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目的:建立HPLC法测定中成药中D-和L-苦杏仁苷的含量,比较D-和L-苦杏仁苷体外酶解差异,为进一步建立中成药中的苦杏仁安全限量标准奠定基础科学数据。方法:采用Agilent ZORBAX Eclipse Plus C_(18)色谱柱(4.6 mm×250 mm,5μm),以乙腈-10 mmol·L~(-1)磷酸二氢钠水溶液为流动相进行梯度洗脱,流速为1 mL·min~(-1),检测波长为210 nm,柱温为25℃。结果:中成药中的D-和L-苦杏仁苷得到良好分离,在质量浓度2~500 mg·L~(-1)(r=0.999 9)范围内均呈良好线性关系。D-和L-苦杏仁苷在体外β-葡萄糖苷酶的作用下,酶解速率存在明显差异,提示L-苦杏仁苷可能具有不同的药理毒理作用。对于通宣理肺丸这一氰苷类中成药的代表,不同厂家的通宣理肺丸和不同剂型的通宣理肺方中的D-、L-苦杏仁苷含量范围以及异构化比例分别为0.015%~0.117%、0.004%~0.021%和5.06%~48.28%,均存在较大差异。结论:该HPLC方法灵敏简便,可用于中成药中苦杏仁苷的质量控制,所得含量及异构化比例等数据可为氰苷类中成药中苦杏仁的安全限量标准制定提供参考。
OBJECTIVE: To establish an HPLC method for the determination of D- and L-amygdalin in Chinese patent medicines. To compare the differences of D- and L-amygdal in vitro enzymatic hydrolysis and establish basic scientific data for further establishing the safety limit of bitter almonds in proprietary Chinese medicines . Methods: The gradient elution was carried out on an Agilent ZORBAX Eclipse Plus C_ (18) column (4.6 mm × 250 mm, 5 μm) using a mobile phase of acetonitrile-10 mmol·L -1 sodium dihydrogenphosphate as mobile phase at a flow rate of 1 mL · min -1, the detection wavelength was 210 nm and the column temperature was 25 ℃. RESULTS: The separation of D- and L-amygdalin from Chinese patent medicines was well-established and showed a good linear relationship in the range of 2 ~ 500 mg · L -1 (r = 0.999 9). In vitro, the rate of enzymolysis of D- and L-amygdaloside was significantly different, suggesting that L-amygdalin may have different pharmacological and toxicological effects. For Tongxuanfeifei pill on behalf of the cyanogen class of proprietary Chinese medicines, different manufacturers Tong Xuanfei lung pills and different forms of Tongxuanlixin Fang D-, L-amygdalin content range and the ratio of isomerization 0.015% ~ 0.117%, 0.004% ~ 0.021% and 5.06% ~ 48.28%, there is a big difference. Conclusion: The HPLC method is sensitive and simple, and it can be used for the quality control of amygdalin in Chinese patent medicines. The data of the content and the isomerization ratio can provide a reference for the safety standard of bitter almonds in cyanogenic Chinese medicines.