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1.
Chinese Journal of Clinical Pharmacology and Therapeutics ; (12): 316-327, 2024.
Article in Chinese | WPRIM | ID: wpr-1014543

ABSTRACT

Positron emission tomography (PET) now plays an important role in the research and development (R&D) of central nervous system (CNS) drugs. PET could characterize the biodistribution, pharmacokinetics, and receptor binding of CNS drugs quantitatively. The present review summarized the quantitative methods of PET used in the pharmacokinetics and receptor occupancy analysis of CNS drugs. Moreover, the present review listed various applications of PET supporting R&D of CNS drugs, which could provide a new direction for the R&D of CNS drugs.

2.
Braz. J. Pharm. Sci. (Online) ; 59: e22045, 2023. tab, graf
Article in English | LILACS | ID: biblio-1439519

ABSTRACT

Abstract The genus Candida represents the main cause of infections of fungal origin. Some species stand out as disease promoters in humans, such as C. albicans, C. glabrata, C. parapsilosis, and C. tropicalis. This study evaluated the antifungal effects of propyl (E)-3-(furan-2-yl) acrylate. The minimum inhibitory concentration of the synthetic compound, amphotericin B and fluconazole alone against four species of Candida ranged from 64 to 512 µg/mL, 1 to 2 µg/mL, and 32 to 256 µg/mL, respectively. The synergistic effect of the test substance was observed when associated with fluconazole against C. glabrata, there was no antagonism between the substances against any of the tested strains. The potential drug promoted morphological changes in C. albicans, decreasing the amount of resistance, virulence, and reproduction structures, such as the formation of pseudohyphae, blastoconidia, and chlamydospores, ensuring the antifungal potential of this substance. It was also possible to identify the fungicidal profile of the test substance through the study of the growth kinetics of C. albicans. Finally, it was observed that the test compound inhibited the ergosterol biosynthesis by yeast


Subject(s)
Candida albicans/drug effects , Ergosterol/agonists , Antifungal Agents/analysis , Candida/classification , Pharmaceutical Preparations/analysis , Microbial Sensitivity Tests/instrumentation
3.
China Pharmacy ; (12): 7-11, 2023.
Article in Chinese | WPRIM | ID: wpr-953709

ABSTRACT

OBJECTIVE To study the variety included in the List of Overseas New Drugs Urgently Needed in Clinic in China and optimization strategy, in order to better meet the needs of patients. METHODS The release process of List of Overseas New Drugs Urgently Needed in Clinic, the characteristics and attributes of the new drugs urgently needed abroad, and the problems in the implementation process were all analyzed to put forward some suggestions for optimizing the List of Overseas New Drugs Urgently Needed in Clinic. RESULTS & CONCLUSIONS The release process of the List of Overseas New Drugs Urgently Needed in Clinic was roughly divided into incubation stage, preparation stage and implementation stage. The treatment fields of 3 batches of overseas new drugs urgently needed in clinic were relatively concentrated on endocrine and metabolic diseases,tumor and skin diseases. Of included 73 varieties, 50 varieties have been approved for market,and 26 varieties have been included in the medical insurance, 4 varieties were included in the Catalogue of Encouraged Generic Drugs. At present, there are still some problems in our country, such as the shortage monitoring system needs to be established and improved; the linkage with medical insurance is weakened; the encouragement of generic drugs is insufficient. It is necessary to strengthen the cooperation of monitored departments in the shortage of new overseas drugs,establish a medical insurance payment system oriented by clinical value, and improve the incentive mechanism to encourage the imitation of overseas new drugs urgently needed in clinic.

