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【Objective】 To analyze the current situation of direct exemption of clinical blood fess for voluntary blood donors and their family members in Henan Province, in order to improve and fully implement the policy. 【Methods】 According to the policy on blood fees exemption issued by China and Henan Province in 2019,the data of hospitals in 18 prefecture-level cities in Henan from 2020 to 2021 were continuously collected from the system of clinical blood fees exemption,including the way of exemption,the number of people (times) of exemption,exemption amount, the proportion of blood fees exemption and the total exemption rate. The experience gained in the past two years after the implementation of the policy was summarized,and the existing problems and causes were analyzed. 【Results】 The rates of direct exemption of blood fees in Henan Province in 2020 and 2021 were 34.53% (8 709/25 221) and 71.68%(23 587/32 906) (P<0.05) ,respectively. In 2021, the direct exemption rate of blood fees in 18 cities was 6.20% (83/1 370) to 88.50% (1 332/1 505) [ (47.35±41.15)%],and increased month by month from 43.19% (1 183/2 507) in January to 83.15% (2 097/2 522) in August, then remained stable at a similar level to August from September to December, with 83.43% (2 744/3 289) in December as the highest for the year. 【Conclusion】 The implementation of the policy of blood fees exemption showed significant effectiveness, which has effectively promoted the development of voluntary blood donation in Henan. However, there is still room for improving the policy in some cities, which is expected to further increase the direct exemption rate of the city and the whole province.
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ABSTRACT Background: Different from the traditional right ventricular pacing, the left bundle branch area pacing (LBBAP) is accomplished with deeper lead implantation and more attempts. However, myocardial damage is unclear in LBBAP. Objective: The objective of the study was to observe the change of troponin T and explore possible factors associated with greater myocardial damage in LBBAP. Methods: Patients with an indication for pacemaker implantation underwent attempts for LBBAP by transventricular septal method. Levels of troponin T were determined before operation, 12 h and 1 week after the operation. Parameters of intraoperation and follow-up were recorded and analyzed. Results: In total, successful LBBAP was achieved in 126 patients. The levels of troponin T increased significantly at 12 h after the operation compared with those before operation (96.45 ± 11.07 [69.06] vs. 16.59 ± 1.84 [11.92] ng/L, p < 0.001), while there were no significant differences between pre- and post-operative levels at 1 week. Correlation and regression analysis showed that only the number of attempts was an independent factor related to the change of troponin T. During 1 year of follow-up, LBBAP was safe and feasible with few complications. Conclusions: Myocardial damage of LBBAP was clinically significant. The number of attempts was an independent factor related to the myocardial damage.
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Research on polymer impurities has always been important in the quality control of cephalosporins. Research on polymers in cephalosporins that lack active amino groups on the C-7 side chain has not been reported. Therefore, our study used cefazolin sodium, which is widely used in the clinic, as an example. The polymer in cefazolin sodium and its product "cefazolin sodium pentahydrate for injection" was analyzed by column switching liquid chromatography-high resolution mass spectrometry. Two polymer impurity peaks were detected and the possible structures of these polymers were suggested. Through two-dimensional liquid chromatography, the chromatographic peaks following Sephadex gel chromatography and high-performance gel chromatography were compared to those obtained by reverse high-performance liquid chromatography (HPLC) for cefazolin sodium as reported in the Chinese Pharmacopoeia. The HPLC method proves more suitable for polymer detection than Sephadex gel chromatography and high-performance gel chromatography. The method of polymer detection for cefazolin sodium was established using the method of related substances HPLC as described in the Chinese Pharmacopoeia.
