各国药典中山梨醇质量标准的比较分析

本文主要对中国药典、欧洲药典、美国药典和日本药典中山梨醇的质量标准进行了分析讨论,并对几项主要指标如含量、酸值、还原糖等的测定方法和限度进行了分析比较。山梨醇的含量中国药典2010年版要求最严格,≥98.0%;酸值,美国药典32版要求较为宽泛,pH为3.5~7.0,欧洲药典7.0版要求较严格,pH为中性;还原糖,欧州药典7.0版要求较宽泛,还原得到的氧化亚铜≤67 mg,日本药局方16版要求较为严格,还原得到的氧化亚铜≤13.6 mg。同时本文还提出了提高山梨醇质量的方法与建议,为生产高质量的山梨醇以及制定注射用山梨醇的质量标准提供参考。

The sorbitol standards in different pharmacopeia,i.e.,the Chinese pharmacopeia,the European pharmacopeia,the United States pharmacopeia and the Japanese pharmacopeia,were analyzed and discussed in this paper.The test methods and limitation of several main indicators in different pharmacopeia were compared,such as content,acidity,reducing sugars,etc.As for the content of sorbitol,ChP 2010 was the strictest,which is not less than 98.0%.For acid value,the requirement in USP 32 was more general as pH value was required in the range of 3.5-7.0,while EP 7.0 was stricter requiring pH to be neutral.As for reducing sugar,the demand of EP 7.0 was more general requiring that the deoxidation product of cuprous oxide should be no more than 67 mg,while JP16 was stricter requiring no more than 13.6mg.This research is supposed to be helpful for the preparation of high-quality sorbitol and the establishment of sorbitol quality standard.

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