超滤和活性炭在注射剂生产工艺中的应用比较

目的比较超滤工艺和活性炭工艺在普通注射剂生产中去除热原的优缺点以及对产品质量的影响。方法①配制浓度为1000EU.mL-1的内毒素指示剂水溶液,分别考察超滤工艺和活性炭工艺去除内毒素指示剂的效果;②分别考察超滤工艺和活性炭工艺在10%的维生素C药液、3%的曲克芦丁药液、0.04%的法莫替丁药液中去除热原的效果及对产品质量的影响。结果①截留分子量为10000的超滤能有效的去除药液中的热原、微粒、病毒等异物,对产品的色泽和澄清度均有一定的改善作用,但对不同产品标示量的均一性会产生影响;②活性炭对产品的色泽有一定的改善,但去除热原的效果不明显,对药品主成分会产生一定的吸附作用。结论超滤去除热原的作用[1]和对产品质量的影响均要优于活性炭。

A comparison on the application of ultrafiltration and active carbon to injection production

OBJECTIVE To compare the advantage and disadvantage of eliminating pyrogen as well as the influence to the production quality of general injection production by ultrafiltration and active carbon technologies.METHODS ①Study the effect on eliminating the endotoxin indicator by ultrafiltration and active carbon technologies,respectively,during compounding the aqueous solution with concentration of 1000EU/mL.②Study the effect on eliminating the pyrogen as well as the influence to the production quality of vitamin C(10%),troxerutin(3%)and famotidine(0.04%)chemicals by ultrafiltration and active carbon technologies,respectively.RESULTS ①The ultrafiltration with a trapping molecular weight of 10000 could eliminate the pyrogen,particle and virus effectively.Meanwhile,it can improve the colour and luster as well as the clarity of the production.However,it will affect the equality of the signs of different production.②The active carbon technology could improve the colour and luster of the production,while the effect on eliminating pyrogen is not obviously,and it will adsorb some essential component of the medicine.CONCLUSION The ultrafiltration is better than active carbon in eliminating pyrogen as well as in the influence to the quality of the production.