Preparation and Quality Control of Cinnamomi Ramulus Formula Granules based on Traditional Standard Decoction
XU Xin1, JIANG Hui-jie1, WANG Jia-nan1, CHEN Yan1, DU Xin-gang2, TANG Lan1, ZHANG Hui1, YAN Ji-zhong1*
1. College of Pharmaceutical Science, Zhejiang University of Technology, Hangzhou 310014, China; 2. Anhui Jiuzhou Fangyuan Pharmaceutical Co. , Ltd. , Bozhou 236800, China
Abstract：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 the β-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.
许鑫, 姜慧洁, 汪佳楠, 陈燕, 杜新刚, 唐岚, 张慧, 颜继忠. 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[J]. 中国药学杂志, 2020, 55(13): 1103-1110.
XU Xin, JIANG Hui-jie, WANG Jia-nan, CHEN Yan, DU Xin-gang, TANG Lan, ZHANG Hui, YAN Ji-zhong. Preparation and Quality Control of Cinnamomi Ramulus Formula Granules based on Traditional Standard Decoction. Chinese Pharmaceutical Journal, 2020, 55(13): 1103-1110.
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2020, Vol. 55 
