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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 develop gastroscopy with defibrillators. METHODS: The oral defoamers were made up of raw materials such as tetracaine hydrochloride, dimethicone, sodium carboxymethyl cellulose and sorbitan oleate-80. Established the pH, microbial limit check, determination of content and other quality control methods, the preparation of the quality control. Results: The pH ranged from 5.0 to 6.0, and the limit of microorganisms was in compliance with the regulations. The average recovery was 100.5% and the RSD was 0.33% (n = 3). In addition to the stability of the foam no change. Conclusion: The preparation is reasonable in design and good in stability. It is feasible to defrost by local anesthetic gastroscopy.