阿昔洛韦国际药典标准的制定

摘要：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；有关物质项下建立了薄层色谱法与高效液相色谱法两种可供选择的方法，色谱检测条件能有效分离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0.0462~0.2490g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。

Establishment of International Pharmacopoeia Standard for Acyclovir

ABSTRACT Objective: To establish the International Pharmacopoeia standard for acyclovir. Methods: In accordance with requirements of the International Pharmacopoeia standard, the existent standards of acyclovir and related literature were referred, appropriate methods were established and validated. Results: The 4 alternative identification methods(IR,TLC,HPLC and UV ) were established ; Under related substance, The 2 alternative methods(TLC and HPLC ) were established. 11 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 0.0462~0.2490g (r=0.9999). Conclusion: The quality standard is feasible ,which considers fully the different laboratory conditions around the world and alternative methods were established; The standard can effectively control the quality of products.