Study On Preparation, Quality Control And Stability Of Levetiracetam Injection

The chemical formula of levetiracetam is (s)-a-Ehtyl-2-oxo-l-pyrrolidiny lacetamide, which featuring special pharmacology efficiency for treatment or prevention of epilepsy and other neurological disorders, as a kind of pyrrolidone derivatives. Levetiracetam injection preparation is made of levetiracetam and some medicinal materials.At present, there is no levetiracetam injection appearing on the market, When the epilepsy patients can’t use oral preparation, levetiracetam injection can reduce the disease in patients with epilepsy, so we develop the levetiracetam injection. In accordance with CDE promulgated "chemical pharmaceutical preparation research techniques guiding principle", and reference to the foreign prescription composition of injection, This article is about the levetiracetam injection prescription technology research.This topic according to levetiracetam’s chemical structure and physicochemical property, aim at the propertises of the different impurity and all kinds of impurity which produce in various conditions,and we obtain the best quality control plan. Therefore, according to the levetiracetam injection synthesis process and structure characteristics of the drug,we design method for the determination of its character, identification, examination and cintent, and to verify the establishment of analysis method.In the stability study, through the influence factor test, accelerated test and long-term test to study the influences such as temperature, humidity and illumination for levetiracetam’s stability,which can provide a scientific basis for the product production, packaging, sto-rage and transportation condition, and determine the validity of drugs according to the p-reliminary test results.The quality standards that this research work established can reflect drug production technology level and inner quality and provide effective analysis method and the judgment standard for levetiracetam’s production and quality control,and can improve the enterprise’s economic benefit and social benefit.