1.The introduction on the new standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; CHEN Ying ; TU Jiasheng ; LIU Yanming ; ZHENG Luxia ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):058-066
According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the Chinese Pharmacopoeia 2025 Edition has been completed. Among them, 52 new pharmaceutical excipients monographs have been added, an increase of 15.5% compared with the 2020 Edition, and the total number has reached 387. This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.
2.The technology of fecal microbiota transplantation and its application progress
Shuo YUAN ; Yi-fan ZHANG ; Peng GAO ; Jun LEI ; Ying-yuan LU ; Peng-fei TU ; Yong JIANG
Acta Pharmaceutica Sinica 2025;60(1):82-95
Fecal microbiota transplantation (FMT) technology originated in China during the Eastern Jin Dynasty and has rapidly developed over the past two decades, becoming a primary method for studying the causal relationship between gut microbiota and the occurrence and progression of diseases. At the same time, the therapeutic effects of FMT in the field of gastrointestinal diseases have gained widespread recognition and are gradually expanding into other disease areas. The FMT procedure is relatively complex, and there is currently no standardized method; its success is influenced by various factors, including the donor, recipient, processing of the fecal material, and the method of implantation. Given the increasingly recognized relationship between gut microbiota and various diseases, FMT has become a research hotspot in both scientific studies and clinical applications, achieving a series of significant advancements. To help researchers better understand this technology, this paper will outline the development history of FMT, summarize common operational methods in research and clinical settings, review its application progress, and look forward to future development directions.
3. Effect of colchicine on LPS induced endothelial mesenchymal transformation and its mechanism
Jun GUO ; Guang-Neng TANG ; Qi ZHAO ; Zheng CAO ; Qiang TU
Chinese Pharmacological Bulletin 2024;40(2):243-248
Aim To investigate the effect of colchicine on lipopolysaccharide (LPS) induced endothelial to mesenchymal transition (EndMT) in human umbilical vein vascular endothelial cells (HUVECs) and its related mechanisms. Methods The EndMT model was established by treating HUVECs with LPS. Cell proliferation rate was detected by CCK-8 assay, cytotoxicity was detected by LDH assay, and the optimal drug concentration was screened. The cells were divided into the normal control group, the normal control + colchicine (10 nmol • L) group, the LPS (10 mg • L) model group, and the LPS + colchicine (10 nmol • L) group. The morphologic changes of the cells were observed under an inverted microscope, the cell migration ability was detected by Transwell assay, and the ability of tube formation was analyzed by tube formation assay. The expression of endothelial markers (CD31/ VE-cadherin) and mesenchymal cell markers (a-SMA/FSP-1) were detected by Western blot. NF-KB inhibitor was used to detect the changes in related signaling pathways. Results CCK-8 and LDH experiments showed that 10 nmol • L colchicine was the optimal concentration. LPS could induce morphological changes in HUVECs, and colchicine could reverse morphological changes in HUVECs to a certain extent. Transwell experiment showed that the migration ability of HUVECs in the LPS treatment group was significantly enhanced (P < 0. 05), and colchicine could significantly reverse this phenomenon (P < 0. 05) . Tube formation experiment showed that LPS decreased the endothelial tube formation ability of HUVECs (P < 0. 05), while colchicine treatment markedly improved LPS-induced tube formation defects (P < 0. 05) . Western blot assay showed that after colchicine co-cultured with LPS, the expression levels of CD31 and VE-cadherin significantly increased compared with the model group (P < 0. 05), while the expression levels of a-SMA and FSP-1 significantly decreased compared with the model group (P < 0. 05) . During the induction of EndMT by LPS, colchicine could inhibit the activation of the NF-KB/Snail signaling pathway. Conclusions Colchicine can effectively inhibit EndMT induced by LPS, and the mechanism may be related to the regulation of the NF-KB/Snail signaling pathway.
