Discussion on the construction of standard system of moxibustion method. / æž„å»ºç¸æ³•åŸºæœ¬æ ‡å‡†ä½“ç³»çš„æŽ¢è®¨.

There is no systematic and whole-process system for moxibustion standard development at home and abroad, which restricts the industry innovation and technological progress to a certain extent. The paper reviews the study status and finds that the technical standard is dominant in moxibustion standard development currently, represented by conventional moxibustion, heat-sensitive moxibustion, moxibustion on the Governor Vessel, moxibustion with seed-size moxa cone and herb-isolated moxibustion, etc. There are many gaps in the standards development of moxibustion material and device, equipment building, moxa smoke purification, and management and job. On the basis of explaining the standard framework of moxibustion, it is suggested that the moxibustion standardization should be deepened in the aspects of hierarchical technical operation, material selection, research and development of new devices, personnel training and equipment management.

Research on E-Commerce Data Standard System in the Era of Digital Economy From the Perspective of Organizational Psychology.

With the rapid development of technology and the economy, the expansion of the network has had a huge impact on the rapid expansion of the industrial agglomeration e-commerce industry, as well as ensuring the shopping experience of consumers. The rapid expansion of industrial cluster e-commerce has avoided precisely the limitations of logistical bottlenecks. Current networks and modern information technologies can provide good support and maintain a huge growth potential. In addition, digital technologies such as multimedia are becoming increasingly important in industry cluster marketing, and the concept of industry cluster e-commerce models is gaining more and more attention from companies. However, virtual e-commerce systems under industrial clusters have not been well researched in the existing studies. In this paper, through extensive research, literature reading and website browsing statistics, the virtual e-commerce models of different industrial agglomerations are studied. Firstly, the concept of big data and the processing of big data are given. Secondly, the concept of industrial agglomeration and the relationship between industrial agglomeration and e-commerce are analyzed. The basic number of domestic Internet users in the last 10 years is also counted, proving that the expansion of the Internet has led to a substantial growth of Internet users in the country and that e-commerce plays a significant role in the future of business activities. Finally the study concludes that different e-commerce models have different performance and roles in industrial agglomeration e-commerce and cannot be generalized. Instead, it is not good and can only develop different industrial agglomeration e-commerce models according to different environments.

Current situation and development strategy of health emergency standardization system / 上海预防医学

In recent years， the increasing scale and scope of public health emergencies have brought serious challenges to China's health emergency system. It is in urgent need to develop the existing health emergency system toward the goal of multi-industry， multi-discipline， multi-professional and multi-regional， while the concept of standardization is essential to achieve this goal. This article describes the construction process of health emergency standardization system by the World Health Organization， the International Organization for Standardization， the United States， and China； analyzes the problems of China's health emergency standardization system by comparing the system between China and the United States， proposes the construction dimensions of China's health emergency standard system， and suggests development strategies targeting the shortcomings of China's health emergency standardization.

Design countermeasure and application practice of hospital project under health building evaluation standard / 中华医院管理杂志

The development of health building in the medical field is still in its infancy. The authors analyzed the development of health building evaluation standard system in the medical field of China, combined with the design experience of the first health building design identification hospital project in China, summarized the design measures of hospital health building according to the evaluation standard system, analyzed the correlation between different design majors and evaluation standards and the design emphasis. It also introduced the application value and practice of the main technology innovation in the process of hospital construction, so as to provide reference for the promotion of health building in the medical field.

Discussion on the Idea to Establish Standardized Construction Standard System for “Internet+TCM Pharmacy ” Based on Questionnaire Survey / 中国药房

