Study on endpoint determination method of tablet coating based on 3σ criteria and logic regression / 中国中药杂志

This paper explores the statistical distribution characteristics of coating film thickness, so as to present a new method for determining coating endpoint based on 3σ criterion and logic regression. Firstly, the spectrum and thickness of 4 batch samples were collected. Secondly, the spectral range of normal products was obtained by 3σ criterion, with the spectral feature NI as the number of test spectrum in the above range. Then, the model based on 3σ criterion and logic regression was built according to the best condition in K-fold cross-validation and the determined threshold of qualified rate in the coating endpoint. Finally, the qualified rate of test set samples at different time points was calculated by the above model, and the above change trend and the threshold value were combined to determine the coating endpoint. The results of KS analysis showed the distribution of thickness of the qualified products followed the normal distribution(P=0.081>0.05). The accuracy of the coating endpoint determination was as high as 100% by the model based on 3σ criterion and logic regression when the determined threshold of qualified rate was 90%. Therefore, the 3σ criterion was feasible to the research of coating eligibility. This paper reveals certain random phenomena in the coating process, and the method features a high accuracy, quick analysis and a good interpretability, which provides a reference for online detection and qualify evaluation in future.

A near-infrared spectroscopy-based end-point determination method for the blending process of Dahuang soda tablets / 浙江大学学报（英文版）（B辑：生物医学和生物技术）

OBJECTIVES@#This study is aimed to explore the blending process of Dahuang soda tablets. These are composed of two active pharmaceutical ingredients (APIs, emodin and emodin methyl ether) and four kinds of excipients (sodium bicarbonate, starch, sucrose, and magnesium stearate). Also, the objective is to develop a more robust model to determine the blending end-point.@*METHODS@#Qualitative and quantitative methods based on near-infrared (NIR) spectroscopy were established to monitor the homogeneity of the powder during the blending process. A calibration set consisting of samples from 15 batches was used to develop two types of calibration models with the partial least squares regression (PLSR) method to explore the influence of density on the model robustness. The principal component analysis-moving block standard deviation (PCA-MBSD) method was used for the end-point determination of the blending with the process spectra.@*RESULTS@#The model with different densities showed better prediction performance and robustness than the model with fixed powder density. In addition, the blending end-points of APIs and excipients were inconsistent because of the differences in the physical properties and chemical contents among the materials of the design batches. For the complex systems of multi-components, using the PCA-MBSD method to determine the blending end-point of each component is difficult. In these conditions, a quantitative method is a more suitable alternative.@*CONCLUSIONS@#Our results demonstrated that the effect of density plays an important role in improving the performance of the model, and a robust modeling method has been developed.

A near-infrared spectroscopy-based end-point determination method for the blending process of Dahuang soda tablets / 浙江大学学报（英文版）（B辑：生物医学和生物技术）

Objectives: This study is aimed to explore the blending process of Dahuang soda tablets. These are composed of two active pharmaceutical ingredients (APIs, emodin and emodin methyl ether) and four kinds of excipients (sodium bicarbonate, starch, sucrose, and magnesium stearate). Also, the objective is to develop a more robust model to determine the blending end-point. Methods: Qualitative and quantitative methods based on near-infrared (NIR) spectroscopy were established to monitor the homogeneity of the powder during the blending process. A calibration set consisting of samples from 15 batches was used to develop two types of calibration models with the partial least squares regression (PLSR) method to explore the influence of density on the model robustness. The principal component analysis-moving block standard deviation (PCA-MBSD) method was used for the end-point determination of the blending with the process spectra. Results: The model with different densities showed better prediction performance and robustness than the model with fixed powder density. In addition, the blending end-points of APIs and excipients were inconsistent because of the differences in the physical properties and chemical contents among the materials of the design batches. For the complex systems of multi-components, using the PCA-MBSD method to determine the blending end-point of each component is difficult. In these conditions, a quantitative method is a more suitable alternative. Conclusions: Our results demonstrated that the effect of density plays an important role in improving the performance of the model, and a robust modeling method has been developed.

