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目的:优选根黄分散片的处方工艺,并对其溶出行为进行考察。方法:以崩解时限为考察指标,采用正交试验设计筛选出最佳处方,RP-HPLC测定根黄分散片中有效成分的含量,绘制其体外溶出曲线。结果:优选出最佳处方:40%的微晶纤维素(MCC)为填充剂,15%的交联聚乙烯吡咯烷酮(PVPP)和7%的低取代羟丙基纤维素(L-HPC)为联合崩解剂,分散片可在3 min内完全崩解并且全部通过2号筛,在10 min时累积溶出度可达到99%以上。结论:该工艺制备的分散片符合规定,可操作性强、重复性好、适合工业化生产的要求。
Objective: To optimize the prescription process of root dispersible tablets, and investigate its dissolution behavior. Methods: Taking the disintegration time as the index of study, the optimal prescription was screened by orthogonal experimental design. The content of active ingredients in root dispersible tablets was determined by RP-HPLC and the in vitro dissolution curve was drawn. RESULTS: The best prescriptions were selected: 40% microcrystalline cellulose (MCC) as filler, 15% crosslinked PVP and 7% L-HPC as In combination with disintegrant, the dispersible tablets can disintegrate completely in 3 min and pass through No.2 sieve completely. The cumulative dissolution rate can reach more than 99% at 10 min. Conclusion: The dispersible tablets prepared by the process are in accordance with regulations, strong operability, good repeatability and suitability for industrialized production.