Methodology and application of process analytical technology (PAT) for traditional Chinese medicine manufacturing:a review / 中国中药杂志

Owing to the advancement in pharmaceutical technology, traditional Chinese medicine industry has seen rapid development. Preferring conventional manufacturing mode, pharmaceutical enterprises of traditional Chinese medicine have no effective process detection tools and process control methods. As a result, the quality of the final products mainly depends on testing and the quality is inconsistent in the same batch. Process analytical technology(PAT) for traditional Chinese medicine manufacturing, as one of the key advanced manufacturing techniques, can break through the bottleneck in quality control of medicine manufacturing, thus improving the production efficiency and product quality and reducing the material and energy consumption. It is applicable to the process control and real-time release of advanced manufacturing modes such as intelligent manufacturing and continuous manufacturing. This paper summarized the general idea of PAT for traditional Chinese medicine manufacturing. Through the analysis of the characteristics and status quo of the technology, we summed up the methodology for the continuous application and improvement of PAT during the whole life-cycle of traditional Chinese medicine. The five key procedures(process understanding, process detection, process modeling, process control, and continuous improvement) were summarized, and the application was reviewed. Finally, we proposed suggestions for the technical and regulatory challenges in implementing PAT in traditional Chinese medicine industry. This paper aims to provide a reference for development and application of PAT in advanced manufacturing, intelligent manufacturing, and continuous manufacturing of traditional Chinese medicine industry.

Research on batch-to-batch quality control of compound Danshen extract based on physical characterization and multivariate statistical analysis / 中国中药杂志

Physical attributes of Chinese herbal extracts are determined by their chemical components, and the physical and chemical attributes jointly affect the preparation process performance and the final product quality. Therefore, in order to improve the quality control of Chinese herbal extracts, we should comprehensively study the batch-to-batch consistency of physical and chemical attributes as well as the correlations between them. This paper first explored the physical attributes affecting the preparation process performance of the compound Danshen extract and developed a method for characterizing the texture attributes. With such main chemical components as water, phenolic acids, saponins, and saccharides and texture, rheology, and other physical attributes taken into consideration, the batch-to-batch quality fluctuation of products from different production lines and time was analyzed by principal components analysis(PCA). Finally, the correlation and partial least squares(PLS) analysis was conducted, and the regression equation was established. The fitting result of the PLS model for dynamic viscosity was satisfying(R~2Y=0.857, Q~2=0.793), suggesting that the chemical components could be adjusted by the component transfer rate in the extraction process, the impurity removal rate in the alcohol precipitation process, and the water retention rate of the concentration process to meet the control of the extract dynamic viscosity. This study clarified the correlations between physical and chemical attributes of the compound Danshen extract and established a method for controlling its physical attributes based on process regulation, which would provide reference for improving the quality control of Chinese herbal extracts.

Material Attribute Research in Quality Control of Traditional Chinese Medicine Pills： A Review / 中国实验方剂学杂志

As intelligent production of traditional Chinese medicine （TCM） has been inevitable， informatization and automation of the production process have become the precondition for realizing intelligent manufacturing of TCM， of which the accumulation of critical material attribute and the critical quality attribute are the basis. The study of material properties is of great significance to achieve the quality control of the final product in the process， but there is a lack of systematic induction and summary of the research on the attribute of TCM pills. Therefore， the authors analyzed and summarized the attributes of raw materials， excipients and intermediates in the pill unit process according to the classification of powder properties， rheological properties and texture properties. What’s more， the impact of material attributes on the quality of the final product was summarized. Besides， this review summarized the attribute characterization techniques involved in the pill process and provided some suggestions for the characterization of product quality attributes. Finally， based on the concept of quality by design （QbD）， the authors proposed that the study of material attribute should be combined with process analytical technology （PAT）， and the focus of drug quality control should be moved forward to guide equipment upgrading， so as to realize intelligent continuous manufacturing of TCM pills.

Advances in the optimization of the linker in proteolysis-targeting chimeras (PROTAC) / 药学学报

With high selectivity and potency, target protein degradation technology has recently emerged as a strategy for drug discovery and design. Proteolysis-targeting chimeras (PROTAC) function as inducers for the degradation of target proteins and are a research focus in drug development. Current research on PROTAC mainly revolves around the rational design of PROTAC molecules, the discovery of new E3 ubiquitin ligase ligands and improvement in drug targeting. In this review, we focus on the PROTAC linker and its effects on the generation of the E3 enzyme-PROTAC-target protein ternary complex from three standpoints: length, binding site and chemical properties. We discuss the influences of the linker on the efficacy and the selectivity of PROTAC molecules.

