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Effect of formulation variables on in vitro release of a water-soluble drug from chitosanesodium alginate matrix tablets

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Asian Journal of Pharmaceutical Sciences 2015年第4期10卷 314-321页

作者： Liang Li Jinfeng Li Shanshan Si Linlin Wang Chenjun Shi Yujiao Sun Zhenglin Liang Shirui Mao School of Pharmacy Shenyang Pharmaceutical UniversityShenyang 110016China jiangsu hengrui Medicine Co. Ltd.Lianyungang 222047China

The objective of this study is to investigate the feasibility of using chitosanesodium alginate(CSeSA)based matrix tablets for extended-release of highly water-soluble drugs by changing formulation *** trimetazidine hydrochloride(TH)as a water-soluble model drug,influence of dissolution medium,the amount of CSeSA,the CS:SA ratio,the type of SA,the type and amount of diluents,on in vitro drug release from CSeSA based matrix tablets were *** release kinetics and release mechanisms were *** vitro release experiments were conducted in simulated gastric fluid(SGF)followed by simulated intestinal fluid(SIF).Drug release rate decreased with the increase of CSeSA ***:SA ratio had only slight effect on drug release and no influence of SA type on drug release was *** the other hand,a large amount of water-soluble diluents could modify drug release *** was found that drug release kinetics showed the best fit to Higuchi equation with Fickian diffusion as the main release *** conclusion,this study demonstrated that it is possible to design extended-release tablets of watersoluble drugs using CSeSA as the matrix by optimizing formulation components,and provide better understanding about drug release from CSeSA matrix tablets.

关键词： Chitosan Sodium alginate Matrix tablets Hydrophilic matrices Trimetazidine hydrochloride Extended-release

Global efforts in conquering lung cancer in China

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Chinese Journal of Cancer 2015年第7期34卷 320-322页

作者： Li Van Li Xu The US Chinese Anti-Cancer Association Beijing Cancer Hospital and Institute Peking University School of Oncology jiangsu hengrui Medicine Co. LTD

Lung cancer,the most prevalent and deadly malignancy in the world,poses a particularly critical healthcare challenge to China due to the rapidly increasing new cases and the unique cancer genetics in Chinese patient *** progress has been made in molecular diagnosis and personalized treatment of the *** field is now moving towards multiple new directions to include(1) new generation of targeted agents such as epidermal growth factor receptor and anaplastic lymphoma kinase inhibitors to overcome resistance to their early generation counterparts;and(2) deeper understanding of tumor genetics of each individual patient and consequently the application of biomarkers to guide personalized treatment as well as novel drug development including combination *** increasing capacity in innovative cancer drug research and development is supported by extensive collaboration within China and globally,and across academia and industry,to build up expertise and infrastructure in early-phase clinical testing of novel *** these combined efforts,new and better medicines will be available for lung cancer patients in China in the near future.

关键词：肺癌表皮生长因子受体中国人群靶向药物联合治疗恶性肿瘤生物标志物医疗保健

Early-Phase Oncology Research Training(EFFORT) program:a hengrui-USCACA joint scholarship

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Chinese Journal of Cancer 2015年第7期34卷 323-324页

作者： Li Yan Li Xu The US Chinese Anti-Cancer Association Beijing Cancer Hospital and Institute Peking University School of Oncology jiangsu hengrui Medicine Co. Ltd

Early-Phase Oncology Research Training(EFFORT)program is a joint effort between jiangsu hengrui Medicine Co.,Ltd,China and the United States-Chinese AntiCancer Association(USCACA)to provide academic and financial support to junior clinical research staff including physicians and nurses of early-phase oncology clinical trial centers in *** program will select 1-2qualified candidates per year and place them through rotation programs at 2-3 phase 1 cancer centers in the United States(US).

