牛黄益金片中黄柏质量控制方法的研究
Method for quality control of Cortex Phellocienciri in Niuhuang Yijin tablets
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摘要: 目的: 建立牛黄益金片的控制方法,确保药品的质量。 方法: 用HPLC法测定制剂中盐酸小檗碱的含量。KromasilTMC18(200 mm×4.6 mm,5μm)柱;乙腈-江0.05mol/L磷酸二氢钾溶液(用磷酸调pH为3.00.05)-0.025 mol/L十二烷基磺酸钠溶液(90:55:55)为流动相;检测波长348 nm。 结果: 盐酸小檗碱0.09432-0.6602μg范围内,进样量与色谱峰面积之间呈良好线性关系,r=0.9993。平均加样回收率为100.29%,RSD为0.58%(n=6)。 结论: 本法专属性强,准确度高,重现性好,可作为该产品质量控制的方法。Abstract: Objective: To develop a method to determine the content of berberine hydrochlide in Niuhuang Yijin tablets to guarantee the quality of it. Methods: The determination was performed on Kromasil C18 column(4.6×250 mm,5 μm) with the mobile phase of CH3CN(0.05 mol/L)-KH2PO4(pH 3.0±0.05,0.025 mol/L)-sodium dodecylsulfonate.The detection wavelength was 348nm. Results: The correlation coefficients was 0.999 3 when the linear range was from 0.094 32 to 0.660 2 μg.The average recovery was 100.29% and RSD was 0.58%. Conclusion: The method was pertinence and accuracy which can be used for quality control of Niuhuang Yijin tablets.
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Key words:
- Niuhuang Yijin tablets /
- berherine /
- HPLC
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