1.A Multi-dimensional Indicator-based Approach for Quality Evaluation of Chinese Patent Medicines
Shuangyan LI ; Siyuan LI ; Sha CHEN ; Yue GUO ; Jun ZHANG ; Cong GUO ; Yan LIU ; An LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(19):229-237
Chinese patent medicines are the core preparations for disease prevention and treatment in clinical traditional Chinese medicine (TCM). Their quality is the key to ensuring safe and effective medication and promoting the high-quality development of the TCM industry. At present, the quality evaluation of Chinese patent medicines faces prominent problems, such as inadequate control of quality consistency, over-reliance on single indicators, one-sided evaluation dimensions, unstable statistical methods, and poor implementability of research findings. These defects lead to insufficient scientificity of evaluation results, making it difficult to support the implementation of policies including centralized procurement, high quality, and favorable prices for Chinese patent medicines. According to the core requirements of quality evaluation for Chinese patent medicines, this study established a four-dimensional comprehensive evaluation system encompassing consistency index(CI), content index(MI), effect index(EI), and preparation index(PI). All evaluation indicators were normalized to achieve horizontal comparability. Meanwhile, an improved radar chart was introduced to realize the visualization of evaluation results. This method can systematically integrate four types of core quality attributes: Quality consistency, component content, biological activity, and preparation characteristics. It can effectively distinguish quality differences among products of the same specification from different manufacturers. The evaluation results are unique, stable, and not affected by the addition or reduction of samples, which takes scientificity, objectivity, and operability into account. This method can provide scientific and technical support for screening high-quality Chinese patent medicines and implementing policies of centralized procurement, high quality, and favorable prices. Moreover, it has important practical significance for improving the quality evaluation system of Chinese patent medicines and advancing the standard and modern development of TCM.
2.Quality Evaluation of Commercially Available Huoxiang Zhengqi Preparations
Yue GUO ; Siyuan LI ; Qingxia XU ; Sha CHEN ; Shuangyan LI ; Jipeng DI ; An LIU ; Yan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(19):238-247
ObjectiveTo establish a comprehensive evaluation framework combining multi-component quantification with daily intake in response to the challenges posed by multiple coexisting dosage forms, single-faceted quality evaluation, and ambiguous clinical equivalence of Huoxiang Zhengqi preparations, and to compare the quality differences and superiority among eight commercially available dosage forms. MethodsA total of 75 batches of Huoxiang Zhengqi preparations from 25 manufacturers were investigated. Ultra-performance liquid chromatography-triple quadrupole-tandem mass spectrometry (UPLC-QqQ-MS/MS) coupled with gas chromatography-triple quadrupole-tandem mass spectrometry (GC-QqQ-MS/MS) was adopted to simultaneously quantify 20 core marker components. Normalization was performed based on equivalent raw herb concentrations to eliminate interferences from dosage forms, excipients, and specifications. Considering the specified clinical dosage, the actual daily intake level was calculated to comprehensively evaluate component retention, content uniformity, and potential differences in in vivo exposure among different dosage forms. ResultsThe quality of Huoxiang Zhengqi preparations differed greatly among dosage forms and manufacturers. On the basis of the recommended daily doses in the package inserts, the total daily intake of the 20 tested components ranged from 3.14 to 614.30 mg·d-1, while that of hesperidin, a quality-control marker, ranged from 0.03 to 40.65 mg·d-1. Atractylodin was detected only in tinctures and soft capsules, with concentrations ranging from (2.68±0.01) to (5.73±0.37) mg·L-1. The soft capsules from manufacturer M22 had the highest atractylodin level, while atractylodin was not detected in the other dosage forms. Nucleosides were most abundant in the oral liquids and tinctures (M4 to M13). The tincture from manufacturer M5 showed the highest nucleoside level of 29.12 mg·L-1, whereas the granules had the lowest nucleoside levels, with that of M23 being only 3.48 mg·L-1. Perillae Folium-related components varied greatly among batches, with an relative standard deviation (RSD) of 87.55%. The daily intake of hesperidin from all three granule products was below 3.6 mg·d-1, the reference value calculated for Huoxiang Zhengqi Shui according to the 2025 edition of the Chinese Pharmacopoeia. ConclusionThe levels of active components differed significantly among different dosage forms of Huoxiang Zhengqi preparations. Tinctures contained more types and higher overall levels of active components, while soft capsules were better at preserving volatile components. Granules and dripping pills had lower overall levels of active components. The comprehensive evaluation method established in this study can provide a basis for the quality control, process optimization, and the selection of high-quality products.
