三七总皂苷肠溶微丸的含量测定及体外释放度考察  

Content Determination and in Vitro Release of Panax Notoginseng Saponins Enteric-Coated Pellets

作　　者：文丽 刘华钢 罗轶 赖玲[3] 陆仕华 秦艳娥[4] WEN Li;LIU Huagang;LUO Yi;LAI Ling;LU Shihua;QIN Yan'e(Guangxi Institute for Food and Drug Control,Key Laboratory of Quality Monitoring and Evaluation of Chinese Materia Medica,National Medical Products Administration,Nanning Guangxi 530021,China;Guangxi Zhuang Autonomous Region Drug Administration,Nanning Guangxi 530029,China;Guangxi Medical University,Nanning Guangxi 530021,China;Nanning First People's Hospital,Nanning Guangxi 530000,China)

机构地区：[1]广西壮族自治区食品药品检验所/国家药品监督管理局中药材质量监测与评价重点实验室,广西南宁530021 [2]广西壮族自治区药品监督管理局,广西南宁530029 [3]广西医科大学,广西南宁530021 [4]南宁市第一人民医院,广西南宁530000

出　　处：《中医药导报》2022年第6期44-48,共5页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：广西自然科学基金资助项目(2010GXNSFB013068);广西企业科技特派员专项项目(桂科攻09321049)。

摘　　要：目的:建立三七皂苷R_(1)、人参皂苷Rg_(1)和人参皂苷Rb_(1)在三七总皂苷(PNS)肠溶微丸中的含量测定方法,并考察其体外释放度,为其质量控制提供依据。方法:采用HPLC法,色谱柱为XB-C_(18)(4.6 mm×250 mm,5μm),流动相为乙腈-水,梯度洗脱,流速为1.0 mL·min^(-1),柱温为30℃,检测波长为203 nm,加样量为20μL。按照2020年版《中华人民共和国药典》通则0931溶出度和释放度测定法,测定PNS在酸中和磷酸盐缓冲液中的释放度。结果:供试品中3种皂苷分离良好,线性关系良好;三七皂苷R_(1)、人参皂苷Rg_(1)和人参皂苷Rb_(1)的线性范围分别为3.477~111.250、4.517~114.985、4.783~152.100μg·mL^(-1);检测限分别为0.584、0.631、0.565μg·mL^(-1),3批制剂中三七皂苷R_(1)、人参皂苷Rg_(1)和人参皂苷Rb_(1)含量分别为10.40%、53.01%、32.49%,与PNS原料中的含量无明显差异,说明PNS主要有效成分的含量在制备过程中没有发生明显变化;三七皂苷R_(1)、人参皂苷Rg_(1)和人参皂苷Rb_(1)在酸中释放量<10%,在pH值=6.8的磷酸盐缓冲液中45 min累积释放量>70%,说明3批制剂的体外释放度具有良好的稳定性和重现性。结论:该方法可以准确、快速的实现PNS肠溶微丸中多种皂苷类成分的定量测定,可用于PNS肠溶微丸的质量控制。Objective:To establish a method for the determination of notoginsenoside R_(1),ginsenoside Rg_(1) and ginsenoside Rb_(1) in Panax notoginseng saponins(PNS)enteric-coated pellets,and to investigate their in vitro release to provide a basis for their quality control.Methods:HPLC method was used.The column was XB-C_(18)(4.6 mm×250 mm,5μm).The mobile phase was acetonitrile-water with gradient elution.The flow rate was 1.0 mL·min^(-1),the column temperature was 30℃,the detection wavelength was 203 nm,and the sample volume was 20μL.The dissolution and release of PNS in hydrochloric acid and phosphate buffer solution were determined according to the dissolution and release determination method of General Rule 0931 of Chinese Pharmacopoeia(2020 Edition).Results:The three saponins in the test product were well separated and had a good linear relationship.The linear ranges of notoginsenoside R_(1),ginsenoside Rg_(1) and ginsenoside Rb_(1) were 3.477-111.250,4.517-114.985,4.783-152.100μg·mL^(-1),respectively.The limits were 0.584,0.631,0.565μg·mL^(-1),respectively.The contents of notoginsenoside R_(1),ginsenoside Rg_(1) and ginsenoside Rb_(1) in PNS in the three batches of preparations were 10.40%,53.01% and 32.49%,respectively.There was no significant difference in the contents of notoginsenoside R_(1),ginsenoside Rg_(1) and ginsenoside Rb_(1) between PNS and PNS raw materials,indicating that the contents of main effective components of PNS did not change significantly during the preparation process.The release amount of notoginsenoside R_(1),ginsenoside Rg_(1) and ginsenoside Rb_(1) in hydrochloric acid was less than 10%,and the cumulative release amount inphosphate buffer solution with pH value of 6.8 for 45 min was more than 70%,indicating that the in vitro release of the three batches of preparations has good stability and reproducibility.Conclusion:This method can accurately and rapidly realize the quantitative determination of various saponins in PNS enteric-coated pellets,and can be used for the quality co

关 键 词：三七总皂苷 肠溶微丸 含量测定 释放度 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]