大众科技
大衆科技
대음과기
DAZHONG KEJI
2014年
6期
143-145
,共3页
聚乙烯%聚丙烯%预灌封注药管%抗氧剂
聚乙烯%聚丙烯%預灌封註藥管%抗氧劑
취을희%취병희%예관봉주약관%항양제
Polyethylene%polypropylene%prefilled injection tube%antioxygen
研究通过高效液相色谱法测定预灌封注药管中添加剂(抗氧剂168,抗氧剂1010)含量,对高密度聚乙烯和高密度聚丙烯为原料制备预灌封注药管的安全性进行评估。结果表明高密度聚乙烯、高密度聚丙烯、预灌封软膏注药管内杆及外套中的抗氧剂含量单个小于0.3%,总量小于0.3%,符合欧洲药典规定。
研究通過高效液相色譜法測定預灌封註藥管中添加劑(抗氧劑168,抗氧劑1010)含量,對高密度聚乙烯和高密度聚丙烯為原料製備預灌封註藥管的安全性進行評估。結果錶明高密度聚乙烯、高密度聚丙烯、預灌封軟膏註藥管內桿及外套中的抗氧劑含量單箇小于0.3%,總量小于0.3%,符閤歐洲藥典規定。
연구통과고효액상색보법측정예관봉주약관중첨가제(항양제168,항양제1010)함량,대고밀도취을희화고밀도취병희위원료제비예관봉주약관적안전성진행평고。결과표명고밀도취을희、고밀도취병희、예관봉연고주약관내간급외투중적항양제함량단개소우0.3%,총량소우0.3%,부합구주약전규정。
Safety assessments are carried up for prefilled injection tube which built of high-density polyethylene and high densitypolypropylene by detecting the content of antioxygen168 and 1010 in the tube with high efficiency liquid chromatography. Content of antioxygen 168 and 1010 in high-density polyethylene, high densitypolypropylene , putter and sleeve of prefilled injection tube are less than 0.3%.The total content of antioxygen is less than 0.3%too. It measure up to standard of European Pharmacopoeia.