The Pharmaceutical Study Of P-Tolylmethylcarbinol Nicotinic Acid Ester

p-Tolylmethylcarbinol nicotinic acid ester is one of Tolynicate and naphthylacetic acid tablet’s main effective components. Tolynicate and naphthylacetic acid tablet is a new drug for hepatic and biliary diseases. Compare with the similar medicine, it has advantages of high curative effect and less side effect. Many studies indicates that it will have very good market prospects and large market competitiveness in China. It will bring new hope to the patients.This study intended to develop the synthesization study of p-tolylmethylcarbinol nicotinic acid este. The raw materials are Nicotinoyl chloride hydrochloride and methyl-p-tolyl carbinol, the synthetic techniques and methods are obtained through experiments, and the best synthetic conditions are determined by orthogonal tests so as to validate the feasibility of the synthetic methods. The preliminary enlarged experiments and pilot tests are conducted to provide data for the industrialized production. In order to confirm the strcture of stuff medicine of p-tolylmethylcarbinol nicotinic acid ester, we bought the standard products of p-tolylmethylcarbinol nicotinic acid ester from Switzerland （PHARAG AG）and carried on inspecting the structure. We carried on UV, ¹H NMR, ¹³C NMR, MS. analysis to resulted products and standard products under the same conditions. The results of our products and standard product were totally unanimous. We analyse synthetically the results of UV, ¹H NMR, ¹³C NMR, MS and the results indicated our product was p-tolylmethylcarbinol nicotinic acid ester.The topic included p-tolylmethylcarbinol nicotinic acid ester’s quality research. Physical and chemical characters, appearance, identification and purity test were studied. The specificity, linearity, veracity, circumscription, accuracy, recision, reproducibility, etectability, durability and system suitability in the experiment were authenticated, the results indicated all those methodologies meeted the demands of pharmacopoeia of the People’s Republic of China, which established the basic for clinic research.In this topic, we conducted the preliminary stability research on produced p-tolylmethylcarbinol nicotinic acid ester. The main content was: influence factor experiment, acceleration test as well as long-term test. The experiment indicated that the stuff medicine has good stabilization. Content, physical and chemical characters of p-tolylmethylcarbinol nicotinic acid ester were not change and there were no degradation products in the test. We forecasted the expiration date of p-tolylmethylcarbinol nicotinic acid ester was five years.