PHarmaceutical Study Of Sangxing Oral Liquid

Exogenous cough is a common clinical disease,caused by the pathogen invading lung.Because pathogenic wind or pathogenic cold can be converted to heat in the body,wind-heat cough is the most common disease.Sangxing Oral Liquid is a kind of hospital preparations,composed of Mori Folium,Armeniacae semen Amarum,Arctii Fructus,Peucedani Radix,Menthae haplocal ycis Herba,Platycodonis Radix,Citri reticulatea Pericarpium,Glycyrrhizae radix et Rhizoma.It has the antipyretic、antitussive and expectorant effects,being used to treat cough with sputum of yellow sticky matter、sore throat、nasal congestion、thirst and headache etc,caused by the pathogen invading lung,in the clinical.1.Study on raw materials:Mori Folium,Armeniacae semen Amarum,Arctii Fructus,Peucedani Radix,Menthae haplocal ycis Herba,Platycodonis Radix,Citri reticulatea Pericarpium,Glycyrrhizae radix et Rhizoma were detected according to the relevant provisions of the Chinese PHarmacopoeia(2015 Edition,part Ⅰ).The results were consistent with the requirements,and can be used in pHarmaceutical research of Sangxing Oral Liquid.2.Study on preparation:Based on the active ingredients of Menthae haplocal ycis Herba and Citri reticulatea Pericarpium,We chose the volume of volatile oil as the index,using L9(34)orthogonal experiment to optimize the extraction process of volatile oil.The optimum one was soak for half an hour with 10-fold total volume of water and distilling for 6 hours.We selected the inclusion rate of volatile oil,the inclusion compound and the yield of inclusion compound,using L9(34)orthogonal experiment to optimize the inclusion process of volatile oil.Then the optimum process was volatile oil and HP-β-CD ratio of 1:12,grinding 85min with 3 times the amount of water.The optimum inclusion process of volatile oil was confirmed.The alcohol extraction process of Arctii Fructus and Peucedani Radix based on their active ingredients was optimized by L16(45)orthogonal experiment with the contents of arctiin,praeruptorin A and the yield of alcohol extract used as indexes.The optimized resulte was to extract 3 times with fifteen times amount of 60%alcohol for 1.5 hours each time.And the optimum alcohol extraction process was verified.The content of amygdalin,chlorogenic acid and yield of water extract was used as indexes to optimize the water extraction process of Mori Folium,Armeniacae semen Amarum,Platycodonis Radix,Glycyrrhizae radix et Rhizoma and foregoing the dregs.The optimum one was soak for half an hour with twenty times amount of water to extract 2 times for 2 hours each time.And the optimum water extraction process was verified.The content of amygdalin,chlorogenic acid and extract yield was used as indexes to research the refining and purification process using water extraction and alcohol precipitation.The optimum one was that the water extract was concentrated to the relative density of 1.06～1.12(60℃),then adding ethanol to the alcohol content of 60%to stand for 48 hours.The content of amygdalin and arctiin was used as indexes to optimiz the enrichment process.The optimized resulte was that alcohol deposit fluid,alcohol extract fluid were recovered ethanol,and then merged to evaporate to the relative density of 1.11～1.13(60℃)through 0.09 Mpa,60℃.The preparation of molding process was studied such as clarity,PH,corrigent and preservatives.We chose centrifugal process by the content of amygdalin and arctiin as indexes through pre-test.The optimum one was to adjust PH 6.0-7.0,10%sucrose as corrigent and 0.05%ethylparaben as preservatives,and then centrifuge for 30 min at the speed of 4800r.3.Study on quality standard:Identifications of Arctii Fructus,Peucedani Radix,Platycodonis Radix,Citri reticulatea Pericarpium,Glycyrrhizae radix et Rhizoma were carried out by TLC.The results showed that feature were clear,negative samples without interference and good reproducibility.Then we established the TLC of the five kinds of traditional Chinese Medicine above.According to Chinese PHarmacopoeia(2015 Edition,PartⅣ,Appendix 0181),the preparation was examined and the results are in line with the requirements.Determination of amygdalin content and arctiin content by HPLC method and methodology validation was done.The results of methodological study showed that amygdalin and arctiin showed good linearity in the range of 25.26～151.6 μg/ml,22.98～137.9 μg/ml,The average recovery rate of amygdalin was 99.96%(RSD=2.81%)and arctiin was 99.83%(RSD=2.82%).The determination method of amygdalin and arctiin were established.4.Study on stability:The long-term stability test of 3 months and the accelerated stability test of 3 months were carried out according to quality standard above.The results showed that the stable quality of preparation.In order to determine its actual validity period,this job is going on.The study results showed that the preparation technology was reasonable and feasible,that quality standard was accurate and that quality of oral liquid were stable.