This article discusses the revision background and core content of 9621 General Requirements for Phar-maceutical Packaging Materials and Containers in the Chinese Pharmacopoeia 2025 Edition.In combination with the requirements of bundling review of pharmaceutical packaging and drug products,as well as harmonization of inter-national standards,it analyzed the revision philosophy of the new guideline and the impact to industry.The new edition of the guideline 9621 introduces the concept of "pharmaceutical packaging system" for the first time,constructing four suitability evaluation dimensions covering protection,compatibility,safety,and functionality,it also introduces the requirements for the self-stability evaluation of plastic and rubber pharmaceutical packaging materials,and strengthening the concept of full lifecycle management and risk management.Through the"1+4+58" standard system,the basis for determining the key quality attributes of packaging materials for phar-maceutical use and the optimization path of dynamic inspection rules have been clarified.This revision has resolved the contradiction between the old version of standards and current regulatory requirements through a systematic upgrade,promoting the transformation of pharmaceutical packaging materials and containers quality control towards a scientific,international,and full lifecycle management model,proving technical supports in ensuring the safety,effectiveness of drug products from standard perspective,including advancing the industry high-quality development.

This article discusses the revision background and core content of 9621 General Requirements for Phar-maceutical Packaging Materials and Containers in the Chinese Pharmacopoeia 2025 Edition.In combination with the requirements of bundling review of pharmaceutical packaging and drug products,as well as harmonization of inter-national standards,it analyzed the revision philosophy of the new guideline and the impact to industry.The new edition of the guideline 9621 introduces the concept of "pharmaceutical packaging system" for the first time,constructing four suitability evaluation dimensions covering protection,compatibility,safety,and functionality,it also introduces the requirements for the self-stability evaluation of plastic and rubber pharmaceutical packaging materials,and strengthening the concept of full lifecycle management and risk management.Through the"1+4+58" standard system,the basis for determining the key quality attributes of packaging materials for phar-maceutical use and the optimization path of dynamic inspection rules have been clarified.This revision has resolved the contradiction between the old version of standards and current regulatory requirements through a systematic upgrade,promoting the transformation of pharmaceutical packaging materials and containers quality control towards a scientific,international,and full lifecycle management model,proving technical supports in ensuring the safety,effectiveness of drug products from standard perspective,including advancing the industry high-quality development.

Sympathetic cues via the adrenergic signaling critically regulate bone homeostasis and contribute to neurostress-induced bone loss, but the mechanisms and therapeutics remain incompletely elucidated. Here, we reveal an osteoclastogenesis-centered functionally important osteopenic pathogenesis under sympatho-adrenergic activation with characterized microRNA response and efficient therapeutics. We discovered that osteoclastic miR-21 was tightly regulated by sympatho-adrenergic cues downstream the β2-adrenergic receptor (β₂AR) signaling, critically modulated osteoclastogenesis in vivo by inhibiting programmed cell death 4 (Pdcd4), and mediated detrimental effects of both isoproterenol (ISO) and chronic variable stress (CVS) on bone. Intriguingly, without affecting osteoblastic bone formation, bone protection against ISO and CVS was sufficiently achieved by a (D-Asp₈)-lipid nanoparticle-mediated targeted inhibition of osteoclastic miR-21 or by clinically relevant drugs to suppress osteoclastogenesis. Collectively, these results unravel a previously underdetermined molecular and functional paradigm that osteoclastogenesis crucially contributes to sympatho-adrenergic regulation of bone and establish multiple targeted therapeutic strategies to counteract osteopenias under stresses.
Adrenergic Agents/pharmacology* ; Apoptosis Regulatory Proteins/pharmacology* ; Bone Diseases, Metabolic/metabolism* ; Humans ; Liposomes ; MicroRNAs/genetics* ; Nanoparticles ; Osteoclasts ; Osteogenesis/physiology* ; RNA-Binding Proteins/pharmacology*

