更昔洛韦胶囊体外溶出度方法考察

Investigation of Dissolution of Ganciclovir Capsule in Vitro

目的探讨更昔洛韦胶囊的最优溶出度测定方法。方法采用《中国药典》2010年版二部附录XC第一法装置,用紫外分光光度法对其溶出方法、介质、转速、取样时间进行测定,计算累计溶出百分率,并绘制溶出曲线。结果更昔洛韦胶囊在30 min内溶出已达到90%以上,RSD为2.0%以内。结论本方法简便、准确,符合溶出度方法的建立原则,可作为该制剂的质量控制。

Objective To establish the optimal dissolution method for Refer to the first method devices presented in ＂ Chinese Pharmacopoeia＂ 2010 ganciclovir capsules. Methods , UV spectrophotometry dissolu- tion method was used to determine the dissolution method, medium, rotational speed, sampling time, calculate the percentage of cumulative dissolution, and draw the dissolution curves. Results The dissolution of ganciclovir capsules achieved more than 90% within 30 min and RSD was less than 2.0%. Conclusion This method is simple, accurate and is in accordance with the principle of dissolution method establishment, which can be used for quality control of this preparation.