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To establish a method for the determination of polymer impurities in cefixime raw materials and preparations, a cefixime degradation solution containing polymer impurities was prepared by forced polymerization. Polymer impurities in the degradation solution were separated and identified by high performance gel chromatography and the column switching-LC-MSn method. A new RP-HPLC method for cefixime polymer was established and validated with a Phenomenex Gemini-C18 column using a mobile phase gradient elution of 0.5% formic acid-water solution and 0.5% formic acid-acetonitrile solution. The results showed that when using this high performance gel chromatography method some small molecular weight impurities were co-eluted with the polymers, resulting in a poor specificity and poor quantitative accuracy. But when using the RP-HPLC method, three polymer impurities were detected with good specificity, sensitivity and robustness, including two cefixime dimers, and dehydrate dimer. Therefore, the described RP-HPLC method is suitable for the quality control of polymer impurities in cefixime, and cefixime degradation solution can be used as suitable solution for analysis of cefixime polymers.
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With the in-depth study of related substances and the development of consistency evaluation of generic drugs, relative correction factors are gaining increasing attention. By analyzing the domestic and foreign literature on correction factors in recent years, this paper describes the correction factor component, the current measurement method and its application. The rules and key points of use of an impurity correction factor and its determination and application are described, and some problems in its determination and application are discussed, providing a reference and basis for the standardization of research on impurity correction factors in the future.
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To establish a method for the determination of polymer impurities in ceftazidime raw materials and preparations, a ceftazidime degradation solution containing polymer impurities was prepared by forced polymerization. Polymer impurities in the degradation solution were separated and identified by high performance gel chromatography and the column switching-LC-MSn method. A new RP-HPLC method for ceftazidime polymer was established and validated with a Phenomenex Gemini-C18 column using a mobile phase gradient elution of 0.02 mol·L-1 phosphate buffer, methanol and acetonitrile. The results showed that when using this high performance gel chromatography method some small molecular weight impurities were co-eluted with the polymers, resulting in a poor specificity and poor quantitative accuracy. But when using the RP-HPLC method, four polymer impurities were detected in the 25-45 min time range with good specificity, sensitivity and robustness, including two ceftazidime dimers, trimers, and derivatives. Therefore, the described RP-HPLC method is suitable for the quality control of polymer impurities in ceftazidime, and ceftazidime degradation solution can be used as suitable solution for analysis of ceftazidime polymers.
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Impurity profiling is one of the most important activities in both assuring drug safety and improving the quality of domestic drugs. Since the basic strategy of impurity profile control was put forward in 2010, a mature control procedure for impurity profile in drugs has been formed in China after nearly ten years of continuous efforts. The progress in impurity profiling before 2010 and from 2010 to 2015 have been reviewed. Since 2015, the concepts, analytical techniques and the application of these techniques in this field have developed rapidly. As a result, the progress in impurity profiling of chemical drugs since 2015 was reviewed in this paper. And the views on future development of impurity profiling in drugs were also put forward.
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<p><b>OBJECTIVE</b>Huannao Yicong Decoction (, HYD), an effective herbal formula against Alzheimer's disease (AD), has been proven to have neuroprotective action in amyloid β-protein(Aβ)-induced rat model. This study was designed to characterize mechanisms by which HYD leads to suppression of inflflammation and apoptosis in the brains of Aβ-induced rat.</p><p><b>METHODS</b>A total of 72 rats were divided into 6 groups, which were referred to as: sham operation group, model group, donepezil-treated group, HYD low-dose group (HYDL), HYD middle-dose group (HYDM) and HYD high-dose group (HYDH). Rats in HYDL, HYDM and HYDH were injected with Aβat the CA1 region of hippocampus to form AD model and were fed the HYD extract at different dose of 3.78, 7.56 and 18.90 g crude drug/kg. The behavioral changes of rats were evaluated by Morris water maze (MWM) before sacrififice. Pathological changes of the brain tissue were evaluated using hematoxylin eosin (HE) staining. The levels of interleukin-1 (IL-1) and tumor necrosis factor-α (TNF-α) were measured by radioimmunoassay. The levels of Aβ and proteins that are associated with apoptosis such as B-cell lymphoma-2 protein (Bcl-2), Bcl-2-associated X protein (Bax), cysteine-aspartic protease (caspase)-3, -8, -9 and -12 in serum were measured by immunohistochemistry.