1.Integration and innovation of wet granulation and continuous manufacturing technology: a review of on-line detection, modeling, and process scale-up.
Guang-di YANG ; Ge AO ; Yang CHEN ; Yu-Fang HUANG ; Shu CHEN ; Dong-Xun LI ; Wen-Liu ZHANG ; Tian-Tian WANG ; Guo-Song ZHANG
China Journal of Chinese Materia Medica 2025;50(6):1484-1495
Continuous manufacturing, as an innovative pharmaceutical production model, offers advantages such as high production efficiency and ease of control compared to traditional batch production, aligning with the future trend of drug production moving toward greater efficiency and intelligence. However, the development of continuous manufacturing technology in wet granulation has been slow. On one hand, this is closely related to its high technical complexity, substantial equipment investment costs, and stringent process control requirements. On the other hand, the long-term use of the traditional batch production model has created strong path dependence, and the lack of mature standardized processes further increases the difficulty of technological transformation. To promote the deep integration of wet granulation technology with continuous manufacturing, this review systematically outlines the current application of wet granulation in continuous manufacturing. It focuses on the development of key technologies such as online detection, process modeling, and process scale-up, with the aim of providing a reference for process innovation and application in wet granulation.
Drug Compounding/instrumentation*
;
Technology, Pharmaceutical/methods*
;
Drugs, Chinese Herbal/chemistry*
;
Models, Theoretical
2.Study on the efficacy of automatic-controlled pressure cupping for lumbar disc herniation.
Bo-Chen PENG ; Min-Shan FENG ; Li LI ; Gui-Ju REN ; Yi-Zhen YUAN ; Li-Jie CHANG ; Shu-Ying REN ; Liu ZENG ; Guang-Wei LIU ; Li-Guo ZHU ; Na YUAN
China Journal of Orthopaedics and Traumatology 2025;38(11):1133-1138
OBJECTIVE:
To observe the clinical efficacy and safety of automatic pressure-controlled pressure cupping in patients with lumbar disc herniation, and compare it with traditional cupping.
METHODS:
A total of 100 patients diagnosed with lumbar disc herniation from January 2022 to August 2024 were selected and divided into two groups:the automatic pressure-controlled pressure cupping group (controlled pressure cupping group) and the traditional cupping group (control group), 50 cases in each group. In the controlled pressure cupping group, there were 18 males and 32 females, with an age of (51.98±12.69) years;in the control group, there were 16 males and 34 females, with an age of (51.32±12.05) years. The visual analogue scale(VAS), comfort score, and lumbar range of motion were observed before treatment and after the 1st, 3rd, and 7th treatments to evaluate the efficacy and safety.
RESULTS:
All patients completed the treatment intervention, with complete follow-up data collected. No adverse reactions or complications occurred during treatment and follow-up. After the 3rd treatment, the VAS score of the controlled pressure cupping group was (2.38±0.49), which was lower than that of the control group (2.94±0.68), with a statistically significant difference (P<0.001). In the controlled pressure cupping group, the VAS scores after the 1st, 3rd, and 7th treatments were significantly better than those before treatment (P=0.026);in the control group, the VAS scores after the 3rd and 7th treatments were better than those before treatment, but the difference was not statistically significant(P=0.182). Repeated-measures analysis of variance (ANOVA) on VAS scores at different time points in both groups showed that there were statistically significant differences in inter-group, time, and interaction effects (P<0.05). After the 1st treatment, in the controlled pressure cupping group, 0 patients felt comfortable, 42 patients (84%) felt mild discomfort, and 8 patients (16%) felt moderate discomfort;in the control group, 0 patients felt comfortable, 28 patients (56%) felt mild discomfort, and 22 patients(44%) felt moderate discomfort;the difference between the two groups was statistically significant(P=0.005). After the 3rd treatment, in the controlled pressure cupping group, 30 patients(60%) felt comfortable, 20 patients (40%) felt mild discomfort, and 0 patients felt moderate discomfort; in the control group, 9 patients (18%) felt comfortable, 41 patients (82%) felt mild discomfort, and 0 patients felt moderate discomfort;the difference between the two groups was statistically significant(P<0.001). There was no statistically significant difference in comfort between the two groups after the 7th treatment(P>0.001). There was no statistically significant difference in lumbar range of motion between the two groups before and after treatment(P>0.05);compared with before treatment, the lumbar range of motion of both groups after treatment was significantly improved, with statistically significant differences (P<0.001).