Interpretation for the group standards in technical specification of long-term follow-up for end point in large population-based cohort study / 中华流行病学杂志

Long-term follow-up for end point is an extremely important and arduous task in large population-based cohort studies, which is also the key to the success of large cohort studies. Thus, the fundamental question of the achievements above is how to construct a large population- based cohort in a standardized way. The Chinese Preventive Medicine Association coordinated experienced researchers from Zhejiang Provincial Center for Disease Control and Prevention and other professional institutes to write up the group standard entitled Technical specification of long-term follow-up for end point in large population-based cohort study (T/CPMA 002-2019). The standard is drafted with principles of emphasizing the scientific, normative, applicability, and feasible nature. This group standard recommended the follow-up target population, time, content, methods, quality control, and indicators assessment. The standard aims to guide the large population-based cohorts that have been or intended to be established in China, including national cohorts, regional population cohorts, and special population cohorts, hence, to improve domestic scientific research level and the international influence, and to support decision-making and practice of disease prevention and control.

An increase in heart rate variability can be an index for end point of resuscitation in trauma patients / 中华创伤杂志(英文版)

PURPOSE@#The measurement of heart rate variability (HRV) is a non-invasive method to analyze the balance of the autonomic nervous system. The aim of this study was to compare the changes of HRV and base deficit (BD) during the treatment of trauma patients.@*METHODS@#Forty-three trauma patients with a low injury severity scores (ISS < 24) and negative base excess on admission were included in this study. Based on the BD changes, patients were divided into three groups: 'end pointed' group (n = 13), patients' BDs instantly cleared after primary hydration; 'needs further resuscitation' group (n = 21), patients' BDs did not reach the end point and thus required further hydration or packed red blood cells transfusion; and 'hydration minimal change' group (n = 9), patients' BDs lower than 2.5 mmol/L at the onset of admission and thereafter had minimal change (near normal range). The changes in HRV during fluid resuscitation were detected and compared to BD changes in their arterial blood gases. All data were analysed using the SPSS software Version 15.0. Repeated measures ANOVA was used to determine the changes in HRV, heart rate, blood pressure, and BD among groups.@*RESULTS@#A significant reverse correlation was found between the BD ratio and the HRV ratio (r = -0.562; p = 0.01). The HRV of patients with aggravated BDs after fluid resuscitation was decreased. There was an increase in HRV at the time of BD clearance. A decrease in HRV after primary crystalloid hydration bore a significant connection with the need for an ICU (p = 0.021) and transfusion of packed red blood cells (p < 0.001).@*CONCLUSION@#Increase in HRV may be a new non-invasive index for the end point of resuscitation in trauma patients.

Application of 4+ 1 photography in determining the end point of double eyelid surgery / 中华整形外科杂志

Objective@#To explore the practicability and reproducibility of judgment method and assessment indexes for the end point of double eyelid surgery using 4+ 1 photography in supine position.@*Methods@#From 2017 October to 2018 October, 158 patients were included and randomly divided into 2 groups. Photos were taken by 4 + 1 photography in supine position of 79 patients, while other 79 patients in control group were evaluated by traditional observation. By 4+ 1 photography in supine position, the surgeon stood at the head side of the patient, taking photos with eyes movement: looking straight forward, looking up, looking downward and eye-closed. It was to observe the upper eyelid creases, upper and lower tissues of double eyelid creases, and upper and lower eyelid margo palpebrae. In addition, the surgeon looked from patient′s feet to observe the indexes such as upper margo palpebrae, to make a decision whether the surgery could finish. In control group, the surgeon observed the upper eyelid creases, upper and lower tissues of double eyelid creases and upper and lower eyelid margo palpebrae. The patient has to sit if necessary.@*Results@#All 158 patients were performed double eyelid surgery successfully. Average times of valuating end point was 1.20 by 4+ 1 Photography in supine position, and 1.53 in control group. The operation time of 4+ 1 photography group is (151.65±21.58) s, and control group were (241.53±33.53) s. The satisfaction level was increased to 89.87% in 4+ 1 photography group, compared to 78.48% in control group.@*Conclusions@#The 4+ 1 Photography method is simple and easy to practice. The observation indexes are accurate and comprehensive. It is useful in determining the end point of double eyelid plasty in supine position.

