益母草饮片标准汤剂研究

Standard decoction of Leonuri Herba

建立益母草饮片标准汤剂质量评价标准。制备13批不同品质的益母草饮片标准汤剂,对盐酸益母草碱和盐酸水苏碱进行含量测定、计算其转移率、测定出膏率及pH、建立HPLC指纹图谱分析方法。结果 13批益母草饮片标准汤剂中盐酸益母草碱和盐酸水苏碱转移率分别为30.0%~53.4%,67.0%~82.6%,干膏得率12.1%~18.3%,pH 5.87~6.22,并用中药色谱指纹图谱相似度评价系统(2012A)软件进行指纹图谱分析,确定了12个共有峰,对13批益母草饮片标准汤剂分别进行相似度评价,其相似度均大于0.9。该研究中益母草饮片制备方法规范,指纹图谱相似度高,其方法精密度、稳定性和重复性良好,可为益母草配方颗粒质量控制提供参考。

To build an evaluation standard for quality of Leonuri Herba standard decoction. 13 batches of Leonuri Herba standard decoction with different quality were prepared. The contents of leonurine hydrochloride and stachydrine hydrochloride were determined; then the transfer rate and the extract rate were calculated and pH value was measured; and HPLC fingerprint method was established for analysis. The results of 13 batches of samples revealed that the transfer rate of leonurine hydrochloride and stachydrine hydrochloride was 30.0%-53.4% and 67.0%-82.6%, respectively; the extract rate was 12.1%-18.3% and the pH value was 5.87-6.22. Moreover, 12 common chromatographic peaks were determined based on fingerprint by using Similarity Evaluation System for Chromatographic fingerprint of Traditional Chinese Medicine （2012A）. The similarity of 13 batches of samples was analyzed and compared, and the results showed that the similarity was higher than 0.9. In this study, the preparation method for Leonuri Herba decoction was standard, with high similarity in fingerprint, showing high precision, stability and repeatability in fingerprint analysis. Thus, this study can provide a reference for the quality control of Leonuri Herba dispensing granules.