1.Interpretation and thoughts on the formulation and revision of the standards for exogenous harmful residues in traditional Chinese medicinal materials in the Chinese Pharmacopoeia 2025 Edition
WANG Ying ; SHEN Mingrui ; LIU Yuanxi ; ZUO Tiantian ; WANG Dandan ; HE Yi ; CHENG Xianlong ; JIN Hongyu ; LIU Yongli ; WEI Feng ; MA Shuangcheng
Drug Standards of China 2025;26(1):083-092
		                        		
		                        			
		                        			As people’s attention to health continues to increase, the market demand for traditional Chinese medicine (TCM) is growing steadily. The quality and safety of Chinese medicinal materials have attracted unprecedented social attention. In particular, the issue of exogenous harmful residue pollution in TCM has become a hot topic of concern for both regulatory authorities and society. The Chinese Pharmacopoeia 2025 Edition further refines the detection methods and limit standards for exogenous harmful residues in TCM. This not only reflects China’s high-level emphasis on the quality and safety of TCM but also demonstrates the continuous progress made by China in the field of TCM safety supervision. Basis on this study, by systematically reviewing the development history of the detection standards for exogenous harmful residues in TCM and analyzing the revisions and updates of these detection standards in the Chinese Pharmacopoeia 2025 Edition, deeply explores the key points of the changes in the monitoring standards for exogenous harmful residues in TCM in the Chinese Pharmacopoeia 2025 Edition. Moreover, it interprets the future development directions of the detection of exogenous residues in TCM, aiming to provide a reference for the formulation of TCM safety supervision policies.
		                        		
		                        		
		                        		
		                        	
2.Effect of different pretreatment methods on the detection of pesticide residues in five traditional Chinese medicines
Wanqing ZHANG ; Yuanxi LIU ; Gaopian CHEN ; Huiru ZHU ; Yufang ZHU ; Xiaoxiao LIU
Drug Standards of China 2024;25(3):251-256
		                        		
		                        			
		                        			Objective:To study effects of different pretreatment methods on the detection of pesticide residues in Angelicae Sinensis Radix,ChrysanthemI Flos,Lych Fructus,Astragali Radix and Lonicerae Japonicae Flos.Methods:The samples were treated with QuEChERS method and high-speed homogenization combined with hydro-phile-lipophile balance(HLB)solid-phase extraction method,and the residual amounts of carbofuran,3-carboxyl-carbofuran,phorate,phorate sulfone,phorate sulfoxide,and methyl isoflurophos were simultaneously determined using UHPLC-MS/MS.With a gradient elutionof 0.1%formic acid solution containing 5 mmol·L-1 ammonium formate and t 0.1%formic acid solution containing 5 mmol·L-1 ammonium formate-acetonitrile(volume ratio of 5:95),Ultra-performance liquid chromatography column Agilent Poroshell 120 SB-C18(2.1 mm × 100 mm,2.7μm)was used at 35 ℃ and the electrospray ion source was scanned in the positive ion mode and detected in the multiple reaction monitoring mode in mass spectrometry.Results:The deviation of the results measured by QuECh-ERS method and HLB solid-phase extraction method was between 9.09%-55.56%.Conclusion:In the selection of the pretreatment method for the detection of pesticide residues in traditional Chinese medicine,it is recommen-ded to take the measurement data of positive samples as the evaluation index and basis,and choose the method with higher measurement value and high extraction efficiency.
		                        		
		                        		
		                        		
		                        	
3.Randomized controlled trial of the clinical effectiveness and safety of Jiuwei-Zhuhuang San plus amoxilcillin sodium and sulbactam sodium for the children with bacterial pneumonia
Zhen DA ; Wenbin HOU ; Siyi WANG ; Youyou ZHENG ; Yuanxi LI ; Huilan LIU ; Yuxin SUN ; Zhaolan LIU
International Journal of Traditional Chinese Medicine 2021;43(12):1174-1178
		                        		
		                        			
		                        			Objective:To evaluate the clinical effectiveness and safety of Jiuwei-Zhuhuang San plus amoxilcillin sodium and sulbactam sodium in the treatment of bacterial pneumonia in children. Methods:A total of 120 patients with bacterial pneumonia in children from 1 year to 14 years old were randomly divided into the study group ( n=90) and the control group ( n=30) with ratio 3 to 1, the random sequence created by SAS software. Both groups were treated with amoxilcillin sodium for basic treatment, the observation group was treated with Jiuwei-Zhuhuang San. Both groups were treated for 1 week and followed up for 1 week. The cough frequency, clinical effective rate, symptoms and signs score, Traditonal Chinese medicine (TCM) pattern scores and adverse event rate were observed. Results:Eighteen cases were dropped and eliminated in the observation group, and 4 cases were dropped and eliminated in the control group, so 72 of observation group and 26 of control group were analyzed. After treatment, the clinical effective rate of the observation group was 27.8% (20/72), and the control group was 0% (0/26), where the difference was significant ( χ2=7.445, P=0.006). The difference of TCM syndrome score before and after treatment in the observation group (-16.8 ± 8.2 vs. -11.0 ± 5.8, t=-3.858) was lower than that of the control group ( P<0.01). There was significant difference between the two groups ( Z=-2.347, P= 0.019) in the TCM syndrome. The cough frequency of the observation group was 41.7% (30/72), and the control group was 26.9% (7/26). There wasn’t any significant differences in the cough frequency between two groups ( P>0.05). There was no statistical difference in symptoms and signs score or adverse event rate between two groups ( P>0.05). Conclusion:On the basis of amoxicillin sodium and sulbactam sodium, combined use of Jiuwei-Zhuhuang San can improve the clinical effectiveness of children with bacterial pneumonia.
		                        		