3. Determination of docusate sodium by ion-pair high-performance liquid chromatography
Lirong CAI ; Haiping SHU ; Sha XIAO ; Yue TAN ; Jinfeng ZHENG ; Changliang LI ; Yanming LIU
Journal of China Pharmaceutical University 2025;56(2):183-187
To reduce the dependency on high-carbon-load chromatographic columns,a new method has been established for the determination of the content of docusate sodium using ion-pair high-performance liquid chromatography (IP-HPLC). Tetrapropylammonium chloride was used as the ion-pair reagent with a mobile phase, composition of acetonitrile:10 mmol/L tetrapropylammonium chloride solution = 66∶34, adjusting pH to 6.5 with 0.1% phosphoric acid solution,flow rate of 1.5 mL/min, detection wavelength of 214 nm,column temperature of 35 °C, and an injection volume of 25 μL,and quantified by an external standard method. The main peak of docusate sodium exhibited a tailing factor of 1.34. The method showed good linearity within the range of 0.02 mg/mL to 0.40 mg/mL, with a correlation coefficient (r) of 0.999 9. It also demonstrated good repeatability, with recovery ranging from 97.0% to 98.2% (n=6). The quantification limit was 3.31 μg/mL, and the detection limit was 2.76 μg/mL.In summary,the new method shows good durability, a wide linear range, and high sensitivity, it is suitable for the determination of docusate sodium.
4.Correlation of seminal plasma oxidation reduction potential and sperm DNA fragmentation index to sperm motion parameters and their predictive value for oligoasthenozoospermia.
Li-Sha CHEN ; Ning ZHANG ; Xing-Chi LIU ; Qian ZHANG ; Li-Yan LI ; Yue-Xin YU
National Journal of Andrology 2025;31(1):11-18
OBJECTIVE:
To investigate the correlation of seminal plasma oxidation reduction potential (ORP), normalized oxidation-reduction potential (nORP) and sperm DNA fragmentation index (DFI) to sperm motion parameters, and their clinical predictive value for oligoasthenozoospermia (OAZ).
METHODS:
This study included 433 male subjects visiting the Clinic of Andrology in our hospital from March to May 2024. According to sperm concentration and the percentage of progressively motile sperm (PMS), we divided them into a normal control (n = 119), an oligozoospermia (OZ, n = 118), an athenozoospermia (AZ, n = 119) and an OAZ group (n = 77). Using the electrode method, we measured the seminal plasma ORP, calculated nORP=ORP/sperm concentration (mV/[10⁶/ml]), and determined DFI and high DNA chromatin sperm (HDS) by flow cytometry based on sperm chromatin structure assay (SCSA), followed by comparison among the four groups in age, abstinence days, semen volume, total sperm count, sperm concentration, PMS, non-progressively motile sperm (NPMS), immotile sperm (IMS), curvilinear velocity (VCL), straight line velocity (VSL), average path velocity (VAP), linearity (LIN), straightness(STR), wobble (WOB), DFI, HDS, ORP and nORP. Using the receiver operating characteristic (ROC) curve, we assessed the predictive value of DFI, ORP and nORP for OAZ, and analyzed the correlation of DFI, ORP and nORP to sperm motion parameters by Pearson and Spearman analyses.
RESULTS:
Statistical analysis revealed statistically significant differences among the four groups in semen volume, abstinence days, total sperm count, sperm concentration, PMS, NPMS, IMS, total sperm motility, VCL, VSL, VAP, STR, DFI, HDS, ORP and nORP (P < 0.05), but not in age, LIN and WOB (P > 0.05). The area under the ROC curve (AUC) for the predictive value of DFI for OAZ was 0.880, with the critical value of 8.920, sensitivity of 74.8% and specificity of 88.2%; that of ORP for AZ was 0.698, with the critical value of 155.375, sensitivity of 70.6% and specificity of 64.7%; and that of nORP for OZ was 0.999, with the critical value of 9.844, sensitivity of 98.3% and specificity of 99.2%. Pearson and Spearman correlation analyses showed that DFI was correlated positively with age, abstinence days, semen volume, IMS, HDS and ORP, but negatively with PMS, NPMS, total sperm motility, VCL, VSL, VAP and STR; ORP positively with abstinence days, semen volume, IMS, DFI and nORP, but negatively with PMS, NPMS, total sperm motility, VSL, LIN and STR; and nORP positively with HDS, but negatively with abstinence days, total sperm count, sperm concentration, PMS and NPMS.
