1.Current status analysis of production and quality control of opioids and their compound oral preparations
Ruifeng HAO ; Chao LI ; Qiuping HUANG ; Huiyue CHENG ; Qin FENG ; Huanhuan YU ; Linggao ZENG ; Jianhua WANG ; Zhu CHEN
Drug Standards of China 2025;26(4):371-379
Opium is obtained by air-drying the milky latex extracted from the unripe capsules of the opium poppy(Papaver somniferum).This latex is rich in benzylisoquinoline alkaloids(BIA),with major active compounds in-cluding morphine,codeine,thebaine,papaverine,and noscapine.Compound licorice oral solution and compound licorice tablets are derivative drugs containing opium.Initially classified as over-the-counter(OTC)medications,both formulations were later reclassified as prescription drugs by the National Medical Products Administration(NMPA),restricting their purchase without proper authorization.Although the national pharmacopeia standards specify the morphine content in the opium raw materials used for compound licorice oral solution and tablets,they lack mandatory requirements for the detection and quantification of the other four major alkaloids.Given the unique nature of opium raw materials and the stringent regulatory requirements for such drugs,it is imperative to enhance and refine simultaneous detection and control methods for all alkaloid components in these products.Furthermore,the establishment of scientific and reasonable detection and control standards for preservatives in compound licorice formulations is crucial to improving overall product quality management and ensuring drug safety and efficacy.This study analyzes and discusses the quality standards,detection methods,and research progress for opium and com-pound licorice preparations,aiming to explore the potential for technological innovation and ensure the safe use of these medications.
2.Current status analysis of production and quality control of opioids and their compound oral preparations
Ruifeng HAO ; Chao LI ; Qiuping HUANG ; Huiyue CHENG ; Qin FENG ; Huanhuan YU ; Linggao ZENG ; Jianhua WANG ; Zhu CHEN
Drug Standards of China 2025;26(4):371-379
Opium is obtained by air-drying the milky latex extracted from the unripe capsules of the opium poppy(Papaver somniferum).This latex is rich in benzylisoquinoline alkaloids(BIA),with major active compounds in-cluding morphine,codeine,thebaine,papaverine,and noscapine.Compound licorice oral solution and compound licorice tablets are derivative drugs containing opium.Initially classified as over-the-counter(OTC)medications,both formulations were later reclassified as prescription drugs by the National Medical Products Administration(NMPA),restricting their purchase without proper authorization.Although the national pharmacopeia standards specify the morphine content in the opium raw materials used for compound licorice oral solution and tablets,they lack mandatory requirements for the detection and quantification of the other four major alkaloids.Given the unique nature of opium raw materials and the stringent regulatory requirements for such drugs,it is imperative to enhance and refine simultaneous detection and control methods for all alkaloid components in these products.Furthermore,the establishment of scientific and reasonable detection and control standards for preservatives in compound licorice formulations is crucial to improving overall product quality management and ensuring drug safety and efficacy.This study analyzes and discusses the quality standards,detection methods,and research progress for opium and com-pound licorice preparations,aiming to explore the potential for technological innovation and ensure the safe use of these medications.
