当归腹痛宁滴丸质量标准提高.docx
《当归腹痛宁滴丸质量标准提高.docx》由会员分享,可在线阅读,更多相关《当归腹痛宁滴丸质量标准提高.docx(13页珍藏版)》请在第一文库网上搜索。
1、当归腹痛宁滴丸质量标准提高朱琳刘东升朱旭江苏蕊姚世霞贺军权杨平荣20150401 20150402当归药材20150403阴性对照A.原标准的薄层色谱图BB.展开剂极性与点样量修改后的薄层色谱图图1薄层色谱图【摘要】目的:提高当归腹痛宁滴丸的质量标准。方法:修改原有当归药材的薄层鉴别方法;采用气相色谱法建立二氯甲烷溶剂残留的检查项;采用高效液相色谱法建立当归腹痛宁滴丸中主成分藁本内酯的含量测定项。结果:修改后的薄层色谱分离良好,斑点清晰;气相色谱法检测当归腹痛宁滴丸中二氯甲烷的最低检出限为3. 15 ugniLT;藁本内酯在0.10642.1290 ug范围内有良好的线性关系,相关系数在0.9
2、999以上,加样回收率n=9)为98 . 096(RSD=2.6%) o结论:通过以上实验所建立的方法简便可靠,重复性好,适用于当归腹痛宁滴丸的质量控制。Key当归腹痛宁滴丸;当归;质量标准;藁本内酯;二氯甲烷溶剂残留R284. 1 【文献标志码】A 1007-8517 (2020) 20-0032-07Improvement of Quality Standard of Danggui Futongning Droplet PillsZHU Linl, 2 LIU Dongshengl, 2 ZHU Xujiangl, 2 SU Ruil, 2 YAOShixial, 2 HE Junqua
3、nl, 2 YANG Pingrongl, 21 . Gansu Institute for Drug Control, Lanzhou 730070, China;2 .Gansu Inspection and testing technical engineering laboratory forChinese herbal and Tibetan medicine, Lanzhou 730070, ChinaAbstract: Objective To improve the quality standard of DangguiFutongning Droplet Pills. Met
4、hods The TLC (thin layer chromatography)identification method of Angelica sinensis was improved, thedetection items of residual dichloromethane solvent were establishedby gas chromatography, and the content determination method ofligustilide was established by liquid chromatography. Results The TLCo
5、f Angelica sinensis was well separated and the spots were clear; Theminimum detection limit of dichloromethane in Danggui Futongningdroplet pills by gas chromatography is 3. 15 u g e mL-1; Thecalibration curves of ligustilide were in a good linearity,R0. 999and the average recovery rate was 98. 0% (
6、RSD=2. 6%) . Conclusion Themethod is simple, reliable and reproducible- It is suitable for thequality control of Danggui FuTongning Droplet Pills.Keywords: Danggui Futongning Droplet Pills; Angelica; QualityStandard; Ligustilide; Residue of Dichloromethane Solvent当归腹痛宁滴丸具有解痉止痛的功效,主要用于妇女痛经、产后宫缩痛、感染性腹
7、泻引起的急性腹痛、小儿秋季腹泻等的治疗。原标准收载于甘肃省药品标准1988年版。1998年收载入卫生部药品标准中药成方制剂第十七册,此标准沿用至今,此标准中收载性状、鉴别(当归)和检查项,标准较为简单,不足以控制当归腹痛宁滴丸的质量。所以有必要提高现行质量标准。当归腹痛宁滴丸是以当归挥发油为主要原料制成的滴丸剂,当归挥发油的主要成分为苯醐类,其中藁本内酯含量最高1,藁本内酯有很强的解痉、平喘、镇定作用,临床上可用于治疗支气管炎和妇科疾病。研究显示,藁本内酯具有良好的改善微循环作用,可用于防治与微循环障碍有关的疾病2-3。与当归腹痛宁滴丸功能主治相吻合,因此当归腹痛宁滴丸的质量控制需定量测定藁本
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- 当归 腹痛 宁滴丸 质量标准 提高
