1.Shuhe Granules (舒和颗粒) in Treating Rheumatoid Arthritis Comorbid with Insomnia with Kidney-Heart Deficiency and Qi-Blood Disharmony Syndrome:An Exploratory Single-Arm Clinical Trial
Yonghao PAN ; Yuxi LI ; Yu GAO ; Xiangbin CHEN ; Kaixin GAO ; Runyue HUANG ; Fei TAN ; Jiamin YUAN ; Biyun XU ; Zhimin YANG
Journal of Traditional Chinese Medicine 2026;67(16):1743-1751
ObjectiveTo investigate the clinical effects and safety of Shuhe Granules (舒和颗粒) in patients with rheumatoid arthritis (RA) comorbid with insomnia. MethodsA single-arm prospective exploratory design was adopted. Thirty RA patients comorbid with insomnia and diagnosed with the traditional Chinese medicine (TCM) syndrome of kidney-heart deficiency and qi-blood disharmony were enrolled. On the basis of maintaining their original RA treatment regimens, all patients received oral Shuhe Granules, one dose per day, for 12 consecutive weeks. The outcomes were assessed before treatment and at weeks 4, 8, and 12 after treatment. Sleep and related psychosomatic function were evaluated using the insomnia severity index (ISI), Pittsburgh sleep quality index (PSQI), fatigue severity scale (FSS), patient health questionnaire-9 (PHQ-9), generalized anxiety disorder-7 (GAD-7), and Montreal cognitive assessment (MoCA) scores. RA-related assessments included the 28-joint disease activity score based on C-reactive protein (DAS28-CRP), pain visual analog scale (VAS), tender joint count (TJC28), swollen joint count (SJC28), morning stiffness duration, and health assessment questionnaire (HAQ) score. Laboratory parameters included erythrocyte sedimentation rate (ESR), serum C-reactive protein (CRP), anti-cyclic citrullinated peptide antibody (anti-CCP), and rheumatoid factor (RF) levels. A literature-based historical control group was established through literature retrieval and meta-analysis. The ISI, PSQI, DAS28-CRP, and pain VAS scores were compared between the treatment group in the present study and the historical control group. Safety assessments were also performed. ResultsCompared with baseline before treatment, ISI and PSQI scores decreased at weeks 4, 8, and 12, while MoCA scores increased at weeks 4, 8, and 12. FSS scores decreased at weeks 4 and 12. At weeks 8 and 12, GAD-7 scores, DAS28-CRP scores, duration of morning stiffness, TJC28, and SJC28 were reduced. At week 12, PHQ-9, pain VAS, and HAQ scores significantly decreased (P<0.05). FSS and DAS28-CRP scores at week 12 were lower than those at week 4, and CRP levels at week 8 were lower than those at week 4 (P<0.05). Compared with the historical control group, the treatment group showed superior improvement in ISI and PSQI scores (P<0.001); however, no statistically significant differences were observed between the two groups in DAS28-CRP or pain VAS scores (P>0.05). No serious adverse events occurred during the study, and the 4 reported mild adverse events were all considered unrelated to the study medication. ConclusionShuhe Granules significantly improve sleep quality, fatigue, emotional status, cognitive function, RA-related symptoms, and joint function in patients with RA comorbid insomnia, with good safety and tolerability.
