糖痹康颗粒HPLC指纹图谱的研究.docVIP

糖痹康颗粒HPLC指纹图谱的研究 　　摘要：目的 建立糖痹康颗粒HPLC指纹图谱，科学评价并有效控制其质量，确保其生产的稳定性。方法 采用德国默克RP-18 endcapped色谱柱（250 mm×4.6 mm，5 ?m），以乙腈-0.1%甲酸水为流动相梯度洗脱，柱温40 ℃，流速1 mL/min，检测波长240 nm，进样量20 ?L。采用国家药典委员会《中药色谱指纹图谱相似度评价系统2004A版》对10批糖痹康颗粒制剂进行相似度评价，并对处方中的9味药进行相关性分析。结果 以汉黄芩苷为参照峰，初步建立糖痹康颗粒HPLC指纹图谱，10批糖痹康颗粒制剂的HPLC指纹图谱相似度在0.90以上，标示出25个共有色谱峰，其中18个归属到方中各药材。结论 该方法分离效果好、准确、简单，可为糖痹康颗粒质量评价提供参考。 　　关键词：糖痹康颗粒；指纹图谱；相似度 　　DOI：10.3969/j.issn.1005-5304.2017.06.019 　　中图分类号：R284.1 文献标识码：A 文章编号：1005-5304（2017）06-0075-04 　　Abstract： Objective To establish the HPLC fingerprints of Tangbikang Granules； To scientifically evaluate and effectively control the quality of Tangbikang Granules； To ensure its production stability. Methods HPLC was performed on the column of Germany Merck RP-18 endcapped （250 mm × 4.6 mm， 5 ?m） with mobile phase of acetonitrile-0.1% formic acid water； column temperature was 40 ℃； flow rate was 1.0 mL/min； detection wavelength was 240 nm； volume injection was 20 ?L. Fingerprint Similarity Evaluation Software （edition 2004A） of Chinese Pharmacopoeia Commission was used to evaluate the similarity of the 10 batches of Tangbikang Granules， and to analyze the correlations of 9 ingredients in Tangbikang Granules. Results Wogonoside was used as the reference peak， and the common mode for the HPLC fingerprints was set up. The similarities of the 10 batches of Tangbikang Granules were above 0.930， and altogether 25 common peaks in the chromatograms were found， of which 18 peaks were assigned to Chinese materia medica in Tangbikang Granules. Conclusion The method has good separability and is accurate and simple， which can provide references for the quality control of Tangbikang Granules. 　　Key words： Tangbikang Granules； fingerprints； similarity 　　糖尿病的慢性并?l症如糖尿病周围神经病变、糖尿病肾病、糖尿病视网膜病变也逐渐成为危害人类健康的杀手[1-2]。糖痹康颗粒由黄芪、桂枝、女贞子、 　　黄芩等中药组成，具有益气养阴、解毒化瘀通络功效，治疗糖尿病周围神经病变疗效显著且安全稳定[3-10]。目前糖痹康颗粒制剂尚无明确的质量控制标准，制备工艺也待考察。为了建立糖痹康颗粒制剂的质量标准，符合现代中药制剂规范要求，保证临床用药安全有效，本研究建立糖痹康颗粒HPLC指纹图谱。 　　1 仪器与试药 　　Waters高效液相色谱仪（型号Alli