跳至主要内容

Botanical Drug Preclinical R&D Technology Platform

Medicilon Botanical Drug Preclinical R&D Technology Service Platform is established based on the existing drug pharmacokinetic and safety evaluation research platform of the company with over decade of research and development experience.

  • Medicilon Botanical Drug Preclinical R&D Technology Service Platform is established based on the existing drug pharmacokinetic and safety evaluation research platform of the company with over decade of research and development experience.
    It is dedicated to providing customized preclinical trial service solutions for clients, with a professional technical service team specializing in drug metabolism, pharmacokinetics, efficacy research, and toxicology.
    Meanwhile，Shanghai Medicilon Inc. (referred to as Medicilon) can assist clients to overcome the bottlenecks in botanical drug development. Medicilon provides high-quality data and rapid turnover to support various drug development and preclinical research activities, in order to help clients select high-value candidate botanical drug for clinical trial applications.
    Medicilon Botanical Drug Preclinical R&D Technology Platform.webp

Research on the Pharmacology of Botanical Drugs

  • In vivo pharmacological studies comprehensively assess the pharmacological effects of test substances through analysis and evaluation using homologous/heterogeneous animal models, transgenic models, and humanized immune system animal models.
    Medicilon Botanical Drug Preclinical R&D Technology Equipment.webp

Pharmacokinetic/Toxicokinetic Studies of Botanical Drugs

  • The complex composition of botanical drug has always been a challenge in preclinical research, and it is also one of the technological barriers for botanical drug to go overseas.
    Different types of botanical drug have different requirements for pharmacokinetics/toxicokinetics. For single-component varieties, it is necessary to fully study their pharmacokinetics, toxicokinetics, and DMPK. For complex varieties, it is essential to determine whether there are clear active ingredients and toxic components before deciding on the approach for pharmacokinetic and toxicological studies. This involves thoroughly considering the basis of their pharmacological or toxicological properties before proceeding with drug metabolism and toxicology research.
    Study the relationship between toxic reactions and exposure, as well as the ADME of the target components.
    Determine and analyze the toxic components of botanical drugs and study the changes of in vivo exposure after repeated administration.

Preclinical Safety Evaluation of Botanical Drugs

  • Safety pharmacology experimentsAcute toxicity testsAcute toxicity testsReproductive toxicity testsGenetic toxicity testsCarcinogenicity testsLocal tolerance tests

Key Technologies for Preclinical Research of Botanical Drugs

  • The Medicilon Botanical drug Preclinical R&D Technology Platform has a laboratory for preclinical research on new drug development and reevaluation of botanical drugs, and conducts research on key technologies, including:
    Study of the substance basis and mechanism of toxic substances;Study of the substance basis of hepatotoxicity of botanical drugs;Determination of biomarkers for botanical drugs;Quality control and analysis of test substances in botanical drugs;Pharmacokinetic and toxicokinetic studies of botanical drugs;Study of biotoxicity biomarkers and toxicological mechanisms in target organs/tissues of botanical drugs;Key technologies for studying allergic reactions to botanical drugs;……
    AAALAC Animal Lab.webp

High-level Preclinical Research Laboratory

  • Medicilon Preclinical Research Laboratory has been certified by AAALAC and meets the GLP standards of both FDA in U.S. and NMPA in China. The preclinical safety evaluation conducted by Medicilon complies with the GLP regulations of the Organization for OECD.
    With a comprehensive animal model library, Medicilon meets the diverse demands of clients in the development of new drugs. The non-human primate experimental facility at Medicilon is the largest in Shanghai, with the highest number of monkeys in captivity.
    Medicilon has extensive experience in establishing efficacy tumor allograft/xenograft models, with a high success rate in modeling and a wide range of tumor cell lines. The platform is internationally leading in this field. In addition, Medicilon also has rich experience in other experimental animal disease models, such as ophthalmic disease models, respiratory system models, arthritis and immune disease models, and cardiovascular disease models.

The Cases of Medicilon

  • Shugan Jieyu Capsule

    In September 2022, the National Medical Products Administration announced that Shugan Jieyu Capsule which produced by Sichuan Jishengtang Pharmaceutical Co., Ltd.(referred to as Jishengtang), became the first second-class protected botanical drug variety. In October 2022, an application for expanding clinical trials to include the treatment of generalized anxiety disorder associated with liver depression and spleen deficiency was approved by the NMPA. The symptoms include irritability, excessive worrying, and palpitations.
    As the partner of Jishengtang, Medicilon provided support for the non-clinical safety evaluation of Shugan Jieyu Capsule, including single-dose and repeated-dose toxicity studies in SD rats for the NMPA application. Medicilon's Pharmacology Department has established various evaluation techniques for psychiatric disorder models, including antidepressants, anti-Alzheimer's drugs, sedatives, hypnotics, anesthetics, anti-Parkinson's disease medications, and antipsychotics. It has made contributions to the development of botanical drugs for new indications.

