目的 運用高效液相色譜-高分辨飛行時間質(zhì)譜聯(lián)用（HPLC-TOF-MS）技術(shù)和高效液相色譜串聯(lián)三重四級桿質(zhì)譜（HPLC-MS/MS）法，對產(chǎn)復康顆?；瘜W成分進行快速鑒定及定量分析，并進行初步藥動學研究。方法 HPLC-TOF-MS法采用ZORBAX Eclipse Plus C₁₈（100 mm×3.0 mm，1.8 μm）色譜柱；流動相為乙腈（A）-0.1%甲酸水（B），梯度洗脫，體積流量0.2 mL/min；質(zhì)譜采用正、負離子掃描，掃描范圍m/z 100~2000。HPLC-MS/MS法采用Waters XBridge^® BEH C₁₈（150 mm×4.6 mm，2.5 μm）色譜柱；流動相為乙腈（A）-0.1%甲酸水（B），梯度洗脫，體積流量0.4 mL/min；Scheduled MRM正負離子切換監(jiān)測模式定量分析。ig給予SD大鼠產(chǎn)復康顆粒（0.5、5 g/kg），給藥后于不同時間點頸靜脈取血0.2 mL，分離血漿，HPLC-MS/MS法檢測產(chǎn)復康顆粒入血成分及含量。結(jié)果 HPLC-TOF-MS法鑒定產(chǎn)復康顆粒中24種成分；建立的HPLC-MS/MS方法分離度良好，各方法學驗證均符合要求，對13種主要成分進行定量分析，水蘇堿、黃芪甲苷和益母草堿的含量較高，可能是其主要活性成分；藥動學結(jié)果顯示，僅在給藥劑量5 g/kg時，血漿中可檢測到水蘇堿和益母草堿，水蘇堿的消除較慢，益母草堿快速消除。結(jié)論 該方法簡便、準確，重復性好，可用于產(chǎn)復康顆粒中多種成分的鑒定和含量的測定，為藥材的質(zhì)量控制、藥動學研究提供了參考。

Objective To establish qualitative and quantitative analysis methods for identification and determination of multi-constituent of Chanfukang granules (CFKG) using high performance liquid chromatography-time-of-flight mass spectrometry (HPLC-TOF-MS) and high performance liquid chromatography-triple quadrupole mass spectrometry (HPLC-MS/MS), and a preliminary pharmacokinetic study was carried out. Methods An Agilent ZORBAX Eclipse Plus C₁₈ column (100 mm×3.0 mm, 1.8 μm) and a Waters XBridge^® BEH C₁₈ column (150 mm×4.6 mm, 2.5 μm) were used with 0.1% formic acid aqueous solution-acetonitrile as mobile phases by gradient elution. The compounds were detected by electrospray ion source in both positive and negative mode with multiple reaction monitoring (MRM) mode. SD rats were ig with CFKG (0.5, 5 g/kg). Blood samples of 0.2 mL were taken from jugular vein at different time points and plasma components and contents were determined by HPLC-MS/MS. Results Twenty-four constituents were identified by HPLC-TOF-MS qualitative analysis and thirteen constituents were quantitatively detected by HPLC-MS/MS. The established HPLC-MS/MS method had a good separation, and all the legal verification met the requirements. The content of stachydrine, Leonurine, and astragaloside IV were high, which may be the main active ingredient. The pharmacokinetic results showed that, only when the dose was 5 mg/kg, stachydrine and Leonurine can detected. Elimination of stachydrine was slow and elimination of Leonurine was fast. Conclusion A rapid and efficient method for studying the chemical constituents was established, which could provide reference for the quality control of Chanfukang granules.