正交试验优选10%氯化钾口服溶液处方及配制方法  

Formula and preparation method of best 10% Potassium Chloride Oral Solution by orthogonal experiment

作　　者：张海霞[1] 冯锐[1] 胡丽敏[1] 孙绍伟[1] 马静[1] 王玉[1] 

机构地区：[1]滨州医学院附属医院,山东滨州256603

出　　处：《药学研究》2015年第1期26-28,共3页Journal of Pharmaceutical Research

摘　　要：目的优选10%氯化钾口服溶液处方及配制方法.方法采用正交试验,以5%羟苯乙酯溶液的用量（mL）、水温（℃）、溶解用水量（mL）作为试验因素,取5个水平,组成3因素5水平正交试验,按标准正交表L25（53）安排.以10%氯化钾口服溶液的外观性状和微生物限量的综合评分为考察指标.结果最佳处方为：氯化钾100g、5%羟苯乙酯溶液6～7mL、加常温纯化水至1000mL;最佳制备方法：将氯化钾溶解于水温为60℃的600mL纯化水中,在搅拌状态下慢慢加入5%羟苯乙酯溶液6～7mL,搅匀,最后加常温纯化水至量.结论正交设计法优选的10%氯化钾口服溶液处方性质稳定,制备方法简便易行.Objective To optimize the formula and preparation method of best 10% Potassium Chloride Oral Solution by orthogonal experiment. Methods The orthogonal experiment was used. The dosage of 5% hydroxy ethyl benzene solution(m L),water temperature(℃) and dissolving water quantity(m L) were experimental factors. Adopting 5 levels together composed the orthogonal experiment of three actors and five levels arranged according to standard orthogonal table L25(53).The appearance of 10% potassium chloride oral solution and the composite score of microbial limit were indexes. Results The best formula was potassium chloride 100 g,5% hydroxy ethyl benzene solution 6 ~ 7 m L and normal temperature purified water add to 1 000 m L. The best preparation method was purified water 600 m L of 60 ℃ dissolving the potassium chloride,slowly adding 5% hydroxy ethyl benzene solution 6 ~ 7 m L in the condition of stirring,till evenly,finally joining the normal temperature purified water. Conclusion The property of best 10% potassium chloride oral solution by orthogonal experiment was stable. The preparation method was simple and easy.

关 键 词：10%氯化钾口服溶液 制备方法 正交设计 

分 类 号：R944.1[医药卫生—药剂学]