2.Trend analysis of changes in blood donor populations in CSBT sentinel sites from 2021 to 2025
Xiaojie GUO ; Junhong YANG ; Wenqin ZHU ; Ruru HE ; Guoqiang FENG ; Ruiqing JU ; Fei TANG ; Zhujiang YE ; Mingliang YUAN ; Xin CHEN ; Zhenping LU ; Dongfu XIE ; Qing XU ; Xia HUANG ; Jia ZENG
Chinese Journal of Blood Transfusion 2026;39(8):1052-1060
Objective: To analyze the structural changes in whole blood and apheresis platelet donations in Chinese Society of Blood Transfusion (CSBT) sentinel units from 2021 to 2025, and to provide evidence for donor recruitment and blood service management. Methods: Aggregated data reported by sentinel sites were collected and stratified according to six indicators: age, sex, donation history, donation volume, donation site, and organization mode. Pearson χ
test, Cramer′V coefficient, Cochran-Armitage trend test and simple linear regression were adopted for analysis. Results: A total of 16 256 973 whole blood donations and 1 576 546 apheresis platelet donations were included. Among whole-blood donations, the proportion of donors aged 18-22 years decreased from 27.30% to 10.60%. The proportion of male donors increased from 58.81% to 63.13%; the proportion of people aged 30 and above increased from 58.40% to 75.30%; the proportion of fixed locations rose from 28.37% to 36.57%; the proportion of social groups increased from 21.69% to 39.69%. The 400-mL donations decreased from 62.12% to 53.46%, while individually initiated voluntary donations remained above 50%. Apheresis platelet donations were predominantly from males, individuals aged 30-39 years, and repeat donors; 2-treatment-unit apheresis platelet donations increased from 67.19% to 74.93%, and individually initiated donations accounted for 92.97%-96.02%. Statistically significant overall annual compositional differences were observed for all six indicators (all P<0.001), whereas linear trends for some sub-categories were not statistically significant. Conclusion: In the participating CSBT sentinel units, among whole blood donations, the proportions of donors aged 18-22 years, university-organized group donations, and donations at blood mobiles decreased, whereas the proportions of organizational group donations and donations at fixed venues increased. The apheresis platelet donation cohort is relatively mature and is evolving toward a high-efficiency donation model. Individual voluntary donation remains the primary organization mode for both donation types. Strategies such as youth donor recruitment, optimized layout of fixed donation sites, and retention of repeat donors should be strengthened to improve the resilience of blood supply.
3.A case of granulomatous vasculitis easily misdiagnosed as ulcerative colitis
Xuhui QI ; Yanyan CHEN ; Fei XU ; Meifang HUANG ; Min CHEN
Chinese Journal of Inflammatory Bowel Diseases 2025;09(2):170-172
Granulomatous vasculitis is a kind of necrotizing granulomatous vasculitis with the prominent feature of detectable anti-neutrophil cytoplasmic antibodies in serum, which often involves the respiratory tract and kidneys, and the onset of symptoms in the digestive tract is rare, and we now report a rare case of granulomatous vasculitis in which the gastrointestinal tract was involved as the first symptom in order to improve the clinician's understanding of this disease.
4.Relationship between serum homocysteine,25-hydroxyvitamin D and frailty and sarcopenia in elderly patients with type 2 diabetes mellitus
Jingrong DAI ; Yan LI ; Jie LI ; Hong HUANG ; Xu HE ; Fei XIAO ; Fang HUANG ; Qingfang LIU
Chinese Journal of Diabetes 2025;33(11):820-826
Objective To explore the correlation between serum homocysteine(Hcy),25-hydroxyvitamin D[25(OH)D]and frailty with type 2 diabites mellitus(T2DM)complicated with sarcopenia.Methods From September 2021 to March 2023,210 elderly T2DM patients were selected from the Department of Geriatrics of The First People's Hospital of Yunnan Province,and divided into simple T2DM(n=99)group,mild sarcopenia(M-Sar,n=59)group and severe sarcopenia(S-Sar,n=52)group.The"Elderly Comprehensive Assessment System"was used to evaluate subjects.The influencing factors of T2DM complicated with sarcopenia were analyzed by Logistic regression.The receiver operating characteristic(ROC)curve was used to analyze the predictive value of Hcy,25(OH)D combined with frailty in evaluating T2DM with sarcopenia.Results In T2DM,M-Sar and S-Sar groups,the age,Hcy,the risk rate of balance gait work falling and the rate of weakness increased in turn(P<0.05),while BMI,hemoglobin,25(OH)D,the rate of good nutrition,the normal rate of basic daily living,the low risk rate of falling,the rate of good balance gait function and the rate of no weakness decreased in turn(P<0.05).Logistic regression analysis showed that serum Hcy,frailty and 25(OH)D were the influencing factors of senile T2DM complicated with sarcopenia.Hcy,25(OH)D and frailty combined to predict T2DM with sarcopenia had an area under ROC carve of 0.815,with a sensitivity of 0.811 and a specificity of 0.717.Conclusions Serum Hcy,25(OH)D and frailty are closely related to T2DM combined with sarcopenia.Detection of Hcy and 25(OH)D combined with frailty score is helpful for early diagnosis of sarcopenia in primary hospitals.
