Z-中药、天然药物原料的前处理技术指导原则 20070823.docVIP

精品资料 精品资料 PAGE / NUMPAGES 精品资料 指导原则编号： 【 Z 】 G P H 1 - 1 中药、天然药物原料的前处理技术指导原则 二Ο Ο 五年三月 目 录 一、概述·······························································································································1 二、基本内容······················································································································1 （一）鉴定与检验·····································································································1 （二）炮制与加工·····································································································2 1、净制························································································································2 2、切制························································································································2 3、炮炙························································································································2 4、粉碎······················································································································· 3 三、参考文献······················································································································3 四、著者······························································································································ 3 1 中药、天然药物原料的前处理技术指导原则 一、概述 中药、天然药物的原料包括药材、中药饮片、提取物和有效成分。为 保证中药、天然药物新药的安全性、有效性和质量可控性，应对原料进行 必要的前处理。原料的前处理包括鉴定与检验、炮制与加工。 二、基本内容 （一）鉴定与检验 药材品种繁多，来源复杂，即使同一品种，由于产地、生态环境、 栽培技术、加工方法等不同，其质量也会有差别；中药饮片、提取物、有 效成分等原料也可能存在一定的质量问题。为了保证制剂质量，应对原料 进行鉴定和检验。检验合格方可投料。 原料的鉴定与检验的依据为法定标准。无法定标准的原料，应按照自 行制定的质量标准进行鉴定与检验。药材和中药饮片的法定标准为国家药 品标准和地方标准或炮制规范；提取物和有效成分的法定标准仅为国家药 品标准。标准如有修订，应执行修订后的标准。 多来源的药材除必须符合质量标准的要求外，一般应固定品种。对品 种不同而质量差异较大的药材，必须固定品种，并提供品种选用的依据。 药材质量随产地不同而有较大变化时，应固定产地；药材质量随采收期不 同而明显变化时，应注意采收期