盐酸特比萘芬乳膏流变学性质的研究

Research on the rheological properties of terbinafine hydrochloride cream

目的对盐酸特比萘芬乳膏进行流变学性质的研究,为该产品的一致性评价提供研究依据。方法采用高级旋转流变仪测定盐酸特比萘芬乳膏稳态和非稳态流变学参数,对参比制剂与6个仿制制剂进行流变曲线、屈服应力、黏度、线性黏弹性、蠕变回复等性质的对比研究。结果盐酸特比萘芬乳膏参比制剂及仿制制剂均为假塑性非牛顿流体;屈服应力试验中,3家仿制制剂与参比制剂大小相当;3家仿制制剂的线性黏弹区范围与参比制剂一致,在0.01%~1%范围内,两者弹性模量均大于黏性模量,均为黏弹性体;蠕变回复曲线可知4家仿制制剂与参比制剂的蠕变行为相当。结论试验测定的6个盐酸特比萘芬乳膏中,大部分仿制制剂与参比制剂的流变学性质基本一致。

Objective To study the rheological properties of terbinafine hydrochloride cream,and provide a research basis for the consistency of this product.Methods The Kinexus rheometer was used to determine the dynamic and steady rheological parameters of terbinafine hydrochloride cream.Comparative studies on the rheological curves,yield stress,viscosity measurement,linear viscoelasticity and creep recovery of original and generic terbinafine hydrochloride cream were carried out.Results The original and generic terbinafine hydrochloride cream were both non-Newtonian fluid with shear thinning.The yield stress of three generic were similar to the original.The linear viscoelastic region of three generic were similar to the original,and the ranges of linear viscoelastic were both 0.01%-1%,the elastic moduli were all greater than the viscosity moduli and were viscoelastic materials.It could be seen from the creep recovery curve that the creep behavior of three generic were basically the same with the original.Conclusion Among the six terbinafine hydrochloride creams measured experimentally,the rheological properties of most generic drugs are basically the same as the original.