1.Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis
Jian LIU ; Hongchun ZHANG ; Chengxiang WANG ; Hongsheng CUI ; Xia CUI ; Shunan ZHANG ; Daowen YANG ; Cuiling FENG ; Yubo GUO ; Zengtao SUN ; Huiyong ZHANG ; Guangxi LI ; Qing MIAO ; Sumei WANG ; Liqing SHI ; Hongjun YANG ; Ting LIU ; Fangbo ZHANG ; Sheng CHEN ; Wei CHEN ; Hai WANG ; Lin LIN ; Nini QU ; Lei WU ; Dengshan WU ; Yafeng LIU ; Wenyan ZHANG ; Yueying ZHANG ; Yongfen FAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):182-188
The Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis (GS/CACM 337-2023) was released by the China Association of Chinese Medicine on December 13th, 2023. This expert consensus was developed by experts in methodology, pharmacy, and Chinese medicine in strict accordance with the development requirements of the China Association of Chinese Medicine (CACM) and based on the latest medical evidence and the clinical medication experience of well-known experts in the fields of respiratory medicine (pulmonary diseases) and pediatrics. This expert consensus defines the application of Qinbaohong Zhike oral liquid in the treatment of cough and excessive sputum caused by phlegm-heat obstructing lung, acute bronchitis, and acute attack of chronic bronchitis from the aspects of applicable populations, efficacy evaluation, usage, dosage, drug combination, and safety. It is expected to guide the rational drug use in medical and health institutions, give full play to the unique value of Qinbaohong Zhike oral liquid, and vigorously promote the inheritance and innovation of Chinese patent medicines.
2.Analysis of abnormal individual dose monitoring results in 206 medical institutions in a selected region in 2024
Hua TUO ; Wenyan LI ; Lantao LIU ; Guiying ZHANG ; Zeqin GUO ; Heyan WU
Chinese Journal of Radiological Health 2025;34(4):471-476
Objective To analyze the abnormal individual dose monitoring results in 206 medical institutions in a selected region in 2024, and to propose improvement measures. Methods Individuals with monitoring results exceeding the investigation level were subjected to high-dose investigation, and the results were statistically analyzed. Results In 2024, the individual dose monitoring of 206 medical institutions in a selected region showed 1.04% abnormal results. The proportions of abnormal results from primary, secondary, and tertiary medical institutions were 12.22%, 3.33%, and 84.45%, respectively. In analysis of the causes of abnormal results, 52.53% of the cases were due to personal dosimeters left in the radiation workplace, and 20.20% were due to the confusion in wearing personal dosimeters inside and outside the lead apron. In analysis of the occupational distribution of the radiation workers with abnormal monitoring results, interventional radiology and diagnostic radiology accounted for 73.34% and 24.44%, respectively. Statistical analysis of the dose range showed that doses in the ranges of 1.25-2.0 mSv and 2.0-5.0 mSv accounted for 42.22% and 33.33%, respectively. In the report of abnormal monitoring results, the proportions of reporting notional dose and reporting measured results accounted for 88.89% and 11.11%, respectively. Among institutions with consecutive abnormal results, primary, secondary, and tertiary medical institutions accounted for 15.39%, 7.69%, and 76.92%, respectively. Conclusion The level of the hospital, occupational type, the perceived importance of the hospital to the management of radiation protection, and the perceived importance and compliance of the radiation workers with the individual dose monitoring are potential causes of abnormal results. It is recommended that employers should enhance radiation protection training for their radiation workers to ensure proper wearing and storage of dosimeters, and progressively improve the standardization and effectiveness of individual dose monitoring practice.
3.Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study.
