乌头碱类成分中药制剂质量控制探讨

目的:探讨乌头碱类成分制剂的质量控制.方法:比较2005年版,2010年版中国药典对乌头类生物碱的质量控制要求,分析乌头碱类生物碱的毒性及其化学结构特征.结果与结论:2010年版药典与2005年版药典比较.2010年版药典对乌头类药材质量控制要求有利于药材使用的安全有效:2010年版药典对含乌头类生物碱成分的中药制剂的质量控制有待进一步加强.建议对含乌头类生物碱成分的中药制剂,在质量标准中研究建立双酯型生物碱的限量检查方法,以及双酯型生物碱水解产物苯甲酰新乌头原碱、苯甲酰乌头原碱和苯甲酰次乌头原碱等单酯型生物碱的总量测定,制定合理的含量范围,以保证用药的安全有效.

Quality Control Criteria for Traditional Chinese Medicine Preparations Containing Aconitium Alkaloids

Objective： To discuss the quality control criteria for preparations containing aconitium alkaloids. Methods： The quality control criteria in Ch.P 2005 and Ch.P 2010 for Radix Aconiti Lateralis Praeparata, Radix Aconiti Praeparata, Radix Aconiti Kusnezoffii Praeparata, and preparations containing aconitium alkaloids were compared. The toxicity and chemical structure were analyzed. Regulta aad Conclusion： The quality control criteria in Ch.P （2010） for Radix Aconiti Lateralis Praeparata, Radix Aconiti Praeparata, Radix Aconiti Kusnezoffii Praeparata is more valid to insure effective and safe use of Tranditional Medicine than that in Ch.P （2005）. However, the quality control criteria in Ch.P （2010） for preparations containing aconitium alkaloids should be strengthened. The limit examination of diester aconitium alkaloids and determination methods for monoester aconitium alkaloids should be established in the quality control criteria of preparations containing aconitium alkaloids.