康脉灵胶囊质量标准研究

Quality standard for Kangmailing Capsule

目的:建立康脉灵胶囊(银杏叶提取物,天麻,川芎)的质量标准。方法:采用HPLC法对制剂中主要成分银杏黄酮 醇苷进行定量分析。色谱柱:WatersμbondapakC18(3.9mm×300mm,5μm),流动相:甲醇 0.4磷酸溶液(50∶50);检 测波长为360nm。对处方中其他成分天麻、川芎、银杏萜内酯以及银杏酸进行薄层色谱检测。结果:槲皮素、山奈素、异 鼠李素分别在0.150μg～1.50μg,0.142μg～1.42μg和0.096μg～0.96μg范围内呈线性。平均回收率均为98.9, RSD分别为0.98,1.15和1.57(n=5)。薄层图谱斑点清晰,阴性对照无干扰,银杏酸限量低于5g·kg-1。结论: 方法准确可靠,专属性强,结果稳定,重现性好,可有效控制制剂质量。

AIM: To establish the quality standard for Kangmailing Capsule(Ginkgo Biloba extract, Rhizoma Gastrodiae, Rhizoma Chuanxiong). METHODS: The flavone glycoside content in Kangmailing Capsule was determined by HPLC. Waters μ bondapak C 18(3.9 mm×300 mm, 5 μm) column was used. The mobile phase was metanol-0.4%H 3PO 4(50∶50), and UV detection wavelength was at 360 nm. Rhizoma Gastrodiae, Rhizoma Chuanxiong, Ginkgo Lactone and Ginkgolic acid in Capsules were identified by TLC. RESULTS: The calibration curves of Quercetin, Kaempferol and Isorhamnetin were linear at the range of 0.150 μg-1.50 μg, 0.142 μg- 1.42 μg and 0. 096 μg-0.96 μg, respectively. The average recovery was all 98.9%, and RSD was 0.98%, 1.15% and 1.57% (n=5). The TLC sports developed were fairly clear, and the blank test showed no interference, the quantitative limitation of Ginkgolic acid was controlled under 5 mg·kg -1. CONCLUSIONS: The established method is accurate,reliable and specific. The results are stable with good reproducibility. The quality of the capsules can be controlled by the method.