1.The introduction on the new standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; CHEN Ying ; TU Jiasheng ; LIU Yanming ; ZHENG Luxia ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):058-066
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.
2.Progress in the application of poloxamer in new preparation technology
Xue QI ; Yi CHENG ; Nan LIU ; Zengming WANG ; Hui ZHANG ; Aiping ZHENG ; Dongzhou KANG
China Pharmacy 2025;36(5):630-635
Poloxamer, as a non-ionic surfactant, exhibits a unique triblock [polyethylene oxide-poly (propylene oxide)-polyethylene oxide] structure, which endows it with broad application potential in various fields, including solid dispersion technology, nanotechnology, gel technology, biologics, gene engineering and 3D printing. As a carrier, it enhances the solubility and bioavailability of poorly soluble drugs. In the field of nanotechnology, it serves as a stabilizer etc., enriching preparation methods. In gel technology, its self-assembly behavior and thermosensitive properties facilitate controlled drug release. In biologics, it improves targeting efficiency and reduces side effects. In gene engineering, it enhances delivery efficiency and expression levels. In 3D printing, it provides novel strategies for precise drug release control and the production of high-quality biological products. As a versatile material, poloxamer holds promising prospects in the pharmaceutical field.
3.Improving the Certainty of Evidence in Animal Experiment Systematic Review/Meta-Analysis: An Empirical Study of the GRADE Method
Tengfei LI ; Qingyong ZHENG ; Jianguo XU ; Yiyi LI ; Yongjia ZHOU ; Caihua XU ; Mingyue ZHANG ; Jiexiang TIAN ; Gang WANG ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2025;45(1):101-111
Animal experiments are essential tools in biomedical research, serving as a bridge between basic research and clinical trials. Systematic reviews and meta-analyses (SRs/MAs) of animal experiments are crucial methods for integrating evidence from animal experiment, which can facilitate the translation of findings into clinical research, reduce translational risks, and promote resource integration in basic research. With the continuous development of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology, its application in SRs/MAs of animal experiments has gained increasing attention. This article first outlines the principles and specific applications of the GRADE methodology in SRs/MAs of animal experiments, including qualitative descriptive systematic reviews, meta-analyses, and network meta-analyses. It then deeply analyzes the misuse of the GRADE methodology in practice, including incorrect evidence grading, improper classification of evidence, misapplication in qualitative systematic reviews, inconsistencies between the documentation of the upgrading and downgrading process and results, and inappropriate use for making recommendations. Furthermore, this article comprehensively discusses the factors influencing the grading of evidence certainty in SRs/MAs of animal experiments, including the impact of bias risk, indirectness, inconsistency, imprecision, and publication bias on evidence downgrading, as well as the role of large effect sizes and cross-species consistency in evidence upgrading. Finally, in response to the issues discussed, improvement strategies are proposed, including further research and optimization of the GRADE methodology for SRs/MAs of animal experiments, the development of reporting guidelines tailored to the characteristics of SRs/MAs in animal experiment research, and enhanced professional training for researchers in the GRADE methodology. This article aims to improve the quality of evidence in SRs/MAs of animal experiments, strengthen their reliability in clinical decision-making, and promote the more efficient translation of findings from animal experiment research into clinical practice.
