1.Quality Evaluation of Propranolol Hydrochloride Tablets Based on National Drug Sampling and Testing
Li LU ; Fangxian SHAO ; Hui XU ; Chaoyu HUANG ; Jialiang ZHU ; Fei YAN ; Rui LI
Herald of Medicine 2025;44(9):1390-1400
Objective To evaluate the quality of propranolol hydrochloride tablets based on national drug sampling,to analyze existing quality issues and improve their quality standards,to provide references and suggestions for the production,quality control,and supervision of this product.Methods A comprehensive evaluation of 178 batches of sampled products was conducted using legal standards combined with exploratory research,including key quality indicators such as related substances,dissolution,content uniformity,content determination,in vitro dissolution profiles,and genotoxic impurity N-nitrosoproranolol.The quality of domestic propranolol hydrochloride tablets and the controllability of the current quality standards for product quality were assessed.Results According to the legal standard methods,the qualification rate of 178 batches of sampled products was 100%.Exploratory research revealed that the impurity levels of samples from six manufacturing enterprises were far below the limit requirements;however,differences existed in genotoxic impurity N-nitrosoproranolol and other aspects.Conclusions The overall quality of propranolol hydrochloride tablets is good,but the current standards need further improvement.It is recommended to add/revise the detection methods for related substances,content,and content uniformity,strictly control N-nitrosoproranolol,and urge enterprises to pay attention to the quality of excipients and the control of the preparation production process.
2.Consistency between MT-9000 and IOLMaster 700 in measuring ocular biometric parameters in cataract eyes
Guohuan WU ; Ying ZHANG ; Chaoyu DU ; Jingjing HUANG ; Liman WANG ; Qinmei WANG
Chinese Journal of Experimental Ophthalmology 2025;43(10):924-929
Objective:To analyze the consistency between MT-9000 and IOLMaster 700 in measuring preoperative ocular biometric parameters in patients with age-related cataracts.Methods:A cross-sectional study was conducted.A total of 536 patients (536 eyes) were consecutively included and scheduled for cataract extraction combined with intraocular lens implantation at Aier Eye Hospital of Wuhan University from June 20 to August 22, 2024.Two visualized sweep-frequency biometers, MT-9000 and IOLMaster 700, were used to measure the biometric parameters of all the patients.The parameters including axial length (AL), white to white (WTW), anterior chamber depth (ACD), lens thickness (LT), central corneal thickness (CCT), and mean keratometry (Km). The AL detection rates of the two instruments were compared, as were the differences in above parameters, and the correlation and consistency of the measurements were analyzed.Patients were divided into three groups based on AL measured by MT-9000: a short axis group (AL<22 mm) comprising 27 eyes, a normal axis group (22≤AL≤25 mm) comprising 392 eyes, and a long axis group (AL>25 mm) comprising 104 eyes.The differences in measured AL in different subgroups were compared.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Aier Eye Hospital, Wuhan University (No.2024IRB06017). Written informed consent was obtained from each subject.Results:The AL detection rate measured by MT-9000 was 99.3% (532/536), higher than 97.6% (523/536) measured by IOLMaster 700, with a statistically significant difference ( χ2=4.841, P=0.028). MT-9000 AL, LT and Km measurements were all higher than IOLMaster 700 measurements, showing statistically significant differences ( Z=6.418, t=4.971, 5.179; all P<0.001). WTW and CCT measurements from MT-9000 were both lower than those from IOLMaster 700, showing statistically significant differences ( Z=-3.017, t=16.322; both P<0.05). After grouping based on AL measurements from MT-9000, there was no statistically significant differences in AL measurements between MT-9000 and IOLMaster 700 in the short axis group and the normal axis group ( Z=-1.530, P=0.126; t=-0.880, P=0.380). In the long axis group, the AL measured by MT-9000 was longer than that by IOLMaster 700, with a statistically significant difference ( Z=7.254, P<0.001). The intra-class correlation coefficient values of AL, WTW, ACD, LT, CCT, and Km measured by MT-9000 and IOLMaster 700 were 1.000, 0.616, 0.997, 0.999, 0.988, and 0.995 (all P<0.001), respectively.The 95% limits of agreement (LoA) of AL, WTW, ACD, LT, CCT, and Km measured by Bland-Altman analysis were -0.06-+ 0.08 mm, -0.64-+ 0.57 mm, -0.06-+ 0.06 mm, -0.04-+ 0.05 mm, -13.6-+ 6.3 μm and -0.26-+ 0.32 D, respectively, which had 6.5%, 3.6%, 5.3%, 6.3%, 6.5% and 4.4% of the data points outside the 95% LoA. Conclusions:MT-9000 shows favorable agreement with IOLMaster 700 in the measurement of AL, ACD, LT, CCT and Km.MT-9000 is suitable for preoperative biometrics measurement in cataract patients.However, the agreement between the two devices is not desirable in the measurement of WTW, and interchangeable use of these two devices is not recommended in this regard.Additionally, MT-9000 outperforms IOLMaster 700 in terms of AL detection rate.
