生地黄标准汤剂质量评价及其指纹图谱的建立  

Quality Evaluation of Standard Decoction of Rehmanniae Radix and Establishment of Its Fingerprint

作　　者：杨巧虹[1] 陈萍[2] YANG Qiaohong;CHEN Ping(Chongqing Quality Testing&Inspection Center for Medical Devices,Chongqing 401147,China;Shaanxi Academy of Tradional Chinese Medicine,Xi’an 710003,China)

机构地区：[1]重庆医疗器械质量检验中心,重庆401147 [2]陕西省中医药研究院,西安710003

出　　处：《医药导报》2021年第10期1383-1390,共8页Herald of Medicine

基　　金：陕西省科技创新能力支撑项目(2018PT-29)。

摘　　要：目的开展生地黄标准汤剂的质量标准研究,为其配方颗粒的质量评价提供参考。方法根据中药饮片标准汤剂制备原则制备生地黄饮片标准汤剂,采用薄层色谱法对15批生地黄标准汤剂进行毛蕊花糖苷、梓醇薄层检识;采用高效液相色谱法对15批生地黄标准汤剂的苯乙醇苷类成分进行含量测定,色谱柱为Diamonsil Plus C 18柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液,流速为0.8 mL·min-1进行梯度洗脱,检测波长为334 nm,柱温为25℃,进样量为10μL;计算出膏率、苯乙醇苷类成分转移率;以毛蕊花糖苷峰为参照峰,采用中药色谱指纹图谱相似度评价系统(2012版)检测,并进行相似度比较。结果标准汤剂出膏率为(58.49±2.83)%;苯乙醇苷类成分含量为(0.051±0.009)%;建立15批生地黄饮片标准汤剂的高效液相指纹图谱,指纹图谱批次间相似度均大于0.96。结论该研究建立的生地黄标准汤剂质量标准可行,适用于生地黄饮片标准汤剂的质量评价。Objective To carry out the quality standard research of standard decoction of Rehmanniae Radix,and to provide a reference for the quality evaluation of its formula granules.Methods The standard decoction of Rehmanniae Radix was prepared according to the preparation principles of the standard decoction of traditional Chinese medicine.The verbascoside and catalpol in 15 batches of standard decoction of Rehmanniae Radix were identified by the thin-layer chromatography(TLC)method.The content of phenylethanol glycosides was detected by the high-performance liquid chromatography(HPLC)method.The chromatographic column was Diamonsil Plus C 18 column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%phosphoric acid solution,the flow rate was 0.8 mL·min-1 with gradient elution,the detection wavelength was 334 nm,the column temperature was 25℃,and the injection volume was 10μL.The extraction rate and the transfer rate of phenylethanol glycosides were calculated.The Similarity Evaluation System of Chromatographic Fingerprints of Traditional Chinese Medicine(Version 2012)was used to detect the peaks with the peak of acteoside as the reference peak and the similarity was compared.Results The extraction rate of the standard decoction was(58.49±2.83)%.The content of phenylethanol glycosides was(0.051±0.009)%.The HPLC fingerprints of 15 batches of standard decoction of Rehmanniae Radix were established,and the similarity of fingerprints among each batch was greater than 0.96.Conclusion The quality standard of standard decoction of Rehmanniae Radix established in this research is feasible,which is suitable for the quality evaluation of standard decoction of Rehmanniae Radix.

关 键 词：生地黄 标准汤剂 色谱法 高效液相 特征指纹图谱 质量评价 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学]