1.Guidelines for standardized implementation of pharmacist-managed clinics (2026 edition)
Pengxiang ZHOU ; Maobai LIU ; Xiaoli DU ; Xiaoyang LU ; Mei DONG ; Rong DUAN ; Ruigang HOU ; Xiaoyu LI ; Qi CHEN ; Yanxiao XIANG ; Weiyi FENG ; Rong CHEN ; Deshi DONG ; Yong YANG ; Li LI ; Xiaocong ZUO ; Jinfang HU ; Hongliang ZHANG ; Qingchun ZHAO ; Qi LIN ; Yang HU ; Jiaying WU ; Rongsheng ZHAO
China Pharmacy 2026;37(9):1105-1112
OBJECTIVE To formulate Guidelines for the standardized implementation of pharmacist-managed clinics ( 2026 edition ) in response to the challenges faced by such clinics in China, including uneven development, large discrepancies in service specifications, insufficient patient awareness, and limited medical insurance coverage. METHODS Led by the Pharmaceutical Affairs Professional Committee of the Chinese Hospital Association, the Evidence-based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, and the Hospital Pharmacy Professional Committee of the Cross-strait Medical and Health Exchange Association, a total of 19 domestic hospital pharmacy experts were organized. Through a systematic review of national policies and literature research, current practical experience was summarized. Consensus on the contents of the guidelines was reached after in-depth discussions. RESULTS &CONCLUSIONS The guidelines covered five sections: definition and connotation of pharmacist-managed clinics, establishment requirements, implementation and management, post competency, and practical research. Firstly, the definition and connotation included three operational forms of pharmacist-managed clinics (independent mode, physician-pharmacist joint mode, and online pharmacist-managed clinic mode) and classified service modes (specialty-specific, drug-specific, and disease-specific pharmacist-managed clinics). The establishment requirements were further refined, covering system construction (pharmaceutical service management system, quality control and assessment mechanism), personnel qualifications (professional credentials, continuing education and professional training, etc), service recipients, as well as service venues and facilities. Subsequently, the implementation and management of pharmacist-managed clinics were proposed, involving service procedures, intervention measures, documentation and records, patient education and follow-up, humanistic care, as well as risk management and quality control. Finally, post competency encompassed the competency requirements for pharmacists providing services in pharmacist-managed clinics, as well as the suggestions on teaching methods; practical research encouraged the conduct of high-quality pharmaceutical practice in the setting of pharmacist-managed clinics. The guidelines provide valuable guidance for the standardized implementation of pharmacist-managed clinics in China in terms of establishment, management, teaching, and research, fill the guideline gap in this field, and can promote the high-quality development of pharmacist-managed clinics.
2.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
3.Pharmacological effect and mechanism of tannic acids in Paeoniae Radix Alba.
Jia-Xin DIAO ; Qi-Tong ZHENG ; Meng-Yao CHEN ; Jiang-Chuan HONG ; Min HAO ; Qing-Mei FENG ; Jun-Qi HU ; Xia-Nan SANG ; Gang CAO
China Journal of Chinese Materia Medica 2025;50(6):1471-1483
The chemical composition of Paeoniae Radix Alba(PRA) is complex, with primary secondary metabolites including monoterpenoids, tannins, triterpenoids, and flavonoids. In previous studies on the material basis of PRA, it was found that, in addition to the widely studied characteristic monoterpene glycosides, tannic acid components also play an important role in the efficacy of PRA. However, their pharmacological effects have not been thoroughly investigated. This paper reviews the tannic acid components in PRA, including pentagaloyl glucose(PGG), tetragaloyl glucose(TGG), trigaloyl glucose(TriGG), and gallic acid, along with their structures, properties, and characteristics to provide a detailed discussion of their pharmacological activities and related mechanisms, aiming to offer a theoretical basis for the material basis research and clinical application of PRA.
Paeonia/chemistry*
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Tannins/chemistry*
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Humans
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Drugs, Chinese Herbal/chemistry*
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Animals
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Plant Extracts
4.Processing technology of calcined Magnetitum based on concept of QbD and its XRD characteristic spectra.
