The manufacturing process is crucial for ensuring the safety and efficacy of traditional Chinese medicine(TCM) preparations. Using advanced technologies, innovative methods, and new equipment tailored for TCM to enhance the quality control of TCM preparations in the manufacturing process helps to ensure the product quality and foster high-quality development of the TCM industry. Upon current technical requirements, such as Guideline for Studies on Pharmaceutical Changes in Marketed Traditional Chinese Medicine Preparations(Trial) and Guideline for Study on Quality Control in Manufacturing Process of Oral Traditional Chinese Medicine Preparations(Trial), this paper analyzes the characteristics and current development of quality control in the manufacturing process of TCM preparations. It also discusses the significant roles that quality control in manufacturing process plays in ensuring the quality consistency and in the evaluation and decision-making of changes in marketed TCM preparations. Furthermore, to benefit the high-quality development of the TCM industry, this paper offers recommendations for improving quality control of TCM preparations in the manufacturing process and implementing new technologies and methods.
Quality Control ; Drugs, Chinese Herbal/chemistry* ; Medicine, Chinese Traditional/standards* ; Decision Making ; Humans

Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards* ; Humans ; Consensus ; Drugs, Chinese Herbal/therapeutic use* ; Surveys and Questionnaires

Objective:To analyze the clinical characteristics of malignant lymphoma of the head and neck in children, and to improve the understanding and diagnosis and treatment of this type of disease by otolaryngologists. Methods:Clinical data of 49 children with malignant lymphoma of the head and neck hospitalized in the Department of Otorhinolaryngology, Head and Neck Surgery of Kunming Children's Hospital from 2013-2021 were retrospectively analyzed and statistically analyzed according to gender, age distribution, duration of the disease, site of onset, type of pathology and survival status. Results:A total of 49 cases of malignant lymphoma of the head and neck in children were collected, of which, 39 were male and 10 female. The minimum age was 3 years, the maximum was 14 years and 4 months, the median age of onset was 7 years, and the largest percentage （51.02%） of children was in the school age（6-12 years）. The duration of the disease ranged from 5 days to 2 years, with a median of 1 month, and the site of the lesion was located in the neck in the majority of cases, 41（83.67%）. The pathologic types of hodgkin lymphoma（HL） were 25 cases（51.02%） and non-hodgkin lymphoma（NHL） were 24 cases（48.98%）, and among hodgkin lymphomas, mixed-cell classical hodgkin lymphoma was the most common, with 9 cases（18.37%）; among non-hodgkin lymphomas,originated from B-cells in 16 cases （32.65%） and from T-cells in 7 cases （14.29%）, with Burkitt's lymphoma being the most numerous of B-cell origin in 13 cases （26.53%）, and T-cell lymphoblastoid lymphoma being the most common of T-cell origin in 4 cases （8.16%）. The follow-up period was from 22 days to 6 years and 10 months, with 3 cases losing, 43 cases surviving, 3 cases dying, with a survival rate of 93 5%, and 3 cases relapsing, with a relapse rate of 6 5%. Conclusion:Children's head and neck malignant lymphoma has its own characteristics in terms of age of onset, gender distribution, site of onset, pathological type and treatment prognosis, which should be comprehensively assessed, diagnosed as early as possible, and multidisciplinary joint treatment actively carried out to propose personalized treatment plans.
Humans ; Male ; Female ; Child ; Head and Neck Neoplasms/therapy* ; Child, Preschool ; Retrospective Studies ; Adolescent ; Lymphoma/therapy* ; Survival Rate ; Hodgkin Disease ; Prognosis ; Infant ; Lymphoma, Non-Hodgkin

