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A temporo-spatial pharmacometabolomics method to characterize pharmacokinetics and pharmacodynamics in the brain microregions by using ambient mass spectrometry imaging

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Acta Pharmaceutica Sinica B 2022年第8期12卷 3341-3353页

作者： Dan Liu Jianpeng Huang Shanshan Gao Hongtao Jin Jiuming He State Key Laboratory of Bioactive Substance and Function of Natural Medicines Institute of Materia MedicaChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100050China Department of Clinical Pharmacy First People’s Hospital of HuaihuaHuaihua 418000China New Drug Safety Evaluation Center Institute of Materia MedicaChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100050China NMPA Key Laboratory for Safety Research and Evaluation of Innovative Drug Beijing 100050China

The brain is the most advanced organ with various complex structural and functional microregions. It is often challenging to understand what and where the molecular events would occur for a given drug treatment in the brain. Herein, a temporo-spatial pharmacometabolomics method was proposed based on ambient mass spectrometry imaging and was applied to evaluate the microregional effect of olanzapine(OLZ) on brain tissue and demonstrate its effectiveness in characterizing the microregional pharmacokinetics and pharmacodynamics of OLZ for improved understanding of the molecular mechanism of drugs acting on the microregions of the brain. It accurately and simultaneously illustrated the levels dynamics and microregional distribution of various substances, including exogenous drugs and its metabolites, as well as endogenous functional metabolites from complicated brain tissue. The targeted imaging analysis of the prototype drug and its metabolites presented the absorption, distribution, metabolism, and excretion characteristics of the drug itself. Moreover, the endogenous functional metabolites were identified along with the associated therapeutic and adverse effects of the drug, which can reflect the pharmacodynamics effect on the microregional brain. Therefore, this method is significant in elucidating and understanding the molecular mechanism of central nervous system drugs at the temporo and spatial metabolic level of system biology.

关键词： Pharmacometabolomics Pharmacokinetics pharmacodynamics Mass spectrometry imaging Antipsychotic drug

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New Developments in the pharmacodynamics and Pharmacokinetics of Combination of Chinese Medicine and Western Medicine

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Chinese Journal of Integrative Medicine 2017年第4期23卷 312-319页

作者： LIU Di LIANG Xiao-chun Department of Traditional Chinese Medicine Peking Union Medical College Hospital Peking Union Medical CollegeTranslational Medicine Center Chinese Academy of Medical Sciences Beijing 100730 China

It is very common to use Chinese medicine (CM) combined with Western medicine (WM) in clinical practice. The appropriate combination of CM with WM can reduce toxicity and enhance effects in order to make the best use of advantages and bypass the disadvantages. However, an inappropriate combination can not only affect the curative effect but even cause death. Therefore, strengthening the complementary advantages of the CM and WM to improve the therapeutic efficacy and reduce side effects has become an important research topic of clinical medicine and pharmacy. Many researchers try to clarify the effects of combining CM with WM on therapeutic efficacy and absorption, distribution, metabolism and excretion by pharmacodynamics and pharmacokinetics studies, providing evidence for clinical application. This review focuses on the new developments in the pharmacodynamics and pharmacokinetics of the combination of CM with WM in order to give references for clinical treatment.

关键词： combination of Chinese and Western medicine pharmacodynamics pharmacokinetics

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Pharmacokinetics and pharmacodynamics of Shengjiang decoction in rats with acute pancreatitis for protecting against multiple organ injury

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World Journal of Gastroenterology 2017年第46期23卷 8169-8181页

作者： Lv Zhu Jun-Yi Li Yu-Mei Zhang Hong-Xin Kang Huan Chen Hang Su Juan Li Wen-Fu Tang Sichuan Provincial Pancreatitis Center Department of Integrative MedicineWest China HospitalSichuan University Department of Traditional Chinese Medicine Wuhan Union Hospital

