甘草次酸衍生物抗肝纤维化的实验研究

目的探讨甘草次酸衍生物(TY501)对四氯化碳(CCl_4)致小鼠肝纤维化的保护作用及其机制。方法采用经典CCl_4造模法建立小鼠肝纤维化模型,给予高、中、低剂量(45、15、5 mg/kg)TY501干预治疗,用秋水仙碱(0.36 mg/kg)作阳性对照。给药30 d后,检测各组小鼠肝功能指标、肝纤维化指标、肝组织羟脯氨酸(Hyp)和转化生长因子-β1(TGF-β1)的量,并取其肝组织进行病理学染色。结果与模型组相比,TY501各治疗组肝功能指标(ALT、AST、ALP、ALB)、肝纤维化指标(HA、LN、PCIII、CIV)及肝组织Hyp、TGF-β1的量均有不同程度改善,其中高剂量组改善作用最为明显(P0.05、0.01);肝组织病理学切片显示,给药组小鼠肝纤维化程度降低,有逆转趋势。结论 TY501对CCl_4造成的肝纤维化有明显的保护作用。     

丹参胶囊在欧盟药品注册中的可读性测试研究和实践

药品说明书是载明药品信息的法定文件,对指导公众合理用药起着至关重要的作用。在欧美药品的申报体系和指南中,均要求申请者在药品上市前必须完成药品说明书可读性测试研究,以保证说明书内容通俗易懂,指导公众合理安全用药,避免用药不当可能导致的风险。由于审评理念和标准的差距,目前中国在新药评审的过程中缺乏药品说明书可读性测试研究的要求、法规和指南。以国内申报欧盟成功的品种丹参胶囊注册上市实践为案例,分析欧盟对于药品说明书可读性测试研究的要求,以期为我国建立和实施药品说明书可读性研究的管理思路提供借鉴和参考。     

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??OBJECTIVE To explore the effects of methyl jasmonic acid(MeJA), arachidonic acid(AA) and acetylsalicylic acid(ASA) on fucoxanthin production and PtZDS gene expression in Phaeodactylum tricornutum.METHODS The full length cDNA of PtZDS gene in P. tricornutum was obtained by HiSeq^TM Illumina 2000 and bioinformatics analysis. HPLC was used to determine the production of fucoxanthin in Phaeodactylum tricornutum, and RT-PCR was used to determine the expression level of PtZDS.RESULTS The total length of PtZDS gene was 1 905 bp, containing an open reading frame of 1 776 bp encoding 591 amino acids.The deduced amino acid sequence analysis showed that PtZDS protein contained a typical amino oxidase domain, NAD(P)-binding Rossmann-like domain and a chloroplastic transit peptide sequence.The phylogenetic analysis demonstrated that PtZDS was homologous with Thalassiosira pseudonana CCMP1335(76%). Under the treatment of 0.1 mg·L^-1 AA, 25 mg·L^-1 ASA and 100 μmol·L^-1 MeJA, the highest yield of unit cell fucoxanthin content was achieved.Upon the observation of PtZDS regulation expression, the expression level of PtZDS reached a peak value under the treatment of 0.1 mg·L^-1 AA, 50 μmol·L^-1 MeJA and 10 mg·L^-1 ASA.CONCLUSION The expression of PtZDS gene has certain relationship with the fucoxanthin synthesis of P. tricornutum. Under the treatment of 100 μmol·L^-1 MeJA, the ability of synthetic fucoxanthinis the strongest in P. tricornutum.     

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??OBJECTIVE To study the impurity profile of cefradine dihydrate. METHODS The impurity peaks of cefradine dihydrate were identified using column-switching technique and LC-MS, and the origination of the impurities were investigated by the forced degradation study.RESULTS The impurity profile of cefradine dihydrate included fourteen impurities, nine of them were structure known impurities controlled by EP, two of them were newly identified impurities and three of them were structure unknown impurities.CONCLUSION The origination and influence factors of the impurities are investigated though the impurity profile study of cefradine dihydrate, and it can provide reference for the quality control of cefradine dihydrate.     

