ポラプレジンク坐剤の品質試験と放射線性直腸炎に対する臨床評価

Abstract

Polaprezinc (PZ) suppositories have been used for radiation proctitis in our hospital.In this study,we established methods to evaluate the quality of hospital-prepared PZ suppositories and investigated their stability.As PZ is dissociated at an acidic pH but not at a medium pH,the release of PZ from the suppository was carried out using chelatometric titration in weakly acidic buffer solutions (pH 3,pH 4,and pH 5).As the release of PZ from the suppository was fastest in the buffer solution at pH 3,we used this pH for the release test for PZ.Conducting this test in the stability investigation showed that the amount of PZ released from the suppository after 84 days was the same as that immediately after manufacture.We also examined the clinical efficacy of the PZ suppository in 5 patients with radiation proctitis,finding that efficacy was satisfactory in 3 patients.These results indicated that the PZ suppository is a good treatment for radiation proctitis.