基于对照制剂的复方丹参片质量评价新模式探讨

目的：以对照制剂为参照物，结合多组分含量测定，建立复方丹参片质量评价新模式。方法：采用YMC Hydrosphere C₁₈色谱柱（4.6 mm×250 mm，5 μm），以乙腈-0.1%磷酸水溶液为流动相进行梯度洗脱，流速1.0 mL·min^-1，柱温30℃，检测波长280 nm，同时测定复方丹参片中丹参素、原儿茶醛、迷迭香酸、丹酚酸B 4个丹参水溶性成分的含量。采用SHISEIDO CAPCELL PAK C₁₈ MGⅡ色谱柱（4.6 mm×250 mm，5 μm），以乙腈-水为流动相进行梯度洗脱，流速1.0 mL·min^-1，柱温30℃，以Alltech 3300蒸发光散射检测器检测，漂移管温度55℃，氮气流速2.0 L·min^-1，同时测定复方丹参片中三七皂苷R₁、人参皂苷Rg₁、人参皂苷Re、人参皂苷Rb₁、人参皂苷Rd 5个三七皂苷类成分的含量。制备复方丹参片对照制剂，将其作为随行对照应用于样品中丹参水溶性成分和三七皂苷类成分的含量测定，对样品的质量进行评价。结果：丹参素、原儿茶醛、迷迭香酸、丹酚酸B、三七皂苷R₁、人参皂苷Rg₁、人参皂苷Re、人参皂苷Rb₁、人参皂苷Rd 9个成分在一定浓度范围内与峰面积呈良好的线性关系，相关系数r不低于0.999 5；平均回收率（n=6）为97.5%~102.6%。11个厂家19批样品中，8批样品中丹参水溶性成分及三七皂苷类成分的含量分别相当于对照制剂的量均≥90.0%，占样品总批数的42.1%，11批样品中丹参水溶性成分及三七皂苷类成分的含量分别相当于对照制剂的量≥70%且<90%，占样品总批数的57.9%。不同厂家产品的质量差异较大。结论：建立的质量评价模式可反映复方丹参片的质量优劣，为建立中成药质量评价新模式提供借鉴和参考。

Objective: Taking reference drug as control,to establish a new quality evaluation model for compound Danshen tablets (CDT) based on multi-component determination. Methods: Simultaneous determination of danshensu,protocatechuic,aldehyde,rosmarinic acid and salvianolic acid B was performed on a YMC Hydrosphere C₁₈ column (4.6 mm×250 mm,5 μm) with acetonitrile-0.1% phosphoric acid as the mobile phase in gradient elution at a flow rate of 1.0 mL·min^-1. The column temperature was 30℃ and the detection wavelength was 280 nm. Simultaneous determination of notoginsenoside R₁,ginsenoside Rg₁,ginsenoside Re,ginsenoside Rb₁ and ginsenoside Rd was performed on a SHISEIDO CAPCELL PAK C₁₈ MGⅡ column (4.6 mm×250 mm,5 μm) with acetonitrile-water as the mobile phase in gradient elution at a flow rate of 1.0 mL·min^-1. The column temperature was 30 and an Alltech 3300 ELSD was used as detector with drift tube temperature of 55 and N₂ flow rate of 2.0 L·min^-1. CDT reference drug was developed and applied as accompanying control in the determination of the contents and quality evaluation of the samples. Results: 4 hydrophilic compounds from Radix Salviae Miltiorrhizae and 5 saponins from Notoginseng Radix et Rhizoma showed good linearity (r ≥ 0.999 5). The average recoveries (n=6) were in the range of 97.5%-102.6%. Among 19 samples from 11 manufactures,the ratio of contents in 8 samples to those in CDT reference drug were above 90%,the ratio in 11 samples were within 70% and 90%,which accounted for 42.1% and 57.9% of all samples,respectively. These results indicated that there were large differences in the quality of CDT from difference enterprises. Conclusion: The proposed quality evaluation model can reflect the quality variation of CDT,which provides reference for establishing new quality evaluation model of Chinese traditional medicine.

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