不同介质制备制霉素搽剂的稳定性考察及医院调剂管理

Investigation on Stability and Hospital Dispensing Management of Nysfungin Liniment Prepared with Different Media

目的建立一种测定制霉素搽剂含量的高效液相色谱法,考察不同介质制备的制霉素搽剂稳定性。方法使用0.9%氯化钠注射液、2.5%碳酸氢钠溶液、开塞露、纯甘油等制备制霉素搽剂,各搽剂分为2组,分别在(25.0±0.5)℃及(5.0±0.5)℃下保存,于第0,7,14,21,28 d测定制霉素含量,考察各搽剂药物含量稳定性。结果4周内0.9%氯化钠、开塞露、纯甘油3种介质制备的制霉素搽剂含量变化不明显,测定结果分别为(102.2±1.3)%与(102.7±1.3)%,(102.0±1.9)%与(103.1±1.3)%,(99.9±3.3)%与(101.5±2.0)%;2.5%碳酸氢钠制备的制霉素搽剂含量变化显著,第0天测定结果为(85.2±2.1)%与(84.3±1.26)%,第28天测定结果为(59.2±1.7)%与(65.1±2.4)%。结论使用0.9%氯化钠、开塞露、纯甘油3种介质制备的制霉素搽剂4周内含量变化不明显,必要时3种介质可相互替代,而制霉素在2.5%碳酸氢钠中不稳定,2.5%碳酸氢钠不能作为调剂介质使用。

OBJECTIVE To established an HPLC method to determine the content of nysfungin liniment,and to investigate the stability of nysfungin liniment prepared with different solvents.METHODS Nysfungin liniment was prepared by 0.9%sodium chloride injection,2.5%sodium bicarbonate solution,glycerol enema and pure glycerol.Each liniment was divided into two groups and stored at(25.0±0.5)℃and(5.0±0.5)℃,respectively.The content of nysfungin was determined on day 0,7,14,21 and 28,and the stability of each liniment was investigated.RESULTS The content of nysfungin liniment prepared with 0.9%sodium chloride,glycerine enema and pure glycerol did not change significantly within 4 weeks,and the measured results were(102.2±1.3)%and(102.7±1.3)%,(102.0±1.9)%and(103.1±1.3)%,(99.9±3.3)%and(101.5±2.0)%,respectively.The content of nysfungin liniment prepared by 2.5%sodium bicarbonate changed significantly,the measured results were(85.2±2.1)%and(84.3±1.26)%on day 0 and(59.2±1.7)%and(65.1±2.4)%on day 28.CONCLUSION The content of nysfungin liniment prepared with 0.9%sodium chloride,glycerine enema and pure glycerol don’t change significantly within 4weeks,and the three media can replace each other when necessary.However,nysfungin in 2.5%sodium bicarbonate was unstable and 2.5%sodium bicarbonate can not be used as a mediator.