复方连萸胶囊的制备工艺及质量标准研究-中药学专业论文.docx

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 3 PAGE 3 质量标准研究结果： 采用 TLC 法对复方连萸胶囊中黄连、山茱萸等药材进行了定性鉴别，斑点清晰， 专属性强。分别建立了以 HPLC 法测定制剂中有效成分盐酸小檗碱和马钱苷含量方法： 盐酸小檗碱：以十八烷基硅烷键合硅胶为填充剂，乙腈-0.1%磷酸为流动相(28﹕72)， 流速为 1.0mL·min-1；检测波长为 265nm，柱温为 30℃；马钱苷：以十八烷基硅烷键 合硅胶为色谱柱填充剂，以乙腈-0.05%磷酸为流动相(11﹕89)，流速为 1.0mL·min-1， 检测波长为 236nm，柱温为 30℃。方法简便可行。 按 2005 年版中国药典一部附录胶囊剂项下的要求进行检查，对制剂中的砷盐、 重金属、水分、崩解时限、微生物等指标进行了考察，结果均符合胶囊剂的制剂通则 要求。 结论 经过筛选，确定复方连萸胶囊的最佳制备工艺，制定出复方连萸胶囊的质量标 准，建立了复方连萸胶囊有效成分的薄层鉴别和含量测定方法。 关键词 复方连萸胶囊，制备工艺，质量标准，正交试验 Abstract Objective：Fufang Lianyu capsules are for the treatment of typeⅡdiabetes and its prescription is a vaild empirical formula and has been offered clinically for many years. It consists of rhizoma coptidis, Fructus cornus, Rhizoma dioscoreae and other herbs, with a function of invigorating kidney yin. In order to better use for clinic, convenient to take and improve the drug bioavailability, the subject which is on the basis of clinical use and pharmacology studies will develope Zhen QingFang into capsules- Fufang Lianyu capsules, focusing on the capsules of the preparation technology and quality standard and laying on the basis of Pharmacy for future development as a new drug. Methods: The subject studies on preparation technology and quality standard of Fufang Lianyu Capsules. Preparation technology methods Extraction process study: A single extraction experiment for rhizoma coptidis was used with ethanol. Used the L9 (34) orthogonal design method.In order to choose the optimal extraction process, the dosage and concentration of alcohol, extraction time and extraction frequency were investigated as the factor.Other herbs used the water-extraction and alcohol-precipitation methods. Effects of three factors, water volume、extraction time、extraction times on extraction were evaluated by orthogonal design; effects of three factors, alcohol volume、concentration of condensed solution、 reaction time on content of Fufang Lianyu capsules of alcohol precipitation were also evaluated by or