1.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
2.Preliminary application of sacral neuromodulation in patients with benign prostatic hyperplasia complicated with underactive bladder after transurethral resection of the prostate
Ning LIU ; Yan ZHANG ; Tao LI ; Qiang HU ; Kai LU ; Lei ZHANG ; Jianping WU ; Shuqiu CHEN ; Bin XU ; Ming CHEN
Journal of Modern Urology 2025;30(1):39-42
[Objective] To evaluate the efficacy and safety of sacral neuromodulation (SNM) in the treatment of patients with benign prostatic hyperplasia (BPH) complicated with underactive bladder (UAB) who respond poorly to transurethral resection of the prostate (TURP). [Methods] A retrospective analysis was performed on 10 patients with BPH and UAB treated with TURP by the same surgeon in Zhongda Hospital Southeast University during Jan.2018 and Jan.2023.The residual urine volume was not significantly relieved after operation, and the maximum urine flow rate and urine volume per discharge were not significantly improved.All patients underwent phase I SNM, and urinary diaries were recorded before and after surgery to observe the average daily frequency of urination, volume per urination, maximum urine flow rate, and residual urine volume. [Results] The operation time was (97.6±11.2) min.During the postoperative test of 2-4 weeks, if the residual urine volume reduction by more than 50% was deemed as effective, SNM was effective in 6 patients (60.0%). Compared with preoperative results, the daily frequency of urination [(20.2±3.8) times vs. (13.2±3.2) times], volume per urination [(119.2±56.7) mL vs. (246.5±59.2) mL], maximum urine flow rate [(8.7±1.5) mL/s vs. (16.5±2.6) mL/s], and residual urine volume [(222.5±55.0) mL vs. (80.8±16.0) mL] were significantly improved, with statistical significance (P<0.05). There were no complications such as bleeding, infection, fever or pain.The 6 patients who had effective outcomes successfully completed phase II surgery, and the fistula was removed.During the follow-up of 1 year, the curative effect was stable, and there were no complications such as electrode displacement, incision infection, or pain in the irritation sites.The residual urine volume of the other 4 unsuccessful patients did not improve significantly, and the electrodes were removed and the vesicostomy tube was retained. [Conclusion] SNM is safe and effective in the treatment of BPH with UAB patients with poor curative effects after TURP.
3.Role and mechanism of platelet-derived growth factor BB in repair of growth plate injury
Hongcheng PENG ; Guoxuan PENG ; Anyi LEI ; Yuan LIN ; Hong SUN ; Xu NING ; Xianwen SHANG ; Jin DENG ; Mingzhi HUANG
Chinese Journal of Tissue Engineering Research 2025;29(7):1497-1503
BACKGROUND:In the initial stage of growth plate injury inflammation,platelet-derived growth factor BB promotes the repair of growth plate injury by promoting mesenchymal progenitor cell infiltration,chondrogenesis,osteogenic response,and regulating bone remodeling. OBJECTIVE:To elucidate the action mechanism of platelet-derived growth factor BB after growth plate injury. METHODS:PubMed,VIP,WanFang,and CNKI databases were used as the literature sources.The search terms were"growth plate injury,bone bridge,platelet-derived growth factor BB,repair"in English and Chinese.Finally,66 articles were screened for this review. RESULTS AND CONCLUSION:Growth plate injury experienced early inflammation,vascular reconstruction,fibroossification,structural remodeling and other pathological processes,accompanied by the crosstalk of chondrocytes,vascular endothelial cells,stem cells,osteoblasts,osteoclasts and other cells.Platelet-derived growth factor BB,as an important factor in the early inflammatory response of injury,regulates the injury repair process by mediating a variety of cellular inflammatory responses.Targeting the inflammatory stimulation mediated by platelet-derived growth factor BB may delay the bone bridge formation process by improving the functional activities of osteoclasts,osteoblasts,and chondrocytes,so as to achieve the injury repair of growth plate.Platelet-derived growth factor BB plays an important role in angiogenesis and bone repair tissue formation at the injured site of growth plate and intrachondral bone lengthening function of uninjured growth plate.Inhibition of the coupling effect between angiogenesis initiated by platelet-derived growth factor BB and intrachondral bone formation may achieve the repair of growth plate injury.
