注射用埃索美拉唑钠在不同溶媒中及与不同药物配伍的稳定性观察
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摘要
目的观察注射用埃索美拉唑钠在不同溶媒中及与不同药物配伍的稳定性。方法将40 mg注射用埃索美拉唑钠分别溶于100 m L的0.9%氯化钠、木糖醇注射液、10%葡萄糖、5%葡萄糖、5%葡萄糖氯化钠、果糖注射液,分别于0、0.5、1、2、3、4、6、8、12 h采用HPLC法测定溶液中埃索美拉唑钠浓度,同时观察溶液外观变化,测定p H值。筛选配伍后稳定性最佳的溶媒,配置埃索美拉唑钠溶液,将100 m L埃索美拉唑钠溶液分别与10 m L维生素C、乳酸左氧氟沙星、复方氨基酸、维生素B6、盐酸甲氧氯普胺、盐酸昂丹司琼、葡萄糖酸钙、痰热清注射液、热毒宁注射液、甘露醇注射液进行配伍,观察配伍后0、0.5、1、2、3、4、6、8、12 h溶液颜色变化。结果注射用埃索美拉唑钠溶于0.9%氯化钠溶液及木糖醇注射液后,溶液p H值及药物浓度在12 h内均处于稳定状态;溶于其他溶溶媒12 h内PH值及药物浓度均有降低。选取0.9%氯化钠溶液作为注射用埃索美拉唑钠的溶媒。埃索美拉唑钠与维生素C注射液配伍8 h后溶液颜色改变,与乳酸左氧氟沙星、复方氨基酸、维生素B6、盐酸甲氧氯普胺、盐酸昂丹司琼、葡萄糖酸配伍后6 h溶液颜色改变,与痰热清注射液、热毒宁注射液配伍后4 h溶液颜色改变,与甘露醇注射液配伍后1 h溶液颜色即发生变化。结论注射用埃索美拉唑钠以0.9%氯化钠为溶媒溶液p H值和药物浓度相对稳定;该药与痰热清注射液、热毒宁注射液、甘露醇注射液等配伍后短时内溶液颜色易出现变化,临床用药中需注意。
Objective To observe the stability of esomeprazole sodium fro injection in different solvent and different drug compatibility. Methods Forty mg esomeprazole sodium for injection was respectively dissolved in 100 m L of 0. 9%sodium chloride,xylitol,10% glucose,5% glucose,5% fructose and glucose and sodium chloride injection. The concentrations of esomeprazole sodium in different solvents at 0,0. 5 h,1 h,2 h,3 h,4 h,6 h,8 h and 12 h were detected by HPLC,and we also observed the changes in appearance and measured p H value. The best solvent with stable drug compatibility was used to mix with esomeprazole sodium solution. The esomeprazole sodium solution of 100 m L was repsectively mixed with 10 m L vitamin C,levofloxacin lactate,compound amino acid,vitamin B6,hydrochloric acid methoxy metoclopramide,ondansetron hydrochloride our Joan,glucose acid calcium,Tanreqing injection Reduning injection and mannitol injection. The color change of compatibility was observed at 0,0. 5 h,1 h,2 h,3 h,4 h,6 h,8 h and 12 h. Results When the esomeprazole sodium for injection was dissolved in 0. 9% sodium chloride and xylitol within 12 h,the PH value and drug concentration were in a stable state; when dissolved in other solutions within 12 h,the PH value and drug concentration were decreased. The 0. 9% sodium chloride injection was selected as esomeprazole sodium solvent,When we mixed esomeprazole sodium with vitamin C,the color changed after 8 h; when we mixed esomeprazole sodium with levofloxacin lactate,compound amino acid,vitamin B6,hydrochloric acid methoxy metoclopramide,ondansetron hydrochloride our Joan and gluconic acid,the color changed after 6 h; and when we mixed esomeprazole sodium with Tanreqing injection and Reduning injection,the color changed after 4 h and when we mixed with mannitol injection,the color changed after 1 h.Conclusion The PH value and drug concentration were in a stable state when the esomeprazole sodium for injection was dissolved in 0. 9% sodium chloride,and the color changed in a short time when the esomeprazole sodium was compatible with Tanreqing injection,Reduning injection and mannitol injection,thus the clinical medication should be paid attention to.
