论文部分内容阅读
目的:研究并确定注射用硫酸头孢匹罗的处方及无菌粉末分装工艺。方法:采用溶析结晶法,制备出合适松密度的无菌碳酸钠结晶,对无菌粉末进行物理化学性质测定,制定合理的处方及制备工艺。结果:确定了注射用硫酸头孢匹罗处方为主药硫酸头孢匹罗1 190 g,无水碳酸钠242 g。结论:该处方设计合理,可实现工业化大生产。
Objective: To study and determine the formulation of cefpirome sulfate for injection and the process of sterile powder packing. Methods: Dissolution crystallization method was used to prepare asepsis sodium bicarbonate crystals with suitable bulk density. The physical and chemical properties of the sterile powders were determined, and reasonable prescriptions and preparation techniques were established. Results: The prescription of cefpirome sulfate for injection was determined to be 190 g cefpiramine sulfate and 242 g anhydrous sodium carbonate. Conclusion: This prescription is reasonable in design and can realize industrialized large-scale production.