A Study On The Solution Crystallization Technology Of Ampicillin Sodium

As the first generation of broad-spectrum semi-synthetic penicillin, ampicillin sodium has extensive antibacterial spectrum, low toxicity, high efficacy and low price,etc., therefore, it has very good prospects, especially ampicillin sodium of solution crystallization, which is much better quality than spray-drying and freeze-drying method, but ampicillin sodium of solution crystallization is greatly influenced by moisture, and also has the problem of instable clarity.In this study, the crystallization process, product quality and stability of ampicillin sodium were studied systematically. Since the water is no necessary introduced in the entire process performed after the dehydration reaction, the dehydration effect greatly affects the product quality. At the same time, the particle size has a significant effect on the clarity stability of the product. The products with larger particle size are of better clarity stability obviously.In order to improve the overall quality, the reactive processes were investigated via the screening of various chemical reagents by orthogonal test to determine the amount of anhydrous magnesium sulfate is crucial for the dehydration effect. It was found that the product with large particle size has obvious advantages. Crystallization temperature, stirring speed, flow method, amount of seed crystal, time of crystallizing, which influence the particle size were investigated,and the big size crystal products were preparated, and the optimal crystallization process was determined.The product qualities, especially the clarity, as well as the stability of the product quality were greatly improved by the optimization of solution crystallization process.