正交设计试验法优选骨刺康复丸水提工艺参数.doc

正交设计试验法优选骨刺康复丸水提工艺参数 　　[摘要] 目的 优选骨刺康复丸的提取工艺参数，为该制剂工业化生产提供依据。 方法 以浸膏得率与青藤碱含量为评价指标，采用流动相：乙腈-乙二胺（32∶68），流速1.0 mL/min，检测波长262 nm；柱温30℃的HPLC Welchrom C18色谱柱（250 mm×4.6 mm，5 μm）测定青藤碱含量，单因素试验考察药材吸水率、提取次数，正交设计试验法考察加水量、煎煮时间、浸泡时间三个因素在不同水平对实验结果的影响。 结果 骨刺康复丸最佳水提工艺参数为：药材吸水率为180.9%，提取2次 ，第一次加10倍量水，提取2.5 h，第二次加8倍量水，提取2 h。按最佳水提工艺参数验证试验结果表明，浸膏得率可达33.08%、RSD为0.64%、青藤碱含量可达16.70 mg/mL、RSD为1.99%。 结论 优选的水提工艺参数科学、合理、稳定、可行，适应于该制剂的工业化生产 [关键词] 骨刺康复丸；浸膏得率；青藤碱含量；正交设计试验；提取工艺 [中图分类号] R284.2 [文献标识码] A [文章编号] 1673-7210（2017）02（a）-0016-05 Optimum water-extracting technology parameter of Guci Kangfu pill by orthogonal design test JIANG Longbo1 ZHANG Yiren1 ZHANG Keren1 CHEN Yetong1 JIANG Cuiping2 ZENG Rong1 PENG Maijiao1 ZOU Long1 1.School of Pharmacy， Hu′nan University of Chinese Medicine， Hu′nan Province， Changsha 410208， China； 2.Pharmacy Department， Liuyang Chinese Medicine Hospital， Hu′nan Province， Liuyang 410300， China [Abstract] Objective To optimize extraction technical parameters of Guci Kangfu pills， and to provide the evidence for industrial production. Methods The rate of extractum and sinomenine contents were selected as evaluation index； Sinomenine content was determined with the mobile phase of acetonitrile-ethlenediamine（32：68）， the flow rate of 1.0 mL/min，detection wavelength 262nm，and HPLC welchrom C18（250 mm×4.6 mm，5 μm） with column temperature of 30℃. The water absorption rate and the number of extraction times were investigated by the single factor experiment. The effects on the experimental results with different levels of the soaking time， the amount of water and the time of extraction was studied by orthogonal method. Results The Guci Kangfu pills optimum water extraction parameters： medicinal water absorption was 180.9%， extracting 2 times， the first with 10 times amount of water， extracting times was 2.5 h， second time with 8 times the amount of water， extracting time was 2 h. The optimum parameters of testing results showed that the extraction rate can re