3.Clinical effect analysis of percutaneous minimally invasive bridging combined internal fixation system in the treatment of clavicle fractures
Pin LYU ; Hao ZHOU ; Jiangang LI ; Ruifeng LI ; Wentao AN
Chinese Journal of Postgraduates of Medicine 2024;47(11):966-972
Objective:To observe the clinical efficacy of percutaneous minimally invasive bridging combined internal fixation system (BCFS) in the treatment of clavicle fractures through a prospective study.Methods:One hundred and sixty-four patients with clavicle fractures admitted to Fengfeng General Hospital of North China Medical Group from June 2019 to June 2022 were included as the study subjects. They were randomly divided into study group and control group with 82 cases each using random number table method. The control group was treated with reconstruction steel plate internal fixation surgery, while the study group was treated with percutaneous minimally invasive BCFS surgery. Compare surgical related indicators, degree of pain, shoulder joint function, complications and treatment outcomes.Results:The intraoperative blood loss in the study group was less than that in the control group: (43.81 ± 5.29) ml vs. (58.79 ± 6.85) ml, and the surgical time and fracture healing time were shorter than those in the control group: (52.06 ± 7.74) min vs. (67.24 ± 8.28) min, (12.42 ± 2.36) weeks vs. (14.50 ± 3.08) weeks, with statistically significant differences ( P<0.05). There was no statistical difference in the hospital stay between two groups ( P>0.05). The visual analog scale (VAS) scores of both groups at 12 and 24 h after surgery were lower than before surgery. The VAS scores at 12 and 24 h after surgery in study group were lower than those in control group: (4.15 ± 0.69) points vs. (5.68 ± 0.82) points and (2.95 ± 0.62) points vs. (3.46 ± 0.73) points, with statistical significances ( P<0.05). After 6 months of surgery, the shoulder joint function indexes were higher than before surgery, pain degree: (10.87 ± 3.25) points vs. (4.15 ± 1.08) points, (10.52 ± 3.19) points vs. (4.09 ± 1.12) points, and the shoulder joint range of motion: (31.24 ± 5.13) points vs. (16.83 ± 3.39) points, (30.52 ± 4.85) points vs. (17.21 ± 3.47) points, daily life: (16.06 ± 3.12) points vs. (7.86 ± 1.15) points, (15.73 ± 3.58) points vs. (6.94 ± 1.17) points, muscle strength: (20.67 ± 2.62) points to (8.78 ± 2.34) points, (21.06 ± 3.48) points to (9.04 ± 3.07) points, and total scores: (78.84 ± 7.16) points vs. (37.62 ± 5.09) points, (77.83 ± 6.04) points vs. (37.28 ± 6.11) points, the differences were statistically significant ( P<0.05), while there were no statistically significant differences in pain level, shoulder joint range of motion, daily life, muscle strength and total score at 6 months after surgery between the two groups ( P>0.05). After 6 months of surgery, the incidence of complications in the study group was lower than that in the control group: 4.88% (4/82) vs. 14.64% (12/82), and the difference was statistically significant ( P<0.05). After 6 months of surgery, the overall excellent and good rate in the observation group was better than that in the control group: 98.78% (81/82) vs. 89.02% (73/82), with a statistically significant difference ( P<0.05). Conclusions:The percutaneous minimally invasive BCFS surgery has a significant therapeutic effect on clavicle fractures, which is beneficial for reducing intraoperative bleeding, shortening surgical time, promoting fracture healing, reducing postoperative pain, improving shoulder joint function, and reducing the incidence of complications. It has more advantages in the treatment of clavicle fractures.
4.Relationship between serum HMGB1 and CTRP3 levels and the degree of pain and lumbar function in patients with lumbar spinal stenosis
Wentao AN ; Pin LYU ; Ruifeng LI ; Hao ZHOU
International Journal of Laboratory Medicine 2024;45(20):2467-2470,2475
Objective To investigate the relationship between serum high mobility group protein B1(HMGB1),C1q/TNF-associated protein 3(CTRP3)and pain degree and lumbar function.Methods A total of 145 patients with lumbar spinal stenosis treated in the hospital from September 2021 to August 2023 were retrospectively selected as the study objects,and were divided into single-segment group(89 cases)and multi-segment group(56 cases)according to the number of lumbar spinal stenosis segments.Serum levels of HMGB1 and CTRP3 were detected by enzyme-linked immunosorbent assay.The clinicopathological features such as pain degree,lumbar function and serum levels of HMGB1 and CTRP3 were compared between the two groups.The correlation of serum HMGB1 and CTRP3 levels with pain degree and lumbar function were ana-lyzed,and the factors influencing the number of segments of lumbar stenosis were analyzed by multivariate Logistic regression.The diagnostic value of serum HMGB1 and CTRP3 levels on lumbar function of patients was analyzed by receiver operating characteristic(ROC)curve.Results Visual analogue scale(VAS)score and serum HMGB1 level in multi-segment group were higher than those in single-segment group(P<0.05),Japanese Orthopaedic Association(JOA)score and serum CTRP3 level were lower than those in single-seg-ment group(P<0.05).Serum HMGB1 level was negatively correlated with CTRP3 and JOA score in pa-tients with lumbar spinal stenosis(r=-0.544,-0.616,P<0.001),and positively correlated with VAS score(r=0.453,P<0.001).The serum CTRP3 level was negatively correlated with VAS score(r=-0.550,P<0.001),and positively correlated with JOA score(r=0.619,P<0.001).JOA score was nega-tively correlated with VAS score(r=-0.485,P<0.001).Multivariate Logistic regression analysis showed that JOA score and serum CTRP3 level were protective factors for multi-segmental stenosis(P<0.05),VAS score and serum HMGB1 level were risk factors for multi-segmental stenosis(P<0.05).The analysis of ROC curve showed that serum HMGB1 and CTRP3 levels could be used as diagnostic indexes of lumbar spinal function in patients with lumbar spinal stenosis,and the combined diagnosis effect was better(P<0.05).Conclusion Serum levels of HMGB1 and CTRP3 are closely related to pain degree and lumbar function in pa-tients with lumbar spinal stenosis.The combination of the two indexes can be used for the clinical diagnosis of lumbar function in patients with lumbar spinal stenosis.
