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目的:比较7个厂家复方银翘氨敏胶囊在4种溶出介质中的溶出曲线,以评价其质量。方法:采用篮法、转速100 r·min~(-1)、溶出介质900 ml进行体外溶出试验,分别考察不同厂家复方银翘氨敏胶囊在盐酸溶液、pH 4.5醋酸盐缓冲液、水和pH 6.8磷酸盐缓冲液4种溶出介质中的体外溶出行为,测定溶出曲线并采用相似因子法进行比较分析。结果:7个厂家复方银翘氨敏胶囊在盐酸溶液中30min时累积溶出度均大于70%,在pH 4.5醋酸盐缓冲液、水和pH 6.8磷酸盐缓冲液中溶出结果差;4种溶出介质中的溶出曲线均存在不同程度的批间差异。结论:各厂家复方银翘氨敏胶囊的质量存在差异,在确保产品具有良好溶出的同时应着力提高制剂的稳定性。
OBJECTIVE: To compare the dissolution profiles of seven manufacturers of Yinqiao Amin-sensitive capsules in four dissolution media to evaluate their quality. Methods: In vitro dissolution test was carried out by basket method with a rotating speed of 100 r · min ~ (-1) and dissolution medium of 900 ml. The effects of different prescriptions of Yinqiao Amin Capsules in hydrochloric acid solution, pH 4.5 acetate buffer solution, In vitro dissolution behavior of the four dissolution media pH 6.8 phosphate buffer solution dissolution curve was measured and the similarity factor method for comparative analysis. Results: The cumulative dissolution rates of the seven products of Yinfang Amin Capsules in seven factories were all higher than 70% in 30min in hydrochloric acid solution, and the dissolution results were poor in pH 4.5 acetate buffer, water and pH 6.8 phosphate buffer solution. Four kinds of dissolution Dissolution curves in the medium there are varying degrees of inter-batch differences. Conclusion: There are differences in the quality of the compound Yinqiao Amin Capsules among various manufacturers. In order to ensure good dissolution of the product, efforts should be made to improve the stability of the preparation.