目的 评价国产复方氨基酸注射液(18AA)的质量现状与存在的问题.方法 采用卫生部药品标准二部第六册(生化药品第一分册)法定检验方法结合探索性研究,如抗氧剂亚硫酸氢钠的紫外分光光度法测定、渗透压摩尔浓度、相对密度、铝盐的原子吸收分光光度法测定、细菌内毒素、体外细胞毒性试验进行样品检验,统计分析检验结果,对复方氨基酸注射液(18AA)的质量现状进行评价.结果 法定检验显示161批样品中152批合格(94.4%),9批不合格(5.6%),不合格项目主要有性状、可见异物、透光率、氨基酸含量;探索性研究显示若增加亚硫酸氢钠、渗透压浓度、相对密度、铝盐检查项,样品的不合格率将显著增加到34.4%.结论 目前绝大部分国产复方氨基酸注射液(18AA)的产品质量能符合现行标准要求,少部分企业产品仍存在性状、可见异物不合格,透光率与氨基酸含量偏低等问题.现行的法定检验标准虽然基本可行,但仍存在一定缺陷.
To evaluate the quality situation and existing problems of Compound Amino Acid Injection (l8AA) made in China. Methods Statutory methods from Drug Standard of Ministry of Public Health Volume Ⅱ part 6 (Section 1 Biochemicals) were carried out, and the exploratory researches, such as UV spectrophotometric determination of anti-oxidant sodium bisulfite, molar concentration of osmotic pressure, relative density, atomic absorption spectrophotometric determination of alum-inum salt, bacterial endotoxin, and cytotoxicity test in vitro also were used. Further quality analysis of Compound Amino Acid Injection (18AA) made in China was evaluated through the samples and the testing results were statistically analyzed. Results Statutory test showed 152 batches in 161 batches of samples were qualified (94.4%), and 9 batches were unqualified (5.6%) which refered to the testing items of characteristics, visible foreign matters, transmittance, and amino acid content. Exploratory studies indicated that the unqualified rate would be significantly increased up to 34.4% if adding the testing items, such as sodium bisulfite, osmolarity, relative density, and aluminum salt. Conclusion The quality of most Compound Amino Acid Injection (18AA) made in China complies with the current standard, but some products from a few enterprises still have existing problems in terms of characteristics, visible foreign matters, transmittance, and lower content of amino acid. It is indicated that the current statutory method can be basically operative, but has its limits.