OBJECTIVES: To analyze the differentially expressed exosomal miRNAs in patients with chronic heart failure (CHF) complicated by hyperuricemia (HUA) and explore their potential as novel diagnostic molecular markers and their target genes. METHODS: This study was conducted among 30 CHF patients with HUA (observation group) and 30 healthy volunteers (control group) enrolled between September, 2020 and September, 2023. Peripheral blood samples were collected from 6 CHF patients with HUA for analyzing exosomal miRNAs by high-throughput sequencing, and the results were validated in the remaining 24 patients using qRT-PCR. GO and KEGG enrichment analyses were performed to predict the the target genes of the identified differential miRNAs. We also validated the differentially expressed miRNAs by animal experiment. RESULTS: A total of 42 differentially expressed exosomal miRNAs were detected in observation group by high-throughput sequencing; among them, miR-27a-5p was significantly upregulated (P=0.000179), and miR-139-3p was significantly downregulated (P=0.000058). In the 24 patients with both CHF and PUA, qRT-PCR validated significant upregulation of miR-27a-5p (P=0.004) and downregulation of miR-139-3p (P=0.005) in serum exosomes. When combined, miR-27a-5p and miR-139-3p had a maximum area under the curve (AUC) of 0.899 (95% CI: 0812-0.987) for predicting CHF complicated by HUA. GO and KEGG enrichment analyses suggested that the differential expressions of miR-27a-5p and miR-139-3p was associated with the activation of the AMPK-mTOR signaling pathway to activate the autophagic response. We obtained the same conclusion from animal experiment. CONCLUSIONS Upregulated exosomal miR-27a-5p combined with downregulated exosomal miR-139-3p expression can serve as a novel molecular marker for diagnosis of CHF complicated by HUA, and their differential expression may promote autophagy in cardiomyocytes by activating the AMPK-mTOR signaling pathway.
Humans ; Hyperuricemia/diagnosis* ; Heart Failure/genetics* ; MicroRNAs/metabolism* ; Exosomes/metabolism* ; Chronic Disease ; Male ; Female ; Middle Aged ; Animals

Imaging examination is a crucial part in diagnosis and treatment of central nervous system infection(CNSI),involving complex imaging sequences and parameters.This consensus was jointly written by multiple CNSI imaging experts in China,aimed to standardize imaging examination of CNSI.

Objective:To develop a maternal assessment scale integrating both positive (affirmation, optimism, self-confidence) and negative psychological states (fear, anxiety, depression) throughout the entire pregnancy cycle and evaluate its reliability and validity.Methods:In December 2020, the scale items were preliminarily identified through a literature review, forming a 55-item questionnaire for pilot survey and expert interviews. A pilot survey was conducted among registered pregnant women at the Obstetrics and Gynecology Hospital of Fudan University from April to May 2021. The feasibility and reliability of the questionnaire was validated through reliability and validity analysis, and revisions were made based on the feedback. The finalized version comprised 43 items, categorized into four key event dimensions (pregnancy, childbirth, transition to motherhood, and complications) and six psychological state dimensions (affirmation, fear, anxiety, depression, optimism, and self-confidence). Among these psychological states, affirmation, self-confidence, and optimism represent positive states, while fear, anxiety, and depression reflect negative states. A formal survey was conducted from December 2021 to November 2022. The normality, multicollinearity, reliability, construct validity, convergent validity, and discriminant validity of each item were analyzed.Results:(1) General information: A total of 625 participants were involved in the pilot survey. For the formal survey, 8 045 questionnaires were distributed, with 6 273 valid responses (78.0%). Among the valid questionnaires, 5 694 (90.8%) reported positive psychological states and 579 (9.2%) negative states. All of the psychological state dimensions were correlated (all P<0.01), with no multicollinearity detected [variance inflation factor (VIF)<10]. The four key event dimensions were also correlated (all P<0.01), with no multicollinearity (VIF<10). (2) Reliability: The overall Cronbach's α coefficient of the questionnaire was 0.830, and removing any single item resulted in the value remaining>0.6. Cronbach's α coefficient values for affirmation, fear, anxiety, depression, optimism, and self-confidence were 0.772, 0.724, 0.648, 0.551, 0.257, and 0.740, respectively. The values for the key event dimensions were as follows: 0.722 for pregnancy, 0.554 for childbirth, 0.621 for transition to motherhood, and 0.568 for complications. (3) Model fit: For the psychological states, the Chi-square to degrees of freedom ratio ( χ2/df) was 19.979 (>3), and the root mean square error of approximation (RMSEA) was 0.055 (<0.08). The model of key event dimensions had a χ2/df of 48.557, RMSEA of 0.087, comparative fit index of 0.400 (<0.9), and incremental fit index of 0.400 (<0.9). (4) Convergent and discriminant validity: The average variance extraction (AVE) values for affirmation, fear, anxiety, depression, optimism, and self-confidence were 0.407, 0.099, 0.188, 0.223, 0.419, and 0.362, with composite reliability (CR) values of 0.822, 0.730, 0.655, 0.584, 0.627, and 0.786, respectively. In the model of key event dimensions, the AVE values for pregnancy, childbirth, transition to motherhood, and complications were 0.167, 0.287, 0.328, and 0.166, with CR values of 0.555, 0.832, 0.746, and 0.633, respectively. Significant correlations were observed between all psychological dimensions except optimism-depression and self-confidence-anxiety pairs (all P<0.05). All four key event dimensions were significantly correlated (all P<0.05). Conclusions:This study preliminarily develops a maternal psychological status assessment scale with satisfactory reliability and validity. This scale can be used to evaluate the comprehensive psychological states of pregnant women during critical pregnancy-related events.