4.Inhibitory Effect of Sesquiterpenoid M36 from Myrrha on Growth of Human Hepatoma Cells
Dongxiao LIU ; Yaxin LIU ; Huiming HUANG ; Lishan OUYANG ; Chaochao WANG ; Jinxin XIE ; Longyan WANG ; Xuejiao WEI ; Peng TAN ; Pengfei TU ; Jun LI ; Zhongdong HU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(5):80-87
ObjectiveThe antitumor activity of sesquiterpenoid M36 isolated from Myrrha against human hepatoma HepG2 cells was investigated in this study. MethodHepG2 cells were treated with M36 at different concentrations (0, 2, 4, 6, 8, 10 μmol·L-1). Firstly, the effects of M36 on the proliferation of human hepatoma HepG2 cells were detected by methyl thiazolyl tetrazolium (MTT), colony formation assay, and EdU proliferation assay. Hoechst staining, flow cytometry analysis, and Western blot were used to explore the effect of M36 on the apoptosis of human hepatoma HepG2 cells. Acridine orange staining and western blotting were used to examine the effect of M36 on autophagy in HepG2 cells. Finally, Western blot was used to detect protein expression of cancer-related signaling pathways. ResultCompared with the blank group, M36 treatment significantly inhibited the proliferation of human hepatoma HepG2 cells (P<0.01), and the half inhibitory concentration (IC50) value of M36 for 48 h was 5.03 μmol·L-1, in a dose- and time-dependent manner. M36 was also able to induce apoptosis and autophagy in human hepatoma HepG2 cells. After treatment with 8 μmol·L-1 M36 for 48 hours, the apoptosis rate of HepG2 cells was (42.03±9.65)% (P<0.01). Compared with the blank group, HepG2 cells treated with 4 and 8 μmol·L-1 M36 for 48 h had a significant increase in cleaved poly ADP-ribose polymerase (cleaved-PARP) protein levels (P<0.01). Acridine orange staining showed that autophagy was significantly activated in HepG2 cells treated with 4 and 8 μmol·L-1 M36 for 48 h compared with the blank group (P<0.01), which was further verified by the up-regulation of microtubule-associated protein 1 light chain 3 Ⅱ (LC3 Ⅱ). Western blot results showed that compared with the blank group, the levels of phosphorylated extracellular regulated protein kinase (p-ERK), phosphorylated p38 mitogen-activated protein kinase (p-p38 MAPK), phosphorylated c-Jun N-terminal kinase (p-JNK), and its downstream nuclear transcription factors c-Jun and p-c-Jun protein were significantly increased in M36 group (P<0.05, P<0.01). The mechanism may be related to the up-regulation of MAPK signaling pathway. ConclusionThe sesquiterpenoid M36 isolated from Myrrha inhibits the proliferation of human hepatoma HepG2 cells and promotes apoptosis and autophagy, which may be related to the activation of the MAPK signaling pathway.
5.Efficacy analysis of the acute endovascular treatment in patients with symptomatic severe anterior intracranial atherosclerotic stenosis
Haolin LIU ; Xiaoxin BAI ; Jun CAI ; Zhuli PENG ; Ruicong CHEN ; Shaoxue LI ; Huai TU ; Jiangling LIANG ; Yuejia LIN
Chinese Journal of Cerebrovascular Diseases 2024;21(3):175-183
Objective Observing the feasibility of acute endovascular treatment for patients with symptomatic anterior intracranial atherosclerotic severe stenosis.Method From Jun 2019 to Jun 2023,30 symptomatic anterior intracranial atherosclerotic severe stenosis cases were retrospectively collected in the Guangdong Hospital of Traditional Chinese Medicine to evaluate the risk stratification score and explore the safety and effectiveness of acute(≤72.0h)endovascular treatment.Endovascular treatment includes balloon dilation+self-expanding stent placement,balloon-mounted stent placement,and balloon dilation.From the clinical experience,the risk stratification score was based on the ABCD3-I score for transient ischemic attacks(TIA)and additional evaluation of cerebral watershed infarction to identify the risk of stroke progression or recurrence in acute stage of symptomatic intracranial