4.
Rev. cuba. reumatol ; 24(2): e1022, mayo.-ago. 2022.
Article in Spanish | LILACS, CUMED | ID: biblio-1409216

ABSTRACT

La artritis reumatoide se clasifica como una enfermedad articular autoinmune crónica poliarticular sistémica que afecta principalmente a manos y pies. El objetivo de este trabajo es mostrar información publicada que contribuye a direccionar el manejo de la artritis reumatoide con nuevos fármacos, a partir del conocimiento de aspectos novedosos relacionados con la fisiopatología y los avances recientes sobre un grupo importante de dianas para el tratamiento de esta enfermedad. Las modificaciones epigenéticas pueden regular la expresión génica sin alterar la secuencia del ADN. La regulación de los ARN no codificantes (ncRNA), la metilación del ADN, la metilación del ARN y las modificaciones de las histonas se consideran los principales mecanismos de las regulaciones epigenéticas. Numerosas investigaciones han establecido que varias anomalías en estos mecanismos terminan en el desarrollo de la AR. Este trabajo resume nuevas dianas, que incluyen proteínas, pequeños metabolitos moleculares y reguladores de la epigenética. Son dianas moleculares prometedoras para el descubrimiento de fármacos que alivien la aparición de enfermedades y resuelvan la falta de respuesta y las respuestas parciales, así como los efectos adversos de los FARME actuales. Es innegable que aún se necesitan mayores esfuerzos para definir con mayor precisión las vías de señalización subyacentes afectadas por estas moléculas recién descubiertas y para desarrollar métodos de terapia apropiados(AU)


Rheumatoid arthritis is classified as a systemic polyarticular chronic autoimmune joint disease that mainly affects the hands and feet. The objective of this work is to show published information that contributes to directing the management of RA with new drugs. Epigenetic modifications can regulate gene expression without altering the DNA sequence. Regulation of non-coding RNAs (ncRNAs), DNA methylation, RNA methylation, and histone modifications are considered the main mechanisms of epigenetic regulations. Numerous investigations have established that various abnormalities in these mechanisms lead to the development of RA. This work summarizes new targets, including proteins, small molecular metabolites and regulators of epigenetics. They are promising molecular targets for drug discovery to alleviate disease onset and resolve non-response and partial responses, as well as adverse effects of current DMARDs. It is undeniable that further efforts are still needed to further define the underlying signaling pathways affected by these newly discovered molecules and to develop appropriate therapy methods(AU)


Subject(s)
Humans , Male , Female , Arthritis, Rheumatoid/history , Epigenomics/methods
5.
Rev. Ciênc. Méd. Biol. (Impr.) ; 21(1): 18-24, maio 05,2022. fig, tab
Article in Portuguese | LILACS | ID: biblio-1370484

ABSTRACT

Introdução: Caryocar brasiliense é conhecida popularmente como Pequi ou Pequizeiro, sendo uma planta com propriedades medicinais para tratamento de doenças respiratórias, úlceras gástricas e dores musculares. Objetivo: comparar a extração de biocompostos por meio de dois métodos extrativos, agitação magnética e banho ultrassônico. Além disso, avaliar a atividade antioxidante, o teor de compostos fenólicos, flavonoides e antocianinas em extratos das folhas e da casca de Pequi (C. brasiliense), com vistas a agregar valor quanto às suas propriedades funcionais. Metodologia: o conteúdo de compostos fenólicos foi determinado pelo método de Folin-Ciocalteu, flavonoides e antocianinas pelo método de Lima e Melo. A atividade antioxidante foi medida pelo método 2,2-difenil-1-picrilhidrazil (DPPH). Resultados: o extrato das folhas de Pequi exibiu maior teor de fenólicos em relação à casca, independente do método de extração. O extrato das folhas obtido em banho ultrassônico apresentou forte atividade antioxidante com valor de 72,2%. Conclusão: os extratos de Pequi demonstraram um perfil fitoquímico promissor que deve ser investigado no futuro para aplicação farmacológica como adjuvante ou precursor na síntese de novos cosméticos ou medicamentos com propriedades antioxidante.


