太子参口含片的制备工艺

目的]确定太子参口含片的制备工艺及处方。方法]以太子参多糖含量为活性成分,考察口含片的外观、口感、片重差异、硬度和崩解时限,通过单因素试验筛选最佳辅料,正交试验确定各辅料成分配比,得出太子参口含片的最佳制备工艺。结果]优选湿法制粒工艺作为太子参口含片最佳制备工艺,优化处方为:填充剂为微晶纤维素(MCC)224 mg、甘露醇60 mg,黏合剂为聚维酮K30(PVP K30)4mg,崩解剂为交联聚维酮(PVPP)4 mg,润滑剂为硬脂酸镁(MS)8 mg。结论]按该处方制备的太子参口含片硬度、崩解时限等各项指标均符合要求。

Preparation Processing of Radix Pseudostellariae Buccal Tablets

Objective ] To determine the preparation processing and formulation of radix pseudostellariae buccal tablets. Method ] radix Pseudostellariae polysaccharide was conducted as active constituent, and the appearance, taste, quality difference, hardness and disintegration time of tablets were used as indicators,the single factor experiments were used to screen adjuvant, and the orthogonal experiments were used to optimize the optimal preparation processing of radix pseudostellariae buccal tablets. Result] Wet granulation method was used as the optimum preparation process, and the optimized formulation was as follows: microcrystalline cellulose ( MCC) and mannitol were used as diluents with a dosage of 224 mg and 60 mg respectively, poly povidone K30 acted as adhesive (4 mg), crospovidone (PVPP) was used as disintegrating agent (4 mg), and magnesium stearate acted as lubricant (8 mg).Conclusion] The hardness and disintegration time of Radix pseudostellari-ae buccal tablets meet the requirements.