Tsutsumi Kikue, Tsuchiya Chikako, Hanawa Kazumi, Suzuki Masahiko, Hanawa Takehisa, Oguchi Toshio
Department of Pharmacy, University of Yamanashi.
Yakugaku Zasshi. 2008 Jun;128(6):965-70. doi: 10.1248/yakushi.128.965.
Beraprost sodium (BPS) is often used for pediatric patients with pulmonary hypertension. The purpose of this study was to determine the expiration date of the powdered medicine prepared by grinding tablets. In the present study, the hygroscopicity and stability of the beraprost tablet (DORNER tablet), ground Dorner tablet and powder formulation (Dorner powder) consisting of the ground DORNER tablet and lactose (EFC lactose) were investigated after storage at various relative humidities (RHs) and light exposures. While the DORNER tablets and ground DORNER tablets were found to adsorb significant amounts of water vapor at an RHs of greater than 51.0%, Dorner powder scarcely adsorbed water. The stability of BPS in the Dorner powder decreased after storage under 3000 lux for 90 days. From these results, the expiration date and storage conditions of Dorner powder were determined to "90 days without exposure to light." We also investigated the stability of BPS in solutions of various pH values on the assumption that Dorner powder may be given to pediatric patients after dissolving in soft drinks. Because BPS degraded significantly below pH 2, pharmacists should alert patients not to take Dorner powder with acidic soft drinks.
贝拉普罗斯钠（BPS）常用于患有肺动脉高压的儿科患者。本研究的目的是确定通过研磨片剂制备的粉末状药物的有效期。在本研究中，对贝拉普罗斯特片（多纳片）、研磨后的多纳片以及由研磨后的多纳片和乳糖（EFC乳糖）组成的粉末制剂（多纳粉）在不同相对湿度（RH）和光照条件下储存后的吸湿性和稳定性进行了研究。虽然发现多纳片和研磨后的多纳片在相对湿度大于51.0%时会吸附大量水蒸气，但多纳粉几乎不吸附水分。多纳粉中的BPS在3000勒克斯光照下储存90天后稳定性下降。根据这些结果，多纳粉的有效期和储存条件确定为“避光保存90天”。我们还假设多纳粉可能在溶解于软饮料后给儿科患者服用，研究了BPS在不同pH值溶液中的稳定性。由于BPS在pH值低于2时会显著降解，药剂师应提醒患者不要将多纳粉与酸性软饮料一起服用。
