目的:研究硫酸阿米卡星中所含硫酸根摩尔数与酸碱度及含量的关系?方法:用硫酸钡重量法测定供试品中所含硫酸根的摩尔数;同时测定效价及酸碱度,通过比较,得出结论?结果:供试品中所含硫酸根摩尔数与酸碱度及效价均有关系?结论:现行中国药典硫酸根摩尔数与pH值规定范围及含量限度不相匹配,应作相应调整?

OBJECTIVE:To study the relationship between acidity and potency of amikacin sulfate & the content of sulfate radical in sample.METHODS:The sulfate radical moles in amikacin sulfate was assaged by barium sulfate gravimetric method,the potency and acidity of sample was determined.RESULTS:The content of sulfate radical in sample was related to its potency and acidity.CONCLUSION:Sulfate radical moles in Chinese Pharmacopeia (edition 1995) was not a match for the acidity range & content requirement. Here are three suggestions to adjust:①Modifying the sulfate radical moles in amikacin sulfate structure to less than 1.8.Then both the carrent acidity & content limit are not changed.②Adopting the regulation in USP ⅩⅩⅢ.③Readjusting the acidity range to pH 3.0～7.0 nad the equivalent of not less than 675μg amikacin per mg.