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葡萄软胶囊质量标准及稳定性的初步研究

Initial study on quality standard and stability of grape soft capsule
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摘要 目的:制定以齐墩果酸(OA)为主要功效成分、葡萄籽油为溶媒制备的葡萄软胶囊的质量标准,并对制剂的稳定性进行初步研究。方法:以SUPELCOSILtmLC-18(250mm×4.6mm,5μm)柱为色谱柱,甲醇:水(86:14)为流动相,流速1ml/min,检测波长215nm,测定葡萄软胶囊中OA的含量。采用加速试验初步观察制剂稳定性。结果:高效液相色谱法测定OA的线性范围为0.0648~0.3240μg/ml,r=0.9992;平均加样回收率为100.97%,标准偏差(RSD)为1.82%;贮存0、1、2、3个月后,葡萄软胶囊中OA平均含量分别为18.69、18.36、18.83、18.22mg/粒,RSD为1.53%。结论:以葡萄皮渣提取物为原料和葡萄籽油为溶媒制备的软胶囊处方设计合理,制剂性质稳定,功效成分OA含量测定方法专属性强、简便、可靠、测定结果准确。 Objective: To establish the quality standard and study the stability of grape soft capsule,which included oleanolic acid(OA) , the main functional component extracted from grape peel and grape seed oil. Methods: The content of OA in grape soft capsule was determined by high-performance liquid chromatog- raphy (HPLC) with SUPELCOSIL^tmLC-18(250 min×4.6 ram,5 μm) ,moving phase: methanol : H20 (86 : 14), flow rate. lml/min, wavelength. 215 nm and the stability of capsule was primarily observed through accelerating test. Results: The linear range of OA determined by HPLC was 0. 064 8-0. 324 0 μg/ml, r=0. 999 2. The average recovery rate was100.97% and RSD was 1.82%. After conservation 0, 1, 2, 3 months, the content of OA in grape soft capsule was 18.69, 18.36, 18.83, 18.22 mg respectively, RSD was 1.53%. Conclusion: This study demonstrates that the prescription of making grape soft capsule is reasonable, the products is steady and the determination method of OA by HPLC is simple, reliable and accurate.
出处 《新疆医科大学学报》 CAS 2007年第11期1219-1221,共3页 Journal of Xinjiang Medical University
基金 新疆维吾尔自治区高校科研计划重点项目(XJEDU2004I29)
关键词 葡萄软胶囊 高效液相色谱 质量标准 稳定性 grape soft capsule high-performance liquid chromatography (HPLC) quality standard sta-bility
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