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.Effect of Mori Folium-Ginseng Radix et Rhizoma on Glucose and Lipid Metabolism and Mechanism in Mouse Model of Type 2 Diabetes Mellitus
Congyi LIU ; Ning WANG ; Jingjing XU ; Tingting WANG ; Na ZHENG ; Zimeng HUANG ; Lingling QIN ; Lili WU ; Tonghua LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):20-28
ObjectiveTo study the effect of the herb pair Mori Folium-Ginseng Radix et Rhizoma (HMG) on glucose and lipid metabolism in the mouse model of type 2 diabetes mellitus and decipher the possible treatment mechanism. MethodsThe db/db mice were chosen as the mouse model of type 2 diabetes mellitus and then treated with HMG at low and high doses (1.56, 3.12 g∙kg-1, respectively) or metformin (0.26 g∙kg-1) by gavage for 6 weeks. The normal group and the model group were treated with double distilled water at the same time according to body weight. The 8-h fasting blood glucose and body weight were measured once a week. The oral glucose tolerance test (OGTT) was conducted at the 6th week of dosing. The mice were sacrificed after the end of dosing. Serum levels of lipids [total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL)], liver function indicators [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)], non-esterified fatty acids (NEFA), glycosylated serum protein (GSP), serum glucose (GLU), fasting insulin (FINS), and renal function indicators [creatinine (Crea) and blood urea nitrogen (BUN)] were measured by enzyme-linked immunosorbent assay. The protein levels of peroxidase proliferator-activating receptor gamma (PPARγ), acetyl coenzyme A carboxylase (ACC), and sterol regulatory element-binding protein-1 (SREBP-1) were determined by Western blot. The pathological changes in the liver and pancreas were examined. ResultsCompared with the normal group, the model group presented increased body weight, elevated levels of blood glucose, TG, TC, AST, ALT, GLU, NEFA, GSP, and HDL-C, up-regulated protein levels of ACC and SREBP-1, and down-regulated protein level of PPARγ (P<0.01). Meanwhile, the model group presented a large amount of lipid droplets and steatosis in the liver, as well as karyopyknosis and lymphocyte infiltration in the pancreas. Compared with the model group, the high- and low-dose HMG groups showed decreased body weight, declined levels of blood glucose, TG, TC, AST, ALT, GLU, NEFA, and GSP, and elevate level of HDL-C (P<0.05, P<0.01). Moreover, the two groups showcased reduced lipid droplets and steatosis in the liver, as well as enlarged islets with clear boundaries and alleviated lymphocyte infiltration and karyopyknosis. Western blot results showed that the high-dose herb pair group demonstrated down-regulated protein levels of ACC and SREBP-1 and up-regulated protein level of PPARγ (P<0.01). ConclusionThe HMG can effectively improve the glucose and lipid metabolism in db/db mice by regulating the expression of PPARγ, SREBP-1, and ACC.
