Study On The Preparation Technology And Quality Standard Of Pihanyao Influenza Granules

Objective:Influenza is a seasonal,frequently occurring disease.The demand for anti influenza drugs is large,the experiment is combined with the theory of traditional Chinese medicine and the prescription of folk medicine,and using modern traditional Chinese medicine preparation technologyand,preparation of Pihanyao influenza granules scure common influenza diseases.It is used in the form of single prescription to develop the anti flu granules with the symptoms of exogenous fever,headache,asthma,sore throat and soft limbs and so on.Prevent and treat common flu diseases.Method:The research is carried out in five aspects:raw material screening,preparation technology,pilot study,quality standard and antibacterial in vitro from Pihanyao influenza granules.1.The quality inspection of 7 batches of raw materials was collected,and the appropriate batches were selected as the raw materials for the preparation of granules.And the method for the determination of HPLC content of API was optimized.2.By orthogonal design method,the Pihanyao medicine liquid of dry extract yield and the content of pihanyao in Maackiain and Fermononetin as evaluation indexes to prefer the water extraction alcohol precipitation and concentration process of raw material medicine optimization in Pihanyao influenza granules.Taking molding rate,melting rate and absorption rate as evaluation indexes,the single variable method was adopted to optimize the forming process of the Pihanyao influenza granules.The packaging materials and dosage of the existing granules in the market of 50 hospital clinics in Chengdu were investigated to reduce the research object of Pihanyao influenza granules packaging materials,and the packaging materials were selected with the molding rate,solubility and moisture absorption rate as evaluation indexes.Establish the process route and preparation method.3.According to the selected technological conditions,3 batch of samples were tested continuously,and through the trials of the quality inspection of intermediate drug substances,trial production of pilot samples,and general inspection of pilot samples,etc.Determine the stability and rationality of the continuous production process.4.The 3 batch of medium test particles were made by name,source,method,character,TLC identification,examination and determination of the content of the effective composition of the high exotoxin and manshenin.The study on the limit,specification and storage of the content of the target composition was preliminarily formulated,and the Pihanyao influenza granules quality standard was formulated.5.In vitro antibacterial test was carried out on the particle sample?batch number 20171221?.The bacteriostasis and minimum inhibitory concentration?MIC?of the drugs on four susceptible influenza bacteria?Staphylococcus aureus,Staphylococcus epidermidis,Klebsiella pneumoniae,Salmonella?were observed by solid continuous dilution method,and the antibacterial effect of the drugs was initially established.Result:1.First batches of raw materials purchased from Baisha village,Xichang,were selected from the 7 batch of samples collected from the origin.The chromatographic conditions of Pihanyaoeffectivecomponent chromatography areoptimized.Thechromatographic conditions:the DiamonsilTMC18 HPLC column?4.6x250mm,5ul,Ser.No.:8132964.?,the mobile phase:acetonitrile water?40:60?,the flow velocity:1.0ml·Min^-11 column temperature:30?,the sample quantity:10?L,the detection wavelength:210nm,analysis time:25min.2.The best water extraction process conditions for:A₃B₂C₁D₃,i.e.,The sample is coarse powder.each water added12 times,extracted three times,each extracting time was 0.5 h,respectively.The best conditions for the pure precipitation process:A₂B₂C₃.The liquor is concentrated to the relative density of1.10,and Alcohol precipitation for 18 hours,with the concentration of ethanol was 60%.The best conditions for the concentration process:Under the condition of 70?,Concentrate the liquid to relative density of:1.20-1.25,glucose as excipient,proportion of extract and excipient 1:4,75%ethanol as wetting agent,proper amount at 60?,drying time 2h.3.The pilot samples of the three batch were tested to be stable and controllable.4.The quality standard of Pihanyao influenza granules was initially established.5.The particle sample had a uniform bacteriostatic effect on four kinds of bacteria,but the bacteriostatic effect was different.The minimum inhibitory concentration?MIC?of Klebsiella pneumoniae is the lowest,The minimum inhibitory concentration?MIC?of Staphylococcus epidermidis is the highest,Staphylococcus aureusg and Salmonella are between them.Conclusion:This study optimizes the quality analysis method of the Pihanyao,optimizes the reasonable and stable preparation method of the Pihanyao influenza granules,and establishes the draft quality standard for the Pihanyao influenza granules,basic research data are provided for developing a safe,effective and inexpensive Pihanyao influenza granules suitable for large-scale production to prevent or treat seasonal influenza.