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1、【精品文档】如有侵权，请联系网站删除，仅供学习与交流南京欧际医药外包服务.精品文档.南京欧际医药科技服务有限公司 电话: 025-86616616 13951724413 传真: 025-86990398 QQ:1010048624电子邮箱service网站: 药物活性筛选及评价服务我们的优势： 既熟悉新药临床前药效学及毒理学指导原则，又可针对客户创新药物的特点提供个性化的活性筛选、药效学研究、作用机理研究服务； 一站式服务：为客户提供整体药效解决方案，提供整体药效学研究外包服务； 可配合客户开展新药上会的答辩工作。抗肿瘤药物体内外筛选服务1. 抗肿瘤药物体外细胞筛选 250余种肿瘤细胞库，提
2、供细胞增殖IC50测定（MTT或CCK-8法）、细胞凋亡检测、细胞周期检测、Western-blot检测、IHC检测、PCR检测。2. 抗肿瘤药物人体肿瘤裸鼠模型及体内活性评价 人肝癌裸鼠原位移植模型HepG-2，人肝癌裸鼠异种移植模型SMMC-7721， QGY-7701， Bel7402，HepG-2，人胃癌裸鼠异种移植模型SGC-7901， BGC-823，MGC-803，MKN-45， HGC-27，人肺癌裸鼠异种移植模型A549， NCI-H460，人肠癌裸鼠异种移植模型LS-174-T， HCT-116， CL187，SW116，人乳腺癌裸鼠异种移植模型BCaP-37， MDA-M
3、B-231，MX-1，人黑色素瘤裸鼠异种移植模型A375，MV3，M14，人鼻咽癌裸鼠异种移植模型CNE-2Z，人宫颈癌裸鼠异种移植模型SiHa，HeLa，人膀胱癌裸鼠异种移植模型EJ，T24，人肾癌裸鼠异种移植模型Ketr-3，人卵巢癌裸鼠异种移植模型A2780，人前列腺癌裸鼠异种移植模型PC-3M，人前列腺癌裸鼠异种移植模型PC-3、DU145裸鼠泪腺移植模型，涎腺腺样囊性癌裸鼠异种移植模型ACC-2，人舌鳞癌裸鼠异种移植模型Tca-8113，人原位胰腺腺癌裸鼠异种移植模型BxPC-3，人白血病裸鼠异种移植模型HL60，人喉表皮癌裸鼠异种移植模型HeP23. 抗肿瘤药物小鼠肿瘤模型及体内活
4、性评价 小鼠肝癌模型H22，小鼠肉瘤模型S180，小鼠宫颈癌模型U14，小鼠艾氏腹水模型EAC，小鼠肺癌模型Lewis，小鼠黑色素瘤模型B16F10，小鼠黑色素瘤模型B16BL6，小鼠黑色素瘤模型B16F1，小鼠乳腺癌模型4T1快速药代（DMPK）分析服务给出待测化合物基本代谢参数如Cmax、Tmax、AUC0-t、AUC0-、血浆清除率CL、分布容积V、生物利用度等必要参数以及其他必要信息，提供对待测化合物代谢特征预判。服务特点：建立和认证LC-MS/MS分析方法以测定受试物在大鼠血浆中的药物浓度，确定母离子、碎片离子、定量分析范围，保证分析方法的精密度、准确度、线性范围、特异性、稳定性等受
5、试物在血浆中的稳定性：将随样品分析测定。质控样品：随行测定高、中、低3个浓度的质控样品，每个浓度至少双样本，质控样品数大于未知样品总数的5%；小鼠急性毒性评价服务 考察受试药物对小鼠的LD50或最大耐受量（Maximal tolerance dose, MTD）。 半数致死量（Median lethal dose, LD50）：在一定试验条件下引起50%受试动物死亡的剂量。该值是经统计学处理所得的结果。 最大耐受量（Maximal tolerance dose, MTD）：不引起受试动物死亡的最高剂量。 制剂安全性试验：溶血试验等服务内容： 1.小鼠急性毒性预试验，确定合理剂量设计 2.可根据
6、受试药物特点选择合适的给药途径，包括灌胃、静脉注射、腹腔注射、皮下注射等 3.对部分可疑动物进行病理组织学检查服务特点： 通过预实验确定给药剂量及组间剂量比； 不同给药途径满足不同受试药物测定需要抗炎症药物体内外筛选服务抗肝炎药物筛选服务 1.D氨基半乳糖胺（D-Gal）诱导的大鼠肝炎模型筛选服务 2.刀豆蛋白A（Con A）诱导的小鼠肝炎模型筛选服务 3.四氯化碳（CCl4）诱导的小鼠肝炎模型筛选服务 4.中华实验猪大面积肝切除致肝衰竭模型筛选服务抗肾炎药物筛选服务 1.同种大鼠肾皮质匀浆加弗氏完全佐剂腹腔注射建立主动型Heymanns肾炎（AHN）模型筛选服务 2.阿霉素（ADR）诱导的大
7、鼠肾病综合征模型筛选服务 3.大鼠进行性被动性Heymann肾炎模型（ppHN）模型筛选服务 4.牛血清白蛋白（BSA）诱导的大鼠肾炎模型筛选服务 5.大鼠IgA肾病模型筛选服务抗关节炎药物筛选服务 1.弗氏完全佐剂（CFA）诱导的大鼠关节炎模型筛选服务 2.II型胶原（CII）诱导的大鼠关节炎（CIA）模型筛选服务 3. II型胶原（CII）诱导的DBA/1小鼠关节炎（CIA）模型筛选服务 4. 小鼠耳廓肿模型服务 5. 大鼠棉球肉芽肿模型服务抗肺炎药物筛选服务 脂多糖（LPS）诱导的小鼠肺炎模型筛选服务抗胃炎药物筛选服务 1. H+，K+-ATP酶活性筛选服务 2.肝郁脾虚证胃溃疡模型服务
8、抗糖尿病药物筛选服务 DDPIV抑制剂筛选模型筛选服务 STZ（链脲佐菌素）致大鼠糖尿病模型筛选服务降血脂药物筛选服务大鼠高脂饮食高血脂模型筛选服务家兔高脂饮食动脉粥样硬化模型筛选服务大鼠混合型高脂血症动物模型筛选服务化疗保护药物筛选服务小鼠氟尿嘧啶骨髓移植模型筛选服务急慢性创面模型筛选服务对小鼠III度烧伤的影响对大鼠皮肤切口模型的影响对兔背部皮肤全层切除模型的影响对兔热液烫伤模型的影响痤疮模型筛选服务对丙酸杆菌致大鼠耳廓痤疮模型的影响对金黄地鼠皮脂腺斑组织形态的影响抗血管生成药物体外及体内活性筛选服务 1. 内皮细胞增殖实验（3H掺入法） 2. 内皮细胞凋亡实验 3. 划痕实验（二维；单层
9、内皮细胞伤口法） 4. 博伊登小室实验（二维；内皮细胞迁移实验） 5. 胶原侵袭实验（三维；内皮细胞迁移侵袭实验） 6. 基质胶实验（二维，内皮细胞成血管能力实验） 7. Beads血管生成实验（三维，内皮细胞成血管能力实验） 8. 大鼠胸主动脉环血管生成实验（三维，血管原位新生血管能力检测） 9. 鸡胚脲囊膜血管生成模型 10. 家兔眼角膜血管生成实验 11. 小鼠基质胶血管生成实验 抗菌药物筛选服务 1.试管稀释法体外抗菌实验 2.小鼠体内抗菌实验 免疫调节药物筛选服务 1. 从外周血、脾、淋巴结中分离单个核细胞服务 2.利用MACS细胞分离技术精确分离各种免疫细胞及其亚群（T细胞、B细胞
