目的 評價國產(chǎn)復方氨基酸注射液(18AA)的質(zhì)量現(xiàn)狀與存在的問題.方法 采用衛(wèi)生部藥品標準二部第六冊(生化藥品第一分冊)法定檢驗方法結(jié)合探索性研究,如抗氧劑亞硫酸氫鈉的紫外分光光度法測定、滲透壓摩爾濃度、相對密度、鋁鹽的原子吸收分光光度法測定、細菌內(nèi)毒素、體外細胞毒性試驗進行樣品檢驗,統(tǒng)計分析檢驗結(jié)果,對復方氨基酸注射液(18AA)的質(zhì)量現(xiàn)狀進行評價.結(jié)果 法定檢驗顯示161批樣品中152批合格(94.4%),9批不合格(5.6%),不合格項目主要有性狀、可見異物、透光率、氨基酸含量;探索性研究顯示若增加亞硫酸氫鈉、滲透壓濃度、相對密度、鋁鹽檢查項,樣品的不合格率將顯著增加到34.4%.結(jié)論 目前絕大部分國產(chǎn)復方氨基酸注射液(18AA)的產(chǎn)品質(zhì)量能符合現(xiàn)行標準要求,少部分企業(yè)產(chǎn)品仍存在性狀、可見異物不合格,透光率與氨基酸含量偏低等問題.現(xiàn)行的法定檢驗標準雖然基本可行,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.