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小柴胡汤煎煮技术规范研究

The Standard Decotion of Xiaochaihu Tang

【作者】 庄延双

【导师】 蔡宝昌;

【作者基本信息】 南京中医药大学 , 中药学, 2012, 硕士

【摘要】 汤剂是我国具有独特疗效并用于预防疾病的有效方剂之一,汤剂具有其独特的优势,在临床上疗效显著。但是现在汤剂煎煮规范普遍缺失,故本文对小柴胡汤的煎煮规范进行了研究。小柴胡汤是东汉张仲景《伤寒论》中的名方,原方由柴胡(24g),黄芩(9g),人参(9g),半夏(9g),甘草(炙,9g)、生姜(切,9g),大枣(4枚)上7味药组成,具有和解少阳、扶正祛邪的作用,是伤寒少阳证主方。文献研究部分对影响汤剂质量的因素,小柴胡汤全方及单味药的化学成分和药理作用,汤剂剂型改革的几种剂型进行概括和总结,最后对指纹图谱的内容作了简单介绍。本文以小柴胡汤浸出物、黄芩苷含量、特征谱、相对密度等作为煎煮工艺优化评价指标,对标准汤剂的考察因素包括,加水量、浸泡时间、煎煮火候(先武火后文火、全程文火)、煎煮时间、煎煮次数、煎煮器具(砂锅(传统器具)与现代器具(不锈钢锅)、砂锅(明火加热)与无明火加热(养生壶)进行了单因素考察,确定了加水量、浸泡时间、煎煮时间、煎煮次数的3个水平,先武火后文火优于全程文火,砂锅优于不锈钢锅和养生壶,进而对小柴胡汤的煎煮工艺进行了正交实验的考察,通过正交软件计算极值优选的最佳工艺为:浸泡40min,煎煮40min,煎煮3次,通过方差分析得出煎煮时间和煎煮次数对黄芩苷的含量和浸膏得率均有显著性差异,浸泡时间和加水量对黄芩苷和浸膏得率的影响无显著性差异。本文在传统煎煮的基础上,通过对各个因素进行单因素考察,确定了浸泡时间、加水量、煎煮时间、煎煮次数的3个水平,建立L9(34)正1交实验确定了小柴胡汤的最佳机器煎煮工艺。本文建立了LSP诱导小白兔发热模型,分别比较了人参,党参入药小柴胡汤的解热效果,通过SPSS16.0统计软件处理,研究表明人参、党参入药小柴胡汤对LSP所致的白兔都有明显的解热作用,3组之间没有显著性差异,证明了党参替代人参的可行性。同时本研究用试剂盒对小鼠血清干扰素(IFN-γ)和肿瘤坏死因子-α(TNF-α)进行了含量测定,从微观角度对其替代的可行性提供了参考。同时对小柴胡汤传统汤剂与复方颗粒剂的指纹图潜及主要的指标性成分(黄芩苷、黄芩素、汉黄芩苷、汉黄芩素、甘草次酸)进行了对比研究,从而为临床使用小柴胡汤的复方颗粒剂提供了实验依据。本文将市售的10批小柴胡颗粒的5种指标性成分(黄芩苷、黄芩素、汉黄芩苷、汉黄芩素、甘草次酸)进行了含量测定同时进行了指纹图谱分析,对其进行了定性和定量分析,从而为市售小柴胡颗粒的质量控制提供了科学依据。为了确保小柴胡汤的安全和有效,本文用ICP-AES法分析市售小柴胡颗粒中的重金属元素和微量元素(As,Cd,Zn,Fe,Mg,Mn),并控制其含量,从而为市售小柴胡颗粒的安全服用提供参考。

【Abstract】 Decotion is one of effective dosimetry that have special effect and can be used to prevent disease.Decotion have obvious clinical efficacy due to its special advantage.But there is no standard of decotion, so this article make a study about standard of Xiaochaihu Tang.Xiaochaihu Tang is one of famous precription in ShangHanLun writed by Mr Cheung in the Eastern Han Dynasty, the original precription include Radix Bupleuri(25g)、Scutellaria baicalensis(9g)、Pinellia ternata(9g),Liquorice(roasted,9g)、Ginger(cut,9g)、Jujube(4values), this precription can harmonize Shaoyang and Rouse,and it is main precription of Shaoyang disease of ShangHan.The research of literature summarize the factor which have influence on decotion qulity,chemical compostion and pharmacological effect of Xiaochaihu Tang of the precreption and the single durg,some formulation of decotion reformation,and at last it make a simple instruction about fingerprint.The index is included the content of extraction, the content of baicalin,fingerprint,relative density to optimize the extracting technology.The factor is included water doses,soaktime,decotion temperature(high heat firstly and then slow fire, slow fire all the way),decotion time,decotion times, decotion instrument(marmite and health-preserving kettle, marmite and stainless steel kettle). There levels of water doses,soaktime,decotion time and decotion times are made sure, high heat firstly and then slow fire is better than slow fire all the way, marmite is better than health-preserving kettle and stainless steel kettle.The best extracion extracting technology is soaking40min,adding lOBei water,decoting40min, decoting3times by orthogonal experiment.This experiment is proved that decotion time and decotion time have significant difference to the content of baicalin and the content of extraction by variance analysis except soaktime and water doses.On the basic of traditon decotion, there levels of water doses,soaktime,decotion time and decotion times are made sure, this article optimize the extracting technology of machine decoction by orthogonal experiment of L9(34).This paper establish the LSP induction heating the little white rabbit model, to compare the fever effect of ginseng, dangshen to Xiaochaihu Tang, through the SPSS16.0statistical software processing, research shows that the ginseng,dangshen medicine radix soup decoction of small white rabbit caused by LSP has obvious antipyretic role, and there is no significant differences between the three groups, and proved the feasibility of the dangshen replace of ginseng. At the same time, this study is about the determination of interferon (IFN-γ) and tumor necrosis factor (TNF-a) in mice serum to ensure the repalcing.This article is made a contrast studies about Xiaochaihu compound granules and Xiaochaihu Tang about fingerprint and5main index(baicalin, baicalein, wogonoside, wogonin, enoxolone) simultaneous determination which can provide a sicentific fact to convice the repalcing Xiaochaihu compound granules of Xiaochaihu Tang.This paper analyze the content of five main index components(baicalin, baicalein, wogonoside, wogonin, enoxolone)and the specific chromatograms of ten batches of Xiaochaihu granules. It is establelished a quantitative and qualitative method. So it provide a scientific fact for the quality control of Xiaochaihu granules on market.This paper provide experimental evidence for the quality control of Xiaochaihu granule by determining the contents of some representative heavy metallic and trace elements (As,Cd,Zn,Fe,Mg,Mn) in Xiaochaihu granule from ten different pharmaceutical enterprises.

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