维生素K1注射液安全性评价实验的探讨

Study of the Safety Evaluation Test for Vitamin K1 Injection

本文旨在研究药物的过敏物质检测方法,为药品的安全性评价提供参考。通过对白色豚鼠(Cavia porcellus)主动全身过敏实验、被动皮肤过敏实验、RBL-2H3细胞脱颗粒实验、β-氨基己糖苷酶释放率实验和L929细胞毒性实验考察不同厂家维生素K1注射液的产品质量。结果发现,供试的10个厂家的产品质量存在明显差异。研究认为细胞实验作为一种快捷有效的过敏物质检测手段,可用于药品的质量评价。

This study was designed to obtain new methods of sensibilisin detection and to supply some references to judge the safety of medicines.The active whole body allergy test,the negative skin allergy test,the RBL-2H3cell degranulation test,theβ-hexosaminidase release rate test,and the L-929cytotoxicity test on white Guinea pigs(Cavia porcellus)were used to judge quality of the vitamin K1injections produced by different manufacturers.The results showed that the production quality was significantly different among the productions from the ten manufacturers.This research suggests that the cell test is an easy effective method for sensibilisin detection and could be used to judge the quality of medicines.