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目的:了解国家六类新药虎贞痛风胶囊重金属含量,建立质控体系,为临床中的安全用药提供科学依据。方法:采用湿法消化法对样品进行前处理,使用ICP-AES进行重金属检测分析。结果:测出虎贞痛风胶囊中含有微量的重金属成分,结果分别是:镉(Cd)≤0.02 mg/kg,铜(Cu)≤4.2 mg/kg,铬(Cr)≤0.16 mg/kg;锌(Zn)≤1.6 mg/kg;铅(Pb)≤0.6 mg/kg。砷(As)未检出。结论:虎贞痛风胶囊含有微量重金属成分,但其含量远低于国家相关标准。对该中药制剂建立可行的重金属检测体系,是完成其安全、有效、稳定、可控目标的一个部分,也为虎贞痛风胶囊符合国际化公认标准奠定基础。
Objective: To understand the content of heavy metals in the national six new drugs Huzheng Tengfeng Capsules and establish a quality control system to provide scientific basis for safe drug use in clinical practice. Methods: Samples were pretreated by wet digestion and heavy metal detection by ICP-AES. Results: The trace amounts of heavy metals contained in Huzhen Gout Capsule were measured. The results were: cadmium (Cd) ≤ 0.02 mg/kg, copper (Cu) ≤ 4.2 mg/kg, chromium (Cr) ≤ 0.16 mg/kg; zinc (Zn) ≤ 1.6 mg/kg; lead (Pb) ≤ 0.6 mg/kg. Arsenic (As) was not detected. Conclusion: Huzheng Gout Capsule contains trace heavy metals, but its content is far below the national standards. The establishment of a viable heavy metal detection system for this Chinese medicine preparation is a part of its goal of achieving safety, efficacy, stability, and controllability, and it also lays the foundation for the compliance of Tiger Tiger Gout Capsules with internationally recognized standards.