5.Study on the Material Basis of Guiqi Baizhu Prescription Inhibiting the Proliferation of Uveal Melanoma Cells Based on Traditional Chinese Medicine Chemical Bioinformatics
WANG Ruifeng ; JIN Xiaojie ; LIU Hao ; LI Chenghao ; ZHANG Min ; Li Mi ; LI Haotian ; ZHANG Yu ; MA Huanhuan ; ZHANG Yuemei
Chinese Journal of Modern Applied Pharmacy 2024;41(14):1900-1912
ABATRACT
OBJECTIVE To utilize the pharmacophore model-molecular docking combined with the virtual screening strategy of free energy calculation and the chemical bioinformatics method of traditional Chinese medicine in cell biology experiments to investigate the components of Guiqi Baizhu prescription that target phosphatidylinositol 3-kinase(PI3K) and inhibit the proliferation of uveal melanoma(UM) cells.
METHODS The pharmacophore model of PI3K inhibitor was constructed, and the compounds of Guiqi Baizhu prescription were virtual screened. The components that fit the pharmacophore model were calculated by molecular docking and binding free energy, and the potential inhibitory components were selected for biological experimental evaluation. The effects of potential inhibitory components on UM cell proliferation were detected by CCK-8 and clonal formation assay. Flow cytometry was used to detect the cell cycle and apoptosis of UM cells. The mitochondrial membrane potential of UM cells was detected using JC-10 staining. The expressions of PI3K and downstream pathway proteins were detected by Western blotting.RESULTS The pharmacophore model included 2 hydrogen bond receptors, 2 aromatic ring centers, and exclusion volumes. The results of the CCK-8 experiment showed that quercetin, tangerine, and nobiletin at concentrations of 10, 20, 40, 80 μmol·L−1, and cyrtin at concentrations of 20, 40, 80 μmol·L−1, were able to inhibit the proliferation of UM cells. The clonal formation experiment showed that quercetin, tangerine, nobiletin, and morusin, at different concentrations, could significantly inhibit the clonal proliferation of UM cells. Flow cytometry showed that UM cells were arrested in the G0/G1 phase by tangeretin and quercetin, while UM cells were arrested in the G2/M phase by nobiletin and morusin. The results of JC-10 staining showed that quercetin, nobiletin, tangeretin, and morusin could reduce the mitochondrial membrane potential of UM cells. Western blotting results showed that 4 compounds could target PI3K, but their downstream pathways were different.CONCLUSION Based on the method of chemical bioinformatics in traditional Chinese medicine, this study explores the material basis for the inhibition of UM cell proliferation by the Guiqi Baizhu prescription. It also provides insights for the modern development of traditional Chinese medicine prescription.
