李煌 马黄璜 乔丽菲 孙承韬 徐伟 褚克丹

摘要：目的 建立栝樓桂枝滴丸的质量标准，并考察其体外溶出度。方法 采用HPLC测定栝楼桂枝滴丸中芍药苷、芍药内酯苷、肉桂酸、6-姜酚、甘草苷、甘草酸和甘草素的含量，通过转篮法测定其体外溶出度。结果 芍药苷、芍药内酯苷的含量分别在0.690～6.900 ?g、0.300～2.996 ?g范围内线性关系良好，平均回收率分别为101.12%、98.52%，RSD分别为2.24%、1.37%；肉桂酸的含量在0.023～0.348 ?g范围内线性关系良好，平均回收率为98.21%，RSD=2.00%；6-姜酚的含量在0.025～0.382 ?g范围内线性关系良好，平均回收率为99.19%，RSD=2.18%；甘草苷、甘草酸、甘草素的含量分别在0.120～2.498 ?g、0.150～2.253 ?g、0.010～0.147 ?g范围内线性关系良好，平均回收率分别为99.80%、100.38%、100.62%，RSD分别为2.10%、1.91%、1.66%。滴丸中7种成分在15 min内累积溶出率均达到98%以上。结论 本方法简便、准确、重复性好，可用于栝楼桂枝滴丸的质量控制，体外溶出度符合要求。

关键词：栝楼桂枝滴丸；质量标准；体外溶出度

DOI：10.3969/j.issn.1005-5304.2017.09.

中图分类号：R284.1 文献标识码：A 文章编号：1005-5304（2017）09-

Study on Quality Standards and Vitro Dissolution of Gualou Guizhi Dropping Pills LI Huang1， MA Huang-huang2， QIAO Li-fei1， SUN Cheng-tao1， XU Wei1， CHU Ke-dan1 （1. College of Pharmacy， Fujian University of Traditional Chinese Medicine， Fuzhou 350122， China； 2. Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine， Fuzhou 350122， China）

Abstract： Objective To establish the quality standards of Gualou Guizhi Dropping Pills； To investigate the vitro dissolution. Methods HPLC was used to determine the contents of paeoniflorin， albiflorin， cinnamic acid， 6-gingerol， liquiritin， glycyrrhizic acid and liquiritigenin in the dropping pills. The vitro dissolution rate of dropping pills was determined by rotating basket method. Results The calibration curves of paeoniflorin and albiflorin were in a good linearity in the range of 0.690–6.900 ?g， 0.300–2.996 ?g， respectively， and the average recoveries were 101.12% and 98.52%， respectively， with RSD of 2.24%， 1.37%， respectively. Cinnamic acid was linear in the range of 0.023–0.348 ?g and the average recovery was 98.21% with RSD of 2.00%. 6-Gingerol was linear in the range of 0.025–0.382 ?g， and the average recovery was 99.19% with RSD of 2.18%. The calibration curves of liquiritin， glycyrrhizic acid and liquiritigenin were in a good linearity in the ranges of 0.120–2.498 ?g， 0.150–2.253 ?g， and 0.010–0.147 ?g， respectively， and the average recoveries were 99.80%， 100.38%， and 100.62%， respectively with RSD of 2.10%， 1.91%， 1.66%， respectively. The accumulated dissolution rates of seven kinds of elements in the dropping pills all reached more than 98% in 15 min. Conclusion The method is simple and accurate， with repeatability， which can be applied to the quality control of Gualou Guizhi Dropping Pills. The vitro dissolution rates meet relevant standards.

Key words： Gualou Guizhi Dropping Pills； quality standards； vitro dissolution

栝楼桂枝汤出自《金匮要略》，由栝楼、桂枝、白芍、生姜、大枣、甘草组成，具有解肌祛邪、舒缓筋脉功效[1]。本课题组前期开展了栝楼桂枝汤的动物、细胞水平相关研究，发现其具有良好的脑保护作用[2-7]，已申报为福建省第二人民医院院内制剂（2013S0001），

基金项目：福建省战略性新兴产业专项（2015Y0067）

并通过大孔树脂对其进行精制纯化，富集有效成分，制成栝楼桂枝滴丸。为有效控制该制剂的质量和疗效，本试验对其进行质量标准和体外溶出度研究。

1 仪器与试药

U-3000型高效液相色谱仪（美国戴安公司），XS105型电子天平（梅特勒-托利多仪器有限公司），KQ-500DE型数控超声波清洗器（昆山市超声仪器有限公司），RCZ-6C1型药物溶出度仪（上海黄海药检仪器厂）。……