3.Ferrum@albumin assembled nanoclusters inhibit NF-κB signaling pathway for NIR enhanced acute lung injury immunotherapy.
Xiaoxuan GUAN ; Binbin ZOU ; Weiqian JIN ; Yan LIU ; Yongfeng LAN ; Jing QIAN ; Juan LUO ; Yanjun LEI ; Xuzhi LIANG ; Shiyu ZHANG ; Yuting XIAO ; Yan LONG ; Chen QIAN ; Chaoyu HUANG ; Weili TIAN ; Jiahao HUANG ; Yongrong LAI ; Ming GAO ; Lin LIAO
Acta Pharmaceutica Sinica B 2025;15(11):5891-5907
Acute lung injury (ALI) has been a kind of acute and severe disease that is mainly characterized by systemic uncontrolled inflammatory response to the production of huge amounts of reactive oxygen species (ROS) in the lung tissue. Given the critical role of ROS in ALI, a Fe3O4 loaded bovine serum albumin (BSA) nanocluster (BF) was developed to act as a nanomedicine for the treatment of ALI. Combining with NIR irradiation, it exhibited excellent ROS scavenging capacity. Significantly, it also displayed the excellent antioxidant and anti-inflammatory functions for lipopolysaccharides (LPS) induced macrophages (RAW264.7), and Sprague Dawley rats via lowering intracellular ROS levels, reducing inflammatory factors expression levels, inducing macrophage M2 polarization, inhibiting NF-κB signaling pathway, increasing CD4+/CD8+ T cell ratios, as well as upregulating HSP70 and CD31 expression levels to reprogram redox homeostasis, reduce systemic inflammation, activate immunoregulation, and accelerate lung tissue repair, finally achieving the synergistic enhancement of ALI immunotherapy. It finally provides an effective therapeutic strategy of BF + NIR for the management of inflammation related diseases.
4.Analysis Method of Empagliflozin and Related Substances in Empagliflozin Bulk Drug and Tablets
Yanlin HE ; Ying XIA ; Chaoyu HUANG ; Hongyu FAN ; Jialiang ZHU ; Rui LI ; Geng LI ; Fei YAN
Herald of Medicine 2025;44(1):24-31
Objective To establish a high-performance liquid chromatography method to detect empagliflozin and related substances in empagliflozin bulk drug and tablets,and to provide technical support for quality control and unified monitoring of empagliflozin bulk drug and its tablets.Methods A liquid chromatography development system with the full factorial design of experiments and the Box-Behnken model was used to screen and optimize the chromatographic parameters.Related substances were detected in empagliflozin API and empagliflozin tablets from different companies with the optimized chromatographic parameters.Results The optimized chromatographic parameters were obtained:Shim-pack GIST C18-AQ column(250 mm×4.6 mm,5 μm)was used,column temperature was 15 ℃,gradient elution with water-acetonitrile as mobile phase was as below,flow rate was 1.2 mL·min-1,detection wavelength was set at 224 nm.The specificity of the method is good,with recoveries ranging from 94.8%to 101.7%,and RSD ranging from 0.5%to 3.1%.The known single impurity in APIs and tablets is less than 0.05%,any other unknown single impurity is less than 0.06%,and the total amount of impurities are less than 0.3%.The related substances of supervised sampling are under good control.Conclusion The method is reliable and robust for determining related substances of empagliflozin and its tablets.
5.Quality Evaluation of Propranolol Hydrochloride Tablets Based on National Drug Sampling and Testing
Li LU ; Fangxian SHAO ; Hui XU ; Chaoyu HUANG ; Jialiang ZHU ; Fei YAN ; Rui LI
Herald of Medicine 2025;44(9):1390-1400
Objective To evaluate the quality of propranolol hydrochloride tablets based on national drug sampling,to analyze existing quality issues and improve their quality standards,to provide references and suggestions for the production,quality control,and supervision of this product.Methods A comprehensive evaluation of 178 batches of sampled products was conducted using legal standards combined with exploratory research,including key quality indicators such as related substances,dissolution,content uniformity,content determination,in vitro dissolution profiles,and genotoxic impurity N-nitrosoproranolol.The quality of domestic propranolol hydrochloride tablets and the controllability of the current quality standards for product quality were assessed.Results According to the legal standard methods,the qualification rate of 178 batches of sampled products was 100%.Exploratory research revealed that the impurity levels of samples from six manufacturing enterprises were far below the limit requirements;however,differences existed in genotoxic impurity N-nitrosoproranolol and other aspects.Conclusions The overall quality of propranolol hydrochloride tablets is good,but the current standards need further improvement.It is recommended to add/revise the detection methods for related substances,content,and content uniformity,strictly control N-nitrosoproranolol,and urge enterprises to pay attention to the quality of excipients and the control of the preparation production process.