De-Wen ZENG ; Jing-Wei ZHOU ; Tian-Xing HE ; Yu-Mei CHEN ; Huan-Huan XU ; Jian FENG ; Yue YANG ; Xin CHEN ; Jia-Liang ZOU ; Lin CHEN ; Hong-Ping CHEN ; Shi-Lin CHEN ; Yuan HU ; You-Ping LIU
China Journal of Chinese Materia Medica 2025;50(9):2391-2403
Guided by the concept of quality by design(QbD), this study optimizes the calcination and quenching process of calcined Magnetitum and establishes the XRD characteristic spectra of calcined Magnetitum, providing a scientific basis for the formulation of quality standards. Based on the processing methods and quality requirements of Magnetitum in the Chinese Pharmacopoeia, the critical process parameters(CPPs) identified were calcination temperature, calcination time, particle size, laying thickness, and the number of vinegar quenching cycles. The critical quality attributes(CQAs) included Fe mass fraction, Fe~(2+) dissolution, and surface color. The weight coefficients were determined by combining Analytic Hierarchy Process(AHP) and the criteria importance though intercrieria correlation(CRITIC) method, and the calcination process was optimized using orthogonal experimentation. Surface color was selected as a CQA, and based on the principle of color value, the surface color of calcined Magnetitum was objectively quantified. The vinegar quenching process was then optimized to determine the best processing conditions. X-ray diffraction(XRD) was used to establish the characteristic spectra of calcined Magnetitum, and methods such as similarity evaluation, cluster analysis, and orthogonal partial least squares-discriminant analysis(OPLS-DA) were used to evaluate the quality of the spectra. The optimized calcined Magnetitum preparation process was found to be calcination at 750 ℃ for 1 h, with a laying thickness of 4 cm, a particle size of 0.4-0.8 cm, and one vinegar quenching cycle(Magnetitum-vinegar ratio 10∶3), which was stable and feasible. The XRD characteristic spectra analysis method, featuring 9 common peaks as fingerprint information, was established. The average correlation coefficient ranged from 0.839 5-0.988 1, and the average angle cosine ranged from 0.914 4 to 0.995 6, indicating good similarity. Cluster analysis results showed that Magnetitum and calcined Magnetitum could be grouped together, with similar compositions. OPLS-DA discriminant analysis identified three key characteristic peaks, with Fe_2O_3 being the distinguishing component between the two. The final optimized processing method is stable and feasible, and the XRD characteristic spectra of calcined Magnetitum was initially established, providing a reference for subsequent quality control and the formulation of quality standards for calcined Magnetitum.
X-Ray Diffraction/methods*
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Drugs, Chinese Herbal/chemistry*
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Quality Control
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Particle Size
5.Clinical characteristics and long-term follow-up study of basal ganglia infarction after minor head trauma in infants and young children.
Huan XU ; Chen-Chen WU ; Ji-Hong TANG ; Jun FENG ; Xiao XIAO ; Xiao-Yan SHI ; Dao-Qi MEI
Chinese Journal of Contemporary Pediatrics 2025;27(1):68-74
OBJECTIVES:
To investigate the clinical characteristics and prognosis of infants and young children with basal ganglia infarction after minor head trauma (BGIMHT).
METHODS:
A retrospective analysis was conducted on the clinical data and follow-up results of children aged 28 days to 3 years with BGIMHT who were hospitalized at Children's Hospital of Soochow University from January 2011 to January 2022.
RESULTS:
A total of 45 cases of BGIMHT were included, with the most common symptom being limb movement disorders (96%, 43/45), followed by facioplegia (56%, 25/45). Cerebral imaging showed that 72% (31/43) had infarction accompanied by basal ganglia calcification. After conservative treatment, 42 children (93%) showed significant symptom improvement, while 3 children (7%) experienced recurrent strokes. The median follow-up time was 82 months (range: 17-141 months). At the last follow-up, 97% (29/30) had residual basal ganglia softening lesions. Among 29 cases participating in questionnaire follow-up, 66% (19/29) recovered normally, 17% (5/29) showed significant improvement in symptoms, and 17% (5/29) had poor improvement. According to the grading of the Global Burden of Disease Control Projects, only 1 child (3%) had severe sequelae. There were no significant differences in age at onset, gender, or presence of concomitant basal ganglia calcification between children with and without neurological sequelae (P>0.05).
