@article{oai:fukuyama-u.repo.nii.ac.jp:00008777, author = {五郎丸, 剛 and 守田, 尚史 and 長谷, 悠紀 and 越智, 良明 and 篠原, 義剛 and 高橋, 浩二郎 and 江藤, 精二}, issue = {31}, journal = {福山大学薬学部研究年報, Annual report of the Faculty of Pharmacy & Pharmaceutical Sciences, Fukuyama University}, month = {Dec}, note = {The use of injectable generic antineoplastic agents has been increasing. Few studies have compared the quality and adverse reactions of generic and branded antineoplastic agents; and therefore, generic agents have not gained wide acceptance. Paclitaxel injections, which are used for treating solid cancers, are being marketed by some companies in Japan. The degree of hypersensitive reactions to these drugs may vary because of the differences in chemical properties of the polyoxyethylene castor oil that is used as a solvent in the paclitaxel preparations. Therefore, we investigated the incidence of pulmonary edema occurring as a hypersensitive reaction in rats administered branded and generic paclitaxel injections. Moreover, we compared the chemical properties of these preparations. We found that the pH of branded and generic paclitaxel preparations diluted with saline was different. This difference in pH may be attributed to a difference in chemical properties from the additive. We observed no significant differences in pulmonary vascular permeability, arterial partial pressure of oxygen, or leakage of protein in the pulmonary alveolus, between paclitaxel preparations administered to rats. These results suggest that both paclitaxel preparations induced pulmonary edema of a similar level in rats, irrespective of the differences in their chemical properties., The use of injectable generic antineoplastic agents has been increasing. Few studies have compared the quality and adverse reactions of generic and branded antineoplastic agents; and therefore, generic agents have not gained wide acceptance. Paclitaxel injections, which are used for treating solid cancers, are being marketed by some companies in Japan. The degree of hypersensitive reactions to these drugs may vary because of the differences in chemical properties of the polyoxyethylene castor oil that is used as a solvent in the paclitaxel preparations. Therefore, we investigated the incidence of pulmonary edema occurring as a hypersensitive reaction in rats administered branded and generic paclitaxel injections. Moreover, we compared the chemical properties of these preparations. We found that the pH of branded and generic paclitaxel preparations diluted with saline was different. This difference in pH may be attributed to a difference in chemical properties from the additive. We observed no significant differences in pulmonary vascular permeability, arterial partial pressure of oxygen, or leakage of protein in the pulmonary alveolus, between paclitaxel preparations administered to rats. These results suggest that both paclitaxel preparations induced pulmonary edema of a similar level in rats, irrespective of the differences in their chemical properties.}, pages = {44--45}, title = {肺障害を指標としたラット過敏反応モデルによる先発および後発パクリタキセル注射液の副作用の比較(発表論文抄録(2012))}, year = {2013} }