Preparation And Preliminary Pharmacodynamic Study Of Zishen Anshen Oral Liquid

Objective: Based on zishen Anshen Decoction,a clinical experience of the Department of Brain Diseases,Affiliated Hospital of Shandong University of Traditional Chinese Medicine,we developed a Chinese herbal compound preparation "ZSASOL" for the treatment of insomnia,and its preparation process,quality standards,and preliminary stability Sex and preliminary pharmacodynamics to conduct research and investigation,with a view to providing a basis for new drug development and clinical use.Methods: 1.Using the sleep time and sleep latency of KM mice as pharmacodynamic indicators,evaluate the effects of various extraction methods on the sleep results of mice,and thus select the best extraction method.2.On the basis of single-factor experimental investigation,using the "normalized value" of the total evaluation of the extraction amounts of the active ingredients Danshensu and Spinotin as the index,the star point test design method was used to optimize the extraction process and clarification process of ZSASOL.Determine the best molding process.3.Use thin layer chromatography(TLC)to qualitatively identify wolfberry,angelica,polygonum multiflorum,and tangerine peel in the preparation,and apply high-performance liquid chromatography(HPLC)to determine the content of danshensu and spinosin Determine and formulate the draft quality standard of ZSASOL.4.A preliminary stability test study on ZSASOL was carried out using the sample retention observation method at room temperature.5.To establish an insomnia model of KM mice with PACA,and to conduct ZSASOL’s preliminary pharmacodynamic studies using sleep latency,sleep time,incubation latency,and number of crossing platforms as indicators.Result: 1.The best extraction method of ZSASOL is water extraction.2.The optimal water extraction process parameters are: add 11 times the amount of water,soak for 24 min,extract twice,each time for 2h.The best clarification method is alcohol precipitation.The best alcohol precipitation process parameters are: concentration to 1.10(room temperature),95% ethanol to add 70% alcohol content,and stand for 24h(4 ℃ ～ 8 ℃).3.Established the TLC identification method for 4 kinds of medicinal taste in ZSASOL.According to the HPLC content determination results of the main ingredients,the content of Danshensu in this preparation should not be less than 0.518 mg / ml,and the content of spinosin should not be less than 0.015 mg / ml,and the relative retention time RSD of each peak in the self-made oral solution is less than 0.2%,and the relative peak area RSD is less than 5%,indicating that the quality stability of the preparation is good.4.Preliminary pharmacodynamics experiments show that ZSASOL has a better sleep-aid effect and there is no obvious rebound phenomenon of benzodiazepines after withdrawal.Conclusion: 1.ZSASOL preparation process is simple and effective,suitable for large industrial production.2.The quality standard control method is accurate and reliable,and the stability of the preparation is good.3.Preliminary pharmacodynamic studies have shown that ZSASOL is effective in soothing sleep and has no obvious rebound phenomenon after stopping the drug.It is safe and reliable,which provides a certain reference for the subsequent mechanism research.