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目的:建立双柏巴布剂中大黄、关黄柏的薄层鉴别方法,并考察其对皮肤的刺激性反应。方法:用薄层色谱鉴别法对双柏巴布剂处方中的大黄、关黄柏进行鉴别,并进行大鼠皮肤刺激试验及人体皮肤适应性考察。结果:各供试品色谱中,在与对照品及对照药材色谱相应的位置上显相同颜色斑点,色谱清晰,附近无杂质斑点干扰。双柏巴布剂用于大鼠和人体皮肤24 h后,给药部位未见红斑、水肿、搔痒,也未见其他异常反应。结论:薄层色谱鉴别方法专属性、重复性好,可作为双柏巴布剂的质量控制指标。该制剂对大鼠和人体皮肤无刺激性,可安全使用。
OBJECTIVE: To establish a method for the identification of rhubarb and cortex phellodendri in Shuangbo Patch, and investigate its irritant response to the skin. Methods: The identification of Rhubarb and Cortex Phellodendri in the prescription of double berberine cloth by thin layer chromatography was carried out, and the skin irritation test in rats and the adaptability of human skin were investigated. Results: The test samples for the chromatography, and the reference substance and the reference drug chromatography was the same position on the same color spots, clear, near no impurity spot interference. After double berberine was applied to rat and human skin for 24 h, there were no erythema, edema and itching at the site of administration, and no other abnormal reaction was observed. Conclusion: TLC identification method specificity, repeatability, and can be used as the quality control index of double berberine cloth. The preparation is non-irritating to rats and human skin and can be safely used.