基于传统煎煮标准汤剂的桂枝配方颗粒制备及质量标准研究  

Preparation and Quality Control of Cinnamomi Ramulus Formula Granules based on Traditional Standard Decoction

作　　者：许鑫 姜慧洁 汪佳楠 陈燕 杜新刚 唐岚[1] 张慧 颜继忠[1] XU Xin;JIANG Hui-jie;WANG Jia-nan;CHEN Yan;DU Xin-gang;TANG Lan;ZHANG Hui;YAN Ji-zhong(College of Pharmaceutical Science,Zhejiang University of Technology,Hangzhou 310014,China;Anhui Jiuzhou Fangyuan Pharmaceutical Co.,Ltd.,Bozhou 236800,China)

机构地区：[1]浙江工业大学药学院,杭州310014 [2]安徽九洲方圆制药有限公司,安徽亳州236800

出　　处：《中国药学杂志》2020年第13期1103-1110,共8页Chinese Pharmaceutical Journal

基　　金：浙江工业大学中药质量控制技术创新团队项目资助(ZYX201601)。

摘　　要：目的依据传统煎药法制备桂枝标准汤剂,研究桂枝配方颗粒的制备工艺及质量标准。方法采用煎药壶法制备16批桂枝标准汤剂,计算其出膏率、肉桂酸和桂皮醛的含量及转移率。基于标准汤剂的参数,对桂枝配方颗粒制备工艺进行改进,采用提取收集同步技术获取挥发油,制粒过程应用β-环糊精包合技术。基于标准汤剂的参数范围,制定桂枝配方颗粒的质量标准。结果制备所得桂枝标准汤剂的出膏率为3.58%~6.10%;肉桂酸含量为0.99%~2.59%,转移率为39.56%~62.28%;桂皮醛含量为1.95%~4.69%,转移率为4.76%~7.85%。依据标准汤剂制定的桂枝配方颗粒质量标准为:1 g桂枝配方颗粒相当于14 g饮片;含肉桂酸0.50%~1.43%,桂皮醛0.98%~3.50%;特征图谱中应有6个特征峰,分别为原儿茶酸、香豆素、肉桂酸、2-甲氧基肉桂酸、桂皮醛和2-甲氧基桂皮醛。结论本实验采用传统煎药壶法确定桂枝标准汤剂的参数范围,并提出了以标准汤剂为指导建立桂枝配方颗粒制备工艺与质量标准的思路,可为含挥发油类中药配方颗粒及相关制剂的研究提供参考。OBJECTIVE To prepare Cinnamomi Ramulus standard decoction according to the traditional decoction method,and study the preparation process and quality control of Cinnamomi Ramulus formula granules.METHODS The standard decoctions of 16 batches of Cinnamomi Ramulus were prepared using decocting pot.The extracting rate,contents and transfer rates of cinnamic acid and cinnamaldehyde were calculated.The preparation process of Cinnamomi Ramulus dispensing granules was improved based on the parameters of standard decoction.The volatile oil was collected while extracting,and theβ-cyclodextrin inclusion technology was applied in the granulation process.Based on the parameters of standard decoction,the quality standard of Cinnamomi Ramulus formula granules was established.RESULTS The extracting rate of Cinnamomi Ramulus standard decoction was 3.58%-6.10%;the cinnamic acid content was 0.99%-2.59%and the transfer rate was 39.56%-62.28%;while the cinnamaldehyde content was 1.95%-4.69%and the transfer rate was 4.76%-7.85%.According to the standard decoction,1 g of Cinnamomi Ramulus formula granules was equivalent to 14 g of pieces,containing cinnamic acid(0.50%-1.43%)and cinnamaldehyde(0.98%-3.50%).Six characteristic peaks in specific spectra were confirmed,including protocatechuic acid(1),coumarin(2),cinnamic acid(3),2-methoxycinnamic acid(4),cinnamaldehyde(5)and 2-methoxycinnamaldehyde(6).CONCLUSION In this study,the quality parameters of Cinnamomi Ramulus standard decoction are determined by traditional decocting pot.The strategy of establishing the preparation process and quality standard of Cinnamomi Ramulus formula granules based on standard decoction is proposed.It can provide reference for the research of Cinnamomi Ramulus dispensing granules and other Chinese medicine preparations containing volatile oil.

关 键 词：桂枝 配方颗粒 挥发油 标准汤剂 制备工艺 质量标准 

分 类 号：R284[医药卫生—中药学]