炒紫苏子标准汤剂的质量标准研究

目的:制备炒紫苏子标准汤剂,并进行质量标准研究。方法:依照标准汤剂的制备要求,制备17批炒紫苏子标准汤剂,计算出膏率。采用高效液相色谱(HPLC)法对炒紫苏子标准汤剂中迷迭香酸进行定量分析色谱柱为Agilent 5 TC-C18(2),流动相为甲醇-0.1%甲酸溶液(40∶60,V/V),检测波长为330 nm,流速为1.0 mL/min,柱温为30℃,进样量为5μL],并计算其转移率。建立17批炒紫苏子标准汤剂的HPLC指纹图谱,利用中药色谱指纹图谱相似度评价系统(2012版)软件对指纹图谱进行分析,并通过对比共有峰的保留时间对色谱峰进行指认。结果:17批炒紫苏子标准汤剂的出膏率为5.55%～9.75%;迷迭香酸的含量为0.44%～1.58%,平均含量为1.08%;迷迭香酸的转移率为18.31%～34.32%,平均转移率为25.42%。在17批炒紫苏子标准汤剂HPLC指纹图谱中,共确定了11个共有峰,相似度均高于0.95;并指认出了其中5个共有色谱峰,分别为咖啡酸(峰3)、木犀草苷(峰5)、迷迭香酸(峰8)、木犀草素(峰9)和芹菜素(峰10)。结论:建立了炒紫苏子标准汤剂的质量控制方法,可为炒紫苏子配方颗粒及相关制剂质量标准的制订提供参考。

Study on Quality Standard of Fried Perilla frutescens Seed Standard Decoction

OBJECTIVE:To prepare standard decoction of fried Perilla frutescens seed and study the quality standard.METHODS:According to the preparation requirements of standard decoction,17 batches of standard decoction of fried P.frutescens seed were prepared,and the yield of paste was calculated.HPLC method was used for quantitative analysis of rosmarinic acid in standard decoction of fried P.frutescens seed.The determination was performed on Agilent 5 TC-C18(2)column with mobile phase consisted of methanol-0.1%formic acid solution(40∶60,V/V)at the flow rate of 1.0 mL/min.The detection wavelength was set at 330 nm,and column temperature was 30℃.The sample size was 5μL.The transfer rate was calculated.HPLC fingerprint was established for 17 batches of standard decoction of fried P.frutescens seed,and analyzed by using TCM Chromatogram Fingerprint Similarity Evaluation System(2012 edition).The chromatogram peaks were identified by comparing retention time of common peak.RESULTS:The yield of paste were 5.55%-9.75%in 17 batches of standard decoction of fried P.frutescens seed.The contents of rosmarinic acid were 0.44%-1.58%,and average content was 1.08%.The transfer rates of rosmarinic acid were 18.31%-34.32%,and average transfer rate was 25.42%.In HPLC fingerprints for 17 batches of standard decoction of P.frutescens seed,a total of 11 common peaks were identified,and the similarity was higher than 0.95.Five common peaks were identified,namely caffeic acid(peak 3),luteolin(peak 5),rosmarinic acid(peak 8),luteolin(peak 9),apigenin(peak 10).CONCLUSIONS:The quality control method of standard decoction of fried P.frutescens seed is established,which can provide reference for the formulation of the quality standard of fried P.frutescens seed granules and related preparations.