1.Textual Research on Key Information of Classic Formula Shengma Gegentang
Yuli LI ; Ping JIANG ; Zhenyi YUAN ; Yuanyuan HE ; Ya'nan MAO ; Shasha WANG ; Wenyan ZHU ; Zhouan YIN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):187-197
Shengma Gegentang is one of the classic formulas in the Catalogue of Ancient Classic Prescriptions (Second Batch). This study reviewed ancient and modern literature and used literature tracing and bibliometric methods to analyze the historical evolution, efficacy, indications, dosage decoctions, and modern clinical disease spectrum of Shengma Gegentang. The results indicated that the earliest record of Shengma Gegentang can be found in the Taiping Huimin Heji Jufang of the Song dynasty, but its origin can be traced back to the Shaoyao Siwu Jiejitang in the Beiji Qianjin Yaofang of the Tang dynasty. The composition dosage of Shengma Gegentang is 413 g of Cimicifugae Rhizoma, 619.5 g of Puerariae Lobatae Radix, 413 g of Paeoniae Radix Alba, and 413 g of Glycyrrhizae Radix et Rhizoma, which are ground into coarse powder. Each dose is 12.39 g, and the amount of water added is 300 mL. 100 mL of solution is decocted and taken at the right time. The four drugs in the formula play the role of relieving exterior syndrome, penetrating pathogenic factors, and detoxicating together. Its indications are widely involved in internal medicine, pediatrics, surgery, ophthalmology and otorhinolaryngology, obstetrics and gynecology, sexually transmitted diseases, and other diseases, such as measles, sores, acne, spots, surgical gangrene, red eyes, toothache, chancre, and fetal poison. The epidemic diseases treated by Shengma Gegentang are complicated, including rash, pox, macula, numbness, summer diarrhea, dysentery, sha disease, febrile symptoms, spring warmth, winter warmth, and cold pestilence. At the same time, it is a plague prevention formula. Although Shengma Gegentang has a wide range of indications, it cannot be separated from the pathogenic mechanism of evil Qi blocking the muscle surface and heat in the lungs and stomach. The modern clinical disease spectrum of Shengma Gegentang involves the ophthalmology and otorhinolaryngology system, nervous system, pediatric-related diseases and syndromes, skin system, hepatobiliary system, and digestive system. It plays a key role in the treatment of epidemic diseases such as measles, chronic hepatitis B, dysentery, and tetanus.
2.Safety and efficacy of puncture cyanoacrylate selective seal under endoscopic ultrasound versus traditional endoscopy in treatment of gastroesophageal varices: A randomized controlled trial
Jiali MA ; Lingling HE ; Hongshan WEI ; Ping LI ; Xiuxia LIANG
Journal of Clinical Hepatology 2025;41(6):1113-1119
ObjectiveTo investigate the safety and efficacy of puncture cyanoacrylate selective seal (PCSS) under endoscopic ultrasound in the treatment of gastroesophageal varices (GOV). MethodsA total of 100 patients with liver cirrhosis who underwent endoscopic therapy for the secondary prevention of GOV bleeding in Beijing Ditan Hospital, Capital Medical University, from March 1 to December 31, 2023 were enrolled and randomly divided into PCSS group and traditional endoscopy group. The patients were followed up for 6 months after surgery, and the two groups were compared in terms of clinical outcome and complications. The primary outcome measure was the rate of alleviation or disappearance of GOV, and the secondary outcome measure was variceal rebleeding and death. The independent-samples t test was used for comparison of normally distributed or approximately normally distributed quantitative data between two groups, and the Wilcoxon non-parametric test was used for comparison of non-normally distributed quantitative data between two groups; the chi-square test or the Fisher’s exact test was used for comparison of qualitative data between two groups. ResultsThere were 50 patients in the PCSS group, among whom 1 patient was lost to follow-up, and there were 50 patients in the traditional endoscopy group, among whom 3 patients were lost to follow-up. There were no significant differences between the two groups in baseline data such as age, sex, Child-Pugh class, varices grade, and GOV typing (all P>0.05). Compared with the traditional endoscopy group, the PCSS group had significantly better results of the number of endoscopic treatment sessions (t=-15.671, P=0.001), the total amount of tissue adhesive used (t=-2.830, P=0.006), and the rate of alleviation or eradication of varices sclerosis (χ2=7.078, P=0.029). Both groups had low rates of postoperative rebleeding, adverse reactions, and complications, and there were no significant differences between the two groups (all P>0.05). ConclusionCompared with traditional endoscopy, PCSS can significantly enhance treatment outcome while maintaining safety standards.
