四类眼用制剂流变学性质的研究-药学学报.PDFVIP

四类眼用制剂流变学性质的研究 * 吴晓鸾，马建芳，范宵宇，王林波, 彭兴盛 （上海市食品药品检验所，上海 200131 ） 摘要: 通过对四类眼用制剂流变学性质的研究，比较眼用凝胶剂与其他3 种 类型眼用制剂流变学性质的区别，为增加眼用凝胶剂质量标准中流变学指标和参 数提供了依据。采用锥板式模具流变仪测定了四类眼用制剂非稳态与稳态流变学 参数，分析测定结果，总结区分眼用凝胶剂与其他类型眼用制剂的流变学指标和 参数。结果显示：① 在线性黏 区内，眼用凝胶剂的 性模量应大于黏性模量； ② 眼用凝胶剂应为具有一定屈服应力和触变性的剪切变稀型非牛顿流体；③ 在 -1 温度为 25℃，剪切速率为 50s 时，眼用凝胶剂动力黏度应大于 0.5 Pa ·S。说 明本文建立的眼用凝胶剂的特征流变学指标和参数，该方法简单，操作性强，对 于眼用凝胶剂的处方设计、生产工艺与质量控制具有重要意义。 关键词：眼用制剂；眼用凝胶剂；流变仪；流变学参数 中国图书分类号：R943 文献标志码：A 文章编号：0513-4870(2017) 收稿日期: 2016-10-12; 修回日期: 2016-11-07 基金项目： *通讯作者 Tel: Fax: E-mail：wanglinbosifdc@163.com Research on rheological properties of four types of ophthalmic preparations WU Xiao-luan, MA Jian-fang, FAN Xiao-yu, WANG Lin-bo*, PENG Xing-sheng (Shanghai Institute for Food and Drug Control, Shanghai 200131, China) Abstract: To provide the basis for the rheological parameters for the additional quality standard of ophthalmic gels, the rheological properties of the ophthalmic gels and the other three types of ophthalmic preparations were compared through the study of the rheological properties for four types of ophthalmic preparations. The cone-plate rheometer was used to determine the dynamic and steady rheological parameters of four types of ophthalmic preparations. The similarities and differences of the measured results were analyzed to summarize the rheological indexes and parameters which can be applied to distinguish the ophthalmic gels and the other types of ophthalmic preparations. The elastic modulus should be greater than the viscous modulus for the ophthalmic gels in the range of the linear viscoelastic region. ②The ophthalmic gels should be shear thinning non-Newtonian fluid with a certain yield stress and thixotropy. ③The