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用高效液相色谱法,以盐酸小檗碱为对照品,测定了中药三类新药抗炎灵中君药黄连的有效成分盐酸小檗碱的含量。采用外标法,按选定的色谱条件,盐酸小檗碱浓度在0.964×10~(-2)mg/m1～5.784×10~(-2)mg/ml范围内,可得良好的线性关系,平均加样回收率为98.97％,变异系数RSD为1.71％,为制定新药抗炎灵胶囊的质量标准提供了检测手段。
By using high performance liquid chromatography and berberine hydrochloride as the reference substance, the content of berberine hydrochloride, an effective component of the Chinese medicine Coptis chinensis in the three classes of traditional Chinese medicine anti-inflammatory and anti-inflammatory agents, was determined. Using the external standard method, according to the selected chromatographic conditions, the concentration of berberine hydrochloride is in the range of 0.964×10 -2 mg/ml to 5.784×10 -2 mg/ml. A good linear relationship can be obtained. The average recovery rate was 98.97%, and the coefficient of variation RSD was 1.71%, which provided a test method for formulating the quality standard of the new drug anti-inflammatory capsule.