Studies On Lansoprazole Enteric Coated Pellets Capsule

Objectives:Lansoprazole is the second generation of proton pump inhibitors antiulcer drug,mainly used in the treatment of gastric ulcer,duodenal ulcer,reflux esophagitis,Zollinger decked out-Ellison syndrome(stomach secrete melanoma),anastomotic ulcer.Micro pill capsule with capsule and micro pill,the advantages of wide application prospect in the market.Methods: The research by establishing the method of release by UV spectrophotometry and HPLC for prescription lansoprazole enteric-coated pellets provide test methods for Formulation process and preparation technology.1 Formulation process Technology: In this paper,lansoprazole and excipients are mixed,centrifugal granulation method is adopted to prepare the pill core,and then the isolation and enteric coating are separately coated to prepare lansoprazole enteric-coated pellets.The effects of the amount of disintegrating agent,the amount of surfactant,the weight gain of gown,the p H value of gown,the weight gain of enteric coating,the amount of enteric coating plasticizer and the amount of enteric coating anti-sticking agent were determined capsule formulation of sorazol enteric-coated.2 Preparation Technology: The preparation technology was confirmed by determining the speed of centrifugal granulation,the drying time of wet pills,the inlet air temperature,the inlet temperature of enteric coating,the filling speed of capsule filling machine.3 Establishment of quality standards and in vitro release studies:Establish quality standards and in vitro release of test established by UV spectrophotometry release and determination of lansoprazole and its related substances and other examinations.At the same time in accordance with the Chp 2015 edition requirement were measured.This research provided a test method for the formulation and validation of lansoprazole enteric-coated pellets.To establish a method of check items character,identification,release,content uniformity,and determination of related substances,etc.,initially identified lansoprazole enteric-coated pellets quality standard,to provide a basis for testing the quality and stability of the sample.Results:1 Prescription screening results for the disintegrant dosage of 12 g,sodium dodecyl sulfate dosage of 6g,isolation gown weight 25 ~ 30%,isolation gown p H value of 10,enteric coating weight gain of 18% ~ 22%,the amount of plasticizer 4g,the amount of anti-adhesive agent 9g.2 Preparation Process :(1)preparation of pellets pellets: Lansoprazole using a 100-mesh sieve,sodium lauryl sulfate,L-HPC mixed,weighed by prescription pill starch core set of centrifugal coating granulating machine,add the right amount to make the binder pill core humid,add successive prescriptions lansoprazole pellets to make a mixture of increasing particle size,then wrapped gowns,pellets take a pill core set of centrifugal coating granulator,uninterrupted spray coating solution to the pellet core until the coating weight gain of 25 to 30%,remove the coated pellets in a dry oven at40 ? for 2 hours,between 16-20 mesh sieve to obtain pellets.Enteric coated pellets to determine the result of taking the pill core set of centrifugal coating granulator,inlet air temperature is 40 ?,continuous spray coating solution to the pellet core,until the coating weight gain of 18 to 22 percent,remove the coated pellets were dried in an oven at 40 ° C for 2 hours and sieved between12-16 mesh pellets.3 Establishment of quality standards and in vitro release studies: Through the establishment of the measurement method checks character,identification,release,content uniformity,and determination of related substances such as,initially identified lansoprazole enteric-coated pellets quality standard,to provide a basis for testing the quality and stability of the sample.At the same time stability test results showed that the samples made at a high temperature,high humidity and light conditions good stability,acceleration and long-term tests showed that samples can be long-term placement.Conclusions: Through the study of the formulation,preparation,quality standard establishment,release and stability of lansoprazole enteric-coated capsules,the indexes of lansoprazole enteric-coated pellets were all in accordance with the requirements,The preparation of lansoprazole pellets enteric-coated capsules samples can apply for clinical application.