多条实时溶出曲线对阿昔洛韦片的质量再评价

Re-evaluation of the quality of acyclovir tablets by real-time dissolution profiles in different mediums

目的:以多条实时溶出曲线评价阿昔洛韦片的内在质量。方法:分别以pH1.0的盐酸溶液、pH4.0的醋酸盐缓冲液、pH6.8的磷酸盐缓冲液和水为溶出介质,设定检测波长254 nm、参比波长550 nm、转速50 r.min-1、光程0.5 mm和桨法,用光纤溶出度实时测定仪测定阿昔洛韦片的溶出曲线。结果:测定了9个厂家生产的阿昔洛韦片在4种溶出介质中的实时溶出曲线,结果显示3个厂家生产的阿昔洛韦片的4条溶出曲线不一致,反映出3个厂家的生产工艺尚不成熟。结论:不同pH溶出介质中的实时溶出曲线可全面反映药物在不同体内环境下的溶出行为,能更有效地评价制剂的内在质量。

OBJECTIVE To evaluate the intrinsic quality of acyclovir tablets by real-time dissolution profiles in different mediums. METHODS The paddle method was used at the rate of 50 r·min^-1 and signals were detected at 254 nm against the reference wavelength of 550 nm. The dissolution profiles of acyclovir tablets were determined with 0. 5 mm fiber optic probe by Fiber-optic Medicine Dissolution Process Real Time Test System in hydrochloric acid solution （pHl. 0）, acetate buffer （pH 4. 0）, phosphate buffer （pH 6. 8） and water. RESULTS The real-time dissolution profiles of acyclovir tablets from nine manufacturers were determined in four dissolution mediums. There was significant difference between the four dissolution profiles of acyclovir tablets from three manufacturers, which suggested instable technological processes. CONCLUSION The dissolution profiles in different mediums can roundly reflect dissolution process in vivo. It can provide a better way of evaluating the intrinsic quality of medicines.