artery stenosis.The score of 0-3 was defined as low-risk,4-7 as medium risk,and 8-13 as high-risk.The successful revascularization of blood flow is determined based on the residual stenosis≤50%and the extended thrombolysis in cerebral infarction(eTICI)>2c.The information of patient receiving endovascular treatment was recorded,including age,sex,risk factors of cerebrovascular disease(hypertension,diabetes,hyperlipidemia,hyperhomocysteinemia,drinking history,smoking history),onset data(time from onset to endovascular treatment,symptoms,progression),diseased vessels,risk stratification score,National Institutes of Health Stroke Scale(NIHSS)score before and 90 days after surgery,modified Rankin scale(mRS)score 90 days after surgery,intraoperative cerebrovascular events(intracranial hemorrhage,occlusion of responsible vessels),and postoperative cerebrovascular events 90 days after surgery(intracranial hemorrhage,cerebral infarction,TIA and in-stent restenosis)and deaths.Results Among 30 patients with symptomatic anterior intracranial atherosclerotic severe stenosis,3 patients were excluded from the time interval between onset and endovascular treatment>72.0 hours,1 patient needed long-term anticoagulant drugs due to other diseases,1 patient lost follow-up,3 patients coexisted with other cardiogenic cerebral embolism diseases,4 patients with non-atherosclerotic arterial stenosis,and 7 patients refused emergency endovascular treatment.11 patients were finally included.(1)All 11 patients were successfully treated with endovascular treatment,and 7 were males;age ranged from 52 to 76 years old,with a median age of 64 years old;there were 9 cases with hypertension,3 cases diabetes,7 cases hyperlipidemia,2 cases hyperhomocysteinemia(only 9cases performed the examination),2cases smoking history,1 case drinking history;time from onset to endovascular treatment is 4.0-72.0 h,with a median time of 12.0 h;there were 3 and 8 cases of infarction in the left and right hemispheres,respectively,with 4,3,and 2 cases accompanied with anterior-posterior watershed,medial watershed,and anlerior-medial-posterior watershed infarctions,and 1 case accompanied by posterior-medial,anterior-medial watershed infarctions.(2)Among the 1 1 patients,the risk stratification score was 10-13 points,with a median score of 11 points;preoperative NIHSS score ranged 0-11 points,with a median score of 7 points.(3)Among the 1 1 patients,10 lesions located in the middle cerebral artery and 1 in the C7 segment of the internal carotid artery;the preoperative stenosis rate was 70%to 99%,with a median stenosis rate of 86%;preoperative eTICI grading was 2a in 7 cases and 2b50 in 4 cases(with slow distal blood flow);9 cases received balloon dilation and self-expanding stent placement,1 case received balloon-mounted stent placement,and 1 case received balloon dilation treatment;the postoperative stenosis rate is 10%to 20%,with a median stenosis rate of 15%;there were 3 cases with postoperative eTICI grade 2c and 8 cases with grade 3.(4)Among the 11 patients,one experienced intracranial hemorrhage on the first day after surgery and one had a new cerebral infarction on the third day after surgery.Eight patients were followed up by imaging 90days after surgery,demonstrating 2 cases of in-stent restenosis;90 days post-surgery,NIHSS score was 0-20 points,with a median score of 2 points;after 90 days of surgery,the mRS score was 0-4 points,with a median score of 1 point.There were 8 patients with mRS score ≤ 2 and no death events occurred.Conclusions Preliminary analysis shows that acute endovascular treatment for symptomatic anterior intracranial atherosclerotic severe stenosis has certain effectiveness,but the safety needs to be further validated.The screening of high-risk patients using risk stratification scores still requires further exploration through large sample and multicenter studies.
