市售葛根配方颗粒与标准汤剂质量比较

Quality Comparison Between Commercial Foumula Granules and Standard Decoction of Puerariae Lobatae Radix

目的探讨葛根配方颗粒替代相应饮片存在的质量问题。方法采用薄层色谱法对葛根配方颗粒、葛根饮片进行定性鉴别;采用高效液相色谱法测定葛根素的含量,色谱柱为ACES C18 AQ Plus柱(150 mm×4.6 mm,5μm),流动相为甲醇-水(22∶78,V/V),流速为1.0 mL/min,检测波长为250 nm,柱温为30℃,进样量为10μL;测定、计算并比较标准汤剂与配方颗粒的干浸膏出膏率。结果葛根配方颗粒及标准汤剂均能在薄层色谱鉴别中检出葛根素及葛根药材的特征斑点;葛根素进样量在0.08510~2.12700μg范围内与峰面积线性关系良好,精密度、重复性试验结果的RSD均小于1.0%,相同葛根当量下10批配方颗粒的葛根素含量均明显低于标准汤剂;10批配方颗粒中有8批的干浸膏出膏率不及标准汤剂的40%。结论市售葛根配方颗粒的生产工艺有待进一步规范,质量亟待提升。

Objective To investigate the quality phroblems of formula granules of Puerariae Lobatae Radix instead of corresponding decoction pieces.Methods The formula granules and decoction pieces of Puerariae Lobatae Radix were qualitatively identified by the thin-layer chromatography(TLC)method.The content of puerarin was determined by the high-performance liquid chromatography(HPLC)method,the chromatographic column was ACES C18 AQ Plus column(150 mm×4.6 mm,5μm),the mobile phase was methanol-water(22∶78,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 250 nm,the column temperature was 30℃,and the injection volume was 10μL.The dry extract yield of standard decoction and preparation was determined,calculated and compared.Results The characteristic spots of puerarin and Puerariae Lobatae Radix in the formula granules and standard decoction of Puerariae Lobatae Radix could be detected by the TLC.The injection volume of puerarin showed a good linear relationship with the peak area in the range of 0.08510-2.12700μg,and the RSDs of precision and repeatability tests were less than 1.0%,the average content of puerarin in 10 batches of formula granules was significantly lower than that in standard decoction.Among the ten batches of formula granules,the dry extract yield of eight bactches was less than 40%of that of the standard decoction.Conclusion The production process of commercial formula granules of Puerariae Lobatae Radix needs to be further standardized,and the quality needs to be improved.