1.Updates and amendments of the Chinese Pharmacopoeia 2025 Edition (Volume Ⅰ)
LI Hao ; SHEN Mingrui ; ZHANG Pang ; ZHAI Weimin ; NI Long ; HAO Bo ; ZHAO Yuxin ; HE Yi ; MA Shuangcheng ; SHU Rong
Drug Standards of China 2025;26(1):017-022
The Chinese Pharmacopoeia is the legal technical standard which should be followed during the research, production, use, and administration of drugs. At present, the new edition of the Chinese Pharmacopoeia is planned to be promulgated and implemented. This article summarizes and analyzes the main characteristics and the content of updates and amendments of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅰ), to provide a reference for the correct understanding and accurate implementation the new edition of the pharmacopoeia.
2.Study on the potential allergen and mechanism of pseudo-allergic reactions induced by combined using of Reduning injection and penicillin G injection based on metabolomics and bioinformatics
Yu-long CHEN ; You ZHAI ; Xiao-yan WANG ; Wei-xia LI ; Hui ZHANG ; Ya-li WU ; Liu-qing YANG ; Xiao-fei CHEN ; Shu-qi ZHANG ; Lu NIU ; Ke-ran FENG ; Kun LI ; Jin-fa TANG ; Ming-liang ZHANG
Acta Pharmaceutica Sinica 2024;59(2):382-394
Based on the strategy of metabolomics combined with bioinformatics, this study analyzed the potential allergens and mechanism of pseudo-allergic reactions (PARs) induced by the combined use of Reduning injection and penicillin G injection. All animal experiments and welfare are in accordance with the requirements of the First Affiliated Experimental Animal Ethics and Animal Welfare Committee of Henan University of Chinese Medicine (approval number: YFYDW2020002). Based on UPLC-Q-TOF/MS technology combined with UNIFI software, a total of 21 compounds were identified in Reduning and penicillin G mixed injection. Based on molecular docking technology, 10 potential allergens with strong binding activity to MrgprX2 agonist sites were further screened. Metabolomics analysis using UPLC-Q-TOF/MS technology revealed that 34 differential metabolites such as arachidonic acid, phosphatidylcholine, phosphatidylserine, prostaglandins, and leukotrienes were endogenous differential metabolites of PARs caused by combined use of Reduning injection and penicillin G injection. Through the analysis of the "potential allergen-target-endogenous differential metabolite" interaction network, the chlorogenic acids (such as chlorogenic acid, neochlorogenic acid, cryptochlorogenic acid, and isochlorogenic acid A) and
3.Discussion on the Pathogenesis of Osteonecrosis of the Femoral Head Under the System of Non-uniform Settlement During Bone Resorption and Multidimensional Composite Bowstring Working in Coordination with the Theory of Liver-Kidney and Muscle-Bone Based on the Concept of Liver and Kidney Sharing the Common Source
Gui-Xin ZHANG ; Feng YANG ; Le ZHANG ; Jie LIU ; Zhi-Jian CHEN ; Lei PENG ; En-Long FU ; Shu-Hua LIU ; Chang-De WANG ; Chun-Zhu GONG
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(1):239-246
From the perspective of the physiological basis of liver and kidney sharing the common source in traditional Chinese medicine(TCM),and by integrating the theory of kidney dominating bone,liver dominating tendon,and meridian sinew of TCM as well as the bone resorption and collapse theory,and non-uniform settlement theory and lower-limb musculoskeletal bowstring structure theory of modern orthopedics,the pathogenesis of osteonecrosis of the femoral head(ONFH)under the system of non-uniform settlement during bone resorption and multidimensional composite bowstring working in coordination with the theory of liver-kidney and muscle-bone was explored.The key to the TCM pathogenesis of ONFH lies in the deficiency of the liver and kidney,and then the imbalance of kidney yin-yang leads to the disruption of the dynamic balance of bone formation and bone resorption mediated by osteoblasts-osteoclasts,which manifests as the elevated level of bone metabolism and the enhancement of focal bone resorption in the femoral head,and then leads to the necrosis and collapse of the femoral head.It is considered that the kidney dominates bone,liver dominates tendon,and the tendon and bone together constitute the muscle-bone-joint dynamic and static system of the hip joint.The appearance of collapse destroys the originally balanced muscle-bone-joint system.Moreover,the failure of liver blood in the nourishment of muscles and tendons further exacerbates the imbalance of the soft tissues around the hip joint,accelerates the collapse of the muscle-bone-joint dynamic and static system,speeds up the process of femoral head collapse,and ultimately results in irreversible outcomes.Based on the above pathogenesis,the systematic integrative treatment of ONFH should be based on the TCM holistic concept,focuses on the focal improvement of internal and external blood circulation of the femoral head by various approaches,so as to rebuild the coordination of joint function.Moreover,attention should be paid to the physical constitution of the patients,and therapy of tonifying the kidney and regulating the liver can be used to restore the balance between osteogenesis and osteoblastogenesis,and to reconstruct the muscle-bone-joint system,so as to effectively delay or even prevent the occurrence of ONFH.
