OBJECTIVE To examine the herbal evidence of “Agaru” Tibetan medicines,conduct biopharcological studies and proveide a basis for the corrent origin and quality control. METHODS Through literature research, combined with field visits and expert consultations, variety classification, origins, characteristics and effects, compound preparation,and quality standards of “Agaru” type Tibetan medicines were compiled and summarized. The morphological and microscopic characteristics of “Aerma” medicinal materials were observed. Physicochemical identification was carried out based on thin-layer chromatography and determination of volatile oil components and content using GC-MS technology. RESULTS The name “Agaru” has evolved from Sanskrit loanwords and is a typical Tibetan medicine characterized by “multiple varieties and multiple origins”. Tibetan medicine often classifies it based on color into three categories: white (transliterated as “A Er Jia” or “A Jia Ga Bu”), black (transliterated as “A Er Na” or “A Ga Na Bao”), and red (transliterated as “A Er Ma” or “A Ga Ku Ao”). There is a significant difference in the varieties and origins of “Agaru” type Tibetan medicines used by Tibetan doctors in different regions, involving about 15 species (including varieties and forms) of plants from 5 families and 7 genera. Among them, “Alma” is widely used clinically, and its mainstream base is the heartwood of Camphora glandulifera (Wall.) Nees. Biopharmacological research was carried out on “Aerma” [C. glandulifera (Wall.) Nees], a clinically used variety of the “Agaru” group of Tibetan medicines, providing basic data for the establishment of its quality standards. CONCLUSION This study completes the botanical verification of the Tibetan medicine “Agaru” and the pharmacognostical research on “Aerma” [C. glandulifera (Wall.) Nees]. This will provide an important basis for the scientific evaluation of quality and in-depth development of “Agaru”.

OBJECTIVE To interpret Guidance on Quality Control for Nanomedicines (interim) issued by center for drug evaluation, NMPA, and provide reference for the development of nanomedicines. METHODS By conducting a systematic review of domestic and international literature and combining background of the guidance, this paper discussed the definition and classification of nanomedicines, quality research and control strategies, process control and stability research. It also proposes points of attention in the quality control studies of nanomedicines with cases. RESULTS and CONCLUSION The special nano-size, structure and surface properties of nanomedicines may significantly change the physicochemical properties and behaviors of active pharmaceutical ingredients in vitro and in vivo, which in turn affect their safety and efficacy. Quality research spans the entire lifecycle of nanomedicines. Critical quality attributes related to nano-characteristics should be evaluated based on the type, composition and structure of nanomedicines, manufacturing process, as well as their clinical use. Risk assessment strategy based on drug evaluation should focus on the impact of the quality attributes of nanomedicines on their safety and efficacy.

Skin, as the first line of defense of the body, is often damaged by various factors, causing skin trauma. Skin wound repair has become a serious health problem. Medical wet dressings can create a sustained moist environment around the wound, stimulating the release of cytokines and cell proliferation, as well as enhancing the function of inflammatory cells, which have broad prospects in promoting wound healing. With the advancement of medical technology, multifunctional wound treatment strategies and auxiliary treatment technologies combined with medical wet dressings have provided better treatment options for skin wound repair and healing. This article summarizes the types and applications of medical wet dressings, elucidates and generalizes the research progress on functional medical wet dressings and related auxiliary treatment technologies, providing insights for researchers to develop new types of medical wet dressings.

Red yeast rice is a kind of traditional Chinese medicine(TCM) commonly used in China and all over the world in medicine, food additives, fermented food and other fields, but the research in this TCM is far from enough. Recently, the safety of red yeast rice health care product has aroused great concern around the world. This article reviews studies on the applied history, fermentation processing technology, material basis and quality control status of red yeast rice, aiming to clarify the factors that may lead to the risk of quality and safety of red yeast rice, and provide references for the safety quality control and risk prevention and control of red yeast and its products in China.

Sleep disorders are increasingly prevalent within the population, and optimal sleep is essential for overall health. The sleep-wake cycle is a multifaceted process influenced by a variety of factors, including several neurotransmitters such as acetylcholine, norepinephrine, serotonin, histamine, dopamine, orexin, and gamma-aminobutyric acid (GABA). The activity of these neurotransmitters is further modulated by numerous nutrients involved in their metabolic pathways. In recent years, GABA has garnered significant attention due to its critical role in sleep regulation. This review aims to examine the mechanisms through which GABA affects sleep, its clinical implications, as well as recent advancements in research and future directions in this field.

Thrombocytopenia is a disorder characterized by a decreased platelet count in the peripheral blood, which can be caused by various congenital and acquired diseases. Currently, thrombopoiesis-promoting drugs used for thrombocytopenia primarily include recombinant human interleukin-11 (rhIL-11), recombinant human thrombopoietin (rhTPO), and thrombopoietin receptor agonist (TPO-RA). Hetrombopag is an innovative oral non-peptide TPO-RA that has been approved for treating chronic adult primary immune thrombocytopenia (ITP) with inadequate response to glucocorticoids and immunoglobulin, as well as severe aplastic anemia (SAA) with poor response to immunosuppressive therapy in China. Clinical studies have demonstrated that hetrombopag is safe and well-tolerated in ITP and SAA patients. Currently, there is an ongoing phase Ⅲ clinical trial investigating the efficacy of hetrombopag in managing chemotherapy-induced thrombocytopenia (CIT). This article provides a review on the research progress of hetrombopag in treating thrombocytopenia, aiming to offer valuable insights for clinical practice.

