To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

ObjectiveTo investigate the effect of Qingrun prescription（QRP）-containing serum on improving insulin resistance in HepG2 cells and its potential mechanisms. MethodsAn insulin resistance model was established in HepG2 cells with 1×10^-6 mol·L^-1 insulin. Branched-chain α-keto acid dehydrogenase （BCKDH） gene silencing was achieved using siRNA， and the cells were divided into 8 groups： normal group， model group （1×10^-6 mol·L^-1 insulin）， metformin group （1 mmol·L^-1 metformin）， high-， medium-， and low-dose QRP groups （20%， 10%， and 5% QRP-containing serum， respectively）， QRP + siRNA-silenced BCKDH （si-BCKDH） group （10% QRP-containing serum + si-BCKDH）， and QRP + si-NC group （10% QRP-containing serum + si-NC）. Glucose levels in the supernatant were measured with a glucose assay kit， while glycogen content was assessed using a glycogen assay kit. Levels of branched-chain amino acids （BCAAs） and branched-chain keto acids （BCKAs） were determined using ultra-high performance liquid chromatography-tandem mass spectrometry （UHPLC-MS/MS）. mRNA transcription and protein expression levels of BCKDH， dishevelled， Egl-10， and pleckstrin （DEP） domain-containing mammalian target of rapamycin （mTOR）-interacting protein （DEPTOR）， mTOR， and ribosomal protein S6 kinase 1 （S6K1） were detected using real-time quantitative polymerase chain reaction （Real-time PCR） and Western blot. ResultsCompared to the normal group， the model group exhibited significantly decreased glucose consumption and glycogen content， increased levels of BCAAs and BCKAs， downregulated expression of BCKDH and DEPTOR， and upregulated mTOR and S6K1 expression （P<0.01）. In comparison to the model group， QRP treatment at all doses significantly enhanced glucose consumption and glycogen content while reducing BCAAs and BCKAs levels （P<0.01）. The high- and medium-dose QRP groups demonstrated significant upregulation of BCKDH mRNA transcription and protein expression， as well as DEPTOR mRNA transcription. Moreover， the DEPTOR protein expression level was significantly increased in high-， medium-， and low-dose QRP groups， while mTOR and S6K1 mRNA and protein expression levels were markedly downregulated （P<0.05， P<0.01）. Compared to the QRP + si-NC group， the QRP + si-BCKDH group exhibited increased BCAAs and BCKAs levels， significantly decreased BCKDH mRNA transcription and protein expression， downregulated DEPTOR mRNA and protein expression， and upregulated mTOR and S6K1 mRNA and protein expression （P<0.05， P<0.01）. ConclusionQRP may improve insulin resistance by reprogramming BCAAs metabolism. This effect involves upregulating BCKDH， reducing BCAAs and BCKAs levels， and suppressing the mTOR pathway activation.

Objective To compare TyG index between the patients with CHF and ADHF to eluci-date the metabolic difference between these two stages.Methods A total of 1156 HF patients ad-mitted in Taizhou People's Hospital between January 2020 and December 2022 were enrolled,and according to 2021 ESC Guidelines for Diagnosis and Treatment of Acute and Chronic Heart Fail-ure,they were divided into CHF group(365 cases)and ADHF group(791 cases).The clinical da-ta,results of laboratory tests,and cardiovascular history were collected,and TyG index was calcu-lated.All-cause death outcome was observed in ADHF patients during a follow-up of 1 year.Results The TyG index was significantly lower in the ADHF group than the CHF group[8.27(7.99,8.62)vs 8.35(8.04,8.75),P=0.001].In the ADHF group,the TyG index was positively correlated with SBP,DBP,TC,TG,LDL-C,FPG,HbA1c,BMI,and LVEF,and negatively with age(P＜0.01).In the CHF group,the index was positively correlated with DBP,TC,TG,LDL-C,FPG,BMI,and HbA1c,and negatively with age(P＜0.05,P＜0.01).Both univariate and multiva-riate logistic regression analyses indicated that the TyG index was a protective factor for ADHF(OR=0.647,95％CI:0.503～0.832,P=0.001;OR=0.694,95％CI:0.536～0.898,P=0.005).Multivariate logistic regression analysis showed that the index in ADHF patients was a protective factor for one-year all-cause mortality(OR=0.483,95％CI:0.254-0.916;P=0.026).Conclusion TyG index might be regarded as an important marker for assessing the metabolic status in HF patients and predicting the prognosis in ADHF patients.

