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.

Objective: To explore the application of photodynamic therapy (PDT) combined with orally administered retinoic acid in the treatment of proliferative verrucous leukoplakia (PVL) and provide a reference for clinical practice. Methods: A case of sequential treatment of PVL with PDT and orally administered retinoic acid was reported. The characteristics, diagnosis, treatment of PVL, and the application of PDT and retinoic acid in oral leukoplakia were retrospectively analyzed based on the literature. Results: After four PDT sessions, a majority of the oral lesions were eliminated in a patient clinically diagnosed with PVL, but the lesions recurred two months later. Subsequently, the patient was treated with retinoic acid at a dose of 10 mg, once a day, orally before bedtime. After continuous treatment for 2 weeks, the oral lesions were significantly reduced. The dose was then adjusted to 10 mg, twice a day, and the treatment was extended for 3 months until the lesions completely disappeared. Following this, a periodic regimen was adopted to continue the administration of retinoic acid at a dose of 10 mg, twice a day (3 weeks of treatment followed by 1 week of drug withdrawal as one cycle), for a total of 6 cycles. No recurrence was observed during the 5-month follow-up after drug withdrawal. A review of the literature indicates that PVL is an oral potentially malignant disorder (OPMD) characterized by multifocality, high recurrence rate, and high malignant transformation rate. Currently, there is no ideal treatment method for PVL. PDT is advantageous because of its low toxicity. Furthermore, it is strongly selective, minimally invasive, and patients experience no scarring. Thus, it has been recommended as the first-line therapy for PVL. However, due to the limitations of local application of photosensitizers in terms of effectiveness, targeting, and penetration depth, the efficacy of PDT in treating PVL remains uncertain. There are a few reports on the treatment of oral leukoplakia with retinoic acid given by oral, but no literature has reported the combination of PDT and retinoic acid given by oral for PVL. Conclusion The sequential combination of PDT and oral retinoic acid therapy is an effective treatment for PVL.

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.

ObjectiveTo evaluate the clinical efficacy and safety of Tongluo Mingmu capsules in the treatment of diabetic retinopathy with blood stasis， collateral obstruction， and Qi and Yin deficiency syndrome. MethodA randomized， double-blind， positive-control， and multi-center clinical trial design method was used. 416 patients with diabetic retinopathy with blood stasis， collateral obstruction， and Qi and Yin deficiency syndrome in four test centers were included （the ratio of the treatment group to the control group was 3∶1）. On the basis of standardized hypoglycemic treatment， the treatment group was given both four Tongluo Mingmu capsules and two Calcium Dobesilate capsule agents three times a day， while the control group were given both two Calcium Dobesilate capsules and four Tongluo Mingmu capsule agents three times a day. The course of treatment was 12 weeks. The curative effect of Tongluo Mingmu capsules was evaluated by comparing the comprehensive curative effect of diabetic retinopathy， traditional Chinese medicine（TCM） syndrome score， corrected visual acuity， fundus changes， fundus fluorescence angiography， and other curative effect indexes before and after treatment in the two groups. At the same time， general examination， laboratory examination， and adverse events were performed to evaluate the safety of the drug. ResultThe baseline demographic data and disease characteristics of the treatment group and the control group were balanced and comparable， with the difference not statistically significant. After 12 weeks of treatment， the total effective rate of the comprehensive curative effect of diabetic retinopathy in the treatment group （61.0%， 189/310） was better than that in the control group （44.1%， 45/102）， and the difference was statistically significant （χ²=8.880， P<0.01）. The total effective rate of TCM syndromes in the treatment group （88.4%， 259/293） was better than that in the control group （69.9%， 65/93）， and the difference was statistically significant （χ²=17.927， P<0.01）. The disappearance rate of dry eyes （χ²=8.305）， dull complexion （χ²=4.053）， lassitude （χ²=10.267）， shortness of breath （χ²=8.494）， and dry stool （χ²=8.657） in the treatment group was higher than that in the control group， and the difference between the groups was statistically significant （P<0.05， P<0.01）. In terms of improving corrected visual acuity （χ²=8.382）， fundus changes （χ²=6.026） ， the treatment group was significantly better than the control group （P<0.05）. During the trial， the incidence of adverse events in the treatment group and the control group was 1.3% and 2.9%， respectively. There was no significant difference between the two groups. In addition， there were no serious adverse events and adverse events leading to withdrawal in both groups. ConclusionTongluo Mingmu capsules can improve the comprehensive curative effect of diabetic retinopathy and enhance the efficacy of TCM syndromes， visual acuity， fundus changes， and fundus fluorescein angiography， with great safety. Therefore， it can provide a new alternative therapeutic drug for patients with diabetic retinopathy.