</p><p><b>RESULTS</b>Compared with the sham operation group, the spatial learning and memory abilities of AD rats were signifificantly decreased (P<0.05 or P<0.01; Expressions of IL-1, TNF-α, Aβ and apoptosis-signaling proteins caspase-3, -8, -9, -12 were signifificantly up-regulated (P<0.05 or P<0.01). The ratio of Bcl-2 to Bax were signifificantly decreased in the model group (P<0.01). When treated with HYD extract, the spatial learning and memory abilities of AD-model rats were significantly increased (P<0.05 or P<0.01), IL-1, TNF-α, Aβ, caspase-3, -8, -9 and -12 were down-regulated (P<0.05 or P<0.01), and the ratio of Bcl-2 to Bax were reduced (P<0.05 or P<0.01).</p><p><b>CONCLUSIONS</b>HYD extract can improve the learning and memory ability defificits, alleviate the inflflammatory response and pathological manifestations induced by Aβinjection in the rat model of AD. HYD down-regulates the levels of IL-1, TNF-α and Aβ, and decreases the rate of apoptosis by modulating apoptosis-signaling-related proteins such as caspase-3, -8, -9, and -12.</p>
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Characteristic chromatogram of Ligustri Lucidi Fructus which were processed by heat treatment with different temperatures and times was developed by HPLC. DPPH, ABTS and FRAP assays were performed to determine the antioxidant activity. The spectrum-effect correlation was studied using Partial Least Squares(PLS)to explore the active ingredients of Ligustri Lucidi Fructus by investigating the relationship between HPLC spectrum and antioxidant activity. S1, S2, S15, S24, S27, S29, S32, S33 and S35 were characteristic compounds in 35 matching characteristic chromatograms which were positive relationship with scavenging DPPH free radical activity. S1, S2, S5, S8, S16, S27 and S33 were significantly positively related to scavenge ABTS free radical activity. S12, S20, S22, S28, S30, S31, S32 and S34 were significantly positively related to restore Fe³⁺ activity. Among the chromatographic peaks, S1, S2, S27 and S33were positively related to scavenge DPPH free radical and ABTS free radical activity, and S32 was positively related to scavenge DPPH free radical and restore Fe³⁺ activity. S3, S19, S21, S22, S23, S33 and S34 were determined as salidroside, luteolin-7-O-glucoside, specnuezhenide, oleuropein, ligustroflavone, luteolin andapigenin, respectively. The results showed that although specnuezhenide and salidroside were stipulated index compounds to evaluate the quality of Ligustri Lucidi Fructus, the Ligustri Lucidi Fructus pharmcodynamic effect did not depend on the contents of those index components. The quality of traditional Chinese medicines(TCMs)should be determined by the compound groups associated with pharmcodynamic effect.
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Consult literature, the chemical composition of the type of system Caesalpinia plants were summarized and discussed in detail its pharmacological effects. The genus contains major chemical components of high isoflavones, chalcones and diterpenoids, pharmacological effects inhibit melanin production, anti-inflammatory, antioxidant, antibacterial, immune regulation, and further research in this genus offer reference.
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To study the heating treatment of Angelica dahurica under different temperature and time conditions on the stability of coumarins and tyrosinase activity. HPLC method was used to determine the contents of imperatorin and isoimperatorin, and tyrosinase activity was assayed by measuring the oxidation rate of L-DOPA in vitro. After heated, the contents of imperatorin increased. Expect for being heated at 90 ℃ for 2 h, the content of isoimperatorin was higher than crude one. Before and after being heated, A. dahurica showed an activating effect on tyrosinase. In the same temperature and time conditions, the activation rate increased with the rise of concentration of tyrosinase extracts. Heating process for A. dahurica could change the contents of imperatorin and isoimperatorin, mainly increasing their concentrations.
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Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) could induce extensive and rapid future liver remnant hypertrophy. However, the morbidity for ALPPS is very high. This paper reports a modified ALPPS (associating microwave ablation and portal vein ligation for staged hepatectomy, AMAPS), which was successfully applied in the treatment of huge hepatocellular carcinoma with cirrhosis, and the procedure of operation was greatly simplified. Hence, AMAPS is feasible and safe in selected patients with primary hepatocellular carcinoma and cirrhosis.
