Studies On Lajiao Fengshi Cataplasm

Lajiao Fengshigao,which is made from drug extraction of capsaicin, borneol, menthol, is widely used in the treatment of joint pain and rheumatism.It is contained in the standards of Ministry of Health for Chinese medicine formulations. In this paper, a new kind of patch named Cataplasm was prepared. The quality of Lajiao Fengshi Cataplasm has been systematic studied to ensure the stability of pharmaceutical preparations controllable, safty and effective. The main results are as follows:(1) The process of using ethanol to extract capsaicin was studied,the process of extraction was selected by L9(34)orthogonal and formulation optimization experiment.The experiment's index is the extractive yield of capsaicin.The ethanol concentration,the ratio of solid to liquid,temperature were inverstigated,the results are as follows:75 vol.%EtOH,temperature 65℃,stock ratio 1:5(m/V); The process of preparation of pepper extract has been studied,the process was selected by the index of the density,and the different kinds of pepper has been inverstigated.(2) The prescription of Lajiao Fengshi Cataplasm has been selected.Throught the pre-experiment,takes the evaluation by the result of peeling test,the optimal prescription is:Polyacrylic acid / sodium polyacrylate copolymer is 5%, cross-linking agent is 0.15%, tackifier-1 is 2%,tackifier-2 is 2%,tackifier-3 is 3%, pH adjustment agent is 0.3%, the regulation of crosslinking agent is 0.05%, the excipients is 1% ,the moisture is 30%;The results of skin compatibility experiment show that the Lajiao Fengshi cataplasm has advantages of good moisture permeability,but has litter irritation to skin.(3) The method of thin layer chromatography(TLC) was used to identify Borneol, menthol in Lajiao Fengshi cataplasm,the results are as follows:in the same position of the thin belt, Reference substance and test materials have the same blot, Repeated tests showed that: this method specific, repeatable;The content of capsaicin in the preparation assayed by high performance liquid chromatography(HPLC) is studied,The mobile phase consisted of Acetonitrile-0.1%Phosphoric acid (41:59),the flow rate was 1.0 mL·min-1,the detection wavelength was 281 nm.the result is: this method had a good linear relationship in the scope of 20.32～203.2μg·mL-1.It has high stability and good accuracy.The capsaicin of prepared cataplasm content uniformity. The method for comparing the in vitro percutaneous permeability of capsaicin of different Formulations has been established. The results of transdermal permeation experiment indicated that in vitro drug percutaneous permeability of cataplasm could reach more than 10% after 24 hours, compared with 7% of Rubber Plaster.