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羟基喜树碱注射液与注射用羟基喜树碱含量与有关物质的比较
引用本文:兰静,胡昌勤,宋丹青.羟基喜树碱注射液与注射用羟基喜树碱含量与有关物质的比较[J].中国药学杂志,2003,38(9):702-704.
作者姓名:兰静  胡昌勤  宋丹青
作者单位:中国药品生物制品检定所,北京,100050
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。

关 键 词:羟基喜树碱注射液  注射用羟基喜树碱
文章编号:1001-2494(2003)09-0702-03
收稿时间:2003-04-03;
修稿时间:2003年4月3日

Content and impurities comparision of hydroxycamptothecin injection and hydroxycamptothecin for injection
LAN Jing,HU Chang-qin,SONG Dan-qing.Content and impurities comparision of hydroxycamptothecin injection and hydroxycamptothecin for injection[J].Chinese Pharmaceutical Journal,2003,38(9):702-704.
Authors:LAN Jing  HU Chang-qin  SONG Dan-qing
Affiliation:National Institute for the Control of Pharmaceutical and Biological Products,Beijing 100050,China
Abstract: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.
Keywords:hydroxycamptothecin injection  hydroxycamptothecin for injection  content  impurities
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