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目的探讨氢溴酸加兰他敏口腔崩解片的处方及制剂工艺。方法通过考察处方中主要辅料不同种类对制剂崩解时限的影响,筛选出最优处方,并对筛选处方进行溶出度测定。结果优选处方中崩解剂MCC-交联PVP的质量比为2∶3,填充剂为甘露醇。片剂在体内、体外的崩解时限均小于30s,硬度达到30~50N,溶出度可达100%。结论氢溴酸加兰他敏口腔崩解片处方及制剂工艺简单,在口腔中崩解和溶出迅速,口感好,且达到了普通片剂的硬度。
Objective To investigate the formulation and preparation of galantamine hydrobromide orally disintegrating tablets. Methods By investigating the impact of the different types of the main excipients on the disintegration time limit of the preparation, the optimal prescriptions were screened and the dissolution of the prescriptions was determined. Results It is preferable that the mass ratio of disintegrant MCC-crosslinked PVP in the prescription is 2: 3 and the filler is mannitol. Tablets in vivo, in vitro disintegration time are less than 30s, hardness 30 ~ 50N, dissolution up to 100%. Conclusion The formulation and preparation of galantamine hydrobromide orally disintegrating tablets are simple, rapid disintegration and dissolution in the oral cavity, good taste, and reached the hardness of ordinary tablets.