《中国药典(二部)》葡萄糖酸钙注射液重金属检查法探讨

Discussion on Heavy Metal Test Method of Calcium Gluconate Injection in Chinese Pharmacopoeia

目的改进葡萄糖酸钙注射液重金属检查法。方法采用2010年版《中国药典(二部)》重金属检查法,对4个陕西药厂生产的葡萄糖酸钙注射液的重金属进行检查,探讨制剂工艺中加入络合剂对重金属检查比色结果的影响,以及采用第二法进行重金属检查的葡萄糖酸钙注射液出现沉淀的原因。结果与结论建议国家药典委员会对2010年版《中国药典(二部)》重金属检查第二法进行修订。

Objective To improve the heavy metal test method of calcium glucohate injection. Methods The heavy metal test method of the Chinese Pharmacopoeia（ edition 2010,Vol. I]） was adopted for detecting the heavy metals in calcium gluconate injection pro- duced by 4 pharmaceutical factories in Shaanxi and investigating the influence of adding eomplexing agent in preparation process on the colorimetric Results of heavy metal test and the causes of precipitate appearing by the second method in heavy metal test method. Results and Conclusion It is suggested that the Chinese Pharmacopoeia Commission amends the second heavy metal test method in the Chinese Pharmacopoeia（ edition 2010,Vol. Ⅱ）.