药学学报, 2017, 52(1): 146-152
引用本文:
吴晓鸾, 马建芳, 范宵宇, 王林波, 彭兴盛. 四类眼用制剂流变学性质的研究[J]. 药学学报, 2017, 52(1): 146-152.
WU Xiao-luan, MA Jian-fang, FAN Xiao-yu, WANG Lin-bo, PENG Xing-sheng. Research in rheological properties of four types of ophthalmic preparations[J]. Acta Pharmaceutica Sinica, 2017, 52(1): 146-152.

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4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4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在线性黏弹区内,眼用凝胶剂的弹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在温度为25℃,剪切速率为50 s-1时,眼用凝胶剂动力黏度应大于0.5 Pa·S。本文确立了眼用凝胶剂的特征流变学指标和参数,测定方法简单、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     
Research in 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:
This study is prepared to provide the basis of 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. The medicines 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 are applied to distinguish the ophthalmic gels and the other types of ophthalmic preparations. ① The elastic modulus should be greater than the viscous modulus for the ophthalmic gels in the range of the linear viscoelastic region. ② The ophthalmic gels should be shear thinning non-Newtonian fluid with a certain yield stress and thixotropy. ③ The dynamic viscosity of the ophthalmic gels should be greater than 0.5 Pa·S at the temperature of 25℃ with the 50 s-1 shear rate. The typical rheological indexes and parameters of the ophthalmic gels were proposed in this article. The determination methods are simple and feasible. The rheological indexes and parameters have an important significance in the prescription design, production technology and quality control of the ophthalmic gels.
Key words:    ophthalmic preparation    ophthalmic gel    rheometer    rheological parameter   
收稿日期: 2016-10-12
DOI: 10.16438/j.0513-4870.2016-0986
通讯作者: 王林波,Tel:13764071601,Fax:86-21-68619161,E-mail:wanglinbosifdc@163.com
Email: wanglinbosifdc@163.com
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