复方丹参缓释片中冰片包合工艺的研究

目的为提高复方丹参缓释片中冰片的稳定性,改善其体外释放度,对冰片进行β-环糊精包合工艺的研究。方法采用饱和水溶液法、气质联用法和正交试验,以冰片与β-环糊精的比例、包合时间、静置时间和干燥方法为因素,以冰片的包合率、包合物收率为评价指标,优选冰片包合工艺技术参数,考察冰片包合前后的体外释放度。结果最佳工艺参数：冰片与β-环糊精的质量比为1∶6,包合时间为0.5 h,静置时间为1.5 h,常压50℃干燥;所制得的冰片包合率为96.16%,包合物收率为98.95%。结论该包合工艺简单,可操作性强,包合率与包合物收率高,适用于研制复方丹参缓释片。

Study on clathration technology of borneol in compound danshen sustained-release tablet

Objective To enhance the stability of borneol in compound danshen sustained-release tablets and improve their in vitro release with the clathration technology of borneol with β-cyclodextrin.Methods Saturation water-solution,GC-MS and orthogonal experiment with the ratio between bemeol and β-cyclodextrin,clathration time,standing time and drying method as technology parameters were applied.In vitro release of borneol,the clathration rate and yield were observed.Results The optimized clathration technology parameters were as follows： the ratio between Bemeol and β-cyclodextrin was 1∶ 6（g∶g）,inclusion time was 0.5 h,standing time was 1.5 h and dried at 50 ℃ NP.The borneol clathration ratio was 96.16%,and the clathration yield was 98.95%.Conclusion The clathration technology parameters of borneol are reasonable,easy and suitable for compound danshen sustained-release tablets.