To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines； further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly； replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.

Objective To explore the influencing factors of rational perioperative drug use,and to establish a rationality prediction model based on machine learning to assist pharmacists in prescription review.Methods A retrospective analysis was conducted on the perioperative prescription data of neurosurgery patients from a tertiary hospital and a central hospital in Shanxi Province between March 2021 and March 2023.Univariate analysis and multivariate Logistic regression were initially used to identify factors influencing rational drug use,followed by Lasso regression and multicollinearity analysis to select important variables.The data was split into a training set and test set at a ratio of 7∶3,and decision tree(DT),multi-layer perceptron(MLP),extreme gradient boosting(XGBoost),support vector machine(SVM),and random forest(RF)learning models were constructed.Results A total of 1 500 prescriptions were included,of which 668 were classified as rational and 832 as irrational.In both the training and test sets,the AUC values of the DT,XGBoost,and RF models exceeded 0.9.The DT model showed the highest sensitivity(0.81),while the RF model demonstrated the highest specificity(0.90).In the RF model,the number of comorbidities,preoperative waiting time,total hospitalization cost,prescribing physician's title,and adverse reaction occurrence negatively impacted prescription rationality,whereas the number of drugs,age,and administration route positively influenced rationality.Conclusion The machine learning-based rational drug use prediction model demonstrates strong predictive performance,effectively assisting pharmacists in prescription review and helping to reduce the incidence of irrational drug use.

Aim To study the effects of different peri-ods of hypoxia on gastrointestinal stress in mice by sim-ulating hypoxia environment at high altitude in a low-pressure oxygen chamber.Methods The normal con-trol group and the model group for 1,3 and 5 days were set up according to different periods of hypobaric hypoxia.The intestinal propulsion rate,visceral sensi-tivity and pathological damage of gastrointestinal tract were detected after hypobaric hypoxia treatment.The contents of IL-1 β,IL-6 and TNF-α in gastrointestinal tract and the contents of gastrointestinal hormone,di-amine oxidase and D-lactic acid were detected by en-zyme-linked immunosorbent assay(ELISA).The ex-pressions of tight-junction protein and tight junction in-jury pathway protein in intestinal tissues were detected by Western blot.Results Compared with the control group,the intestinal propulsion rate of the model group was accelerated,and the intestinal sensitivity in-creased.The expression of intestinal mucosal injury markers increased.Gastrointestinal motility inhibiting hormone decreased and gastrointestinal motility promo-ting hormone increased.The expression of tight junc-tion proteins ZO-1,claudin-1,occludin and VASP of tight junction injury-related pathway decreased,while the expression of NF-κB,HIF-1α and VEGF in tight junction injury-related pathway increased.The expres-sions of IL-1 β,IL-6 and TNF-α in gastrointestinal tis-sue increased.The content of pepsin in gastric tissue increased.The injury of gastrointestinal tissue was less in the 1-day group,and more serious in the 3-day and 5-day groups.Conclusions Stress injury occurs in the gastrointestinal tract of mice at different time points in hypoxia and hypoxia environment,and the gastroin-testinal function injury is more serious after three days of exposure,which may be related to the activation of NF-κB/HIF-1α/VEGF/VASP pathway.

Oromucosal drug delivery preparations offer advantages such as convenient administration,suitability for patients with dysphagia,rapid onset of action,and avoidance of first-pass metabolism in the liver.The 2020 edition of the Chinese Pharmacopoeia,EP11.0,BP2022,USP44-NF39,and JP18 all include relevant standards for the quality control of different oromucosal drug delivery systems.This article compares the differences in general re-quirements for oromucosal formulations among different countries and provides an overview of inspection items for marketed oral mucosal formulations and those documented in pharmacopoeias both domestically and internationally.Foreign pharmacopoeias include a wide range of oromucosal drug delivery formulations,with more refined quality control measures for systemic action.These findings can serve as a reference for the improvement and enhancement of standards for oromucosal drug delivery systems in China.

