Quality control strategy of traditional Chinese medicine based on pharmaceutical product lifecycle management / 中国中药杂志

Quality control is pivotal in the research and development of traditional Chinese medicine, whose connotation is not limi-ted to the qualitative or quantitative detection of an indicator component, but extends to the establishment of a whole process quality control system from the perspective of pharmaceutical product lifecycle management. This study discussed the quality control strategy of Chinese medicine based on the concept of pharmaceutical product lifecycle management, and proposed the following suggestions:(1) to focus on the "holistic view" and "phased" characteristics of quality control and strengthen the establishment of quality control strategy based on top-level design;(2) to strengthen the research on quality control of Chinese medicine based on quality risk management, focus on the correlations of quality control indicators with the safety and effectiveness of traditional Chinese medicine, and establish a quality evaluation system consistent with the characteristics of traditional Chinese medicine;(3) to consider the characteristics of different registration classifications in the establishment of quality control strategy;(4) to highlight the quality correlation research, strengthen the quality transfer research, ensure the quality traceability, and establish a sound quality management system;(5) to strengthen the quality research on marketed drugs to achieve dynamic quality improvement.

Intrinsic "self-consistent" phenomenon based on holistic view of traditional Chinese medicine / 中国中药杂志

The fundamental principle of traditional Chinese medicine(TCM) is holism, and it is crucial for TCM to address the key issue of the "holistic view" of Chinese herbal medicine. While the overall regulatory effects of Chinese herbal medicine have been widely recognized, the holistic internal logic of individual ingredients of Chinese herbal medicines require further clarification. In order to comprehensively understand the mechanism of action of Chinese herbal medicine, this paper combined the holistic view of Chinese herbal medicine with differentiation thinking to explore the intrinsic logical relationships within Chinese herbal medicine. Starting from the perspective of the coexistence of multiple components in Chinese herbal medicine, this paper systematically examined the "self-consistent" phenomenon within single Chinese herbal medicine. This phenomenon refers to the consistent or opposing actions of various components in terms of their physical and chemical properties, pharmacokinetic effects, biological effects, flavors and properties, and TCM efficacy. The paper summarized various logical relationships of syndrome differentiation exhibited by the same Chinese herbal medicine, analyzed the underlying reasons, and focused on analyzing external factors affecting the "self-consistent" phenomenon in the efficacy of Chinese herbal medicine, aiming to better elucidate the theoretical basis of the pharmacological effects of Chinese herbal medicine, further enrich the scientific connotation of the holistic view of Chinese herbal medicine, and provide theoretical guidance for the preparation process, compatibility patterns, and formulation design of Chinese herbal medicine.

Visão Holística da Enfermagem na assistência prestada a pacientes com dor crônica / Holistic view of nursing care in patients with chronic pain

Objetivo: Elucidar para profissionais de enfermagem quais os aspectos a serem considerados na assistência prestada a pacientes com dor crônica. Metodologia: Trata-se de uma revisão integrativa da literatura, descritiva e exploratória, nas bases de dados BIREME e SciELO. Foram selecionados 16 artigos em português, inglês e francês, publicados entre 2013 a Julho de 2018. Resultados: assegurar o cuidado de forma holística na dor crônica depreende do reconhecimento da relação sujeito/mundo, visto que a dor crônica reflete além dos fatores neurofisiológicos, a experiência previa individual e elementos cognitivos e comportamentais. Conclusão: o Enfermeiro como norteador do cuidado deve embasar sua prática clínica em uma abordagem que compreenda a dor crônica e o cliente em sua totalidade, estabelecendo um cuidado humanizado que considere a saúde em todos seus aspectos, físico, psicossocial e ambiental.

Objective: To elucidate for nursing professionals the aspects to be considered in the care given to patients with chronic pain. Methodology: This is an integrative review of the descriptive and exploratory literature in BIREME and SciELO databases. Sixteen articles were selected in Portuguese, English and French, published between 2013 and July 2018. Results: ensuring holistic care in chronic pain reflects the recognition of the subject / world relationship, since chronic pain reflects beyond neurophysiological factors, previous individual experience and cognitive and behavioral elements. Conclusion: The nurse as the care guide should base her clinical practice on an approach that understands chronic pain and the client in its totality, establishing a humanized care that considers health in all its aspects, physical, psychosocial and environmental.

Quality evaluation strategy of Chinese materia medica preparation based on characteristics of “structural composition of multi-components” / 中草药

The scientific and objective quality evaluation of traditional Chinese medicine preparations has always been a historical problem in the process of modernization of traditional Chinese medicine. In the past, the single component evaluation model of “point for surface, one for all” and the index selection method of “content-only theory” were mostly used in the quality evaluation of traditional Chinese medicine preparations, which seriously deviated from the characteristics of the overall view of traditional Chinese medicine, and it was difficult to objectively and accurately evaluate the quality of traditional Chinese medicine preparations. At present, the quality evaluation model of traditional Chinese medicine preparations based on multiple indicators has become the consensus of many experts and scholars. However, the complexity of the multi-components of traditional Chinese medicines has made it impossible to accurately identify all the components in the quality evaluation of traditional Chinese medicine preparations, and it is even more impossible to use all the components as the standard for quality evaluation. According to the characteristics of traditional Chinese medicine, a limited number of representative components which can represent the overall effect of traditional Chinese medicine preparations were selected by means of network pharmacology, molecular docking, etc. Based on the content of representative components and their proportional relationship, the quality evaluation strategy of traditional Chinese medicine preparation based on the characteristics of “components structure” was established, in order to provide new ideas for the quality evaluation of traditional Chinese medicine preparations in the future.

Ideas for New Drug Discovery of Prevention and Treatment of Diabetic Nephropathy Based on “Holistic View” in Tibetan Medicine / 中国实验方剂学杂志

Diabetic nephropathy(DN) is a kind of severe diabetes mellitus(DM) complications,which is one of the most common cause of end-stage renal failure.The incidence of DN increases with the increase of the number of DM patients,and early prevention is the key.DM and DN are characteristic advantages of Tibetan medicine,the "holistic view" of dynamic balance based on the three major factors in the body(Sanyin,included rlung,mkhris-pa and bad-gan) is a unique understanding of DM and DN among Tibetan medical practitioners,and which has rich and unique clinical and medication experiences in DN treatment.This paper discussed the medical theory "holistic view" on the Tibetan medicine for DM and DN,dug commonly used Tibetan drugs and Tibetan medical prescriptions for clinical treatment of DN,in order to provide new ideas for the treatment of DN and the discovery of new drugs for DN, and give full play to the unique advantages of Tibetan medicine.

Discussion on Consistency of TCM Yin-Yang Balance and Microecological Balance / 中国中医药信息杂志

With the rise of microecology and medical model getting into the stage of the development of the ecological medicine, the intersection and consistency in the cognition traditional of Chinese and Western medical system are highlighted. Yin-yang theory is the core theory in TCM. In order to extend the guidance effects of theory of the balance of yin and yang in the clinic, and help TCM theory and curative effect be further recognized by the world, this article analyzed the consistency of different systems by comparing TCM balance theory and microecology, with a purpose to explore the closed link between TCM balance theory and microecology and microscopic nature of TCM balance theory.