Acute Toxicity Test for Relazovacฎ

(Maximum Tolerance Measurement)

Abstract:

 

Mice were administered (ig) Relazovacฎ 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 Relazovacฎ; 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 4ฐC until use.

 

2. The Animals were obtained from Hubei Animal Experiment Center.  Kunming mice weighed 19ฑ1g, 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 19ฑ1g), 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

 

                         9.23gื3   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