4.Effects of long non-coding RNA nuclear enriched abundant transcript 1 on the proliferation,apoptosis and migration of keloid fibroblasts
Yanfeng ZHANG ; Huimin ZHANG ; Xiang HE ; Yuping ZHENG
Chinese Journal of Tissue Engineering Research 2025;29(2):347-354
BACKGROUND:It has been elucidated that downregulation of nuclear enriched abundant transcript 1(NEAT1)inhibits the progression of keloid fibroblasts,but the exact mechanism is not fully understood. OBJECTIVE:To investigate the influences of long non-coding RNA nuclear enriched abundant transcript 1(lncRNA NEAT1)on the proliferation,apoptosis and migration of keloid fibroblasts by regulating the miR-136-5p/ubiquitin-specific protease 4(USP4)axis. METHODS:Keloid fibroblasts were divided into five groups:si-NC group,control check group,si-NEAT1 group,si-NEAT1+miR-136-5p inhibitor group,and si-NEAT1+inhibitor-NC group.qRT-PCR was performed to measure the expressions of NEAT1 and miR-136-5p;cell counting kit-8 assay and EDU staining were performed to measure cell proliferation;flow cytometry was performed to measure apoptosis;scratch-healing experiment was performed to measure cell migration;western blot assay was performed to measure the protein expressions of USP4,p27,Bax,matrix metalloproteinase-9,α-smooth muscle actin,and type I collagen α1 chain;dual-luciferase assay was performed to examine the relationship of NEAT1 with miR-136-5p as well as the relationship of miR-136-5p with USP4. RESULTS AND CONCLUSION:Compared with the si-NC group,the NEAT1 expression,absorbance value at 450 nm,percentage of EDU positive cells,scratch-healing rate,the protein expressions of USP4,matrix metalloproteinase-9,α-smooth muscle actin,and type I collagen α1 chain decreased in the si-NEAT1 group(P<0.05),while the expression of miR-136-5p,apoptosis rate,and the protein expressions of p27 and Bax increased(P<0.05).miR-136-5p inhibitor reversed the effect of silencing NEAT1 on the biological behavior of keloid fibroblasts.There was a targeted regulatory relationship between NEAT1 and miR-136-5p as well as between miR-136-5p and USP4.To conclude,silencing NEAT1 may inhibit the proliferation and migration of keloid fibroblasts and induce apoptosis by regulating the miR-136-5p/USP4 axis..
5.Effect of deep muscle stimulation combined with electromyographic biofeedback on the spasms of the triceps surae and gait changes after stroke
Qiming ZHANG ; Di LIAO ; Zhiliang ZHONG ; Lihua LIN ; Xiang ZHENG ; Qiong LI ; Sharui SHAN
Chinese Journal of Tissue Engineering Research 2025;29(2):385-392
BACKGROUND:Deep muscle stimulation has the effects of releasing muscle adhesion,relieving muscle spasm,improving and restoring muscle compliance and elasticity.Electromyographic biofeedback therapy can promote nerve recovery and improve lower limb motor function and gait. OBJECTIVE:To observe the effect of the effect of deep muscle stimulation combined with electromyographic biofeedback therapy on the spasm of the triceps surae and gait changes after stroke by using a digital muscle detector and three-dimensional gait analysis system. METHODS:A total of 72 patients who met the inclusion criteria were selected from the Rehabilitation Department of the First Affiliated Hospital of Guangdong Pharmaceutical University from October 2020 to October 2023.And they were enrolled and randomly divided into two groups(n=36 per group):a control group and a combined group.The control group received routine rehabilitation therapies,electromyographic biofeedback and pseudo deep muscle stimulation,while the combined group received true deep muscle stimulation treatment on the basis of the control group,five times per week,for 4 consecutive weeks.The oscillation frequency and dynamic stiffness of the affected gastrocnemius muscle,active range of motion of the ankle dorsiflexion muscle,electromyographic signal of the tibialis anterior muscle,Fugl-Meyer assessment of the lower limbs,and three-dimensional gait analysis parameters were statistically analyzed before and after treatment in two groups. RESULTS AND CONCLUSION:After treatment,oscillation frequency and dynamic stiffness values of the inner and outer sides of the affected gastrocnemius muscle in both groups of patients were significantly reduced compared with before treatment(P<0.05),and the combined group showed a more significant decrease compared with the control group(P<0.05).The active range of motion of the ankle dorsiflexion muscle,electromyographic signal of the tibialis anterior muscle,and Fugl-Meyer scores after treatment were significantly increased or improved compared with before treatment(P<0.05),while the combined group showed a more significant increase or improvement compared with the control group(P<0.05).In terms of gait parameters,the walking speed,frequency,and stride in both groups of patients were significantly increased compared with before treatment(P<0.05),while the combined group showed a more significant increase compared with the control group(P<0.05).The percentage time of support phase on the healthy side was shortened compared with before treatment(P<0.05),while the combined group showed a more significant decrease compared with the control group(P<0.05).In addition,there was no significant difference between the two groups except for the percentage of healthy side support(P>0.05).To conclude,the combination of deep muscle stimulation and electromyographic biofeedback can effectively alleviate triceps spasm in the short term after stroke,improve ankle dorsiflexion function,enhance lower limb motor function,and improve gait.The treatment effect is significant and worthy of clinical promotion and application.
