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雷帕霉素口服液的测定与稳定性研究 被引量:10

Determination of Rapamicin Oral Solution and Its Stability
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摘要 以油酸聚乙二醇甘油酯为表面活性剂,制备了雷帕霉素口服液。分别采用HPLC和HPLC-MS法测定制剂中雷帕霉素的含量及有关物质。按照药典要求检查口服液的颜色和澄清度,并考察其稳定性。结果表明所制备的雷帕霉素口服液质量稳定。 Rapamicin oral solution was prepared using glycolysed ethoxylated glycerides as the anxiliary solvent. The HPLC and HPLC-MS methods were established for the determination of rapamicin and its related substances, respectively. The color and clarity as well as the stability, were examined according to the Ch E The results showed that the quality of rapamicin oral solution was satisfactory.
出处 《中国医药工业杂志》 CAS CSCD 北大核心 2006年第11期765-767,共3页 Chinese Journal of Pharmaceuticals
关键词 雷帕霉素 口服液 稳定性 测定 rapamicin oral solution stability determination
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参考文献4

  • 1Stepkowski SM,Chen H,Daloze P.Rapamycin,a potent immunosuppressive drug for vascularized heart,kidney and small bowel transplantation in the rat[J].Transplantation,1991,51 (1):22-26.
  • 2Chen H,Wu J,Xu D,et al.Rapamycin reverse acute heart,kidney and pancreas allograft rejection and prevents accelerated heart allogaft rejection in the rat[J].Transplant Proc,1993,25(1):719-720.
  • 3Kahan BD,Julian BA,Pescovitz MD,et al.Sirolimus reduces the incidence of acute rejection episodes despite lower cyclosporine doses in caucasian recipients of mismatched primary renal allografts:a phase Ⅱ trial 1[J].Transplantation,1999,68 (10):1526-1532.
  • 4美国家用产品公司.口服雷帕霉素配方[P].CN:94116780.1,1995-09-27.

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