OBJECTIVE：To provide reference for establishing stan dardized construction standard system of “internet+TCM pharmacy”. METHODS ： Questionnaire through literature review ， investigation and expert consultation were compiled. A questionnaire survey was carried out among TCM staff to understand the current situation and problems of “internet + TCM pharmacy”in Chinese medical institutions. Based on the results of the questionnaire ，a frame of standardized construction standard system for “internet+TCM pharmacy ”was tried to constructed. RESULTS & CONCLUSIONS：A total of 74 questionnaires were distributed and 74 were returned ，including 1 invalid questionnaire ，with an effective rate of 98.65％. Among the 73 respondents， more than 60％ were from TCM hospitals ，or with the title of vice senior or above ，and 55（75.3％）were national TCM characteristic technology inheritance talents. The survey results showed that more than 80％ of TCM pharmacies in medical institutions were equipped with full-time reviewers ，provided decocting service ，set up decocting room ，and carried out distribution service，and could achieve the same-day or part of the same-day delivery. More than half of the respondents believed that the prescriptions of TCM decoction pieces in their medical institutions were issued in strict accordance with the relevant requirements ， the rational drug use monitoring software was used ，and the error analysis of relevant work links was carried out regularly ， prescription coping training was regularly carried out for dispensers ，and decoction knowledge and operation process training were carried out for decoction personnel. However ，the vast majority of respondents （67，accounting for 91.8％）thought that their medical institutions only used traditional methods to control and evaluate the quality of finished decoction products. The results of the evaluation of the importance of 6 links and 17 key points of operation showed that the highest concentration of opinions was the quality of decoction pieces ，and the key points of operation were special drug treatment. The results of principle component analysis and maximum variance analysis showed that current construction of “internet+TCM pharmacy ”was mainly reflected in the two dimensions as TCM decocting ，consultation and distribution servi ces. Statistical analysis indicated that there were significant differences in staff training ，awareness of laws and policies ， regular error analysis ，patient satisfaction survey ，optimization of payment and consulting services among different levels and categories institutions （P＜0.05）. It was necessary to carry out the standardization construction of “internet+TCM pharmacy”. It is suggested that the standard system for standardized construction of“Internet + TCM pharmacy ”should be established from 5 aspects：basic construction conditions ，the standardization of procurement and acceptance ，the standardization of dispensing ，the standardization of decocting and distribution service and the standardization of pharmaceutical consultation services.

[Framework construction and standardization practice of standard system for Sichuan Dao-di herbs].

Dao-di herbs is one of the characteristics of traditional Chinese medicine different from other ethnic medicine. Sichuan province is rich in varieties and resources of Dao-di herbs, and its development scale and benefits are not obvious in recent decades due to the lag of standards behind the development of the times and objective needs. From the point of view of the whole process and the whole industrial chain, the significance of standardization system for quality assurance, healthy development of the industry, and development of the industry of Sichuan Dao-di herbs are presented in this paper. At present, Sichuan has made every effort to promote the construction and practice of the standardization system for Sichuan Dao-di herbs, to promote the rapid and high-quality development of Dao-di herbs industry in Sichuan.

Framework construction and standardization practice of standard system for Sichuan Dao-di herbs / 中国中药杂志

Dao-di herbs is one of the characteristics of traditional Chinese medicine different from other ethnic medicine. Sichuan province is rich in varieties and resources of Dao-di herbs, and its development scale and benefits are not obvious in recent decades due to the lag of standards behind the development of the times and objective needs. From the point of view of the whole process and the whole industrial chain, the significance of standardization system for quality assurance, healthy development of the industry, and development of the industry of Sichuan Dao-di herbs are presented in this paper. At present, Sichuan has made every effort to promote the construction and practice of the standardization system for Sichuan Dao-di herbs, to promote the rapid and high-quality development of Dao-di herbs industry in Sichuan.

Construction of technical standard system for production and processing of medicinal materials of animal-derivative / 中草药

Medicinal animal resource is an important component of traditional Chinese medicine resource. With the decreasing of wild medicinal animal resources, it is necessary to carry out the artificial breeding of medicinal animal to ensure the sustainable development of traditional Chinese medicine industry. There are 106 kinds of medicinal animals in Chinese Pharmacopoeia (2015 Edition), only 22 species (except livestock and poultry) of them have selection or breeding standards, while most of the 211 legislations are local standards. It is far behind the degree of agricultural standardization which can not achieve standardized production of animal medicinal materials. It is urgent to establish a technical standard system for production and processing of medicinal materials of animal-derivative, including basic, product, process, safety, environmental protection, management and working standards for common animal medicinal materials, which can fill the gap of industry and control the quality of animal medicinal materials, animal Chinese herbal pieces and products containing animal ingredients from the source.

Primary health information standard system based on semantic interoperability.

