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Artificial Bear Bile:A Novel Approach to Balancing Medical Requirements and Animal Welfare

Engineering 2024年第7期38卷 100-112页

作者： Yong Li Yuhong Huang Nan Feng Heping Zhang Jing Qu Shuanggang Ma Yunbao Liu Jiang Li Shaofeng Xu Ling Wang Mi Zhang Jie Cai Weiping Wang Ru Feng Hang Yu Bo Yu Dailiang Liang Heping Qin Suxiang Luo Yanfen Li Meifeng Li Ruihua Wang Chen Ma Yan Wang Xiaobo Cen Xiaoxian Xu Boli Zhang Xiaoliang Wang Shishan Yu State Key Laboratory of Bioactive Substance and Function of Natural Medicines Institute of Materia MedicaChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100050China The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300250China Zhongshan Belling Biotechnology co. Ltd.Zhongshan 528437China Zhongshan Anshi Biopharmaceutical co. Ltd.Zhongshan 528437China e WestChina-Frontier Pharma Tech Co.Ltd.Chengdu 610041China Tianjin University of Traditional Chinese Medicine Tianjin 301617China

Bear bile has been a valuable and effective medicinal material in traditional Chinese medicine(TCM)for over 13 ***,the current practice of obtaining it through bear farming is under scrutiny for its adverse impact on bear ***,we present a new approach for creating artificial bear bile(ABB)as a high-quality and sustainable alternative to natural bear *** study addresses the scientific challenges of creating bear bile alternatives through interdisciplinary collaborations across various fields,including resources,chemistry,biology,medicine,pharmacology,and TCM.A comprehensive efficacy assessment system that bridges the gap between TCM and modern medical terminology has been established,allowing for the systematic screening of therapeutic *** the utilization of chemical synthesis and enzyme engineering technologies,our research has achieved the environmentally friendly,large-scale production of bear bile therapeutic compounds,as well as the optimization and recomposition of ABB *** resulting ABB not only closely resembles natural bear bile in its composition but also offers advantages such as consistent product quality,availability of raw materials,and independence from threatened or wild *** preclinical efficacy evaluations have demonstrated the equivalence of the therapeutic effects from ABB and those from commercially available drained bear bile(DBB).Furthermore,preclinical toxicological assessment and phase I clinical trials show that the safety of ABB is on par with that of the currently used *** innovative strategy can serve as a new research paradigm for developing alternatives for other endangered TCMs,thereby strengthening the integrity and sustainability of TCM.

关键词： Artificial bear bile Chemical profile Formula optimization pharmacodynamic consistency Preclinical toxicological assessment

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comparative efficacy of secukinumab against adalimumab and infliximab in patients with moderate-to-severe plaque psoriasis

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Chinese Medical Journal 2022年第1期135卷 11-19页

作者： Ran Pan Xiaolun Wang Min Shu Jaydeep Das Manik Kalra Zhidong Wang beijing novartis pharma co.ltd. ShanghaiChina novartis Healthcare Pvt.ltd. HyderabadIndia

Background: Psoriasis is a common, chronic, immune-mediated inflammatory skin disease with increased epidermal proliferation. The objective of this review was to systematically identify the evidence and perform a network meta-analysis (NMA) to estimate the relative efficacy of secukinumab (SEC) against adalimumab (ADA) and infliximab (INF) for the treatment of moderate-to-severe plaque ***: A systematic literature review (SLR) was conducted according to a pre-specified protocol to identify relevant studies. Initially, the databases were searched from database inception till June 2013, and the SLR was updated in April 2020. The eligibility criteria included adult patients (≥18 years old) with moderate-to-severe plaque psoriasis, and the SLR included randomized controlled trials (RCTs). The comparators of interest were SEC, ADA, INF, and placebo (PLA), while outcomes of interest were Psoriasis Area and Severity Index (PASI) (50, 75, and 90) at weeks 12, 16, and 24. A Bayesian NMA for PASI was utilized with a framework that evaluated the probability of PASI responses in different categories of PASI thresholds within a single ***: A total of 23 RCTs that assessed the efficacy of SEC, ADA, and INF in patients with moderate-to-severe plaque psoriasis were identified. At 12 weeks, SEC was associated with a significantly better response compared with PLA and ADA for PASI 75 and 90, while response results were comparable against INF. At 12 weeks, risk ratio (95% confidence interval) derived from NMA for SECvs. ADA and INF for PASI 75 was 1.35 (1.19, 1.57) and 1.01 (0.90, 1.18), respectively. At the 16-week and 24-week time interval, SEC was significantly better than PLA, ADA, and INF for PASI 75 and ***: Efficacy of SEC in the treatment of patient populations with moderate-to-severe plaque psoriasis is well demonstrated through NMA.

