As people’s attention to health continues to increase, the market demand for traditional Chinese medicine (TCM) is growing steadily. The quality and safety of Chinese medicinal materials have attracted unprecedented social attention. In particular, the issue of exogenous harmful residue pollution in TCM has become a hot topic of concern for both regulatory authorities and society. The Chinese Pharmacopoeia 2025 Edition further refines the detection methods and limit standards for exogenous harmful residues in TCM. This not only reflects China’s high-level emphasis on the quality and safety of TCM but also demonstrates the continuous progress made by China in the field of TCM safety supervision. Basis on this study, by systematically reviewing the development history of the detection standards for exogenous harmful residues in TCM and analyzing the revisions and updates of these detection standards in the Chinese Pharmacopoeia 2025 Edition, deeply explores the key points of the changes in the monitoring standards for exogenous harmful residues in TCM in the Chinese Pharmacopoeia 2025 Edition. Moreover, it interprets the future development directions of the detection of exogenous residues in TCM, aiming to provide a reference for the formulation of TCM safety supervision policies.

ObjectiveTo observe the effect of Shenshu Fujian decoction on platelet-derived growth factor （PDGF）/naked cuticle homolog 2 （NKD2） /Wnt signaling pathway in rats with chronic renal failure （CRF）. MethodsSixty male SD rats were randomly divided into normal group， model group， Niaoduqing group （5 g·kg^-1）， low-dose Shenshu Fujian decoction group （5.5 g·kg^-1）， medium-dose Shenshu Fujian decoction group （11 g·kg^-1）， and high-dose Shenshu Fujian decoction group （22 g·kg^-1）， with 10 rats in each group. A CRF rat model was established by feeding a 0.5% adenine diet for 21 days. After successful modeling， intragastric administration was given once daily for 28 consecutive days. After treatment， the renal morphology of rats was observed. Serum creatinine （SCr） and blood urea nitrogen （BUN） levels were detected. Hematoxylin-eosin （HE） staining and Masson staining were used to detect renal histopathological changes， and collagen volume fraction （CVF） was calculated. Serum levels of inflammatory markers interleukin （IL）-1β and IL-6 were measured using enzyme-linked immunosorbent assay （ELISA）. The expressions of fibronectin 1 （FN1）， type Ⅰ collagen （ColⅠ）， α-smooth muscle actin （α-SMA）， platelet-derived growth factor receptor-β （PDGFR-β）， NKD2， dishevelled protein 2 （DVL2） and β-catenin in renal tissue were detected by immunohistochemistry and Western blot. ResultsCompared with the normal group， the model group showed significant renal pathological changes， a markedly increased kidney weight/body weight ratio （P<0.01）， significantly elevated CVF （P<0.01）， and notably increased serum levels of SCr， BUN， IL-1β， and IL-6 （P<0.01）. Expression levels of FN1， ColⅠ， α-SMA， PDGFR-β， NKD2， DVL2， and β-catenin in renal tissue were also significantly increased （P<0.01）. Compared with the model group， all treatment groups showed significantly decreased kidney weight/body weight ratios and CVF （P<0.01）， as well as markedly decreased serum SCr， BUN， IL-1β， and IL-6 levels. Protein expression levels of FN1， ColⅠ， α-SMA， PDGFR-β， NKD2， DVL2， and β-catenin in renal tissue were decreased， with more pronounced effects observed in the Niaoduqing， medium-dose， and high-dose Shenshu Fujian decoction groups （P<0.05， P<0.01）. ConclusionShenshu Fujian decoction improves renal function， reduces inflammation， and reverses renal fibrosis in CRF rats， possibly by downregulating the expression of PDGF/NKD2/Wnt signaling pathway-related proteins.

Objective: To analyze the nucleic acid load of human parvovirus B19 in major commercially available blood products in China, including human albumin, human intravenous immunoglobulin, human rabies immunoglobulin and various coagulation factor products, aiming to provide evidence for improving blood product manufacturing processes and quality control of source plasma. Methods: A total of 98 batches of coagulation factor products were tested for human parvovirus B19 nucleic acid using real-time fluorescent quantitative PCR, including 42 batches of human prothrombin complex, 35 batches of human coagulation factor Ⅷ, and 21 batches of human fibrinogen. Additionally, 6 batches of human albumin, 6 batches of human intravenous immunoglobulin, and 38 batches of human rabies immunoglobulin were tested for human parvovirus B19 nucleic acid. Results: Human parvovirus B19 nucleic acid were undetectable in human albumin, human intravenous immunoglobulin and human rabies immunoglobulin. Among the 98 batches of coagulation factor products tested for human parvovirus B19 nucleic acid, B19 nucleic acid reactivity rate was 69.0% (29/42) for human prothrombin complex batches, but nucleic acid concentration were all significantly lower than 10 IU/mL. The reactivity rate of B19 nucleic acid in 35 batches of human coagulation factor Ⅷ was 48.6% (17/35), with nucleic acid concentration all below 10 IU/mL. The reactivity rate of B19 nucleic acid in 21 batches of human fibrinogen was 61.9% (13/21), with nucleic acid concentration all below 10 IU/mL. Conclusion: No human parvovirus B19 has been detected in human albumin, human intravenous immunoglobulin, or human rabies immunoglobulin. Human parvovirus B19 nucleic acid may exist in commercially available coagulation factor products, highlighting the need for enhanced screening of human parvovirus B19 nucleic acid in these products. It is also recommended that B19 viral nucleic acid testing be conducted on source plasma, particularly for coagulation factor products.