CONCLUSION
Oxidative stress (OS) may be an important pathological factor for elevated ORP, increased DFI and changes of routine sperm motion parameters, consequently leading to OAZ. As OS markers, DFI and ORP have a high predictive value for OS-induced OAZ.
Male
;
Humans
;
DNA Fragmentation
;
Semen/metabolism*
;
Sperm Motility
;
Spermatozoa
;
Oxidation-Reduction
;
Adult
;
Oligospermia
;
Sperm Count
;
Semen Analysis
;
Asthenozoospermia
5.Clinical characteristics of patients with pregnancy-related chronic pain visiting pain clinic
Dan WANG ; Qingshan LIU ; Lei HUA ; Kai SHA ; Beibei ZHOU ; Shu ZHANG ; Xiaofeng SHEN ; Li YUE
Chinese Journal of Anesthesiology 2025;45(10):1304-1308
Objective:To analyze the clinical characteristics of patients with pregnancy-related chronic pain visiting the pain clinic.Methods:The number of pregnant patients who completed a pregnancy registration at the Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University from 2022 to 2024 was collected. The medical records were reviewed to identify the patients who visited the department of pain of our hospital due to chronic pain related to pregnancy. The clinical characteristics such as the visiting situation, gestational weeks, age and types of pain were analyzed.Results:From 2022 to 2024, the total number of registered pregnant patients was 64, 818, of which, 2, 224 cases visited the pain clinic, and the annual proportions of pregnancy-related chronic pain visits were 2.540%, 3.836% and 3.889% respectively. Among the patients who attended the clinic, 77.97% were pregnant (5.82% in early pregnancy, 41.93% in mid-pregnancy, and 52.25% in late pregnancy), and 21.03% were postpartum patients. A total of 83.72% were aged 20-34 yr. The types of pain were pelvic girdle pain (40.96%), limb joint pain (28.82%), low back pain (14.16%), cervical spondylosis (3.64%), peripheral nerve entrapment syndrome (3.42%), headache (2.97%), chest and back pain (2.79%), pelvic and perineal pain (1.66%), neuralgia (0.94%) and other pains (0.63%).Conclusions:From 2022 to 2024, the proportion of registered pregnant women at our hospital who visited to the pain clinic due to pregnancy-related chronic pain increases year by year. The common types of pain are pelvic girdle pain, limb joint pain and low back pain.
6.Operation efficiency of community health centers in Chaoyang district,Beijing:Based on DEA-Malmquist analysis
Zheng WANG ; Yue CHEN ; Sha-sha YUAN
Chinese Journal of Health Policy 2025;18(7):44-51
Objective:To analyze the operation efficiency of community health centers with inpatient beds in Chaoyang District,Beijing,providing evidence-based support for optimizing community health centers health resource allocation under the hierarchical medical system.Methods:Data on health resource inputsand service outputs were collected from all 10 eligible community health centers in Chaoyang District(2018-2023).Static efficiency was evaluated using the DEA-BCC model,while dynamic efficiency was assessed via the Malmquist index model.Results:Human capital input showed a year-on-year increase.Inpatient beds,outpatient visits,and inpatient discharges exhibited a fluctuating upward trend overall,with 2020 as a turning point.Static efficiency analysis revealed that mean technical efficiency first increased then decreased.The proportion of institutions exhibiting decreasing returns to scale decreased from 60%(2018)to 20%(2023).Dynamic efficiency analysis indicated that total factor productivity(TFP)fluctuated in a"rise → decline → rise → decline → rise"pattern,with a marginal overall decrease(mean:0.998).Conclusion:The technological change index was identified as the core driver of TFP changes in the sample community health centers during 2018 and 2023.Given the continuous increase in human capital input,future efforts to optimize health resource allocation should prioritize enhancing technical efficiency and technological advancement.
7.Repurposing drugs for the human dopamine transporter through WHALES descriptors-based virtual screening and bioactivity evaluation.
