RP-HPLC法同时测定固肠止泻丸中盐酸小檗碱及盐酸巴马汀含量.doc

RP-HPLC法同时测定固肠止泻丸中盐酸小檗碱及盐酸巴马汀含量[摘要] 目的：建立固肠止泻丸中盐酸小檗碱和盐酸巴马汀的含量测定方法。方法：采用反相高效液相色谱法，色谱柱：Waters Symmetry C18柱（3.9 mm×150 mm，5 μm）；流动相：磷酸盐缓冲液[0.05 mol/L磷酸二氢钾-0.05 mol/L庚烷磺酸钠(1∶1)，含0.2%三乙胺，并用磷酸调节pH值至3.0]-乙腈(70∶30)；流速：1.0 ml/min；检测波长：265 nm。结果：盐酸小檗碱和盐酸巴马汀的线性范围分别为0.017 020~0.136 200 mg/ml(r＝0.999 9)和0.008 464~0.067 710 mg/ml(r＝0.999 8)，平均回收率(n＝9)分别为98.24%和98.31%。结论：本方法简便、灵敏、准确，可用于完善固肠止泻丸的质量控制。 [关键词] 盐酸小檗碱；盐酸巴马汀；固肠止泻丸；高效液相色谱法 [中图分类号] R917 [文献标识码]A [文章编号]1673-7210（2007）12（b）-118-02 Contents determination of berberine hydrochloride and palmatine hydrochloride simultaneously in Guchang Zhixie Pills by RP-HPLC ZHU Jing-yi，LI Yi-yun （Yangzhou Institute for Drug Control of Jiangsu Province, Yangzhou225009, China） [Abstract] Objective:To establish a method for the contents determination of berberine hydrochloride and palmatine hydrochloride simultaneously in Guchang Zhixie Pills. Methods: RP-HPLC method was established with analysis column of Waters Symmetry C18(3.9 mm×150 mm,5 μm) and the mobile phase was phosphate buffer solution [0.05 mol/L potassium dihydrogen phosphate-0.05 mol/L sodium heptanesulfonate(1∶1)，contained 0.2% triethylamine (to make up the pH 3.0 with the phosphoric acid)]-Acetonitrile (70∶30), and the flow rate was 1.0 ml/min, detective wavelength was set at 265 nm. Results:The linear range of berberine hydrochloride and plmatine hydrochloride were 0.017 020~0.136 200 mg/ml(r＝0.999 9) and 0.008 464~0.067 710 mg/ml (r＝0.999 8) respectively, and the average recoveries(n=9) were 98.24% and 98.31% respectively.Conclusion:This is a specific, sensitive, simple and reproducible RP-HPLC method for the quality control of Guchang Zhixie Pills. [Key words] Berberine hydrochloride; Palmataine hydrochloride; Guchang Zhixie Pills;RP-HPLC 固肠止泻丸为国家药品标准收载品种，由乌梅或乌梅肉、黄连、干姜等6味中药组成，具有调和肝脾、涩肠止痛的功效，临床上常用于治疗溃疡性结肠炎、急慢性肠炎、痢疾等引起的腹痛、腹泻、肠鸣等。固肠止泻丸药品标准为卫生部药品标准中药成方制剂第20册[1]，其中仅以薄层色谱法对盐酸小檗碱进行鉴别，不能对方中君药黄连进行质量评价，本文采用RP-HPLC法同时测定固肠止泻丸中盐酸小檗碱和盐酸巴马汀的含量，为进一步完善该制剂的质量控制标准提供依据。