Objective To evaluate the efficacy of immunotherapy combined with local treatment in elderly patients with advanced non-small cell lung cancer(NSCLC).Methods A total of 164 elderly patients with advanced NSCLC admitted in Chinese PLA General Hospital from January 2018 to October 2022 were selected as subjects.According to whether they have received immunotherapy combined with local treatment,they were divided into local treatment group(n=82)and non-local treatment group(n=82).The primary endpoint was overall survival(OS),while secondary endpoints included progression-free survival(PFS),objective response rate(ORR),and disease control rate(DCR).Cox proportional hazard models were applied to assess prognostic factors.Results The median OS in local treatment group was superior to non-local treatment group.Multivariate analysis confirmed that Eastern Cooperative Oncology Group performance status score ≥ 2 points,bone metastasis,and pleural effusion were independent poor prognostic factors.Conclusion The combination of immunotherapy and local treatment may provide OS of elderly patients with advanced NSCLC.

Objective:To compare the efficacy of gasless robotic surgery via transaxillary approach and combined axillary-retroauricular approach for unilateral N1b PTC, and to explore the safety and effectiveness of gasless robotic surgery via transaxillary approach for unilateral N1b PTC. Methods:Unilateral N1b PTC patients who underwent surgery in the Department of Otolaryngology, Sun Yat Sen Memorial Hospital, Sun Yat sen University between July 2016 and December 2024 were included and analyzed. According to the inclusion and exclusion criteria and the differences of surgical approaches, the patients were divided into the transaxillary approach（TA） group and the combined axillary-retroauricular approach（TARA） group. The demographic data, operation time, intraoperative blood loss, postoperative drainage volume, postoperative complications, shoulder function evaluation, postoperative visual analogue scale（VAS） of neck aesthetics and recurrence of the two groups were statistically analyzed. Results:A total of 88 patients undergoing gasless robotic surgery were included in this study, including 23 cases in the TA group and 65 cases in the TARA group. The proportion of males in the TA group was significantly higher than that in the TARA group（56.5% vs 21.5%, χ²=9.776, P=0.002）. The total operation time in the TA group was significantly lower than that in the TARA Group（180.00[155.00, 220.00]min vs 220.00[177.50, 272.50]min, z=-2.775, P=0.006）, and the postoperative blood loss in the TA group was significantly lower than that in the TARA Group（30.00[20.00, 50.00]ml vs 50.00[30.00, 60.00]ml, Z=-2.127, P=0.033）. The proportion of area Ⅱ-Ⅴ in the TA group and the TARA group was 87.0% and 70.8%, respectively, and there was no significant difference between the two groups（P>0.05）. There was no significant difference in lateral cervical lymph node dissection and central lymph node dissection between the two groups（P>0.05）. During the follow-up period, no recurrence was found in the two groups, and there was no significant difference in the incidence of complications between the two groups（P>0.05）. According to the stratification of dynamic recurrence risk assessment, it can be seen that the proportion of curative effect satisfaction in the TA group was as high as 95.7%, and that in the TARA group was as high as 81.5%, with no significant difference between the two groups. There was no significant difference in VAS score of neck, Constant Shoulder Score and NDⅡ scale between the two groups（P>0.05）. Conclusion:Gasless robotic surgery via transaxillary approach for unilateral N1b PTC is safe and feasible, and the amount postoperative lymph node acquisition is equivalent to that of combined axillary-retroauricular approach, which can provide a new choice for the treatment of unilateral N1b PTC patients.
Humans ; Robotic Surgical Procedures/methods* ; Axilla/surgery* ; Male ; Female ; Operative Time ; Middle Aged ; Adult ; Treatment Outcome ; Postoperative Complications

