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目的:制备加味玉屏风软胶囊,并建立其质量控制方法。方法:以大豆油为油溶性基质,单硬脂酸甘油酯为助悬剂,司盘-80作为润湿剂制备加味玉屏风软胶囊内容物,采用高效液相-蒸发光散射(HPLC-ELSD)检测法测定内容物中黄芪甲苷的含量。结果:药材提取物粉末过80目筛,加入防风、白术、太子参挥发油,5%的单硬脂酸甘油酯,1%的司盘80制得均匀稳定的内容物混悬液;HPLC-ELSD法测定黄芪甲苷含量,黄芪甲苷进样量的线性范围为0.402 4~4.024μg(r=0.998 8);平均回收率为99.06%(RSD=3.04%)。结论:该制剂内容物处方合理,制备工艺简单,含量测定方法准确、重复性好,可作为其质量控制方法。
Objective: To prepare flavored Yupingfeng soft capsule and establish its quality control method. Methods: The contents of soft jade Yupingfeng soft capsules were prepared by using soybean oil as oil-soluble matrix and glyceryl monostearate as suspending agent and Span-80 as wetting agent. HPLC-ELSD ) Determination of content Determination of Astragaloside content. Results: The medicinal extract powder was passed through a 80-mesh sieve and added with a stable suspension of contents of windproof, Atractylodes macrocephala, Radix Pseudostellariae Radix, 5% glyceryl monostearate and 1% Span 80; HPLC-ELSD The linear range of astragaloside IV was 0.402 4 ~ 4.024 μg (r = 0.998 8). The average recovery was 99.06% (RSD = 3.04%). Conclusion: The prescription of the preparation is reasonable, the preparation process is simple, the content determination method is accurate and the repeatability is good, which can be used as the quality control method.