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目的:研制尿囊素的皮肤科新制剂,并建立含量测定方法。方法:采用高效液相色谱法测定含量。用C_(18)柱以甲醇-0.03mol/L磷酸二氢钠液(40:60)为流动相,流速0.5ml·min~(-1)检测波长217nm。结果:尿囊素线性范围40.96～204.80μg·ml~(-1),r=0.9994,平均回收率100.7％,RSD为0.5％(n=6)。结论:本品制备简单,含量测定用高效液相色谱法,测定方法专属性强,结果准确可靠,并能很好地控制制剂质量。
Objective: To develop a new dermatology preparation of allantoin and to establish a method for determination of its content. Methods: The content was determined by high performance liquid chromatography. The mobile phase was methanol -0.03mol / L sodium dihydrogen phosphate solution (40:60) at a flow rate of 0.5ml · min ~ (-1) and the detection wavelength was 217nm. Results: The linear range of allantoin was 40.96 ~ 204.80μg · ml ~ (-1), r = 0.9994, with an average recovery of 100.7% and a RSD of 0.5% (n = 6). Conclusion: The preparation of this product is simple, the determination of content by high performance liquid chromatography, the determination of specificity, the results are accurate and reliable, and can well control the quality of the preparation.