Study On Difenidol Hydrochlride Double-layer Osmotic Pump Tablets

Drug anti vertigo has a long history,and there are many kinds of drugs for treatment,mainly including the following categories:anticholinergic drugs,antihistamines,calcium antagonists,gastrointestinal stimulants,sympathomimetic drugs,various traditional Chinese medicine and compound preparations.However,in the market,these anti vertigo drugs are all ordinary preparations,with short biological half-life and short efficacy.Patients are required to take them2-3 times a day.Frequent administration is easy to reduce patients'compliance,which may lead to large fluctuation of blood drug concentration in the body,adverse reactions or failure to play the role of drugs.At present,Difenidol hydrochloride is widely used in the treatment of nausea and vomiting caused by vertigo and anesthesia radiation.In order to meet the actual needs of clinical medication?reduce the peak and valley fluctuations,reduce the number of medication to increase the compliance of patients,etc.?,this study was carried out on Difenidol hydrochloride double-layer osmotic pump controlled release tablets.In this study,Difenidol hydrochloride was selected as the model drug,and advanced osmotic pump technology was used to prepare Difenidol hydrochloride double-layer osmotic pump tablets with significant slow and controlled release effect.In this paper,the related physical and chemical properties of the main drug Difenidol hydrochloride were tested,including the determination of its equilibrium solubility and oil-water distribution coefficient;the determination of the content and release degree of the prepared double-layer osmotic pump tablets;the optimization and validation of the controlled-release formulation of Difenidol hydrochloride,and the subsequent investigation of the stability of Difenidol hydrochloride osmotic pump preparations.In the research process of this project,polyoxyethylene?PEO?,sodium chloride?NaCl?and other auxiliary materials were used to prepare the drug layer,and polyoxyethylene?PEO?,sodium chloride?NaCl?,polyvinylketone?PVP?and other auxiliary materials were used to prepare the booster layer,and polyethylene glycol?PEG?,cellulose acetate?CA?were used to prepare the coating solution,so as to prepare Difenidol hydrochloride double-layer osmotic pump tablets.Through the observation of the state of the pressed core and the release state of the double coated membrane,the two-layer osmotic pump tablets with slow and controlled release characteristics were selected.From this,we can get the optimized prescription A?including 75 mg of Difenidol,80 mg of peo-n10,20 mg of NaCl,120 mg of booster layer and 5%of coating thickness?.In addition,the content and release of Difenidol hydrochloride double-layer osmotic pump tablets were tested,and the release curve of f₂ similar factor was used to evaluate the release degree of each prescription,providing a certain judgment standard for the selection and optimization of the prescription.At the end of the project,the factors affecting the stability of Difenidol hydrochloride?including high humidity test,high temperature test,strong light irradiation test,accelerated test?and the long-term test and accelerated test are also investigated.The results show that the Difenidol hydrochloride double-layer osmotic pump sheet is only sensitive to environmental humidity,so the later packaging requires materials with good sealing performance.