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目的对不同厂家、不同批号的盐酸雷尼替丁胶囊进行溶出度考察。方法以蒸馏水为溶出介质,采用转篮法对3个厂家4个批号的盐酸雷尼替丁胶囊进行溶出度测定,测得结果用Weibull分布模型提取参数进行方差分析,并采用相似因子法评价不同厂家药品溶出度的相似程度。结果不同厂家的药品溶出参数存在显著性差异(P<0.01);相似因子分析发现不同厂家药品溶出度存在差异,同一厂家不同批号药品溶出度相似。结论生产单位应对产品进行溶出度检查,并与国内外同类产品进行溶出度比较,以便更好地控制药品质量。
Objective To investigate the dissolution of ranitidine hydrochloride capsules of different manufacturers and batches. Methods Distilled water was used as the dissolution medium to determine the dissolution rate of 4 batches of ranitidine hydrochloride capsules in three batches by the spin basket method. The results were analyzed by variance with the Weibull distribution model, and the similarities were used to evaluate the differences Manufacturers of drug dissolution similarities. Results There were significant differences (P <0.01) in the dissolution parameters of drugs from different manufacturers. The similarity factor analysis showed that the dissolution rates of different manufacturers were different, and the dissolution rates of different batches of drugs from the same manufacturer were similar. Conclusion The production unit should check the dissolution rate of the product and compare with the dissolution rate of similar products at home and abroad in order to better control the quality of the drug.