连翘滴眼液的制备与质量控制

摘要

Objective To prepare Forsythia suspensa Eye Drops and establish it's quality control method.Methods Alcohol extracting-water precipitating method is applied to extract the effective ingredient as primary medicine, while borax, boric acid, ethyl hydroxybenzoate is applied as excipient for the preparation of Forsythia suspense Eye Drops.The content of forsythin in the agent is determined by HPLC, as well as the observation of stability and pharmacodynamics.The eye drops' quality control is on the basis of Chinese Pharmacopoeia.Results In the density range of 20- 200 μg/mL, the linear relation is good( r = 0.999 9), the average recovery rate is 99.53％, RSD is 1.51％(n = 6).Conclusion The methods is rational and controllable.%目的 制备连翘滴眼液,建立其质量控制方法.方法 采用醇提水沉法提取连翘有效成分连翘苷,以此为主药,以硼砂、硼酸、羟苯乙酯等为辅料制备连翘滴眼液;采用高效液相色谱法测定制剂中连翘苷的含量;进行稳定性考察和药效学研究,依据对滴眼液进行质量控制.结果 连翘苷质量浓度在20～ 200μg/mL范围内与峰面积线性关系良好(r=0.9999),平均加样回收率为99.53%,RSD为1.51%(n=6).结论 连翘滴眼液制备工艺合理,质量可控.