The Pharmaceutical Study Of Tolynicate And Naphthylaceticacid Film-Coated Tablets

As a genuine choleretic, Tolynicate and naphthylacetic acid film-coated tabletstimulates liver cells to increase the secretion of bile in its physiological composition.α-naphthylacetic acid and p-tolylmethylcarbinol nicotinic acid ester combined in aratio of 2:1, complement each other to warrant a rapid onset of the bile secretion and along-lasting bile production.Tolynicate and naphthylacetic acid film-coated tablet ismore effective and has less adverse reaction than other medicine. Tolynicate andnaphthylacetic acid film-coated tablet has not been manufactured in china. Additionally,it will benifit patients with diabetes or hepatomiliang diseases by changingsugar-coated to film-coated.This project will improve economic performance andsocial effect. In this paper, the pharmaceutical of the tolynicate and naphthylacetic acidfilm-coated tablet is studied.In the preformulation researches, high-performance liquid chromatography(HPLC)method was developed for determination of content, drug release and relationalsubstance. The stability of p-tolylmethylcarbinol nicotinic acid ester andα-naphthaleneacitic acid were studied at the same time. Secondly, the prescription andpreparation process of the film-coated tablet was studied, which include thephysicochemical properties of p-tolylmethylcarbinol nicotinic acid ester andα-naphthaleneacitic acid, the interaction study between the medicine and excipients,the design and filtrating of the prescription, the process and the quality evaluation ofthe film-coated tablet.In addition, we studied quality of tolynicate and naphthylacetic acid film-coated tablet such as figure, discrimination, weight diversity, content assaying, release andmicrobe limitation checking of the film-coated tablets. The checking result accordedwith the relevant regulations of Chinese Pharmacopoeia.The last we studied the stability of tolynicate and naphthylacetic acid film-coatedtablet. The accelerating tests of stability and long term tests of stability were studied.The result suggested that tolynicate and naphthylacetic acid film-coated tablet werestable in storage condition. The result of preliminary test on stability indicated that thisfilm-coated tablet is very stable.