The Studies On The Preparation Procedure Screening And Quality Standard Of The Naoshuan Kangfu Pills

The Naoshuan Kangfu pills is a kind of effective antithrombotic drugs,in this thesis,aims to study the formulation and preparation the Naoshuan Kangfu pills and its quality standard,stability,for a more deeply and comprehensively research.In the paper,the optimal process was studied by orthogonal design test and puerarin content,contrast experiment and single factor test with the yield of extract as the index.Three influence factors were selected in this experiment,including the volume of water,times of extraction,duration of extraction.Methods of granulation were studied,excipients were selected,stable and fesaible processing technonlogy of the Naoshuan Kangfu pills was established.Thro ugh the comprehensive consideration,as a result,the best is medicinal material decoct 3 times,eight times more water and decoct for 2 hours every time.Alcohol content is 75%.When pharmaceutical excipients select aerosil,microcrystalline cellulose,CMS,2.5%HPMC 50%ethyl alcohol and magnesium stearate,drug particles has good formation,weight,hardness,frangibility,disintegration time are moderate.The pills with with smooth surface.Identificate pseudo-ginseng,sang-dragon,radix Puerariae,Rhizoma Chuanxiong,Radix Paeoniae Rubra by the thin-layer chromategraphy.With reference to Chinese pharmacopoeia 2015 edition an appendix 0101 tablet under the relevant provisions,inspect the weight variation,distitegration time,mircrobial limit,heavy metal content and arsenicum content.To prove the content determination method is reliable accurate through measurement precision test,reproducibility test,stability test and added aconitine recovery.The content of the Naoshuan Kangfu pills was determined by HPLC,as the ginsenoside Rg1,ginsenoside Rb1 and notoginsenoside Ri for index.Through the methodological evaluation,this method applies to the quality control of the Naoshuan Kangfu pills.According to the establishment of the appearance characters,distitegration time,thin-layer chromategraphy,mircrobial limit,and dermination content to determine the stability of the Naoshuan Kangfu pills.The results showed that every index accords with the regulation through measuring.The preparation of the Naoshuan Kangfu pills in high temperature,high humidity,illumination,accelerated experiment and long-term experiment under the condition of relatively stable.