Preparation and preliminary quality evaluation of aspirin/L-glutamate compound pellets

L-glutamate is an important component of protein. It can prevent gastrointestinal damage caused by NSAIDs. We constructed two-phase enteric-coated granules of aspirin and L-glutamate compound by extrusion spheronization method and fluidized bed coating. The subliminal effective dose of L-glutamate is 100 mg/kg tested by model of gastric ulcer of rats induced by aspirin and drug administration. HPLC-UV and UV-Vis methods were adopted to determine content and cumulative release of aspirin and L-glutamate as quality analysis method indexes. The prescription and process optimization were carried out with yield, sphericity and dissolution. The two-phase compound granules have good sphericity of 0.93 +/- 0.05 (aspirin pellets) and 0.94 +/- 0.02 (L-glutamate pellets), content of salicylic acid (0.24 +/- 0.03)%, dissolution of aspirin (2.36 +/- 0.11)%. Quality evaluation and preliminary stability meet the commercial requirements. The stored environment of compound preparation should be sealed in a cool and dark place.

Automated summary

In this study, two-phase enteric-coated granules of aspirin and L-glutamate compound were constructed using extrusion spheronization method and fluidized bed coating. The quality analysis and optimization of the compound were conducted, resulting in granules with good sphericity and dissolution. The quality evaluation and preliminary stability of the compound met commercial requirements, and it should be stored in a sealed cool place.