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目的:建立天麻素速溶片溶出度的测定方法。方法:采用浆法,转速为50 r/min,介质体积是900 mL测定溶出曲线,以C18为色谱柱,流动相为乙腈-0.05%磷酸水溶液(20∶80),检测波长为220 nm,流速为1.0 mL/min,柱温为25℃,进样量是100μL。结果:天麻素在11～132μg/mL(r=0.9997)浓度范围内与峰面积有良好的线性关系,采用pH 6.8磷酸盐溶液为天麻素速溶片溶出度测定介质。结论:该方法简便、准确、专属性强,可用于该制剂的质量控制。
Objective: To establish a method for the determination of dissolution rate of instant gastrodin tablets. Methods: The leaching curve was obtained by using the slurry method with a rotation speed of 50 r / min and a medium volume of 900 mL. The mobile phase consisted of acetonitrile-0.05% phosphoric acid solution (20:80) with C18 as the mobile phase and the detection wavelength was 220 nm. 1.0 mL / min, column temperature was 25 ℃, the injection volume was 100μL. Results: The gastrodin had a good linear relationship with the peak area in the concentration range of 11 ~ 132μg / mL (r = 0.9997). The pH 6.8 phosphate solution was used to determine the dissolution rate of gastrodin. Conclusion: The method is simple, accurate and specific and can be used for the quality control of the preparation.