Journal of Pharmaceutical Investigation
- Volume 24 Issue 3
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- Pages.115-129
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- 1994
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- 2093-5552(pISSN)
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- 2093-6214(eISSN)
Damage of Ibuprofen Suppository on Rectal Mucosa of Rats
이부프로펜 좌제의 흰쥐 직장점막 자극성 시험
- Lee, Sung-Hack (College of Pharmacy, Seoul National University) ;
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Kim, Moon-Kyoung
(College of Pharmacy, Seoul National University) ;
- Han, Yong-Hae (College of Pharmacy, Seoul National University) ;
- Shim, Chang-Koo (College of Pharmacy, Seoul National University)
- Published : 1994.09.20
Abstract
In the present study, quantitative and qualitative histology was used to assess the effects of ibuprofen suppositories with various treatments on the rectal mucosa of rats. Two suppositories were prepared with Witepsol W35 and compared with two commercial ibuprofen suppositories Reference I (Showa Pharm.ind., Tokyo, Japan), Reference II (P.Pharm., Seoul, Korea). Single and multiple dose(dosing interval 4 hr, n=4) studies were conducted. All suppositories significantly increased epithelial cell loss, but the extent of rectal irritation was variable. These studies showed that the incorporation of ibuprofen into the suppository bases increases the morphological change in rectal tissue both for the single and multiple administrations of suppositories, but which was significantly recovered within 24 hr although the interanimal variability in scores was very substantial. Multiple administration of ibuprofen suppositories caused significant damage to rectal mucosa, but it must be considered that these were under the severe condition, that is, interval of administration (4 hr) was three times shorter than normal interval of administration and dose was fifteen times larger than usual human dose. Aluminum oxide