基于HPLC,PCA与相似度评价的芍药甘草汤传统汤剂与配方颗粒汤剂的差异规律分析

目的: 比较芍药甘草汤传统汤剂与配方颗粒汤剂的成分差异. 方法: 制备传统汤剂(TD)、自制配方颗粒汤剂(DGD-S)、市售A厂和B厂配方颗粒汤剂(DGD-A,DGD-B)共4类11批芍药甘草汤,采用HPLC建立指纹图谱,流动相乙腈(A)-0.05%磷酸水溶液(B,pH 2.42)梯度洗脱(0~8 min,16%A;8~35 min,16%~50%A;35~36 min,50%~100%A;36~38 min,100%~16%A;38~40 min,16%A),检测波长250 nm.以3批TD的平均信息为标准汤剂信息,从成分的出现或消失、指标性成分含量、共有峰面积、主成分分析及指纹图谱相似度共5个方面全面对比芍药甘草汤不同剂型的差异信息. 结果: DGD与TD比较,未见有紫外吸收的化学成分的出现与消失.指标性成分含量差别较大,其中DGD中甘草酸铵含量均与TD存在极显著差异.DGD-A中23个共有峰峰面积的总和与TD无显著差异,而DGD-S,DGD-B的共有峰面积之和与TD存在极显著差异,二者分别相当于TD的2.5,3.2倍.在PCA中,DGD-A更接近于TD,表明其各单体成分的绝对量更接近于TD,而DGD-S,DGD-B的绝对量远大于TD.DGD-A与标准汤剂的相似度最小,表明DGD-A中各成分间的比例与标准汤剂相差较大. 结论: 芍药甘草汤DGD与TD间仅有成分比例的明显差异,并无成分本身的明显差异;应按比例调整某些DGD的用量以使其与汤剂等效.

Differential Regularity Analysis Between Traditional Decotions and Dispensing Granules of Shaoyao Gancao Decoctions Based on HPLC,PCA and Similarity Evaluation

Objective: To compare difference of chemical components between traditional decotions and dispensing granules decoctions of Shaoyao Gancao decoctions. Method: Four types of 11 kinds of Shaoyao Gancao decoctions were prepared,including traditional decotions(TD),dispensing granules decoctions made by self(DGD-S),dispensing granule decoctions made by factory A and B (DGD-A,DGD-B),fingerprint was eastablished by HPLC,mobile phase consisted of acetonitrile(A)-0.05% phosphoric acid solution(B,pH of 2.42) with gradient elution(0-8 min,16%A;8-35 min,16%-50%A;35-36 min,50%-100%A;36-38 min,100%-16%A;38-40 min,16%A),detection wavelength was set at 250 nm.Taking average information of three batchese of TD for stabdard decoction information,difference informations of Shaoyao Gancao decoctions preparations were compared by five aspects,including appear or disappear of components,contents of index components,common peak area,principal component analysis and fingerprint similarity. Result: Compared with TD,composition of chemical components in DGDs did not change.The content of index components between three kinds of DGD and TD had great difference,especially difference of ammonium glycyrrhizinate were very notable.Total peak area comparison showed that sum of 23 total peak area between TD and DGD-A had no significant difference,but it had significant difference between TD and DGD-S,DGD-B,they were equivalent to 2.5 and 3.2 times of TD,respectively.In PCA plot,DGD-A was closer to TD which showed that the absolute amount of monomer composition was closer to TD,while the absolute amount of DGD-S,DGD-B were far more than TD.Similarity between DGD-A and standard decoctions was minimum,which showed that difference of components proportion between DGD-A and standard decoctions was maximum. Conclusion: Significant difference between TD and DGD only exists in proportion of ingredients,not related to components themselves,suggesting that more experiments should be done to validate whether its drug properties are changed and in clinical application,dosage must be reduced proportionally,so that curative effect is similar to TD.