1.The level of HBV cccDNA in liver tissue and its clinical significance in patients in the convalescence stage of hepatitis B virus-related acute-on-chronic liver failure
Zhekai CAI ; Long XU ; Wenli LIU ; Yingqun XIAO ; Qingmei ZHONG ; Wei ZHANG ; Min WU
Journal of Clinical Hepatology 2025;41(1):57-62
ObjectiveTo investigate the expression level of HBV cccDNA in patients in the convalescence stage of hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF) and its correlation with HBV markers and liver histopathological changes. MethodsA total of 30 patients in the convalescence stage of HBV-ACL who were hospitalized in The Ninth Hospital of Nanchang from January 2015 to October 2023 were enrolled as liver failure group, and 9 patients with chronic hepatitis B (CHB), matched for sex and age, were enrolled as control group. The content of HBV cccDNA in liver tissue was measured, and its correlation with clinical data and laboratory markers was analyzed. The independent-samples t test or the Mann-Whitney U test was used for comparison of continuous data between two groups, and a one-way analysis of variance or the Kruskal-Wallis H test was used for comparison between multiple groups; the Fisher’s exact test was used for comparison of categorical data between groups. A Spearman correlation analysis was performed. ResultsThe liver failure group had a significantly lower content of HBV cccDNA in liver tissue than the control group (-0.92±0.70 log10 copies/cell vs -0.13±0.91 log10 copies/cell, t=2.761, P=0.009). In the liver failure group, there was no significant difference in the content of HBV cccDNA in liver tissue between the HBeAg-positive patients and the HBeAg-negative patients (P>0.05); there was no significant difference in the content of HBV cccDNA in liver tissue between the patients with different grades (G0-G2, G3, and G4) of liver inflammatory activity (P>0.05); there was no significant difference in the content of HBV cccDNA in liver tissue between the patients with different stages (S0-S2, S3, and S4) of liver fibrosis (P>0.05); there was no significant difference in the content of HBV cccDNA in liver tissue between the patients with negative HBV DNA and those with positive HBV DNA (P>0.05). For the liver failure group, the content of HBV cccDNA in liver tissue was positively correlated with the content of HBV DNA in liver tissue (r=0.426, P=0.043) and was not significantly correlated with the content of HBV DNA in serum (P>0.05). ConclusionThere is a significant reduction in the content of HBV cccDNA in liver tissue in the convalescence stage of HBV-ACLF. HBV cccDNA exists continuously and stably in liver tissue and can better reflect the persistent infection and replication of HBV than HBV DNA in serum and liver tissue.
2.Textual Research and Analysis of Historic Origin and Ancient and Modern Application of Classic Formula Shengjiangsan
Lyuyuan LIANG ; Jialei CAO ; Xinghang LYU ; Weixiao LI ; Wenxi WEI ; Bingqi WEI ; Zhe WANG ; Yiping WANG ; Bingxiang MA ; Wenli SHI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):219-227
Shengjiangsan is a classic formula for treating warm diseases with wide clinical application and accurate efficacy. There are different opinions on the origin of this formula and lacks key information research on this formula. Therefore, in this study, we conducted systematic research into the historic origin, composition, and other key information of this Shengjiangsan. Results showed that Shengjiangsan has different versions, with "Neixian Fufang", "Jiawei Jianghuangwan", "Peizhensan", and "Taijiwan" being the same formula with different names. Shengjiangsan was first recorded as "Neixian Fufang" in Wanbing Huichun written by GONG Tingxian from the Ming dynasty, inherited and developed by YANG Lishan from Qing dynasty, and has been passed down to modern times. Pills and powder are two main forms of Shengjiangsan, and powder has become more popular nowadays. According to the measurement system of Ming and Qing dynasties, the recommended dosage and usage of Shengjiangsan are as follows. For the pill version of Shengjiangsan, Bombyx Batryticatus of 74.6 g, Curcumae Longae Rhizoma of 9.325 g, Cicadae Periostracum of 9.325 g, and Rhei Radix et Rhizoma of 149.2 g were processed into pills for preparation. Single dosage