以标准汤剂为基准的小红参配方颗粒量值传递研究

Quantitative transfer relationships of Rubia yunnanensis Diels formula granules based on standard decoctions

目的以标准汤剂中出膏率、小红参萘酚苷A含量和特征图谱为基准,研究配方颗粒的量值传递规律。方法制备小红参标准汤剂样品,建立小红参萘酚苷A含量及特征图谱测定方法,以其为基准进行药材-饮片-标准汤剂-配方颗粒量值传递研究。结果15批标准汤剂结果表明,出膏率范围为15.3%~28.4%;小红参萘酚苷A的含量范围为15.83~29.39 mg·g^(-1),转移率范围为21.79%~40.47%;共标定6个特征峰,指认峰1小红参萘酚苷A、峰4小红参醌苷乙2个特征峰。收集不同来源15批次小红参药材、饮片及3批中试配方颗粒,并测定小红参萘酚苷A含量及特征图谱,小红参药材中小红参萘酚苷A含量范围为14.32~19.79 mg·g^(-1);小红参饮片中小红参萘酚苷A含量范围为12.71~18.81 mg·g^(-1);小红参配方颗粒中小红参萘酚苷A含量范围为18.71~19.80 mg·g^(-1);其饮片-药材转移率范围为64.41%~119.62%;标准汤剂-饮片转移率范围为21.79%~40.47%;饮片-配方颗粒转移率为26.10%~28.73%。特征图谱结果中小红参药材、饮片、配方颗粒均检测出6个特征峰,且相对保留时间均在规定范围内。结论以小红参标准汤剂为基准,其药材-饮片-标准汤剂-配方颗粒中小红参萘酚苷A,6个特征峰的传递规律稳定,均在标准汤剂范围内,说明小红参配方颗粒制备工艺及质量稳定,与标准汤剂等效。

Objective To study the quantitative transfer relationships of Rubia yunnanensis Diels granules based on extraction rates,contents of Rubinaphthin A and characteristic chromatograms of standard decoctions.Methods The standard decoction samples of Rubia yunnanensis Diels were prepared before a method for determination of contents and characteristic chromatograms was established.The quantitative transfer relationships between herb-herbal pieces,standard decoctions,and formula granules were studied.Results The results of study on 15 batches of standard decoctions showed that the extraction rates ranged from 15.3% to 28.4%,the content of Rubinaphthin A in Rubia yunnanensis Diels ranged from 15.83 mg·g^(-1) to 29.39 mg·g^(-1) and the transfer rate ranged from 21.79% to 40.47%.A total of six characteristic chromatogram were identified,with two characteristic peaks identified for peak 1 of Rubinaphthin A and peak 4 of Rubinaphthin A.Fifteen batches of Rubia yunnanensis Diels herbs and herbal pieces and three batches of pilot formula granules from different sources were collected.The content of Rubinaphthin A in Rubia yunnanensis Diels herbs ranged from 14.32 mg·g^(-1) to 19.79 mg·g^(-1),from 12.71 mg·g^(-1) to 18.81 mg·g^(-1) in herbal pieces,and from 18.71 mg·g^(-1) to 19.80 mg·g^(-1) in formula granules.The transfer rate of herbal pieces to herbs ranged from 64.41% to 119.62%,that of standard decoction to herbal pieces from 21.79% to 40.47%,and that of herbal pieces to formula granules from 26.10% to 28.73%.Six characteristic peaks were detected in Rubia yunnanensis Diels herbs,herbal pieces and formula granules,and the relative retention time was within the specified range.Conclusion The quantitative transfer relationships between herb-herbal pieces,standard decoctions,and formula granules of Rubia yunnanensis Diels are stable and within the range of standard decoctions,indicating that the quality of Rubia yunnanensis Diels formula granules is stable and equivalent to standard decoctions.