		                        		
		                        		
		                        	
4.Effect of different delivering methods on pelvic floor function in vaginal delivery
Zheng ZHOU ; Tiemei SHI ; Xinlu WANG ; Chen LIU ; Wang NIU ; Yuanxi ZHANG
Chinese Journal of Medical Imaging Technology 2017;33(3):433-436
		                        		
		                        			
		                        			Objective To explore the effect of different delivering methods on the pelvic floor function in vaginal delivery by transvaginal three-dimensional ultrasound.Methods Eighty-four patients delivered transvaginal were classified into three groups according to the mode of delivery (perineal integrity group [n=32],episiotomy group [n=30] and forceps delivery group [n=22]).The hiatal images at resting,Valsalva,levator ani muscle maximum contraction were obtained and compared in three groups.Results There were no differences between perineal integrity group and episiotomy group in hiatal diameter and area (P>0.05).There were significantly differences between perineal integrity group and forceps delivery group in hiatal diameter,area and change in hiatal area from rest to pelvic floor muscle contraction and from rest to Valsalva (all P<0.05).Conclusion The injury of the pelvic floor of forceps delivery group is bigger than perineal integrity.And episiotomy is no significant difference with pelvic floor function injury.
		                        		
		                        		
		                        		
		                        	
5.Research progresses of three dimensional power Doppler ultrasound in diagnosis of thyroid nodules
Chen LIU ; Tiemei SHI ; Zheng ZHOU ; Wang NIU ; Yuanxi ZHANG
Chinese Journal of Interventional Imaging and Therapy 2017;14(6):382-385
		                        		
		                        			
		                        			Thyroid nodule is a common diseases of neck,which property is usually identified by ultrasound examination.Color doppler ultrasonography can reflect the distribution of blood vessels and blood flow within the nodules.And with development of new technologies,three-dimensional ultrasound increase the accuracy of identification.Three-dimension power doppler ultrasound (3D-PDUS) can reflect blood flow information within the nodule space,which is more accurate than two-dimensional ultrasound and it can be used to evaluate the blood flow in nodules qualitatively and quantitatively,provide a new reference for clinical diagnosis of thyroid nodule.
		                        		
		                        		
		                        		
		                        	
6.Ultrasound value in diagnosis of deep infiltrating endometriosis in rectosigmoid: Meta-analysis
Wang NIU ; Tiemei SHI ; Yuanxi ZHANG ; Can ZONG ; Zheng ZHOU ; Chen LIU
Chinese Journal of Medical Imaging Technology 2017;33(6):912-916
		                        		
		                        			
		                        			Objective To explore the diagnostic value of comparing enhanced transvaginal ultrasound (E-TVS),none enhanced transvaginal ultrasound (TVS),and transrectal ultrasound (TRS) in preoperative detection of deep infiltrating endometriosis (DIE) in the rectosigmoid by Meta-analysis.Methods The literatures published from January 1990 to June 2016 were searched.The information of literatures were selected and evaluated.The included data was statistically analyzed by Meta-disc 1.4 software.Results Totally 25 literatures were enrolled.The pooled sensitivity,specificity,positive likelihood ratio,negative likelihood ratio,diagnostic odds ratio were 0.92,0.96,16.64,0.09,227.95 for E-TVS,0.83,0.97,16.95,0.17,112.97 for TVS,0.94,0.96,14.43,0.08,208.72 for TRS,respectively.Area under the curve were 0.980 4,0.966 3,0.979 0,respectively.Conclusion Diagnostic value of the three ultrasonography in preoperative detection of DIE in the rectosigmoid are E-TVS,TRS,TVS.E-TVS can be used as the preferred method of ultrasonic diagnosis of DIE in the rectosigmoid.
		                        		
		                        		
		                        		
		                        	
7.Progresses of ultrasound in evaluation of pelvic organ prolapse
Tiemei SHI ; Yuanxi ZHANG ; Chen LIU ; Min GAO
Chinese Journal of Interventional Imaging and Therapy 2017;14(12):772-775
		                        		
		                        			
		                        			Ultrasonography can clearly show pelvic anatomic structures,as well as the location and length of mesh after pelvic floor reconstructive operation.The consistency of ultrasonic diagnosis of severe pelvic organ prolapse with pelvic organ prolapse quantitation is good.Furthermore,ultrasonography can provide imaging basis for evaluating the safety and efficacy of pelvic floor reconstruction.The progresses of ultrasound in diagnosis of severe pelvic organ prolapse and postoperative evaluation of pelvic floor reconstruction were reviewed in this article.
		                        		