5.Knowledge, attitude and practice of salt reduction and hypertension status and related factors among restaurant practitioners in Beijing City
Jianhui HUANG ; Jingjuan REN ; Ru ZHENG ; Fei XU ; Yan QU ; Jiali DUAN ; Ye HAN
Chinese Journal of Preventive Medicine 2025;59(8):1299-1304
A convenience sampling method was employed to recruit 445 food service employees from 67 Chinese restaurants across all 16 administrative districts of Beijing City from August to December in 2022. A questionnaire survey was conducted to assess their knowledge, attitudes, and behaviors regarding salt reduction and hypertension. The results revealed that awareness was highest for the statement "Hypertensive patients should reduce salt intake" (88.3%), while awareness of "China′s diagnostic criteria for hypertension" was the lowest (23.8%). Positive attitude endorsement rates were 96.0% for willingness to reduce salt, 95.3% for perceived self-efficacy in salt reduction, and 93.0% for agreement with a low-salt diet. Regarding behaviors, the rates of actively reducing salt when ordering takeout or dining out, using low-sodium salt, and using salt-reducing spoons were 73.7%, 45.4%, and 55.5%, respectively. The overall compliance rate for salt-reduction related behaviors was 73.9%. Multivariable logistic regression analysis demonstrated that: compared to the 18-29 age group, employees aged 30-39 ( OR=2.19, 95% CI: 1.16-4.14), 40-49 ( OR=3.36, 95% CI: 1.52-7.42), and 50-59 ( OR=3.25, 95% CI: 1.25-8.50) were significantly more likely to achieve compliance with salt-reduction behaviors; chefs were significantly more likely to achieve behavioral compliance compared to managerial staff ( OR=2.08, 95% CI: 1.08-3.98); employees in catering with adequate knowledge about salt reduction and hypertension were significantly more likely to exhibit behavioral compliance compared to those with inadequate knowledge ( OR=3.32, 95% CI: 1.83-5.92); employees in catering with positive attitudes towards salt reduction were significantly more likely to achieve behavioral compliance compared to those with negative attitudes ( OR=5.81, 95% CI: 2.05-16.43). In conclusion, food service employees in Beijing exhibit insufficient knowledge about salt intake and hypertension. While they demonstrate strong willingness to reduce salt, this does not consistently translate into action. Compliance with salt-reduction behaviors is influenced by age, education level, and job position. There is an urgent need to strengthen the dissemination of knowledge regarding high salt intake and hypertension and to implement personalized interventions targeting salt-reduction behaviors and skills.