AIM To explore the pharmacokinetics and pharmacodynamics of Shengjiang decoction(SJD) in rats with acute pancreatitis(AP) for protecting against multiple organ injury.METHODS An AP model was established by retrograde perfusion of 3.5% sodium taurocholate into the biliopancreatic duct, and a control group(CG) received 0.9% sodium chloride instead. Twelve male Sprague-Dawley rats were randomly divided into a CG treated with SJD(CG + SJD) and a model group treated with SJD(MG + SJD), both of which were orally administered with SJD(5 g/kg) 2 h after surgery. Blood samples were collected via the tail vein at 10, 20, and 40 min and 1, 2, 3, 4, 6, 8, and 12 h after a single dose of SJD to detect its main components using high-performance liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameters were compared. In the pharmacodynamic experiment, 18 male SpragueDawley rats were randomly divided into a CG, an AP model group(MG), and an SJD treated AP group(SJDG). Serum amylase, lipase, and inflammatory cytokines were measured, and heart, lung, liver, spleen, pancreas, kidney, and intestine tissues were collected for pathological examination.RESULTS The MG + SJD displayed significantly shorter mean residence time(MRT) and higher clearance(CL) for emodin and aloe-emodin; significantly shorter time of maximum concentration and T1/2 and a lower area under curve(AUC) for aloe-emodin; a significantly higher AUC and lower CL for rhein; and longer MRT and lower CL for chrysophanol than the CG + SJD. In the pharmacodynamic experiment, the amylase, interleukin(IL)-6, IL-10, and tumor necrosis factor(TNF)-α levels in the MG were higher than those in the CG(P < 0.05). After the herbal decoction treatment, the SJDG had higher IL-10 and lower TNF-α levels than the MG(P < 0.05). The MG had the highest pathological scores, and the pathological scores of the lung, pancreas, kidney, and intestine in the SJDG were significantly lower than those in the MG(P < 0.05).CONCLUSION AP may have varying effects on the pharmacokine

关键词： Pancreatic distribution pharmacodynamics Shengjiang decoction Pharmacokinetics Acute pancreatitis

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Pharmacokinetics/pharmacodynamics study of Fixtral SB as compared to supra bioavailable itraconazole and conventional itraconazole

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World Journal of Pharmacology 2023年第1期12卷 1-11页

作者： Syed Mujtaba Hussain Naqvi Monil Yogesh Neena Gala Snehal Muchhala Anand Arumugam Dhananjay Panigrahi Dipak Patil Rahul Rathod Amey Mane Medical Affairs Dr Reddy’s LaboratoriesHyderabad 500016India Global Clinical Management Dr Reddy’s LaboratoriesHyderabad 500016India Formulation Development Dr Reddy’s LaboratoriesHyderabad 500016India

BACKGROUND Itraconazole is a broad-spectrum triazole antifungal inhibiting fungal growth by inhibiting ergosterol synthesis and exhibits a nonlinear pharmacokinetic profile.Erratic absorption pattern with wide fluctuations in blood levels causes inconsistent and unpredictable clinical behaviour of this drug despite its low minimum inhibitory concentration(MIC)as compared to other antifungal agents.AIM To compare the oral bioavailability and bioequivalence of Fixtral SB(supra bioavailable itraconazole)with reference product R2(supra bioavailable 2×50 mg itraconazole).METHODS The study population consisted of 54 healthy volunteers,aged between 18-45 years and randomized to receive a single oral dose of either test[T;Fixtral SB(supra bioavailable itraconazole)100 mg]or reference product(R1;Sporanox 100 mg×2 capsules and R2;Lozanoc capsules 50 mg×2 capsules).Blood samples were taken pre-dose and post-dose up to 96 h.The study evaluated bioequivalence by comparing the oral bioavailability of the test product with reference product R2.The pharmacodynamic characteristics of the drug were evaluated by comparing the test product with reference product R1.Pharmacokinetics(PK)-PD comparative analysis[area under the concentration-time curve(AUC)/minimum inhibitory concentration(MIC)>25]was performed for conventional itraconazole 100 mg and supra bioavailable itraconazole 50 mg.Adverse events(AEs)assessments were performed in each study period and post-study evaluation.RESULTS Statistical analysis of primary PK variables revealed bioequivalence,with confidence intervals being completely inside the acceptance criteria of 80%-125%.The peak concentration levels of itraconazole were achieved at 10 h(T)and 8.5 h(R2),respectively.Pharmacodynamic parameter assessment showed that AUC/MIC for R1 are comparable to Fixtral SB 100mg for MIC levels up to 16mcg/mL(P>0.05 and observed P=0.3196).Six AEs were observed that were mild to moderate in severity and resolved.No severe AE was reported.CONCLUSION Test product itraconazole Capsule 100

