ウリナスタチン膣坐剤の製剤化およびその品質評価

抄録

Hospitals prepare ulinastatin vaginal suppositories for use in the treatment of threatened abortion.As it is important to ensure that suppositories are uniform,we developed an analytical procedure for ulinastatin in the suppository and examined the suitability of the preparation procedure.
We could successfully use the spectroscopical analysis procedure for ulinastatin described in JP XIV when the suppository base was removed from the mixture after the color reaction with trypsin,but not when it was removed before.The reproducibility and accuracy of our analytical procedure were very good.The preparation of the ulinastatin suppository from its injection was found to require careful control of the water loss from the mixture.When this was done,ulinastatin content in the suppository was the same as in the original injection,and the content uniformity was good.Testing for change in ulinastatin content and microbial growth during the storage of suppositories in a refrigerator for 3-months produced satisfactory results.
In conclusion,the method for the preparation of this drug from the injection and that for the analysis of the ulinastatin in the suppository that we developed should be useful to hospitals.