注射用二丁酰环磷腺苷钙与转化糖电解质注射液的配伍稳定性及辅助用药管理对策研究
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摘要
目的探讨注射用二丁酰环磷腺苷钙在转化糖电解质注射液中的稳定性及辅助用药管理。方法配制对照品溶液、供试品溶液、配伍溶液。按照《中国药典》(2015年版)的要求检查注射用二丁酰环磷腺苷钙与转化糖电解质注射液配伍溶液的颜色、澄清度、pH、不溶性微粒,采用高效液相色谱法检测配伍溶液中的药物相对百分含量。结果二丁酰环磷腺苷钙的峰形良好,保留时间为5.6min。二丁酰环磷腺苷钙在5.62~500.00μg/mL质量浓度的线性关系良好,定量限为5.62μg/mL,检测限为2.81μg/mL。二丁酰环磷腺苷钙的相对标准偏差(RSD)为0.36%,该分析方法的重复性良好。低、中、高浓度各样品在室温下放置0、1、2、4、6、12h和1、2、3、4、5、6d稳定,回收率分别为(101.3±0.89)%、(98.6±1.06)%、(99.2±0.91)%。0、1、2、4、6、12、24h后,配伍溶液Ⅰ~Ⅴ均为无色澄清液体、pH值均无明显变化。配伍溶液Ⅲ~Ⅴ的不溶性微粒符合药典的规定,Ⅰ、Ⅱ≥10μm不溶性微粒数量超出药典的规定。配伍溶液Ⅰ~Ⅴ中的二丁酰环磷腺苷钙相对百分含量符合药典要求。结论注射用二丁酰环磷腺苷钙的使用应严格掌握其适应证,并只能使用说明书规定的溶媒。
Objective To investigate the compatibility stability of calcium dibutyryladenosine cyclophosph-ate in multiple electrolytic and invert sugar injection and the management of hospital adjuvant drugs.Methods Preparation of reference solution,sample solution and compatibility solution.According to the requirements of the Chinese Pharmacopoeia(2015 Edition),the color,clarity,pH value and insoluble particles of compatibility solution with calcium dibutyryladenosine cyclophosph-ate and multiple electrolytic and invert sugar injection were examined.Results The spike of calcium dibutyryladenosine cyclophosph-ate was good,the retention time was 5.6 min.Calcium dibutyryladenosine cyclophosph-ate had a good linear relationship at the concentration of 5.62-500.00μg/mL.The limit of quantification was 5.62μg/mL and the detection limit was 2.81μg/mL.The relative standard deviation(RSD)of calcium dibutyryladenosine cyclophosph-ate was0.36%.The method was reproducible.The samples with low,medium and high concentrations were stable at room temperature for 0,1,2,4,6,12 hand 1,2,3,4,5,6 d,the recoveries were(101.3±0.89)%,(98.6±1.06)%and(99.2±0.91)%respectively.After 0,1,2,4,6,12 and 24 h,theⅠ-Ⅴof the compatible solution was colorless clarified liquid,and the pH value had no obvious change.The insoluble particles of compatible solution Ⅲ-Ⅴ accorded with the stipulation of Pharmacopoeia,and the number of insoluble particles ofⅠand Ⅱ≥10μm micron exceeded the stipulation of Pharmacopoeia.The relative percentage of the drugs in compatibility solutionsⅠ-Ⅴ met the requirements of pharmacopoeia.Conclusion The indication of calcium dibutyryladenosine cyclophosph-ate for injection should be strictly controlled and only the solvent prescribed in the instructions should be used.
Objective To investigate the compatibility stability of calcium dibutyryladenosine cyclophosph-ate in multiple electrolytic and invert sugar injection and the management of hospital adjuvant drugs.Methods Preparation of reference solution,sample solution and compatibility solution.According to the requirements of the Chinese Pharmacopoeia(2015 Edition),the color,clarity,pH value and insoluble particles of compatibility solution with calcium dibutyryladenosine cyclophosph-ate and multiple electrolytic and invert sugar injection were examined.Results The spike of calcium dibutyryladenosine cyclophosph-ate was good,the retention time was 5.6 min.Calcium dibutyryladenosine cyclophosph-ate had a good linear relationship at the concentration of 5.62-500.00μg/mL.The limit of quantification was 5.62μg/mL and the detection limit was 2.81μg/mL.The relative standard deviation(RSD)of calcium dibutyryladenosine cyclophosph-ate was0.36%.The method was reproducible.The samples with low,medium and high concentrations were stable at room temperature for 0,1,2,4,6,12 hand 1,2,3,4,5,6 d,the recoveries were(101.3±0.89)%,(98.6±1.06)%and(99.2±0.91)%respectively.After 0,1,2,4,6,12 and 24 h,theⅠ-Ⅴof the compatible solution was colorless clarified liquid,and the pH value had no obvious change.The insoluble particles of compatible solution Ⅲ-Ⅴ accorded with the stipulation of Pharmacopoeia,and the number of insoluble particles ofⅠand Ⅱ≥10μm micron exceeded the stipulation of Pharmacopoeia.The relative percentage of the drugs in compatibility solutionsⅠ-Ⅴ met the requirements of pharmacopoeia.Conclusion The indication of calcium dibutyryladenosine cyclophosph-ate for injection should be strictly controlled and only the solvent prescribed in the instructions should be used.