4.Research progress on extrahepatic targeted delivery of mRNA-LNP
Lei LI ; Cai-li ZHAO ; Ning ZHANG ; Chun-lei LI
Acta Pharmaceutica Sinica 2025;60(2):359-368
Messenger ribonucleic acid (mRNA) is a promising therapeutic drug with great potential in the fields of immunology, oncology, vaccines and inborn metabolic diseases. However, due to its instability and susceptibility to nuclease degradation, efficient delivery vectors are required. Lipid nanoparticles (LNPs) are recognized as the most mature delivery vectors due to their advantages of easy formulation, high stability, efficient cell uptake and endosomal escape. However, the accumulation of LNPs in the liver severely limits the targeting and treatment of mRNA-LNP technology beyond the liver. To overcome this obstacle, researchers have been focusing on various means to achieve precise delivery of extrahepatic tissues and organs. This article mainly expounds the research progress of LNP-specific delivery mRNA from three aspects: endogenous targeting, active targeting and selection of administration route, in order to provide ideas and directions for the design of new mRNA-LNP delivery systems in the future.
5.The effect of rutaecarpine on improving fatty liver and osteoporosis in MAFLD mice
Yu-hao ZHANG ; Yi-ning LI ; Xin-hai JIANG ; Wei-zhi WANG ; Shun-wang LI ; Ren SHENG ; Li-juan LEI ; Yu-yan ZHANG ; Jing-rui WANG ; Xin-wei WEI ; Yan-ni XU ; Yan LIN ; Lin TANG ; Shu-yi SI
Acta Pharmaceutica Sinica 2025;60(1):141-149
Metabolic-associated fatty liver disease (MAFLD) and osteoporosis (OP) are two very common metabolic diseases. A growing body of experimental evidence supports a pathophysiological link between MAFLD and OP. MAFLD is often associated with the development of OP. Rutaecarpine (RUT) is one of the main active components of Chinese medicine Euodiae Fructus. Our previous studies have demonstrated that RUT has lipid-lowering, anti-inflammatory and anti-atherosclerotic effects, and can improve the OP of rats. However, whether RUT can improve both fatty liver and OP symptoms of MAFLD mice at the same time remains to be investigated. In this study, we used C57BL/6 mice fed a high-fat diet (HFD) for 4 months to construct a MAFLD model, and gave the mice a low dose (5 mg·kg-1) and a high dose (15 mg·kg-1) of RUT by gavage for 4 weeks. The effects of RUT on liver steatosis and bone metabolism were then evaluated at the end of the experiment [this experiment was approved by the Experimental Animal Ethics Committee of Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences (approval number: IMB-20190124D303)]. The results showed that RUT treatment significantly reduced hepatic steatosis and lipid accumulation, and significantly reduced bone loss and promoted bone formation. In summary, this study shows that RUT has an effect of improving fatty liver and OP in MAFLD mice.
