恩替卡韦片的制备及其体外溶出曲线研究

目的制备恩替卡韦片,并与市售恩替卡韦片进行体外溶出曲线的比较。方法采用乳糖、羧甲淀粉钠、PVPK30压制成恩替卡韦片,分别以0.05 mol·L-1磷酸二氢钾、水和0.01 mol·L-1盐酸作为介质,用浆法绘制不同溶出介质中的溶出曲线,并计算出相似因子（f2）。结果在0.05 mol·L-1磷酸二氢钾溶液、水、0.01 mol·L-1盐酸介质中,自制恩替卡韦片和市售恩替卡韦片的溶出曲线f2依次为78,51和51。结论自制恩替卡韦片和市售片在0.05 mol·L-1磷酸二氢钾、水和0.01 mol·L-1盐酸中的体外溶出行为一致。

Preparation and in Vitro Dissolution of Entecavir Tablets

OBJECTIVE To prepare entecavir tablets and compare the dissolution curves of self-made and market available entecavir tablets. METHODS Entecavir tablets were prepared using lactose, carboxymethyl starch sodium and PVPK30. Intellectual diffusion meter was used to determine the dissolution curve of market available entecavir tablets and self-made tablets. 0.05 mol·L^-1 KH₂PO₄, water and 0.01 mol·L^-1 HCl were used as dissolution mediums. Than similarity factors(f₂) were calculated in different dissolution mediums. RESULTS The f₂ were 78, 51 and 51 in 0.05 mol·L^-1 KH₂PO₄, water and 0.01 mol·L^-1 HCl, respectively. CONCLUSION The dissolution profiles of self-made entecavir tablets are same as that of market available ones.