Objective:To study the clinical characteristics of congenital tuberculosis (CTB).Methods:From June 2016 to February 2021, the clinical data of infants with CTB admitted to the neonatal department of our hospital were retrospectively analyzed, including their clinical characteristics, diagnosis, treatment and prognosis.Results:A total of 7 infants with CTB were enrolled into the study. 4 mothers had in vitro fertilization embryo transfer (IVF-ET) due to tubal obstruction and 2 mothers who were diagnosed of tubal tuberculosis. The 7 infants included 1 male and 6 female, 6 preterm and 1 full-term. The median age of onset was 18 d (7~30 d).All of the 7 infants had fever, 6 had shortness of breath and poor response, 5 had apnea, 3 were coughing, 1 showed pale skin colour, 1 had bilateral rales in the lung, 6 had hepatomegaly, 3 splenomegaly and 1 lymphadenopathy. Chest X-ray showed patchy exudation in 3 infants, miliary pattern of opacification in 2 infants, patchy opacification in 1 infant, bilateral increased lung markings in 1 infant. The positive rate of acid-fast bacilli (AFB) was 50% in all sputum samples. Specimens from glottic and subglottic area showed higher positive rate than oropharyngeal specimen. PCR MTB-DNA tests of sputum samples were positive in all 7 cases. 1 infant received invasive respiratory support for 1 d and died after discharge. 2 infants improved significantly after initial treatment, received 1~2 months of anti-TB therapy outside the hospital and died of severe respiratory failure. Of the 4 infants survived, 1 was cured and 3 significantly improved.Conclusions:Mothers with tubal tuberculosis receiving IVF-ET may cause high risk of CTB. Sputum AFB test and sputum PCR MTB-DNA test are preferred diagnostic tests. Genetic test of drug-resistant TB may guide clinical drug use. Glottic or deeper throat specimens can increase the positive rate.

Objective:To investigate the endoscopic characteristics in patients with active ulcerative colitis (UC) affect the endoscopic remission after treatment.Methods:A retrospective case-control study was conductd. The clinical and endoscopic data of 79 cases who underwent colonoscopy in Nanjing Drum Tower Hospital from January 2014 to September 2020 were collected. Mayo endoscopic score (MES) ≤1 was defined as endoscopic remission. Patients were divided into remission and non-remission groups based on the endoscopic remission after treatment achieved or not. Univariate and multivariate analyses were performed to screen the factors affecting endoscopic remission in UC patients by Cox regression.Results:Among the 79 UC patients, 33 were male and 46 were female, with a median age of 42.0 (27.0) years and a median disease course of 30.0 (63.0) months. There were 33 cases in remission group and 46 cases in non-remission group. The composition proportion of the two groups was significantly different in the choice of therapeutic drugs in the treatment of patients ( P<0.05), and there were no statistically significant differences in other clinical data (all P>0.05). Univariate analysis suggested that the complete disappearance of vascular texture (39.4% vs. 76.1%, HR=0.303, 95% CI: 0.146-0.626, P=0.001) and inflammatory hyperplastic polyps (27.3% vs. 67.4%, HR=0.264, 95% CI: 0.118-0.588, P=0.001) were less in the remission group than those in the non-remission group.Multivariate analysis after correction for confounding factors indicated that complete disappearance of vascular texture ( HR=0.455, 95% CI: 0.208- 0.995, P=0.048) and inflammatory hyperplastic polyps ( HR=0.364, 95% CI: 0.153-0.868, P=0.023) were still independent risk factors affecting endoscopic remission. Active UC patients with inflammatory polyps and complete disappearance of vascular texture are difficult to achieve endoscopic remission, with the risk increasing by 63.6% and 54.5% respectively. Conclusions:Inflammatory hyperplastic polyps and complete loss of vascular texture are independent risk factors for endoscopic remission in patients with active UC.

