Calcium chloride injection and production method thereof

Abstract

The invention relates to a calcium chloride injection and a production method thereof, and relates to the technical field of calcium chloride injection production, a solvent of the calcium chloride is water for injection, and the injection contains the following components: 80-120 g / L of calcium chloride; the concentration of the water for injection is 800-1200 g / L; hydrochloric acid is a proper amount of component for adjusting the pH value to 5.3-5.8; and the sodium hydroxide is a proper amount of component used for adjusting the pH value to 5.3-5.8. According to the calcium chloride injection and the production method thereof, the problems of solution turbidity, calcium ion precipitation, oxidative degradation and the like caused by insufficient dissolution and local supersaturation of calcium chloride in the prior art are effectively solved by accurately controlling the concentration of calcium chloride and adopting a nitrogen protection dissolution process. Meanwhile, a 0.22 mu m polyethersulfone two-stage filter element series connection filtering process, an integrity testing process with the foaming point larger than or equal to 3450 kPa and a sterilization and leak detection integrated process are adopted, the sterility guarantee level and stability of the product are remarkably improved, the endotoxin of the finished product is smaller than 0.5 EU / mL, the number of visible foreign matter larger than or equal to 10 mu m is reduced by larger than or equal to 60%, and the clinical safety and effectiveness of the injection are ensured.

Images