苯巴比妥分散片_____苯巴比妥分散片；制备；质量控制

小儿苯巴比妥分散片的制备及质量控制

http://www.100md.com 《广东药学院学报》 2001年第4期

苯巴比妥分散片,,苯巴比妥分散片；制备；质量控制,1材料与试药,2处方与制备,3质量控制,4讨论,参考文献

     摘要目的：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240 nm。结果：分散均匀性试验表明该分散片在1 min内均匀分散并通过2号筛。苯巴比妥浓度线性范围为1～20 μg/mL,r=0.9999,平均回收率为9928%，RSD为021%(n=6)。结论：所制得的分散片符合中国药典2000年版的规定，质量控制方法可靠。

    关键词苯巴比妥分散片；制备；质量控制

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

    CHEN Lianjian,LI Cheng,LI Ting,HUANG Fuxing,GUO Hua,LI Junfeng,HE Shutang,FAN Xu

    (The Affiliated People's Hospital of Futian,Guangdong Medical College,Shenzhen,Guangdong 518033)

    Abstract 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. ......

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