Research on feedforward control method of mixing process for compound Danshen Dripping Pills based on quality by design(QbD) / 中国中药杂志

The mixing process is one of the key operation units for solid preparation of traditional Chinese medicine. The physical properties such as particle size, density and viscosity of the mixture are key factors that need to be controlled, which will directly affect the performance of the preparation molding process and product quality. Subsequent dripping process performance and appearance qua-lity of dripping pills will be affected by dynamic viscosity of materials in the mixing process. Based on this, with mixing process of compound Danshen dripping pills as the object, a feedforward control method for the dripping pill mixing process was established based on the concept of quality by design(QbD). Firstly, critical quality attribute(CQA)-dynamic viscosity, critical material attributes(CMAs)-the moisture content of compound Danshen extract, average molecular weight of polyethylene glycol 6000 and critical process parameter(CPP)-mixing temperature were identified through the analysis of properties for multiple batches of the raw materials and excipients as well as technological mechanism. Then the Box-Behnken experimental design was used to establish the regression model among CMA, CPP and CMA(R■=0.972 0, RMSE =16.24) to obtain the design space. Finally, through the verification of three batches within the design space, the mixing process temperature was adjusted according to the properties of the raw materials and exci-pients to achieve accurate control of the dynamic viscosity attribute. The relative deviation between the actual dynamic viscosity value and the target value was less than 3.0 %. The feedforward control of the mixing process of compound Danshen dripping pills was rea-lized in this study, which can contribute to improving quality consistency of the mixing process intermediates, simultaneously provide a reference for the research on the process quality control of other Chinese medicine dripping pills.

Recent research progress in key technologies of Chinese materia medica manufacturing process quality control / 中草药

The development of Chinese materia medica (CMM) has risen to the level of national strategy. Under the new situation that the pharmaceutical industry implements the "Made in China 2025" strategy, quality control of the production process of CMM is one of the key areas in which the CMM industry needs to accelerate its breakthrough. The key common issues in process design, analysis and detection, process modeling, and manufacturing equipment and other aspects in the field of quality control of CMM production processes was analyzed in the paper. The progress in the three aspects of process understanding, real-time analysis method development and process control strategy establishment in the quality control system of CMM production process was reviewed. Combined with the author's corporate research practices, this paper introduces the application progress of key technologies such as quality by design (QbD), process analytical technology (PAT), experimental design (DOE), and multivariate statistical analysis in the above three research directions, and analyzes the difficulties problems in practical industrial application. The application prospect is prospected. The purpose of this article is to provide reference for CMM enterprises to apply and improve the quality control technology in the production process.

Application Progress of Texture Analyzer in Pharmaceutical Preparation Research / 中国实验方剂学杂志

Texture analyzer is a multifunctional physical property analyzer. Through a variety of test modes such as compression， puncture， shearing and stretching， hardness， adhesion， elasticity， cohesiveness and other physical property parameters are characterized. The results are objective， sensitive， and accurate， which can provide theoretical basis and reference for interpretation of basic theoretical， optimization of prescription technology and quality control research of pharmaceutical preparations. Firstly， the principles， test modes， measurement indexes and measurement data analysis methods of texture analyzer were summarized in this paper. Secondly， the application progress of texture analyzer in solid preparations， semi-solid preparations， liquid preparations， traditional Chinese medicine decoction pieces and their intermediates was described in detail， and compared with the commonly used measurement methods of physical property indicators. Finally， the application prospects of texture analyzer and its research contents to be improved were reviewed， so as to facilitate the use of texture analyzer by pharmaceutical researchers to promote the development of related fields of pharmaceutics， and to provide new ideas and methods for the research and development of pharmaceutical preparations.

