阿奇霉素颗粒溶出度检查方法研究

Azithromycin particle dissolution

目的建立阿奇霉素颗粒中主药溶出度的测定方法。方法采用紫外分光光度法，在482nm波长处测定阿奇霉素颗粒中主药的吸收度，并计算回收率和溶出度。结果阿奇霉素检测浓度线性范围为13．79—110．32mg·L^-1（r=0．9990）；平均回收率为99．2％（RSD=1．12％，n=9）；3批样品在45min溶出量均在75％以上。结论本方法准确、可靠，可用于该制剂的溶出度测定。

Aim To establish a method for azithromycin particles dissolution in the main drug. Method UV spectrophotometry was adopted the wavelength being set at the 482 nm, and the recovery and dissolution were caleulat. Results The linear range was 13.79 110.32 g·L^-1 （ r = 0.9 990）. The average recovery rate was 99.2% （ RSD = 1.12% ,n =9）. 3 batches of samples approved the dissolutions of 45 min were all above 75 percent. Conclusion This method is accurate, reliable and can be used for the preparation of the dissolution of azithromycin.