1.Quality Analysis and Suggestion of Zukamu Preparation Based on National Drug Sampling and Testing
Shengyun DAI ; Dongxue WU ; Rui WU ; Meng XIAO ; Jie LIU ; Chaojie LIAN ; Xiaoru HU ; Feng WEI ; Jian ZHENG ; Jialiang ZHU
Herald of Medicine 2025;44(10):1600-1605
Objective To examine the quality of Zukamu preparations through the national drug sampling and testing,and further understand their current quality status and existing problems.This work is benefit for improving the quality standard of Zukamu preparations and providing technical support for the drug regulatory authorities.Methods Samples of Zukamu preparations were collected from a total of 29 provinces in China,and were tested for description,identification,other requirements(weight variation,particle size,determination of water,disprsion,and microbial limit items),and assay in accordance with the national pharmaceutical standards.The test data were analyzed to evaluate the quality status of the Zukamu preparations,and exploratory research was carried out to address the problems found in the test.Results A total of 97 batches of Zukamu preparations were sampled,and the passing rate was 100.0%according to the current quality standard.Exploratory study,revealed that Zukamu preparation were subject to 4 testing standards,with uneven test items,missing items,poor operability,and lack of exclusivity in some items.The test based on the existing standards can't comprehensively evaluate the quality of the preparation.Conclusions Based on the national drug sampling and testing,combined with exploratory research on drug safety,authenticity and effectiveness,it is recommended to unify the quality standards of Zukamu preparations by combining with the work of standard improving,revising the identification method of thin-layer chromatography,increasing the content determination,and establishing the quick test method,thereby effectively evaluating and controling the quality of the samples of Zukamu preparations.
2.Research Progress on the Wuwei Qingzhuo Preparation of Mongolian Medicine and Shiliu Jianwei Preparation of Zang Medicine
Shengyun DAI ; Dongxue WU ; Rui HUANG ; Jie LIU ; Xiaoru HU ; Meng XIAO ; Chaojie LIAN ; Feng WEI ; Jian ZHENG ; Jialiang ZHU
Herald of Medicine 2025;44(1):61-67
Based on the results of the National Drug Sampling and Inspection Programme,we summarized the history,the standard collection,the production enterprises and the dosage form specifications,the quality standard study,the pharmacological and pharmacodynamic study,and the clinical application study of Wuwei Qingzhuo preparation of Mongolian medicine and Shiliu Jianwei preparation of Zang medicine,to provide the basis for improved quality standards for both preparations.The development of these two preparations was searched and analyzed through literature.The available information shows that there is very little research on the two preparations and insufficient pharmacological experimental and clinical experimental data.The two preparations are basically the same in prescription and efficacy.However,the quality standards are very different,which are not conducive to the quality control of the two and their related dosage forms.And it is suggested that the Chinese Pharmacopoeia should take the situation of this category into comprehensive consideration,and unify the quality standards of the two preparations.
3.Treatment of Hypertensive Left Ventricular Hypertrophy Based on the Theory of"Yang Leading to Qi and Yin Leading to Formation"
Cheng MA ; Jun HU ; Wenjing LIAN ; Jie WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(1):164-168
Left ventricular hypertrophy(LVH)is one of the common target organ damage of hypertension."Yang leading to qi and yin leading to formation"is the basic form of human material and energy metabolism and disease development.The pathogenesis of hypertension LVH is inseparable from the imbalance of yin and yang.The deficiency of"yang leading to qi"leads to the decline of zang-fu function,deficiency of qi and blood,and the excess of"yin leading to formation"leads to the accumulation of pathological products such as phlegm and fluid,both of which are important pathogenesis of hypertensive LVH.Hypertensive LVH can be seen at the beginning of yin deficiency and yang hyperactivity,liver hyperactivity and wind movement,qi and blood deficiency,and later yin and yang deficiency,phlegm and blood stasis interjunction and other symptoms.In the treatment of hypertensive LVH,the early stage should be based on nourishing yin and extinguishing wind,regulating qi and blood,and the later stage should be based on supplementing yin and yang,expelling phlegm and promoting blood,so as to improve the clinical efficacy of TCM treatment of this disease.
4.Dimeric natural product panepocyclinol A inhibits STAT3 via di-covalent modification.
