琥乙红霉素缓释片释放度研究

目的建立琥乙红霉素缓释片体外释放研究分析的硫酸显色法。方法以900 mL经脱气处理的0.1 mol/L盐酸溶液为释放介质,转速为75 r/min,75%的硫酸溶液为显色剂,采用紫外-可见分光光度法于482 nm波长处对琥乙红霉素缓释片的释放度进行测定。结果琥乙红霉素显色后质量浓度在40～72μg/mL范围内与吸收度呈良好线性关系(r=0.999 9);平均回收率为99.75%,RSD为0.76%;12 h内3批样品的释放量均在标示量的90%以上。结论该方法操作简便、准确可靠,可用于琥乙红霉素缓释片释放度的测定,为质量标准的制订提供了依据。

Study on Release Rate of Erythromycin Ethylsuccinate Sustained- Release Tablets

Objective To establish the sulfuric acid color method of Erythromycin Ethylsuccinate Sustained- Release Tablets in its study of in vitro release analysis. Methods With 900 mL of 0.1 mol/L degassing treated hydrochloric acid as the dissolution media, the rotational speed of 75 r/min and 75% sulfuric acid solution as the color reagent, the release rate of Erythromycin Ethylsuccinate Sustained- Release Tablets was measured at 482 nm by ultraviolet and visible spectrophotometry. Results After coloration of erythromycin ethylsuccinate, the good linear relationship was between the absorbability and the concentration range of 40-72 μg/mL（ r=0. 999 9）. The average recovery rate was 99.75%, RSD was 0. 76%. The release amount of the 3 batches of samples within 12 h was over 90% of labeled amount. Conclusion This method is simple, accurate and reliable, which can be used for the release rate determination of Erythromycin Ethylsuccinate Sustained- Release Tablets to provide the basis for formulating the quality standards of this preparation.