1.Discrete element modeling and breakage behavior analysis of oral solid dosage form particles
Lin-xiu LUO ; Tian-bing GUAN ; An-qi LUO ; Zeng LIU ; Yu-ting WANG ; Yan-ling JIANG ; Zheng LU ; Jing-cao TANG ; Shuang-kou CHEN ; Hui-min SUN ; Chuan-yun DAI
Acta Pharmaceutica Sinica 2024;59(4):1057-1066
The breakage pattern of unit particles during the production of oral solid dosage forms (OSD) is closely related to the quality of intermediate or final products. To accurately characterize the particles and study the evolution law of particle breakage, the Bonding model of the discrete element method (DEM) was used to investigate the breakage patterns of model parameters, particle shape and process conditions (loading mode and loading rate) on the dynamic breakage, force-time curve, breakage rate, maximum breakage size ratio and fracture strength of particles. The results showed that the particle breakage force was positively correlated with normal strength and bonded disk scale, negatively correlated with normal stiffness per unit area and tangential stiffness per unit area, and weakly correlated with tangential strength. The particle breakage rate was negatively correlated with the aspect ratio of the particles, and the maximum breakage size ratio was positively correlated with the aspect ratio of the particles; among the three loading modes, the breakage rate of compression breakage model was the largest, the breakage rate of shear breakage model was the second largest, and the breakage rate of wear breakage model was the smallest; the maximum breakage size ratio was positively correlated with the loading rate, the loading mode and the loading rate had no mutual influence on particle breakage rate, but had mutual influence on the maximum breakage size ratio. The research results will provide a theoretical basis for the shift of OSD from batch manufacturing to advanced manufacturing.
2.Clinical characteristics of children with anti-neutrophil cytoplasmic antibody-associated vasculitis
Jing-Qi LIU ; Yong-Zhen LI ; Lan-Jun SHUAI ; Yan CAO ; Xiao-Yan LI ; Ying WANG ; Tian SHEN ; Shuang-Hong MO ; Xiao-Jie HE ; Xiao-Chuan WU
Chinese Journal of Contemporary Pediatrics 2024;26(8):823-828
Objective To study the clinical characteristics of children with anti-neutrophil cytoplasmic antibody(ANCA)-associated vasculitis(AAV).Methods A retrospective analysis was conducted on the clinical data of 25 children diagnosed with AAV at the Second Xiangya Hospital of Central South University from January 2010 to June 2022.Results Among the AAV children,there were 5 males and 20 females,with a median age of onset of 11.0 years.Involvement of the urinary system was seen in 18 cases(72%);respiratory system involvement in 10 cases(40%);skin involvement in 6 cases(24%);eye,ear,and nose involvement in 5 cases(20%);joint involvement in 4 cases(16%);digestive system involvement in 2 cases(8%).Eleven cases underwent kidney biopsy,with 5 cases(46%)showing focal type,2 cases(18%)showing crescentic type,2 cases(18%)showing mixed type,and 2 cases(18%)showing sclerotic type.Immune complex deposits were present in 5 cases(45%).Seven cases reached chronic kidney disease(CKD)stage Ⅴ,with 2 cases resulting in death.Two cases underwent kidney transplantation.At the end of the follow-up period,2 cases were at CKD stage Ⅱ,and 1 case was at CKD stage Ⅲ.Of the 16 cases of microscopic polyangiitis(MPA)group,13(81%)involved the urinary system.Of the 9 cases of granulomatosis with polyangiitis(GPA),6 cases(66%)had sinusitis.Serum creatinine and uric acid levels were higher in the MPA group than in the GPA group(P<0.05),while red blood cell count and glomerular filtration rate were lower in the MPA group(P<0.05).Conclusions AAV is more common in school-age female children,with MPA being the most common clinical subtype.The onset of AAV in children is mainly characterized by renal involvement,followed by respiratory system involvement.The renal pathology often presents as focal type with possible immune complex deposits.Children with MPA often have renal involvement,while those with GPA commonly have sinusitis.The prognosis of children with AAV is poor,often accompanied by renal insufficiency.
