市售滴眼用利福平临用配制后在不同条件下稳定性考察

发布时间：2018-02-01 11:09

本文关键词： 利福平眼用制剂稳定性贮存条件避光冷藏(~℃)　出处：《药物分析杂志》2015年09期 　论文类型：期刊论文

【摘要】：目的:考察市售3个厂家滴眼用利福平配制后不同条件下的稳定性。方法:采用HPLC法,使用Shimpack Vp-ODS色谱柱(4.6 mm×150 mm,5μm),以甲醇-乙腈-0.075 mol·L-1磷酸二氢钾溶液-1.0 mol·L-1枸橼酸溶液(30∶30∶26∶4)为流动相,流速1.0 m L·min-1,柱温为室温,检测波长254 nm。按外标法以峰面积计算含量。不同厂家滴眼用利福平配制后在室温避光、避光冷藏2种贮存条件下,0、1、3、7、14、28 d利福平的含量。结果:3厂家滴眼用利福平配制后稳定性存在差别,滴眼用利福平在避光冷藏下稳定性较好,但14 d后,3厂家利福平含量均下降超过5%。结论:配制好的利福平滴眼液应低温、避光保存,生产厂家应标注配制后的使用时限。
[Abstract]:Objective: to investigate the stability of rifampicin in three manufacturers under different conditions. Methods: HPLC method was used. A Shimpack Vp-ODS column of 4.6 mm 脳 150 mm ~ 5 渭 m was used. The mobile phase was methanol-acetonitrile -0.075 mol 路L-1 potassium dihydrogen phosphate solution -1.0 mol 路L -1 citric acid solution 30: 30: 264). The flow rate was 1.0 mL 路min -1, the column temperature was room temperature, the detection wavelength was 254 nm. The content was calculated according to the external standard method. The content of rifampicin in two kinds of storage conditions was 1 ~ (1) C ~ (3) C ~ (7) C ~ (7) C ~ (14) ~ (28) d. Results the stability of rifampicin was different after dropping rifampicin in three factories. The stability of rifampicin drops was better than that of light cold storage, but the content of rifampicin decreased more than 5 after 14 days. Conclusion: the prepared rifampicin eye drops should be stored in low temperature and light free. The manufacturer shall mark the time limit after preparation.
【作者单位】：池州市人民医院药剂科;
【分类号】：R969.2
【正文快照】： 滴眼用利福平是用于治疗沙眼、角膜炎、结膜炎等的常用滴眼剂,因其价格便宜,疗效确切,深受医患青睐。由于利福平配制后稳定性差,各厂家均将利福平与辅料制成颗粒、片剂或丸剂,在临用前加至配套缓冲液中,振摇溶解后使用。为了考察不同厂家滴眼用利福平配制后的有效期,对市售3个

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