阿奇霉素粉-液双室袋与传统粉针配制的比较研究
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摘要
目的通过实验系统评价新型阿奇霉素粉-液双室袋的便利性,安全性和准确性。方法采用计算配制时间来评价双室袋的便利性;通过对配制过程中出现的刺伤、划伤等伤害人次,和配制后不溶性微粒数来评价双室袋的安全性;通过高效液相色谱法检测配制浓度和残留量来评价双室袋配制的准确性。结果双室袋配制时间明显少于粉针配制时间[(22.5±4.7)s vs(89.2±15.5)s,P<0.05];配制过程中不会造成人员伤害,配制后的不溶性微粒数明显少于粉针配制(P<0.05);由于双室袋配制过程中不产生药物残留,故其药物浓度更接近理论值。结论新型阿奇霉素粉-液双室袋在便利性、安全性和准确性上都明显优于粉针配制,具有显著的临床应用优势。
Objective To systematically evaluate the convenience, safety and accuracy of a new powder-liquid double chamber bag packing of azithromycin. Methods The convenience of the dual-chamber bag was evaluated by calculating the preparation time. The safety of the dual-chamber bag was determined by the occurrence of stabbing and cutting injures during the preparation, as well as the number of insoluble particles after the preparation. The accuracy of the dual-chamber bag was estimated by the actu al concentration and drug residue amounts measured by high performance liquid chromatography(HPLC). Results The preparation time of the dual-chamber bag was significantly less than that of the traditional powder [(22.5±4.7)s vs(89.2±15.5)s, P<0.05]. Personal injury was not found during the preparation process using the dual-chamber bag, and significantly less insoluble particles was detected after the process. And the drug concentration of azithromycin is closer to the theoretical value because of no drug residuals. Conclusion The new dual-chamber bag packing of azithromycin is superior to the traditional powder in convenience, safety, and accuracy, which suggests an outstanding advantage in clinical application.
Objective To systematically evaluate the convenience, safety and accuracy of a new powder-liquid double chamber bag packing of azithromycin. Methods The convenience of the dual-chamber bag was evaluated by calculating the preparation time. The safety of the dual-chamber bag was determined by the occurrence of stabbing and cutting injures during the preparation, as well as the number of insoluble particles after the preparation. The accuracy of the dual-chamber bag was estimated by the actu al concentration and drug residue amounts measured by high performance liquid chromatography(HPLC). Results The preparation time of the dual-chamber bag was significantly less than that of the traditional powder [(22.5±4.7)s vs(89.2±15.5)s, P<0.05]. Personal injury was not found during the preparation process using the dual-chamber bag, and significantly less insoluble particles was detected after the process. And the drug concentration of azithromycin is closer to the theoretical value because of no drug residuals. Conclusion The new dual-chamber bag packing of azithromycin is superior to the traditional powder in convenience, safety, and accuracy, which suggests an outstanding advantage in clinical application.
引文
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[9]孙利华,伍红艳,刘美娟,等.非PVC粉-液双室输液软袋的价值分析[J].中国医院药学杂志,2013,33(3):244-24 6.
[2]高春林,蒋明海.阿奇霉素制剂研究进展[J].齐齐哈尔大学学报:自然科学版,2007,23(5):14-18.
[3]程开生,尹莉芳,周建平.双室袋输液发展概况[J].药学进展,2006,30(11):498-501.
[4]伍红艳,吴述敏,崔夏子,等.非PVC粉-液双室输液软袋与传统型输液包装的功能比较[J].中国药学杂志,2011(6):474-476.
[5]国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:114-115.
[6]李英,王宇航,赵立波,等.双室袋法与注射器法配制静脉输液的不溶性微粒比较[J].中国药学杂志,2013,48(22):1969-1971.
[7]纪立伟,胡欣,左明新,等.光阻法检查常用注射液丁基胶塞穿刺落屑情况[J].中国药学杂志,2006,41(11):872-874.
[8]李珺,刘守玉,马洪滨.概述新型双室袋生产设备的发展[J].中国医学装备,2012,9(11):67-70.
[9]孙利华,伍红艳,刘美娟,等.非PVC粉-液双室输液软袋的价值分析[J].中国医院药学杂志,2013,33(3):244-24 6.