首页|参苏丸质量标准提高研究

参苏丸质量标准提高研究

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目的 通过修订参苏丸中甘草的鉴别方法,并整合参苏丸陈皮中橙皮苷、枳壳中柚皮苷和新橙皮苷的含量测定方法,提高参苏丸质量标准。方法 在2020年版《中国药典》方法的基础上,对参苏丸中甘草的薄层色谱鉴别方法进行了改进,同时新增高效液相色谱法对陈皮中橙皮苷、枳壳中柚皮苷和新橙皮苷的含量测定。结果 改进薄层色谱法可以用于鉴别处方中的甘草。含量测定方法柚皮苷在0。0140~0。2235 mg·ml-1(r=1。0000)范围内有良好的线性关系,水丸平均加样回收率为97。22%,RSD为0。68%(n=6),蜜丸平均加样回收率为99。43%,RSD为0。32%(n=6);橙皮苷在0。0114~0。1824 mg·ml-1(r=1。0000)范围内有良好的线性关系,水丸平均加样回收率为95。93%,RSD为0。48%(n=6),蜜丸平均加样回收率为96。86%,RSD为0。32%(n=6);新橙皮苷在0。0131~0。2102 mg·ml-1(r=1。0000)范围内有良好的线性关系,水丸平均加样回收率为100。21%,RSD为0。49%(n=6),蜜丸平均加样回收率为97。57%,RSD为0。42%(n=6)。结论 本方法专属性强、重现性好,可有效控制参苏丸质量。
Quality Standard Improvement of Shensu Pills
Objective To improve the quality standard of Shensu pills by revising the thin layer chro-matography method for identification of Glycyrrhiza uralensis Fisch and establishing a high performance liquid chromatograph(HPLC)method for quantification of naringin,hesperidin and neohesperidin.Methods Based on the 2020 edition of Chinese Pharmacopoeia,a thin layer chromatography method was established for identification of Glycyrrhiza uralensis Fisch.A HPLC method was also established for quan-tification of naringin,hesperidin and neohesperidin.Results The first method could well identify Glycyrrhiza uralensis Fisch and Platycodon grandiflorum.The calibration curve of naringin was linear over the range of 0.0140-0.2235 mg·ml-1(r=1.0000)and the average recovery of water pills was 97.22%(RSD=0.68%,n=6),compared with 99.43%(RSD=0.32%,n=6)for candied pills.The calibration curve of hesperidin was in good linearity over the range of 0.0114-0.1824 mg·ml-1(r=1.0000)and the average recovery was 95.93%for water pills(RSD=0.48%,n=6),and 96.86%for candied pills(RSD=0.32%,n=6).The calibration curve of neohesperidin was in good linearity over the range of 0.0131-0.2102 mg·ml-1(r=1.0000)and the average recovery of water pills was 100.21%(RSD=0.49%,n=6),and that of candied pills was 97.57%(RSD=0.42%,n=6).Conclusion This method is sensitive and reproducible,which can be used for quality control of Shensu Pills.

Shensu pillsthin layer chromatographyhigh performance liquid chromatographcontent detenmination

祝雨薇、曹红、张贵英、胡丹

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100166 北京,联勤保障部队药品仪器监督检验总站

参苏丸 薄层色谱法 高效液相色谱法 含量测定

2024

解放军药学学报
中国人民解放军总后勤部卫生部 药品仪器检验所

解放军药学学报

影响因子:0.529
ISSN:1008-9926
年,卷(期):2024.37(3)