口疾灵含漱液的制备与质量控制

The preparation and quality control of Koujiling gargle

目的:研究口疾灵含漱液的制备及质量控制。方法:采用双波长等吸收点法同时测定两主药含量,并考察了制剂的稳定性。结果:甲硝唑在～μ,醋酸氯己定在～μ范围内线性关系良好,γ,平均回收率甲硝唑为420g/ml210g/ml=0.9999,99.97%RSD% 0.042 ( n;醋酸氯己定为,( =5)99.50%RSD% 1.18 n )。=5结论:该制剂配方合理,制备工艺简单,质控方法可靠,稳定性良好。

Objective: To study the preparation and quality control standard of Koujiling gargle. Methods:The contents of two main ingredients were determined by dual-wavelength isobestic point spectrophotometry and the stability of preparation was examined. Results: The calibration curve of metronidazole was linear in the range of 4～μ～μγ20g/ml. The calibration curve of chlorhexidine acetate was linear in the range of 210g/ml, =0.9999.The average recovery of metronidazole was 99.97% (RSD=0.042%, n=5) and that of chlorhexidine acetate was 99.50%(RSD=1.18%, n=5). Conclusion: The new preparation is rational in formula, simple in production, reliable in quality control and good in stability.