大蒜油液体硬胶囊剂的制备及稳定性考察

Study on Preparation and Stability of Garlic Oil Liquid-filled Hard Capsules

将大蒜油与其他基质混合后灌装于明胶硬胶囊中,用封口液封口,得到大蒜油液体硬胶囊。对产品的性状、大蒜素含量和溶出度进行了检测,考察其在光照、不同温度和湿度条件下的稳定性。结果表明,制备的大蒜油液体硬胶囊为黄色透明硬胶囊,无臭。油溶性基质的大蒜油液体硬胶囊在光照、高温和湿度75.0%的条件下稳定,大蒜素含量和溶出度检测结果合格,在湿度92.5%条件下胶囊易软化;而水溶性基质的大蒜油液体硬胶囊在高温和高湿条件下不稳定,易变脆或软化。加速试验结果表明油溶性基质的大蒜油液体硬胶囊在温度40℃、湿度75.0%条件下放置180 d各项指标基本稳定。

Garlic oil liquid-filled capsules were prepared by mixing garlic oil with other matrix, then filled into hard gelatin capsules and sealed. Stability test were conducted to inspect the properties, relative allicin content and dissolution of products under light, different temperature and humidity conditions. The results showed that the garlic oil liquid-filled capsules were hard capsules with transparent yellow and had no odor. The garlic oil liquid-filled capsules with oil-soluble matrix were stable under light, high temperature and 75% humidity conditions, the relative allicin content and dissolution of products were qualified; however, under the condition of 92.5% humidity, the capsules were easy to soften. Garlic oil liquid-filled capsules with water-soluble matrix were instable under high temperature or high humidity conditions, as they were easy to soften and crisp. Accelerated tests showed that indicators of garlic oil liquid-filled capsules with oil-soluble matrix were basically stable under the condition of 40 ℃, 75% humidity for 180 d.