Objective To compare TyG index between the patients with CHF and ADHF to eluci-date the metabolic difference between these two stages.Methods A total of 1156 HF patients ad-mitted in Taizhou People's Hospital between January 2020 and December 2022 were enrolled,and according to 2021 ESC Guidelines for Diagnosis and Treatment of Acute and Chronic Heart Fail-ure,they were divided into CHF group(365 cases)and ADHF group(791 cases).The clinical da-ta,results of laboratory tests,and cardiovascular history were collected,and TyG index was calcu-lated.All-cause death outcome was observed in ADHF patients during a follow-up of 1 year.Results The TyG index was significantly lower in the ADHF group than the CHF group[8.27(7.99,8.62)vs 8.35(8.04,8.75),P=0.001].In the ADHF group,the TyG index was positively correlated with SBP,DBP,TC,TG,LDL-C,FPG,HbA1c,BMI,and LVEF,and negatively with age(P＜0.01).In the CHF group,the index was positively correlated with DBP,TC,TG,LDL-C,FPG,BMI,and HbA1c,and negatively with age(P＜0.05,P＜0.01).Both univariate and multiva-riate logistic regression analyses indicated that the TyG index was a protective factor for ADHF(OR=0.647,95％CI:0.503～0.832,P=0.001;OR=0.694,95％CI:0.536～0.898,P=0.005).Multivariate logistic regression analysis showed that the index in ADHF patients was a protective factor for one-year all-cause mortality(OR=0.483,95％CI:0.254-0.916;P=0.026).Conclusion TyG index might be regarded as an important marker for assessing the metabolic status in HF patients and predicting the prognosis in ADHF patients.

Objective To evaluate the efficacy of immunotherapy combined with local treatment in elderly patients with advanced non-small cell lung cancer(NSCLC).Methods A total of 164 elderly patients with advanced NSCLC admitted in Chinese PLA General Hospital from January 2018 to October 2022 were selected as subjects.According to whether they have received immunotherapy combined with local treatment,they were divided into local treatment group(n=82)and non-local treatment group(n=82).The primary endpoint was overall survival(OS),while secondary endpoints included progression-free survival(PFS),objective response rate(ORR),and disease control rate(DCR).Cox proportional hazard models were applied to assess prognostic factors.Results The median OS in local treatment group was superior to non-local treatment group.Multivariate analysis confirmed that Eastern Cooperative Oncology Group performance status score ≥ 2 points,bone metastasis,and pleural effusion were independent poor prognostic factors.Conclusion The combination of immunotherapy and local treatment may provide OS of elderly patients with advanced NSCLC.

