摘要
目的:对近年来进口的69批次醋酸戈舍瑞林植入剂的关键质量控制项目的测定结果进行总结,同时对本品质量控制情况进行回顾和展望。方法:对项目数据进行统计和批间趋势分析,对释放度等关键指标从实验原理、实验设计等方面加以研究。结果:69批次样品主要项目批间趋势总体稳定,现行标准项目设置可行,对醋酸戈舍瑞林植入剂进行质量控制的总体状况较好。结论:醋酸戈舍瑞林植入剂质量较好,总体状况稳定。本文为有效控制植入制剂质量、科学评价其安全性和有效性提供参考。
Objective:To summarize the results of the key quality control items of 69 batches of goserelin acetate sustained-release depot imported in recent years. And the quality control situation is evaluated and prospected.Methods:The determination results were subjected to statistical and quality trend analysis,and dissolution method is listed in terms of experimental principles and experimental design.Results:The trend in the 69 batches of samples is generally stable,the current standard is comprehensive and suitable for overall quality control of goserelin acetate sustained-release depot.Conclusion:The quality of goserelin acetate sustained-release depot among the batches is stable. This article provides a reference for effectively controlling the quality of implants and scientifically evaluating their safety and effectiveness. The standardization of dissolution methods and the study of the correlation between in vitro and in vivo are still difficult points for implant quality control.
作者
吕晶
郑璐侠
陈钢
邵泓
Lü Jing;ZHENG Lu-xia;CHEN Gang;SHAO Hong(Shanghai Institute for Food and Drug Control,Shanghai 201203,china)
出处
《药物分析杂志》
CAS
CSCD
北大核心
2020年第6期971-981,共11页
Chinese Journal of Pharmaceutical Analysis
基金
国家科技重大专项—重大新药创制(2017ZX09101001-007)。
