新鱼腥草素钠滴眼液的研制与质量控制

目的制备新鱼腥草素钠滴眼液并控制其质量。方法以新鱼腥草素钠为主药，聚山梨酯80、磷酸二氢钠等为辅料制备新鱼腥草素钠滴眼液。采用高效液相色谱（HPLC）法测定制剂中新鱼腥草素钠的含量，依据《中华人民共和国药典》对滴眼液进行质量控制。结果所制剂的新鱼腥草素钠滴眼液质量稳定，含量准确，平均回收率为100.15%，RSD＝0.49%（n＝9）。结论该制备处方合理，工艺简单，质量稳定，含量测定快速、准确。

Preparation and Quality Control of Sodium New Houttuyfonate Eyedrops

Objective To prepare a new kind of sodium new houttuyfonate eyedrops and to control its quality. Methods In the preparation of the sodium new houttuyfonate eyedrops,sodium new houttuyfonate served as the basic remedy while polysorbate 80 and sodium dihydrogen phosphate etc.were used as adjuvants.The content of the basic remedy in the preparation was determined with HPLC,and the quality control of the eyedrops was carried out according to the Pharmacopoeia of the People's Republic of China. Results The eyedrops prepared was shown to be stable in quality and accurate in the content of the basic remedy.The average rate of recovery was 100.21%,RSD=0.48(n=9). Conclusion The formula of the preparation was rational,the technology of preparation was simple,and its content determination was quick and accurate.