The Pharmaceutical Study Of α-Naphthylacetic Acid

As a stuff medicine of tolynicate and naphthylacetic acid which was a new drugfor hepatic and biliary diseases,a-naphthylacetic acid can used to active chronicinflammation of biliary system,also used to the dyspepsia ache caused by taking fattyfood and drink of the patients who have the functional defect of choleresis.It has theeffect of encouraging choleresis, antiinflammatory and protecting liver.α-naphthylacetic acid was a good cholagogue and has a long duration.The sales hasbeen growing steadily since it went into the foreign market.It indicates this medicinewill have very good market prospects and large market competitiveness in China. Itwill bring new hope to the patients.This task intended to develop the pharmaceutical study ofα-naphthylaceticacid.Raw material content was used to evaluate the quality of thetechnology, orthogonal tests were used to confirm the optimum synthesis technology.Based on the small-scale test,enlarged test and middle-scale production wereconducted.In order to confirm the strcture of stuff medicine ofα-naphthylaceticacid,we bought the standard products ofα-naphthylacetic acid from foreign countriesand carried on inspecting the structure.Ⅰcarried on UV, ~1H NMR,~13C NMR, MSanalysis to resulted products and standard products under the same conditions. Theresults of our products and standard product were totally unanimous. We analysesynthetically the results of UV, ~1H NMR, ~13C NMR, MS and the results indicated ourproduct wasα-naphthylacetic acidThe study included checkingα-naphthylacetic acid indexes of quality.Physicaland chemical characters,appearance,identification and purity test were studied.Thespecificity,linearity,veracity,circumscription,accuracy,precision,reproducibility,detectability, durability and system suitability in the experiment were authenticated,the results indicated all those methodologies meeted the demands of pharmacopoeia of thePeople’s Republic of China,which established the basic for clinic research.In this topic, we conducted the preliminary stability research on producedα-naphthylacetic acid.The main content was: influence factor experiment, accelerationtest as well as long-term test. The experiment indicated that the stuff medicine hasgood stabilization.Content,physical and chemical characters ofα-naphthylacetic acidwere not change and there were no degradation products in the test.The expiration dateofα-naphthylacetic acid was three years.