【热毒宁注射液与左氧氟沙星、加替沙星配伍的稳定性研究】盐酸左氧氟沙星滴眼液
摘 要 目的：探究热毒宁与左氧氟沙星、加替沙星配伍的稳定性。方法：室温25 ℃观察不同浓度热毒宁与左氧氟沙星、加替沙星两种混合液90 min内的外观、pH及吸收光谱图变化。结果：热毒宁与左氧氟沙星、热毒宁与加替沙星在较高浓度混合后立即出现浑浊，90 min内浑浊度不变；两次较低浓度混合液外观未见异常，pH 及热毒宁相对百分含量变化不大，而吸收光谱图与理论加和图谱比较，出现明显位移及波峰降低。结论：热毒宁与左氧氟沙星、加替沙星两种药物无论浓度高低均存在配伍禁忌。
关键词 热毒宁 左氧氟沙星 加替沙星 吸收光谱 配伍禁忌
中图分类号：R286；R942 文献标识码：B 文章编号：1006-1533(2012)15-0024-04
Compatible stability of Reduning injection with levofloxacin and gatifloxacin
LIU Hui-ru1, LU Xue-jun1, WANG Yan-qing2
(Hebei Normal University of Science and Technology, Qinhuangdao 066004, China;
Hebei Qinhuangdao Hospital Maternity and Child, Qinhuangdao 066004 , China）
ABSTRACT Objective: To investigate the compatible stability of Reduning injection with levofloxacin and gatifloxacin. Method: We observed the appearance variation of the mixtures of different concentrations of Reduning injection with levofloxacin and gatifloxacin, and measured pH and absorption spectrum of the mixtures at 25℃. Result: The mixtures with higher concentrations of Reduning injection became turbid immediately and the turbidity was kept unchanged within 90 min. The appearance of the mixtures with lower concentrations of Reduning injection was kept unchanged, however, pH of and Reduning relative contents in the mixtures showed a little change. An obvious peak shift and peak value reduction were observed when comparison was made between the absorption spectrum and the theoretically additive spectrum. Conclusion: Regardless of the concentrations of Reduning injection, there was incompatibility between Reduning injection and levofloxacin or gatifloxacin.
KEY WORDS Reduning injection; levofloxacin; gatifloxacin; absorption spectrum; incompatibility
热毒宁注射液是由青蒿、金银花、栀子等制成的澄明液体，主要成份为绿原酸、栀子苷，具有清热、疏风、解毒之功效。临床上常与左氧氟沙星、加替沙星联合应用以治疗各种感染性疾病。有关热毒宁与其它药物配伍稳定性研究及配伍禁忌的报道较多[1-4] ，但尚未见有关热毒宁与左氧氟沙星、加替沙星两种药物配伍稳定性的报道。本文在不同药物浓度和不同观测时间下进行配伍观察和相关测定，旨在探讨热毒宁与左氧氟沙星、加替沙星配伍的稳定性，为临床应用提供参考。
1 材料与方法
1.1 仪器
U-4100型紫外-可见-近红外光谱仪( 日本日立公司)；CT-6021A pH检测仪（深圳市力源检测仪器有限公司）。
1.2 药品
热毒宁注射液由江苏康缘药业股份有限公司生产，批号100910；左氧氟沙星氯化钠注射液(0.2 g/100 ml)由四川科伦药业股份有限公司生产，批号 G10121908-1 ；加替沙星氯化钠注射液(0.2 g/100 ml)由成都倍特药业有限公司生产，批号，20100805；0.9%氯化钠注射液由吉林科伦康乃尔制药有限公司生产，批号 S090804I2 。
1.3 贮备液的配制
精密量取热毒宁注射液4 ml置于100 ml容量瓶中，用 0.9% 氯化钠溶液稀释至刻度（浓度0.04 ml/ml）, 摇匀备用（贮备液）；另将热毒宁用0.9% 氯化钠溶液配制成 0.15 ml/ml 和0.10 ml/ml 两种浓度；左氧氟沙星氯化钠注射液和加替沙星氯化钠注射液，用0.9% 氯化钠溶液分别稀释成 2.00 mg/ml和1.00 mg/ml 两种浓度。
1.4 方法
1.4.1 外观及 pH的检测