CAJ | 학술논문

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1000 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。
목적：우선10%록화갑구복용액처방급배제방법。방법채용정교시험，이5%간분을지용액적용량（mL）、수온（℃）、용해용수량（mL）작위시험인소，취5개수평，조성3인소5수평정교시험，안표준정교표 L25（53）안배。이10%록화갑구복용액적외관성상화미생물한량적종합평분위고찰지표。결과최가처방위：록화갑100 g 、5%간분을지용액6~7 mL、가상온순화수지1000 mL；최가제비방법：장록화갑용해우수온위60℃적600 mL순화수중，재교반상태하만만가입5%간분을지용액6~7 mL，교균，최후가상온순화수지량。결론정교설계법우선적10%록화갑구복용액처방성질은정，제비방법간편역행。
Pbjective 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 solu-tion( 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. ResuIts The best formula was potassium chloride 100 g,5% hydroxy ethyl benzene solution 6~7 mL and normal temperature puri-fied water add to 1 000 mL. The best preparation method was purified water 600 mL of 60 ℃ dissolving the potassium chlo-ride,slowly adding 5% hydroxy ethyl benzene solution 6~7 mL in the condition of stirring,till evenly,finally joining the normal temperature purified water. ConcIusion The property of best 10% potassium chloride oral solution by orthogonal experiment was stable. The preparation method was simple and easy.