3.Effect of Mori Folium-Ginseng Radix et Rhizoma on Glucose and Lipid Metabolism and Mechanism in Mouse Model of Type 2 Diabetes Mellitus
Congyi LIU ; Ning WANG ; Jingjing XU ; Tingting WANG ; Na ZHENG ; Zimeng HUANG ; Lingling QIN ; Lili WU ; Tonghua LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):20-28
ObjectiveTo study the effect of the herb pair Mori Folium-Ginseng Radix et Rhizoma (HMG) on glucose and lipid metabolism in the mouse model of type 2 diabetes mellitus and decipher the possible treatment mechanism. MethodsThe db/db mice were chosen as the mouse model of type 2 diabetes mellitus and then treated with HMG at low and high doses (1.56, 3.12 g∙kg-1, respectively) or metformin (0.26 g∙kg-1) by gavage for 6 weeks. The normal group and the model group were treated with double distilled water at the same time according to body weight. The 8-h fasting blood glucose and body weight were measured once a week. The oral glucose tolerance test (OGTT) was conducted at the 6th week of dosing. The mice were sacrificed after the end of dosing. Serum levels of lipids [total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL)], liver function indicators [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)], non-esterified fatty acids (NEFA), glycosylated serum protein (GSP), serum glucose (GLU), fasting insulin (FINS), and renal function indicators [creatinine (Crea) and blood urea nitrogen (BUN)] were measured by enzyme-linked immunosorbent assay. The protein levels of peroxidase proliferator-activating receptor gamma (PPARγ), acetyl coenzyme A carboxylase (ACC), and sterol regulatory element-binding protein-1 (SREBP-1) were determined by Western blot. The pathological changes in the liver and pancreas were examined. ResultsCompared with the normal group, the model group presented increased body weight, elevated levels of blood glucose, TG, TC, AST, ALT, GLU, NEFA, GSP, and HDL-C, up-regulated protein levels of ACC and SREBP-1, and down-regulated protein level of PPARγ (P<0.01). Meanwhile, the model group presented a large amount of lipid droplets and steatosis in the liver, as well as karyopyknosis and lymphocyte infiltration in the pancreas. Compared with the model group, the high- and low-dose HMG groups showed decreased body weight, declined levels of blood glucose, TG, TC, AST, ALT, GLU, NEFA, and GSP, and elevate level of HDL-C (P<0.05, P<0.01). Moreover, the two groups showcased reduced lipid droplets and steatosis in the liver, as well as enlarged islets with clear boundaries and alleviated lymphocyte infiltration and karyopyknosis. Western blot results showed that the high-dose herb pair group demonstrated down-regulated protein levels of ACC and SREBP-1 and up-regulated protein level of PPARγ (P<0.01). ConclusionThe HMG can effectively improve the glucose and lipid metabolism in db/db mice by regulating the expression of PPARγ, SREBP-1, and ACC.
4.Implementation Evaluation of Clinical Practice Guidelines for Integrative Medicine
Ziying YE ; Chen TIAN ; Yilong YAN ; Qiaofeng LI ; Jinling NING ; Tingting LI ; Long GE
Medical Journal of Peking Union Medical College Hospital 2024;15(2):413-421
5.Application study on the prevention and treatment of spleen aminopeptide oral solution on seasonal allergic rhinitis
Haiyun SHI ; Kaili ZHENG ; Change FAN ; Huijiao CAI ; Tingting MA ; Huiyu NING ; Hongtian WANG ; Junjing ZHANG ; Xueyan WANG
Chinese Journal of Preventive Medicine 2024;58(8):1219-1229
Methods:A total of 392 patients with seasonal allergic rhinitis were selected from the population of the epidemiological investigation project of allergic diseases in Hohhot, Inner Mongolia. The project was led by Department of Allergy, Beijing Shijitan Hospital, Capital Medical University, and assisted by Hohhot First Hospital from April to May 2023. The patients were randomly divided into a spleen aminopeptide group (296 cases) and control group (96 cases) at a ratio of 3∶1, and the enrollment period was from June 1 to 14, 2023. The treatment group was treated with spleen aminopeptide oral solution for 12 weeks starting from 4-6 weeks (±7 days) before the pollen dispersal period, while the control group was treated with a simulated agent of spleen aminopeptide oral solution. Both the treatment group and the control group were treated with oral