Analysis on the Characteristics of Quality Variation of National Medical Device Supervision and Inspection in 2020 / 中国医疗器械杂志

This study is based on the summary of the characteristics of quality variation of national medical device supervision and inspection in 2020. According to the results of the national medical device supervision and inspection through comparative analysis, this study puts forward suggestions on the medical device production and supervision measures for the post-marketing products, so as to further improve the level of the medical device and ensure the safety use of medical device.

Analysis on the Quality Status of in Vitro Diagnostic Reagents for National Medical Device Supervision and Inspection in 2020 / 中国医疗器械杂志

OBJECTIVE@#This paper puts forward suggestions on the development of in vitro diagnostic reagents and supervision measures for the post-marketing products, so as to further improve the quality of in vitro diagnostic reagents and ensure the safety use of medical device.@*METHODS@#This paper summarizes the quality of in vitro diagnostic reagents and analyzes the causes of the problems, according to the results of the national medical device supervision and inspection in 2020.@*RESULTS@#The overall quality of in vitro diagnostic reagents for national medical device supervision and inspection in 2020 is stable and the unqualified detection rate is 1.6%. However, there are some problems. For example, the management of raw materials is unscientific, the faultiness in the preparation of reference materials, the understanding of standards is unthorough, and the management of instructions is unimportance.@*CONCLUSIONS@#It is suggested that manufacturers of in vitro diagnostic reagents should improve the binding force of the quality management system, strengthen the awareness of risk management, attach importance to communicate with regulatory authorities, study standards sufficiently and strengthen the management of instructions. It is also suggested that the regulatory authorities should strengthen supervision and inspection, and further complete the evaluation guidance and standard publicity and implementation.

Analysis of Quality Status of National Medical Device Supervision and Inspection in 2019 / 中国医疗器械杂志

Summarize the quality status and variety quality change characteristics of the sampling products through the Summary and analysis, according to the results of the national medical device supervision and inspection in 2019. Put forward suggestions on the development of the medical device industry and supervisory measures. Thereby, further improve the level of the medical device and ensure the safety use of medical device.

Research Advances of Traditional Chinese Medicine in Treating Osteonecrosis of Femoral Head by Regulating Bone MetabolismRelated Signaling Pathways / 中国实验方剂学杂志

Osteonecrosis of the femoral head （ONFH） is a serious orthopedic disease caused by many factors. It is difficult to cure clinically and has a poor prognosis， which poses a serious threat to human health. The pathogenesis of this disease is still unclear. The ONFH caused by different causes involves the disorder of a variety of metabolic pathways in vivo. Abnormal proliferation and differentiation of bone mesenchymal stem cells （BMSCs）， imbalance of bone metabolism， and increased destruction of bone trabeculae caused by abnormal transduction of bone metabolism-related signaling pathways may be the important causes of ONFH. BMSCs are pluripotent stem cells with self-renewal and multidirectional differentiation ability， which have good regeneration rate. Improving the osteogenic and differentiation ability of BMSCs is the key to inhibit bone absorption and promote bone matrix reconstruction， which plays an important role in bone remodeling. In recent years， there are many studies on the prevention and treatment of ONFH in traditional Chinese medicine（TCM）， and it has been found that a variety of single herbs， monomers and compounds can regulate the differentiation direction and process of BMSCs by targeting signal molecules， with great potential for bone defect repair and anti-femoral head necrosis activity. Nowadays， prevention and treatment of ONFH by regulating bone metabolism signaling pathways has become a hot research topic. In this paper， the mechanism and related signal transduction pathways of TCM in preventing and treating ONFH were reviewed to explore some mechanisms of alleviating the rate of bone loss， promoting bone formation， and repairing bone defects， so as to provide reference for further research on the prevention and treatment of ONFH by TCM. The related clinical application studies also provided specific targets for gene-assisted therapy of ONFH.