4.Based on supramolecular chemistry to explore the scientific connotation of predecocting gypsum in Maxingshigan decoction preliminarily
Yao-zhi ZHANG ; Shu-chang YAO ; Lu-ping YANG ; Yi-hang ZHAO ; An-qi XU ; Xue-mei HUANG ; Peng-long WANG
Acta Pharmaceutica Sinica 2024;59(6):1828-1840
It has gradually become a consensus in the industry that the traditional Chinese medicine gypsum should be decocted first, but the understanding of decocting method is not completely unified in the works of doctors since ancient times, and there are occasional disputes about whether it is necessary to decocting first. In this study, the phase determination, physical and chemical characterization, qualitative and quantitative analysis of inorganic and organic components of the decoctions of herbal pairs and the whole prescription Maxingshigan decoction with gypsum as the center, and the pre-decoctions and co-decoctions of them were carried out to explore the scientific connotation of the pre-decoctions of gypsum. Results show that decoction phases were different between the co-decoctions and pre-decoctions of licorice-gypsum (Gancao-Shigao, GC-SG), ephedra-gypsum (Mahuang-Shigao, MH-SG) and almond-gypsum (Xingren-Shigao, XR-SG). The results of the micromorphology, particle size and zeta potential of herbal pairs and prescription (Quanfang, QF) showed that the supramolecular particles in pre-decoctions were smaller, more uniform and more stable than the co-decoctions. The results of organic components analysis showed that different cooking methods did not change the organic composition and content. ICP-OES results showed that the content of inorganic components in pre-decoctions was higher than in co-decoctions for the same boiling time of gypsum. The IR results showed that the pre-decoctions had stronger chemical functional group effect than the co-decoctions. To sum up, compared with the co-decoction, the pre-decoction of gypsum has different phase state and chemical composition interaction, and the difference of inorganic composition is an important material basis affecting the change of phase state compared with the co-decoction. It indicates that the material basis of traditional Chinese medicine decoction is indeed different whether gypsum is decocted first or not, which can provide a basis for the clinical application of decocted gypsum.
5.Based on supramolecular chemistry to explore the scientific connotation of the compatibility between licorice and the insoluble mineral medicine gypsum
Yao-zhi ZHANG ; Wen-min PI ; Lin-ying WU ; Lu-ping YANG ; Shu-chang YAO ; Xiang ZHANG ; Xue-mei HUANG ; Peng-long WANG
Acta Pharmaceutica Sinica 2024;59(4):1048-1056
Licorice-gypsum (gancao-shigao, GC-SG) drug pair was used as the research object, using supramolecular chemistry to explore the scientific connotation of combining herbal medicine GC with insoluble mineral medicine SG in clinical application of traditional Chinese medicine. ① The Tyndall effect, microscopic morphology and particle size of the single and co-decocted of GC and SG were observed, the paste content and conductivity were determined, and the interaction between GC and SG was detected by isothermal titration calorimetry (ITC) and infrared absorption spectroscopy (IR). ② Calcium chloride (CaCl2), a soluble calcium salt of equal gypsum quality, was used instead of SG with GC for co-decocting to explore the effect of calcium salt content on the water decocting, and the characteristics were combined with the Tyndall effect, microscopic morphology, paste content and conductivity. ITC and IR techniques were used to detect the interaction between the two, and the interaction between them was detected by ITC and IR. The zeta potential and ultraviolet-visible spectrophotometry (UV-vis) of GC-SG and GC-CaCl2 co-decoction were compared, and the inorganic and organic components in the co-decoction were detected by inductively coupled plasma optical emission spectrometer (ICP-OES) and high performance liquid chromatography (HPLC). The results showed: ① Compared with the liquid phase of single decoction, GC-SG co-decoction had more obvious Tyndall effect, and showed uniform spherical nanoparticles under electron microscope. Physical characterization results such as paste content and conductivity showed that co-decoction promoted the dissolution of each other's components; ITC and IR results showed that there was strong interaction between GC and SG, which preliminatively indicated that GC and SG co-decoction promoted the formation of uniform and stable supramolecular system of traditional Chinese medicine. ② When soluble calcium salt was used to substitute insoluble SG with GC for co-decocting, a stronger but astigmatic light path appeared