盐酸苯环壬酯片的酸性色素比色法及其溶出度测定

王维贤;高立军;杨造萍

中国药学杂志 ›› 2000, Vol. 35 ›› Issue (04) : 265-267.

中国药学杂志 ›› 2000, Vol. 35 ›› Issue (04) : 265-267.
药品检验

盐酸苯环壬酯片的酸性色素比色法及其溶出度测定

  • 王维贤;高立军;杨造萍
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Acid dye spectrophotometry method for drug content and determination of dissolution of phencynonate hydrochloride tablets

  • Wang Weixian
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摘要

目的:测定盐酸苯环壬酯片的含量及溶出度。方法:采用浓剂萃取、酸性色素比色法测定含量,检测波长413 nm。溶出度以转篮法测定,转速100 r·min-1,溶出介质500 ml pH 3磷酸盐缓冲液。结果:3.0~15.0μg·ml-1范围内线性良好,r=0.9999(n=5),平均回收率99.95%(n=9),RSD为土0.65%。片剂30 min定时取样测定,主药溶出90%以上。结论:方法简便、准确、专属,可作为该制剂的含量浏定和质量控制。

Abstract

OBJECTIVE: To determine the content and dissolution of phencynonate hydrochloride tablets (PHT). METHODS: A solvent extractionacid dye spectrophotometry method was used with the detection wavelength at 413 nm.A basker method was used to study the dissolution,the rotative velocity was 100 r·min-1and the solvent was 500 ml of phosphate buffer solution (pH 3). RESULTS: The linear range of the standard curve was 3.0~15.0 μg·ml-1,r=0.9999,n=5.The average recovery of assay was 99.95% with a relative standard deviation of 0.65% (n=9).The drug dissolution rate for 30 min was over 90%. CONCLUSION: This method is convenient,accurate and specific for the content determination of PHT.

关键词

盐酸苯环壬酯片 / 酸性色素比色法 / 含童浏定

Key words

phencynonate hydrochloride tablets / acid dye spectrophotometry / content determination / dissolution

引用本文

导出引用
王维贤;高立军;杨造萍. 盐酸苯环壬酯片的酸性色素比色法及其溶出度测定[J]. 中国药学杂志, 2000, 35(04): 265-267
Wng Weixin . Acid dye spectrophotometry method for drug content and determination of dissolution of phencynonate hydrochloride tablets[J]. Chinese Pharmaceutical Journal, 2000, 35(04): 265-267

参考文献

[1]徐国柱,蔡志基,董良,等.盐酸苯环壬酯预防运动病临床试验研究.中国临床药理学杂志,1993,9(9):65. [2]袁淑兰,乔建忠,阮金秀,等.盐酸苯环壬酯人体药代动力学及生物利用度研究.中国临床药理学杂志,1995,11(2):98 [3]王维贤,高立军.高效液相色谱法测定盐酸苯环壬酯片的含量.药物分析杂志,1999,19(5):311. [4]卫生部新药标准 WS-003/(x-002)-97.

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