Introduction: Caryocar brasiliense is a medicinal plant used in the treatment of respiratory diseases, gastric ulcers and muscle pain. Objective: to compare the extraction of natural compounds using two extractive methods, magnetic stirring and ultrasonic bath. In addition, to evaluate the antioxidant activity, the content of phenolic compounds, flavonoids and anthocyanins in the leaves and bark of Pequi (C. brasiliense), with a view to adding value through its functional properties. Methodology: the phenolic content was determined by the Folin-Ciocalteu method, flavonoids and anthocyanins by the Lima and Melo method. Antioxidant activity was measured using the 2.2-diphenyl-1-picrilhhydrazyl (DPPH) method. Results: the extract of the Pequi leaves exhibited a higher phenolic content in relation to the bark for both extraction methods. The Pequi leaf in an ultrasonic bath showed strong antioxidant activity with a value of 72.2%. Conclusion: Pequi extracts demonstrated a promising phytochemical profile that should be investigated in the future for pharmacological application as an adjuvant or precursor in the synthesis of a new cosmetic or medicine with antioxidant function.


Subject(s)
Plants, Medicinal , Reference Drugs , Malpighiales
6.
Cancer Research on Prevention and Treatment ; (12): 340-346, 2022.
Article in Chinese | WPRIM | ID: wpr-986519

ABSTRACT

Objective To establish a druggability evaluation method for new targets of anti-tumor drugs by analyzing the mutation genes of common tumors in the digestive system. Methods We collected the mutant gene data of the five common tumors of the digestive system (esophageal cancer, gastric cancer, colorectal cancer, liver cancer and pancreatic cancer) in the Integrative Onco Genomics database, and screened out the genes with higher mutation rates in each tumor. We evaluated the druggability of these genes or their encoded proteins, and discovered the potential targets for the new anti-tumor drugs. Results A total of five tumors, 35 cohorts and 5445 tumor samples were collected in this study. The top 10 mutation genes were selected for further analysis. The canSAR database was used to analyze the druggability of unpublished mutant genes or their encoded proteins, and a total of 17 potential therapeutic drug targets were screened out. Conclusion A method for evaluating druggability of targets based on mutant genes or their encoded protein is established in this study. The application of this method can provide a reference for discovering new anti-tumor therapeutic target, saving the cost and time of target screening in new drug development.

7.
International Eye Science ; (12): 803-808, 2022.
Article in Chinese | WPRIM | ID: wpr-923416

ABSTRACT

@#Age-related macular degeneration(ARMD)is one of the main causes of irreversible visual impairment in the middle-aged and elderly people, which severely impacts the patient's life quality and poses a substantial health economic burden on society. There are two types of late ARMD in clinic: wet ARMD and dry ARMD. Anti-vascular endothelial growth factor drugs, as first-line clinical drugs for wet ARMD, achieved remarkable efficacy. For dry ARMD, however, effective therapies are in the air. This review focuses on the potential drugs, biological therapies and traditional Chinese medicines that made significant progresses in clinical trials for dry ARMD, including anti-inflammatory drugs(doxycycline and FHTR2163), anti-oxidants(risuteganib and elamipretide), complement inhibitors(APL-2 and zimura), visual cycle modulators(ALK-001), neuroprotective agents(brimonidine), stem cell transplantation(MA09-hRPE and BMMF), gene therapy(HMR59), and traditional Chinese medicine(saffron, curcumin, quercetin and resveratrol). The new drugs exhibited favorable clinical efficacy and broad application prospects, which would foster hope for improvement and treatment of ARMD.

8.
China Journal of Chinese Materia Medica ; (24): 1120-1125, 2022.
Article in Chinese | WPRIM | ID: wpr-928032

ABSTRACT

Since the implementation of drug registration in China, the classification of Chinese medicine has greatly met the needs of public health and effectively guided the transformation, inheritance, and innovation of research achievements on traditional Chinese medicine(TCM). In the past 30 years, the development of new Chinese medicine has followed the registration transformation model of " one prescription for single drug". This model refers to the R&D and registration system of modern drugs, and approximates to the " law-abiding" medication method in TCM clinic, while it rarely reflects the sequential therapy of syndrome differentiation and comprehensive treatment with multiple measures. In 2017, Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices released by the General Office of the CPC Central Committee and the General Office of the State Council pointed out that it is necessary to " establish and improve the registration and technical evaluation system in line with the characteristics of Chinese medicine, and handle the relationship between the traditional advantages of Chinese medicine and the requirements of modern drug research". Therefore, based on the development law and characteristics of TCM, clinical thinking should be highlighted in the current technical requirements and registration system of research and development of Chinese medicine. Based on the current situation of registration supervision of Chinese medicine and the modern drug research in China, the present study analyzed limitations and deficiency of " one prescription for single drug" in the research and development of Chinese medicine. Additionally, a new type of " series prescriptions" was proposed, which was consistent with clinical thinking and clinical reality. This study is expected to contribute to the independent innovation and high-quality development of the TCM industry.


