Respiratory diseases have a high incidence and pose a serious threat to human life and health. The synergistic effect of multi-component and multi-target of traditional Chinese medicine has obvious advantages in the treatment of respiratory diseases, and Jiegeng Decoction comes from Zhang Zhongjing′s “Treatise on Typhoid Fever” in the Han Dynasty, which is a representative prescription for the treatment of pulmonary carbuncle and throat diseases, and has the functions of promoting lung and dissolving phlegm, relieving pharyngeal pain, and clearing heat and detoxifying. This article reviews the pharmacological mechanism and clinical application of platycodon decoction in the treatment of respiratory diseases. Modern pharmacological studies have shown that Jiegeng Decoction exerts anti-inflammatory, expectorant, anti-cough, antiviral, anti-tumor, and anti-pulmonary fibrosis pharmacological effects by inhibiting Toll-like receptor 4 (TLR4), nuclear factor κB (NF-κB), nuclear factor E2-related factor 2 (Nrf2) and transforming growth factor-β/Smad protein (TGF-β/Smad). Clinically, allergic rhinitis, various pneumonia, chronic pharyngitis and other respiratory diseases are treated by addition, subtraction, chemical cut, and combined medication. Through multidisciplinary research integrating network pharmacology, molecular docking, chemical proteomics, and lipidomics, this study elucidates the potential therapeutic mechanisms of Jiegeng Decoction in treating respiratory diseases.However, the research of Jiegeng Decoction still faces some challenges and problems, and at the basic research level, it is necessary to deeply analyze its pharmacological mechanism of action and the function of small RNA components. At the level of applied research, it is necessary to improve the targeting of effective components to specific diseases. At the level of formulation development, it is necessary to break through the limitations of traditional decoctions and explore new dosage forms based on supramolecular theory.

Depression is a serious mental disorder characterized by low mood, loss of interest, and negative self-perception. In recent years, the phenomena of comorbidity between depression and disorders of non-brain organs or related diseases have been verified in clinical practice, epidemiological researches, biological researches and other aspects, underscoring the importance and urgency of elucidating the mechanism underlying the comorbidity of depression and non-brain organs disorders or related diseases. Both of them can “cause depression due to disease” and “cause disease due to depression”. Based on the theories of traditional chinese medicines (TCMs) and Western medicine, the related researches were summarized from the past decade concerning the mutual deterioration between depression and disorders of non-brain organs or related diseases from the “Brain↔X”interacitve perspective. In addition, this paper also introduces the bidirectional causal relationships between the brain and the five internal organs, as well as the six hollow organs in the context of depression. Based on the the concept of interdisciplinary integration, in order to offer a novel perspective for a comprehensive and in-depth interpretation of the preogression of depression, theoretical foundation for enhancing the overall efficacy, safety and tolerability of drug treatments, and references for developing scientific and effective therapeutic strategies, and broader possibilities for the holistic management of depression, this paper elucidates the crosstalk mechanisms between brain and non-brain organs from the multi-organ and multi-system perspectives.

Traditional Chinese medicine injection (TCMI) represents an emerging form of traditional Chinese medicinal preparation that integrates traditional Chinese medical theory with modern pharmaceutical technology. TCMI possesses irreplaceable advantages in the treatment of critical illnesses. However, as the clinical application of TCMI expands and rapidly develops, its adverse reactions, particularly pseudo-allergic reactions, have garnered significant academic attention. Such reactions can be triggered upon the first administration of the medication without the involvement of IgE. Currently, research on the types of TCMI that cause pseudo-allergic reactions and their mechanisms remains inadequate, and standardized detection methods and quality control indicators for sensitizing components are lacking. This article systematically reviews the inducing factors and key components of pseudo-allergic reactions, focusing on exploring their potential mechanisms, including the direct stimulatory effect on mast cells/basophils and the complement system activation pathway. Additionally, it summarizes commonly used research models in this field, including in vitro cell models and in vivo animal experimental systems. Finally, future research directions are proposed to address the existing challenges in TCMI safety studies.

