玳玳黄酮滴丸质量分析

Quality Analysis on Daidai Flavones Dropping Pills

关键词:  玳玳黄酮滴丸  薄层色谱  高效液相色谱法  含量测定

Key words:  Daidai Flavones dropping pills  TLC  HPLC  content determination

摘要:

目的 建立玳玳黄酮滴丸质量评价方法。方法 采用薄层色谱法鉴别玳玳黄酮滴丸，并对玳玳黄酮滴丸进行重金属及砷盐的检查；建立高效液相色谱法同时测定玳玳黄酮滴丸主要药效成分柚皮苷和新橙皮苷含量的方法。结果 薄层色谱主要成分斑点清晰可见，阴性对照无干扰；玳玳黄酮滴丸重金属及砷盐的限量均小于百万分之十；新橙皮苷在4.088~16.352 μg·mL^-1内呈良好线性关系，柚皮苷在4.084~16.336 μg·mL^-1内呈良好线性关系，3批玳玳黄酮滴丸新橙皮苷平均含量分别为75.32，74.82，73.76 mg·g^-1，柚皮苷平均含量分别为63.05，63.21，62.07 mg·g^-1。结论 所建立的鉴别、检查、含量测定方法稳定简便，可有效控制玳玳黄酮滴丸质量。

Abstract:

OBJECTIVE To establish a method for the quality evaluation of Daidai Flavones dropping pills.METHODS TLC was applied to the identification of Daidai Flavones dropping pills and to check heavy metal and arsenic salts in Daidai Flavones dropping pills. In addition, the contents of naringin and neohesperidin in Daidai Flavones dropping pills was determined by HPLC. RESULTS The qualitative identification with TLC was specific, and negative control had no interference. The contents of heavy metals and arsenic salts were less than ten over one million of Daidai Flavones dropping pills. Neohesperidin had a good linearity in the range of 4.088-16.352 μg·mL^-1, naringin had a good linearity in the range of 4.084?16.336 μg·mL^-11. The average contents of neohesperidin in three batches of daidai flavones dropping pills were 75.32, 74.82, 73.76 mg·g^-1, respectively; and naringin were 63.05, 63.21, 62.07 mg·g^-1, respectively. CONCLUSION The established method is stability and simple, and can be used to control the quality of Daidai Flavones dropping pills effectively.