文档介绍：成都中医药大学硕士学位论文摘要通络糖泰颗粒是成都中医药大学附属医院谢春光教授多年临床经验方,由黄连、玄参等中药组成,具有活血祛瘀、通络止痛、养阴清热之功效,临床用于糖尿病周围神经病变证。本课题对该制剂进行了工艺、质量标准以及加速稳定性研究。在提取工艺方面,醇提工艺,以丹参酮ⅡA为评价指标,用正交分析法确定制法,丹参加8倍80%乙醇提取2次,每次40分钟;水提工艺,以干膏收率和盐酸小檗碱为评价指标,用正交分析法,处方剩余药物与丹参药渣煎煮3次,每次加入15倍量水,每次煎煮1小时,滤过,合并上述所有滤液,~(60~70℃)的清膏。在成型工艺方面,以糊精为赋形剂,甜菊素为矫味剂。制粒工艺以颗粒成型率为评价指标,采用正交分析法,确定以药粉与糊精按比例(1:)混合加入20%量的75%%的甜菊素制粒,干燥,整粒。在质量标准及加速稳定性研究方面,建立了黄连、丹参、玄参、芥子四味饮片薄层鉴别方法以及盐酸小檗碱的含量测定方法。对本品按照制定的相关标准进行6个月加速稳定性试验。结果可以说明该制剂工艺科学、合理,质量可控、稳定。关键字:通络糖泰颗粒;制备工艺;质量标准;加速稳定性万方数据成都中医药大学硕士学位论文AbstractTongluo Tangtai Granuleis ording to the clinicalpractice by professor of Xie Chunguang of the affiliated hospital of the Chengdu University of traditional Chinese posed of Rhizoma coptidis, Radix scrophulariaeand other the efficacy of invigorate the circulation of blood,activating meridians to stop pain,replenishing the vital essence and removing heatand useing for clinical treatment of diabetic peripheral neuropathy topic have beenstudied about the preparation process, quality standards and stability tests. In the extractionprocess,we took TanshinoneⅡAas the index,andusethe orthogonal analysis method to determine the preparation method. Salvia miltiorrhizawas plusing 8 times 80% ethanol and extracting2 timeswitn 40 minutes of each time in Alcohol extraction water extraction process, we made Berberine Hydrochloride and yield rate of dry extract as the index,and usedthe orthogonal analysis method to determine the preparation miltiorrhiza dregsand other drugs ofthe prescriptionare to add 15 times waterand extracting3timeswitn 1hours of each we filtered the filtrateand merg it, for which wasconcentrated to a relative density of about ~ (60~70℃) the forming process, we used t dextrin as excipient and stevioside as flavoring made particle forming rateas the index,and usedthe or