供试品

红外鉴别法供试品与对照品的图谱基本一致，无显著性差异，表明供试品与对照品是同种物质。

Infrared identification method shows that the infrared spectroscopic test result of the test article and that of the reference substance are basically the same , with no significant difference .

供试品溶液的pH对细菌内毒素检查法结果的影响

Effect of pH Value on Bacterial Endotoxin Test

目的确定细菌内毒素检查法中，供试品溶液的pH对细菌内毒素检查法检测结果的影响。

OBJECTIVE To confirm the effect of pH value of sample solution on bacterial endotoxin test .

供试品阳性对照管24h内试验菌生长良好。

Test bacteria grew well in the positive-controlled tubes within 24 hours .

供试品溶液在2h内稳定；

The testing solution for assay was stable within 2 hours .

并对2种CHO细胞蛋白标准品和4种供试品进行SDSpage分析。

Two kinds of CHO protein standards and four kinds of samples were analyzed with SDS PAGE .

方法：采用液-液萃取法制备血样供试品，HPLC法测定。

Single dose . Methods : Lc / Lc extract was used to prepare test samples and HPLC was used to determine breviscapine .

将供试品炽灼残渣分成两份，每份加入5ml稀盐酸。

Take up the residue in2 quantities , each of5 ml , of dilute hydrochloric acid R.

木犀草苷含量测定：确立了金银花木犀草苷含量测定的适宜HPLC参数条件（包括供试品制备方法、流动相的选择、检测波长的选择等）。

Determine the content of galuteolin : Established the HPLC experiment parameters of Lonicera Japonica determination ( the preparation method of samples , the selection of moving phase , The choice of detection wavelength and so on ) .

采用旋涡混合器以水为溶剂制备供试品溶液，以大口径HP-快速GC残留溶剂柱为分离柱，FID为检测器，用外标法进行定量。

Water as solvent , sample solution was prepared by using vortex mixer . The determination was performed on a wide bore HP-fast GC residual solvent column with FID detector . The external standard method was used for quantitative analysis .

标准对照溶液：制备方法同供试品溶液，使用规定体积的标准铅溶液（10ppmPb）替代供试品进行试验。

Reference solution ( standard ) . Prepare as described for the test solution , using the prescribed volume of lead standard solution ( 10 ppm Pb ) R instead of the substance to be examined .

结论：本品1mL含奥沙利铂2mg的供试品及其稀释液对细菌内毒素检查无干扰。可用鲎试验法代替家兔热原检查法控制奥沙利铂注射液的热原。

Conclusion : It is available for test of the bacterial endotoxin by diluting the oxaliplatin for injection to 2 mg / mL in tachypleus amebocyte lysate method and it can substitute for the Rabbit Method in quality control .

结果确定生脉注射液细菌内毒素限值为3.75EU/mL，最佳检测条件为供试品稀释10倍，特异性鲎试剂灵敏度为0.25EU/mL。

RESULTS The bacterial endotoxins limit value of Shengmai injection was 3.75EU/mL and the experiment showed that the interference elements could be excluded by diluting Shengmai injection 10 times .

方法：研碎供试品，置针管中于60℃保温作气固顶空平衡，顶空气以气相色谱法测定，氢焰检测器，SE-30固定相，柱温80℃。

Methods : Pulverized sample was put into a syringe and maintained at 60 ^ for balance . The cyclohexane was determined with GC using SE-30 as stationary phase , a column temperature of 80 ℃, and a hydrogen flame detector .

方法将相同浓度的供试品溶液与对照品溶液点于同一硅胶GF254薄层板上，采用薄层色谱法，观察各主斑点的位置、大小及颜色。

Methods Drop the sample liquor and the contrast liquor with the same consistence on the one siliceous GF 254 thin-layer vitreous board and use thin-layer chromatography to observe the place of the every main fleck , size and color .

结果注射用头孢哌酮钠舒巴坦钠（2∶1）稀释成1.25mg/ml供试品液后，用0.125EU/ml的鲎试剂，对细菌内毒素检查无干扰。

Results The cefoperazone / sulbactam ( 2 ∶ 1 ) for injection in concentration of 1.25 mg / ml has no interference to the bacterial endotoxin test , and the lowest limit of detection of the bacterial endotoxin accords with the regulation .

方法采用水溶解醋酸乙酯提取-聚酰胺小柱纯化去杂方法制备供试品。

Methods : Water-soluble ethyl-acetate-extracting polyamide column purification was adopted .

方法采用聚酰胺柱纯化去杂的方法制备供试品溶液。

Methods The sample was prepared through polyamide column .

结果供试品中检出了格列苯脲。

RESULTS Glibenclamide was detected in Shiwei Yuquan capsule .

方法：薄层色谱法鉴别供试品中黄芩苷和橙皮苷等成分；

Methods : TLC was used to identify Baicalin and Hesporidin in the formulary .

样品经二甲亚砜超声提取，离心，过滤得供试品溶液。

Samples was made by extracting with DMSO , ultrasonic , centrifugation and filtration products .

方法：以不同配比的溶剂，溶解或乳化供试品。结论：十四烷酸异丙酯溶解凡士林基质性能最好；

Method : The solutions for testing were dissolved or emulsified in different matching solvent .

结果：供试品对鲎试剂与内毒素的反应无干扰作用。

Result : The samples were no showed interferential efforts on the King Crab reagent .

结果供试品1∶600稀释后，对细菌内毒素检查法无干扰作用。

RESULTS The test was not disturbed by the diluted solution ( 1 ∶ 600 ) .

供试品的抗原性残留量小于或等于23%时，豚鼠无过敏反应发生；

Guineas pig would have no hypersensitive reaction when antigenicity residue was no more than 23 % .

用水制备供试品溶液，加入氯化钠消除电离干扰，将供试品溶液喷入乙炔-空气火焰，用标准曲线法测定氯化钾的含量。

The sample solutions were prepared with water and sodium chloride was added to eliminate ionization interference .

目的是确认所采用的方法是否适合于供试品的微生物限度检查。

The aim is to confirm the method used to the suitability of the samples for it .

结论：供试品的生物学测试结果显示了FGF/胶原蛋白复合海绵具有较好的生物相容性，在临床植入医用等领域有应用潜力。

FGF / Collagen compound sponge proves good biological compatibility and has a cheerful prospect in medicine .

结论硅胶柱色谱和凝胶柱色谱的混合利用可以提高供试品的分离纯化效果。

ConclusionThe co-utilization of silica gel column and gel chromatography can greatly improve the efficiency of isolation and purification .

方法不同提取溶剂、不同提取方法，较为的供试品溶液制备方法。

Method Different extraction solvents and methods have been screened to get the most efficient way for sample preparation .