Objective To study the impact of consistency evaluation policy on pharmaceutical enterprises from four aspects:reference preparations,evaluation methods,input costs,and market competitions,and government incentives fo...Objective To study the impact of consistency evaluation policy on pharmaceutical enterprises from four aspects:reference preparations,evaluation methods,input costs,and market competitions,and government incentives for generic drug manufacturers,so as to put forward relevant suggestions.Methods Literature research method and statistical analysis method were used to provide data support for paper writing,making suggestions,and enhancing the predictability of policy.Results and Conclusion Some pharmaceutical enterprises faced difficulties in obtaining reference preparations,high input costs for exploring evaluation methods,and greater market competition.Consistency evaluation is a key measure to comprehensively improve the quality and efficacy of generic drugs.However,difficulties in obtaining reference preparations,high input costs and complex evaluation methods all affect the enthusiasm of companies.Therefore,national and local regulatory agencies have issued some supporting policies,which should be improved to assist enterprises in conducting consistency evaluations.展开更多
目的建立利巴韦林胶囊溶出曲线测定方法,考察国内利巴韦林胶囊溶出行为,为该品种仿制药质量一致性评价工作提供实验依据。方法采用《中国药典》2010年版（二部）附录ⅩC第一法（篮法）,转速50 r/min,分别以p H 1.2盐酸溶液、p H 4.5醋...目的建立利巴韦林胶囊溶出曲线测定方法,考察国内利巴韦林胶囊溶出行为,为该品种仿制药质量一致性评价工作提供实验依据。方法采用《中国药典》2010年版（二部）附录ⅩC第一法（篮法）,转速50 r/min,分别以p H 1.2盐酸溶液、p H 4.5醋酸盐缓冲液、p H 6.8磷酸盐缓冲液、水为溶出介质,溶出介质体积900 m L,于不同时间点取样测定并绘制4种溶出介质下的溶出曲线。采用高效液相色谱法进行溶出度测定。色谱柱为C18柱,流动相为4 g/L的磷酸二氢钠溶液（用5%氢氧化钠溶液调节p H至5.0±0.05）-乙腈（98︰2）,流速为1.0 m L/min,检测波长为225 nm,进样量为10μL。结果利巴韦林供试品溶液浓度在2.5~200μg/m L范围内与峰面积呈良好的线性关系（r=1）;精密度、稳定性试验的RSD≤0.5%,4种溶出介质中平均回收率分别为101.3%、100.7%、100.2%和100.4%。p H4.5和p H6.8溶出介质中各企业胶囊溶出行为比较一致并可以迅速溶出,p H1.2和水溶出介质中溶出行为差异较大,且有部分企业不能达到15 min的平均溶出量大于85%。结论建立的溶出曲线测定方法准确、可靠。国产利巴韦林胶囊之间溶出行为存在差异,其制剂工艺水平还有提升的空间。展开更多
文摘Objective To study the impact of consistency evaluation policy on pharmaceutical enterprises from four aspects:reference preparations,evaluation methods,input costs,and market competitions,and government incentives for generic drug manufacturers,so as to put forward relevant suggestions.Methods Literature research method and statistical analysis method were used to provide data support for paper writing,making suggestions,and enhancing the predictability of policy.Results and Conclusion Some pharmaceutical enterprises faced difficulties in obtaining reference preparations,high input costs for exploring evaluation methods,and greater market competition.Consistency evaluation is a key measure to comprehensively improve the quality and efficacy of generic drugs.However,difficulties in obtaining reference preparations,high input costs and complex evaluation methods all affect the enthusiasm of companies.Therefore,national and local regulatory agencies have issued some supporting policies,which should be improved to assist enterprises in conducting consistency evaluations.
文摘目的建立利巴韦林胶囊溶出曲线测定方法,考察国内利巴韦林胶囊溶出行为,为该品种仿制药质量一致性评价工作提供实验依据。方法采用《中国药典》2010年版（二部）附录ⅩC第一法（篮法）,转速50 r/min,分别以p H 1.2盐酸溶液、p H 4.5醋酸盐缓冲液、p H 6.8磷酸盐缓冲液、水为溶出介质,溶出介质体积900 m L,于不同时间点取样测定并绘制4种溶出介质下的溶出曲线。采用高效液相色谱法进行溶出度测定。色谱柱为C18柱,流动相为4 g/L的磷酸二氢钠溶液（用5%氢氧化钠溶液调节p H至5.0±0.05）-乙腈（98︰2）,流速为1.0 m L/min,检测波长为225 nm,进样量为10μL。结果利巴韦林供试品溶液浓度在2.5~200μg/m L范围内与峰面积呈良好的线性关系（r=1）;精密度、稳定性试验的RSD≤0.5%,4种溶出介质中平均回收率分别为101.3%、100.7%、100.2%和100.4%。p H4.5和p H6.8溶出介质中各企业胶囊溶出行为比较一致并可以迅速溶出,p H1.2和水溶出介质中溶出行为差异较大,且有部分企业不能达到15 min的平均溶出量大于85%。结论建立的溶出曲线测定方法准确、可靠。国产利巴韦林胶囊之间溶出行为存在差异,其制剂工艺水平还有提升的空间。
