Re-evaluation of bioequivalence of generic drugs is one of the key research focus currently. As a means to ensure consistency of the therapeutic effectiveness of drug products, clinical bioequivalence has been widely accepted as a gold standard test. In vitro dissolution testing based on the theory of the BCS is the best alternative to in vivo bioequivalence study. In this article, the conventional dissolution method and flow-through cell method were used to investigate the dissolution profiles of domestic amoxicillin capsules in different dissolution media, and the absorption behavior of the drugs with different release rates (t85% = 15-180 min) in the gastrointestinal tract was predicted by Gastro Plus. The flow-through cell method was thought better to reflect the release characteristics in vivo, and amoxicillin capsules with regard to the release rates up to 45 min (t85% = 45 min) were having a satisfied bioequivalence with the oral solution according to the C(max) and AUC. Although two different dissolution profiles of domestic amoxicillin capsules were found by flow-through cell methods, prediction results revealed that domestic capsules were probably bioequivalent to each other.

Presently, there are many issues in traditional Chinese medicine (TCM) decoction, such as the uncertain sources of TCM, the lack of reminder for medication taboo, the nonstardard herb operation, and difficult supervision, etc. A digital service system of TCM decoction was established to solve the problems mentioned above. The digital service system mainly includes automatic coding for checking in & out, drug medication taboo database, digital operation in decoction, distribution through 2D code, the corresponding application for mobile phone, and the information supervision platform for TCM decoction. The digital service system of TCM decoction can track the quality & duty of the pieces, remind decoction medicine contraindications, improve the standard operation process of decoction, develop decoction distribution & tracking through cell phone, save the waiting time, and hence provides a new supervising method for TCM decoction. The digital service system of TCM decoction solves the key issues for the formula, operation, delivery and supervision of TCM. In the same vein, this system will expand the market share of TCM decoction and promote the development of TCM.

One hundred and eighty three women with high risk of breast cancer identified in Baoding First Central Hospital from June 2007 to June 2014,were enrolled in the study.In these 183 cases,41 received preventive therapy (22.4％),142 did not.Factors associated with acceptance of chemoprevention included older age,menopause,comorbidities,lower level education,being married,higher BMI,having high level hyperplasia of ductal epthelia and counseling to breast specialists (P ＜ O.05);whilenot informed by doctors was the main reason for failed taking preventive agents(95.1％,135/142).Thirteen of 41 women receiving chemoprevention discontinued the therapy (31.7％);no-insurance,no side-effects and higher BMI were related to the discontinuing (P ＜ 0.05).The 1-,2-,3-,and 5-year adherence rates of chemoprevention was 86.1％ (31/36),65.4％ (17/26),59.1％ (13/22),8/13 and 5/10,respectively.The results show that chemoprevention rate is low among Chinese women at high risk of breast cancer,and the long-term adherence to preventive therapy is poor.Corresponding measures should be taken to strengthen the chemoprevention of breast cancer.

ABSTRACT:Objective To observe whether N-acetyl-seryl-aspartyl-lysyl-proline (Ac-SDKP)can inhibit rat silicotic fibrosis by regulating stimulatory G proteinα(Gαs)/inhibitory G proteinα(Gαi)signal.Methods Male Wistar rats were randomly divided into three groups (n=1 0 ):control 1 6-w group,silicosis 1 6-w group,and Ac-SDKP pre-treatment group.The pathological changes of the lung tissue was observed by HE staining;the expressions ofα-smooth muscle actin (α-SMA),Collagen Ⅰ,fibronectin (Fn),Gαs,Gαi2 ,Gαi3 and cAMP were detected by Western blot.Immunofluorescence was performed on lung tissue sections to detect the coexpression ofα-SMA/Gαi3 . Results Within silicosis 16-w group,HE staining showed that the silicotic nodule volume increased,nodule fusion and the formation of interstitial fibrosis could be seen,and cell fibrous nodules were visible.Immunofluorescence staining showed the enhanced coexpression ofα-SMA/Gαi3 in fibrosis area.Compared with those in control group, the expressions ofα-SMA,Collagen Ⅰ,Fn,Gαi2 and Gαi3 significantly increased in silicosis 1 6-w group,but the expressions of Gαs and cAMP decreased.Compared with silicosis 1 6-w group,Ac-SDKP pre-treatment group had alleviated lung injury and decreased coexpression ofα-SMA/Gαi3 .The expressions ofα-SMA,Collagen Ⅰ,Fn,Gαi2 and Gαi3 protein significantly decreased in Ac-SDKP pre-treatment group,while the expressions of Gαs and cAMP increased obviously.Conclusion Ac-SDKP can regulate the expressions of Gαs and Gαi and promote the formation of cAMP,thus playing an effective role against silicotic fibrosis.