OBJECTIVE Lagotis brevituba Maxim., a type Ⅰ of the 2025 edition of the Chinese Pharmacopoeia, is included. The “Pharmaceutical Standards of the Ministry of Health of the People′s Republic of China-Tibetan Medicine (Volume 1)” includes the Lagotis integra W. W. Smith and the Lagotis brevituba Maxim. Previous research found that there were significant differences in the plant morphology of the Lagotis integra W. W. Smith native to Sichuan and Tibet, and there were also cases of mixed use between the Lagotis integra W. W. Smith and the Lagotis brevituba Maxim.. To identify Lagotis brevituba Maxim. and Lagotis integra W.W.Smith from different geographical origins, and conduct a comparative study on their morphology and histology, so as to provide a scientific basis for their authentication and the improvement of national drug standards. METHODS The methods stipulated in plant taxonomy and the General Provisions of the 2025 Edition of the Chinese Pharmacopoeia, Part Ⅳ, were adopted to conduct a study on the characteristics and microscopic identification (root and stem, root and leaf cross-sections, powder microscopic identification) of different Tuercao. Image acquisition was carried out using instruments such as cameras, stereomicroscopes, optical microscopes, and full slip scanning microscopes to comprehensively compare the differences among different Tuercao. RESULTS The main differences among the three types of Tuercao plants lie in plant height, leaf shape, inflorescence length, corolla color and rhizome length. The main differences among medicinal materials lie in the shape and color of the leaves and the length of the inflorescences. The main differences in microstructure lie in the color of the cross-section of the root and stem under mixed fluorescence and the number of vascular bundles in the middle veins of the leaves. Except for the differences in powder color and the number of accessory cells of the stomata on the lower epidermis of the leaves, the other microscopic features of the powder are also consistent. CONCLUSION There are varying degrees of differences among the three types of Tuercao in terms of plant morphology, medicinal material properties and microscopic characteristics. Among them, the traits (the root and stem have white dot-like vascular bundles arranged in rings, with a black ring surrounding the vascular bundles) and microscopic features (such as root epidermal cells, etc.) can be suggested to supplement and improve the current standards.

OBJECTIVE To evaluate the chemical composition differences among Polygalae Radix resources from different sources, origins, and parts. METHODS The UHPLC-TOF-MS technology was employed to establish the UHPLC-TOF-MS fingerprint of Polygalae Radix. The chemical components were identified based on MS/MS fragments, combined with the dictionary of natural products database and literature data. Chemometrics was used to analyze the differences in chemical compositions among different Polygalae Radix resources. RESULTS The UHPLC-TOF-MS fingerprint of Polygalae Radix was established, and 145 chemical components were identified. The fingerprint similarity among Polygalae Radix from different origins was high. The peak areas of 43 saponin components showed relatively small variations and good consistency, while the peak areas of 54 glycosyl ester components exhibited significant differences in a few individual samples. Additionally, the peak areas of 48 xanthones components demonstrated abundant characteristic variations. Wild and cultivated Polygalae Radix also showed high fingerprint similarity but exhibited distinct differences in the contents of four xanthones components. Significant differences were observed in the chemical component contents between the core and the bark of Polygalae Radix, with the contents in the core mostly much lower than those in the bark. CONCLUSION This study identifies the chemical components in Polygalae Radix and evaluates the quality of Polygalae Radix resources from different sources, providing a scientific basis for elucidating its material basis and quality control.

OBJECTIVE To explore the correlation between the appearance traits and inner compositions content of Scutellaria barbata, and provide a theoretical basis for the “quality evaluating through morphological identification”. METHODS Colorimeter, electronic tongue, ultra-performance liquid chromatography (UPLC), and UV spectrophotometry were used to measure the color, taste, and the contents of scutellarin, scutellarein, luteolin, apigenin, and total flavonoids in Scutellaria barbata. Correlation analysis and regression analysis were conducted on the trait indicators and the content of chemical compounds. RESULTS The quantified color and bitterness values of Scutellaria barbata showed a certain correlation with intrinsic components, but no significant regression relationship. The contents of scutellarin, scutellarein, luteolin, apigenin, and total flavonoids were negatively correlated with b*(P＜0.05, P＜0.01), and positively correlated with bitter taste and tibber aftertaste(P＜0.05,P＜0.01). Under certain conditions, greener coloration and stronger bitterness corresponded to higher contents of scutellarin, scutellarein, apigenin, and total flavonoids. CONCLUSION The study initially revealed that the morphological indicators of Scutellaria barbata could serve as the basis for evaluating its quality, and preliminarily expounds the scientific connotation of the theory of distinguishing the quality by morphological identification, which holds that Scutellaria barbata with green color and bitter taste is of better quality. The research results provide a reference for establishing objective and scientific quality evaluation methods.