6.Analysis of component composition and content determination of six constituents for Xeriga-4 Powder
Jun LI ; Yue-Wu WANG ; Qian ZHANG ; Ping CUI ; Ri-Gui YE ; Ji-ri-mu-ba-tu
Chinese Traditional Patent Medicine 2024;46(1):14-22
AIM To analyze the component composition of Xeriga-4 Powder,and to determine the contents of phellodendrine,chlorogenic acid,gardenoside,berberine,rutin and curcumin.METHODS The high performance liquid chromatography-Q-exactive orbitrap mass spectrometry(HPLC-Q-Exactive-MS)qualitative analysis was performed on a 35℃thermostatic Agilent ZORBAX SB-Aq column(4.6 mm×150 mm,5 μm),with the mobile phase comprising of methanol-0.1%formic acid flowing at 0.35 mL/min in a gradient elution manner,and electron spray ionization source was adopted in positive and negative ion scanning.High performance liquid chromatography tandem mass spectrometry(HPLC-MS/MS)quantitative analysis was performed on a 35℃thermostatic Shim-pack GIST-HP C18 column(2.1 mm×100 mm,3 μm),with the mobile phase comprising of methanol-0.1%formic acid flowing at 0.25 mL/min in a gradient elution manner,and electron spray ionization source was adopted in positive and negative ion scanning with multiple reaction monitoring mode.RESULTS Total 65 constituents were identified,containing 19 alkaloids,13 organic acids,13 flavonoids,7 curcumins,6 iridoids,4 fatty acids,2 aldehydes,and 1 amino acid.Six constituents showed good linear relationships within their own ranges(r≥0.999 1),whose average recoveries were 96.44%-102.37%with the RSDs of 2.05%-3.74%.CONCLUSION This study can provide a reference for the quality control for Xieriga-4 Powder.
7.Identification of Phenolic Acid Derivatives in Danshen Using MS3 and MS2 Spectra Matching Strategy
Han LI ; Ke ZHANG ; Ting LI ; Wei CHEN ; Jun LI ; Peng-Fei TU ; Yun-Fang ZHAO ; Yue-Lin SONG
Chinese Journal of Analytical Chemistry 2024;52(2):267-276,中插19-中插27
"MS/MS spectrum to structure"plays a critical role in the confirmative identification of complicated matrices and is currently regarded as an extremely challenging endeavor.MS/MS information provides vital clues to structural identification.In this study,a strategy was proposed to facilitate unambiguous identification through matching MS3 with MS2 spectra.Initially,MS3 spectra of the featured ions(c-and y-type ions)generated by the decomposition of ester functional group in esters and the MS2 spectrum of the structural unit([M-H]-)were all captured on the Qtrap-MS platform equipped with two tandem-in-space collision cells,including the second quadrupole cell(q2)and linear ion trap(LIT)chambers(actually the third quadrupole unit).Subsequently,the MS/MS spectrum matching between MS3 spectra of the ester compound and MS2 spectra of the structural unit(s)were achieved.As a result,the findings corresponding to MS3 and MS2 spectra matching were summarized.Finally,based on HR-MS/MS information of total salvianolic acid derivatives(TSA),36 kinds of compounds were preliminarily identified through matching with literature information and database retrieval.The applicability of MS3 and MS2 spectra matching strategy was further justified by the confirmative identification of phenolic acid compounds(Rosmarinic acid and salvianolic acid B)in TSA.Above all,MS3 and MS2 spectra matching strategy was quite meaningful towards advancing"MS/MS spectrum to structure"analysis through recognizing and identifying featured fragment ions,and also provided inspiration and new insights for the structural characterization.
8.Study on effect and mechanisms of Carthami Flos water extract and hydroxysafflower yellow A on primary dysmenorrhea rats with cold coagulation and blood stasis
Ran WANG ; Ying SUN ; Boyang JIAO ; Chun LI ; Jun LI ; Pengfei TU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(10):1397-1407
Objective To explore the pharmacological effects and regulatory mechanisms of Carthami Flos water extract and its main constituent,hydroxysafflower yellow A(HSYA),on primary dysmenorrhea rats with cold coagulation and blood stasis.Methods Forty-two female specific pathogen-free grade rats aged 6-8 weeks were divided into blank,model,HSYA(0.01 g/kg),ibuprofen(0.04 g/kg),and low(0.06 g/kg),medium(0.20 g/kg),and high(0.40 g/kg)Carthami Flos water extract dose groups using the random number table method,with six rats per group.A rat model was established using ice water bath stimulation combined with estradiol benzoate and oxytocin.Continuous gavage was administered for 6 days from the seventh day of modeling.After the intervention,the writhing reaction test was conducted.The rats,uteri,and ovaries were weighed to calculate the organ index.An enzyme-linked immunosorbent assay and radioimmunoassay were used to detect the prostaglandin E2(PGE2)and prostaglandin F2α(PGF2α)contents in the uterus,thromboxane