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国产相模湾霉素(Sagamicin,SGM)是由棘孢小单孢菌JIM-401变株产生的氨基糖苷抗生素类。但在其发酵过程中还产生庆大霉素(Gentamicin C_1a,GMC_1a)等其它组份。为了控制此药质量,目前用纸层一生物显影(B.P.)法进行测定。其过程较长,影响测定结果的因素较多,诸如对小组份分辨率低,显色面积测量误差较大,检定菌种选择不统一等,都会影响测定的精度,故不能适应生产和药品质量控制的需要。经过研究,我们试用反相高效液相色谱荧光检测(RP-HPLC)法分离和定量分析SGM和GMC_1a等组份含量。 使用Waters高效液相色谱仪,510泵,420荧光检测器(激发波长338nm,发射波长425nm)710B自动进样器,730数据处理机,721系统控制器,Radial-Pak C18柱,10cm× 3mm I.D,(Waters公司)流动相:乙睛:无水甲醇:0.1％三羟基甲基氨基甲烷适当比例。流速1.5ml/min。纸速0.25cm/min,在室温下进行分析。
Domestic Sagamicin (SGM) is an aminoglycoside antibiotic produced by a strain of Micromonospora sp. JIM-401. However, gentamicin (Gentamicin C-1 a, GMC-1 a) and other components are also produced during the fermentation. In order to control the quality of this medicine, the present paper by a biological development (B.P.) method for determination. The process is relatively long, and there are many factors that affect the determination result, such as low resolution of the small component, large measurement error of the color area, inconsistent selection of the tested strains, etc., which will affect the accuracy of the measurement and therefore can not be adapted to the quality of the production and the medicine Control needs. After researching, we tried RP-HPLC to separate and quantitatively analyze the content of SGM and GMC-1a. 510 pump, 420 fluorescence detector (excitation wavelength 338 nm, emission wavelength 425 nm) 710B autosampler, 730 data processor, 721 system controller, Radial-Pak C18 column, 10 cm x 3 mm ID , (Waters) Mobile Phase: Acetone: Anhydrous methanol: 0.1% Trihydroxymethylaminomethane Appropriate proportions. Flow rate 1.5 ml / min. Paper speed 0.25cm / min, at room temperature for analysis.