CONCLUSIONS
The most common initial symptom of BGIMHT is limb movement disorder, and imaging results indicate that most children have concurrent intracranial calcifications. Most infarct lesions later transform into softening lesions, resulting in a generally good prognosis.
Humans
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Male
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Female
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Infant
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Child, Preschool
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Craniocerebral Trauma/complications*
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Follow-Up Studies
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Retrospective Studies
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Basal Ganglia/pathology*
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Infant, Newborn
6.Efficacy and Safety of Yangxue Qingnao Pills Combined with Amlodipine in Treatment of Hypertensive Patients with Blood Deficiency and Gan-Yang Hyperactivity: A Multicenter, Randomized Controlled Trial.
Fan WANG ; Hai-Qing GAO ; Zhe LYU ; Xiao-Ming WANG ; Hui HAN ; Yong-Xia WANG ; Feng LU ; Bo DONG ; Jun PU ; Feng LIU ; Xiu-Guang ZU ; Hong-Bin LIU ; Li YANG ; Shao-Ying ZHANG ; Yong-Mei YAN ; Xiao-Li WANG ; Jin-Han CHEN ; Min LIU ; Yun-Mei YANG ; Xiao-Ying LI
Chinese journal of integrative medicine 2025;31(3):195-205
OBJECTIVE:
To evaluate the clinical efficacy and safety of Yangxue Qingnao Pills (YXQNP) combined with amlodipine in treating patients with grade 1 hypertension.
METHODS:
This is a multicenter, randomized, double-blind, and placebo-controlled study. Adult patients with grade 1 hypertension of blood deficiency and Gan (Liver)-yang hyperactivity syndrome were randomly divided into the treatment or the control groups at a 1:1 ratio. The treatment group received YXQNP and amlodipine besylate, while the control group received YXQNP's placebo and amlodipine besylate. The treatment duration lasted for 180 days. Outcomes assessed included changes in blood pressure, Chinese medicine (CM) syndrome scores, symptoms and target organ functions before and after treatment in both groups. Additionally, adverse events, such as nausea, vomiting, rash, itching, and diarrhea, were recorded in both groups.
RESULTS:
A total of 662 subjects were enrolled, of whom 608 (91.8%) completed the trial (306 in the treatment and 302 in the control groups). After 180 days of treatment, the standard deviations and coefficients of variation of systolic and diastolic blood pressure levels were lower in the treatment group compared with the control group. The improvement rates of dizziness, headache, insomnia, and waist soreness were significantly higher in the treatment group compared with the control group (P<0.05). After 30 days of treatment, the overall therapeutic effects on CM clinical syndromes were significantly increased in the treatment group as compared with the control group (P<0.05). After 180 days of treatment, brachial-ankle pulse wave velocity, ankle brachial index and albumin-to-creatinine ratio were improved in both groups, with no statistically significant differences (P>0.05). No serious treatment-related adverse events occurred during the study period.
CONCLUSIONS
Combination therapy of YXQNP with amlodipine significantly improved symptoms such as dizziness and headache, reduced blood pressure variability, and showed a trend toward lowering urinary microalbumin in hypertensive patients. These findings suggest that this regimen has good clinical efficacy and safety. (Registration No. ChiCTR1900022470).
Humans
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Amlodipine/adverse effects*
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Drugs, Chinese Herbal/adverse effects*
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Male
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Female
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Hypertension/complications*
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Middle Aged
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Treatment Outcome
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Drug Therapy, Combination
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Adult
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Blood Pressure/drug effects*
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Double-Blind Method
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Aged
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Antihypertensive Agents/adverse effects*
7.Expert consensus on prognostic evaluation of cochlear implantation in hereditary hearing loss.