Wenyan KANG ; Chao GAO ; Xiaoyan LI ; Xiaoxue WANG ; Huizhu ZHONG ; Qiao WEI ; Yonghua TANG ; Peijian HUANG ; Ruinan SHEN ; Lingyun CHEN ; Jing ZHANG ; Rong FANG ; Wei WEI ; Fengjuan ZHANG ; Gaiyan ZHOU ; Weihong YUAN ; Xi CHEN ; Zhao YANG ; Ying WU ; Wenli XU ; Shuo ZHU ; Liwen ZHANG ; Naying HE ; Weihuan FANG ; Miao ZHANG ; Yu ZHANG ; Huijun JU ; Yaya BAI ; Jun LIU
Chinese Medical Journal 2025;138(22):2907-2916
INTRODUCTION:
Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD.
METHODS:
In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging.
RESULTS:
A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline.
CONCLUSIONS:
Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies.
REGISTRATION
ClinicalTrials.gov , NCT07034222.
Humans
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Alzheimer Disease/drug therapy*
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Male
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Female
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Aged
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Middle Aged
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Cognitive Dysfunction/drug therapy*
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Aged, 80 and over
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Amyloid beta-Peptides/metabolism*
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Biomarkers
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East Asian People
4.Prospective randomised controlled observation of tympanic chamber injection of gangliosides in the treatment of refractory sudden deafness.
Mengyuan WANG ; Qi DONG ; Yuqin XU ; Yaxiu LI ; Jing LIU ; Jie LI ; Wenyan ZHU ; Wandong SHE
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(3):218-222
Objective:This study aimed to evaluate the therapeutic effect of intratympanic injection of ganglioside in patients with refractory sudden deafness. Methods:A total of 120 patients with sudden deafness, aged 18-65 years, whose onset was within 11-42 days, failed to respond to conventional treatment, and had an average hearing threshold(500-4 000 Hz)>60 dB were selected. They were prospectively and randomly divided into a control group of 61 cases and an experimental group of 59 cases. The control group was treated according to the recommended protocol of the Chinese Medical Association(postauricular injection of methylprednisolone), while the experimental group was treated with intratympanic injection of monosialotetrahexosylganglioside sodium+postauricular injection of methylprednisolone. Both groups were simultaneously administered oral ginkgo biloba extract and citicoline tablets. Hearing was re-examined two weeks after the completion of treatment, and the therapeutic effects of the two different treatment methods were compared and analyzed. Results:The effective rate was 29.51% in the control group and 54.24% in the experimental group(P<0.01). The average hearing threshold improved by 11.57 dB HL in the control group and 22.50 dB HL in the experimental group(P<0.05). Conclusion:The combination of postauricular injection of methylprednisolone and intratympanic injection of ganglioside is more effective than postauricular injection of methylprednisolone alone in the treatment of refractory sudden deafness. The earlier the treatment, the better the therapeutic effect.
Humans
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Middle Aged
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Hearing Loss, Sudden/drug therapy*
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Adult
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Prospective Studies
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Young Adult
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Aged
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Adolescent
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Male
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Female
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Injection, Intratympanic
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Gangliosides/administration & dosage*
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Methylprednisolone/therapeutic use*
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Treatment Outcome
5.Expert consensus on prognostic evaluation of cochlear implantation in hereditary hearing loss.