Biological evaluation of 2,3-dioxoindolin-N-phenylacetamide derivatives as potent CDC25B and PTP1B phosphatase inhibitors

A series of 2,3-dioxoindolin-N-phenylacetamide derivatives was evaluated for inhibitory activity against CDC25B and PTP1B enzymes. Most of the derivatives showed inhibitory activity against CDC25B (IC50 = 3.2-23.2 µg/mL) and PTP1B (IC50 = 2.9-21.4 µg/mL). Compound 2h showed the most inhibitory activity in vitro with IC50 values of 3.2 and 2.9 µg/mL against CDC25B and PTP1B, respectively, compared with the reference drugs Na3VO4 (IC50 = 2.7 µg/mL) and oleanolic acid (IC50 = 2.3 µg/mL). The results of selectivity experiments showed that the 2,3-dioxoindolin-N-phenylacetamide derivatives were selective inhibitors against CDC25B and PTP1B. Enzyme kinetic experiments demonstrated that compound 2h was a specific inhibitor with the typical characteristics of a mixed inhibitor. In cytotoxic activity assays compound 2h had potent activity against A549, HeLa, and HCT116 cell lines. In addition, compound 2h showed potent tumor inhibitory activity in a colo205 xenograft model in vivo.

Synthesis and antibacterial activity of a series novel 5,7-diisoprenyloxyflavone derivatives

In the present study, a series of novel 5,7-diisoprenyloxyflavone derivatives were designed, synthesized, and evaluated for their antibacterial activity. Most of these compounds displayed significant antibacterial effects against Gram-positive bacteria, especially against strains of multidrug-resistant clinical isolates. Compounds 4c, 4g, 4i, 4j, 4k, 4l, 4n, 4q and 4t showed high levels of antimicrobial activity against Staphylococcus aureus RN4220 with minimum inhibitory concentrations of 4.0-20 µM. Compound 4k showed the most potent activity among these compounds against all multidrug-resistant clinical isolates tested. Unfortunately, none of the compounds were active against Gram-negative bacteria at the doses of 24-164 µM.

Suberoylanilide hydroxamic acid overcomes erlotinib-acquired resistance via phosphatase and tensin homolog deleted on chromosome 10-mediated apoptosis in non-small cell lung cancer / 中华医学杂志(英文版)

BACKGROUND@#Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as erlotinib and gefitinib, are widely used to treat non-small cell lung cancer (NSCLC). However, acquired resistance is unavoidable, impairing the anti-tumor effects of EGFR-TKIs. It is reported that histone deacetylase (HDAC) inhibitors could enhance the anti-tumor effects of other antineoplastic agents and radiotherapy. However, whether the HDAC inhibitor suberoylanilide hydroxamic acid (SAHA) can overcome erlotinib-acquired resistance is not fully clear.@*METHODS@#An erlotinib-resistant PC-9/ER cell line was established through cell maintenance in a series of erlotinib-containing cultures. NSCLC cells were co-cultured with SAHA, erlotinib, or their combination, and then the viability of cells was measured by the 3-(4,5-Dimethyl thiazol-2-yl)-2,5-diphenyl tetrazolium bromide assay and apoptosis was determined by flow cytometry and western blotting. Finally, the expression of phosphatase and tensin homolog deleted on chromosome 10 (PTEN) was assessed by western blotting.@*RESULTS@#The half-maximal inhibitory concentration of parental PC-9 cells was significantly lower than the established erlotinib-acquired resistant PC-9/ER cell line. PC-9/ER cells demonstrated reduced expression of PTEN compared with PC-9 and H1975 cells, and the combination of SAHA and erlotinib significantly inhibited cell growth and increased apoptosis in both PC-9/ER and H1975 cells. Furthermore, treating PC-9/ER cells with SAHA or SAHA combined with erlotinib significantly upregulated the expression of PTEN mRNA and protein compared with erlotinib treatment alone.@*CONCLUSIONS@#PTEN deletion is closely related to acquired resistance to EGFR-TKIs, and treatment with the combination of SAHA and erlotinib showed a greater inhibitory effect on NSCLC cells than single-drug therapy. SAHA enhances the suppressive effects of erlotinib in lung cancer cells, increasing cellular apoptosis and PTEN expression. SAHA can be a potential adjuvant to erlotinib treatment, and thus, can improve the efficacy of NSCLC therapy.

