柴胡挥发油巴布剂的研制及药效学研究-药剂学专业论文.docxVIP

5.3 鉴别······································································ 23 5.4 检查 ····································································· 23 5.5 含量测定 ······························································· 25 5.6 规格 ····································································· 28 6. 柴胡挥发油巴布剂药效学研究········································· 29 6.1 试剂和试验材料 ······················································ 29 6.2 柴胡挥发油巴布剂对肺炎链球菌解热作用 ····················· 29 6.3 柴胡挥发油巴布剂对酵母菌解热作用 ··························· 31 7. 柴胡挥发油巴布剂皮肤刺激性及过敏性试验······················· 33 7.1 局部刺激性试验 ······················································· 33 7.2 皮肤过敏试验 ·························································· 36 讨 论 ······································································· 40 参考文献 ······································································· 42 综 述··········································································· 45 附 件（攻读学位期间发表论文目录） ································ 56 致 谢··········································································· 57 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 10 PAGE 10 柴胡挥发油巴布剂的研制及药效学研究 研究生:张丽敏 导 师:曾凡波 中文摘要 柴胡是我国的传统中药和常用中药，在临床上广泛应用于外感发热，已上市产 品有口服液，注射液。注射液的主要有效成分是挥发油。柴胡注射剂在临床上广泛 用于治疗感冒发热，但作为肌肉注射剂量偏大。因此选取合适的给药途径以更好的 促进吸收是现在研究的重点。透皮吸收制剂可使药物在胃肠道免受各种因素的影响； 免除肝脏的首过效应；皮肤层兼具储库作用，避免药物浓度的峰谷现象；给药方法 简单、可减轻副作用、在发生问题时能及时停止给药；可减少给药次数和剂量等。 本文研制及考察了柴胡挥发油巴布剂，并按照药品注册管理办法进行了柴胡挥发油 的提取、急性毒性研究、处方筛选、质量标准研究、药效学和安全性研究。 本文参照柴胡注射液的制备工艺采用水蒸汽蒸馏法提取挥发油，将柴胡用水浸 泡 6 小时后，用挥发油提取器提取挥发油。 本文研究了柴胡挥发油经灌胃和尾静脉注射两种给药途径的急性毒性，以指导 临床安全用药。灌胃以 0.8 为组间系数给予小鼠同容量不同浓度的药物，连续观察两 周内小鼠毒性反应和死亡率，计算 LD50。尾静脉注射以 0.85 为组间系数给予小鼠同 容量不同浓度的药物，连续观察两周内小鼠毒性反应和死亡率，计算 LD50。两种途 径给药后小鼠均出现呼吸急促和惊厥，出现四肢运动障碍，呼吸减慢直至死亡。Ig 和 iv 的 LD50 分别为 2.09ml/kg、0.08ml/kg。 本文采用了国际新型水溶性聚合物基质 Viscomate NP 700 作为主要辅料，加入 交联剂和有机酸来优化聚合物的结构，加入一定量的保湿剂、黏合剂和促渗剂作为 巴布剂的辅料，利用正交设计优化法，以巴布剂的外观和粘附力为指标，优选了各 种主成分的用量配比。并用 Franz 扩散池对促皮渗透剂进行了筛选。研究表明，油酸， 氮酮和丙二醇等 3 种渗透促进剂对药物都有促渗作用。油酸，氮酮和丙二醇