氯地乳膏的制备及质量控制

目的制备氯地乳膏并建立其质量标准。方法用高效液相色谱法测定氯地乳膏中氯霉素和醋酸地塞米松的含量。选用XB—C18柱（250mm×4．6mm，5um），流动相为甲醇-水（70：30），流速为1．0mL／min，检测波长为240nm，柱温为室温。结果氯霉素、醋酸地塞米松质量浓度线性范困分别为400—2000ug／mL（r=0．9993）和8～40ug／mL（r=0．9996），平均回收率分别为99．81％（RSD=0．87％）和99．47％（RSD=0．70％）。结论制备工艺合理，质量标准可行。

Preparation and Quality Standard of Chloramphenicol and Dexamethasone Cream

Objective To prepare Chloramphenicol and Dexamethasone Cream and to set up its quality standard. Methods The HPLC method was used to determine the contents of chloramphenicol and dexamethasone acetate in Chloramphenicol and Dexamethasone Cream. The XB- C18 column（250 mm×4.6 mm, 5 um）was used with methanol-water （70：30）as the mobile phase. The flow rate was 1.0 mL/min and the column temperature was room temperature. The detection wavelength was set at 240 nm. Results The calibration range of ehloramphenicol was 400 - 2 000 ug/mL （ r = 0. 999 3） and the average recovery rate was 99. 81%, RSD = 0. 87% ; the calibration range of dexamethasone acetate was 8-40ug/mL（r=0.999 6）and the average recovery rate was 99.47%, RSD=0.70%. Conclusion Chloramphenicol and Dexamethasone Cream is reasonable in preparation technology. The HPLC method can be used in the quality control of Chloramphenieol and Dexamethasone Cream.