Preparation And Evaluation Of Domperidone Tablets

[Objective] To preparate Domperidone Tablets and establish methods of quality control, the release behavior in vitro was investigated. To evaluate the consistency with marketed drugs.[Method] Domperidone tablets were prepared by wet granulation compression. Appearance, tablet weight difference, dissolution as index, through the test selection and prescription selection to determine the prescription and preparation technology.According to Chinese pharmacopoeia 2010 edition and the relevant provisions of the national drug standards, Identified by TLC,UV spectrophotometry as a kind of analysis method is to determinate content and related substances and established quality standards.Established the dissolution determination method of Domperidone tablets,, content and related substances were determined by using HPLC method, and establish quality standards.Dissolution, related substances and content comparison of Domperidone tablets dissolution uniformity and dissolution in vitro, and were tested in vitro dissolution and controlled drugs already on the market comparison assessment and similarity of controlled drugs already on the market.[Results]The best preparation of domperidone tablets is:powder:MCC:lactose: starch=1:3:1:5, With 0.5% magnesium stearate lubricant,5% PVP K30 aqueous solution as a binder, prepared domperidone tablets. It has good formability, stable quality.Determination of identification, dissolution and related substances and content., the reference substance and the test samples have the same color spots in the corresponding position, the color is clear, no negative interference, separation effect is good in the TLC; Determination of the dissolution is a reliable method, the RSD are less than 2; Using high performance liquid chromatography (HPLC) method to determinate the content and related substances of Domperidone tablets, the RSD are less than 2.Dissolution behavior is similar to drugs already on the market, the results of the determination of related substances and content meets the requirements.All the indexes of 6 months accelerated test and 12 months long-term test conform to the rules.[Conclusion] The preparation of Domperidone tablets is reliable and the preparation quality can be more stabilized. It is similar to the dissolution behavior of drugs already on the market, with consistency.