感毒清口崩片的药学研究

【作者】 张春容；

【导师】 肖丹；

【作者基本信息】 成都中医药大学 ， 中药药剂学， 2006， 硕士

【摘要】 感毒清口崩片是由射干、黄芪两味中药组成，具有清热解毒、益气扶正，利咽化痰的功能；主治病毒性上呼吸道感染及各种流行性发热、咽喉肿痛等疾病。本课题在中医药理论指导下，根据大量的文献资料，结合处方中各药物成分的理化性质，采用现代药学研究技术，并依据国家药品注册管理办法，对制剂的制备工艺，质量标准和初步稳定性试验进行了系统研究。 制备工艺研究中，分别以射干次野鸢尾黄素含量、黄芪甲苷含量、干膏得率为指标，采用单因素试验和正交试验相结合的方法；用大孔吸附树脂对射干次野鸢尾黄素、黄芪甲苷进行富集纯化，从而筛选出射干、黄芪的提取、纯化、浓缩和干燥工艺。成型工艺研究中，采用直接压片法制备了感毒清口崩片。质量标准研究中，建立了黄芪的薄层色谱鉴别和成品次野鸢尾黄素的含量测定方法。稳定性研究中，对三批中试样品留样观察3个月，结果各项指标均符合规定。 研究结果表明：该制剂制备工艺科学、合理、可行，质量标准稳定、可控，成品性质稳定。更多还原

【Abstract】 Ganduqing orally disintegrating tablet is a compound preparation with Rhizoma Belamcandae, Radix Astragali and pharmaceutic excipient. It has the function of clearing away Heat-toxin, benefiting vital energy and proping up vital-qi, easying the throat and removing the phlegm. It plays the role of treating upper respiratory tract infection, different epidemic pyrexia, faucitis gall and etc. With the guidance of the theories of Traditional Chinese Medicine, on the basis of abundant literature materials, in combination with the property of each ingredient in this prescription, we systematically studied Preparation process, Quality standard and Preliminary Stability by adopting the modern pharmacy research technology and according as the national drugs registration policing method.Taking the contents of Irisforentin, Astragaloside IV and amount of dry extract cream as the evaluation indexes, to explore the optimum the procedure of extraction, purification, concentration and torrefaction, the single factor test and orthogonal test was adopted, the macroporous resin purification was used. In the preparation process, rapidly disintegrating tablets were prepared by direct compression. In Quality standard research, TLC was adopted to distinguish Radix Astragali, HPLC method was adopted to measure the content of Irisforentin in finished products. In Stability research, all the three samples of enlarge test met the request of Quality standard and were proved to be steady during the observation time of three months.The study shows that the preparation process is scientific, reasonable and practical. Moreover, the quality standard is controllable and the quality of the sample is steady as well.更多还原