6.Consistency between MT-9000 and IOLMaster 700 in measuring ocular biometric parameters in cataract eyes
Guohuan WU ; Ying ZHANG ; Chaoyu DU ; Jingjing HUANG ; Liman WANG ; Qinmei WANG
Chinese Journal of Experimental Ophthalmology 2025;43(10):924-929
Objective:To analyze the consistency between MT-9000 and IOLMaster 700 in measuring preoperative ocular biometric parameters in patients with age-related cataracts.Methods:A cross-sectional study was conducted.A total of 536 patients (536 eyes) were consecutively included and scheduled for cataract extraction combined with intraocular lens implantation at Aier Eye Hospital of Wuhan University from June 20 to August 22, 2024.Two visualized sweep-frequency biometers, MT-9000 and IOLMaster 700, were used to measure the biometric parameters of all the patients.The parameters including axial length (AL), white to white (WTW), anterior chamber depth (ACD), lens thickness (LT), central corneal thickness (CCT), and mean keratometry (Km). The AL detection rates of the two instruments were compared, as were the differences in above parameters, and the correlation and consistency of the measurements were analyzed.Patients were divided into three groups based on AL measured by MT-9000: a short axis group (AL<22 mm) comprising 27 eyes, a normal axis group (22≤AL≤25 mm) comprising 392 eyes, and a long axis group (AL>25 mm) comprising 104 eyes.The differences in measured AL in different subgroups were compared.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Aier Eye Hospital, Wuhan University (No.2024IRB06017). Written informed consent was obtained from each subject.Results:The AL detection rate measured by MT-9000 was 99.3% (532/536), higher than 97.6% (523/536) measured by IOLMaster 700, with a statistically significant difference ( χ2=4.841, P=0.028). MT-9000 AL, LT and Km measurements were all higher than IOLMaster 700 measurements, showing statistically significant differences ( Z=6.418, t=4.971, 5.179; all P<0.001). WTW and CCT measurements from MT-9000 were both lower than those from IOLMaster 700, showing statistically significant differences ( Z=-3.017, t=16.322; both P<0.05). After grouping based on AL measurements from MT-9000, there was no statistically significant differences in AL measurements between MT-9000 and IOLMaster 700 in the short axis group and the normal axis group ( Z=-1.530, P=0.126; t=-0.880, P=0.380). In the long axis group, the AL measured by MT-9000 was longer than that by IOLMaster 700, with a statistically significant difference ( Z=7.254, P<0.001). The intra-class correlation coefficient values of AL, WTW, ACD, LT, CCT, and Km measured by MT-9000 and IOLMaster 700 were 1.000, 0.616, 0.997, 0.999, 0.988, and 0.995 (all P<0.001), respectively.The 95% limits of agreement (LoA) of AL, WTW, ACD, LT, CCT, and Km measured by Bland-Altman analysis were -0.06-+ 0.08 mm, -0.64-+ 0.57 mm, -0.06-+ 0.06 mm, -0.04-+ 0.05 mm, -13.6-+ 6.3 μm and -0.26-+ 0.32 D, respectively, which had 6.5%, 3.6%, 5.3%, 6.3%, 6.5% and 4.4% of the data points outside the 95% LoA. Conclusions:MT-9000 shows favorable agreement with IOLMaster 700 in the measurement of AL, ACD, LT, CCT and Km.MT-9000 is suitable for preoperative biometrics measurement in cataract patients.However, the agreement between the two devices is not desirable in the measurement of WTW, and interchangeable use of these two devices is not recommended in this regard.Additionally, MT-9000 outperforms IOLMaster 700 in terms of AL detection rate.
