基于标准汤剂的鲜地黄配方颗粒质量标准研究  

Study on quality standard of fresh Rehmanniae Radix formula granules based on standard decoction

作　　者：张志鹏 徐杰 刘佩仪 黄梦婷 钟志奎 程学仁 ZHANG Zhi-peng;XU Jie;LIU Pei-yi;HUANG Meng-ting;ZHONG Zhi-kui;CHENG Xue-ren(Guangdong Provincial Key Laboratory of Traditional Chinese Medicine Formula Granule,Guangdong Yifang Pharmaceutical Co.,Ltd.,Foshan 528244,China;China Traditional Chinese Medicine Holdings Co.,Ltd.,Foshan 528300,China)

机构地区：[1]广东一方制药有限公司,广东省中药配方颗粒企业重点实验室,广东佛山528244 [2]中国中药控股有限公司,广东佛山528300

出　　处：《中草药》2023年第4期1127-1137,共11页Chinese Traditional and Herbal Drugs

基　　金：广东省科技计划项目(2018B030323004);广东特支计划科技创业领军人才项目(2017TY04R197)。

摘　　要：目的 建立基于标准汤剂的鲜地黄配方颗粒质量标准,为鲜地黄配方颗粒质量控制提供参考。方法 根据《中药配方颗粒质量控制与标准制定技术要求》,制备25批鲜地黄标准汤剂,测定各批次标准汤剂的出膏率、指标成分梓醇和地黄苷D的含量,构建能全面表征鲜地黄环烯醚萜苷类成分和苯乙醇苷类成分的UPLC特征图谱;基于标准汤剂出膏率、指标成分含量、特征图谱的一致性,制备3批鲜地黄配方颗粒,验证制定标准的合理性。结果 鲜地黄标准汤剂出膏率实测范围为13.93%~20.09%;梓醇和地黄苷D的质量分数分别为36.14~73.37、2.96~5.33 mg/g;环烯醚萜苷类成分特征图谱共标定了10个共有峰,指认峰3、4、6分别为梓醇、地黄苷D、益母草苷;苯乙醇苷类成分特征图谱共标定了8个共有峰,指认峰1、4、5、6分别为洋地黄叶苷C、毛蕊花糖苷、焦地黄苯乙醇苷B1、异毛蕊花糖苷;3批鲜地黄配方颗粒出膏率、指标成分含量、特征图谱均与同批次药材制备的标准汤剂接近,且均在质量标准规定范围内。结论 该研究建立的基于标准汤剂的鲜地黄配方颗粒质量标准科学合理、稳定可行,可为鲜地黄配方颗粒的质量控制提供参考。Objective The quality standard of fresh Rehmanniae Radix formula granules based on standard decoction was established to provide reference for the quality control of fresh Rehmanniae Radix formula granules. Methods According to the Technical Requirements for Quality Control and Standard Formulation of Chinese Medicine Formula Granules, 25 batches of fresh Rehmannia standard decoction were prepared, the extraction rate and the contents of catalpol and rehmannioside D were determined in each batch of standard decoction, and the UPLC characteristic chromatogram that can fully characterize the iridoid glycosides and phenylethanolic glycosides of fresh Rehmanniae Radix was constructed;Three batches of fresh Rehmanniae Radix formula granules were prepared based on the consistency with the extraction rate, index component content and characteristic chromatogram of the standard decoction to verify the rationality of the standard formulation. Results The measured range of the extraction rate of fresh Rehmanniae Radix standard decoction was 13.93%—20.09%;The measured contents of catalpol and rehmannioside D were 36.14—73.37 mg/g and 2.96—5.33 mg/g;Ten common peaks were identified in the characteristic chromatogram of iridoid glycosides. The identified peaks 3, 4 and 6 were catalpol, rehmannioside D and leonuride;Eight common peaks were calibrated in the characteristic chromatogram of phenylethanolic glycosides, and peaks 1, 4, 5 and 6 were identified as purpureaside C, verbascoside, jionoside B1and isoacteoside;The extract rate, index component content and characteristic chromatogram of the three batches of fresh Rehmanniae Radix formula granules were close to the standard decoction prepared from the same batch of medicinal materials, and were within the scope of the quality standard. Conclusion The quality standard of fresh Rehmanniae Radix formula granules based on standard decoction established in this study is scientific, reasonable, stable and feasible, and can provide a reference for the quality control of fres

关 键 词：鲜地黄 标准汤剂 配方颗粒 质量标准 梓醇 地黄苷D 益母草苷 洋地黄叶苷C 毛蕊花糖苷 焦地黄苯乙醇苷B1 异毛蕊花糖苷 

分 类 号：R283.6[医药卫生—中药学]