滤膜吸附对克拉霉素片溶出度的干扰试验

Interference from Filter Film Adsorption for Dissolution of Clarithromycin

目的:查找克拉霉素片溶出度偏低的原因,研究滤膜吸附对克拉霉素片不同时间点的溶出度结果的干扰程度,探索克拉霉素片溶出液合适的处理方法。方法:选择两种不同厂家的克拉霉素片剂,按照日本橘皮书溶出度方法制备溶出液,经不同方式处理后,检测其溶出度计算滤膜吸附率。结果:14种微孔滤膜对两个厂家的克拉霉素均有不同的吸附作用,且有的滤膜其吸附率超过了规定限度。结论:通过蒸煮滤膜和更换美国进口膜均能降低克拉霉素的吸附率;弃去初滤液的体积>5ml或者离心处理溶出液均能有效减少和防止滤膜对药物吸附产生的干扰。

To find the reasons for the low dissolution of clarithromycin tablets and study the interference from filter film adsorption at various time points to explore the appropriate processing approach for dissolution solution of clarithromycin tablets. Methods： Clarithromyein tablets from two different manufacturers were used. The dissolution solution was prepared according to Japanese Orange Book. The dissolution was determined after different processing and the adsorption rate of the filter film was calculated. Results： Totally 14 kinds of filter films were tested with different adsorption for elarithromycin, and the adsorption rate of some kinds of filter films exceeded the prescribed limit. Conclusion： The absorption rate of filter films for clafithromycin can be decreased by boiling the films and using American membranes. The interference from filter film adsorption can be reduced and inhibited by rejecting the first filtrate above 5ml or centrifuging dissolution solution.