CAJ | 학술논문

目的：建立复方枣仁安神胶囊中黄连质量标准。方法：采用薄层色谱鉴别法对黄连进行定性鉴别，采用UPLC法测定黄连中盐酸小檗碱的含量。色谱条件：色谱柱：Waters Acquity UPLC BEH C18（2.1 mm×100 mm，1.7μm）；流动相：乙腈-0.05 moL·L-1磷酸二氢钾溶液（30∶70）（0.5%三乙胺，磷酸调pH值至3.0~4.0）；检测波长为345 nm；流速：0.25 mL·min-1；柱温：25℃。结果：在试验条件下，薄层斑点清楚，阴性无干扰，分离效果较好，重复性良好。UPLC 方法学考察表明，制剂中盐酸小檗碱在0.25~1.50μg范围内与峰面积呈良好的线性关系（r=0.9999），平均回收率为97.56%，RSD=1.54%（n=6）。结论：该方法准确、快速，重复性好，可用于复方枣仁安神胶囊中黄连的质量控制。
목적：건립복방조인안신효낭중황련질량표준。방법：채용박층색보감별법대황련진행정성감별，채용UPLC법측정황련중염산소벽감적함량。색보조건：색보주：Waters Acquity UPLC BEH C18（2.1 mm×100 mm，1.7μm）；류동상：을정-0.05 moL·L-1린산이경갑용액（30∶70）（0.5%삼을알，린산조pH치지3.0~4.0）；검측파장위345 nm；류속：0.25 mL·min-1；주온：25℃。결과：재시험조건하，박층반점청초，음성무간우，분리효과교호，중복성량호。UPLC 방법학고찰표명，제제중염산소벽감재0.25~1.50μg범위내여봉면적정량호적선성관계（r=0.9999），평균회수솔위97.56%，RSD=1.54%（n=6）。결론：해방법준학、쾌속，중복성호，가용우복방조인안신효낭중황련적질량공제。
Objective:To establish quality standards of Coptis chinensis in Compound Zaorenanshen Capsules. Methods: The TLC method for qualitative identification of Coptis chinensis and the UPLC method for the determination of berberine hydrochloride were employed. Chromatographic conditions were as follows. The Waters Acquity UPLC BEH C18 (2.1 mm×100 mm, 1.7 μm) column was adopted with the mobile phase of acetonitrile-0.05moL·L-1 potassium dihydrogen phosphate solution (30∶70) (0.5%triethylamine phosphate, pH value adjusted to 3.0-4.0) at the detection wavelength of 345 nm, the lfow rate of 0.25 mL·min-1 and the column temperature of 25 ℃. Results: Under the experimental conditions, good separation and reproducibility were obtained as the thin layer spot was clear, negative with no interference. The UPLC methodological study showed that berberine hydrochloride had a good linear relationship (r=0.9999) in a range of 0.25-1.5 μg, and the average recovery was 97.56%with a RSD value of 1.54%(n=6). Conclusion:This accurate, rapid, reproducible method can be used for quality control of Coptis chinensis in Compound Zaorenanshen Capsules.