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公告栏:
治疗性结核DNA疫苗SDS含量检测
作者:孔雯雯1  魏荣华1  王玮1  周飞燕1  梁艳2  吴雪琼2  倪世明1  黄明1 
单位:1. 广州白云山拜迪生物医药有限公司, 广东 广州 511495;
2. 中国人民解放军总医院第八医学中心结核病重点实验室, 北京 100091
关键词:十二烷基硫酸钠 结核 DNA疫苗 吖啶橙 
中图分类号:R917
文献标志码:
出版年,卷(期):页码:2021,31(1):39-42,
收稿日期:2020-4-1
摘要:
目的 应用吖啶橙法来检测治疗性结核DNA疫苗中的十二烷基硫酸钠(sodium dodecyl sulfate,SDS)的残留量。方法 将SDS标准液与吖啶橙混合后,经甲苯萃取处理后在波长499 nm测定吸光度值,根据标准曲线计算供试品中SDS的含量。结果 SDS浓度在0.005~0.32 mg·mL-1的范围内,相关系数r >0.99,线性关系良好。该法受高温、辅料和核酸的影响较小。3批制剂的SDS残留量均小于0.02 mg·mL-1结论 建立的方法操作简便、专属性、准确度和重现性较好,可用于结核DNA疫苗制剂中SDS残留量的检测。
OBJECTIVE To develop a method for the content determination of sodium dodecyl sulfate(SDS)in therapeutic tuberculosis DNA vaccine by acridine orange. METHODS The standard solution of SDS was mixed with acridine orange,then the mixture was extracted with toluene and determined the absorbance at the wavelength of 499 nm.The concentration of SDS in samples could be determined by standard curve. RESULTS The standard curve of SDS concentration showed good linearity at the range of 0.005-0.32 mg·mL-1(r>0.99).And the method was relatively smaller affection by high temperature,excipients and nucleic acid.The content of SDS from three batches of preparations were all lower than 0.02 mg·mL-1. CONCLUSION The developed method is simple,specific,accurate,and reproducible,which can be used for the determination of SDS residue in tuberculosis DNA vaccine.
基金项目:
国家科技重大专项资助(2018ZX10731301-005-003)
作者简介:
孔雯雯,硕士研究生,工程师,研究方向:生物医药的质量控制,E-mail:enya87@163.com
通讯作者:
参考文献:
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