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Archive > Volume 16 Issue 3 > 2024,16(3):449-456. DOI:https://doi.org/10.1016/j.chmed.2023.03.005 Prev Next

基于HPLC和化學計量學對滑膜炎顆粒和膠囊進行質量控制

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HPLC combined with chemometrics for quality control of Huamoyan Granules or Capsules

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    摘要:
    目的：滑膜炎顆粒和膠囊是同組方不同劑型的中成藥，由于制備工藝的不同，同組方不同劑型的中成藥化學成分差異較大，但對其差異比較和質量控制的研究較少。為提高中成藥臨床應用的有效性和安全性，本文提出了基于高效液相色譜法（HPLC）與化學計量學相結合，對同組方不同劑型中成藥進行質量控制研究的思路。 方法：基于HPLC指紋圖譜和化學計量學對差異標志物進行探究，最后通過HPLC建立相關成分的定量分析方法。 結果：建立了滑膜炎顆粒和膠囊的質量控制方法。首先，通過HPLC指紋圖譜系統(tǒng)分析了滑膜炎顆粒和膠囊的化學成分。進一步探索發(fā)現(xiàn)，共有特征峰20個，共有峰57個。采用化學計量學方法探索滑膜炎顆粒和膠囊之間的潛在差異標志物，與20個特征峰相交后篩選差異標志物。最終建立了9種成分的HPLC定量分析方法，包括7種差異標志物。HPLC定量分析結果顯示，滑膜炎顆粒和膠囊樣品中8種成分的含量差異有統(tǒng)計學意義。因此，篩選和控制滑膜炎顆粒和膠囊之間的差異標志物是十分必要和重要的。 結論：本研究為滑膜炎顆粒和膠囊的常規(guī)質量評價和控制提供了一種快速有效的方法。同時為同組方不同劑型中成藥的質量評價和控制提供了可行的方法。

    Abstract:
    Objective: Huamaoyan Granules (HMYG) and Huamaoyan Capsules (HMYC) are Chinese patent medicines with different dosage forms of the same prescription. Due to the different preparation process, the chemical composition of these Chinese patent medicines varies greatly among different forms, but there were few studies on the difference comparison and quality control of them. In order to improve the effectiveness and safety in its clinical application, an idea combining high performance liquid chromatography (HPLC) and chemometrics was put forward to study the quality control of Chinese patent medicines in different dosage forms of the same prescription. Methods: The differential markers of HMYG and HMYC were explored based on HPLC fingerprint and chemometrics including orthogonal projections to latent structures-discriminant analysis (OPLS-DA), principal component analysis (PCA), and hierarchical cluster analysis (HCA). Finally, the quantitative analysis method of related components was established by HPLC. Results: A quality control method for HMYG and HMYC was established. Firstly, the chemical components of HMYG and HMYC were systematically analyzed by HPLC fingerprinting. Further exploration showed that there were 20 characteristic peaks and 57 common peaks. Then, the potential differential markers between HMYG and HMYC were explored by chemometrics, and the differential markers were screened after intersection with the 20 characteristic peaks. Finally, HPLC quantitative analysis methods for nine components were established, including seven differential markers (neochlorogenic acid, protocatechualdehyde, chlorogenic acid, cryptochlorogenic acid, caffeic acid, rosmarinic acid and salvianolic acid A). The results of HPLC quantitative analysis showed that the contents of eight components in HMYG and HMYC samples were significantly different. According to the above results, the differential markers between HMYG and HMYC screened based on HPLC fingerprint and chemometrics can effectively characterize the differences between the two dosage forms. Conclusion: The present work provides a rapid and effective method for routine quality evaluation and control of HMYG and HMYC. This work also provides feasible methods for the quality evaluation and control of Chinese patent medicines with different dosage forms of the same prescription.

    關鍵詞:
    化學計量學;中成藥;高效液相色譜指紋圖譜;滑膜炎顆粒和膠囊;質量控制;滑膜炎

    Keywords:


    Project Supported:
    This study was supported by Shineway Pharmaceutical Group Ltd. (No. 2020110031006073).

    Clc Number:

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