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目的:考察及筛选脑血康分散片的最佳处方和确定制备工艺。方法:经过前处理水蛭浸膏和系列试验筛选填充剂、崩解剂等辅料,通过内外加入崩解剂法,确定处方和制备工艺。结果:该制剂确定了以微晶纤维素为填充剂,以交联羧甲基纤维素钠、低取代羟丙基纤维素作为崩解剂的分散片处方。该制剂的平均崩解时限为52 s,含氮量为5.47 mg/片,分散均匀性、重量差异及微生物限度均符合规定。结论:研制的脑血康分散片处方合理、工艺可行,符合分散片的质量要求。
Objective: To investigate and screen the optimal prescription of Naoxuekang dispersible tablets and determine the preparation process. Methods: After pretreatment of leeches extract and series of test screening fillers, disintegrants and other excipients, through the addition of disintegrator inside and outside the law to determine the prescription and preparation process. Results: The formulation identified microcrystalline cellulose as a filler, with croscarmellose sodium, low-substituted hydroxypropyl cellulose as a dispersant tablet formulations. The average disintegration time of the preparation was 52 s and the nitrogen content was 5.47 mg / tablet. The dispersion uniformity, weight difference and microbial limit were all within the limits. Conclusion: The prescription of Naoxuekang dispersible tablets is reasonable, the technology is feasible and meets the quality requirements of dispersible tablets.