than single decocting solution, the zeta potential was reduced, and a large number of accumulated polymers were formed. The results of paste content and conductivity showed that the dissolution of the co-decocting component was reduced than the single decocting component. ITC, UV-vis and IR results showed that there was interaction between GC with Ca2+ and SG. The formation of polysink indicated that a large amount of soluble calcium salt would destroy the stability of supramolecular Chinese medicine. The results of ICP-OES and HPLC showed that the glycyrrhizic acid (GA) content of the former lower than the latter, which was related to the formation of a large number of polycondensates with the increase of Ca2+ concentration and the decrease of the dissolution of GA and other active ingredients. This study indicates that the compatibility of GC and SG can form a uniform and stable supramolecular system of traditional Chinese medicine. Calcium salt, the main component of SG, is taken as the starting point. Excessive soluble Ca2+ can promote the aggregation of active ingredients such as GA, so as to reveal the scientific connotation of the compatibility of GC and SG, an insoluble mineral medicine.
6.Exploring the risk "time interval window" of sequential medication of Reduning injection and penicillin G injection based on the correlation between biochemical indexes and metabolomics characteristics
Ming-liang ZHANG ; Yu-long CHEN ; Xiao-yan WANG ; Xiao-fei CHEN ; Hui ZHANG ; Ya-li WU ; Liu-qing YANG ; Shu-qi ZHANG ; Lu NIU ; Ke-ran FENG ; Wei-xia LI ; Jin-fa TANG
Acta Pharmaceutica Sinica 2024;59(7):2098-2107
Exploring the risk "time interval window" of sequential medication of Reduning injection (RDN) and penicillin G injection (PG) by detecting the correlation between serum biochemical indexes and plasma metabonomic characteristics, in order to reduce the risk of adverse reactions caused by the combination of RDN and PG. All animal experiments and welfare are in accordance with the requirements of the First Affiliated Experimental Animal Ethics and Animal Welfare Committee of Henan University of Chinese Medicine (approval number: YFYDW2020002). The changes of biochemical indexes in serum of rats were detected by enzyme-linked immunosorbent assay. It was determined that RDN combined with PG could cause pseudo-allergic reactions (PARs) activated by complement pathway. Further investigation was carried out at different time intervals (1.5, 2, 3.5, 4, 6, and 8 h PG+RDN). It was found that sequential administration within 3.5 h could cause significant PARs. However, PARs were significantly reduced after administration interval of more than 4 h. LC-MS was used for plasma metabolomics analysis, and the levels of serum biochemical indicators and plasma metabolic profile characteristics were compared in parallel. 22 differential metabolites showed similar or opposite trends to biochemical indicators before and after 3.5 h. And enriched to 10 PARs-related pathways such as arachidonic acid metabolism, steroid hormone biosynthesis, linoleic acid metabolism, glycerophospholipid metabolism, and tryptophan metabolism. In conclusion, there is a risk "time interval window" phenomenon in the adverse drug reactions caused by the sequential use of RDN and PG, and the interval medication after the "time interval window" can significantly reduce the risk of adverse reactions.
7.The Preclinical Models of Glioma Dependent on Alternative Lenthening of Telomeres (ALT) and Current Applications
Jin-Kai TONG ; Si-Xiang YAN ; Yan-Duo ZHANG ; Kai-Long HOU ; Ke ZHANG ; Hao-Nan ZHANG ; Shun CHANG ; Shu-Ting JIA
Progress in Biochemistry and Biophysics 2024;51(2):269-275
Glioma is the most common malignancy of the central nervous system, originating mainly from glial cells. Because of its highly aggressive nature, glioma has one of the highest rates of death among all types of cancer. Therefore, it is very important to develop new therapeutic approaches and drugs for glioma treatment. Instead of activate the telomerase, approximately 30% of glioma use alternative lenthening of telomere (ALT) to maintain telomere length. The mechanism of ALT development is poorly understood, however, some genetic mutations have been reported to induce the development of ALT glioma, such as ATRX, IDH1, p53, etc. The lack of ALT glioma cell lines and preclinical ALT glioma models has limited the mechanistic studies of ALT glioma. Therefore, this review listed ALT glioma cell lines that derived from primary culture or gene editing in the last decade, as well as the xenografted animal models established by ALT glioma cell lines, and discussed the role and significance these cell and animal models play in preclinical studies.
