小儿苯巴比妥分散片的制备及质量控制

Preparation of children's dispersible phenobarbital tablets and its quality control

目的 :制备小儿苯巴比妥分散片并建立质量控制方法。方法 :以低取代羟丙基纤维素、羟丙甲纤维素等为辅料研制该分散片 ,紫外分光光度法测定该片中苯巴比妥的含量 ,测定波长为 2 4 0nm。结果 :分散均匀性试验表明该分散片在 1min内均匀分散并通过 2号筛。苯巴比妥浓度线性范围为 1～ 2 0 μg/mL ,r=0 .9999,平均回收率为 99 2 8% ,RSD为 0 2 1 % (n =6)。结论 :所制得的分散片符合中国药典 2 0 0 0年版的规定 。

Objective:To prepare children's dispersible phenobarbital tablets and establish the method for its quality control. Methods:The dispersible tablets was prepared by taking lose subsfrits hydroxypropyl cellulose and hydroxypropymethyl cellulose as excipient.The phenobarbital content in tablets was determined by UV spectrophotometry at 240 nm.Results:The uniformity test of dispersion showed that the tablets could smoothly disperse and pass through a No.2 sieve within 1 min. The phenobarbital concentration was linear within the range of 1-20 μg/mL with r = 0.9999,the average recovery was 99.28% with RSD =0.21% ( n =6).Conclusions:The dispersible tablets accord with the requirement of CHP(2000).The method for quality control is reliable.