Chinese Journal of Chromatography

Chinese Journal of Chromatography ›› 2019, Vol. 37 ›› Issue (11): 1200-1208.DOI: 10.3724/SP.J.1123.2019.06010

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Quality consistency evaluation of Fufanggancao tablets based on the control mode of standard preparation and quantitative fingerprint

YAN Hui1, SUN Guoxiang1, CHI Hanxiao1, ZHANG Jing1, SUN Wanyang2, HOU Zhifei3, LI Xianlin4, PU Daojun5, CHEN Zhenhong6   

  1. 1. College of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China;
    2. Institute of Traditional Chinese Medicine & Natural Products, Jinan University, Guangzhou 510632, China;
    3. Hebei Chemical and Pharmaceutical College, Shijiazhuang 050026, China;
    4. China National Pharmaceutical Industry Co., Ltd., Beijing 101300, China;
    5. Southwest Pharmaceutical Co., Ltd., Chongqing 400038, China;
    6. Xinjiang Fuwo Pharmaceutical Co., Ltd., Shaya 842200, China
  • Received:2019-06-15 Online:2019-11-08 Published:2020-12-11
  • Supported by:
    National Natural Science Foundation of China (No. 81573586).

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Abstract: The control mode of standard preparation (SP) and quantitative high performance liquid chromatography (HPLC) fingerprint of Fufanggancao tablets (FFGCTs) combined with the quantification of five markers were successfully developed and applied to the precise and accurate assessment of the quality consistency of 145 FFGCTs from nine manufacturers. The profiling was determined by reversed-phase HPLC at 220 nm wavelength, where the reference fingerprint (RFP) of the FFGCTs reserved as standard preparation was established. Subsequently, the SP-RFP was considered as the evaluation standard, and a systematic quantitative fingerprint method was applied to the integrative quality discrimination of 145 batches of FFGCTs, from both qualitative and quantitative perspectives. Besides, the chromatographic systematic error of quantitative fingerprints was corrected by the double marker calibration method. The results showed that the qualities of the FFGCTs from the nine manufacturers were completely qualified. Moreover, all raw herb fingerprints and the simulated sample were determined by using the combined chromatographic conditions applied to the FFGCTs, which helped identify the source of the profiling peaks in the preparation and establish the correlation between the raw herb fingerprints and the preparation fingerprints. This eventually aided the intelligent prediction of the quality of the preparation or raw herbs and effective prevention of the inputs of inferior raw materials. In addition, we employed the ultraviolet full fingerprint dissolution method to differentiate the FFGCTs from five manufacturer dissolution, in which the rationality of the preparation process was evaluated. The method is feasible and accurate, and it can be applied to evaluate the quality and process technology consistency of FFGCTs. This paper provides a fundamental standard preparation evaluation mode and the basic operation procedure for the quality consistency assessment of traditional Chinese medicine.

Key words: standard preparation (SP) of Fufanggancao tablets, double marker calibration method, quantitative fingerprint, systematic quantitative fingerprint method, unified chromatographic condition, quantitative fingerprint predicting quality intelligently

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