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      聲明公告
      青海春天關于收到上海證券交易所《監管問詢函》并回復的公告
      發布時間:2016-02-05

      青海春天藥用資源科技股份有限公司
      關于收到上海證券交易所《監管問詢函》并回復的
      公告

             本公司董事會及全體董事保證本公告內容不存在任何虛假記載、誤導性陳述或者重大遺漏,并對其內容的真實性、準確性和完整性承擔個別及連帶責任。
       

             青海春天藥用資源科技股份有限公司(以下簡稱“公司”)于 2016 年 2 月 5 日收到上海證券交易所上市公司監管一部《關于對青海春天藥用資源科技股份有限公司相關信息披露事項的監管問詢函》(上證公函[2016]0154 號,以下簡稱“《監管問詢函》”),內容如下:

             青海春天藥用資源科技股份有限公司:

             “2016 年 2 月 4 日,國家食品藥品監督管理總局公布《關于冬蟲夏草類產品的消費提示》(以下簡稱“《消費提示》”),稱冬蟲夏草類產品屬中藥材,不屬于藥食兩用物質,長期食用會造成砷過量攝入,存在較高風險。

             鑒于你公司主營冬蟲夏草類產品,請你公司核實公司冬蟲夏草類產品是否存在《消費提示》所述的風險,是否符合國家相關藥品食品法律法規規定的質量要求。

             同時,鑒于前述事項可能引起媒體關注,請你公司嚴格遵守《上海證券交易所股票上市規則》的相關要求,不得以新聞發布或接受媒體采訪的形式,先于指定媒體發布可能影響公司股價的重大信息。

             請公司盡快核實前述事項,并對外披露。”
       

             現我公司就上交所《監管問詢函》所關注事項回復如下:

             一、國家食品藥品監督管理總局于 2016 年 2 月 4 日在其官方網站(www.cfda.gov.cn)發布了《關于冬蟲夏草類產品的消費提示》(以下簡稱《提示》),內容如下:

             “近期,食品藥品監管總局組織開展了對冬蟲夏草、冬蟲夏草粉及純粉片產品的監測檢驗。檢驗的冬蟲夏草、冬蟲夏草粉及純粉片產品中,砷含量為 4.4~9.9 mg/kg。

             冬蟲夏草屬中藥材,不屬于藥食兩用物質。有關專家分析研判,保健食品國家安全標準中砷限量值為 1.0 mg/kg,長期食用冬蟲夏草、冬蟲夏草粉及純粉片等產品會造成砷過量攝入,并可能在人體內蓄積,存在較高風險。”

             由于我公司控股子公司青海春天藥用資源科技利用有限公司生產、銷售的冬蟲夏草純粉片為唯一具備合法生產、銷售身份的冬蟲夏草純粉片,故我公司特對該《提示》作出如下回復和說明:

             (一)冬蟲夏草及冬蟲夏草純粉片的服用安全性,是經研究證實的。

             國家食品藥品監管總局于 2012 年 8 月開展“冬蟲夏草作為保健食品試點”工作(國食藥監保化[2012]225 號),我公司按國家相關要求完成了冬蟲夏草純粉片的安全毒理學評價試驗研究。各項試驗結果均顯示,以凈制冬蟲夏草為原料的冬蟲夏草純粉片安全無毒,并且,在急性毒性試驗和亞慢性毒性試驗(服用周期占實驗動物生命 1/10 左右的時間)中,冬蟲夏草純粉片的最大劑量分別相當于人推薦用量的 257 倍、137.2 倍,均未觀察到有害作用。

              (二)冬蟲夏草的砷攝入量遠低于國際食品法典委員會制訂的國際標準。

             冬蟲夏草屬中藥材,每日服用量很小,但目前我國對冬蟲夏草中藥材沒有砷含量標準的要求。

             如果從風險提示和監管的角度選擇參考標準的話,國際食品法典委員會(由聯合國糧農組織 FAO 和世界衛生組織 WHO 共同建立)制訂的標準是具有國際權威的,標準以每日砷的最高允許攝入量來衡量,其數值為不超過每千克體重 0.050 毫克。香港地區,就是在此基礎上,制訂中藥標準為“砷每日不得過 1500 微克”。

             《中華人民共和國藥典》規定的冬蟲夏草原草最高服用量 9 克,砷攝入量也只為國際標準的 2.97%,而由凈制冬蟲夏草制成的冬蟲夏草純粉片最高用量只有 3.5 克,所帶來的砷攝入量僅為國際標準的 1.16%(若以 0.1 克/片規格的冬蟲夏草純粉片為例,每天服用量超過 3000 片,才超過砷的日攝入量的安全標準)。

             (三)至今為止,在國內外關于冬蟲夏草的研究工作中,并未有服用冬蟲夏草、冬蟲夏草純粉片造成砷過量攝入、在人體內蓄積的結論或報導。在諸多關于冬蟲夏草的臨床研究文獻中,根據疾病的不同連續服用周期從數天到 12 個月不等,最長服用周期為連續 6 個月、停 1-3 個月并持續 3 年,均未發現明顯不良反應。

             二、春天藥用自 2014 年 7 月 18 日起,即嚴格按照青海省食品藥品監督管理局下發的《關于冬蟲夏草純粉片相關事宜的通知》(青食藥監辦[2014]53 號)試點產品的相關規定生產、銷售冬蟲夏草純粉片。

             三、我公司將嚴格遵守《上海證券交易所股票上市規則》的要求,認真履行相關信息披露工作。

             四、我公司正在開展對控股子公司暫未獲換發新的《藥品生產許可證》相關事項的核實工作,股票正在停牌(詳見我公司 2016-002 號公告)。我公司所有信息均以我公司在上海證券交易所網站(http://www.sse.com.cn)、《中國證券報》、《上海證券報》和《證券時報》刊登的信息為準,敬請廣大投資者注意投資風險。

             特此公告。

      青海春天藥用資源科技股份有限公司

      董事會

      2016 年 2 月 5 日
       

             青海春天藥用資源科技股份有限公司關于收到上海證券交易所《監管問詢函》并回復的公告

       
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