氯磷酸二钠基本性质及稳定性考察研究  

Observational Study on the Basic Characters and Stability of Disodinum Clodronate

作　　者：张天英[1] 李洪影[1] 国玉芝[1] 颜承云[1] 刘亮 

机构地区：[1]黑龙江省佳木斯市佳木斯大学附属第一医院,佳木斯市154003 [2]黑龙江省佳木斯市肿瘤医院,佳木斯市154002

出　　处：《中国病案》2013年第4期52-54,共3页Chinese Medical Record

基　　金：黑龙江省中医管理局科研项目;编号:ZHY12-Z193

摘　　要：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。Objective To investigate the basic characters of disodinum clodronate and the influential factors of its stability. Meth- otis Ion chromatography was performed to measurement the concentration of disodinum elodronate 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 HCl or NaOH had no influence on ion chromatographic peaks pattern compared with the control sample. After heat treatment, the retention time and the peaks of which were 11.03 min and 4.32 rain, increased significantly, the peaks with retention time 1.42rain 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 dodronate 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.

关 键 词：氯磷酸二钠 稳定性 电位滴定法 离子色谱法 

分 类 号：R318.08[医药卫生—生物医学工程]