Xinyu SHI ; Xianbao CAO ; Renjie CHAI ; Suijun CHEN ; Juan FENG ; Ningyu FENG ; Xia GAO ; Lulu GUO ; Yuhe LIU ; Ling LU ; Lingyun MEI ; Xiaoyun QIAN ; Dongdong REN ; Haibo SHI ; Duoduo TAO ; Qin WANG ; Zhaoyan WANG ; Shuo WANG ; Wei WANG ; Ming XIA ; Hao XIONG ; Baicheng XU ; Kai XU ; Lei XU ; Hua YANG ; Jun YANG ; Pingli YANG ; Wei YUAN ; Dingjun ZHA ; Chunming ZHANG ; Hongzheng ZHANG ; Juan ZHANG ; Tianhong ZHANG ; Wenqi ZUO ; Wenyan LI ; Yongyi YUAN ; Jie ZHANG ; Yu ZHAO ; Fang ZHENG ; Yu SUN
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(9):798-808
Hearing loss is the most prevalent disabling disease. Cochlear implantation(CI) serves as the primary intervention for severe to profound hearing loss. This consensus systematically explores the value of genetic diagnosis in the pre-operative assessment and efficacy prognosis for CI. Drawing upon domestic and international research and clinical experience, it proposes an evidence-based medicine three-tiered prognostic classification system(Favorable, Marginal, Poor). The consensus focuses on common hereditary non-syndromic hearing loss(such as that caused by mutations in genes like GJB2, SLC26A4, OTOF, LOXHD1) and syndromic hereditary hearing loss(such as Jervell & Lange-Nielsen syndrome and Waardenburg syndrome), which are closely associated with congenital hearing loss, analyzing the impact of their pathological mechanisms on CI outcomes. The consensus provides recommendations based on multiple round of expert discussion and voting. It emphasizes that genetic diagnosis can optimize patient selection, predict prognosis, guide post-operative rehabilitation, offer stratified management strategies for patients with different genotypes, and advance the application of precision medicine in the field of CI.
Humans
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Cochlear Implantation
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Prognosis
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Hearing Loss/surgery*
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Consensus
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Connexin 26
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Mutation
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Sulfate Transporters
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Connexins/genetics*
6.Expert consensus on the diagnosis and treatment of cemental tear.
Ye LIANG ; Hongrui LIU ; Chengjia XIE ; Yang YU ; Jinlong SHAO ; Chunxu LV ; Wenyan KANG ; Fuhua YAN ; Yaping PAN ; Faming CHEN ; Yan XU ; Zuomin WANG ; Yao SUN ; Ang LI ; Lili CHEN ; Qingxian LUAN ; Chuanjiang ZHAO ; Zhengguo CAO ; Yi LIU ; Jiang SUN ; Zhongchen SONG ; Lei ZHAO ; Li LIN ; Peihui DING ; Weilian SUN ; Jun WANG ; Jiang LIN ; Guangxun ZHU ; Qi ZHANG ; Lijun LUO ; Jiayin DENG ; Yihuai PAN ; Jin ZHAO ; Aimei SONG ; Hongmei GUO ; Jin ZHANG ; Pingping CUI ; Song GE ; Rui ZHANG ; Xiuyun REN ; Shengbin HUANG ; Xi WEI ; Lihong QIU ; Jing DENG ; Keqing PAN ; Dandan MA ; Hongyu ZHAO ; Dong CHEN ; Liangjun ZHONG ; Gang DING ; Wu CHEN ; Quanchen XU ; Xiaoyu SUN ; Lingqian DU ; Ling LI ; Yijia WANG ; Xiaoyuan LI ; Qiang CHEN ; Hui WANG ; Zheng ZHANG ; Mengmeng LIU ; Chengfei ZHANG ; Xuedong ZHOU ; Shaohua GE
International Journal of Oral Science 2025;17(1):61-61
Cemental tear is a rare and indetectable condition unless obvious clinical signs present with the involvement of surrounding periodontal and periapical tissues. Due to its clinical manifestations similar to common dental issues, such as vertical root fracture, primary endodontic diseases, and periodontal diseases, as well as the low awareness of cemental tear for clinicians, misdiagnosis often occurs. The critical principle for cemental tear treatment is to remove torn fragments, and overlooking fragments leads to futile therapy, which could deteriorate the conditions of the affected teeth. Therefore, accurate diagnosis and subsequent appropriate interventions are vital for managing cemental tear. Novel diagnostic tools, including cone-beam computed tomography (CBCT), microscopes, and enamel matrix derivatives, have improved early detection and management, enhancing tooth retention. The implementation of standardized diagnostic criteria and treatment protocols, combined with improved clinical awareness among dental professionals, serves to mitigate risks of diagnostic errors and suboptimal therapeutic interventions. This expert consensus reviewed the epidemiology, pathogenesis, potential predisposing factors, clinical manifestations, diagnosis, differential diagnosis, treatment, and prognosis of cemental tear, aiming to provide a clinical guideline and facilitate clinicians to have a better understanding of cemental tear.