Abstract:Photodynamic therapy(PDT)is a minimal invasive therapy that have been clinically approved for the cancer treatment with selective cell toxicity. When activated by appropriate wavelength of light, photosensitizers transfer the absorbed photon energy to the surrounding molecular oxygen to generate reactive oxygen species, which result in cell death, vessel damage and immune activation of tumor site. This paper summarize the main challenges and recent solutions for PDT application, such as the low tissue penetration of light, toxicity induced by nonspecific accumulation of skin and poor PDT effect of hypoxia tumor.

Background: We hypothesized that specific amino acids or acylcarnitines would have benefits for the differential diagnosis of diabetes. Thus, a targeted metabolomics for amino acids and acylcarnitines in patients with diabetes and its complications was carried out. Methods: A cohort of 54 normal individuals and 156 patients with type 2 diabetes mellitus and/or diabetic complications enrolled from the First Affiliated Hospital of Jinzhou Medical University was studied. The subjects were divided into five main groups: normal individuals, impaired fasting glucose, overt diabetes, diabetic microvascular complications, and diabetic peripheral vascular disease. The technique of tandem mass spectrometry was applied to obtain the plasma metabolite profiles. Metabolomics multivariate statistics were applied for the metabolic data analysis and the differential metabolites determination. Results: A total of 10 cross-comparisons within diabetes and its complications were designed to explore the differential metabolites. The results demonstrated that eight comparisons existed and yielded significant metabolic differences. A total number of 24 differential metabolites were determined from six selected comparisons, including up-regulated amino acids, down-regulated medium-chain and long-chain acylcarnitines. Altered differential metabolites provided six panels of biomarkers, which were helpful in distinguishing diabetic patients. Conclusion Our results demonstrated that the biomarker panels consisted of specific amino acids and acylcarnitines which could reflect the metabolic variations among the different stages of diabetes and might be useful for the differential diagnosis of prediabetes, overt diabetes and diabetic complications.

Background: We hypothesized that specific amino acids or acylcarnitines would have benefits for the differential diagnosis of diabetes. Thus, a targeted metabolomics for amino acids and acylcarnitines in patients with diabetes and its complications was carried out. Methods: A cohort of 54 normal individuals and 156 patients with type 2 diabetes mellitus and/or diabetic complications enrolled from the First Affiliated Hospital of Jinzhou Medical University was studied. The subjects were divided into five main groups: normal individuals, impaired fasting glucose, overt diabetes, diabetic microvascular complications, and diabetic peripheral vascular disease. The technique of tandem mass spectrometry was applied to obtain the plasma metabolite profiles. Metabolomics multivariate statistics were applied for the metabolic data analysis and the differential metabolites determination. Results: A total of 10 cross-comparisons within diabetes and its complications were designed to explore the differential metabolites. The results demonstrated that eight comparisons existed and yielded significant metabolic differences. A total number of 24 differential metabolites were determined from six selected comparisons, including up-regulated amino acids, down-regulated medium-chain and long-chain acylcarnitines. Altered differential metabolites provided six panels of biomarkers, which were helpful in distinguishing diabetic patients. Conclusion Our results demonstrated that the biomarker panels consisted of specific amino acids and acylcarnitines which could reflect the metabolic variations among the different stages of diabetes and might be useful for the differential diagnosis of prediabetes, overt diabetes and diabetic complications.