CONCLUSION
Automatic pressure-controlled pressure cupping can effectively relieve symptoms in patients with lumbar disc herniation, with excellent safety.
Humans
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Female
;
Male
;
Intervertebral Disc Displacement/physiopathology*
;
Middle Aged
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Adult
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Lumbar Vertebrae/physiopathology*
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Cupping Therapy/methods*
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Pressure
;
Aged
;
Treatment Outcome
3.Effect of phenytoin and levetiracetam on busulfan blood concentration in children undergoing hematopoietic stem cell transplantation.
Shi-Xi XU ; Guang-Ting ZENG ; Jing-Yu WANG ; Shu-Lan LIU ; Jing LIU ; Bo-Yan DENG ; Ji-Ming LUO ; Jie LIN ; An-Fa WANG
Chinese Journal of Contemporary Pediatrics 2025;27(11):1378-1383
OBJECTIVES:
To study the effect of prophylactic phenytoin (PHT) or levetiracetam (LEV) on busulfan (BU) blood concentration in children undergoing hematopoietic stem cell transplantation.
METHODS:
Pediatric patients conditioned with BU plus cyclophosphamide and fludarabine at the First People's Hospital of Chenzhou from September 2023 to February 2025 were retrospectively included. Patients were grouped by prophylactic antiepileptic regimen into PHT (n=24) and LEV (n=26). BU blood concentrations at the end of infusion (0 hour) and at 1, 2, and 4 hours post-infusion were compared between groups.
RESULTS:
At 0 hour post-infusion, BU blood concentrations did not differ significantly between groups (P>0.05). At 1, 2, and 4 hours post-infusion, BU blood concentrations were higher in the LEV group than in the PHT group (P<0.05). The area under the concentration-time curve from 0 to ∞ (AUC0-∞) was greater in the LEV group (P<0.001), and the attainment rate of AUC0-∞ was higher in the LEV group than in the PHT group (73% vs 21%, P<0.001). No significant differences were observed between groups in time to hematopoietic engraftment or in the incidence of BU-related adverse drug reactions (P>0.05).
CONCLUSIONS
Compared with PHT, LEV prophylaxis is associated with higher BU blood concentration and a higher AUC0-∞ attainment rate. There is no observed difference in BU efficacy or safety between PHT and LEV.
Humans
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Levetiracetam/therapeutic use*
;
Busulfan/pharmacokinetics*
;
Hematopoietic Stem Cell Transplantation
;
Male
;
Female
;
Child
;
Child, Preschool
;
Phenytoin/pharmacology*
;
Infant
;
Retrospective Studies
;
Anticonvulsants/pharmacology*
;
Adolescent
4.Hepatitis C virus infection:surveillance report from China Healthcare-as-sociated Infection Surveillance System in 2020
Xi-Mao WEN ; Nan REN ; Fu-Qin LI ; Rong ZHAN ; Xu FANG ; Qing-Lan MENG ; Huai YANG ; Wei-Guang LI ; Ding LIU ; Feng-Ling GUO ; Shu-Ming XIANYU ; Xiao-Quan LAI ; Chong-Jie PANG ; Xun HUANG ; An-Hua WU
Chinese Journal of Infection Control 2024;23(1):1-8
Objective To investigate the infection status and changing trend of hepatitis C virus(HCV)infection in hospitalized patients in medical institutions,and provide reference for formulating HCV infection prevention and control strategies.Methods HCV infection surveillance results from cross-sectional survey data reported to China Healthcare-associated Infection(HAI)Surveillance System in 2020 were summarized and analyzed,HCV positive was serum anti-HCV positive or HCV RNA positive,survey result was compared with the survey results from 2003.Results In 2020,1 071 368 inpatients in 1 573 hospitals were surveyed,738 535 of whom underwent HCV test,4 014 patients were infected with HCV,with a detection rate of 68.93%and a HCV positive rate of 0.54%.The positive rate of HCV in male and female patients were 0.60%and 0.48%,respectively,with a statistically sig-nificant difference(x2=47.18,P<0.001).The HCV positive rate in the 50-<60 age group was the highest(0.76%),followed by the 40-<50 age group(0.71%).Difference among all age groups was statistically signifi-cant(x2=696.74,P<0.001).In 2003,91 113 inpatients were surveyed.35 145 of whom underwent HCV test,resulting