保健食品标准中重装量差异指标的分析及应用
近年来, 保健食品注册和备案技术指引要求保健食品制剂制订重量差异或装量差异指标, 如片剂等剂型应制订重量差异指标, 胶囊剂等剂型应制订装量差异指标, 以替代原先对包装食品通用的净含量与负偏差指标。在执行过程中, 检测机构众多检验结果显示有不少生产企业可能未能完全理解重量差异和装量差指标的具体分析算法和应用细节要求, 导致抽检结果与生产企业出厂检验结果不一致的情况。本文着重对重量差异和装量差异测定方法的质控目的、限度设定、计算与判定方法等进行详细解读, 以帮助相关企业更好地理解重量差异和装量差异的指标特性和分析应用要点, 阐明重量差异和装量差异指标与包装食品通用的净含量与负偏差指标的不同, 使规范制订保健食品标准并正确执行分析检验。
In recent years, the instruction for registration and recordation of health foods require to built up the specification of weight variation or content variation for the health foods in the form of preparations (weight variation for tablets and content variation for capsules etc.), instead of the specification of net content and negative deviation for common packed foods. After enforcement, data from the inspecting institutes appealed that a few health food manufacturers do not understand the calculation and analytical details of weight variation or content variation very well, so that some inconformity appeared between the official inspecting examinations and the manufacturing approval examinations. This paper reviewed the correct explanation for the quality control purpose, limit setting, calculation methods, and judge criterion for weight variation and content variation, and described the deference from net content and negative deviation for common packed foods, in order to help relevant manufacturers understand the features and analytical details of weight variation and content variation., formally draw up standards of health food products and enforce the analytical procedures exactly.
标题：保健食品标准中重(装)量差异指标的分析及应用
英文标题：Analysis and application of weight variation and content variation in standards of health foods
作者：
关日晴 广东省药品检验所
中文关键词:保健食品,重量差异,装量差异,
英文关键词:health food,weight variation,content variation,
发表日期：2020-02-17
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