Objective To observe the stability of esomeprazole sodium fro injection in different solvent and different drug compatibility. Methods Forty mg esomeprazole sodium for injection was respectively dissolved in 100 m L of 0. 9%sodium chloride,xylitol,10% glucose,5% glucose,5% fructose and glucose and sodium chloride injection. The concentrations of esomeprazole sodium in different solvents at 0,0. 5 h,1 h,2 h,3 h,4 h,6 h,8 h and 12 h were detected by HPLC,and we also observed the changes in appearance and measured p H value. The best solvent with stable drug compatibility was used to mix with esomeprazole sodium solution. The esomeprazole sodium solution of 100 m L was repsectively mixed with 10 m L vitamin C,levofloxacin lactate,compound amino acid,vitamin B6,hydrochloric acid methoxy metoclopramide,ondansetron hydrochloride our Joan,glucose acid calcium,Tanreqing injection Reduning injection and mannitol injection. The color change of compatibility was observed at 0,0. 5 h,1 h,2 h,3 h,4 h,6 h,8 h and 12 h. Results When the esomeprazole sodium for injection was dissolved in 0. 9% sodium chloride and xylitol within 12 h,the PH value and drug concentration were in a stable state; when dissolved in other solutions within 12 h,the PH value and drug concentration were decreased. The 0. 9% sodium chloride injection was selected as esomeprazole sodium solvent,When we mixed esomeprazole sodium with vitamin C,the color changed after 8 h; when we mixed esomeprazole sodium with levofloxacin lactate,compound amino acid,vitamin B6,hydrochloric acid methoxy metoclopramide,ondansetron hydrochloride our Joan and gluconic acid,the color changed after 6 h; and when we mixed esomeprazole sodium with Tanreqing injection and Reduning injection,the color changed after 4 h and when we mixed with mannitol injection,the color changed after 1 h.Conclusion The PH value and drug concentration were in a stable state when the esomeprazole sodium for injection was dissolved in 0. 9% sodium chloride,and the color changed in a short time when the esomeprazole sodium was compatible with Tanreqing injection,Reduning injection and mannitol injection,thus the clinical medication should be paid attention to.
引文
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[6]李旭梅,涂厉标.奥美拉唑的化学配伍禁忌及药物相互作用[J].中国临床药学杂志,2013,18(5):320-322.
[7]王健苗.埃索美拉唑镁联合盐酸依托必利分散片治疗反流性食管炎40例[J].医药导报,2013,29(10):1311-1313.
[8]马林,黄厚武,万元胜,等.注射用奥美拉唑在配制过程中变色问题[J].医药导报,2014,28(3):374.
[9]陈刚.两种埃索美拉唑制剂的人体生物等效性研究[J].中国药房,2014,20(2):116-117.
[10]宋超,郑磊,李娟,等.埃索美拉唑与第1代质子泵抑制剂对幽门螺旋杆菌感染疗效比较Meta分析[J].中国现代应用药学,2013,30(8):914-916.
[11]Hu XC.The efficacy comparison of esomeprazole and omeprazole to treat with the patients Helicobacter pylori(Hp)positive chronic gastritis[J].Strait Pharm J,2012,24(5):67-69.
[12]李婷婷,郑子栋.RP-HPLC法测定埃索美拉唑钠的有关物质[J].药物分析杂志,2013,33(4):656-657.
[2]霍花,楽智鹏,陈胜新.基于多元线性回归的医院药剂科生产率影响因素分析[J].药学实践杂志,2011,12(5):112-113.
[3]王延华.医院药剂科药品质量管理体会[J].中国伤残医学,2014,11(1):147-148.
[4]胡珍梅.医院药剂科管理模式之我见[J].中国医药指南,2014,12(31):369-372.
[5]张婷,梁伟,刘芳.奥美拉唑的安全性评价及风险管理[J].中国医院用药评价与分析,2012,12(8):681-683.
[6]李旭梅,涂厉标.奥美拉唑的化学配伍禁忌及药物相互作用[J].中国临床药学杂志,2013,18(5):320-322.
[7]王健苗.埃索美拉唑镁联合盐酸依托必利分散片治疗反流性食管炎40例[J].医药导报,2013,29(10):1311-1313.
[8]马林,黄厚武,万元胜,等.注射用奥美拉唑在配制过程中变色问题[J].医药导报,2014,28(3):374.
[9]陈刚.两种埃索美拉唑制剂的人体生物等效性研究[J].中国药房,2014,20(2):116-117.
[10]宋超,郑磊,李娟,等.埃索美拉唑与第1代质子泵抑制剂对幽门螺旋杆菌感染疗效比较Meta分析[J].中国现代应用药学,2013,30(8):914-916.
[11]Hu XC.The efficacy comparison of esomeprazole and omeprazole to treat with the patients Helicobacter pylori(Hp)positive chronic gastritis[J].Strait Pharm J,2012,24(5):67-69.
[12]李婷婷,郑子栋.RP-HPLC法测定埃索美拉唑钠的有关物质[J].药物分析杂志,2013,33(4):656-657.