目的 建立牛黄降压胶囊中体外培育牛黄的替代使用的定性鉴别和定量测定方法。方法 采用薄层色谱法对方中体外培育牛黄定性鉴别，采用高效液相色谱法对胆红素进行含量测定。结果 在与胆酸对照品色谱相应的位置上，牛黄降压胶囊（替代方）和牛黄降压胶囊（原方）的供试品均显相同颜色的斑点；在与猪去氧胆酸对照品色谱相应的位置上，牛黄降压胶囊（原方）显相同颜色的斑点，而牛黄降压胶囊（替代方）未显相同颜色的斑点。胆红素在0.035 52~0.592 00 μg与峰面积的线性良好。胆红素平均回收率为97.73%，RSD值为3.22%（n=6）。结论 方法简便，灵敏度高，重现性好，可用于牛黄降压胶囊中体外培育牛黄的替代使用情况控制。

Objective To develop the identification and assay of alternative use of Calculus Bovis Sativus in Niuhuang Jiangya Capsules. Methods TLC method was used for the qualitative identification of Calculus Bovis Sativus,. HPLC method was used to determine the contents of bilirubin. Results At the corresponding position of the chromatogram of cholic acid reference substance, Niuhuang Jiangya Capsules (substitution) and Niuhuang Jiangya Capsules showed the same color spots. In the corresponding position with the chromatogram of hyodeoxycholic acid reference substance, Niuhuang Jiangya Capsulesshowed the same color spots, but Niuhuang Jiangya Capsules (substitution) had no the same color spots. Bilirubin had good linearity in the range of 0.035 52 -0.592 00 μg. The average recovery rate was 97.73% with RSD values of 3.22% (n=6).Conclusion This method is accurate, reliable, sensitive and suitable for the quality control of alternative use of Calculus Bovis Sativus in Niuhuang Jiangya Capsules.

R927.2