醫療機構中藥製劑現狀研究及發展對策
專論
作者：王階 喬夕瑤 林飛
[摘要] 中藥製劑作為中醫藥特色療效在臨床上的實際反映，不僅滿足醫院臨床、科研和教學的需要，也對深化醫藥衛生體製改革、提高人民健康水平、促進經濟發展起著重要作用。然而管理審批偏西藥化、規模出現萎縮、臨床與科研欠同步、區域發展失衡等問題卻讓中藥製劑在矛盾中緩慢前進，這不僅阻礙了中藥製劑在臨床上的有效發揮，也為中藥製劑現代化發展帶來不利影響。經研究分析顯示目前醫療機構中藥製劑的現狀中影響因素主要有法律法規欠完善、成本高於收益、製劑研發人才短缺。分析認為打破這一矛盾、提高中醫臨床療效、促進中藥製劑現代化發展的必要措施是：政府及相關部門通過調整審批政策、加速調劑使用、改革定價係統、納入醫保報銷範疇、整合優勢資源等方式加大政策扶持力度；醫療機構通過汲取傳統與現代精髓、儲備專業人才、開發特色製劑積極開展中藥製劑研發工作；企業攜手醫院，優勢互補，實現功能轉型等方式迅速轉化中藥製劑成果應用於臨床。
[關鍵詞] 醫療機構；中藥製劑；新藥研發；臨床療效
[Abstract] As the actual clinical reflecting of transform Chinese medicine special curative effect， Chinese medicine preparation not only satisfies the need of hospital clinic， scientific research and teaching， but also plays an important role in deepening medical and health system reform， improving people′s health level and contributing to the economic growth. However， some problems about administration and approval （tending to western medicine）， contraction of the scale， lack of synchronization for clinic and scientific research， and the imbalance of regional development make Chinese medicine preparation move forwards slowly in contradiction. It has not only reduced the effectiveness of the Chinese medicine preparation in hospital clinic， but also brought bad effect on modernized development of Chinese medicine preparation. Research shows that main influencing factors of status quo of Chinese medicine preparation in medical institution include imperfect laws and regulations， high cost than income， and shortage of talents in preparation research. The analysis indicated that the necessary measures to break the contradiction， improve clinical effect of Chinese medicine， and promote the modernization development of Chinese drugs preparation were as follows： government and related departments should strengthen the supporting force in policy by adjusting the examination and approval policy， speeding up dispensing use， reforming pricing system， including into medicare reimbursement， integrating advantage resources and so on； medical institution should actively carry out research and development of traditional Chinese Medicine through drawing the traditional and modern essence， reserving professional talents， and developing characteristic preparation； companies cooperate with hospitals for complementary advantages， which can rapidly transform Chinese medicine preparation into clinical practice.
[Key words] medical institutions； Chinese drugs preparation； new drug research development； clinical effect
doi：10.4268/cjcmm20152101
醫療機構中藥製劑是以臨床應用效果良好的中藥處方為基礎研製而成，具有臨床療效確切、使用方便、費用相對低廉等優勢，體現出中醫地域特色、醫院特色、專科特色和臨床大夫臨床經驗積累，是中醫臨床用藥的重要組成部分。中藥製劑是醫療實踐過程中逐步發展起來，基於傳統中藥製作方法和理論體係，伴隨現代製藥技術在其間的滲透，形成具有中醫藥特色的中藥製劑[1]。特點為臨床需要、固定處方、自製自用、質量可控和批準注冊[2]，兼具靈活性、實用性、有效性、安全性，擁有傳統丸、散、膏、丹等多種劑型，是中醫特色治療優勢所在。
1 發展醫療機構中藥製劑的重要性
醫療機構中藥製劑在繼承傳統、保持和發揮中醫藥特色和優勢方麵，具有不可替代的地位；在滿足中醫臨床需求、彌補已上市中成藥品種不足方麵，擔任著獨特角色；在防治重大疾病、抗擊SARS、防治甲流等工作中，發揮了至關重要作用；在中藥新藥創新過程中，提供著豐富的源泉和寶貴的臨床實踐平台。總之，醫療機構中藥製劑是中醫藥發展過程中不可或缺的重要組成部分。