| Objectives:With the development of Great Health products,the New Chinese Decoction Pieces has developed rapidly.However,due to the lack of unified understanding on the issues of tradition and modernity,inheritance and innovation,the supervision policies and pilot methods of various provinces across the country have not been unified.It has seriously restricted the healthy and rapid development of Traditional Chinese Medicine Decoction Pieces industry.Therefore,strengthening the research on standards and policies has become the most important guarantee to guide its production and management practice and promote the healthy and rapid development.Taking Yunnan Province as an example,the present situation and development policies of direct oral powder decoction pieces of Traditional Chinese Medicine,Microfine Granular Powder and Traditional Chinese Medicine dispensing granule were discussed respectively.With their safety,effectiveness and quality controllability as the core,to study the restrictive factors and policy requirements for the development of New Chinese Decoction Pieces in Yunnan Province at the present stage,and tentatively put forward suggestions on development policies.Methods:On-the-spot investigation and literature research.In Yunnan Province,visit research enterprises,medical institutions and other related units,enterprise leaders and clinicians and other research objects.The contents include:(1)the production catalogue and sales of the New Chinese Decoction Pieces,(2)the problems encountered in research and development,production,sale and after-sale of all kinds of the new Chinese decoction pieces,and the technical and policy support needed by enterprises.opinions and suggestions on the development of New Chinese Decoction Pieces in Yunnan Province.Comments and Suggestions on the clinical application of New Chinese Decoction Pieces,and its problems in clinical application.Literature research:(1)inquire about relevant laws and regulations,policy documents;(2)compare and analyze the quality standards of traditional decoction pieces and New Chinese Decoction Pieces,and consult the literature on its safety,effectiveness,quality control and so on.Conclusions:(1)The New Chinese Decoction Pieces is an important supplement to the traditional decoction pieces,which has the advantages of easy to use,clean and hygienic,and has its practicability and existence value.Direct oral powder decoction pieces of Traditional Chinese Medicine adapt to the development of great health industry and the trend of self-medication of the masses.there are many production enterprises and considerable sales of products,and the state should support its development.(2)similar to the situation of Traditional Chinese Medicine dispensing granule and Microfine Granular Powder,direct oral powder decoction pieces of Traditional Chinese Medicine is easy to adulterate and confuse,and it is difficult to supervise,but it should not be the reason for forbidding powdering.The varieties that have advantages in milling should support their development and actively guide them as long as they meet the requirements of safety.It is suggested that the state should issue a systematic revised guidance document for the research on the standard of Traditional Chinese Medicine Decoction Pieces,guide the supervision,management and standard research of each province,strengthen the research on quality controllability,and severely crack down on fraud and adulteration.It is necessary to strengthen the comparative study on the safety and efficacy of New Chinese Decoction Pieces and Traditional Chinese Medicine Decoction Pieces,such as acute toxicity and long-term toxicity.In the formulation of standards,we should combine the characteristics of varieties,according to the laws of Traditional Chinese Medicine,strengthen the research on heavy metals and pesticide residues,and make a systematic evaluation of their safety.(3)It is suggested that the national competent departments should clarify the standard management measures for Traditional Chinese Medicine dispensing granule as soon as possible,end the pilot work as soon as possible,liberalizeand guide the management of the production and use of Traditional Chinese Medicine dispensing granule,and actively promote the healthy and rapid development of traditional Chinese medicine and traditional Chinese medicine industry.(4)the provincial standard Traditional Chinese Medicine Decoction Pieces can be circulated throughout thecountry in accordance with the law,on the premise that it is also necessary to complete the filing procedures of National Medical Products Administration and solve the problems of homonyms(or different processing methods)or synonyms of different provinces Traditional Chinese Medicine Decoction Pieces.(5)the New Chinese Decoction Piecesshould be used under the guidance of the theory of Traditional Chinese Medicine,adhere to the clinical value orientation,and actively support the positive and innovative development of New Chinese Decoction Pieces on thepremise of ensuring safety. |
