(Maximum Tolerance Measurement)
Since LD50 could
not be measured due to the low toxicity of Apazinฎ; 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 4ฐC until use.
2. Animals were obtained from
Methods:
Adherent to established
protocols [1], 22 Kunming mice (weight 19ฑ1g) 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 adults 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
Studies conducted
from April to June of 2002