ABSTRACT
With the continuous improvement of people's living standards and the greatly accelerated pace of life, patients' requirements for traditional Chinese medicine(TCM) pharmaceutical care are constantly raised, and personalized TCM preparations used are increasing year by year. However, a series of problems, such as the bottleneck of preparation technology, the lack of preparation specifications, and the weak legal basis for supervision, have become prominent, leading to the uneven product quality of personalized pre-parations. This paper systematically summarized and analyzed the current situation and existing problems of personalized TCM preparations, including dosage form application, preparation technology, production equipment, quality standard, clinical application, and administration mode. Additionally, it put forward an inheritance and innovation research mode of personalized TCM preparation technology based on the physical fingerprint of raw materials and innovation research and intellectual property protection mode of "research-patent-technology-equipment-standard". Furthermore, innovative development strategies were proposed, such as the production standard system of clinical preparations based on the whole process traceability and the regional processing service mode of clinical preparations based on industry 4.0. The present study is expected to provide beneficial references for the inheritance and innovation development of personalized TCM preparations.
Subject(s)
Humans , Biological Products , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality ControlABSTRACT
In recent years, only a small number of new Chinese medicines have been approved for marketing, which has embodied the bottleneck in the development of the Chinese medicine industry. To tackle this problem, the National Medical Products Administration has issued a series of regulations and technical requirements. In the context of new regulations, this study deeply explored the research and development strategies of new Chinese medicines under the guidance of the new classification of drug registration, and discussed the key technical issues in the research and development.
Subject(s)
China , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Pharmaceutical Preparations , ResearchABSTRACT
With continuous introduction of relevant national policies on famous classical formulas, the research of famous classical formulas is popular all over the country. Different from other new drugs, in the research and development process of famous classical formulas, substance benchmark is earlier than the product, suggesting that the research and development of substance benchmark is of great significance. Based on previous work of the authors, content of substance benchmark of famous classical formulas was analyzed, which was included in the document <italic>The Management Regulation of Simplified Registration and Approval over Chinese Herbal Medicine Compound Preparations of Ancient Famous Classical Formulas</italic> released by the National Medical Products Administration in May 2018. In this paper, the significance of substance benchmark development was described, a five-stage of research strategy was proposed, covering the prescription textual research and historical evolution, the collection and quality evaluation of medicinal materials, the processing method and quality evaluation of decoction pieces, the preparation and quality research of substance benchmark, the drafting and formulating of quality standard over substance benchmark. At the same time, some suggestions were put forward to the feasibility of compound preparations development over famous classical formulas, the implementation difficulty of resource evaluation over Chinese medicinal materials, and the irrationality on the quality correlation of Chinese medicinal materials. All of these are expected to provide reference and enlightenment for the development and policy officially landed over ancient famous classical formulas.
ABSTRACT
Although the country has promulgated a list of 100 classical famous formula,there are still many confusions and choices in the development of compound preparations from classical prescriptions. In this paper,the development strategy of classical formula compound preparation was elaborated from three aspects:the evaluation of draggability,the consideration of industrialization and the clinical orientation. The draggability evaluation includes pharmacy and preclinical safety. It should focus on the factors such as substance benchmark,dosage,toxic herbal medicines,clinical use and so on. Industrialization considerations need to focus on how to use modern industrialization methods to prepare modern compound preparations with the same quality as material benchmarks. The use of extracts may be an effective way to solve the problems of low utilization rate of decoction pieces and inadequate industrial advantages. Clinical orientation should be clear about the main effect,take into account the secondary effect, pay attention to the negative effect, and consider the level of clinical value. A series of corresponding development strategies and ideas are proposed in order to provide references for enterprises and researchers who select and layout classical famous formula, to promote the development of classical prescription compound preparation.
ABSTRACT
As an outstanding representative of traditional Chinese medicine prescription, classical herbal formulae are the essence of traditional Chinese medicine great treasure. To support the development of classical herbal formulae, the state and relevant administrative departments have successively promulgated the relevant encouraged policies.But some key issues of classic herbal formulae in the development process have not reached a unified consensus and standard, and these problems were discussed in depth here.The authors discussed the registration requirements of classical herbal formulae, proposed the screening specific indicators of classical herbal formulae, determination basis of prescription and dosage,screening method of production process, and the basic principle of clinical localization, in order to bring out valuable opinions and provide a reference for classical herbal formulae development and policy formulation.
ABSTRACT
As an outstanding representative of traditional Chinese medicine(TCM) prescriptions accumulated from famous TCM doctors' clinical experiences in past dynasties, classical TCM excellent prescriptions (cTCMeP) are the most valuable part of TCM system. To support the research and development of cTCMeP, a series of regulations and measures were issued to encourage its simplified registration. There is still a long-way to go because many key problems and puzzles about technology, registration and administration in cTCMeP R&D process are not resolved. Based on the analysis of registration and management regulations of botanical drug products in FDA of USA and Japan, and EMA of Europe, the possible key problems and countermeasures in chemistry, manufacture and control (CMC) of simplified registration of cTCMeP were analyzed on the consideration of its actual situation. The method of "reference decoction extract by traditional prescription" (RDETP) was firstly proposed as standard to evaluate the quality and preparation uniformity between the new developing product under simplified registration and traditional original usages of cTCMeP, instead of Standard Decoction method in Japan. "Totality of the evidence" approach, mass balance and bioassay/biological assay of cTCMeP were emphatically suggested to introduce to the quality uniformity evaluation system in the raw drug material, drug substance and final product between the modern product and traditional decoction.
