胃镜除泡剂的制备及质量考察

Preparation and Quality Control of Antifoam Agents Used in Fibergastroscope

目的 :目的 :研制胃镜检查用局麻除泡剂。方法 :由盐酸丁卡因、二甲硅油、羧甲基纤维素钠、脱水山梨醇油酸酯 -80等原料组成 ,制成口服消泡剂。建立了酸碱度、微生物限度检查、含量测定等质量控制方法 ,对制剂进行了质量控制。结果 :pH值 5 .0～ 6 .0 ,微生物限度检查符合规定 ,含量测定平均回收率为10 0 .5 % ,RSD为 0 .33% (n =3)。除泡剂稳定无变化。结论 :本制剂设计合理 ,稳定性好 ,作胃镜检查时的局麻消泡是可行的。

Objective: To prepare a oral emulsion liquor for anaesthesia and antifoam in fibergastroscope examination.Method: The antifoam agent was consisted of tetracaine, dimethicone, CMC-Na, and sorbitan oleate 80.Result: The pH value was 5.0- 6.0,the average recovery was 100.5% with RSD 0.33%(n=3).Conclusion: The design of antifoam agents formulation is reasonable, the oral emulsion liquor for anesthesia and antifoam in fibergastroscope examination is applicable.