According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the Chinese Pharmacopoeia 2025 Edition has been completed. Among them, 52 new pharmaceutical excipients monographs have been added, an increase of 15.5% compared with the 2020 Edition, and the total number has reached 387. This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.

Objective:To construct analytical dimensions for policy texts related to the pilot work of Health Impact Assessment (HIA) system in Zhejiang Province and conduct quantitative analysis, thereby providing references for improving the pilot work.Methods:Policy texts issued by Zhejiang Province between February 11, 2018, and February 29, 2024, which involved HIA content, were selected. The policy instruments theory was employed to construct an analytical framework around the dimensions of policy instruments, policy objectives, policy actors, and the interactions between policy instruments and policy objectives, and between policy instruments and policy actors. Based on this framework, a combination of literature analysis and content analysis was used to conduct a multi-dimensional quantitative analysis of the policy texts related to the pilot work of HIA system in Zhejiang Province.Results:Fifty core policy texts were included and 1 588 codes were obtained. In terms of policy instruments, environmental-type instruments were the most widely used (852 items), with internal responsibilities and methodological measures being the most frequently used; supply-type instruments were the second most used (459 items), with mechanism improvement being the most frequently used; demand-type instruments were the least used (277 items), with multi-stakeholder participation being the most frequently used. In terms of policy objectives, the objective of system construction dominated (701 articles, accounting for 56.45%), while the proportion of policy coverage, evaluation technology, and effectiveness evaluation was relatively low. In terms of policy subjects, the Party committee and government were the main policy subjects (434 articles, accounting for 39.20%), followed by health departments and public policy-making departments, while the proportion of public health institutions and social forces was extremely low. In the interaction between policy instruments and policy objectives, policy coverage, system construction, and effectiveness evaluation objectives all responded most frequently to environmental-type instruments, while the evaluation technology objectives responded more frequently to supply-type instruments. In the interaction between policy instruments and policy subjects, the Party committee and government played a dominant role in the use of policy instruments, with the health department and public policy-making department in the middle.Conclusions:The pilot work of the HIA system in Zhejiang Province presented a " environment-driven, system-construction-priority, Party-committee-and-government-led" policy characteristic. The main challenges were the imbalanced structure of policy instruments, insufficient synergy among policy objectives, and the need for greater participation of multiple stakeholders.

Objective:To establish a method for determining the sialylation levels of N-glycan profiles based on ion-exchange chromatography in glycoprotein drugs.Methods:The separation was performed in a column picking with anion-exchange resin(4.6 mm × 250 mm,5 μm,or equivalent).Mobile phase A was 20％ acetonitrile solution,while mobile phase B was a 20％acetonitrile solution containing 0.1 mol·L-1 ammonium formate(pH 4.5).The flow rate was 0.60 mL·min-1.Detection was performed using a fluorescence detector with excita-tion and emission wavelengths of 330 and 420 nm,respectively.The injection volume was 5 μL.Results:Within the target loading sample range of 40％ to 160％,the peak area showed a good linear relationship with protein concentration(r＞0.99).The average recovery rates at three concentration levels were 106.25％,100.00％,and 106.67％,respectively.The limit of quantification was 0.03％.Conclusion:This method is suitable for detecting the sialylation levels of N-glycan profiles in various glycoprotein drugs.

According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition,the Chinese Pharmacopoeia 2025 Edition has been completed.Among them,52 new pharmaceutical excip-ients monographs have been added,an increase of 15.5%compared with the 2020 Edition,and the total number has reached 387.This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition,which can contribute to accurately under-stand and utilize the standards in Chinese Pharmacopoeia.

Objective:To analyze the relationship between 24-hour urinary calcium (24 h UCa) level and the risk of end-stage kidney disease (ESKD), cardiovascular disease (CVD), and all-cause mortality.Methods:In the Chinese Cohort Study of Chronic Kidney Disease, we examined 3 375 patients aged 18-74 years with CKD stages 1-4. Kaplan-Meier survival and Cox proportional hazard regression models were used to test a time-to-event association between levels of 24 h UCa and incidence of ESKD, CVD, and all-cause mortality.Results:During a follow-up of 4.17 (3.37, 5.20) years, 179, 145, 104 and 38 ESKD events occurred in <0.60, 0.60-, 1.20-, ≥2.32 mmol 24 h UCa groups. Higher levels of 24 h UCa (1.20-,≥2.32 mmol) were independently associated with a lower incidence of ESKD events in patients with CKD, with HR (95% CI) of 0.71 (0.54-0.93) and 0.43 (0.29-0.64), respectively. No significant associations with CVD and all-cause mortality endpoints were detected. Conclusion:Among patients with CKD, levels of 24 h UCa displayed an association with the risk of ESKD among patients with CKD stages 1-4.

