The Study On The Improvement Of Coating Process And The Upgrading Of Quality Standard Of Yanyan Tablets

Objective: Yanyan Tablets have recorded in the drug standard of Ministry of public health of the people’s Republic of China(Chinese Medicine), it is rigorous,reasonable compatibility,obvious curative effect,high cure rate and no obvious toxic side effects,have a solid foundation of clinical.Yanyan Tablets which are producted by a pharmaceutical of Gui Zhou are suger coated tablets,they have a lot of disadvantages such as easy to present the color spot,complicated operation and so on,so they can, t meet the requirements of the market.So our group prepara compound Yanyan film coated tablets through the modern traditional Chinese medicine preparation technology and improve the related control standard of the quality.Methods: the film coated tablet weight,coating formulation and coating conditions were established by the single factor test and the orthogonal design.To identificate the Radix Scrophularise,tree peony bark and Redix Ophiopogonis through TLC identification method;To determine the content of the gallic acid and cinnamic acid through high performance liquid chromatography method;At the same time our group investigate the preliminary stability,fomulate the draft standard of quality. and test the pilot Yanyan Tablets which are producted according to the requiremengs of the draft standard of quality.Results: The increased weight gain of optimized Yanyan Tablets was 5 %;the coating prescription of Yanyan film coated tablets is 2%HPMC:5%acrylic resin Ⅳ, titanium dioxide: talcum powder(1 g:1 g), 1 m L of glycerol, citric yellow 0..05 g;the coating paraments of Yanyan Tablets are coating liquid jet velocity 10 g/min, atomization pressure is 0.2 Mpa, the coating pan turn 15r/min into cylinder, air temperature is 50 ℃; The thin layer chromatography(TLC) methods were established to identify the Radix Scrophularise,tree peony bark and Redix Ophiopogonis, compared with the negative group, the thin layer plate spots were clear, with strong specificity; to determinate the content of gallic acid and cinnamic in Yanyan tablets with HPLC, in the results of study on methodology show that the result is reliable, strong specificity, and can be used for quality control of Yanyan tablets. hree consecutive batches of pilot products were analyzed using the established quality standard.The results of stability test showed that Yanyan Tabltes when stored at room temperaturefor 12 months.The results showed that the prepation and quality control methods were feasible and stable.They establish the standard of the new drugs of traditional Chinese Medicine. Conclusion: The traditional coating process of Yanyan Tablets of a pharmaceutical factory is improved by our group,the process is feasible and the quality standard of Yanyan Tablets is reliable.This study established reliable academic foundation and experimental basis for industrial scale.