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目的 :测定盐酸苯环壬酯片的含量及溶出度。方法 :采用溶剂萃取、酸性色素比色法测定含量 ,检测波长 413nm。溶出度以转篮法测定 ,转速 10 0r·min-1,溶出介质 5 0 0mlpH 3磷酸盐缓冲液。 结果 :3.0～ 15 .0 μg·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± 0 .6 5 %。片剂 30min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测定和质量控制。
Objective: To determine the content and dissolution of phencynonate hydrochloride tablets. Methods: Solvent extraction and acid colorimetry were used to determine the content. The detection wavelength was 413nm. Dissolution rate measured by basket method, speed 10r · min-1, dissolution medium 500mlpH3 phosphate buffer. Results: The linearity was good in the range of 3.0-15.0 μg · ml-1, r = 0.9999 (n = 5). The average recovery was 99.95% (n = 9) with RSD of ± 0.56%. Tablet 30min sampling timing determination, the main drug dissolution of more than 90%. Conclusion: The method is simple, accurate and specific, and can be used as the content determination and quality control of the preparation.