| 引用本文: | 韩宜芯,李西蒙,康媛,高源,张小雨,齐云.基于脑卒中治疗作用的清开灵注射液生物活性质控方法的建立[J].中国现代应用药学,2021,38(23):2926-2931. |
| HAN Yixin,LI Ximeng,KANG Yuan,GAO Yuan,ZHANG Xiaoyu,QI Yun.Establishment of Bioactivity Assay Method for the Quality Control of Qingkailing Injection Based on Its Application in Treating Cerebral Stroke[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(23):2926-2931. |
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| 摘要: |
| 目的 从清开灵注射液的临床应用出发，依据其改善氧化应激在治疗脑卒中过程中发挥的作用，建立基于生物活性的清开灵注射液的质量控制新方法。方法 考察清开灵注射液对超氧阴离子、羟自由基、DPPH自由基的清除以及其总抗氧化能力这4种生物活性指标的作用强度，选择线性关系和灵敏度最佳的生物指标进行方法学考察，并以该法测定3个批次的清开灵注射液样品的生物活性，比较其质量优劣。结果 与另外3种方法相比，清开灵注射液的总抗氧化能力与其浓度之间的线性关系良好、灵敏度高，且符合方法学对于日内精密度、日间精密度和稳定性的要求。3个批次的清开灵注射液生物活性之间无显著差异，以水溶性维生素E当量代表的三者的质量相当接近。结论 总抗氧化能力适用于评价清开灵注射液在与此活性相关的应用（如脑卒中）中质量的优劣，此法可作为现行质量控制方式的有益补充，从而应用到清开灵注射液的质量控制工作中。 |
| 关键词: 清开灵注射液 脑卒中 抗氧化 生物活性测定法 质量控制 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.23.003 |
| 分类号:R917 |
| 基金项目:国家自然科学基金项目（81873066）；“重大新药创制”国家科技重大专项（2015ZX09501004-001-003）；中国医学科学院医学与健康科技创新工程项目（2016-I2M-3-015） |
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| Establishment of Bioactivity Assay Method for the Quality Control of Qingkailing Injection Based on Its Application in Treating Cerebral Stroke |
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HAN Yixin, LI Ximeng, KANG Yuan, GAO Yuan, ZHANG Xiaoyu, QI Yun
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Institute of Medicinal Plant Development, Chinese Academy of Medical Science, Beijing 100193, China
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| Abstract: |
| OBJECTIVE To establish a new bioactivity assay method for the quality control of Qingkailing injection based on its effect of ameliorating oxidative stress in treating cerebral stroke. METHODS Four bioactivity indicators including investigating the activity of Qingkailing injection on scavenging superoxide anion radical, hydroxy radical and DPPH radical along with its total antioxidant capacity were assessed. Among these, the total antioxidant capacity assay with the best linearity and sensitivity was selected for further methodological investigation, and then applied to compare the quality of three batches of Qingkailing injections. RESULTS Total antioxidant capacity assay possessed the best linearity and sensitivity compared with the other 3 methods. Following methodological investigation exhibited that its intra- and inter-day precision, stability were also conformance to requirements. The biological qualities of three batches' samples, which was represented by the concentration of trolox with equivalent activity, were similar without statistical difference. CONCLUSION The total antioxidant capacity assay is suitable for evaluating the quality of Qingkailing injection in its clinical applications associated with the antioxidant capacity, such as cerebral stroke, etc. This method also serves as a beneficial supplement for the current quality control mode. |
| Key words: Qingkailing injection cerebral stroke antioxidant activity bioactivity assay method quality control |