  • Xiao Chai Hu Granules for Children

    In May 2023, Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd.(referred to as Baiyunshan Guanghua) obtained the clinical trial approval for the first domestic and international improved Xiao Chai Hu Granules for children. The medicine belongs to the 2.3 class of improved botanical drugs in China. It is an improved formulation based on the classic formula of Xiao Chai Hu Granules and is the first innovative formulation specifically developed for children. The new product optimizes the formulation process for pediatric medication patterns, improves quality control based on the efficacy needs of the pediatric population, evaluates the efficacy and safety based on the growth and development characteristics of children, and precisely identifies clinical indications for the pediatric population.
    As a partner of Baiyunshan Guanghua, Medicilon provided a series of pharmacological and toxicological studies for the development of Xiao Chai Hu Granules for children, including single-dose and repeated-dose toxicity studies in early-age SD rats and efficacy studies in young rats. Through rigorous experimental design, professional research techniques, standardized project management, compliant test operations, and efficient communication, Medicilon accelerated the process of product launch, helped to create exclusive products, and met the growing health needs of the pediatric population.
标签：

评论

发表评论

此博客中的热门博文

Medicilon and Binhui Biopharmaceutical Have Reached a Strategic Collaboration to Jointly Draw a New Blueprint for the Development of New Biological Drugs

  On March 18, Medicilon and Binhui Biopharmaceutical (Binui Bio) announced a strategic collaboration.  The two parties will work together to jointly explore the possibilities in cutting-edge fields such as oncolytic viruses, nucleic acid drugs and protein drugs. Gather and Work Together to Create Advantages      Facilitate the Research and Development of Oncolytic Viruses, Nucleic Acids, Proteins and Other Drugs As a one-stop biopharmaceutical comprehensive preclinical R&D service CRO, Medicilon has been developing and accumulating for 20 years, always adhering to the spirit of innovation, and has successfully constructed bi/multi-specific antibodies,  ADCs ,  mRNA vaccines ,  small nucleic acid drugs ,  PROTAC , and  CGT technical service platform  that have helped 421 INDs obtain clinical approval.  It is this outstanding achievement that has earned Medicilon wide recognition in the industry and laid a solid foundation f...
发表评论
阅读全文

A Nickel-Catalyzed Reductive Alkylation of Aryl Bromides and Chlorides for Sp3-Sp2 Bond Formation

  In 2012, a nickel-catalyzed reductive alkylation method of aryl bromides and chlorides was reported. Under the optimized conditions, a variety of aryl and vinyl bromides as well as active aryl chloride can be reductively coupled with alkyl bromides in high yields. The protocols were highly functional-group tolerant and the reactions were not air or moisture sensitive. The reaction showed different chemoselectivity than conventional cross-coupling reactions. Substrates bearing both anelectrophilic and nucleophilic carbon resulted in selective coupling at the electrophilic carbon (R-X) and no reaction occurred at the nucleophilic carbon (R-[M]). The 2010 Nobel Prize in Chemistry was awarded for the Pd-catalyzed cross-coupling, and in the past decade the progress in cross-coupling has not only had a significant impact on academic research but has also influenced the industrial synthetic application. The transition-metal-catalyzed union of nucleophilic organo-boronic acids with elect...
发表评论
阅读全文

What is Toxicokinetics?

Toxicokinetics  is essentially the study of “how a substance gets into the body and what happens to it in the body”. Four processes are involved in toxicokinetics. The study of the kinetics (movement) of chemicals was originally conducted with pharmaceuticals and thus the term pharmacokinetics became commonly used. In addition, toxicology studies were initially conducted with drugs. However, the science of toxicology has evolved to include environmental and occupational chemicals as well as drugs. Toxicokinetics is thus the appropriate term for the study of the kinetics of all toxic substances. Frequently the terms  toxicokinetics ,  pharmacokinetics , or disposition may be found in the literature to have the same meaning. Disposition is often used in place of toxicokinetics to describe the time-course of movement of chemicals through the body (that is, how does the body dispose of a xenobiotic?). The disposition of a toxicant along with its’ biological reactivi...
发表评论
阅读全文