OBJECTIVE To study the effects of traditional Chinese medicine compound Sanhuang powder on renal changes and its potential molecular mechanism in cisplatin (CDDP)-induced acute kidney injury (AKI) mice. METHODS The eight-week-old male C57BL/6J mice were randomly divided into control group, model group and Sanhuang group, with 6 mice in each group. The mice in model group and Sanhuang group were injected with CDDP (20 mg·kg^-1) intraperitoneally as an AKI mouse model, and the treated mice were given Sanhuang (6.5 g·kg^-1) for six consecutive days prior to CDDP injection. Blood and kidney tissues from all mice were collected 72 hours after CDDP administration for biochemical testing, histopathological evaluation, Western blot analysis, immunohistochemical staining, and quantitative real-time polymerase chain reaction (qRT-PCR) detection. RESULTS The results revealed that compared with control group, Scr and BUN in model group were significantly increased (P<0.001). Periodic acid-Schiff (PAS) staining revealed extensive damage to the renal tubule structure in acute kidney injury (AKI) mice, accompanied by an elevated renal tubule injury score. Western blot analysis demonstrated a significant upregulation of KIM-1 (P<0.01), while the expression levels of catalase(CAT), SOD2, GPX1 and GPX4 were significantly reduced (P<0.05). Furthermore, the expression levels of SIRT2, SIRT3, SIRT5, and SIRT6 were also significantly decreased in AKI mice (P<0.05). Compared with the model group, the Sanhuang group exhibited a significant downregulation in the levels of Scr and BUN (P<0.01) with the mitigated renal pathological damage; the Sanhuang group also exhibited a significant upregulation in the expression levels of CAT, GPX1, and GPX4 (P<0.05). Additionally, the protein expression levels of SIRT2, SIRT3, and SIRT5 were notably elevated (P<0.01). The expressions of SOD2 and SIRT6 showed an increasing trend (P>0.05). The findings from immunohistochemical staining corroborated those obtained from Western blot analysis. Furthermore, the results of qRT-PCR confirmed a significant increase in the mRNA expression levels of CAT, GPX1, SIRT2, SIRT3, and SIRT5 in AKI mice after Sanhuang powder treatment (P<0.05). CONCLUSION Sanhuang powder has a protective effect on CDDP-induced mice with AKI, and its mechanism is related to inhibiting oxidative stress and promoting Sirtuins expression in the kidney of AKI mice.

OBJECTIVE To establish a laser diffraction method for determination of the particle size distribution of haloperidol. METHODS The Mastersizer 2000 laser size analyzer was used to determine the particle size distribution of haloperidol by the wet measurement. The sample was dispersed using 0.5% Triton X-100 aqueous solution, the sample refractive index was 1.52, the sample absorption rate was 0.1, and the shading rate was 10%-30%. The samples were determined after sonicating for 30 s at the pump speed of 2 000 r·min^-1. RESULTS A variety of haloperidol products could be analyzed by laser diffraction method. The D[4,3] could show the size difference between different products. The RSD of d(0.5) was less than 4%, and the RSDs of d(0.1)and d(0.9)were both less than 6%. CONCLUSION The method is simple, accurate, and reproducible, which is suitable for the particle size control of haloperidol.

OBJECTIVE To establish an optimized method for determination of encapsulation efficiency of amphotericin B liposomes, and study the key factors affecting the encapsulation efficiency. METHODS The commonly used methods for the separation of liposome free drugs were investigated, the separation conditions were optimized, the formula for calculating the encapsulation efficiency was optimized, and the specificity, linearity and range, precision, accuracy and encapsulation stability of the methods were investigated. The effects of pH and osmotic pressure on encapsulation efficiency were investigated. RESULTS The liposome solution samples were preferably loaded by solid phase extraction and alkaline dilution conditions, and the dilution factor was adjusted to 10. The chromatographic method had good specificity, good linearity of amphotericin B in the range of 0.5-15.0 μg·mL^-1 (r=0.999 9), good system precision (RSD=0.277%), high accuracy of encapsulation efficiency measurement method (RSD≤1.01%), strong operability, good reproducibility, small randomness, and little influence by operators. If the pH was too large or too small, it was easy to cause the encapsulation efficiency test to be too large, and the encapsulation efficiency was relatively stable at pH 5-8. At the same time, with the increase of osmotic pressure, the encapsulation rate decreased, and the encapsulation rate reached the maximum value when the salt concentration was 0%. CONCLUSION This article provides an efficient and reliable technical means for the quality control of liposomal encapsulation rate of amphotericin B liposome injection, and provides an important reference and practical guidance for the development and quality research of liposomal drug carriers.

