1.The introduction on the revised standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; LUI Yanming ; YUAN Yaozuo ; CHEN Ying ; DAI Hong ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):051-057
According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the Chinese Pharmacopoeia 2025 has been completed. Among them, 52 new pharmaceutical excipients monographs have been added, and the total number has reached 387. 245 pharmaceutical excipients monographs have been revised, of which 109 monographs have only textual revisions and 136 monographs have substantive revisions. This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.
2.The technology of fecal microbiota transplantation and its application progress
Shuo YUAN ; Yi-fan ZHANG ; Peng GAO ; Jun LEI ; Ying-yuan LU ; Peng-fei TU ; Yong JIANG
Acta Pharmaceutica Sinica 2025;60(1):82-95
Fecal microbiota transplantation (FMT) technology originated in China during the Eastern Jin Dynasty and has rapidly developed over the past two decades, becoming a primary method for studying the causal relationship between gut microbiota and the occurrence and progression of diseases. At the same time, the therapeutic effects of FMT in the field of gastrointestinal diseases have gained widespread recognition and are gradually expanding into other disease areas. The FMT procedure is relatively complex, and there is currently no standardized method; its success is influenced by various factors, including the donor, recipient, processing of the fecal material, and the method of implantation. Given the increasingly recognized relationship between gut microbiota and various diseases, FMT has become a research hotspot in both scientific studies and clinical applications, achieving a series of significant advancements. To help researchers better understand this technology, this paper will outline the development history of FMT, summarize common operational methods in research and clinical settings, review its application progress, and look forward to future development directions.
3.The clinical efficacy and safety of bilateral internal iliac artery Fogarty balloon occlusion in uterine curettage for patients with cesarean scar pregnancy
Jing SHI ; Longsheng WANG ; Lin'an DU ; Jun XIE ; Yushan YUAN ; Ying CHEN
Journal of Interventional Radiology 2024;33(2):156-160
Objective To discuss the clinical efficacy and safety of bilateral internal iliac artery Fogarty balloon occlusion in uterine curettage for patients with cesarean scar pregnancy(CSP).Methods The clinical data of a total of 80 CSP patients,who were admitted to the Fuyang People's Hospital of China between January 2021 and September 2022 to receive treatment,were retrospectively analyzed.The patients were divided into the observation group(n=40)and the control group(n=40).For the patients of the observation group,the hysteroscopic uterine curettage was carried out under the situation of bilateral internal iliac artery Fogarty balloon occlusion and during the operation the internal iliac artery was intermittently blocked.The embryo was removed,and the hemostasis was accomplished by electrocoagulation or surgical suture.For the patients of the control group,the hysteroscopic uterine curettage was performed within 1-2 days after uterine artery embolization(UAE).The digital subtraction angiography(DSA)fluoroscopy time,body surface radiation dose,blood loss during uterine curettage,time spent for uterine curettage,length of hospital stay,and postoperative follow-up results were compared between the two groups.Results Successful uterine curettage was accomplished and the uterus was retained in all the patients.In the observation group,no balloon-related complications occurred.In the control group,all the 40 patients developed different degrees of fever,pain at uterine area,and other post-embolization symptoms after UAE.In the observation group and the control group,the DSA fluoroscopy time was(9.2±1.1)seconds and(1 273.6±141.1)seconds respectively,the body surface radiation dose was(7.7±0.8)mGy and(1 503.8±101.8)mGy respectively,the differences between the two groups were statistically significant(both P<0.05);the blood loss during uterine curettage was(30.3±14.7)mL and(27.5±13.2)mL respectively,the time spent for uterine curettage was(41.6±16.2)min and(42.8±15.0)min respectively,the differences between the two groups were not statistically significant(both P>0.05);the length of hospital stay was(6.0±0.7)days and(7.3±0.8)days respectively,the difference between the two groups was statistically significant(P<0.05).All patients were followed up for more than 3 months,the time of β-hCG turning to negative,time of vaginal bleeding,time of menstruation returning to normal,and patient satisfaction rate in the observation group were(21.1±2.4)days,(8.2±1.1)days,(29.5±2.2)days and 95.0%(38/40)respectively,which in the control group were(24.6±3.3)days,(13.6±2.6)days,(46.7±7.3)days and 67.5%(27/40)respectively,the differences in the above indexes between the two groups were statistically significant(all P<0.05).Conclusion In performing uterine curettage for CSP patients,both bilateral internal iliac artery Fogarty balloon occlusion and UAE can significantly reduce the intraoperative blood loss,but bilateral internal iliac artery Fogarty balloon occlusion is superior to UAE in reducing radiation dose,in shortening the patient's hospital stay,the time of β-hCG turning to negative,the time of vaginal bleeding and the time of menstruation returning to normal,and in improving the patient satisfaction rate.
