Oral rehydration salt powder II effervescent tablets: Preparation and quality control / 第二军医大学学报

ABSTRACT

Objective: To develop and prepare oral rehydration salt powder II (ORS II) effervescent tablets. Methods: Taking the mass/tablet, rigidity, disintegration time, and pressing status as the main indicators, we optimized the formulation and preparation process of the effervescent tablet by single factor test. The character, identification, disintegration time, acidity, and content determination of the tablets were also investigated. Results: It was found that the optimized preparation process of the effervescent tablets was to mix the acid part, which was granulated with ethanol, with the base part, and then compressed the mixture. The optimal formula was composed of NaCl (11.5%), KCl (4.93%), C6H8O7 (6.21%), NaHCO3 (8.15%), C6 H12 O6 (65.7%), and PEG-6000 (3%). The rigidity of the prepared effervescent tablet was 4.5 kg and the disintegration time was 175 s. Conclusion: The formulation of the present product is consistent with the corresponding Chinese Pharmacopoeia monograph, requiting no additional effervescent; the preparation process is simple and the products are stable, and the product my be developed into a new oral rehydration salt formulation.