Objective:To explore the risk factors affecting the survival and efficacy of patients with acute myeloid leukemia with myelodysplasia-related changes(AML-MRC)transformed from myelodysplastic syndrome(MDS).Methods:The clinical data of 60 patients with AML-MRC transformed from MDS who hospitalized in The Third Affiliated Hospital of Soochow University from January 2010 to December 2021 were retrospectively analyzed.The demographic data and laboratory parameters,cytogenetic karyotypes,target genes of AML detected by next generation sequence,risk stratification,treatment regimen,therapeutic efficacy and survival outcome were documented.Rank sum test and Chi-square test or Fisher exact test were used to compare the survival and efficacy.The effects of clinical parameters,risk stratification and treatment regimens on the survival and efficacy of the AML-MRC patients were analyzed by univariate and multivariate analysis.Results:The median overall survival(OS)of the AML-MRC patients was 4.5 months,the 1-year OS rate was 28.3％,and the complete remission(CR)rate after treatment was 33.3％.The univariate analysis showed that age≥60 years,leukocytosis,severe thrombocytopenia,poor-risk group and only accepted hypomethylating agents(HMAs)or supportive therapy were the risk factors affecting OS.COX multivariate analysis showed that thrombocytopenia(HR=4.46),HMAs therapy(compared to transplantation,HR=10.47),supportive therapy(compared to transplantation,HR=25.80)and poor-risk group(compared to medium-risk group,HR=13.86)were independent hazard factors for median OS of patients with AML-MRC.The univariate analysis showed that the risk factors affecting 1-year OS in patients with AML-MRC were age ≥ 60 years,thrombocytopenia,time of transformation from MDS to AML(TTA)≥3 months,fibrinogen-albumin ratio index(FARI)≥ 0.07,CONUT score≥5,poor-risk group and supportive therapy.Binary logistic regression analysis showed that the independent risk factors for 1-year OS in AML-MRC patients were age ≥ 60 years(HR=11.23),thrombocytopenia(HR=8.71),FARI ≥ 0.07(HR=5.19)and poor-risk group(HR=14.00).The risk factors affecting CR of AML-MRC patients in univariate analysis were age ≥ 60 years,thrombocytopenia,FARI ≥ 0.1,CONUT score ≥ 5,poor-risk group and supportive therapy,while binary logistic regression analysis showed that age ≥ 60 years(HR=7.35),CONUT score ≥ 5(HR=9.60),thrombocytopenia(HR=12.05)and poor-risk group(HR=32.5)were independent risk factors affecting CR of the patients.Conclusion:The OS of AML-MRC patients is poor,old age(≥ 60 years old),supportive therapy,HMA therapy,poor-risk,thrombocytopenia,FARI ≥ 0.07 and CONUT score ≥ 5 may be associated with poor prognosis.

Objective:To investigate which indicator is more advantageous when using arterial oxygen saturation(SaO2)and fingertip pulse oxygen saturation(SpO2)for blood oxygen detection in patients with hyperleukocytic acute leukemia(HAL).Methods:In this prospective research,the difference between SaO2 and SpO2 of 18 HAL patients(observation group)and 14 patients(control group),as well as the relationship between the difference and white blood cell(WBC)counts were analyzed.Results:SaO2 was lower than SpO2 in the observation group(P＜0.05),and SpO2-SaO2 difference was positively correlated with WBC counts(r=0.47).However,there was no statistical difference between SaO2 and SpO2 in the control group.SaO2 and PO2 showed a downward trend with the prolongation of detection time after arterial blood was collected in the observation group,but there was no statistical difference.There was no downward trend of SaO2 and PO2 in the control group.Conclusion:HAL patients have a phenomenon where SaO2 is lower than SpO2,that is pseudohypoxemia,and this phenomenon may be caused by excessive consumption of oxygen by the leukemia cells in vitro.SpO2 can be monitored bedside in real time and is non-invasive,it is a better way to detect the blood oxygen status of HAL patients.

Curettage is the main treatment method for oral maxillofacial cystic lesions,but simple curettage may easily damage surrounding structures such as adjacent teeth and nerves,leading to incomplete removal of the cyst and large jaw defects.The curettage assisted by endoscopy can provide a good surgical field for the surgeons,can clearly identify the important anatomical structure during the operation and can remove the cyst wall tissue as much as possible,thereby reducing the damage and reducing the recurrence rate of the lesion.This article combines the characteristics of maxillofacial surgery with clinical treatment experience,summarizes relevant literature from both domestic and international sources,and engages in discussions with experts in order to provide reference for the clinical treatment of jaw cystic lesions with endo-scope assisted curettage.

