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2019, v.29(10) 681-683

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胺碘酮在0.9%氯化钠、5%葡萄糖和木糖醇注射液中的稳定性考察
Compatibility of Amiodarone Hydrochloride Injection in 0. 9% Sodium Chloride,5% Glucose and Xylitol Injection

张炳镰;陈绍芳;
ZHANG Binglian;CHEN Shaofang;Foshan Women and Children Hospital;Shunde Hospital of Southern Meducal University/The First People's Hospital of Shunde;

摘要(Abstract):

目的研究盐酸胺碘酮注射液在临床常用3种输液(0.9%氯化钠注射液、5%葡萄糖注射液和木糖醇注射液)配伍溶液中的稳定性。方法采用高效液相色谱(HPLC)法测定盐酸胺碘酮输液剂配伍溶液中不同时间点(5 h内)的含量变化,色谱条件为Agilent TC-C_(18)(2)色谱柱(250 mm×4.6 mm,5μm),流动相甲醇∶三乙胺-磷酸缓冲液(p H 3.2,65∶35,V/V),波长为242 nm,流速1.0 m L·min(-1),柱温30℃,并观察其外观性状和p H的变化情况。结果盐酸胺碘酮注射液在0.45~3.6 mg·m L(-1),柱温30℃,并观察其外观性状和p H的变化情况。结果盐酸胺碘酮注射液在0.45~3.6 mg·m L(-1)浓度范围内的线性关系良好(R(-1)浓度范围内的线性关系良好(R2=0.999 7),日内RSD值为2.23%,3种盐酸胺碘酮的配伍溶液在不同时间点的p H值、含量及外观性状等比较无显著变化。结论盐酸胺碘酮与0.9%氯化钠注射液、5%葡萄糖注射液和木糖醇注射液配伍后(室温下)5 h内其含量、外观和p H值均无明显变化,其配伍稳定性好。
OBJECTIVE To observe the compatibility of amiodarone hydrochloride injection in mixing 3 kinds of infusions( 0.9%sodium-chloride injection,5% glucose injection and xylitol injection). METHODS The contents of amiodarone hydrochloride in mixing 3 kinds of infusions were determined at different time within 5 h by HPLC,the conditions of HPLC were agilent TC-C_(18)( 2) analysiscolumn( 250 mm× 4.6 mm,5 μm),mobile phase methanol: triethylamine-phosphate( p H 3. 2,65 ∶ 35,V/V),flow-rate1.0 m L·min2=0.999 7),日内RSD值为2.23%,3种盐酸胺碘酮的配伍溶液在不同时间点的p H值、含量及外观性状等比较无显著变化。结论盐酸胺碘酮与0.9%氯化钠注射液、5%葡萄糖注射液和木糖醇注射液配伍后(室温下)5 h内其含量、外观和p H值均无明显变化,其配伍稳定性好。
OBJECTIVE To observe the compatibility of amiodarone hydrochloride injection in mixing 3 kinds of infusions( 0.9%sodium-chloride injection,5% glucose injection and xylitol injection). METHODS The contents of amiodarone hydrochloride in mixing 3 kinds of infusions were determined at different time within 5 h by HPLC,the conditions of HPLC were agilent TC-C_(18)( 2) analysiscolumn( 250 mm× 4.6 mm,5 μm),mobile phase methanol: triethylamine-phosphate( p H 3. 2,65 ∶ 35,V/V),flow-rate1.0 m L·min(-1),column temperature 30 ℃,detection wavelength 242 nm. Moreover the appearance of the solution was observed,and the pH values of compatible solution were determined. RESULTS Amiodarone hydrochloride was liner in the range of amiodarone hydrochloride 0.45-3. 6 mg·m L(-1),column temperature 30 ℃,detection wavelength 242 nm. Moreover the appearance of the solution was observed,and the pH values of compatible solution were determined. RESULTS Amiodarone hydrochloride was liner in the range of amiodarone hydrochloride 0.45-3. 6 mg·m L(-1)( R(-1)( R2= 0. 999 7),the intra-day RSD value was 2. 23,the pH value,content and appearance of hydrochloric amiodarone injection with three infusions had no significant change after 5 h at room temperature. CONCLUSION Amiodarone hydrochloric injection remained stable in three kinds of infusions respectively with 5 h.

关键词(KeyWords): 高效液相色谱法;盐酸胺碘酮;配伍;稳定性
HPLC;amiodarone hydrochloride;compatibility

Abstract:

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作者(Authors): 张炳镰;陈绍芳;
ZHANG Binglian;CHEN Shaofang;Foshan Women and Children Hospital;Shunde Hospital of Southern Meducal University/The First People's Hospital of Shunde;

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