DRUG DELIEVERY AND FORMULATION RESEARCH LABORATORIES
Department of pharmacutics and Pharmaceutical Technology
School of pharmacy college of Medicine of The University
of Lagos.
P.M.B. 12003, Lagos Nigeria.
PRODUCT:
Cleanser 109 mixture
MANUFACTURER: Adewural
Natural Medical
centre,
Lagos
DOSAGE FORM:
Liquid
SAMPLE SIZE:
190ml x 1 amber plastic bottle
with
tamper-proof closure
SAMPLING METHOD: Sample
brought by the company'
s representative
BATCH NO:
003
MFG.DATE:
Feb. 2004
EXP.DATE:
Feb. 2006
TEST
RESULT SPECIFICATION
PHYTOCHEMISTRY Alkaloids,tannins,flavanoids,reducing sugar
cardiac
glycosides with steroidal nucleus and
steroidal rings are present whileanthra-
quinones are absent.
PHYSICOCHEMICAL A brown mixture with characteristic odour
and
taste. Packed in 190ml amber plastic
bottle
with tamper proof closure.
ACUTE TOXICITY STUDY (LD50) OF CLEANSER 109 MIXTURE, A HERBAL REMEDY
Method
40 day-old male and female white albino mice with average 19.23+or-
0.1893g were used for the study.They are fasted for ten hours prior to their use for the toxicity test. Five doses (0.84,1.69,3.37,6.74
and 13.48g/kg) of the dried drug extract were administered orally to a total of twenty-five mice divided into five groups
(n=5 mice per group).The control animals (6th group) were given only purified water.The general symptoms of toxicity and mortality
were within 24 hours (1).
RESULT:
- No death was recorded through out the study.
- Mortality could not be established after administering.
13.48g/kg, which was the achievable dose possible.
- There was no evidence of dose related toxicity.
REMARK:
- The result shows that the product (cleanser 109 mixtu-
re) is not harmful to the mice.
- The highestachievable dose of cleanser 109 (13.48g/kg),
did not cause any toxicity in mice.
- Hayes (2) reported that no dose related toxicity
is considered above 5g/kg.
CONCLUSION:
- The safety assessment of the product at up to 13.48g/kg
dose showed no toxicity in mice.
- The product cleanser 109 mixture could be considered
highly safe in the mice.