3.Randomized Controlled Trials on Chinese Herbal Medicine Therapy for Atopic Dermatitis: An Evidence Map
Mingyue LIU ; Baixiang HE ; Jingqiu HU ; Youran DAI ; Lingling REN ; Shufan GE ; Kelin LI ; Qiubai JIN ; Ping SONG ; Huiyan CHI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):138-145
ObjectiveTo characterize the evidence distribution and methodological quality of randomized controlled trials (RCTs) on oral Chinese herbal medicine (CHM) for atopic dermatitis (AD) based on evidence mapping. MethodsSeven databases (CNKI, Wanfang Data, VIP, CBM, Cochrane Library, PubMed, and Embase) and the Chinese Clinical Trial Registry were searched for the RCTs in Chinese and English. Evidence distribution was presented graphically and textually, and methodological quality was assessed via the Cochrane Risk of Bias tool (ROB 1.0). ResultsA total of 168 RCTs were included. The number of annual publications showing an increasing trend, and 72.6% RCTs had sample sizes of 51-100 participants. The studies evaluated 108 distinct CHM interventions categorized as decoctions, granules, Chinese patent medicines, and extracts. Compound Glycyrrhizin was the most frequently used, followed by Xiaofengsan and Chushi Weiling decoction. Among the RCTs, 57.1% had the treatment courses of 4-8 weeks. Outcome measures predominantly focused on clinical response rate, skin lesion severity scores, and adverse events, with less attention to TCM symptom scores, skin barrier function, and relapse rates. The overall risk of bias was generally high. ConclusionWhile CHM for AD is a research hotspot and demonstrates clinical advantages, the related studies have problems such as unclear clinical positioning, poor research standardization and methodological quality, and insufficient prominence of TCM clinical advantages. Large-sample, methodologically rigorous, and high-quality studies are needed to enhance the evidence base for CHM in treating AD.
4.Randomized Controlled Trials on Chinese Herbal Medicine Therapy for Atopic Dermatitis: An Evidence Map
Mingyue LIU ; Baixiang HE ; Jingqiu HU ; Youran DAI ; Lingling REN ; Shufan GE ; Kelin LI ; Qiubai JIN ; Ping SONG ; Huiyan CHI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):138-145
ObjectiveTo characterize the evidence distribution and methodological quality of randomized controlled trials (RCTs) on oral Chinese herbal medicine (CHM) for atopic dermatitis (AD) based on evidence mapping. MethodsSeven databases (CNKI, Wanfang Data, VIP, CBM, Cochrane Library, PubMed, and Embase) and the Chinese Clinical Trial Registry were searched for the RCTs in Chinese and English. Evidence distribution was presented graphically and textually, and methodological quality was assessed via the Cochrane Risk of Bias tool (ROB 1.0). ResultsA total of 168 RCTs were included. The number of annual publications showing an increasing trend, and 72.6% RCTs had sample sizes of 51-100 participants. The studies evaluated 108 distinct CHM interventions categorized as decoctions, granules, Chinese patent medicines, and extracts. Compound Glycyrrhizin was the most frequently used, followed by Xiaofengsan and Chushi Weiling decoction. Among the RCTs, 57.1% had the treatment courses of 4-8 weeks. Outcome measures predominantly focused on clinical response rate, skin lesion severity scores, and adverse events, with less attention to TCM symptom scores, skin barrier function, and relapse rates. The overall risk of bias was generally high. ConclusionWhile CHM for AD is a research hotspot and demonstrates clinical advantages, the related studies have problems such as unclear clinical positioning, poor research standardization and methodological quality, and insufficient prominence of TCM clinical advantages. Large-sample, methodologically rigorous, and high-quality studies are needed to enhance the evidence base for CHM in treating AD.
