Das Gupta V
Am J Hosp Pharm. 1981 Mar;38(3):363-4.
The stability of disulfiram in aqueous suspension is reported. Aqueous suspensions of disulfiram were prepared from bulk powder and from disulfiram tablets. Acacia and sodium benzoate were present in the suspension, the final concentration of which was 25 mg/ml disulfiram. Suspensions were stored in amber bottles under fluorescent light at 24 degrees C for 178 days (tablets) and 295 days (bulk powder). Samples were taken at various intervals during storage and assayed by high-pressure liquid chromatography (HPLC) and a modified NF method. Both types of suspension were stable. Potency remained constant, and no new peaks appeared in the chromatograph. Physical integrity of the suspensions was maintained. The suspension made from tablets contained less foam and air than the one made from bulk powder; both types were easily dispersible. A degradation product of disulfiram, diethyldithiocarbamic acid, did not interfere with the assay. The HPLC assay method was more reproducible than the modified NF method. Aqueous suspensions of disulfiram are stable at room temperature for the indicated time periods, and the HPLC assay method for disulfiram is reproducible and accurate.
本文报道了双硫仑水混悬液的稳定性。双硫仑水混悬液由原料药粉末和双硫仑片剂制备而成。混悬液中加入了阿拉伯胶和苯甲酸钠,双硫仑的最终浓度为25mg/ml。混悬液储存于棕色瓶中,在24℃荧光灯下分别放置178天(片剂)和295天(原料药粉末)。储存期间定期取样,采用高压液相色谱法(HPLC)和改良的美国国家处方集(NF)方法进行测定。两种混悬液均稳定。效价保持恒定,色谱图中未出现新的峰。混悬液的物理完整性得以维持。片剂制成的混悬液比原料药粉末制成的混悬液产生的泡沫和空气少;两种类型均易于分散。双硫仑的降解产物二乙基二硫代氨基甲酸不干扰测定。HPLC测定方法比改良的NF方法更具重现性。双硫仑水混悬液在室温下在所指示的时间段内是稳定的,且双硫仑的HPLC测定方法具有重现性且准确。