6.Construction of a family-centered care program for children with tuberculosis based on the double ABC-X model and intervention effects evaluation
Ning DONG ; Lei SHEN ; Yonghong TAO ; Yuanhao WU ; Xiaowen WEI ; Lin ZHANG
Shanghai Journal of Preventive Medicine 2025;37(2):184-189
ObjectiveTo construct a family-centered care model for children with tuberculosis based on the double ABC-X model, and to evaluate its clinical effects. MethodsFrom December 2022 to October 2023, 64 newly admitted children with tuberculosis who met the criteria and their caregivers were recruited from the tuberculosis department of Shanghai Public Health Clinical Center were randomly divided into an experimental group (32 cases) and a control group (32 cases).The control group was given a conventional health care, while the experimental group was given a family-centered health care intervention based on the double ABC-X model, in which a multidisciplinary care team provided personalized information and emotional support for the caregivers and their children. Medication adherence of the children, caregiver’s teading burden, and disease management competence were compared between the 2 groups. ResultsA total of 29 cases in the experimental group and 27 cases in the control group completed the intervention. At 12 weeks of intervention, the medication adherence score (7.72±0.45 vs 7.41±0.50, P<0.05) and disease management competence score (36.97±7.85 vs 31.56±7.30, P<0.05) were higher in the experimental group than that in the control group while the caregiving burden score (31.79±13.40 vs 40.04±9.01, P<0.05) and difficulty of disease management score (30.41±12.41 vs 38.56±9.48, P<0.05) were lower than that in the control group. At 24 weeks of intervention, the medication adherence score (7.34±0.97 vs 6.70±1.14, P<0.05) and disease management competence score (42.07±6.93 vs 35.63±7.32, P<0.05) were higher in the experimental group than that in the control group as well, but the caregiving burden score (31.62±11.72 vs 39.63±10.17, P<0.05) and difficulty of disease management score (30.59±10.87 vs 37.81±9.32, P<0.05) were lower than that in the control group. ConclusionFamily-centered care based on the double ABC-X model can effectively promote medication adherence among children with tuberculosis, reduce caregivers’ care burden and disease management difficulties, and improve caregiver’s disease management competence.
7.Components and Brain-protective Effect of Chuanxiong Rhizoma-Paeoniae Radix Rubra in Improving Ischemic Stroke Based on UPLC-Q-TOF-MS
Qizhong JIN ; Jie ZHANG ; Lijuan XIU ; Fan XU ; Lei WANG ; Ning WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):20-29
ObjectiveTo investigate the chemical constituents of Chuanxiong Rhizoma-Paeoniae Radix Rubra(CRPRR) that cross the blood-brain barrier in rats with ischemic stroke, their brain-protective effects, and their impact on inflammatory factors including tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-18 (IL-18) based on ultra-high performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS) and pharmacodynamic experiments. MethodsA focal cerebral ischemia-reperfusion injury model was established in rats via the middle cerebral artery occlusion/reperfusion (MCAO/R) method using intraluminal suture. Neurological function was evaluated using behavioral scoring. UPLC-Q-TOF-MS was employed to identify the chemical constituents of CRPRR that crossed the blood-brain barrier and entered the cerebrospinal fluid in MCAO/R model rats. Male Sprague-Dawley rats were randomly divided into six groups: sham operation group, model group, low-, medium-, and high-dose CRPRR groups (1.35, 2.7, 5.4 g·kg-1, respectively), and an edaravone group (5 mg·kg-1), with 12 rats in each group. The sham and model groups received normal saline, while the treatment groups received the respective doses of CRPRR once daily by gavage for three consecutive weeks. The brain-protective effects of CRPRR were assessed using the Longa five-point scoring method, open field test, Morris water maze, 2,3,5-triphenyltetrazolium chloride (TTC) staining, hematoxylin and eosin (HE) staining, and transmission electron microscopy. ResultsNine chemical constituents were identified in the cerebrospinal fluid containing CRPRR, namely paeoniflorin, senkyunolide F, senkyunolide G, paeonimetabolin Ⅰ, paeoniflorin derivative, senkyunolide H, benzoylpaeoniflorin, senkyunolide A, and ligustilide. Animal experiment results showed that compared with the sham operation group, the model group exhibited disordered neuronal arrangement, severe vacuolation, nuclear pyknosis, and evident mitochondrial swelling. Chromatin aggregation and peripheralization were also observed. Neurological scores and the number of crossings in the central region were significantly increased (P<0.01), while platform crossings were significantly decreased (P<0.01), and clear infarct areas were present (P<0.01). Serum levels and protein expression of TNF-α, IL-1β, and IL-18 were significantly elevated (P<0.01). Compared with the model group, all dose groups of CRPRR showed marked improvement in neuronal morphology which was close to the normal level, with mitochondrial swelling alleviated and chromatin distribution more uniform. The medium- and high-dose groups significantly reduced neurological scores (P<0.01), while the low-, medium-, and high-dose groups significantly reduced the number of central crossings (P<0.01) and infarct volume (P<0.01), and decreased TNF-α, IL-1β, and IL-18 levels (P<0.05, P<0.01) compared with the model group. Furthermore, the medium- and high-dose groups significantly reduced TNF-α protein expression (P<0.05,P<0.01), and the high-dose group significantly reduced IL-1β and IL-18 protein expression (P<0.01). ConclusionThis study confirmed that CRPRR improves neurological function and alleviates brain tissue damage in MCAO/R rats. Its mechanism may be associated with the downregulation of inflammatory factors TNF-α, IL-1β, and IL-18, as well as the presence of nine active chemical constituents in cerebrospinal fluid, namely paeoniflorin, senkyunolide F, senkyunolide G, paeonimetabolin Ⅰ, paeoniflorin derivative, senkyunolide H, benzoylpaeoniflorin, senkyunolide A, and ligustilide, which are closely related to their brain-protective effects.