6.Improvement of lower limb walking function in patients with chronic non-specific low back pain by biofeedback assisted electrical stimulation
Xiang ZHENG ; Mingxing ZHANG ; Ya HUANG ; Sharui SHAN
Chinese Journal of Tissue Engineering Research 2025;29(3):547-553
BACKGROUND:There have been many studies on biofeedback therapy and three-dimensional gait function analysis for chronic non-specific low back pain at home and abroad,but few studies on the combination of the two have been reported. OBJECTIVE:To study the effect of biofeedback assisted electrical stimulation on the change of walking ability in chronic non-specific low back pain by collecting gait parameter data through three-dimensional gait analysis. METHODS:Sixty patients with chronic non-specific low back pain,34 males and 26 females,aged 32-58 years,were selected and admitted to First Affiliated Hospital of Guangdong Pharmaceutical University from June 2021 to September 2022.They were divided into control group(n=30)and trial group(n=30)according to the principle of random allocation.Both groups of patients received conventional treatment of dynamic interference with the waist,20 minutes/time,once/day,5 times a week,for 20 times.The control group received supine bypass and prone bypass suspension core muscle training on the basis of conventional treatment,5 times a week,for 20 times.The trial group received biofeedback assisted electrical stimulation therapy on the basis of the control group,20 minutes/time,once/day,5 times a week,for 20 times.The low back pain score,the mean value of electromyography and the gait parameters were compared and analyzed before and after treatment between the two groups. RESULTS AND CONCLUSION:(1)After treatment,the numerical rating scale score,Japanese Orthopaedic Association score,and Oswestry disability index of the two groups were significantly improved compared with those before treatment(P<0.05).Numerical rating scale score,Japanese Orthopaedic Association score,and Oswestry disability index of the trial group were better than those of the control group(P<0.05).(2)After treatment,the mean values of surface electromyography of rectus abdominis,gluteus maximus,and erector spinae muscle in the two groups were higher than those before treatment(P<0.05),and the mean values of surface electromyography of rectus abdominis,gluteus maximus,and erector spinae muscle in the trial group were higher than those in the control group(P<0.05).(3)After treatment,the step width,step speed,step frequency,step length ratio between healthy and diseased sides,the relative value of support between healthy and diseased sides,the relative value of swing between diseased and healthy sides,the sagittal motion range of hip joint and knee joint between healthy and diseased sides and the foot angle between healthy and diseased sides were all better than those before treatment in both groups(P<0.05).The above indexes of the trial group were better than those of the control group after treatment(P<0.05).(4)These results suggest that biofeedback assisted electrical stimulation can significantly alleviate chronic non-specific low back pain,and improve the lower limb walking function.
7.Characterization of postural stability in elderly patients with idiopathic normal pressure hydrocephalus
Xiaoxiao LIANG ; Jiejiao ZHENG ; Linru DUAN ; Xi CHEN ; Tingyu ZHANG
Chinese Journal of Tissue Engineering Research 2025;29(6):1208-1213
BACKGROUND:Impaired postural control is an important risk factor for falls and secondary damage in patients with idiopathic normal pressure hydrocephalus.Most of the existing studies have analyzed the gait parameters of patients during straight-line walking,but few have analyzed the postural stability characteristics of patients during static and dynamic activities. OBJECTIVE:To analyze the characteristics of postural stability in elderly patients with idiopathic normal pressure hydrocephalus. METHODS:Twenty-two patients clinically diagnosed with idiopathic normal pressure hydrocephalus at the Department of Neurosurgery,Huadong Hospital Affiliated to Fudan University,Shanghai,China,from September 2022 to February 2023 were selected as the patient group,and 18 healthy accompanying family members were selected as the healthy control group.The postural stability characteristics of the subjects were assessed using the Timed Up-and-Go Test,Multi-Directional Reach Test,Berg Balance Scale,and Static Balance Function Test(reaction time,speed of movement,directional control,maximum offset distance,and endpoint travel). RESULTS AND CONCLUSION:The time required to complete the Timed Up-and-Go Test was significantly longer in the patient group than in the healthy control group(P<0.05).The results of the stretching test in the four directions of anterior,posterior,leftand right were significantly lower in the patient group than in the healthy control group(P<0.05).The Berg Balance Scale scores in the patient group were lower than those in the healthy control group(P<0.05).In the Static Balance Function Test,the results of reaction,movement speed,directional control,maximum offset distance and endpoint travel index were smaller in the patient group than the healthy control group(P<0.05).To conclude,patients with idiopathic normal pressure hydrocephalus exhibit overall postural control deficits,and impaired reaction and execution abilities make these patients unable to make timely and accurate motor responses in the face of disturbances from internal or external sources,resulting in postural instability and increasing the risk of falls.
