目的 建立中药配方颗粒辅料麦芽糊精的检测方法，为中药配方颗粒质量评价提供分析技术支持。方法 建立配方颗粒中果糖、葡萄糖、蔗糖、麦芽糖、乳糖的HPLC定量检测方法，根据样品经糖化酶水解后的葡萄糖增加量换算出麦芽糊精含量。基于中药浸膏与麦芽糊精不同比例混合物的中红外光谱（mid-infrared spectroscopy，MIRS）特征峰差异，建立配方颗粒中麦芽糊精的半定量检测方法。结果 所建立的HPLC方法可以准确定量检测配方颗粒中果糖、葡萄糖、蔗糖、麦芽糖、乳糖。如果中药浸膏自身含有较多可经糖化酶水解产生葡萄糖的成分（淀粉、蔗糖等），HPLC检测配方颗粒中麦芽糊精时存在系统性正误差，可通过中药浸膏酶解后葡萄糖增加量、待测样品酶解后蔗糖减小量等部分修正正误差。如果中药浸膏自身少含或不含淀粉、蔗糖等可经糖化酶水解产生葡萄糖的成分，HPLC检测配方颗粒中麦芽糊精时存在系统性负误差，换算公式偏差、麦芽糊精纯度、样品处理损失等导致根据样品酶解后葡萄糖增加量计算的麦芽糊精“检测含量”预期低于根据生产投料计算的麦芽糊精“名义含量”。麦芽糊精含量越高，配方颗粒MIRS中1200～900 cm^-1区域的最强峰位置和整体谱带特征越接近于麦芽糊精，可以据此直观判断样品中麦芽糊精含量范围。结论 检测中药配方颗粒辅料麦芽糊精时，灵敏、准确的HPLC定量检测可作为参考方法，简便、绿色的MIRS半定量检测可作为快检方法。

Objective To develop the determination methods for the excipient maltodextrin in traditional Chinese medicine formula granule (TCM FG), in order to provide analytical technical supports for the quality assessment of TCM FG. Methods A HPLC method was established for the quantitative determination of fructose, glucose, sucrose, maltose and lactose in TCM FG. The content of maltodextrin was calculated based on the increase of glucose after the amyloglucosidase-catalyzed hydrolysis of the sample. Mid-infrared spectroscopy (MIRS) method for the semi-quantitative determination of maltodextrin in TCM FG was developed according to the characteristic peaks of the mixtures of TCM extract and maltodextrin with different mass ratios. Results Fructose, glucose, sucrose, maltose and lactose in TCM FG can be determined accurately by the HPLC method. Positive systematic errors for the HPLC determination of maltodextrin in TCM FG can be observed when the TCM extract contains a lot of ingredients (such as starch and sucrose) that can be enzymatically hydrolyzed to generate glucose. These positive errors may be partly corrected according to the increase of glucose after the enzymatic hydrolysis of the pure extract or the decrease of sucrose after the enzymatic hydrolysis of the sample. Negative systematic errors for the HPLC determination of maltodextrin in TCM FG can be observed when the TCM extract contains few ingredients (such as starch and sucrose) that can be enzymatically hydrolyzed to generate glucose. The detected content of maltodextrin calculated from the increase of glucose after the enzymatic hydrolysis of the sample should be lower than the nominal content of maltodextrin calculated from the production formula of the sample because of the bias of the conversion equation, the purity of maltodextrin, and the mass loss during the sample preparation. As the increase of maltodextrin, the position of the strongest peak and the whole band features in the range of 1200-900 cm^-1 of MIRS of TCM FG sample become more similar to maltodextrin, allowing for an intuitive estimation of the maltodextrin content range.. Conclusion For the determination of maltodextrin in TCM FG, the sensitive and accurate HPLC quantitative method can be used as the reference method, while the simple and green MIRS semi-quantitative method can be used for the rapid analysis.

R283.6

国家自然科学基金项目（82003943）