The Study On Preparation And Quality Standards Of Nixintongbi Capsules

Objective:to sure the technology of preparation and establish the quality standards of the Capsules.Methods:1)Through simPlex factor and direct cross exPerimentation,use the clathration rate and utilization rate of xintahua volatile oil as the index of volatile oil extract,to sure the technology Parameter;2)use the method of HPLC determine the contents of Bsalvianolic acid B as index,to sure the aqueous extraction technology Parameter of Salvia miltiorrhiza Bge etc.tetro-saPidity medical material;3)use the method of HPLC determine the contents of ferulic acid as the detective comPositons with yield of the alcohol extraction technology Parameter of Ligusticum chuanxion etc.tetro-saPidity medical material;4)After being mdae into inclusion comPound withβ-CYD,the mentholum was made into granules together with the extraction of alcohol and aqueous extract,then use them to granulate and Padding caPsule;5)EmPloy thin layer chromatograPhy and contents determination to have qualitation and quantitation discrimination,while institute the quality criteria of PreParation.Result:1)The oPtimum extraction of Xintahua's volatile oil is to reflux 12-fold waters soaked half an hour,and extract 2 hours;2)The oPtimum extraction Procedure of aqueous extract is to reflux it with 16-fold water for 3 times 0.5 hour each time;3)The optimized extraction Porcedure of alcohol extract is to extract it with 60%alcohol add it 8-fold reflux-extracting for 2 times 1 hours each time and centrifuge;4)The oPtimum inclusion condition was as follows,the ratio of volatile oil toβ-CYD is 1:5(ml/g),add 9-fold waters,the inclusion temPerature was 40℃and inclusion time was 60 minites;5)Angelica in Ningxintongbi caPsule mwa made qualitative differentiation with TCL of Salvia miltiorrhiza Bge. Ligusticum chuanxion,Allium macrostemon Bge.Carthamus tinctorius,Platycodon grandiflorum and the content of salvianolic acid B was understanded with HPLC.The method of salvianolic acid B with HPLC:mobile phase:methanol-methyl cyanide-methanoic acid-water(25:10:1:64),detect wavelength:286nm.Conclusions:It was Proved that oPtimum design of exPeriment Procedure of the extraction,modeling technique and nitial stability study,acute toxicity test is reliable,the Process is controled for quality and noxious ProPerty that will do well datas for new drug to rePort to a higher authority.