The Quality Study Of (S)-oxiracetam Tablets

Alzheimer’s disease(AD),also known as dementia,common in elderly people,is a gradual neurodegenerative disease.Its clinica symptoms are serious memory decline,cognitive dysfunction and abnormal psychomorot.Alzheimer’s disease has a high mortality and cost a lot of medical expenses.As society develops and ages,altheimer’s disease has become an assignable global issue,so it is the hotpot of international medicine development to develop specific medicine for altheimer’s disease.So far,many medicines for treatment of altheimer’s disease have been in the market and attained effects partly.As it is a long-term process to treat altheimer’s disease,a large majority of the therapeutics have side effects,weakly tolerated and not suitable for long-term therapy,so it is necessary to develop medicines having better effects and less side effectsAmong medicines treat altheimer’s disease,pyrrolidinones nootropics have perfect effects,and oxiracetam is one.Oxiracetam can work on cerebral cortex and hippocampus selectively and promote the functional recovery of nerve cell by meas of improving the metabolism of brain,so it is the most widely used nootropics at present,having more perfect effects,fewer side effects and more toleratedOxiracetam is chiral drug and come into the market as racemate mixtures.As the enantiomer of chiral drug usually has better effects and fewer side effects,oxiracetam is chirally seperated.Researchs find that(S)-oxiracetam has better effects than(R)-oxiracetam and(RS)-oxiracetam and no obvious differences are found in pharmacokinetcs,pharmacology and toxicology,so(S)-oxiracetam has better social significances and social benefits than oxiracetam.This article study the quality of(S)-oxiracetam tabletsThis article establishs methods to analysis the related substances in(S)-oxiracetam tablets and determine the contents and dissolution rates of(S)-oxiracetam tablets.The analytical methods verified utilizing system suibatility test,specificity test,linear test,precision test,accuracy test,stability test and so on,results show the methods established are applicable.This article conducts process scale-up test basing on established prescription and fabrication procedure and examine the projects of process scale-up products,including characters,tablet weight variation,hardness,related substances,content and dissolution rates.Results show that process scale-up products meet requitments and the prescription and preparation process and applicable to the mass production.This article study the preliminary stability of(S)-oxiracetam tablets,examine the samples after stress test,accelerated test and long-term test.Results show(S)-oxiracetam tablets have good stability.