Study On Dexibuprofen Sustaind-Release Capsule

Buluofen, the other name is 2-(4-isobutylphenyl)propionic acid, is one of the most universal non-steroidal anti-inflammatory drugs (NSAID) in clinic. According to the good effect of eliminate inflammation, pain town and hot solution,it is bordly used to cure rheμmatism or type rheμmatism disease and joint muscle pain, headache pain, month menstrual cramp and so on in the variety chronic dull pain. The pharmacological activity of buprofen was revealed mainly coming from Dexibuprofen. Compared with Ibuprofen (racemic modification), Dexibuprofen have higher curative effect of the same dosage.Buluofen has a short half-life, multifarious administration was neeeded to maintain the treatment density,increasing the adverse reactions. Buluofen difficultly dissolves in water and body fluid. In order to satisfy the demand in clinical, Dexibuprofen sustaind-release capsule was obtained according to the prescription on the basis of traditional prescription.1 Prescription ScreeningThis prescription with blank radicle pill for core, first carried on wrapping dress to the radicle pill with Stearic acid ether aqua, avoided the mutual influence of the radicle pill and medicine layer. Then gathered with the Polyvinylpyrrolidone K30 in ethanol, ascending Dexibuprofen package at the blank radicle pills. The experiment proved that after prescription and craft system of sieving, the sample's dissolution rate meet the related request.2 Technology ResearchAccording to the characteristics of dosage form, investigated the factors which influence Dexibuprofen sustained-release pellets shape, yield, content and dissolution. We adopted circularly and alternately to carry on Dexibuprofen powder to wrap dress, controlled the grain degree of radicle pill, sieved the integrity prescription and technology, attained the quality control request.3 Quality controllthe release degree check item of Buprofen sustaind-release capsule. carried on researchs respectively by character, identification and content determination quality standards of Dexibuprofen sustaind-release capsule, drewed up the quality standard drafted plan. On these grounds we carried examinations on three batches of semi products, all match the various rules of Dexibuprofen sustaind-release capsule quality standard.4 Initial stability studyPlaced the samples with commercial packaging, through accelerated test and Long-term test, investigated for 6 months,the results of appearance,release degree and content uniformity etc. point investigationg items that proved,various index signs all at stipulate inside the scope, the validity period of this article temporarily decided two years.