7.Analysis Method of Empagliflozin and Related Substances in Empagliflozin Bulk Drug and Tablets
Yanlin HE ; Ying XIA ; Chaoyu HUANG ; Hongyu FAN ; Jialiang ZHU ; Rui LI ; Geng LI ; Fei YAN
Herald of Medicine 2025;44(1):24-31
Objective To establish a high-performance liquid chromatography method to detect empagliflozin and related substances in empagliflozin bulk drug and tablets,and to provide technical support for quality control and unified monitoring of empagliflozin bulk drug and its tablets.Methods A liquid chromatography development system with the full factorial design of experiments and the Box-Behnken model was used to screen and optimize the chromatographic parameters.Related substances were detected in empagliflozin API and empagliflozin tablets from different companies with the optimized chromatographic parameters.Results The optimized chromatographic parameters were obtained:Shim-pack GIST C18-AQ column(250 mm×4.6 mm,5 μm)was used,column temperature was 15 ℃,gradient elution with water-acetonitrile as mobile phase was as below,flow rate was 1.2 mL·min-1,detection wavelength was set at 224 nm.The specificity of the method is good,with recoveries ranging from 94.8%to 101.7%,and RSD ranging from 0.5%to 3.1%.The known single impurity in APIs and tablets is less than 0.05%,any other unknown single impurity is less than 0.06%,and the total amount of impurities are less than 0.3%.The related substances of supervised sampling are under good control.Conclusion The method is reliable and robust for determining related substances of empagliflozin and its tablets.
8.Human immunodeficiency virus-associated Hodgkin lymphoma: a clinical analysis of 22 cases
Chaoyu WANG ; Jun LIU ; Dehong HUANG ; Jieping LI ; Yao LIU
Journal of Leukemia & Lymphoma 2024;33(1):48-51
Objective:To investigate the clinical characteristics, therapeutic efficacy and prognosis of patients with human immunodeficiency virus (HIV)-associated Hodgkin lymphoma.Methods:A retrospective case series study was conducted. The clinical data of 22 HIV-associated Hodgkin lymphoma patients in Chongqing University Cancer Hospital from December 2013 to June 2022 were retrospectively analyzed. Their clinical features, laboratory results, treatment, and prognosis were analyzed. Kaplan-Meier method was used to perform survival analysis.Results:The age [ M ( Q1, Q3)] of 22 patients was 44 years old (36 years old, 53 years old); 18 cases were male, 4 cases were female; clinical staging was stage Ⅲ in 5 patients and stage Ⅱ in 17 patients. All 22 patients were infected with HIV through sexual transmission, with 10 cases transmitted through man sex with man and 12 cases transmitted through heterosexual transmission. Nine patients were found to be infected with HIV at the time of diagnosis of lymphoma, and 13 patients presented with lymphoma at 22.2 months (12.3 months, 38.4 months) after diagnosis of HIV infection. Of the 22 patients, 3 abandoned treatment; 19 patients were treated with antiretroviral therapy combined with ABVD regimen chemotherapy, 9 patients had complete remission, and 10 patients had partial remission. After follow-up of 46.8 months (24.8 months, 64.5 months), the 5-year progression-free survival rate was 83.9%, and the 5-year overall survival rate was 89.5%. Conclusions:HIV-associated Hodgkin lymphoma exhibits an invasive process in clinical practice, and standardized antiretroviral therapy combined with ABVD regimen chemotherapy can lead to long-term survival for patients.
9.Regulatory Effects of Stilbene Glucoside on JNK and PP 2B in APP/PS1/Tau Transgenic Dementia Mice
Wenxue WU ; Yanzhao SU ; Chaoyu LIU ; Junjie TAN ; Zhenzhong LI ; Jian HUANG ; Xiaoying ZHU ; Yanhua LIAO ; Zhongshi HUANG
China Pharmacy 2020;31(19):2339-2345
OBJECTIVE:To study the regulatory effects of stilbene glucosid e(TSG)on c-Jun N-terminal kinase (JNK)and protein phosphortase 2B(PP2B)in APP/PS1/Tau transgenic dementia (3×Tg-AD)mice,and to explore its potential mechanism of anti-Alzheimer’s disease (AD). METHODS :Totally 45 male 3×Tg-AD mice were randomly divided into model group ,positive control group (huperzine A ,0.15 mg/kg),TSG low-dose ,medium-dose and high-dose groups (0.033,0.1,0.3 g/kg),with 9 mice in each group. Another 9 normal male C 57BL/6J mice were included into normal control group. Administration groups were given relevant medicine intragastrically ,once a day ,for consecutive 60 d. Normal control group and model group were given constant volume of normal saline intragastrically. After medication ,Morris water maze experiment was used to test the spatial learning and memory ability of mice in each group ;Nissl staining was used to observe the changes of Nissl bodies in cerebral cortex and hippocampus ;mRNA and protein expressions of JNK and PP 2B were detected by qRT-PCR and Western blotting assay. RESULTS:Compared with normal control group ,the escape latency was significantly prolonged (P<0.01),the retention time of the original platform quadrant was significantly shortened (P< and the times of crossing the platform was significantly reduced in model group (P<0.01);the number of Nissl bodies in cerebral cortex and hippocampus was significantly 729011126@qq.com reduced,the staining was slight ;the relative expressions of JNK mRNA and protein were significantly increased (P< 0.01),and the relative expressi ons of PP 2B mRNA and protein were significantly decreased (P<0.01). Compared with model group ,the escape latency was significantly shortened in positive control group and TSG groups (P<0.01);the retention time of the original platform quadrant was significantly prolonged (P<0.01);the times of crossing the platform was significantly increased (P<0.01);the number of Nissl bodies in cerebral cortex and hippocampus was increased significantly ,the staining was heavy ;the relative expression of JNK protein was significantly decreased(P<0.05 or P<0.01),the relative expressions of PP 2B mRNA and protein were significantly increased (P<0.01), while the relative expression of JNK mRNA was significantly decreased in TSG high-dose group (P<0.05). CONCLUSIONS :TSG can improve the learning and memory ability and neuronal damage of 3 × Tg-AD mice. The mechanism may be related to down-regulating the transcription and expression of protein kinase JNK ,up-regulating the transcription and expression of protein phosphatase PP 2B.
