| 李秀岩,张艳梅,孙佳琳,吴丽红,李永吉.正交试验优化青防肿痛外敷散纯化工艺[J].,2017,17(5):826-829 |
| 正交试验优化青防肿痛外敷散纯化工艺 |
| Optimization of Purification Technology for Qingfang Zhongtong Powder by Orthogonal Experiment |
| 投稿时间：2016-07-21 修订日期：2016-08-17 |
| DOI：10.13241/j.cnki.pmb.2017.05.006 |
| 中文关键词: 青防肿痛外敷散 正交试验 纯化工艺 水沉淀法 |
| 英文关键词: Qingfang Zhongtong powder Orthogonal experiment Purification technology Water-deposition process |
| 基金项目:国家自然科学基金项目（81473359)；黑龙江中医药大学科研基金项目（2014bs06） |
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| 中文摘要: |
| 摘要 目的：优选青防肿痛外敷散最佳纯化工艺。方法：以干膏率、青藤碱及粉防己碱转移率为指标，设置综合评分。单因素考察筛选直接沉淀法和水沉淀法，正交试验法优选水沉淀法中最佳相对密度、放置时间和加水倍量，将水沉淀法和直接沉淀法及纯化前试验数据对比，并将最佳纯化工艺做三批重复性验证试验。结果：水沉淀法最佳工艺为将滤液减压浓缩至相对密度为1.10～1.15（70 ℃）的稠膏，稠膏加7倍量的水搅匀，放置48 h。单因素试验结果证明水沉淀法优于直接沉淀法。重复性试验验证结果证明工艺稳定可靠。结论：此纯化工艺可在保留活性成分的同时，有效的去除杂质，最大程度减少使用剂量，为后期制剂成型和中试放大生产研究奠定了良好基础。 |
| 英文摘要: |
| ABSTRACT Objective: To optimize purification technology of Qingfang Zhongtong powder. Methods: Used dry extract yielding rate, the content of sinomenine and tetrandrine as indexes, set up comprehensive score, direct-deposition process and water-deposition process was optimized by single factor experiment. The technological parameter of water-deposition process like relative density, placing time and the amount of water were optimized by orthogonal experiment. The results were compared with the ones of direct-deposition process. Three batches of repetitive verification test of the best purification technology were carried out. Results: Optimum of purification technology was: concentrating under vacuum to relative density was 1.10～1.15 (70℃), adding 7 times amounts of water then placing 48 hours. Single factor experiment proved that water-deposition was superior to direct-deposition process. Repetitive verification test indi- cated that the best purification technology was stable and reliable. Conclusion: The optimum purification technology can keep active in- gredients, remove impurities and reduce the dose, which offer good foundation for later pharmaceutical studies. The technological pro- cess was simple and suited for large scale production. |
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