6.Analysis of in Vitro Activity and Mechanism of Dunhuang Yifang Daxiefei Decoction on Pneumonia Based on Chemical Bioinformatics
Jia LIN ; Xiaojie JIN ; Chenghao LI ; Ruifeng WANG ; Yehu HOU ; Yixi ZHANG ; Hao LIU ; Min ZHANG ; Juan YAO ; Jintian LI ; Yongqi LIU
Chinese Journal of Modern Applied Pharmacy 2024;41(7):871-886
OBJECTIVE
To explore the effectiveness, potential mechanism and compatibility characteristics of efficacy groups of Dunhuang medical prescription Daxiefei decoction in preventing and treating pneumonia based on chemical bioinformatics method.
METHODS
To study the effect of Daxiefei decoction freeze-dried powder solution on the proliferation activity of lung epithelial cells through cell experiments. Daxiefei decoction was divided into three groups: clearing away heat group, resolving phlegm group, and nourishing Yin group according to its efficacy characteristics. The chemical components of Daxiefei decoction were obtained by TCMSP database and literature search, and the targets were predicted in Swiss Target Prediction database. Pneumonia disease targets were obtained by DrugBank, TTD, Genecards and DisGeNET databases. STRING database and Cytoscape were used to construct the intersection target interaction network and "drug-component-target- pathway" network and DAVID database was used for KEGG pathway enrichment analysis. The network was used to analyze the scientific connotation of the compatibility of efficacy groups. Furthermore, molecular docking was used to evaluate the target-compound affinity and molecular dynamics was used to explore the dynamic molecular mechanism.
RESULTS
Cell experiments showed that Daxiefei decoction can maintain the proliferation of lung epithelial cells, reverse the decrease of mitochondrial activity induced by LPS and reduce apoptosis. Complex network analysis showed that the pathways enriched by the three functional groups contained in Daxiefei decoction were mainly distributed in two modules: inflammation regulation and reducing airway mucus hypersecretion. Each module was connected by a common target gene and had its own focus. The results of molecular docking showed that the components quercetin, baicalein, isorhamnetin etc. might be the effective multi-target components of Daxiefei decoction. SRC, EGFR, PPARA etc. had good affinity with each potential active component, which might be a potential target of Daxiefei decoction for preventing and treating pneumonia. Molecular dynamics simulation showed that the potential active component quercetin formed stable intermolecular interactions with SRC.
CONCLUSION
This study initially reveal the material basis and molecular mechanism of Daxiefei decoction in the prevention and treatment of pneumonia. It also explores the scientific connotation of Daxiefei decoction in the prevention and treatment of pneumonia with different efficacy groups, and its modern development and clinical application provide chemical bioinformatics basis.
7.Clinical features and genetic analysis of a child with acute form of Tyrosinemia type I due to a novel variant of FAH gene.
Qinghua ZHANG ; Chuan ZHANG ; Yupei WANG ; Weikai WANG ; Ruifeng XU ; Ling HUI ; Xuan FENG ; Xing WANG ; Lei ZHENG ; Binbo ZHOU ; Yan JIANG ; Shengju HAO
Chinese Journal of Medical Genetics 2023;40(2):171-176
OBJECTIVE:
To analyze the clinical phenotype and genetic basis for a child with acute form of tyrosinemia type I (TYRSN1).
METHODS:
A child with TYRSN1 who presented at the Gansu Provincial Maternal and Child Health Care Hospital in October 2020 was selected as the subject. The child was subjected to tandem mass spectrometry (MS-MS) and urine gas chromatography-mass spectrometry (GC-MS) for the detection of inherited metabolic disorders, in addition with whole exome sequencing (WES). Candidate variants were validated by Sanger sequencing.
RESULTS:
The child's clinical features included abdominal distension, hepatomegaly, anemia and tendency of bleeding. By mass spectrometry analysis, her serum and urine tyrosine and succinylacetone levels have both exceeded the normal ranges. WES and Sanger sequencing revealed that she has harbored c.1062+5G>A and c.943T>C (p.Cys315Arg) compound heterozygous variants of the FAH gene, which were inherited from her father and mother, respectively. Among these, the c.943T>C was unreported previously.
