痰热清注射液中熊胆粉部分指纹图谱和成分测定  

Determination of fingerprint of bear bile powder in Tanreqing Injection and its main components

作　　者：简龙海[1] 闻宏亮[1] 毛秀红[1] 夏晶[1] 王柯[1] 季申[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《中成药》2013年第1期109-113,共5页Chinese Traditional Patent Medicine

摘　　要：目的建立HPLC-UV法测定痰热清注射液中熊胆粉部分的指纹图谱并定量测定其中熊去氧胆酸、鹅去氧胆酸。方法 Waters Atlantis C18色谱柱(4.6mm×15cm,5μm),流动相为乙腈-0.1%磷酸,梯度洗脱,测定波长为203nm。结果痰热清注射液中熊胆粉部分具4个共有峰,包括熊去氧胆酸、鹅去氧胆酸。13批样品的指纹图谱相似度较高。熊去氧胆酸、鹅去氧胆酸分别在进样量6.532～685.6μg、2.605～208.4μg范围内线性关系良好(r均为0.999 9),平均回收率(n=9)分别为99.2%、100.4%,RSD分别为2.0%、2.5%。结论该方法可用于痰热清注射液中熊胆粉部分的质量控制。AIM To set up a method of simultaneously determining the fingerprint of bear bile powder in Tanreqing Injection and its main components by HPLC-UV. METHODS The samples were directly analyzed hy HPLC-UV. A Waters Atlantis C18 column （4.6 mm× 15 cm, 5 μm） was adopted and the mobile phase was comprised of acetonitrile-0. 1% phosphoric acid in gradient elution mode. The detection wavelength was set at 203 nm. RESULTS Four co-possessing peaks from bear bile powder in Tanreqing Injection were confirmed, including ursodesoxycholic acid and chenodeoxycholic acid. The similarity results of thirteen batches of samples showed high in fingerprint. The linear ranges of ursodesoxycholic acid and chenodeoxycholic acid were 6. 532-685.6 μg （r = 0. 999 9） and 2. 605-208.4 μg （ r = 0. 999 9）, respectively. The average recoveries （ n = 9） were 99.2% （ RSD of 2.0% ） and 100. 4% （RSD of 2.5% ）, respectively. CONCLUSION The method can be used for quality control of Tanreqing Injection.

关 键 词：痰热清注射液 HPLC 熊胆粉 指纹图谱 熊去氧胆酸 鹅去氧胆酸 

分 类 号：R286[医药卫生—中药学]