3.Surveillance analysis of Mycobacterium tuberculosis and HIV co-infection in Liaoning Province from 2016 to 2021
LIANG Shuang ; JIANG Yiwen ; ZHANG Yan ; LI Yue ; QI Wei ; CAO Hongwei
China Tropical Medicine 2024;24(4):422-
Abstract: Objective To analyze the surveillance of Mycobacterium tuberculosis/HIV (TB/HIV) co-infection in Liaoning Province from 2016 to 2021, providing a scientific basis for formulating future prevention and control measures applicable to the province-wide co-infection. Methods A descriptive analysis was conducted on patient registration, two-way screening, and treatment information from the annual report of patients with TB/HIV co-infection in Liaoning Province from 2016 to 2021. Results From 2016 to 2021, 222 cases of TB/HIV co-infection were registered in Liaoning Province, accounting for 0.16% (222/136 709) of TB patients and 1.42% (222/15 584) of HIV/AIDS patients. In HIV/AIDS, the symptom screening rate was 96.01%, showing a downward trend (χ2trend=982.28, P<0.05). The TB detection rate was 0.47%, also showing a downward trend (χ2trend=36.56, P<0.05), while the chest radiograph or sputum detection rate was 94.61%, showing an overall upward trend (χ2trend=96.5, P<0.05). Among TB patients, 65 188 were tested for HIV antibodies, with a detection rate of 47.68%, which showed an overall upward trend (χ2trend=3 326.38, P<0.05). There were 39 HIV-positive cases detected, with the positive detection rate in TB patients decreasing from 0.12% to 0.07%. From 2016 to 2021, the majority of co-infected patients were male and ≥15 years old, with 496 cases (92.36%) of males and 41 cases (7.64%) of females. Among the 537 patients with co-infection, 47 cases (8.75%) received anti-tuberculosis therapy alone, 72 cases (13.41%) received anti-HIV therapy alone, and 408 cases (75.98%) received combined therapy, with an overall downward trend (χ2trend=9.54, P<0.05). Conclusions Focus should be placed on the male population and those aged ≥15 years, with future efforts aimed at enhancing two-way screening work among TB and HIV/AIDS patients and improving the rate of combined treatment.
4. Eplerenone protects contralateral kidney tissue from obstruction in pregnant rats with chronic kidney disease
Chang XU ; Wen-Ping ZHOU ; Jie-Qi NIU ; Hong-Shuang WANG ; Meng-Juan ZHANG ; Jia-Zhi LIU ; Chang XU ; Qing-You XU ; Wen-Ping ZHOU ; Jie-Qi NIU ; Yun-Zhao XIONG ; Yan ZHONG ; Zheng WANG ; Qing-You XU ; Yun-Zhao XIONG ; Yan ZHONG ; Xiang-Ting WANG ; Zheng WANG ; Hong-Shuang WANG ; Meng-Juan ZHANG ; Jia-Zhi LIU
Chinese Pharmacological Bulletin 2023;39(8):1534-1540
Aim To study the protective effect of eplerenone on the contralateral kidney in pregnant rats with chronic kidney disease (CKD) and its mechanism. Methods Female Wistar rats were randomly divided into sham-operation group, sham-operation pregnancy group, model group and eplerenone group. The rats in the model group and eplenone group had ligation unilateral ureter, and the rats in the eplenone group were treated with 100 mg • kg
5.Comparative study on the theme of traditional Chinese medicine policies among different provinces of China
Shuang YANG ; Ruifeng LI ; Xinying AN ; Zhihong XIAO ; Hongyun WANG ; Yan WANG ; Huan GOU ; Peng GAO ; Youliang HUANG
China Pharmacy 2023;34(6):653-659
OBJECTIVE To clarify the core content of traditional Chinese medicine (TCM) policy in the provinces of China, so as to provide reference for optimizing the structure of the policy system of traditional Chinese medicine in China and assisting the inheritance and innovation of TCM industry in various regions. METHODS The websites of directly affiliated organs in 31 provinces, excluding Hong Kong, Macao and Taiwan, were retrieved to collect the TCM policies released from 2000 to 2021. The importance of keywords in the TCM policies of each province was measured based on term frequency-inverse documentation frequency (TF-IDF) keyword extraction method, and the similarities and differences were analyzed among TCM policies. RESULTS & CONCLUSIONS A total of 99 documents related to TCM policies of various provinces were obtained in this study, most of which were released after 2016. The theme of national TCM policy covered four aspects: building TCM talent team, perfecting TCM service system, strengthening TCM resource management and promoting TCM industry innovation. The TF-IDF values of “medical institutions”“traditional Chinese medicine”“medical treatment” were higher than other keywords in each province, indicating that the provinces paid more attention to the construction of TCM service system and the management of TCM resources than other aspects. Anhui and Jiangsu, Beijing and Henan, Hubei and Jilin, Hubei and Tianjin, and Hubei and Yunnan had the more degree of similarity in TCM policies, which all contained 16 of the same keywords. Therefore, the above regions should be encouraged to strengthen exchanges and cooperation and realize mutual promotion and joint development. Among all the keywords whose importance ratio was greater than 0.2,“ Tibetan medicine” was unique to Qinghai and Tibet,“ disease type” was unique to Guangdong, and the TF-IDF value of “supervision and management” in Beijing was higher, indicating that the emphasis of TCM policy formulation in different provinces was various. Meanwhile, the top 10 keywords of TF- IDF value in all provinces did not have words related to financial input, and the TF-IDF values of “informatization” in most provinces did not rank at the top. It is suggested to increase financial input or encourage social financing, and add “Internet+new business” in the field of TCM.
