枳实饮片标准汤剂的质量控制

目的：建立枳实饮片标准汤剂的质量控制方法，为枳实配方颗粒及其他枳实相关产品的质量评价提供参考。方法：从市场上收集了不同品质的16批枳实饮片，其中包括13批酸橙枳实和3批甜橙枳实，按标准化煎煮工艺制备枳实饮片标准汤剂，以辛弗林转移率、标准汤剂的出膏率和pH等为综合评价指标，建立枳实饮片标准汤剂的质量控制体系。结果：13批酸橙枳实饮片标准汤剂中辛弗林转移率处于35.7%~92.7%，平均转移率61.9%；3批甜橙枳实饮片标准汤剂中辛弗林转移率处于53.1.%~84.4%，平均转移率73.2%。13批酸橙枳实饮片标准汤剂的出膏率处于20.7%~43.8%，平均出膏率28.4%；3批甜橙枳实饮片标准汤剂的出膏率范围为13.8%~17.6%，平均出膏率15.4%。说明酸橙枳实饮片标准汤剂的出膏率高于甜橙枳实饮片标准汤剂的出膏率。13批酸橙枳实饮片标准汤剂的pH 4.48~5.32，平均pH 4.99；3批甜橙枳实饮片标准汤剂的pH 4.77~5.38，平均pH 5.06。与相应的对照指纹图谱相比，13批酸橙枳实饮片标准汤剂的HPLC指纹图谱相似度均>0.9，找到6个共有峰，其中3个指认为柚皮苷、橙皮苷和新橙皮苷；3批甜橙枳实饮片标准汤剂的HPLC指纹图谱相似度均>0.9，找到2个共有峰，其中1个指认为橙皮苷。酸橙枳实饮片标准汤剂图谱中的色谱峰数量明显多于甜橙枳实饮片标准汤剂。结论：建立的质量评价方法精密度、重复性、稳定性良好，适用于枳实相关产品的质量评价。酸橙和甜橙的枳实饮片标准汤剂应该作为2个品种，不同基原枳实饮片标准汤剂应该分别进行研究。以枳实为例，建议多基原的中药配方颗粒以“种名+中药饮片+配方颗粒”的形式命名。

Quality Control of Standard Decoction of Aurantii Fructus Immaturus

Objective: To establish a quality control method of standard decoction of Aurantti Fructus Immaturus(AFI),and to provide reference for quality evaluation of AFI dispensing granules and other related products of AFI. Method: A total of 16 batches of AFI pieces with different quality were collected from the market,including 13 batches of Citrus aurantium and 3 batches of C. sinensis,and the standard decoction of AFI was prepared according to the standard decoction process.Transfer rate of synephrine,dry extract rate and others of the standard decoction were regarded as evaluation indicators and relative assessment are conducted. Result: Transfer rates of synephrine in 13 batches of standard decoction of AFI(C. aurantium) were ranged from 35.7% to 92.7% with the average value was 61.9%;dry extract rates were varied from 20.7% to 43.8% and the average value was 28.4%;pH values were 4.48-5.32 with the average value was 4.99;the HPLC fingerprint similarities were >0.9 by comparing with the corresponding control fingerprint,6 common peaks were found and 3 of them were identified as naringin,hesperidin and neohesperidin.Transfer rates of synephrine in 3 batches of standard decoction of AFI(C. sinensis) were changed from 53.1% to 84.4%,and the average value was 73.2%;dry extract rates were shifted from 13.8% to 17.6% and the average value was 15.4%;pH values were 4.77-5.38 with the average value was 5.06;the HPLC fingerprint similarities were >0.9 by comparing with the corresponding control fingerprint,2 common peaks were found and one of them were identified as hesperidin. Conclusion: From the HPLC fingerprint of standard decoction of AFI,we can easily understand that the number of peaks in C. aurantium is obviously more than that of C. sinensis.This method has good precision,reproducibility and stability,it is suitable for quality evaluation for related products of AFI.Simultaneously,the research provides a good reference for identifying sources of AFI.