ObjectiveTo investigate the feasibility of apical sodium-dependent bile salt transporter (ASBT) and asialoglycoprotein receptor (ASGPR) in the design of oral liver-targeting preparations for the treatment of hepatic alveolar echinococcosis (HAE) by measuring the expression of ASBT and ASGPR. MethodsA total of 18 male Sprague-Dawley rats were selected, among which 10 were used to establish a model of HAE (HAE group) and 8 were used as controls (normal group). Immunofluorescence assay, Western blotting, and quantitative real-time PCR were used to measure the expression distribution, protein expression level, and mRNA expression level of ASBT in the ileal tissue of HAE model rats and normal rats; the same methods were used to measure the expression level of ASGPR in the non-diseased liver tissue and the marginal zone of liver tissue lesion of HAE model rats and the liver tissue of normal rats. The t-test was used for comparison of normally distributed continuous data between two groups; a one-way analysis of variance was used for comparison between three groups, and the least significant difference t-test was used for comparison between two groups. ResultsThe results of immunofluorescence assay, Western blotting, and quantitative real-time PCR showed that compared with the normal group, the HAE group had significantly upregulated expression of ASBT in the ileal tissue (t=5309, 4.110, and 28.060, all P＜0.05) and a significantly higher expression level of ASGPR (the closer to the lesion, the higher the expression) (F=110666, 128.201, and 143.879, all P＜0.001). ConclusionASBT and ASGPR can be used as potential mediated receptors for oral liver-targeting preparations for HAE, which provides a theoretical basis for the design of oral liver-targeting preparations for the treatment of HAE.

Objective To explore the relationship between different statuses of vitamin D and parathyroid hormone (PTH) during pregnancy with glucose metabolism and the risk of gestational diabetes mellitus (GDM). Methods A total of 4138 pregnant women who had antenatal care in 3 hospitals of Hefei from March 2015 to December 2017 were recruited during 21-24 weeks. Baseline questionnaires were performed and serum 25-hydroxyvitamin D [25(OH) D] and PTH levels were measured in fasting venous blood. Glucose tolerance tests were performed during 24 to 28 weeks. Multivariate linear regression model and multivariate logistic regression model were applied to analyze the differences of glucose metabolism index and GDM risk among pregnant women at different statusesof25(OH)DandPTH.Results Theaveragelevelof25(OH)Dinthesecondtrimesterwas(39.8±16.6) nmol/L, with the median PTH 10.7 (6.9, 16.7) ng/L and the detection rate of GDM 20.4％. Covariance analysis showed no statistically significant association of vitamin D and PTH levels with glucose metabolism indexes. Pregnant women with high PTH and vitamin D deficiency had higher 1h postprandial plasma glucose ( 1hPG) , the area under the glucose curve ( AUCglu ) levels, and GDM risk compared with pregnant women with middle/lower PTH and vitamin D deficiency ( control group, all P<0.05) , and higher PTH accompanied with vitamin D non-deficiency ( Group 2, all P<0.05) . However, significant changes in glucose metabolism indicators and GDM risk were not observed in low-level PTH-pregnant women with vitamin D deficiency ( group 1) and group 2 pregnant women compared with control group. Conclusion There is an interaction between vitamin D/PTH levels and glucose metabolism during pregnancy. Vitamin D deficiency with elevated PTH level is associated with abnormal glucose metabolism.

Objective To compare the efficacy of trastuzumab plus pertuzumab (HP) combined with either nab-paclitaxel plus carboplatin or docetaxel plus carboplatin as neoadjuvant therapy for HER2-positive breast cancer in real-world clinical practice. Methods Clinical data of HER2-positive breast cancer patients who received neoadjuvant therapy with either HP combined with nab-paclitaxel plus carboplatin or HP combined with docetaxel plus carboplatin and subsequently underwent surgery were retrospectively collected from 11 tertiary grade-A hospitals in Hebei Province from June 2019 to December 2021. The total pathological complete response (tpCR) rates of the two groups were compared. Results A total of 76 patients were included in the study, with 47 in the nab-paclitaxel group and 29 in the docetaxel group. The tpCR rate was significantly higher in the nab-paclitaxel group than that in the docetaxel group (72.3% vs. 48.3%, χ²=4.463, P=0.035). Subgroup analysis indicated that patients older than 40 years, with cN2-3, cTNM stage Ⅲ, hormone receptor-positive status, and Ki67>30% had significantly higher tpCR rates in the nab-paclitaxel group than those in the docetaxel group (P<0.05). Conclusion In real-world clinical practice, the efficacy of HP combined with nab-paclitaxel plus carboplatin as neoadjuvant therapy for HER2-positive breast cancer is superior to that of HP combined with docetaxel plus carboplatin.