Subject(s)
China , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Prescriptions , Public Health
9.
Braz. J. Pharm. Sci. (Online) ; 57: e19087, 2021. tab, graf
Article in English | LILACS | ID: biblio-1345459

ABSTRACT

This study aims to analyze the new drugs registered in Brazil from 2003 to 2013 from the perspective of childcare needs, drug safety and considering the disease burden of the country. This is a retrospective cohort study including new drugs registered in Brazil between 2003 and 2013. Drug indications were related to the Disability-Adjusted Life Year (DALY) of the 2015 Global Burden of Disease Study. Association between the number of new drugs and DALY was determined by Spearman's coefficient. Post-marketing safety alerts specific to the pediatric population have been identified in the WHO Drug Information Bulletin and on websites of drug regulatory agencies. A total of 134 new drugs were included in the cohort and 46 (34.3%) had a pediatric indication. There was no evidence of an association between the disease burden in children in Brazil and the number of pediatric drugs. The safety alert data associated with the pediatric population published after registration of the new drugs were scarce. The number of new drugs launched in Brazil with a pediatric indication was small, reflecting the international challenges of developing effective and safe medicines for children. No association was found between the number of new drugs and the disease burden.


Subject(s)
Brazil/ethnology , Pharmaceutical Preparations/analysis , Drug Approval/legislation & jurisprudence , World Health Organization , Child Care/methods , Child Health/classification , Cohort Studies , Reference Drugs , Health Services Needs and Demand/classification
10.
China Journal of Chinese Materia Medica ; (24): 1701-1705, 2021.
Article in Chinese | WPRIM | ID: wpr-879082

ABSTRACT

Since "the implementation of good clinical practice"(GCP), especially after 2015, the overall quality of new drug cli-nical trials in China has made significant progress, but compared with developed countries, there are still some obvious quality problems in clinical trials in China. Clinical trials of new drugs of traditional Chinese medicine are an important part of clinical trials of new drugs in China. In addition to some common problems in all clinical trials, there are also some special quality problems. In terms of security data, such as the collection of human safety data is not standardized, the management and judgment of unexpected serious adverse reactions(SUSAR) were not professional and timely, the relationship between adverse events and trial drug was not fully judged by investigator, In terms of effective data, such as primary efficacy outcome of the scale cannot be traced, TCM syndrome data cannot meet the requirements of "source data" in the revised GCP and the quality of traditional Chinese medicine placebo is not high, in terms of overall quality system construction, the sponsors and research institutions have not established a quality assurance system that conforms to the characteristics of new drug research of traditional Chinese medicine, etc. The quality of clinical trials of new drugs of traditional Chinese medicine is based on the current GCP and ICH-GCP in China, we should also consider the characteristics of clinical trials of new traditional Chinese medicine drugs, and formulate targeted quality control measures according to the characteristics of these new drugs of traditional Chinese medicine, to improve the overall quality of clinical trials of new drugs of traditional Chinese medicine in China, which has important strategic significance for promoting the research and development of new drugs of traditional Chinese medicine in China.


Subject(s)
Humans , China , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Quality Control
11.
China Journal of Chinese Materia Medica ; (24): 1696-1700, 2021.
Article in Chinese | WPRIM | ID: wpr-879081

ABSTRACT

At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.


