【作者】 张继良；

【导师】 孙灵根；

【作者基本信息】 成都中医药大学 ， 药剂学， 2011， 硕士

【摘要】 YSTM颗粒为葛根、银杏叶等药味经加工制成的制剂(YSTM为处方简写),主要功能：活血化瘀,通脉活络,舒经止痛。用于冠心病心绞痛属于血瘀证者,症见胸痛、胸闷、憋气、心慌、气短、神倦乏力、眩晕、头痛、肢体麻木。本课题以中医药理论为指导,运用现代制药技术,对该颗粒剂进行了临床前药学相关部分的研究。根据临床用药需要及处方药味成分特点,确定制成颗粒剂并拟定了工艺路线。以葛根素含量及浸膏收得率为评价指标,采用正交法试验,确定提取工艺为：取葛根等药味,加5倍量60%乙醇,回流提取二次,每次2小时,合并提取液,滤过,滤液减压回收乙醇,浓缩至相对密度为1.10(60℃)的流浸膏。开展成型工艺相关研究,确定的成型工艺为：取2/3量流浸膏喷雾干燥成浸膏粉,加入糊精适量,混匀,过80目筛,作为母核,取其余1/3量流浸膏加入阿司帕坦0.3%溶解作为黏合剂,沸腾制粒。经三批中试试制证明,拟定制备工艺稳定可行。在制剂质量标准研究中,重点对薄层色谱鉴别与含量测定开展了研究。试验对方中药味均进行了鉴别,其中银杏叶、川芎、延胡索展开效果较好；采用HPLC法测定葛根中葛根素的含量,并作了系统方法学研究,暂定本品每袋含葛根以葛根素(C21H20O9)计不得少于105.0mg,均收入标准正文。以常温留样观察法考察样品长期稳定性,试验结果表明三批样品性状、鉴别、检查及含量测定等均符合规定。以上试验表明：制定的工艺合理可行,建立的质量标准可控,样品质量稳定。更多还原

【Abstract】 YSTM granule is Chinese medicine processed preparation that made from pueraria lobata and ginkgo leaves and so on(YSTM is a shorthand for the prescription). Main function is promoting blood circulation by removing blood stasis, going through pulse and retinervus and reducing pain. It is used to people who have coronary heart disease and angina of blood stasis. Symdrome has chest pain, chest tightness, suffocation, palpitation, shortness of breath, fatigue, dizziness, headache and numbness. Using Chinese medicine theory to direct and using modern pharmaceutical technology, the subject researches pre-clinical pharmaceutical part of the granule.According to clinical needs and prescription components, determine to make into granule and develop a processing route. Evalution standards are Puerarin content and rate of the cream.Adopting the orthogonal method select the the extraction process as follows:Weigh medicine by the proportion of prescriptions. Reflux with 5 times of 60% ethanol for 2 times,2 hours each time, filter and combine the filtrate. Recycle the ethanol. Concentrate to a thick extract with a relative density of 1.10(60℃). Take 2/3 of the cream to spray-dry into powder, adding an amount of dextrin, mix up and go through 80 mesh sieve. Add moderate dextrin and 3 grams of aspartame, mix up, use it as the kernel. The other 1/3 of the cream is as the adhesives for boiling granulation. The three batches of the med-term tests prove that the development process is stable and possible.Focus on TLC and HPLC during the quality standard research. TLC is used to identify the ingredients in prescription respectively, among which ginkgo leaves, szechuan lovage rhizome and yanhusuo have comparatively better results. The content of puerarin in pueraria lobata is determined using HPLC as indicators of internal quality control, and the systematic methodology are accomplished. All results comply with the specified standards concerned, thus the method is included into the normal test of quality standard. Through determinatioan of the med-term tests samples, combining the actual production, the content of puerarin per package is no less than 105.0mg. Examine the long-term stability by observation methord at room temperature. The results show that three batches of the samples’chatacter, identification, examination and determination all meet the requirements.The results of above tests indicate that the preparation technology is reasonable and practical, the standard is controllable, and the quality of the sample is stable on the whole as well.更多还原