硅橡胶质量参数与氟尿嘧啶植入剂释放度的相关性研究

Study on the correlation between the quality parameters of silicone rubber and the releasing of fluorouracil implants

目的分析硅橡胶分子量及黏度特性对氟尿嘧啶植入剂释放度的影响。方法依据GN/T21863-2008标准和《中国药典》对不同批号硅橡胶的分子量分布和黏度进行检测,记录数均分子量、分子量分布和黏度,采用相同制剂工艺制备20份不同硅橡胶的小试样品,依据国家药品标准WS1-(X-103)-2005Z对小试样品的释放度进行检测,以数均分子量(X1)、分子量分布(X2)和黏度(X3)作为X变量,以120h释放度结果作为Y变量,使用Minitab 16.0软件进行多元回归分析,确定硅橡胶关键质量参数。结果多元回归分析表明,数均分子量和黏度参数是关键质量参数(P<0.05),分子量分布为非关键质量参数(P>0.05);120h释放度的线性回归方程:Y=-0.3+3.76 X1+0.267 X3。结论硅橡胶数均分子量和黏度是影响氟尿嘧啶植入剂释放度的关键质量参数,产品生产过程中应依据制剂工艺参数对硅橡胶的制备进行严格控制,从而最大程度降低硅橡胶对产品质量稳定性造成的影响。

Objective To analyze the effect of the molecular weight and viscosity of silicone rubber on the release of fluorouracil implants.Methods According to GN/T21863-2008 standard and Chinese Pharmacopoeia,the molecular weight and viscosity of different batches silicone rubber were tested,number average molecular weight,molecular weight distribution and viscosity were recorded,which as X variables.20 different silicone rubber samples were produced by same preparation process,and WS1-(X-103)-2005Z were used to test the release of each sample,which as Y variable.Minitab 16 software was used to determine the key quality parameters of silicon rubber by multiple regression analysis.Results Number average molecular weight and viscosity were the key quality parameters of silicon rubber,P<0.05,molecular weight distribution was not the key quality parameter of silicon rubber,P>0.05;The linear regression equation was:Y=-0.3+3.76 X 1+0.267 X 3.Conclusion Number average molecular weight and viscosity of silicone rubber were the key factors affecting the quality parameters of fluorouracil implants releasing,thus strictly control treatment should been implemented on the two quality parameters during production process,for reducing the effect of silicone rubber on the quality stability of the product maximally.