无水乳糖在头孢克洛片生产中的应用

Application of Anhydrous lactose in Production of Cefaclor Tablets

目的简化头孢克洛片的生产工序,消除湿法制粒对产品稳定性的不利影响。方法以无水乳糖作为填充剂,采用直接压片法制备头孢克洛片,通过加速及长期稳定性试验考察样品的稳定性,通过生物等效性试验考察样品的临床疗效。结果加速和长期稳定性试验表明,样品在有效期内主要指标变化较小,稳定性良好;生物等效性试验表明,采用该工艺制备的头孢克洛片与礼来苏州制药有限公司希刻劳胶囊生物等效。结论采用无水乳糖作为直接压片辅料生产出的头孢克洛片质量稳定,疗效可靠。

Objective To simplify the preparation process of Cefaelor Tablets and to eliminate the adverse effect of wet granulation technique on stability. Methods The technique of direct compression was adopted using anhydrous lactose as the main fillers to prepare Cefaclor Tablets. The accelerated test and longtime stability test were used to study the stability of Cefaclor Tablets. The relative bioavailability test was used to study the bioequivalence. Results Little change of the main programs was happened during the accelerated test and longtime stability test before expiration date. Bioequivalence was found when compared Cefaclor Tablets with Ceclor of Lilly Suzhou Pharmaceutical Company. Conclusion The technique of direct compression with anhydrous lactose as the main fillers to prepare Cefaclor Tablets is feasible with good stability and curative effect.