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

关键词:  制霉素  搽剂  稳定性  高效液相色谱法  调剂管理

Key words:  nysfungin  liniment  stability  HPLC  dispensing management

摘要:

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0，7，14，21，28d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。

Abstract:

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 4 weeks, 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.