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目的建立灵敏度高、专属性强的茵栀黄注射液中鞣质的检测方法。方法以茵栀黄注射液为模型药物,采用高效液相色谱法测定注射液中水解没食子酸。Diamonsil ODS色谱柱(250 mm×4.6 mm,5μm);流动相为甲醇-0.05%磷酸水溶液(5︰95);体积流量1.0 mL/min;检测波长271 nm;柱温室温;进样量20μL。结果没食子酸进样量在36.125～231.20 ng与峰面积线性关系良好,平均回收率为99.6%,RSD为1.77%。茵栀黄注射液中不能检测出游离没食子酸,而水解没食子酸量较高,提示茵栀黄注射液中含有一定量的可水解鞣质。结论通过测定注射液中水解没食子酸,可以达到间接控制注射液中鞣质残留量的目的。
Objective To establish a method for the determination of tannins in Yinzhihuang injection with high sensitivity and specificity. Methods Yin Zhi Huang injection as a model drug, using high performance liquid chromatography in the determination of hydrolyzate gallic acid injection. Diamonsil ODS column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of methanol-0.05% phosphoric acid solution (5:95), the volume flow rate was 1.0 mL / min, the detection wavelength was 271 nm and the column temperature was 20 μL. Results The injection volume of gallic acid had a good linear relationship with the peak area from 36.125 to 231.20 ng with an average recovery of 99.6% and a RSD of 1.77%. Yinzhihuang injection can not detect free gallic acid, and hydrolysis of gallic acid is higher, suggesting that Yinzhihuang injection contains a certain amount of hydrolysable tannin. Conclusion The objective of indirect control of tannin residues in the injection solution can be achieved by measuring the hydrolysis of gallic acid in the injection solution.