延释制剂仿制药品生命周期管理中的一致性评价要点

我国仿制药品质量和疗效一致性评价是国务院于2012年1月开始、2015年8月铺开的一项系统工程,仿制药品质量一致性评价是药品整个生命周期管理中一个非常重要的环节,但是延释仿制药品推进速度尤为缓慢。笔者借鉴国内外文献资料、结合实际工作经验,试从综合考虑与设计、处方工艺研发、中试放大与技术转移等重点环节提出几点自身认识供方家探讨。

Influences of different diluents on ignition delay of syngas at gas turbine conditions：A numerical study

Ignition delay of syngas is an important factor that affects stable operation of combustor and adding diluents to syngas can reduce NO_x emission.This paper used H_2O,CO_2 and N_2 as diluents and calculated ignition delay of syngas in temperature range of 900-1400 K and at pressures of 10 and 30 atm respectively.In high temperature range,comparing with N_2 dilution,adding H_2O and CO_2 can significantly inhibit autoignition of syngas because they have higher collision efficiencies in reaction H + O_2(+ M) = HO_2(+ M).As for low temperature conditions,adding H_2O can increase reactivity of syngas,especially under high pressure,because of its high collision efficiency in reaction H_2O_2(+ M) = 2OH(+ M).Comparing with different dilution rates shows that for syngas and operating conditions in this paper,adding N_2 mainly influences temperature rising process of syngas combustion,thus inhibiting reactivity of syngas.In addition,this paper calculated ignition delay of syngas at different equivalence ratios(φ= 0.5,1.0).Higher equivalence ratio(φ≤1) means that less air(especially N_2) needs to be heated,thus promoting ignition of syngas,

调释制剂及其专利在药品生命周期管理的作用

探讨调释制剂在专利药生命周期管理的作用。通过三个调释制剂优化生命周期管理的案例,说明药品生命周期的特点、专利在药品生命周期管理的作用、优化药品生命周期管理的调释制剂方法。开发原有活性成分的调释制剂可以延长药物的生命周期;还应重视制剂手段在优化生命周期管理的作用,加强和完善药品的知识产权在平衡仿制与创新中的作用。