Objective:To analyze the relationship between 24-hour urinary calcium (24 h UCa) level and the risk of end-stage kidney disease (ESKD), cardiovascular disease (CVD), and all-cause mortality.Methods:In the Chinese Cohort Study of Chronic Kidney Disease, we examined 3 375 patients aged 18-74 years with CKD stages 1-4. Kaplan-Meier survival and Cox proportional hazard regression models were used to test a time-to-event association between levels of 24 h UCa and incidence of ESKD, CVD, and all-cause mortality.Results:During a follow-up of 4.17 (3.37, 5.20) years, 179, 145, 104 and 38 ESKD events occurred in <0.60, 0.60-, 1.20-, ≥2.32 mmol 24 h UCa groups. Higher levels of 24 h UCa (1.20-,≥2.32 mmol) were independently associated with a lower incidence of ESKD events in patients with CKD, with HR (95% CI) of 0.71 (0.54-0.93) and 0.43 (0.29-0.64), respectively. No significant associations with CVD and all-cause mortality endpoints were detected. Conclusion:Among patients with CKD, levels of 24 h UCa displayed an association with the risk of ESKD among patients with CKD stages 1-4.

Objective:To establish a method for determining the sialylation levels of N-glycan profiles based on ion-exchange chromatography in glycoprotein drugs.Methods:The separation was performed in a column picking with anion-exchange resin(4.6 mm × 250 mm,5 μm,or equivalent).Mobile phase A was 20％ acetonitrile solution,while mobile phase B was a 20％acetonitrile solution containing 0.1 mol·L-1 ammonium formate(pH 4.5).The flow rate was 0.60 mL·min-1.Detection was performed using a fluorescence detector with excita-tion and emission wavelengths of 330 and 420 nm,respectively.The injection volume was 5 μL.Results:Within the target loading sample range of 40％ to 160％,the peak area showed a good linear relationship with protein concentration(r＞0.99).The average recovery rates at three concentration levels were 106.25％,100.00％,and 106.67％,respectively.The limit of quantification was 0.03％.Conclusion:This method is suitable for detecting the sialylation levels of N-glycan profiles in various glycoprotein drugs.

Objective:To construct analytical dimensions for policy texts related to the pilot work of Health Impact Assessment (HIA) system in Zhejiang Province and conduct quantitative analysis, thereby providing references for improving the pilot work.Methods:Policy texts issued by Zhejiang Province between February 11, 2018, and February 29, 2024, which involved HIA content, were selected. The policy instruments theory was employed to construct an analytical framework around the dimensions of policy instruments, policy objectives, policy actors, and the interactions between policy instruments and policy objectives, and between policy instruments and policy actors. Based on this framework, a combination of literature analysis and content analysis was used to conduct a multi-dimensional quantitative analysis of the policy texts related to the pilot work of HIA system in Zhejiang Province.Results:Fifty core policy texts were included and 1 588 codes were obtained. In terms of policy instruments, environmental-type instruments were the most widely used (852 items), with internal responsibilities and methodological measures being the most frequently used; supply-type instruments were the second most used (459 items), with mechanism improvement being the most frequently used; demand-type instruments were the least used (277 items), with multi-stakeholder participation being the most frequently used. In terms of policy objectives, the objective of system construction dominated (701 articles, accounting for 56.45%), while the proportion of policy coverage, evaluation technology, and effectiveness evaluation was relatively low. In terms of policy subjects, the Party committee and government were the main policy subjects (434 articles, accounting for 39.20%), followed by health departments and public policy-making departments, while the proportion of public health institutions and social forces was extremely low. In the interaction between policy instruments and policy objectives, policy coverage, system construction, and effectiveness evaluation objectives all responded most frequently to environmental-type instruments, while the evaluation technology objectives responded more frequently to supply-type instruments. In the interaction between policy instruments and policy subjects, the Party committee and government played a dominant role in the use of policy instruments, with the health department and public policy-making department in the middle.Conclusions:The pilot work of the HIA system in Zhejiang Province presented a " environment-driven, system-construction-priority, Party-committee-and-government-led" policy characteristic. The main challenges were the imbalanced structure of policy instruments, insufficient synergy among policy objectives, and the need for greater participation of multiple stakeholders.