10、、NK细胞、CD4+T细胞、CD8+T细胞、CD25+T细胞、中性粒细胞、单核-巨噬细胞等）3.对各种免疫细胞群进行功能性实验检测服务药物安全性评价服务雄性大鼠生殖毒性评价服务 雄性SD大鼠连续给药3-6个月，评价受试药物对雄性大鼠生殖系统有无毒性作用。服务内容：检测雄性大鼠长期给药后的体重增长及睾丸、附睾、心、肝、脾、肺、肾、胸腺脏器系数、精子畸形率；大鼠睾丸的每日精子生成量；病理组织学研究，使用睾丸的连续切片，并进行TUNEL检测，观察到药物引起的生精细胞凋亡。服务特点： 专门针对雄性大鼠生殖系统进行安全性评价，更具有针对性； 多指标检测受试药物对大鼠生殖毒性的影响，结果准确可靠。大鼠长期
11、毒性评价服务 大鼠连续给药1-6个月，评价受试药物对大鼠长期毒性的影响。服务内容： 血液学指标检测：项目：白细胞总数（WBC）、红细胞总数（RBC）、血红蛋白（HGB）、红细胞比积（HCT）、红细胞平均体积（MCV）、平均血红蛋白含量（MCH）、平均血红蛋白浓度（MCHC）、红细胞体积分布宽度（RDW）、血小板总数（PLT）、血小板平均体积（MPV）、血小板体积分布宽度（PDW）、血小板比积（PCT）、网红百分比（Retic）、中性粒细胞百分比（NEUT%）、淋巴细胞百分比（LYMPH%）、单核细胞百分比（MONO%）、嗜酸细胞百分比（EOS%）、嗜碱细胞百分比（BASO%）、未染色大细胞百分
12、比（LUC%）、高核酸浓度网状红细胞比率（H-RTC）、中核酸浓度网状红细胞比率（M-RTC）、低核酸浓度网状红细胞比率（L-RTC）。共22个指标。 生化指标：项目：天门冬氨酸氨基转换酶（AST）、丙氨酸氨基转换酶（ALT）、碱性磷酸酶（ALP）、尿素氮（BUN）、总蛋白（TP）、白蛋白（ALB）、血糖（GLU）、总胆红素（TBI）、肌酐（CREA）、总胆固醇（CHO）、甘油三酯（TG）、肌酸激酶（CK）、-谷氨酰转移酶（GGT）。共13个指标。 电解质：钠（Na+）、钾（K+）、氯（Cl-）。共3个指标。 凝血指标： 项目：凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、纤维蛋白酶
13、时间（Fbg）、凝血酶时间（TT）。共4个指标。 病理组织学检查服务特点： 1. 根据药物作用特点制定长期毒性研究方案，更具有针对性； 2. 多指标检测受试药物对大鼠长期毒性的影响，结果准确可靠。Nanjing OGpharma Co., Ltd.Address: No. 106 Jiangdongzhong Road, Suite B 1306, Nanjing, PRC PC: 210019 Tel: 0086-25-86616616 13951724413 Fax: 0086-25-86990398Email: serviceWeb: Service of Preclinical Pha
14、rmacology Study Pharmacodynamic study Drug activity evaluation in vitro Drug activity evaluation in vivo Study on mechanism of drug activity Evaluation of mouse acute toxicity，the LD50 data will be provided. Evaluation of reproductive toxicity in male rats Evaluation of long-term toxicity on rats, d
15、ogs, monkeys, etc., to evaluate the potential drug toxicity on liver, kidney, heart, brain, spleen, etc.Service of Pharmacokinetic studyAnalysis of biological samples Pharmacokinetic study in vivo (Absorption, Distribution, Metabolism, and Excretion) Comprehensive drug metabolism research Comprehens
16、ive drug research using isotope labelingBioanalytical Bioanalytical method development, validation and establishment LC/MS/MS bioanalytical method establishment and/or transfer for new drugs and their metabolites orgeneric drug assay Method validation in multiple species and various matrices accordi
17、ng to GLPguidelines Partial or cross-validation of established methods Certificate of analysis (COA) as well as re-certification for test substances,reference /metabolitestandardPharmacokinetic sample analysis and metabolite evaluation Nonclinical PK/TK/bioavailability/bioequivalence sample analysis
18、 Clinical PK/bioavailability/bioequivalence sample analysis LC/MS/MS sample assay of parent and key metabolites in all phases of drug development using singleor multiple analyte assay methodsFeatures:The experienced technicians can complete the projects in the shortest time.Provide the most reliable
19、 and comprehensive data timely during the experiments.Innovative and efficient project management to guarantee project development smoothlyNonclinical ADME Facilities for in-life studies in rats, mice, and dogs and monkeys Study types include radiolabel mass balance, tissue distribution, metabolite
