胃镜润滑剂的质量控制

Preparation and Quality Control of Gastroscopy Lubricant

目的建立胃镜润滑剂质量控制方法。方法以淀粉为黏合剂,甘油为润滑剂,蒸馏水为溶剂,盐酸利多卡因为主药制备胃镜润滑剂,采用紫外分光光度法,测定胃镜润滑剂中盐酸利多卡因的含量。结果盐酸利多卡因的平均回收率为100.42%,RSD为1.09%。结论本制剂制备工艺简便可行,质量稳定可控。

Objective To prepare gastroscopy lubricant and establish a quality control method. Methods The lubricant was prepared with lidocaine hydrochloride ,and with distilled water as the solvent, glyeerd as the lubricant, and starch as the adhesive. The content of lidocaine hydrochloride was measured by ultravided spectrophotometry. Results The average recovery rate of lidocaine hydrochloride was 100.42% and RSD was 1.09%. Conclusions This lubricant is simple in terms of the preparing process, and its quality is stable and controllable.