益气温阳胶囊的药学研究

【作者】 马莉；

【导师】 肖丹；

【作者基本信息】 成都中医药大学 ， 中药药剂学， 2003， 硕士

【摘要】 益气温阳胶囊是由红参、附子、甘草三味中药组成的复方制剂。具有益气温阳，救逆固脱的功效，用于阳气亏耗，阳不制阴，所表现出的畏寒肢冷、四肢厥逆等虚寒证候；也可用于阳虚(气虚)所致的惊悸、怔忡、喘咳、泻泄等症。本课题以中医药理论为指导，依照《药品注册管理办法》的要求，对益气温阳胶囊进行了临床前药学部分的研究。根据处方的功能主治结合药物成分的性质，拟订了工艺路线，确定了提取方法及最佳工艺条件，对分离除杂、浓缩干燥及成型工艺进行了相应的考察，中试结果稳定。为确保制剂的安全性，对方中生物碱类成分进行研究，规定了乌头碱的限量。同时，制定了质量标准，进行了初步稳定性试验。研究结果表明：益气温阳胶囊制剂工艺具科学性、合理性、可行性；质量标准具可控性；成品质量稳定。更多还原

【Abstract】 Yiqi Wcnyang capsule is a pure TCM compund preparation, which consists of Ginseng, Common monkshood prepared daughter root, glycyrrhizia, and has the function of tonifying Qi to warm Yang and treating collapse. Therapying the symptoms of aversion to cold, Cold limbs, deadly extremities due to Yang deficiency and palpitation due to terror and distress feeling, dyspnea with cough, diarrhea.Under the guidance of the theories of TCM and Pharmacy, according to the standard of the "registering and managing Method of material medica", Yiqi Wenyang capsule has been researched on pre-clinical pharmacy. Based on the function and treatment of prescription as well as the characters of effective component of the herbs, the best extract methods and conditions were made. At the same time the optimal purifying, condensing and moulding conditions were screened. In order to evaluate the security of the preparation, alkaloid of the prescription have been investigated and set limit to aconitic acid. After the preparation study, the quality standard was built up and the preliminary stability was fulfilled, all of these indicate that the preparation procedure was scientific, reasonable and practicable, the standard is controllable, and the quality of the sample was steady as well.更多还原