School of Pharmacy, Shenyang Pharmaceutical University, Benxi, P. R. China.
J Sep Sci. 2018 Mar;41(6):1182-1191. doi: 10.1002/jssc.201700620. Epub 2017 Sep 21.
Liuwei Dihuang Pill, a classical traditional Chinese medicine, has been widely used to treat kidney yin deficiency in China for hundreds of years. Little attention, however, has been paid to quality control methods for this formulation. In the present study, we aimed to establish a comprehensive and practical quality evaluation system for Liuwei Dihuang Pill. Thus, ultraviolet spectroscopic fingerprints and multi-wavelength fusion fingerprints have been proposed for quality consistency evaluation of the popular patent. The similarity analysis of Liuwei Dihuang Pill samples was evaluated by systematic quantitative fingerprint method from qualitative and quantitative perspectives. The results showed that 26 batches of samples were classified into five grades for fusion fingerprints and three grades for ultraviolet spectroscopic fingerprints. Moreover, the fingerprint-efficacy correlation was also established and confirmed through the partial least squares model to visualize the antioxidant activity of Liuwei Dihuang Pill in vitro. In conclusion, these results indicated that integrating ultraviolet spectroscopic fingerprints and multi-wavelength fusion fingerprints coupled with antioxidant activities provide a rapid and effective approach to monitor the quality consistency of Liuwei Dihuang Pill.
六味地黄丸是一种经典的中药方剂，在中国已有数百年的历史，被广泛用于治疗肾阴虚。然而，人们对该制剂的质量控制方法关注甚少。本研究旨在建立一个全面实用的六味地黄丸质量评价体系。因此，提出了紫外光谱指纹图谱和多波长融合指纹图谱，用于评价该专利品种的质量一致性。采用系统定量指纹法从定性和定量两个方面对六味地黄丸样品的相似性进行了评价。结果表明，26 批样品在融合指纹图谱上分为 5 个等级，在紫外光谱指纹图谱上分为 3 个等级。此外，还通过偏最小二乘模型建立了指纹-功效相关性，以直观地显示六味地黄丸的体外抗氧化活性。总之，这些结果表明，结合紫外光谱指纹图谱和多波长融合指纹图谱以及抗氧化活性，可以快速有效地监测六味地黄丸的质量一致性。
