Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.

ObjectiveTo evaluate the inhibitory effect of online-sold “preservative-free” cosmetics against contaminated microorganisms during storage and use, to establish a method for assessing the preservative efficacy of such cosmetics, and to provide data support for the formulation of relevant standards. MethodsA total of 16 batches of cosmetics claiming preservative free were collected to determine their pH value, water activity, total aerobic microbial count (TAMC) and total molds and yeasts count (TYMC). Meanwhile, preservatives not listed in the Safety and Technical Standards for Cosmetics (2015 edition) (referred to as “unlisted preservatives”) were screened. In addition, a preservative challenge test was conducted on these cosmetics. ResultsAll the 16 batches of samples were generally weakly acidic, and with a water activity ≥0.6, which were suitable for microbial growth. Unlisted preservative not labeled on the package was detected in one batch of cosmetic. The results of neutralizer verification showed that three batches required further dilution to eliminate the antimicrobial interference. After inoculation with challenge microorganisms and cultivation for 7 days, two batches of cosmetics did not achieve a bacterial reduction rate of 99.90%, and the fungal reduction rate did not reach 90.00% either. While another two batches of cosmetics experienced microbial growth during testing, indicating a failure of the preservative challenge test. The overall pass rate was 75.00%. ConclusionSome online-sold preservative free cosmetics have insufficient preservation efficacy and pose a certain risk of microbial contamination.

Objective:To investigate the current status of endoscopic treatment for gastroesophageal varices in portal hypertension in China, and to provide supporting data and reference for the development of endoscopic treatment.Methods:In this study, initiated by the Liver Health Consortium in China (CHESS), a questionnaire was designed and distributed online to investigate the basic condition of endoscopic treatment for gastroesophageal varices in portal hypertension in 2022 in China. Questions included annual number and indication of endoscopic procedures, adherence to guideline for preventing esophagogastric variceal bleeding (EGVB), management and timing of emergent EGVB, management of gastric and isolated varices, and improvement of endoscopic treatment. Proportions of hospitals concerning therapeutic choices to all participant hospitals were calculated. Guideline adherence between secondary and tertiary hospitals were compared by using Chi-square test.Results:A total of 836 hospitals from 31 provinces (anotomous regions and municipalities) participated in the survey. According to the survey, the control of acute EGVB (49.3%, 412/836) and the prevention of recurrent bleeding (38.3%, 320/836) were major indications of endoscopic treatment. For primary [non-selective β-blocker (NSBB) or endoscopic therapies] and secondary prophylaxis (NSBB and endoscopic therapies) of EGVB, adherence to domestic guideline was 72.5% (606/836) and 39.2% (328/836), respectively. There were significant differences in the adherence between secondary and tertiary hospitals in primary prophylaxis of EGVB [71.0% (495/697) VS 79.9% (111/139), χ2=4.11, P=0.033] and secondary prophylaxis of EGVB [41.6% (290/697) VS 27.3% (38/139), χ2=9.31, P=0.002]. A total of 78.2% (654/836) hospitals preferred endoscopic therapies treating acute EGVB, and endoscopic therapy was more likely to be the first choice for treating acute EGVB in tertiary hospitals (82.6%, 576/697) than secondary hospitals [56.1% (78/139), χ2=46.33, P<0.001]. The optimal timing was usually within 12 hours (48.5%, 317/654) and 12-24 hours (36.9%, 241/654) after the bleeding. Regarding the management of gastroesophageal varices type 2 and isolated gastric varices type 1, most hospitals used cyanoacrylate injection in combination with sclerotherapy [48.2% (403/836) and 29.9% (250/836), respectively], but substantial proportions of hospitals preferred clip-assisted therapies [12.4% (104/836) and 26.4% (221/836), respectively]. Improving the skills of endoscopic doctors (84.2%, 704/836), and enhancing the precision of pre-procedure evaluation and quality of multidisciplinary team (78.9%, 660/836) were considered urgent needs in the development of endoscopic treatment. Conclusion:A variety of endoscopic treatments for gastroesophageal varices in portal hypertension are implemented nationwide. Participant hospitals are active to perform emergent endoscopy for acute EGVB, but are inadequate in following recommendations regarding primary and secondary prophylaxis of EGVB. Moreover, the selection of endoscopic procedures for gastric varices differs greatly among hospitals.

