金雀根片剂药学的分析-药剂学专业论文.docxVIP

PAGE PAGE 10 对金雀根二苯乙烯苷片剂的性状、鉴别（TLC）、检查（片重差异、崩解时 限、微生物限度）进行了研究。建立了金雀根二苯乙烯苷片剂中三种指标性成 分 carasinol B 、kobophenol A 、 (+)-α-viniferin 的含量测定方法及溶出度的测 定方法，对这两种方法进行了完整的方法学验证。 关键词：金雀根；carasinol B 、kobophenol A 、 (+)-α-viniferin；片剂；指 纹图谱；大孔吸附树脂；提取纯化；制剂工艺；质量标准； Abstract Toluylene glycosides from Caragana sinica (Buc’hoz) Rehd.(TGC)，which is mainly active site of Caragana sinica (Buc’hoz) Rehd，shows a wide range of physiological activity on the basis of modern pharmacological researches, such as the stimulation of osteoblast proliferation, promoting bone growth and adjusting bone metabolism. There have not been any formulations of TGC on the market yet. The aimof this project is to extract and purify TGC, which has therapeutic effects on osteoporosis, from Caragana sinica (Buc’hoz) Rehd, to make formulation of TGC, to optimize the production process of TGC, to establish its pharmaceutical quality and thus to prepare for the new drug application of TGC. The research mainly includes the following five parts: Quality standards of Caragana sinica. The quality standards of Caragana sinica.was established, which mainly includes identification and assayof CKV (carasinol B 、 kobophenol A 、 (+)-α-viniferin). Optimization of extraction and purification process for effective ingredients (TGC) The extraction process for effective ingredients in Caragana sinica was optimized. Three extraction methods were investigated, including soaking, hot refluxing and decoction with water. The orthogonal test design was used in the optimization, and the synthetic score based on the extraction rate of CKV was used as the assessment indices. TGC were purified from Caragana sinica. by macroreticular resin. Purification is the key step to guarantee the quality of TGC extract. The best resin was selected by comparison of the adsorption capacity, elutive ratio and purity of CKV in the product. The technical procedure for purification of CKV with the optimum macroreticular resin was screened by cont