摘要
目的:评价盐酸伐昔洛韦系列制剂抽样样品的质量现状及存在问题,为质量标准的提高和临床用药提供参考。方法:采用法定检验方法对抽样样品进行检验,分析评价其质量;并对抽样样品进行探索性研究,测定全部样品的D-伐昔洛韦杂质、阿昔洛韦杂质及盐酸伐昔洛韦含量。结果:按法定方法检验,样品合格率为100%;探索性研究结果表明,盐酸伐昔洛韦系列制剂中有关物质D-伐昔洛韦杂质含量较高,为0.32%~2.32%,平均0.86%;阿昔洛韦杂质与盐酸伐昔洛韦含量与法定检验结果相似。结论:法定检验和探索性研究结果表明,盐酸伐昔洛韦系列制剂总体质量良好。通过探索性研究,可为该产品生产工艺和质量标准的提高提供参考。
Objective: To evaluate the quality status and existing problems in the samples of valacyclovir hydrochloride preparations to provide valuable reference for the technology improvement,quality standard and clinical use of the drugs.Methods: The samples were examined by the statutory method,and the quality was analyzed and evaluated.The exploratory study was carried out on the samples,and the content of D-type valaciclovir impurities,aciclovir impurities and valaciclovir hydrochloride in all the samples were determined.Results: According to the statutory method,the sample pass rate was 100%.The exploratory study showed that the content of D-type valaciclovir impurities was high in valaciclovir hydrochloride series preparations (0.32%-2.32%,with the average value of 0.86%),and the contents of acyclovir impurities and valaciclovir hydrochloride were similar to the results of statutory method.Conclusion: The results of statutory and exploratory studies showed that the overall quality of valaciclovir hydrochloride series preparations is good.The exploratory study can provide reference for improving the production processas and quality standards of the products.
作者
王媛媛
谢育媛
郭江红
姜红
Wang Yuanyuan;Xie Yuyuan;Guo Jianghong;Jiang Hong(Hubei University of Chinese Medicine,Wuhan 430065,China;Hubei Institute for Drug Control)
出处
《中国药师》
CAS
2019年第8期1556-1560,共5页
China Pharmacist
关键词
盐酸伐昔洛韦系列制剂
质量分析
法定检验
探索性研究
D-伐昔洛韦
Valacyclovir hydrochloride preparations
Quality analysis
Statutory test
Exploratory study
D-type valacyclovir
