Investigation on safety limits of traditional Chinese medicine containing endogenous cyanide glycosides as toxic ingredients / 国际药学研究杂志

ABSTRACT

Objective To evaluate the safety limits of amygdalin in the Chinese patent medicines and Chinese herbal medi-cines,so as to provide reference for establishing the standard in the safety limits of endogenous cyanide glycosides as toxic ingredients. Methods The toxicity differences between D-amygdalin and L-amygdalin were explored by CCK-8 assay. The daily safe dose of amyg-dalin was deduced by the no-observed-adverse-effect level(NOAEL)of cyanide. Based on the deduced results,the safety limits of amygdalin in thirty-six Chinese patent medicines and three different kinds of Chinese herbal medicine were calculated. Results The half maximal inhibitory concentration of D-amygdalin and L-amygdalin was(3.5±2.0)and(6.6±0.4)mmol/L,respectively,and the daily safe dose of amygdalin was 104.30 mg. Conclusion The toxicity of D-amygdalin was approximately two times that of L-amygda-lin. To establish the safety limits of amygdalin,the sum content of the epimer could be regarded as the D-amygdalin itself to enlarge the safety scope. The content of amygdalin of three Chinese patent medicines was determined to exceed the maximum safety limit for all measured batches,indicating some kind of safety risk. Moreover,in the researches on safety limit establishment,the toxicity-alleviat-ed processing effect should be included.