当归多糖口服液的制备和质量标准及其药效学评价-中药学专业论文.docxVIP

万方数据 万方数据 1. 急性毒性实验·············································································································· 35 2. 当归多糖口服液的药效学评价·················································································· 36 3. 结果分析及讨论·········································································································· 40 研究总结····································································································································· 42 参考文献····································································································································· 45 综述一 两种名贵药用植物多糖的免疫调节作用································································50 综述二 当归多糖对于骨髓抑制及胃肠道损伤小鼠的保护作用······································ 60 致 谢··········································································································································67 附 录··········································································································································68 华中科技大学硕士学位论文 华 中 科 技 大 学 硕 士 学 位 论 文 PAGE 1万方数据 PAGE 1 万方数据 摘 要 当归是一味补血活血传统中药，其有效成分为当归多糖。有研究表明，当归多糖 对肿瘤、感染、贫血、糖尿病等具有一定的疗效。采用传统工艺经提取、分离、纯化 的当归多糖由于提取产率低且成本高，无法大批量生产，不利于制成产品进入临床。 本文拟采用新型澄清剂工艺提取道地药材“岷县当归”中的当归多糖制备当归多糖口 服液，并对其进行质量控制和药效学评价，为当归多糖制剂的放大生产和进入临床实 验奠定一定的理论及物质基础。 传统当归多糖提取方法包括以下几个步骤，依次为：醇浸、水提、pH 调节、醇 沉等步骤。所得的当归粗多糖糖含量为 40%左右，产率约为 2%。该法所得粗多糖制 成口服液口感差，且极易出现沉淀。 本课题采用澄清剂工艺得到当归粗多糖，并测定其产率和糖含量。对口服液制备 工艺进行优化后得到了符合药典相关规定的当归多糖口服液，并制定其质量标准。通 过建立小鼠骨髓抑制模型，以传统水提醇沉工艺制备的当归多糖水提液为对照考察其 药效学。 第一部分 当归多糖提取工艺的改进 以甘肃岷县当归作为原材料，采用澄清剂工艺代替传统水体醇沉法得到当归粗多 糖，并测定其产率和糖含量。对工艺中澄清剂用量、醇沉体积和水提液浓度三个影响 当归粗多糖品质的因素进行优化，得到最佳的当归粗多糖提取工艺。 澄清剂工艺提取当归粗多糖的主要工艺流程为：醇浸、水提、加入澄清剂、浓缩、 醇沉。最佳的当归粗多糖提取工艺为：澄清剂用量为当归多糖饮片重量的 1%、乙醇 加入量为原有溶液体积的 1 倍、水提液体积为 10 倍当归饮片投入量。澄清工艺所得 当归粗多糖产率为 2.5%，糖含量大于 50%。该制备方法满足实验室制备当归多糖口 服液的要求。 第二部分 当归多糖口服液的制备 在澄清剂工艺提取当归粗多糖的基础上，分别考察制备方法、添加剂的种类及用 量和灭菌方法对当归多糖口服液制备的影响。当归多糖口服液制备方法中考察了粉末 溶解和直接浓缩两种方法；添加剂分别考察了羧甲