6.National bloodstream infection bacterial resistance surveillance report 2023: Gram-positive bacteria
Chaoqun YING ; Jinru JI ; Zhiying LIU ; Qing YANG ; Haishen KONG ; Jiangqin SONG ; Hui DING ; Yanyan LI ; Yuanyuan DAI ; Haifeng MAO ; Pengpeng TIAN ; Lu WANG ; Yongyun LIU ; Yizheng ZHOU ; Jiliang WANG ; Yan JIN ; Donghong HUANG ; Hongyun XU ; Peng ZHANG ; Xinhua QIANG ; Hong HE ; Lin ZHENG ; Junmin CAO ; Zhou LIU ; Ying HUANG ; Yan GENG ; Haiquan KANG ; Dan LIU ; Guolin LIAO ; Lixia ZHANG ; Fenghong CHEN ; Yanhong LI ; Baohua ZHANG ; Haixin DONG ; Xiaoyan LI ; Donghua LIU ; Qiuying ZHANG ; Xuefei HU ; Liang GUO ; Sijin MAN ; Dijing SONG ; Rong XU ; Youdong YIN ; Kunpeng LIANG ; Aiyun LI ; Zhuo LI ; Hongxia HU ; Guoping LU ; Jinhua LIANG ; Qiang LIU ; Yinqiao DONG ; Jilu SHEN ; Shuyan HU ; Liang LUAN ; Jian LI ; Ling MENG ; Dengyan QIAO ; Xiusan XIA ; Bo QUAN ; Dahong WANG ; Chunhua HAN ; Xiaoping YAN ; Fei LI ; Shifu WANG ; Ping SHEN ; Yunbo CHEN ; Yonghong XIAO
Chinese Journal of Clinical Infectious Diseases 2025;18(2):118-132
Objective:To report the nationwide surveillance results of pathogenic profiles and antimicrobial resistance patterns of Gram-positive bloodstream infections in China in 2023.Methods:The clinical isolates of Gram-posttive bacteria from blood cultures were collected in member hospitals of National Bloodstream Infection Bacterial Resistant Investigation Collaborative System(BRICS)during January to December 2023. Antimicrobial susceptibility testing was performed using the dilution method recommended by the Clinical and Laboratory Standards Institute(CLSI). Statistical analyses were conducted using WHONET 5.6 and SPSS 25.0 software.Results:A total of 4 385 Gram-positive bacterial isolates were obtained from 60 participating center. The top five pathogens were Staphylococcus aureus( n=1 544,35.2%),coagulase-negative Staphylococci( n=1 441,32.9%), Enterococcus faecium( n=574,13.1%), Enterococcus faecalis( n=385,8.8%),and α-hemolytic Streptococci( n=187,4.3%). The prevalence of methicillin-resistant Staphylococcus aureus(MRSA)and methicillin-resistant coagulase-negative Staphylococci(MRCNS)was 26.2%(405/1 544)and 69.8%(1 006/1 441),respectively. Notably,all Staphylococci remained susceptible to glycopeptide or daptomycin. Staphylococcus aureus demonstrated excellent susceptibility(>97.0%)to cephalobiol,rifampicin,trimethoprim-sulfamethoxazole,linezolid,minocycline,tigecycline,and eravacycline. No Enterococcus exhibiting resistance to linezolid were detected. Glycopeptide resistance was uncommon but more frequent in Enterococcus faecium(resistance to vancomycin and teicoplanin:both 1.7%)compared to Enterococcus faecalis(both 0.3%). The detection rates of MRSA and MRCNS exhibited significant regional variations across the country( χ2=17.674 and 148.650,respectively,both P<0.001). No vancomycin-resistant Enterococci were detected in central China. Institutional comparison demonstrated higher prevalence of MRSA( χ2=14.111, P<0.001)and MRCNS( χ2=4.828, P=0.028)in provincial hospitals than that in municipal hospitals. Socioeconomic analysis identified elevated detection rates of both MRSA( χ2=18.986, P<0.001)and MRCNS( χ2=4.477, P=0.034)in less developed regions(per capita GDP
7.National bloodstream infection bacterial resistance surveillance report (2023) : Gram-negative bacteria
