中国药房2011，Vol.22Issue(44)：4204-4207,4.
HPLC-MS法测定双黄连口服液中木犀草苷和绿原酸的含量并评价二者对成品质量的影响
Content Determination of Galuteolin and Chlorogenic Acid in Shuanghuanglian Oral Solution by HPLC-MS and Evaluation of the Effects of Them on the Quality of Products
摘要
Abstract
OBJECTIVE: To establish the method for the content determination of galuteolin in Shuanghuanglian oral solution, and to investigate the effects of galuteolin and chlorogenic acid on the quality control of products. METHODS: The content of galuteolin was determined by HPLC-MS. The Agilent HC-C18 column was adopted with mobile phase consisted of 0.2% phosphoric acid (A)-acetonitrile(B) with gradient elution at the flow rate of 1.0 mL·min-1. The column temperature was 25 ℃ and the injection volume is 10 μL. The detection wavelength was set at 350 nm. The method for the content determination of chlorogenic acid was same to the method of content determination of Shuanghuanglian oral solution stated in the appendix I of Chinese Pharmacopeia (2010 edition). The effects of galuteolin and chlorogenic acid on the quality control of products were analyzed by determining the contents of galuteolin and chlorogenic acid in 9 batches of Shuanghuanglian oral solution and 4 batches of simulated sample. RESULTS: The linear range of galuteolin was 3.9~39.0 μg·mL-1 (r=0.999 9) with an average recovery of 99.5% (RSD=3.6%). The contents of galuteolin in 9 batches of Shuanghuanglian oral solution were 5.56~30.20 μg·mL-1, there was significant difference. The contents of chlorogenic acid were 0.71~0.94 μg·mL-1, there was no significant difference. The contents of galuteolin in 4 batches of simulated sample were 0~33.28μg·mL-1, there was significant difference. The contents of chlorogenic acid were 1.07~1.23 μg·mL-1, there was no significant difference. CONCLUSION: It's not accurate, specific and effective enough just to inflect the content of Shuanghuanglian oral solution with chlorogenic acid. It is suggested that the content determination of galuteolin is included in the quality control of product.关键词
木犀草苷/绿原酸/双黄连口服液/金银花/高效液相色谱-质谱联用法/含量测定Key words
Galuteolin/ Chlorogenic acid/ Shuanghuanglian oral solution/ Lonicera japonica/ HPLC-MS/ Content determination分类
医药卫生引用本文复制引用
吕海鸿,王雪芹,刘乃强,樊磊磊,李振国,邢向伟..HPLC-MS法测定双黄连口服液中木犀草苷和绿原酸的含量并评价二者对成品质量的影响[J].中国药房,2011,22(44):4204-4207,4.基金项目
河南省科技攻关计划项目(102102310017) （102102310017）
