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目的:测定龙芍续骨胶囊中芍药苷的含量,并考察中性氧化铝层析纯化对芍药苷含量测定的影响。方法:采用高效液相色谱法测定芍药苷含量,以中性氧化铝纯化富集芍药苷。液相条件:Kromasil-C18(250mm×4.6 mm,5μm)色谱柱;以甲醇-水(28∶72)为流动相,流速为1.0 m L·min-1,检测波长为230 nm,柱温30℃。结果:芍药苷在0.048~1.68μg范围内与峰面积呈良好线性关系(r=0.9996),精密度和稳定性试验的RSD分别为0.31%和0.86%,平均回收率为99.19%,RSD为0.97%(n=6)。结论:本方法简单,稳定易行,灵敏度高,可控性强,重复性好,可用于龙芍续骨胶囊中芍药苷的含量测定。建议在本品质量标准中规定每1 g内容物含白芍以芍药苷(C23H28O11)计,不得少于0.38 mg。
OBJECTIVE: To determine the content of paeoniflorin in Long Shao Continuum Capsule and investigate the influence of neutral alumina chromatography on the determination of paeoniflorin. Methods: The content of paeoniflorin was determined by high performance liquid chromatography. Paeoniflorin was purified by neutral alumina. The mobile phase was Kromasil-C18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol and water (28:72) with a flow rate of 1.0 mL · min -1. The detection wavelength was 230 nm and the column temperature was 30 ℃. Results: Paeoniflorin had a good linear relationship with the peak area in the range of 0.048-1.68 μg (r = 0.9996). The RSDs of precision and stability were 0.31% and 0.86% respectively. The average recovery was 99.19% with a RSD of 0.97 % (n = 6). Conclusion: The method is simple, stable and easy to operate, high sensitivity, strong controllability, good repeatability, and can be used for the determination of paeoniflorin in Long Shao Continuum Capsule. It is recommended in this product quality standards for each 1 g content containing peony root with paeoniflorin (C23H28O11) dollars, not less than 0.38 mg.