Studyes On Prearation And Quality Standards Of Guaifenesin And Dextromethorpha Hydrobromide Sutainde Release Tablets

High incidence of respiratory diseased worldwide.Upper respiratory tract infections and bronchitis were common diseases of the respiratory system.Their common clinical manifestations were cough and expectoration.Antitussive and expectorant drugs were important respiratory diseases medicine.Guaifenesin and Dextromethorphan Hydrobromide Sustained Release TabletsIts's main active ingredient were dextromethorphan hydrobromide and guaifenesin,it is hydrophilic gel matrix sustained-release tablets.Guaifenesin and Dextromethorphan Hydrobromide Sustained Release TabletsIts was used for cough and expectoration which caused by the upper respiratory tract infection and bronchitis.Compared to other similar drugs,It had better efficacy,longer duration of action,completely absorbed,less side effects,and no addiction advantagesGuaifenesin and Dextromethorphan Hydrobromide Sustained Release Tablets(8oomg:60mg)is the model drug In this study.Samples prepared using wet granulation method in the preparation process of the study.Materials compatibility tests selected the type and scope of accessories.In the prescription screening and process research,the main indexes were the particle flow resistance,hardness,friability and release.We determine the optimal formulation and process by tableting pressure study.Prepared three batches of pilot samples,and examined its release,verify its technology and prescription repeatability.By comparison with the control quality of drugs in vitro studies,we proved the homemade medicines to control the quality of medicines equivalent.Quality Standardused UV spectrophotometer,high performance liquid chromatography,eluted instrument,such as laboratory equipments.Referring to the national drug standards[WS1-139-83-89]?[WS-113(X-91)-93-(1)]and Chinese pharmacopoeia,quality Standard researched on the identification methods,related substances,the release of the examination and determination of the content.We developed Guaifenesin and Dextromethorphan Hydrobromide Sustained Release Tablets's quality standards by method validation.In stability studies,three batches of pilot samples were tested of factors testing,6-month accelerated testing and 9-month long trial.The results showed that the indicators were good,so determined its packaging,storage and transportation conditions and two-year term.