8.Relationship between long non-coding RNA and osteoarthritis
Shanbin ZHENG ; Tianwei XIA ; Jiahao SUN ; Zhiyuan CHEN ; Xun CAO ; Chao ZHANG ; Jirong SHEN
Chinese Journal of Tissue Engineering Research 2025;29(11):2357-2367
BACKGROUND:As a common disease in middle-aged and elderly,osteoarthritis is difficult to cure,and the pathogenesis is not clear.Long non-coding RNA participates in the pathogenesis of osteoarthritis through many ways,such as regulating translation,promoting or inhibiting mRNA,and adsorbing miRNAs. OBJECTIVE:To review the types of common long non-coding RNA in osteoarthritis,and the influence of multiple long non-coding RNAs on the pathological factors related to osteoarthritis,to analyze the future application of long non-coding RNAs in osteoarthritis. METHODS:Literature retrieval was conducted in CNKI,WanFang Data,VIP database,PubMed,Web of Science and Sciencedirect databases,using the search terms of"osteoarthritis,degenerative joint disease,degenerative arthritis,OA,LncRNA,long non-coding RNA,long noncoding RNA,long intergenic non-coding RNA"in Chinese and English.All relevant literature published from 1976 and May 2024 was retrieved.After literature screening,induction,analysis and summary,93 articles were finally included for review. RESULTS AND CONCLUSION:This review collected 25 long non-coding RNAs that are well studied with osteoarthritis.Long non-coding RNAs,as a molecular sponge for miRNA,are competing endogenous RNAs to competitively adsorb miRNAs and then affect downstream targets.Long non-coding RNAs can regulate physiopathological processes such as chondrocyte apoptosis and proliferation,cartilage extracellular matrix degradation,and inflammatory responses.Long non-coding RNAs are expected to become a biomarker and potential therapeutic target for the clinical diagnosis and therapeutic prognosis of osteoarthritis,and it may become a new strategy for the clinical treatment of osteoarthritis in the future.
