头孢氨苄片含量测定中的问题及讨论
Discussion about the problems in assay of cefalexin tablets
分类号：
出版年·卷·期（页码）：2010,30 (10):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
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目的: 探讨解决药品生产中低限投料问题的方法。 方法: 应用中国药典2005年版和日本药典15重(装)量差异检查方法对存在低限投料的样品进行对比分析;应用中国药典2005年版头孢氨苄含量测定方法对存在低限投料的糖衣片样品进行含量均匀度检查分析。 结果: 日本药典重(装)量差异检查及含量均匀度检查(糖衣片)分析均能表明有企业存在低限投料的问题。 结论: 日本药典重(装)量差异检查方法和对糖衣片增加含量均匀度检查可防止生产企业进行低限投料。
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Objective: To approach a method to solve the problem of low limit manufacture. Method: To do a comparative study of the low assay samples from weight variation of ChP and JP;to do test for content uniformity of the low assay sugar coated samples. Results: The low limit manufacture problem was confirmed by weight variation of JP and test for content uniformity of ChP. Conclusion: Two methods can prevent the low limit manufacture problem of pharmaceutical factory.
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