HPLC同时测定通络化痰胶囊中14种成分的含量  

Simultaneous Determination of Fourteen Constituents in Tongluo Huatan Capsules by HPLC

作　　者：林林 谭会洁 何慧 刘广桢 LIN Lin;TAN Hui-jie;HE Hui;LIU Guang-zhen(Shandong Insititute for Food and Drug Control,Jinan 250101,China;Shandong Traditional Chinese Medicine Standard Innovation and Quality Evaluation Engineering Laboratory,Jinan 250101,China)

机构地区：[1]山东省食品药品检验研究院,济南250101 [2]山东省中药标准创新与质量评价工程实验室,济南250101

出　　处：《中国药学杂志》2022年第4期295-300,共6页Chinese Pharmaceutical Journal

基　　金：山东省自然科学基金项目资助(ZR2013HM074)。

摘　　要：目的 建立同时测定通络化痰胶囊中腺苷、没食子酸、天麻素、对羟基苯甲醇、丹酚酸B、牛磺熊去氧胆酸、人参皂苷Rb;、牛磺鹅去氧胆酸、芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚和丹参酮Ⅱ;14种成分的含量测定方法。方法 以十八烷基键合硅胶为填充剂(Agilent Eclipse XDB C;色谱柱),乙腈(A)-0.1%甲酸溶液(B)为流动相,梯度洗脱(0~20 min, 5%A→25%A;20~40 min, 25%A→40%A;40~60 min, 40%A→85%A),柱温30℃,流速1 mL·min^(-1),检测波长:220 nm, 35~45 min,切换为203 nm。结果 14种成分可以实现完全分离,并与其他成分均能达到良好的分离;腺苷、没食子酸、天麻素、对羟基苯甲醇、丹酚酸B、牛磺熊去氧胆酸、人参皂苷Rb;、牛磺鹅去氧胆酸、芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚和丹参酮Ⅱ;分别在0.040 58~0.811 6、0.042 43~0.848 6、0.040 24~0.804 8、0.059 71~1.194、0.351 6~7.031、0.178 4~3.568、0.206 7~4.133、0.161 1~3.222、0.016 18~0.323 6、0.020 96~0.419 2、0.031 87~0.637 4、0.020 06~0.401 2、0.010 63~0.212 6、0.021 92~0.438 4μg进样量范围内,与色谱峰峰面积呈良好线性响应;平均回收率(n=6)分别为98.2%,99.2%,99.1%,98.9%,99.3%,99.6%,98.9%,99.1%,98.9%,98.7%,99.1%,98.9%,98.7%和99.2%;RSD分别为1.0%,1.4%,1.3%,0.86%,0.84%,0.79%,1.2%,0.92%,1.1%,0.92%,0.69%,1.0%,0.93%和1.2%。结论 该方法多种成分同时测定,操作简便,准确、重复性好,可用于通络化痰胶囊的质量控制。OBJECTIVE To develop a method for determining 14 constituents in Tongluo Huatan capsules by HPLC. METHODS The quantitative analysis was carried out on Agilent Eclipse XDB C;column, using mobile phase consisting of acetonitrile(A)-0.1% formic acid solution(B) by a gradient elution program(0-20 min, 5%A→25%A;20-40 min, 25%A→40%A;40-60 min, 40%A→85%A) at a flow rate of 1 mL·min^(-1)at 30 ℃. The detection wavelength was set at 220 nm, and changed to 203 nm between 35 and 45 min. RESULTS The linear ranges of adenosine, gallic acid, gastrodin, 4-hydroxybenzyl alcohol, salvianolic acid B, tauroursodeoxycholic acid, ginsenoside Rb;, taurochenodeoxycholic acid, aloe-emodin, rhein, emodin, chrysophanol, physcion, and tanshinone Ⅱ;fell within the ranges of 0.040 58-0.811 6, 0.042 43-0.848 6, 0.040 24-0.804 8, 0.059 71-1.194, 0.351 6-7.031, 0.178 4-3.568, 0.206 7-4.133, 0.161 1-3.222, 0.016 18-0.323 6, 0.020 96-0.419 2, 0.031 87-0.637 4, 0.020 06-0.401 2, 0.010 63-0.212 6 and 0.021 92-0.438 4 μg, respectively. The recoveries were 98.2%, 99.2%, 99.1%, 98.9%, 99.3%, 99.6%, 98.9%, 99.1%, 98.9%, 98.7%, 99.1%, 98.9%, 98.7% and 99.2%, respectively. The relative standard deviations were 1.0%, 1.4%, 1.3%, 0.86%, 0.84%, 0.79%, 1.2%, 0.92%, 1.1%, 0.92%, 0.69%, 1.0%, 0.93% and 1.2%, respectively(n=6). CONCLUSION This method is simple, accurate, reproducible and convenient for the quality control of Tongluo Huatan capsules.

关 键 词：高效液相色谱法 通络化痰胶囊 熊胆粉 天麻 三七 丹参 大黄 多种成分同时测定 

分 类 号：R917[医药卫生—药物分析学]