论文部分内容阅读
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 in vitro dissolution of three different solid dosage forms of Tianshu preparations. Methods: The microcapsule method and HPLC method were used to evaluate the cumulative dissolution rate of ferulic acid at different time points. The dissolution parameters were extracted by Weibull distribution model and the dissolution rate was evaluated by similarity factor method. Results: The dissolution rates of three Tianshu solid preparations were in accordance with the relevant regulations of Chinese Pharmacopoeia. The Td values of Tianshu dripping pills (A), capsules (B) and tablets (C) were 6.15, 11.30, 18.66, The similarity factor f2 <50, dissolution and A is not equivalent. Conclusion: The dissolution rates of three Tianshu preparations were significantly different. The dissolution of A was significantly better than that of B and C, which provided the basis for improving the production technology, evaluating and controlling the product quality.