痔科消炎止痛洗剂质量标准的建立  

Quality Standard for Zhike Xiaoyan Zhitong Lotion

作　　者：朱田密[1] 胡晓雪[1] 陈树和[1] 谈道彬[1] 林爱珍[2] 孙光军[2] 

机构地区：[1]湖北省中医院药事部,武汉430061 [2]湖北省中医院肛肠科,武汉430061

出　　处：《中国药师》2015年第8期1391-1393,共3页China Pharmacist

摘　　要：目的:建立痔科消炎止痛洗剂的质量标准。方法:采用TLC法对痔科消炎止痛洗剂中黄柏、当归、黄芪进行定性鉴别;采用HPLC法测定黄柏中盐酸小檗碱含量,色谱条件为Agilent 5 TC-C18色谱柱(250 mm×4.6 mm,5μm),流动相:乙腈-0.05 mol·L^-1磷酸二氢钾溶液(30∶70),流速:1.0 ml·min^-1,检测波长:265 nm,柱温:30℃。结果:痔科消炎止痛洗剂中黄柏、当归、黄芪的薄层色谱斑点清晰,专属性强,阴性对照无干扰;盐酸小檗碱在0.029~3.628μg范围内,呈良好的线性关系(r=0.999 9),平均回收率为97.83%,RSD=2.05%(n=6)。结论:定性、定量方法准确可靠、重复性好,能有效控制痔科消炎止痛洗剂的内在质量。To establish the quality standard for Zhike Xiaoyan Zhitong lotion. Methods： Phellodendri chinensis Cor-tex, Angelicae sinensis Radix and Astragali Radix in the preparation were identified by TLC. The content of berberine hydrochloride, the effective component in Phellodendri chinensis Cortex, was determined by HPLC with the chromatographic conditions as follows： an Agilent 5 TC-C18 column （250 mm x 4. 6 mm, 5 μm） was used, the mobile phase was acetonitrile-0. 05 mol·L-1 potassium dihydro-gen phosphate （30∶70） with the flow rate of 1. 0 ml·min-1 , the detection wavelength was 265 nm, and the column temperature was at 30 ℃. Results：The spots of Phellodendri chinensis Cortex, Angelicae sinensis Radix and Astragali Radix in Zhike Xiaoyan Zhitong lotion on TLC were clear with strong specificity and without any interference from the negative controls. There was a good linear rela-tionship for berberine hydrochloride within the range of 0. 029-3. 628 μg（r=0. 999 9）, and the average recovery was 97. 83% （RSD=2. 05%, n=6）. Conclusion：The qualitative and quantitative methods are accurate, reliable and repeatable, which can effectively control the inherent quality of Zhike Xiaoyan Zhitong lotion.

关 键 词：痔科消炎止痛洗剂 质量标准 薄层色谱法 高效液相色谱法 盐酸小檗碱 

分 类 号：TQ460.72[医药卫生—药物分析学]