论文部分内容阅读
目的:建立六君保玄颗粒中盐酸小檗碱、丹酚酸B含量测定方法,为新药质量标准的建立提供科学依据。方法:均采用高效液相色谱法测定。色谱柱:Diamonsil C18色谱柱(250 mm×4.6 mm,5μm);柱温:25℃;流速:1.0 m L/min;盐酸小檗碱流动相:乙腈-磷酸三乙胺水溶液(30∶70);盐酸小檗碱检测波长:429 nm;丹酚酸B流动相:甲醇-乙腈-甲酸-水(30∶10∶1∶59);丹酚酸B检测波长:286 nm。结果:盐酸小檗碱和丹酚酸B的进样量分别在0.0262~0.524、0.597~11.94μg范围内与峰面积呈良好线性关系,平均加样回收率分别为98.89%、99.38%,RSD分别为1.54%、1.26%。结论:上述含量测定方法具有简便、快捷、重复性好、适用性强等优点,可为六君保玄颗粒质量标准的建立提供参考。
OBJECTIVE: To establish a method for the determination of berberine hydrochloride and salvianolic acid B in Liujun Bao Xuan Granules, which can provide a scientific basis for the establishment of new drug quality standards. Methods: All were determined by high performance liquid chromatography. Column: Diamonsil C18 column (250 mm × 4.6 mm, 5 μm); column temperature: 25 ° C .; flow rate: 1.0 mL / min; berberine hydrochloride mobile phase: ; Berberine hydrochloride detection wavelength: 429 nm; salvianolic acid B mobile phase: methanol - acetonitrile - formic acid - water (30:10:1:59); salvianolic acid B detection wavelength: 286 nm. Results: The injection volume of berberine hydrochloride and salvianolic acid B showed a good linear relationship with the peak area in the range of 0.0262 ~ 0.524,0.597 ~ 11.94μg, the average recovery rates were respectively 98.89%, 99.38%, RSD For 1.54%, 1.26%. Conclusion: The method of determination of content is simple, fast, good repeatability, applicability and other advantages, can provide a reference for the establishment of Liu Jun Bao Xuan granule quality standards.