Traditional Chinese medicine (TCM) decoction is a complex dispersion system, and its active components are mostly to form different phases in the form of solutes or dispersed substances, such as true solution, colloidal phase, suspension phase, etc. The active components are complex and diverse, and the formation, transformation, and transmission of each phase may affect the metabolism and action process of the pharmacodynamic components in biological bodies. However, the study on the phase differences and effective phases in TCM decoction is still in the initial stage. In this paper, we will be explored the quality basis and mechanism of TCM decoction from the perspectives of the formation, characterization, transformation, transmission and mechanism of the ordered phase in TCM decoction, and look forward to the quality research mode of TCM based on phase structure, so as to provide a reference for explaining the effect mechanism of TCM decoction from the perspective of structural TCM decoction.

The use of traditional dressings, such as gauze, cotton and bandages, has been gradually reduced in medical practice due to their disadvantages, including poor permeability and the tendency to cause secondary injuries during replacement. In contrast, functional hydrogels have attracted much attention due to their excellent biocompatibility, high water retention, ease of introduction of functional components and accelerated wound healing. This paper describes the mechanisms of skin wound healing and the properties of different types of wound dressings. It summarizes the research progress in functional hydrogels constructed by physical or chemical crosslinking over the past five years. Additionally, it offers insights into the future development trends of functional hydrogels.

In recent years, National Medical Products Administration has successively issued special documents such as “Several Measures to Further Strengthen the Scientific Regulation of Traditional Chinese Medicine(TCM) and Promote the Inheritance, Innovation and Development of TCM”, “Special Regulations on Registration and Management of TCM” and “Special Regulations on the Management of TCM Standards”, which put forward new requirements for the research, formulation and management of TCM standards, and is of great significance for the comprehensive construction of a new system for the management of TCM standards, the establishment of the most rigorous TCM standards, and the promotion of high-quality development of TCM industry. Due to the natural source of TCM, the complex composition of drug components, the unique theoretical system and the safety and effectiveness derived from clinical practice, it is difficult to objectively evaluate and effectively control the quality of TCM preparations based on qualitative and quantitative quality control models based on chemical components and the quality standards established thereby. How to realize the advanced characterization and objective identification of TCM quality based on the characteristics of TCM, and to study and establish the corresponding quality standard of TCM preparation has become an important content of TCM quality research, the focus and difficulty of TCM supervision scientific research, and the bottleneck of TCM quality improvement and standard formulation. At present, the quality control of TCM preparations has established a whole process quality control system from TCM crude drugs, decoction pieces to preparations, and formed a quality standard system of TCM preparations based on the characteristics of TCM consisting of the standards of TCM crude drugs, decoction pieces, extracts and preparations. By sorting out the development history of TCM quality standards, this paper analyzs the problems and challenges in the research of TCM quality standards, and discusss the strategies and methods for the research of TCM preparation quality standards based on the characteristics of TCM in combination with the scientific research results of TCM regulatory science in recent years, and the actual research and development and review of TCM, so as to provide reference for colleagues in the industry.

OBJECTIVE To evaluate and analyze real-world post-marketing adverse drug reactions(ADRs) of sindilizumab and provide critical reference for safe clinical medication. METHODS The data were sourced from the National Adverse Drug Reaction Monitoring System database, covering ADR reports related to sindilizumab in Beijing area in the past five years. These reports identified sindilizumab as the suspected drug to the ADRs. Statistical analysis was conducted using SPSS 22.0 software. RESULTS A total of 155 sindilizumab-related ADR reports were analyzed. In terms of gender distribution, the ratio of male to female patients was 1.77∶1. Skin reactions were the most common ADRs reported. Allergic reactions dominated ADR reports occurring within 24 hours. Severe ADRs accounted for 26.45% of the reports, with most severe reactions occurring after 24 hours of medication use (P=0.005). In patients with tumors not included in the approved indications, the risk of experiencing severe ADRs was significantly higher compared with those with indicated conditions (P=0.006). Nine patients experienced ADRs due to drug dosages exceeding the recommended dosage in the instructions. Additionally, the concomitant use of the drug with lenvatinib was associated with the emergence of new safety signals, including myocardial infarction and diabetic ketoacidosis, necessitating heightened vigilance in clinical practice. CONCLUSION This investigation has uncovered an augmented risk of severe ADRs in individuals receiving medications for non-indicated uses. Consequently, implementation of stricter surveillance measures is needed for patients with off-label conditions to facilitate timely medical interventions. Notably, a significant incidence of severe ADRs is observed to occur beyond the initial 24-hour period following treatment. Thus, individuals receiving the drug in day-care unit should be explicitly instructed to closely monitor their post-medication health status upon discharge and to seek immediate medical consultation in case of any arising discomfort. There exists noncompliance with the recommended dosage, thus attention should be paid to such cases. Moreover, concurrent use of sindilizumab with lenvatinib has been identified to induce myocardial infarction and diabetic ketoacidosis, representing a new safety signal that demands clinical caution.