夏枯草饮片及标准汤剂质量评价相关性研究

Correlation Study on Quality Evaluation of Decoction Pieces and Standard Decoction of Prunellae Spica

目的建立夏枯草饮片标准汤剂质量评价方法,并对夏枯草饮片及其标准汤剂进行相关性研究。方法采用HPLC测定15批夏枯草饮片及标准汤剂中咖啡酸和迷迭香酸的含量,计算转移率、出膏率;采用超高液相色谱法建立夏枯草饮片及其标准汤剂指纹图谱,并进行相关性分析。结果 15批夏枯草饮片中咖啡酸和迷迭香酸的含量分别为0.11~0.26 mg/g和2.35~7.57 mg/g,标准汤剂中咖啡酸和迷迭香酸的含量分别为3.32~4.11 mg/g和8.34~32.83 mg/g。咖啡酸转移率为151.6%~260.6%,平均(193.6±58.1)%;迷迭香酸转移率为28.3%~58.1%,平均(47.0±14.1)%;出膏率为9.1%~12.9%,平均(10.8±3.2)%。夏枯草饮片及标准汤剂指纹图谱分别有7个共有峰,对比两者对照指纹图谱,共6个共有峰。结论 15批夏枯草饮片与标准汤剂的化学成分基本一致,建立的质量评价方法可用于标准汤剂及相关制剂的质量控制。

Objective To establish the quality evaluation method for standard decoction of Prunellae Spica; To conduct the correlation study on decoction pieces and standard decoction of Prunellae Spica. Methods The contents of caffeic acid and rosemary acid of 15 batches of decoction pieces and standard decoction of Prunellae Spica were determined by HPLC, and the transfer rate and the extractum rate were calculated. The fingerprints of decoction pieces and standard decoction were evaluated by UPLC and the correlations among them were evaluated. Results The contents of caffeic acid and rosemary acid of 15 batches of decoction pieces were in the range of 0.11–0.26 mg/g and 2.35–7.57 mg/g. The contents of caffeic acid and rosemary acid of 15 batches of standard decoction were in the range of 3.32–4.11 mg/g and 8.34–32.83 mg/g. The transfer rate of caffeic acid was in the range of 151.6%–260.6%, and the average transfer rate was（193.6±58.1）%. The transfer rate of rosemary acid was in the range of 28.3%–58.1%, and the average transfer rate was（47.0±14.1）%. The extractum rate was in the range of 9.1%–12.9%, and the average extractum rate was（10.8±3.2）%. Seven common peaks were confirmed in the fingerprints of decoction pieces and standard decoction of Prunellae Spica. Compared the two reference fingerprints, there were six common peaks. Conclusion The main chemical constituents of decoction pieces and standard decoction of Prunellae Spica are basically identical. The established quality evaluation method can be used for quality control of standard decoction and related preparations.