辐照环境中氢化可的松注射液的稳定性研究

以不同剂量Y射线模拟辐照环境,考察氢化可的松注射液的稳定性。将同一批号的氢化可的松注射液经60CoY射线辐照,吸收剂量设定为2、4、8、16、26和34kay。观察注射液颜色和澄明度的变化,并采用高效液相色谱(HPLC)法测定氢化可的松注射液含量变化。结果表明:氢化可的松注射液含量随吸收剂量显著下降(p〈0.01),当吸收剂量为2kGy以上时含量下降超出质量合格范围;氢化可的松经辐照后变浑浊,颜色也经历先变黄后又无色,提示氢化可的松溶液中生成了溶解度较小的物质,在辐照环境中极不稳定。...

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Bibliographic Details
Published in辐射研究与辐射工艺学报 Vol. 31; no. 1; pp. 41 - 44
Main Author 管海燕 胡大强 藕顺龙 卢来春
Format Journal Article
LanguageChinese
Published 第三军医大学大坪医院野战外科研究所药剂科 重庆400042 2013
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ISSN1000-3436

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Summary:以不同剂量Y射线模拟辐照环境,考察氢化可的松注射液的稳定性。将同一批号的氢化可的松注射液经60CoY射线辐照,吸收剂量设定为2、4、8、16、26和34kay。观察注射液颜色和澄明度的变化,并采用高效液相色谱(HPLC)法测定氢化可的松注射液含量变化。结果表明:氢化可的松注射液含量随吸收剂量显著下降(p〈0.01),当吸收剂量为2kGy以上时含量下降超出质量合格范围;氢化可的松经辐照后变浑浊,颜色也经历先变黄后又无色,提示氢化可的松溶液中生成了溶解度较小的物质,在辐照环境中极不稳定。
Bibliography:Hydrocortisone, Irradiation, Stability, HPLC
The same batches of hydrocortisone injection were irradiated by 60Co y-rays with different absorbed doses of 2, 4, 8, 16, 26, and 34 kGy, respectively. The color and clarity of hydrocortisone injection were inspected and the content of hydrocortisone was analyzed by HPLC. The results show that the injection content decreases with the increment of absorbed doses (p〈0.01), and it is out of the control quality when the absorbed dose more than 2 kGy Moreover the color becomes yellow and then is transferred transparent. The hydrocortisone injection is unstable to radiation as it will generate some colored and less soluble substances under radiation environment.
31-1258/TL
GUAN Haiyan HU Daqiang 0U Shunlong LU Laichun (Department of Pharmacy, Daping Hospital, Researgh Institute of Surgery of the Third Military University, Chongqing 400042, China)
ISSN:1000-3436