以标准汤剂为基准的仙灵脾(淫羊藿)配方颗粒量值传递研究

Study on Process Quantitative Transfer Law of Xianlingpi (Epimedium Brevicornum Maxim) Formula Granules Based on Standard Decoction

关键词:  仙灵脾(淫羊藿)配方颗粒  双霍苷A  标准汤剂  特征图谱  量值传递

Key words:  Xianlingpi (Epimedium brevicornum Maxim.) formula granules  diphylloside A  standard decoction  characteristic chromatogram  quantitative transfer relationship

摘要:

目的 以仙灵脾（淫羊藿）标准汤剂为基准，研究指标成分在药材-饮片-标准汤剂-配方颗粒的量值传递规律。方法 制备15批仙灵脾标准汤剂样品，建立仙灵脾特征图谱及以双霍苷A为指标的含量测定，辅以出膏率及转移率分析仙灵脾药材-饮片-标准汤剂-配方颗粒量值传递规律。结果 15批标准汤剂出膏率为8.7%~17.0%；双霍苷A的含量为46.0~145.8 mg·g-1，转移率为30.0%~63.6%；仙灵脾药材中双霍苷A含量为23.2~48.3 mg·g-1，相应饮片中双霍苷A含量为24.9~49.3 mg·g-1，配方颗粒中双霍苷A含量为83.2~97.4 mg·g-1，其饮片-药材转移率为88.4%~102.1%，配方颗粒指标成分转移率为49.3%~56.1%。特征图谱结果中仙灵脾药材、饮片、标准汤剂和配方颗粒共指认5个共有峰，峰1（S）为双藿苷A，峰2为朝藿定A，峰3为朝藿定C，峰5为宝藿苷II，峰4相对保留时间均在规定范围内。结论 以仙灵脾标准汤剂为基准，其药材-饮片-标准汤剂-配方颗粒中双霍苷A，5个特征峰的传递规律稳定，均在标准汤剂范围内，说明仙灵脾（淫羊藿）配方颗粒制备工艺及质量稳定，与仙灵脾（淫羊藿）标准汤剂等效。

Abstract:

OBJECTIVE To study the quantitative transfer law of Xianlingpi (Epimedium brevicornum Maxim.) herb- herbal pieces- standard decoction- formula granules based on index component of standard decoction. METHODS 15 batches of standard decoction samples of Xianlingpi were prepared, and the content and characteristic chromatogram determination methods were established. Based on this, the quantitative transfer law of herb- herbal pieces- standard decoction- formula granules was analyzed supplemented with the yeild rate and the transfer rate. RESULTS The results of 15 batches of standard decoction showed that the yield rate ranged from 8.7% to 17.0 %. The content of diphylloside A in Xianlingpi ranged from 46.0 mg·g-1 to 145.8 mg·g-1 and the transfer rate of standard decoction ranged from 30.0 % to 63.6 %. The content range of diphylloside A in Xianlingpi herbs was 23.2 mg·g-1~ 48.3 mg·g-1 and tthe content range of diphylloside A in Xianlingpi decoction pieces was 24.9 mg·g-1~ 49.3 mg·g-1. Meanwhile, the content of diphylloside A in Xianlingpi formula granules ranged from 83.2 mg·g-1 to 97.4 mg·g-1. The transfer rate of herbal pieces to herbs ranged from 88.4% to 102.1% and the transfer rate of formula granules was 49.3% to 56.1%. Five common peaks were identified in Xianlingpi herbs, herbal pieces, standard decoction and formula granules with four characteristic peaks identified for the peak 1 of diphylloside A, peak 2 of epimedin A, peak 3 of epimedin C and peak 5 of ikarisoside A.and the relative retention time of peak 4 was within the specified range. CONCLUSION The quantitative transfer relationship of Xianlingpi herb-herbal pieces-standard decoction-formula granules is stable and within the range of standard decoction, indicating that the technology and quality of Xianlingpi formula granule are stable and equivalent to standard decoction.