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目的:建立决闭胶囊的质量标准。方法:采用TLC法对决闭胶囊中赤芍、香附、肉桂进行定性鉴别;采用HPLC法对决闭胶囊中芍药苷、桂皮醛进行含量测定,色谱柱为Wondasil C_(18)(250 mm×4.6 mm,5μm),流动相为甲醇-0.2%磷酸水溶液梯度洗脱,流速为1.0 ml·min~(-1),检测波长为230 nm、290 nm,柱温为40℃,进样量10μl。结果:TLC斑点清晰,分离度好,阴性对照无干扰;芍药苷、桂皮醛分别在进样量0.368~3.680μg(r=0.999 9)、0.191~1.914μg(r=0.999 9)范围内与峰面积呈良好线性关系,平均加样回收率分别为101.90%、99.66%,RSD分别为1.90%、2.77%(n=6)。结论:该方法快速、准确、专属性强,可作为决闭胶囊质量控制的方法。
Objective: To establish the quality standard of Jinduan capsule. Methods: The contents of paeoniflorin and cinnamaldehyde in Jieduan capsule were determined by TLC. The chromatographic column was Wondasil C 18 (250 mm × 4.6 mm) , 5μm). The mobile phase consisted of a gradient of methanol-0.2% phosphoric acid. The flow rate was 1.0 ml · min -1. The detection wavelength was 230 nm and 290 nm. The column temperature was 40 ℃. Results: The spots of TLC were clear and the resolution was good. There was no interference with the negative control. Paeoniflorin and cinnamaldehyde were detected in the range of 0.368 ~ 3.680μg (r = 0.999 9), 0.191 ~ 1.914μg (r = 0.999 9) The average recoveries were 101.90% and 99.66%, respectively, with RSDs of 1.90% and 2.77%, respectively (n = 6). Conclusion: The method is rapid, accurate and specific and can be used as a quality control method for Jinduan capsule.