Xinyu SHI ; Xianbao CAO ; Renjie CHAI ; Suijun CHEN ; Juan FENG ; Ningyu FENG ; Xia GAO ; Lulu GUO ; Yuhe LIU ; Ling LU ; Lingyun MEI ; Xiaoyun QIAN ; Dongdong REN ; Haibo SHI ; Duoduo TAO ; Qin WANG ; Zhaoyan WANG ; Shuo WANG ; Wei WANG ; Ming XIA ; Hao XIONG ; Baicheng XU ; Kai XU ; Lei XU ; Hua YANG ; Jun YANG ; Pingli YANG ; Wei YUAN ; Dingjun ZHA ; Chunming ZHANG ; Hongzheng ZHANG ; Juan ZHANG ; Tianhong ZHANG ; Wenqi ZUO ; Wenyan LI ; Yongyi YUAN ; Jie ZHANG ; Yu ZHAO ; Fang ZHENG ; Yu SUN
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(9):798-808
Hearing loss is the most prevalent disabling disease. Cochlear implantation(CI) serves as the primary intervention for severe to profound hearing loss. This consensus systematically explores the value of genetic diagnosis in the pre-operative assessment and efficacy prognosis for CI. Drawing upon domestic and international research and clinical experience, it proposes an evidence-based medicine three-tiered prognostic classification system(Favorable, Marginal, Poor). The consensus focuses on common hereditary non-syndromic hearing loss(such as that caused by mutations in genes like GJB2, SLC26A4, OTOF, LOXHD1) and syndromic hereditary hearing loss(such as Jervell & Lange-Nielsen syndrome and Waardenburg syndrome), which are closely associated with congenital hearing loss, analyzing the impact of their pathological mechanisms on CI outcomes. The consensus provides recommendations based on multiple round of expert discussion and voting. It emphasizes that genetic diagnosis can optimize patient selection, predict prognosis, guide post-operative rehabilitation, offer stratified management strategies for patients with different genotypes, and advance the application of precision medicine in the field of CI.
Humans
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Cochlear Implantation
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Prognosis
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Hearing Loss/surgery*
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Consensus
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Connexin 26
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Mutation
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Sulfate Transporters
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Connexins/genetics*
8.Cryo-EM structures of Nipah virus polymerase complex reveal highly varied interactions between L and P proteins among paramyxoviruses.
Lu XUE ; Tiancai CHANG ; Jiacheng GUI ; Zimu LI ; Heyu ZHAO ; Binqian ZOU ; Junnan LU ; Mei LI ; Xin WEN ; Shenghua GAO ; Peng ZHAN ; Lijun RONG ; Liqiang FENG ; Peng GONG ; Jun HE ; Xinwen CHEN ; Xiaoli XIONG
Protein & Cell 2025;16(8):705-723
Nipah virus (NiV) and related viruses form a distinct henipavirus genus within the Paramyxoviridae family. NiV continues to spillover into the humans causing deadly outbreaks with increasing human-bat interaction. NiV encodes the large protein (L) and phosphoprotein (P) to form the viral RNA polymerase machinery. Their sequences show limited homologies to those of non-henipavirus paramyxoviruses. We report two cryo-electron microscopy (cryo-EM) structures of the Nipah virus (NiV) polymerase L-P complex, expressed and purified in either its full-length or truncated form. The structures resolve the RNA-dependent RNA polymerase (RdRp) and polyribonucleotidyl transferase (PRNTase) domains of the L protein, as well as a tetrameric P protein bundle bound to the L-RdRp domain. L-protein C-terminal regions are unresolved, indicating flexibility. Two PRNTase domain zinc-binding sites, conserved in most Mononegavirales, are confirmed essential for NiV polymerase activity. The structures further reveal anchoring of the P protein bundle and P protein X domain (XD) linkers on L, via an interaction pattern distinct among Paramyxoviridae. These interactions facilitate binding of a P protein XD linker in the nucleotide entry channel and distinct positioning of other XD linkers. We show that the disruption of the L-P interactions reduces NiV polymerase activity. The reported structures should facilitate rational antiviral-drug discovery and provide a guide for the functional study of NiV polymerase.
Nipah Virus/chemistry*
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Cryoelectron Microscopy
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Viral Proteins/genetics*
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RNA-Dependent RNA Polymerase/genetics*
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Phosphoproteins/genetics*
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Humans
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Models, Molecular
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Protein Binding
9.Laboratory Diagnosis and Molecular Epidemiological Characterization of the First Imported Case of Lassa Fever in China.
Yu Liang FENG ; Wei LI ; Ming Feng JIANG ; Hong Rong ZHONG ; Wei WU ; Lyu Bo TIAN ; Guo CHEN ; Zhen Hua CHEN ; Can LUO ; Rong Mei YUAN ; Xing Yu ZHOU ; Jian Dong LI ; Xiao Rong YANG ; Ming PAN
Biomedical and Environmental Sciences 2025;38(3):279-289
OBJECTIVE:
This study reports the first imported case of Lassa fever (LF) in China. Laboratory detection and molecular epidemiological analysis of the Lassa virus (LASV) from this case offer valuable insights for the prevention and control of LF.
