(Maximum Tolerance Measurement)
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
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
Studies conducted from April to June of 2002