线测定方法,并考察参比制剂与仿制制剂体外溶出曲线的一致性。方法 采用浆法,转速为50 r·min-1,以pH 1.2的盐酸溶液和水各900 mL为溶出介质,并采用相似因子(f2)法评价相似性。结果 建立的3条溶出曲线均具有较好的区分能力,由仿制制剂与参比制剂在2种介质中溶出曲线的f2可知,A厂家相似,B、C厂家不相似。结论 本实验为阿苯达唑片体外溶出曲线一致性评价提供了试验依据。
Abstract
OBJECTIVE To establish a determination method of the dissolution curves of albendazole tablets with differentiation ability and investigate the similarity of dissolution curves in vitro between reference preparation and generic preparations.METHODS Paddle method was adopted with rotation speed of 50 r·min-1 and the dissolution medium volume was 900 mL. The dissolution media were pH 1.2 hydrochloric acid solution and water. The similarity factor (f2) method was used to evaluate the comparability of dissolution curves.RESULTS The three established dissolution curves had good distinguishing ability. As shown by the similarity factor (f2), the generic preparation from manufacture A was similar to the reference preparation, while those from the manufacture B and C were not similar.CONCLUSION The study provides the experimental basis for the consistency evaluation of the dissolution curves of abendazole tablets.
关键词
仿制药 /
阿苯达唑片 /
溶出曲线 /
一致性评价 /
高效液相色谱法 /
相似因子
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Key words
generic drug /
albendazole tablet /
dissolution curve /
consistency evaluation /
HPLC /
similarity factor (f2)
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中图分类号：
R917
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