Based on medical cases about ginger juice in A Clinical Guide with Case Histories （《临证指南医案》）， we found that YE Tianshi apply ginger juice into the medicine mainly take its function of warming stomach to stop nausea， acrid-moist to unblock the collaterals， dissolving phlegm to expel fluid retention. It is often used with Ganjiang （Zingiber officinale）， Fuzi （Cyperus rotundus） and other warm medicinals to warm the yang qi； with Banxia （Pinellia ternata）， Huanglian （Picrorhiza kurroa） and other bitter-acrid medicinals to clear dampness and heat； with Zhuli （Arundo donax）， Juhong （Citrus reticulata） and other phlegm-resolving medicinals to clear turbid phlegm. Compared with the whole ginger， ginger juice is soft and easy to be absorbed； it is acrid-moist and can unblock the collaterals with stronger power. At the same time， it can enhance the effect of dissolving phlegm to expel fluid retention. Ginger juice can improve the efficacy of the medicinals and broaden the scope of ginger's medicinal use.

Objective: To examine the developmental trajectory of fine motor ability in schoolage children with attention deficit hyperactivity disorder (ADHD) for two years, so as to provide scientific evidence to promote motor development in ADHD children. Methods: From April to June 2019, 31 children aged 6-8 years old were selected from a public elementary school. They were diagnosed with ADHD by two psychiatric professionals according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria. Additionally, 31 typical developmental children, matched for age, sex and IQ with the ADHD group, were recruited as the control group. Fine motor ability was assessed with tasks of hand manual dexterity in Movement Assessment Battery for Children-2 (MACB-2), and a followup assessment was conducted from April to June 2021. The development changes of fine motor ability between two groups of children were compared by using t test and repeated measures analysis of variance. Results: Between baseline and followup periods after two years, the total score of hand fine motor in the ADHD group did not show significant improvement (7.4±3.0, 8.0±3.4; t=-1.05, P>0.05), while there was a small effect size improvement in typically developing control group (9.5±2.1, 10.5±2.4; t=-2.12, effect size=0.38, P<0.05). Followup after two years, coin/peg throwing scores with dominant hand improved between ADHD group and control group (7.0±3.3, 9.5±3.2; 8.4±2.8, 11.6±1.6) (t=-3.74, -6.33, P<0.01; effect size=0.67, 1.14), with a smaller improvement in the ADHD group. The score for threading beads/threads decreased in between ADHD group and control group (7.9±2.4, 5.8±3.1; 9.2±1.1, 8.2±1.9) (t=3.89, 2.78, P<0.01; effect size=0.70, 0.50), with a greater decrease in the ADHD group. Conclusions The development speed of fine motor ability in children with ADHD aged 6-8 is slow and continues to lag behind normal developmental children. Fine motor development in children with ADHD should be closely monitored, and targeted interventions should be implemented when necessary.

Objective To explore the impact of exercise intervention on the reading abilities of chil-dren with Chinese developmental dyslexia(CDD).Methods Twenty-seven CDD children were recruited from patients of Peking University Sixth Hospital,and randomly divided into a CDD exercise interven-tion group of 14 and a CDD control group of 13.Another 14 age-matched normal children were select-ed into a normal control group.All groups kept daily physical activities in school,while the CDD ex-ercise intervention group additionally underwent 8-week individualized gross and fine motor interven-tion.The literacy,reading fluency and reading comprehension of all groups were evaluated by using"Elementary School Students'Literacy Test and Evaluation Scale",one-minute word reading and ele-mentary school students'reading ability assessment.Results Before the intervention,there were no sig-nificant differences between the exercise intervention and control groups in the literacy level,reading fluency,and reading comprehension(P>0.05),which were all significantly lower than the normal con-trol group(P<0.05).However,after the intervention,significant improvement was observed in the aver-age literacy level,reading fluency,and reading comprehension of the CDD exercise intervention group,and the literacy and reading fluency of the CDD control group,as well as the average literacy level and reading comprehension of the normal control group.Moreover,there were no significant differ-ences between the CDD exercise intervention and control groups in the average literacy level and read-ing fluency score(P>0.05),both significantly lower than the normal control group(P<0.05).Mean-while,the reading comprehension score of the CDD exercise intervention group was significantly higher than the CDD control group(P<0.05),but significantly lower than the normal control group(P<0.05).Conclusion Eight-week targeted gross and fine motor intervention can effectively improve reading abili-ty of DD children,especially their reading comprehension.