20、profiling/radio-profiling and identification/characterization, as well as drug discovery PK, formulation bioavailability screening, bioequivalence evaluation, toxicokinetic, cassette PK, and drug-drug interaction Various routes of administration including I.V., oral, buccal, sublingual, I.M.,S.C., t
21、opical Radiolabel AME studies services Comprehensive Metabolism Services In-vitro metabolism and stability studies Metabolism studies in microsomes, hepatocytes, S9 fraction Interspecies comparisons in mouse, rat, rabbit, pig, dog, monkeyand human P450 enzyme mapping (phenotyping), inhibition and in
22、duction studies Protein binding Metabolite profiling and identification Metabolite (known and unknown) profiling/radio-profiling using state- of-the-art radiodetection methods including TopCount or ARC Stop Flow for low activity or volatile samples. Metabolite identification and characterization usi
23、ng the latest LC/MS/MS instrumentation including AB Sciex API 5000/4000 and Shimadzu LCMS-IT-TOF and Brucker 500/300HMz NMR Bulk metabolite isolation and purification of metabolites formetabolite structure confirmationFeatures Comprehensive interspecies comparison Complete metabolism pathway charact
24、erization and metabolitestructure identification Dedicated biotransformation department with years of experience working with challenging drug candidates with complexmetabolism profiles Developed many multiple-analyte and pg/mL level bioanalyticalLC/MS/MS methods Comprehensive Radiolabel Study Servi
25、cesDrug Screening ServiceAnti-cancer new drug screening models of OGpharmaIn vitro anti-cancer activity screening OGpharma owns pure cell lines and characteristic cancer cell bank, such as colorectal cancer, breast cancer, skin cancer, lung cancer, liver cancer, gastric cancer, leukemia cell lines,
26、etc. The reliable IC50 value of tested drugs is offered to the clients with in vitro screening experiments. Cytotoxicity assays (e.g. MTT,CCK-8), Clonogenicity assays, Apoptosis, Cell cycle analysis, In vitro drug combination studiesIn vivo human cancer nude mice xenograft models Over 30 human tumor
27、 nude mice xenograft models, such as human liver cancer (HepG-2, Bel7402, QGY-7701, etc), human gastric cancer (MGC-803, SGC-7901, MKN-45, HGC-27, etc), human lung cancer (NCI-H460, A549), human colorectal cancer (Ls-174-T, HCT-116, CL187, SW116), human breast cancer (BCaP-37, MDA-MB-231, MX-1), hum
28、an melanoma (A375, MV3, M14), human nasopharyngeal cancer (CNE-2Z), human cervical cancer (SiHa, Hela), human bladder cancer (EJ, T24), human renal cancer (Ketr-3), human prostate cancer (PC-3M), human tongue squamous cancer (Tca-8113), human leukemia (HL60), human ovarian cancer (A2780), human sali
