尿素软膏的质量研究

目的 建立尿素软膏的定性定量方法。方法 采用TLC对该制剂中尿素成分进行定性鉴别；采用高效液相色谱法测定尿素的含量。色谱柱为Ultimate XB-NH2柱（4.6 mm×200 mm，5 μm），流动相为乙腈-甲醇-水（10%磷酸调pH至3.6） （90∶7∶3）；检测波长：200 nm；柱温：30 ℃；流速：0.8 mL·min-1；进样量：20 μL。结果 尿素TLC定性鉴别专属性强；尿素进样量在2~40 μg内呈良好的线性关系（r=0.999 5），平均回收率为98.8%（n=9）。结论 本方法定性专属性强，定量准确可靠，方法简便易行，灵敏度高，适用于尿素软膏的质量控制。

Study on Quality Specification for Urea Ointment

OBJECTIVE To establish the quality and quantity methods of urea ointment. METHODS Urea in urea ointment was identified by TLC. The sample was purified with XB-NH2 column and its content was determined with HPLC. The XB-NH2 column（4.6 mm×200 mm, 5 μm） was used and mobile phase was acetonitrile-methanol-water（90∶7∶3, adjusted to pH 3.6 with 10% phosphoric acid）. The detection wavelength was 200 nm, and the flow rate was 0.8 mL·min-1. RESULTS Within the range of 2-40 μg, peak area and urea injection quantity were in linear（r=0.999 5）, and the average recovery was 99.9%（n=9）. CONCLUSION The method is specific, effect, sensitive and accurate. It can be used for quality control of urea ointment.