关键词： Supra-Bioavailable itraconazole Conventional itraconazole Oral bioavailability pharmacodynamics Efficacy Adverse events

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Individualized immunosuppression: new strategies from pharmacokinetics,pharmacodynamics and pharmacogenomics

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Hepatobiliary & Pancreatic Diseases International 2005年第3期4卷 332-338页

作者： Geng Chen and Jia-Hong Dong Army Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, Chongqing 400038, China Army Institute of Hepatobiliary Surgery Southwest Hospital Third Military Medical University Chongqing 400038 China. jhdong@***

The ultimate goal of transplantation is the donor-specific immune tolerance, but at least in the first 15 to 20 years of this century, immunosuppressive agents are still the determinant of clinical outcome of transplant recipients. Individualizing patient's immunosuppression to optimize the balance between therapeutic efficacy and the occurrence of adverse events poses a great challenge to physicians. DATA SOURCES:The data in this article were taken mostly from MEDLINE (2000-2004), part of which were from the research of the authors. RESULTS:Individualized immunosuppression remains a problem because of the narrow therapeutic index and wide inter- and intra-patient variation of commonly-used im- munosuppressants. Recent progress in study of pharmaco-kinetics and pharmacodynamics improved the clinical outcome of transplant recipients. More importantly, the emergence of pharmacogenomics might provide a promising and complementary tool for traditional therapeutic drug monitoring (TDM). CONCLUSIONS:Individualizing organ recipient's immunosuppression to balance the therapeutic efficacy and the adverse events represents a great challenge to transplant clinicians. Pharmacogenomics shows great promise for an interesting and hopefully better future.

关键词： immunosuppression pharmacokinetics pharmacodynamics pharmacogenomics

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Evaluation of pharmacokinetics and pharmacodynamics relationships for Salvianolic Acid B micro-porous osmotic pump pellets in angina pectoris rabbit

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Asian Journal of Pharmaceutical Sciences 2014年第3期9卷 137-145页

作者： Shu-Ling Kan Jin Li Jian-Ping Liu Hong-Liang He Wen-Jing Zhang Department of Pharmaceutics China Pharmaceutical UniversityNanjingPR China Department of Pharmacy Xuzhou Medical CollegeXuzhouPR China

The work aims to investigate the in vitro release,pharmacokinetics(PK),pharmacodynamics(PD)and PK-PD relationships of Salvianolic Acid B micro-porous osmotic pump pellets(SalB-MPOPs)in angina pectoris New Zealand White(NZW)rabbits,compared with those of SalB immediate-release pellets(SalB-IRPs).The SalB plasma concentrations and Superoxide dismutase levels(PD index)were recorded continuously at predetermined time interval after administration,and the related parameters were calculated by using Win-Nonlin software.The release profile of MPOPs was more sustained than that of IRPs.PK results indicated that the mean C_(max) was significantly lower,the SalB plasma concentrations were steadier,both area under concentration-time curve from 0 to 24 h(AUC_(0-24 h))and from 0 to infinity(AUC_(0-∞))were presented larger,and both the peak concentration time(T_(max))and mean residence time(MRT)were prolonged for MPOPs,as compared with those of IRPs.PD results suggested that peak drug effect(E_(max))was lower and the equilibration rate constant(k_(e0))between the central compartment and the effect compartment was higher of MPOPs vs.those of IRPs.PKePD relationships demonstrated that the effectconcentration-time(ECT)course of MPOPs was clockwise hysteresis loop,and that of IRPs was counter-clockwise hysteresis loop.Collectively,those results demonstrated that MPOPs were potential formulations in treating angina pectoris induced by atherosclerosis.