6.Influential factors of adverse pregnancy outcome in women with subchorionic hematoma
Kadir GULISITAN ; Baowen QI ; Yan LIU ; Shuang SUI ; Huili HE
Chinese Journal of Primary Medicine and Pharmacy 2023;30(5):688-691
Objective:To investigate the influential factors of adverse pregnancy outcomes in women with subchorionic hematoma.Methods:A total of 101 women with subchorionic hematoma who received treatment in the People's Hospital of Xinjiang Uygur Autonomous Region from January 2017 to June 2020 were included in this study. They were divided into a control group and an adverse pregnancy outcome group according to whether there was an adverse pregnancy outcome. The epidemiological characteristics, hematoma characteristics observed on ultrasound images, and pregnancy outcomes were compared between the two groups.Results:There was no significant difference in the number of women who used assisted reproductive technology between the control and adverse pregnancy outcome groups [6 (8.0%) vs. 8 (30.7%), χ2 = 8.38, P = 0.004]. There was a significant difference in hematoma volume between adverse pregnancy outcome and control groups [(4.12 ± 0.61) mL vs. (6.36 ± 0.87) mL, t = 6.73, P = 0.009]. There was a significant difference in the number of patients who had obstetric complications between control and adverse pregnancy outcome groups [11 (14.7%) vs. 16 (61.5%), χ2 = 21.66, P = 0.001]. There was a significant difference in the number of patients who had hematomas located at the edge of the placenta between the control and adverse pregnancy outcome groups [15 (20.0%) vs. 12 (46.2%), χ2 = -4.81, P = 0.001]. Conclusion:Women who use assisted reproductive technology for pregnancy, have obstetric complications, or have a subchorionic hematoma with hematoma at the edge of the placenta are more likely to experience a miscarriage. Therefore, women of childbearing age should actively treat the primary disease and be alert to the occurrence of placental abruption.
7.Considerations on investigation on quality standard of Chinese patent medicine
Li-xing NIE ; Yan-pei WU ; Jing LIU ; Xiao-ru HU ; Feng-yan HE ; Ya-dan WANG ; Qi WANG ; Jian-dong YU ; Zhong DAI ; Feng WEI ; Shuang-cheng MA
Acta Pharmaceutica Sinica 2023;58(8):2260-2270
Chinese patent medicine (CPM) is an important part of traditional and Chinese medicine (TCM). Its quality has direct impact on the safety and effectiveness of clinical use. The quality standard is the pivotal approach to guarantee the quality of CPM. Due to the complex material basis, multitudinous quality influencing factors and unveiled active ingredients, dose-effect
8.Research progress on influencing factors of early adiposity rebound in children and the effect on adolescent development in girls.
Shi Qi FAN ; Shuang Qin YAN ; Fang Biao TAO
Chinese Journal of Preventive Medicine 2023;57(1):86-90
With the increasing rate of overweight and obesity in children worldwide, adiposity rebound(AR)closely related to obesity has become the spotlight, and early AR phase has a broad impact on pubertal development in girls, but the specific mechanism of action isn't very clear.This paper is review of the prevalence of early AR at home and abroad, and its influencing factors, the impact of AR on the adolescent development of girls and related mechanisms, to identify high-risk individuals with early AR, early AR to identify early adolescent development, and take early intervention measures to promote children's health.
Female
;
Adolescent
;
Child
;
Humans
;
Adiposity
;
Pediatric Obesity/epidemiology*
;
Adolescent Development
;
Body Mass Index
;
Overweight/epidemiology*
9.Risk factors analysis and prediction model construction of submucosal deep infiltration of early colorectal tumor.
