中国卫生产业
中國衛生產業
중국위생산업
China Health Industry
2015年
19期
38-40
,共3页
刘芳馨%李军鸽%王文龙%于智莘
劉芳馨%李軍鴿%王文龍%于智莘
류방형%리군합%왕문룡%우지신
阿昔洛韦%包装规格%初步稳定性%含量测定
阿昔洛韋%包裝規格%初步穩定性%含量測定
아석락위%포장규격%초보은정성%함량측정
Acyclovir%Packing specification%Preliminary stability%Content determination
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。
目的:對阿昔洛韋包裝規格改變的可行性進行論證。方法採用堆密度試驗和裝量試驗,確定包裝容器;對變更包裝規格後的阿昔洛韋原料藥進行初步穩定性攷察。結果變更原料藥的包裝規格對阿昔洛韋的質量沒有影響,工藝簡單、穩定。結論可採用20 mL規格的管製抗生素瓶裝阿昔洛韋原料藥,包裝規格為5g/瓶。
목적:대아석락위포장규격개변적가행성진행론증。방법채용퇴밀도시험화장량시험,학정포장용기;대변경포장규격후적아석락위원료약진행초보은정성고찰。결과변경원료약적포장규격대아석락위적질량몰유영향,공예간단、은정。결론가채용20 mL규격적관제항생소병장아석락위원료약,포장규격위5g/병。
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.