摘要
处方优化方法的合理选用对高效、经济地设计药物剂型发挥着很大的作用。目前在药剂学研究中普遍应用的统计学实验设计方法有正交设计、均匀设计、析因设计、单纯形设计及中央多点等距设计(CCD)等。本文以盐酸川芎嗪(TMPH)缓释片剂为模型药物,通过其优化设计过程,对多种优化方法的设计要求和预测能力进行了横向对比,期望能有助于处方优化方法的合理选择。
Precise and high performance experimental design, formulation optimization method and its reasonable application are very important in the development of new pharmaceutical preparations. Using tetramethy pyrazine hydrochloride (TMPH) as a model drug, different statistical optimization methods were investigated during the design of TMPH sustained release tablet, such as orthogonal design, uniform design, full factorial design, simplex lattice design and central composite design. The differences between the five statistical methods were analyzed by the response surface methodology. The result of this paper will be helpful in the reasonable selection of formulation optimization methods in the pharmaceutical development and research.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2010年第5期365-370,共6页
Chinese Journal of New Drugs
关键词
处方设计
缓释制剂
正交设计
均匀设计
中央多点等距设计
performulation
sustained release
orthogonal design
uniform design
central composite design