心包固定液的制备工艺改进及稳定性考察  

To improve the preparation process of pericardial fixation fluid and study its stability

作　　者：孙昕[1] 谷媛媛 杨雪萍[1] 刘卫[1] 

机构地区：[1]解放军88医院药剂科,山东泰安271000

出　　处：《药学实践杂志》2014年第4期288-289,296,共3页Journal of Pharmaceutical Practice

摘　　要：目的改进心包固定液的制备工艺并考察其稳定性。方法将心包固定液的制备分为A液(缓冲液)、B液(戊二醛液),配制完成后置于冰箱冷藏备用,临用前A、B两液等量混合均匀,得到新鲜配制的心包固定液。采用酸度计和羟胺盐法,以pH值和含量为指标,对消毒前、后的A液与B液,以及B液、心包固定液在常温放置、冷藏储存多种情况下进行稳定性考察。结果消毒后A液、B液的pH值及含量均有所降低,但降幅很小,且在规定范围内。临用前将A液、B液混匀,戊二醛处于碱性条件下,具有强杀菌活性和心包固定作用;稳定性考察表明,B液、心包固定液、AB混合液常温放置半年pH值和含量已不符合规定,冷藏放置1年各项指标正常,稳定性较好。结论心包固定液制备工艺的改进合理、可行,样品稳定性好,保质期延长至1年。Objective To establish a population pharmacokinetic（PPK） model of metformin in healthy Chinese subjects,and evaluate the effect of different physiological factors on pharmacokinetic parameters of metformin.Methods The preparation of pericardial fixation liquid is divided into solution A（buffer solution） and solution B（glutaraldehyde solution）,which were reserved in the refrigerator before used.Before the experiment,solution A and B were mixed evenly to make fresh pericardial fixation fluid.Stability of solution A and B before and after disinfection,solution B,pericardial fixation fluid at room temperature and 4℃ in the refrigerator were studied using pH meter and hydroxylamine salt method with pH value and the content as indexes.Results The decline of pH value and the content was slight after disinfection for both solution A and B within the prescribed scope.when glutaraldehyde was in alkaline condition after the mix of solution A and B,it was with strong bactericidal activity and pericardial fixation ability; stability study showed that pericardial fixation fluid was more stable in cold storage than at room temperature within one year.Conclusion The improved preparation process of pericardial fixation fluid is reasonable and feasible.The pericardial fixation fluid has good stability,and the quality guarantee period could be extended to one year.

关 键 词：心包固定液 制备工艺 溶液稳定性 

分 类 号：TQ460.6[化学工程—制药化工]