关键词：肿瘤早期程序训练奖学金试验中心研究人员财政支持

N-Heterocyclic Carbene-catalyzed Reactions of o-Aminonitriles with Carbonyl Compounds Approach to 2,3-Dihydroquinazolin-4(1H)-ones

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Chinese Journal of Chemistry 2014年第9期32卷 865-870页

作者： Hongxin Chai Jiarong Li Liupan Yang Mingxing Liu Deli Yang Qi Zhang Daxin Shi School of Chemical Engineering and Environment Beijing Institute of TechnologyBeijing 100081China jiangsu hengrui Medicine Co. Ltd.No.7 Kunlunshan RoadLianyungang Eco&Tech Development ZoneLianyungangJiangsu 222047China

A green,efficient and convenient N-heterocyclic carbene-catalyzed procedure for the synthesis of novel 2,3-dihydroquinazolin-4(1H)-one derivates via condensation of o-aminonitriles and various carbonyl compounds was d... 详细信息

关键词： quinazolin-4(1H)-one N-heterocyclic carbene carbonyl o-aminonitrile fused pyrimidinone

Collaborative assembly-mediated siRNA delivery for relieving inflammation-induced insulin resistance

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Nano Research 2020年第11期13卷 2958-2966页

作者： Shiyang Shen Li Zhang Mengru Li Zhizi Feng Huixia Li Xiao Xu Shiqi Lin Ping Li Can Zhang Xiaojun Xu Ran Mo State Key Laboratory of Natural Medicines Jiangsu Key Laboratory of Drug Discovery for Metabolic DiseasesCenter of Advanced Pharmaceuticals and BiomaterialsChina Pharmaceutical UniversityNanjing210009China

Obesity plays a primary causative role in insulin resistance and hyperglycemia that contributes to type 2 *** lipid storage in the liver renders activation of the resident macrophages and chronic secretion of inflammatory mediators,therefore causing or aggravating insulin ***,we develop collaborative assemblies using a“one-pot”synthesis method for macrophage-specific delivery of small interfering RNAs(siRNAs)that target the inflammatory *** nanocomplex(NC)composed of the siRNA molecule,a synthetic thiol-bearing methacrylated hyaluronic acid(sm-HA)and protamine forms through an electrostatic-driven physical assembly,which is chemically crosslinked to acquire the collaboratively assembled nanocapsule(cNC)*** obtained cNC displays significantly higher stability than *** moieties as flexible assembly units can be easily equipped on cNC for long circulation,active targeting,or controlled siRNA ***-F decorated with folic acid,a macrophage-targeting ligand promotes the siRNA accumulation in the activated macrophages in the liver of the obese mouse ***-F loaded with siRNA targeting inflammatory indicators efficiently control the macrophage inflammatory response by reducing the expression of the inflammatory proteins(>40%reduction)and ameliorating the insulin resistance symptoms of the obese mice.

关键词： small interfering RNA(siRNA)delivery collaborative assembly nanomedicine insulin resistance diabetes

Genomic profiling of colorectal cancer in large-scale Chinese patients:amplification and somatic mutations in ERBB2

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Oncology Research 2024年第9期32卷 1429-1438页

作者： YUZHI LIU EVELYNE BISCHOF ZHIQIN CHEN JIAHUAN ZHOU BEI ZHANG DING ZHANG YONG GAO MING QUAN Department of Oncology Shanghai East HospitalTongji University School of MedicineShanghaiChina State Key Laboratory of Oncogenes and Related Genes Shanghai Cancer InstituteDepartment of OncologyRenji HospitalSchool of MedicineShanghai Jiao Tong UniversityShanghaiChina jiangsu hengrui pharmaceuticals Co. Ltd.ShanghaiChina D Medicines Inc. ShanghaiChina

