CAJ | 학술논문

目的：建立反相高效液相色谱(RP-HPLC)法测定微量泵输液连接管中残留醋酸奥曲肽的浓度，分析研究在冲管过程中连接管内醋酸奥曲肽溶液浓度水平的动态变化。方法：采用RP-HPLC法测定醋酸奥曲肽溶液浓度，色谱柱：Ultropac Column TSK ODS-120A(4.6 mm×250 mm，5μm)；流动相：0.3%四甲基氢氧化铵水溶液(内含0.0185%的三乙胺，用磷酸调pH值为6.0)；乙腈(108∶88)；流速为1.0 ml/min；柱温为35℃；检测波长为210 nm；进样量为40μl。采用模拟临床微量泵给药及常用输液连接管(容积为8.0 ml)，泵药速度为6.3 ml/h，泵药结束后用适量溶媒冲管，对冲管前、冲管过程中不同时段泵出药液及冲管结束后管内残留药液分别取样；测定各取样点药液浓度，并计算泵出液浓度与配药原液浓度的比值(R)及R值的相对标准偏差(RSD)。结果：测定的醋酸奥曲肽浓度水平为0.1～6.4μg/ml，与峰面积呈良好的线性关系(r=0.9979)；定量限为0.4μg/ml，检测限为0.1μg/ml；加样回收率实验平均为96.9%，RSD值为2.2%。冲管过程中的前3/4时间里R值均＞90%，测定结果波动较小。结论：RP-HPLC测定方法速度快、灵敏度高，可用于微量泵输液连接管中醋酸奥曲肽溶液浓度的测定，测定结果可作为冲管操作的重要依据。
목적：건립반상고효액상색보(RP-HPLC)법측정미량빙수액련접관중잔류작산오곡태적농도，분석연구재충관과정중련접관내작산오곡태용액농도수평적동태변화。방법：채용RP-HPLC법측정작산오곡태용액농도，색보주：Ultropac Column TSK ODS-120A(4.6 mm×250 mm，5μm)；류동상：0.3%사갑기경양화안수용액(내함0.0185%적삼을알，용린산조pH치위6.0)；을정(108∶88)；류속위1.0 ml/min；주온위35℃；검측파장위210 nm；진양량위40μl。채용모의림상미량빙급약급상용수액련접관(용적위8.0 ml)，빙약속도위6.3 ml/h，빙약결속후용괄량용매충관，대충관전、충관과정중불동시단빙출약액급충관결속후관내잔류약액분별취양；측정각취양점약액농도，병계산빙출액농도여배약원액농도적비치(R)급R치적상대표준편차(RSD)。결과：측정적작산오곡태농도수평위0.1～6.4μg/ml，여봉면적정량호적선성관계(r=0.9979)；정량한위0.4μg/ml，검측한위0.1μg/ml；가양회수솔실험평균위96.9%，RSD치위2.2%。충관과정중적전3/4시간리R치균＞90%，측정결과파동교소。결론：RP-HPLC측정방법속도쾌、령민도고，가용우미량빙수액련접관중작산오곡태용액농도적측정，측정결과가작위충관조작적중요의거。
Objective: To establish a RP-HPLC method for the determination of the content of octreotide acetate in octreotide acetate solution. To understand the dynamic change of octreotide acetate solution concentration in the process of punching tube. Methods: The concentration of the octreotide acetate solution was determined by RP-HPLC. Chromatographic conditions:Ultropac Column TSK ODS-120A(4.6 mm×250 mm, 5 μm)and 0.1%TFA water 0.1%TFA acetonitrile as the mobile phase at aflow rate of 1 ml/min were used with a column temperature of 35℃, a detection wavelength of 210 nm and an injection volume of 40 μl. Sampling method: Using simulated clinical micro pump injection, after the end of administration Flush the pipes with the same volume of solvent;Sampling to pump out liquid In the different periods in the process of washing pipe. The concentration of sample solution was determined and the ratio(R)of liquid concentration was calculated. Results: The standard curve of octreotide was linear in the range of 0.1~6.4 μg/ml, r=0.9979. The limit of quantification was 0.4 μg/ml, The detection limit was 0.1 μg/ml. The average recovery rate was 96.9%and RSD was 2.2%. Before the 3/4 time the concentration ratio of Sample solution(R)>90%in the process of punching tube. Conclusion:The method is practicable and accurate and can be used for the Determination of the concentration of octreotide acetate solution. The results of determination can be used as the basis for operation method.