关键词： Moderate-to-severe plaque psoriasis Secukinumab against adalimumab and infliximab Indirect comparison PASI response

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A practical synthesis of (-)fosfomycin from its enantiomer

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Chinese Chemical Letters 2008年第11期19卷 1297-1300页

作者： Meng Zhang Zheng Yu Ji Jun Li Da Li Yin beijing collab pharma co. Ltd. Beijing 102600 China Institute of Materia Medica Peking Union Medical College Beijing 100050 China

（＋）-cis-（1S, 2R）-Epoxypropylphosphonic acid, the enantiomer of fosfomycin, which is the industrial side-product in the preparation of the antibiotic fosfomycin, was converted into （-）fosfomycin by a seven-step procedure. The esterification of the dihydroxyphosphonic intermediate was the key step. The title compound was obtained in good yield and its optical purity was up to the medicine quality standard of Chinese pharmacopoeia.

关键词： Fosfomycin Enantiomer Phosphonate

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Development and Validation of a Simoa Assay for Determination of Recombinant Batroxobin in Human Serum

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Current Medical Science 2021年第3期41卷 618-625页

作者： Bian-zhen WANG Meng-jia WANG Min-rui WANG Lun OU Li-hou DONG Kelly DONG Hai-feng SONG State Key Laboratory of Proteomics Beijing Proteome Research CenterNational Center of Protein Sciences(Beijing)Beijing Institute of LifeomicsBeijing 102206China United-Power pharma Tech co LtdBeijing J02206China

Recombinant batroxobin(S3101)is a thrombin-like serine protease that binds to fibrinogen or is taken up by the reticuloendothelial system.A literature survey showed no adequate method that could determine sufficient concentrations to evaluate pharmacokinetic parameters for phase I clinical ***,a sensitive method is urgently needed to support the clinical pharmacokinetic evaluation of *** this study,a sensitive bioanalytical method was developed and validated,using a Quanterix single molecular array(Simoa)***,to thoroughly assess the platform,enzyme-linked immunosorbent assay and electrochemiluminescence assay were also developed,and their performance was compared with that of this novel technology *** assay was validated in compliance with the current *** with the Simoa assay were precise and accurate,presenting a valid assay range from 6.55 to 4000 pg/*** intra-and inter-run accuracy and precision were within-19.3%to 15.3%and 5.5%to 17.0%,respectively.S3101 was stable in human serum for 280 days at-20℃and-70℃,for 2 h prior to pre-treatment and 24 h post pre-treatment at room temperature(22℃-28℃),respectively,and after five and two freeze-thaw cycles at-70℃and-20oC,*** Simoa assay also demonstrated sufficient dilution linearity,assay sensitivity,and parallelism for quantifying S3101 in human *** Simoa assay is a sensitive and adequate method for evaluating the pharmacokinetic parameters of S3101 in human serum.

关键词： enzyme-linked immunosorbent assay electrochemiluminescence assay quanterix single molecular array recombinant batroxobin ligand-binding assay

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A randomized,double-blind,placebo-controlled trial assessing the efficacy and safety of tegaserod in patients from China with chronic constipation

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World Journal of Gastroenterology 2007年第5期13卷 732-739页

作者： San-Ren Lin Mei-Yun Ke Jin-Yan Luo Yao-Zong Yuan Ji-Yao Wang Shelley diTommaso Verena Walter Jiaqing Huang The 3rd Hospital Beijing Medical University Beijing China Peking Union Medical college Hospital BeijingChina The 2nd Hospital of Xian Jiaotong University Shanxi China Shanghai Ruijin Hospital Shanghai China Shanghai Zhongshan Hospital Shanghai China novartis pharma AG Basel Switzerland novartis pharmaceuticals corp East HanoverNew Jersey United States

