阿昔洛韦原料药变更药品包装规格可行性研究

摘要

Objective We demonstrated the feasibility of changing the package of the acyclovir. Methods We determined acyclovir API specifications of changing pack of containers by using bulk density test and loading capacity test. We change the packing specification of acyclovir API in preliminary stability test. Results We changed the packing of the API specifi-cation which has no effect on the quality of acyclovir. Conclusion The 20mL specifications of the control of antibiotic raw material medicine acyclovir bottled, packaging specifications for 5g/bottle.%目的：对阿昔洛韦包装规格改变的可行性进行论证。方法采用堆密度试验和装量试验，确定包装容器；对变更包装规格后的阿昔洛韦原料药进行初步稳定性考察。结果变更原料药的包装规格对阿昔洛韦的质量没有影响，工艺简单、稳定。结论可采用20 mL规格的管制抗生素瓶装阿昔洛韦原料药，包装规格为5g/瓶。