Objective: To analyze the nucleic acid load of human parvovirus B19 in major commercially available blood products in China, including human albumin, human intravenous immunoglobulin, human rabies immunoglobulin and various coagulation factor products, aiming to provide evidence for improving blood product manufacturing processes and quality control of source plasma. Methods: A total of 98 batches of coagulation factor products were tested for human parvovirus B19 nucleic acid using real-time fluorescent quantitative PCR, including 42 batches of human prothrombin complex, 35 batches of human coagulation factor Ⅷ, and 21 batches of human fibrinogen. Additionally, 6 batches of human albumin, 6 batches of human intravenous immunoglobulin, and 38 batches of human rabies immunoglobulin were tested for human parvovirus B19 nucleic acid. Results: Human parvovirus B19 nucleic acid were undetectable in human albumin, human intravenous immunoglobulin and human rabies immunoglobulin. Among the 98 batches of coagulation factor products tested for human parvovirus B19 nucleic acid, B19 nucleic acid reactivity rate was 69.0% (29/42) for human prothrombin complex batches, but nucleic acid concentration were all significantly lower than 10 IU/mL. The reactivity rate of B19 nucleic acid in 35 batches of human coagulation factor Ⅷ was 48.6% (17/35), with nucleic acid concentration all below 10 IU/mL. The reactivity rate of B19 nucleic acid in 21 batches of human fibrinogen was 61.9% (13/21), with nucleic acid concentration all below 10 IU/mL. Conclusion: No human parvovirus B19 has been detected in human albumin, human intravenous immunoglobulin, or human rabies immunoglobulin. Human parvovirus B19 nucleic acid may exist in commercially available coagulation factor products, highlighting the need for enhanced screening of human parvovirus B19 nucleic acid in these products. It is also recommended that B19 viral nucleic acid testing be conducted on source plasma, particularly for coagulation factor products.

Chemotherapy is one of the major approaches for the treatment of metastatic lung cancer, although it is limited by the low tumor delivery efficacy of anticancer drugs. Bacterial therapy is emerging for cancer treatment due to its high immune stimulation effect; however, excessively generated immunogenicity will cause serious inflammatory response syndrome. Here, we prepared cancer cell membrane-coated liposomal paclitaxel-loaded bacterial ghosts (LP@BG@CCM) by layer-by-layer encapsulation for the treatment of metastatic lung cancer. The preparation processes were simple, only involving film formation, electroporation, and pore extrusion. LP@BG@CCM owned much higher 4T1 cancer cell toxicity than LP@BG due to its faster fusion with cancer cells. In the 4T1 breast cancer metastatic lung cancer mouse models, the remarkably higher lung targeting of intravenously injected LP@BG@CCM was observed with the almost normalized lung appearance, the reduced lung weight, the clear lung tissue structure, and the enhanced cancer cell apoptosis compared to its precursors. Moreover, several major immune factors were improved after administration of LP@BG@CCM, including the CD4⁺/CD8a⁺ T cells in the spleen and the TNF-α, IFN-γ, and IL-4 in the lung. LP@BG@CCM exhibits the optimal synergistic chemo-immunotherapy, which is a promising medication for the treatment of metastatic lung cancer.

