Pranskuniene Zivile, Bernatoniene Jurga, Kalveniene Zenona, Masteikova Ruta, Mekas Tauras, Velziene Saule, Ivanauskas Kostas, Suchockas Vytautas, Mintauckiene Inesa, Savickas Arunas
Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, A. Mickeviciaus 9, 44307 Kaunas, Lithuania.
Acta Pol Pharm. 2013 Jul-Aug;70(4):727-36.
The aim of this study was to evaluate the effect of different capsule filling manufacturing techniques and storage conditions on the release of the active ingredients from herbal capsules during the dissolution test in vitro. Different techniques for the preparation of the original mixture of dry extracts were applied, and subsequently capsules with six different fillings were prepared. The stability of the capsules was evaluated in different long-term storage conditions, registering changes in the water content (loss of drying), capsule disintegration time, and phenolic compounds dissolution test in vitro. The baseline of phenolic compounds release in the control capsules (filled with the mixture of the powder of dry herbal extracts) was the highest, compared to other capsule groups, yet during long-term storage, these capsules accumulated too much moisture, which impeded capsule disintegration time and phenolic compounds release. The study showed that moisture and temperature changes occurring during the storage of the preparation had a negative effect on the release of phenolic compounds from herbal capsules. Capsules filled with pellets demonstrated a uniform and stable release of the active ingredients in different long-term storage conditions, which indicates that the manufacturing technology of dry herbal extracts affects the stability of the active ingredients.
本研究的目的是评估不同胶囊填充制造技术和储存条件对草药胶囊在体外溶出试验期间活性成分释放的影响。应用了不同的干浸膏原始混合物制备技术,随后制备了六种不同填充物的胶囊。在不同的长期储存条件下评估胶囊的稳定性,记录水分含量(干燥失重)、胶囊崩解时间以及体外酚类化合物溶出试验的变化。与其他胶囊组相比,对照胶囊(填充干草药提取物粉末混合物)中酚类化合物的释放基线最高,但在长期储存期间,这些胶囊积累了过多水分,这阻碍了胶囊崩解时间和酚类化合物的释放。研究表明,制剂储存期间发生的水分和温度变化对草药胶囊中酚类化合物的释放有负面影响。填充小丸的胶囊在不同的长期储存条件下表现出活性成分的均匀稳定释放,这表明干草药提取物的制造技术会影响活性成分的稳定性。