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Acute Toxicity Test for Relazovac®
(Maximum Tolerance Measurement)
Abstract:
Mice were administered (ig) Relazovac® extract three times a day
until the maximum tolerance dosage (MTD) was determined to be 1282.05
times human dosage.
Objective:
LD50 can not be measured because of the low toxicity of Relazovac®;
MTD was determined instead.
Materials:
1. The Medicine, provided by LIFEnhance, Inc., consists
of a brown extract (lot number 20020402. 0.13g extract is equal to 1g
crude drugs. It is dissolved in distilled water to a final concentration
of 100% 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], 22 Kunming mice (weight of 19±1g),
half ♂ (male) and half ♀ (female) were starved for16 hours,
then fed 20g Relazovac extract per dose (20ml/kg) three times a day.
Mice were inspected daily for 7 consecutive days. In total 60g/kg (equivalent
to 461.54/kg crude drugs) of Relazovac extract was administered; 1282.05
times the clinical dosage of 18g/day.
Result:
No lethality was 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 (50kg)
Mouse tolerance level = ---------×-------------
Mouse
avg. wt (20g) human adult daily dosage
9.23g×3 50000g
=----×----
20g 18g
=
1282.05 times
The tolerance is the total amount 20g/Kg ×3=60g/kg medicine, equal
to 461.54g/kg crude drugs. The mice MTD levels were established at 1282.05
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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