Escitalopram Oxalate Citalopram Tablets Preparation Technology And Quality Evaluation

Depression as a rapid development of modern economy’s "by-product",already more and more widely influenced the modern people’s life.Escitalopram oxalate citalopram is widely used in all kinds of the frist line clinical treatment of the depression,including the elderly,young men and women.Compared with the similar drugs,it has shorter work time,less adverse reaction,fewer side effects,higher security,better efficacy and tolerability and better compliance.In the treatment of depression,anxiety,panic disorder such as drugs has a lot of attention.Escitalopram oxalate citalopram is the first-line antidepressant drugs,escitalopram citalopram is a levorotatory enantiomers of the racemic citalopram,its mechanism of action is to improve the central nervous system serotonin(5-HT),inhibit the reuptake of 5-HT,the 5-HT1A,5-HT2,dopamine D1,D2 dopamine,adrenergic receptors,histamine H1,cholinergic receptors,benzodiazepines and opioid receptor without or with low affinity,it has good tolerance,almost it have no anticholinergic effects on the cardiovascular system.First,in this thesis,on account of the direct powder compression method of escitalopram oxalate citalopram design and select prescriptions,through the single factor investigation method to Investigation of the content of filler,the dosage of disintegrants,the dosage of the lubricant and dligants,with the appearance,degree of hardness,brittle broken,disintegration time and the dissolution profile as an index,The final prescriptionis each tablet contains escitalopram oxalate citalopram 12.78 mg,microcrystalline cellulose ph102100 mg,cross-linked carboxymethyl cellulose sodium 3 mg,1 mg powder silica gel,2 mg magnesium stearate,talc powder 3.2 mg.By using single factor test,preparation technology was optimized,screening and optimizing the raw material size,tablet hardness,coating weight and any other projects.Preparation process selected direct powder compression method,the basic steps are raw materials mixing,tabletting,coating etc.A set of scientific and accurate analysis method is the precondition of controlling the quality of pharmaceutical production.This topic established the quality control of escitalopram oxalate citalopram tablets analysis method,and through using the prescription and preparation process of screening a number of tablets,verified the analyzes methods,by investigating the specificity of analytical method,repeatability and accuracy of the solution stability,linear,and so on,completed the dissolution,the levels of material,methodology validation,to establish the quality standard for the quality control of escitalopram oxalate citalopram tablets.