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botanical drug clinical trial: Common issues and future options

Acta Pharmaceutica Sinica B 2021年第1期11卷 300-303页

作者： Yu Sun Jiahua Qian Department of Traditional Chinese Medicine and Ethnopharmaceuticals Center for Drug EvaluationNational Medical Products AdministrationBeijing 100022China Center for drug Evaluation National Medical Products AdministrationBeijing 100022China

In order to understand this disparity between human use and drugs approved by regulatory agencies,we analyzed botanical drug clinical trials registered at *** to detect trends in current trials and guide future trials.A total of 195 botanical drug clinical trials were registered from 2016 to2019,of which 81 are phaseⅡor phaseⅡ/Ⅲ.95%of all phaseⅡandⅡ/Ⅲstudies were designed with100 or less participants per arm,indicating a more observational nature due to the limited power to detect differences in outcomes between treatment and control *** to the limited number of participants,efficacy outcome from results may be highly subjective.14%of the total trials were phaseⅠ*** botanical drugs with well-documented or extensive history of human use,phaseⅠmay not provide significant additional information,and may,therefore,not be *** the trial design,we suggest added-on studies when botanical drugs are used as part of a combination ***,we believe standardized data collection methods and criteria are critical to utilizing the vast collection of human experience as quality evidence to support regulatory approval.

关键词： Traditional Chinese medicine(TCM) botanical drug Clinical trial Real-world evidence(RWE) Randomized-controlled trial(RCT)

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New botanical drug, HL tablet, reduces hepatic fat as measured by magnetic resonance spectroscopy in patients with nonalcoholic fatty liver disease: A placebo-controlled, randomized, phase Ⅱ trial

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World Journal of Gastroenterology 2017年第32期23卷 5977-5985页

作者： Jae Yoon Jeong Joo Hyun Sohn Yang Hyun Baek Yong Kyun Cho Yongsoo Kim Hyeonjin Kim Department of Internal Medicine Hanyang University Guri HospitalHanyang University College of Medicine Department of Internal Medicine Dong-A University HospitalDong-A University College of Medicine Department of Internal Medicine Kangbuk Samsung HospitalSungkyunkwan University School of Medicine Department of Radiology Hanyang University Guri HospitalHanyang University College of Medicine Department of Radiology Seoul National University Hospital

AIM To evaluate the efficacy and safety of HL tablet extracted from magnolia officinalis for treating patients with nonalcoholic fatty liver disease(NAFLD).METHODS Seventy-four patients with NAFLD diagnosed by ultrasonography were randomly assigned to 3 groups given high dose(400 mg) HL tablet, low dose(133.4 mg) HL tablet and placebo, respectively, daily for 12 wk. The primary endpoint was post-treatment change of hepatic fat content(HFC) measured by magnetic resonance spectroscopy. Secondary endpoints included changes of serum aspartate aminotransferase, alanine aminotransferase(ALT), cholesterol, triglyceride, free fatty acid, homeostasis model assessment-estimated insulin resistance, and body mass index(BMI).RESULTS The mean HFC of the high dose HL group, but not of the low dose group, declined significantly after 12 wk of treatment(high dose vs placebo, P = 0.033; low dose vs placebo, P = 0.386). The mean changes of HFC from baseline at week 12 were-1.7% ± 3.1% in the high dose group(P = 0.018),-1.21% ± 4.97% in the low dose group(P = 0.254) and 0.61% ± 3.87% in the placebo group(relative changes compared to baseline, high dose were:-12.1% ± 23.5%, low dose:-3.2% ± 32.0%, and placebo: 7.6% ± 44.0%). Serum ALT levels also tended to decrease in the groups receiving HL tablet while other factors were unaffected. There were no moderate or severe treatment-related safety issues during the *** HL tablet is effective in reducing HFC without any negative lipid profiles, BMI changes and adverse effects.

关键词： botanical drug Nonalcoholic fatty liver disease Magnetic resonance spectroscopy Randomized controlled trial Magnolia officinali

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Status and Thoughts of Chinese Patent Medicines Seeking Approval in the US Market

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Chinese Journal of Integrative Medicine 2014年第6期20卷 403-408页

作者：雷翔陈静刘春香林佳楼静商洪才 Tiani'n UniversityTraditional Chinese Medicine Tianjin Institute of Clinical Evaluation of Traditional Chinese Medicine Tianjin University of Traditional Chinese Medicine

Veregen^TM and Fulyzaq are the first two botanical drug products that were approved by the Food and drug Administration （FDA） to market in the US in recent years. Additional herbal medicines, including Compound Danshen Dripping Pills （复方丹参滴丸）, Fuzheng Huayu Tablets （扶正化瘀片）, Xuezhikang Capsule （血脂康胶囊）, Guizhi Fuling Capsule （桂枝茯苓胶囊）, Kanglaite Capsule （康莱特胶囊） and Kanglaite Injection （康莱特注射液）, have filed the investigational new drug （IND） application to the FDA and are in phaseⅡ or phase Ⅲ clinical development. In order to gain better understanding of the process of botanical drug approval in the US, this article examines the aforementioned drugs by looking at their composition, indication, prior clinical experience and clinical development process, and summarizes key features that enabled IND filing and marketing approval by the FDA.