AIM： To evaluate the efficacy and safety of tegaserod, 6 mg twice daily （b.i.d.）, in men and women with chronic constipation （CC） from China. METHODS： This was a multicenter, double-blind, placebo-controlled study. Following a 2-wk treatmentfree baseline period, patients were randomized to receive either tegaserod （6 mg b.i.d.） or placebo （b.i.d.） for 4 wk. An analysis of covariance with repeated measures was used to determine the overall effect of treatment for the primary efficacy variable; the change from baseline in the number of complete spontaneous bowel movements （CSBMs） during the 4-wk treatment period. Secondary efficacy endpoints included other measures of response in terms of CSBMs, and patients＇ daily and weekly assessment of bowel habits. Safety was also assessed, based on the incidence and severity of adverse events （AEs）. RESULTS： A total of 607 patients were randomized to receive either tegaserod （n = 304） or placebo （n = 303）. Tegaserod treatment resulted in a rapid and significant increase from baseline in the adjusted mean number of CSBMs per week over wk 1-4 compared with placebo （1.39 vs 0.91, P = 0.0002）. A statistically significant difference in favor of tegaserod was also observed for a mean increase ≥ 1 CSBM/wk over wk 1-4 （47.7% vs 35.0%, tegaserod vs placebo, respectively, P = 0.0018） and for the absolute number of≥ 3 CSBMs/wk over wk 1-4 （25.0% vs 14.5%, tegaserod vs placebo, respectively, P = 0.0021）. Improvements in other symptoms of CC were also seen in the tegaserod group, including improved stool form and reduced straining. In addition, more patients in the tegaserod group reported satisfactory relief from their constipation symptoms. The frequency and severity of AEs was comparable between tegaserod and placebo groups, with the exception of a greater incidence of diarrhea in patients receiving tegaserod （3.6%） compared with placebo （1.7%）. coNCLUSION： Tecjaserod treatment improved multiple symptoms of CC and was associated with a fa

关键词： Chronic constipation tegaserod China complete spontaneous bowel movement Placebocontrolled Stool

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Short-Term Efficacy of Treating Hepatitis B Virus-Related Acute-on-Chronic Liver Failure Based on cold Pattern Differentiation with Hot Herbs: A Randomized controlled Trial

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Chinese Journal of Integrative Medicine 2016年第8期22卷 573-580页

作者：郭玉明李丰衣宫嫚张琳王伽伯肖小河李筠赵艳玲王立福张晓锋 China Military Institute of Chinese Materia Medica 302 Military HospitalBeijing 100039China Treatment and Research Center for Infectious Diseases 302 Military HospitalBeijing 100039China Integrative Medical Center for Liver Diseases 302 Military HospitalBeijing 100039China Medical Affairs Novartis Pharma ChinaBeijing 100004China

Objective： To evaluate the clinical efficacy and safety of Yinchen Zhufu Decoction（茵陈术附汤, YCZFD） in the treatment of acute-on-chronic liver failure caused by hepatitis B virus（HBV-ACLF） with cold pattern in Chinese medicine（CM）. Methods： This is a multi-center randomized controlled trial of integrative treatment of CM and Western medicine（WM） for the management of HBV-ACLF patients. A total of 200 HBV-ACLF patients with cold pattern were equally randomly assigned to receive YCZFD and WM（integrative treatment） or WM conventional therapy alone respectively for 4 weeks. The primary end point was the mortality for HBV-ACLF patients. Secondary outcome measures included Model for End-Stage Liver disease（MELD） score, liver biochemical function, coagulation function and complications. Adverse events during treatment were reported. Results： The mortality was decreased 14.28% in the integrative treatment group compared with WM group（χ^2=6.156, P=0.013）. The integrative treatment was found to significantly improve the MELD score（t=2.353, P=0.020）. There were statistically significant differences in aspartate transaminase, total bilirubin, indirect bilirubin, direct bilirubin and prothrombin time between the two groups（P〈0.05 or P〈0.01）. The complications of ascites（χ^2=9.033, P=0.003） and spontaneous bacteria peritonitis（χ^2=4.194, P=0.041） were improved significantly in the integrative treatment group. No serious adverse event was reported. conclusions： The integrative treatment of CM and WM was effective and safe for HBV-ACLF patients with cold pattern in CM. The Chinese therapeutic principle ＂treating cold pattern with hot herbs＂ remains valuable to the clinical therapy.（Trial registration No. Chi CTR-TRC-10000766）

关键词： hepatitis B virus-related acute-on-chronic liver failure mortality Chinese medicine cold pattern Yinchen Zhufu Decoction

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An established LC-MS/MS method and a developed PK model for the study of pharmacokinetic properties of benapenem in infected mice

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Journal of Chinese pharmaceutical Sciences 2019年第11期28卷 802-811页

作者： Xiwei Ji Zisheng Kang Yun Li Xiping Yang Xifeng Ma Chongtie Shi Yuan Lv Institute of Clinical pharmacology Peking University First HospitalBeijing 100191China XuanZhu pharma co. Ltd.Jinan 250101ShandongChina

