美洲大蠊抗CCl4肝损伤药效学研究及水提物制剂研究-药剂学专业毕业论文.docxVIP

成都中医药大学硕士研究生学位论文 成都中医药大学硕士研究生学位论文 万方数据 万方数据 中文摘要 本文主要开展美洲大蠊抗四氯化碳所致肝损伤药效学研究、水提物制剂研究 及质量研究。 首先，以体内药效学实验分别考察了美洲大蠊药材粉末、提取物的抗肝损伤 药效；继而从蛋白组成的分子量特点及含量两方面对各提取物展开比较。而后筛 选获得水提物活性盐析部位，并对该部位的氨基酸组成、蛋白分子量及分离展开 研究。结果显示药材粉末药效不佳；95%乙醇提取物、水回流提取物药效不佳， 而闪式水提物药效良好且其蛋白电泳图谱与前者具有显著差异，以闪式水提物蛋 白含量最高。 然后，对其水提物的制备工艺进行了优化：以单因素试验结合正交设计优选 闪提工艺参数为以药材最粗粉投料，溶媒用量 25 倍，提取电压 70V，提取温度 55℃，提取时间 3.5min，提取 1 次；考察了原药材浓度对高速离心纯化效果的 影响，结果提取液原药材浓度为 0.5g2mL-1 时最佳；60℃减压干燥制得水提物。 最后，分别从性状、鉴别、水分检查和含量测定方面对水提物开展质量研究； 以吸湿率、堆密度及休止角为评价指标，采用单因素试验筛选美洲大蠊胶囊填充 剂种类、比例及用量，并根据制粒难度与颗粒性状确定润湿剂浓度，成型工艺条 件为按药粉-可溶性淀粉-微晶纤维素（50:25:25）的比例，以 90%乙醇润湿，挤 压制粒，装入 0 号胶囊（每粒 0.29g）；在中间体质量研究基础上结合胶囊剂质 量控制项目对制剂开展质量研究。 研究结果表明：本研究所得美洲大蠊水提物 25～50%饱和度硫酸铵盐析沉淀 有效；本制剂制备工艺合理可行，制剂质量稳定可控。 关键词：美洲大蠊 化学性肝损伤 闪式提取 蛋白 水提物 胶囊剂 I Abstract We not only studied the pharmacodynamics of Periplaneta americana against hepatic injury caused by CCl4, but also the preparation and quality evaluation of its extract with water (SEW). First, the drug effect of its powder and extracts was investigated by in vivo experiment respectively; then the extracts were compared from the molecular weight and content of protein; after that the products of EW separated by gradient ammonium sulfate fractionation method was tested in order to screen the active fraction; The results showed that its powder had poor efficacy, as well as the extracts with alcohol (EA) and the refluxing extract with water (REW), while the efficacy of SEW was satisfactory, and the electrophoresis map of SEW was quite different from the one of EA and REW, and the former had the highest protein content. Secondly, the preparation of its extract with water (EW) was optimized: the optimizing extraction parameters that were obtained by single factor test and orthogonal design were as follow: P. americana coarse powder was extracted with 25 times the amount of water at 70 V and 55℃ for 1 time, 3.5 minutes every time; the study on the influence of crude drug content on purification effect showed that the optimal crude drug