中国临床药学杂志

目的 :开发氢溴酸加兰他敏片剂 ,老药新用 ,用于治疗阿尔茨海默病 (即早老性痴呆 )。方法 :利用含量测定、溶出度、稳定性试验等方法 ,结合药物性质 ,筛选制剂处方、工艺 ,并进行质量研究。结果 :确定处方、工艺 ,建立质量标准。结论 :所制氢溴酸加兰他敏片符合《中国药典》2 0 0 0年版二部附录 IA所规定的片剂质量标准 [1 ] 。

AIM: To develop a new dosage form of galanthamine hydrobromide for treating senile dementia as a new use. METHODS: The formulation and preparation method of galanthamine hydrobromide tablet were selected by means of assay, dissolution test, stability test as well as drug properties; the quality of galanthamine hydrobromide tablet was studied. RESULTS: The formulation, the preparation method and the quality standard of the tablet were established. CONCLUSION: The preparation conforms to the quality requirements under Tablets of Appendix IA of Pharmacopoeia of P.R.China (part Ⅱ, Edi 2000).