Benapenem is a new parenteral beta-lactam antibacterial with a broad antibacterial spectrum. In the present study, we developed and validated a simple, rapid and sensitive assay method using D6-benapenem as internal standard(IS) after one-step precipitation with methanol to determine benapenem in the plasma of infected mice. Separation was achieved on a reverse phase C18 column with a mobile phase composed of acetonitrile containing 0.2% formic acid–water(0.2% formic acid) and 10 mmol/L ammonium acetate in gradient elution mode. A triple quadrupole tandem mass spectrometer with electrospray ionization source was used as detector and operated by multiple reaction monitoring(MRM) in the positive ion mode. Calibration curves were linear(r>0.99) between 10 and 2000 ng/m L. The quantitative limit was 10 ng/m L, and the intra-and inter-precisions were covery of benapenem and IS was 97.07%–107.09% and 92.47%–111.59%, respectively. The intra-and inter-accuracies were –9.70%– –11.00%, and the matrix effects of benapenem and IS were 85.68%–92.04% and 83.17%–92.04%, respectively. The method was successfully applied to the preclinical pharmacokinetic(PK) studies of benapenem. We also developed a two-compartment model to characterize the PK profiles of benapenem in infected mice, which could provide a better understanding of the PK properties of benapenem.

关键词： LC-MS/MS Benapenem Infected mice pharmacokinetics Modeling

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An improved synthesis of (-)-7-isopropyl-cis-l-amino-2-indanol the chiral auxiliary for 6π-azaelectrocyclization

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Chinese Chemical Letters 2009年第10期20卷 1204-1206页

作者： Su Yun Liu Shigeo Katsumura beijing collab pharma co. ltd. No. 26 Jinyuan Street Daxing Industrial Development Area Beijing 102600 China School of Science and Technology Kwansei Gakuin University Gakuen 2-1 Sanda Hyogo 669--1337 Japan

（-）-7-Isopropyl-cis-l-amino-2-indanol, a key chiral auxiliary and ligand in the highly stereo-selective asymmetric 6π- azaelectrocyclization, has been prepared previously by two methods. Each however involved using of one extreme condition, i.e. high temperature or high pressure, for the respective reaction. A modified reaction route employed mild condition for synthesis was presented in this report.

关键词： Chiral cis-1-Amino-2-indanol Asymmetric dihydroxylation

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Management of acute heart failure-Is there a paradigm shift around the corner?

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World Journal of Cardiovascular Diseases 2013年第2期3卷 1-7页

作者： C. Pater, T. Severin novartis pharma AG Basel Switzerland

It has become increasingly apparent that the looming epidemic of heart failure calls for systematic treatment approaches tailored to the needs of individual patient phenotypes. Although chronic heart failure (CHF) therapies are continuously evolving based on the increasing understanding of the involved etiology, acute heart failure (AHF) therapies are still based on hemodynamic improvements and symptom alleviation. Guidelines on AHF management have highlighted that the currently administered AHF therapies lack evidence and have raised concerns on the safety and efficacy of some of the hitherto accepted treatment modalities. Additionally, the high mortality and morbidity rates associated with the current AHF therapies also add to the imperative need to revisit AHF management. The last decade has witnessed a paradigm shift in the way we define and diagnose AHF. Apart from it being recognized as a distinct clinical entity, research has also led to new data on the pathophysiological changes associated with AHF. These developments along with the limited short- and long-term effects of currently used therapies may herald a paradigm shift in the way we plan and deliver management strategies to treat the pathological progression of heart failure.

关键词： Acute Heart Failure Hemodynamic Clinical and Residual congestion Vasodilators Diuretics Management Strategies

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Efficacy and safety of secukinumab over 52 weeks in Chinese psoriasis patients with concomitant psoriatic arthritis

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Chinese Medical Journal 2021年第21期134卷 2629-2631页

作者： Lin Cai Jian-Zhong Zhang Min Zheng Shi-Fa Zhang Manmath Patekar Department of Dermatology Peking University People’s HospitalBeijing 100044China Department of Dermatology Second Affiliated Hospital School of MedicineZhejiang UniversityHangzhouZhejiang 310009China Department of Dermatology General Hospital of Shenyang Military RegionShenyangLiaoning 110016China novartis pharma AG BaselSwitzerland

Psoriasis is a chronic,systemic inflammatory disease characterized by demarcated,scaly,erythematous skin *** arthritis(PsA)is the most common comorbidity.

关键词： patients plaques morbidity

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