注射用双黄连与头孢唑林钠配伍稳定性考察

目的：建立同时测定双黄连中黄芩苷和头孢唑林钠含量的高效液相色谱法，探讨双黄连与头孢唑啉钠配伍的稳定性及贮存期。方法：色谱柱：Hypersil C18（250mm×4．6mm，5μm）；流动相：乙腈-水-磷酸（25：75：0．01）；流速：0．8ml·min^-1；检测波长：275nm；柱温：30℃；进样量20μl。用经典恒温法、留样观察法考察配伍液的含量、pH及外观等变化。结果：黄芩苷线性范围为20．4～102．0mg·L^-1，r=0．9982（n=5）；头孢唑林线性范围为50．4～252．0mg·L^-1，r=0．9997（n=5）；日内、日间RSD均小于5％（n=5）。恒温加速实验时，配伍液中黄芩苷较稳定，头孢唑林钠降解遵循一级动力学反应，20℃t0．9为13．8d，t1/2为90．5d。室温留样观察4h，配伍前后药物残存率〉95％，pH、外观均无明显改变。结论：该法适合于同时测定双黄连和头孢唑林钠的浓度，双黄连和头孢唑林钠可以配伍使用。

Study on the Stability of Compatibility of Shuanghuanglian Powders for Injection with Cefazolin Sodium Injection

Objective： To establish an HPLC method for simultaneous determination of Shuanghuanglian and cefazolin sodium and study the stability and expiration of their mixture. Method： Chromatographic determination was performed on Hypersil C18 column （250 mm ×4.6mm, 5μm） with acetonitrile-water-phosphoric acid （25： 75：0.01 ） as the mobile phase and a flow rate was 0.8ml·min^-1. Detection wavelengths were UV 275nm. The temperature of the column was 30℃. The changes in the content, pH and appearance were observed by classical constant-temperature experiment and room temperature storage, respectively. Result： The linearity range for baicalin was obtained from 20.4, mg·L^-1 to 102.0mg·L^-1 and the linear regression equation was C = 4. 0756 × 10^-4H ＋ 0. 2087, r = 0.998 2, n = 5; The linearity range for cefazolin was obtained from 50.4 mg·L^-1 to 252.0mg·L^-1 and the linear regression equation was C =4. 2468 × 10^-4H ＋ 3. 8634, r = 0. 999 7, n = 5. The relative standard deviation of the intra-day and inter-day were less than 5%. Baicalin was stable and the decomposition for cefazolin was one-grade kinetic reaction with accelerating experiment. The t0.9 was 13.8 days and t1/2 was 90.5 days at 20℃. There were no significant changes on the content, pH and color within 4 hours under room temperature storage. Conclusion： The study provides a simple method for simultaneous determination of Shuanghuanglian and cefazolin sodium. Shuanghuanglian and cefazolin sodium can be mixed with sodium chloride injection.