蛇床子素分散片处方筛选及溶出度的研究

Prescription Selection of Osthole Dispersible Tablets and Its Dissolution Level

目的优选蛇床子素分散片处方,并建立溶出度测定方法。方法在单因素试验基础上,采用正交试验以崩解时限、分散均匀性为指标对蛇床子素分散片处方进行优化;采用紫外分光光度法测定分散片中蛇床子素的溶出度,测定波长为322nm。结果最佳处方为蛇床子素10%,崩解剂交联聚维酮20%(外加),填充剂微晶纤维素和乳糖分别为30%和40%,黏合剂为75%乙醇进行湿法制粒压片,优选处方的崩解时间小于10s,分散均匀且全部通过二号筛;蛇床子素在为6～16μg.mL-1(n=6,r=0.999 9)时,线性关系良好,蛇床子素分散片60min内累积溶出百分率为88%。结论蛇床子素分散片制备工艺简单,溶出度高,符合《中国药典》2010年版的相关规定,具有实用价值。

Objective To select the best prescription of osthole dispersible tablets and to establish the method for determination of its dissolution level.Methods According to the single factor experiments and the orthogonal test,the formulation of osthole dispersible tablets was optimized through the dispersal uniformity and disintegration time.The dissolubility of the osthole dispersible tablets was determined by UV spectrophotometer at the wavelength of 322 nm.Results The optimal formulation consisted of 10% osthole,20% PVPP as disintegrating agent,30% MCC and 40% lactose as filling agents,75% ethanol as adhesives.The osthole dispersible tablets could disintegrate in less than 10 s and come through NO.2 sieve.The linear range of osthole was 6~16 μg·mL-1(n=6,r=0.999 9),and the cumulative dissolution percentages of the osthole dispersible tablets were above 88% in 60 minutes.Conclusion The preparation technique of osthole dispersible tablet is simple,producing good dissolution.It is also consistent with items on tablets preparation requirements in ChP(2010),and has practical value.