基于药效及正交试验研究蓝金口服液提取纯化工艺  

Extraction and purification process of Lanjin Oral Liquid based on pharmacodynamic and orthogonal experiments

作　　者：宋军 陈静 刘学武 邹振兴 宋太发 徐康平 周书奥 谭桂山 王毅清 张乐佳 SONG Jun;CHEN Jing;LIU Xuewu;ZOU Zhenxing;SONG Taifa;XU Kangping;ZHOU Shu'ao;TAN Guishan;WANG Yiqing;ZHANG Lejia(Hunan Zhongjia Bio-pharmaceutical Co.,Ltd.,Changsha,Hunan 410036,China;Hunan Key Laboratory of Pharmacodynamics and Safety Evaluation of New Drugs,Changsha,Hunan 410331,China;Xiangya School ofPharmaceutical Sciences,Central South University,Changsha,Hunan 410013,China)

机构地区：[1]湖南中嘉生物医药有限公司,湖南长沙410036 [2]新药药效与安全性评价湖南省重点实验室,湖南长沙410331 [3]中南大学湘雅药学院,湖南长沙410013

出　　处：《湖南中医药大学学报》2022年第12期2029-2036,共8页Journal of Hunan University of Chinese Medicine

基　　金：湖南省高新技术产业科技创新引领计划(2020GK4083)。

摘　　要：目的对蓝金口服液的提取纯化工艺进行筛选,确定最佳提取纯化工艺。方法比较蓝金口服液不同提取纯化工艺样品对干酵母所致发热大鼠体温的影响,以样品药物效应强度筛选提取纯化工艺,在该药效实验结果的基础上,采用正交试验,以浸膏得率、绿原酸和腺苷提取量为评价指标,考察浸泡时间、料液比、提取时间3个因素对处方药材提取效果的影响,选择最佳提取工艺;以醇沉液沉降、过滤情况,沉淀质量,制剂澄清度及绿原酸,腺苷转移率为评价指标,采用单因素考察方法,选择最佳醇沉纯化工艺。结果最佳提取纯化工艺:取金银花、连翘、柴胡、荆芥,加10倍量水,蒸馏法提取芳香水,备用;在上述药渣中加入板蓝根、射干、甘草,补加水至总药材的10倍量,提取1.5 h,第2次加8倍量水提取1.0 h;合并两次提取液,减压浓缩后加乙醇至醇浓度为30%,醇沉纯化。结论实验建立的蓝金口服液提取纯化工艺稳定可靠,重现性良好,为蓝金口服液的后续研发提供依据。Objective To determine the optimal extraction and purification process of Lanjin Oral Liquid.Methods The effects of Lanjin Oral Liquid samples with different extraction and purification processes on the body temperature of rats with fever caused by dry yeast were compared,and those processes were screened according to the drug effect.Then based on the results,orthogonal experiment was conducted to investigate the impacts of soaking time,solid-liquid ratio and extraction time on the extracting effect of prescription medicinal materials,with the extract yield and the amount of chlorogenic acid and adenosine extraction as evaluation indexes,by which the optimal extraction process was selected;meanwhile,single factor test was used to determine the best purification process of alcohol precipitation,with sedimentation and filtration of the alcohol deposit liquid,weight of sediment,clarity of the preparation,and the transfer rate of chlorogenic acid and adenosine as evaluation indexes.Results The optimal extraction and purification process was as followed:10 times amount of water was added to Jinyinhua(Lonicerae Japonicae Flos),Lianqiao(Forsythiae Fructus),Chaihu(Bupleuri Radix),and Jinjie(Schizonepetae Herba),then the aromatic water was extracted by distillation and set aside;Banlangen(Radix Isatidis),Shegan(Rhizoma Belamcandae)and Gancao(Licorice)were supplemented into the above herbal residue,and decocted for 1.5 h with water in 10 times amount of the total medicinal materials,then the residues were decocted for 1 h for the second time with water in 8 times amount of them;at last,the two extractions were combined,decompressed and concentrated,then ethanol was added into the final extraction until the ethanol concentration reaches 30%in order to purify the final extraction.Conclusion The extraction and purification process determined by the experiments is stable,reliable and reproducible,which provides a basis for the follow-up research and development of Lanjin Oral Liquid.

关 键 词：蓝金口服液 药效筛选 正交试验 提取纯化工艺 腺苷 绿原酸 

分 类 号：R285.5[医药卫生—中药学]