in a detection rate of 38.57%;775 patients were infected with HCV,with a positive rate of 2.21%.In 2020,HCV positive rates in hospitals of different scales were 0.46%-0.63%,with the highest in hospital with bed numbers ranging 600-899.Patients'HCV positive rates in hospitals of different scales was statistically signifi-cant(X2=35.34,P<0.001).In 2020,12 provinces/municipalities had over 10 000 patients underwent HCV-rela-ted test,and HCV positive rates ranged 0.19%-0.81%,with the highest rate from Hainan Province.HCV posi-tive rates in different departments were 0.06%-0.82%,with the lowest positive rate in the department of pedia-trics and the highest in the department of internal medicine.In 2003 and 2020,HCV positive rates in the depart-ment of infectious diseases were the highest,being 7.95%and 3.48%,respectively.Followed by departments of orthopedics(7.72%),gastroenterology(3.77%),nephrology(3.57%)and general intensive care unit(ICU,3.10%)in 2003,as well as departments of gastroenterology(1.35%),nephrology(1.18%),endocrinology(0.91%),and general intensive care unit(ICU,0.79%)in 2020.Conclusion Compared with 2003,HCV positive rate decreased significantly in 2020.HCV infected patients were mainly from the department of infectious diseases,followed by departments of gastroenterology,nephrology and general ICU.HCV infection positive rate varies with gender,age,and region.
5.Implementation of surveillance,prevention and control of healthcare-asso-ciated infection in maternal and child healthcare institutions:A nation-wide investigation report
Shuo LI ; Xi YAO ; Hui-Xue JIA ; Wei-Guang LI ; Xun HUANG ; Shu-Mei SUN ; Xi CHENG ; Qing-Lan MENG ; Xiang ZHANG ; Jing-Ping ZHANG ; Ya-Wei XING ; Qing-Qing JIANG ; Lian-Xuan WU ; Bing-Li ZHANG ; Xiao-Jing LIU ; Liu-Yi LI
Chinese Journal of Infection Control 2024;23(3):323-329
Objective To investigate the implementation of surveillance,prevention and control measures for healthcare-associated infection(HAI)in maternal and child healthcare(MCH)institutions,and provide policy evi-dence for optimizing HAI prevention and control in MCH institutions.Methods Stratified sampling was conducted among the MCH institutions at provincial,municipal and county levels in 8 provinces/autonomous regions.A uni-fied questionnaire was designed and the online survey was conducted through"Questionnaire Star".Results The data from 123 MCH institutions were included in the analysis.90.24%of the MCH institutions carried out compre-hensive surveillance on HAI.The ratios of MCH institutions which implemented targeted surveillance on HAI in neonatal intensive care unit(NICU),surgical site infection,multidrug-resistant organisms(MDROs)and HAI in intensive care units(non-NICU excluded)were 89.66%,85.96%,80.77%,and 74.19%,respectively.51.22%MCH institutions adopted information surveillance system on HAI cases.94.31%MCH institutions carried out surveillance on hand hygiene compliance.Over 90%MCH institutions carried out surveillance on environment hy-giene in high-risk departments.71.54%MCH institutions conducted centralized cleaning,disinfection,sterilization and supply for reusable medical instruments in the central sterile supply department(CSSD).Over 90%MCH insti-tutions established three-level pre-examination triage systems.86.18%set up transitional wards.MCH institutions generally adopted a management model with established effective communication,full appointment visits,and sepa-rate visits for special medical groups,such as registered pregnant women,high-risk newborns,healthcare groups,and long-term rehabilitation patients.However,the ratio of institutions conducting on-line follow-up visits was less than 50%.Conclusion MCH institutions have generally carried out comprehensive and targeted surveillance on HAI.Information surveillance need to be facilitated.Hand hygiene and environmental hygiene surveillance has been popularized to a certain extent at all levels of MCH institutions.The cleaning,disinfection,sterilization,and supply processes of reusable medical devices in a few MCH institutions are not standardized.Special medical populations get effective management.On-line healthcare is to be further promoted.
