NGHIÊN CỨU XÂY DỰNG TIÊU CHUẨN CƠ SỞ VIÊN NÉN BAO PHIM GLUCOPENTO

Abstract

Objectives: To establish in-house specifications for Glucopento film-coated tablets, derived from the Vietnamese traditional remedy Ngu vi tieu khat thang, which has supportive effects in diabetes treatment. Methods: Quality parameters were established in compliance with the regulations of the Vietnamese Pharmacopoeia V. Results: The Glucopento film-coated tablets are flat, cylindrical, with a white film coating, a light brown cross-section inside, an herbal aroma, and a bitter taste. The tablets meet the standard for weight uniformity (± 5%) and have a disintegration time of 22.83 minutes. Furthermore, the components of Gymnema sylvestre, Scrophularia ningpoensis, and Oroxylum indicum were successfully identified. Regarding the preservative limit, sodium benzoate was determined to be 2.161 mg/tablet. Finally, the product also meets the microbial limit requirements, including total aerobic bacterial count, yeasts and molds, bile-tolerant Gram-negative bacteria, Escherichia coli, and Salmonella. Conclusion: The successful establishment of these in-house specifications is an important step in controlling the quality of Glucopento film-coated tablets derived from herbal ingredients, ensuring consistent quality, safety, and effectiveness.