Abstract: OBJECTIVE To compare the acute toxicity between formula granule and decoction of Aconiti Kusnezoffii Radix Cocta and Pinelliae Rhizoma Praeparatumcum Zingibere Et Alumine. METHODS Referring to Technical Guidelines for the Study of Single Dose Administration Drug Toxicity published by CFDA in 2014, the acute toxicity test of formula granule and decoction of Aconiti Kusnezoffii Radix Cocta and Pinelliae Rhizoma Praeparatumcum Zingibere et Alumine was performed. According to the experimental results, the toxicity differences were studied with minimum lethal dose method (MLD) and maximum administration dose method (MAD) respectively. RESULTS The MLD value of the decoction was between 25.6-32 g·kg^-1, and the MLD value of the formula granule was between 40-50 g·kg^-1 of Aconiti Kusnezoffii Radix Cocta. The MAD value of formula granule and decoction of Pinelliae Rhizoma Praeparatumcum Zingibere et Alumine were both 238.872 g·kg^-1. It was equivalent to 1 592.48 times of the upper limit (9 g·d^-1) dose of the 2015 Edition of Pharmacopoeia. CONCLUSION The toxicity of formula granule is significantly lower than the decoction of Aconiti Kusnezoffii Radix Cocta. Formula granule and decoction of Pinelliae Rhizoma Praeparatum Cum Zingibere et Alumine are both non-toxic.