Development And Preliminary Pharmacodynamics Of New Drugs For Wind Cold Based On Data Mining

Objective: Objective to explore the prescription and medication rules of Chinese patent medicine for cold in Pharmacopoeia of the people’s Republic of China,it is found that there are few Chinese patent medicines for treating wind cold,the indication of Shufeng jiebiao prescription is wind cold,in order to develop Shufeng jiebiao prescription as a new clinical drug,the pharmacodynamics and granule preparation were studied to provide experimental basis.Methods:(1)Study on the medication rule of Chinese patent medicine in the treatment of common cold: Screening of Chinese patent medicine for cold from Pharmacopoeia of the people’s Republic of China(2020 Edition),with the help of V2.5 software of traditional Chinese Medicine Inheritance auxiliary platform,the frequency of drug use,drug efficacy category,nature and taste channel,medication rule,new prescription combination mining were analyzed.(2)Pharmacodynamic study: hot plate method,acetic acid writhing method and shufengjiebiao granule were used to observe the pathological changes of xylene induced ear swelling in mice,effect of shufengjiebiao Granule on pathological changes of LPS induced acute lung injury in mice,objective to verify the anti-inflammatory and analgesic effects of shufengjiebiao granule.(3)Study on Preparation and quality standard:Firstly,the essential oils of Schizonepeta tenuifolia and notopterygium Incisum were extracted by water distillation,then the effective components of Ligusticum chuanxiong,Radix Saposhnikoviae and Radix Angelicae dahuricae were extracted by ethanol reflux method,at the same time,the above-mentioned drug residues were decocted with bupleurum,fermented bean and licorice.Finally,the volatile oil was used as raw material β-Cyclodextrin inclusion;the extract was purified,concentrated,collected and dried,and the inclusion compound of excipients and volatile oil was added to form granules.According to the fourth part of Chinese Pharmacopoeia(2020 Edition),Radix Saposhnikoviae,Schizonepeta tenuifolia,Rhizoma Notopterygii,Radix Angelicae dahuricae,Radix Bupleuri and Rhizoma Chuanxiong were identified by TLC;the content of imperatorin,saposhnikovin glycoside and amigoside in Angelica dahurica was determined by HPLC.At the same time,the method of precision determination and stability test were invesigated.Preparation molding process: the selection of excipients,particle size,solubility and moisture determination were investigated.Results:(1)Study on the medication rule of Chinese patent medicine in the treatment of common cold: a total of 130 Chinese patent medicine prescriptions were obtained,involving 250 kinds of traditional Chinese Medicine,among them,licorice,Platycodon grandiflorum,Scutellaria baicalensis,Forsythia suspense,honeysuckle and so on are used frequently;the drugs were mainly antipyretic,antidepressant and expectorant;most of the drugs are cold,warm and flat.The main flavor is bitter,pungent and sweet.The main channel is lung channel,followed by stomach channel and spleen channel.Commonly used drug pairs are "licorice Platycodon","tangerine peel licorice","Scutellaria baicalensis Georgi Forsythia","Forsythia Platycodon","honeysuckle Forsythia",etc.Through the entropy cluster analysis of complex system,two different core combinations were extracted,six groups in each group,and six potential new prescriptions were mined.(2)Pharmacodynamic study: the results show that the hot plate method,the pain threshold of shufengjiebiao granule(6g/kg)at 30 min was significantly different from that of the control group;acetic acid writhing: compared with the control group,shufengjiebiao granule could significantly reduce the writhing times of mice(P<0.05);the method of xylene induced ear swelling in mice,the results of HE staining showed that shufengjiebiao granule could relieve inflammatory reaction in different degrees;LPS induced acute lung injury in mice: HE staining of lung tissue in each dose group verified that the low,medium and high intervention groups of shufengjiebiao granule showed different degrees of inflammatory reaction,which could significantly reduce LPS induced acute inflammatory lung injury.(3)Study on Preparation and quality standard: the volatile oil of Schizonepeta tenuifolia and Saposhnikovia divaricata were 0.1ml and 0.5ml respectively;the effective components of Ligusticum chuanxiong,Radix Saposhnikoviae and Radix Angelicae dahuricae were extracted,and the extract was 9.2g,18.3g and 2.2g respectively;the extract was obtained by boiling 64.3g.A TLC method for the identification of Radix Saposhnikoviae,Herba Schizonepeta,Rhizoma Notopterygii,Radix Angelicae dahuricae,Rhizoma Chuanxiong and Radix Bupleuri in shufengjiebiao granules was established,the spots are clear,Good separation,Negative without interference,Determination of amiloride,cimicifugin and imperatorin in Radix Saposhnikoviae and Radix Angelicae dahuricae: Objective to establish a HPLC method for the determination of amigoside in Radix Saposhnikoviae,Draw standard curve,the regression equation is y=15.885x+26.806,R2=0.9996,the results show that in the range of 7.5-120μg/ ml,the linear relationship is good;to establish a method for the determination of cimicifugin in Radix Saposhnikoviae,Draw standard curve,the regression equation is y=33.185x+25.263,R2=0.9999,the results show that in the range of 3.75-60μg/ml,the linear relationship is good;the regression equation was y=49.677x+8.3563,R2=0.9998,which showed that the content of imperatorin in Radix Angelicae dahuricae ranged from 1.25-20μg/ml.The linear relationship was good in the range of 0.5g/ml.(3)Preparation forming process: preparation of volatile oil inclusion complex with dextrin and sucrose as excipients,preparation of soft wood with dextrin and sucrose ratio of 1∶3;pass through No.1 sieve and dry at 50℃,examination: the average qualified rate of particle size was 91.51%,which was higher than 85% in the Pharmacopoeia.The solubility was completely dissolved within 5 minutes,and the average water content was 6.1%.All the indexes of three batches of granules(20190502,20190508,20190514)met the requirements of Chinese Pharmacopoeia 2020.Conclusion: Based on the data mining of Chinese patent medicines for cold in the Pharmacopoeia of the people’s Republic of China,it is concluded that most of the Chinese patent medicines for cold are wind heat cold,while wind cold cold is less.The preparation of shufengjiebiao granule for treating wind cold is scientific and reasonable.The quality standard is effective and controllable,and the quality of the finished product is stable.The granule preparation has the pharmacological effect of anti inflammation and analgesia,which provides drug choice for clinical treatment of wind cold.