10.A feasibility study of fetal intelligent navigation echocardiography in the prenatal screening of right aortic arch with left-sided ductus arteriosus
Bei ZHAO ; Bowen ZHAO ; Chaoyu ZHOU ; Chao HUANG ; Mei PAN ; Bei WANG ; Xiaohui PENG
Chinese Journal of Ultrasonography 2020;29(11):946-951
Objective:To investigate the feasibility of applying Fetal Intelligent Navigation Echocardiography (FINE) combined with Virtual Intelligent Sonographer Assistance (VIS-Assistance ?) in the prenatal screening of right aortic arch (RAA) with left-sided ductus arteriosus (LDA). Methods:A total of 32 fetuses with RAA and LDA during middle and late pregnancy in Zhejiang University Medical College Affiliated Sir Run Run Shaw Hospital from Jauary 2018 to Jauary 2020 were included in this retrospective study, and the datas about fetal cardiac three-dimensional volume were analyzed. The time-space correlation imaging (STIC) volume data were collected by using FINE by Senior doctor A. The two diagnostic elements of the transverse aortic arch on the right side of the trachea and the "U" -shaped vascular ring, as well as the three-vessel tracheal diagnostic section were obtained by low-aged doctor B and middle-aged doctor C by using VIS-Assistance ? technology. And then the detection rates of diagnostic sections and diagnostic elements for fetuses with RAA and LDA were calculated. The postpartum outcomes of fetuses with RAA and LDA were followed up. Results:Thirty-two fetuses were included in the study after excluding 2 cases due to the poor quality images, and the datas about fetal cardiac three-dimensional volume of the 32 fetuses were analyzed. The detection rate of one diagnostic element (the aortic arch on the right side of the trachea) were 84.4% vs 87.5% before VIS-Assistance ?, and 93.8% vs 93.8% after VIS-Assistance ? for each doctor B and doctor C , respectively. Another diagnostic element ( "U" -shaped vascular ring) were 78.1% vs 87.3% before VIS-Assistance ?, and 90.6% vs 90.6% after VIS-Assistance ? for doctor B and doctor C, respectively. But no significant difference was found before and after VIS-Assistance ? between the two each doctors(all P>0.05). The detection rate of three-vascular tracheal diagnosis view were 65.6% vs 71.9% before VIS-Assistance ? and 84.4% vs 87.5% after VIS-Assistance ? for doctor B and doctor C, respectively. There was significant difference before and after VIS-Assistance ? of doctor C( P<0.05). The scores of image quality after VIS-Assistance ? were significantly higher than that before VIS-Assistance ? for doctor B and doctor C, respectively [3(2.5, 3) vs 3.25(3.0, 3.5), and 3(2.5, 3.5) vs 3.5(3.0, 3.5)]. The agreement between two doctors performing VIS-Assistance ? was investigated using Bland-Altman analysis and the result showed that within 95% of the differences fall in the agreement interval. No obvious clinical symptoms of compression were found in 32 neonates after follow-up. Conclusions:The application of FINE combined with VIS-Assistance ? technology can easily and reliably obtain the key diagnostic view of RAA with LDA (three-vessel and tracheal view), and clearly display all diagnostic elements, having high repeatability and stability. VIS-Assistance ? technology can improve the detection rate and image quality even if the doctor was lack of experience. So it can be used as an effective supplementary means for prenatal screening of RAA and LDA.

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