antihistamines and/or nasal glucocorticoids as needed during the pollen dispersal period. Evaluate the therapeutic effect by comparing the symptom scores, drug scores and quality of life scores of the two groups, and detect the expression levels of cytokines in serum. Symptom scores, quality of life scores, drug scores and laboratory results were compared by independent sample t test/Kruskal-Wallis test and χ2 test/Fisher′s exact test. Results:Compared with the control group, spleen aminopeptide treatment for 12 weeks significantly improved symptoms of nasal congestion [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=6.308, P<0.05], nasal itching [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=4.966, P<0.05], sneezing [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=5.245, P<0.05], runny nose [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=5.41, P<0.05] and tearing [ M( Q1, Q3):1(0, 2) vs. 1(0, 3), H=4.664, P<0.05]. At 12 weeks of treatment, the scores of nasal symptoms and ocular symptoms in control group and experimental group were significantly increased compared with baseline ( P<0.05). In experimental group, nasal congestion [ M( Q1, Q3):1(0, 1) vs. 1(0, 2), H=4.042, P<0.05], eye itching/foreign body sensation/redness symptom scores [ M( Q1, Q3):1(0, 2) vs. 1(0, 2), H=5.302, P<0.05] and total scores [ M( Q1, Q3):4(-1, 9) vs. 5(0, 12.5), H=3.958, P<0.05] were significantly increased. The antihistamine drug score of the splenic peptide treatment group at 6 weeks were lower than that of the control group ( H=4.232, P<0.05). After 12 weeks of treatment, the antihistamine drug score [ M( Q1, Q3):10(0, 24) vs. 19(2, 36.5), H=6.67, P<0.05] and the total drug score [ M( Q1, Q3):28.5(5, 77.5) vs. 46(6, 155.5), H=3.995, P<0.05] were significantly lower than those of the control group. The serum IL-17A levels of the treatment group were significantly lower than those of the control group after 6 weeks (0.7±1.77 vs. 0.85±1.67 ,H=10.08, P<0.05) and 12 weeks (0.81±1.63 vs. 0.94±1.73, H=5.196, P<0.05) of splenic aminopeptide treatment. Conclusions:Early treatment with spleen aminopeptide oral solution can significantly improve nasal and ocular symptoms of patients with seasonal allergic rhinitis, reduce the use of drugs during the onset period, and improve the quality of life. It may exert an immunomodulatory effect by reducing the expression level of IL-17A in the serum of patients.Objects:To conduct a study on the prevention and treatment of seasonal allergic rhinitis in Hohhot, Inner Mongolia, evaluate the preventive and therapeutic effects of spleen aminopeptide oral solution on seasonal allergic rhinitis, and explore its related mechanisms.
6.Application study on the prevention and treatment of spleen aminopeptide oral solution on seasonal allergic rhinitis
Haiyun SHI ; Kaili ZHENG ; Change FAN ; Huijiao CAI ; Tingting MA ; Huiyu NING ; Hongtian WANG ; Junjing ZHANG ; Xueyan WANG
Chinese Journal of Preventive Medicine 2024;58(8):1219-1229
Methods:A total of 392 patients with seasonal allergic rhinitis were selected from the population of the epidemiological investigation project of allergic diseases in Hohhot, Inner Mongolia. The project was led by Department of Allergy, Beijing Shijitan Hospital, Capital Medical University, and assisted by Hohhot First Hospital from April to May 2023. The patients were randomly divided into a spleen aminopeptide group (296 cases) and control group (96 cases) at a ratio of 3∶1, and the enrollment period was from June 1 to 14, 2023. The treatment group was treated with spleen aminopeptide oral solution for 12 weeks starting from 4-6 weeks (±7 days) before the pollen dispersal period, while the control group was treated with a simulated agent of spleen aminopeptide oral solution. Both the treatment group and the control group were treated with oral antihistamines and/or nasal glucocorticoids as needed during the pollen dispersal period. Evaluate the therapeutic effect by comparing the symptom scores, drug scores and quality of life scores of the two groups, and detect the expression levels of cytokines in serum. Symptom scores, quality of life scores, drug scores and laboratory results were compared by independent sample t test/Kruskal-Wallis test and χ2 test/Fisher′s exact test. Results:Compared with the