防风色原酮类对照提取物含量标定及其在防风药材质量控制中的应用

Calibration on chromone reference extract and application on quality control of Saposhnikoviae Radix

对防风色原酮类对照提取物进行含量标定,建立以防风色原酮类对照提取物为对照的防风药材质量控制方法,完善防风药材质量控制体系,进一步探讨对照提取物法在中药质量控制中的可行性。该研究以升麻素苷、升麻素、5-O-甲基维斯阿米醇苷和亥茅酚苷为指标对所制备防风色原酮类对照提取物的含量进行标定,利用已知含量的防风色原酮类对照提取物为对照,建立防风药材HPLC含量测定方法,测定20批防风药材中4种成分的含量,并与以对照品为对照的含量测定结果进行比较,t检验结果显示,2种含量测定方法测定的升麻素苷、升麻素、5-O-甲基维斯阿米醇苷及亥茅酚苷含量P分别为0.16、0.39、0.14、0.42,均无显著性差异。该研究验证了防风色原酮类对照提取物代替单体对照品用于防风药材的质量控制的可行性,为中药对照提取物在中药质量控制中的应用奠定了基础,为中药质量控制体系的完善提供新的研究思路和模式。

The calibration of chromone reference extract(CRE) was conducted and a quality control method of Saposhnikoviae Radix(SR) was established based on CRE. Meanwhile, the quality control system of SR was improved and the feasibility of using reference extract as a substitute for single reference substance in quality control of Chinese medicine was discussed. In this study, the content of the prepared CRE was calibrated with prim-O-glucosylcimifugin, cimifugin, 4′-O-β-D-glucosyl-5-O-methylvisamminol, and secO-glucosylhamaudol as indicators. Subsequently, an HPLC analytical method was developed to determine the content of four chromones in 20 batches of SR samples based on the CRE with known content as the standard substance. T-test was used for the comparison of the determination results of the two methods(single chemical component and CRE as reference substances, respectively), and the P values of prim-O-glucosylcimifugin, cimifugin, 4′-O-β-D-glucosyl-5-O-methylvisamminol, and sec-O-glucosylhamaudol were 0. 16,0. 39, 0. 14, and 0. 42. The results demonstrated that there was no significant difference between the two methods. This study initially verified the feasibility that the CRE could be used as a substitute for single reference substance in quality control of SR. In conclusion,this study is expected to provide a scientific basis and a new research model for the application of reference extract in the quality control of Chinese medicine.