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甲苯磺酸溴苄铵与选定大容量注射剂及添加剂的稳定性和视觉相容性。

Stability and visual compatibility of bretylium tosylate with selected large-volume parenterals and additives.

作者信息

Perentesis G P, Piltz G W, Kirshcenbaum H L, Navalakha P, Aronoff W, Cutie A J

出版信息

Am J Hosp Pharm. 1983 Jun;40(6):1010-2.

PMID:6869385
Abstract

The stability of bretylium tosylate when mixed with large-volume parenteral (LVP) solutions was assessed over a four-week period, and the compatibility of bretylium tosylate when mixed with eight frequently used drugs was evaluated. Bretylium tosylate admixtures of approximately 1 mg/ml were prepared in both polyvinyl chloride (PVC) bags and glass bottles of 5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer's injection. The admixtures were examined visually and stored for four weeks at 25 +/- 0.5 degree C under fluorescent light. The concentrations of bretylium tosylate were determined spectrophotometrically at times 0.25, 0.5, 1, 3, 8, 24, and 48 hours and twice weekly thereafter for four weeks. Spectrophotometric assays were confirmed with high-pressure liquid chromatography. Admixtures of bretylium tosylate were prepared with aminophylline, calcium gluconate, digoxin, regular insulin, lidocaine hydrochloride, phenytoin sodium, procainamide hydrochloride, and quinidine gluconate in 5% dextrose injection and 0.9% sodium chloride injection. The admixtures were examined visually for 48 hours. The concentration of bretylium tosylate did not change appreciably during the four-week study period. There were no signs of haze, precipitation, color change, or evolution of gas. There were no apparent differences in stability when comparing the glass with the PVC containers. Bretylium tosylate was also found to be compatible with all the additives tested except phenytoin sodium; a precipitate formed immediately when the latter drug was added to the bretylium tosylate solution. Bretylium tosylate was stable for four weeks in the LVP solutions studied in both glass and PVC containers. The admixtures of bretylium sodium with the other drugs were all visually compatible except those containing phenytoin sodium.

摘要

在四周的时间内评估了托西溴苄铵与大容量注射剂(LVP)溶液混合时的稳定性,并评估了托西溴苄铵与八种常用药物混合时的相容性。在聚氯乙烯(PVC)袋和玻璃瓶中,分别用5%葡萄糖注射液、0.9%氯化钠注射液和乳酸林格氏注射液制备了浓度约为1mg/ml的托西溴苄铵混合物。对这些混合物进行外观检查,并在25±0.5摄氏度的荧光灯下储存四周。在0、0.25、0.5、1、3、8、24和48小时以及此后四周每周两次用分光光度法测定托西溴苄铵的浓度。用高压液相色谱法对分光光度法测定进行了验证。在5%葡萄糖注射液和0.9%氯化钠注射液中,将托西溴苄铵与氨茶碱、葡萄糖酸钙、地高辛、正规胰岛素、盐酸利多卡因、苯妥英钠、盐酸普鲁卡因胺和葡萄糖酸奎尼丁混合制备混合物。对这些混合物进行48小时的外观检查。在为期四周的研究期间,托西溴苄铵的浓度没有明显变化。没有出现浑浊、沉淀、颜色变化或气体产生的迹象。比较玻璃容器和PVC容器时,稳定性没有明显差异。还发现托西溴苄铵与除苯妥英钠以外的所有测试添加剂都相容;当将后一种药物加入托西溴苄铵溶液中时,立即形成沉淀。在玻璃和PVC容器中研究的LVP溶液中,托西溴苄铵在四周内是稳定的。除含有苯妥英钠的混合物外,托西溴苄铵与其他药物的混合物在外观上都是相容的。

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