6.Clinical efficacies of different surgical methods on elderly patients with lumbar tuberculosis
Shuai WANG ; Zhao-Liang DONG ; Shu-Ren LIU ; Chen-Guang JIA ; Lian-Bo WANG
Journal of Regional Anatomy and Operative Surgery 2024;33(7):619-623
Objective To explore the clinical efficacies of different surgical methods for elderly patients with lumbar tuberculosis.Methods The clinical data of 289 elderly patients with lumbar tuberculosis admitted to Hebei Chest Hospital from August 2018 to August 2021 were retrospectively analyzed.According to surgical methods,the patients were divided into the posterior group(109 cases),the anterior and posterior combination group(81 cases),and the anterior group(99 cases).The time of bone graft and fusion,operation time,hospital stay,intraoperative blood loss,and complications of the three groups were collected and compared among the three groups.The spine Cobb angle was regularly determined,the correction degree was calculated;the levels of erythrocyte sedimentation rate(ESR),white blood cell count(WBC),and C-reactive protein(CRP)were collected and compared among the three groups;and the Frankel grading and visual analogue scale(VAS)scores of the three groups were compared.Results After a 2-year follow-up,there was no significant difference in the time of bone graft and fusion among the three groups(P>0.05),the anterior group had the shortest operation time,the posterior group had the shortest hospital stay,and the lowest intraoperative blood loss and incidence of complications,with statistically significant differences(P<0.05).The correction degree of the anterior and posterior combination group was better than that of the posterior group and the anterior group(P<0.05),and the Cobb angles after operation and at the last follow-up in the posterior group was better(P<0.05).The anterior and posterior combination group had better improvement effect on CRP and ESR at the last follow-up(P<0.05),the WBC level of the posterior group was lower(P<0.05).The proportions of patients in grade E of Frankel grading at the last follow-up in the three groups were higher than those after surgery(P<0.05);compared with the preoperative period,the VAS scores at the last follow-up of the three groups decreased(P<0.05),and the VAS score of the posterior group was lower(P<0.05).Conclusion The effects of anterior surgery,posterior surgery and anterior and posterior combined surgery in the treatment of elderly lumbar tuberculosis are good,and the approach method can be scientifically and reasonably formulated according to patients' physical condition to improve the clinical treatment effect.
