The Design And Quality Standard Studies Of Amitriptyline Hydrochloride Controlled Porosity Osmotic Pump Tablets

ObjectiveTo investigate formula of Amitriptyline Hydrochloride Controlled porosity osmotic pump tablets and influencing factor of the in vitro release. To establishthe quality standard and to explore the stability for it. The data was provided for the before clinical research and clinical research.MethodWe use Amitriptyline Hydrochloride as a model drug. On the basis of Extensive literatures and investigating the properties of Amitriptyline Hydrochloride and ethylcellulose. Choosing lactose and mannitol as osmotic agent, Cellulose acetate, polyethylene glycol and Dibutyl phthalate were use as the coating materials,Acetone was selected as the coating solution. Then, we use the things witch to be made the Amitriptyline Hydrochloride Controlled porosity osmotic pump tablets. The evaluation stantard for the drug release profile in vitro basis on the cumulative percent release.According to investigate of the univariate which include dose and species 0f osmotic agent; dose and species of pore forming agent and the orthogonal design of Amitriptyline Hydrochloride Controlled porosity osmotic pump tablets to selected optimal formula. The quality control studies of Amitriptyline Hydrochloride Controlled porosity osmotic pump tablets were researched. And it series of experiments were carried out, including description, recovery, precision, assay, and release. ResultsThe best formula of self-made Amitriptyline Hydrochloride Controlled porosity osmotic pump tablets is lactose:190mg, PEG400:10%(percent of CA), and coating increase 4% on weight. It complies to the character of zero-order release. And the release of it in 24 hours were more than 90%. It was be confirmed when we studied the quality standard of Amitriptyline Hydrochloride controlled porosity osmotic pump tablets that the best wave of Amitriptyline Hydrochloride was 239nm in UV spectrophotometry,Ethylcellulose had no interference with it at this wave. The linear correlation that belongs to the concentration of Amitriptyline Hydrochloride with absorbance was good, between 6.036μg/ml～18.108μg/ml. Regression equation was: A=0.0431C-0.0037 (r=0.9999). The recoveries were 98.59～101.7%. The within-day precision was 0.52～1.2% and the between-day precision was 0.90～1.2%. The complex prescription Amitriptyline Hydrochloride Controlled porosity osmotic pump tablets are stable in the stress testing, the accelerated testing and the long-term testing.ConclusionsThe best formula was ascertained by Orthogonal design, and the drug release profile of self-made Amitriptyline Hydrochloride Controlled porosity osmotic pump tablets accord with the character of zero-order release in 24 hours. The UV spectrophotometry was used to study the quality standard of it, the method has a good specificity, reproducibility, precision. It can be further investigated by the internal release of body.