摘要
目的 考查国内不同企业羟基喜树碱制剂的产品质量。方法 用高效液相色谱UV检测法和蒸发光散射检测法(ELSD)对来源于国内 5个企业 7个批次的羟基喜树碱制剂进行含量和有关物质的比较。结果 羟基喜树碱注射液B厂和C厂的产品中杂质喜树碱的含量大于 3% ,注射用羟基喜树碱中仅D厂 ,杂质喜树碱含量大于 3% ;其它各厂的产品中 ,杂质喜树碱含量均小于 1%。结论 羟基喜树碱制剂质量的好坏、稳定与否与其制剂是粉针剂还是注射液没有直接的必然的联系 ;不管是哪一种制剂 ,只要生产企业能够提高质量意识 ,严把质量关 ,都能够得到高质量的产品。
OBJECTIVE: To investigate the quality, of hydroxycamptothecine preparations manufactured by different companies. METHODS: The content and impurities of seven batches of hydroxycamptothecin preparations from five companies were measured by HPLC-UV and HPLC-ELSD. RESULTS: Between the companies of hydroxycamptothecin injection and hydroxycamptothecin for injection, there are the contents of impurity in company B, C and D were more than 3% but that of others was less than 1%. CONCLUSION: There were little relation between the quality and the preparation forms of hydroxycamptothecine. The eligible product can be attained only when the manufactury enhance the consciousness of product quality.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2003年第9期702-704,共3页
Chinese Pharmaceutical Journal
