Pre-clinical validation of a vaginal cream containing copaiba oil (reproductive toxicology study).

Abstract

The aims of this study was to evaluate the effects of oil-resin of Copaiba (Copaifera duckei Dwyer), aired in vaginal cream on the reproductive performance of female rats (Rattus norvegicus). To determine the components of the C. duckei oleoresin, gas chromatography coupled with mass spectrometry (CG-MS) was used, and considering the trans-caryophyllene sesquiterpene as a phytochemical marker in the oleoresin. Due to the extensive use of copaiba oleoresin in the suppository form for gynecological infections, an evaluation was carried out on the effects of copaiba oleoresin (Copaifera duckei Dwyer), delivered in a vaginal cream, on the reproductive performance of female Wistar rats. For this purpose, three groups (n=5-6/group) of female rats were treated as follows: 1--vaginal cream of copaiba oleoresin (28.6 mg/kg), 2--base vaginal cream and 3--control (physiological saline 0.9%), administered intravaginally, for 30 days before pregnancy, and from day zero to day 20 during pregnancy. Laparotomy was performed on the 21st day of pregnancy, followed by the determination of reproductive variables: number of live and dead fetuses, mass of the fetuses and placentas, number of implantations and resorptions, number of corpora lutea, pre- and post-implantation loss, and analyses of the fetuses with regard to external and internal anomalies and/or malformations (skeletal and visceral). The trans-caryophyllene present in the sample is suggested as a phytochemical marker and the results of this study demonstrate an absence of maternal toxicity and foetotoxicity embryofoetotoxicity at the dose administered, corresponding to ten times the recommended dose for use in humans. Accordingly, no significant statistical difference was observed between the treated and control groups, for the variables analyzed. Thus, it is concluded that the vaginal cream containing 2.5% copaiba oleoresin is safe during gestation, in female rats (Rattus norvegicus) of the Wistar strain.

• Authors: C S Lima, B J L de Medeiros, H A S Favacho, K C dos Santos, B R de Oliveira, J C Taglialegna, E V M da Costa, K J de Campos, J C T Carvalho
• Journal: Phytomedicine : international journal of phytotherapy and phytopharmacology (Phytomedicine) Vol. 18 Issue 12 Pg. 1013-23 (Sep 15 2011) ISSN: 1618-095X [Electronic] Germany
• PMID: 21665449 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2011 Elsevier GmbH. All rights reserved.

Chemical References

• Plant Preparations
• copaiba oleoresin

Topics

• Abnormalities, Drug-Induced
• Administration, Intravaginal
• Animals
• Animals, Newborn (abnormalities)
• Chromatography, Gas
• Drug Evaluation, Preclinical
• Female
• Fetal Resorption (chemically induced)
• Fetal Weight (drug effects)
• Male
• Organ Size (drug effects)
• Osteogenesis (drug effects)
• Placenta (drug effects)
• Plant Preparations (administration & dosage, chemistry, toxicity)
• Plants, Medicinal (chemistry)
• Pregnancy
• Rats
• Rats, Wistar
• Reproduction (drug effects)