关于中成药质量标准中乌头碱限量检查的探讨

Limit examination of aconitine for preparations containing aconitium alkaloids

探讨含乌头类药材中成药质量标准中乌头碱限量检查的方法及限度要求。分析2010年版《中华人民共和国药典》收载的含乌头类药材的中成药的乌头碱限量检查的相关要求。认为含乌头类药材中成药的乌头碱限量检查及限度要求有待进一步研究和规范。建议根据品种情况,如制剂中乌头类药材用量、次/日服(用)药材量、给药途径、用药疗程等建立合理的乌头碱限量检查,制定合理的限量要求。建议研究建立双酯型生物碱限量检查以替代单一的乌头碱限量检查,以更好地控制产品质量,保证药品安全有效。

The methods and limits on the quality control criteria of aconitine limit for preparations containing Aconitium alkaloids were discussed. The limits of aconitine for preparations containing Aconitium alkaloids in Ch. P （2010） were analyzed. The quality conrtol criteria in Ch. P （2010） for preparations containing Aconitium alkaloids should be strengthened. The limit examination of aconitine should be investigated definitely