4.The efficacy and safety of hydromorphone patients-controlled intravenous analgesia in patients with scar pregnancy after uterine artery embolization
Jing SHI ; Jun XIE ; Yushan YUAN ; Linna LI ; Ying CHEN
Journal of Interventional Radiology 2024;33(3):240-244
Objective To evaluate the postoperative analgesia efficacy and clinical safety of hydro-morphone patients-controlled intravenous analgesia(PCIA)in patients with scar pregnancy after auxiliary uterine artery embolization(UAE).Methods A total of 116 patients with scar pregnancy,who received auxiliary UAE at the Fuyang Municipal People's Hospital of China between January 2021 and September 2022,were enrolled in this study.According to the intravenous self-controlled analgesic drugs used after UAE,the patients were randomly and equally divided into observation group(n=58)and control group(n=58).Ten minutes before the procedure,intravenous injection of 2 mg hydromorphone(observation group)or 2 μg/kg sufentanyl(control group)was performed,and the PCIA pump was connected.In the observation group,the mixed solution of 10 mg hydromorphone+100 mg flurbiprofen axetil+100 mL saline was put in the analgesic pump,while in the control group,the mixed solution of 2 μg/kg sufentanyl+flurbiprofen axetil 100 mg+100 mL saline was put in the analgesic pump.The post-UAE 0.5-h,4-h,8-h,12-h,24-h and 48-h visual analogue scale(VAS)scores,the Bruggrmann comfort scale(BCS)scores,the number of pressing analgesic pump times within postoperative 48 hours,the used dosage of analgesic drugs,the adverse reactions,and the incidence of postoperative complications were recorded.Results The difference in the post-UAE 0.5-h VAS scores between the observation group and the control group was not statistically significant(P>0.05),while the post-UAE 4-h,8-h,12-h,24-h and 48-h VAS scores in the observation group were significantly lower than those in the control group,and the differences were statistically significant(all P<0.05).The post-UAE 0.5-h,4-h,8-h,12-h,24-h and 48-h BCS scores in the observation group were significantly higher than those in the control group,and the differences were statistically significant(all P<0.05).The number of pressing analgesic pump times and the used dosage of analgesic drugs within postoperative 48 hours in the observation group were lower than those in the control group,and the differences were statistically significant(all P<0.05).No statistically significant differences in the complications such as drowsiness,skin itching,hypoxia,or respiratory depression,etc.existed between the two groups,while the difference in the incidence of adverse reactions between the two groups was statistically significant(P<0.05).Conclusion Hydromorphone and sufentanil PCIA can relieve the pain in scar pregnancy patients after UAE.Hydromorphone is superior to sufentanil in reducing the number of pressing analgesic pump times within postoperative 48 hours,reducing the used dosage of analgesic drugs,and decreasing the incidence of adverse reactions,therefore,hydromorphone PCIA has a certain promotion value.(J Intervent Radiol,2024,33:240-244)
5.Effect of electroacupuncture on the expression of P53 and P21 in articular cartilage and subchondral bone of aged rats with knee osteoarthritis
Xiarong HUANG ; Lizhi HU ; Guanghua SUN ; Xinke PENG ; Ying LIAO ; Yuan LIAO ; Jing LIU ; Linwei YIN ; Peirui ZHONG ; Ting PENG ; Jun ZHOU ; Mengjian QU
