反渗透膜浓缩技术对60mg促肝细胞生长素粉针剂常见金属元素含量影响的研究

目的了解反渗透膜浓缩技术对60mg促肝细胞生长素（PHGF）中钠（Na）、钾（K）、镁（Mg）、钙（Ca）、铁（Fe）、铬（Cr）、锰（Mn）、镍（Ni）、铜（Cu）、锌（Zn）、砷（As）、银（Ag）、镉（Cd）、锑（Sb）、钡（Ba）、铅（Ph）等金属元素含量的影响，为药品工艺改进、质量控制及临床安全用药提供科学依据。方法采用在线内标，建立电感耦合等离子体质谱（ICPMS）技术对样品常见金属元素的检测方法，并对药品金属元素进行检测，比较2种规格药品中金属元素含量差异。结果ICPMS测定PHGF常见金属元素线性相关系数均〉0．9990；方法准确度、精确度和稳定性均达到要求，有证参考物质全血验证，方法准确度、精密度高。60mgPHGF与20mgPHGF生产工艺稳定，元素批间相对误差分别在0．00％-5．48％、0．24％-6．05％之间；2种规格药品各检测元素比较，Na、Mg、K、Fe、Ni、Zn、As、A异、Cd间均P〉0．05；Ca、Mn、Cu、Sb、Ba、Pb问均P〈0．01；Cr间P〈0．05。结论60mgPHGF与20mgPHGF检测元素比较，Na、Mg、K、Fe、Ni、Zn、As、Ag、Cd元素含量没明显差异；Ca、Mn、Cu、Sb、Ba、Pb元素含量有非常显著差异，20mgPHGF中Ca、Mn、Ba、Pb含量高。

Study on Differences of Contents of Common Elements between 60 mg and 20 mg Promoting Hepatocytic Growth Factors Powder Injections

Objective To investigate the influence of concentrated technology with RO membrane （reverse osmosis membrane） to common metal elements （Na, Mg, K, Ca, Cr, Mn, Fe, Ni, Cu, Zn, As, Ag, Cd, Sb, Ba and Pa） in 60 mg Pormoting Hepatocytic Growth Factors （PHGF）. Methods The weighed samples were digested by microwave digest, and prepared into a 10 ml solution. Based on internal standard method, the method of analyzing samples was established. Common metal elements in digested sample solutions were analyzed by ICP-MS. Results The linear correlative coefficients for the common elements were more than 0.999 0. The accuracy, precision and stability of the method were detected, and they all conformed with the analysis standard. The production technology of 60 mg PHGF and 20 mg PHGF were stable, and their RSDs were among 0.00% -5.48% and 0.24% -6.05%. The test results between the 2 medicine, for Na, Mg, K, Fe, Ni, Zn, As, Ag, Cd was P 〉0.05; for Ca, Mn, Cu, Sb, Ba, Pb, P 〈0.01, and for Cr, P 〈 0.05. Conclusion Between 60 mg and 20 mg PHGF, there is apparent differences in contents of Ca, Mn, Cu, Sb, Ba, Pb. There are no differences in contents of Na, Mg, K, Fe, Ni, Zn, As, Ag, Cd. Contents of Ca, Mn, Ba, Pb are higher in 20 mg PHGF powder.