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目的:建立蜜炼强力枇杷膏的薄层鉴别和主药罂粟壳中吗啡含量测定方法。方法:采用薄层色谱法对该制剂中枇杷叶、罂粟壳和薄荷脑进行定性鉴别;利用高效液相色谱法,以0.05 mol/L磷酸二氢钾溶液-0.025 mol/L庚烷磺酸钠溶液-乙腈(42∶42∶16)为流动相,检测波长为220 nm,对该制剂中罂粟壳中吗啡进行测定。结果:薄层定性鉴别斑点清晰,阴性对照无干扰;含量测定吗啡在0.02～0.16μg范围内与峰面积呈良好线性关系,平均回收率为100.2%,RSD为1.76%(n=6)。结论:该薄层鉴别和含量测定方法专属性强、重现性好、可靠性强,可作为该制剂的质量控制方法。
OBJECTIVE: To establish a thin layer identification of Mi Lian strong loquat cream and determination of morphine content in the main drug poppy shell. Methods: The loquat leaves, poppy and menthol were qualitatively identified by thin-layer chromatography. High performance liquid chromatography (HPLC) was used with 0.05 mol / L potassium dihydrogen phosphate solution-0.025 mol / L sodium heptanesulfonate Solution-acetonitrile (42:42:16) as the mobile phase at a detection wavelength of 220 nm, the morphine in the opium poppy shell was determined. Results: The TLC was qualitatively identified and the spots were clear. The content of morphine showed a good linear relationship with the peak area in the range of 0.02-0.16 μg with an average recovery of 100.2% and a RSD of 1.76% (n = 6). Conclusion: The method of TLC identification and content determination is of high specificity, good reproducibility and high reliability, and can be used as quality control method of the preparation.