Study On The Preparation Technology And Quality Standard Of Zihe Puchuan Granule

Because of the complexity of the pathogenesis of cough variant asthma(CVA),there is no systematic and unified understanding in the field of modern medicine.The particularity of clinical manifestations often leads to misdiagnosis,which brings about a further development of the disease to typical asthma.Zihe Pochuan Fang is a clinical Chinese medical prescription of the China-Japan Friendship Hospital,it has a good effect on the treatment of CVA.It is important for the treatment of CVA to make it into granules by using the modern technology.ObjectiveZihe Pochuan Fang contains ten herbs for example Astragalus mongholicus,Astragalus mongholicus,Fructus Chebulae,Aster tataricus Linn and Mangnolia officinalis etc.It has the effect of Warming Yang,invigorating the spleen and relieving cough and asthma.The thesis aims to make Zihe Pochuan Fang into granules by studying on extraction and purification technology and quality standard.MethodsThis study mainly includes the extraction and purification technology,the molding process,the pilot study of Zihe Pochuan 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 and ginger by water vapor distillation extraction process.The inclusion process of volatile oil was optimized by orthogonal test.The water extraction,alcohol precipitation and drying process were investigated.The water extraction,alcohol precipitation and drying process were investigated.The water extraction,alcohol precipitation and drying process were investigated by using the orthogonal test.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 Zihe Pochuan Keli.3.Study on three batches Pilotscale:We prepared three batches Pilotscale samples by optimization of the extraction process,and then granulated by the optimization of forming process,in order to determine the optimum process is stable and feasible.4.Study on the quality standard:By using thin-layer chromatography(TLC),we made qualitative analysis on five herbs and established the quality standard of the granule by HPLC.5.Study on the stability:Study the accelerated stability and long-term stability of three batches of particles.Results1.The optimized factors were:adding 8-fold water,extracting for 11 h without infusion.The optimized inclusion conditions were:the ratio of β-CD and volatile oil was 8:1(g:mL),temperature was 50℃ and stirring time was 2 h.Repeated experiments showed that the inclusion process can be well reproduced.X-ray scattering technique and microscopic imaging analysis indicated that stable inclusion compound has been formed from volatile oil and β-CD.The optimum water extraction and alcohol precipitation process:adding 10 times water,extracting 3 times,each time for 1.5 hours.The filtrate was concentrated to a relative density of 1.10-1.15(60℃),the alcohol concentration of 60%.The technology is reasonable and feasible,which can provide certain references for preparation.2.The molding process is determined as follows:Choose wet granulation as the method,extract powder with excipients in the ratio of 1.5:1,90%ethanol as a wetting agent.The ambient relative humidity controls under 74%.The prepared granules packed into bags and the process is finished.3.Three Pilotscale experiment showed that the process was stable and feasible.4.Establishment of quality standards:We made qualitative analysis on five herbs and established the HPLC method to determine the content of Astragaloside and Mangiferin of Zihe Pochuan Keli,the method is simple,stable and feasible.The content of Astragaloside in granules should not be less than 0.16mg/g.The content of Mangiferin in granules should not be less than 0.25mg/g.5.Study on the stability:The quality of Zihe Pochuan Keli is fine,the content of the index composition meets the requirement and the particle is more stable after being placed under the constant temperature and constant humidity.ConclusionThe stable and feasible preparation process was established through the research of extraction,purification and forming process of Zihe Pochuan Keli,and prepared qualified shaped particles.The study had established the qualitative identification and quantitative determination through the relevant quality standards,providing strong evidence in order to ensure the formulation quality and achieve the expected experimental objective.