氯霉素氢化可的松软膏的研制及质量控制

目的研制氯霉素氢化可的松软膏并建立质量控制标准。方法以FAPG软膏基质(脂肪醇和丙二醇)配制含1%氯霉素、0.5%氢化可的松软膏。采用HPLC法,以Agilent Eclipse XDB-C18(150 mm×4.6 mm,5μm)为色谱柱,甲醇-水(55∶45)为流动相,检测波长240 nm,流速0.9 ml.min-1,进样量10μl,对氯霉素氢化可的松软膏进行含量测定,室温下留样观察6个月,分别考察氯霉素、氢化可的松在软膏剂中的稳定性。结果氯霉素、氢化可的松保留时间分别为2.95、6.43 min;药物浓度与峰面积线性关系良好。氯霉素线性范围为50.18～401.44 mg.L-1,回归方程为C=0.075 93X+0.198 7,r=0.999 9(n=5),平均回收率为100.44%(n=9);氢化可的松线性范围为25.13～200.02 mg.L-1,回归方程为C=0.097 0X+0.357 0,r=0.999 9(n=5),平均回收率为99.86%(n=9)。氯霉素、氢化可的松在软膏剂中室温下保存6个月稳定。结论该制剂为溶液型软膏剂,氯霉素在该软膏剂中的稳定性较在乳膏剂中增加。制剂制备容易,控制方法快速、准确。

Preparation and quality control of chloramphenicol hydrocortisone ointment

Objective To prepare chloramphenicol and hydroeortisone ointment and to establish quality control standard. Methods Ointment was prepared containing 1% ehloramphenicol and 0.5% hydrocortisone with FAPG ointment base（ fatty alcohol propylene glycol ）. HPLC method was need with Agilent Eclipse XDB-ClS （ 150 mm x 4.6 mm ,5 μm） column. The mobile phase consisted of methanol - water （55：45）. The detection wavelength was at 240 nm. The flow rate was 0.9 ml . min-1 and the injection volume was 10 μl. The stability of ehloramphenicol and hydrocortisone ointment was obseroed with 6 months at room temperature. Results The linear range of chloramphenieol was from 50.18 to 401.44 mg . L- 1, the regression equation was C = 0. 075 93X ＋ 0. 198 7, r = 0. 999 9 （n = 5 ）and the average recovery was 100.44% （n = 9）. The linear range of hydrocortisone was from 25.13 to 200.02 mg . L-1, The regression equation was C = 0. 097 0X ＋ 0. 357 0, r = 0. 999 9 （ n = 5 ） and the average recovery was 99.86% （ n = 9 ）. The stability of ehloramphenieol and hydrocortisone ointment with 6 months at room temperature was good. Conclusion The preparation is solution type ointment. The stability of chloramphenicol is increased in the ointment. The preparation of the ointment is easy, and the method of quality control is rapid and accurate