MIX FOR IDENTIFICATION TEST IN THE PROCESS OF QUALITY CONTROL OF THE MEDICINE 'GLYCINE TABLETS FOR SUBLINGUAL APPLYING 0,1G' METHODS OF ITS PREPARATION AND IDENTITY EVALUATION IN THE PROCESS OF QUALITY CONTROL OF THE AFOREMENTIONED MEDICINE

摘要

The invention relates to the chemical-pharmaceutical industry and specifically to mix for identification test in the process of quality control of the medicine 'Glycine tablets for sublingual applying 0.1g.' its preparation method and method of identity evaluation in the process of quality control of the mentioned medicine. There is prepared mix containing 50% ethaπσl and porphyrized tablets in a ratio 100:0.5. The method involves dissolution of 1.25g of porphyrized tablets in 250ml of 50% ethanol. Process of dissolution takes 20 minutes and is carried out at a temperature of 400C in the apparatus for dissolving determination at a paddle rotation speed of 200rpm. After mix is dissolved it is allowed for 10 minutes RT. Method of identification test includes hydro-alcohol mix preparation using 50% ethanol as described before. Then there are selected 4ml of the mix for light transmission spectrophotometer analysis at a wave length of 700±2 in a cuvet with layer thickness of 10mm relative to 50% ethanol. Water mix is prepared by dissolving of 2,5 g of porphyrized tablets in 250 ml, of purified water for 20 minutes at a temperature of 37 0C. Experiments with water mix and hydro-alcohol mix are similar. Therefore there is determined difference between light transmission coefficients of water mix and hydro-alcohol mix and the obtained value is compared to the limit of 30 to 50%.