Study On Dextromethorphan Hydrobromide Dispersible Tablets

Objective:This study intends to use Polacrilin Potassium as flavoring agents.Using the method of orthogonal design to choose the best prescription of dextromethorphan hydrobromide dispersion tablets.Establish the quality control standard and investigate its stabilityMethod: Ion exchange of DM and Polacrilin Potassium to prepared drug loaded resin.Mix with the tablet excipients such as adhesive agent,bulking agent,disintegrating agent,prepare the soft material,then preparation of particles.Adding lubricating agent evenly,compression molding.By the interference test of materials,raw materials compatibility test,prescription experimental study on screening test and processing,the dissolution and stability test,and finally determine the prescription and technology of Dextromethorphan Hydrobromide Dispersible Tablets.explore the conditon of High performance liquid chromatography of Dextromethorphan Hydrobromide,establish a method for its quality control.By means of destructive experiments,influencing factors,accelerated and long-term tests,the operability and stability of the formulation and process were further investigated.Results: ? Polacrilin Potassium resin type IRP-88,by the Inside and outside addition disintegrant croscarmellose sodium?CCNa?.Orthogonal test was used to find the best prescription was A₂B₁C₂D₃;?In addition to the slow dissolution in water,the dissolution of the dispersible tablets was faster in the other 3 media?0.1mol/L HCl,pH4.5 acetic acid sodium acetate buffer,pH6.8 phosphate buffer?;?the mobile phase methane sulfonic acid solution acetonitrile?70:30?is used to Determination of the content;detection wavelength: 280 nm,flow rate: 1.0mL/mi;?Excipients do not interfere with the determination,good linearity,high precision,repeatability,stability,good recovery.Raw materials and products are not strong acid and alkali resistance and oxidant;?The determination results of 3 batches were 100%,100.39%and 99.88%,respectively.The total average content was 99.99% and the content of RSD was 1.54%,Results meet the requirements;?The results of Influencing factor test showed that :This product under the condition of the high temperature?60degrees C?and high humidity RH92.5% increased a slight the relevant substances,sothis product should avoid long-term storage at high temperature,and moisture-proof packaging;?The accelerated test showed that the change trend of the related substances of the reference preparation and the self-made sample was basically the same,all increased slightly,and the increasing trend of the control drug was more obvious than that of the product,but the limit was within the range of qualified.Long term experiments are still in progress.Conclusion: The syudy optimized Dextromethorphan Hydrobromide Dispersible Tablets prescription and preparation technology,the preparations is uniform,moderate hardness,neat appearance,fast disintegration.High performance liquid chromatography?HPLC?is easy to use,with little interference and high precision.It can be used for the determination of DM and related substances.