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English Abstract

Depression is a common affective disorder with depressive mood as its major clinical feature. The clinical manifestations of the disease are usually insomnia, persistent low mood, thinking retardation etc. Severe patients may have a suicide tendency. According to a recent study, depression would rank fourth in the world 10 leading diseases. And by 2020, depression is predicted by WHO to become the top 2 world disease, second only to heart disease. In China, there are more than 30 million depressed patients, depression has become the 5th major death cause factor, and among which appeared an age inclination to the young people. As for the depression medicine, in spite of western chemical medicine, China has its unique Chinese proprietary medicine based on the guidance of TCM theory. This research aims to investigate the development and commercialization of CPM antidepressants in China through systematically analyzing drug registry, patent approval, academic publication, clinical registry, market sales, and firms’ business activities. Multi-data-collection method was used to help do the research. The writer collected the medicine information from CFDA and website of yaopintong, patent information from CIPRN, academic literature information from CNKI, clinical trial registration information from ChiCTR, market scale information from website of menet, and the firms information from different official websites, coverage and other publications. This study found that the 15 different types of Chinese proprietary medicine for antidepressant being used in China are as follow: Jieyu Anshen Keli、Jieyu Anshen capsules、Shuganjieyu capsules、ShuyuJiubaowan、Puyu capsule、Jieyuwan、 Jiuwei Zhenxin Keli、Wuling capsule、Bajitian oligosaccharide capsule、Anle Tablet、Naolejing、Yuejuwan、Xiaoyaowan、Jiawei Xiaoyaowan、Baicaoxiang Jieyu Anshen capsules. And the related fundamental researches, such as animal experiments, clinical experiments, even some clinical trial registrations are usually taken in medical universities, hospitals or other medicine research institutions. Medicine firms can get the exclusive producing right through the cooperation with those institutions. According to the research, the market share of Chinese proprietary medicine for antidepressant is getting larger and larger and it will become even bigger through persistent researching and producing.

Chinese Abstract

抑鬱症是一類以抑鬱心境為主要特徵的情感障礙,該疾病的臨床表現通常為失 眠、長時間情緒低落、思維遲緩等,嚴重者可能出現自殺傾向。目前,抑鬱症 在世界十大疾病中排位第四,據 WHO 預測,到 2020 年抑鬱症將上升為僅次於 心臟病的世界第二大疾病。在我國,抑鬱症患者已超過 3000 萬,且年齡呈年輕 化趨勢,抑鬱症自殺是我國死亡原因的第五位。而在中國,對於抑鬱症的藥物 治療除了西方醫學中使用的化學藥,還有中醫藥理論指導的中成藥。本研究希 望通過收集抗抑鬱用中成藥的現有產品、專利註冊、學術文獻、臨床註冊、市 場規模、廠商等各方面的信息,了解中國抗抑鬱用中成藥的研發、生產、銷售 以਀使用情況,從而進一步確定抗抑鬱用中成藥在中國的發展਀商業化的現狀。 本研究採用混合資料收集法,分別從國家食品藥品監督管理總局(簡稱 CFDA) 網站和藥品通網站收集抗抑鬱用中成藥的藥品信息,從中國知識產權網(簡稱 CIPRN)中的藥物專利檢索網頁中收集抗抑鬱用中成藥的專利信息,從中國知 網(簡稱 CNKI)中收集抗抑鬱用中成藥的相關學術文獻信息,從中國臨床試 驗註冊中心(簡稱 ChiCTR)網站中收集有關的臨床試驗註冊項目信息,從米 內網數據庫中獲取抗抑鬱用中成藥的市場信息,最後根據米內網中確定的抗抑 鬱用中成藥的生產廠商,從各公司官方網站、新聞報導、文獻發表中收集廠商 的相關信息。研究發現,目前在中國使用的具有抗抑鬱療效的中成藥有解鬱安 神顆粒、解鬱安神膠囊、舒肝解鬱膠囊、舒鬱九寶丸、蒲鬱膠囊、解鬱丸、九 味鎮心顆粒、烏靈膠囊、巴戟天寡糖膠囊、安樂片、腦樂靜、越鞠丸、逍遙丸、 加味逍遙丸、白草香解鬱安神膠囊這 15 種。有關抗抑鬱用中成藥的動物實驗、 臨床實驗等基礎研究,通常為醫藥類大學、醫院等研究機構在進行,對藥物的 臨床試驗註冊也大多為這類研究機構通過各種科研項目的資助完成,廠商在研 究階段可以跟大學、醫院等進行合作,從而獲得擁有獨家生產權利的中成藥。 抗抑鬱藥中,中成藥所佔的市場份額正在逐年擴大,隨著不斷的研發與完善, 中成藥治療抑鬱症將會越來越成熟。 關鍵詞: 中成藥;抗抑鬱藥;藥品註冊;專利批准;臨床註冊;技術商業化

Issue date





Institute of Chinese Medical Sciences






Depression, Mental -- Treatment -- China

抑鬱症 -- 治療 -- 中國

Medicine, Chinese -- China

中國醫藥 -- 中國



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