摘要
目的结合临床使用现状,对不同厂家注射用盐酸表柔比星进行质量对比,为临床使用及标准提升提供参考。方法参考各国药典、相关部门颁发标准和相关文献,选择临床有意义的指标进行比较,包括对制剂外观、pH值、复溶时间、有关物质、含量及样品在不同溶媒、不同储存条件下稳定性等指标,比较市场上3厂家盐酸表柔比星制剂之间的质量差异。结果 3厂家9个批次的样品均为橙红色疏松块状物;在说明书比对中,B、C2厂家的贮藏条件较A厂家更严格,增加温度要求;关于复溶时间,A、C 2厂家产品的复溶时间均<60 s,符合A厂家的检验标准,而B厂家的复溶时间平均2 min以上,且B厂家的检验标准未规定复溶时间;3厂家各批次样品在不同溶媒中配制成溶液后的百分含量及有关物质方面,A厂家产品中多柔比星酮的含量约是B厂家的2倍,而C厂家仅第一批次有极少数样品检测出多柔比星酮。结论不同厂家注射用盐酸表柔比星在复溶时间、稳定性、含量及有关物质等方面存在一定差异,其中有关物质多柔比星和多柔比星酮、粉针剂复溶时间等差异较大,建议有关厂家从制剂原辅料、制剂工艺等方面入手,不断提高制剂质量。
Objective To compare the quality of Epirubicin Hydrochloride Injection from different manufacturers based on the current clinical use,so as to provide reference for clinical use and standard improvement. Methods By referring to the pharmacopoeia of various countries,the standards issued by the related ministry of health,the standards issued by the bureau and relevant literature,the clinically meaningful indexes were selected for comparison,including the appearance of the preparation,pH value,resolution time,relevant substances,content and the stability of the sample in different solvent and different storage conditions,etc. The quality differences of Epirubicin Hydrochloride preparation from 3 manufacturers in the market were compared. Results A total of 9 batches of samples from 3 manufacturers were all orange-red loose lumps. In the comparison of instructions,the storage conditions of B and C manufacturers were stricter than those of A manufacturers,and the temperature requirements were increased. As per the resolution time,both manufacturers A and C was less than 60 s,which met the enterprise standard of A,while the average resolution time of manufacturer B was more than 2 min,and the enterprise standard of manufacturer B did not stipulate the resolution time. In terms of the percentage content and related substances of each batch of samples from the three manufacturers prepared into solutions in different solvents,the amount of doxorubicin in the products of manufacturer A was about two times as the manufacturer B,while only a few samples of manufacturer C were detected in the first batch. Conclusion Different manufacturers of Epirubicin Hydrochloride for Injection have certain differences in the re dissolution time,stability,content and related substances. The redissolution time of related substances doxorubicin,doxorubicin ketone and powder injection are quite different. It was suggested that the manufacturers should continue to improve the quality of the preparation from the aspects of raw and auxiliary ma
作者
宋钰
都丽萍
曹雅睿
张岩
梅丹
SONG Yu;DU Li-ping;CAO Ya-rui;ZHANG Yan;MEI Dan(Department of Pharmacy,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences&Peking Union Medical College,Beijing 100730,China)
出处
《临床药物治疗杂志》
2021年第11期34-40,共7页
Clinical Medication Journal
基金
2018年度首都卫生发展科研专项(首发2018-3-4017)
国家药典委员会药品标准制修订研究课题(CHP-LC-2019002)。
关键词
注射用盐酸表柔比星
高效液相色谱法
质量比较
Epirubicin Hydrochloride for Injection
high performance liquid chromatography
quality comparison