Ding LUO ; Zhou SHA ; Junli MAO ; Jialing LIU ; Yue ZHOU ; Haibo WU ; Weiwei XUE
Journal of Pharmaceutical Analysis 2025;15(8):101368-101368
Computational approaches, encompassing both physics-based and machine learning (ML) methodologies, have gained substantial traction in drug repurposing efforts targeting specific therapeutic entities. The human dopamine (DA) transporter (hDAT) is the primary therapeutic target of numerous psychiatric medications. However, traditional hDAT-targeting drugs, which interact with the primary binding site, encounter significant limitations, including addictive potential and stimulant effects. In this study, we propose an integrated workflow combining virtual screening based on weighted holistic atom localization and entity shape (WHALES) descriptors with in vitro experimental validation to repurpose novel hDAT-targeting drugs. Initially, WHALES descriptors facilitated a similarity search, employing four benztropine-like atypical inhibitors known to bind hDAT's allosteric site as templates. Consequently, from a compound library of 4,921 marketed and clinically tested drugs, we identified 27 candidate atypical inhibitors. Subsequently, ADMETlab was employed to predict the pharmacokinetic and toxicological properties of these candidates, while induced-fit docking (IFD) was performed to estimate their binding affinities. Six compounds were selected for in vitro assessments of neurotransmitter reuptake inhibitory activities. Among these, three exhibited significant inhibitory potency, with half maximal inhibitory concentration (IC50) values of 0.753 μM, 0.542 μM, and 1.210 μM, respectively. Finally, molecular dynamics (MD) simulations and end-point binding free energy analyses were conducted to elucidate and confirm the inhibitory mechanisms of the repurposed drugs against hDAT in its inward-open conformation. In conclusion, our study not only identifies promising active compounds as potential atypical inhibitors for novel therapeutic drug development targeting hDAT but also validates the effectiveness of our integrated computational and experimental workflow for drug repurposing.
8.Role of DHA in long-term cognitive impairment after multiple sevoflurane anesthesia in newborn mice
Sufang JIANG ; Jiaqi LI ; Tianyu CAO ; Jiaqi YUE ; Lichao DI ; Shizhao WANG ; Fuzhen ZHANG ; Rongtian KANG ; Huan CHEN ; Huixian CUI ; Sha LI ; Lining HUANG
Chinese Journal of Anesthesiology 2025;45(5):559-563
Objective:To evaluate the role of docosahexaenoic acid (DHA) in long-term cognitive impairment after multiple sevoflurane anesthesia in newborn mice.Methods:Clean-grade healthy male C57BL/6 mice, aged 6 days, were used in this study. Ten mice were divided into 2 groups ( n=5 each) by the random number table method: control group (group C) and sevoflurane group (group S). The animals inhaled 3% sevoflurane for 2 h at 6, 7 and 8 days after birth. The DHA content was detected by ultra-high performance liquid chromatography-mass spectrometry at 9 days of age. Fifty-two mice were selected and divided into 4 groups ( n=13 each) by a random number table method: control+ normal saline group (group C+ S), sevoflurane anesthesia + normal saline group (group S+ S), control+ DHA group (group C+ D), and sevoflurane anesthesia+ DHA group (group S+ D). The sevoflurane anesthesia method was the same as the one mentioned above. DHA 50 mg/kg was administered by intragastric gavage from postnatal days 6-19 (at 6, 7 and 8 days after birth, 2 h before anesthesia) in C+ D and S+ D groups. The equal volume of normal saline was given instead in C+ S group and S+ S group. The novel object recognition test was conducted at 37 days of age, and the Morris water maze test was performed at 42 days of age. The corpus callosum and hippocampal tissues were isolated at 47 days of age for examination of the ultrastructure of myelin (with a transmission electron microscope) and for determination of the expression of myelin basic protein (MBP) in hippocampal tissues (by Western blot). The G-ratio was calculated. Results:Compared with group C, the content of DHA in hippocampal tissues was significantly decreased in group S ( P<0.05). Compared with group C+ S, the discrimination index was significantly decreased, the percentage of duration of staying at the target platform quadrant and the number of crossing the original platform were decreased, the expression of MBP was down-regulated, and the G-ratio in the original platform and hippocampus was increased in S+ S group ( P<0.05). Compared with group S+ S, the discrimination index was significantly increased, the percentage of duration of staying at the target platform quadrant and the number of crossing the original platform were increased, the expression of MBP was up-regulated, and the G-ratio in the original platform and hippocampus was decreased in S+ D group ( P<0.05). Conclusions:The mechanism of long-term cognitive impairment following multiple sevoflurane anesthesia may be related to a decrease in the content of DHA, which subsequently leads to myelin structural damage in neonatal mice.