Research Progress on Rehmanniae Radix Preparata / 世界科学技术-中医药现代化

This paper is based on the literature of the last ten years by summarizing and analyzing the progress in the study of Rehmanniae Radix, focusing on the research progress are reviewed at the dynamic changes of the main Chemical indicators of Rehmanniae Radix Preparata, objective expression of four kinds of processed products (Steamed, steamed with wine, wine stew, ancient law (steamed for nine times and shined for nine times) ) and the objective expression of four kinds of processed products and the change of the pharmacological effects.There are many objective expression methods for processing end points of different processed products of Rehmanniae Radix Preparata, But processing are unclear until now. Innovative research on standardized unification and new research ideas are needed.

Application Values of Intraaortic Palloon Pumping in the Treatment of Acute Left Heart Failure / 现代生物医学进展

Objective:To evaluate the application values of intraaortic palloon pumping in the treatment of acute left heart failure.Methods:From February 2013 to January 2016,102 patients in our hospital for diagnosis and treatment of acute left heart failure were selected as the research object,all the patients were equally divided into the observation group and control group with 51 patients in each group according to the random draw envelope principle.The control group was given routine drug treatment,the observation group was given intraaortic palloon pumping treatment based on the treatment in control group,the prognosis of two groups were observed and compared between two groups.Results:The total effective rate of observation group and control group were 96.1％ and 84.3 ％,respectively,which was significantly higher in the tobservation group than that of the control group (P＜0.05).The LVEF values in the observation group and control group after treatment were 65.22 ± 4.52 ％ and 58.20 ± 5.31％ respectively,which were significantly higher than those before treatment 45.29± 5.14 ％ and 45.20± 4.89 ％,and the LVEF value of observation group was significantly higher than that of the control group (P＜0.05).After 6 months' treatment,the incidence of death,refractory ischemia,malignant arrhythmia and other recent primary end points in the observation group was 5.9 ％,the control group was 21.6 ％,which was significantly higher than that of the observation group (P＜0.05).Conclusion:Aortic balloon pump implantation could promote the improvement of left ventricular function,improve the treatment effect,reduce the occurrence of recent primary end point event in the treatment of acute left heart failure.

Research on whole blending end-point evaluation method of Angong Niuhuang Wan based on QbD concept / 中国中药杂志

The blending end-point determination of Angong Niuhuang Wan (AGNH) is a key technology problem. The control strategy based on quality by design (QbD) concept proposes a whole blending end-point determination method, and provides a methodology for blending the Chinese materia medica containing mineral substances. Based on QbD concept, the laser induced breakdown spectroscopy (LIBS) was used to assess the cinnabar, realgar and pearl powder blending of AGNH in a pilot-scale experiment, especially the whole blending end-point in this study. The blending variability of three mineral medicines including cinnabar, realgar and pearl powder, was measured by moving window relative standard deviation (MWRSD) based on LIBS. The time profiles of realgar and pearl powder did not produce consistent results completely, but all of them reached even blending at the last blending stage, so that the whole proposal blending end point was determined. LIBS is a promising Process Analytical Technology (PAT) for process control. Unlike other elemental determination technologies such ICP-OES, LIBS does not need an elaborate digestion procedure, which is a promising and rapid technique to understand the blending process of Chinese materia medica (CMM) containing cinnabar, realgar and other mineral traditional Chinese medicine. This study proposed a novel method for the research of large varieties of traditional Chinese medicines..

Research progress of on-line monitoring technology for drug powder blending process / 中国药学杂志

Blending process is one of the key links of the pharmaceutical process, since the uniformity of drug products not only affects the appearance but also influences homogeneity and stability of the intrinsic quality, and then affects the efficacy of the products. Therefore, to ensure the safety and effectiveness of drugs, it is necessary to analyze and control the uniformity of the drug powder in the process of blending. Compared with the traditional method for the end point determination of the blending process, online monitoring technology has obvious advantages and broad application prospects. This paper summarized the research progress of online monitoring technologies for blending process in the pharmaceutical industry. Firstly, four kinds of online monitoring technologies were introduced and compared, which were the near infrared spectroscopy, thermal sensing technology, Raman spectroscopy and chemical imaging technology. Then the methods and principles of on-line monitoring algorithms were summarized and expounded. After that, a brief introduction of the application of near infrared monitoring equipment for pharmaceutical blending process was given. And then the research progress of the online monitoring of the blending process in the domestic pharmaceutical industry was summarized. Finally, the development trend of online monitoring technology of blending process was looked into the future.

