复方醋酸氟轻松乳膏含量测定研究.docVIP

复方醋酸氟轻松乳膏含量测定研究 　　[摘要] 目的 建立复方醋酸氟轻松乳膏中尿囊素和冰片的定量方法。 方法 尿囊素采用Intersil ODS-3 C18柱（250mm×4.6mm，5μm），流动相为甲醇：水（2：98），检测波长为210nm，流速为1.0mL/min，外标法计算。冰片以水杨酸甲酯为内标物，采用气相色谱法，DB-WAX毛细管色谱柱（30m×0.53mm×1.0μm），柱温130℃，进样口温度220℃，FID检测器，检测器温度为280℃。 结果 尿囊素和冰片的线性范围分别为0.05015～1.003 mg/mL和0.4728～4.728mg/mL，回归方程分别为Y=130310X+1418.5（r=0.9998）和Y=1.2213X-0.0082（r=1.0000）。尿囊素和冰片的平均回收率分别为102.12%（RSD=0.59%）和100.25%（RSD=0.60%）。 结论 本方法简便、快捷，灵敏度高，结果准确，可用于本制剂的质量控制。 　　[关键词] 复方醋酸氟轻松乳膏；尿囊素；冰片；高效液相色谱法；气相色谱法 　　[中图分类号] R927.11 [文献标识码] B [文章编号] 2095-0616（2015）13-33-04 　　[Abstract] Objective To establish a method for the determination of allantoin and borneol in compound fluocinonide cream. Methods Allantoin was detected by Intersil ODS-3 C18 column（250mm×4.6mm， 5μm） with methanol-water（2：98） as the mobile phase at the flow rate of 1.0mL/min. The detection wavelength was at 210 nm. It was calculated by the external standard method. Borneol. Methyl salicylate was selected as internal standard. Gas chromatography was adopted. The column was DB-WAX capillary column （30m×0.53mm×1.0μm） and column temperature was 130℃. The injector temperature was 220℃ and the detector was FID whose temperature was 280℃. Results The linear range of allantoin and borneol were 0.05015 to 1.003mg/mL and 0.4728 to 4.728mg/mL. Regression equations were Y=130310X+1418.5（r=0.9998） and Y=1.2213X-0.0082（r=1.0000） respectively. The average recovery of allantoin and borneol were 102.12%（RSD=0.59%）and 100.25%（RSD=0.60%）respectively. Conclusion The method is simple， rapid， sensitive， accurate and reliable which can be used for quality control of compound fluocinonide cream. 　　[Key words] Compound fluocinonide cream； Allantoin； Borneol； High Performance Liquid Chromatography； Gas chromatography 　　复方醋酸氟轻松乳膏为《中国人民解放军医疗机构制剂规范》[1]（2002）版收载的品种，用途为止痒抗过敏，用于急性、亚急性、慢性湿疹，皮肤瘙痒症，过敏性皮炎。本品种为复方制剂，处方中有醋酸氟轻松、氯霉素、冰片、氧化锌、尿囊素五个成分，但现标准中只有醋酸氟轻松和氯霉素的含量测定。为更好的控制该品种的质量，根据军队医疗机构制剂标准提高计划课题2013年度检查评估会有关事项，本次针对尿囊素、冰片进行研究，建立了含量测定方法并进行方法学验证。方法专属性强，灵敏度高，重复性好，从而可以更好地有效地控