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建立了Re(Sn)-HEDP药盒主要成分HEDP(1-hydroxyethylidenediphosphonicacid)和氯化亚锡含量188的分析方法。以标记率、HEDP和氯化亚锡的含量、无菌和内毒素检查为测试项目,按照中国药典对188Re(Sn)-HEDP药盒进行了影响因素试验(强光、高温和高湿度)和低温保存有效期试验等稳定性研究。
A method for the determination of 1-hydroxyethylidenediphosphonic acid (HEDP) and stannous chloride (188) in Re (Sn) -HEDP kit was established. The labeling rate, the content of HEDP and stannous chloride, the aseptic and endotoxin tests were used as the test items, and the influencing factors tests (bright light, high temperature and high humidity) and 188Re (Sn) -HEDP kit were carried out according to the Chinese Pharmacopoeia Study on the stability of low temperature preservation test.