中国药典通则与ICH Q4B有关含量均匀度检查判定法比较  

Comparative Evaluation of Content Uniformity between General Chapter of Chinese Pharmacopoeia and ICH Q4B

作　　者：耿颖[1] 宁保明[1] 陈华[1] 谭德讲[1] 赵海鹏 朱容蝶 史言顺 尚悦[5] 魏宁漪[1] Geng Ying;Ning Baoming;Chen Hua;Tan Dejiang;Zhao Haipeng;Zhu Rongdie;Shi Yanshun;Shang Yue;Wei Ningyi(National Institutes for Food and Drug Control,Beijing 102629,China;Weifang Food and Drug Inspection and Testing Center;Beijing Concord Pharmaceutical Factory;Beijing Institute of Petrochemical Technology;Chinese Pharmacopoeia Commission)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]山东省潍坊市检验检测中心 [3]北京协和药厂 [4]中国石油化工学院 [5]国家药典委员会

出　　处：《中国药师》2022年第5期878-883,897,共7页China Pharmacist

摘　　要：含量均匀度检查用于确定检查小剂量或单剂量的固体、半固体和非均相液体制剂含量符合标示量的程度。当前国际人用药品注册技术协调会(ICH)成员国家开展含量均匀度检查遵循<Q4B在ICH地区使用的药典文本的评估和建议,附件6剂量单位均一性通则>。我国当选为ICH管理委员会正式成员后,中国药典四部通则<0941含量均匀度检查法>面临向ICH转化实施。本文系统研究了含量均匀度检查法判定的统计学考虑,采用蒙特卡洛数据模拟方法对ICH和中国药典含量均匀度检查判定方法进行考察,从应用范围、统计学考量和方法差异等方面,对中国药典通则与ICH通则进行全面的差异对比和分析评估,为中国药典含量均匀度的实施和ICH转化提供基础数据和统计学支持。Content uniformity test is used to determine the consistent degree with labeled amount for small or single-dose solid,semi-solid and heterogeneous liquid preparations.At present,drug regulatory agencies in the ICH regions have harmonized the inspection of content uniformity by following ICH<Q4 B Evaluation and Recommendation of Pharmacopoeia Texts for Use in the ICH Regions,Annex 6 Uniformity of Dosage Units General Chapter>.Under the background that the Chinese drug regulatory agency was formally elected as a member of the ICH management committee,the general chapter of Chinese Pharmacopoeia(ChP)<0941 Test for Content Uniformity>is facing harmonization and implementation according with ICH Q4 B.This paper systematically studied the statistical considerations of content uniformity.By using statistical Monte Carlo simulation methods,comprehensive comparison and analyses on the differences in the principles between ChP and ICH were carried out in terms of application scope,statistical considerations and method differences,so as to provide basic data and statistical support for ChP general chapter of content uniformity test to implement and harmonize with ICH guidance.

关 键 词：含量均匀度检查 统计学 人用药品注册技术要求国际协调会 中国药典 转化实施 

分 类 号：R917[医药卫生—药物分析学]