5.Application of a digital chylous plasma assessment device in the determination of chylous plasma
Lingyue GUO ; Caina LI ; Hongyan GAO ; Wei WEI ; Ping ZHANG ; Yan LIU ; Yajie WANG ; Weidong HE
Chinese Journal of Blood Transfusion 2025;38(9):1236-1241
Objective: To develop a simple digital chylous plasma device and validate its ability to accurately, standardly, and non-destructively determine chylous plasma in blood banks and clinical transfusions in hospitals. Methods: A digital chylous plasma assessment device was designed and manufactured. This device was used to measure the chylous degrees of chylous plasma samples before freezing, after freeze-thawing, before viral inactivation, and after viral inactivation. The measured chylosity index values were categorized according to the requirements specified in Appendix A of the Chinese national standard GB 18469-2001 "Quality Requirements for Whole Blood and Blood Components". This process established a digital standard for chylous plasma, enabling the identification of severe, moderate and mild chylous plasma, and non-chylous plasma. Results: The initial simple product of the digital chylous assessment device was successfully designed and manufactured. There was no significant difference in the degree of chylous plasma between pre-freezing 468.11±217.73 lux and post-thawing 538.91±273.39 lux of chylous plasma (P>0.05), or between pre-viral inactivation 858.33±387.79 lux and post-viral inactivation 928.33±166.51 lux of chylous plasma (P>0.05). The median of chylous degree values for plasma chylous index grades 0 to 6 were 45 lux, 250 lux, 620 lux, 835 lux, 1 130 lux, 1 390 lux, and 1 700 lux, respectively. The defined cutoff values/ranges for the chylous degree values corresponding to plasma chylous index grade 0 to 6 were ≤125 lux, 126-465 lux, 466-740 lux, 741-1 000 lux, 1 001-1 233 lux, 1 234-1 560 lux, and ≥1 561 lux. Conclusion: This study successfully developed the initial product of the digital chylous device and established digital standards for classifying chylous plasma. The device demonstrates the potential to meet the needs for assessment of chylous plasma in both blood banks and clinical transfusions in hospitals, thereby promoting the development and application of standardized, non-destructive chylous plasma assessment technology.
6.Research progress of needle-free injection technology
He ZHANG ; Shuo LI ; Yi CHENG ; Zeng-ming WANG ; Nan LIU ; Meng LI ; Hui ZHANG ; Ai-ping ZHENG
Acta Pharmaceutica Sinica 2024;59(3):591-599
Needle-free injection technology (NFIT) refers to the drug delivery systems in which drugs are propelled as high-speed jet streams using any of the pressure source to penetrate the skin to the required depth. NFIT is a promising drug delivery system as it enables the injection of liquids, powders, and depot/projectiles, and has the advantages of preventing needle stick accidents, improving drug bioavailability, eliminating needle-phobia, increasing vaccine immunity, simplifying operations and is convenient for patients to use. NFIT and its research background, the structure and classification of needle-free jet injectors (NFJI), drugs that can be delivered using NFJI and the factors affecting the injection effect are comprehensively reviewed in this paper. The limitations and potential development directions are summarized to provide a theoretical basis for the application and development of NFIT.
