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本文根据正交设计和单纯形法的特点,将正交设计与单纯形法组合运用,名之为正交设计一单纯形优化方法。通过对复方降压片中四种成分进行RP-HPLC分离优化,实验证明,该法简便、有效;同时建立了相应的定量分析方法。其中维生素B_6、维生素B_1、硫酸双肼酞嗪和双氢克尿塞的平均回收率及变异系数分别为99.8%,CV%:1.2;100.0%,CV%=1.5;99.7%,CV%=1.6和99.9%,CV%=1.6(n=26),达到制剂分析的要求。
Based on the characteristics of the orthogonal design and the simplex method, this paper combines the orthogonal design with the simplex method. The design of orthogonal design is a simplex optimization method. The RP-HPLC separation and optimization of the four components of the compound antihypertensive tablets showed that the method was simple and effective, and the corresponding quantitative analysis method was established. The average recovery and coefficient of variation for vitamin B 6 , vitamin B 1 , dipyridllium sulfate and hydrochlorothiazide were 99.8%, CV%: 1.2, 100.0%, CV% = 1.5, 99.7%, and CV% = 1.6 and 99.9%, respectively. CV% = 1.6 (n = 26) to meet the formulation analysis requirements.