目的 建立牛黃降壓膠囊中體外培育牛黃的替代使用的定性鑒別和定量測(cè)定方法。方法 采用薄層色譜法對(duì)方中體外培育牛黃定性鑒別，采用高效液相色譜法對(duì)膽紅素進(jìn)行含量測(cè)定。結(jié)果 在與膽酸對(duì)照品色譜相應(yīng)的位置上，牛黃降壓膠囊（替代方）和牛黃降壓膠囊（原方）的供試品均顯相同顏色的斑點(diǎn)；在與豬去氧膽酸對(duì)照品色譜相應(yīng)的位置上，牛黃降壓膠囊（原方）顯相同顏色的斑點(diǎn)，而牛黃降壓膠囊（替代方）未顯相同顏色的斑點(diǎn)。膽紅素在0.035 52~0.592 00 μg與峰面積的線性良好。膽紅素平均回收率為97.73%，RSD值為3.22%（n=6）。結(jié)論 方法簡(jiǎn)便，靈敏度高，重現(xiàn)性好，可用于牛黃降壓膠囊中體外培育牛黃的替代使用情況控制。

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