Chinese Journal of Tissue Engineering Research 2024;28(8):1174-1179
BACKGROUND:There are many treatment methods for knee osteoarthritis,among which electroacupuncture,as an important non-drug treatment,is effective in the treatment of knee osteoarthritis,but its exact mechanism is not clear. OBJECTIVE:Effect of electroacupuncture on the expression of p53 and P21 in articular cartilage and subchondral bone of aged rats with knee osteoarthritis. METHODS:Eight 6-month-old male Sprague-Dawley rats were included in the young group and sixteen 24-month-old male Sprague-Dawley rats were randomly divided into old group(n=8)and electroacupuncture group(n=8).The rats in the electroacupuncture group received electroacupuncture stimulation once a day,5 days a week,for 8 continuous weeks,and the other two groups did not do any treatment.Eight weeks later,the level of type Ⅱ collagen C-terminal peptide in peripheral blood was detected by ELISA,the morphology of left knee cartilage and subchondral bone was observed by safranin O-fast green staining,the degree of knee cartilage degeneration was evaluated by modified Mankin's score,the microstructure of left knee cartilage and subchondral bone was detected by micro-CT,and the expression levels of matrix metalloproteinase 13,P53,P21 Mrna and protein were detected by RT-PCR and western blot respectively. RESULTS AND CONCLUSION:Compared with the young group,the level of C-terminal peptide of type Ⅱ collagen in the peripheral blood was increased in the old group(P<0.05).The micro-CT results showed that the bone volume fraction,bone mineral density and the number of bone trabeculae were decreased in the old group compared with the young group(P<0.05),while the trabecular separation increased(P<0.05).Safranin O-fast green staining showed that in the old group,the surface layer of cartilage was uneven with fissures,the morphology of chondrocytes was irregular and stained unevenly,the boundary between the cartilage and subchondral bone was blurred,and the matrix loss was serious.The Mankin's score was higher in the old group than the young group(P<0.05).The expression of matrix metalloproteinase 13,P53,P21 at Mrna and protein levels increased in the old group compared with the young group(P<0.05).Compared with the old group,electroacupuncture decreased the level of C-terminal peptide of type Ⅱ collagen(P<0.05),increased the bone volume fraction,bone mineral density and the number of bone trabeculae(P<0.05),and decreased the trabecular separation(P<0.05).Safranin O-fast green staining showed that in the electroacupuncture group,the surface of cartilage was smooth and red staining was uniform,and the cell morphology and structure were between the young group and the old group.Following electroacupuncture treatment,the Mankin's score(P<0.05),matrix metalloproteinase 13 and P21 Mrna expression(P<0.05),and matrix metalloproteinase 13 and P53 protein expression decreased(P<0.05),while there was a decreasing trend of P53 Mrna and P21 protein expression,but with no statistical significance(P>0.05).To conclude,electroacupuncture may delay articular cartilage degeneration and subchondral osteoporosis in aged rats by inhibiting the expression of P53 and P21,so as to protect joints and delay joint aging.