BACKGROUND: To realize semantic interoperability for Primary Health Information System (PHIS), this study analyzes and applies existing health information data standards in China. This research aims to establish a Primary Health Information Standard System (PHISS), and achieve the semantic level interoperability and application of primary health information. METHODS: First, the PHISS in accordance with the structural standards of national information standards system in China was constructed. Second, application of semantic interoperability level with reference to the interoperability model was standardized. Thirdly, referring to the data element model, PHIS data element dictionary with good interoperability is developed by standardizing data element attributes of identifiers, names, definitions and permissible value. Fourthly, based on PHIS data element dictionary, PHIS dataset is developed following the relevant rules for health information datasets. RESULTS: PHISS is composed of basic class standards, data class standards, technical class standards, security and privacy class standards, management class standards. In this study, we reorganized the data class standards that meet the requirements of PHIS, also develops and adds PHIS data element, PHIS data element dictionary and PHIS dataset. PHIS data element dictionary includes 16 parts and PHIS dataset includes 22 parts, which satisfies the data standardization requirements of PHIS. CONCLUSIONS: The establishment of the PHISS can meet the needs for the interconnection of the residents' basic health service information and realize the semantic level interoperability of various information services. The key steps of this method are based on semantic interoperability. Relevant data elements and datasets with semantic interoperability are selected. Moreover, an information standard system is constructed, and the information standardization requirements of the PHIS are met.

[Construction of high quality Chrysanthemi Flos pieces standard system based on comprehensive analysis of ancient and modern Chinese and foreign pharmacopoeia].

To study the evolution of Chinese ancient and modern pharmacopoeia standards and compare the domestic and foreign pharmacopoeias, further understand the international requirements on chrysanthemum quality, and establish a more suitable and modern standard system for high quality Chrysanthemi Flos pieces. Newly Revised Materia Medica, Welfare Pharmacy, Collected Essentials of Species of Materia Medica (Bencao Pinhui Jingyao), Chinese Pharmacopoeia and other herbal remedies in various generations were reviewed to summarize the evolution of domestic standards on Chrysanthemi Flos pieces. Then they were compared with those in European Pharmacopoeia, United States Pharmacopoeia, Japanese Pharmacopoeia and other foreign Pharmacopoeias to establish a modern and international high-quality Chrysanthemi Flos pieces standard system with Chinese medicine characteristics and produce more internationally recognized high-quality Chinese medicine pieces.

Development of quantitative monoclonal antibody-specific immobilization of platelet antigens assay for antibodies against human platelet antigen-1a, 3a, and 5b.

Human platelet antigens (HPAs) are platelet-specific alloantigens that cause alloimmunization. Alloantibodies induced via pregnancy and transfusion may result in various clinical syndromes. The monoclonal antibody-specific immobilization of platelet antigens (MAIPA) assay is the gold standard for the detection and identification of HPA antibodies. The present study aimed to develop standardized quantitative MAIPA assays for antibodies against HPA-1a, 3a, and 5b. MAIPA protocol was applied on serial dilutions of standard or reference reagents containing antibodies against HPA-1a, 3a, and 5b. Optimal experimental parameters were determined, and standard curves were constructed with a linear regression. The sensitivity, specificity, and reproducibility of the assays were also evaluated. The optimum reagents and conditions for the MAIPA assays were decided through repeated testing and comparison. The intra-assay coefficients of variation (CVs) are 1.3~3.6%, 2.7~5.2%, and 4.7~5.3%; the inter-assay CVs are 4.0~5.6%, 4.4~5.9%, and 3.2~6.3%, respectively, for HPA-1a, HPA-3a, and HPA-5b antibodies. In specificity tests, some monoclonal antibodies and sera with other antibodies were tested and no obvious positive result was observed. The standardized quantitative MAIPA assays for antibodies against HPA-1a, 3a, and 5b have good sensitivity, reproducibility, and specificity. They have important application value in clinical diagnosis of alloimmunization disease caused by HPA antibodies and safe transfusion of platelets.