ObjectiveTo investigate the developmental characteristics of gross motor skills and executive functions, and the correlation between them in school-age children with attention deficit hyperactivity disorder (ADHD). MethodsFrom November, 2020 to May, 2021, 90 children with ADHD were recruited from Peking University Sixth Hospital and Beijing Haidian Wanquan Primary School, and other 90 children with normal development from this primary school were recruited matched their age and gender. Gross motor skills were assessed with the Test of Gross Motor Development in Children, Third Edition (TGMD-3), and inhibitory control, working memory, and cognitive flexibility were assessed with Stroop Color Words Test (SCWT), Rey-Osterrich Complex Figure Test (ROCFT) and Trail Making Test (TMT), respectively. ResultsThe TGMD-3 score was significantly lower in children with ADHD than in normal children (t = -6.275, P < 0.001), while the test results of SCWT, ROCFT and TMT were worse (|t| ≥ 1.986, P ≤ 0.05). The TGMD-3 score of children with ADHD was negatively correlated with the word sense reaction time (r = -0.261), the number of word sense errors (r = -0.404) and the number of color errors (r = -0.326) (P < 0.05), positively correlated with the delayed structural memory scores (r = 0.228) (P < 0.05), and negatively correlated with the TMT-A reaction time (r = -0.255), the number of TMT-A errors (r = -0.329), TMT-B reaction time (r = -0.214) and the number of TMT-B errors (r = -0.474) (P < 0.05). Stratified linear regression analyses showed that the TGMD-3 score of children with ADHD was significant only in predicting test results for inhibitory control and cognitive flexibility (P < 0.05), with explanations of 8.7% and 22.5%, respectively. ConclusionDevelopments of both gross motor skills and executive function delay in children with ADHD, and there is a relation between them, especially the level of gross motor skills relating to the developments of inhibitory control and cognitive flexibility.

Objective This study aims to investigate the regulatory effects of Fujiu Patch(composed of Sinapis Semen,Kansui Radix,Corydalis Rhizoma and Asari Radix et Rhizoma)on the CD4+ T helper 17 cell(Th17)/CD4+CD25+ regulatory T cell(Treg)balance in asthmatic rats via the signal pathway of IL-6/signal transducer and activator of transcription 3(STAT3)as well as IL-2/signal transducer and activator of transcription 5(STAT5),and to reveal its anti-asthma mechanisms.Methods An experimental asthma model was constructed by ovalbumin(OVA)combined with aluminum hydroxide sensitization and challenge,and then the rats were administered with Fujiu Patch at Dazhui(DU14),Feishu(BL13)and Shenshu(BL23)points for 4 hours each time,once every other day for 7 times.Immunohistochemistry was used to detect the positive expressions of Th17 specific cytokine(IL-17)and Treg transcription factor(Foxp3)in rat lung tissue.The percentage of Th17 and Treg cells in peripheral blood was examined by flow cytometry analysis,and the expressions of IL-6/STAT3 and IL-2/STAT5 pathway-related proteins in lung tissue were assayed with Western Blot.Results Compared to the model group,IL-17 positive expression in the rat lung showed a significant reduction in the Fujiu Patch group(P＜0.01),while the positive expression of Foxp3 was obviously increased(P＜0.05).Meanwhile,the protein expression levels of IL-6 and phospho-STAT3 were were significantly declined(P＜0.01),and the protein expression levels of IL-2 and phospho-STAT5 were were significantly elevated(P＜0.01).However,there was no significant alteration in the total protein expressions of STAT3 and STAT5(P＞0.05).Furthermore,the proportion of Th17 cells in peripheral blood of rats in the Fujiu Patch group was lower than that in the model group,while the proportion of Treg cells was higher than that in the model group.Statistically-significant differences were observed(all P＜0.01).Conclusion These findings indicate that Th17/Treg immune imbalance occurs in asthmatic rat.Fujiu Patch may exert anti-asthma effects via inhibiting the expression of IL-6,downregulating the expression of phospho-STAT3,diminishing the level of IL-17-producing Th17 cells,as well as increasing the expressions of IL-2-mediated STAT5 phosphorylation,raising the level of Foxp3-expressing Treg cells,promoting Th17/Treg balance and suppressing immune responses in rat with asthma.