The role of serum magnesium level in type 2 diabetes mellitus.

Background: Diabetes mellitus is one of the most common metabolic disorder and leading cause of death and disability in the world. The incidence of diabetes is increasing globally and in India. Magnesium depletion has a negative impact on glucose homeostasis and insulin sensitivity in patients with type 2 diabetes. Hypomagnesaemia can lead to development of complications in diabetes. Hence there is need for the study to explore the status of magnesium in type 2 diabetes. Objectives: To estimate and compare the serum magnesium levels in type 2 diabetes patients with age/sex matched non diabetic controls. Methods: A case control study was done in randomly chosen 100 type 2 diabetic patients and 100 non diabetic age/sex matched controls. Estimation of serum magnesium was done by enzymatic end point method. Results: 37% of diabetic patients had low serum magnesium levels (Mg2+ level ≤1.5 mg/dL) and 9 % of controls had low serum magnesium levels. The mean serum magnesium levels were 1.96 ± 0.54 mg/dL and 2.375 ± 0.449 mg/dL in diabetics and controls respectively (P value <0.0001 highly significant). Hypomagnesaemia (Mg2+ level ≤1.5 mg/dL) was correlating with retinopathy (P = 0.041 significant). Conclusion: This study demonstrated that low serum Mg2+ status is common in type 2 diabetes mellitus patients when compared to non-diabetic controls. It may be prudent in clinical practice to periodically monitor plasma Mg2+ concentration in diabetic patients. If plasma Mg2+ is low, an intervention to increase dietary intake of magnesium may be beneficial to prevent the complications.

Evaluation on effect of ultrafiltration technology on endotoxin removal from recombinant MUC1-MBP fusion protein / 吉林大学学报(医学版)

Objective To evaluate the effectiveness of ultrafiltration technology in endotoxin removal from purified recombinant MUC1-MBP fusion protein (MUC1-MBP)and to demonstrate the effect of ultrafiltration on endotoxin removal.Methods CM Sepharose FF weak cation exchange (CM)(CM group), CM combined with Phenyl Sepharose 6 FF exchange (C6)(CM+C6 group),CM combined with ultrafiltration (CM+ultrafiltration group), and CM combined with C6 and ultrafiltration (CM+C6+ultrafiltration group)were used to purify the MUC1-MBP from E.coli. and remove endotoxin;the expression level of endotoxin was detected by Chromogenic End-point Tachypleus Amebocyte Lysate.Results There was a single band at the expected molecular weight of 62 000 by SDS-PAGE analysis.and the purity>96% by Quantity One analysis.The endotoxin levels in CM group and CM +C6 group were quite high and there was no significant difference between two groups (P>0.05 );the endotoxin level in CM+ultrafiltration group was significantly lower than that in CM group, and there was significant difference (P0.05 ). Conclusion The effects of CM or CM combined with C6 on endotoxin removal are quite poor, especially C6;CM combined with ultrafiltration are quite effective on endotoxin removal,and ultrafiltration plays an important role in endotoxin removal.

Analysis of influence factors on hepatitis B virus relapse after nucleos(t)ide analogues withdrawal in the chronic hepatitis B patients who met nucleos (t) ide analogues cessation criteria / 中华传染病杂志

