| ObjectiveTo study the preparation,quality standards, transdermal rate,release rate of liposome gel of Total Leaves Saponins of PanaxNotoginseng.Method:1. To determination loss on drying in Total saponins of Panax:According to Chinese Pharma copoeia of2010(page:424),Use AppendixIXG to determination its Loss on drying of total saponins of Panax.2. To determination the Content Ginsenoside Rb3in Total LeavesSaponins of Panax Notoginseng Chromatographic conditionsis:AgilentZORBOXSB-C18column. Mobile phase:Acetonitrile is mobilephase A,0.2%phosphoric acid solution is mobile phase B,Thengradientelution.Thespecificmethod:0-19min,A:30%-35%;19-21min,A:35%-50%;21-26min,A:50%-50%.Velocityofflow:1.0mL·min-1;Wavelength:203nm;Column temperature:25℃.According to this Chromatographicconditions we Conduct verification Testing of Preparations moldingprocess and Content determination of Active ingredients3. The research preparations molding process:On the basis ofPreliminary experiments and kinds of References,To choose soy lecithin and cholesterol,The mass ratio of lipid and drug andconcentrationofdrug,To use film dispersion method,L9(34)orthogonaltest and High-speed centrifugation to determine encapsulationefficiency.With the level of Encapsulation efficiency to FilterOptimum process and different concentrations of Carbomer940asmatrix.To determine Carbomer940final dosage with The appearanceof the gelling agent and ease of coating and then Join Glycerin toAdjusting Moisture retention of gels.4. Study on Quality Standard:Useing HPLC to determine thecontent of Ginsenoside Rb3in liposome gel of Total Leaves Saponinsof Panax Notoginseng.Chromatographic conditions is as the same as2.5. Study on in vitro transdermal rate:To use franz diffusioncell method conducting vitro transdermal experiments.To researchginsenoside Rb3′s transdermal absorption in liposome gel of TotalLeaves Saponins of Panax Notoginseng and use HPLC to determine theContent of ginsenoside Rb3.6. Study on Releasing:To use HPLC to determine the Content ofginsenoside Rb3in accept liquid and slurry method Is used todetermine in vitro release test.To calculate liposome gel of TotalLeaves Saponins of Panax Notoginseng in saline′s releasing in twohours.Result:1.The raw materials of Total saponins of Panax PharmaceuticalLoss on drying is4.29%,Comply with the provisions of the ChinesePharmacopoeia.2.The Result of Ginsenoside Rb3′s content in Total LeavesSaponins of Panax Notoginseng is12.67%,Comply with the provisions of the Chinese Pharmacopoeia.3. The optimum conditions is:The use of ratioLecithin andcholesterol′s4:1;Grease and drug is6:1;The mass concentrationof Ginsenoside Rb3is90mg/ml.Then the weight ratio of Carbomer940is0.5%andthe concentration of Glycerin is0.6mL/10g. Observeingthe gels complying with the Relevant provisions of the ChinesePharmacopoeia.4. Study on Quality Standard:Ginsenoside Rb3′s linear rangeis Y=2.71X+2.628,r=0.9995;Precision:The average of peak area is1339.53,RSD is0.23%;Repeatability:the average of content ofGinsenoside Rb3is0.238%;RSD is0.98%;Stability:The average ofpeak area is649.42;RSD is1.32%;Result:The test solution is stablein12hours.Recoveries:The average of recovery rate is101.46%,RSD:0.80%.The content of Total Leaves Saponins of Panax Notoginsengin Three batches are199.37mg/10g,194.44mg/10g,195.64mg/10g.5. Study on in vitro transdermal rate:Ginsenoside Rb3′sCumulative transdermal rate is13.39%in liposome gel of TotalLeaves Saponins of Panax Notoginseng.Study on Releasing:Ginsenoside Rb3′s Cumulative transdermal rate is49.70%whthin12hours in liposome gel of Total Leaves Saponins of Panax Notoginseng.Conclusion:The development of Liposome Gel of Total Leaves Saponins ofPanax Notoginseng has good transdermal rate and spread ability,withits active ingredients has a good Stability.Through the study ofThe raw materials of Total saponins of Panax is Loss on drying,theMethod for determination of ginsenoside Rb3is Content,thepreparation of molding process,quality control,transdermal rateand releaseing.All of this Lay the foundation for liposome gel of Total Leaves Saponins of Panax Notoginseng is further developing. |