Yan Hui, Sun Guoxiang, Chi Hanxiao, Zhang Jing, Sun Wanyang, Hou Zhifei, Li Xianlin, Pu Daojun, Chen Zhenhong
College of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China.
Institute of Traditional Chinese Medicine & Natural Products, Jinan University, Guangzhou 510632, China.
Se Pu. 2019 Nov 8;37(11):1200-1208. doi: 10.3724/SP.J.1123.2019.06010.
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.
成功建立了复方甘草片（FFGCTs）的标准制剂（SP）控制模式、定量高效液相色谱（HPLC）指纹图谱以及5种标志物的定量方法，并将其应用于精确、准确地评估来自9个厂家的145批FFGCTs的质量一致性。采用反相HPLC在220 nm波长下测定指纹图谱，建立了作为标准制剂保留的FFGCTs的对照指纹图谱（RFP）。随后，将SP-RFP作为评价标准，从定性和定量两个角度，应用系统定量指纹图谱方法对145批FFGCTs进行综合质量判别。此外，采用双标志物校正法校正定量指纹图谱的色谱系统误差。结果表明，9个厂家的FFGCTs质量均完全合格。此外，采用与FFGCTs相同的色谱条件测定了所有原料药指纹图谱和模拟样品，有助于识别制剂中指纹图谱峰的来源，建立原料药指纹图谱与制剂指纹图谱之间的相关性。这最终有助于智能预测制剂或原料药的质量，有效防止劣质原料的投入。另外，采用紫外全指纹图谱溶出度法区分了5个厂家FFGCTs的溶出情况，对制剂工艺的合理性进行了评价。该方法可行、准确，可用于评价FFGCTs的质量和工艺技术一致性。本文为中药质量一致性评价提供了一种基本的标准制剂评价模式和基本操作程序。