Jinru JI ; Zhiying LIU ; Chaoqun YING ; Qing YANG ; Haishen KONG ; Jiangqin SONG ; Hui DING ; Yanyan LI ; Yuanyuan DAI ; Haifeng MAO ; Pengpeng TIAN ; Lu WANG ; Yongyun LIU ; Yizheng ZHOU ; Jiliang WANG ; Yan JIN ; Donghong HUANG ; Hongyun XU ; Peng ZHANG ; Xinhua QIANG ; Hong HE ; Lin ZHENG ; Junmin CAO ; Zhou LIU ; Ying HUANG ; Yan GENG ; Haiquan KANG ; Dan LIU ; Guolin LIAO ; Lixia ZHANG ; Fenghong CHEN ; Yanhong LI ; Baohua ZHANG ; Haixin DONG ; Xiaoyan LI ; Donghua LIU ; Qiuying ZHANG ; Xuefei HU ; Liang GUO ; Sijin MAN ; Dijing SONG ; Rong XU ; Youdong YIN ; Kunpeng LIANG ; Aiyun LI ; Zhuo LI ; Hongxia HU ; Guoping LU ; Jinhua LIANG ; Qiang LIU ; Yinqiao DONG ; Jilu SHEN ; Shuyan HU ; Liang LUAN ; Jian LI ; Ling MENG ; Dengyan QIAO ; Xiusan XIA ; Bo QUAN ; Dahong WANG ; Chunhua HAN ; Xiaoping YAN ; Fei LI ; Shifu WANG ; Ping SHEN ; Yunbo CHEN ; Yonghong XIAO
Chinese Journal of Clinical Infectious Diseases 2025;18(1):47-62
Objective:To report the results of bacterial resistant investigation collaborative system(BRICS)on the distribution and antimicrobial resistance profile of clinical Gram-negative bacteria isolates from bloodstream infections in China in 2023,and provide reference for clinical tretment of bloodstream infections and prevention and control of bacterial resistance.Methods:The clinical isolates of Gram-negative bacteria from blood cultures in member hospitals of BRICS were collected during January 2023 to December 2023. Antibiotic susceptibility tests were conducted by agar dilution or broth dilution methods recommended by Clinical and Laboratory Standards Institute(CLSI). WHONET 5.6 and SPSS 25.0 were used to analyze the data.Results:During the study period,11 492 strains of Gram-negative bacteria were collected from 60 hospitals,of which 10 098(87.9%)were Enterobacterales and 1 394(12.1%)were non-fermentative bacteria. The top 5 bacterial species were Escherichia coli(50.0%), Klebsiella pneumoniae(26.1%), Pseudomonas aeruginosa(5.1%), Acinetobacter baumannii complex(5.0%)and Enterobacter cloacae complex(4.1%). The ESBL-producing rates in Escherichia coli, Klebsiella pneumoniae and Proteus mirablilis were 46.8%(2 685/5 741),18.3%(549/2 999)and 44.0%(77/175),respectively. The prevalence of carbapenem-resistant Escherichia coli(CREC)and carbapenem-resistant Klebsiella pneumoniae(CRKP)were 1.3%(76/5 741)and 15.0%(450/2 999);32.9%(25/76)and 78.0%(351/450)of CREC and CRKP were sensitive to ceftazidime/avibactam combination,respectively. 94.7%(72/76)and 90.2%(406/450)of CREC and CRKP were sensitive to aztreonam/avibactam combination. Furthermore,57.9%(44/76)and 79.1%(356/450)were sensitive to imipenem/relebactam combination. The prevalence of carbapenem-resistant Acinetobacter baumannii(CRAB)complex was 64.6%(370/573),while more than 80.0% of CRAB complex was sensitive to tigecycline,eravacycline and polymyxin B. The prevalence of carbapenem-resistant Pseudomonas aeruginosa(CRPA)was 17.0%(99/581). There were differences in the composition ratio of Gram-negative bacteria in bloodstream infections and the prevalence of important Gram-negative bacteria resistance among different regions in China,with statistically significant differences in the prevalence of CREC,CRKP,CRPA and CRAB complex( χ2=10.6,28.6,10.8 and 19.3, P<0.05). The prevalence of ESBL-producing Escherichia coli, CREC,CRAB complex and CRKP were higher in provincial hospitals than those in municipal hospitals( χ2=12.5,9.8,12.7 and 57.8,all P<0.01). Conclusions:Gram-negative bacteria are the main pathogens causing bloodstream infections in China,and Escherichia coli is ranked in the top,while the trend of Klebsiella pneumoniae increases continuously with time. CRKP infection shows a slow upward trend,CREC infecton maintains a low prevalence level,and CRAB complex infection continues to exhibit a high prevalence rate. The composition and resistance patterns of pathogens causing bloodstream infections vary to some extent across different regions and levels of hospitals in China.
