摘要
目的优化筛选盐酸昂丹司琼氯化钠注射液的处方、生产工艺。方法对影响昂丹司氧化钠琼注射液产品质量的关键因素pH值调节剂及其用量、直接接触药液包装材料及灭菌条件等进行考察筛选。结果 pH值采用盐酸调节剂;半成品pH值控制在3.5～5.5之间;采用中、高硼硅玻璃瓶和非PVC包装,过热灭菌的生产工艺,产品质量稳定。结论由稳定性考察试验可确定该生产工艺设计合理,客观可行,能稳定的保证产品质量。
Objective To optimize the preparation process of Ondansetron Hydrochloride and Sodium Chloride Injection.Methods The kind and amount of pH value regulator,packaging materials in direct contact physic liquor,sterilization conditions,which were the key factor affecting the quality in production process of Ondansetron Hydrochloride and Sodium Chloride Injection,were selected and studied.Results Hydrochloric acid was used as pH value regulators,The pH of semifinished was controlled between 3.5 ～ 5.5.Borosilicate glass bottles and non-PVC packaging were used as packaging materials,heat sterilization of the production process was adopted,and the quality of product was stable.Conclusion The production process was reasonable,objective and feasible determined by the stability test,and can ensure quality of product.
出处
《齐鲁药事》
2011年第5期254-256,共3页
qilu pharmaceutical affairs
关键词
盐酸昂丹司琼氧化钠注射液
生产工艺
直接接触药液包装材料
Ondansetron Hydrochloride and Sodium Chlorlede Injection
Production process
Packaging materials in direct contact physic liquor