Objective To explore the influence factors on hepatitis B virus (HBV) relapse after nucleos(t)ide analogues (NA) withdrawal in the chronic hepatitis B (CHB) patients who met NA cessation criteria. Methods Eighty-one consecutive CHB patients were treated with NA, 38 with lamivudine (LAM), 25 with adefovir dipivoxil (ADV), 12 with entecavir (ETV), 6 with LAM +ADV. Among recruited patients, 40 were hepatitis B virus e antigen (HBeAg) positive, 41 were HBeAg negative, 67 of them were initial treatment, 14 were retreatment due to resistance to NA at baseline. The treatment was discontinued after meeting China therapeutic end-point criteria. HBV DNA, HBV serological markers, alanine aminotransferase (ALT) were measured respectively at baseline, every month before virological response, every 3 months after virological response, every month within first 6 months and every 2 months over 6 months after drugs withdrawal. Twelve probable influence factors on relapse which were sex, age, HBV family history, baseline HBV DNA,baseline HBeAg status, baseline ALT, virological response time, total duration of treatment, duration of additional treatment, the level of hepatitis B virus surface antigen (HBsAg) at cessation therapy,initial treatment or retreatment, drug category were analyzed with univariate, multivariate Cox regression modle and stratified analysis. The cumulative relapse was calculated by the Kaplan-Meier method. Results A total of 36 patients (44. 4%) relapsed within 1 year. Initial treatment or retreatment, HBV family history, virological response time, the level of HBsAg at cessation therapy were independent risk factors. The relapse rate of retreatment was higher than that of initial treatment (78.6% vs 37. 3% , χ2 = 7. 983, P = 0. 005) , those of patients with HBV family history higher than without family history (64. 5% vs 15.0%, χ2 =12. 096,P = 0.002), those of patients obtained virological response within 3 months lower than after 3 months(34. 0% vs 64. 3% , χ2 =6. 823,P=0. 009) , those of patients with HBsAg≤150 μg/L at cessation therapy lower than >150 μg/L(27. 6% vs 53. 8%, χ2=5. 199,P=0. 023). Conclusions Retreatment, HBV family history, later virological response and higher HBsAg level at cessation therapy are risk factors of relapse after NA withdrawal. Such patients should be treated with prolonged duration after meeting end-point criteria to strengthen the efficacy.

The hemodynamic "target": a visual tool of goal-directed therapy for septic patients

OBJECTIVE: To improve understanding of the hemodynamic status of patients with sepsis by nursing teams through the attainment of hemodynamic parameters using a pentaxial "target" diagram as a clinical tool. Parameters include cardiac index (CI), arterial oxygen saturation (SaO2), mean arterial pressure (MAP), arterial blood lactate, and central venous oxygen saturation (ScvO2). METHODS: Design: Prospective descriptive study. Setting: The intensive care unit of a university hospital. Patients: During a 6-month period, 38 intubated septic shock patients were included in the study. Survivors and nonsurvivors were compared. Interventions: MAP, CI, SaO2, ScvO2 and lactate were measured at 0, 6, 12, 24, 36, and 48 h. Measurements were recorded on the target diagram along with the norepinephrine infusion rate and the hemoglobin (Hb) level. The number of lactate and ScvO2 measurements achieved during the target period were compared to a 6-month retrospective control period just before starting the protocol. We assessed the nurse knowledge status prior to the introduction of target diagram. We then performed a post-test after implementing the new recording technique. MEASUREMENTS AND RESULTS: The nursing team expressed a positive attitude toward the target concept. The mean number of lactate and ScvO2 measurements performed for each patient during the control period was significantly lower than during the target period, and those values were rarely used as goal values before the introduction of the target diagram. At 24 hours, 46 percent of the survivors had achieved all the goal parameter values of the target diagram, compared to only 10 percent of nonsurvivors (P = .01). CONCLUSION: The target diagram is a visual multiparametric tool involving all the medical and nursing team that helps achieve goal-directed therapy for septic patients. The number of goal values reached at each time point during the first 48 hours was closely linked to mortality.

