| 严丽,谢莉,冯春蕾,于新兰,吴光翠,张金魁,林鹏程.维药红豆杉质量控制研究及建议[J].中国药事,2023,(3):321-326 |
| 维药红豆杉质量控制研究及建议 |
| Research and Suggestions on Quality Control of Uygur Medicine Taxus Chinensis Herba |
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| DOI：10.16153/j.1002-7777.2023.03.010 |
| 中文关键词: 红豆杉 质量标准 薄层色谱 高效液相色谱 紫杉醇 10-脱乙酰巴卡亭Ⅲ |
| 英文关键词: Taxus Chinensis Herba quality standard TLC HPLC paclitaxel 10-deacetvlbaccatin Ⅲ |
| 基金项目:青海省自然科学基金项目-面上项目(编号 2019-ZJ-905) |
| 作者 | 单位 | | 严丽 | 新疆维吾尔自治 区药品检验研究院,中药(维药)质量控制重点实验室,乌鲁木齐 830054 | | 谢莉 | 新疆维吾尔自治 区药品检验研究院,中药(维药)质量控制重点实验室,乌鲁木齐 830054 | | 冯春蕾 | 新疆维吾尔自治 区药品检验研究院,中药(维药)质量控制重点实验室,乌鲁木齐 830054 | | 于新兰 | 新疆维吾尔自治 区药品检验研究院,中药(维药)质量控制重点实验室,乌鲁木齐 830054 | | 吴光翠 | 新疆维吾尔自治 区药品检验研究院,中药(维药)质量控制重点实验室,乌鲁木齐 830054 | | 张金魁 | 青海民族大学药学院,西 宁 810007 | | 林鹏程 | 青海民族大学药学院,西 宁 810007 |
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| 中文摘要: |
| 目的：研究维药红豆杉药材的质量控制方法并对质量标准提出建议。方法：采用硅胶G薄层色谱板，以紫杉醇、10-脱乙酰巴卡亭Ⅲ和红豆杉对照药材为对照，建立薄层色谱鉴定方法；依照《中华人民共和国药典》2020年版四部通则相关规定对红豆杉药材的水分、总灰分、酸不溶性灰分进行检查，测定其醇溶性浸出物的含量；采用高效液相色谱法建立红豆杉特征性成分紫杉醇的含量测定方法。结果： 建立的红豆杉薄层色谱专属特征显著。药材水分含量为4.3%~7.0%，总灰分为2.4%~5.4%，酸不溶性灰分为0.2%~1.8%，醇溶性浸出物含量为14.0%~35.4%。紫杉醇含量在6.70~80.44 μg·ml-1(r=0.9998)线性关系良好，加样回收率平均为99.3%。15批红豆杉药材中紫杉醇含量为0.003%~0.024%。结论：建立的红豆杉质量控制方法简便、重复性和专属性良好，研究结果可为红豆杉质量控制及标准的制修订提供一定参考。 |
| 英文摘要: |
| Objective: To study the quality control methods of the medicinal materials of Taxus chinensis, a Uygur medicine, and put forward suggestions on quality standards. Methods: The TLC identifi cation method was established with silica gel G thin layer plate, paclitaxel, 10-deacetylbacatine Ⅲ and Taxus chinensis were used as the control substance.According to the four general principlesof The Chinese Pharmacopoeia (2020 edition), the water content, total ash content and acid insoluble ash content of Taxus chinensis were examined, and the content of alcohol-soluble extract was determined. A HPLC method was established for the determination of taxol, the characteristic component of Taxus chinensis. Results: The established TLC features of Taxus chinensis were signifi cant. The medicinal materials contents of water, total ash, acid insoluble ash and alcohol soluble extract ranged from 4.3% to 7.0%, 2.4% to 5.4%, 0.2% to 1.8%, 14.0% to 35.4%. The linear relationshipof paclitaxel content was 6.70-80.44 μg· mL-1 (r= 0.9998), and the average recovery was 99.3%. The content of paclitaxel in 15 batches of Taxus chinensis was 0.003%-0.024%. Conclusion: The established quality control methods of Taxus chinensis was simple repeatability and specifi city. The results of the study could provide some reference for the quality control and standard establishment of Taxus chinensis. |
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