关键词： Chinese medicine botanical drug Food and drug Administration's review

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Screening Test for Antibiotics in Medicinal Plants(STAMP):Using Powdered Plant Materials Instead of Extracts

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American Journal of Plant Sciences 2013年第12期4卷 2340-2350页

作者： Marielle Cascaes Inácio Fabio Carmona Tiago Antunes Paz Maysa Furlan Fernando Arcanjo da Silva Bianca Waléria Bertoni Suzelei de Castro Franca Ana Maria Soares Pereira Departamento de Producao Vegetal Faculdade de Ciências AgronomicasUniversidade Estadual Paulista“Júlio de Mesquita Filho”BotucatuBrasil Departamento de Puericultura e Pediatria Faculdade de Medicina de Ribeirao PretoUniversidade de Sao PauloRibeirao PretoBrasil Departamento de Química Orgânica Instituto de QuímicaUniversidade Estadual Paulista“Júlio de Mesquita Filho”AraraquaraBrasil Unidade de Biotecnologia Universidade de Ribeirao PretoRibeirão PretoBrasil

Plants are a rich source of antibiotics, but screening all the existing plant species for biological activity using current methods can be time and resource consuming. The present study is to investigate whether powdered plant materials would perform as well as plant extracts in the screening of plants with antimicrobial activity. In the new method proposed (STAMP), we compared in vitro antimicrobial activity of powdered plant materials from 12 species against bacteria and fungi. We confirmed these results with their corresponding aqueous (wet) and hydro-alcoholic extracts and one species testing the antimicrobial activity of two isolated compounds. Compared with hydro-alcoholic extracts, screening using the powdered plant materials correctly identified the majority of the species with antimicrobial activity against Candida albicans (sensitivity 91%, specificity 86%), C. parapsilosis (sensitivity 100%, specificity 67%), and Staphylococcus aureus (sensitivity 64%, specificity 86%). For bacteria, the method performed better in a pH of 9.0. The antimicrobial activity of two compounds isolated from one species (maytenin and netzahualcoyone) confirmed the results. In conclusion, the use of powdered plant materials for screening plants with antimicrobial properties is a cheap, widely available, technically easy, time sparing, reproducible, and sensitive method and can significantly shorten the time and money spent during drug development.

关键词： Herbal drug botanical drug Phytotherapics Natural Products

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Enlightenment of COVID-19 Treated by botanical drugs on the Development of drugs for Rare Diseases in China

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Asian Journal of Social Pharmacy 2023年第2期18卷 137-148页

作者： Li Qiao Wang Su Wang Aili Wu Di Chen Yuwen School of Business Administration Shenyang Pharmaceutical UniversityShenyang 10016China Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang 110032China

Objective To study the feasibility of developing botanical drugs to treat intractable diseases and play an important role in dealing with major public health *** From January 1990 to May 2021,a bibliographic search was carried out on the use of botanical drugs,rare disease drugs,related registration management policies and regulations in PubMed and *** following keywords were searched in the database:Rare disease policies and regulations,orphan drugs,botanical drugs for intractable diseases,botanical drugs for the treatment of new coronary pneumonia,traditional Chinese medicine,and emergency guidelines for major public health *** data were obtained from“Chinese Pharmacopoeia”and relevant Chinese government websites for sorting and *** and Conclusion Based on 39 Chinese corresponding policies and regulations,challenges and opportunities of developing and researching drugs for treating rare diseases were found out after the analysis and *** on the study of national policies on drugs for rare diseases,the priority review and approval procedures in the drug registration,as well as China’s emergency guidelines and policies for major public health events,some problems in the use of drugs for rare diseases are found ***,it is recommended to actively adopt the property rights protection system,explore the folk prescriptions of traditional Chinese medicine and the potential of hospital preparations,and the registration review strategy of giving priority to the use of botanical drugs for rare ***,the international status of botanical drugs for rare disease and the influence of responding to major public health events can be enhanced.

关键词： COVID-19 botanical drug intractable disease rare disease public health event

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