B2(TXB2)and 6-keto-prostaglondin F1α(6-keto-PGF1α)in plasma,and estradiol(E2)in the serum.Hematoxylin and eosin staining were used to detect the pathological changes in uterine tissue.Immunohistochemistry was used to determine cyclooxygenase-2(COX-2)expression in uterine tissue,whereas immunofluorescence was used to measure follicle-stimulating hormone receptor(FSH-R)expression in ovarian tissue.Western blotting was used to detect gonadotropin-releasing hormone receptor(GnRH-R)and FSH-R expression in uterine tissue.Results Compared with the blank group,the rats in the model group exhibited an increase in uterine and ovarian indices and increased PGE2 and PGF2α in the uterus.TXB2 in the plasma and E2 in the serum were also evaluated.Additionally,6-keto-PGF1α decreased,and COX-2,GnRH-R,and FSH-R expression in the uterus and FSH-R expression in the ovaries also increased(P<0.05).The morphology of the uterine tissue was disordered.Compared with the model group,the low Carthami Flos water extract dose group showed a decrease in uterine index(P<0.05).In the medium and high Carthami Flos water extract dose groups,the writhing response decreased,as did the uterine and ovarian indicesand PGE2 and TXB2 contents.The 6-keto-PGF1α content increased,whereas the GnRH-R protein expression in the uterus decreased(P<0.05).The high Carthami Flos water extract dose group also showed a decrease in PGF2α and FSH-R protein expression in the uterus(P<0.05).In the HSYA group,the writhing response decreased,the uterine and ovarian indices decreased,the PGE2,PGF2α,and TXB2 contents decreased,and GnRH-R and FSH-R protein expression decreased in the uterus(P<0.05).The serum E2 levels of the groups that received Carthami Flos water extract at various doses and those of the HSYA group were reduced,and the uterine morphology was improved.COX-2 expression in the uterus and FSH-R protein expression in the ovaries were also reduced(P<0.05).Conclusion Carthami Flos water extract and HSYA can improve the pathological state of primary dysmenorrhea rats with cold coagulation and blood stasis.Its mechanism may be related to regulating the hypothalamic-pituitary-ovary axis.
9.Relationship between macular microcirculation,cytokines and anti-VEGF efficacy in DME patients
Yu JIN ; Miao LIU ; Fangxiu YUAN ; Ling WANG ; Qiongjuan ZENG ; Yuzhen ZHU ; Jiaojiao TU ; Jun WANG
China Modern Doctor 2024;62(31):18-22
Objective To investigate the changes of macular microcirculation and aqueous humor cytokine expression in patients with diabetic macular edema(DME)after anti-vascular endothelial growth factor(VEGF)treatment,and analyze the relationship with efficacy.Methods A total of 62 patients(91 eyes)with DME who were treated in the First Hospital of Nanchang from October 2021 to August 2023 were selected and treated with intravitreal injection of conbercept.According to the reduction of central macular thickness(CMT),they were divided into efficacy significant group(CMT reduction≥100μm,59 eyes)and non-efficacy significant group(CMT reduction<100μm or increase,32 eyes).The changes of CMT,vessel density(VD)of superficial capillary plexus(SCP),fovea avascular area(FAZ),VEGF,interleuki(IL)-6,IL-8,and IL-10 after anti-VEGF treatment were analyzed.Receiver operating characteristic(ROC)curve was used to evaluate the predictive value of each index.Results Before treatment,the levels of VEGF and IL-10 in aqueous humor in efficacy significant group were significantly higher than those in non-efficacy significant group,and the level of IL-8 was significantly lower than that in non-efficacy significant group(P<0.05).After treatment,levels of VEGF,IL-6,IL-8 and IL-10 in aqueous humor in both groups were significantly lower than before treatment(P<0.05).The levels of VEGF,IL-6 and IL-8 in aqueous humor in efficacy significant group were significantly lower than those in non-efficacy significant group,and the level of IL-10 was significantly higher than that in non-efficacy significant group(P<0.05).Before and after anti-VEGF treatment,there were no significant changes in FAZ area and SCP-VD in both groups(P>0.05).Correlation analysis showed that VEGF(r=0.571,P<0.001)and IL-10(r=0.382,P=0.008)in aqueous humor at baseline were positively correlated with CMT reduction,IL-8 was negatively correlated with CMT reduction(r=-0.689,P<0.001).IL-6,FAZ area and SCP-VD were not correlated with CMT reduction(P>0.05).Cytokine levels were not correlated with FAZ area and SCP-VD(P>0.05).ROC curve results showed that area under the curve of IL-8,VEGF and IL-10 at baseline predicting anti-VEGF efficacy were 0.825,0.813 and 0.676,respectively.Conclusion The levels of VEGF,IL-8,and IL-10 in aqueous humor at baseline in DME patients were correlated with anti-VEGF efficacy and could predict the efficacy of anti-VEGF.
