ISO 23419:2021 中药 颗粒制造程序和质量保证的一般要求

标准编号：ISO 23419:2021

中文名称：中药 颗粒制造程序和质量保证的一般要求

英文名称：Traditional Chinese medicine — General requirements for manufacturing procedures and quality assurance of granules

发布日期：2021-12

标准范围

本文件规定了由中药提取物或口服粉末制成的颗粒剂和紧实剂的制造程序、质量和安全保证的一般要求。本文件不包括由纯化合物（化学定义）制成的颗粒或致密物，即使它们是作为汤剂块或天然草药和矿物药物的天然成分分离出来的。

This document specifies general requirements for manufacturing procedures and quality and safety assurance of granules and compactates made from traditional Chinese medicine extracts or powder for oral use. This document excludes granules or compactates made from pure compounds (chemically defined) even if they are isolated as naturally occurring constituents of decoction pieces or crude herbal and mineral drugs.

标准预览图