6.Correlation between Helicobacter pylori infection and gastrointestinal tumor in the physical examination population in Xi'an City
Lin HE ; Yudong MU ; Ying SUN ; Zhimin YUAN ; Jun YUAN
Journal of Public Health and Preventive Medicine 2024;35(1):104-108
Objective To analyze the spatial distribution of Helicobacter Pylori (Hp) infection and its correlation with gastrointestinal tumors in the physical examination population of Xi'an city, and to provide reference for the prevention of gastrointestinal tumors in this area. Methods A total of 23 200 subjects who underwent physical examination in 25 public hospitals in Xi'an from January 2019 to January 2023 were selected as the research objects. The basic Information of the patients was derived through the Hospital Information System (HIS), and all subjects underwent 13C-breath test and gastroenterological endoscope. ArcGIS 10.6 software was used to draw a statistical map of Hp infection in Xi 'an for spatial autocorrelation analysis. Hp infection in patients with different gastrointestinal tumors was analyzed. Results In this study population, there were 10 858 cases of Hp infection , with an infection rate of 46.80% ; among them , 5 491 cases were male, with an infection rate of 46.60% , and 5,367 cases were female, with an infection rate of 47.01% , and there was no significant difference in the infection rate between genders (P>0.05). The prevalence of HP infection was higher in the 30-year-old and 20-year-old groups, 55.62% and 42.71%, respectively, and the infection rate showed a first increase and then a decreasing trend with age (χ2trend = 6201.21, 6945.22 , P<0.001 ). The spatial distribution of Hp infection rate in the physical examination population of each administrative region county in Xi'an was globally spatially positively correlated, with spatial clustering (Moran's I=0.14, P=0.02). Local spatial autocorrelation showed that the five districts and counties presented high-high clustering. A total of 418 cases of gastrointestinal tumors were detected, with a detection rate of 1.80% , including 156 cases of gastric cancer , 85.90% of Hp infection rate, 106 cases of gastric mucosa-associated lymphoid tissue lymphoma, 83.02% of Hp infection rate, 98 cases of colon cancer, 80.61% of Hp infection rate, 58 cases of rectal cancer, 84.48% of Hp infection rate, and the differences were statistically significant (χ2=13.49, 16.16, 17.27, 24.66, P<0.05 for all). Conclusion The distribution of Hp infection in the physical examination population of Xi'an city has the characteristics of spatial aggregation and is related to gastrointestinal tumor diseases. It is suggested to carry out Hp infection education for the population in key areas to prevent the occurrence of gastrointestinal tumor diseases.
7.Clinical Effectiveness and Safety of Bairui Granules (百蕊颗粒) in Treating Patients with Acute Pharyngitis with Wind-Heat Syndrome: A Multi-Center, Double-Blind, Double-Simulation, Randomized Controlled Trial
Siming LIU ; Hui ZHOU ; Qiang LI ; Min ZHOU ; Qixiang WU ; Shanjun YANG ; Jun WANG ; Jingjing YUAN ; Ying ZHANG ; Ziqi ZHU ; Jingyi HU ; Shuang WU ; Mengting LI ; Zhanfeng YAN
Journal of Traditional Chinese Medicine 2024;65(11):1139-1145
ObjectiveTo evaluate the clinical effectiveness and safety of Bairui Granules (百蕊颗粒) in the treatment of acute pharyngitis with wind-heat syndrome. MethodsA multicenter, double-blind, double-simulation, randomised controlled trial was conducted, in which 162 patients with acute pharyngitis and wind-heat syndrome from 7 centers were recruited, and each center was divided into trial group and control group on the ratio of 2∶1. In the trial group, 108 cases were orally administered with Bairui Granules plus Reyanning Granules (热炎宁颗粒) simulant, and in the control group, 54 cases were orally administered with Reyanning Granules plus Bairui Granules simulant for 5 days, with a follow-up visit on the 6th day. Full analysis set (FAS) analysis and per protocol set (PPS) were used for analysis, respectively. The primary efficacy index was the disappearance rate of sore throat after 5-day treatment; the secondary efficacy indexes were the disappearance rate of sore throat after 3-day treatment, as well as the visual analogue score (VAS) of sore throat before treatment, every day during the treatment, and follow-up on day 6, and the traditional Chinese medicine (TCM) syndrome score was performed before treatment and at the follow-up on day 6. The effectiveness on TCM syndrome was evaluated at the follow-up on day 6, and the changes of vital signs, blood routine, urine routine, liver functions, kidney function, the adverse events before and after the treatment were recorded, and safety analysis set (SS) was analysed. Results162 patients entered the FAS and SS analyses, and 158 cases (105 cases in the trial group and 53 cases in the control group) entered the PPS analysis. FAS analysis showed that the disappearance rate of sore throat after 5-day treatment was 80.56% (87/108) in the trial group and 64.81% (35/54) in the control group, and the difference between groups was statistically significant (χ2 = 5.10, P = 0.0239). PPS analysis showed that the disappearance rate of sore throat after 5-day treatment was 80.00% (84/105) in the trial group and 64.15% (34/53) in the control group, and the difference between groups was statistically significant (χ2 =4.85, P = 0.0277). FAS and SS analyses both showed that the difference in disappearance rate of sore throat between groups on 3-day treatment was not statistically significant (P>0.05). Compared with those before treatment, the VAS scores of sore throat were lower in both groups during treatment on day 2, 3, 4, 5, and follow-up on day 6 (P<0.01), but the difference between groups at each time point was not statistically significant (P>0.05). TCM syndrome scores of both groups at the follow-up were lower than that before treatment, and those of the trial group were lower than those of the control group (P<0.01). The cure rate and effective rate of TCM syndrome of the trial group were significantly higher than those of the control group (P<0.01). There was no significant difference in blood routine, urine routine, liver function, kidney function between groups before and after treatment (P>0.05), and no serious adverse events occured in both groups. ConclusionBairui Granules showed clinical effectiveness in the treatment of acute pharyngitis of wind-heat syndrome, and it could significantly improve the clinical symptoms, accelerate the disappearance time of sore throat with good safety.
