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| Study of preparation and quality of Torasemide Injection |
| LI Puchao1 WANG Xiaowen1 TANG Hai2 ZHU Boru1 LIU Quanli |
1. College of Pharmacy, Baotou Medical College, Inner Mongolia Autonomous Region, Baotou 014040, China;
2. Tasly Research Institute Jiangsu Tasly Diyi PHarmaceutical Co., Ltd., Tianjin 300410, China |
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Abstract Objective To explore the formulation and preparation process of Torasemide Injection with high quality and stability. Methods The formulation of Torasemide Injection was determined by screening excipents and proportion. The preparation process of torasemide for injection was determined by investigating the temperature of liquid mixing and pH, decarbonization process and filtration material, filling container and freeze-parameters. Results The best prescriptions were Torasemide (10 mg), Sodium Bicarbonate (20 mg), Mannitol (100 mg). The preparation temperature is controlled at 15-25℃, and the pH value of the liquid was adjusted to 9.0 by 5% sodium hydroxide, and stored below 10℃at the same time. Polyethersulfone membrane was used for filtration with 0.45 μm+0.22 μm. Colorless low-borosilicate glass controlled injection bottle 5 ml or 10 ml, butyl bromine rubble plug for packaging. The optimum freeze-drying process conditions was that products were pre-frozen for 3 hours at -40℃. The heat conducting oil was heated to 0℃for 40-60 hours. The heat conducting oil was heated to 20℃for 6-8 hours. The final product was kept at 35℃for 6-8 hours. The contents of 202009031, 202009032 and 202009033 samples were 100.21%, 100.83% and 99.82% respectively by high performance liquid chromatography. During months long-term test and accelerated test, the moisture content of 202009031 samples increased, but all of them were within the limit, and other inspection indexes did not change significantly. During months long-term test and accelerated test of 202009032 and 202009033 samples, the related substances increased slightly and the moisture content increased slightly, but all of them were within the limits, and the other indexes did not change significantly. Conclusion The Torasemide Injection prepared by this prescription and process has stable quality, good feasibility and suitable for industrial production.
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