Studyes On Prearation And Quality Standards Of Pantoprazole Sodium Enteric Coated Capsules

Peptic ulcer is the most common diseases of the digestive system.Because of its unique mechanism of action,the role of high specificity,and effect intensity and long time,Proton pump inhibitors(PPI)is widely used in various disorder associated with acid as a treatment for peptic ulcer drugs.Pantorazole sodium(PTAS)is the third generation of proton pump inhibitor(PPI)after omeprazole,lansoprazole has come out.Used for digestive system disease were reviewed the progress of the treatment process by consulting the data systematically.This topic in pantorazole sodium enteric micro pill capsule(specifications 40 mg)as the model drug,the bottom of the fluidized bed spray device is adopted to improve the sample preparation,according to the results of material compatibility test determine the scope of the supplementary material type selection.Through the prescription screening and research process,The formulation of it was optimized through plasticizers,the level of membrane weight and composition and proportion of excipients,the size of eteric-coated pellets on drug release behavior.The optimized formulation was the pantorazole sodimn enteric optimal prescription and process of the micro pill capsule by brittle breaking degrees,disintegration time limit and in vitro release degree as the main evaluation index of prescription screening.by taking the preparation of small sample and pilot three batch samples,verify the prescription and process of repeatability.Through with the original development agent(pan completed lok(?))research and drug release in vitro quality comparison model fitting,and the results prove that pilot samples and products quality equivalent(pan completed lok(?))By using high performance liquid chromatograph,uv-vis detector,dissolution tester and equipment with reference to the United States and the European pharmacopoeia,substances,release,acid strength and content uniformity and content determination method were studied systematically,and increased the impurities A,B,C,DF,E control,through the methodology validation,finally made the pantorazole sodium enteric micro pill capsule quality standardThrough pilot production of three groups of samples to enlarge stability study and the factors affecting the test,the results showed that the packaging material must choose the aluminum-plastic blister packaging.By accelerated test for 6 month and 9 month,the results showed that the samples of the character,content determination and releasing degrees,acid strength,related substances and content uniformity index had no significant change.To know pantorazole sodium enteric suitable conditions for micro pill capsule is sealed and keep at room temperature;Tentative date for 24 months.