阿昔洛韦国际药典标准的制定

Establishment of International Pharmacopoeia Standard for Acyclovir

目的:制定阿昔洛韦《国际药典》质量标准。方法:参照国内外阿昔洛韦质量标准和相关文献,按照《国际药典》标准制定要求,建立合适的方法并进行验证。结果:建立了红外光谱、薄层色谱、高效液相色谱及紫外吸收等4种可供选择的鉴别方法;建立了薄层色谱法与高效液相色谱法两种可供选择的有关物质检查方法,高效液相色谱法能有效分离11种已知杂质;采用干燥失重法测定水分;采用滴定法测定含量,阿昔洛韦在0.0462~0.2490 g范围内与消耗高氯酸滴定液体积呈良好的线性关系(r=0.9999)。结论:制定的标准充分考虑了全球不同发展地区的实验室水平,同一项目建立不同方法可供选择,使标准具有可行性,且能有效衡量产品的质量。

Objective:To establish the International Pharmacopoeia standard for acyclovir.Methods:In accordance with the requirements of the International Pharmacopoeia standard,the existent standards of acyclovir and related literature were referred,and appropriate methods were established and validated.Results:Four alternative identification methods(IR,TLC,HPLC and UV)were established.Under related substance,two alternative methods(TLC and HPLC)were established.Eleven known impurities could be separated well by the HPLC method.The method of loss on drying was selected for water determination.Under titration for assay,the linear range was 0.0462-0.2490 g(r=0.9999).Conclusion:The quality standard was feasible,which fully considered the different laboratory conditions around the world and alternative methods were established.The standard can effectively control the quality of products.