Preparation Technology And Pharmacokinetics Research Of Bitong Transdermal Paste

Bitong prescription is made of four kinds of medicine,such as Caowu,Angelica sinensis,Alpinia officinarum and clove.It has remarkable curative effect on rheumatism,rheumatoid arthritis,rheumatic numbness and other diseases.In this paper,it is made into transdermal preparation,optimized preparation process and evaluated its quality.Comparison of HPLC chromatograms of different samples with different samples The RSD values of methodological investigation are less than 3,which indicates that the established instrument method is stable and feasible,and thecalculated similarity is above 0.9.It shows that the control fingerprint is representative and the similarity between the samples is good.A single factor and orthogonal test were used to optimize the alcohol extraction process of Bitong prescription.The optimum extraction process was determined as follows:ethanol volume fraction is 70,material-liquid ratio is 1:7,soaking time is 1h,extraction is 3 times.The results show that the extraction rate of the index components is high and stable.The formulation and process of Bitong transdermal patch were determined by single factor investigation and orthogonal test,and the optimum preparation process was 2.5 g pressure sensitive adhesive,1,2-propanediol dosage of 2 mL、5%azone,30%drug loading,and verified test.The appearance,adhesion and weight of Bitong transdermal patch all meet the requirements of pharmacopoeia,and the release degree in vitro can reach 70%within 12h,and the change trend of cumulative permeability in 12h is stable.The results showed that the average content of mesaconitine was 0.272 mg/paste,aconitine was 0.118 mg/paste,hypaconitine was 0.204 mg/paste,and the galangin average content 2.075 mg/paste.The pharmacokinetics of Bitong transdermal patch in rats.After transdermal administration of rats,the maximum absorption concentration can be reached after 120 min,Cmax concentration 2.33μg·mL-1,AUC(0-t)is 718.9,the Tmax of percutaneous administration is 120 min,the peak time is longer,which indicates that the patch can prolong the release of the drug and can act on the diseased site for a long time to achieve a certain therapeutic effect.