control group, spleen aminopeptide treatment for 12 weeks significantly improved symptoms of nasal congestion [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=6.308, P<0.05], nasal itching [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=4.966, P<0.05], sneezing [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=5.245, P<0.05], runny nose [ M( Q1, Q3):2(1, 2) vs. 2(1, 3), H=5.41, P<0.05] and tearing [ M( Q1, Q3):1(0, 2) vs. 1(0, 3), H=4.664, P<0.05]. At 12 weeks of treatment, the scores of nasal symptoms and ocular symptoms in control group and experimental group were significantly increased compared with baseline ( P<0.05). In experimental group, nasal congestion [ M( Q1, Q3):1(0, 1) vs. 1(0, 2), H=4.042, P<0.05], eye itching/foreign body sensation/redness symptom scores [ M( Q1, Q3):1(0, 2) vs. 1(0, 2), H=5.302, P<0.05] and total scores [ M( Q1, Q3):4(-1, 9) vs. 5(0, 12.5), H=3.958, P<0.05] were significantly increased. The antihistamine drug score of the splenic peptide treatment group at 6 weeks were lower than that of the control group ( H=4.232, P<0.05). After 12 weeks of treatment, the antihistamine drug score [ M( Q1, Q3):10(0, 24) vs. 19(2, 36.5), H=6.67, P<0.05] and the total drug score [ M( Q1, Q3):28.5(5, 77.5) vs. 46(6, 155.5), H=3.995, P<0.05] were significantly lower than those of the control group. The serum IL-17A levels of the treatment group were significantly lower than those of the control group after 6 weeks (0.7±1.77 vs. 0.85±1.67 ,H=10.08, P<0.05) and 12 weeks (0.81±1.63 vs. 0.94±1.73, H=5.196, P<0.05) of splenic aminopeptide treatment. Conclusions:Early treatment with spleen aminopeptide oral solution can significantly improve nasal and ocular symptoms of patients with seasonal allergic rhinitis, reduce the use of drugs during the onset period, and improve the quality of life. It may exert an immunomodulatory effect by reducing the expression level of IL-17A in the serum of patients.Objects:To conduct a study on the prevention and treatment of seasonal allergic rhinitis in Hohhot, Inner Mongolia, evaluate the preventive and therapeutic effects of spleen aminopeptide oral solution on seasonal allergic rhinitis, and explore its related mechanisms.
7.Progress and challenges in the research of urinary extracellular vesicles as disease biomarkers
Ning LI ; Tingting ZHU ; Linli LYU
Chinese Journal of Laboratory Medicine 2024;47(8):969-974
Urinary extracellular vesicles (uEV) have recently garnered significant attention as crucial components in urine. Advances in high-throughput omics and single-vesicle technologies have deepened our understanding of the origins and contents of uEV, which include proteins, lipids, RNA, and DNA. These vesicles reflect the pathophysiological status of their source organs. uEV are highly stable, traceable, and can be enriched with various contents, making them promising biomarkers, particularly for urogenital diseases.
8.Advances in Imaging of Interstitial Lung Disease in Connective Tissue Diseases
Yanxia SHI ; Hongbin LI ; Tingting REN ; Rongxia NING
Chinese Journal of Medical Imaging 2024;32(9):961-965
Interstitial lung disease is a common lung disease of connective tissue disease,which seriously affects the survival rate and quality of life of patients with connective tissue disease.Interstitial lung disease may occur in the whole course of connective tissue disease.Therefore,imaging plays an important role in the whole disease cycle of connective tissue-associated interstitial lung disease.At present,high-resolution computed tomography is the cornerstone of screening,diagnosis and follow-up of connective tissue-associated interstitial lung disease,but ionizing radiation is a potential limiting factor in its clinical application.In recent years,new imaging techniques have developed rapidly,and some promising research results have been achieved in the early screening,diagnosis and efficacy evaluation of connective tissue-associated interstitial lung disease,and they are gradually moving towards non-invasive,low-radiation and accurate imaging analysis techniques.This article reviews the advances in imaging research of connective tissue-associated interstitial lung disease,and analyzes the advantages and disadvantages of various new imaging techniques,as well as the challenges and prospects.
