| The pathogenesis of allergic bronchial asthma is complex,but it is believed to be mainly related to the two major factors of allergy and infection.Allergic bronchial asthma is a highly reactive disease of the trachea and bronchus.It is caused by antigenic or non antigen stimulation,characterized by exhaled dyspnea,accompanied by wheezing,duration or long or short.Repeated attacks for a long time,often accompanied by chronic bronchitis and emphysema.In the treatment of allergic bronchial asthma,western medicine is mostly controlled and slowed down,which is difficult to cure,and there are certain side effects of taking large doses of drugs.At present,from the perspective of traditional Chinese medicine,drugs for treating this disease have been developed with good curative effect and low toxic and side effects.The GuiShao zichuan prescription is a clinical experience in the treatment of allergic bronchial asthma,and its clinical efficacy is stable and safe.The use of modern traditional Chinese medicine preparation technology to make new preparations to make its clinical application more extensive,with more important research significance and research value.ObjectiveThe GuiShao zichuan prescription is composed of 11 herbs,such as astragalus,cassia branch,dried ginger,and paeonia,which has the effect of invigorating the lungs and reducing the asthma.This study on the basis of guarantee the original effect,combined with modern Chinese native medicine preparation techniques,The GuiShao zichuan granules were prepared from Decoction,and the content of effective substances and the pharmacological activity were taken as the preferred indicators.The extraction process,the molding process,the scaled-up production of three batches of pilot tests,The quality standard of the GuiShao zichuan Granules has been initially established.MethodsThe research topics of the project mainly include the extraction and purification process of The GuiShao zichuan granules,the molding process,the scale-up of the pilot test,and the study of the quality standards.The specific process methods for each part are as follows:1.study on Extraction and purification process:① Through single-factor analysis and orthogonal test,the optimum extraction process of volatile oils from the volatile oils of cassia twig,dried ginger,and cinnamon was investigated using volatile oil yield as an index;on this basis,an appropriate kinetic model was used.The experimental data of the extraction process were fitted to obtain the kinetic relationship model of the extraction process of mixed volatile oil.② The orthogonal experimental design was carried out to investigate the inclusion temperature,inclusion time,the ratio of β-CD and mixed oil,and each factor had 3 levels.The β-cyclodextrin inclusion process of mixed volatile oil was studied.The volatile oil inclusion rate was used as an index for optimization.③After the volatile oil was extracted,the aqueous solution was combined with the water extraction part.The extraction rate of astragaloside and paeoniflorin was taken as the inspection index.The water addition times,extraction time and extraction times were selected as the influencing factors.and by orthogonal experiment to investigate the best water extraction process of Que son out of particles.④ Taking the transfer rate of astragaloside and paeoniflorin as an index,we investigated the relative density and alcohol concentration of alcohol precipitation process by single factor,and selected the best alcohol precipitation process.⑤ The optimal temperature conditions were determined by using astragaloside and paeoniflorin in terms of the rate of loss,and the single factor was to investigate the concentration temperature,the concentration temperature of alcohol and the drying temperature of alcohol.2.Study on the forming process:Wet granulation was used to study relevant parameters.The wetting agent and its concentration,types and proportions of auxiliary materials,and auxiliary materials were determined by the particle moisture absorption rate,particle formation rate,soft material properties,and the ease of screening;The quality of the semi-finished products is controlled,and the solubility,rest Angle,heap density and critical relative humidity of the granules are measured so as to effectively control the production environment and load of the products during the production process.Based on the literatures and experiments,the relevant parameters of the molding process were determined,and the process route was established.3.Summary of pilot study:The trial of each batch was based on the collected particle 10kg,and the drug delivery was carried out.According to the optimization of the extraction and purification process and forming enrichment process parameters,three batch of pilot enlarge experiment was carried out,the detection of three groups of astragalus armour and paeoniflorin content in samples,the results conform to the standard.4.The establishment of quality standards:The TLC identification method of radix astragali,radix paeoniae,alba,white mustard,schisandra and licorice was established.The content determination method of astragaloside and paeoniflorin was established by HPLC,and the method was verified by methodological investigation.The content of Astragalus(C31H68O14)in graunls not less than 0.41 per 1g,And the content of paeoniflorin(C23H28O11)in graunls not less than 6.86 per 1g.ConclusionIn this paper,the extraction and purification process,preparation process and concentration drying parameters of The GuiShao zichuan granules were studied.,A reasonable and feasible preparation process was established,and the qualified samples were selected through three batches of test amplification.Through the study of relevant quality standards,determine the TLC of The GuiShao zichuan granules of six herbs,and the content of index component astragaloside and paeoniflorin determination,method of inspection is stable and feasible and provide a strong basis for the protection of granule quality,so as to better control the quality of The GuiShao zichuan granules. |
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