is Bombyx Batryticatus of 1.15 g, Curcumae Longae Rhizoma of 0.14 g, Cicadae Periostracum of 0.14 g, and Rhei Radix et Rhizoma of 2.3 g, with halved dosage applied for children. For the powder version of Shengjiangsan, the dosage varied in accordance with the severity of the disease. Bombyx Batryticatus of 1.84 g, Curcumae Longae Rhizoma of 0.28 g, Cicadae Periostracum of 0.92 g, and Rhei Radix et Rhizoma of 3.68 g were processed into powder for patients with mild symptoms. Bombyx Batryticatus of 2.48 g, Curcumae Longae Rhizoma of 0.37 g, Cicadae Periostracum of 1.23 g, and Rhei Radix et Rhizoma of 4.91 g were processed into powder for patients with severe symptoms. Bombyx Batryticatus of 3.68 g, Curcumae Longae Rhizoma of 1.84 g, Cicadae Periostracum of 0.55 g, and Rhei Radix et Rhizoma of 7.36 g were processed into powder for patients with critical conditions. In this formula, four herbs were ground to fine powder. For patients with mild symptoms, the whole formula was divided into four dosages, and each dosage weighed 6.71 g. The 200 mL yellow rice wine and 18.65 g honey were added, and the solution was stirred and taken cold till full recovery. For patients with severe symptoms, the whole formula was divided into three dosages, and each weighed 8.95 g. 300 mL yellow rice wine and 27.98 g honey were added, and the solution was stirred and taken cold. For patients with critical conditions, the whole formula was divided into two dosages, and each weighed 13.43 g. 400 mL yellow rice wine and 37.3 g honey were added, and the solution was stirred and taken cold. Shengjiangsan has the effect of ascending lucidity and descending turbidity, dissipating wind, and clearing heat. It is specialized in treating severe heat in exterior, interior, and triple energizers in warm diseases and has a wide modern clinical application. In this study, the historic evolution and key information of Shengjiangsan were reviewed and analyzed, and the key information table of Shengjiangsan was attached, serving as a reference for scholars' research and a theoretical basis for its market transformation.
3.Mechanism of Xiezhuo Jiedu Formula in Treating Ulcerative Colitis Through Pyroptosis Regulation Based on Bioinformatics and Animal Experiments
Qiang CHUAI ; Wenjing ZHAI ; Shijie REN ; Xiaomeng LANG ; Xin KANG ; Wenli WEI ; Jingyuan LIU ; Jianping LIU ; Jie REN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(16):105-113
ObjectiveThis study aims to explore the potential mechanism of the Xiezhuo Jiedu formula in regulating pyroptosis for the treatment of ulcerative colitis (UC) using bioinformatics and in vivo animal experiments. MethodsDifferentially expressed genes (DEGs) in colon tissues of UC patients were retrieved from the Gene Expression Omnibus (GEO) database. Pyroptosis-related genes were obtained from the GEO and GeneCards databases. The intersection of these datasets yielded pyroptosis-related DEGs (Pyro-DEGs). Pyro-DEGs were subjected to Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analysis using the Metascape database. A protein-protein interaction (PPI) network was constructed using the STRING database. Least absolute shrinkage and selection operator (LASSO) prediction model and receiver operating characteristic (ROC) analysis were conducted to identify core Pyro-DEGs with diagnostic and therapeutic potential. Immune infiltration analysis of the UC datasets was performed using the deconvolution method (CIBERSORT), along with correlation analysis with core Pyro-DEGs. Sixty male Sprague-Dawley (SD) rats were randomly divided into a control group, a model group, high-, medium-, and low-dose groups of Xiezhuo Jiedu formula (26.64, 13.32, 6.66 g·kg-1), and a mesalazine group (0.27 g·kg-1), with 10 rats in each group. UC was established by intrarectal administration of 3,5-trinitrobenzenesulfonic acid (TNBS) dissolved in ethanol. The control and model groups were given distilled water by gavage, while the treatment groups were administered the corresponding drugs for 7 consecutive days. Hematoxylin-eosin (HE) staining was used to observe the colon histopathology. Enzyme-linked immunosorbent assay (ELISA) was used to detect the levels of inflammatory factors such as interleukin-1β (IL-1β), IL-10, IL-18, and transforming growth factor-β (TGF-β). Immunohistochemistry (IHC) and Western blot were applied to detect the expression of Caspase-1, gap junction alpha-1 protein (GJA1), peroxisome proliferator-activated receptor gamma (PPARG), and S100 calcium-binding protein A8 (S100A8). Real-time quantitative polymerase chain reaction (Real-time PCR) was utilized to measure mRNA expression of Caspase-1, GJA1, PPARG, and S100A8. Western blot was performed to assess protein expression levels of Caspase-1, GJA1, PPARG, and S100A8. ResultsGEO datasets GSE87466 and GSE87473 yielded 64 Pyro-DEGs. KEGG analysis indicated that these genes were enriched in the NOD-like receptor signaling pathway, tumor necrosis factor (TNF) signaling pathway, and hypoxia-inducible factor 1 (HIF-1) signaling pathway. Four core Pyro-DEGs (Caspase-1, GJA1, PPARG, and S100A8) were identified. Immune infiltration analysis showed that expression of these genes was positively correlated with mast cells, neutrophils, M0 macrophages, M1 macrophages, and dendritic cells. Animal experimental results indicated that compared with the control group, the model group had significantly increased levels of IL-1β and IL-18, significantly decreased levels of IL-10 and TGF-β. The model group showed enhanced Caspase-1, GJA1, and S100A8 staining, and significantly increased mRNA and protein expression of Caspase-1, GJA1, and S100A8 (P<0.01). In contrast, the expression of PPARG was reduced in the model group (P<0.01). After treatment, all dosage groups showed varying degrees of improvement (P<0.05, P<0.01), with the high-dose group showing the most significant improvement (P<0.01). ConclusionCaspase-1, GJA1, PPARG, and S100A8 are core Pyro-DEGs closely associated with the pathogenesis of UC. These genes may collaborate with immune cells such as mast cells, neutrophils, and M0 macrophages to mediate disease development. The Xiezhuo Jiedu formula may regulate the expression of core Pyro-DEGs through the NOD-like receptor, TNF, and HIF-1 core signaling pathways, thereby modulating immune homeostasis in UC rats and effectively alleviating UC.
4.Textual Research and Ancient and Modern Application of Classical Prescription Sinisan
Lyuyuan LIANG ; Qing TANG ; Jialei CAO ; Wenxi WEI ; Yuxin ZHANG ; Jinyu CHEN ; Hejia WAN ; Chen CHEN ; Ruiting SU ; Bingqi WEI ; Shen'ao DING ; Bingxiang MA ; Wenli SHI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):182-193
Sinisan is a classical prescription developed and applied by ancient medical experts and it is first recorded in the Treatise on Cold Damage written by ZHANG Zhongjing in the Eastern Han Dynasty. Later physicians have modified this prescription based on this original one. The bibliometrics methods were used to analyze the key information and research trend of Sinisan. According to the inclusion and exclusion criteria, 69 pieces of effective data were extracted, involving 67 ancient traditional Chinese medicine (TCM) books. The results showed that the name, composition, and decocting methods of Sinisan in later generations were inherited from the original record in the Treatise on Cold Damage. The original plants of medicinal materials used in Sinisan are basically clear. We recommend Bupleuri Radix as the dried root of Bupleurem scorzonerifolium, Paeoniae Radix Alba as the dried root of Paeonia lactiflora, Aurantii Fructus as the dried fruit of Citrus aurantium, Glycyrrhizae Radix et Rhizoma as the dry root and rhizome of Glycyrrhiza uralensis. Raw materials of Bupleuri Radix and Paeoniae Radix Alba, Aurantii Fructus stir-fried with bran, and stir-fried Glycyrrhizae Radix et Rhizoma should be used for preparation of Sinisan. According to measurement system in the Han Dynasty, a bag of Sinisan is composed of 1.25 g Bupleuri Radix, 1.25 g Paeoniae Radix Alba, 1.25 g Aurantii Fructus, and 1.25 g Glycyrrhizae Radix et Rhizoma. The materials should be grounded into coarse powder and taken with a proper amount of rice soup, 3 times a day. Sinisan has the effects of regulating qi movement and harmonizing the liver and spleen. It can be used for treating reversal cold in limbs and cold damage. In modern clinical practice, Sinisan can be used to treat chronic gastritis, irritable bowel syndrome, and dyspepsia. The above research results provide scientific reference for the future research and development of Sinisan.
