Study On Quality Standard And Formulation Process Of Nevirapine Tablets

Nevirapine is human immunodeficiency virus (HIV-1) non-nucleoside reversetranscriptase inhibitor (NNRTI), By the German Boehringer Ingelheim companyresearch and development, the United States in1996September approved by FDA, thebrand name Viramune, is now in the countries listed, suitable for the treatment of HIV-1infection, and other anti HIV-1drugs. China in early2000formally put into the market.At present, nevirapine tablets without inspection standard, domestic manufacturersto perform their respective production standards,Cause product quality uneven, some good and some bad, can not be unified scaledrug inspection departments of quality inspection，Therefore, a comparative study andevaluation of the quality of the collection of domestic nevirapine tablets mainlymanufacturers samples and inspection standard,Determination of related substances, content, solubility determination, comparisonstudy on the determination of residual solvents detection project, design method andlimit tests new set, unified quality standards, to facilitate the drug quality control andproduction requirements.At present domestic nevirapine tablets manufacturers have adopted the wetgranulation process for preparing tablets， International direct powder compressionmethod because of simple process, low energy consumption has gradually become themain preparation tablets, The FDA certification through the United States of ZhejiangHuahai pharmaceutical production of nevirapine tablet as the reference, using thesolubility curve similarity as the main index, Using single factor experiment design withorthogonal design selected filler, disintegrating agent, type and amount of lubricant andother accessories, Explore the optimal prescription and technology, nevirapine tabletsprepared by direct compression method results show, using CMS-Na as disintegrating agent, MCC as filler, silica as glidants, magnesium stearate as lubricant and referencepreparations dissolving curve is the most consistent.By influencing factor test,accelerated test of nevirapine tablets stability were investigated, The results show that,nevirapine tablets in high humidity conditions were weight gain, that should adoptmoistureproof packaging, The direct compression method of nevirapine tablets at atemperature of40±2℃, kept for3months under the condition of RH75%, results theindexes compared with0months basic consistent, showed that the product after3months of acceleration test, quality stability.