29、vary adenoid cystic cancer (ACC-2), human pancreatic cancer (BxPC-3), human laryngeal cancer (HeP2), etc.In vivo mice cancer models Over 10 mice cancer models, such as mouse liver cancer (H22), mouse cervical cancer (U14), mouse lung cancer (Lewis), mouse melanoma (B16BL6, B16F10, B16F1), mouse brea
30、st cancer (4T1), mouse sarcoma (S180), mouse ehrlich ascites cancer (EAC), etc. In vitro and in vivo anti-angiogenesis new drug screening models New drug screening service by Luminex high-throughput protein quantitative analysisFeatures: We have over 250 pure (cancer or normal) and characteristic ca
31、ncer cell lines. The experienced technicians can complete the projects in the shortest time with our mature 17 human tumor nude mice xenograft models and 9 mice tumor models. Also we have the assay development capability. Evaluate anti-cancer activity of the tested medicine systematically in vitro a
32、nd in vivo Provide the most reliable and comprehensive data timely during the experimentsCase： OGpharma successfully completed a project of 60 anti-cancer compounds activity screening in vitro. Two drug candidates were confirmed with following human cancer nude mice xenograft models.Anti-inflammatio
33、n new drug screening models of OGpharmaAnti-hepatitis new drug screening models Rat hepatitis model induced by D-galactosamine (D-Gal) Mouse hepatitis model induced by concanavalin A (Con A) Mouse hepatitis model induced by carbon tetrachloride (CCl4)Anti- nephritis new drug screening models Rat nep
34、hrotic syndrome model induced by adriamycin (ADR) Rat progressive passive Heymann nephritis model (ppHN) Rat nephrotic model induced by bovine serum albumin (BSA) Rat active Heymann nephritis (AHN) model established by injecting i.p. renal cortex homogenate and Freund s complete adjuvantAnti-arthrit
35、ic new drug screening models Rat arthritis model induced by Freunds complete adjuvant(CFA) Rat arthritis model induced by type II collagen Anti-pneumonia drug screening model Mouse pneumonia model induced by lipopolysaccharide (LPS) Immunomodulatory drug screening modelsFeatures: The experienced tec
36、hnicians can complete the projects in the shortest time. Provide the most reliable and comprehensive data timely during the experiments. Guarantee the model stable and reliable by biochemical test and pathological examination during the model establishment. Evaluate more objectively the effect of dr
37、ugs by quantitative analysis of the pathological injury score. Help the clients to further study the drug mechanisam by providing the services of relevant WB, IHC, ELISA and cytokine analysis.Successful Case： OGpharma successfully completed a project of 16 anti-hepatitis drugs activity screening and succeeded in obtaining 1 candidate drug which was confirmed to develop further preclinical research.