抗乳腺增生片的制备工艺、质量控制标准、主要药效学初步评价及急性毒性实验.pdf

抗乳腺增生片的制备工艺、质量控制标准、主要药效学初步评价及急性毒性实验.pdf

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目 录 中文摘要··································································1 Abstract ··································································3 英文缩略词表 ····························································5 正文 ·······································································6 前言 ·······································································6 1.研究课题的目的 ······················································6 2.课题的理论与实际意义 ·············································6 3. 国内外研究情况简介 ················································8 第一章 抗乳腺增生片的制备工艺研究 ···························10 1.试验材料 ·····························································10 1.1仪器与设备 ·························································10 1.2 材料与试剂 ························································10 2. 制备工艺试验研究 ·················································11 2.1 处方及处方分析 ··················································11 2.2 提取纯化工艺的研究 ············································14 2.3 浓缩干燥工艺的研究 ············································33 2.4 制剂成型工艺的研究 ············································34 2.5 处方及制法 ························································39 2.6 中试放大生产 ·····················································39 3. 讨论 ··································································41 小结 ······································································46 第二章 抗乳腺增生片质量控制研究 ······························47 1.材料与仪器 ··························································47 2. 方法与结果 ··························································47 2.1 鉴别 ································································47 2.2 检查 ································································53 2.3 含量测定 ··························································54 3.讨论 ··································································73

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