摘要
目的建立牡丹皮标准汤剂及配方颗粒的制备工艺。方法采用煎药壶法进行15批牡丹皮标准汤剂的制备,建立标准汤剂的参数范围及指纹图谱。为改进牡丹皮配方颗粒的制备工艺,采用加热回流装置,对牡丹皮进行常规提取,在减压浓缩过程中利用挥发油收集器同步回收丹皮酚,将收集的丹皮酚加回浓缩液,再经过喷雾干燥及干法制粒制备牡丹皮配方颗粒。通过指标成分的含量测定及指纹图谱比较饮片、提取液、浸膏、喷干粉、配方颗粒与标准汤剂间的相关性。结果煎药壶法所得的牡丹皮标准汤剂参数范围(平均值的70%～130%)如下:出膏率19. 46%～36. 14%;芍药苷含量1. 83%～3. 40%,转移率60. 32%～100. 00%;丹皮酚含量1. 25%～2. 33%,转移率14. 42%～26. 78%。牡丹皮配方颗粒中芍药苷和丹皮酚的含量均符合标准汤剂参数范围。结论本实验确定了煎药壶法制备的牡丹皮标准汤剂参数范围,并建立了一种新的牡丹皮配方颗粒制备工艺,两者在指标成分含量上具有较好的一致性,为指导企业实际生产提供一定科学依据。
OBJECTIVE To establish the preparation technology of Moutan Cortex standard decoction and formula granules. METHODS Moutan Cortex standard decoction was prepared by decocting pot and the parameters and fingerprints of 15 batches of decoction were established. To improve the preparation process of Moutan Cortex formula granules, paeonol was quickly recovered by using volatile oil collection device in the process of vacuum concentration, and the collected paeonol was added back to the coneent rated solution. Then, the formula granules of Moutan Cortex were prepared by spray drying and dry granulating. The correlation between the decoction pieces, extract, concentrate, powder, formula granules and standard decoction were compared by taking the contents of paeoniflorin, paeonol and fingerprint as indexes. RESULTS The range of parameters for Moutan Cortex standard decoction（70% - 130% of the average value） were as follows： the dry extract rate was 19.46% -36. 14%. The content of paeoniflorin was in the range of 1.83% - 3.40%, and the transfer rate was 60. 32% - 100.00%. The content of paeonol was 1.25% - 2. 33%, and the transfer rate was 14.42% -26. 78%. The contents of paeoniflorin and paeonol in the formula granules of Moutan Cortex conformed to the range of standard decoction parameters. CONCLUSION The parameters of Moutan Cortex standard decoctions prepared by decocting pot are confirmed, and a new preparation process of Moutan Cortex formula granules is established. Both of standard decoction and formula granules have good consistency in the contents of the index components, which could provide a certain scientific basis for the guidance of actual production.
作者
姜慧洁
顾唯芝
许鑫
汪佳楠
陈燕
颜继忠
JIANG Hui-jie;GU Wei-zhi;XU Xin;WANG Jia-nan;CHEN Yan;YAN Ji-zhong(College of Pharmaceutical Sci-ences,Zhejiang University of Technology,Hangzhou 310014,China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2018年第21期1869-1875,共7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)
关键词
牡丹皮
标准汤剂
配方颗粒
制备工艺
指纹图谱
丹皮酚
Moutan Cortex
standard decoction
formula granule
preparation process
fingerprint
paeonol
