防己饮片标准汤剂质量标准研究

Quality Evaluation of Standard Decoction of Fangji(Stephaniae tetrandrae)

目的建立防己饮片标准汤剂质量评价方法,对防己标准汤剂进行质量标准研究。方法采用HPLC测定12批防己饮片及标准汤剂中防己诺林碱和粉防己碱的含量,计算转移率、出膏率;采用高效液相色谱法建立标准汤剂指纹图谱,并进行相关性分析。结果 12批防己标准汤剂中防己诺林碱和粉防己碱分别为0.14%~0.36%和0.33%~0.60%,饮片中防己诺林碱和粉防己碱分别为0.37%~0.77%和0.95%~1.56%。防己诺林碱转移率为22.31~88.12%,平均(45.47±19.1)%;粉防己碱转移率为21.08%~54.98%,平均(42.57±10.3)%;出膏率为12.2%~16.7%,平均(14.26±0.85)%。防己标准汤剂指纹图谱分别有6个共有峰,其中指认了两个色谱峰。结论 12批防己标准汤剂的化学成分基本一致,建立的质量评价方法可为防己标准汤剂及防己相关产品的质量控制提供参考。

Objective This study aims to establish the quality control method for standard decoction of Fangji(Stephaniae tetrandrae).Methods The contents of fangchinoline and tetrandrine in 12 batches of Fangji(Stephaniae tetrandrae) decoction pieces and standard decoction were determined by high performance liquid chromatography(HPLC), and the transfer rate and the solid content were calculated. The fingerprint of standard decoction was established by HPLC, and the correlation was analyzed. Results Fangchinoline and tetrandrine in 12 batches of standard decoction of Fangji(Stephaniae tetrandrae) were 0.14%~0.36% and 0.33%~0.60%, respectively. The contents of fangchinoline and tetrandrine in decoction pieces were 0.37%~0.77% and 0.95%~1.56%, respectively. The transfer rates of tetrandrine were 22.31%~88.12%, with an average of(45.47±19.1)%. The transfer rates of tetrandrine were 21.08%~54.98%, with an average of(42.57±10.3)%. The extract rates were 12.2%~16.7%, with an average of(7.13±0.85)%. Six common peaks in the fingerprint of Fangji(Stephaniae tetrandrae) decoction were recorded, and two peaks were identified.Conclusion The chemical constituents of 12 batches of Fangji(Stephaniae tetrandrae) standard decoction were identified with high similarity.The established quality evaluation method can be used for the quality control of standard decoction and related preparations.