8.The Uptake and Distribution Evidence of Nano-and Microplastics in vivo after a Single High Dose of Oral Exposure
Tao HONG ; Wei SUN ; Yuan DENG ; Da Jian LYU ; Hong Cui JIN ; Long Ying BAI ; Jun NA ; Rui ZHANG ; Yuan GAO ; Wei Guo PAN ; Sen Zuo YANG ; Jun Ling YAN
Biomedical and Environmental Sciences 2024;37(1):31-41
Objective Tissue uptake and distribution of nano-/microplastics was studied at a single high dose by gavage in vivo.Methods Fluorescent microspheres (100 nm, 3 μm, and 10 μm) were given once at a dose of 200 mg/(kg·body weight). The fluorescence intensity (FI) in observed organs was measured using the IVIS Spectrum at 0.5, 1, 2, and 4 h after administration. Histopathology was performed to corroborate these findings.Results In the 100 nm group, the FI of the stomach and small intestine were highest at 0.5 h, and the FI of the large intestine, excrement, lung, kidney, liver, and skeletal muscles were highest at 4 h compared with the control group (P < 0.05). In the 3 μm group, the FI only increased in the lung at 2 h (P < 0.05). In the 10 μm group, the FI increased in the large intestine and excrement at 2 h, and in the kidney at 4 h (P < 0.05). The presence of nano-/microplastics in tissues was further verified by histopathology. The peak time of nanoplastic absorption in blood was confirmed.Conclusion Nanoplastics translocated rapidly to observed organs/tissues through blood circulation;however, only small amounts of MPs could penetrate the organs.
9.Liuwei Dihuang Pills-elicited inhibition of MMP-2/MMP-9 via RAGE on tight junction protein of Aβ1-40-injured bEnd.3 cells
Rui DING ; Yong YUAN ; Ya-Quan JIA ; Ai-She GAO ; Zhen-Qiang ZHANG ; Jun-Ying SONG
Chinese Traditional Patent Medicine 2024;46(2):424-430
AIM To investigate the protective effects and the mechanism of the Liuwei Dihuang Pills on mouse brain microvascular endothelial(bEnd.3)cells damaged by β-Amyloid protein1-40(Aβ1-40).METHODS CCK8 method was used to detect the effects of Aβ1-40 and medicated serum of Liuwei Dihuang Pills(MSLDP)on cell activity,and to screen the appropriate concentration.bEnd.3 cells of the control group,the Aβ1-40 group,the MSLDP+Aβ1-40 group and the MSLDP group had their low density lipoprotein-associated protein 1(LRP1),receptor for advanced glycation end products(RAGE),matrix metalloproteinase-2(MMP-2),MMP-9,scaffold protein zonule protein-1(ZO-1)detected by Western blot.bEnd.3 cells assigned into the control group,the Aβ1-40 group,the FPS-ZM1(RAGE inhibitor)+Aβ1-40 group and the FPS-ZM1+Aβ1-40+MSLDP group had their expressions of RAGE,MMP-9,MMP-2 and ZO-1 detected by Western blot as well.RESULTS The cell activity of bEnd.3,was dose-dependently decreased by Aβ1-40(P<0.01),but was protected by MSLDP(P<0.05,P<0.01).And 10 μmol/L Aβ1-40 and 10%MSLDP were selected for subsequent experiments.Compared with the control group,the Aβ1-40 group displayed increased protein expressions of RAGE,MMP-2 and MMP-9(P<0.01),decreased protein expressions of LRP1,ZO-1 and BDNF(P<0.05,P<0.01),and decreased fluorescence intensities of LRP1 and ZO-1(P<0.01).Compared