		                        		
		                        		
		                        	
8.Progresses of translabial ultrasound in evaluation of postpartum anal sphincter complex
Yuanxi ZHANG ; Tiemei SHI ; Chen LIU ; Qier MU ; Min GAO
Chinese Journal of Interventional Imaging and Therapy 2017;14(11):699-702
		                        		
		                        			
		                        			The injury of anal sphincter complex during childbirth can result in long-term anal incontinence problems.Recently,several new techniques in ultrasound have been used to evaluate the function and injury of anal sphincter,such as tomographic ultrasound imaging,volume contrast imaging and speckle reduction imaging.The diagnosis rate of the injury of anal sphincter complex has been improved rapidly.The development of 2D and 3D ultrasound in evaluating function and injury of postpartum anal sphincter complex were reviewed in this article.
		                        		
		                        		
		                        		
		                        	
9.The combination of sephedex and docetaxel used in intervention for clinical treatment of primary liver cancer
Jingxian LI ; Yanping JIANG ; Jiaping WANG ; Li GUO ; Li ZHU ; Rui LIU ; Ruimin ZHAO ; Yuyun TONG ; Yuanxi JIAN
Journal of Practical Radiology 2017;33(5):739-741,753
		                        		
		                        			
		                        			Objective To study the clinical efficacy of the combination of sephedex and docetaxel used in transcatheter arterial chemoembolization (TACE) for clinical treatment of primary liver cancer.Methods 120 patients with primary liver cancer in our hospital were divided into the experimental group and the control group randomly and equally, the 60 cases in experimental group were treated with sephedex suspensoid (Sephedex, G-50, 300-500 μm) and docetaxel-iodized oil, while other 60 cases in control group were treated with docetaxel-iodized oil suspension liquid.Results The success rate of surgical intubation in the two groups was 100%.After an average follow-up of 12 months, the postoperative tumor diameter of the experimental group was reduced by (4.4±1.4) cm, while that of the control group was (1.8±1.0) cm;The overall response rate was 70% in the experimental group in contrast to 30% in the control group;the alpha fetal protein (AFP) value was decreased by (33.2±15.2) μg/L in the experimental group and (10.4±9.8) μg/L in the control group.Conclusion The combination of sephedex, docetaxel suspensoid and iodized oil shows great potential in TACE treatment of primary liver cancer, from which the treatment effect can be improved significantly.
		                        		
		                        		
		                        		
		                        	
10.Aromatase inhibitors and TAM in the treatment of post-menopausal Luminal B breast cancer patients
Jinghong ZHANG ; Yan LIU ; Xiaomeng HAO ; Rui HUI ; Fenglin ZANG ; Peng LIU ; Yuanxi ZHU ; Yi YANG ; Jin ZHANG
Chinese Journal of General Surgery 2010;25(6):449-452
		                        		
		                        			
		                        			Objective To evaluate a therapeutic strategy using aromatase inhibitors and TAM in postmenopausal Luminal B breast cancer patients. Methods The clinical data of 733 primary breast cancer cases receiving postoperative endocrine thempy from July 2002 to Mar 2005 in Tianjin Cancer Hospital were retrospectively analyzed.Diagnosis was confirmed by pathology in all the cases.All patients were post-menopausal and ER-positive.501 patients were given tamoxifen(TAM 2.5 mg qd,po),232 patients were given aromatase inhibitors(Letrozole 10 mg bid,po).The follow-up time ranged from 36 to 90 months.Median follow-up time was 46 months.Results The disease-free-survival(DFS)rate of Luminal B breast cancer patients in aromatase inhibitors(AIS)group was higherthan that in TAM group(90.6% vs.88.6%,P=0.038).In TAM group,subgroup analysis showed 3-year DFS of node-positive with HER2(+)is lower than that of node-positive with Her-2-negative(88.2% vs.90.4%,P=0.037);3-year DFS of ER+/PR+ group in HER2(+) patients was higher than that of ER+/PR-group(90.8% vs.89.5%.P=0.032).In AIs group,in spite of the axillary lymph node status,there was no significant difference of 3-year DFS between HER2(+)patients and HER2(-)ones(P>0.05).3-year DFS of ER+/PR+with HER2(+) patients was higher than that of ER+/PR-ones with HER2(+)(91.9% vs.90.5%,P=0.029).Hot flush,vaginal bleeding and thromboembolics in AIS group is less frequent,but muscle pain and bone fracture is more common than that in TAM group(P<0.05).Conclusion Compared to TAM, AIs is more effective and safer with postmenopausal Luminal B patients,and the effect is independent on node stams.
		                        		
		                        		
		                        		
		                        	
            
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