9.Quality evaluation of Jingtian granule based on fingerprint combined with chemical pattern recognition
Wei ZHAO ; Shuhe CHEN ; Bin YAN ; Qiongfang ZHENG ; Weixin ZHANG ; Yuanming BA
China Pharmacy 2025;36(3):300-305
OBJECTIVE To establish the ultra-high performance liquid chromatography (UPLC) fingerprint of Jingtian granule, and to evaluate its quality by chemical pattern recognition. METHODS Luna® Omega Polar C18 column (150 mm×2.1 mm, 1.6 μm) was used as the chromatographic column, and acetonitrile-0.2% phosphoric acid solution was used as the mobile phase for gradient elution. The flow rate was 0.2 mL/min, the column temperature was 30 ℃, and the detection wavelength was 265 nm. With peak 16 as the reference peak, the UPLC fingerprint of Jingtian granule was established by the Similarity Evaluation System of Chromatographic Fingerprint of Traditional Chinese Medicine (2012 edition). The common peaks were identified, the similarity evaluation was carried out, and the ownership of each common peak was confirmed. Hierarchical cluster analysis (HCA) and principal component analysis (PCA) in chemical pattern recognition methods were used to classify 13 batches of samples (S1- S13), and orthogonal partial least squares-discriminant analysis (OPLS-DA) was used to identify the key components of the differences between different batches of samples. RESULTS RSDs of precision, repeatability and stability of the UPLC method were not more than 4.4%. A total of 25 common peaks were identified in the fingerprints of 13 batches of Jingtian granules. By comparing with the reference substance fingerprint, 10 common peaks were identified, namely peak 3 (hydroxymethyl-2-furaldehyde), peak 5 (salidroside), peak 8(chlorogenic acid), peak 15 (cinnamic acid), peak 19 (aloe-emodin), peak 20 (ammonium glycyrrhizinate), peak 21 (rhein), peak 23 (emodin), peak 24 (glycyrrhetinic acid), peak 25 (chrysophanol). The similarities of fingerprints of 13 batches of samples were 0.955-0.996. The results of HCA showed that 13 batches of samples could be divided into three categories, among which samples S1, S5, S7, S11-S13 were clustered in one category, S4 and S6 were clustered in one category, S2, S3 and S8-S10 were clustered in one category. PCA results showed that the cumulative variance contribution rate of principal components 1-7 was 92.666%. OPLS-DA further identified 13 differential components, which were mainly derived from Polygonati Rhizoma with wine steaming, Rhodiolae Crenulatae Radix Et Rhizoma, prepared Rhei Radix Et Rhizoma and Glycyrrhizae Radix Et Rhizome Praeparata Cum Melle. CONCLUSIONS The established UPLC fingerprint of Jingtian granule is simple, stable and reproducible. Combined with the chemical pattern recognition method, it can effectively reveal the overall quality difference between different batches of Jingtian granule. The quality of Polygonati Rhizoma with wine steaming, Rhodiolae Crenulatae Radix Et Rhizoma, prepared Rhei Radix Et Rhizoma, Dioscoreae Nipponicae Rhizoma, Polyporus, Cinnamomi Ramulus, Glycyrrhizae Radix Et Rhizome Praeparata Cum Melle is the key to the overall quality of Jingtian granule.
10.Epidemiological investigation of the first confirmed case of mpox in Huai'an, Jiangsu Province
Lei XYU ; Qiang GAO ; Pengfei YANG ; ZHENG ZHANG
Journal of Public Health and Preventive Medicine 2025;36(1):23-26
Objective To investigate the discovery and disposal process and epidemiological characteristics of the first confirmed case of mpox (formerly named monkeypox) in Huai'an, Jiangsu Province, and to provide reference for the prevention and control of key infectious diseases in this region. Methods The on-site epidemiological investigation data of the first confirmed case of mpox on June 21, 2023, as well as the results of nucleic acid detection and gene sequencing of laboratory specimens were analyzed retrospectively. Possible sources of infection were explored. Results The first confirmed case of mpox was an AIDS patient, men who had sex with men (MSM), who had no history of travel abroad or outside the city within 21 days before the onset of the disease, but had interacted with some people outside the city, and the epidemiological trajectory was complex. The detection of mpox virus nucleic acid was positive (BioGerm reagent: Ct value 21.8, ZhuoCheng reagent: Ct value 21.2). According to genetic sequencing, the first confirmed case was classified as C.1.1 lineage of clade IIb. During the investigation on the source of infection of the first confirmed case, one new asymptomatic infected person was found. Based on the epidemiological investigation and laboratory results, the first confirmed case was believed to be caused by local infection, however, the source of infection was unclear. Although there was an epidemiological association with asymptomatic infected people, the direct evidence of mutual infection was insufficient, and it could not be ruled out that there was still a hidden transmission chain between regions. The source of infection of the asymptomatic infected person was presumed to be the first confirmed case or an unidentified person with whom he had high-risk sex and caused anal bleeding. Conclusion The first confirmed case is caused by local infection. Awareness of case diagnosis and reporting in medical institutions should be improved, and publicity and education should be provided to key exposed populations, especially those men who have sex with men, to prevent the occurrence of large-scale local epidemic.


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