治疗性结核DNA疫苗SDS含量检测  

Determination of the Contents of Sodium Dodecyl Sulfate in Therapeutic Tuberculosis DNA Vaccine

作　　者：孔雯雯 魏荣华 王玮 周飞燕 梁艳 吴雪琼 倪世明 黄明 KONG Wenwen;WEI Ronghua;WANG Wei;ZHOU Feiyan;LIANG Yan;WU Xueqiong;NI Shiming;HUANG Ming(Guangzhou Bai Yun Shan Baidi Bio-Technology Co.,Lid,Guangzhou,Guangdong 511495,China;Tuberculosis Key Laboratory,the Sth Medical Center of PLA General Hospital,Beijing 100091,China)

机构地区：[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

出　　处：《今日药学》2021年第1期39-42,共4页Pharmacy Today

基　　金：国家科技重大专项资助(2018ZX10731301-005-003)。

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·m L^(-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·m L^(-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 of0.005-0.32 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.

关 键 词：十二烷基硫酸钠 结核 DNA疫苗 吖啶橙 

分 类 号：R917[医药卫生—药物分析学]