METHODS:
Samples of cerebrospinal fluid (CSF), blood, urine, saliva, and environmental materials were collected from the patient and their close contacts for LASV nucleotide detection. Whole-genome sequencing was performed on positive samples to analyze the genetic characteristics of the virus.
RESULTS:
LASV was detected in the patient's CSF, blood, and urine, while all samples from close contacts and the environment tested negative. The virus belongs to the lineage IV strain and shares the highest homology with strains from Sierra Leone. The variability in the glycoprotein complex (GPC) among different strains ranged from 3.9% to 15.1%, higher than previously reported for the seven known lineages. Amino acid mutation analysis revealed multiple mutations within the GPC immunogenic epitopes, increasing strain diversity and potentially impacting immune response.
CONCLUSION
The case was confirmed through nucleotide detection, with no evidence of secondary transmission or viral spread. The LASV strain identified belongs to lineage IV, with broader GPC variability than previously reported. Mutations in the immune-related sites of GPC may affect immune responses, necessitating heightened vigilance regarding the virus.
Humans
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China/epidemiology*
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Genome, Viral
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Lassa Fever/virology*
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Lassa virus/classification*
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Molecular Epidemiology
;
Phylogeny
10.Identification of Alumen and Ammonium alum Based on XRD, FTIR, TG-DTA Combined with Chemometrics
Bin WANG ; Jingwei ZHOU ; Huangsheng ZHANG ; Jian FENG ; Hanxi LI ; Guorong MEI ; Jiaquan JIANG ; Hongping CHEN ; Fu WANG ; Yuan HU ; Youping LIU ; Shilin CHEN ; Lin CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):178-186
ObjectiveTo establish the multi-technique characteristic profiles of Alumen by X-ray diffraction(XRD), Fourier-transform infrared spectroscopy(FTIR) and thermogravimetric-differential thermal analysis(TG-DTA), and to explore the spectral characteristics for rapid identification of Alumen and its potential adulterant, Ammonium alum. MethodsA total of 27 batches of Alumen samples from 8 production regions were collected for preliminary identification based on visual characteristics. The PDF standard cards of XRD were used to differentiate Alumen from A. alum, and the XRD characteristic profiles of Alumen were established, and then the common peaks were screened. Based on hierarchical clustering analysis(HCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA), the characteristic information that could be used for identification of Alumen was selected with variable importance in the projection(VIP) value>1. FTIR characteristic profiles of Alumen were established, and key wavenumbers for identification were screened by HCA and OPLS-DA with VIP value>1. Meanwhile, the thermogravimetric differences between Alumen and A. alum were analyzed by TG-DTA, and the thermogravimetric traits that could be used for identification were screened. ResultsAlumen and A. alum could not be effectively distinguished by traits alone. However, by comparing the PDF standard cards of XRD, 15 batches of Alumen and 12 batches of A. alum could be distinguished. In the XRD profiles, 10 characteristic peaks were confirmed, corresponding to diffraction angles of 14.560°, 24.316°, 12.620°, 32.122°, 17.898°, 34.642°, 27.496°, 46.048°, 40.697° and 21.973°. In the FTIR profiles, 4 wavenumber ranges(399.193-403.050, 1 186.010-1 471.420, 1 801.190-2 620.790, 3 612.020-3 997.710 cm-1) and 12 characteristic wavenumbers(1 428.994, 1 430.922, 1 432.851, 1 434.779, 1 436.708, 1 438.636, 1 440.565, 1 442.493, 1 444.422, 1 446.350, 1 448.279, 1 450.207 cm-1) were identified. In the TG-DTA profiles, there were characteristic decomposition peaks of ammonium ion and mass reduction features near 555.34 ℃ for A. alum. These characteristics could serve as important criteria for distinguishing the authenticity of Alumen. ConclusionXRD, FTIR and TG-DTA can be used to rapidly detect Alumen and A. alum, and combined with the discriminant features selected through chemometrics, the rapid and accurate identification of Alumen and A. alum can be achieved. The research findings provide new approaches for the rapid identification of Alumen.


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