罗红霉素原位胶化滴眼液的制备及质量控制

目的制备罗红霉素原位胶化滴眼剂并建立其质量控制方法。方法以硼酸为渗透压调节剂、海藻酸钠为胶化剂制备滴眼剂;采用紫外分光光度法测定其主药罗红霉素含量,测定波长为482 nm。结果所制得的制剂为无色澄明液体,鉴别、检查均符合《中国药典》2010年版的相关规定;罗红霉素线性范围为15～60 mg/L（r=0.999 6）,平均回收率为97.75%（RSD=1.87%,n=3）。结论本制剂制备工艺简便可行,质量稳定可控。

Preparation and ualit control of in-situ Gelling of Roxithormycin Eye Drops

Objective To prepare in-situ gelling of Roxithormycin Eye Drops and establish its qualit control method.Methods The in-situ gellin of Roxithormycin Eye Drops were prepared with boric acid as buffer to regulate the pH and osmotic pressure and with sodium polymannuronate as peptizer.The content of penciclovir was determined by UV at the wavelength of 482 nm.Results The sustained-release eye drops were colorless or yellowish limpid liquid with its test and identification results all in conformity with the related stipulation stated in Chinese Pharmacopeia（2010 edition）.There was a good linear corrrlation within a range of 15-60 mg/L（r = 0.999 6） of roxithormycin concentration,the average reconvery was 97.75%（RSD = 1.87%,n = 3）.Conclusion The preparative method is simple and feasible and the qualit of in-situ gelling of roxithormycin eye drops is stable and controllable.