依地酸二钠根管冲洗剂的制备及质量控制

Preparation and Quality Control of Disodium Edetate Endodontic Irrigation Solution

目的:制备依地酸二钠根管冲洗剂并建立其质量控制方法。方法:以依地酸二钠为主药制备冲洗剂;采用络合滴定法测定其中主药含量,同时考察制剂稳定性。结果:所制制剂鉴别等均符合《中国医院制剂规范》相关规定;平均标示含量为100.5%,平均加样回收率为99.59%(RSD=0.38%,n=9);室温密闭条件下放置6mo内各项指标未见明显变化。结论:本制剂制备工艺简单可行,质量稳定可控。

OBJECTIVE：To prepare disodium edetate endodontic irrigation solution and establish its quality control method. METHODS： The endodontic irrigation solution was prepared with disodium edetate as principal agent. The content of disodium edetate was determined by complexometric titration. The stability of the preparation was observed. RESULTS： The preparation was in line with China Hospital Preparation Standard in identification etc, with average labeled content at 100.5% and average recovery at 99.59% （RSD = 0.38%, n = 9） .The indexes of the irrigation solution showed no evident changes within 6 months at room temperature. CONCLUSION： The preparation is simple in technology, and its quality is stable and controllable.