Neck dissection(ND)is one of the main treatment methods for oral and maxillofacial malignancies.Although ND type is in con-stant improvement,but intraoperative peal-pull-push injury of the accessory nerve,muscle,muscle membrane,fascia and ligament induced shoulder syndrome(SS)is still a common postoperative complication,combined with the influence of radiochemotherapy,not only can cause pain,stiffness,numbness,limited dysfunction of shoulder neck and arm,but also may have serious impact on patient's life quality and phys-ical and mental health.At present,there is still a lack of a systematic evaluation and rehabilitation management program for postoperative SS of oral and maxillofacial malignant tumors.Based on the previous clinical practice and the current available evidence,refer to the relevant lit-erature at home and abroad,the experts in the field of maxillofacial tumor surgery and rehabilitation were invited to discuss,modify and reach a consenusus on the etiology,assessment diagnosis,differential diagnosis,rehabilitation strategy and prevention of SS,in order to provide clinical reference.

Objective:To investigate the effects of tetrabromobisphenol A (TBBPA) on ionizing radiation (IR)-induced liver toxicity based on a zebrafish model and provide a scientific basis for assessing microplastic-radiation exposure hazards to the survival and health of aquatic organisms and humans.Methods:Healthy adult zebrafish aged 4-6 months were grouped (20 fish each group, sex in half) by random number table method in three different ways. The TBBPA exposure concentration screening experiment was divided into 4 groups: control group and TBBPA (3, 30 and 300 μg/L) treatment groups. The experiment of effects of double exposure on liver function was divided into 5 groups: control group, IR (10, 20 or 30 Gy) groups and IR+ TBBPA (60, 300 and 1 500 μg/L) treatment groups. The experiment of effects of TBBPA on hepatic radiation toxicity was divided into 3 groups: control group, IR (20 Gy) group, and IR+ TBBPA (300 μg/L) group. The changes in liver function indexes, oxidative stress markers, pro-inflammatory cytokines, and liver cell apoptosis were monitored, differential metabolic pathways and metabolites were identified upon untargeted metabolomics assays, and inter-group data were compared by One-way ANOVA test.Results:The activities of ALT and AST in zebrafish liver increased in a dose-dependent manner after exposure to TBBPA, and the differences between 300 μg/L TBBPA group and control group were statistically significant ( t=-2.22, -3.20, P<0.05). IR at a dose of 20 Gy or above induced a significant decline of liver function, and at this radiation dose, combined exposure to 300 μg/L or above TBBPA intensified the liver toxicity (compared with the control group, t=-8.18 to -4.63, P<0.05, compared with IR group, t=-5.22 to -0.30, P < 0.05). Compared with the control group, the activities of ALT and AST, levels of ROS, MDA and SOD, mRNA and protein expression levels of TNF-α, IL-1β, Cox-2, Caspase-8 and Caspase-9, and cell apoptosis in zebrafish livers of IR and IR+ TBBPA groups increased gradually (compared with the control group, t=-12.29 to -2.88, P<0.05, compared with IR group, t=-4.40 to -2.31, P<0.05). The differences in the content of D-gluconic acid, p-cresol and other metabolites in liver tissues were more and more significant among the three groups, involving multiple KEGG pathways such as biosynthesis, degradation and metabolism. Conclusions:Exposure to 300 μg/L TBBPA can aggravate IR-induced liver toxicity of zebrafish, which involves the mechanism that further elevates the levels of oxidative stress, inflammation, and apoptosis, as well as radiation-induced liver metabolic disorders.

Microwave technology has been widely applied in various fields such as military affairs, communication, transportation, medical treatment, and industrial and agricultural production. Nevertheless, such technology poses potential threats to human health while bringing convenience to production and life. Previous studies have shown that the reproductive system is one of the most sensitive targets to microwave radiation, and its microwave damage effect and treatment have garnered wide concern. This paper reviews the recent domestic and foreign studies on the impacts of microwave radiation on reproductive health and its treatment, especially the damage effects, mechanisms, and treatment method, from the aspects of epidemiological investigations and animal experiments. The purpose is to provide suggestions and references for future research on the effects of microwave radiation on reproductive damage and its treatment.