甲磺酸帕珠沙星眼用凝胶的制备及质量控制.pdfVIP

甲磺酸帕珠沙星眼用凝胶的制备及质量控制 450003) 中图分类号 R927．2；R988．1文献标识码 A 文章编号 i001—0408(2008)19—1490—02 摘要 目的：制备甲磺酸帕珠沙星眼用凝胶并建立其质量控制方法。方法：以甲磺酸帕珠沙星为主药，聚乙烯醇为基质制备眼用 凝胶；采用高效液相色谱法测定其中主药的含量，并考察其稳定性。结果：所制制剂为淡黄色胶体，鉴别、检查均符合2005年版《中 9)，平均回收率为98．67％ 国药典》中的相关规定；甲磺酸帕珠沙星检测浓度的线性范围为20．O～80．0弘g·mL-1(r=0．999 靠。 关键词 甲磺酸帕珠沙星眼用凝胶；制备；质量控制 and ControlofPazufloxacinMesilate Gel Quality Ophthalmic Preparation CHEN Central 464000，China) Jian．hua(He’nanXinyangMunicipalHospital，Xinyang LI Provincial 450003，China) Jin—wei，HEXi．kui，TANYi(He’nan People’SHospital，Zhengzhou mesilate andtOestablishits controlmethod． ABSTRACTOBJECTIVE：To gel quality preparepazufloxacinophthalmic as ma- was with mesilate as andwithPVA一124base METHODS：The pazufloxacinophthalmicprincipalagent gel prepared terial．Thecontentof mesilatewasdeterminedHPLCandthe ofthe was aswell． pazufloxacin by stabilitygel investigated its fittedthe ofChinese edi— RESULTS：Thewas and preparedgel yellowishliquid property description of mesilatewas the was tion)．Thelinear 20．0～80．0肛g·mLq(r=0．9999)，andaveragerecovery rangepazufloxacin stratificationwasnotedforthe2一month under 98．67％(RSD=0．79％，It／=3)．No samplewithinstorage is and con— CONCLUSION：The ofthe mesilate feasible，its