Objective:To investigate the endoscopic characteristics in patients with active ulcerative colitis (UC) affect the endoscopic remission after treatment.Methods:A retrospective case-control study was conductd. The clinical and endoscopic data of 79 cases who underwent colonoscopy in Nanjing Drum Tower Hospital from January 2014 to September 2020 were collected. Mayo endoscopic score (MES) ≤1 was defined as endoscopic remission. Patients were divided into remission and non-remission groups based on the endoscopic remission after treatment achieved or not. Univariate and multivariate analyses were performed to screen the factors affecting endoscopic remission in UC patients by Cox regression.Results:Among the 79 UC patients, 33 were male and 46 were female, with a median age of 42.0 (27.0) years and a median disease course of 30.0 (63.0) months. There were 33 cases in remission group and 46 cases in non-remission group. The composition proportion of the two groups was significantly different in the choice of therapeutic drugs in the treatment of patients ( P<0.05), and there were no statistically significant differences in other clinical data (all P>0.05). Univariate analysis suggested that the complete disappearance of vascular texture (39.4% vs. 76.1%, HR=0.303, 95% CI: 0.146-0.626, P=0.001) and inflammatory hyperplastic polyps (27.3% vs. 67.4%, HR=0.264, 95% CI: 0.118-0.588, P=0.001) were less in the remission group than those in the non-remission group.Multivariate analysis after correction for confounding factors indicated that complete disappearance of vascular texture ( HR=0.455, 95% CI: 0.208- 0.995, P=0.048) and inflammatory hyperplastic polyps ( HR=0.364, 95% CI: 0.153-0.868, P=0.023) were still independent risk factors affecting endoscopic remission. Active UC patients with inflammatory polyps and complete disappearance of vascular texture are difficult to achieve endoscopic remission, with the risk increasing by 63.6% and 54.5% respectively. Conclusions:Inflammatory hyperplastic polyps and complete loss of vascular texture are independent risk factors for endoscopic remission in patients with active UC.

Objective:To study the intestinal mucosal state of ulcerative colitis (UC) through UC endoscopic scores and to investigate the correlation between the endoscopic scores and clinical activity and histological scores.Methods:A retrospective analysis was performed on data of 152 patients who underwent colonoscopy or sigmoidoscopy in Nanjing Drum Tower Hospital from January 2014 to September 2019. The results were graded with 7 endoscopic scores, namely, Mayo endoscopic score(MES), modified Baron score(MBS), endoscopic activity index(EAI) , Sutherland index(DAI or UCDAI) , Rachmilewitz endoscopic index(REI), Lemann endoscopic index (LEI), and ulcerative colitis endoscopic index of severity(UCEIS). Spearman correlation coefficients between endoscopic score and partial Mayo scores, Truelove-Witts disease severity score and Nancy index (NI), Robarts index (RHI) and Geboes score (GS) were calculated respectively. Consistency of each endoscopic score among different observers was analyzed.Results:Except for the weak correlation between DAI and Truelove - Witts classification ( r= 0.469, P < 0.001), all other endoscopic scores were moderately positively correlated with clinical activity scores with significance( all P<0.001). However, the correlation between 7 endoscopic scores and histological scores was weak ( P<0.001). Except that the consistency of MBS among observers was medium, those of MES, DAI and LEI among observers were poor, and those of UCEIS, EAI and REI among observers were worse ( P<0.001). Conclusion:Endoscopic scores were moderately correlated with clinical activity indexes and weakly correlated with histological scores. However, patients with endoscopic remission may have histologic inflammatory activity, so attention should be paid to histological mucosal healing after endoscopic remission. The consistency of all 7 endoscopic scoring stystems among observers was low, and the repeatability was poor.