Zhi Hao CHEN ; Li Zhou DOU ; Yue Ming ZHANG ; Yong LIU ; Shun HE ; Yan KE ; Xu Dong LIU ; Yu Meng LIU ; Hai Rui WU ; Shuang Mei ZOU ; Gui Qi WANG
Chinese Journal of Oncology 2023;45(7):613-620
Objective: To investigate the risk factors for the development of deep infiltration in early colorectal tumors (ECT) and to construct a prediction model to predict the development of deep infiltration in patients with ECT. Methods: The clinicopathological data of ECT patients who underwent endoscopic treatment or surgical treatment at the Cancer Hospital, Chinese Academy of Medical Sciences from August 2010 to December 2020 were retrospectively analyzed. The independent risk factors were analyzed by multifactorial regression analysis, and the prediction models were constructed and validated by nomogram. Results: Among the 717 ECT patients, 590 patients were divided in the within superficial infiltration 1 (SM1) group (infiltration depth within SM1) and 127 patients in the exceeding SM1 group (infiltration depth more than SM1). There were no statistically significant differences in gender, age, and lesion location between the two groups (P>0.05). The statistically significant differences were observed in tumor morphological staging, preoperative endoscopic assessment performance, vascular tumor emboli and nerve infiltration, and degree of tumor differentiation (P<0.05). Multivariate regression analysis showed that only erosion or rupture (OR=4.028, 95% CI: 1.468, 11.050, P=0.007), localized depression (OR=3.105, 95% CI: 1.584, 6.088, P=0.001), infiltrative JNET staging (OR=5.622, 95% CI: 3.029, 10.434, P<0.001), and infiltrative Pit pattern (OR=2.722, 95% CI: 1.347, 5.702, P=0.006) were independent risk factors for the development of deep submucosal infiltration in ECT. Nomogram was constructed with the included independent risk factors, and the nomogram was well distinguished and calibrated in predicting the occurrence of deep submucosal infiltration in ECT, with a C-index and area under the curve of 0.920 (95% CI: 0.811, 0.929). Conclusion: The nomogram prediction model constructed based on only erosion or rupture, local depression, infiltrative JNET typing, and infiltrative Pit pattern has a good predictive efficacy in the occurrence of deep submucosal infiltration in ECT.
Humans
;
Retrospective Studies
;
Colorectal Neoplasms/pathology*
;
Nomograms
;
Neoplasm Staging
;
Risk Factors
10.Progress on clinical trials of common gastrointestinal cancer drugs in China from 2012 to 2021.
Hui Yao HUANG ; Da Wei WU ; Qi ZHU ; Yue YU ; Hai Xue WANG ; Jun WANG ; Man GA ; Xin Yu MENG ; Jing Ting DU ; Shuang Man MIAO ; Zhi Xia ZHAO ; Xin WANG ; Pu SHANG ; Min Jiang GUO ; Li Hong LIU ; Yu TANG ; Ning LI ; Cai CAO ; Bing He XU ; Yan SUN ; Jie HE
Chinese Journal of Oncology 2022;44(3):276-281
Objective: Systematically summarize the research progress of clinical trials of gastric cancer oncology drugs and the overview of marketed drugs in China from 2012 to 2021, providing data and decision-making evidence for relevant departments. Methods: Based on the registration database of the drug clinical trial registration and information disclosure platform of Food and Drug Administration of China and the data query system of domestic and imported drugs, the information on gastric cancer drug clinical trials, investigational drugs and marketed drugs from January 1, 2012 to December 31, 2021 was analyzed, and the differences between Chinese and foreign enterprises in terms of trial scope, trial phase, treatment lines and drug type, effect and mechanism studies were compared. Results: A total of 114 drug clinical trials related to gastric tumor were registered in China from 2012 to 2021, accounting for 3.7% (114/3 041) of all anticancer drug clinical trials in the same period, the registration number showed a significant growth rate after 2016 and reached its peak with 32 trials in 2020. Among them, 85 (74.6%, 85/114) trials were initiated by Chinese pharmaceutical enterprise. Compared with foreign pharmaceutical enterprise, Chinese pharmaceutical enterprise had higher rates of phase I trials (35.3% vs 6.9%, P=0.001), but the rate of international multicenter trials (11.9% vs 67.9%, P<0.001) was relatively low. There were 76 different drugs involved in relevant clinical trials, of which 65 (85.5%) were targeted drugs. For targeted drugs, HER2 is the most common one (14 types), followed by PD-1 and multi-target VEGER. In the past ten years, 3 of 4 marketed drugs for gastric cancer treatment were domestic and included in the national medical insurance directory. Conclusions: From 2012 to 2021, China has made some progress in drug research and development for gastric carcinoma. However, compared with the serious disease burden, it is still insufficient. Targeted strengthening of research and development of investment in many aspects of gastric cancer drugs, such as new target discovery, matured target excavating, combination drug development and early line therapy promotion, is the key work in the future, especially for domestic companies.
China
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Gastrointestinal Agents/therapeutic use*
;
Gastrointestinal Neoplasms
;
Humans
;
Pharmaceutical Preparations
;
United States
;
United States Food and Drug Administration

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