国产与原研乙酰螺旋霉素片溶出曲线考察

Comparative analysis of dissolution curves between domestic acetylspiramycin tablets and the original tablets

目的采用光纤药物溶出度实时测定仪,研究国产和原研乙酰螺旋霉素片在不同p H值介质中的溶出曲线,评价制剂质量。方法采用浆法,转速50r/min,以p H1.2盐酸溶液、p H4.0醋酸盐缓冲液、p H6.8磷酸盐缓冲液和水为溶出介质,采用光纤药物溶出度实时测定仪测定国内8家企业的样品与原研制剂的溶出曲线,并用AV值法与原研制剂的溶出曲线进行比较。以p H1.2盐酸溶液为溶出介质,采用光纤药物溶出度实时测定仪测定国内41家企业的229批次样品,用AV值法计算企业内批次间溶出曲线的相似性。结果国产样品在4种介质中的溶出行为与原研制剂均不相似。国产样品企业内批次间溶出曲线不相似。国产样品在p H1.2介质中的溶出行为差异较大。结论国产乙酰螺旋霉素片的处方工艺与原研制剂存在较大差异,国内各企业产品质量参差不齐。

Objective To study dissolution curve profiles of domestic acetylspiramycin tablets in different pH media by the fiber-optic real time dissolution test system and evaluate the drug quality. Methods The paddle method was used at a rate of 50r/min, the dissolution curves of the samples of 8 domestic enterprises and the original tablets were detected in the following four media including water, pill.2 hydrochloric acid solution, pH4.0 acetate buffer solution, and pH6.8 phosphate buffer solution by the fiber-optic real time dissolution test system, and the results were compared by method of AV value. In the pill.2 hydrochloric acid solution, the dissolution of the 41 domestic enterprises of 229 batches of samples were detected by the fiber-optic real time dissolution test system, and the results were compared by method of AV value. Results Domestic sample in 4 kinds of medium dissolution behavior and original tablets are not similar. Domestic enterprises in the samples batch to batch dissolution curve dissimilarity. There were large differences in dissolution behavior among domestic sample in medium of pill .2. Conclusion There is significant difference in the quality of domestic products from several manufacturers and a pronounced gap exists as compared between the domestic manufacturing technique and the abroad.