Humans
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Dental Cementum/injuries*
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Consensus
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Diagnosis, Differential
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Cone-Beam Computed Tomography
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Tooth Fractures/therapy*
7.Early warning method for invasive mechanical ventilation in septic patients based on machine learning model.
Wanjun LIU ; Wenyan XIAO ; Jin ZHANG ; Juanjuan HU ; Shanshan HUANG ; Yu LIU ; Tianfeng HUA ; Min YANG
Chinese Critical Care Medicine 2025;37(7):644-650
OBJECTIVE:
To develop a method for identifying high-risk patients among septic populations requiring mechanical ventilation, and to conduct phenotypic analysis based on this method.
METHODS:
Data from four sources were utilized: the Medical Information Mart for Intensive Care (MIMIC-IV 2.0, MIMIC-III 1.4), the Philips eICU-Collaborative Research Database 2.0 (eICU-CRD 2.0), and the Anhui Medical University Second Affiliated Hospital dataset. The adult patients in intensive care unit (ICU) who met Sepsis-3 and received invasive mechanical ventilation (IMV) on the first day of first admission were enrolled. The MIMIC-IV dataset with the highest data integrity was divided into a training set and a test set at a 6:1 ratio, while the remaining datasets were served as validation sets. The demographic information, comorbidities, laboratory indicators, commonly used ICU scores, and treatment measures of patients were extracted. Clinical data collected within first day of ICU admission were used to calculate the sequential organ failure assessment (SOFA) score. K-means clustering was applied to cluster SOFA score components, and the sum of squared errors (SSE) and Davies-Bouldin index (DBI) were used to determine the optimal number of disease subtypes. For clustering results, normalized methods were employed to compare baseline characteristics by visualization, and Kaplan-Meier curves were used to analyze clinical outcomes across phenotypes.
RESULTS:
This study enrolled patients from MIMIC-IV dataset (n = 11 166), MIMIC-III dataset (n = 4 821), eICU-CRD dataset (n = 6 624), and a local dataset (n = 110), with the four datasets showing similar median ages and male proportions exceeding 50%; using 85% of the MIMIC-IV dataset as the training set, 15% as the test set, and the rest dataset as the validation set. K-means clustering based on the six-item SOFA score was performed to determine the optimal number of clusters as 3, and patients were finally classified into three phenotypes. In the training set, compared with the patients with phenotype II and phenotype III, those with phenotype I had the more severe circulatory and respiratory dysfunction, a higher proportion of vasoactive drug usage, more obvious metabolic acidosis and hypoxia, and a higher incidence of congestive heart failure. The patients with phenotype II was dominated by respiratory dysfunction with higher visceral injury. The patients with phenotype III had relatively stable organ function. The above characteristics were consistent in both the test and validation sets. Analysis of infection-related indicators showed that the patients with phenotype I had the highest SOFA score within 7 days after ICU admission, initial decreases and later increases in platelet count (PLT), and higher counts of neutrophils, lymphocytes, and monocytes as compared with those with phenotype II and phenotype III, their blood cultures had a higher positivity rates for Gram-positive bacteria, Gram-negative bacteria and fungi as compared with those with phenotype II and phenotype III. The Kaplan-Meier curve indicated that in the training, test, and validation sets, the 28-day cumulative mortality of patients with phenotype I was significantly higher than that of patients with phenotypes II and phenotype III.
CONCLUSIONS
Three distinct phenotypes in septic patients receiving IMV based on unsupervised machine learning is derived, among which phenotype I, characterized by cardiorespiratory failure, can be used for the early identification of high-risk patients in this population. Moreover, this population is more prone to bloodstream infections, posing a high risk and having a poor prognosis.