10.Study on effect and mechanisms of Carthami Flos water extract and hydroxysafflower yellow A on primary dysmenorrhea rats with cold coagulation and blood stasis
Ran WANG ; Ying SUN ; Boyang JIAO ; Chun LI ; Jun LI ; Pengfei TU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(10):1397-1407
Objective To explore the pharmacological effects and regulatory mechanisms of Carthami Flos water extract and its main constituent,hydroxysafflower yellow A(HSYA),on primary dysmenorrhea rats with cold coagulation and blood stasis.Methods Forty-two female specific pathogen-free grade rats aged 6-8 weeks were divided into blank,model,HSYA(0.01 g/kg),ibuprofen(0.04 g/kg),and low(0.06 g/kg),medium(0.20 g/kg),and high(0.40 g/kg)Carthami Flos water extract dose groups using the random number table method,with six rats per group.A rat model was established using ice water bath stimulation combined with estradiol benzoate and oxytocin.Continuous gavage was administered for 6 days from the seventh day of modeling.After the intervention,the writhing reaction test was conducted.The rats,uteri,and ovaries were weighed to calculate the organ index.An enzyme-linked immunosorbent assay and radioimmunoassay were used to detect the prostaglandin E2(PGE2)and prostaglandin F2α(PGF2α)contents in the uterus,thromboxane B2(TXB2)and 6-keto-prostaglondin F1α(6-keto-PGF1α)in plasma,and estradiol(E2)in the serum.Hematoxylin and eosin staining were used to detect the pathological changes in uterine tissue.Immunohistochemistry was used to determine cyclooxygenase-2(COX-2)expression in uterine tissue,whereas immunofluorescence was used to measure follicle-stimulating hormone receptor(FSH-R)expression in ovarian tissue.Western blotting was used to detect gonadotropin-releasing hormone receptor(GnRH-R)and FSH-R expression in uterine tissue.Results Compared with the blank group,the rats in the model group exhibited an increase in uterine and ovarian indices and increased PGE2 and PGF2α in the uterus.TXB2 in the plasma and E2 in the serum were also evaluated.Additionally,6-keto-PGF1α decreased,and COX-2,GnRH-R,and FSH-R expression in the uterus and FSH-R expression in the ovaries also increased(P<0.05).The morphology of the uterine tissue was disordered.Compared with the model group,the low Carthami Flos water extract dose group showed a decrease in uterine index(P<0.05).In the medium and high Carthami Flos water extract dose groups,the writhing response decreased,as did the uterine and ovarian indicesand PGE2 and TXB2 contents.The 6-keto-PGF1α content increased,whereas the GnRH-R protein expression in the uterus decreased(P<0.05).The high Carthami Flos water extract dose group also showed a decrease in PGF2α and FSH-R protein expression in the uterus(P<0.05).In the HSYA group,the writhing response decreased,the uterine and ovarian indices decreased,the PGE2,PGF2α,and TXB2 contents decreased,and GnRH-R and FSH-R protein expression decreased in the uterus(P<0.05).The serum E2 levels of the groups that received Carthami Flos water extract at various doses and those of the HSYA group were reduced,and the uterine morphology was improved.COX-2 expression in the uterus and FSH-R protein expression in the ovaries were also reduced(P<0.05).Conclusion Carthami Flos water extract and HSYA can improve the pathological state of primary dysmenorrhea rats with cold coagulation and blood stasis.Its mechanism may be related to regulating the hypothalamic-pituitary-ovary axis.

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