5.Relationship Between Gastroesophageal Reflux Disease-Related Symptoms and Clinicopathologic Characteristics and Long-Term Survival of Patients with Esophageal Adenocarcinoma in China
Kan ZHONG ; Xin SONG ; Ran WANG ; Mengxia WEI ; Xueke ZHAO ; Lei MA ; Quanxiao XU ; Jianwei KU ; Lingling LEI ; Wenli HAN ; Ruihua XU ; Jin HUANG ; Zongmin FAN ; Xuena HAN ; Wei GUO ; Xianzeng WANG ; Fuqiang QIN ; Aili LI ; Hong LUO ; Bei LI ; Lidong WANG
Cancer Research on Prevention and Treatment 2025;52(8):661-665
Objective To investigatethe relationship between gastroesophageal reflux disease (GERD) symptoms and clinicopathological characteristics, p53 expression, and survival of Chinese patients with esophageal adenocarcinoma. Methods A total of
6.Key Information Research and Ancient and Modern Application Analysis of Classic Prescription Houpo Sanwutang
Wenli SHI ; Qing TANG ; Huimin CHEN ; Jialei CAO ; Bingqi WEI ; Lan LIU ; Keke LIU ; Yun ZHANG ; Yujie CHANG ; Yihan LI ; Jingwen LI ; Bingxiang MA ; Lvyuan LIANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):214-221
Houpo Sanwutang, included in the Catalogue of Ancient Classical Prescriptions (Second Batch), was first recorded in the Synopsis of Golden Chamber written by ZHANG Zhongjing from the Eastern Han dynasty and was modified by successive generations of medical experts. A total of 37 pieces of effective data involving 37 ancient Chinese medical books were retrieved from different databases. Through literature mining, statistical analysis, and data processing, combined with modern articles, this study employed bibliometrics to investigate the historical origin, composition, decoction methods, clinical application, and other key information. The results showed that the medicinal origin of Houpo Sanwutang was clearly documented in classic books. Based on the conversion of the measurements from the Han Dynasty, it is recommended that 110.4 g Magnolia Officinalis Cortex, 55.2 g Rhei Radix et Rhizoma, and 72 g Aurantii Fructus Immaturus should be taken. Magnolia Officinalis Cortex and Aurantii Fructus Immaturus should be decocted with 2 400 mL water first, and 1 000 mL should be taken from the decocted liquid. Following this, Rhei Radix et Rhizoma should be added for further decoction, and then 600 mL should be taken from the decocted liquid. A single dose of administration is 200 mL, and the medication can be stopped when patients restore smooth bowel movement. Houpo Sanwutang has the effect of moving Qi, relieving stuffiness and fullness, removing food stagnation, and regulating bowels. It can be used in treating abdominal distending pain, guarding, constipation, and other diseases with the pathogenesis of stagnated heat and stagnated Qi in the stomach. The above results provide reference for the future development and research of Houpo Sanwutang.
