噙化上清片成型工艺及质量标准提升研究

Molding process and improving quality standard investigation of Qinhuashangqing tablets

通过优选噙化上清片的成型工艺并提升其质量标准.采用湿法制粒技术,通过单因素试验优选噙化上清片成型工艺;采用TLC对处方中薄荷药材和薄荷素油进行定性鉴别;采用HPLC测定甘草中甘草酸含量.优选的成型工艺为取处方量药材,薄荷粉碎成细粉;甘草粉碎成粗粉用10倍量氨水（1→100）渗漉,渗漉速度为5 m L/min·kg,渗漉液浓缩至相对密度1.05（60℃测）,加入上述细粉中混匀,用60%乙醇制粒,60℃干燥,加入1%的硬脂酸镁和薄荷油,搅匀,压制成片.薄荷药材和薄荷素油的薄层鉴别斑点清晰,阴性无干扰;甘草酸质量在0.0203-0.6496μg与峰面积具有良好的线性关系（r=0.9999）,平均回收率100.32%,RSD 1.18%;噙化上清片成型的工艺操作简单,所建立的质量控制方法专属性强,重复性好,较原标准有了较大提升,可用于噙化上清片的质量评定.

This paper was to optimize molding process of Qinhuashangqing tablets and improve its standards. Wet granulation technology was adopted, and molding technology was optimized by single factor test;TLC was used for qualitative identification of Menthae haplocalycis herba and Peppermint oil;The content of glycyrrhizic acid was determined by HPLC. The best molding process of Qinhuashangqing tablets was as follows： Menthae haplocalycis herba was crushed into fine powder; Licorice was crushed into a meal and diacolation with ten times the amount of ammonia （ 1→100 ）, at a speed of 5 mL/min · kg, diacolation liquid enrichment to relative density 1.05 （60℃） ;adding haplocalycis herba fine powder, granulation 60% ethanol and dry with 60℃ ;adding 1% magnesium stearate and peppermint oil, mixed evenly, pressing into pieces; The spots of Herba Menthae and peppermint oil on TLC plates were clear without interference by the blank reference; glycyrrhizic acid showed a good linear relationship in the range of 0. 0203 to 0. 64961xg, and the average recovery was 100. 32% with RSD of 1.18%. This optimized process was simple and stable. This established quality control method was specific and reproducible, showing improved quality standard, which could be applied to quality assessment of Qinhuashangqing tablets.