Impaired Parahippocampal Gyrus-Orbitofrontal Cortex Circuit Associated with Visuospatial Memory Deficit as a Potential Biomarker and Interventional Approach for Alzheimer Disease / 神经科学通报·英文版

The parahippocampal gyrus-orbitofrontal cortex (PHG-OFC) circuit in humans is homologous to the postrhinal cortex (POR)-ventral lateral orbitofrontal cortex (vlOFC) circuit in rodents. Both are associated with visuospatial malfunctions in Alzheimer's disease (AD). However, the underlying mechanisms remain to be elucidated. In this study, we explored the relationship between an impaired POR-vlOFC circuit and visuospatial memory deficits through retrograde tracing and in vivo local field potential recordings in 5XFAD mice, and investigated alterations of the PHG-OFC circuit by multi-domain magnetic resonance imaging (MRI) in patients on the AD spectrum. We demonstrated that an impaired glutamatergic POR-vlOFC circuit resulted in deficient visuospatial memory in 5XFAD mice. Moreover, MRI measurements of the PHG-OFC circuit had an accuracy of 77.33% for the classification of amnestic mild cognitive impairment converters versus non-converters. Thus, the PHG-OFC circuit explains the neuroanatomical basis of visuospatial memory deficits in AD, thereby providing a potential predictor for AD progression and a promising interventional approach for AD.

Advances in hyperprogressive disease of PD-1/PD-L1 antibody drugs and rational drug therapy / 药学学报

With the significant breakthrough that programmed cell death 1 (PD-1)/programmed cell death 1 ligand 1 (PD-L1) antibody drugs achieved promising clinical outcomes across various tumor types, immunotherapy targeting immune checkpoint has been considered a promising way to treat cancer. However, most recently studies suggest that the hyperprogressive disease occurred frequently during the therapy of using PD-1/PD-L1 antibody drugs and has become an urgent problem to be solved. In this review, we summarize the progress and potential reasons of hyperprogressive disease caused by PD-1/PD-L1 blockade, and further discuss its application based on the rational use of biomarkers for searching the benefit patients.

White matter change in diffusion tensor imaging of amnestic mild cognitive impairment / 中华神经科杂志

Objective To investigate the features of white matter impairment and its relationship with cognition in patients with amnestic mild cognitive impairment (aMCI).Methods Eighty-three cases of aMCI and 85 normal aging volunteers were scanned with diffusion tensor imaging (DTI) using MR system.All subjects completed the neuropsychological battery.We analyzed the differences between two groups using tract-based spatial statistics and the association between regions in difference and cognition using correlation analysis.Results There were significant differences between aMCI and normal control in the neuropsychological battery including the Mini-Mental State Examination(26.2 ± 2.6 vs 28.3 ± 1.3,F =43.224,P =0.000),Mattis Dementia Rating Scale-2 (131.4 ± 6.9 vs 138.0 ± 3.5,F =62.308,P =0.000),Auditory Verbal Learning Test-delayed recall(2.4 ± 1.6 vs 7.5 ± 2.0,F =324.018,P =0.000),Boston Naming Test(8.7 ± 1.4 vs 9.2 ± 1.0,F =6.821,P =0.010),Rey-Osterrich Complex Figure Test (12.1 ± 7.3 vs 18.5 ± 6.1,F =40.674,P =0.000),Symbol Digit Modulation Test (30.0 ± 10.1 vs 38.6 ± 9.8,F =30.786,P =0.000),Trail-Making Test Part B ((256.8 ± 124.5) s vs (178.1 ± 59.0) s,F =27.601,P =0.000).Significantly higher diffusivity indexes and radial diffusivity were also found in aMCI subjects compared to healthy elders in the parahippocampal,superior longitudinal fasciculus,inferior longitudinal fasciculus,superior fronto-occipital fasciculus,inferior fronto-occipital fasciculus,unciform fasciculus,corticospinal tract,corpus callosum,cingulum,corona radiate.We also found that axial diffusivity was significantly increased in the parahippocampal,superior longitudinal fasciculus,inferior longitudinal fasciculus,superior fronto-occipital fasciculus,inferior fronto-occipital fasciculus,unciform fasciculus,corticospinal tract and corpus callosum,whereas fractional anisotropy changes were not observed in aMCI.Diffusivity indexes values in bilateral frontal lobe (left r =0.67 ; right r =0.70),left cingulum (r =0.63),parietal white matter (r =0.69) and radial diffusivity values in left parietal (r =0.68) were significantly related to Trail Making Test A among aMCI (all P ＜ 0.05).Conclusions In aMCI patients,there was a wide range of white matter damage,with no brain region-specific.Executive function deficit was related to the white matter impairment in bilateral frontal lobe,left cingulate and parietal lobe.The specificity and sensitivity of four DTI parameters fordetecting white matter lesions are variant.Trial registration Clinical Research Center of Jiangsu Province (BL2013025)

Synthesis of benzothiazole derivatives and their binding characteristics with beta-amyloid / 药学学报

