远志药材及其炮制品的质量研究

【作者】 张文娟；

【导师】 王亚洲；

【作者基本信息】 西北大学 ， 中药学， 2008， 硕士

【摘要】 目前中药的质量控制研究是中药热点研究问题之一。远志为大宗常用药材,临床应用以制远志为主要规格。近年来由于市场需求猛增,而野生资源急剧减少,栽培品供应有限,商品质量明显下降,直接影响到远志的临床疗效。因此,远志药材及其炮制品的质量控制研究就成为行业亟待解决的问题。本文采用单一指标成分测定、指纹图谱技术结合现代统计学方法,对远志及制远志进行了质量控制研究,期望为远志药材及其饮片的质量控制提供参考。本文共分四章,作者的主要贡献如下:1.采集了18个产地野生远志样品和5个主产区的栽培样品,采用HPLC法测定了其中远志皂苷元的含量,野生品含量在0.13%～0.50%之间,栽培品含量在0.32%～0.42%之间;建立了远志药材的HPLC指纹图谱,并对色谱峰进行了聚类分析,结果野生和栽培远志的指纹谱一致,聚类结果与传统道地产区的记载相一致。在此基础之上,采用多元逐步回归法对远志不同药用部位和商品规格进行成分群分析,获得远志质量等级的拟合评价公式。本研究可用于远志的质量评价及新资源开发。2.以远志皂苷元(C₃₀H₄₅O₆Cl)和甘草酸(C₄₂H₆₂O₁₆)为指标,采用L₉（3⁴）正交试验法,考察了制远志的炮制工艺。最佳炮炙工艺为:取甘草6份,加水煎煮3次,每次30分钟,合并滤液,浓缩至远志量的2.5倍体积,加入净远志100份,140℃浸润90分钟,取出,100℃烘干;根据20批中试实测结果,制定了制远志专属性的质量标准,暂定制远志中远志皂苷元(C₃₀H₄₅O₆Cl)不得少于0.30%,甘草酸(C₄₂H₆₂O₁₆)不得少于0.03%。本研究为制远志工艺规范化提供了相应的技术参数和质量控制指标。3.采用指纹图谱技术结合变异系数法,对制远志和生远志、远志-甘草（100:6）及蜜远志进行了比较分析,三种规格及配伍具有23个共有色谱峰;制远志的变异最大,其变异与2个色谱峰（CV＞2.02）关系密切。更多还原

【Abstract】 To establish the evaluating index and method of principal component for quality control in Polygala tenuifolia Willd,Our article analyzed the wild Polygala tenuifolia、cultivated Polygala tenuifolia、commercial PolygaIa tenuifolia and the Processed Radix Polygalae by HPLC fingerprint、Statistica and content mensuration.The results are almost consistent with chronically using.Then,seven ranks of Polygala tenuifolia samples from Ping Yao of Shanxi were analyzed by HPLC with gradient elution. Clustering method and Principal Component Analysis（PCA）were processed according to the peak area.We owned the evaluating equation.This method confirms the conclusion that Polygala tenuifolia has many effective components,demonstrating that it can be used for the quality evaluation and development of new resource of POlygala tenuifolia.Besides,one orthogonal test was employed to determine the effects of the three factors.The content of senegenin(C₃₀H₄₅O₆Cl)and glycyrrhizic acid(C₄₂H₆₂O₁₆)were determined by HPLC.The best decoction techinics was satifued with some conditions as follows:Adding 100mL water to Glycytthizae,its baking time was 30min,baking three times.The best preparative technics was satisfied with some conditions as follows:Adding 2.5 multiple Radix Glycytthizae-water to Radix Polygalae,its baking time was 90min.baking temperature was 140℃,and drying temperature was 100℃. This research is meaningful to standardization of stir-bake with Radix Glycytthizae on Radix Polygalae.Furthermore,we had constituted a special standard for Processed Radix Polygalae.HPLC fingerprint and Coefficient of Variance were used to analysis Radix Polygalae and Processed Radix Polygalae.The result showed that the Processed Radix Polygalae was the most variation.更多还原