高效液相色谱法测定复方丹参片中三七皂苷的含量

摘要

目的：对不同厂家的复方丹参片中的三七皂苷含量进行分析，为临床药物厂商制药改进和监管部门加强监管提供依据。方法采用HPLC法（高效液相色谱法）测定广州白云山制药、广西日田药业、安徽华佗国药厂、通化颐生药业、济南宏济堂制药、长春新安药业、北京北卫药业、吉林省百年六福堂药业八个不同厂家复方丹参片中三七皂苷的含量，并比较不同厂家含量的差异性。结果八个厂家的复方丹参片中三七皂苷的含量分别为0.154%、0.175%、0.7773%、0.8311%、1.3297%、1.3912%、1.5217%、3.1245%，各厂家复方丹参片不同批号间三七皂苷含量无统计学差异，不同厂家复方丹参片中三七皂苷类含量具有显著性差异，但含量普遍较低。结论各厂家应提高复方丹参片中三七皂苷的含量，相关医药监管部门应加大该药的规范生产力度，提高药物中三七皂苷的含量，以更好的应用于临床。%Objective To analyze the content of panax notoginseng saponins in compound salvia tablets of different manufactures and to provide references for the pharmaceutical improvement of clinical drug manufacturers and strengthening supervision of supervision departments.MethodsThe content of panax notoginseng saponins in compound salvia tablets of 8 different manufactures including Guangzhou Baiyun Mountain Pharmaceutical,Guangxi Ritian Pharmaceutical,Anhui Hua Tuo Pharmaceutical Factory,Tonghua Yisheng Pharmaceutical,Jinan Hongjitang Pharmaceutical,Changchun Xinan Pharmaceutical,BeijingNorth Wei Pharmaceutical and Jilin Hundred-year Luk Fook Tong Pharmaceutical were detected by high performance liquid chromatography (HPLC) and differences in contents of manufactures were compared.Results Contents of panax notoginseng saponins in compound salvia tablets of 8 different manufactures were 0.154%,0.175%,0.7773%,0.8311%,1.3297%,1.3912%,1.5217% and 3.1245% respectively.The content of panax notoginseng saponins in compound salvia tablets of different batch numbers of one manufacture had no statistical difference.Contents of panax notoginseng saponins in compound salvia tablets of different manufactures had significant differences but contents were commonly low.ConclusionManufacturers should improve the content of panax notoginseng saponins in compound salvia tablets and relevant drug supervision departments should strengthen the intensity of standardization of the drug production to improve the content of panax notoginseng saponins in compound salvia tablets in order to achieve a better clinical application.