目的:建立还原型谷胱甘肽肠溶片的含量测定方法,优化处方及制备工艺。方法:采用高效液相色谱法。色谱柱:十八烷基硅烷键合硅胶柱,流动相:磷酸盐溶液(取磷酸二氢钠6.80 g,庚烷磺酸钠2.20 g,加水溶解成1000 m L,用磷酸调节PH至3.0)—甲醇(96∶4),流速:1.0 m L/min,检测波长:210 nm。考察黏合剂、崩解剂和肠溶衣增重,以还原型谷胱甘肽释放度为指标得出肠溶片的最佳处方。结果:制得的肠溶片崩解时间及释放度符合规定。结论:该方法简便、可靠、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 glutathione enteric-coated tablets, optimize prescription and preparation process. Methods: Using high performance liquid chromatography. Column: octadecylsilane bonded silica gel, mobile phase: phosphate solution (take sodium phosphate monobasic 6.80 g, sodium heptane sulfonate 2.20 g, dissolved in water 1000 m L, adjusted to pH 3.0 with phosphoric acid) - methanol (96: 4), flow rate: 1.0 m L / min, detection wavelength: 210 nm. The best prescription of enteric-coated tablets was obtained by measuring the release of glutathione as an index for the weight gain of binders, disintegrants and enteric coatings. Results: The prepared enteric-coated tablets disintegration time and release meet the requirements. Conclusion: The method is simple, reliable, accurate and specific and can be used for the quality control of the preparation.