复方甘草锌口腔复合膜的质控方法研究

目的：确定金属锌的含量，并且建立高效液相色谱法测定甘草锌口腔复合膜剂中甘草酸和氨来阽诺含量的方法。方法：通过配位滴定方法测定金属锌含量；色谱柱为Kromasil—C18柱（Φ200mm×4．6mm，5μm），以甲醇-0．2m01／L醋酸铵溶液-冰醋酸（67：33：1）为流动相，检测波长为250nm，流速为0．8ml／min，进样量为20μl，柱温：室温。结果：金属锌含量为0．67％；甘草酸在4．90—9．80μg／ml范围内与峰面积呈良好的线性关系（r=0．9999，n=9），平均回收率为98．81％，RSD值为0．62％（n=9）；氨来呫诺在1～6μg／ml范围内与峰面积呈良好的线性关系（r=0．9999，n=9），平均回收率为99．61％，RSD值为0．90％（n=9）。结论：该方法简便、灵敏、准确，重现性好，可用于复方甘草锌口腔复合膜剂的质量控制。

Study on method of quality control of licorzinc oral complex pellicle

Objective： To determine the content of metal zinc and establish the method of HPLC for the content of licorzinc oral complex pellicle and amlexanox. Methods： The content of zinc metal was detected by the coordination of the titration method; column was Kromasil-C18 （Φ200mm×4.6mm,5μm）;mobile phase was methanol-0.2 mol/L ammonium acetate solution- glacial acetic acid （67：33 ：1）;detection wavelength was 250 nm , velocity of flow was 0.Sml/min;injection volume was 20 μl; and column temperature was room temperature. Results： The content of metal zinc was 0.67%;Glycyn＇hizinate in 4.90- 9.80 μg/ml range had a good linear relationship with the peak area （r=0.999 9, n=9）, the average recovery was 98.81%, RSD was 0.62% （n=9）; Amlexanox in 1-6 μg/ml range had a good linear relationship with the peak area （r=0.999 9, n=9）,the average recovery was 99.61%, RSD was 0.90% （n=9）. Conclusion： The method is simple, sensitive, accurate, reproducible and can be used for quality control of licorzinc oral complex pellicle.