Construction of high quality Chrysanthemi Flos pieces standard system based on comprehensive analysis of ancient and modern Chinese and foreign pharmacopoeia / 中国中药杂志

To study the evolution of Chinese ancient and modern pharmacopoeia standards and compare the domestic and foreign pharmacopoeias, further understand the international requirements on chrysanthemum quality, and establish a more suitable and modern standard system for high quality Chrysanthemi Flos pieces. Newly Revised Materia Medica, Welfare Pharmacy, Collected Essentials of Species of Materia Medica (Bencao Pinhui Jingyao), Chinese Pharmacopoeia and other herbal remedies in various generations were reviewed to summarize the evolution of domestic standards on Chrysanthemi Flos pieces. Then they were compared with those in European Pharmacopoeia, United States Pharmacopoeia, Japanese Pharmacopoeia and other foreign Pharmacopoeias to establish a modern and international high-quality Chrysanthemi Flos pieces standard system with Chinese medicine characteristics and produce more internationally recognized high-quality Chinese medicine pieces.

[How to adapt to the requirements of "clinical value-oriented drug innovation" for pharmaceutical research in application process of new traditional Chinese medicine].

On August 9, 2015, the State Council promulgated the "Opinions of the State Council on the reform of drug and medical device review and approval system" (Guofa 2015 No. 44), and established the "clinical value-oriented drug innovation" model to encourage the research and development of new drugs. Following that, China Food and Drug Administration (CFDA) promulgated the "Notice on several policies for drug registration review and approval" (2015 No. 230 ) on November 11, 2015, clearly specifying that CFDA would "implement one-time approval for clinical trials application of the new drugs, and no longer take a phased declaration, review and approval system; for the new drugs that apply for clinical trials, mainly review the scientific natureof the clinical protocols and the risk control of the new drugs to guarantee the safety of subjects". Accordingly, the evaluation ideas and forms of new drug registration have also been adjusted greatly. For example, issues like the rationality of the drug manufacturing process, whether the scale can reflect the stability of the process, whether the preparation process is sufficient, and whether the choice of dosage form is reasonable are no longer the focus of evaluation before clinical trials. Issues regarding whether the preparation process design is reasonable, whether the effective components can be transferred to the preparation to a maximum extent, whether the process parameters determined in small and middle pilot trials can adapt to the requirements of mass production, no longer act as the reasons for refusing the clinical trials. The corresponding risks shall be borne by the applicant as the subject of liability. The focus in registration evaluation is mainly transferred to how to ensure the consistence of quality between clinical trial samples and the samples already available on market by guaranteeing stable sources of drug raw materials and stable quality of medicines as well as control of the whole preparation process. These issues run through the whole process of new drug development, but also have different focuses in different stages. According to the "Measures on communicating about drug research and development and technical review" (2016 No. 94) (On Trial) issued by CFDA on June 2, 2016, the applicants may communicate with the drug evaluation center in different phases in the process of new drugs registration in respects of medicine material problems, technological problems, and quality control of the preparations. In this paper, the transformation of Chinese medicine research model was described mainly in the following aspects: how to control the quality of medicines from origins, technology design of the preparation and technology process research, and how to establish whole-process quality system. The paper also reflects the concept that the quality of new Chinese drugs research and development comes from design.

[Analysis of historical origin and standardization system construction of Citri Grandis Exocarpium].

To understand the history development and changes of Citri Grandis Exocarpium and initially establish its standard system after exploring the historical origins and modern development of Citri Grandis Exocarpium. In CNKI, Wanfang database and other academic search platforms were searched for literature on Citri Grandis Exocarpium and Chinese medicine standard system； the books related to its modern cultivation techniques and processing technology were also accessed, and after combining with the actual situation analysis, the prospective design of the standard system of Citri Grandis Exocarpium was finally established with research conclusion. The earliest records of the Citri Grandis Exocarpium were documented in the Northern and Southern Dynasties, but its medicinal value was discovered in the Song Dynasty. Its drug use was developed on the basis of Jupi（orange peel） and Citri Exocarpium Rubrum. In 21st century, a number of large-scale, intensive Citri Grandis Exocarpium bases have been formed due to high price, good planting efficiency, and rapid growth of cultivation areas. The standard system includes the technical specifications of seed selection and seedling cultivation of Citri Grandis Exocarpium, technical norms of cultivation, technical specifications of fertilizing and weeding, technical specifications of irrigation and drainage, technical standard of pest and disease control, standard of medicinal materials grade, standard of processing technology of sliced pieces and the quality standard of slices, etc.