Objective To study the need for blood compatibility evaluation of medical devices that come into indirect contact with blood in order to accurately evaluate the risk of their interaction with blood.Methods Seven medical devices with indirect contact with blood were selected as samples including extension tubes of central venous catheters,port bodies of implantable drug delivery devices,infusion sets,receiving lines of dialysis equipment,auxiliary lines of left ventricular assist devices,blood monitors and catheter holders,with high-density polyethylene as the negative control,glass beads as the positive control and blank whole blood or plasma for the blank control.Partial thromboplastin time(PTT)test,platelet count test and hematology test(white blood cell and red blood cell count)were performed by direct contact method and indirect contact method,respectively.In the direct contact method,whole blood or plasma was in direct contact with the sample;while in the indirect contact method,whole blood or plasma was not in direct contact with the extraction solution,with no direct contact with the sample.Results With the indirect contact method the ratios(expressed as a percentage)of the PTT,platelate,WBC and RBC counts of the samples,positive and negative controls to those of the blank control were all higher than those with the direct contact method,and the indirect contact method had the sensitivity lower than that of the direct contact method.Conclusion Medical devices indirectly contacting blood have low risks for causing coagulation and platelet and hematologic adverse reactions,which are suggested to be evaluated for hemolysis testing only in case of the history of safe clinical use.[Chinese Medical Equipment Journal,2025,46(8):44-49]

Hepatocellular carcinoma (HCC) is a leading cause of cancer-associated death globally. Liver transplantation (LT) has emerged as a key treatment for patients with HCC, and the Milan criteria have been adopted as the cornerstone of the selection policy. To allow more patients to benefit from LT, a number of expanded criteria have been proposed, many of which use radiologic morphological characteristics with larger and more tumors as surrogates to predict outcomes. Other groups developed indices incorporating biological variables and dynamic markers of response to locoregional treatment. These expanded selection criteria achieved satisfactory results with limited liver supplies. In addition, a number of prognostic models have been developed using clinicopathological characteristics, imaging radiomics features, genetic data, and advanced techniques such as artificial intelligence. These models could improve prognostic estimation, establish surveillance strategies, and bolster long-term outcomes in patients with HCC. In this study, we reviewed the latest findings and achievements regarding the selection criteria and post-transplant prognostic models for LT in patients with HCC.

The Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis （GS/CACM 337-2023） was released by the China Association of Chinese Medicine on December 13^th， 2023. This expert consensus was developed by experts in methodology， pharmacy， and Chinese medicine in strict accordance with the development requirements of the China Association of Chinese Medicine （CACM） and based on the latest medical evidence and the clinical medication experience of well-known experts in the fields of respiratory medicine （pulmonary diseases） and pediatrics. This expert consensus defines the application of Qinbaohong Zhike oral liquid in the treatment of cough and excessive sputum caused by phlegm-heat obstructing lung， acute bronchitis， and acute attack of chronic bronchitis from the aspects of applicable populations， efficacy evaluation， usage， dosage， drug combination， and safety. It is expected to guide the rational drug use in medical and health institutions， give full play to the unique value of Qinbaohong Zhike oral liquid， and vigorously promote the inheritance and innovation of Chinese patent medicines.

In vitro,platelets are readily activated,which complicates the process of quality control.In con-trast,nanoparticles possess distinct advantages due to their small size,high surface area ratio,biocompatibili-ty,and modifiability.These properties enable them to inhibit platelet aggregation through encapsulation or multi-modification,thereby ensuring the stability of quality control products for clinical platelet assays.This paper delineates the properties of the two existent forms of platelet-nanoparticle complexes,their synthesis principles,and their applications in the medical field.The text goes on to examine the preparation methods of some platelet-nanoparticle complexes and their applications in the fields of cancer therapy,wound healing,and immune disorders.It also explores the potential relationship between platelet-nanoparticle complexes and exo-some-nanoparticle complexes.Additionally,the future research directions of nanoparticles in platelet plasmino-genics are discussed in this paper,emphasizing the effects of nanoparticle concentration,size,and surface modi-fication on platelet aggregation.This provides a theoretical basis for the development of stable and controllable platelet plasminogenics.