7.Effect of intravenous infusion of low-dose remifentanil on obese scarred uterine puerperae undergoing cesarean section under epidural anesthesia
Chang CHEN ; Chao LIU ; Guang-Le WEI ; Shu WANG ; Lin JI ; Ti-Jun DAI
Journal of Regional Anatomy and Operative Surgery 2024;33(11):945-949
Objective To investigate the effect of intravenous infusion of low-dose remifentanil on obese scarred uterine puerperae undergoing cesarean section under epidural anesthesia.Methods A total of 87 obese scarred uterine puerperae undergoing cesarean section under epidural anesthesia were selected as the study subjects,and they were randomly divided into the conventional group(n=43)and the remifentanil group(n=44).From the beginning of skin incision,puerperae of the conventional group and the remifentanil group were intravenously injected with normal saline and low-dose remifentanil respectively until the end of the operation.The vital signs,pain and comfort scores,intraoperative complications of puerperae,and status of newborns were compared between the two groups at different points during the operation.Results During fetal extraction and peritoneal exploration,the heart rate,mean arterial pressure and pain scores of puerperae in the remifentanil group were lower than those in the conventional group,and the differences were statistically significant(P<0.05);the intraoperative comfort score of puerperae in the remifentanil group was higher than that in the conventional group,and the difference was statistically significant(P<0.05).The incidence of nausea and vomiting of puerperae in the remifentanil group was lower than that in the conventional group,and the difference was statistically significant(P<0.05).There was no significant difference in the Apgar score at 1 minute and 5 minutes after delivery,requiring initial resuscitation or pH value of umbilical vein blood between newborns delivered by puerperae of the two groups(P>0.05).Conclusion Intravenous infusion of 0.05 μg·kg-1·min-1 low-dose remifentanil not only significantly reduces intraoperative pain and improves comfort of obese scarred uterine puerperae undergoing cesarean section under epidural anesthesia,but also helps to reduce the incidence of adverse reactions and ensure maternal and infant safety.
8.Progress in Prevention and Treatment of Dysplasia in Ulcerative Colitis Based on Cyclooxygenase-2/p53 Axis.
Yi-Lin ZHANG ; Shu-Sen YANG ; Yu-Shan LIU ; Shu-Guang YAN
Acta Academiae Medicinae Sinicae 2024;46(6):940-948
Ulcerative colitis(UC)is a chronic inflammatory bowel disease characterized by non-specific,persistent inflammation in the intestines.This chronic inflammation often increases the risk of serious complications such as colorectal cancer.Dysplasia acts as a driver of cancer development and plays a connecting role in the occurrence and development of chronic intestinal inflammation and colorectal cancer.Cell proliferation/apoptosis imbalance is the driving factor for dysplasia development.The abnormal proliferation/apoptosis of intestinal mucosal epithelial cells may be affected by cyclooxygenase-2(COX-2),tumor suppressor gene p53,or both.Therefore,reasonable regulation of COX-2/p53 axis may be a key to achieving intestinal mucosal proliferation/apoptosis balance.This article discusses the effects and mechanism of COX-2 and p53 in regulating the occurrence and development of dysplasia in UC from the proliferation/apoptosis imbalance of intestinal mucosal epithelial cells,aiming to provide a reference for understanding the mechanism of dysplasia in UC and developing targeted therapeutic drugs.
Colitis, Ulcerative/metabolism*
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Humans
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Cyclooxygenase 2/metabolism*
;
Tumor Suppressor Protein p53/metabolism*
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Intestinal Mucosa/metabolism*
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Apoptosis
;
Cell Proliferation
9.Acute effects of NO2 on hospitalization risk of children with respiratory diseases in Foshan City
Xin-hong CHEN ; Rui-xue HE ; Shu-xia LIU ; Cheng XING ; Shu-guang XIE ; Chuan-gang FAN
Journal of Public Health and Preventive Medicine 2023;34(1):54-58
