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作 者:温俊霞[1,2] 任艳平[2] 朱红[2] 张兰桐[2]
机构地区:[1]河北省胸科医院药学部,石家庄050041 [2]河北医科大学药学院药物分析教研室,石家庄050017
出 处:《药物分析杂志》2012年第11期2043-2045,2059,共4页Chinese Journal of Pharmaceutical Analysis
摘 要:目的:建立抗痨胶囊HPLC特征图谱,为抗痨胶囊的质量控制提供依据。方法:采用DiamonsilTMC18(250 mm×4.6 mm,5μm)色谱柱,柱温为30℃,检测波长为275 nm。流动相为甲醇-乙腈-0.5%磷酸水溶液,梯度洗脱,流速1.0 mL.min-1,进样体积20μL。结果:HPLC特征图谱中主要成分得到有效分离,得到17个共有峰,各批次抗痨胶囊特征图谱与对照图谱相似度均在0.9以上,可用于抗痨胶囊的定性鉴别。结论:建立了抗痨胶囊特征图谱,此方法简单、准确、重复性良好,为抗痨胶囊的质量控制提供了有效的方法。basis for Objective: To establish a method of HPLC specific chromatogram for Kanglao Kanglao capsules so as to provide capsules quality control. Methods: The DiamonsilTM C18 (250 mm × 4.6 mm, 5 μm) column was adopted, the column temperature was controlled at 30 ℃, and the detection wavelength was 275 nm. The mobile phase for HPLC specific chromatogram establishment was methanol - acetonitrile - 0.5 % phosphoric acid solution with gradient elution at a flow rate of 1.0 mL min-1 and the injection volume was 20 μL. Results: The major components in HPLC fingerprints have effective segregation, 17 common peaks were obtained in reference fingerprint. Good similarities with correlation coefficients higher than 0.9 standard fingerprint, which could be utilized for the identification of were found in fingerprints between samples and Kanglao capsules. Conclusion: The analytical method of HPLC specific chromatogram of Kanglao capsules was established. The method is accurate and simple, which can be used as a quality control method for Kanglao capsules
关 键 词:中药制剂 抗痨胶囊 岩白菜素 特征图谱 高效液相色谱法 标准提高 质量控制
分 类 号:R917[医药卫生—药物分析学]
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