Alzheimer's disease (AD) is a progressive neurodegenerative disease endangering human health seriously. Recent reports have revealed that beta-amyloid aggregates play a key role in the pathogenesis of AD. Thus, targeting the Abeta plaques benzothiazole derivatives were synthesized with the scaffold of the most promising imaging agent PIB ([11C]-6-OH-BTA-1, [11C]-2-(4-(methylamino)phenyl)-6-hydroxybenzothiazole) and C = N as linker to study the binding characteristics with the target protein through surface plasmon resonance (SPR) technique. These derivatives were synthesized through simple yet effective method with high yields and characterized by 1H NMR and FTIR. The binding properties (K(D)) were determined with Biacore X-100 instrument according to the fitting-plot curve. Compounds 3a and 3f showed high binding affinity for Abeta1-40. The results suggest that benzothiazole derivatives could be served as a scaffold to develop novel beta-amyloid imaging agents for the diagnosis of AD.

Association of single nucleotide polymorphisms in inflammation-related genes with amnestic mild cognitive impairment / 中华行为医学与脑科学杂志

ObjectiveTo examine whether the single nucleotide polymorphisms in inflammation-related genes are associated with the risk of amnestic mild cognitive impairment (aMCI).MethodsThe study recruited 116 aMCI patients and 93 matched healthy controls.All subjects underwent extensive assessment of cognitive function,genotyping was carried out on the platform of matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry.Results ( 1 ) There was prominent discrepancy between aMCI and controls in the memory,attention and executive functions,20 minutes delayed recall of auditory verbal memory test (AVMT) (3.0(0.0 ～ 10.0 ),8.0 (0.0 ～ 12.0),t =- 8.533,P ＜ 0.05 ),recall of Rey-Osterrieth complex figure test ( R-O CFT) (11.2 ±8.3,16.1 ±8.0,t=4.216,P＜0.05),digit span test (DST) (12.0(7.0 ～ 19.0),13.0(7.0 ～20.0),Z=-2.516,P＜0.05),trail making test A (TMTA) (80.0s(35.0 ～200.0)s,72.0s(29.0 ～512.0)s,Z=-3.113,P＜0.05),trail making test B (TMTB) ((180.1 ±72.7)s,(141,7 ±52.1)s,t=-4.385,P＜0.05 ).(2) No significant differences were found in frequencies of alleles,genotypes and hapolotypes of inflammation mediator genes ( interleukin 10,interleukin 1 A,interleukin 1 B,tumor necrosis factor,interleukin 6,α1- an-tichymotrypsin gene,transforming growth factor B1 ) between aMCI and controls (P ＞ 0.05 ).ConclusionThe results indicate that polymorphisms in the inflammation-related candidate genes do not appear to be involved in the risk of developing aMCI.

Association study of candidate gene polymorphisms of tau protein pathway with amnestic mild cognitive impairment / 中华神经科杂志

Objective To investigate the relationship between amnestic mild cognitive impairment and functional genes associated with hyperphosphorylated tau protein.Methods One hundred and sixteen amnestic mild cognitive impairment (aMCI) patients and 93 normal controls were recruited for the study.Multi-dimension neuropsychologic tests were used to assess the cognitive function extensively.MassARRAY and iPlex systems were used to measure candidate SNP polymorphisms,analyze genotypic,allelic or haplotypic distributions and their interaction with ApoE ε4 and the correlation with the cognitive function in the subjects.Results ( 1 ) The scores of neuropsychologic tests in memory domain ( Auditory Verbal Learning Test (AVLT)-first immediate recall,AVLT-second immediate recall,AVLT-second immediate recall,AVLT-5 minute delayed recall,AVLT-20 minute delayed recall,AVLT-recognition,Rey-Osterrich Comolex Test-delay) in aMCI patients ( 3.0 ( 0-7.0 ),5.0 ( 1.0-10.0),6.0 ( 1.0-11.0 ),4.0 (0-11.0),3.0(0-10.0),20.0(8.0-24.0),11.2 ±8.3) were significantly lower than those in the normal controls(4.0(0-9.0),7.0(2.0-11.0),9.0(3.0-12.0),8.0(0-12.0),8.0(0-12.0),22.0 (10.0-24.0),16.1±8.0) (Z=-3.592,-6.802,-6.408,-8.173,-8.533,-5.647 andt=4.216 respectively,all P ＜0.01 ) ; (2) Genotypic distributions of rs242562 GG in aMCI (7.826％ ) were significantly lower than those in normal controls (20.65％,OR =0.3525,95％ CI 0.1411-0.8807,P =0.024 98),however there were no differences in the genotypic,allelic or haplotypic distributions between aMCI patients and controls of glycogen synthase kinase-3β,cyclin dependent protein kinase-5,calcium and calmodulin-dependent protein kinase-Ⅱ,cell division cycle 2,dual-specificity tyrosine-phosphorylation regulated kinase 1A and low density lipoprotein receptor-related protein 6; (3) MAPT/STH rs242562 genotype was correlated with AVLT-immediate recall,AVLT-delayed recall,Rey-Osterrieth Complex Test,Rey-Osterrieth Complex Test-delayed recall and Clock Drawing Test (H =9.763,12.258,10.508,9.624,10.767,F =3.700,3.123 and H =6.591 respectively,all P ＜ 0.05 ) ; (4) There were no differences in the distributions of MAPT/STH rs242562 GG genotype and ApoE ε4 haplotype between aMCI patients and normal controls.Conclusions MAPT/STH rs242562 GG genotype decreases the genetic risk of aMCI,which might have important role in memory function in aMCI.The interaction between rs242562 GG and ApoE ε4 doesn' t affect the susceptibility to aMCI.