Subject(s)
Humans , Biomedical Research , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal , Ethical Review , Medicine, Chinese Traditional , Multicenter Studies as Topic , Pharmaceutical Preparations
12.
China Journal of Chinese Materia Medica ; (24): 1691-1695, 2021.
Article in Chinese | WPRIM | ID: wpr-879080

ABSTRACT

The relevant laws and regulations of drug clinical trials were introduced in this paper. It is pointed out that with drug re-gulatory laws and technological advances, clinical trials have become an important link in the development of new drugs of traditional Chinese medicines(TCM). Clinical trials of new drugs of TCM must comply with the requirement of "Good Clinical Practice for Trial on Medicinal Products". In view of the particularities of clinical trials of new drugs of TCM, China has established an ethical review system for clinical research in TCM and carried out ethical review and certification of TCM research. In order to guide the development of clinical trials of new drugs of TCM, relevant departments have promulgated a series of guidelines for clinical trials of it, and established a new review system and technical requirements for clinical trials. Since 1983, the "national clinical pharmacology base" has been established. At present, there are 96 drug clinical trial institutions and 32 phase I clinical research wards in TCM hospitals, which can meet the development of clinical trials of new drugs of TCM. In the long-term practice, the technical team has continued to grow and develop, the research experience and technical strength have been significantly improved, and a large number of experts have become the backbone of clinical research in Chinese medicine. It is pointed out that we should attach importance to risk and benefit assessment, human experience, select scientific, objective and appropriate effectiveness indexes, evaluate the efficacy of TCM syndromes, and encourage the use of electronic methods in clinical research of new drugs of TCM. Based on the analysis of clinical trials of TCM in recent five years, it is pointed out that the active degree of clinical trials of new drugs of TCM is not high, the innovation ability of it is insufficient and the ability and enthusiasm of all aspects need to be improved. It is of great significance to carry out clinical trials of new traditional Chinese medicines to upgrade the TCM industry and produce high-level evidence-based medicine evidences. The high quality development of TCM can be promoted by strengthening clinical trials of new drugs of TCM.


Subject(s)
Humans , China , Drugs, Chinese Herbal , Evidence-Based Medicine , Medicine, Chinese Traditional , Syndrome
13.
China Journal of Chinese Materia Medica ; (24): 1686-1690, 2021.
Article in Chinese | WPRIM | ID: wpr-879079

ABSTRACT

This article proposes that the research and development of new Chinese medicines should be based on the clinical values of traditional Chinese medicine(TCM), and expounds the multiple clinical values of new Chinese medicines such as therapeutic effects, adjuvant treatment effects, improvement of disease symptoms, improvement of quality of life, prevention of diseases, etc., so as to broaden the clinical indications of new Chinese medicines. It is pointed out that the clinical value of TCM determines the clinical efficacy evaluation method of new Chinese medicines, so as to construct a clinical evaluation system of new Chinese medicines with the characteristics of TCM. It is proposed that the clinical value of new Chinese medicines should be found under the guidance of TCM theo-ry and clinical practice, and the theoretical innovation of TCM should be emphasized. There is no difference in the clinical value of drugs, and the key is to meet the clinical needs of patients. The research and development of new Chinese medicines ignores the theoretical guidance of Chinese medicine, and relying solely on animal experiment data may lead to failure of clinical trials. Different from the individualized treatment of TCM clinical syndrome differentiation, summarizing the core pathogenesis of TCM is the basis for the development of new Chinese medicines. It is necessary to summarize the pathogenesis of the disease under the guidance of TCM theory and encourage the application of modern medical methods to clarify the diagnosis of the disease. In view of the characteristics of new Chinese medicine research and development, it is proposed that the supporting role of human experience should be emphasized, and the technical points of clinical trials of new syndrome-type Chinese medicines should be explained.The use of objective indicators for syndrome evaluation, the selection of appropriate scales, and the formulation of reasonable treatment courses are advocated. During the research and development of new Chinese medicines, it is not only necessary to pay attention to modern medical safety indicators, but also to observe the evolution of TCM syndromes and specific TCM symptoms.


