CAJ | 학술논문

目的考察影响氯磷酸二钠稳定性的影响因素.方法采用离子色谱法测量原料药中氯磷酸二钠的含量,并用离子色谱法比较在酸碱、氧化、加热和强光照射处理前后原料药各组分的保留时间和含量的变化情况.总结氯磷酸二钠原料药的稳定性的影响因素.结果电位滴定法测量均值13.563g/L ,CV=9.08%;离子色谱法检测均值13.193g/L ,CV=3.90%.0.1mol/L HCI处理2小时、0.1mol/LNaOH处理2小时和光照处理后离子色谱峰与供试品无差异.加热处理后,保留时间4.32min和11.03min峰值显著升高,11.42min和11.83min峰消失,且氯磷酸二钠峰峰尾有出现小峰.氧化处理后,保留时间2.57min峰值显著升高,氯磷酸二钠峰峰前出现小峰.结论离子色谱法测量稳定性强于电位滴定法,两个方法测量的均值无显著性差异.氯磷酸二钠(原料药)耐酸碱和强光,但对加热和氧化敏感.
목적고찰영향록린산이납은정성적영향인소.방법채용리자색보법측량원료약중록린산이납적함량,병용리자색보법비교재산감、양화、가열화강광조사처리전후원료약각조분적보류시간화함량적변화정황.총결록린산이납원료약적은정성적영향인소.결과전위적정법측량균치13.563g/L ,CV=9.08%;리자색보법검측균치13.193g/L ,CV=3.90%.0.1mol/L HCI처리2소시、0.1mol/LNaOH처리2소시화광조처리후리자색보봉여공시품무차이.가열처리후,보류시간4.32min화11.03min봉치현저승고,11.42min화11.83min봉소실,차록린산이납봉봉미유출현소봉.양화처리후,보류시간2.57min봉치현저승고,록린산이납봉봉전출현소봉.결론리자색보법측량은정성강우전위적정법,량개방법측량적균치무현저성차이.록린산이납(원료약)내산감화강광,단대가열화양화민감.
@@@@Objective To investigate the basic characters of disodinum clodronate and the influential factors of its stability .Meth-ods Ion chromatography was performed to measurement the concentration of disodinum clodronate in API .To compare the changes of component retention time and content of each bulk drug before and after the influential factors ,such as acid ,oxidation ,heat and light irradiation treatment with the application of Ion chromatography .Then summarize the influential factors of the stability of disodinum clodronate .Results The average concentration was measured to 13 .563g/L and CV was 9 .08% by potentiometric titration ,and The average concentration was measured to 13 .193g/L and CV was 3 .90% by ion chromatography .Treated by 0 .1 mol/L HCI or NaOH had no influence on ion chromatographic peaks pattern compared with the control sample .After heat treatment ,the retenrion time and the peaks of which were 11 .03 min and 4 .32 min ,increased significantly ,the peaks with retention time 1 .42min and 11 .83min disappears ,and there was a small peak nearby disodinum clodronate peak tail .After oxidation treatment ,the peak value with retention time 2 .57min increased significantly ,there was a small peak before disodinum clodronate peak .Conclusion Ion chromato-graphy is more stable than potentiometric titration method in the disodinum clodronate concentration measurement ,the average value of the two methods are of no significant difference .Disodinum clodronate (API) has strong resistance with acid and alkali treatment , and is sensitive to heat and oxidation .