羧甲纤维素钠流变特性及其对制剂助悬影响的研究

Rheology of Carboxymethylcellulose Sodium and its Effect on Suspension Performance

目的:探讨羧甲纤维素钠作为助悬剂时其结构参数、黏度与混悬剂稳定性的相关性,指导混悬剂处方筛选。方法:采用流变仪对不同相对分子质量、取代度、浓度的羧甲纤维素钠溶液流变特性进行研究,并在同一剂量的处方中加入不同质量的羧甲纤维素钠作为助悬剂,观察混悬液的稳定性。结果:当羧甲纤维素钠水溶液浓度在0.5%~4%时,具有假塑性,是一种典型的剪切变稀流体。相对分子质量大、取代度高、黏度大的羧甲纤维素钠有利于体系的稳定。较高浓度的羧甲纤维素钠有助于体系的稳定性。结论:羧甲纤维素钠的结构参数、浓度与溶液的流变性以及混悬液的稳定性相关。黏度值可以作为混悬制剂处方筛选依据之一。

Objective: To discuss the correlation between structural parameters,viscosity and suspension stability of carboxymethylcellulose sodium as a suspension aid in order to guide the formulation screening of suspension. Methods: Rheological properties of carboxymethylcellulose sodium solution with different molecular weight,degree of substitution and concentration were studied by a rheometer. The same dose of carboxymethylcellulose sodium was added to the formulation as a suspension aid and the stability of suspension was observed. Results: When the concentration was between 0.5% and 4%,carboxymethylcellulose sodium aqueous solution showed pseudoplasticity and formed typical shear thinning fluid. Carboxymethylcellulose sodium with high molecular weight,high degree of substitution and high viscosity was beneficial to the stability of system. Higher concentration of carboxymethylcellulose sodium contributed to the stability of system. Conclusion: The structural parameters and concentration of carboxymethylcellulose sodium are related to the rheology of solution and the stability of suspension. Viscosity value can be used as one basis for formulation screening of suspension preparations.