ABSTRACT
Strengthening the standard formulation and quality management of traditional Chinese medicine（TCM） dispensing granules is an important part of the strategic planning for the development of TCM in China. In order to examine the clinical application and overall quality control of the existing national standards for TCM dispensing granules， this study classified and summarized the varieties in the existing standards， analyzed their clinical applicability， and discussed the characteristics of the test methods for identification， content determination and specific chromatogram/fingerprint. It was found that the coverage of the existing standards was inadequate in terms of quantity， and it was even weaker in the aspects of therapeutic efficacy， herb family， processing method and preparation method of TCM dispensing granules. It was concluded that the characteristics of national standards in test methods were summarized as follows：guided by clinical application， based on the reference system， taking specific chromatogram as a breakthrough， so as to improve the overall quality control of TCM dispensing granules. It is suggested that the coverage of national standards should be subsequently expanded to meet the needs of market development. In order to enhance clinical applicability， the content of national quality standards should be increased， including increasing variety diversity to meet the needs of clinical application， raising the standard requirements to improve the clinical medication experience， and strengthening effectiveness research to highlight clinical efficacy. At the same time， the accessibility of regulatory inspection is enhanced， the rules for the management of varieties without national standards are promulgated to lay the foundation for the healthy and orderly development of TCM dispening granule industry.
ABSTRACT
@#Objective To prepare the 1st batch of national standard of recombinant trypsin in order to standardize and improve the quality of recombinant trypsin.Methods Enzyme-substrate identification,HPLC identification,N-terminal sequencing and TOF-MS were used to confirm the property and structure of recombinant trypsin;the purity was determined by HPLC;according to the methods in Chinese Pharmacopoeia(Volume Ⅲ 3603,2020 edition),the specific activity of the candidate standard was determined,and the stability and uniformity were investigated.Results The structure of recombinant trypsin was confirmed,and the specific activity of the 1 st batch of national standard of recombinant trypsin was 5 169 U/mg,containing 80% β-trypsin and 9% α-trypsin.The RSD of purity of α,β-trypsin and retention time of 12 candidate standards were all less than 2.0%.The purity of α,β-trypsin showed no obvious decrease stored at 25 ℃ and relative humidity(RH) 80% for 10 d,while the purity of β-trypsin decreased slightly and the purity of α-trypsin increased slightly stored at 40℃ and RH 80% for 10 d.The purity of β-trypsin decreased slightly when exposed to light(4 000 lx) for 10 d.Conclusion The national standard of recombinant trypsin with accurate structure and high purity was prepared,which can be used for system suitability test of the purity determination.
ABSTRACT
In the past ten years, the research and application of microbiome has continued to increase. The microbiome has gradually become the research focus in the fields of life science, environmental science, and medicine. Meanwhile, many countries and organizations around the world are launching their own microbiome projects and conducting a multi-faceted layout, striving to gain a strategic position in this promising field. In addition, whether it is scientific research or industrial applications, there has been a climax of research and a wave of investment and financing, accordingly, products and services related to the microbiome are constantly emerging. However, due to the rapid development of microbiome sequencing and analysis related technologies and methods, the research and application from various countries have not yet unified on the standards of technology, programs, and data. Domestic industry participants also have insufficient understanding of the microbiome. New methods, technologies, and theories have not yet been fully accepted and used. In addition, some of the existing standards and guidelines are too general with poor practicality. This not only causes obstacles in the integration of scientific research data and waste of resources, but also gives related companies unfair competition opportunity. More importantly, China still lacks national standards related to the microbiome, and the national microbiome project is still in the process of preparation. In this context, the experts and practitioners of the microbiome worked together and developed the consensus of experts. It can not only guide domestic scientific research and industrial institutions to regulate the production, learning and research of the microbiome, the application can also provide reference technical basis for the relevant national functional departments, protect the scale and standardized corporate company's interests, strengthen industry self-discipline, avoid unregulated enterprises from disrupting the market, and ultimately promote the benign development of microbiome-related industries.
Subject(s)
Humans , China , Consensus , Industry , MicrobiotaABSTRACT
According to 'National Standard of Undergraduate Teaching Quality for Nursing Science',the mode of community nursing practice was explored and implemented by the School of Nursing in Tianjin Medical University. Focus on competency, the syllabus of community nursing practice was revised. Optimizing the management system of community nursing practice, developing the team of high-quality teachers, building standardized community nursing practice bases, and improving the evaluation system of community nursing practice aimed to enhance comprehensive quality of nursing undergraduates and the quality of community nursing practice. Within the concept of "big health", our school is exploring the new mode of combining community nursing practice with health management-oriented nursing personnel training, which lays an important foundation for training applied nursing talents to meet the needs on development of community health services.
ABSTRACT
According to 'National Standard of Undergraduate Teaching Quality for Nursing Science', the mode of community nursing practice was explored and implemented by the School of Nursing in Tianjin Medical University. Focus on competency, the syllabus of community nursing practice was revised. Optimizing the management system of community nursing practice, developing the team of high-quality teachers, building standardized community nursing practice bases, and improving the evaluation system of community nursing practice aimed to enhance comprehensive quality of nursing undergraduates and the quality of community nursing practice. Within the concept of "big health", our school is exploring the new mode of combining community nursing practice with health management-oriented nursing personnel training, which lays an important foundation for training applied nursing talents to meet the needs on development of community health services.
ABSTRACT
TheStandardized Manipulations of Acupuncture and Moxibustion has been published and gradually standardized the clinical practice. It provided a solid foundation for the standardization of acupuncture and moxibustion therapeutic effects. It also provided powerful convictable effects on the accuracy and scientificity of acupuncture and moxibustion clinical practice, which gained well-acceptance from patients. In the treatment of certain diseases, acupuncture and moxibustion have become irreplaceable so that acupuncture and moxibustion can be strongly promoted both at home and abroad. There were some common problems occurred during the establishment of the national standardization onStandardized Manipulations of Oral and Lip Acupuncture. This article reviewed, analyzed and discussed questions occurred during the standardization establishment. The results showed that according to the principle of standardized production, a rigorous, scientific and reasonable text standard can be established. Advices or opinions gained during the process can be used as references for future standardization establishment. It was concluded that the standardization of acupuncture had great guidance in the acupuncture clinical application. It is an arduous and long-term mission to achieve and strengthen the position of international standardization of acupuncture and moxibustion. The government should increase the effort on investment and promotion of acupuncture and moxibustion standardization. Conversation and cooperation should also be strengthened with international communities to promote the standardization implementation.