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目的:研究血塞通的主要成分三七总皂苷(PNs)并开发既可方便吞咽困难的患者用药,又可替代静脉注射给药用于急症患者,方便临床用药,同时改善了其苦涩味的血塞通分散片。方法根据初步筛选的处方,采用正交试验,以崩解时间作考察指标,采用直观分析与方差分析确定处方的最佳用量。结果 :根据正交试验结果,以1000片计,处方的最佳用量为三七总皂苷100.0g、乳糖220.0g、淀粉220.0g、羧甲淀粉钠40.0g、羟丙纤维素35.0g、微粉硅胶12.0g、硬脂酸镁6g、甜菊素13.0g,此处方能制出每片重0.646 g,压力5.5-6.5 kg/mm~(2),崩解时限小于2min的血塞通分散片。结论该制剂的制备工艺可行,成型工艺处方组成合理,适合工业化大生产。
Objective: To study the main components of Xuesaitong notoginseng saponins (PNs) and the development of patients with difficulty swallowing medication, but also instead of intravenous administration for emergency patients, to facilitate clinical use, while improving its bitter taste Xuesaitong dispersible tablets. Methods According to the preliminarily selected prescriptions, the orthogonal test was used to disintegrate the time as the index of investigation. The optimal dosage of prescription was determined by visual analysis and ANOVA. Results: According to the orthogonal test results, the best dosage of prescription was 100.0g of Panax notoginseng saponins, 220.0g of lactose, 220.0g of starch, 40.0g of sodium starch glycolate, 35.0g of hydroxypropylcellulose, 12.0g, 6g of magnesium stearate and 13.0g of stevia. The prescription can produce the Xuesaitong Dispersible Tablet with the weight per unit weight of 0.646g, the pressure of 5.5-6.5kg / mm ~ (2) and the disintegration time of less than 2min. Conclusion The preparation process of the preparation is feasible. The prescription of the molding process is reasonable and suitable for industrialized large-scale production.