The study of prescription process certification and stability of Omeprazole Enteric Capsules
RUAN Xizhe
CUI Chenghong
LI Mingjie
SUN Yiwei
Abstract：Objective To screen the optimal prescription of Omeprazole Enteric Capsules and observe its stability. Methods Omeprazole Enteric Capsules synthesised with optimizing prescription were determined according to methods of China Pharmacopoeia(2015 edition)for related substances,assay,acid - resistance,dissolution and the stability was inves-tigated. Results Assay,related substance,acid - resistance,dissolution and stability test of Omeprazole Enteric Capsules all met with the quality standard in China Pharmacopoeia(2015 edition). The capsules had good acid - resistance and dis-solved fast and completely in artificial intestinal juice. Conclusion This process had solved the stability of omeprazole ef-fectively. The preparation process with good reproducibility and high accuracy was suitable for mass production.
Keywords：OmeprazoleEnteric capsuleFormulation processStability
Publication Date：2016-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 404-407 )