氨咖黄敏胶囊质量标准的改进研究

目的改进现有的氨咖黄敏胶囊的质量标准。方法在原有标准的基础上,对马来酸氯苯那敏、对乙酰氨基酚、咖啡因的薄层鉴别展开条件进行改进,并增加了人工牛黄的薄层鉴别和胆红素质量分数测定项,以更好地控制人工牛黄质量。结果在TLC图谱中可检出氨咖黄敏胶囊的特征斑点,7批样品薄层结果一致,阴性无干扰,耐用性良好;胆红素质量浓度在0.806 4-8.064μg·mL^-1范围内与吸光度线性关系良好（r=0.999 5）,平均回收率为102.8%,RSD为1.7%（n=9）。结论改进后的薄层鉴别方法重复性好,优于现行标准薄层鉴别项下的鉴别方法;胆红素质量分数测定方法准确、专属性强、重复性好,可更好地控制氨咖黄敏胶囊的质量。

Study on the improvement of quality standard for Ankahuangmin capsules

Objective To improve the quality standard for Ankahuangmin capsules. Methods The development systems of TLC identification of chlorphenamine maleate, paracetamol, caffeine and artificial cow-bezoar were optimized based on the original standard of Ankahuangmin capsules. And the TLC identification of artificial cow-bezoar and determination of bilirubin content were added to control the quality of artificial cow-bezoar. Results Spot features could be observed in the TLC of Ankabuangmin capsules. The TLC of 7 batches of samples were consistent with excellent durability and no interference of negative. It showed a good linear relationship in the range of 0.806 4-8.064μg·mL^-1for bilirubin （r= 0.999 5）. The average recovery rate was 102.8% （RSD = 1.7%, n = 9）. Conclusion The improved TLC method with good reproducibility was better than that under current standards. The determination method of bilirubin was accurate, specific and reproducible, which could better control the quality of Ankahuangmin capsules.