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利福平胶囊与利福平微丸胶囊的酸稳定性比较

Comparison for the acid Stability of the Rifampicin Micro Pill Capsules and the Rifampicin Capsules

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【作者】 刘英杨淑先崔春英朱琳李思思

【Author】 LIU Ying~1 YANG Shu-xian~ CUI Chun-ying~1 ZHU Lin~2 LI Si-si~3 (1.Henan Provincial Institute for Drug Control,Zhengzhou,450003;2.The first subhospital attached to Zhengzhou University;3.Kangli Medicine and technology Limited Company of Henan Province,Zhengzhou,450003,China)

【机构】 河南省药品检验所郑州大学第一附属医院药剂科河南省康利医药技术开发有限公司

【摘要】 目的:对利福平胃溶胶囊与利福平微丸胶囊的酸稳定性加以比较,从体外溶出方面说明利福平不同制剂的酸稳定性差异。方法:用高效液相色谱法与紫外分光光度法分别同时测定利福平胃溶胶囊的溶出度与利福平微丸胶囊的释放度。高效液相色谱法色谱柱:Mltech Alltima CN(5μm,250×4.6 mm);柱温:30℃;流动相:0.01 mol·L-1庚烷磺酸钠溶液(用稀磷酸调 pH 至2.0)-乙腈(44:56);流速:1.0 mL·min-1;检测波长:254nm;检测灵敏度为0.1 Aufs,进样量10 μL。紫外分光光度法测定波长:474nm,以 pH6.8的磷酸盐溶液为稀释溶剂。结果:利福平胃溶胶囊在溶出过程中降解明显,而利福平微丸胶囊在释放过程中基本无降解。结论:利福平微丸胶囊较利福平胃溶胶囊的酸稳定性好,抑制了利福平的降解,从而减少了毒副反应。

【Abstract】 To compare the acid stability of rifampicin micro pill capsules and rifampicin gastric capsules and ex- plain the differences of the acid stability for the rifampicin micro pill capsules and rifampicin gastric capsules.Method:To determine the dissolution of the rifampicin gastric capsules by UV spectrum method and the release of rifampicin micro pill capsules by HPLC respectively.The high performance liquid chromatography-The analytical column was Alhech Alltima CN (250mm×4.6mm,5μm).The column temperature was 30℃.The mobile phase was consisted of the 0.01 moL·L-1 sodi- um heptanesulfonate solution(pH2.0)—acetonitrile (44:56).The flow rate was 1.0 mL·min-1.The detection wavelength was 254nm.The detection sensitivity was 0.1 Aufs and the inject volume was 10μL.The UV spectrum method—the detec- tion wavelength was 474 nm and the dilution solvent was pH6.8 phosphate buffer.Results:The decomposition of the rifampi- cin gastric capsules is notable and rifampicin micro pill capsule is seldom decomposed.Conclusion:The acid stability,of rif- ampicin micro pill capsules is better than that of the rifampicin gastric capsules,the rifampicin micro pill capsules suppress the decompose of rifampicin and decrease the sub responses of rifampicin.

  • 【文献出处】 药物分析杂志 ,Chinese Journal of Pharmaceutical Analysis , 编辑部邮箱 ,2005年09期
  • 【分类号】R927.11
  • 【被引频次】2
  • 【下载频次】136
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