Z-中药、天然药物稳定性研究技术指导原则 20080820.docVIP

精品资料 精品资料 PAGE / NUMPAGES 精品资料 中药、天然药物稳定性研究技术指导原则 目 录 一 、 概 述 ·················································· 1 二 、稳 定 性 研 究 实 验 设 计 ····································2 （ 一 ）样 品 的 批 次 和 规 模 ··································2 （ 二 ）包 装 及 放 置 条 件 ····································2 （ 三 ）考 察 时 间 点 ········································2 （ 四 ）考 察 项 目 ··········································3 （ 五 ）分 析 方 法 ··········································3 三 、 稳 定 性 研 究 实 验 方 法 ··································· 3 （一）影 响 因 素 试 验 ······································3 1 、高 温 试 验 ·············································3 2 、高 湿 试 验 ·············································4 3 、光 照 试 验 ·············································4 （ 二 ）加 速 试 验 ··········································4 （ 三 ）长 期 试 验 ··········································5 （ 四 ）药 品 上 市 后 的 稳 定 性 研 究 ····························5 四 、 稳 定 性 研 究 要 求 与 结 果 评 价 ····························· 5 （ 一 ）稳 定 性 研 究 要 求 ····································5 1 、 新 药 ················································ 5 2 、 已 有 国 家 标 准 药 品 ···································· 6 3 、 其 他 ················································ 6 （ 二 ）稳 定 性 研 究 结 果 评 价 ································7 2 1 、贮 存 条 件 的 确 定 ·······································7 2 、包 装 材 料 / 容 器 的 确 定 ··································7 3 、有 效 期 的 确 定 ·········································7 五 、 名 词 解 释 ············································· 8 六 、 参 考 文 献 ············································· 8 七 、 著 者 ················································· 8 八 、 附 录 ················································· 8 稳定性研究报告的一般内容 3 一、概述 中药、天然药物的稳定性是指中药、天然药物（原料或制剂）的 化学、物理及生物学特性发生变化的程度。通过稳定性试验，考察中 药、天然药物在不同环境条件（如温度、湿度、光线等）下药品特性 随时间变化的规律，以认识和预测药