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复方巴甘颗粒的制备及巴旦仁脂肪酸指纹图谱研究
徐江玲
学位类型硕士
导师阿布力米提·伊力、阿吉艾克拜尔·艾萨
2013-05-28
学位授予单位中国科学院大学
学位授予地点北京
学位专业有机化学
关键词复方巴甘颗粒 制备工艺 质量标准 巴旦仁 指纹图谱
其他摘要

复方巴甘颗粒是新疆莎车县维吾尔医医院的院内制剂,由巴旦仁、破布木果、榅桲子、甘草、白皮松子五味药材组成。因原工艺路线简单、且没有相应的标准可以控制其质量。所以,本论文按照中药新药研究的要求和方法,对其制备工艺、质量标准进行了全面而系统地研究。同时,为全面有效地控制巴旦仁的质量,对其脂肪酸成分进行指纹图谱研究。

依照处方中各味药材所含不同成分的药理作用、理化性质,结合处方的功能主治,拟定用水提取。以甘草酸含量、总多糖含量和水浸出物量为评价指标,选取加水倍量、提取次数和提取时间作为考察因素,通过单因素和正交试验,确定最佳水提取工艺为:加15倍量水,提取3次,每次1.5小时。然后,以甘草酸含量、总多糖含量和水浸出物量为考察指标,结合实验数据和实际工业化生产的条件确定浓缩、纯化工艺条件为:将提取液浓缩至生药:药液(g/mL)为1:10时,以8000 rpm高速离心15分钟。最后,以吸湿率、成型率和溶化性作为评价指标,对辅料的种类、配比和湿润剂乙醇的浓度进行了筛选,确定成型工艺条件为:干浸膏粉与乳糖(1:1.5)混匀,用45%乙醇润湿,制成颗粒。该制备工艺路线合理、简单可行。

复方巴甘颗粒的质量标准研究包括性状、检査、薄层色谱鉴别和含量测定研究。建立了制剂中巴旦仁、甘草的薄层色谱鉴别方法和高效液相色谱法(HPLC)同时测定甘草苷、甘草酸含量的方法。本实验方法简单、准确、重现性好,可用于复方巴甘颗粒的质量控制。

本研究还利用气相色谱-质谱联用技术(GC-MS)对12个品种的巴旦仁脂肪酸成分进行了分析,建立了巴旦仁脂肪酸成分的指纹图谱,并运用《中药色谱指纹图谱相似度评价系统A》和统计产品与服务解决方案软件(SPSS)分别进行了相似度评价和聚类分析。巴旦仁脂肪酸成分的指纹图谱有10个共有峰,并具有较好的精密度、重复性和稳定性。12个样品的脂肪酸成分相似度在0.98以上。实验结果表明,建立的指纹图谱可为巴旦仁及其制品的鉴伪及质量控制提供理论依据。

; The Fufang Bagan granule comes from Shache Uygur medicine hospital inXinjiang province, and is consist of five kinds of herbs, which are Amygdalus communis ,Cyonia obonga, Cordia dichotoma, Glycyrrhiza uralensis and Pinus gerardiana. Because the original process route is simple, and there is no corresponding standard can control the quality, according to the requirement of Chinese medicine research and methods, the following systematic and comprehensive researches have been conducted: the drafting of preparation process and the drawing up of the quality stander. At the same time, to effectively control the quality of almonds, the fingerprint on the fatty acid composition in almonds has been studied. Regard to the the physiochemical property of the effective components, as well as the main action of the whole recipe, a plan of extracting technology has been made. Using single factor and orthogonal design to optimize the water extraction technology, and with the multiple water, the extraction times and the extraction time as the facors, the best extraction process was determined as follows: adding 15 times water, extracting 3 times and each time for 1.5 hours. Then, with the content of glycyrrhizic acid, the content of total polysaccharide and water extracts as the evaluation index, and combined with the experimental data and the actual production conditions, the process of concentration and purification was determined as follows: the extract was concentrated to the proportion of rude herb and concentration liquid (g/mL) as 1:10; the concentaction was purified by the speed of 8000rpm, 15 minutes. Finally, with hydroscopicity, formability and solubility as the indexes, molding process conditions were determined as follows: dry extract powder and lactose were mixed in proportion of 1:1.5, with 45% ethanol as wetting agent. The preparation process is reasonable, simple and feasible. The study of the quality standard control includes of the examination of the granule's character, TLC and determination of content. The method of TLC identification for Amygdalus communis,Glycyrrhiza uralensis and simultaneous determination of glycyrrhizic acid and liquiritin in Fufang Bagan Granule by HPLC were established.These methods were simple, accurate, reproducible and can be used for quality control of Fufang Bagan Granule. This paper also studied the fatty acid composition of 12 almond samples using GC-MS technology, and established the fingerprint of fatty acid composition in almonds, and the similarity evaluation and cluster analysis of dates were made by “Similarity evaluation system for chromatographic fingerprint of TCM(Version 2004 A)” and “Statistical Product and Service Solutions(SPSS )” software. The fingerprint has 10 common peaks, and has good precision, repeatability and stability. The similarity of fatty acid composition of the 12 samples was above 0.98. Experimental results show that the establishment of the fingerprint can provide a theoretical reference for quality control of the almond and its products.
文献类型学位论文
条目标识符http://ir.xjipc.cas.cn/handle/365002/2521
专题资源化学研究室
作者单位中国科学院新疆理化技术研究所
推荐引用方式
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徐江玲. 复方巴甘颗粒的制备及巴旦仁脂肪酸指纹图谱研究[D]. 北京. 中国科学院大学,2013.
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