Nghiên cứu bào chế dung dịch tiêm mesna 10%

Abstract

In view that mesna is commonly indicated for urothelial intoxication (as uroprotector) in patients treated with ifosfamide and cyclophosphamide, but its injection dosage forms currently used in Viet Nam are ait imported, a solution of mesna 10% for injection was formulated and prepared with disodium edetate as excipient. Mesna (10%) and disodium edetate (0.25 mg/mi) were dissolved in water, adjusted to pH 7.4 with NaOH 1.0N. Dissolved oxygen was removed by nitrogen purging, and finally sterilized at 121 °C/15 minutes in an autoclave. For quality control, the obtained solutions were quantitatively analyzed by PPLC. The quantitative procedure was validated to meet the conventional requirements as specificity, linearity (0.25-0.75 mg/ml), precision (RSD < 2%) and accuracy (99.77101.60%). Study on the stability proved the the obtained mesna injections remained stable after 12 months’ storage at either 40 + 2 °C (75 ± 5% relative humidity) or 30 ±2 °C (75 ± 5% relative humidity).