雌二醇凝胶流变学性质及动力黏度测定方法的研究  

Rheological property and dynamic viscosity determination method of estradiol gel

作　　者：范霄宇[1] 刘蔚[1] 陈佳[1] 王林波[1] 彭兴盛[1] 陈桂良[1] FAN Xiao-yu LIU Wei CHEN Jia WANG Lin-bo PENG Xing-sheng CHEN Gui-liang(Shanghai Institute for Food and Drug Control, Shanghai 200131, China)

机构地区：[1]上海市食品药品检验所,上海200131

出　　处：《药物分析杂志》2016年第10期1880-1884,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：研究雌二醇凝胶流变学性质并建立动力黏度测定方法。方法：采用锥板式流变仪从稳态和非稳态2个方面对雌二醇凝胶进行流变学性质的研究。稳态方法包括流变曲线的测定、屈服应力的测定、触变性的测定、动力黏度的测定,非稳态方法包括线性粘弹区的测定、凝胶点的测定、相位角的测定。结果：雌二醇凝胶为屈服应力较大,触变性较小的剪切变稀型非牛顿流体。采用锥板式流变仪测得的动力黏度值为2.78 Pa·s（RSD=0.05%）;采用3种不同（CP4/40、CP1/50与CP1/60）转子锥板式流变仪测得的动力黏度值分别为2.78 Pa·s（RSD=0.05%）、2.78 Pa·s（RSD=0.22%）和2.79 Pa·s（RSD=0.39%）。线性粘弹区为0.1%～1%的应变范围。凝胶点的振荡频率值分别为49.66、62.7和114.7 Hz。温度在10～40℃范围内变化,相位角变化不显著。结论：流变仪测定雌二醇凝胶的动力黏度方法简单、准确,重现性好,适用于该凝胶动力黏度的测定。Objectives：To investigate the rheological properties of estradiol gel and establish a determination method for its dynamic viscosity.Methods：The cone-plate rheometer was used to investigate the rheological properties of estradiol gel in both steady state and unsteady state.The steady state includes determination of rheological curve,yield stress,thixotropy,dynamic viscosity;the unsteady state includes determination of linear viscoelastic region,gel point,phase angle.Results：Estradiol gel was a non-newtonian shear-thinning fluid with high yield stress and low thixotropy.The dynamic viscosity was 2.78 Pa·s（RSD：0.05%） based on the coneplate rheometer.The dynamic viscosity were 2.78 Pa·s（RSD=0.05%）,2.78 Pa·s（RSD=0.22%）,2.79 Pa·s（RSD=0.39%） using the cone plate rheometer with three different rotors including CP4/40,CP1/50 and CP1/60,respectively.The linear viscoelastic region was ranged in 0.1%-1% of strain.Oscillation frequency of gel point were 49.66 Hz,62.7 Hz,and 114.7 Hz,respectively.The change of phase angle was not significant with temperature between 10-40 ℃.Conclusion：The established determination method of dynamic viscosity for estradiol gel is convenient,accurate,and with good reproducibility,which is suitable for the dynamic viscosity of estradiol gel.

关 键 词：药物黏度测定 雌二醇凝胶 流变曲线 屈服应力 触变性 动力黏度 线性粘弹区 凝胶点 流变仪 

分 类 号：R917[医药卫生—药物分析学]