摘要
建立盐酸多柔比星脂质体注射液的微生物限度检查方法,并进行方法适用性考查。根据《中华人民共和国药典》2020年版四部通则1105和1107进行方法适用性试验及微生物限度检查,采用薄膜过滤法并使用10%吐温80作为中和剂时,可有效消除药物的抑菌活性,计数回收率能达到0.5~2要求,3批样品的微生物限度检查结果均符合规定。该方法能够去除抑菌性,可用于盐酸多柔比星脂质体注射液的质量控制。
To establish a microbial limit test method for doxorubicin hydrochloride liposome injection,and carry out the method applicability.According to General Principles 1105 and 1107 of Chinese Pharmacopoeia(2020 edition),the applicability method test and microbial limit test were carried out.when the membrane filtration method was used and add 10%polysorbate 80,the antibacterial activity of the drug could effectively eliminated,and the counting recovery rate could meet the requirements of 0.5~2,the microbial limit test results of three batches of samples all meet the requirements,the established method could effectively remove the bacteriostatic components and be applicable to the quality control of doxorubicin hydrochloride liposome injection.
作者
申晓婷
王红芳
SHEN Xiao-ting;WANG Hong-fang(Shanxi Zhendong Pharmaceutical Co.Ltd.,Changzhi 047100,China)
出处
《安徽化工》
2025年第4期157-160,164,共5页
Anhui Chemical Industry
关键词
盐酸多柔比星脂质体注射液
微生物限度检查法
薄膜过滤法
抑菌性
doxorubicin hydrochloride liposome injection
microbial limit test
membrane filtrationn
antimicrobial activity
