丹皮酚微海绵质量标准研究及其形态学考察.doc

丹皮酚微海绵质量标准研究及其形态学考察 李沙沙1 ，陈活计2，朱红霞3，翁立冬2，刘 莉2，刘 强2 (（1. 暨南大学附属第一医院药学部，广东 广州 510630；2. 南方医科大学中医药学院，广东 广州510515；3.南方医科大学中西医结合医院，广东 广州 510315） 摘要： 目的 对丹皮酚微海绵进行质量标准研究及形态学考察。方法 采用HPLC法测定丹皮酚微海绵中丹皮酚的含量。色谱条件：色谱柱为Thermo Syncronis C18 柱（250mm×4.6mm，5μm）；以甲醇-水（65∶35）为流动相；检测波长为276nm，流速为1.0mL·min-1。采用H-3000N扫描电镜对所形成的丹皮酚微海绵进行形态学观察，用Mastersize 2000激光衍射粒度分析仪对丹皮酚微海绵的粒径大小和粒径分布均匀性进行测定。结果 丹皮酚在10～1000μg·mL-1的浓度范围内，与峰面积呈良好的线性关系（R2=0.9993）；平均回收率为98.95％，RSD为2.90%；丹皮酚微海绵中丹皮酚的平均含量为0.7741g·g-1。扫描电镜显示，丹皮酚微海绵是一种粒径分布比较均匀，球状多孔结构，球表面和内部有很多孔组成，球表面没有药物结晶存在。用激光衍射粒度分析仪测得微海绵表面积平均粒径为10.23±0.74μm，体积平均粒径为23.27±0.76μm。结论 制备的丹皮酚微海绵粒径分布均匀，稳定性好。所建立的丹皮酚微海绵质量分析方法稳定可靠，重现性好，可用于丹皮酚微海绵的质量控制。 关键词： 丹皮酚微海绵；质量标准研究；形态学考察 中图分类号：R284.1 文献标志码: A 文章编号:1003-9783(2016)02- doi：10.3969/j.issn.1003-9783.2016.02 ?Quality?Specification?Studies and Morphology Observation of Paeonol Microsponge LI Shasha1,CHEN Huiji2, ZHU Hongxia3,WENG Lidong2, LIU Li2, LIU Qiang2 (1.Pharmaceutical department, the first affiliated Hospital of Jinan University, Guangzhou 510630，Guangdong，China；2.School of Traditional Chinese Medicine, Southern Medical University, Guangzhou 510515，Guangdong，China；3. TCM-Integrated Hospital of Southern Medical University, Guangzhou510315,Guangdong，China) Abstract：Objection To study the?quality?specification?and the morphology of the paeonol microsponges. Methods HPLC method was used for determination the paeonol content in the microsponge. The chromatographic separations were performed using an HPLC column 250 × 4.6 mm with a particle size of 5 μm (Syncronis C18; Thermo Fisher Scientific Inc., Rockford, IL, USA). A mixture of methanol and distilled water (65∶45) was used as the mobile phase. The filtered mobile phase was pumped at a flow rate of 1 mL·min-1, and the wavelength was set at 276 nm. The morphology and appearance of the microsponges were studied using an H-3000N scanning electron microscopic (SEM) with a system. And the particle size and particle size distribution of the microsponges were determin