9.Clinical characteristics of patients with pregnancy-related chronic pain visiting pain clinic
Dan WANG ; Qingshan LIU ; Lei HUA ; Kai SHA ; Beibei ZHOU ; Shu ZHANG ; Xiaofeng SHEN ; Li YUE
Chinese Journal of Anesthesiology 2025;45(10):1304-1308
Objective:To analyze the clinical characteristics of patients with pregnancy-related chronic pain visiting the pain clinic.Methods:The number of pregnant patients who completed a pregnancy registration at the Obstetrics and Gynecology Hospital Affiliated to Nanjing Medical University from 2022 to 2024 was collected. The medical records were reviewed to identify the patients who visited the department of pain of our hospital due to chronic pain related to pregnancy. The clinical characteristics such as the visiting situation, gestational weeks, age and types of pain were analyzed.Results:From 2022 to 2024, the total number of registered pregnant patients was 64, 818, of which, 2, 224 cases visited the pain clinic, and the annual proportions of pregnancy-related chronic pain visits were 2.540%, 3.836% and 3.889% respectively. Among the patients who attended the clinic, 77.97% were pregnant (5.82% in early pregnancy, 41.93% in mid-pregnancy, and 52.25% in late pregnancy), and 21.03% were postpartum patients. A total of 83.72% were aged 20-34 yr. The types of pain were pelvic girdle pain (40.96%), limb joint pain (28.82%), low back pain (14.16%), cervical spondylosis (3.64%), peripheral nerve entrapment syndrome (3.42%), headache (2.97%), chest and back pain (2.79%), pelvic and perineal pain (1.66%), neuralgia (0.94%) and other pains (0.63%).Conclusions:From 2022 to 2024, the proportion of registered pregnant women at our hospital who visited to the pain clinic due to pregnancy-related chronic pain increases year by year. The common types of pain are pelvic girdle pain, limb joint pain and low back pain.
10.CT and MRI manifestations of Rosai-Dorfman disease in nasal cavity and paranasal sinus
Luxi WANG ; Lifen ZHANG ; Yue NIU ; Wei CHEN ; Hanyu XIAO ; Yiyin ZHANG ; Yan SHA
Chinese Journal of Radiology 2025;59(3):293-298
Objective:To explore the CT and MRI features of Rosai-Dorfman disease (RDD) in nasal cavity and paranasal sinus.Methods:The study was a cross-sectional study. From July 2007 to August 2023, the imaging findings of 23 patients with pathologically confirmed sinonasal RDD were retrospectively analyzed in the Eye & ENT Hospital of Fudan University. Among 23 patients, there were nine males and 14 females with 44±16 years old. Imaging features including tumor location, the extent, density, signal, enhancement pattern of tumors, bone change, abnormal lesions in peripheral lymph nodes and other regions were recorded. The apparent diffusion coefficient (ADC) value of lesions in patients performed diffusion weighted imaging (DWI) were measured.Results:For the 23 cases, totally 20 patients showed bilateral sinonasal involvement and three patients had unilateral lesions. Totally nine patients had lesions confined to the nasal cavity and paranasal sinuses, and 14 patients had lesions with extrasinonasal invasion, including orbit (6 cases), nasolacrimal duct (9 cases), anterior skull base (3 cases), nasal dorsum subcutaneous tissue (2 cases) and hard palate (1 case). Soft tissue lesions on the posterior wall of the subglottic trachea were found in 2 cases and intracranial lesions were found in 1 case. Totally 10 patients were accompanied by lymph nodes enlargement. The lesions showed isodense on all 20 non-contrast enhanced CT images, and mild enhancement in three cases, moderate enhancement in seven cases and significant enhancement in seven cases on CT enhancement images. Bone changes were found in 19 of 20 patients on CT, showing mild bone destruction in five cases and bone destruction with hyperplasia in 14 cases. The lesions showed isointense on T 1WI in all 14 cases. The lesions were graded as isointense in nine cases, hypointense in four cases and hyperintense in one case on T 2WI. The lesions displayed moderate to obvious homogeneous enhancement on enhanced MRI. The lesions showed significant diffusion limitation and ADC value was (0.66±0.08)×10 -3 mm 2/s in 11 cases on DWI. Conclusions:The CT and MRI imaging characteristics of sinonasal RDD are diffuse masses on both sides of nasal cavity and paranasal sinuses, accompanied by bone hyperplasia. The lesions show isointense or hypointense on T 2WI, and may involve adjacent tissues and may be accompanied by lymph nodes enlargement in the retropharyngeal and neck.

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