关键词： Salvianolic Acid B Pharmacokinetics pharmacodynamics SalB micro-porous osmotic pump pellets PKePD relationships

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STUDIES ON THE pharmacodynamics AND PHARMACOKINETICS OF PACLITAXEL(Zisu~)

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Chinese Journal of Cancer Research 2000年第4期12卷 235-238页

作者：韩锐何小庆刘红岩雷小虹程青赵万洲 Institute of Materia Medica Chinese Academy of Medical Sciences & Peking Union Medical College Beijing China

Pharmacological studies demonstrated that paclitaxel (Zisu() was very active in the inhibition of the growth of human cancer cell panel including KB cells, HCT-8, A2780, and MCF-7 cells. The IC50 was as low as 0.0019, 0.0019, 0.0036 and 0.01 ( g/ml respectively. Experimental therapeutic studies indicated that paclitaxel(Zisu() significantly inhibited the growth of melanoma B-16, Walker carcinomsarcoma and heterotransplanted human ovarian cancer in nude mice. Biochemical pharmacological studies showed that paclitaxel (Zisu() could accelerate microtubule assembly and inhibit its deassembly; population in G1 was decreased while the cell population in G2+M phase was increased significantly. In addition, a polyploid cell population appeared. Pharmacokinetic studies demonstrated that the t1/2( was 0.12 h and t1/2( was 5.02 h when it was injected intravenously at a dose of 5 mg/kg in rats. The AUC, Vc and CLs were 11.82(( g.h)/ml, 0.50L/kg and 0.42L(h.kg) respectively.

关键词： Paclitaxel(Zisu() pharmacodynamics Pharmacokinetip

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pharmacodynamics for predicting therapeutic outcome and countering resistance spread:The cefditoren case

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World Journal of Clinical Infectious Diseases 2012年第3期2卷 28-38页

作者： Francisco Soriano María-José Giménez Lorenzo Aguilar Department of Microbiology School of Medicine University Complutense

The relationship between pharmacokinetics and pharmacodynamics is a key instrument to improve antimicrobial stewardship and should be aimed to identification of the drug exposure measure that is closely associated not only with the ability to kill organisms but also to suppress the emergence of resistant subpopulations. This article reviews published studies for efficacy prediction with cefditoren and those aimed to explore its potential for countering resistance spread, focusing on the three most prevalent community-acquired isolates from respiratory infections: Streptococcus pneumoniae(S. pneumoniae), Haemophilus influenzae(H. influenzae) and Streptococcus pyogenes(S. pyogenes). Studies for efficacy prediction include in vitro pharmacodynamic simulations(using physiological concentrations of human albumin) and mice models(taking advantage of the same protein binding rate in mice and humans) to determine the value of the pharmacodynamic indices predicting efficacy, and Monte Carlo simulations to explore population pharmacodynamic coverage, as weapons for establishing breakpoints. Studies exploring the potential of cefditoren(free concentrations obtained with 400 mg cefditoren bid administration) for countering spread of resistance showed itscapability for countering(1) intra-strain spread of resistance linked to fts I gene mutations in H. influenzae;(2) the spread of H. influenzae resistant strains(with fts I gene mutations) in multi-strain H. influenzae niches or of S. pneumoniae strains with multiple resistance traits in multi-strain S. pneumoniae niches; and(3) for overcoming indirect pathogenicity linked to β-lactamase production by H. influenzae that protects S. pyogenes in multibacterial niches. This revision evidences the ecological potential for cefditoren(countering resistance spread among human-adapted commensals) and its adequate pharmacodynamic coverage of respiratory pathogens(including those resistant to previous oral compounds) producing community-acquired infections.

