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Research On Preparation Method And Quality Control Of Compound Ibuprofen Suspension

Posted on:2008-03-28Degree:MasterType:Thesis
Country:ChinaCandidate:X CuiFull Text:PDF
GTID:2144360212997255Subject:Pharmacology
Abstract/Summary:PDF Full Text Request
Febrile seizures (febrile seizure,FS or febrile convulsion, FC) is a common pediatric diseases of the nervous system during children period, is a kind of acute symptoms convulsion. The peak of the disease is 6 months to 3 years (by 90%), with a significant age-dependent, self-limited to a certain extent, the majority of seizures stopped attacks after six years. In Europe and North America the incidence of children is about 2% -5%, in Japan is about 6% - 9%. Maliana Islands in the western Pacific as much as 14%, the incidence is about 3.9% of our children, boys slightly more than girls.In recent years, it has made great progress in the study of febrile seizures, There are many important discoveries have been made in the research of genetic and immunity in the etiology. However, because of the complicated risk factors, the lack of direct evidence in some factors, it needs further study. Relations in febrile seizures and epilepsy are clearly explained, the pathological changes of the nerves and mechanism in brain damage have been researched, treatment and prevention have been constantly explore, All of these provide new theoretical basis in the diagnosis, treatment and prevention of febrile seizures.Although the eventual development of the disease caused brain damage and epilepsy probability is not large, the majority of results are also good prognosis,But do not rule out the possibility that some children will be left to varying degrees of aftermath in the convulsions, so children with febrile seizures should actively prevention and treatment,must not be taken lightly. According to the easy-specific symptoms in children period, we developed a new Preparations called compound Ibuprofen oral suspension in the experiment. In this experiment, the main research are component of their prescription, preparation methods and quality standards. Through analysis the test conditions to determine the preparation methods and quality standards of the compound Ibuprofen oral suspension.Preparation is the main agents initially identified three prescriptions, according to agents made preparation for the test preparations,In accordance with the Chinese Pharmacopoeia 2005 under appendix IO determination of the settlement volume requirements,The experimental study was selected prescription.Prescription Screening in Preparation experimental is under the settlement volume ratio in the 2005 version of Appendix IO Pharmacopoeia for indicators to screening, use the Orthogonal test and range analysis to aselect the best prescription.Optimization prescription: Ibuprofen 2000mg Sodium Phenobarbital 800mg Sodium carboxymethyl 400mg cellulose 2ml Glycerol Sodium 500mg Citrate Ethylparaben 22.5mg Polysorbate 80 0.1ml Sucrose 25.5gPreparation Methods:Take ibuprofen have dried milk in small bowl on research,Adding glycerol, Polysorbate 80,After grinding uniform,Swelling of sodium carboxymethyl cellulose into full Mucilage(about sodium carboxymethyl cellulose with 10ml water into Mortar ),phenobarbital sodium, sodium citrate, ethylparaben and sugar dissolved in water purification,mortar accession to the above, plus purified water to the entire volume.Experimental study Ibuprofen of Oral Suspension system for the characters to identify, inspect and made a determination,Content was determined by high performance liquid chromatography (HPLC), the process was performed on a C18 column(25X4.6mm.I.D.,particle size 5um); with sodium acetate buffer (sodium acetate 6.13g and water 750 ml, the oscillation solution pH3.0 was adjusted by acetic acid) - acetonitrile (60:40) as the mobile phase. UV detection at 263nm; velocity is 1.0 ml per minate, column is 35℃; Sample volume of 20μl. Ibuprofen at the 0.0419mg?ml-1~0.8372mg?ml-1showed a good linear relationship standard curve equation Y=1332.7X+7.6852; r=0.9995; Phenobarbital sodium in the sample volume between 0.0179mg?ml-1 ~0.3576 mg?ml-1 good linear relationship standard curve equation Y=2195.2X+5.673; r=0.9994. Stability in the experiment, the RSD of ibuprofen and sodium phenobarbitathe were 1.94%,1.57%.The stability of agents within 36 hours. Precision experiments, the RSD of ibuprofen and sodium phenobarbital low, middle and high concentration were 1.19%,0.77%,0.63%,0.97%,0.77%,0.68%;Precision of intra-day were 1.14%,0.54%,0.24%,0.81%,0.55%,0.37%;Precision of inter-day were 1.51%,1.71%,1.73%,1.75%,1.67%,1.71%,shows good precision; reproducibility of the experiments, RSD of sodium phenobarbital and ibuprofen were 0.78% 1.05%, show good reproducibility; the average recovery rate of Ibuprofen is 99.34% and RSD is 1.07%;the average recovery rate of sodium phenobarbital is 99.66% and RSD is 0.99%, shows a good degree of accuracy; the lowest detection limit of ibuprofen, the minimum quantitative limits for 0.0813μg,0.2066μg,the lowest detection limit of sodium Phenobarbital, the minimum quantitative limits for 0.0111μg,0.0265μg.In short, through experimental research, the preparation process is simple, easy to operate, the quality of the preparation is stable, the method of determination is accurate and convenient. Results were in line with regulations, and the preparation for further research on an experimental basis. Meanwhile, we also believe that through the further toxicology, pharmacology, clinical experimental studies, bring the useful help for the clinical treatment of disease.
Keywords/Search Tags:ibuprofen, sodium phenobarbital, preparation quality, standard, HPLC
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