Subject(s)
Humans , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Quality of Life , Research , Syndrome
14.
China Journal of Chinese Materia Medica ; (24): 730-735, 2021.
Article in Chinese | WPRIM | ID: wpr-878900

ABSTRACT

In recent years, the National Medical Products Administration has established a communication system for the process of drug R&D and registration. In this paper, the reform policies on establishing the communication system for drug evaluation in recent years were summarized, and the channels, processes, methods and types of communication were also collected. In addition, the communication status of new drugs of traditional Chinese medicine(TCM) was summarized according to the whole process of R&D, including summary of clinical practice, Investigational New Drug Applications, period of clinical trials, New Drug Applications, and post-marketing researches. Meanwhile, the current problems such as ineffective, inefficient, repeated or even no communication were analyzed, and relevant suggestions were proposed accordingly in order to provide reference for better communication on R&D and registration of new drugs of TCM.


Subject(s)
Communication , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Pharmaceutical Preparations
15.
China Journal of Chinese Materia Medica ; (24): 4581-4584, 2021.
Article in Chinese | WPRIM | ID: wpr-888161

ABSTRACT

Clinical trail report is a summary of the process and results of clinical trail, an important basis to support the effectiveness and safety evaluation of drug marketing and an important technical data required for drug registration. Safety analysis is the main part and the most common issue of clinical trial report. In this article, it is summarized and analyzed the common problems found in the safety analysis part of the clinical trial report of new drugs of traditional Chinese medicine(TCM) in combination with the clinical professional evaluation of the application for marketing license of innovative TCM. The common problems in writing the safety aspects of clinical trail reports were summarized and analyzed, including the omissions of adverse events and laboratory test results, the failure to provide a detailed list of laboratory test outliers, the lack of professional depth in the analysis of the causal relationship between adverse events and TCM. In view of the common problems, it is suggested that the drug use degree, adverse events and adverse reactions, as well as laboratory examination should be considered. Check the three dimensions for necessary medical analysis, collation and summary and continuously improve the quality of safety analysis in clinical trial reports.


Subject(s)
Clinical Trials as Topic , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese Traditional
16.
Gac. méd. Méx ; 156(6): 610-611, nov.-dic. 2020.
Article in Spanish | LILACS | ID: biblio-1249974

ABSTRACT

Resumen La implementación en instituciones de salud de un cuadro básico permite adquirir y administrar una larga lista de medicamentos que presenta a los médicos las alternativas de tratamiento, así como la descripción académica colegiada de indicaciones, dosis, efectos secundarios, interacciones y análisis de costo-beneficio, con lo que se facilita la prescripción médica y la administración de insumos para la salud. El Comité de Ética y Transparencia en la Relación Médico-Industria emite diversas recomendaciones para la optimización de los beneficios generados por los cuadros básico de medicamentos.


Abstract The implementation of an essential medicines list in health institutions allows acquiring and administering a long list of drugs that offers treatment alternatives to physicians, as well as a collegiate academic description of indications, doses, side effects, interactions and cost-benefit analyses, thus facilitating medical prescription and administration of health products. The Committee of Ethics and Transparency in the Physician-Industry Relationship issues several recommendations for optimizing the benefits generated by essential medicines lists.


Subject(s)
Humans , Drug Prescriptions , Ethics Committees , Guidelines as Topic , Drugs, Essential/therapeutic use , Physicians/ethics , Cost-Benefit Analysis , Drug Industry/ethics
17.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 177-183, 2020.
Article in Chinese | WPRIM | ID: wpr-872936

ABSTRACT

Traditional Chinese medicine (TCM), as the unique health resources, huge potential economic resources, scientific and technological resources with original advantages, excellent cultural resources and important ecological resources, has made remarkable achievements in Chinese economic and social development in recent years. However, there are still some problems in the reform and development of TCM, especially the lack of willingness to innovate and low ability in commercialization of research and development findings in such companies. Meanwhile, the globalization level of TCM is not high. All these problems have seriously restricted the overall development of TCM. Taking TCM enterprises as the research object, this paper uses SWOT analysis to carry out comprehensive strategic analysis on its advantages, disadvantages, opportunities and risks. It is concluded that TCM enterprises in China should focus on research and development of classical formula compound preparations and innovative TCM products, and then propose product development and innovation strategies.