Li LI ; Yuezhou WANG ; Yiqiu WANG ; Xiaoyang LI ; Qihong DENG ; Fei GAO ; Wenhua LIAN ; Yunzhan LI ; Fu GUI ; Yanling WEI ; Su-Jie ZHU ; Cai-Hong YUN ; Lei ZHANG ; Zhiyu HU ; Qingyan XU ; Xiaobing WU ; Lanfen CHEN ; Dawang ZHOU ; Jianming ZHANG ; Fei XIA ; Xianming DENG
Acta Pharmaceutica Sinica B 2025;15(1):409-423
Homo- or heterodimeric compounds that affect dimeric protein function through interaction between monomeric moieties and protein subunits can serve as valuable sources of potent and selective drug candidates. Here, we screened an in-house dimeric natural product collection, and panepocyclinol A (PecA) emerged as a selective and potent STAT3 inhibitor with profound anti-tumor efficacy. Through cross-linking C712/C718 residues in separate STAT3 monomers with two distinct Michael receptors, PecA inhibits STAT3 DNA binding affinity and transcription activity. Molecular dynamics simulation reveals the key conformation changes of STAT3 dimers upon the di-covalent binding with PecA that abolishes its DNA interactions. Furthermore, PecA exhibits high efficacy against anaplastic large T cell lymphoma in vitro and in vivo, especially those with constitutively activated STAT3 or STAT3Y640F. In summary, our study describes a distinct and effective di-covalent modification for the dimeric compound PecA to disrupt STAT3 function.
5.Research Progress on the Wuwei Qingzhuo Preparation of Mongolian Medicine and Shiliu Jianwei Preparation of Zang Medicine
Shengyun DAI ; Dongxue WU ; Rui HUANG ; Jie LIU ; Xiaoru HU ; Meng XIAO ; Chaojie LIAN ; Feng WEI ; Jian ZHENG ; Jialiang ZHU
Herald of Medicine 2025;44(1):61-67
Based on the results of the National Drug Sampling and Inspection Programme,we summarized the history,the standard collection,the production enterprises and the dosage form specifications,the quality standard study,the pharmacological and pharmacodynamic study,and the clinical application study of Wuwei Qingzhuo preparation of Mongolian medicine and Shiliu Jianwei preparation of Zang medicine,to provide the basis for improved quality standards for both preparations.The development of these two preparations was searched and analyzed through literature.The available information shows that there is very little research on the two preparations and insufficient pharmacological experimental and clinical experimental data.The two preparations are basically the same in prescription and efficacy.However,the quality standards are very different,which are not conducive to the quality control of the two and their related dosage forms.And it is suggested that the Chinese Pharmacopoeia should take the situation of this category into comprehensive consideration,and unify the quality standards of the two preparations.
6.Quality Analysis and Suggestion of Zukamu Preparation Based on National Drug Sampling and Testing
Shengyun DAI ; Dongxue WU ; Rui WU ; Meng XIAO ; Jie LIU ; Chaojie LIAN ; Xiaoru HU ; Feng WEI ; Jian ZHENG ; Jialiang ZHU
Herald of Medicine 2025;44(10):1600-1605
Objective To examine the quality of Zukamu preparations through the national drug sampling and testing,and further understand their current quality status and existing problems.This work is benefit for improving the quality standard of Zukamu preparations and providing technical support for the drug regulatory authorities.Methods Samples of Zukamu preparations were collected from a total of 29 provinces in China,and were tested for description,identification,other requirements(weight variation,particle size,determination of water,disprsion,and microbial limit items),and assay in accordance with the national pharmaceutical standards.The test data were analyzed to evaluate the quality status of the Zukamu preparations,and exploratory research was carried out to address the problems found in the test.Results A total of 97 batches of Zukamu preparations were sampled,and the passing rate was 100.0%according to the current quality standard.Exploratory study,revealed that Zukamu preparation were subject to 4 testing standards,with uneven test items,missing items,poor operability,and lack of exclusivity in some items.The test based on the existing standards can't comprehensively evaluate the quality of the preparation.Conclusions Based on the national drug sampling and testing,combined with exploratory research on drug safety,authenticity and effectiveness,it is recommended to unify the quality standards of Zukamu preparations by combining with the work of standard improving,revising the identification method of thin-layer chromatography,increasing the content determination,and establishing the quick test method,thereby effectively evaluating and controling the quality of the samples of Zukamu preparations.