[Research on Standard System of Home Use Electronic Medical Devices].

Medical device going home is an inevitable trend, however, using these devices has potential safety risks. Through introducing the home use electronic medical device products and related medical device standards, this paper provides recommendations on construction of standard system for home use electronic medical devices, to improve the advancement of existing medical device standard system and guide future medical standardization work, to fully utilize standars's guiding and security role in the scientific and technological innovation, industrial development.

A holistic strategy for quality and safety control of traditional Chinese medicines by the "iVarious" standard system.

An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines (TCMs). However, the current quality standard research lacks the top-design and systematic design, mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "iVarious" system. This system highlighted a holistic strategy for effectiveness, security, integrity and systematization of quality and safety control standards of TCMs. The establishment of "iVarious" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.

A holistic strategy for quality and safety control of traditional Chinese medicines by the"iVarious"standard system / 药物分析学报

An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines (TCMs). However, the current quality standard research lacks top-level design and systematic design, mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "iVarious" system. This system highlighted a holistic strategy for effectiveness, security, integrity and systematization of quality and safety control standards of TCMs. The establishment of "iVarious" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.

A holistic strategy for quality and safety control of traditional Chinese medicines by the"iVarious"standard system / 药物分析学报

An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines (TCMs). However, the current quality standard research lacks top-level design and systematic design, mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "iVarious" system. This system highlighted a holistic strategy for effectiveness, security, integrity and systematization of quality and safety control standards of TCMs. The establishment of "iVarious" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.

Construction of System Framework of Basic Dataset of Nursing Management Information for Hospital of TCM / 医学信息学杂志

Starting with the concepts of basic dataset and basic dataset of nursing management information of hospital of Tradtional Chinese Medicine (TCM),the paper introduces the research purpose,construction principle,construction method,construction contents and system framework of the basic dataset standard system of nursing management information of hospital of TCM,in order to lay a foundation for achieving nursing management data resource sharing and exchange of hospital of TCM.

How to adapt to the requirements of "clinical value-oriented drug innovation" for pharmaceutical research in application process of new traditional Chinese medicine / 中国中药杂志

On August 9, 2015, the State Council promulgated the "Opinions of the State Council on the reform of drug and medical device review and approval system" (Guofa 2015 No. 44), and established the "clinical value-oriented drug innovation" model to encourage the research and development of new drugs. Following that, China Food and Drug Administration (CFDA) promulgated the "Notice on several policies for drug registration review and approval" (2015 No. 230 ) on November 11, 2015, clearly specifying that CFDA would "implement one-time approval for clinical trials application of the new drugs, and no longer take a phased declaration, review and approval system; for the new drugs that apply for clinical trials, mainly review the scientific natureof the clinical protocols and the risk control of the new drugs to guarantee the safety of subjects". Accordingly, the evaluation ideas and forms of new drug registration have also been adjusted greatly. For example, issues like the rationality of the drug manufacturing process, whether the scale can reflect the stability of the process, whether the preparation process is sufficient, and whether the choice of dosage form is reasonable are no longer the focus of evaluation before clinical trials. Issues regarding whether the preparation process design is reasonable, whether the effective components can be transferred to the preparation to a maximum extent, whether the process parameters determined in small and middle pilot trials can adapt to the requirements of mass production, no longer act as the reasons for refusing the clinical trials. The corresponding risks shall be borne by the applicant as the subject of liability. The focus in registration evaluation is mainly transferred to how to ensure the consistence of quality between clinical trial samples and the samples already available on market by guaranteeing stable sources of drug raw materials and stable quality of medicines as well as control of the whole preparation process. These issues run through the whole process of new drug development, but also have different focuses in different stages. According to the "Measures on communicating about drug research and development and technical review" (2016 No. 94) (On Trial) issued by CFDA on June 2, 2016, the applicants may communicate with the drug evaluation center in different phases in the process of new drugs registration in respects of medicine material problems, technological problems, and quality control of the preparations. In this paper, the transformation of Chinese medicine research model was described mainly in the following aspects: how to control the quality of medicines from origins, technology design of the preparation and technology process research, and how to establish whole-process quality system. The paper also reflects the concept that the quality of new Chinese drugs research and development comes from design.