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 extractionacid 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
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Key words
phencynonate hydrochloride tablets /
acid dye spectrophotometry /
content determination /
dissolution
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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
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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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脚注
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