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Acute Toxicity Test for Leucozepin®

(Maximum Tolerance Measurement)
Abstract:
 
Mice were administered (ig) Leucozepin® extract three times a day until the maximum tolerance dosage (MTD) was determined to be 344.42 times human dosage.
 
Objective:
 
LD50 can not be measured because of the low toxicity of Leucozepin®; MTD was determined instead.
 
Materials:
 
1.    The Medicine, provided by LIFEnhance, Inc., consists of a brown extract (lot number 20020408). 0.11g extract is equal to 1g crude drugs. It is dissolved in distilled water to a final concentration of 83.33% and can be stored in refrigerator at 4°C until use.
 
2. The Animals were obtained from Hubei Animal Experiment Center.  Kunming mice weighed 19±1g, equal number of ♂(male)♀(female). The mice feed also obtained from Hubei Animal Experiment Center.
 
Methods:
 
Adherent to established protocols [1], 24 Kunming mice (weight of 19±1g), half ♂ (male) and half ♀ (female) were starved for16 hours, then fed 16.67g Leucozepin extract per dose (20ml/kg) three times a day. Mice were inspected daily for 7 consecutive days. In total 50.01g/kg (equivalent to 454.64g/kg crude drugs) of Leucozepin extract was administered; 344.42 times the clinical dosage of 66g/day.
 
Result:
No mice died after taking the medicine and no abnormal phenomena was observed for their activities except the following: their excrement became a little soft and the color a little dark and they ate little more after given the medicine two times. But the next day, they became normal. According to the formula in the literature [2], the tolerance times is calculated as follows.
 
                       Mouse tolerance     human adult avg. wt (50kg)
The mice's tolerance times=---------×-------------
                       Mouse avg wt (20g)      human adult daily dosage
 
                         3.03g×3   50000g
= ----×----
                                                   20g      66g
                                         
 = 344.42 times
                                         
The tolerance is the total amount 16.67g/Kg ×3=50.01g/kg medicine, equal to 454.64g/kg crude drugs. The mice MTD levels were established at 344.42 times human adult's dosage levels.
 
Reference: 
[1] Guidebook for New Medicine Research of Chinese Herbal Medicine. Medicine Management Department of Public Health Ministry of P.R China, P203-204
[2] Chen Qi. Research Methodology of Pharmacology of Chinese Herbal Medicine, People Health Press, 1991,118-119
Testing Unit: Chinese and Western Medicine Institute of Hubei Traditional Chinese Medicine Academy
 Studies conducted from April to June of 2002