注射用塩酸リトドリン製剤の先発医薬品と後発医薬品における品質比較

Abstract

Very little information is available on the quality of generic products. In this regard, it has recently been reported that several adverse reactions, among them angialgia and phlebitis, occurred when generic versions of injectable ritodrine hydrochloride products were used in pregnant patients and that these adverse reactions subsided when the generic products were switched to the original product. This suggests that the generic products contained impurities that caused the adverse reactions. It is therefore essential to determine the constituents of generic products and compare them with those of the original product.On doing this for the original and generic ritodrine hydrochloride products using high performance liquid chromatography, we found that 4 out of the 8 generics examined contained significantly higher amounts of impurities than the original product. In addition, it seemed that the generics contained unidentified impurities that were not present in the original product. For the other four generics, there was no difference in the proportion of impurities between them and the original product. These results suggest that there can be a great difference in quality between the original product and some generics. We must therefore choose generics based on quality information to minimize unpredictable adverse reactions so that more cost effective therapy may be achieved.In the present study, we obtained information on the quality of a particular group of generic products, but we feel it is necessary to gather information on more generic products to ensure safety when using them.