3种不同天舒固体剂型溶出度研究

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f250,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。

Study on in vitro Dissolution of Three Solid Preparations of Tianshu

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 Weibull 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 Chinese Pharmacopeia; the T_d of Tianshu (A, B and C) preparations were as follows: 6.15, 11.30 and 18.66 minute; the similarity factors (f_</em>2) 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.