引文
[1]赵峻波,薛俊峰,姬馨彤,等.二丁酰环磷腺苷钙联合依达拉奉治疗急性脑出血的疗效观察[J].中华老年心脑血管病杂志,2012,14(12):1296-1297.
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[3]孙泽刚,冯泽瑞,许迎春,等.心肌缺血再灌注致急性肺损伤的机制与二丁酰环磷腺苷钙的保护效应[J].中国循证心血管医学杂志,2016,8(7):846-849.
[4]任柏林,杨清存,卢锡华.5%转化糖电解质液不同输注速度对患者围术期血糖及电解质的影响[J].临床麻醉学杂志,2015,31(9):877-879.
[5]陈瑶,刘青青,肖雨婷.转化糖电解质注射液对择期手术患者血糖及电解质的影响[J].中国医院药学杂志,2012,32(24):1991-1993.
[6]徐刚,高勐,冯艳平.转化糖电解质注射液用于老年食管癌患者的安全性分析[J].中国老年学杂志,2014,34(15):4134-4135.
[7]潘丹婷,林淑瑜,甘惠贞.注射用二丁酰环磷腺苷钙与肌苷注射液配伍稳定性考察[J].解放军药学学报,2015,31(2):155-157.
[8]陈文平,张淑波,丁婷.某院27例二丁酰环磷腺苷钙不良反应报告分析[J].中国医院药学杂志,2016,36(5):402-404.
[9]LANGILLE S E.Particulate matter in injectable drug products[J].PDA J Pharm Sci Technol,2013,67(3):186-200.
[10]HOSSAIN M A,FRICIU M,AUBIN S,et al.Stability of penicillin G Sodium diluted with 0.9%Sodium chloride injection or 5%dextrose injection and stored in polyvinyl chloride bag containers and elastomeric pump containers[J].Am J Health Syst Pharm,2014,71(8):669-673.
[11]李秋,廖华,王珊.转化糖电解质与两种药物配伍致微粒增加[J].医药导报,2012,31(2):255-256.
[12]洪远,叶建林,殷建忠,等.转化糖电解质注射液与7种临床常用药配伍禁忌分析[J].药学与临床研究,2013,21(5):570-571.
[13]GOLOCORBIN K S,ILIKOVIC I,MIKOV M.Reasons for and frequency of off-label drug use[J].Med Pregl,2015,68(1/2):35-40.
[14]AROCAS CASAV,MATEO CARMONA J,GARCA MOLINA O,et al.Off-label prescription of drugs at hospital[J].Farm Hosp,2016,40(2):63-71.
[15]KANNAN S,BAHL A,KHOSLA P P.Knowledge and perception of off-label drug use amongst prescribing physicians in a tertiary care hospital[J].Int J Risk Saf Med,2015,27(4):219-223.
[2]徐海明,张景泽,张蕾,等.人参果总皂苷联合二丁酰环磷腺苷钙治疗慢性心力衰竭合并缓慢型心律失常的疗效[J].中国老年学杂志,2017,37(6):1384-1386.
[3]孙泽刚,冯泽瑞,许迎春,等.心肌缺血再灌注致急性肺损伤的机制与二丁酰环磷腺苷钙的保护效应[J].中国循证心血管医学杂志,2016,8(7):846-849.
[4]任柏林,杨清存,卢锡华.5%转化糖电解质液不同输注速度对患者围术期血糖及电解质的影响[J].临床麻醉学杂志,2015,31(9):877-879.
[5]陈瑶,刘青青,肖雨婷.转化糖电解质注射液对择期手术患者血糖及电解质的影响[J].中国医院药学杂志,2012,32(24):1991-1993.
[6]徐刚,高勐,冯艳平.转化糖电解质注射液用于老年食管癌患者的安全性分析[J].中国老年学杂志,2014,34(15):4134-4135.
[7]潘丹婷,林淑瑜,甘惠贞.注射用二丁酰环磷腺苷钙与肌苷注射液配伍稳定性考察[J].解放军药学学报,2015,31(2):155-157.
[8]陈文平,张淑波,丁婷.某院27例二丁酰环磷腺苷钙不良反应报告分析[J].中国医院药学杂志,2016,36(5):402-404.
[9]LANGILLE S E.Particulate matter in injectable drug products[J].PDA J Pharm Sci Technol,2013,67(3):186-200.
[10]HOSSAIN M A,FRICIU M,AUBIN S,et al.Stability of penicillin G Sodium diluted with 0.9%Sodium chloride injection or 5%dextrose injection and stored in polyvinyl chloride bag containers and elastomeric pump containers[J].Am J Health Syst Pharm,2014,71(8):669-673.
[11]李秋,廖华,王珊.转化糖电解质与两种药物配伍致微粒增加[J].医药导报,2012,31(2):255-256.
[12]洪远,叶建林,殷建忠,等.转化糖电解质注射液与7种临床常用药配伍禁忌分析[J].药学与临床研究,2013,21(5):570-571.
[13]GOLOCORBIN K S,ILIKOVIC I,MIKOV M.Reasons for and frequency of off-label drug use[J].Med Pregl,2015,68(1/2):35-40.
[14]AROCAS CASAV,MATEO CARMONA J,GARCA MOLINA O,et al.Off-label prescription of drugs at hospital[J].Farm Hosp,2016,40(2):63-71.
[15]KANNAN S,BAHL A,KHOSLA P P.Knowledge and perception of off-label drug use amongst prescribing physicians in a tertiary care hospital[J].Int J Risk Saf Med,2015,27(4):219-223.