Evaluation of supine fulcrum pressurized radiograph for predicting spinal flexibility in adolescent idiopathic scoliosis / 中华放射学杂志

Objective To examine supine fulcrum pressurized radiograph to predict spinal flexibility in adolescent idiopathic scoliosis (AIS). Methods 1. Empirical study: put two points (A and B) on one side of the plastic stick and one point on the other side ( C), pressurize on the plastic stick when point C is in the middle of A and B, and then measure the projection shifting of point A. Repeat the pressure test when the distance between A and C doubled. Analyze the effect of increasing distance on diminishing pressure. 2.Clinical study :45 patients ( 16 males and 29 females) underwent standing anteroposterior radiograph ,fulcrum lateral flexion radiograph, supine lateral flexion radiograph. The Cobb's angles were measured and the flexibility ratio was determined on preoperative fulcrum radiograph. Results (1) If the length of A and C was 25 cm, pressurize on point C, when pressure quantitative scale number located 1 scale and 2 scale of the rule, projection shifting of point A were 5 cm and 10 cm. If the length of A and C was 50 cm, pressurize on point C, when pressure quantitative scale number located 1 scale and 2 scale of the rule, projection shifting of point A were 8 cm and 15 cm. The longer the distance, the lesser the pressure force of plastics stick. (2)The Cobb angles and curve flexibility provided by fulcrum lateral flexion radiograph had significant difference from that provided by supine lateral flexion radiograph in male group and female group. Cobb angles of male group was 28. 6°± 4. 1 °, 16. 7°± 4. 6° respectively (t= 7. 438, P ＜ 0. 01 )and curve flexibility was 47. 6% ±8. 1% ,69. 4% ± 8. 5% respectively( t = 7. 438, P ＜ 0. 01 ). Cobb angles of female group was 24.5°± 2. 7°,12. 6°±2. 4° respectively(t = 17. 540,P ＜0. 01 )and curve flexibility was 53.4% ±5.2% ,76. 0% ±4. 7% respectively(t = 17. 54, P ＜ 0. 01 ). The flexibility of spinal main curve of female patients was obviously higher than male patients. Conclusions Supine fulcrum pressurized technique can make up for the insufficiency of supine lateral flexion technique, and provide a convenient, safe, precise and useful method for evaluation of spinal flexibility in AIS.

Abnormal expression and significance of Runx2 in osteoblasts of adolescent idiopathic scoliosis patients / 中华外科杂志

<p><b>OBJECTIVE</b>To investigate the possible relationship between Runx2 and the low bone mass of adolescent idiopathic scoliosis(AIS) patients at the osteoblast level.</p><p><b>METHODS</b>Twenty eight AIS patients (mean age 14.9 years, mean Cobb angle 57.3 degrees ) in experimental group, including 2 male and 26 female, underwent posterior instrumentation between March and December 2008. They were divided into two groups. Patients in group A maintained normal bone mineral density (BMD). Patients in group B sustained osteopenia. Normal group, including 8 patients (2 males and 6 females) with a mean age of 15.3 years, were age-matched non-scoliosis adolescents who underwent spinal surgery. BMD of the lumbar spine and proximal femur was measured by using dual energy X-ray absorptiometry in three groups. Small cancellous bone samples were harvested from the iliac crest during the operation. The chipped explants were cultured to obtained the osteoblasts. P2 generation osteoblasts were analyzed to confirm the cell phenotype. Expression of mRNA and protein of Runx2 were detected by using RT-PCR and Western blot in P2 generation osteoblasts from three groups.</p><p><b>RESULTS</b>The expression of Runx2 of osteoblasts had decreased obviously in group B compared with group A and group C (P < 0.05). However, there was no significant difference between group A and group C (P > 0.05).</p><p><b>CONCLUSIONS</b>The abnormal expression of Runx2 of osteoblasts may be responsible for the low bone mass in adolescent idiopathic scoliosis patients.</p>

