近红外光谱技术监测腰痛宁胶囊生产过程中混合均匀度的研究.pdfVIP

• 374 • 现代药物与临床 Drugs Clinic 第 27 卷 第 4 期 2012 年 7 月 近红外光谱技术监测腰痛宁胶囊生产过程中混合均匀度的研究 李云霞 1,2，郭艳玲 1,2，刘 玺 1,2 1. 承德颈复康药业集团有限公司，河北 承德 067000 2. 河北省中药新辅料工程技术研究中心，河北 承德 067000 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 0.5 h 已接近均匀，1 h 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。 关键词：腰痛宁胶囊；近红外光谱技术；混合均匀度；在线检测 中图分类号：R286.02 文献标志码：A 文章编号：1674 - 5515(2012)04 - 0374 - 04 Monitoring of powder mixture uniformity of Yaotongning Capsule in manufacturing process by near-infrared spectroscopy LI Yun-xia1,2, GUO Yan-ling1,2, LIU Xi1,2 1. Chengde Jingfukang Pharmaceutical Group Co., Ltd., Chengde 067000, China 2. Hebei Provincial Engineering Technology Research Center for New Pharmaceutical Excipients in Traditional Chinese Medicine, Chengde 067000, China Abstract: 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. Key words: Yaotongning C