ABSTRACT
Objective To provide an index system and model for evaluating the development strategies of military preventive medicine (MPM).Methods SWOT was used to analyze the internal and external conditions of the development strategies of MPM,and the evaluation index system was constructed.The weight of each evaluation index was determined based on the analytic hierarchy process (AHP) and expert consultation.The evaluation model of MPM development strategies and confrontation matrix were constructed based on SWOT analysis.The effectiveness of the index system and model was evaluated through empirical research.Results The evaluation index system was constructed,which included four grade-one indexes (R&D quality,difficulty,requirement and support) and sixteen grade-two indexes (research level,academic status,etc.).The advantage and disadvantage models,opportunity threat model and SWOT evaluation model were established.The confrontation matrix of development strategies for MPM was developed.Conclusion This evaluation index system and model can accurately evaluate MPM development strategies and provide reference for formulating development strategies of MPM.
ABSTRACT
TCM service trades are an inevitable choice for TCM development, and also one of the most important levels in the national development strategy pattern. For the Belt and Road, it is necessary to promote the rapid development of TCM service trades, not only for promoting transformation cross domain development of TCM industry in Gansu, but also for promoting Gansu economic and social development. Based on the analysis of the significance and opportunities of the TCM service trades, this article proposed the specific strategies for promoting the development of TCM service trades in Gansu Province.
ABSTRACT
OBJECTIVE:To provide reference for the development of hospital preparation in our hospital. METHODS:The method of SWOT analysis was applied to analyze competitive strengths,weaknesses,opportunities and challenge about the develop-ment of pharmaceutical preparations in our hospital,and to explore the development strategies of hospital preparation. RESULTS &CONCLUSIONS:The strengths include the prominent specialty characteristics of clinical key subject,a long R&D history,diverse dosage forms and varieties,definite therapeutic efficacy,etc. The weaknesses contain production capacity shrinkage,deficient con-struction of professional team,external exchange and cooperation deficiency,etc. The opportunities contain national health con-sciousness enhancement,hospital preparation included into local medical insurance reimbursement,etc. The threats contain great difficulty to register new preparation and low preparation pricing,etc. It is suggested to rely on advantage resources to enhance clin-ical formulation development,strengthen human resource management and team building,strengthen cooperation and exchanges to enhance research and development,strengthen the meticulous management to improve operational capacity,in order to formulate scientific development strategy.
ABSTRACT
As a kind of regional folk medicinal herbs, "Qi medicinal herbs" have their own distinguishing medicinal features, and are the important basis for the development of regional medical work. So according to the existent documents and main results of the research and typical data, "Taibai Qi medicinal herbs" are taken as the principal regional folk medicinal herbs to integrate and summarize the present situation of "Qi medicinal herbs", and to analyze and conclude the characteristics of natural resources of "Qi medicinal herbs". Research and development strategies of "Qi medicinal herbs" are proposed in this paper, which provide a reference for their naming method and research.
ABSTRACT
The improvement of women and children health,along with the growth in health needs,brings forth new challenges to maternal and children health care institutions.The dual demands of quantity and quality in maternal and children health services compel the institutions to improve capabilities under the current conditions,and more importantly,to further clarify the functional orientation which is the key issue for its development.This article is based on the analysis of the historical development and current situation of the maternal and children health care institutions,which sets up the functional orientation according with the rules and characteristics of maternal and children health services.The paper proposed a series of suggestions on its development,such as the health service admission system,appropriate staffing standards and the institution-construction standards.
ABSTRACT
OBJECTIVE:To recommend the development strategies for small and medium-size pharmaceutical commercial enterprises. METHODS: We analyzed the development and change of the macro-policies and industrial surroundings and discussed different strategies available for small and medium-size pharmaceutical commercial enterprises. RESULTS & CONCLUSIONS: Among those suitable strategies, which include scale enlargement, service differentiation, and countryside & community market expansion etc, small and medium enterprises should choose different kinds of strategies according to their special characteristics. Meanwhile they should incessantly enhance their real strength and spare no effort to cultivate their own competitive advantage to seek survival and development.
ABSTRACT
OBJECTIVE: To discuss the competitive intelligence(CI) development strategies in Chinese pharmaceutical enterprises. METHODS: The CI in Chinese pharmaceutical enterprises was overviewed and the problems were analyzed. Then development strategies of CI were put forward. RESULTS & CONCLUSION:CI is one of the powerful competitive tools in pharmaceutical enterprises; development strategies of which should be further explored.