复方蒙药广枣-肉豆蔻片的制备与质量控制

Preparation and Quality Control of Compound Mongolian Medicine Fructus Choerospondiatis-Nutmeg Tablets

研究了广枣-肉豆蔻片的制备过程并对其质量进行控制。基于《中国药典》(2020年版)片剂项要求,考察片剂的外观性状、硬度、崩解时限、重量差异及脆碎度;采用高效液相色谱法测定广枣-肉豆蔻片中4种抗氧化成分的含量。结果表明,片剂外表光滑,色泽均匀,硬度值处于30~40 N,崩解时限控制在10 min内,脆碎度小于1%;槲皮素、原儿茶酸、甲基丁香酚、肉豆蔻醚分别在0.16~0.8μg/mL(r=0.999)、4~20μg/mL(r=0.999)、8~40μg/mL(r=0.999)、100~500μg/mL(r=0.999)内呈良好的线性关系,平均回收率分别为99.3%、101.6%、100.3%、99.3%。且方法学验证项下精密度、稳定性和重复性试验的相对标准偏差(relative standard deviation,RSD)数值均未超过2%。该含量测定方法操作简便、专属性强、结果准确可靠,可为复方蒙药广枣-肉豆蔻片的质量标准提供参考。

The preparation process of Fructus choerospondiatis-Nutmeg tablets was discussed and its quality was investigated.Based on the requirements of tablets in the Chinese Pharmacopoeia(2020 edition),the appearance,hardness,disintegration time,weight difference and brittleness of the tablets were investigated,and the contents of four antioxidant components in Fructus choerospondiatis-Nutmeg tablets were determined by high performance liquid chromatography.The results show that the tablets are smooth in appearance,uniform in color,with hardness values in the range of 30~40 N,disintegration time controlled within 10 min,and the degree of brittleness less than 1%.Quercetin,protocatechuic acid,methyl eugenol,and myristyl ether show good linear relationships within 0.16~0.8μg/mL(r=0.999),4~20μg/mL(r=0.999),8~40μg/mL(r=0.999),and 100~500μg/mL(r=0.999),with average recoveries of 99.3%,101.6%,100.3%,and 99.3%,respectively.The relative standard deviation(RSD)values of precision,stability and reproducibility tests under methodological validation do not exceed 2%.The content determination method is simple,proprietary,accurate and reliable,and can be used as a reference for the quality standard of the compound Mongolian medicine Fructus choerospondiatis-Nutmeg tablets.