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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 multiple real-time dissolution curves. Methods: The detection wavelength was 254 nm, the reference wavelength was 550 nm and the rotation speed was 50%, respectively, using hydrochloric acid solution of pH1.0, acetate buffer solution of pH4.0, phosphate buffer solution of pH6.8 and water as dissolution medium. r.min-1, optical path length 0.5 mm and paddle method, and the dissolution curve of acyclovir tablets was determined by real-time optical fiber dissolution tester. Results: The real-time dissolution profiles of acyclovir tablets produced by 9 manufacturers in 4 dissolution media were determined. The results showed that the 4 dissolution curves of acyclovir tablets produced by 3 manufacturers were inconsistent, Production process is not yet ripe. CONCLUSION: The real-time dissolution curves of different pH dissolution media can fully reflect the dissolution behavior of drugs in different in vivo environments and evaluate the intrinsic quality of the preparation more effectively.