Enhancive effect of FGL1 gene silencing on sensitivity of human lung adenocarcinoma PC-9 cells to docetaxel / 中国药理学通报

Aim To investigate the effect of fibrinogenlike protein 1 (FGL1)) silencing on docetaxel sensitivity in human lung adenocarcinoma PC-9 cells. Methods Western blot was used to detect the expression of FGL1 protein in human normal bronchial epithelial cell line BEAS-2B and human lung adenocarcinoma cell line PC-9. The FGL1 gene in PC-9 cell line was silenced by siRNA. CCK-8 assay was used to detect the inhibitory effect of silencing FGL1 on PC-9 cell proliferation and its effect on docetaxel sensitivity. Results Compared with BEAS-2B cell line, FGL1 was highly expressed in PC-9 cell line, and the relative expression of FGL1 protein was 6. 5 times that of BEAS-2B cell line with statistically significant difference (P <0. 01). Silencing FGL1 by transfection with FGLlsiRNA could enhance the inhibitory effect of docetaxel on PC-9 cells. Compared with FGLlsiNC group, the IC50value of PC-9 cells in FGL1siRNA group was significantly reduced with statistically significant difference (P < 0. 01). Conclusions Specific silencing of FGL1 gene could inhibit the expression of FGL1 in human lung adenocarcinoma cell PC-9, inhibit the proliferation of PC-9 cells and increase the sensitivity to docetaxel.

Effect of pre-acupuncture at Neiguan (PC 6) and Zusanli (ST 36) on exercise-induced fatigue / 中国针灸

OBJECTIVE@#To observe the therapeutic effect of pre-acupuncture at Neiguan (PC 6) and Zusanli (ST 36) on exercise-induced fatigue.@*METHODS@#A total of 50 subjects were divided into an observation group and a control group by random number table method, 25 cases in each one. In the observation group, acupuncture was applied at Neiguan (PC 6) and Zusanli (ST 36) before exercise, once a day, consecutive 5-day treatment was required. In the control group, there was no intervention. The subjective fatigue perception score, serum levels of lactate and lactate dehydrogenase, heart rate and oxygen saturation before and after exercise were observed in the two groups.@*RESULTS@#Compared before exercise, the subjective fatigue perception scores, serum levels of lactate and lactate dehydrogenase and heart rates after exercise were increased in the two groups (0.05).@*CONCLUSION@#Pre-acupuncture at Neiguan (PC 6) and Zusanli (ST 36) can effectively reduce the subjective fatigue perception score，serum levels of lactate and lactate dehydrogenase and heart rate to improve exercise-induced fatigue.

Prognostic Value of CD14HLA-DR Myeloid Derived Suppressor Cells in Diffuse Large B Cell Lymphoma / 中国实验血液学杂志

OBJECTIVE@#To investigate the role of myeloid-derived suppressor cells (MDSC) in the prognosis of patients with diffuse large B cell lymphoma (DLBCL).@*METHODS@#The peripheral blood of 52 DLBCL patients and 30 healthy volunteers was collected. The CD14HLA-DR was used as the immune marker for MDSC. The role of MDSC in the prognosis of DLBCL patients was analyzed by combination with the related clinicopathological data.@*RESULTS@#The proportion of MDSC in peripheral blood of newly diagnosed DLBCL patients increased significantly (P＜0.01). The expression of MDSC in DLBCL patients was related with clinical staging, lactate dehydrogenase (LDH) level and IPI score (P＜0.01). There was no significant correlation with sex, age, and B symptoms. Univariate analysis showed that the clinical stage, serum LDH level, IPI score and MDSC level were the adverse factors affecting the overall survival (OS). Multivariate analysis showed that IPI score and MDSC level were independent risk factors for OS in DLBCL patients.@*CONCLUSION@#MDSC can be used as an important index to evaluate the prognosis of DLBCL patients, contributing to evaluate the immune and tumor microenvironment of DLBCL patients.

Establishment of extraction method for Gardeniae Fructus extract and its application in evaluating different Gardeniae Fructus decoction pieces / 中国中药杂志

In this experiment,the gradation analysis method was used to evaluate the quality of different pieces of Gardeniae Fructus through the extraction rate difference and the difference analysis of the main components in the extract. In this experiment cold-dip and hot-dip methods were used to compare the yield of Gardeniae Fructus extract and the content of chemical constituents with water,25%,50%,75% and 95% ethanol fractions. By weighted calculation,the optimal extraction method of Gardeniae Fructus was determined,and this was verified by practical application. RESULTS:: showed that for the water-soluble extract,cold dip method was better than the hot dip method; and for alcohol-soluble extract,75% ethanol under cold dip method was best. The verification results showed that water-soluble extracts under cold dip methods could be used to significantly distinguish the raw Gardeniae Fructus( GF) and processed( stir-baked) GF( GFP) collected from the market. Meanwhile,this method could be also used to distinguish the same batch of GF,GFP and carbonized GF( GFC) with significant differences,respectively( P<0. 05). Ethanol-soluble extract can be used to clearly distinguish GFP and GFC pieces in the same batch( P<0. 05). The results of content determination showed that the variation coefficient of components in GF processed products was higher than that in extracts,and the content of hydroxygeniposide was the most significant component between GF and its processed products. It is suggested that the method of water-soluble extract of GF and the determination of the content of gardoside should be combined together to evaluate the quality of GF and its heat processed products.