7.Ancient and Modern Literature Analysis and Key Information Research of Classic Formula Qingfeitang
Lyuyuan LIANG ; Jinyan ZHANG ; Jialei CAO ; Jing TANG ; Mengmeng GENG ; Yiqing ZHAO ; Hejia WAN ; Yiping WANG ; Bingqi WEI ; Bingxiang MA ; Wenli SHI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(24):179-189
Qingfeitang, specialized in resolving phlegm to stop cough and producing fluid to moisten dryness, is a classic prescription inherited and developed by physicians of successive generations and has been included in the Catalogue of Ancient Classic Prescriptions (First Batch) published by the National Administration of Traditional Chinese Medicine (TCM) in 2018. Relevant ancient books data and modern literature were collected by bibliometrics to analyze the historic origin, formula composition, herb origin, preparation methods, processing methods, clinical effect, and indications of Qingfeitang. The key information of Qingfeitang was summarized to provide reference for the clinical application of the decoction. In this study, a total of 43 pieces of effective data on relevant ancient literature, including 35 ancient TCM books, were collected based on a systematic collation of relevant historic and modern literature. Results showed that "Qingfeitang" was originated from the "Renshen Qingfeitang" recorded in the Taiping Holy Prescriptions for Universal Relief from the Qing dynasty. The name of "Qinfeitang" was first recorded in the Yeshi Luyanfang written by YE Dalian in the Song dynasty. We suggested the modern dosage and usage of Qingfeitang as follows: "Scutellariae Radix of 5.60 g, Platycodon grandiflora, Poria, Tangerine, Fritillaria, and Cortex Mori of 3.73 g respectively, Angelicae Sinensis Radix, Asparagi Radix, Gardeniae Fructus, Armeniacae Semen Amarum, and Ophiopogonis Radix of 2.61 g respectively, Schisandra of 1 g, and Glycyrrhizae Radix et Rhizoma of 1.12 g, and they were taken 3 times daily. The above formula is recommended to be decocted with 400 mL of water, with 3.37 g ginger and 6 g jujubae fructus, to 320 mL, and taken after a meal, three times per day". Qingfeitang has the effect of resolving phlegm to stop cough and producing fluid to moisten dryness, specialized in treating cough, asthma, rash, and other symptoms in ancient times. Modern applications are mainly focused on the respiratory system, used for treating diseases such as bronchopneumonia and cough. The above research results provide a reference basis for the later development and research of Qingfeitang.
8.Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study.
Wenyan KANG ; Chao GAO ; Xiaoyan LI ; Xiaoxue WANG ; Huizhu ZHONG ; Qiao WEI ; Yonghua TANG ; Peijian HUANG ; Ruinan SHEN ; Lingyun CHEN ; Jing ZHANG ; Rong FANG ; Wei WEI ; Fengjuan ZHANG ; Gaiyan ZHOU ; Weihong YUAN ; Xi CHEN ; Zhao YANG ; Ying WU ; Wenli XU ; Shuo ZHU ; Liwen ZHANG ; Naying HE ; Weihuan FANG ; Miao ZHANG ; Yu ZHANG ; Huijun JU ; Yaya BAI ; Jun LIU
Chinese Medical Journal 2025;138(22):2907-2916
INTRODUCTION:
Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD.
METHODS:
In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging.
RESULTS:
A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline.
CONCLUSIONS:
Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies.
REGISTRATION
ClinicalTrials.gov , NCT07034222.