Subject(s)
Humans , Carcinoma, Hepatocellular , Fibrosis , Hepatectomy , Hypertrophy , Ligation , Liver , Liver Cirrhosis , Microwaves , Portal VeinABSTRACT
AIM: To investigate the effectiveness of minimally invasive conjunctivorhinostomy for complete bicanalicular obstruction, and to evaluate the advantages, complications, and degree of satisfaction after this technique. ●METHODS: Twenty - two patients ( 22 eyes ) with complete bicanalicular obstruction were selected as the research subjects, all patients were treated by minimally invasive conjunctivorhinostomy. The post - operation follow- up lasted for 3 - 27mo. Medical records were reviewed for demographic data, surgical time, length of the tubes, duration of follow-up, patency of the tube, postoperative complications, whether satisfied or dissatisfied with this procedure. Meanwhile, the data was analyzed for evaluating the clinical efficacy of minimally invasive conjunctivorhinostomy. ●RESULTS: The overall operative success rate was 95%(21/22), and the overall patient satisfaction was 68% (15/22 ) . The post - operation complications included:granulation tissue proliferation of the lower end of the tube 2 cases (9%), middle turbinate blocked the opening of tube 3 cases ( 14%) , nasal mucosa covering the opening of tube 1 case ( 5%) , the tube was blocked by secreta 5 cases ( 23%) , foreign body sensation 10 cases (45%), dry eye 2 cases ( 9%), regurgitation of nasal secreta discharge 8 cases (36%). ●CONCLUSION: Minimally invasive conjunctivorhinostomy can treat the complete bicanalicular obstruction. This operation method is characterized by simplicity, high success rate, short operative time, less tissue trauma, less complications, without facial scarring, and it is worth clinical promotion.
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AIM: To investigate the efficacy of 23G minimally vitrectomy without irrigation in cataract phacoemulsification and trabeculectomy of malignant glaucoma, and to analyze such compound operative procedures for phakic malignant glaucoma. ●METHODS:A total of 21 phakic malignant glaucoma patients (21 eyes) underwent anterior vitrectomy without irrigation by using 23G vitrectomy. During surgical course phacoemulsification with anterior and posterior continuous circular capsulorhexis, trabeculectomy combined with iridectomy would be completed. lntraocular pressure, anterior chamber depth changes and postoperative complications were observed after the operation. ●RESULTS:ln the three-month follow-up, intraocular pressures were reduced from ( 57. 18 ± 6. 18 ) mmHg to (16. 15 ± 2. 43 ) mmHg, there was statistical difference compared with pre - operation ( P ● CONCLUSION: The compound surgical method of anterior vitrectomy combined with phacoemulsifier and trabeculectomy can effectively treat phakic malignant glaucoma. Early diagnosis and early compound surgery may effectively reduce the intraocular pressure of malignant glaucoma.
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The critical attribute was analyzed in clavulanate potassium tablet of amoxicillin according to the principle QbD. By investigation of the drug impurity profile, the cycle-closed dimer and penicilloic acid of amoxicillin were considered to be the critical impurities, and the sources and the degradation pathways of these two impurities were discussed. The research confirmed that crystal form was the critical attribute of drug substance. The drying process in the tablet granulation was regarded as the critical process parameter. The tablet formulation was also another factor in the impurity generation. This study provides a new idea for the evaluation of drug quality.