7.Treatment of Hypertensive Left Ventricular Hypertrophy Based on the Theory of"Yang Leading to Qi and Yin Leading to Formation"
Cheng MA ; Jun HU ; Wenjing LIAN ; Jie WANG
Chinese Journal of Information on Traditional Chinese Medicine 2025;32(1):164-168
Left ventricular hypertrophy(LVH)is one of the common target organ damage of hypertension."Yang leading to qi and yin leading to formation"is the basic form of human material and energy metabolism and disease development.The pathogenesis of hypertension LVH is inseparable from the imbalance of yin and yang.The deficiency of"yang leading to qi"leads to the decline of zang-fu function,deficiency of qi and blood,and the excess of"yin leading to formation"leads to the accumulation of pathological products such as phlegm and fluid,both of which are important pathogenesis of hypertensive LVH.Hypertensive LVH can be seen at the beginning of yin deficiency and yang hyperactivity,liver hyperactivity and wind movement,qi and blood deficiency,and later yin and yang deficiency,phlegm and blood stasis interjunction and other symptoms.In the treatment of hypertensive LVH,the early stage should be based on nourishing yin and extinguishing wind,regulating qi and blood,and the later stage should be based on supplementing yin and yang,expelling phlegm and promoting blood,so as to improve the clinical efficacy of TCM treatment of this disease.
8.Establishment and Application of a Duplex Real Time Fluorogenic Quantitative PCR Assay System for miR-451a and miR-21-5p
Shu-Xiao HU ; Hui-Xiang CHEN ; Sheng HU ; Yi-Xia ZHAO ; An-Quan JI ; Yang LI ; Jie LIAN ; Qi-Fan SUN
Progress in Biochemistry and Biophysics 2024;51(3):706-715
ObjectiveBody fluid stains left at crime scenes are frequently trace amounts, while the identification of body fluids through real time fluorogenic quantitative technique often necessitates the repeated detection within the limited sample, as multiple miRNA markers are the basis for the identification. Based on the goal of both the throughput and efficiency improvement of miRNA analysis in trace samples, a duplex real time fluorogenic quantitative PCR assay system was designed to accurately quantify two miRNAs simultaneously, and the system should be further verified by actual sample for the body fluid identification. MethodsThe duplex real time fluorogenic quantitative PCR system of miR-451a to miR-21-5p was established with specially designed primers and probes, and the concentrations of the primers and probes were both optimized. The specificity, sensitivity and reproducibility of the system were validated, while its capability for body fluid identification was assessed using the miR-451a to miR-21-5p ratio. ResultsThe optimized assay system exhibited excellent specificity and repeatability, with coefficients of variation consistently below 8% for both intra- and inter-batch variability. The amplification efficiency of miR-451a and miR-21-5p reached 71.77% and 74.81%, respectively, with high and relatively consistent results. By utilizing this duplex real time fluorogenic quantitative PCR assay system, a total of 58 body fluid samples were analyzed, exhibiting a discrimination rate of 100% between blood and non-blood samples, as well as between peripheral blood and menstrual blood samples. Moreover, the results, obtained from single real time fluorogenic quantitative PCR assay system and duplex real time fluorogenic quantitative PCR assay system, showed no statistically significant difference with randomly selected blood samples (n=20). Compared to previous single real time fluorogenic quantitative PCR assay system, the sensitivity of duplex real time fluorogenic quantitative PCR assay system exhibited remarkable improvement. A minimum input of only 0.1 ng total RNA was sufficient for accurate detection of peripheral blood and menstrual blood samples, while saliva, semen, and vaginal secretion required only 1 ng total RNA for precise identification purposes. Additionally, the duplex real time fluorogenic quantitative PCR assay system successfully differentiated between different types of body fluids in simulated samples under natural outdoor conditions. ConclusionThe duplex real time fluorogenic quantitative PCR assay system effectively reduced both the time and material costs by half compared to the single system, especially suitable for the examination of body fluid stains left at crime scenes, solving the contradiction between the trace amount and the multiple sample volumes demand of repeated real time fluorogenic quantitative PCR. The duplex real time fluorogenic quantitative PCR assay successfully distinguished blood and other body fluid, as well as peripheral blood and menstrual blood samples, which maintains an equivalent capability for body fluid identification with half sample, time and reagent consumption. This system provides an efficient tool for identifying suspicious body fluids, as well as a foundation for more multiplexed real time fluorogenic quantitative PCR assay system research.
