论文部分内容阅读
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。
Objective: To optimize the best external anti-inflammatory pain treatment of pure green. Methods: The dry weight of the rate of sinomenine and tetrandrine transfer rate as an indicator, set the comprehensive score. The single factor test screened the direct precipitation method and the water precipitation method. The orthogonal test method was the best relative density in water precipitation method, the storage time and the water addition multiple. The water precipitation method, the direct precipitation method and the pre-purification test data were compared. The best purification process to do three batches of repeated verification test. Results: The optimum conditions of water precipitation were that the filtrate was concentrated under reduced pressure to a thick paste with a relative density of 1.10 ~ 1.15 (70 ℃). The thick paste was added with 7 times the amount of water and stirred for 48 hours. Single factor test results show that water precipitation method is better than direct precipitation method. Repeatability test results show that the process is stable and reliable. Conclusion: This purification process can effectively remove impurities while preserving the active ingredient, minimizing the use of dosage, which lays a good foundation for the research of post-formulation and pilot scale production.