Study on Sodium Bentonite Used as Disintegrant to Aspirin Tablets

Objective: aspirin as a model drug research sodium bentonite as a disintegrant in oral solid dosage; aspirin induced gastric mucosal injury experiments investigated the gastric mucosa protective effect of sodium bentonite. Methods: (1) design absorbent device, the Washburn equation visits Na-bentonite water swelling. (2) using the fixed conical bottom Act, the determination of sodium bentonite angle of repose, study mobility. (3) to sodium bentonite and common disintegrant suppress blank model sheet, tablet hardness and disintegration time was measured, comparative study of disintegrating properties of sodium bentonite. (4) by a single factor and orthogonal design, to tablet weight difference, hardness and disintegration time indicators prescription and process optimization of new excipients sodium bentonite preparation of aspirin tablets; (5) different doses of Na-bentonite model mice before and after oral administration to take full stomach, the general observation by the gastric mucosa, gastric mucosal injury indicators and pathological diagnosis, study of sodium bentonite on aspirin-induced inhibition of gastric mucosal injury. Results: (1) the Washburn water absorption kinetics equation shows that sodium bentonite water absorption rate constant is better than pre-gelatinized starch, but low-substituted hydroxypropyl cellulose, cross-linked sodium carboxymethyl starch and microcrystalline cellulose. Sodium bentonite with pregelatinized starch, crosslinked sodium carboxymethyl starch, similar to the suction process, water is slower to reach the saturation time is long. Sodium bentonite swelling volume of cross-linked sodium carboxymethyl starch equivalent. (2) the angle of repose of the sodium bentonite is greater than 45 °, and low-substituted propyl cellulose, should adopt the same amount of material mixed gradually increasing shear mixing. (3) sodium bentonite as a blank model sheet disintegrant disintegration time in the disintegration time of the shortest cross-linked sodium carboxymethyl cellulose disintegrant followed by the effect superior to cross-linked sodium carboxymethyl starch, low-substituted hydroxyalkyl propyl cellulose, and pregelatinized starch. (4) the optimized prescription aspirin and processes: aspirin and the filler microcrystalline cellulose ratio is 1:1, the disintegrant is 5% sodium bentonite, starch binder is 6%, 0.5% magnesium stearate lubricant, using a wet granulation tableting. (5) different doses of bentonite to model mice before and after oral administration to take full stomach through the gastric mucosa general observation, the results of gastric mucosal injury indicators and pathological diagnosis, sodium bentonite on aspirin-induced gastric mucosal injury. inhibition. Conclusion: (1) sodium bentonite as a tablet of aspirin tablet disintegrating agents with good disintegration properties, does not affect the dissolution of aspirin tablets and content determination. (2) sodium bentonite inhibition of aspirin-induced gastric mucosal injury can reduce the side effects of aspirin.