注射用红花黄色素的质量控制及安全性研究  

Study on quality control and safety of safflower yellow pigment for injection

作　　者：钟勇 刘菡菡 赵永发 谢俊 ZHONG Yong;LIU Hanhan;ZHAO Yongfa;XIE Jun(Jiangxi Jiayou Shuguang Orthopaedic Hospital,Nanchang 330006,China)

机构地区：[1]江西嘉佑曙光骨科医院,江西南昌330006

出　　处：《临床医药实践》2023年第7期509-512,526,共5页Proceeding of Clinical Medicine

基　　金：江西省中医药管理局科技计划项目(项目编号:2022B429)。

摘　　要：目的:探讨注射用红花黄色素的质量控制方法,建立其质量标准,并对安全性进行研究。方法:采用Wonda Sil C18高效液相色谱柱进行精密度、稳定性、重复性试验,建立指纹图谱。对红花黄色素的外观、pH、不溶性微粒、羟基红花黄色素A含量以及无菌情况及细菌内毒素进行检查。结果:方法学考察表明,检测方法精密度、稳定性、重复性均为良好;指纹图谱各色谱峰能有效分离;外观、pH检查稳定,不溶性微粒符合要求;羟基红花黄色素A的平均含量(n=6)为每瓶67.61 mg;无菌检查均显示无细菌生长,每1 mg红花黄色素中内毒素<0.12 EU,安全性好。结论:建立的方法操作简便、重复性好,质量控制准确可靠,可用于对注射用红花黄色素的质量控制和安全性评价。Objective:To explore the quality control method of safflower yellow pigment for injection,establish its quality standard,and study its safety.Methods:The precision,stability and repeatability tests of WondaSil C18 HPLC column were carried out to establish the fingerprint.The appearance,pH,insoluble particles,content of hydroxyl safflower yellow pigment A,sterility test and bacterial endotoxin test of safflower yellow pigment.Results:Methodological investigation showed that the precision,stability and repeatability of the detection method were good.The chromatographic peaks of the fingerprint can be separated effectively.Appearance,pH check is stable,incompatibility particles meet the requirements.The average content of hydroxyl safflower yellow pigment A(n=6)was 67.61 mg in one bottle.Sterility test showed no bacterial growth,endotoxin<0.12 EU per 1 mg safflower yellow pigment,good safety.Conclusion:The established method is simple,reproducible,accurate and reliable for quality control,and can be used for quality control and safety evaluation of safflower yellow pigment for injection.

关 键 词：红花黄色素 注射液 指纹图谱 质量标准 安全评价 

分 类 号：R284.1[医药卫生—中药学]