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金陵药业股份有限公司

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№ CN122922273AInvention
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胃得安胶囊指纹图谱的建立方法及其指纹图谱和应用

本发明公开了一种胃得安胶囊剂指纹图谱的建立方法及其指纹图谱和应用。该方法采用高效液相色谱法，包括：以胃得安胶囊制备供试品溶液；以柚皮苷，橙皮苷，黄芩苷，盐酸小檗碱，枸橘苷，黄芩素，汉黄芩素，汉黄芩苷，异樱花素的混合溶液为对照品溶液；采用HPLC分别测定并得到液相色谱；将色谱图导入中药色谱指纹图谱相似度评价系统分析，得到胃得安胶囊的指纹图谱。色谱条件为：使用ZORBAX SB‑C色谱柱；以乙腈为流动相A，以0.1%磷酸溶液为流动相B。本发明建立了胃得安胶囊HPLC指纹图谱，实现了由单一成分定量到整体化学轮廓表征的升级，可较全面反映胃得安胶囊的质量信息，保证产品质量均一稳定，应用于胃得安胶囊全过程质量评价体系或工艺关键点控制，确保临床用药安全有效。

❖金陵药业股份有限公司; 金陵药业股份有限公司福州梅峰制药厂李剑; 徐红; 夏云; 季莉莉; 王煜; 徐子旭; 刘群; 张娇娇Oct 16, 2026§ 3/10 ClaimsG01N 30/02 (2006.01), G01N 30/06 (2006.01), G01N 30/30 (2006.01) +6