南瓜子饮片标准汤剂的制备及质量标准的研究

Study on preparation and quality standard of pumpkin seed standard decoction

目的 制备南瓜子饮片标准汤剂,建立其质量评价方法,为制定南瓜子配方颗粒质量标准提供参考依据。方法 按照传统煎煮方法制备15批南瓜子饮片标准汤剂,测定其出膏率范围,并建立了饮片标准汤剂质量标准,包括采用薄层色谱法(TLC)以丙氨酸为对照进行定性鉴别,采用高效液相色谱法(HPLC)建立特征图谱及质量分数测定方法,并计算其转移率。结果 15批南瓜子饮片标准汤剂出膏率范围为10.4%~18.3%,均值为15.1%;薄层色谱斑点清晰,分离度好,比移值适当;苯丙氨酸质量分数范围为0.56~1.99 mg/g,均值为1.43 mg/g,转移率范围为42.7%~86.1%,均值为69.7%,所建立的特征图谱呈现13个特征峰,相似度均大于0.9。结论 建立了南瓜子饮片标准汤剂的质量标准,测定方法全面、准确,可为南瓜子配方颗粒的标准制定提供参考。

Objective The pumpkin seed standard decoction was prepared,and its quality evaluation method was established to provide reference for the formulation of pumpkin seed formula granules quality standard.Methods According to the traditional decocting method,15 batches of pumpkin seed standard decoction were prepared,and the range of the paste yield was determined.The quality standard of the standard decoction was established,including the qualitative identification with alanine by TLC,the establishment of characteristic spectra and mass fraction determination method by HPLC,and the calculation of their transfer rate.Results The extraction rate of 15 batches of pumpkin seed standard decoction ranged from 10.4%to 18.3%,with an average of 15.1%.TLC spots were clear,the separation degree was good,and the specific shift value was appropriate.The mass fraction of phenylalanine ranged from 0.56 to 1.99 mg/g with an average value of 1.43 mg/g,and the transfer rate ranged from 42.7%to 86.1%with an average value of 69.7%.The established eigenmaps showed 13 characteristic peaks,and the similarity was all greater than 0.9.Conclusion The established method of quality standard of pumpkin seed standard decoction is comprehensive and accurate,which can provide reference for the formulation of pumpkin seed formula granules.