TOPSIS法结合多指标成分综合评价复方罗布麻片Ⅰ的质量  

Comprehensive Evaluation of the Quality of Compound Luobuma TabletⅠby TOPSIS Method Combined with Multi-Target Ingredients

作　　者：谢美晓 陈家仪[1] 邓雯姬 谢思敏[1] 栗建明[1] XIE Meixiao;CHEN Jiayi;DENG Wenji;XIE Simin;LI Jianming(Guangzhou Institute for Drug Control,Guangzhou,Guangdong,China 510160)

机构地区：[1]广东省广州市药品检验所,广东广州510160

出　　处：《中国药业》2023年第15期75-79,共5页China Pharmaceuticals

摘　　要：目的建立复方罗布麻片Ⅰ的质量评价方法。方法采用高效液相色谱法测定复方罗布麻片Ⅰ中维生素B_(1)、维生素B_(6)和氢氯噻嗪含量,根据2020年版《中国药典(四部)》通则0941含量均匀度检查法测定样品中各成分的含量均匀度。色谱柱为Inertsil C_(18)柱(250 mm×4.6 mm,5μm),流动相为0.01 mol/L庚烷磺酸钠溶液-乙腈-甲醇-二乙胺(400:80:20:0.5,V/V/V/V,用20%磷酸溶液调pH至3.5),流速为0.8 mL/min,检测波长为270 nm,进样量为20μL。采用优劣解距离(TOPSIS)法分析维生素B_(1)、维生素B_(6)及氢氯噻嗪3种成分的含量及含量均匀度,并评价复方罗布麻片Ⅰ的质量。结果维生素B_(1)、维生素B_(6)、氢氯噻嗪质量浓度分别在0.926~18.523μg/mL、1.030~20.608μg/mL、3.966~59.488μg/mL范围内与峰面积线性关系良好(r=0.9999,0.9999,0.9995,n=6);精密度、重复性、稳定性试验结果的RSD均小于3.0%;平均加样回收率分别为100.52%,98.84%,99.58%,RSD分别为1.43%,1.36%,1.05%(n=6)。TOPSIS法分析结果显示,3家企业维生素B_(1)的综合评分均最低,工艺相对较差;企业B的综合评分最高,产品质量最好。结论TOPSIS法结合多指标成分分析法准确可靠、专属性强、操作简便,可用于复方罗布麻片Ⅰ质量的综合评价。Objective To establish a quality evaluation method for Compound Luobuma TabletⅠ.Methods The contents of vitamin B1,vitamin B_(6)and hydrochlorothiazide in Compound Luobuma TabletⅠwere determined by the high-performance liquid chromatography(HPLC)method.The content uniformity of each component in the sample was determined according to the general rule 0941 of the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ).The chromatographic column was Inertsil C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was 0.01 mol/L sodium heptanesulfonate solution-acetonitrile-methanol-diethylamine(400∶80∶20∶0.5,V/V/V/V,the pH was adjusted to 3.5 with 20%phosphoric acid solution),the flow rate was 0.8 mL/min,the detection wavelength was 270 nm,and the injection volume was 20μL.The content and content uniformity of vitamin B1,vitamin B_(6)and hydrochlorothiazide were analyzed by the technique for order preference by similarity to an ideal solution(TOPSIS)method,and the quality of Compound Luobuma TabletⅠwas evaluated.Results The linear ranges of vitamin B1,vitamin B_(6)and hydrochlorothiazide were 0.926-18.523μg/mL,1.030-20.608μg/mL,3.966-59.488μg/mL(r=0.9999,0.9999,0.9995,n=6).The RSDs of precision,repeatability,and stability tests results were all lower than 3.0%.The average recoveries of vitamin B1,vitamin B_(6)and hydrochlorothiazide were 100.52%,98.84%,and 99.58%,with RSDs of 1.43%,1.36%,and 1.05%(n=6),respectively.The TOPSIS method results show that the comprehensive score of vitamin B1 was the lowest in the three manufacturers,and the process was relatively poor,the comprehensive score of the product was the highest and the quality of the product was the best in manufacturer B.Conclusion The TOPSIS method combined with multi-target ingredients analysis is accurate,reliable,highly specific,and simple,which can be used for the comprehensive evaluation of the quality of Compound Luobuma TabletⅠ.

关 键 词：复方罗布麻片Ⅰ 优劣解距离法 维生素B1 维生素B6 氢氯噻嗪 多指标成分 

分 类 号：R284.1[医药卫生—中药学]