盐酸利多卡因膜剂的试制

Prescription of Lidocaine hydrochloride film

目的 :优化盐酸利多卡因口腔膜剂的处方工艺 ,达到速释的目的。方法 :通过正交设计优化盐酸利多卡因膜剂的制备工艺 ,以紫外分光光度法测定样品含量 ,采用改良的释放度测定第三法测定膜剂体外释放度。结果 :3批样品外观符合要求 ,平均含量为39.02 % ,6min释放百分率为85 % ;测定方法的回收率为 (100.68±0.39) %,精密度RSD为0.47%。结论 :样品外观良好 ,含量均匀 ,释放迅速 ,符合要求。该测定方法简便 ,准确可靠。

Objective:To select the best presciption of Lidocaine hydrochloride buccal film with quick dissoˉlution rate.Methods:The process conditions of preparing Lidocaine hydrochloride buccal film was optimized by orthonormal experiment design,and the content of Lidocaine hydrochloride in the sample was determined by UV spectrophotometry.The third method improved of determining dissolution rate was used to determine the disˉsolution rate of the film.Results:The appearance of the three samples conformed to the requirements,and the average content of Lidocaine hydrochloride in the samples was39.02%,and the average percentage of dissoluˉtion was85%at6minute;the average recovery was(100.68±0.39)%,RSD was0.47%.Conclusion:The apˉperance of the film is good,the content of Lidocaine hydrochloride in the samples is uniform,and the dissolution rate is quick.All the requirements are fulfiled.The methods used in the experiment is simple,accurate and credible.