盐酸丁卡因栓剂的制备及质量控制

PREPARATION AND QUALITY CONTROL OF TETRACAINI HYDROCHLORIDUM EMULSION SUPPOSITORY

目的：制备油包水型盐酸丁卡因乳剂栓并对其进行质量控制。方法：以盐酸丁卡因为主药，半合成脂肪酸脂、苯甲酸为油相，聚乙二醇１０００ 、蒸溜水为水相，司盘－ ８０ 为乳化剂制备栓剂。采用紫外分光度法测定栓剂中盐酸丁卡因的含量。结果与结论：栓剂的重量差异、溶散时限均符合《中国药典》９５ 版要求。含量测定方法操作简便、准确，平均回收率为１０１－１２％ ，ＲＳＤ＝０－８２％ 。

AIM To prepare the w/o emulsion suppository of tetracaini hydrochloridum and to esfabclish the mefhods for its qualify control.METHOD Suppository was prepared with the tetracaini hydrochloridum as staplemedicine,semi-synthesis aliphatic ester and benzoicacid as oil-phase, PEG- 1000 and distilled water as water-phase and Span- 80 as emulsifying agent.The content of tetracaini hydrochloridumin in the suppository was determined with the spectrophotometer methed.RESULTS AND CONCLUSION Weight-difference and burn-offrate of emulsion suppository accords with the requirement of Chinese pharmacopeia(publishde in 1995).This mothod is simple and accurate.Average recovery is 101 12% and RSD 0 82%.