Study on quality standard of rice as excipients during rice stir-frying method / 中国中药杂志

Commercially available japonica rice and indica rice with different trade names were collected,and then based on the method of rice stir-frying,their many indexes were evaluated,for example the physical and chemical properties such as appearance color,grain type,broken kernel ratio,length-width ratio,1 000-grain weight,specific heat capacity,moisture content,amylose content,and protein content. The discriminant function analysis was used to determine the effective factors affecting the quality of rice as excipients. The results showed that two types of rice could be distinguished by rice color parameter a*,grain parameter circularity,1 000-grain weight and amylose content. These four effective factors can be used as the quality evaluation indexes for fried rice as excipients.Protein is one of the main components of rice,and its content affects the quality of rice. There is a significant difference in the protein content between japonica rice and indica rice. Therefore,protein content should be used as one of the evaluation indexes for rice quality. After comprehensive consideration,it is suggested that the red-green value a*shall not be less than 0. 50; the circularity not less than 53. 0,the 1 000-grain weight not less than 16. 0 g,the amylose content not less than 12. 0% and the protein content not less than4. 0% in the japonica rice; the red-green value a*shall not be lower than-1. 0,the circularity not less than 41. 0,the 1 000-grain weight not less than 13. 0 g,the amylose content not less than 9. 0% and the protein content not less than 3. 5% in the indica rice. In this study,the quality evaluation standards for rice as excipients( japonica rice,indica rice) were supplemented and improved,laying foundation for the development of quality standards for rice as excipients with the rice stir-frying method.

Polarity of ameloblasts and odontoblasts and their related regulators / 华西口腔医学杂志

The polarity of ameloblasts and odontoblasts is crucial for their differentiation and function. Polarity-related molecules play an important role in this process. This review summarizes the process of polarity formation of ameloblasts and odontoblasts and their related regulators.

Analysis of Variety Selection for Medical Device Supervision and Inspection / 中国医疗器械杂志

This article introduces the process and principles of variety selection for medical device supervision and inspection, and it analyzes the reason and consideration of the variety selection data of national medical device supervision and inspection from 2017 to 2019, it also put forward a collection of selected varieties for reference in the future by sorting out the classified catalogue of medical devices and diagnostic reagents.

Risk Point Analysis of Product Quality and Safety in Sample Inspection of National Medical Device Supervision / 中国医疗器械杂志

This paper reviews the quality and safety risk points of medical devices found in the sampling inspection of national medical device supervision in recent years. These risk points are summarized into quality management system, product technical requirements, national standards and industry standards, etc. Several specific risk scenarios are further summarized. Based on the above efforts, a more comprehensive risk point system is constructed. Then it is illustrated with typical examples. In view of the existing problems, the corresponding suggestions are put forward to the production enterprises and supervision departments respectively.

Establishment of Sampling Inspection Scheme Paradigm for Medical Device Sampling Inspection / 中国医疗器械杂志

This paper introduces the sampling scheme and the inspection scheme paradigm followed in organizing the sampling inspection of medical devices. The sampling scheme paradigm includes the definition and operation guidelines for sampling products, the regulations for individual sampling batches and related model specifications, accessory data, validity period, storage conditions, etc., the requirements for sampling areas, places and quantities, and the requirements for samples to be sent to inspection institutions. The inspection scheme paradigm includes the provisions for inspection basis, inspection items and determination principles.

