标准摘要
[中文适用范围]： 本标准规定了口服中药浸膏、散剂颗粒剂、压片的生产工艺及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）制成的颗粒或压片，即使它们作为汤剂或天然草药和矿物药物的天然成分被分离出来。 [外文原描述]： 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.
英文名称Traditional Chinese medicine — General requirements for manufacturing procedures and quality assurance of granules