Humans
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Machine Learning
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Sepsis/therapy*
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Respiration, Artificial
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Intensive Care Units
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Organ Dysfunction Scores
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Male
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Female
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Middle Aged
;
Adult
8.Association between albumin and recompensation in patients with hepatitis B/C virus-related decompensated liver cirrhosis
Danqing XU ; Yingyuan ZHANG ; Jingru SHANG ; Caifen SA ; Wenyan LI ; Li LIU ; Zhijian DONG
Journal of Clinical Hepatology 2025;41(11):2323-2328
ObjectiveTo investigate the association between albumin (Alb) and recompensation by comparing recompensation rate between hepatitis B/C virus-related decompensated liver cirrhosis patients with different Alb levels, and to provide guidance for the identification and management of high-risk patients in clinical practice. MethodsRelated clinical data were collected from 734 patients with hepatitis B/C virus-related decompensated liver cirrhosis who attended The Third People’s Hospital of Kunming from January 1, 2016 to December 31, 2022, and they were divided into three groups based on the level of Alb. The linear regression analysis and chi-square test were used for trend tests. The Kaplan-Meier curve was plotted for the cumulative incidence rate of recompensation in the three groups, and the log-rank test was used for comparison between groups. A Cox proportional-hazards regression model analysis was used to investigate the association between Alb and recompensation in patients with hepatitis B/C virus-related decompensated liver cirrhosis. ResultsAmong the 734 patients with hepatitis B/C virus-related decompensated liver cirrhosis, 270 achieved recompensation, with a recompensation rate of 36.8%. All patients had a median Alb level of 29.90 (25.90 — 34.80) g/L on admission, and according to the level of Alb, they were divided into <25.9 g/L group with 177 patients, 25.9 — 34.8 g/L group with 377 patients, and >34.8 g/L group with 180 patients; 36 patients (20.3%) in the <25.9 g/L group, 138 (36.6%) in the 25.9 — 34.8 g/L group, and 96 (53.3%) in the >34.8 g/L group achieved recompensation, and the recompensation rate increased with the increase in Alb level (χ2=41.730, P<0.001). After adjustment for all confounding factors, compared with the <25.9 g/L group, there was a significant increase in the incidence rate of recompensation in the 25.9 — 34.8 g/L group (hazard ratio [HR]=1.842, 95% confidence interval [CI]: 1.274 — 2.663) and the >34.8 g/L group (HR=2.336, 95% CI: 1.575 — 3.463). The Kaplan-Meier survival analysis showed that there was a significant difference in the cumulative incidence rate of recompensation between the three groups (χ2=41.632, P<0.001). ConclusionAlb level is an influencing factor for recompensation in patients with hepatitis B/C virus-related decompensated liver cirrhosis, and the recompensation rate increases with the increase in Alb level.
9.Yunpi Huatan Tongqiao Prescription Regulates Microglial Cell Polarization Phenotype to Improve Inflammation and Cognitive Impairment in OSA Mice by Down-regulating Glycolysis
Wenyan PU ; Anqi LIU ; Yan LIN ; Xuejun LI ; Hongyu ZHANG ; Zhiyan JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):35-42
ObjectiveTo validate the efficacy of Yunpi Huatan Tongqiao prescription (YHTP) in down-regulating glycolysis to modulate microglia phenotype and improve inflammation and cognitive memory deficits in obstructive sleep apnea (OSA) mice. MethodForty-eight male Balb/C mice were randomly divided into a normal group, a model group, a montelukast sodium group (30 mg·kg-1), and low, medium, and high dose groups of YHTP (8.28, 16.56, and 33.12 g·kg-1), with 8 mice in each group. All groups, except the normal group, received intraperitoneal injections of lipopolysaccharide (LPS) and underwent chronic intermittent hypoxia (CIH) modeling for 4 weeks. Subsequently, the mice were treated with medications for 4 weeks and then sampled. Animal behavioral tests assessed memory impairment due to hypoxia. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was used to measure mRNA expression levels of M1-associated inflammatory factors interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), and markers such as T lymphocyte activation antigen (CD86) and inducible nitric oxide synthase (iNOS), as well as M2-associated inflammatory factors interleukin-10 (IL-10), transforming growth factor-β (TGF-β), and the marker mannose receptor (CD206) in hippocampal tissue. Western blot was employed to detect differences in the expression of M1 and M2 microglia phenotypic markers (CD86, CD206) and glycolysis-related proteins glucose transporter type 1 (GLUT1), hexokinase 2 (HK2), phosphofructokinase (PFKM), pyruvate kinase 2 (PKM2), and monocarboxylic acid transporter 1 (MCT1). ResultBehavioral tests showed that compared to the results in the normal group, the Y-maze autonomous alternation rate was significantly reduced in the model group (P<0.01). The latency time for the target hole in the Barnes' maze during the training period (days 2, 3, 4) and testing period (days 5, 12) was significantly increased (P<0.05, P<0.01). M1 glial cell markers CD86 and iNOS, as well as inflammatory factors IL-1β and TNF-α mRNA, were significantly elevated (P<0.01). In contrast, the mRNA expression of M2 glial cell markers IL-10, CD206, and TGF-β was significantly reduced (P<0.01). The protein expression of glycolytic proteins HK2, PFKM, PKM2, MCT1, and the M1 marker CD86 was significantly increased (P<0.05, P<0.01), while M2 marker CD206 protein expression was significantly decreased (P<0.01). Compared to the results in the model group, the Y-maze autonomous alternation rate was significantly increased in the medium and high dose groups of YHTP (P<0.05, P<0.01). The latency time for the target hole during the training (day 4) and testing periods (days 5, 12) was significantly reduced (P<0.01). Real-time PCR results indicated that mRNA expression levels of M1-related pro-inflammatory factors in the hippocampal tissue were significantly reduced in the low, medium, and high dose groups of YHTP (P<0.01), while M2-related inflammatory factors' mRNA expression was significantly increased (P<0.01). Western blot results showed that in the medium and high dose groups of YHTP, the expression of the M1 marker CD86 in the hippocampus was reduced, whereas the expression of the M2 marker CD206 was significantly increased (P<0.01), with a significant decrease in the expression of glycolysis-related proteins (P<0.01). ConclusionYHTP can improve inflammation and cognitive impairment induced by hypoxia in OSA model mice. This is achieved by downregulating glycolysis in brain microglia, inhibiting M1 activation, reducing pro-inflammatory factor release, and promoting M2 activation, thereby exerting a therapeutic effect on inflammation and cognitive impairment caused by OSA.
10.Pharmacokinetics and in vitro-in vivo correlation of progesterone suspension injection
Lanlan LIU ; Qilin CAI ; Wenyan ZHANG ; Zhen YAN ; Lifang YIN
Journal of China Pharmaceutical University 2024;55(2):217-223
Abstract: To investigate the in vitro release, in vivo pharmacokinetics, and the in vitro-in vivo correlation of progesterone suspension injection, self-made progesterone suspension injection was taken as an example. The in vitro release curves of three different particle sizes of progesterone suspension injections were measured using paddle method and dialysis bag method. The in vivo pharmacokinetic characteristics of self-made progesterone suspension injection was studied on SD rats. The plasma concentration of self-made progesterone preparation was detected after intramuscular injection, and correlated with the in vitro release profiles obtained by the dialysis bag method after processing by Wagner-Nelson method. The results showed that when the in vitro release of three different particle sizes of progesterone suspension injections was measured by the paddle method, more than 85% was rapidly released within 20 min, while 85% cumulative release was reached at 40 h, 84 h and 120 h by dialysis bag method, respectively. The release rate obtained by the dialysis bag method was basically consistent with the in vivo release trend, with a correlation coefficient of >0.95, indicating a strong in vivo and in vitro correlation. This study provides some reference for the establishment of the in vitro and in vivo correlation of long-acting suspension injection.

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