摘要
目的 针对一批含量不合格阿莫西林颗粒进行结果分析。方法 高效液相色谱法测定阿莫西林颗粒含量及含量均匀度，并对颗粒是否研磨成粉末作不同处理。结果 6次含量测定结果相差较大；颗粒研磨成粉末对含量测定结果没有显著性影响（P〉0．05），但可使测定结果的相对标准偏差（RSD）较小；含量均匀度检查示每包实际含量与标示量相差很大（A＋1．80S〉15．0），且单包含量的多少对应不同的色谱图谱。结论 该批阿莫西林颗粒含量不合格是含量均匀性较差所致，厂家用两种原料生产同批产品可能是其根本原因。
Objective To analyze the results of one batch amoxicillin granules with content disqualification. Methods HPLC was used to determine content and examine content uniformity of the amoxicillin granules with or without grinding granule to powder. Results It has obvious difference among six content determinations; Grinding to powder has no significant influence to content of granule （ P 〉 0.05 ）, but can acquire lesser relative standard deviation （RSD） of content results; Content uniformity test shows difference between actual value and its dosage （ A ＋ 1.80S 〉 15.0） ,attended by different chromatogram with different content of each package. Conclusion The disqualification of content results from its content uniformity, but two active ingredients of different quality were used to manufacture amoxicillin granules maybe is the underlying reason.
出处
《中国卫生产业》
2007年第07X期112-113,共2页
China Health Industry
关键词
阿莫西林颗粒
含量测定
含量均匀度
Amoxicillin granules
Content determination
Content uniformity