18.
Chinese Traditional and Herbal Drugs ; (24): 2273-2282, 2020.
Article in Chinese | WPRIM | ID: wpr-846436

ABSTRACT

Coronavirus disease 2019 (COVID-19) has become a major global epidemic, and traditional Chinese medicine (TCM) has played an important role in the prevention and control of major epidemics. Taking Shufeng Jiedu Capsule as an example, this paper summarized the ideas and research practice of TCM in early intervention, blocking disease progression, improving symptoms, anti-inflammation and immunoregulation, suppressing "cytokine storm", syndrome differentiation and playing the advantages of compatibility based on the understanding of COVID-19. The idea of establishing a scientific model for the research and development of new drugs of TCM was put forward.

19.
China Pharmacy ; (12): 2184-2189, 2020.
Article in Chinese | WPRIM | ID: wpr-825645

ABSTRACT

OBJECTIVE:To pro vide reference f or resolving structural imbalance of “supply and demand dislocation ”in each stage of new drug R&D funds in China. METHODS :Through analyzing the fund demand in each stage of new drug R&D and the problem of “supply and demand dislocation ”in detail ,a financing scheme matching the fund demand of each stage was designed , and analyzed with the financing process of “Wanke”. RESULTS & CONCLUSIONS :In the basic stage of new drug R&D ,there was a large demand for funds ,but there were great technical risks ,transformation risks and investment risks ,little attention and support from investors ,resulting in the lack of R&D funds in this stage. It is suggested to increase the investment of R&D enterprises themselves. In the stage of new drug discovery ,the risks of R&D and investment were still high ,more funds were needed and funds were in short supply. It is suggested to attract more venture capital into this stage. From preclinical stage to clinical stage Ⅱ,there was a greater demand for funds. It is suggested that this stage should mainly rely on venture capital and pledge financing with patents. From the clinical stage Ⅲ to pre-marketing ,R&D had entered the mature stage with less investment risk. Therefore ,more venture capital could be obtained in this stage ,and there was a situation of excess capital. At this time ,in addition to venture capital ,R&D enterprises can also choose listing financing. In the post-marketing stage ,the sales right of a certain region in the product sales link could be transferred to provide new reserve funds for the next round of new drug R&D ,so as to achieve a virtuous circle of R&D activities. One of the reasons for the success of “Wanke”R&D financing lied in the combination of various financing methods in the financing process. It is suggested that China should improve the financial financing system and patent value evaluation system at the national level ,so as to promote the drug patent pledge financing in China as soon as possible. Finally ,new drug R&D institute must establish the concept of independent innovation ,speed up the output of technological innovation results ,so as to achieve the improvement of China ’s independent R&D capability.

20.
Mem. Inst. Oswaldo Cruz ; 115: e200229, 2020. tab, graf
Article in English | LILACS, SES-SP | ID: biblio-1135249

ABSTRACT

Malaria and tuberculosis are no longer considered to be neglected diseases by the World Health Organization. However, both are huge challenges and public health problems in the world, which affect poor people, today referred to as neglected populations. In addition, malaria and tuberculosis present the same difficulties regarding the treatment, such as toxicity and the microbial resistance. The increase of Plasmodium resistance to the available drugs along with the insurgence of multidrug- and particularly tuberculosis drug-resistant strains are enough to justify efforts towards the development of novel medicines for both diseases. This literature review provides an overview of the state of the art of antimalarial and antituberculosis chemotherapies, emphasising novel drugs introduced in the pharmaceutical market and the advances in research of new candidates for these diseases, and including some aspects of their mechanism/sites of action.


Subject(s)
Humans , Tuberculosis/drug therapy , Malaria/drug therapy , Antimalarials/therapeutic use , Antitubercular Agents/therapeutic use , Tuberculosis/diagnosis , Neglected Diseases , Malaria/diagnosis
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