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Background and Objective: The results of epidemiologic studies on the relationship between the coffee consumption and pancreatic cancer risk were inconsistent. Thus, we performed an update meta-analysis of cohort studies to quantitatively summarize the association between coffee consumption and pancreatic cancer risk
Methods: We searched CBM [China Biology Medicine disc] and MEDLINE for studies of coffee consumption and pancreatic cancer risk up to June 2015. A total of 20 cohort studies were identified in this metaanalysis, and we analyzed these studies using random effects model. The dose-response analysis was conducted too
Results: The overall relative risk [RR] for highest coffee consumption versus lowest coffee consumption was 0.75 [95% Confidence Interval [CI], 0.63-0.86]. Statistic significant heterogeneity was found among these studies [I[2] =37.8%, P for heterogeneity =0.045]. The pooled RR for increment of 1 cup/day of coffee consumption was 0.99 [95%CI, 0.96-1.03] for the nine studies, without statistically significant
Conclusions: High coffee consumption is associated with a reduced pancreatic cancer risk. However, the result should be accepted with caution, due to the potential confounder and bias could not be excluded. Further well designed studies are needed to confirm the finding
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Furbenicillin is a broad-spectrum semisynthetic penicillin with strong antibacterial activity against Gram-negative bacteria. Furbenicillin sodium is determined by volumetric method in current criteria. However, the criteria does not contain an assay of related substances of furbenicillin sodium. In this study, we established a method for detection and analysis of furbenicillin sodium and its related substances by HPLC. The analysis was performed with a C18 column under a gradient elution, the detection wavelength was 225 nm, and the column temperature was 35 degrees C. The reliability and accuracy of established method was validated in this study. Pure samples of furbenicillin sodium and its related substances were prepared. The structures, biological activities, and chromatographic retention behaviors of furbenicillin sodium and its related substances were identified using NMR, CLSI agar dilution method, and HPLC. All results in the current study provide ample evidence that this method is able to determine the reasonable limits in the quality-control protocol for furbenicillin sodium.
Subject(s)
Anti-Bacterial Agents , Chemistry , Chromatography, High Pressure Liquid , Magnetic Resonance Spectroscopy , Penicillins , Quality Control , Reproducibility of ResultsABSTRACT
The molecular descriptors of impurities with known structure in cefdinir were calculated, selected and associated with the chromatographic retention behavior to establish a model. This quantitative structure retention relationships (QSRR) model for the related substances of cefdinir was established under specific chromatographic condition and verified by other impurities. 12 molecular descriptors were used to establish the QSRR model, F_AFRBWF, Blbn_J, SsCH3, SssCH2, SsNH2, SssNH, SssS, SHdCH2, EEM_AFc, EEM_AFpl, EEM_XFpl and Pi_MaxQ. The relativity between true values and predictions in QSRR of cefdinir is R2 = 0.9836 (n = 18), ΔRRT is no more than 0.154, as 10.17% in RRT. The results indicate that the QSRR model for the related substances of cefdinir can be used to evaluate the analysis methods for related substances and predict the chromatographic behavior of new impurities, which will provide a new way for the evaluation of the effectiveness for drug quality control.
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Cephalosporins , Chemistry , Reference Standards , Chromatography , Models, Chemical , Quality Control , Structure-Activity RelationshipABSTRACT
The article introduces the main changes related to specifications of antibiotics in the Chinese Pharmacopoeia 2015, and discusses the trend of the quality control of antibiotics. The main strategy of antibiotic quality control in this edition of Chinese Pharmacopoeia has been changed to chemical analysis, with biological assay as auxiliary. The revision not only keeps in line with international standards, but also fully reflects the status of domestic antibiotic manufacturing and the quality control level. Solving the key points of specifications of antibiotics through development of new technologies and analysis methods is the trend in the field of antibiotic control in China.
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Microbial control is one of the important parts of drug safety guarantee system. Chinese pharmacopoeia 2015 edition has constructed a complete system for pharmaceutical microbial control after continuous efforts since the 2005 edition. The new edition Chinese pharmacopoeia not only achieves the unity of three parts, but also makes harmonization between Chinese pharmacopoeia and ICH, thus is fully in line with international quality control system. In this paper, the revision progress of the last several editions of Chinese pharmacopoeia is reviewed. The main characteristics of pharmaceutical microbial control system in Chinese pharmacopoeia 2015 edition is clarified by revealing the formation process. The trend of this field in China is outlined by discussion on some hot issues.