格列齐特3种片剂的溶出度比较

目的 :对市售 3种格列齐特片剂进行溶出度比较。方法 :按中国药典 2 0 0 0版溶出度方法 ,用紫外分光光度法测定其含量 ,测定波长为 2 2 6nm。结果 :A ,B ,C 3个厂家的片剂标示百分含量分别为98.5 % ,10 0 .0 %和 99.0 % ;6 0min时的平均溶出度分别为 4 8.4 % ,89.6 %和 86 .9% ;180min时的平均溶出度分别为 90 .7% ,90 .9%和 90 .7%。根据统计学分析A厂与B ,C厂的片剂在 6 0min时溶出度差异有非常显著意义 (P <0 .0 1) ,B厂和C厂的片剂差异有显著意义 (P <0 .0 5 ) ;在 180min时A ,B ,C厂 3种片剂的溶出度差异无显著意义 (P >0 .0 5 )。结论 :A厂产品的溶出度符合中国药典2 0 0 0版的要求

Comparison of dissolution in three kinds of gliclazide tablets

AIM: To compare the dissolution of gliclazide tablets from three domestic pharmaceutical factories. METHODS: According to the method mentioned in the Chinese Pharmacopeia (Edition 2000), the content of the tablets was assayed using the ultraviolet spectrophotometry at the wavelength of 226 nm. RESULTS: The mean contents of the tablets from producer A, B, and C were 98.5 %,100.0 %, and 99.0 %, respectively. The respective mean dissolution was 48.4 %, 89.6 %,86.9 % at 60 min, and was 90.7 % , 90.9 %, 90.7 % at 180 min. There was significant difference of dissolution among the A and B, C tablets at 60 min ( P <0.01), and it showed a significant difference between tablets from producer B and C ( P < 0.05 ). However, the difference of dissolution at 180 min was insignificant among the three producers ( P >0.05). CONCLUSION: Gliclazide tablet of producer A conforms to the criteria set by the Chinese Pharmacopeia (Edition 2000).