with the Aβ1-40 group,the MSLDP group shared decreased expressions of RAGE,MMP-2,MMP-9 proteins and RAGE fluorescence intensity(P<0.05,P<0.01),and increased expressions of LRP1,ZO-1 and BDNF proteins,and the fluorescence intensity of LRP1 and ZO-1(P<0.05,P<0.01);the Aβ1-40+FPS-ZM1 group displayed decreased protein expressions of MMP-2,MMP9 and RAGE(P<0.05,P<0.01),and increased ZO-1 protein expression(P<0.05);and the Aβ1-40+FPS-ZM1+ MSLDP group displayed an even more decreased protein expressions of MMP-2,MMP9 and RAGE(P<0.01),increased ZO-1 protein expression(P<0.01)due to the the combination use of FPS-ZM1 and MSLDP.CONCLUSION Liuwei Dihuang Pills can protect the tight junction of bEnd.3 injured by Aβ1-40 and neurovascular units from Alzheimer's disease by alleviating the dysfunction of the blood-brain barrier via RAGE-mediated MMP-2/MMP-9 pathway inhibition.
10.Study on the effect of different administration regimens of iprrazole enteric-coated tablets on inhibiting gastric acid secretion
Ting-Yuan PANG ; Zhi WANG ; Zi-Shu HU ; Zi-Han SHEN ; Yue-Qi WANG ; Ya-Qian CHEN ; Xue-Bing QIAN ; Jin-Ying LIANG ; Liang-Ying YI ; Jun-Long LI ; Zhi-Hui HAN ; Guo-Ping ZHONG ; Guo-Hua CHENG ; Hai-Tang HU
The Chinese Journal of Clinical Pharmacology 2024;40(1):92-96
Objective To compare the effects of 20 mg qd and 10 mg bidadministration of iprrazole enteric-coated tablets on the control of gastric acid in healthy subjects.Methods A randomized,single-center,parallel controlled trial was designed to include 8 healthy subjects.Randomly divided into 2 groups,20 mg qd administration group:20 mg enteric-coated tablets of iprrazole in the morning;10 mg bid administration group:10 mg enteric-coated tablets of iprrazole in the morning and 10 mg in the evening.The pH values in the stomach of the subjects before and 24 h after administration were monitored by pH meter.The plasma concentration of iprazole after administration was determined by HPLC-MS/MS.The main pharmacokinetic parameters were calculated by Phoenix WinNonlin(V8.0)software.Results The PK parameters of iprrazole enteric-coated tablets and reference preparations in fasting group were as follows:The Cmax of 20 mg qd group and 10 mg bid group were(595.75±131.15)and(283.50±96.98)ng·mL-1;AUC0-t were(5 531.94±784.35)and(4 686.67±898.23)h·ng·mL-1;AUC0-∞ were(6 003.19±538.59)and(7 361.48±1 816.77)h·ng·mL-1,respectively.The mean time percentage of gastric pH>3 after 20 mg qd and 10 mg bid were 82.64%and 61.92%,and the median gastric pH within 24 h were 6.25±1.49 and 3.53±2.05,respectively.The mean gastric pH values within 24 h were 5.71±1.36 and 4.23±1.45,respectively.The correlation analysis of pharmacokinetic/pharmacodynamics showed that there was no significant correlation between the peak concentration of drug in plasma and the inhibitory effect of acid.Conclusion Compared with the 20 mg qd group and the 10 mg bid group,the acid inhibition effect is better,the administration times are less,and the safety of the two administration regimes is good.


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