Study On The Preparation Method And Quality Standard Of Shumian Capsule

Objective:Nowadays,the lack of sleeping time,psychological pressure and some complicated factors lead to insomnia.This causes the incidence of insomnia to increase year by year.Shumian capsules is composed of nine traditional Chinese Medicine.It has the effect of nourishing heart and soothing the mind.It is a prescription of clinical experience.This study combined modern science and technology to optimize the preparation process,undertake preliminary quality standard research and relieve insomnia pain for more patients.Methods:The subject mainly carries on the investigation in the following three aspects.1.Study on preparation process:According to the substance basis and physical and chemical properties of each kind of medicine in the prescription,the prescription was divided into alcohol extract and water extract.Ginseng,Schisandra chinensis and Zizyphus jujube kernel were extracted by alcohol,and the extraction rate,total ginsenoside content and alcohol A content of Fructus Schisandrae were evaluated.The other herbs were extracted by water,the extraction rate and the comprehensive score of ginsenoside content of Polygala tenuifolia were used as the best extraction technology.The temperature and pressure of the concentrated drying process were investigated.2.Study on forming process:The single factor experiment was used to investigate the granulation method,and the effects of the kinds of auxiliary materials,the ratio of drug to aid and the concentration of ethanol on the granulation were investigated,and the relevant parameters were determined and the best molding process was obtained.3.Quality standard research:According to the relevant regulations of the Pharmacopoeia in 2015,the qualitative and quantitative aspects of the quality standard were investigated.The qualitative identification of Schisandra chinensis,Zizyphus jujube kerne,Angelica sinensis and Radix Polygala in capsule contents was carried out by TLC.The content of ginsenoside and Schisandrin A were determined by HPLC and the content of total ginsenoside was determined by UV spectrum.The quality standard of ginsenoside was established.Results:1.Determine the optimal extraction process:The best alcohol extraction technology:the three medicinal herbs were extracted for 3 times with 6 times of 75%ethanol and each time was 1.5 hours.Optimum water extraction process:add 8 times water,brewed 3 times,1.5hours each time.2.Optimum forming process:Used wet granulation with lactose as type,80%ethanol as wetting agent,the amount of wetting agent was 5%of the material,and controled environmental relative humidity under 75%.3.Quality standard determination:TLC qualitative identification of Schisandra chinensis,Zizyphus jujube kerne,Angelica sinensis and Radix Polygala was established.Determination of Schisandrin and Tenuifolin by HPLC.Content determination condition:Schisandrin:The column:Inertsil ODS-3C₁₈（4.6mm×250mm,5μm）;the mobile phase:carbinol-water（62:38）;flow rate:1mL/min;detection wavelength:250nm;temperature:30℃.Tenuifolin:The column:Inertsil ODS-3C₁₈（4.6mm×250mm,5μm）;the mobile phase:carbinol-0.05%phosphoric acid aqueous solution（65:35）;flow rate:1mL/min;detection wavelength:210nm;temperature:25℃.The content limit of this product is as follows:every1g of Tenuifolin(C₃₆H₅₆O₁₂)is not less than 3.52mg,Schisandrin(C₂₄H₃₂O₇)is not less than1.20mg,the total ginsenoside is not less than 2.30mg.Conclusion:In this paper,the preparation technology of Shumian capsule was studied,the optimum extraction technology was determined,and the feasible molding process was established.The relative detection met the standard of 15 Pharmacopoeia,and the qualitative identification and content determination of the capsule were carried out.Establish relevant quality standards to provide basis for controlling product quality.