玄芪化瘀丸（浓缩丸）制备工艺及质量标准的研究

发布时间：2017-12-31 21:34

  本文关键词：玄芪化瘀丸（浓缩丸）制备工艺及质量标准的研究　出处：《新疆医科大学》2017年硕士论文　论文类型：学位论文

  更多相关文章： 玄芪化瘀浓缩丸 星点设计-效应面法 制备工艺 质量标准

【摘要】：目的:研究玄芪化瘀浓缩丸的制备工艺,并建立其质量标准。方法:(1)采用单因素试验结合星点设计-效应面的方法,以黄芪甲苷含量、哈巴俄苷含量、总多糖含量及浸膏得率为评价指标,对提取次数、提取时间及加水倍数进行考察,优选黄芪等药材水提的工艺参数;(2)研究玄芪化瘀浓缩丸的最佳成型工艺;(3)采用薄层色谱法对玄芪化瘀浓缩丸中全方药材进行鉴别。(4)采用高效液相色谱法测定玄芪化瘀浓缩丸中黄芪甲苷、哈巴俄苷和丹酚酸B的含量并进行方法学的考察,制定质量标准。结果:(1)玄芪化瘀浓缩丸的最佳提取工艺为13倍量水连续回流提取2次,每次130 min。(2)玄芪化瘀浓缩丸的最佳成型工艺为取丹参、三七粉碎成细粉,备用。水提液浓缩至相对密度为1.35~1.40(60℃)的稠膏,取1/3的稠膏备用,其余稠膏60℃减压干燥,粉碎成细粉,与药材细粉混匀,加入稠膏中,混合均匀,制成丸粒,干燥,即得。(3)建立玄芪化瘀浓缩丸中黄芪、三七、玄参、丹参的薄层色谱鉴别方法。(4)采用高效液相色谱法测定玄芪化瘀浓缩丸中黄芪甲苷、哈巴俄苷、丹酚酸B的含量。黄芪甲苷色谱条件为:流动相为乙腈-水(33:67),检测器为蒸发光散射检测器,氮气压力为40 psl,漂移管温度为60℃,流速为1.0 mL/min;哈巴俄苷和丹酚酸B色谱条件为:流动相为甲醇-1%甲酸(45:55),紫外检测器的检测波长分别为278 nm和286 nm,柱温为30℃,流速为1.0 mL/min。结论:玄芪化瘀浓缩丸制备工艺合理、可行;制订的质量标准简便、可靠、稳定,能有效控制制剂的质量。
[Abstract]:Objective: To study the preparation technology of Qi Xuan Huayu pill, and establish its quality standard. Methods: (1) by using single factor test method combined with the central composite design, with the content of astragaloside, harpagoside content, total polysaccharide content and extract yield as the evaluation index, the extraction times. The extraction time and the amount of water were investigated. The optimum parameters of water extraction of Radix Astragali etc.; (2) the best molding process of Xuan Qi Huayu pill; (3) were identified by TLC on the Xuan Qi stasis pill in medicine. (4) determined by Xuan Qi Huayu pill in Huangqi a method by high performance liquid chromatography, and the content of harpagoside and salvianolic acid B on methodology, set up quality standard. Results: (1) the best extraction process of Xuan Qi stasis pill for 13 times the amount of water for extracting 2 times, every time 130 min. (2) Xuan Qi stasis the best concentrated pill 鎴愬瀷宸ヨ壓涓哄彇涓瑰弬,涓変竷绮夌�庢垚缁嗙玻�

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