Objective To investigate the prevalence of nonalcoholic fatty liver disease and the risk factors in Jingyuan county of Ningxia Autonomous Region.Methods The population proportionate sampling method was applied to enroll a representative sample of 10 639 adults in Jingyuan county and the study was conducted using questionnaires and physical examinations.A total of 10 553 people were included in the analysis after excluding those with missing data.High-resolution ultrasound was used to examine the liver and fasting blood was collected in the morning for measurement of blood glucose,blood lipid,and uric acid.The participants were divided into two groups of those with and without nonalcoholic fatty liver disease;the difference in blood biochemical indexes between fatty liver and non-fatty liver groups was compared,and the logistic regression model was used to explore the risk factors affecting the prevalence of fatty liver.Results The prevalence of nonalcoholic fatty liver disease was 7.60％.The prevalence of thyroid nodules was higher in men than in women (8.60％ vs.6.82％,x2=1 1.772,P=0.001).The prevalence rate of fatty liver increased with age (x2=57.336,P＜0.001),the prevalence rates among ≥18 years-＜29 years,≥30 years-＜39 years,≥40years-＜49 years,≥50 years-＜59 years,≥60 years-＜69 years,and above 70 years were 2.92％,6.50％,8.81％,9.59％,8.08％,and 4.77％ respectively.The detection rate of overweight,obesity,abdominal obesity,impaired fasting glucose,impaired glucose tolerance,diabetes,hypertension,hyperuricemia,and dyslipidemia were higher in nonalcoholic fatty liver disease group than in the normal group (P＜0.05).Logistic regression analysis showed that nonalcoholic fatty liver disease group had a higher risk for overweight,obesity,abdominal obesity,impaired fasting glucose,impaired glucose tolerance,diabetes,hypertension,hyperurcemia,and dyslipidemia (OR=5.41,12.45,2.99,1.85,2.05,3.30,1.41,2.23,and 1.98).Conclusion The incidence of nonalcoholic fatty liver in Jingyuan county of Ningxia Autonomous Region was higher.The groups of overweight,obesity,abdominal obesity,impaired fasting glucose,impaired glucose tolerance,diabetes,hypertension,hyperuricemia,and dyslipidemia were high risk factors for nonalcoholic fatty liver disease.

Objective To investigate the prevalences of the obesity and hypertension in southern mountain regions of Ningxia. Methods A cross-sectional study was conducted among a representative sample of 10 639 adults using questionnaires, physical examinations, and blood pressure measurement in southern mountain areas with a population proportionate sampling method. Results The prevalences of overweight,obesity,central obesity,high percentage of body fat,and hypertension were 33.53%,10.71%,19.50%,27.69%,and 31.57% respectively, which were 30.31%,9.62%,16.70%,24.90%,and 27.61% after age-adjustment in rural areas of Ningxia,and increased with aging(Ptrend<0.05). The prevalences of overweight,obesity,and hypertension were higher in males than those in females(P<0.05),and that of central obesity was higher in females than in males(P=0.003).The prevalences of hypertension in subjects with overweight, obesity, central obesity, high percentage of body fat were 38. 14%, 53.75%,52.69%,and 48.90%,respectively. Body mass index,waist circumference,and percentage of body fat were positively correlated with systolic and diastolic blood pressure(P<0.05). The multivariable logistic model revealed that the risk of hypertension in different types of obesity increased about 1.5 times. Conclusion There is high prevalence of obesity and hypertension among the adults in southern mountain areas of Ningxia. The prevalence of hypertension in obesity,central obesity,and high percentage of body fat is closed to or more than half of the population investigated.

Objective To investigate the clinical effects of high-density micropulse photocoagulation (HD-SDM) combined with intravitreal injection of ranibizumab for diabetic macular edema (DME).Methods Thirty-one patients (31 eyes) with DME were randomly divided into two groups.Group A (15 eyes) received HD-SDM combined with intravitreal injection of ranibizumab.Group B (16 eyes) only received intravitreal injection of ranibizumab.The best corrected visual acuity (BCVA) and central macular thickness (CMT) of the two groups before and after treatment were analyzed,and the annual injection times of the two groups were compared.Results The average annual injection times was 3.67 ± 1.11 in group A,and 9.12 ±2.63 in group B.The difference was significant between the two groups (t =2.05,P ＜ 0.05).There were significant differences in CMT before and after treatment in both groups (all P ＜ 0.05).There was no significant difference in CMT between the two groups(t =1.19,P ＞ 0.05).There were significant differences in BCVA before and after treatment in both groups (all P ＜ 0.05),but there was no significant difference before and after treatment between the two groups(all P ＞ 0.05).Conclusion Both HD-SDM combined with intravitreal injection of ranibizumab and single intravitreal injection of ranlbizumab are effective for DME,but the combining treatment can remarkably decrease the annual injection times and had a good compliance of patients,is a good choice for DME patients.