Objective To understand the molecular epidemiological characteristics of Norovirus outbreaks and the genome evolution of Norovirus epidemic strains in Hainan Province from 2020 to 2022.Methods The information and samples have been collected from the norovirus outbreaks from 2020 to 2022.Norovirus was detected by using the real-time PCR in these samples,then the detected sequences were amplified the analyzed.The Norovirus se-quences of 8 strains had been amplified and analyzed.Results From 2020 to 2022,39 gastroenteritis outbreaks were reported,and 25 outbreaks caused by Norovirus which mainly occurred in childcare institutions and schools(20/25,80％).The Norovirus outbreaks were mainly concentrated in counties around Haikou(northeast),which including Ding'an(5 cases),Wenchang(4 cases),Chengmai(4 cases),and Lingao(3 cases);following by western regions which included Baisha(2 cases),Ledong(2 cases),and Dongfang(3 cases).1 case was in Wanning in the southeast.Among individuals aged 2-17,the positive proportion of Norovirus in males was higher than that in females.Among individuals aged over 55,the proportion of Norovirus positive in females was higher than that in males.The gender of positive samples among individuals aged 18-40 was related to their profession.According to RT-PCR typing and sequencing,GⅡ group Norovirus were classified in13 outbreaks.There were 4 genotypes detected.GⅡ.2[P1 6]was the main epidemic strain with 60％(9/13),and the other three genotypes were GⅡ.4 Sydney[P31](15.4％,2/13)GⅡ.4 Sydney[P16](7.7％,1/13)and GⅡ.3[P12](7.7％,1/13).Further genic analysis of 8 Norovirus strains showed that all of them were still in the same branch as the previ-ous strain,and all exhibited a certain amount of amino acid variation.Conclusion Norovirus is the main pathogen of gastroenteritis outbreaks in Hainan province,and the main epidemic strain is GⅡ.2[P16].It is necessary to continue to strengthen the monitoring that provides scientific evidence for the prevention and control of norovirus out-breaks in Hainan region.

Objective: human cysteine protease inhibitor S; helicobacter pylori antibody typing; human epidermal growth factor receptor 2 ; gastric cancer; pathological stage; gastric cancer lymph node metastasis Methods: A total of 150 gastric cancer patients admitted to Chaohu Hospital Affiliated to Anhui Medical University for surgery from December 2021 to December 2023 were selected as the study objects. Serum CST4 and HP antibody typing were performed before surgery, and HER2 expression levels in gastric cancer tissues were detected by immunohistochemistry after surgery. The clinicopathological data of gastric cancer patients with different serum CST4, HP antibody types and HER2 expression were compared and the correlation was analyzed. ROC curve was used to compare the predictive value of single and combined detection of serum CST4, HP antibody typing and HER2 expression in lymph node metastasis and TNM staging of gastric cancer. Results: Patients with CST4, HPI and HER2-positive expression had deeper tumor invasion and were more likely to develop distant lymph node metastasis, and TNM stages were more likely to occur in Ⅲ and Ⅳ stages(P<0.05). Meanwhile, patients with CST4 positive expression were more likely to have vascular and nerve invasion(P<0.05). In patients with HPI positive expression, tumors were more likely to occur in the cardia and the bottom of the stomach, and the tumor diameter was larger and vascular invasion was more likely(P<0.05), while HER2 was negatively correlated with the degree of tumor differentiation, and the tumors were more likely to occur in high and secondary differentiation(P<0.05). ROC curve analysis showed that the AUC of single and combined detection of serum CST4, HPI and HER2 expression to predict lymph node metastasis of gastric cancer were 0.780, 0.676, 0.611 and 0.872, respectively(P<0.05). The AUC for TNM stage diagnosis of gastric cancer were 0.762, 0.635, 0.613 and 0.801(P<0.05), respectively. The diagnostic efficiency of combined detection was higher than that of single detection. Conclusion The expression of CST4, HPI and HER2 in serum is closely related to the depth of tumor invasion, lymph node metastasis and TNM stage. The expression of CST4, HPI and HER2 in serum can be used as an important predictor of lymph node metastasis and TNM stage in gastric cancer patients, providing a new idea for clinical diagnosis.

Objective:To investigate the relationship between serum osteopontin (OPN), bone morphogenetic protein 2 (BMP2), retinol binding protein 4 (RBP4) and renal function and bone mineral density in patients with diabetes nephropathy (DN).Methods:A total of 120 patients with DN diagnosed in the Affiliated Hospital of Jining Medical University from January 2020 to December 2021 were selected as the DN group, 60 patients with simple diabetes as the type 2 diabetes mellitus (T2DM) group, and 60 subjects with normal glucose tolerance test as the control group. The serum OPN, BMP2, RBP4, low bone mineral density (LBMD), femoral neck bone density (FNBMD) and renal function indicators of the three groups were compared. According to the urinary albumin excretion rate (UAER) of DN patients, the patients were divided into microalbuminuria DN group (71 cases) and massive albuminuria DN group (49 cases), and stratified comparison was made. The simple linear correlation analysis was used to analyze the OPN of DN patients. BMP2, RBP4, renal function and bone mineral density.Results:The fasting blood glucose (FPG), glycated hemoglobin (HbA 1c), serum creatinine (Scr), UAER, and cystatin (CysC) levels of DN group patients were significantly higher than those of T2DM group and control group, and the differences were statistically significant (all P<0.05); The FPG and HbA 1c in the T2DM group were higher than those in the control group, and the differences were statistically significant (all P<0.05); The OPN and BMP2 of DN group patients were higher than those of T2DM group and control group, while the RBP4, LBMD, FNBMD of DN group were lower than those of T2DM group and control group, and the differences were statistically significant (all P<0.05); The OPN and BMP2 of the T2DM group were higher than those of the control group, while RBP4 was lower than that of the control group, and the differences were statistically significant (all P<0.05); The levels of FPG, HbA 1c, Scr, UAER, and CysC in patients with macroalbuminuria DN were significantly higher than those in patients with microalbuminuria DN, and the differences were statistically significant (all P<0.05); The OPN and BMP2 of patients in the large albuminuria DN group were higher than those in the microalbuminuria DN group, while the RBP4, LBMD, and FNBMD of patients in the large albuminuria DN group were lower than those in the microalbuminuria DN group, and the differences were statistically significant (all P<0.05). The OPN of DN group patients was positively correlated with Scr, UAER, and CysC (all P<0.05), while BMP2 was positively correlated with UAER and CysC (all P<0.05); The OPN and BMP2 of DN group patients were negatively correlated with LBMD and FNBMD (all P<0.05), while RBP4 was positively correlated with LBMD and FNBMD (all P<0.05). Conclusions:OPN, BMP2, RBP4 are closely related to the degree of renal function impairment and bone loss in DN patients, and can to some extent reflect the degree of bone metabolism and osteoporosis in T2DM patients.

