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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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醋酸戈舍瑞林植入剂质量回顾与分析

Trend analysis and evaluation of quality of Goserelin acetate sustained-release depot

分类号:R917
出版年·卷·期(页码):2020,40 (6):971-981
DOI: 10.16155/j.0254-1793.2017.01.01
-----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。

-----英文摘要:---------------------------------------------------------------------------------------

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.

-----参考文献:---------------------------------------------------------------------------------------

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