邓哲　冯伟红　章军　焦梦姣　张国瑗　王淑慧　程锦堂　刘安

[摘要]制备桂枝饮片标准汤剂并建立质量标准，为配方颗粒等临床非传统用药形式提供质量参照，同时也为含挥发油的饮片标准汤剂研究提供參考。从市场上收集14批不同质量的桂枝饮片，在中药饮片标准汤剂制备原则基础上进一步完善提取工艺，制备桂枝饮片标准汤剂，计算出膏率、桂皮醛的转移率、pH等参数，评价工艺稳定性；建立指标成分含量测定方法和特征图谱。结果表明桂枝饮片标准汤剂的出膏率为606%～895%，平均出膏率为718%；桂皮醛转移率为296%～543%，平均转移率为432%；pH 433～482。14批桂枝饮片标准汤剂特征图谱与对照特征图谱相似度均>09。该研究建立的制备方法稳定、质量标准完善，适用于桂枝饮片标准汤剂质量评价。

[关键词]桂枝饮片； 挥发油； 标准汤剂； 质量标准

[Abstract]To prepare Cinnamomi Ramulus pieces standard decoction and establish its quality standard， provide quality reference for formula granules and other clinic nontraditional forms of medicines， and lay a foundation for standard decoction research for the pieces containing essential oil 14 batches of Cinnamomi Ramulus pieces with different quality were collected from market and their extraction process was further improved based on the preparation principle of standard decoction to prepare the standard decoction of Cinnamomi Ramulus pieces Then its transfer rate of Cinnamaldehyde， dry extract rate and pH value were calculated to evaluate its process stability； and a method for chromatographic fingerprint and content determination was also established Results revealed that the dry extract rate for standard decoction of Cinnamomi Ramulus pieces was from 606%895%， with an average value of 718%； the transfer rate of cinnamaldehyde was at the range of 296%543%， with an average of 432%； and the pH value was at the range of 433482 The fingerprint similarities between 14 batches of standard decoction of Cinnmomi Rammulus pieces and reference fingerprint were all>09 The established method for standard decoction was stable and its quality standard was perfect， suitable for evaluating the quality of standard decoction of Cinnanomi Ramulus pieces

[Key words]Cinnamomi Ramulus pieces； volatile oil； standard decoction； quality standard

中药饮片标准汤剂是以中医理论为指导、临床应用为基础，参考现代提取方法，经标准化工艺制备而成的单味中药饮片水煎剂，用于标化临床用药，保障用药的准确性和剂量的一致性[1]。中药标准汤剂作为一种标准物质和标准体系，可以标化所有以水为溶媒的包括配方颗粒在内的新型用药形式。它能够有效的解决配方颗粒标准不统一而导致配方颗粒市场“乱”相的问题[2]。2016年8月5日国家药典委起草的“中药配方颗粒质量控制与标准制定技术要求（征求意见稿）”也明确提出中药配方颗粒的所有药学研究均须与标准汤剂进行对比，以保证与标准汤剂质量一致性。