黄连传统汤剂与配方颗粒汤剂成分差异分析  

Component difference between traditional decotion and formula granules decoction of traditional Chinese medicine berberine

作　　者：王青晓[1] 王翀[2] 刘瑞新[3] 王盼盼[4] 高晓洁[4] 桂新景 孟祥乐[3] 李学林[3] 

机构地区：[1]河南省食品药品检验所,郑州450003 [2]中国食品药品检定研究院,北京100050 [3]河南中医学院第一附属医院药学部,郑州450000 [4]河南中医学院,郑州450008

出　　处：《中国新药杂志》2016年第12期1378-1384,共7页Chinese Journal of New Drugs

基　　金：国家自然科学基金青年基金资助项目(81001646);郑州市科学技术局专项(CZSYJJ14012);河南省高等学校重点科研项目(16A360021)

摘　　要：目的:比较黄连传统汤剂(TD)与黄连配方颗粒汤剂(DGD)的成分差异。方法:黄连饮片与市售3个厂家的配方颗粒共4类10批,采用HPLC建立指纹图谱,以2批自制黄连饮片汤剂的平均信息为标准汤剂信息,从成分的出现或消失、指标性成分的含量、共有峰面积、主成分分析(PCA)及指纹图谱相似度共5个方面全面对比其差异信息。结果:1三类DGD与TD的指标性成分含量差别较大,其中DGD-A(A厂的DGD供试品)中指标性成分含量均与TD存在显著性差异(P<0.05)。2共有峰面积比较结果显示,DGDA与DGD-C(C厂的DGD供试品)中8个共有峰峰面积的总和与TD具有显著差异,二者分别相当于TD的0.37倍和0.86倍。而DGD-B(B厂的DGD供试品)的共有峰面积之和与TD无显著性差异。3在PCA图中,DGD-A与DGD-C更接近于TD,表明其各单体成分的绝对量更接近于TD,而DGD-B的绝对量远大于TD。4 DGD-A与TD的相似度最小,表明DGD-A中各成分之间的比例与TD相差较大。结论:传统黄连饮片与配方颗粒间存在成分含量比例的差异,部分批次也存在成分本身的差异,临床用药应按比例调整不同厂家配方颗粒的用量以使其与汤剂等效。Objective： To compare the difference of chemical components between traditional decotion（ TD） and dispensing granules decoction（ TGD） of berberine. Methods： Ten batches of four kinds of berberine decoction were prepared,and the fingerprint was established by HPLC. The average information of two batches of homemade berberine herbs decoction was used as the standard information. By comparing the contents of index components and the common peak area and principal component analysis,combined with comparison of fingerprint similarity,the different information was compared comprehensively. Results： The contents of index components had great difference among three kinds of DGD and TD,especially the DGD-A,which had significant difference with TD for all the index components（ P 〈0. 05）. The result of total peak area comparison showed that there wasno significant difference in the total peak area of the nine common peaks between TD and DGD-A or DGD-C,but significant difference between TD and DGD-S or DGD-B（P〈0.01）,and the peak areas were equivalent to 0. 37 and 0. 86 times of TD,respectively. In the PCA plot,DGD-A and DGD-C were close to TD,which indicated that the absolute amount of the monomer composition was close to TD,and the absolute amount of DGD-B was far higher than TD. The similarity between DGD-A and standard decoction was the lowest,which suggested that the proportion of the components in DGD-A had large difference with the standard decoction. Conclusion： The composition of the chemical components of formula granules decoction of berberine is different to that of the traditional decotion,and also different among some batches,suggesting that the dosage of the granules must be adjusted appropriatly in clinical application to obtain similar efficacy to TD.

关 键 词：黄连 传统汤剂 配方颗粒汤剂 主成分分析 相似度分析 

分 类 号：R931[医药卫生—生药学]