中药配方颗粒发展现状及企业生存策略探讨

Discussion on Development Status of Traditional Chinese Medicine Dispensing Granules and Survival Strategy of Enterprises

中药配方颗粒作为传统饮片的重要补充形式,具有免煎易服、携带方便、便于调剂等优点,极大提高了中医药应急服务能力,更符合人们的现代生活需求。随着中药配方颗粒结束试点,市场全面放开,竞争加剧,且处于新标准、旧标准切换使用的过渡期,存在品种不足、规格变换和质量差异等问题,生产企业面临新的机遇和挑战。基于此,笔者拟通过系统梳理中药配方颗粒试点以来的政策法规、企业布局、标准制定等内容,并针对“后试点”阶段存在的问题,从企业生存和发展角度出发,建议企业应建立中药配方颗粒全产业链质量管控体系,降低过程成本,增加企业竞争力;进一步加大科研投入,攻克疑难品种关键技术问题,积极有序推进国家标准研究,保证临床配方品种完整;建立健全配方颗粒疗效评价机制,构建中药配方颗粒和中药饮片间的一致性评价体系。政府部门应加强引导,充分调动科研机构、企业、医院等单位的积极性,探索建立“政-产-学-研-用”模式,推动中药配方颗粒行业平稳有序发展。

As an important complementary form of decoction pieces of traditional Chinese medicine(TCM),TCM dispensing granules has the advantages of being free of decoction,easy to take,easy to carry and easy to be dispensed,which greatly improves the capacity of emergency services of TCM and is more in line with the needs of modern society.With the end of the pilot project of TCM dispensing granules,the market has been fully liberalized,the competition has been intensified,and it is in the transition period of switching between the new standard and the old one,and there are some problems such as the shortage of varieties,the change of specifications and the difference of quality,and the production enterprises are facing new opportunities and challenges.Based on this,the authors intend to systematically sort out the policies and regulations,enterprise layout and standard formulation since the pilot of TCM dispensing granules.In view of the problems in the post-pilot stage and from the perspective of survival and development of enterprises,it is suggested that enterprises should establish a quality control system for the whole industry chain of TCM dispensing granules to reduce process costs and increase enterprise competitiveness,further increase the investment in scientific research,overcome the key technical problems of difficult varieties,actively and orderly promote the research of national standards,in order to ensure the integrity of clinical formula varieties,and establish and improve the efficacy evaluation mechanism of TCM dispensing granules,build a consistency evaluation system between TCM dispensing granules and decoction pieces.Government departments should strengthen the guidance,fully mobilize the enthusiasm of scientific research institutions,enterprises and hospitals,and explore the establishment of"government-industry-study-research-application"mode to promote the development of TCM dispensing granule industry.