Objective: To investigate the relationship between fine motor skills and executive function in school aged boys with attention deficit hyperactivity disorder (ADHD) aged 6-10 years, so as to provide a reference for promoting executive function. Methods: From November 2022 to May 2021,65 boys with ADHD were recruited from a tertiary hospital in Beijing and a public elementary school in Beijing, and 65 boys with typical development according to age and sex were recruited as controls. Children s fine motor skills were assessed using the movement assessment battery for children, second version (MABC-2), and children s inhibitory control, working memory, and cognitive flexibility were assessed using the Stroop color word test (SCWT), Rey osterrich complex figure test (ROCFT) and trail making test (TMT), respectively. Independent samples t-tests were used to analyze the differences between the two groups, and Pearson correlation analysis and stratified regression analysis were used to explore the relationship between fine motor skills and executive functioning in boys with ADHD. Results: In the fine motor skills test, boys with ADHD scored significantly lower (8.68±3.62) than control boys (11.22±2.27)( t =4.80, P <0.05); in the executive function test, the results of SCWT, ROCFT, and TMT tests were significantly worse in boys with ADHD than in normal boys ( t =-4.53-4.42, P < 0.05). Correlation analysis showed that the fine motor skill scores of boys with ADHD were negatively correlated with the number of word sense errors ( r =-0.35) and color errors ( r =-0.42), and positively correlated with memory scores for delayed structure ( r =0.30) and detail ( r =0.25), which were negatively correlated with TMT-A ( r =-0.34),TMT-B reaction time ( r =-0.26), number of errors ( r =-0.43) ( P <0.05). Stratified regression analysis showed that fine motor skill scores of boys with ADHD were predictive of test results for inhibitory control, working memory and cognitive flexibility, with explanatory rates of 15%, 7%, and 19%, respectively. Conclusion Fine motor skills in boys with ADHD are correlated with executive functions, and fine motor skills could predict inhibitory control, working memory and cognitive flexibility to some extent. The development of fine motor skills in boy with ADHD could promote their executive functions.

ObjectiveTo explore the characteristics of fine motor skills of school-age children with attention deficit hyperactivity disorder (ADHD) in different sexes. MethodsFrom April, 2021 to April, 2023, 66 ADHD children from grades one to four in Beijing Haidian Wanquan Primary School were screened by psychiatrists, and other 69 ADHD children were recruited from hospitals and patient groups of WeChat, accounting to 135 ADHD children. Meanwhile, a total of 135 typically developed (TD) children matched with sex and age (< 0.5 year) were recruited from the same primary school as controls. They were assessed with Movement Assessment Battery for Children (MABC-2) four subtests of manual dexterit. ResultsAfter controlling age, the subtest scores and the total score of fine motor of MABC-2 were less in ADHD boys and girls than in the TD boys and girls (P < 0.05). The main effect of sex was significant on the subtest scores and the total score of fine motor for ADHD children (F > 5.133, P < 0.05), and they were less in the boy than in the girls (P < 0.05). ConclusionThe development of fine motor delays in school-aged ADHD children, especially for the boys.

Humans ; China/epidemiology* ; SARS-CoV-2 ; COVID-19

ObjectiveA rapid enrichment and detection method for Escherichia coli O157∶H7 was developed by using multienzyme isothermal rapid amplification （MIRA） fluorescence method combined with metal organic frameworks immunomagnetic beads. MethodsUsing rfbE gene as the target， the primers， probes and reaction system were screened， and the specificity， sensitivity and practical application of this method were investigated. ResultsThe detection limit of Escherichia coli O157∶H7 was 1.18×10⁵ CFU‧mL^-1， and the detection limit of DNA concentration was 9 pg‧μL^-1. The detection process was completed in 20 minutes. The test results of 47 strains （24 target strains and 23 non-target strains） were consistent with real-time PCR （RT-PCR）. ConclusionA method based on metal-organic framework immunomagnetic beads enrichment combined with MIRA assay is developed in this study. The method is simple， rapid and suitable for rapid enrichment and detection of Escherichia coli O157∶H7 in food.