新目安眼膏制备工艺及含量测定方法的研究  

Preparation and assay of new Muan eye ointment

作　　者：李篮[1] 何群[2] 赵碧清[2] 黄略[2] 

机构地区：[1]湖南化工职业技术学院,湖南株洲412004 [2]湖南中医药大学,长沙410208

出　　处：《中南药学》2012年第9期648-651,共4页Central South Pharmacy

摘　　要：目的建立制备新目安眼膏的最佳工艺,并建立测定新目安眼膏中更昔洛韦含量的方法。方法采用正交实验法,以成型性、涂展性和均匀性为考察指标对新目安眼膏的制备工艺进行了优化,且采用高效液相法对更昔洛韦的含量进行测定。结果正交实验表明,基质配比最优用量为PEG-4000 1.0 g、PEG-400 4.0 g、聚山梨酯-80为1.5 g。建立了高效液相法测定更昔洛韦的方法:Phenomenex C18(250 mm×4.6 mm,5μm)柱,流动相为甲醇-水(10:90),流速:1.0 mL·min-1,测定波长252 nm,柱温30℃,进样量20μL。结论新目安眼膏的制备工艺简单,符合质量要求。定量方法操作简单、灵敏度高、结果准确,可用于测定新目安眼膏中阿昔洛韦的含量。Objective To study the preparation of new Muan eye ointment and establish an HPLC method for the simultaneous determination of ganciclovir in new Muan eye ointment.Methods The prescription of new Muan eye ointment was optimized by orthogonal experiment in formability,spreadability and uniformity.We simultaneously determined ganciclovir in new Muan eye ointment.Results The optimal prescription contained 1.0 g PEG-4000,4.0 g PEG-400,1.5 g Polysorbate-80.The chromatography was performed on a reversed phase encapped column [ Phenomenex C18（250 mm×4.6 mm,5 μm） ] at 30 ℃ with a mobile phase consisting of methyl alcohol-water =10 ： 90（v/v）.The flow rate was 1.0 mL · min-1.Ganciclovir was monitored with UV detector at 252 nm.Conclusion The prescription and technology of new Muan eye ointment are reasonable and simple.The HPLC method is simple and accurate,which can be used to simultaneously determine ganciclovir in new Muan eye ointment.

关 键 词：新目安眼膏 正交实验 制备工艺:高效液相色谱法 

分 类 号：R944.21[医药卫生—药剂学] R927.2[医药卫生—药学]