Ma Hui-Wen, Zou Qi, Li Chun, Yin Zhen, Yi Hong, Tian Lian-Chao, Ren Cheng-Tao, Liu Xiao-Qian, Wang Zhi-Min
National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China.
School of Traditional Chinese Medicine, Guangdong Pharmaceutical University, Guangzhou 510006, China.
Zhongguo Zhong Yao Za Zhi. 2018 Jul;43(14):2878-2883. doi: 10.19540/j.cnki.cjcmm.2018.0090.
To establish the HPLC fingerprint and determine five index components (loganic acid， chlorogenic acid， loganin， sweroside and asperosaponin Ⅵ) of Zishen Yutai pills by high performance liquid chromatography, and provide a scientific basis for its quality control. The fingerprint chromatogram was analysed by the chromatographic fingerprint similarity evaluation system for tradition Chinese medicine (2012), fifteen common peaks were obtained at the wavelength of 254 nm. Different batches of Zishen Yutai pills showed a similarity of above 0.90 in HPLC fingerprint profiles. For the quantitive analysis method, The separation of five components showed good regression (>0.999 2) with linear ranges, and the mean recoveries were in the range of 97.62%-101.9%, with the RSD (=9) less than 3%. The established fingerprint and quantitative analysis methods are highly specific, simple and accurate, which can reflect the quality of Zishen Yutai pills more comprehensively, and can be used for its quality control.
采用高效液相色谱法建立滋肾育胎丸的HPLC指纹图谱并测定其中5种指标成分（马钱子酸、绿原酸、马钱子苷、獐牙菜苷和asperosaponinⅥ），为其质量控制提供科学依据。采用《中药色谱指纹图谱相似度评价系统（2012版）》对指纹图谱进行分析，在254nm波长下得到15个共有峰。不同批次的滋肾育胎丸HPLC指纹图谱相似度均在0.90以上。对于定量分析方法，5种成分的分离呈现良好的线性关系（>0.999 2），平均回收率在97.62% - 101.9%之间，RSD（n = 9）小于3%。所建立的指纹图谱和定量分析方法特异性强、简便准确，能更全面地反映滋肾育胎丸的质量，可用于其质量控制。