8.Clinical Efficacy of"Triple-posture Positive Bone-setting"Chiropractic Manipulation Combined with Tongluo Huoxue Formula for the Treatment of Lumbar Spinal Stenosis of Qi Deficiency and Blood Stasis Type
Long CHEN ; Zhou-Hang ZHENG ; Yu ZHANG ; Meng-Shu WANG ; Zhao-Yuan ZHANG ; Wei-Feng GUO ; Huan CHEN ; Xing-Ming LIU ; Dong-Chun YOU ; Rong-Hai WU
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(6):1450-1456
Objective To observe the clinical efficacy of"triple-posture positive bone-setting"chiropractic manipulation combined with Tongluo Huoxue Formula for the treatment of lumbar spinal stenosis(LSS)with qi deficiency and blood stasis syndrome.Methods Sixty patients with LSS of qi deficiency and blood stasis type were randomly divided into trial group and control group,with 30 cases in each group.The trial group was treated with"triple-posture positive bone-setting"chiropractic manipulation(a chiropractic manipulation performed under the positive cooperation of the patients at three postures)combined with Tongluo Huoxue Formula,while the control group was treated with"triple-posture positive bone-setting"chiropractic manipulation combined with conventional western medicine.The course of treatment for the two groups covered 4 weeks.Before and after treatment,the patients of the two groups were observed in the changes of pain visual analogue scale(VAS)score,Japanese Orthopedic Association(JOA)score of lumbar function,Oswestry Disability Index(ODI)score,straight-leg raising test results and serum interleukin 6(IL-6)and C-reactive protein(CRP)levels.After treatment,the clinical efficacy and safety of the two groups were evaluated.Results(1)After 4 weeks of treatment,the total effective rate of the trial group was 96.67%(29/30)and that of the control group was 63.33%(19/30).The intergroup comparison(tested by Fisher's exact test)showed that the clinical efficacy of the trial group was significantly superior to that of the control group(P<0.05).(2)After treatment,the lumbar function indicators of pain VAS scores and ODI scores in the trial group were significantly lower(P<0.05),and the JOA scores were significantly higher than those before treatment(P<0.05),while in the control group,only the ODI scores were significantly lower than those before treatment(P<0.05).The intergroup comparison showed that the decrease of VAS and ODI scores and the increase of JOA scores in the trial group were significantly superior to those in the control group(P<0.05 or P<0.01).(3)After treatment,the Laseque s sign of the trial group was significantly improved compared with that before treatment(P<0.05),while no significant improvement was presented in the control group(P>0.05).The intergroup comparison showed that the improvement of Laseque's sign in the trial group was significantly superior to that in the control group(P<0.01).(4)After treatment,the levels of serum inflammatory factors of IL-6 and CRP in the two groups were lower than those before treatment(P<0.05),and the decrease of serum IL-6 level in the trial group was significantly superior to that in the control group(P<0.05),but CRP level in the two groups after treatment did not differ from that before treatment,no statistically significant difference was shown between the two groups after treatment,either(P>0.05).(5)The incidence of adverse reactions in the trial group was 6.67%(2/30)and that in the control group was 13.33%(4/30),and the intergroup comparison(by Fisher's exact test)showed that there was no significant difference between the two groups(P>0.05).Conclusion The therapeutic effect of"triple-posture positive bone-setting"chiropractic manipulation combined with Tongluo Huoxue Formula exert certain effect for the treatment of LSS patients with qi deficiency and blood stasis syndrome,and it has more obvious advantages in improving the lumbar function,promoting the rehabilitation of the patients,and lowering the level of serum inflammatory factors than"triple-posture positive bone-setting"chiropractic manipulation combined with conventional western medication.
