中国药业2012,Vol.21Issue(5):28-29,2.
二巯丙磺钠胶囊的制备和质量控制
Preparation and Quality Control of Sodium Dimercaptosulphonate Capsule
孙克刚 1施建国 1李鹏1
作者信息
- 1. 上海禾丰制药有限公司,上海,201206
- 折叠
摘要
Abstract
Objective To study the preparation and quality control methods of sodium Dimercaptosulphonate Capsule. Methods Addingpregelatinized starch in the prescription as Fillers. HPLC was used for the determination of sodium dimercaplosylphonate Thechro-matographic procedure was carried out by esing Zorbax ODSCu(250 mm×4.6mm,5μm)as an analytic column and a mixtereof 0.05mol/L potassium dihydrogen phosphare-acctonite(90.3:9.7) as mobile phase at a flow rate of 1.0mL/min.The detectionwavelength was set at 200nm.Results The linear rangc of sodium dimercaplosulphonalc was during 160-240μg/mL(r=0.9997).In the three talches of samples,The acerage recovery rate and RSD value of sodium dimercaplosulphonate were 100.0% and 0.46%.The content of the three batches of samples were 98.4%,99.2%,100.2%.Conclusion This preparation method is simpleand controllable and controllable,The quality control methods is accurate,simple and good for the determination of quality conlrol.关键词
二巯丙磺钠胶囊/质量控制/高效液相色谱法Key words
Sodium Dimercaptosulphonate Capsule/ quality control/ HPLC分类
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孙克刚,施建国,李鹏..二巯丙磺钠胶囊的制备和质量控制[J].中国药业,2012,21(5):28-29,2.