目的 建立骨痛寧膠囊的質(zhì)量控制方法。方法 用薄層色譜（TLC）法鑒別骨痛寧膠囊的主要成分當(dāng)歸、川芎和白芍，用高效液相色譜-蒸發(fā)光散射檢測（HPLC-ELSD）法測定黃芪甲苷的量，以Diamonsil C₁₈（250 mm×4.6 mm，5 μm）柱為色譜柱，流動相為乙腈-水（34：66），體積流量為1.0 mL/min，柱溫30 ℃；ELSD條件：漂移管溫度為105 ℃，高純氮?dú)怏w積流量為2.5 L/min。結(jié)果 薄層色譜斑點(diǎn)清晰，分離度良好，陰性對照無干擾。黃芪甲苷在1.02～6.12 μg線性關(guān)系良好（r=0.999 1），平均回收率為99.61%，RSD為2.80%。結(jié)論 該方法操作簡便，結(jié)果準(zhǔn)確、可靠，重復(fù)性好、專屬性強(qiáng)，可用于該制劑的質(zhì)量控制。

Objective To establish the quality standard for Gutongning Capsules. Methods Angelicae Sinensis Radix, Chuanxiong Rhizoma, and Paeoniae Alba Radix in Gutongning Capsules were identified by TLC. The content of astragaloside IV was determined by HPLC-ELSD. Using Diamonsil C₁₈ column (250 mm × 4.6 mm, 5 μm), the mobile phase was acetonitrile-water (34:66), The flow rate was 1.0 mL/min. Column temperature was 30℃; ELSD conditions: drift tube temperature of 105℃, high purity nitrogen flow rate of 2.5 L/min. Results The TLC spots were clear and well separated without negative interference. The measured value of astragaloside Ⅳ showed a good linear correlation between 1.02-6.12 μg (r=0.999 1). The average recovery was 99.61% and RSD was 2.80%. Conclusion The method is simple, accurate, reproductive, and highly specific. It can be used to control the quality of Gutongning Capsule.

中國中醫(yī)科學(xué)院自主選題項(xiàng)目（No.2011xycz-11）