液晶化黄精片剂的制备及其质量评价

Preparation and Quality Evaluation of Polygonatum sibiricum Liquisolid Tablets

以胶体二氧化硅粉为涂层,微晶纤维素为载体,制备黄精提取物的自由流动粉末,并按片剂制备方法制得黄精片。以甘草素与异甘草素为指标测定片剂的溶出度,以傅里叶变换红外光谱、扫描电子显微镜检测黄精提取物与辅料之间的相互作用,并对片剂的相关质量进行检测,探讨液晶化技术对黄精片质量的影响。结果表明,通过液晶化技术制备的黄精片含量均匀、性能稳定、溶出性增强,所得液晶片剂的各项指标达到了《中国药典》2015版的相关要求。该研究方法数据可靠,可为黄精提取物的有效利用和片剂开发提供参考。

Using the colloidal silica powder as the coating material and microcrystalline cellulose as the carrier material,in this work,the free-flowing powder extract of Polygonatum sibiricum was obtained,with which P.sibiricum tablets were eventually prepared.The dissolution of the tablets was determined by using liquiritigenin and isoliquiritigenin.The interaction between P.sibiricum extract and excipients was detected by Fourier transform infrared spectroscopy(FTIR)and scanning electron microscopy(SEM).The relative quality of the tablets was also detected by exploring the effect of liquisolid technology on the quality of P.sibiricum tablets.Our results show that the P.sibiricum tablets prepared by the liquisolid technology possessed uniform content,stable performance and enhanced dissolution.All indexes of the liquisolid technology tablets meet the requirements of“Chinese Pharmacopoeia(2015 edition)”.The data generated by the method of the present study are trustworthy,and could provide a reliable reference for the effective utilization of P.sibiricum extract and the development of tablets.