Extraction Process And Quality Control Of Fufang Chaigui Fang

Background:Depression is a mental disorder,whose etiology is complex and involved multiple systems of the human body.This disease sometimes threats humans’ life.Currently,the synthetic antidepressants give the priority to clinical treatment of drugs,mainly including tricyclic antidepressants(amitriptyline),selective 5-HT again uptake inhibitors(fluoxetine),5-HT and NE dual reuptake inhibitors(venlafaxine)and so on.Though these drugs play an important role in treating depression,their efficiency is less than 70%.There has some disadvantage,such as slow onset,severe adverse reactions,high recurrence rate and expensive drug prices.The anti-depressant Chinese medicine has been used in the market at present,but the effect is not as well as synthetic antidepressants.There is a lot of active substance in Chinese medicine.And the action mechanism of active substance are blurred.To sum up,there has no anti-depressants of well effect,less side effects and cheap price on the market at present.Based on the anti-depressant effect of Xiaoyaosan,we used the analysis technology of chemical composition,observation of clinical trials and the verification of pharmacological efficacy to screen the best anti-depressive prescription.We gain the the Fufang Chaigui Fang which is composed by the Bupleurum,paeoniae alba,Angelica,Atractylodes,licorice and mint.In order to develop the modern Chinese new medicine of stronger antidepressant action with relatively clear mechanism,more stable and controllable quality,we conduct a systematic study for Fufang Chaigui Fang.We study the extraction process,chemical composition and quality standard,stability and so on.Objective:In order to obtain the pure antidepressant active substances,our research identify the process of Fufang Chaigui Fang according to the physicochemical properties of the medicinal materials and their active substances.We prepare three batches of samples and identify the main chemical substances of the extraction of Fufang Chaigui Fang.In order to control the quality of Fufang Chaigui Fang,we establish quality standards.To further study the factors of stability,influence factor test is also performed.Methods:The optimum extraction process is screened by combining the chemical analysis and the pharmacological efficacy.The process parameters is optimized based on the extract rate and content of saikosaponin d,atractylenolide III and paeoniflorin.The technology of LC-MS is applied to analyze the chemical components of the extract.The quality standard of extract is established in accordance with the quality standard of traditional Chinese medicine.And the influence factors test is performed to investigate stability from the extract of Fufang Chaigui.Results:1.The optimal extraction process is screened,namely that prescription proportion of Fufang Chaigui herbs with ethanol is extracted at 2 times.The alcohol extract is obtained by concentrating and drying the ethanol solution.The residues of the ethanol extract is extracted with water for 2 times.The solution is put into ethanol to precipitated.Concentration and drying the supernatant to receive the water extraction.Mixed alcohol extract and water extract when extract of Fufang Chaigui is obtained.2.The process was determined as follow:Prescription proportion of Fufang Chaigui herbs with 8 times amount of 85%ethanol is extracted 2 hour at 2 times.Concentrating and drying the ethanol to gain ethanol extract.Then the residues of the ethanol extract with 8 times amount of water is extracted 2 hour at 2 times.The aqueous is concentrated to 1.10 g/mL and put into ethanol to precipitated when the density is 50%and then deposited for 48 hour.Concentrating and drying the supernatant to gain water extract after alcohol precipitation.The extract of Fufang Chaigui has been obtained.3.Three batch of samples is prepared by pharmaceutical companies.And 72 compounds are identified from the extract using LC-MS Technology.4.TLC identification of ginger and licorice and UPLC-PDA fingerprint method are established,The content of saikosaponin d,paeoniflorin and atractylenolide III are used for quality control.Conclusion:The best extraction process was obtained and the pilot samples are produced,which shows that the process is stable and feasible.A systematic analysis method for the chemical composition of the extract was established.The quality standard system was established,and the factors affecting for the stability of the drug was also studied,which lays a foundation for the research and development of the preparation of the anti-depressive new drug of Fufang Chaigui.