Objective This paper summarizes and evaluates the existing animal models of Post-infectious irritable bowel syndrome(PI-IBS)based on the clinical diagnostic criteria and symptom characteristics of PI-IBS in Chinese and western medicine.The goal of this study is to seek out animal models with a high degree of clinical agreement between Chinese and western medicine,and to provide an accurate animal model for the prevention and treatment of PI-IBS in traditional Chinese medicine.Methods The animal strains,modelling methods,and mechanisms of the existing PI-IBS animal models were summarized based on the clinical diagnostic features and symptomatology of PI-IBS,as well as the degree of match was evaluated and the strengths and weaknesses of the preparation of animal models were analyzed,by reviewing the articles related to PI-IBS animal experiments and the preparation of animal models.Results A thorough analysis discovered that Campylobacter jejuni infection model,Trichinella infection model,and liver depression and spleen deficiency syndrome in models of disease and symptom combination showed a comparatively high level of clinical agreement between Chinese and western medicine.Conclusion The existing PI-IBS models had the high degree of coincidence with western medicine,Chinese medicine four diagnoses and syndrome are generally less embodied and collected in the modeling process.The primary symptoms in Chinese medicine diagnosis are primarily based on the observation of animal apparent behaviors,while the observation of the sub-syndrome manifestations is relatively less,which results in failure of judgment of TCM syndrome types.Therefore,it is still necessary to further standardize the criteria for evaluating symptoms and the techniques for identifying disease-syndrome combination animal models.PI-IBS model with the syndrome-clinical characteristics in Chinese and western medicine has significant application value and prospects in the future.The multifactorial composite method of western medicine pathological injury+Chinese medicine etiological stimulation can establish a PI-IBS model with a higher degree of coincidence,which can provide theoretical support for the study of the pathogenesis of PI-IBS,the difference of syndrome,and the prevention and treatment with integrative Chinese and western medicine.It is crucial to guide the clinical diagnosis and treatment of PI-IBS.

ObjectiveTo investigate the prevalence of stroke in Songjiang District from 2017 to 2022, to analyze the epidemiological characteristics of stroke incidence, so as to provide a scientific basis for the formulation of stroke prevention and control policies. MethodsData of new stroke incidence from 2017 to 2022 in Songjiang District were obtained from the Shanghai Stroke and Acute Myocardial Infarction Registration and Reporting Information System. In addition, different classifications such as time of onset, gender, age group and types of stroke, were statistically analyzed. Statistical indicators, such as the number of incidence, crude incidence rate, standardized incidence rate and average age of incidence were calculated simultaneously. Joinpoint software were used to calculate the annual change percentage (APC) and the trend of stroke incidence in Songjiang District. ResultsFrom 2017 to 2022, the newly reported cases of stroke were 12 988 in Songjiang District, the crude incidence rate was 325.76/10⁵, and the standardized incidence rate was 127.58/10⁵. The crude incidence rate and standardized incidence rate in males were 363.45/10⁵ and 157.17/10⁵, respectively, but 288.68/10⁵ and 99.02/10⁵ in females. The mean age of onset was (73.12±11.75) years, of which the mean age of onset was (70.86±11.96) years for men and (75.91±10.85) years for women. The incidence of stroke increased with age, rising rapidly after 60 years and reaching a peak in the age group of ≥ 80 years old. The crude incidence rate and standardized incidence rate of stroke in Songjiang District showed a downward trend from 2017 to 2022, with an APC of -6.20% and -8.01%, respectively (P=0.018, 0.007). The newly reported stroke was dominated by ischemic stroke, accounting for 82.81% of the total cases, with a crude incidence rate of 269.77/10⁵ and a standardized rate of 103.84/10⁵. The incidence of stroke presented seasonal characteristics, with the highest incidence in winter, accounting for 26.11% of the whole year. ConclusionThe incidence rate of stroke in Songjiang District shows a declined trend, but the overall incidence is still at a high level. The situation of prevention and control is still serious, with a heavy disease burden. It is necessary to strengthen health education and disease management for the elderly.

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 analyze the effect of neurofeedback training based on early start Denver model(ESDM)on children with autism spectrum disorder(ASD). Methods From August,2020 to May,2024,a total of 60 children with ASD from Hangzhou Children's Hospital were randomly divided into control group(n=30)and observation group(n=30).The control group received ESDM intervention,while the observation group received neurofeedback training in addition,for six months.They were assessed with Autism Treatment Evaluation Checklist(ATEC)and Psycho-Educational Profile-3rd Edition(PEP-3). Results After treatment,the score of ATEC was lower in the observation group than in the control group(t=3.545,P<0.05),the scores of cognition(t=2.236,P=0.029),emotional expression(t=2.293,P=0.025)and problem be-havior(Z=2.099,P=0.036)were higher in the observation group than in the control group.The score differenc-es of ATEC(Z=3.620,P<0.001),and cognition(Z=2.920,P<0.05)and problem behaviors(Z=4.209,P<0.05)of PEP-3 before and after intervention were higher in the observation group than in the control group. Conclusion Combination of neurofeedback training could improve the effect of ESDM on ASD.