8.Shaoyao Gancao Decoction Combined with Electroacupuncture Against Poststroke Spasticity in Rats
Ying SHANG ; Yaqi HUANG ; Fei WANG ; Hailong ZHAO ; Shengfu ZHANG ; Nenggui XU ; Bin GUO
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(4):982-991
Objective To observe the effect of Shaoyao Gancao decoction combined with electroacupuncture on poststroke spasticity in rats.Methods Healthy male Sprague-Dawley(SD)rats were randomly divided into blank group,model group,electroacupuncture group,baclofen group,electroacupuncture combined with high dose of Chinese medicine group,electroacupuncture combined with middle dose of Chinese medicine group,electroacupuncture combined with low dose of Chinese medicine group,high dose of Chinese medicine group,middle dose of Chinese medicine group and low dose of Chinese medicine group,with 10 rats in each group.Open field test and integrated electromyography of quadriceps femoris were tested before modeling and on the 1st,3rd and 6th day after modeling.The samples were taken on day 6.The expression of inflammatory factors in M1 cortex were detected by liquid phase factor technique.The expression of brain-derived neurotrophic factor(BDNF),synaptophysin(SYP),postsynaptic density 95(PSD95),Nestin and β-catenin in M1 cortex was detected by ELISA and Western blot.Results Compared with model group and other intervention groups,the electroacupuncture combined with middle dose of Chinese medicine group make best total distance(P=0.021)and average speed(P=0.021)in open field test on 6th day.make better in integrated electromyography of quadriceps femoris test(P=0.006)on day 3,have higher Ⅱ type fiber ratio,promote IL-10(P=0.006),GMcsf(P=0.045)secretion.ELISA and Western blot also showed that this group behave better in the test of BDNF,SYP,PSD95,Nestin and β-catenin.Conclusion Electroacupuncture combined with Shaoyao-Gancao decoction groups were effective in the treatment of poststroke spasticity in rats,and its mechanism may be to improve the inflammatory environment of the injured site,promote the proliferation of neural stem cells and synaptic regeneration.
9.Analysis of factors influencing right atrial strain in patients with pulmonary arterial hypertension
Jin-xin XU ; Jie-xuan ZHENG ; Tao-ran HUANG ; Dong-ling LUO ; Yuan ZHU ; Cao-jin ZHANG ; Hong-wen FEI
Chinese Journal of Interventional Cardiology 2025;33(5):249-259
Objective To analyze the correlation between right atrial strain at various stages and various influencing factors in patients with pulmonary hypertension,and to explore the role of right atrial strain in the assessment of pulmonary hypertension.Methods A total of 239 cases diagnosed with pulmonary hypertension who underwent echocardiography and complete right heart catheterization at hospital from October 2021 to December 2023 were included.Conventional ultrasound parameters such as right heart strain,right atrial area(RA area),inferior vena cava diameter(IVC diameter),and collapse rate of the inferior vena cava(IVC diameter changes)were measured.The heart rate(HR)corresponding to the ultrasound images were recorded.General information such as age and gender,as well as catheter data including mean right atrial pressure(mRAP),mean pulmonary artery pressure(mPAP),and pulmonary vascular resistance(PVR),were collected.The relationship between right atrial strain and its influencing factors was analyzed,and further analysis was conducted by dividing into shunt group and non-shunt group based on the presence or absence of left-to-right shunt disease.Results The correlation with RA reservoir strain(RASr)from high to low is RV global strain(RV4CSL),RV free wall strain(RVFWSL),RA area,IVC diameter,mRAP,age,HR,and PVR;the correlation with RAconduit strain(RAScd)from high to low is RV4CSL,RVFWSL,RA area,IVC diameter,mRAP,age,PVR,and HR;the correlation with RA contraction strain(RASct)from high to low is RA area,RV4CSL,RVFWSL,mRAP,IVC diameter,and HR.The collapse rate of the inferior vena cava is correlated with strain at various stages of the right atrium;gender is correlated with RASr and RASct.Conclusions Right atrial strain can reflect changes in right atrial function,with the highest correlation to right ventricular strain and right atrial area.Right atrial strain can indicate the severity of right ventricular function and right atrial remodeling,serving as an evaluative index for the condition and treatment outcomes of pulmonary arterial hypertension.
10.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.

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