CONCLUSION
Considering her clinical phenotype and result of genetic testing, the child was diagnosed with TYRSN1 (acute type). The compound heterozygous variants of the FAH gene probably underlay the disease in this child. Above finding has further expanded the spectrum of FAH gene variants, and provided a basis for accurate treatment, genetic counseling and prenatal diagnosis for her family.
Female
;
Humans
;
Gas Chromatography-Mass Spectrometry
;
Genetic Testing
;
Mutation
;
Phenotype
;
Prenatal Diagnosis
;
Tyrosinemias/genetics*
;
Child
8.Expert consensus on measurement and clinical application of serum HBV RNA in patients with chronic HBV infection
Yanna LIU ; Rong FAN ; Ruifeng YANG ; Shi LIU ; Jie WANG ; Hao LIAO ; Chao QIU ; Rui DENG ; Hongxin HUANG ; Peng HU ; Sujun ZHENG ; Wenhong ZHANG ; Xiangmei CHEN ; Hongsong CHEN ; Jian SUN ; Fengmin LU
Chinese Journal of Hepatology 2022;30(5):505-512
Since the discovery of circulating hepatitis B virus (HBV) RNA in the peripheral blood of patients with chronic hepatitis B in 1996, a growing number of studies have focused on clarifying the biological characteristics and clinical application value of serum HBV RNA. This consensus mainly summarizes the research progress of serum HBV RNA existing profiles, quantitative detection methods, and current clinical applications. In order to better apply this indicator for the clinical management of patients with chronic HBV infection, recommendations on quantitative detection target regions, detection results, and clinical applications are put forward.
9.Aviation medical assessment of asymptomatic septum pellucidum cyst in civil aviation recruitment—4 case reports
Xiaolong LI ; Jiang WU ; Hao YAN ; Ruifeng LIU ; Qing WANG
Chinese Journal of Aerospace Medicine 2022;33(4):231-234
Objective:To investigate the aeromedical assessment of asymptomatic septum pellucidum (SP) cyst in civil aviation pilot candidates.Methods:The clinical data of 4 pilot candidates with asymptomatic SP cyst collected in the physical examination and recheck for recruitment were analyzed and relevant literatures were reviewed.Results:Three cases were found with widened SP in the physical examination for civil aviation pilot candidates, and were further diagnosed as SP cyst by cranial MRI in recheck. One case was found with SP cyst by medical imaging in recheck but the initial physical examination. None of them had any clinical symptoms. According to Medical Specification for Recruitment of Civil Aviation Airman Trainees, 4 civil aviation pilot candidates were eliminated.Conclusions:SP cyst is very rare in civil aviation pilot candidates, and most of them are asymptomatic. But it may cause severe craniocerebral damages with further development and endanger safety of flight. Cranial MRI can give definitive diagnosis. Aviation medical examiners should strengthen their understanding of such rare diseases as asymptomatic SP cyst in the physical examination for recruitment.
10.Aviation medical assessment of asymptomatic septum pellucidum cyst in civil aviation recruitment—4 case reports
Xiaolong LI ; Jiang WU ; Hao YAN ; Ruifeng LIU ; Qing WANG
Chinese Journal of Aerospace Medicine 2022;33(4):231-234
Objective:To investigate the aeromedical assessment of asymptomatic septum pellucidum (SP) cyst in civil aviation pilot candidates.Methods:The clinical data of 4 pilot candidates with asymptomatic SP cyst collected in the physical examination and recheck for recruitment were analyzed and relevant literatures were reviewed.Results:Three cases were found with widened SP in the physical examination for civil aviation pilot candidates, and were further diagnosed as SP cyst by cranial MRI in recheck. One case was found with SP cyst by medical imaging in recheck but the initial physical examination. None of them had any clinical symptoms. According to Medical Specification for Recruitment of Civil Aviation Airman Trainees, 4 civil aviation pilot candidates were eliminated.Conclusions:SP cyst is very rare in civil aviation pilot candidates, and most of them are asymptomatic. But it may cause severe craniocerebral damages with further development and endanger safety of flight. Cranial MRI can give definitive diagnosis. Aviation medical examiners should strengthen their understanding of such rare diseases as asymptomatic SP cyst in the physical examination for recruitment.


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