芍药甘草分散片的处方工艺研究

Study on the formulation and preparation process of Peony and Licorice Dispersible Tablets

目的:建立芍药甘草汤分散片的处方工艺。方法:以崩解时限为考察指标,先对填充剂、崩解剂、主药量、润滑剂的种类和用量进行单因素考察,然后采用正交设计考察交联聚维酮(PVPP)、低取代羟丙基纤维素(L-HPC)、微晶纤维素(MCC)和主药量的用量对分散片崩解时间的影响。结果:采用30%主药;15%PVPP和5%L-HPC为崩解剂;2%微粉硅胶和0.5%硬脂酸镁为润滑剂;10%MCC和乳糖为填充剂,干法制粒制备,崩解时间小于1min。结论:所制备的芍药苷草分散片具有崩解快,分散均匀,有效成分溶出速率快的特性。该分散片的处方合理,工艺可行,操作简便,符合分散片的质量要求。

Objective： To prepare the formulation and preparation process of peony and licorice dispersible tablets. Method： The disintegration time was selected as the test index. The amounts and categories of filler, disintegrant, main dosage, lubricant were experiment by single factor. Then the amounts of PVPP, L-HPC main dosage, MCC were screened by orthogonal design. Results：30%was the main dosage;15%PVPP and 5%L-HPC as disintegrant;2%powder silica gel and 0.5%magnesium stearate as the lubricant;10%MCC and lactose as the filler, dry method preparation.The prescription craft is simple and disintegration time is less than 1 min. Conclusion：The preparation of the Peony and Licorice dispersible tablets can disintegrate quickly, evenly dispersed with the characteristics of fast dissolution rate of effective component. The dispersible tablets prescription is reasonable and the process is feasible with simple operation which meets the quality requirements of dispersible tablets.