Study On The Preparation Technology And Quality Standard Of Qifangbimin Granules

The pathogenesis ofAllergic Rhinitis is complex,fu zheng qu xie is the foundation of traditional Chinese medicine in treatment of this disease,At present,there is an urgent needof traditional Chinese medicine to treat the disease.The development of new drugs from TCM which has significant effect,low drug side effect and can cure the disease fundamentally is the focus of current research.Qifang Bimindecoction is a classical prescription for the treatment of Allergic Rhinitis,which has a significant and stable effect.Using modern Chinese medicine preparation technology to develop a new preparation,it will increase the extensive clinical application and has important research significance and value.ObjectiveThe Qifang Bimin decoction,which is composed with Astragalus membranaceus,Paeonia lactiflora Pall and other twelve kinds of TCM.This prescription has the function of Jianpi Yifei,Wenyang Gubiao Dakwah nasal.In this paper,On the basis of ensuring the original efficacy.We prepare Qifang Bimindecoction into granules.By using the content of drug components and pharmacological activity as index to optimize the preparation process,and then established the quality standard.MethodsThis study mainly includes the extraction and purification technology,the molding process,the pilot study of Qifang Bimin Keli,the quality standard research,the main methods are as follows:1.Study on extraction and purification process:With recovery ratio as evaluation indexes,the single factor study was used to study the volatile oil extraction process of ramulus cinnamomi、ginger、cinnamon、magnoliaby water vapor distillation extraction process.Meanwhile,study the preparation of β-cyclodextrin(β-CD).The study employed the extraction rate of astragaloside IVand paeoniflorin as evaluation indexes to investigate extraction conditions and alcohol precipitation.We take guinea pig of allergic rhinitis caused by TDI asmodel,to study the efficacy between Qifang Bimin Keli and traditional decoction.2.Study on the forming process:Granulation methods were investigated,and combine the literatures and experiments to determine the related parameters(such as the ratio between extract power and excipients,ethanol concentration and so on)of molding technology.Finally established the forming process of Qifang Bimin Keli.3.Study on the quality standard:By using(TLC),we made qualitative analysis on Astragali,Radix Paeoniae Alba,Saposhnikovia divaricate,Fructus Schisandrae,Glycyrrhiza uralensis.By using high-performance liquid phase chromatography method,we determine the content of Astragalus glycosides and paeoniflorin,which is the main effective components of Qifang Bimin Keli.Initially established its quality standard.Results1.Determined the Guizhi,magnolia and other four herbs Volatile Oil Extraction and inclusion process:crud drug was extracted 10 hours with 8 folds the amount of water,mixed volatile oil-β-CD ratio was 1:8,inclusion temperature was 40℃,and the inclusion time was 3 hour.The optimum water extraction and alcohol precipitation process was extracted 3 times,with 12 folds the amount of water,1.5 h for each time.The extracts were concentrated to the relative density of 1.15～1.20(60℃)with the concentration of alcohol precipitation 60%.And then storaged in refrigeration overnight,filtered,the filtrate recovery of ethanol and concentrated to the amount,dry extract with reduced pressure and finally the extract power was get.Guinea pigs behavioral symptom scores showed both granules and traditional decoction have therapeutic effect on the treatment of allergic rhinitis.Futhermore,the efficacy of granules are as well as traditional decoction,slightly better than the traditional decoction.The pharmacodynamic result demonstrated that the reaserched technology is feasible.2.The molding process is determined as follows:Choose wet granulation as the method,extract powder mixed with excipientsin the ratio of 3:2,94%ethanol as a wetting agent.The ambient relative humidity controls under 74%.The prepared granules packed into bags and the process is finished.3.The establishment of quality standards:Establishedthe TLC qualitative identification methods of Astragalus membranaceus,Paeonia lactiflora Pall,Saposhnikoviae Radix,Schisandra,Radix Glycyrrhizae,and good specificity.We established the HPLC method to determin the content of Astragaloside and paeoniflorin of Qifang Bimin Keli,the method is simple,stable and feasible.The content of Astragalus(C31H68O14)in graunls not less than 0.43 per 1g,And the content of paeoniflorin(C23H28O11)in graunls not less than 1.43 per 1g.ConclusionThe optimum preparation process and quality standards methods were finally established,the methods were reasonable,stable and feasible.It can effectively control the quality of preparation,thus,laying the foundation for developing it into new drugs.