基于QbD理念安宫牛黄丸整体混合终点评价方法探究.docVIP

基于QbD理念安宫牛黄丸整体混合终点评价方法探究 　　[摘要]大品种中药安宫牛黄丸混合终点判断是关键的技术问题。基于质量源于设计（QbD）理念的控制策略，研究提出一种整体混合终点的判断方法，为含矿物质中药混合提供方法学。采用激光诱导击穿光谱（LIBS）技术获得安宫牛黄丸混合中间体的光谱数据。结合移动窗相对标准偏差法（MWRSD）法，朱砂、雄黄和珍珠粉为整合研究指标，通过比较相邻混合时间光谱的差异，快速评价整体混合过程。雄黄、朱砂和珍珠粉3个药味的混合过程并非完全一致，但在混合的最后一个阶段，3个药味均达到了混合均匀；得到建议混合终点。采用LIBS过程技术建立的微区时序分析方法，实施过程控制。所建立的方法无需标准光谱库，具有分析快速、近似无损、无需复杂的样品前处理的等特点，为大品种中药制剂的质量研究提供新思路 [关键词]安宫牛黄丸； 混合终点； 激光诱导击穿光谱； 质量源于设计； 过程分析技术 [Abstract]The blending endpoint determination of Angong Niuhuang Wan （AGNH） is a key technology problem The control strategy based on quality by design （QbD） concept proposes a whole blending endpoint determination method， and provides a methodology for blending the Chinese materia medica containing mineral substances Based on QbD concept， the laser induced breakdown spectroscopy （LIBS） was used to assess the cinnabar， realgar and pearl powder blending of AGNH in a pilotscale experiment， especially the whole blending endpoint in this study The blending variability of three mineral medicines including cinnabar， realgar and pearl powder， was measured by moving window relative standard deviation （MWRSD） based on LIBS The time profiles of realgar and pearl powder did not produce consistent results completely， but all of them reached even blending at the last blending stage， so that the whole proposal blending end point was determined LIBS is a promising Process Analytical Technology （PAT） for process control Unlike other elemental determination technologies such ICPOES， LIBS does not need an elaborate digestion procedure， which is a promising and rapid technique to understand the blending process of Chinese materia medica （CMM） containing cinnabar， realgar and other mineral traditional Chinese medicine This study proposed a novel method for the research of large varieties of traditional Chinese medicines [Key words]Angong Niuhuang Wan； whole blending endpoint； laserinduced breakdown spectroscopy； quality by design； process analytical technology 安?m牛黄丸是中医治疗高热症的“温病三宝