Humans
;
Alzheimer Disease/drug therapy*
;
Male
;
Female
;
Aged
;
Middle Aged
;
Cognitive Dysfunction/drug therapy*
;
Aged, 80 and over
;
Amyloid beta-Peptides/metabolism*
;
Biomarkers
;
East Asian People
9.Association of urinary cadmium levels with peripheral leukocyte classification counts among middle-aged and older adults aged 40-89 in selected areas of China
Yufei LUO ; Yuan WEI ; Xiaochen WANG ; Yi ZHANG ; Wenli ZHANG ; Bing WU ; Zhengxiong YANG ; Xiaojie DONG ; Ruiting HAO ; Yifu LU ; Xiaoshuang FU ; Ziyue ZHU ; Ying ZHU ; Yuebin LYU ; Dongqun XU ; Xiaoming SHI
Chinese Journal of Preventive Medicine 2024;58(6):839-846
Objective:To investigate the association of urinary cadmium levels with peripheral leukocyte classification counts among middle-aged and older adults aged 40 to 89 years in selected areas of China.Methods:The research was based on the survey of the impact of soil quality of agricultural land on human health in typical areas conducted in 2019-2020. A total of 5 600 middle-aged and older adults aged 40 to 89 years were included by using a multi-stage stratified random sampling method. Baseline characteristics of the subjects were collected and physical examinations were performed. Random midstream urine was collected to measure urinary cadmium and urinary creatinine and fasting venous blood was collected to measure the leukocyte count, neutrophil count, lymphocyte count, monocyte count and eosinophil count. The linear mixed effect model was used to analyse the association of urinary cadmium levels with leukocyte classification counts, and the dose-response relationship between them was analyzed by using the restricted cubic spline (RCS) function.Results:The age of the subjects was (63.17±12.02) years; 2 851 (50.91%) were males; and the M ( Q 1, Q 3) of urinary creatinine-corrected urinary cadmium levels was 2.69 (1.52, 4.69) μg/g·creatinine. After adjusting for confounding factors, the results of linear mixed effects model analysis showed that for each 1-unit increase in urinary creatinine-corrected urinary cadmium level, the percentage change [% (95% CI)] of leukocyte count and lymphocyte count was -1.70% (-2.61%, -0.79%) and -1.57% (-2.86%, -0.26%), respectively. RCS function showed a negative linear relationship between urinary creatinine-corrected urinary cadmium levels and leukocyte counts and lymphocyte counts, respectively (all Pnon-linear>0.05). Conclusion:Urinary cadmium levels are negatively associated with leukocyte count and lymphocyte count among middle-aged and older adults aged 40 to 89 years in selected areas of China.
10.Research on Determination Method of Particulate Matter in Drug Packaging Materials Based on the Pharmacopoeia of the People's Republic of China(2025 Edition)
Dongwei WANG ; Wenli LI ; Wei XIONG ; Jing ZHANG ; Lei CHEN ; Kai XU
Herald of Medicine 2024;43(11):1740-1744
Objective To establish and interpret of the Pharmacopoeia of the People's Republic of China(2025 Edition),to determine particulate matter in pharmaceutical packaging materials,and to provide further guidance and support for the later use of the standard.Methods By reviewing the existing problems in the use of Chinese pharmaceutical packaging materials standards(YBB standards)standards combined with the construction of new standard system for pharmaceutical packaging materials in the Pharmacopoeia of the People's Republic of China,also about the validation data of the pharmaceutical packaging materials,the scope、testing methods、requirements and the experimental parameters of the Pharmacopoeia of the People's Republic of China determination of particulate matter in pharmaceutical packaging materials are studied and interpreted in detail.Results Compared with the current YBB standard,the Pharmacopoeia of the People's Republic of China-determination of particulate matter in pharmaceutical packaging materials has solved the problems of incomplete application scope and unreasonable requirements and parameters in the YBB standard.Conclusion The content of the Pharmacopoeia of the People's Republic of China(2025 Edition)determination of the particulate matter in drug packaging materials method is more scientific、applicable and operable.This method can standardize the determination of a particulate matter in drug packaging materials and can also play a supporting role in the construction of the standard system to promote industrial development.

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