Title丙泊酚注射液与依托咪酯脂肪乳注射液的配伍稳定性研究
Other TitlesStudy on the Compatible Stability of Propofol Injection and Etomidate Fat Emulsion Injection
Authors白瑶
洪飚
刘玉琴
Affiliation北京大学深圳医院 广东 深圳 518036
Keywords丙泊酚注射液
依托咪酯脂肪乳注射液
配伍
稳定性
Propofol injection
Etomidate fat emulsion injection
Compatible
Stability
Issue Date2016
Publisher中国医学创新
Citation中国医学创新. 2016, 111-114.
Abstract目的:探究分析丙泊酚注射液与依托咪酯脂肪乳注射液混合溶液的配伍稳定性,为临床运用提供实验依据。方法:同一个实验组人员使用同一个移液器取丙泊酚注射液和依托咪酯注射液,按照V∶V=1∶1的比例于25℃恒温下分别存放0、1、3、5、7、9、10 h,分别测定不同时间点配伍溶液的乳剂粒径分布、ζ电位以及pH值。采用高效液相色谱(HPLC)法测定两种药物的含量。采用核磁共振波谱(NMR)法检测0、1、3、5、7、9、10 h不同时间点二者混合后的一维氢谱信号丙泊酚的酚羟基对位的芳香环质子(4-H)峰面积和依托咪酯的咪唑上两个氮原子之间的质子(5-H)峰面积。结果:通过测定,不同时间的配伍溶液的pH值分别为(7.60±0.41)、(7.50±0.39)、(7.55±0.40)、(7.62±0.43)、(7.64±0.42)、(7.58±0.40)、(7.59±0.40),不同时间点的pH值两两比较差异均无统计学意义(P>0.05)。同样,不同时间的配伍溶液的乳剂粒径分布、ζ电位两项指标两两比较差异均无统计学意义(P>0.05);通过高效液相色谱法测定不同时间的配伍溶液的含量。以0 h的药物含量为100%计算,1、3、5、7、9、10 h的配伍溶液中丙泊酚含量为(99.80±1.20)、(98.80±1.18)、(99.40±1.16)、(98.40±1.20)、(98.50±1.15)、(98.80±1.22)%,组内两两比较差异均无统计学意义(P>0.05),同样依托咪酯含量在不同时间点的含量两两组内比较,差异均无统计学意义(P>0.05)。采用核磁共振波谱法检测不同时间点二者混合后的一维氢谱信号峰面积,丙泊酚4-H在不同时间点的峰面积均在(53025430.60±58943.70)上下浮动,组内两两比较差异均无统计学意义(P>0.05)。依托咪酯5-H在不同时间点的峰面积基本在(16342703.21±3785.60)变化,组内两两比较差异均无统计学意义(P>0.05)。结论:丙泊酚注射液与依托咪酯脂肪乳注射液按照V∶V=1∶1的比例混合,乳剂粒径分布、ζ电位、pH、两种药物的含量以及一维氢谱信号丙泊酚4-H峰面积和依托咪酯5-H峰面积各项指标均无明显变化,说明两种的配伍溶液在室温下10 h内是稳定的。
Objective:To investigate and analyze the compatible stability of the injection mixture composed of Propofol and Etomidate fat emulsion,to provide a experimental basis for clinical use.Method:The same experiment group who used the same pipette to take Propofol injection and Etomidate injection.The mixture with volume ratio of Propofol injection to Etomidate fat emulsion injection equaling 1∶1,was stored for 0,1,3,5, 7,9 h and 10 h at 25 ℃,and its emulsion particle size distribution,ζ potential and pH value at different time points were measured.The content of two kinds of drugs were determined using high performance liquid chromatography method.The areas of one-dimensional H1-NMR peaks of proton para to the phenolic hydroxyl group of Propofol(4-H), and proton bonding to the C atom between the two N atoms of Etomidate(5-H) at the above time points were detected using nuclear magnetic resonance spectroscopy(NMR) method.Result:The pH values of the compatible solution at different times were (7.60±0.41),(7.50±0.39),(7.55±0.40),(7.62±0.43),(7.64±0.42), (7.58±0.40),(7.59±0.40),which showed no significant differences between any two different time points (P>0.05).Similarly,the emulsion particle size distribution and ζ potential of the compatible solution at different time points showed no significant differences (P>0.05).Calculation on drug content of 0 h was 100%,the contents of Propofol of compatible solution were(99.80±1.20),(98.80±1.18),(99.40±1.16),(98.40±1.20), (98.50±1.15),(98.80±1.22)%,which showed no significant differences between any two different time points (P>0.05).Also the content of Etomidate of compatible solution showed no significant differences between any two samples at different time points(P>0.05).5-H and 4-H peak areas of Propofol and Etomidate of compatible solution at different time points respectively fluctuated within the range of(53 025 430.60±58 943.70), (16 342 703.21±3785.60),there showed no significant differences between any two different time points (P>0.05).Conclusion:In the compatible solution composed of Propofol injection and Etomidate fat emulsion injection with volume ratio of 1∶1,the emulsion particle size distribution,ζ potential,pH value,the content of the two drugs,as well as the H1-NMR peak areas of 4-H of Propofol and 5-H peak of Etomidate are not change significantly,it indicates that the compatible solution is stable in 10 h at room temperature.
URIhttp://hdl.handle.net/20.500.11897/448605
ISSN1674-4985
DOI10.3969/j.issn.1674-4985.2016.02.031
Appears in Collections:深圳医院

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