复方薄荷脑苯酚搽剂质量标准研究  

Quality Standard of Compound Menthol Phenol Liniment

作　　者：陈燕霞[1] 陈洁[1] 黄樱华[1] 丘振文[1] 李得堂[1] 黄月纯[1] 孙亦群[1] CHEN Yanxia;CHEN Jie;HUANG Yinghua;QIU Zhenwen;LI Detang;HUANG Yuechun;SUN Yiqun(The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou,Guangdong,China 510405)

机构地区：[1]广州中医药大学第一附属医院,广东广州510405

出　　处：《中国药业》2022年第3期81-83,共3页China Pharmaceuticals

基　　金：广州中医药大学第一附属医院创新强院工程项目[2017ZWB10]。

摘　　要：目的建立复方薄荷脑苯酚搽剂中水杨酸和苯酚的定量分析方法。方法采用紫外-可见分光光度法测定水杨酸的含量,检测波长为300 nm;采用高效液相色谱法测定苯酚含量,色谱柱为Agilent Zorbax SB-C;柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(48∶52,V/V),流速为1.0 mL/min,柱温为25℃,检测波长为270 nm,进样量为10μL。结果水杨酸质量浓度在0.005 1~0.030 4 mg/mL范围内与吸光度线性关系良好(r=0.999 2,n=6),平均加样回收率为100.90%,RSD为0.69%(n=9)。苯酚进样量在0.264 0~3.299 8μg范围内与峰面积线性关系良好(r=0.999 9,n=6),平均加样回收率为100.54%,RSD为0.61%(n=9);水杨酸和苯酚精密度、重复性、稳定性试验结果的RSD均小于2%。结论该方法操作简便,结果准确,重复性和稳定性均好,可用于控制复方薄荷脑苯酚搽剂的质量。Objective To establish a method for the quantitative analysis of salicylic acid and phenol in Compound Menthol Phenol Liniment.Methods The content of salicylic acid was determined by the ultraviolet-visible(UV-Vis) spectrophotometry at the detection wavelength of 300 nm.The content of phenol was determined by the high-performance liquid chromatography(HPLC)method,the chromatographic column was Agilent Zorbax SB-C;column(250 mm×4.6 mm,5μm),the mobile phase was methanolwater(48-52,V/V),the flow rate was 1.0 mL/min,the column temperature was 25℃,the detection wavelength was 270 nm,and the injection volume was 10μL.Results The mass concentration of salicylic acid showed a good linear relationship with absorbance in the range of 0.005 1-0.030 4 mg/mL(r=0.999 2,n=6),the average recovery rate was 100.90% with an RSD of 0.69%(n=9).The injection volume of phenol showed a good linear relationship with absorbance in the range of 0.264 0-3.299 8μg(r=0.999 9,n=6),the average recovery rate was 100.54% with an RSD of 0.61%(n=9).The RSDs of precision,repeatability and stability tests of salicylic acid and phenol were less than 2%.Conclusion The method is simple,accurate,reproducible and stable,which can be used for the quality control of Compound Menthol Phenol Liniment.

关 键 词：复方薄荷脑苯酚搽剂 水杨酸 苯酚 含量测定 质量控制 

分 类 号：R932[医药卫生—生药学] R286.0[医药卫生—药学]