Chemical, pathological and toxicological studies of the effects of RICOM-1013-J of Ricinus communis var minor on women volunteers and rodents.
RICOM-1013-J (Ricinus communis var minor) administered orally once to each of 12 women volunteers at a dose of 2.5-2.7 g per 8 months, protected against pregnancy over a period of 7-8 months of study. A study of the effect of a contraceptive dose (20 mg/kg) on metabolic parameters in rat (food and water in-take, urine and faecal output and body weight) over a period of 4 months showed a slight decrease in all the parameters in the first 1-8 weeks. This effect was reversible attaining pretreatment levels from week 16. The LD(50) in an acute toxicity test in mice was 63.1 +/- 16.0 g/kg s.c. Determination of blood urea, sodium (Na(+)), potassium (K(+)), chloride (Cl(-)) and bicarbonate (HCO$_¿3¿ ¿-¿$)as a measure of renal function and alkaline phosphatase (ALP), transaminases (GPT and GOT) and transpeptidases (GGT) as a measure of liver function showed that liver function profiles in pretreated rats were not significantly different from control (p < 0.05) on day 21 to day 150. However, serum levels of ALP and GGT at day 120 to day 150 were moderately but significantly elevated (p > 0.05) compared with the control. There were no significant changes in renal function profiles in pretreated rats (p < 0.05) compared with the control. The results of the liver and renal function profiles in women volunteers showed that there were no significant (p < 0.05) changes in renal functions on day 206 following RICOM-1013-J administration. However, serum levels of ALP and GGT showed a slight rise in about 70% of volunteers, whereas bilirubin and transaminases levels were normal. The present results indicate a very high efficacy and margin of safety of RICOM-1013-J in women volunteers. The increase in ALP and GGT in both animal and women volunteers suggest mild intrahepatic cholestatic changes which may be attributed to an oestrogenic effect of RICOM-1013-J.
Das
S C
SC
Department of Chemical Pathology, University of Jos, Jos, Nigeria.
Isichei
C O
CO
Okwuasaba
F K
FK
Uguru
V E
VE
Onoruvwe
O
O
Olayinka
A O
AO
Ekwere
E O
EO
Dafur
S J
SJ
Parry
O
O
D000328:Adult; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D003271:Contraceptive Agents, Female / Q000009:adverse effects / Q000494:pharmacology*; D004231:Diuresis / Q000187:drug effects; D004327:Drinking Behavior / Q000187:drug effects; D005243:Feces; D005247:Feeding Behavior / Q000187:drug effects; D005260:Female; D006801:Humans; D007677:Kidney Function Tests; D008111:Liver Function Tests; D008297:Male; D051379:Mice; D008807:Mice, Inbred BALB C; D010840:Phytosterols / Q000009:adverse effects / Q000494:pharmacology*; D011247:Pregnancy; D051381:Rats; D017208:Rats, Wistar
D003271:Contraceptive Agents, Female; D010840:Phytosterols; C405144:RICOM-1013-J