摘要
为了加强对我国变态反应原制品的质量控制,《中华人民共和国药典》2020年版中新增了螨变应原制品总论。该总论是我国针对变应原类制品建立的首个国家标准。本文介绍了螨变应原总论相关内容并对其中涉及质量控制关键参数制定情况进行说明,旨在为正确理解和执行该总论提供参考。
In order to strengthen the quality control of allergen products in China,the general monograph of mite allergen products was added to the Chinese Pharmacopeia 2020(VolumeⅢ).This general monograph is the first national standard for allergen products in China.In this paper,the contents of the general monograph of mite allergen are introduced,and the considerations for the draft of the key parameters are explained.The paper aims to providea reference for the accurate understanding and implementation of the national standard for mite allergen products.
作者
张影
杨蕾
赵爱华
ZHANG Ying;YANG Lei;ZHAO Aihua(NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国药品标准》
CAS
2022年第3期258-262,共5页
Drug Standards of China
基金
2016年药品医疗器械审评审批制度改革课题“过敏原制品质量控制通用技术要求(总论)建立”。
关键词
螨虫
变应原制品
质量控制
标准
mite
allergen product
quality control
standard
