摘要
目的确定番石榴叶冻干粉针的合理处方和制备工艺。方法选用适宜赋形剂,对处方进行筛选,用冷冻干燥法将其制备成冻干粉针,并对冻干粉针与注射液的稳定性进行初步考察。结果以甘露醇(8mg/mL)为支架剂、药液质量浓度为6mg/mL的处方较好,制成的冻干粉针质量比注射液更稳定。结论番石榴叶冻干粉针处方和工艺可行,质量稳定。
Objective To study the reasonal formulation and preparation technique of Guave Leaves Powder for Injection. Methods The formulation of Guave Leaves Powder for Injection was optimized by choice of suitable vehicle. The Guave Leaves Powder for Injection was made by freeze-drying. The stability of guave leaves solution and powder for injection were examined primarily. Results The better prescription was 8 mg/mL mannitol and 6 mg/mL drug components. The quality of Guave Leaves Lyophilized powder is more stable than that of solution for injection. Conclusion Both the formulation and preparation technique of Guave Leaves Powder for Injection are feasible and its quality was stable.
出处
《中国药业》
CAS
2008年第12期60-61,共2页
China Pharmaceuticals
关键词
番石榴叶冻干粉针
处方
工艺
Guave Leaves Powder for Injection
formulation
technique