目的 建立HPLC法同時測定婦科養(yǎng)榮膠囊中梓醇、地黃苷D、益母草苷、棕矢車菊素、異澤蘭黃素、洋川芎內(nèi)酯 H、洋川芎內(nèi)酯I、洋川芎內(nèi)酯A和藁本內(nèi)酯的含量的方法，結(jié)合化學(xué)計量學(xué)對其質(zhì)量進行評價。方法 采用Agilent Extend XDB-C₁₈色譜柱（250 mm×4.6 mm，5 μm）；流動相乙腈-0.2%磷酸溶液，梯度洗脫，體積流量1.0 mL/min；柱溫30℃，檢測波長210 nm（檢測梓醇、地黃苷D和益母草苷）、345 nm（檢測棕矢車菊素和異澤蘭黃素）和280 nm（檢測洋川芎內(nèi)酯 H、洋川芎內(nèi)酯I、洋川芎內(nèi)酯A和藁本內(nèi)酯）；采用聚類分析、主成分分析等化學(xué)計量學(xué)方法對婦科養(yǎng)榮膠囊進行質(zhì)量評價。結(jié)果 9種成分分別在5.53～110.60、1.97～39.40、2.29～45.80、0.66～13.20、1.74～34.80、1.36～27.20、2.68～53.60、3.41～68.20、9.27～185.40 μg/mL線性關(guān)系良好（r≥0.999 1），平均加樣回收率（RSD）分別為99.91%（0.67%）、98.67%（1.18%）、97.94%（1.07%）、96.76%（0.96%）、98.13%（1.32%）、97.97%（1.66%）、99.89%（0.87%）、100.11%（0.75%）、100.03%（0.84%）；10批樣品聚類分析分為2類，各成分含量差異與生產(chǎn)階段有關(guān)。結(jié)論 該方法操作簡便、重復(fù)性好，可用于婦科養(yǎng)榮膠囊的質(zhì)量控制。

Objective To set up an HPLC gradient elution method of catalpol, rehmannioside D, ajugol, jaceosidin, eupatilin, senkyunolide H, senkyunolide I, senkyunolide A and ligustilide in Fuke Yangrong Capsules simultaneously. Methods The Agilent Extend XDB-C₁₈ (250 mm×4.6 mm, 5 μm) chromatographic column was used, with mobile phase composed of acetonitrile-0.2% phosphoric acid solution as a mobile phase in gradient elution, the flow rate was 1.0 mL/min, the column temperature was 30 ℃. The detection wavelength were 210 nm for catalpol, rehmannioside D and ajugol, 345 nm for jaceosidin and eupatilin, and 280 nm for senkyunolide H, senkyunolide I, senkyunolide A and ligustilide, Quality evaluation of Fuke Yangrong Capsules by cluster analysis and principal component analysis with SPSS 26.0 software. Results Nine constituents showed good linear relationships within the ranges of 5.53—110.60, 1.97—39.40, 2.29—45.80, 0.66—13.20, 1.74—34.80, 1.36—27.20, 2.68—53.60, 3.41—68.20, 9.27—185.40 μg/mL(r ≥ 0.999 1), whose average recoveries were 99.91%, 98.67%, 97.94%, 96.76%, 98.13%, 97.97%, 99.89%, 100.11% and 100.03% with the RSD of 0.67%, 1.18%, 1.07%, 0.96%, 1.32%, 1.66%, 0.87%, 0.75% and 0.84%, respectively. The samples of 10 batches of Fuke Yangrong Capsules could be divided into two categories, the content difference of each component is related to the production stage. Conclusion The simple,accurate and repeatable method can be used for quality control of multiple indicator components in Fuke Yangrong Capsules.

R284.1

湖南省衛(wèi)生健康委科研計劃項目（20200121）