9.Assessment of respiratory protection competency of staff in healthcare facilities
Hui-Xue JIA ; Xi YAO ; Mei-Hua HU ; Bing-Li ZHANG ; Xin-Ying SUN ; Zi-Han LI ; Ming-Zhuo DENG ; Lian-He LU ; Jie LI ; Li-Hong SONG ; Jian-Yu LU ; Xue-Mei SONG ; Hang GAO ; Liu-Yi LI
Chinese Journal of Infection Control 2024;23(1):25-31
Objective To understand the respiratory protection competency of staff in hospitals.Methods Staff from six hospitals of different levels and characteristics in Beijing were selected,including doctors,nurses,medical technicians,and servicers,to conduct knowledge assessment on respiratory protection competency.According to exposure risks of respiratory infectious diseases,based on actual cases and daily work scenarios,content of respira-tory protection competency assessment was designed from three aspects:identification of respiratory infectious di-seases,transmission routes and corresponding protection requirements,as well as correct selection and use of masks.The assessment included 6,6,and 8 knowledge points respectively,with 20 knowledge points in total,all of which were choice questions.For multiple-choice questions,full marks,partial marks,and no mark were given respective-ly if all options were correct,partial options were correct and without incorrect options,and partial options were correct but with incorrect options.Difficulty and discrimination analyses on question of each knowledge point was conducted based on classical test theory.Results The respiratory protection competency knowledge assessment for 326 staff members at different risk levels in 6 hospitals showed that concerning the 20 knowledge points,more than 60%participants got full marks for 6 points,while the proportion of full marks for other questions was relatively low.Less than 10%participants got full marks for the following 5 knowledge points:types of airborne diseases,types of droplet-borne diseases,conventional measures for the prevention and control of healthcare-associated infec-tion with respiratory infectious diseases,indications for wearing respirators,and indications for wearing medical protective masks.Among the 20 knowledge questions,5,1,and 14 questions were relatively easy,medium,and difficult,respectively;6,1,4,and 9 questions were with discrimination levels of ≥0.4,0.30-0.39,0.20-0.29,and ≤0.19,respectively.Conclusion There is still much room for hospital staff to improve their respiratory protection competency,especially in the recognition of diseases with different transmission routes and the indications for wearing different types of masks.
10.Effects of Ziyin Liangxue Formula Combined with Prednisone on Immune Function and ST2/IL-33 Pathway in Mice with Immune Thrombocytopenia
Bing-Jie ZHAO ; Hong CHE ; Lian HU ; Wen-Jing YI ; Li XIAO ; Pei-Jia LIU ; Song-Shan LIU
Journal of Experimental Hematology 2024;32(1):202-207
Objective:To investigate the effects of Ziyin Liangxue formula combined with prednisone on immune function and the ST2/IL-33 pathway in mice with immune thrombocytopenia.Methods:In 40 BALB/c mice,32 were constructed as immune thrombocytopenia mouse models by antiplatelet serum injection.After successful modeling,the mice were randomly divided into model group,Ziyin Liangxue formula group(0.2 ml/10 g),prednisone group(0.2 ml/10 g),and Ziyin Liangxue formula+prednisone group(0.2 ml/10 g),8 mice in each group,and the other 8 mice were set as control group.The drugs were administered by gavage at the dose,and the model group and control group were given equal amounts of saline by gavage once a day for 2 weeks of continuous intervention.Blood samples and spleen tissues were collected,the peripheral platelet count was measured by automatic hematology analyzer,the pathological changes in spleen tissue was observed by HE staining,the levels of serum transforming growth factor(TGF)-β,interleukin(IL)-17,and peripheral blood thrombopoietin(TPO)were detected by enzyme-linked immunosorbent assay(ELISA),the expression of IL-33,sST2,and ST2 in spleen tissue was detected by Western blot,and the cell counts of peripheral blood Th17 and Treg were detected by flow cytometry.Results:Compared with the control group,the number of platelets,the level of TPO,TGF-β,and Treg cells were significantly decreased(P<().05),while the level of IL-17,Thl7 cells,and the expression of IL-33,sST2,and ST2 protein were significantly increased in the model group(P<0.01).Compared with the model group,the number of platelets,the level of TPO,TGF-β,and Treg cells were significantly increased(P<0.05),while the level of IL-17,Th17 cells,and the expression of IL-33,sST2,and ST2 protein were significantly decreased in the Ziyin Liangxue formula+prednisone group(P<0.01).Conclusion:Ziyin Liangxue formula+prednisone can effectively regulate Th17/Treg balance,thus effectively improve immune thrombocytopenia,and the mechanism may be related to the regulation of ST2/IL-33 signaling pathway.

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