关键词： Cefditoren Pharmacodynamia Pharmacokinetics pharmacodynamics Streptococcus pneumoniae Haemophilus influenzae Streptococcus pyogenes Resistance Indirect pathogen

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Study on pharmacodynamics of recombinant interferon α-2b suppository

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沈阳药科大学学报 2008年第S1期25卷 119-120页

作者： LIU Miao,LIU Zheng,SUN Liang(School of Life Sciences and Biopharmaceuticals,Shenyang Pharmaceutical University,Shenyang 110016,China)

Objective To investigate the antiviral activity of recombinant interferonα-2b suppository(IFNα-2b)in vivo and in vitro.Methods The cytopathic-effect inhibition assay was applied in this study to investigate the antiviral activity of this drug as well as yingtelong and axiluowei as positive control.The guinea pig model of vaginitis and skin infection caused by HSV-2 infection were established,treated with IFNα-2b suppository at dosages of 60000、180000、540000 IU,using IFNα-2b injection 180000 IU·kg-1 as controls.Score the pathological changes of appearance and skin,the virus activities of vaginal secretion and tissue sections of viginae were assayed after treatment.Results The TD50 of IFN α-2b and yingtelong for Vero cells was(>100)μg·mL-1 and(>100000)IU·mL-1,respectively.The IC50 of IFN α-2b and yingtelong and axiluowei for Herpes virus type 1 was(0.29±0.08)μg·mL-1 and(185.0±28.8)IU·mL-1 and(0.19±0.03)μg·mL-1,respectively.The mean scores for vaginal and skin lesion of the treated groups were lower than those of untreated group.Among these concentrations,the IFNα-2b suppository of 540000 IU·kg-1 group.Showed highest anti-viral activity.The virus activity in vaginal secretion of treated group was lower than that of untreated group too(P<0.01 or P<0.05).Tissue sections of viginae after treatment with IFNα-2b suppository showed significantly therapeutical effects on the degrees of vaginal lesion.At the same dosage,The anti-HSV activity of IFNα-2b suppository was also compared with IFNα-2b injection,the results showed that the activity of suppository of 540000 IU·kg-1 group was similar to that of the injection.Conclusions The IFNα-2b suppository has anti-viruses function both in vivo and in vitro.

关键词： recombinant interferon α-2b suppository herpes simple virus pharmacodynamics

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Advances in the clinical application of oxycodone in the perioperative period

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World Journal of Clinical Cases 2022年第16期10卷 5156-5164页

作者： Hong-Yang Chen Zi-Ning Wang Wei-Yi Zhang Tao Zhu Department of Anesthesiology West China HospitalSichuan UniversityChengdu 610041Sichuan ProvinceChina The Research Units of West China(2018RU012)-Chinese Academy of Medical Sciences West China HospitalSichuan UniversityChengdu 610041Sichuan ProvinceChina Department of Anesthesiology West China School of Clinical MedicineSichuan UniversityChengdu 610041Sichuan ProvinceChina

To review the research progress of pure opioid receptor agonist oxycodone.The research progress of oxycodone in terms of pharmacokinetics,pharmacodynamics,adverse reactions,clinical application,combined medication and new progress in clinical application was summarized by referring to the literature.Oxycodone is a semi-synthetic thebaine derivative of opioid alkaloids,and is a pure opioidμandκreceptor agonist.The main action sites are the central nervous system and visceral smooth muscle.Due to its advantages of low adverse reactions,good analgesic effects,and a wide range of safe doses,the drug has been widely used in the control of acute and chronic postoperative pain,as well as malignant and non-malignant pain.Since the end of the 20^(th) century,researchers have begun to formulate antipyretic analgesics,opioid receptor agonists,opioid receptor antagonists,dopamine receptor antagonists and other drugs with oxycodone in different proportions to enhance the analgesic effect.At the same time,it can reduce the dosage of oxycodone and reduce its adverse reactions,so as to achieve the purpose of limiting opioid abuse.With the continuous research on the efficacy and safety of oxycodone in the perioperative period at home and abroad,oxycodone has become the only dual-opioid potent analgesic that can be used in clinical work.

关键词： Oxycodone Anesthesia Acute pain Clinical application pharmacodynamics

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