9.Small cell carcinoma of the ovary of hypercalcaemic type: a clinicopathological analysis of sixteen cases
Jing ZHAO ; Rongkui LUO ; Tingting CHEN ; Jing LIN ; Jie ZHANG ; Shilei ZHANG ; Xianrong ZHOU ; Xiang TAO ; Yan NING
Chinese Journal of Pathology 2024;53(12):1210-1216
Objective:To investigate the clinicopathological, molecular pathological features, and family genetic pedigree of small cell carcinoma of the ovary, hypercalcemic type (SCCOHT).Methods:A total of 16 cases of SCCOHT diagnosed in Obstetrics and Gynecology Hospital of Fudan University from January 2013 to January 2023 were collected. The clinicopathologic features, SMARCA4/2/B1 protein expression, outcomes and SMARCA4 gene detection were reported. A follow-up study was also carried out.Results:The average age at diagnosis was 28.7 years (range 17-38 years). The preoperative calcium level was evaluated in 3 of 6 patients. The tumor was unilateral in all 16 cases, ranged from 8 to 26 cm (average 15.8 cm) in the greatest dimension. Extraovarian spread was present in 7 cases. In 10 cases, the tumors were initially misinterpreted as other ovarian neoplasms. BRG1 and BRM expression by immunohistochemistry were all lost in detected cases, while INI1 exhibited retained nuclear expression. All BRM-negative SCCOHTs also lacked BRG1 protein,but retained INI1 expression. SCCOHTs were only focally positive for EMA, CKpan, Calretinin, SALL4, and diffusely positive for WT1. Two of nine cases exhibited mutation-type p53 immunoreactivity. Ki-67 index was 58% on an average. ER, PR, FOXL2, α-inhibin, chromogranin A and LCA were negative in all the cases. SMARCA4 sequencing was available in 8 cases of SCCOHT, which revealed a germline SMARCA4 mutation in one patient, and others carried somatic mutation. Furthermore, two daughters, mother and an aunt of a patient with germline mutation were reported to be SMARCA4 mutation carriers. Follow-up was available for 15 patients, and the 6-month, 1-year and 2-year survival rate was 65.8%, 45.1%, and 22.6%, respectively. For patients in FIGO stages Ⅱ+Ⅲ, 6-month, 1-year survival rate was 53.6% and 35.7% respectively, compared to 80% (6-month) and 60% (1-year) in patients of staged I ( P=0.358). Conclusions:With dismal prognosis of SCCOHT, accurate diagnosis is necessary. The typical age distribution, a panel of various staining results, especially concomitant loss of BRG1 and BRM may be of diagnostic aid and can be used to distinguish SCCOHT from its histological mimics. After the diagnosis of SCCOHT, genetic testing and genetic counseling are recommended.
10.Clinical pharmacists participating in the analysis of drug therapy for a case of Bartonella henselae meningitis
Tingting PENG ; Ruixi YANG ; Hong NING ; Yalan TIAN
Chinese Journal of Pharmacoepidemiology 2024;33(1):106-110
Clinical pharmacists participated in the anti-infection treatment of a patient with Bartonella henselae meningitis.According to the clinical manifestations and the quantitative metagenomic second-generation sequencing(mNGS)of cerebrospinal fluid,the patient was diagnosed as Bartonella henselae infection.According to the relevant clinical guidelines and foreign case treatment reports,it is recommended to use minocycline hydrochloride capsule oral treatment combined with rifampicin injection.Follow-up treatment of the patient was dynamically adjusted based on the reexamination results of cerebrospinal fluid and related inflammatory indicators.In the treatment process,clinical pharmacists give full play to their professional expertise,provide the patient with individualized pharmaceutical care,optimize anti-infection programs,and further promote clinical rational drug use.

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