摘要
目的:比较天舒制剂3种不同固体剂型的体外溶出度。方法:采用小杯法和HPLC法,以阿魏酸为指标,考察不同时间的累积溶出度,并以威布尔分布模型提取溶出参数,采用相似因子法对溶出度进行评价。结果:3种天舒固体制剂溶出度符合《中国药典》相关规定,天舒滴丸(A)、胶囊(B)、片剂(C)的Td值分别为6.15,11.30,18.66,B,C的相似因子f2<50,溶出度与A不等效。结论:3种天舒制剂的溶出度有显著差异,A的溶出度显著优于B和C,为改进生产工艺,评价和控制产品质量提供依据。
Objective：To compare the dissolution of Tianshu dropping pill （A）, capsule （B） and tablet （C） in vitro. Method：Small vessel and HPLC method were applied to determine the accumulated dissolution rate of ferulic acid at the different time, data were analyzed by WeibuU distribution, and the dissolution rate was evaluated by similar factor method. Result： The dissolution results of 3 kinds of Tianshu were all up to the standards of Chi- nese Pharmacopeia; the Td of Tianshu （A, B and C） preparations were as follows： 6. 15, 11.30 and 18.66 minute; the similarity factors （f2） of preparation B and C were less than 50, and the dissolutions of preparation B and C were significantly different from preparation A. Conclusion： Among them, the dissolution profile of preparation A was superior to other preparations. This provides the basis of improving the preparation process, evaluating and controlling the quality.
出处
《中国实验方剂学杂志》
CAS
北大核心
2010年第18期10-13,共4页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家科技重大新药创制专项(2009ZX09313-032
2009ZX09308-003)
关键词
天舒制剂
溶出度
HPLC
威布尔分布
相似因子
Tianshu preparation
dissolution in vitro
HPLC
Weibull distribution
similarity factor