OBJETIVO: Melhorar a compreensão do "status" hemodinâmico de pacientes em sepse pelas equipes de enfermagem através da obtenção de parâmetros hemodinâmicos usando um diagrama-alvo pentaxial como ferramenta clínica. Os parâmetros usados foram índice cardíaco, saturação arterial de oxigênio, pressão arterial media, lactato sangüíneo arterial e saturação venosa central de oxigênio. MÉTODOS: Estudo descritivo prospectivo, realizado na Unidade de Terapia Intensiva de um Hospital Universitário. Pacientes: Durante um período de 6 meses, 38 pacientes intubados em choque séptico foram incluídos no estudo. Foram comparados sobreviventes vs. não sobreviventes. Intervenções: Os cinco parâmetros referidos foram medidos nas horas 0, 6, 12, 24, 36 e 48. As medidas foram registradas no diagrama alvo, juntamente com a velocidade de infusão de norepinefrina e nível de hemoglobina. O número de medidas de lactato e saturação venosa central de oxigênio realizado durante o período de estudo foi comparado com um período retrospectivo de 6 meses imediatamente precedendo a introdução do protocolo. Avaliamos o nível de conhecimento das equipes de enfermagem antes da introdução do diagrama-alvo. Após a realização do protocolo realizamos uma nova avaliação. MEDIDAS E RESULTADOS: A equipe de enfermagem exprimiu uma atitude positiva em relação ao conceito de diagrama alvo. O número de medidas de lactato e saturação venosa central de oxigênio foi significativamente menor durante o período controle anterior ao protocolo. E os valores medidos raramente foram empregados como valores meta antes da introdução do diagrama-alvo. Na medida de 24 horas, 46 por cento dos sobreviventes haviam atingido todas as metas do diagrama-alvo, contra apenas 10 por cento dos não sobreviventes (P = 0,01). CONCLUSÃO. O diagrama-alvo é uma ferramenta visual multiparamétrica envolvendo, as equipes médicas e de enfermagem, que auxilia a obtenção de uma estratégia terapêutica para pacientes...

Comparison between Real-Time PCR and Agarose Gel Electrophoresis for DNA Quantification / 대한진단검사의학회지

BACKGROUND: Real-time polymerase chain reaction (PCR) is generally regarded as a very accurate and time-saving method, but it is expensive to run. We evaluated the reliability of an inexpensive and a researcher-friendly gel electrophoresis-based PCR method for the quantification of mRNA, and the results were compared with those obtained by real-time PCR. METHODS: We compared the results of relative quantification for MMP-1 measured by real-time PCR and by ethidium bromide stained-agarose gel electrophoresis after end-point PCR. RESULTS: There was significant but very weak correlation between real-time PCR and end-point PCR for relative quantification of MMP-1 (r=0.16, P<0.01). CONCLUSIONS: Our results suggest that the use of the gel electrophoresis-based end-point PCR is inappropriate for quantifying mRNA. Therefore, in order to confirm the result of relative quantification by end-point PCR, the newly established real-time PCR method or northern hybridization should be applied.

Far Prognostic Clinical Study on Patients of Medicinal Bracket Operation of Coronary Artery with Salvia Tablet / 浙江中医药大学学报

0.05) between both groups on re-infarction rate, PCI operation, in-hospital rate of heart diseases and post-operation stroke;while there’s statistical meaning(P

Value of Chemosensitivity Assay In Vitro on Breast Cancer / 中国普外基础与临床杂志

Objective To explore the value of chemosensitivity assay in vitro on breast cancer.MethodsIn vitro chemosensitivity of 6 species of chemotherapeutic agents applied to 38 cases of breast cancer patients were detected by tissue culture-end point staining-computer image analysis(TECIA).ResultsThe sensitivity to chemotherapeutic agents commonly used in the breast cancer level from high to low was as follow:Doxorubicin(ADM),Paclitaxel(TAX),Vinorelbine(NVB),Cyclophosphamide(CTX),Cisplatin(DDP)and Fluorouracil(FU).ConclusionDrugs sensitivity experiment of cancer in vitro by TECIA has an important value to instruct clinical medication and individual chemotherapy for breast cancer.

FT-IR spectroscopy in quality control of the processing techniques of Radix Rehmanniae Preparata with millet wine / 中成药

AIM: To study the process of Radix Rehmannia Preparata and find “the proper processing end point”, then standardize the slice. METHODS: Monolithic surveillance to the process and analyzing the change of the characteristic peaks between dried Radix Rehmannia and Radix Rehmannia Preparata by FT IR spectroscopy. RESULTS: We can know the dynamic change in Radix Rehmannia Preparata during the convenient processing course by the FT IR spectroscopy. CONCLUSION:FT IR is a powerful measure to standardize processing techniques, standardize the slice on the base of traditional processing experiences.