CN105708812A — 一种5-（2-氟苯基）-n-甲基-1-（3-吡啶基磺酰基）-1h-吡咯-3-甲氨冻干粉针及其制备方法
Assigned to JIANGSU CAREPHAR PHARMACEUTICAL Co Ltd · Expires 2016-06-29 · 10y expired
What this patent protects
本发明公开了一种氟呐普拉赞（5-（2-氟苯基）-N-甲基-1-（3-吡啶基磺酰基）-1H-吡咯-3-甲氨）无机或有机酸盐的冻干粉针及制备方法。取自制氟呐普拉赞无机或有机酸盐、抗氧剂、稳定剂、pH值调节剂和针用活性炭。方法是先将稳定剂、抗氧剂加入到90%注射用水中，将注射用水降温到25度以下，加入氟呐普拉赞无机或有机酸盐并搅拌使其溶解，调pH值到5.0-7.0，加入针用活性炭60度保温吸附30min，再加注射用水定容到全量，过滤，灌装，进冻干箱冻干，冻干周期约为24小时，出箱，轧盖，贴签，包装即得氟呐普拉赞冻干粉针。本发明制得的氟呐普拉赞无机或有机酸盐冻干…
USPTO Abstract
本发明公开了一种氟呐普拉赞（5-（2-氟苯基）-N-甲基-1-（3-吡啶基磺酰基）-1H-吡咯-3-甲氨）无机或有机酸盐的冻干粉针及制备方法。取自制氟呐普拉赞无机或有机酸盐、抗氧剂、稳定剂、pH值调节剂和针用活性炭。方法是先将稳定剂、抗氧剂加入到90%注射用水中，将注射用水降温到25度以下，加入氟呐普拉赞无机或有机酸盐并搅拌使其溶解，调pH值到5.0-7.0，加入针用活性炭60度保温吸附30min，再加注射用水定容到全量，过滤，灌装，进冻干箱冻干，冻干周期约为24小时，出箱，轧盖，贴签，包装即得氟呐普拉赞冻干粉针。本发明制得的氟呐普拉赞无机或有机酸盐冻干粉针用0.9%氯化钠或5%葡萄糖复溶后，含量均一、溶液澄明度合格、稳定性好、适合工业化生产。
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