7.Stability study of umbilical cord mesenchymal stem cells formulation in large-scale production
Wang-long CHU ; Tong-jing LI ; Yan SHANGGUAN ; Fang-tao HE ; Jian-fu WU ; Xiu-ping ZENG ; Tao GUO ; Qing-fang WANG ; Fen ZHANG ; Zhen-zhong ZHONG ; Xiao LIANG ; Jun-yuan HU ; Mu-yun LIU
Acta Pharmaceutica Sinica 2024;59(3):743-750
Umbilical cord mesenchymal stem cells (UC-MSCs) have been widely used in regenerative medicine, but there is limited research on the stability of UC-MSCs formulation during production. This study aims to assess the stability of the cell stock solution and intermediate product throughout the production process, as well as the final product following reconstitution, in order to offer guidance for the manufacturing process and serve as a reference for formulation reconstitution methods. Three batches of cell formulation were produced and stored under low temperature (2-8 ℃) and room temperature (20-26 ℃) during cell stock solution and intermediate product stages. The storage time intervals for cell stock solution were 0, 2, 4, and 6 h, while for intermediate products, the intervals were 0, 1, 2, and 3 h. The evaluation items included visual inspection, viable cell concentration, cell viability, cell surface markers, lymphocyte proliferation inhibition rate, and sterility. Additionally, dilution and culture stability studies were performed after reconstitution of the cell product. The reconstitution diluents included 0.9% sodium chloride injection, 0.9% sodium chloride injection + 1% human serum albumin, and 0.9% sodium chloride injection + 2% human serum albumin, with dilution ratios of 10-fold and 40-fold. The storage time intervals after dilution were 0, 1, 2, 3, and 4 h. The reconstitution culture media included DMEM medium, DMEM + 2% platelet lysate, 0.9% sodium chloride injection, and 0.9% sodium chloride injection + 1% human serum albumin, and the culture duration was 24 h. The evaluation items were viable cell concentration and cell viability. The results showed that the cell stock solution remained stable for up to 6 h under both low temperature (2-8 ℃) and room temperature (20-26 ℃) conditions, while the intermediate product remained stable for up to 3 h under the same conditions. After formulation reconstitution, using sodium chloride injection diluted with 1% or 2% human serum albumin maintained a viability of over 80% within 4 h. It was observed that different dilution factors had an impact on cell viability. After formulation reconstitution, cultivation in medium with 2% platelet lysate resulted in a cell viability of over 80% after 24 h. In conclusion, the stability of cell stock solution within 6 h and intermediate product within 3 h meets the requirements. The addition of 1% or 2% human serum albumin in the reconstitution diluent can better protect the post-reconstitution cell viability.
8.A reporter gene assays for bioactivity determination of human chorinonic gonadotropin
Ying HUANG ; Xiao-ming ZHANG ; He-yang LI ; Lü-yin WANG ; Hui ZHANG ; Ping LÜ ; Jing LI ; Xiang-dong GAO ; Cheng-gang LIANG
Acta Pharmaceutica Sinica 2024;59(2):432-438
This study constructed a LHCGR-CRE-luc-HEK293 transgenic cell line according to the activation of the cAMP signaling pathway after recombinant human chorionic gonadotropin binding to the receptor. The biological activity of recombinant human chorionic gonadotropin was assayed using a luciferase assay system. The relative potency of the samples was calculated using four-parameter model. And the method conditions were optimized to validate the specificity, relative accuracy, precision and linearity of the method. The results showed that there was a quantitative potency relationship of human chorinonic gonadotropin (hCG) in the method and it was in accordance with the four-parameter curve. After optimization, the conditions were determined as hCG dilution concentration of 2.5 μg·mL-1, dilution ratio of 1∶4, cell number of 10 000-15 000 cells/well, and induction time of 6 h. The method had good specificity, relative accuracy with relative bias ranging from -8.9% to 3.4%, linear regression equation correlation coefficient of 0.996, intermediate precision geometric coefficient of variation ranging from 3.3% to 15.0%, and linearity range of 50% to 200%. This study successfully established and validated a reporter gene method to detect hCG biological activity, which can be used for hCG biological activity assay and quality control.