8.Components and Brain-protective Effect of Chuanxiong Rhizoma-Paeoniae Radix Rubra in Improving Ischemic Stroke Based on UPLC-Q-TOF-MS
Qizhong JIN ; Jie ZHANG ; Lijuan XIU ; Fan XU ; Lei WANG ; Ning WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):20-29
ObjectiveTo investigate the chemical constituents of Chuanxiong Rhizoma-Paeoniae Radix Rubra(CRPRR) that cross the blood-brain barrier in rats with ischemic stroke, their brain-protective effects, and their impact on inflammatory factors including tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-18 (IL-18) based on ultra-high performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS) and pharmacodynamic experiments. MethodsA focal cerebral ischemia-reperfusion injury model was established in rats via the middle cerebral artery occlusion/reperfusion (MCAO/R) method using intraluminal suture. Neurological function was evaluated using behavioral scoring. UPLC-Q-TOF-MS was employed to identify the chemical constituents of CRPRR that crossed the blood-brain barrier and entered the cerebrospinal fluid in MCAO/R model rats. Male Sprague-Dawley rats were randomly divided into six groups: sham operation group, model group, low-, medium-, and high-dose CRPRR groups (1.35, 2.7, 5.4 g·kg-1, respectively), and an edaravone group (5 mg·kg-1), with 12 rats in each group. The sham and model groups received normal saline, while the treatment groups received the respective doses of CRPRR once daily by gavage for three consecutive weeks. The brain-protective effects of CRPRR were assessed using the Longa five-point scoring method, open field test, Morris water maze, 2,3,5-triphenyltetrazolium chloride (TTC) staining, hematoxylin and eosin (HE) staining, and transmission electron microscopy. ResultsNine chemical constituents were identified in the cerebrospinal fluid containing CRPRR, namely paeoniflorin, senkyunolide F, senkyunolide G, paeonimetabolin Ⅰ, paeoniflorin derivative, senkyunolide H, benzoylpaeoniflorin, senkyunolide A, and ligustilide. Animal experiment results showed that compared with the sham operation group, the model group exhibited disordered neuronal arrangement, severe vacuolation, nuclear pyknosis, and evident mitochondrial swelling. Chromatin aggregation and peripheralization were also observed. Neurological scores and the number of crossings in the central region were significantly increased (P<0.01), while platform crossings were significantly decreased (P<0.01), and clear infarct areas were present (P<0.01). Serum levels and protein expression of TNF-α, IL-1β, and IL-18 were significantly elevated (P<0.01). Compared with the model group, all dose groups of CRPRR showed marked improvement in neuronal morphology which was close to the normal level, with mitochondrial swelling alleviated and chromatin distribution more uniform. The medium- and high-dose groups significantly reduced neurological scores (P<0.01), while the low-, medium-, and high-dose groups significantly reduced the number of central crossings (P<0.01) and infarct volume (P<0.01), and decreased TNF-α, IL-1β, and IL-18 levels (P<0.05, P<0.01) compared with the model group. Furthermore, the medium- and high-dose groups significantly reduced TNF-α protein expression (P<0.05,P<0.01), and the high-dose group significantly reduced IL-1β and IL-18 protein expression (P<0.01). ConclusionThis study confirmed that CRPRR improves neurological function and alleviates brain tissue damage in MCAO/R rats. Its mechanism may be associated with the downregulation of inflammatory factors TNF-α, IL-1β, and IL-18, as well as the presence of nine active chemical constituents in cerebrospinal fluid, namely paeoniflorin, senkyunolide F, senkyunolide G, paeonimetabolin Ⅰ, paeoniflorin derivative, senkyunolide H, benzoylpaeoniflorin, senkyunolide A, and ligustilide, which are closely related to their brain-protective effects.
