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Archive > Volume 17 Issue 3 > 2025,17(3):575-583. DOI:https://doi.org/10.1016/j.chmed.2024.11.001 Prev Next

中藥顆粒質(zhì)量一致性評(píng)價(jià)策略研究：以流化床制備的無(wú)糖型養(yǎng)胃顆粒為例

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Research on comprehensive quality consistency evaluation strategy for TCM Granules: A case study with sugar-free Yangwei Granules produced by fluid-bed granulation

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    摘要:
    目的：以無(wú)糖養(yǎng)胃顆粒作為模型藥物，開(kāi)發(fā)一種用于傳統(tǒng)中藥顆粒的質(zhì)量一致性評(píng)估策略，并展示所開(kāi)發(fā)方法的有效性。方法：該策略整合了多種方法，包括高效液相色譜指紋圖譜法和物理指紋圖譜法，用于分析中藥顆粒樣本在化學(xué)和物理性質(zhì)上的相似性。近紅外（NIR）光譜結(jié)合主成分聚類(lèi)分析方法用于準(zhǔn)確監(jiān)測(cè)正常操作條件（NOC）樣本，并識(shí)別不同類(lèi)型的異常操作條件（AOC）樣本，特別是那些偏離正常范圍的樣本。結(jié)果：高效液相色譜指紋圖譜法和物理指紋圖譜法的結(jié)合為樣本的化學(xué)和物理性質(zhì)提供了見(jiàn)解。NIR 光譜結(jié)合主成分聚類(lèi)分析法在監(jiān)測(cè) NOC 樣本和識(shí)別 AOC 樣本方面具有高準(zhǔn)確性，且不會(huì)出現(xiàn)誤判。該方法在 HPLC 指紋圖譜法和物理指紋圖譜法單獨(dú)缺乏足夠分辨率的情況下，證明是一種有用的補(bǔ)充方法。結(jié)論：本研究證實(shí)了綜合評(píng)估中藥顆粒劑質(zhì)量一致性方法的可行性和有效性。該策略具有高度的通用性，并對(duì)提升中藥顆粒劑的質(zhì)量控制流程具有重要意義。

    Abstract:
    Objective: To develop a quality consistency evaluation strategy for traditional Chinese medicine (TCM) granules using sugar free Yangwei Granules as a model drug, and demonstrate the effectiveness of the developed method. Methods: The strategy integrates several methods including, HPLC fingerprint and physical fingerprint methods analyze the similarity in chemical and physical properties of the TCM granule samples. Nearinfrared (NIR) spectroscopy with principal components cluster analysis method is used to monitor normal operating conditions (NOC) samples accurately and to identify different types of abnormal operating conditions (AOC) samples, particularly those that deviate from the normal range. Results: The combined use of HPLC fingerprint and physical fingerprint provides insights into the chemical and physical properties of the samples. NIR spectroscopy, combined with principal components cluster analysis, achieves high accuracy in monitoring NOC samples and identifying AOC samples without misjudgment. The approach proves useful as a complementary method in cases where HPLC fingerprint and physical fingerprint alone lack sufficient resolution. Conclusion: This study establishes the feasibility and utility of the integrated approach for assessing the quality consistency of TCM granules. The strategy shows a high degree of generalization and holds significant importance for enhancing the quality control processes of TCM granules.

    關(guān)鍵詞:
    化學(xué)計(jì)量學(xué);多變量分析;近紅外光譜;質(zhì)量一致性評(píng)價(jià)策略;無(wú)糖型養(yǎng)胃顆粒;中藥顆粒

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    Project Supported:
    This work was supported by the National Key Research and Development Program of China (No. 2023YFC3504501), the China Postdoctoral Science Foundation (No. 2024M752839), the National Natural Science Foundation of China (No. 82404868), and Postdoctoral Fellowship Program of CPSF (No. GZC20232358).

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