Objective To observe the effect of non-invasive ventilator assisted vibration sputum evacuation on the level of cardiac function indicators in patients with acute heart failure in the intensive care unit(ICU).Methods A total of 120 patients with acute heart failure who received treatment in the ICU of Tongde Hospital of Zhejiang Province from September 2020 to March 2023 were selected as the study subjects.The patients were randomly divided into a control group and an experimental group using a random number table method,with 60 patients in each group.A total of 120 patients were treated with conventional symptom therapy and non-invasive ventilation.The control group received routine nursing intervention,while the experimental group received non-invasive ventilator assisted vibration sputum evacuation.Arterial partial pressure of oxygen(PaO2),arterial partial pressure of carbon dioxide(PaCO2),pulse oxygen saturation(SpO2),respiratory rate(RR),heart rate,blood pressure,central venous pressure,serum and ultrasound cardiac function indicators,and prognosis of two groups of patients were recorded after 2 weeks of intervention.Results After the intervention,PaO2,SpO2,and left ventricular ejection fraction(LVEF)were significantly increased in both groups,while PaCO2,RR,heart rate,blood pressure,central venous pressure,N-terminal pro-brain natriuretic peptide(NT-proBNP),cardiac troponin T(cTnT),left ventricular end-systolic diameter(LVESD),and left ventricular end-diastolic diameter(LVEDD)were significantly decreased compared to before the intervention(all P<0.05).Compared with the control group,the experimental group showed significant increases in PaO2,SpO2,blood pressure,central venous pressure,and LVEF after intervention[PaO2(mmHg,1 mmHg≈0.133 kPa):68.24±5.81 vs.59.63±6.86,SpO2:0.95±0.03 vs.0.87±0.04,systolic blood pressure(mmHg):116.05±4.11 vs.104.13±3.95,diastolic blood pressure(mmHg):68.19±4.13 vs.62.85±4.12,central venous pressure(mmHg):9.42±1.29 vs.8.12±4.12,LVEF:0.49±0.05 vs.0.43±0.04,all P<0.05],while PaCO2,RR,heart rate,NT-proBNP,cTnT,LVESD,and LVEDD were significantly reduced[PaCO2(mmHg):42.12±4.08 vs.52.13±4.61,RR(beats/min):18.85±1.75 vs.21.54±2.51,heart rate(bpm):89.53±8.14 vs.101.11±10.26,NT-proBNP(ng/L):1687.25±589.67 vs.2145.36±751.03,cTnT(ng/L):70.58±5.15 vs.81.45±6.89,LVESD(mm):34.51±3.11 vs.38.89±3.55,LVEDD(mm)46.11±3.22 vs.49.74±3.75,all P<0.05].The mechanical ventilation time,ICU hospitalization time,and pulmonary infection relief time of the experimental group were significantly shortened compared to the control group[mechanical ventilation time(hours):72.14±10.06 vs.78.96±12.97,ICU hospitalization time(days):10.74±2.15 vs.12.88±3.26,pulmonary infection relief time(days):3.58±0.79 vs.5.14±1.12,all P<0.05],and the incidence of pulmonary infection was significantly reduced[1.67%(1/60)vs.11.67%(7/60),P<0.05],However,there was no statistically significant difference in the mortality rate between the experimental group and the control group[10.00%(6/60)vs.21.67%(13/60),P>0.05].Conclusion The non-invasive ventilator assisted vibration sputum evacuation can improve symptoms of hypoxemia and cardiac function,stabilize hemodynamics,shorten the course of acute heart failure in ICU patients,and reduce the incidence of pulmonary infections.

Objective To explore the value of T2*mapping in quantitatively evaluate changes in knee joint cartilage and subchon-dral bone of new recruits before and after intensive training.Methods MRI scans of the right knee joint were performed three times on 20 new recruits:before intensive training,after one week of intensive training,and after one month of rest.The knee joint cartilage was divided into six regions:lateral femur(LF),medial femur(MF),lateral tibia(LT),medial tibia(MT),patella cartilage(PC),and trochlea cartilage(TC).Using the posterior angle of the meniscus as a boundary,LF and MF were divided into the cLF/cMF and pLF/pMF.Divid-ed into superficial zone(SZ)cartilage and deep zone(DZ)cartilage based on a thickness of 1/2 of the cartilage.The subchondral bone was divided into superficial bone(SB)within 5 mm of the joint cartilage,and deep bone(DB)within 6-10 mm of the joint cartilage.The T2*values of each region of cartilage and subchondral bone were evaluated through region of interest(ROI)analysis.Single fac-tor analysis of variance was used to compare the changes in T2*values.The LSD test method was used for inter-group comparison.Results After one week of intensive training,MT-SZ,cMF-SZ,PC-SZ,TC-SZ were significantly higher than before intensive training(P＜0.05).After one month of rest,there was no statistically significant difference in the T2*value of the cartilage area compared with before intensive training(P＞0.05).There was a trend of"rising first and then falling".There was no statistically signifi-cant difference in the T2*value of subchondral bone of the knee joint before intensive training and after one week of intensive training(P＞0.05).Compared with after one month of rest,except for cLF-DB,pLF-DB,trochlea cartilage-deep bone(TC-DB),the T2*value of the subchondral bone of the remaining knee joint increased before intensive training and after one week of intensive training,with sta-tistically significant differences(P＜0.05).Conclusion T2*mapping can display the changes in the ultrastructure and biochemical components of joint cartilage and subchondral bone after the new recruits intensive training,detect early injuries and conduct non-invasive quantitative evaluation.