Objective To explore the acute effects of NO2 on children's respiratory hospitalization risk in Foshan City. Methods The daily average concentrations of six air pollutants such as NO2 and fine particulate matter, and meteorological data including average temperature and relative humidity in Foshan were collected from 2016 to 2019. Data on the daily number of children newly hospitalized for respiratory diseases (ECRH) in Foshan Women and Children Hospital were retrieved. Time series analysis was used to quantitatively evaluate the effect of daily NO2 concentration on the hospitalization risk of children with respiratory diseases. Results From 2016 to 2019, the average ECRH in the hospital was 10. The daily average concentrations of air pollutants NO2, PM2.5, PM10, and SO2 were 42.0 μg/m3, 35.3 μg/m3, 58.1 μg/m3, and 11.4 μg/m3, respectively. The air pressure, daily average temperature and relative humidity of atmosphere were 1008.4 Pa, 23.7℃ and 73.3%, respectively. ECRH was significantly correlated with the daily average concentration of NO2 (r=0.079, P<0.05). After excluding temperature, humidity and other influencing factors, for every 10 μg/m3 increase of NO2 concentration in the single pollutant model, the excess risk of ECHR in the hospital increased by 1.22% (95% CI: 0.06%, 2.40%) and 1.37% (95% CI: 0.23%, 2.53%) in lag0 and Lag1 day, respectively. The strongest effect appeared in lag0:7 with the excess risk increasing by 1.70% (95% CI:0.12%, 3.31%). In the NO2 + SO2 + CO + O3_8h + PM2.5 and NO2 + SO2 + CO + O3_8h + PM10 multi-pollutant models, significance correlation still existed between the daily average NO2 concentration and ECHR in lag0, lag1 and lag0:1 to lag0:7. The strongest effect appeared in lag0:1, and the excess risks were 4.06% (95% CI: 1.83%, 6.34%) and 3.95% (95% CI: 1.85%, 6.09%), respectively. Dose-response relationship analysis showed a linear relationship between the daily average NO2 concentration and ECHR, and the excess risk of new hospitalization gradually increased with the increase of daily average NO2 concentration. Conclusion There was a significant correlation between NO2 concentration and hospitalization risk of children with respiratory diseases in Foshan City, which suggests that the government should further strengthen the prevention and control of air pollution.
10.Effect of acupuncture exercise therapy synchronizing isokinetic muscle strength training for postoperative rehabilitation of meniscectomy under arthroscopy.
Shu-Yi CUI ; Jun-Hui WANG ; Jia-Xin ZHAO ; Jia-Yan LIANG ; Guang-Tian LIU ; Wen YAN
Chinese Acupuncture & Moxibustion 2023;43(10):1118-1122
OBJECTIVE:
To observe the effect of acupuncture exercise therapy synchronizing isokinetic muscle strength training on the motor function, stability and proprioception of knee joint, as well as the anxiety emotion in patients after meniscectomy under arthroscopy.
METHODS:
A total of 70 patients after meniscectomy under arthroscopy were randomized into an observation group (35 cases, 2 cases were eliminated, 2 cases dropped off) and a control group (35 cases, 2 cases were eliminated, 1 case dropped off). Acupuncture was applied at Chize (LU 5), Neixiyan (EX-LE 4), Dubi (ST 35),Yanglingquan (GB 34), etc. on the affective side in the two groups. After 30 min, the needles of the knee joint area were withdrew, while the needle at elbow was continuously retained, the observation group was given acupuncture exercise therapy synchronizing isokinetic muscle strength training, and the control group was given conventional acupuncture exercise therapy. The treatment was given once a day, 7-day treatment was taken as one course, and totally 4 courses were required in the two groups. Before and after treatment, the knee joint Lysholm score, the knee joint isokinetic muscle strength flexion/extension ratio (H/Q), joint position sense measurement (JPS) and Hamilton anxiety scale (HAMA) score were compared in the two groups.
RESULTS:
After treatment, the knee joint Lysholm scores and H/Q were increased compared with those before treatment in the two groups (P<0.001), and the knee joint Lysholm score and H/Q in the observation group were higher than those in the control group (P<0.001); the JPS and HAMA scores were decreased compared with those before treatment in the two groups (P<0.001), the JPS and HAMA score in the observation group were lower than those in the control group (P<0.05).
CONCLUSION
Acupuncture exercise therapy synchronizing isokinetic muscle strength training can effectively improve the motor function, stability and proprioception of knee joint, as well as the anxiety emotion in patients after meniscectomy under arthroscopy.
Humans
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Arthroscopy
;
Meniscectomy
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Resistance Training
;
Treatment Outcome
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Osteoarthritis, Knee/therapy*
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Acupuncture Therapy
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Exercise Therapy
;
Muscles
;
Muscle Strength
;
Acupuncture Points


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