Objectives:Human epidermal growth factor receptor 2(HER2)-targeted therapies have demonstrated potential benefits for metastatic colorectal cancer(mCRC)patients with HER2 amplification,but are not satisfactory in cases of HER2 mutant ***:Consequently,further elucidation of amplifications and somatic mutations in erythroblastic oncogene B-2(ERBB2)is *** genomic profiling was conducted on 2454 Chinese CRC cases to evaluate genomic alterations in 733 cancer-related genes,tumor mutational burden,microsatellite instability,and programmed death ligand 1(PD-L1)***:Among 2454 CRC patients,85 cases(3.46%)exhibited ERBB2 amplification,and 55 cases(2.24%)carried ERBB2 mutation.p.R678Q(28%),p.V8421(24%),and p.S310F/Y(12%)were the most prevalent of the 16 detected mutation *** comparison to the ERBB2 altered(alt)group,KRAS/BRAF mutations were more prevalent in ERBB2 wild-type(wt)samples(ERBB2wt ***2alt,KRAS:50.9%vs.25.6%,p<0.05;BRAF:8.5%vs.2.3%,p<0.05).32.7%(18/55)of CRCs with ERBB2 mutation exhibited microsatellite instability high(MSI-H),while no cases with HER2 amplification displayed *** genes varied between ERBB2 copy number variation(CNV)and ERBB2 single nucleotide variant(SNV);TP53 alterations tended to co-occur with ERBB2 amplification(92.3%)as opposed to ERBB2 mutation(58.3%).KRAS and PIK3CA alterations were more prevalent in ERBB2 SNV cases(KRAS/PIK3CA:45.8%/31.2%)compared to ERBB2 amplification cases(KRAS/PIK3CA:14.1%/7.7%).Conclusion:Our study delineates the landscape of HER2 alterations in a large-scale cohort of CRC patients from *** findings enhance our understanding of the molecular features of Chinese CRC patients and offer valuable implications for further investigation.

关键词： Colorectal cancer ERBB2 HER2 Human epidermal growth factor receptor 2 Genetic profiling Precision oncology

Effect of Tongluojiunao injection made from Sanqi(Radix Notoginseng) and Zhizi(Fructus Gardeniae) on brain microvascular endothelial cells and astrocytes in an in vitro ischemic model

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Journal of Traditional Chinese Medicine 2014年第6期34卷 725-732页

作者： Weihong Li Xingguang Li Qinghong Du Feng Li Yuan zhu Yang Liu Jie Ma Liangqin Wan Fanghe Li Sai Zhang School of Preclinical Medicine Beijing University of Chinese Medicine Encephalopathy Center Jiangsu Province Hospital of Traditional Chinese Medicine Medical Affairs Novartis Pharmaceuticals (China)

OBJECTIVE: To explore the effect of Tongluojiunao injection(TLJN) prepared with Sanqi(Radix Notoginseng) and Zhizi(Fructus Gardeniae) on the interaction between brain microvascular endothelial cells(BMECs) and astrocytes in an in vitro ischemic ***: First, an in vitro model of cerebral ischemia in BMECs or astrocytes was established by oxygen-glucose deprivation(OGD). TLJN was used as a medicine of intervention. The OGD-injuredBMECs were cultured in various astrocyte-conditioned media. Cell activity, alkaline phosphatase(AKP) and γ-glutamyl transpeptidase(γ-GT) activity,interleukin-1 beta(IL-1β), and tumor necrosis factor alpha(TNF-α) content in BMECs were ***, OGD-injured astrocytes were cultured in various BMEC-conditioned media. Cell activity, as well as expression of brain-derived neurotrophic factor(BDNF) and glial cell-derived neurotrophic factor(GDNF) in astrocytes, were ***: The results of paracrine signaling of normal BMECs or astrocytes showed a protective effect on each other: conditioned media from normal astrocytes improved cell viability, AKP, and γ-GT activity, and reduced IL-1β and TNF-α content of injured BMECs; conditioned media from normal BMECs improved cell viability and expression of BDNF and GDNF in injured astrocytes. However, once the BMECs or astrocytes were injured by OGD, the protective effect decreased or disappeared. The above-mentioned protective induction was effectively recovered by TLJN ***: The therapeutic benefit of TLJN was achieved by recovering two-way induction between BMECs and astrocytes, enhancing activity of injured BMECs and astrocytes, stabilizing enzymatic barriers, promoting expression of neurotrophic factors, and inhibiting inflammatory cytokines.