Association between insulin-like growth factor-1 receptor gene polymorphisms and with susceptibility to adolescent idiopathic scoliosis / 中华外科杂志

<p><b>OBJECTIVE</b>To investigate the association of insulin-like growth factor-1 receptor (IGF-1R) gene polymorphisms and with susceptibility to adolescent idiopathic scoliosis (AIS).</p><p><b>METHODS</b>This study included 200 patients with AIS and 200 healthy controls. Height, menarche status, curve pattern, Cobb angle, and Risser sign in female patients were recorded. Blood samples were taken form each subject by venipuncture. Genetic DNA was extract from peripheral blood leukocytes using standard phenol/chloroform extraction. PCR-RFLP (polymerase chain reaction-restriction-fragment length polymorphism) was used for the genotyping.</p><p><b>RESULT</b>The genotype and allele frequency distribution were similar between AIS and normal control (P>0.05). The mean maximum Cobb angle, Risser sign, menarche status of different genotypes of IGF-1R gene were similar with each other among female AIS patients (P>0.05).</p><p><b>CONCLUSIONS</b>The IGF-1R gene is neither associated with the occurrence nor the curve severity of AIS.</p>

Clinical utility of mammography,ultrasound and ~(18)F-FDG dual-head coincidence imaging for diagnosis of primary breast cancer / 上海第二医科大学学报

Objective To assess the diagnostic value of mammography,ultrasound and 18F-fluorodeoxyglucose(18F-FDG) dual-head coincidence(DHC) imaging in the detection of primary breast cancer. Methods The results of 54 female patients with 57 breast lesion sites examined by mammography,ultrasound and 18F-FDG dual-head coincidence(DHC) imaging were analysed and compared with pathologic findings.The sensitivity of mammography was compared with combined mammography with ultrasound or triple-tests,and the sensitivity of 18F-FDG DHC imaging was compared with combined mammography and ultrasound. Results The individual sensitivities of mammography,ultrasound and 18F-FDG DHC imaging in the diagnosis of primary breast cancer were 89.13%,91.30% and 91.30%,respectively,those for specificities were 72.73%,72.73% and 63.64%,respectively,and those for accuracies were 85.96%,87.72% and 85.96%,respectively.The sensitivity,specificity and accuracy of combined mammography with ultrasound were 100%,63.64% and 92.98%,respectively,and those of triple-tests were 97.83%,81.82% and 94.74%,respectively.Combined mammography with ultrasound and triple-tests were more sensitive than mammography(P0.05).Triple-tests were more sensitive than combined mammography with ultrasound(P

Studies on anti-hyperglycemic effect and its mechanism of Dendrobium candidum / 中国中药杂志

<p><b>OBJECTIVE</b>To study the anti-hyperglycemic effect and its mechanism of Dendrobium candidum (DC).</p><p><b>METHOD</b>Normal mice, adrenaline-induced hyperglycemic mice, streptozotocin-induced diabetic (STZ-DM) rats were used. The mechanisms of the anti-hyperglycemic action were studied with radio-immunoassay, immunohistochemical HRP-SPA stain, etc.</p><p><b>RESULT</b>DC could not obviously decrease the serum glucose concentrations and insulin levels in normal mice. It could increase serum insulin levels and decrease serum glucagons concentrations in STZ-DM rats. The results of immunohistochemical stain demonstrated that the number of islet beta cells was increased and that of islet a cells was decreased in STZ-DM rats. It could also decrease the serum glucose concentrations and increase liver glucogen contents in adrenaline-induced hyperglycemic mice.</p><p><b>CONCLUSION</b>DC has obvious anti-hyperglycemic effects in adrenaline-induced hyperglycemic mice and STZ-DM rats. Its mechanisms are stimulating the secretion of insulin from beta cells and inhibiting the secretion of glucagons from a cells, and it can probably decrease the decomposition of liver glucogen and increase the synthesis of liver glucogen.</p>