安儿宁含片制备工艺研究

Study on Preparation Technology of Anerning Buccal Tablets(安儿宁含片)

目的:研究安儿宁含片的提取及制剂工艺。方法:采用正交试验法,优化提取工艺;分别以制颗粒效果、口感以及片剂成型效果为指标,优选制剂工艺。结果:最佳提取工艺为:加水提取2次,第1次加10倍量水,提取3 h;第2次加8倍量水,提取2 h,提取温度为90℃;制剂工艺为:以45%用量的甘露醇:预胶化淀粉(2:1)为填充剂,2%阿斯巴甜加0.25%薄荷脑为矫味剂,80%乙醇制粒,加入微粉硅胶及硬脂酸镁,混匀,压片。结论:按优化工艺制备的安儿宁含片光洁均匀,口感适中有清凉感。

Objectives： To study the extraction and preparation process of Anerning Buccal Tablets. Methods： The extraction process was optimized by orthogonal experiment designs; The preparation process were preferred with granule preparation situation, texture and tablet forming effect as index. Results： The optimum extracting technical conditions were as follows： extract twice with water, 10 times of water addition and 3 h of extraction time for the first time and 8 times of water addition and 2 h of extraction time for the second time; the optimized preparation process was that mannitohamylum pregelatinisatum （2：2） was used as filler, accounting for 45%; 2% aspartame and 0.25% menthol was used as correctant, granulated with 80% ethanol, added gum arabic and magnesium stearate, mixed and tableted. Conclusions： According to the optimization process of preparation, Anerning Buccal Tablets had uniform color and smooth appearance, good in taste with cool texture.