Research Progress of Processing in Production Place and Processing Methods of Bupleuri Radix / 中国实验方剂学杂志

Bupleuri Radix is a traditional Chinese medicine commonly used in clinical practice, which has the effects of relieving fever, relieving liver and depression, and promoting Yangqi. At present, the varieties of Bupleuri Radix are relatively chaotic, and the processing in the production areas is relatively extensive. In the processing of Bupleuri Radix, the processed products contained in the 2015 edition of Chinese Pharmacopoeia are raw products and vinegar-processed products. In addition, the specifications on Chinese medicine processing in various provinces and cities contain many processing methods, such as stir-frying with wine, stir-frying with honey, processed with turtle blood, etc. However, there are great differences in processing specifications among provinces and cities, and the processing methods lack clear process parameters, so the quality of Bupleuri Radix decoction pieces produced on these basis is uneven, which affects the clinical application of the decoction pieces. By consulting ancient books and relevant literature, the authors conduct textual research on the varieties of Bupleuri Radix, and systematically summarized the processing methods and processing methods in the producing area, so as to provide reference for the establishment of processing technology specifications and quality standards of Bupleuri Radix decoction pieces.

Study on quality transfer law of rice-processed Codonopsis Radix in processing based on “correlation between external apparence color and internal component” / 中草药

Objective: To study the correlation between the apparent color of the samples and the important variable components of HPLC fingerprint of rice-processed Codonopsis Radix (rpCR) in processing and its quality transfer law, and lay the foundation for revealing the processing principle of rpCR. Methods: This experiment was based on the experience of the process of rpCR and the apparent color change of traditional processed slices, the visual analyzer was used to analyze the change of apparent color of rpCR from different process time. HPLC fingerprint was used to evaluate the dynamic changes of chemical constituents of rpCR in processing. Then, the multivariate statistical method was used to analyze the correlation between the apparent color and the important variable components of the HPLC fingerprint. Results: In the processing of rpCR, the total color value (E*) of sample powder showed a downward trend, the apparent color of the samples changed from light yellowish brown to dark yellow; The proportions of the 10 chemical components varied greatly, corresponding to peaks of 7, 9, 10, 2, 3, 1, 20, 15, 6, and 4 in HPLC fingerprint, among them peak 4 was confirmed to be 5-hydroxymethyl-2-furaldehyde; Components 1, 3 and 4 were highly significantly and negatively relevant with the change of total color value Eab*, and peak 2 was highly significantly and positively correlated with the change of total color value Eab*, while peak 6 and peak 15 were positively relevant with the change of total color value Eab*. Conclusion: Compounds 1, 2, 3, 4, 6, and 15 were the components with obvious changes in process of rpCR, which were significantly correlated with the change of color and could be used as chemical markers for the monitoring processing and quality control of rpCR.

Clinical analysis of apparently healthy subjects with leukopenia / 国际检验医学杂志

Objective To investigate the incidence of leukopenia in superficial healthy population and its correlation with age and sex.Methods A total of 40 031 healthy subjects, including 23 393 males and 16 638 females, were selected from January to July, 2018.Their blood routine tests were performed to analyze the age, sex, neutropenia of leukopenia patients.Results The prevalence of leukopenia was 1.22％ (490/40 031), 0.37％ (151/40 031) in males, 0.85％ (339/40 031) in females.The incidence in females was higher, with statistical significance (P＜0.05).Age:the average age of males was higher.There was no difference between the incidence of leukopenia in the population aged less than 60 years and over 60 years.There was no significant difference in lymphocyte and monocyte counts between men and women with leukopenia (P＞0.05), but there was significant difference in WBC and NEU counts (P＜0.05).Neutropenia was found in 206 leukopenia patients, accounting for 42.04％ (206/490), and thrombocytopenia was found in 21 patients, accounting for4.29％ (21/490), and anemia was found in 71 patients, accounting for 14.49％ (71/490).Conclusion The incidence of leukopenia is 1.22％in the apparently healthy population.The incidence of leukopenia in females is higher than that in males.Leukopenia is more severe in women than in men, neutropenia is more severe too.

Analysis of Changing the Original Test Result after Retesting in National Medical Device Sampling and Testing from 2013 to 2016 / 中国医疗器械杂志

The types and the reasons of changing the original test result after retesting in national medical device sampling and testing from 2013 to 2016, are summarized and analyzed. Firstly, collecting data of "standards not complied" and retesting. Then, giving specific examples when summarizing five types of changing the original test result after retesting. Meanwhile, analyzing the relevant reasons, discovering the deep problems. Finally, giving suggestions for the above problems.