摘要
目的采用近红外光谱技术检测腰痛宁胶囊粉末的混合均匀度,确定混合终点。方法使用近红外光谱仪采集腰痛宁胶囊药粉混合过程图谱,通过计算机分析软件,进行药粉混合均匀度的趋势分析,同时采集不同混合时间的样品,以士的宁、马钱子碱的含量变化为指标,监控生产过程中不同混合时间、取样点中样品的成分变化情况,以验证确认混合终点。结果经过大量的试验数据的统计、分析、验证,腰痛宁胶囊药粉在混合0.5h已接近均匀,1h时已经混合均匀并稳定,与近红外的光谱趋势相一致。结论此方法简便、可靠,可以用于腰痛宁胶囊生产中混合均匀度的趋势分析,确定混合终点。
Objective To detect mixture uniformity of Yaotongning Capsule by near-infrared （NIR） spectroscopy and to make sure the mixing end. Methods NIR spectra of Yaotongning Capsule powder in the mixing process were collected. Through computer analysis software, trend of powder mixing uniformity was analyzed. Samples collected at different mixing time were used to monitor the component change and confirm the mixing end with the changes of strychnine and brucine as indexes. Results Through extensive statistics, analysis, and validation, Yaotongning Capsule powder mixed for 0.5 h was close to uniform, and 1 h was homogeneous and stable, which was consistent with the trend of NIR spectroscopy. Conclusion This method is simple and reliable, and could be used for the trend analysis in Yaotongning Capsule manufacturing process and determination of the mixing end.
出处
《现代药物与临床》
CAS
2012年第4期374-377,共4页
Drugs & Clinic
关键词
腰痛宁胶囊
近红外光谱技术
混合均匀度
在线检测
Yaotongning Capsule
near-infrared spectroscopy
mixing uniformity
detection on line
