基于Microtox技术的白芷、川芎及其成方制剂都梁软胶囊质量生物评价研究  

Biological Evaluation of Quality of Baizhi(白芷),Chuanxiong(川芎),and Duliang Soft Capsules(都梁软胶囊):Based on Microtox Assay

作　　者：田韦韦 韩李阳 华桦[1] 刘俐 余东梅 王道权 黄介 全云云 鄢良春[1] 赵军宁[1] TIAN Weiwei;HAN Liyang;HUA Hua;LIU Li;YU Dongmei;WANG Daoquan;HUANG Jie;QUAN Yunyun;YAN Liangchun;ZHAO Junning(Sichuan Academy of Chinese Medical Sciences,Sichuan Institute for Translational Chinese Medicine,State Key Laboratory of Quality Evalu-ation of Traditional Chinese Medicine,National Administration of Traditional Chinese Medicine,Sichuan Key Laboratory of Translational Chi-nese Medicine,Sichuan Engineering Technology Research Center for Formation Principle and Quality Evaluation of Genuine Medicinal Materi-als,Sichuan Engineering Technology Research Center for System Development of Genuine Medicinal Materials,Laboratory for Rapid Detection of Toxicity of Traditional Chinese Medicine in Sichuan Provincial Administration of Chinese Medicine,Chengdu 610041;Sichuan University,West China School of Pharmacy,Chengdu 610041;Chongqing Pharscin Pharmaceutical Group Co.,Ltd.,Chongqing 401121)

机构地区：[1]四川省中医药科学院,四川省中医药转化医学中心,国家中医药管理局中药质量生物评价重点研究室,中医药转化医学四川省重点实验室,四川省道地药材系统开发工程技术研究中心,四川省道地药材形成原理与品质评价工程研究中心,四川省中医药管理局中药毒性快速检测实验室,成都610041 [2]四川大学药学院,成都610041 [3]重庆华森制药有限公司,重庆401121

出　　处：《中药药理与临床》2023年第6期43-47,共5页Pharmacology and Clinics of Chinese Materia Medica

基　　金：四川省中医药管理局科学技术研究专项课题(编号:2021ZD001);四川省科技厅基本科研业务专项(编号:A-2021N-Z-4);国家重大新药创制专项课题(编号:2015ZX09501004-001-005);四川省杰出青年基金团队项目(编号:2017TD0003);广东省新黄埔中医药联合创新研究院联合创新研究项目(编号:2021IR002、2022IR014);中央财政转移支付地方项目(编号:Z-2022N-1);四川省中医药科技产业创新团队专项(编号:2022C009)。

摘　　要：目的:以Microtox技术应用于白芷、川芎及其成方制剂都梁软胶囊探讨其质量控制。方法:参照本实验室建立的Microtox技术方法体系,以青海弧菌Q67为测试菌种,对10个不同批次的白芷、川芎和都梁软胶囊进行生物质量控制研究。结果:3个批次的青海弧菌Q67发光强度值接近,且均随着时间变化呈现先降低后稳定的特点,在平衡后的15 min~60 min处于相对平稳状态。复苏稀释液、渗透压调节液及待测样品溶液不干扰青海弧菌Q67发光强度的测定,方法学RSD值符合要求。安徽产区白芷批间差异无统计学意义(P>0.05),四川产区白芷批间差异部分有统计学意义(P<0.05),且安徽产区与四川产区IC_(50)值存在交叉重合。彭州产区川芎批间差异部分有统计学意义(P<0.05),眉山产区川芎批间差异部分有统计学意义(P<0.05),且彭州产区与眉山产区IC_(50)值存在交叉重合。都梁软胶囊批间差异部分有统计学意义(P<0.05)。结论:基于Microtox技术建立的质量生物评价方法专属性强,精密度高,重复性良好。白芷、川芎和都梁软胶囊对青海弧菌Q67的发光效应存在显著的浓度-效应关系,部分批次之间IC_(50)值差异具有统计学意义(P<0.05),提示Microtox技术可以用于白芷、川芎和都梁软胶囊的质量控制,本方法以期作为一种新的质量生物评价方法用于中药的质量波动检测及安全风险预警,提高中药质量控制的可靠性。Objective:To apply microtox assay in the quality control of Baizhi(白芷),Chuanxiong(川芎),and the Duliang Soft Capsules(都梁软胶囊) prepared with the two medicinals.Methods:With the optimal microtox assay system developed by our laboratory and the test strain Vibrio qinghaiensis Q67,the quality of 10 different batches of Baizhi,Chuanxiong,and Duliang Soft Capsules was assessed.Results:The luminescence intensity of the three batches of Q67 was similar,which decreased over time and then tended to be stable at 15 min-60 min.The diluted rehydration solution,osmotic pressure regulator,and sample solution tested did not interfere with the determination of luminescence intensity of Q67,and the RSD value of the methodology met the requirements.There was no significant difference between batches of Baizhi from Anhui(P>0.05),while the difference between batches of Baizhi from Sichuan was significant(P<0.05).The IC_(50) values of Baizhi from the above two production areas overlapped.The difference between batches of Chuanxiong from Pengzhou was significant(P<0.05),so was that from Meishan(P<0.05).The IC_(50) values of Chuanxiong from the two production areas overlapped.There were significant differences between batches of Duliang Soft Capsules(P<0.05).Conclusion:The Microtox assay-based biological evaluation method is highly specific,precise,and reproducible.Baizhi,Chuanxiong,and Duliang Soft Capsules show significant concentration-effect relationship with the luminescence intensity of Q67,and IC_(50) values of some batches are significantly different(P<0.05).These results demonstrate that Microtox assay can be applied to the quality control of Baizhi,Chuanxiong,and Duliang Soft Capsules,and is expected to be used in the detection of quality fluctuations and toxicity risks of Chinese medicine and to improve the quality of Chinese medicine.

关 键 词：白芷 川芎 都梁软胶囊 Microtox技术 青海弧菌Q67 质量控制 生物评价 

分 类 号：R286.0[医药卫生—中药学]