Quality tests were made on two kinds of oleic acids as raw materials (OA), JIS extra pure reagent (OA-JIS) and guaranteed reagent with content of about 99%(OA-GR), which were used for the material of ethanolamine oleate injection (EO-
i). Furthermore, the effect of the difference of OA on the quality of EO-
i was studied.
The content of peroxide in OA-JIS was higher when it was stored at room temperature than in a cold place. Therefore, it is necessary to store OA-JIS in consideration not only of light and air but of temperature.
The pH of EO-
i with OA-GR was same as that with OA-JIS, while the viscosity of EO-
i with OA-GR was higher. EO-
i with OA-GR remained colorless before and after sterilization, whereas in the case of OA-JIS, the pale yellow color became more intense by sterilization. Light and temperature had no effect on the stability of EO-
i, e. g., production of peroxide, the content of oleic acid and pH.
Although the further comparative study on effectiveness and safety of OA-GR and OA-JIS as the sclerosing agent for esophageal varix is necessary, it is thought, from the above results, that the use of OA-GR is desirable in pharmaceutical aspect.
View full abstract