中国药事
中國藥事
중국약사
Chinese Pharmaceutical Affairs
2015年
8期
840-844
,共5页
药品安全监测%药品质量评价%探索性研究%葡萄糖注射液%评价性抽验%质量分析%电导率测定%渗透压测定%灭菌方法%5-羟甲基糠醛(5-HMF)%包装标识
藥品安全鑑測%藥品質量評價%探索性研究%葡萄糖註射液%評價性抽驗%質量分析%電導率測定%滲透壓測定%滅菌方法%5-羥甲基糠醛(5-HMF)%包裝標識
약품안전감측%약품질량평개%탐색성연구%포도당주사액%평개성추험%질량분석%전도솔측정%삼투압측정%멸균방법%5-간갑기강철(5-HMF)%포장표식
drug safety monitoring%drug quality assessment%exploratory tests%glucose injection%evaluative sampling inspection%quality analysis%conductivity test%osmotic pressure test%sterilization methods%5-hydroxymethyl furfural (5-HMF)%packing mark
目的：监测和评价葡萄糖注射液质量现状，为进一步改进提高其生产工艺和质量标准提供参考。方法：采用法定检验方法对抽样进行检验，分析评价其质量；并对抽样进行如下探索性研究：研究了灭菌及冷却条件与5-羟甲基糠醛（5-HMF）产生量的关系，测定了全部样品的渗透压与电导率，比较了各厂家包装标示的规范性。结果：按法定方法检验，样品合格率为100%；探索性研究表明：灭菌时间、灭菌温度和冷却方式与5-HMF产生量密切相关；渗透压平均值为270 mOsmol·kg-1，最低260 mOsmol·kg-1，最高287 mOsmol·kg-1，均在等渗范围内；电导率平均值为20.09μs·cm-1，最低8.75μs·cm-1，最高54.6μs·cm-1，仅有1家企业3批样品电导率大于50μs·cm-1，经研究查明是加入盐酸调节pH值所致；1批产品包装标识未标注百分浓度。结论：法定检验和探索性研究结果表明，葡萄糖注射液总体质量良好。通过探索性研究，可为该产品生产工艺和质量标准进一步提高提供参考。
目的：鑑測和評價葡萄糖註射液質量現狀，為進一步改進提高其生產工藝和質量標準提供參攷。方法：採用法定檢驗方法對抽樣進行檢驗，分析評價其質量；併對抽樣進行如下探索性研究：研究瞭滅菌及冷卻條件與5-羥甲基糠醛（5-HMF）產生量的關繫，測定瞭全部樣品的滲透壓與電導率，比較瞭各廠傢包裝標示的規範性。結果：按法定方法檢驗，樣品閤格率為100%；探索性研究錶明：滅菌時間、滅菌溫度和冷卻方式與5-HMF產生量密切相關；滲透壓平均值為270 mOsmol·kg-1，最低260 mOsmol·kg-1，最高287 mOsmol·kg-1，均在等滲範圍內；電導率平均值為20.09μs·cm-1，最低8.75μs·cm-1，最高54.6μs·cm-1，僅有1傢企業3批樣品電導率大于50μs·cm-1，經研究查明是加入鹽痠調節pH值所緻；1批產品包裝標識未標註百分濃度。結論：法定檢驗和探索性研究結果錶明，葡萄糖註射液總體質量良好。通過探索性研究，可為該產品生產工藝和質量標準進一步提高提供參攷。
목적：감측화평개포도당주사액질량현상，위진일보개진제고기생산공예화질량표준제공삼고。방법：채용법정검험방법대추양진행검험，분석평개기질량；병대추양진행여하탐색성연구：연구료멸균급냉각조건여5-간갑기강철（5-HMF）산생량적관계，측정료전부양품적삼투압여전도솔，비교료각엄가포장표시적규범성。결과：안법정방법검험，양품합격솔위100%；탐색성연구표명：멸균시간、멸균온도화냉각방식여5-HMF산생량밀절상관；삼투압평균치위270 mOsmol·kg-1，최저260 mOsmol·kg-1，최고287 mOsmol·kg-1，균재등삼범위내；전도솔평균치위20.09μs·cm-1，최저8.75μs·cm-1，최고54.6μs·cm-1，부유1가기업3비양품전도솔대우50μs·cm-1，경연구사명시가입염산조절pH치소치；1비산품포장표식미표주백분농도。결론：법정검험화탐색성연구결과표명，포도당주사액총체질량량호。통과탐색성연구，가위해산품생산공예화질량표준진일보제고제공삼고。
Objective: To monitor and evaluate the quality status of glucose injection and to provide valuable references for improvement of production technology and quality standards.Methods: Statutory testing methods were used to examine samples and analyze quality status. Exploratory tests were also conducted to study the relationship between sterilization and cooling condition with production quantity of 5-hydroxymethyl furfural (5-HMF), measure osmotic pressure and conductivity of all samples, and compare standardization of packing marks of each manufacturer.Results: Statutory tests showed all the samples were qualiifed (100%). Exploratory tests showed the production quantity of 5-HMF was closely related with sterilization duration, temperature and cooling condition. The osmotic pressure was in the isotonic range with the average, minimum, and maximum value being 270 mOsmol·kg-1, 260 mOsmol·kg-1, and 287 mOsmol·kg-1 respectively. The average, minimum, and maximum values of conductivity were 20.09 μs·cm-1, 8.75 μs·cm-1, and 54.6 μs·cm-1. Only one manufacturer had the conductivity of its three batches of samples higher than 50 μs·cm-1 which was due to addition of hydrochloric acid to adjust pH, as the study investigated. Package of one batch of sample was not marked with percentage concentration. Conclusion:The results of statutory and exploratory tests showed the overall quality status of glucose injection was good. Exploratory tests also provided references for improvement of production technology and quality standards.
