拉莫三嗪分散片的制备及质量研究

Preparation and Quality Study of Lamotrigine Dispersible Tablets

目的:制备拉莫三嗪分散片,并对其进行质量评价。方法:采用湿法制粒法制备拉莫三嗪分散片,以崩解时间为考察指标,以处方中碳酸钙的用量(A)、低取代羟丙基纤维素(L-HPC)的用量(B)、羧甲基淀粉钠的用量(C)及聚维酮K30的质量分数(D)为因素,采用正交试验优化处方;考察优化后处方所制3批片剂的崩解时间,测定45min内的体外溶出度,并与市售药品(倍德林)体外溶出行为进行比较;进行影响因素(高温、强光、高湿)试验。结果:每片样品中A、B、C分别为25.75、8.75、3.5mg,D为1.0%。3批样品的平均崩解时间为23.8、22.5、22.2s,45min内的体外溶出度超过90%,溶出行为与倍德林相似(f2均>50)。高温试验第5、10天有关物质略有升高,其他各项考察指标均未见明显变化。结论:该处方工艺可靠,所制片剂质量稳定。

OBJECTIVE：To prepare Lamotrigine dispersible tablets,and to evaluate the quality of it.METHODS：Lamotrigine dispersible tablets were prepared with wet granulation.The formulation was optimized by orthogonal design using disintegration time as index with the amount of calcium carbonate（A）,L-HPC（B）,sodium starch glycolate（C）and mass fraction of povidone K30（D）as factors.The disintegration time of 3 batches of tablets in optimized formulation was investigated,and in vitro dissolution of the tablets within 45 min was determined and compared with that of medicine on the market（Beidelin）.The influencing factors（high temperature,high light and high moisture）were investigated as well.RESULTS：A,B and C were 25.75,8.75,3.5 mg,respectively;D was 1.0%.Mean disintegration time of 3 batches of samples were 23.8,22.5,22.2 s.The dissolution of the tablets was over 90% within 45 min in vitro.The dissolution behavior of the tablets was similar to that of Beidelin（f250）.In high temperature test,related substance was increased slightly,but other index were stable 5 d and 10 d later.CONCLUSIONS：The technology is reliable,the tablets were stable.