正交试验优选10%氯化钾口服溶液处方及配制方法

张海霞，冯锐，胡丽敏，孙绍伟，马静，王玉

(滨州医学院附属医院，山东 滨州 256603)

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100 g 、5%羟苯乙酯溶液6～7 mL、 加常温纯化水至1 000 mL；最佳制备方法：将氯化钾溶解于水温为60 ℃的600 mL纯化水中，在搅拌状态下慢慢加入5%羟苯乙酯溶液6～7 mL，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。

关键词：10%氯化钾口服溶液;制备方法;正交设计

作者简介：张海霞，女，主管药师，研究方向：临床药学，E-mail:byfyzhx@163.com

中图分类号：R944.1文献标识码：A

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

by orthogonal experiment

ZHANGHai-xia，FENGRui，HULi-min，SUNShao-wei，MAJing，WANGYu

(AffiliatedHospitalofBinzhouMedicalCollege,Binzhou256603，China)

Abstract：ObjectiveTo optimize the formula and preparation method of best 10% Potassium Chloride Oral Solution by orthogonal experiment.MethodsThe orthogonal experiment was used.The dosage of 5% hydroxy ethyl benzene solution(mL),water temperature(℃) and dissolving water quantity(mL) 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.ResultsThe best formula was potassium chloride 100 g,5% hydroxy ethyl benzene solution 6～7 mL and normal temperature purified water add to 1 000 mL.The best preparation method was purified water 600 mL of 60 ℃ dissolving the potassium chloride,slowly adding 5% hydroxy ethyl benzene solution 6～7 mL in the condition of stirring,till evenly,finally joining the normal temperature purified water.ConclusionThe property of best 10% potassium chloride oral solution by orthogonal experiment was stable.The preparation method was simple and easy.

Key words:10% Potassium Chloride Oral Solution;Preparation method;Orthogonal experiment

10%氯化钾溶液在临床上为口服电解质补充药，主要用于治疗和预防各种原因引起的低钾血症。由于医院制剂配制的10%氯化钾口服溶液，属于非最终灭菌制剂，易被微生物污染而变质,因此中国医院制剂规范(西药制剂)收载的10%氯化钾溶液处方中加入防腐剂5%羟苯乙酯溶液10 mL·(1 000 mL)-1[1],羟苯乙酯的含量为0.05%，以保证该制剂的质量。但在储存和应用中发现10%氯化钾口服溶液不够稳定，特别在20 ℃以下易析出许多小结晶，使得制剂性状不合格。为此，人们做了很多实验，有的从制备方法着手试验研究[2~5]，有的从防腐剂用量进行试验研究[3]。……