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??OBJECTIVE To explore the effects of different bio-adhesive materials on in vitro adhesion and retention in artificial gastric acid fluid of Panax notoginseng saponins(PNS) bio-adhesive pellets.METHODS PNS bio-adhesive pellets were prepared with different bio-adhesive materials.The in vitro adhesion of PNS bio-adhesive pellets was determined by the tissue retention method, using HPLC method to determine the contents of PNS(including notoginseng saponins R₁, ginseng saponin Rg1 and ginseng saponin Rb₁) retained in the pellets after a certain period of time in artificial gastric acid fluid.RESULTS The contents of PNS retained in PNS bio-adhesive pellets prepared with chitosan and chitosan-carbomer after being placed in artificial gastric acid fluid for 2 h were the largest, which were (27.60??7.45)% and (19.80??3.55)% for R1, (27.01??5.49)% and (19.67??1.39)% for Rg₁ and (47.07??6.26)% and (51.08??7.44)% for Rb₁, respectively.For in vitro adhesion, HPMC and HPMC-carbomer combination was the best, followed by chitosan and chitosan-carbomer combination.CONCLUSION PNS bio-adhesive pellets prepared with chitosan and chitosan-carbomer combination bio-adhesive materials can protect PNS from degradation in artificial gastric acid fluid and have good adhesion property.     

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??OBJECTIVE To proteins in toad venom. To investigate the by proteomic approach. METHODS The total proteins from the ear-side gland of toad were digested by trypsin, and the peptides were further analyzed by the NanoLC-linear trap quadropole (LTQ)-Orbitrap Velos Pro.. The raw data acquired by mass spectrometer were imported into MaxQuant software for the identification of peptides and proteins. The proteins were categorized based on gene ontology annotation in biological process, cellular component and molecular function. RESULTS A total of 407 protein groups and 880 peptides were identified. There were 76 pathways associated with the identified proteins in toad venom, including the 5-HT receptor mediated signaling pathway, beta adrenergic receptor signaling pathway, blood coagulation, cadherin signaling pathway, cholesterol biosynthesis, etc.. CONCLUSION This study lays the foundation for further exploration of the proteins in toad venom and their functions.     

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??OBJECTIVE To study the influence of bioavailability of Epimedium flavonoids after processing by suet oil. METHODS Pharmacokinetics parameters of rats Epimedium flavonoids and icariin and baohuoside ?? was determining by the method of pharmacology effect and plasma concentration method. RESULTS The concentration of the Epimedium flavonoids, icariin and baohuoside ?? in micelles groups were higher than that of the active pharmaceutical ingredient(API). ??_max were increased by 77.94%, 38.99% and 49.90%; AUC_0-t increased by 95.19%, 37.76% and 43.49%; AUC_0-?? increased by 119.35%, 35.37% and 46.26% on Epimedium flavonoids, icariin and baohuoside ?? group. CONCLUSION Suet oil improved the bioavailability of Epimedium flavonoids and promoted its absorption.     

血栓弹力图在脓毒症患者病情评估中的作用研究

目的研究血栓弹力图(TEG)在脓毒症患者病情评估的价值。方法回顾性分析中山大学孙逸仙纪念医院重症医学科2017年4月至2017年11月的脓毒症患者57例,根据SOFA评分分为A组(SOFA≥10分)(26例)和B组(10分SOFA≥2分)(31例),另外选择同期非脓毒症且凝血功能正常患者作为对照组C组(43例)。取静脉血检测TEG,分析比较各组间各项TEG检测指标。结果各组TEG检查结果比较,凝血反应时间(R值)和凝血酶形成时间(K值):A组C组B组,结果有统计学意义P0.05;纤维蛋白凝块形成及加固的速率(α角)和血凝块最大强度和硬度(MA值):A组C组B组,结果有统计学意义P0.05。R值、K值与SOFA评分呈正相关(均P0.05),α角、MA值与SOFA评分呈负相关(均P0.05),B组患者28天死亡率为12.9%,随SOFA评分升高,A组患者28天死亡率高达46.1%。结论血栓弹力图能较全面、准确地分析脓毒症患者凝血状态,与SOFA评分存在一定相关性,血栓弹力图监测对评价脓毒症患者严重程度及指导治疗有重要意义。