调养化斑颗粒的药学部分分析-pharmaceutical analysis of tiaoyanghuaban granules.docxVIP

3 3 成都中医药大学硕士论文 中 文 摘 要 调养化斑颗粒是由何首乌、黄芪、熟地黄、川芎、当归、陈皮六味中药 制成的复方制剂，具有补肾填精、益气活血化斑的功效，本方主治气血两虚 型黄褐斑，在临床已使用多年，经数千例患者使用，药效得到充分肯定。本 课题在中医药理论的指导下，应用现代制药技术，并依据国家药品注册管理 办法，对制剂的制备工艺，质量标准和稳定性试验进行了系统研究。 根据处方的功能主治及药物所含成分的理化性质，拟定了工艺路线，采 用单因素筛选法分别考察当归、川芎及陈皮挥发油的提取工艺，用正交试验 以多指标综合评分方法优选药渣与制何首乌、黄芪、熟地黄的水提工艺，确 定了适宜提取方法及工艺条件。对浓缩、干燥、成型工艺条件及辅料进行了 相应的考察，确定了调养化斑颗粒的制备工艺。研究制定了制剂的质量标准， 对方中六味药进行了薄层色谱鉴别研究，最终以制何首乌、黄芪、当归与川 芎、陈皮的鉴别方法简便，重现性和专属性良好而收入标准；采用高效液相 色谱法对制剂中 2，3，5，4ˊ-四羟基二苯乙烯-2-O-β-D 葡萄糖苷进行含量 测定，进行了系统的方法学研究，试验结果均符合要求，根据多批样品的测 定结果，制订了 2，3，5，4ˊ-四羟基二苯乙烯-2-O-β-D 葡萄糖苷的含量限 度，暂定本品每袋（5g）含二苯乙烯苷不得少于 7.28mg。 采用常温留样考察进行了制剂的长期稳定性试验。研究结果表明：该制 剂制备工艺合理可行，质量标准可控，成品质量基本稳定。 关键词：调养化斑颗粒 制备工艺 质量标准 长期稳定性 成都中医药大学硕士论文 成都中医药大学硕士论文 4 4 Abstract Tiaoyang huaban Granule is a compound preparation which consists of six Chinese herbs(pdygonumAstragalus,Rehmannia,Angelica,Ligusticum,citruset c).It is applied mainly to treat yellowish-brown spot,which is caused by lack ing of qi and blood.Under the guidance of Traditional Chinese medicine the- ory, applying modern pharmaceutical technology and according to correlative regulations of patent traditional Chinese medicine, we systematically studied the Preparation process, Quality standard and Preliminary Stability . On the basis of the function and treatment as well as the characers of the effective component of the herbs, the preparation process is designed to studying the extraction of volatile oil and water-extract.The optimum extract conditions about water-extract was selected by using orthogonal design which use quite a few assessing norms to evaluate them comprehensively. At the same time the optimal condensing and moulding conditions were screened. The quality standard was set up, which includes the thin layer chromatography identification of five Chinese herbs in the prescription and the determination of the content of 2,3,5,4’-tetrahydroxy-stilbene -2-O-β-D-glucoside assayed by HPLC, which accomplished the systematic methodology. Stability research had kept on 12 mon