注射用盐酸柔红霉素的质量评价

Quality assessment of daunorubicin hydrochloride for injection

目的按照国家计划抽验要求,评价国内不同企业生产的注射用盐酸柔红霉素的质量。方法按国家标准检验与探索性研究相结合,对抽验样品进行检验,对检验结果进行统计分析。结果共抽取样品17批次,按国家标准检验合格率100.0%。探索性研究对主要杂质的来源与结构进行了研究;建立溶液的澄清度检查方法;对包材相容性及稳定性进行了考察。结论目前国内注射用盐酸柔红霉素总体质量较好;现行标准有待进一步提高,建议现行标准修订有关物质检查方法,增加特定杂质的控制,增加溶液的澄清度检查;建议企业优化生产工艺,以提高产品质量。

Objective To evaluate the suitability of the statutory standard and the quality condition of daunorubicin hydrochloride for injection of different domestic manufacturers. Methods The official method was used to test the samples combined with the exploratory research. Then the results were analyzed using statistical methods to evaluate the quality of daunorubicin hydrochloride for injection. Results According to the statutory standards for the examination, the qualified rate of the 17 batches of samples was 100.0%. Exploratory research studied the source and the structures of major impurities. A method for detecting the clarity of a solution was established. This paper also investigated the compatibility of packaging materials and the stability of formulation quality. Conclusion Overall, the quality of daunorubicin hydrochloride for injection general at present is positive. The statutory standard needs to be improved. Related substances tests, the control of specific impurities, and the control of the clarity of the solution should be included. In order to improve the quality of products, manufacturers should optimize the production processes.