Preparation And Evaluation Of Meprazole Enteric-Coated Capsules

Objective:Preparation of omeprazole enteric capsule, establish quality standard, evaluate its consistency with drugs already on the market.Methods:Intermediates of omeprazole enteric capsule pellet of angle of repose and bulk density examination, establish the quality standards of pellet capsule and preparation; By high performance liquid chromatography (HPLC) method, the omeprazole enteric capsules content and in vitro release degree were determined, and establish omeprazole enteric capsule quality standard, using similarity judgement of f2 similarity factor;By influencing factor test, accelerated test and long-term stability experiment, in order to appearance shape, the material, acid strength, release degree as evaluation index, and content of omeprazole enteric capsules in preliminary stability test.Results:Omeprazole enteric capsules content determination of chromatographic conditions for: stationary phase:Thermo scientific SyncronisC8 (150×4.5μm,5μm); Column temperature 30 ℃; Flow velocity; 1.0ml/min; Detection wavelength of 302 nm; Mobile phase:0.01 mol/1 sodium hydrogen phosphate solution(with phosphoric acid to adjust the PH to 7.6)-acetonitrile=70:30. Determine the release degree method, Uses the method of dissolution determination device for releasing degrees for determination; Pellet content determination results of 86 mg/g, Then choose 3 hollow capsule filling according to bulk density; And omeprazole enteric capsule was up to something on related substance and content uniformity, etc. Self-restraint sample and controlled drug release in different release medium degree of f2 factors were greater than 50, the release behavior similar to that of consistent; Through the stability of the investigation results show that omeprazole enteric capsules appearance, releasing degrees, acid strength and content had no obvious change, the number of relevant material impurities without increasing, the description in this paper, the preparation of omeprazole enteric capsules with stable quality.Conclusion:This paper establish omeprazole and in vitro release of enteric capsules content determination method is reliable, can be used as omeprazole enteric capsule quality standard content; The preparation of omeprazole enteric capsules quality is stable.