OBJECTIVE To improve the precision of individualized levetiracetam (LEV) dosing by employing three regularized regression models to identify key influencing factors and constructing a dose-concentration prediction model. METHODS This study included steady-state LEV blood concentration monitoring data from 405 pediatric epilepsy patients. Lasso, Ridge, and Elastic Net regression models were employed to select and model covariates influencing LEV concentration and develop prediction models. A 10-fold cross-validation was used to optimize the regularization parameters of the models. Model performance was evaluated using mean squared error (MSE), root mean squared error (RMSE), and the coefficient of determination (R²). RESULTS The Lasso and Elastic Net models identified eight key variables affecting LEV concentration: daily dose, per kilogram body weight dose, age, gender, alanine aminotransferase, creatinine, blood urea nitrogen, and albumin. In contrast, the Ridge model retained all variables. The three models demonstrated similar predictive accuracy on the test set, with an R² of approximately 0.39 and an RMSE of around 3.5 mg·L^-1, The Lasso model yielded the same results as the Elastic Net model. Considering both accuracy and simplicity, the Lasso or Elastic Net model offered relatively high precision and interpretability for dose-concentration prediction. CONCLUSION Dosage and renal function were identified as key factors influencing steady-state LEV concentrations. Regularized regression models such as Lasso can support improving individualized LEV dosing strategies in pediatric epilepsy patients.

OBJECTIVE To construct a Markov model reflecting the course of systemic lupus erythematosus (SLE) according to the occurrence and development of the disease, thus to provide scientific reference for the health economic evaluation of the disease. METHODS The health economics evaluation literature of SLE in domestic and foreign databases was comprehensively searched, the evaluation models and methods reported in the literature were reviewed, and a complete Markov evaluation model of SLE was constructed. RESULTS In the existing literature, some studies used evaluation models highlighting certain organ damage caused by SLE, and some were micro-simulations based on individual data, lacking a clear and complete model framework. Based on the existing research experience and the commonly used SLE disease activity scale (SLEDAI-2K), this paper established a Markov model based on the mutual transformation of mild, moderate, and severe SLE disease activity and included related organ damage. CONCLUSION SLE has a long, complex, and highly heterogeneous course. A complete Markov model can be established based on the characteristics of the disease course to provide guidance for future health economics evaluation of SLE.

OBJECTIVE To clarify the current status and challenges regarding the accreditation of drug testing institutions in China, and to explore pathways for enhancing their quality management, testing capabilities, and regulatory effectiveness through these mechanisms. So as to provide a basis for promoting the internationalization of drug inspection and testing, supporting drug safety supervision, and helping China move from a pharmaceutical country to a pharmaceutical powerhouse. METHODS A systematic review was conducted on the historical development of accreditation of drug testing institutions in China under the and CNAS frameworks. Comparative analysis was performed on the regulatory frameworks, practices, and management models of drug testing laboratories in China, the United States, and Europe. Policy documents and practical research were incorporated to identify prevailing challenges. RESULTS China has established a multi-tiered drug testing system spanning national, provincial and municipal levels. While all provincial institutions have obtained CNAS accreditation, and municipal-level institutions are progressively achieving, however, there are problems such as unclear legal qualifications, insufficient resources for recognizing technological capabilities in emerging fields, and uneven regional capabilities. CONCLUSION China can comprehensively enhance its capabilities and provide technical support for drug safety and high-quality development of the pharmaceutical industry through strengthening the legal responsibilities of drug testing institutions, strict technical capability standards, relying on CNAS to promote international mutual recognition, and exploring joint audit mechanisms.

OBJECTIVE To explore the quality management model on human radiolabeled mass balance study (HRMBS), so as to promote the scientific application of HRMBS in the new drug development and approvals in China. METHODS Based on the specific risk of radioactive isotope labeling in HRMBS, and compared with common phase Ⅰ clinical trials, the quality management model for HRMBS is developed by comparative and benchmarking analyses according to the quality requirements in the regulation of Good Clinical Practice of Drug in China. RESULTS A new risk-based quality management system (RB-QMS) has been developed based on the concept of radioactive protection, in aspects of “man, machine, materials, methods, and environment”. This approach, which is proved effective in clinical practice, explored on the risk-based quality assurance and quality control tips regarding personnel, equipment, drugs and samples, in-site regulations and procedures, and environment in hospital. CONCLUSION Our RB-QMS is helpful for implementation of HRMBS. Good quality management is the assurance for the authenticity and reliability of clinical trial data,and our study benefits China′s innovative drug development and improves the clinical research ability of hospitals.