抗痨胶囊HPLC特征图谱的研究

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Diamonsil^TMC₁₈(250 mm×4.6 mm,5 μm)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20 μL。 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。

Objective: To establish a method of HPLC specific chromatogram for Kanglao capsules so as to provide basis for Kanglao capsules quality control. Methods: The Diamonsil^TM 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 were found in fingerprints between samples and standard fingerprint,which could be utilized for the identification of 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.

1 ZHOU Wen-xiao(周文枭),CUI De-bin(崔德斌). Quantitation of bergenin in Kanglao capsules by HPLC(高效液相色谱法测定抗痨胶囊中岩白菜素的含量).China Med Her(医药导报),2004,23(10):777
2 Drug specifications promulgated by the Ministry of Public Health, P R China(中华人民共和国卫生部药品标准).Chinese Traditional Patent Formulation(中药成方制剂).Vol 12(第十二册).1997.88
3 LI Gang(李刚). Research of effects on anti-pulmonary tuberculosis of anti tuberculosis capsule in vitro and in vivo(抗痨胶囊剂体内外抗肺结核作用研究).China Pract Med(中国实用医药),2010,5(20):5
4 HE Shu-yun(何树芸),GUO Yao-wu(郭耀武),YANG Hai-yan(杨海燕). Quantitation of bergenin in Kanglao capsules and Japanese Ardisia Herb by HPLC(HPLC法测定抗痨胶囊及矮地茶中岩白素的含量).Northwest Pharm J(西北药学杂志),2003,18(6):254
5 GU Rui-min(谷瑞敏),TU Hong-yi(涂洪谊),SUN He-gu(孙鹤谷).Discussion of traditional Chinese medicine chromatographic fingerprint similarity calculation method(中药色谱指纹图谱相似度计算方法的探讨).Chin Tradit Pat Med(中成药),2009,31(7):998