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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
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