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眼络通颗粒剂的质量控制项目研究 被引量:5

Studies on the Quality Control Method of Yanluotong Granules
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摘要 目的:研究眼络通颗粒剂的质量控制方法。方法:采用硅胶 G 薄层色谱法对颗粒剂中2种主要成分川芎和三棱进行定性鉴别;用 RP-HPLC 法对葛根素进行含量测定,采用 Kromasil 100-5 C_(18)(4.6mm×250mm,5μm)为色谱柱,甲醇-水(30∶70)作流动相,检测波长为250nm。结果:葛根素进样量在0.06~0.65μg的范围内与峰面积呈良好的线性关系,r=0.9999,日内、日间精密度 RSD 分别为0.85%和0.48%(n=5),高、中、低3个浓度平均加样回收率(n=3)分别为101.2%,101.1%,101.4%,RSD 分别为1.1%,0.94%,0.41%。结论:本法操作简便,重复性好,结果准确可靠。 Objective: To establish a quality control method for Yanluotong granules. Methods: The two main ingredients Rhizoma Chuanxiong and Rhizoma sparganii were identified by silical Gel thin layer chromatography and the puerarin was determined by RP - HPLC with a Kromasil 100 - 5 C18 (4. 6 mm × 250 mm,5μm) column. The mobile phase was methanol -water( 30: 70). The flow rate was 0.5 mL · min^-1. The detection wavelength was 250 nm. Results: The calibration curve was linear in the range of 0. 06 - 0. 65μg for puerarin with r = 0. 9999. Intra-day and inter - day precisions were 0.85% and 0. 48% ( n = 5 ). The average recoveries of high, middle and low three concentration from sample were 101.2% ,101. 1% ,101.4% with RSD = 1. 1% ,0.94% ,0. 41% (n =3)respeotinely. Conclusion: Both methods are simple, reproducible, accurate and reliable. It may be used for the quality control of this granules.
出处 《药物分析杂志》 CAS CSCD 北大核心 2005年第8期912-915,共4页 Chinese Journal of Pharmaceutical Analysis
基金 浙江省嘉兴市科技局项目资助课题(20021063)
关键词 反相高效液相色谱法 薄层色谱法 葛根素 川芎 三棱 眼络通颗粒剂 质量控制项目 颗粒剂 络通 平均加样回收率 RP - HPLC TLC puerarin Rhizoma Chuanxiong Rhizooma sparganii Yanluotong granules
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