9.Study on the Correlation Between Sleep Status and Traditional Chinese Medicine Constitution Types of Sub-healthy Population in Lingnan Area
Bai-Shu CHEN ; Jin-Ling LONG ; Yan CHEN ; Qing-Song ZHANG ; Yi LUO ; Shu-Hui CHEN ; Ying-Zhen LI
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(7):1676-1681
Objective To explore the correlation between sleep status and traditional Chinese medicine(TCM)constitution types of sub-healthy population in Lingnan area.Methods From May 2022 to May 2023,an investigation was carried out in a sub-healthy population of 688 persons who lived in Shenzhen for more than 5 years,had no serious cardiovascular disease and were confirmed by the sub-health rating scale.The questionnaire survey of Pittsburgh Sleep Quality Index(PSQI)scale and the TCM constitution classification rating scale was conducted,and multiple linear regression analysis was performed to explore the correlation between the sleep status and TCM constitution types.Results(1)A total of 688 questionnaires were released,of which 19 were lost to follow-up,and 669 were responded.After weeding out the 29 invalid questionnaires,640 valid questionnaires were finally included for the analysis.(2)According to the PSQI score,the population was divided into excellent sleep group(total PSQI score<8)of 350 cases and poor sleep group(total PSQI score≥8)of 290 cases.The item scores of time for falling asleep,sleep time and sleep disorder as well as the total PSQI score of the excellent sleep group were significantly lower than those of the poor sleep group(P<0.05 or P<0.01).(3)The persons with excellent sleep usually had the balanced constitution(86.86%),while the persons with poor sleep often had the biased constitution(79.64%).The top three biased constitution types in the persons with poor sleep were damp-heat constitution(15.52%),phlegm-damp constitution(13.79%)and qi-stagnation constitution(13.10%).(4)Multiple linear regression analysis showed that the time for falling asleep was positively correlated with phlegm-damp constitution and qi-stagnation constitution(P<0.01),and was negatively correlated with balanced constitution(P<0.05);the sleep efficiency was positively correlated with damp-heat constitution and inherited special constitution(P<0.05 or P<0.01),and was negatively correlated with balanced constitution(P<0.05);sleep disorder was positively correlated with qi-stagnation constitution and yin-deficiency constitution(P<0.01);hypnotic drugs were positively correlated with yin-deficiency constitution(P<0.01);daytime dysfunction was positively correlated with phlegm-damp constitution(P<0.05).Conclusion The sleep status of sub-healthy population in Lingnan area has a certain correlation with TCM constitution types.Damp-heat constitution,phlegm-damp constitution,qi-stagnation constitution,yin-deficiency constitution,balanced constitution and inherited special constitution are the six constitution types that affect sleep status.It is of great significance to guide the sub-healthy population to achieve the purpose of prevention before illness by improving their constitution after the identification of TCM constitution types.
10.Surface markers and cytokine expression of blood Tc17 cells in early stage of acute ST-elevation myocardial infarction
Chang LIU ; Liqin SUN ; Long SHU ; Bo ZHANG
Chinese Journal of Immunology 2024;40(11):2350-2354,2360
Objective:To investigate phenotype and function of IL-17A-expressing CD8+T cells(i.e.Tc17 cells)in early stage of acute ST-elevation myocardial infarction(STEMI).Methods:Blood leukocytes were harvested from healthy donors and STEMI patients,and Tc17 cells were recognized by flow cytometry based on expressions of CCR6,CD161,CCR5,IL-23R and RORγt.Activation status,cytokine expression profiles and proliferation of Tc17 cells were evaluated by flow cytometry.Results:CCR6+CD161+CD8+T cells,either in healthy donors or STEMI patients,highly expressed CCR5,IL-23R and RORγt.Therefore,they were identified as Tc17 cells.Compared with healthy donors,frequency of Tc17 cells in total CD8+T cells was increased in STEMI patients.Besides,phenotype of Tc17 cells in STEMI patients was more skewed towards effector memory T cells.Tc17 cells in healthy donors predominantly expressed IL-17A and IL-22,whereas Tc17 cells in STEMI patients expressed IL-10 and TGF-β in addition to IL-17A and IL-22.However,Tc17 cells,either in healthy donors or STEMI patients,did not express IFN-γ,IL-5,Foxp3,and Ki67.Conclu-sion:In early stage of STEMI,Tc17 cells up-regulate IL-10 and TGF-β expressions while producing IL-17A and IL-22,probably participate in and regulate post-STEMI acute inflammation.

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