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FORMULATION DUNE SOLUTION LIQUIDE STABLE A BASE DE PARACETAMOL DESTINEE A LA PERFUSION ET SON PROCEDE DE PREPARATION
专利权人:
LABORATOIRES DORCAS
发明人:
ZGARNI SADOK
申请号:
TN2011000430
公开号:
TN2011000430A1
申请日:
2011.08.19
申请国别(地区):
TN
年份:
2013
代理人:
摘要:
the present invention relates to stable pharmaceutical formulations of paracetamol in an aqueous solvent. paracetamol (inn of acetaminophen or n - (4-hydroxyphenyl) acetamide) is a widely used analgesic and antipyretic in the hospital setting. paracetamol is the degradation rate with the increase in temperature and light.the present invention is intended to solve the problems of the stability of the molecule of a convenient and satisfactory. the aqueous solvent may be water or aqueous mixtures containing water and a polyol such as propylene glycol or polyethylene glycol (peg). it is also possible to use a water soluble alcohol, such as ethanol.the stability of these solutions is also determined by other parameters, such as ph adjustment is appropriate, the elimination of the oxygen dissolved in the vehicle, the addition of an antioxidant agent, as well as the use of a heat treatment to remove all traces of e formation of paracetamol.the formulation of the invention calls for the elimination of dissolved oxygen by bubbling an inert gas such as nitrogen, pure and free oxygen, as it contains a buffering agent in pka values between 4.5 to 6.5, preferably as close to 5.5.this agenttamponnant is advantageously selected from acetate buffer, citrate, phosphate, phosphate buffer, bicarbonate, citrate, tartrate. this formulation for injection contains an agent isotonisant, intended to create a osmotoque pressure similar to that of the physiological saline. the isitinisant agent is selected from sodium chloride, sorbitol and glucose.the formulation of the invention is prepared by mixing water of oxygen free, high temperature, cosolvent, antioxidant, isotonisant agent, buffering agent \". paracetamol is introduced into the mixture and stirred until completely dissolved in the liquid inert gas continuously.the preparation, in bulk or packed in containers, heating temperature is the main \"at least for a period of at least 15 minutes. the heater is designed to eliminate any trace
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