肌苷氯化钠注射液内控质量标准的制订  

Formulation of Internal Control Quality Standard of Inosine and Sodium Chloride Injection

作　　者：王丽军[1] 刘栋[1] 

机构地区：[1]中国人民解放军第一五三中心医院药械科,河南郑州450042

出　　处：《中国药业》2014年第22期51-53,共3页China Pharmaceuticals

摘　　要：目的建立肌苷氯化钠注射液内控质量标准。方法依据该制剂法定质量标准,选择性状、鉴别、p H、肌苷含量作为内控质量检验项目,采用紫外分光光度法和高效液相色谱法对肌苷含量的测定进行比较性试验。结果该制剂中肌苷的2种方法含量测定结果差异无统计学意义,可用紫外分光光度法代替高效液相色谱法测定肌苷含量。结论该制剂内控质量标准简单、快速、准确,适合于注射液半成品的检验。Objective To establish the internal control quality standard of Inosine and Sodium Injection. Methods The character, iden- tification,pH,inosine content were selected as in detection items of the internal control quality according to the legal quality standard. The inosine content was determined by high performance liquid ehromatography（HPLC） and uhraviolet（UV） spectrophotometry. Results No sta- tistically significant difference were noted in the inosine content between the two kinds of detection method,which indicating that the UV spectrophotometry could replace HPLC for determining the inosine content. Conclusion The internal control quality standard of this prepa- ration is simple,quick and accurate,which is suitable for the detection of half- finished product of this injection.

关 键 词：肌苷 注射液 高效液相色谱法 紫外分光光度法 

分 类 号：R927.1[医药卫生—药学] R977.6