海峡药学
海峽藥學
해협약학
STRAIT PHARMACEUTICAL JOURNAL
2015年
8期
36-40
,共5页
高丹玲%刘用国%刘钐%林晨煦
高丹玲%劉用國%劉釤%林晨煦
고단령%류용국%류삼%림신후
注射用头孢唑林钠%澄清度%细胞毒性%丁基胶塞
註射用頭孢唑林鈉%澄清度%細胞毒性%丁基膠塞
주사용두포서림납%징청도%세포독성%정기효새
Cefazolin Sodium for Injection%Clarity of solution%Cytotoxicity%Butyl rubber stopper
目的：通过建立注射用头孢唑林钠细胞毒性检测方法，评价2009年和2011年国抽部分样品及胶塞的细胞毒性，探讨注射用头孢唑林钠溶液澄清度与细胞毒性的相关性。方法采用L929细胞，MTT 比色法，以样品浓度0．78mg? mL －1为评价浓度，以头孢唑林钠原料为阴性对照，以相对增殖抑制度为评价指标，以浊度值表征样品澄清度。结果样品浊度值与样品在浓度为0．78mg? mL －1时的细胞相对增殖抑制度之间有负的直线相关关系；当样品浊度大于4号时，与头孢唑林钠原料相比，样品的细胞毒性已接近2级。对细胞生长产生影响的毒性物质不是造成澄清度下降的主要物质，但是样品澄清度越差则细胞毒性可能越大。结论药用卤化丁基胶塞质量标准中，除了热原、溶血和急性毒性试验，生物安全性能检查项目中还应包括细胞毒性试验。
目的：通過建立註射用頭孢唑林鈉細胞毒性檢測方法，評價2009年和2011年國抽部分樣品及膠塞的細胞毒性，探討註射用頭孢唑林鈉溶液澄清度與細胞毒性的相關性。方法採用L929細胞，MTT 比色法，以樣品濃度0．78mg? mL －1為評價濃度，以頭孢唑林鈉原料為陰性對照，以相對增殖抑製度為評價指標，以濁度值錶徵樣品澄清度。結果樣品濁度值與樣品在濃度為0．78mg? mL －1時的細胞相對增殖抑製度之間有負的直線相關關繫；噹樣品濁度大于4號時，與頭孢唑林鈉原料相比，樣品的細胞毒性已接近2級。對細胞生長產生影響的毒性物質不是造成澄清度下降的主要物質，但是樣品澄清度越差則細胞毒性可能越大。結論藥用滷化丁基膠塞質量標準中，除瞭熱原、溶血和急性毒性試驗，生物安全性能檢查項目中還應包括細胞毒性試驗。
목적：통과건립주사용두포서림납세포독성검측방법，평개2009년화2011년국추부분양품급효새적세포독성，탐토주사용두포서림납용액징청도여세포독성적상관성。방법채용L929세포，MTT 비색법，이양품농도0．78mg? mL －1위평개농도，이두포서림납원료위음성대조，이상대증식억제도위평개지표，이탁도치표정양품징청도。결과양품탁도치여양품재농도위0．78mg? mL －1시적세포상대증식억제도지간유부적직선상관관계；당양품탁도대우4호시，여두포서림납원료상비，양품적세포독성이접근2급。대세포생장산생영향적독성물질불시조성징청도하강적주요물질，단시양품징청도월차칙세포독성가능월대。결론약용서화정기효새질량표준중，제료열원、용혈화급성독성시험，생물안전성능검사항목중환응포괄세포독성시험。
ABSTRACT:OBJECTIVE To study the correlation between clarity of solution and cytotoxicity of cefazolin sodium for injection and evaluate the cytotoxicity test results of samples and rubber stopper from 2009 and 2011 by establis-hing the cytotoxicity test of cefazolin sodium for injection.METHODS Using L929 cells and MTT assay,the sample concentration was 0.78 mg? mL-1 ,and use cefazolin sodium active pharmaceutical ingredient as negative control.The relative inhibition of proliferation was used as evaluation indicator,the turbidity values was used to characterize clarity of solution of samples.RESULTS There was a negative linear correlation between the sample turbidity value and the relative inhibitory effect of cell proliferation with the sample at a concentration of 0.78 mg? mL-1 .Namely clarity of solution being worse,cytotoxicity may be bigger.When the sample turbidity was more pronounced than that of the reference suspensionⅣ,compared with cefazolin sodium active pharmaceutical ingredient,the cytotoxicity of the sam-ple was close to level 2.The toxic substance that has an impact on cell growth is not the cause of the decline in clarity of solution,but the clarity of solution test results for the samples that use non-coated halogenated butyl rubber stopper can be used as the reference index of cytotoxicity.CONCLUSION Based on the fact that butyl rubber stopper may increase the cytotoxicity of medicines,we recommend that the biosafety performance tests of the quality standard for pharmaceutical halogenated butyl rubber stopper should also include in cytotoxicity test,in addition to pyrogen,he-molysis,and acute toxicity test,to evaluate potential effects the rubber stopper migratory substances on cytotoxicity.