关键词： Endothelial cells Astrocytes Paracrine communication Oxygen-glucose-deprivation Ton-gluojiunao injection

Phase II clinical trial using camrelizumab combined with apatinib and chemotherapy as the first-line treatment of advanced esophageal squamous cell carcinoma

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Cancer Communications 2020年第12期40卷 711-720页

作者： Bo Zhang Ling Qi Xi Wang Jianping Xu Yun Liu Lan Mu Xingyuan Wang Lidan Bai Jing Huang Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021P.R.China jiangsu hengrui Medicine Co.Ltd. LianyungangJiangsu 222047P.R.China

Background:Effective therapeutic options are limited for patients with advanced esophageal squamous cell carcinoma(ESCC).The incorporation of an immune checkpoint inhibitor and a molecular anti-angiogenic agent into the commonly adopted chemotherapy may produce synergistic ***,we aimed to investigate the efficacy and safety of camrelizumab plus apatinib combined with chemotherapy as the first-line treatment of advanced ***:In this single-arm prospective phase II trial,patients with unresectable locally advanced or recurrent/metastatic ESCC received camrelizumab 200 mg,liposomal paclitaxel 150 mg/m2,and nedaplatin 50 mg/m2 on day 1,and apatinib 250 mg on days *** treatments were repeated every 14 days for up to 9 cycles,followed by maintenance therapy with camrelizumab and *** primary endpoint was objective response rate(ORR)according to the Response Evaluation Criteria in Solid Tumors(version 1.1).Secondary endpoints included disease control rate(DCR),progression-free survival(PFS),overall survival(OS),and ***:We enrolled 30 patients between August 7,2018 and February 23,*** median follow-up was 24.98 months(95%confidence interval[CI]:23.05-26.16 months).The centrally assessed ORR was 80.0%(95%CI:61.4%-92.3%),with a median duration of response of 9.77 months(range:1.54 to 24.82+months).The DCR reached 96.7%(95%CI:82.8%-99.9%).The median PFS was 6.85 months(95%CI:4.46-14.20 months),and the median OS was 19.43 months(95%CI:9.93 months–not reached).The most common grade 3-4 treatmentrelated adverse events(AEs)were leukopenia(83.3%),neutropenia(60.0%),and increased aspartate aminotransferase level(26.7%).Treatment-related serious AEs included febrile neutropenia,leukopenia,and anorexia in one patient(3.3%),and single cases of increased blood bilirubin level(3.3%)and toxic epidermal necrolysis(3.3%).No treatment-related deaths ***:Camrelizumab plus apatinib combined with liposomal paclitaxel and nedapl

关键词： anti-angiogenesis apatinib camrelizumab chemotherapy esophageal squamous cell carcinoma first-line immunotherapy liposomal paclitaxel nedaplatin objective response rate

Reprogrammed siTNFα/neutrophil cytopharmaceuticals targeting inflamed joints for rheumatoid arthritis therapy

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Acta Pharmaceutica Sinica B 2023年第2期13卷 787-803页

作者： Yijun Chen Kaiming Li Mengying Jiao Yingshuang Huang Zihao Zhang Lingjing Xue Caoyun Ju Can Zhang State Key Laboratory of Natural Medicines Jiangsu Key Laboratory of Drug Discovery for Metabolic DiseasesCenter of Advanced Pharmaceuticals and BiomaterialsChina Pharmaceutical UniversityNanjing 210009China

Rheumatoid arthritis(RA)is an autoimmune disease characterized by severe synovial inflammation and cartilage *** great progress in RA therapy,there still lacks the drugs to completely cure RA ***,we propose a reprogrammed neutrophil cytopharmaceuticals loading with TNFα-targeting-siRNA(siTNFα)as an alternative anti-inflammatory approach for RA *** loaded siTNFαact as not only the gene therapeutics to inhibit TNFαproduction by macrophages in inflamed synovium,but also the editors to reprogram neutrophils to anti-inflammatory *** the active tendency of neutrophils to inflammation,the reprogrammed siTNFα/neutrophil cytopharmaceuticals(siTNFα/TP/NEs)can rapidly migrate to the inflamed synovium,transfer the loaded siTNFαto macrophages followed by the significant reduction of TNFαexpression,and circumvent the pro-inflammatory activity of neutrophils,thus leading to the alleviated synovial inflammation and improved cartilage *** work provides a promising cytopharmaceutical for RA treatment,and puts forward a living neutrophil-based gene delivery platform.

关键词： Neutrophil cytopharmaceuticals siRNA Macrophages Rheumatoid arthritis Tumor necrosis factorα Gene delivery Anti-inflammatory Cartilage protection