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Acute Toxicity Test for Apazin®
(Maximum Tolerance Measurement)
Abstract:
Mice were administered Apazin® extract three times a day until
the maximum tolerance dosage (MTD) was determined to be 1077.44 times
human dosage.
Objective:
Since LD50 could not be measured due to the low toxicity of Apazin®;
MTD was determined instead.
Materials:
1. The Medicine, provided by LIFEnhance, Inc., consists of a brown extract
(lot number 20020403). 0.15g extract is equal to 1g crude drugs. Extract
is dissolved in distilled water to a final concentration of 96.97% and
can be stored at 4°C until use.
2. Animals were obtained from Hubei Animal Experiment Center. Kunming
mice weighed 19±1g, equal numbers ♂(male) and ♀(female). Mice
feed also obtained from Hubei Animal Experiment Center.
Methods:
Adherent to established protocols [1], 22 Kunming mice (weight 19±1g)
half ♂(male) and half ♀(female), were starved for 16 hours,
then fed 19.394g Apazin extract per dose (20ml/kg) three times a day. Mice
were inspected daily for 7 consecutive days. In total 58.182g/kg
(equivalent to 387.88g/kg crude drugs) of Apazin extract was administered;
1077.44 times clinical dosage of 18g/day.
Result:
No lethalities were observed nor were there any behavioral abnormalities. Mice
feces seemed softer and were of a slightly darker color. After
two dosages feed consumption declined somewhat but recovered by the following
day. Tolerance levels were calculated as follows:
Mouse
tolerance human
adult avg wt (50 kg)
Mouse tolerance level = --------- × -------------
Mouse
avg wt (20g) human
adult daily dosage
7.75g ×3 50000g
=
----×----
20g 18g
=1077.44
times
The tolerance is the total amount 19.394g/Kg ×3=58.182g/kg medicine,
equal to 387.88g/kg crude drugs. The mice MTD levels were established
at 1077.44 times human adult's dosage levels.
References:
[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 Facility: Chinese and Western Medicine Institute of Hubei Traditional
Chinese Medicine Academy
Studies conducted from April to June of 2002
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