含淀粉水解产物栓剂的物理化学性质比较

Belniak Piotr, Świąder Katarzyna, Szumiło Michał, Hyla Aleksandra, Poleszak Ewa

Chair and Department of Apply Pharmacy, Faculty of Pharmacy, Medical University of Lublin, 1 Chodźki St., 20-093 Lublin, Poland.

Saudi Pharm J. 2017 Mar;25(3):365-369. doi: 10.1016/j.jsps.2016.09.004. Epub 2016 Sep 17.

The purpose of this work was to determine the effect of starch hydrolysates (SH) on the physicochemical properties of suppositories. The study was conducted with suppositories with acetaminophen (AAP) a typical antipyretic analgesic, as model drug on lipophilic (cocoa butter) and hydrophilic base (polyethylene glycol 1500 + 400). The suppositories with and without the addition of SH were examined for physicochemical tests according to European Pharmacopoeia 8th edition (Ph. Eur.): the uniformity of mass of single-dose preparation test, the softening time determination of lipophilic suppositories test, the disintegration of suppositories test, and dissolution test with flow-through apparatus. The results confirm the possibility of using starch hydrolysates as a cheap and safe addition to modify physicochemical properties of suppositories.

本研究旨在确定淀粉水解物（SH）对栓剂理化性质的影响。以对乙酰氨基酚（AAP，一种典型的解热镇痛药）为模型药物，在亲脂性基质（可可脂）和亲水性基质（聚乙二醇1500 + 400）中制备栓剂进行研究。根据欧洲药典第8版（Ph. Eur.）对添加和未添加SH的栓剂进行理化测试：单剂量制剂的质量均匀度测试、亲脂性栓剂的软化时间测定、栓剂的崩解测试以及流通池装置的溶出度测试。结果证实了使用淀粉水解物作为一种廉价且安全的添加剂来改变栓剂理化性质的可能性。