3D打印丹参酮ⅡA磺酸钠口腔崩解片及其溶出度测定

3D printed orally disintegrating tablet of sodium TanshinonⅡA sulfonate and its dissolution rate in vitro

目的采用3D打印技术制备丹参酮ⅡA磺酸钠口腔崩解片(ODT),并测定其体外溶出度。方法以丹参酮ⅡA磺酸钠及辅料作为铺层粉末,通过3D打印技术制备丹参酮ⅡA磺酸钠口腔崩解片,并检测口腔崩解片的崩解时限和体外溶出度等。结果丹参酮ⅡA磺酸钠片剂直径约10mm,厚度约3mm,质量为(161.3±4.8)mg,硬度为(1.84±0.31)kg,其表面较为平整,色泽均匀,边缘较整齐,横切面内部可见微观结构较均匀,呈现疏松多孔隙结构。丹参酮ⅡA磺酸钠片剂体外崩解时间为(25.22±1.35)s,口腔内的崩解时间为(26.51±1.58)s,符合中国药典要求,其味道略甜,口感良好,无明显砂砾感。丹参酮ⅡA磺酸钠浓度在1~14μg/mL时,质量浓度与吸光度线性关系良好,其体外溶出迅速,2min内可释放90%以上,5min内基本上已完全溶出。结论采用3D打印技术制备的丹参酮ⅡA磺酸钠口腔崩解片工艺简易,口感良好,崩解时限短,溶出度良好,具有一定的应用潜力及可行性。

Objective To prepare oral disintegrating tablets(ODT)of sodium tanshinoneⅡA sulfonate by 3D printed technology and determine its dissolution rate in vitro.Methods The disintegrating tablets of sodium tanshinoneⅡA sulfonate were prepared by 3D printed technology with sodium tanshinoneⅡA sulfonate and its excipients as the laying powder.The disintegration time and dissolution in vitro of the disintegrating tablets were measured.Results Sodium tanshinoneⅡA sulfonate tablets had a diameter of about 10 mm,a thickness of about 3 mm,a mass of(161.3±4.8)mg and a hardness of(1.84±0.31)kg.Its surface was smooth,its color was uniform,its edge was neat,and its internal microstructure was uniform,showing porous structure.The in vitro disintegration time of tanshinoneⅡA sulfonate tablets was(25.22±1.35)s,and the disintegration time in oral cavity was(26.51±1.58)s,which accords with the requirements of Chinese Pharmacopoeia.The taste was slightly sweet,the taste was good,and there was no obvious grit feeling.When the concentration of tanshinoneⅡA sodium sulfonate was at 1-14μg/mL,the mass concentration had a good linear relationship with absorbance.It was released rapidly in vitro,released more than 90%in 2 min,and was completely dissolved in 5 min.Conclusion The oral disintegrating tablets of sodium tanshinoneⅡA sulfonate prepared by 3 Dprinted technology have the advantages of simple process,good in taste,short in disintegration time and good in dissolution.It has certain application potential and feasibility.