9.Study on the correlation between hyperopia reserve and ocular biometric parameters after ciliary muscle paralysis in 4-14 year-old students from Hotan County, Xinjiang
Ning LI ; Yan WANG ; Lei YANG ; Qian PU ; AYINU·NULAHOU ; Xiaolong LI ; Yong ZHAO ; Yunxian GAO
International Eye Science 2025;25(8):1371-1376
AIM: To explore the relationship between hyperopia reserve and ocular biometric parameters in 4-14 year-old Uyghur students from Hotan County, Xinjiang, and to provide scientific evidence for myopia prevention.METHODS: From September 1 to October 31, 2023, a stratified random cluster sampling method was used to select 3 264 students(3 264 eyes)from 6 schools in Hotan County. Participants underwent uncorrected distance visual acuity testing, cycloplegic refraction, and ocular biometric measurements. The correlation between spherical equivalent(SE)and ocular biometric parameters was analyzed by multiple linear regression.RESULTS: A total of 1 998 non-myopic students(1 998 eyes)were included in the study, with 1 354 students(67.77%)showing insufficient hyperopia reserve. The detection rate of insufficient hyperopia reserve decreased with age, from 94.12% at age 4 to 18.13% at age 14(P<0.001). Multiple linear regression analysis showed that in the group with sufficient hyperopia reserve, age, gender, uncorrected distance visual acuity, axial length(AL), and keratometry(K)explained 66.5% of the variance in SE; while in the group with insufficient hyperopia reserve, these factors explained only 28.0% of the SE variance.CONCLUSION: In non-myopic Uyghur students aged 4-14 in Hotan County, Xinjiang, the detection rate of insufficient hyperopia reserve was 67.77%. In the group with insufficient hyperopia reserve, age, gender, AL, and K explained only a small portion of the SE variance, suggesting that the refractive status of this population may be influenced by more complex factors.
10.Analysis of the monitoring results of radiation health technical service quality in Jiangxi Province, 2022-2024
Zhe HUANG ; Ning ZHOU ; Lingling GUO ; Zhongwen XU ; Lei DENG
Chinese Journal of Radiological Health 2025;34(3):390-394
Objective To access the current situation of the service capacity of radiation health technical service institutions in Jiangxi Province, analyze the existing problems of these institutions, and provide a scientific basis for standardizing the management of such institutions and improving their service capability. Methods A total of 11 radiation health technical service institutions in Jiangxi Province in the National Occupational Health Technical Service Organization Management Information System were selected as the monitoring objects. During the period from 2022 to 2024, 5-6 technical service institutions were selected each year and comprehensively evaluated and inspected using a checklist formulated by the state. Results Among the 16 quality monitoring results of 11 institutions, 2 (12.5%) were rated as excellent, 12 (75%) as qualified, and 2 (12.5%) as unqualified. The risk level assessment identified 7 (43.75%) high-risk institutions, 9 (56.25%) medium-risk institutions, and 0 (0%) low-risk institutions. Conclusion The overall service capacity of radiation health technical service institutions in Jiangxi Province needs to be improved. Notably, institutions within the health system, such as centers for disease control and prevention, show significant shortcomings in both on-site and laboratory testing capabilities.

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