中药注射剂工艺中活性炭除热原效果评价

摘要

目的：建立中药注射剂工艺中活性炭去除热原效果的评价方法。方法以动态浊度法，测定中药注射剂浓配药液中活性炭使用前后细菌内毒素的含量，评价其去除热原的效果。结果在双黄连粉针剂和注射用丹参(冻干)2种粉针剂浓配药液的活性炭使用效果的评价中，双黄连药液中的吸附率≥70%，丹参药液中的吸附率＞95%。结论中药粉针剂在制造过程中加入活性炭吸附大量热原是合理的。但对于大剂量的细菌内毒素，活性炭不能完全吸附去除。%Objective To establish the pyrogen removing effect of activated carbon in the technics of traditional Chinese medicine (TCM) injections. Methods The content of bacterial endotoxin concentration was detected by kinetic turdimetric assay to evaluate the effect of removing pyrogen before and after using activated carbon in concentrated solution of TCM injection. Results The activated carbon adsorption rate of Shuanghuanglian concentrated solution≥70%and the activated carbon adsorption rate of Danshen concentrated solution>95%. Conclusion Pyrogen manufacturing process is scientific and rational by adding activated carbon adsorption in powder injection of TCM. The bacterial endotoxin of large doses can't be removed fully by activated carbon adsorption.