9.Diagnostic value of plasma SPINK4 expression in colorectal adenocarcinoma and progressive adenoma
Longmei ZHOU ; Ping LI ; Yuhuan SHANG ; Yanling WANG ; Chunying YIN ; Dan LI ; Peiyuan HE
Chongqing Medicine 2024;53(1):50-54
Objective To investigate the clinical diagnostic value of plasma serine protease inhibitor Ka-zal-type 4(SPINK4)expression in colorectal adenocarcinoma(CRC)and progressive adenoma(AA).Methods A total of 62 patients with CRC(CRC group)and 15 patients with AA(AA group)diagnosed by colonoscopy and pathological examination in this hospital from June 2020 to December 2021 were selected,and 22 healthy people undergoing physical examination during the same period were selected as the HC group.The expression of SPINK4 in plasma was detected by ELISA,and the expression of CEA in plasma was detected by electrochemiluminescence,and the correlation was analyzed.The diagnostic efficiency was analyzed by re-ceiver operating characteristic(ROC)curve,and the expression of p53 in CRC tissues was detected by immu-nohistochemistry.Results The expression of plasma SPINK4 in the CRC group and AA group was lower than that in the HC group(Z=3.72,-0.41,P<0.05),and the expression of CEA in the CRC group was higher than that in the HC group(Z=-3.63,P<0.05).The area under the curve(AUC),accuracy,sensi-tivity and specificity of SPINK4 combined with CEA in the diagnosis of CRC and AA were higher than those of SPINK4 and CEA alone.The positive rate of mutant type p53 in SPINK4 low expression group and CEA high ex-pression group was significantly increased in CRC patients(72.55%,75.00%,P<0.05).Conclusion The expression of plasma SPINK4 is decreased in CRC and AA,and the combined detection of SPINK4 and CEA has a good di-agnostic efficiency in CRC and AA.
10.Direct Determination of 23 Kinds of Per-and Polyfluoroalkyl Substances in Crude Plant Extracts by Liquid Chromatography-Tandem Mass Spectrometry Coupled with Online Solid Phase Extraction
Nan SHEN ; Tong-Zhu HAN ; Can-Can SHENG ; Xiu-Ping HE ; Jun-Hui CHEN ; Chen-Guang LIU ; Xian-Guo LI
Chinese Journal of Analytical Chemistry 2024;52(2):286-295,后插1-后插5
A new method for simultaneous determination of 23 kinds of per-and polyfluoroalkyl substances(PFASs)(13 kinds of perfluoro carboxylic acids,4 kinds of perfluoro sulfonic acids,and 6 kinds of new substitutes)in plant leaf tissue by ultra-high performance liquid chromatography-tandem mass spectrometry(UHPLC-MS/MS)using automatic online solid phase extraction(SPE)to remove the matrix interference components in plant crude extracts was developed.The plant leaf samples were extracted twice with 1%formic acid-methanol solution,then evaporated to dry,redissolved with 70%methanol solution,and directly injected for analysis.After 23 kinds of target PFASs were purified automatically by online SPE with a WAX column,the six-way valve was switched to rinse PFASs onto an alkaline mobile phase system-compatible C18 analytical column.Then,the 23 kinds of target PFASs were separated within 16 min by gradient elution using a binary mobile phase system of methanol/water(Containing 0.4%ammonium hydroxide).Tandem mass spectrometry was performed in multiple reaction monitoring(MRM)mode for online detection of various PFASs,and quantification was carried out by internal standard method.The results of the method validation showed that satisfactory average recoveries of 23 kinds of PFASs in plant leaf samples(64.2%-125.5%),precision(relative standard deviations(RSDs)of 0.7%-12.8%),linearity(R2>0.990),and sensitivity(the detection limits(S/N=3)were in the range of 0.02-0.50 μg/kg)were achieved.Finally,this method was used to detect PFASs in the marine green tide algae(Enteromorpha prolifera)and several tree leaves,and a total of 6 kinds of PFASs were detected,in which PFBA was the main contaminant.Compared with the reported offline SPE methods,the proposed online SPE technique significantly simplified the sample pretreatment process and provided an automatic,simple,and environment-friendly method for the routine monitoring of legacy and emerging PFASs in plant tissues.

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