By applying "homeostasis" to the study of the meridian and collateral system， the concept of meridian and collateral homeostasis has been proposed which refers to a balanced and stable state of meridian and collateral system， and plays an important role in maintaining body health and can provide a reference for the diagnosis and treatment of diseases. Phenomics realizes the cross-scale correlation from micro-phenotypic data， such as genome， proteome， and metabolome， to macro-phenotypic data， such as physiological state， behavioral activities， and external manifestations. From the perspective of phenomics， this paper proposes a meridian and collateral homeostasis dynamic mapping model of "macroscopic signs and microscopic expression". This model combines macro signs such as the four examinations of traditional Chinese medicine （TCM）， biophysical indicators of acupoints， and micro expression information such as genes， proteins， and metabolism， and systematically investigates the relationship between meridian and collateral homeostasis and health and disease， thereby providing ideas and references for the identification of pre-disease states as well as precise diagnosis and treatment in TCM.

Objective:To examine the associations of BMI and waist circumference (WC) with the risk of chronic kidney disease (CKD) and its subtypes in adults in China.Methods:The data from the China Kadoorie Biobank were used. After excluding those with cancer, coronary heart disease, stroke, or CKD at baseline survey, 480 430 participants were included in this study. Their body height and weight, and WC were measured at baseline survey. Total CKD was defined as diabetic kidney disease (DKD), hypertensive nephropathy (HTN), glomerulonephritis (GN), chronic tubulointerstitial nephritis (CTIN), obstructive nephropathy (ON), CKD due to other causes, and chronic kidney failure. Cox proportional hazards regression model was used to estimate the associations between exposure factors and risks of outcomes.Results:During a follow-up period of (11.8±2.2) years, 5 486 cases of total CKD were identified, including 1 147 cases of DKD, 340 cases of HTN, 1 458 cases of GN, 460 cases of CTIN, 598 cases of ON, 418 cases of CKD due to other causes, and 1 065 cases of chronic kidney failure. After adjusting for socio-demographic factors, lifestyle factors, baseline prevalence of hypertension and diabetes, and WC and compared to participants with normal BMI (18.5-23.9 kg/m 2), the hazard ratios ( HRs) of total CKD for underweight (<18.5 kg/m 2), overweight (24.0-27.9 kg/m 2), and obese (≥28.0 kg/m 2) were 1.42 (95% CI: 1.23-1.63), 1.00 (95% CI: 0.93-1.08) and 0.98 (95% CI: 0.87-1.10), respectively. Stratification analysis by WC showed that BMI was negatively associated with risk for total CKD in non-central obese participants (WC: <85.0 cm in men and <80.0 cm in women) ( HR=0.97, 95% CI: 0.96-0.99), while the association was positive in central obese participants (≥90.0 cm in men and ≥85.0 cm in women) ( HR=1.03, 95% CI: 1.01-1.05). The association between BMI and GN was similar to that of total CKD. BMI was associated with an increased risk for HTN, with a HR of 1.12 (95% CI: 1.06-1.18) per 1.0 kg/m 2 higher BMI. After adjusting for potential confounders and BMI, compared to participants with non-central obesity, the HRs for pre-central obesity (WC: 85.0-89.9 cm in men and 80.0-84.9 in women) and central obesity were 1.26 (95% CI: 1.16-1.36) and 1.32 (95% CI: 1.20-1.45), respectively. With the exception of HTN and CTIN, WC was positively associated with risks for all CKD subtypes. Conclusions:BMI-defined underweight and central obesity were independent risk factors for total CKD, and BMI and WC had different associations with risks for disease subtypes.