Objective: To understand the awareness and service utilization of HIV preexposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) among the young students aged 15-24 in Hefei, so as to provide reference for the prevention and treatment of AIDS among young students in the future. Methods: From May to June 2022, a stratified random cluster sampling method was used to select two different types of universities(undergraduate and vocational colleges) in Hefei, and a crosssectional survey was conducted among the 916 young students at the selected schools. The Chisquare test was used for statistical analysis. Results: Among the surveyed young students, 88.4% had heterosexual orientation, and 12.4% had sexual behavior including 8.8% of homosexual sexual behavior and 91.2% of heterosexual sexual behavior. The rate of condom use was 70.0% in the last homosexual intercourse, and the rate of condom use was 83.7% in the last heterosexual intercourse. About 41.9% of young students heard of PrEP, and the proportions of young students who knew about PrEP, consulted PrEP and used PrEP were 43.0%, 15.9% and 9.4% respectively. About 38.3% of young students had heard of PEP, and the proportions of young students who knew about PEP, consulted PEP and used PEP were 18.2%, 15.4% and 6.0%. Conclusions The awareness rate and utilization rate of PrEP and PEP among young students in Hefei are relatively low. PrEP and PEP publicity should be combined with education of HIV knowledge, and enhance the awareness rate of the young students, in order to reduce the risk of AIDS infection among young students with highrisk behaviors.

[Objective] To establish a real-time fluorescence quantitative PCR nucleic acid detection method of human parvovirus B19 and validate the method systematically. [Methods] Specific primers and probes for the highly conserved regions of the three genotypes of B19 virus were designed, and B19 quantitative amplification standard curves were established. The accuracy, precision (repeatability and intermediate precision), linear range, quantification limit, detection limit, specificity, anti cross contamination, genotyping and anti-interference ability of this method were verified. [Results] When the quantitative reference range for B19 virus was 2.0×10¹ to 1.0×10⁸ IU/mL, a double logarithmic regression analysis was performed between the measured values and the theoretical values, and the regression equation R²≥0.98 showed good linear correlation. The quantification limit was 20 IU/mL, with a detection rate of 100%. The detection limit was 10 IU/mL, and the detection rate is 95.23%. Three genotypes of B19 virus samples can be effectively detected. The plasma of seven non B19 pathogens, including hepatitis A virus, hepatitis B virus, hepatitis C virus, human immuno-deficiency virus, human cytomegalovirus, hepatitis E virus and Treponema pallidum, was non reactive and has good species specificity. Simultaneously, in the presence of seven other concurrent pathogens, positive samples with a weak positive concentration of E3 IU/mL could be stably detected, and the B19 nucleic acid testing method was not interfered with. When the hemoglobin concentration was 431 mg/dL, triglycerides (1 269 turbidity) and unconjugated bilirubin concentration was 20 mg/dL, this method was non reactive for all three common plasma interfering substances. In the presence of three common plasma interfering substances, positive samples with a weak positive concentration of E3 IU/mL could be stably detected, and the B19 nucleic acid testing method was not interfered with. The deviation between the detection values of standard substances at two concentration levels of S1 (E5 IU/mL) and S2 (E4 IU/mL) and the target values were≤±0.5 log value. The CV values of positive sample 1 (concentration level E5 IU/mL) and positive sample 2 (concentration level E4 IU/mL) for daily precision confirmation and continuous 5-day intra-day precision confirmation were both≤5%. [Conclusion] This method has strong specificity, high sensitivity, wide linear range, stability, reliability and high accuracy, and can be used for the detection of human parvovirus B19 nucleic acid in plasma.