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目的:研究制定苦桉祛疹凝胶的质量标准。方法:采用TLC法鉴别处方药材黄柏、蛇床子、苦参、广藿香、大叶桉;并采用HPLC法测定制剂中蛇床子素、苦参碱及氧化苦参碱、小檗碱的含量。结果:采用TLC法可鉴别出与黄柏、蛇床子、苦参、广藿香、大叶桉对应的斑点。采用HPLC法测定含量,蛇床子素在0.00456~0.02736 mg/m L范围内有良好的线性范围(r=0.9993),平均回收率为97.59%,RSD为2.903%(n=6);苦参碱在0.1192~0.3576 mg/m L范围内有良好的线性范围(r=0.9993),平均回收率为103.39%,RSD为2.377%(n=6);氧化苦参碱在0.0744~0.2232 mg/m L范围内有良好的线性范围(r=0.9991),平均回收率为99.17%,RSD为2.449%(n=6);小檗碱在0.0685~1.096μg范围内有良好的线性范围(r=1),平均回收率为95.34%,RSD为0.03%(n=6)。结论:所建立的质量标准简便可行、重现性好,可用来评价苦桉祛疹凝胶的质量。
Objective: To develop the quality standard of Eucalyptus eruption rash gel. Methods: The prescriptions of Phellodendron, Cnidium, Sophora, Patchouli and Eucalyptus grandis were identified by TLC method. The contents of Osthole, Matrine and Oxymatrine and Berberine were determined by HPLC. Results: By TLC method can be identified with cork, Cnidium, Sophora, patchouli, Eucalyptus grandis corresponding spots. The content of Osthol in the range of 0.00456 ~ 0.02736 mg / m L was good (r = 0.9993) with the average recovery of 97.59% and the RSD of 2.903% (n = 6) (R = 0.9993), the average recovery was 103.39% and the RSD was 2.377% (n = 6) in the range of 0.1192 ~ 0.3576 mg / m L. Oxymatrine was in the range of 0.0744 ~ 0.2232 mg / m L (R = 0.9991), with an average recovery of 99.17% and a RSD of 2.449% (n = 6). There was a good linear range of berberine in the range of 0.0685 ~ 1.096μg (r = 1) , The average recovery was 95.34%, RSD was 0.03% (n = 6). Conclusion: The established quality standards are simple and feasible, reproducible, and can be used to evaluate the quality of Eucalyptus Rubella gel.