Effects of Bifidobacterium triple viable bacteria on serum micro-inflammation, nutritional status and endpoint events in elderly peritoneal dialysis patients / 中华老年医学杂志

Objective:To observe the changes of serum micro-inflammatory and nutritional status in elderly peritoneal dialysis patients after treatment with bifidobacterium triple viable bacteria, and the impact of Bifidobacterium triple viable bacteria treatment on the endpoint.Methods:Totally 180 elderly patients receiving peritoneal dialysis were divided into control group and observation group, with 90 cases in each.Both groups were treated on the basis of the routine treatment, the observation group was treated with oral Bifidobacterium triple viable bacteria for twelve months.Before treatment, 6 months and 12 months after treatment, fasting venous blood from the patients in the two groups were collected in the morning.The levels of serum micro-inflammatory indexes[tumor necrosis factor-α(TNF-α), interleukin-6(IL-6), interleukin-8(IL-8), C-reactive protein(CRP)]were detected by ELISA.The nutritional status and dialysis adequacy indexes[nutritional status: albumin(ALB), hemoglobin(Hb), transferrin(TRF), prealbumin(PA), calcium ion, phosphorus ion; indicators of dialysis adequacy: serum creatinine(Scr), blood uric acid(BUA), blood urea nitrogen(BUN), cystatin C(Cys-c)levels]were detected by automatic blood biochemical analyzer.After 24 months of follow-up, the occurrence of endpoint events(peritonitis, abdominal pain, malnutrition, abdominal infection, cardiovascular and cerebrovascular accidents)in the two groups was recorded.Results:After 24 months of treatment, the levels of TNF-α, IL-6, IL-8 and CRP in the two groups were lower than those before treatment, and the observation group was lower than control group[(25.7±4.0)μg/L vs.(33.6±6.0)μg/L, (2.9±0.7)ng/L vs.(4.9±1.2)ng/L, (17.0±7.2)ng/L vs.(22.8±7.9)ng/L, (4.6±0.7)mg/L vs.(6.9±1.2)mg/L]( t=10.272, 13.134, 5.040, 15.575, respectively, P<0.05 for all). After 24 months of treatment, the levels of ALB, Hb, TRF, PA and calcium ion of the two groups were higher than before treatment, and the levels of phosphorus ion were lower than before treatment, and the changes of the above indicators in observation group were more obvious than those in the control group[(45.7±5.2)g/L vs.(39.8±4.9)g/L, (72.7±8.0)g/L vs.(68.6±9.0)g/L, (4.3±1.0)g/L vs.(3.0±0.6)g/L, (321.5±29.0)mg/L vs.(297.6±25.1)mg/L, (4.9±1.3)mmol/L vs.(2.9±0.9)mmol/L, (1.3±0.9)/L vs.(1.8±0.3 mmol/L)]( t=7.737, 3.213, 9.880, 5.9 00, 11.937, 4.415, P<0.05 for all). There was no significant difference in intestinal flora between the two groups before treatment( P>0.05). After 24 months, an increase was observed in Lactobacilli and Bifidobacteria in both groups, while Enterobacteria and Enterococcus in both groups were decreased, and the changes of the above indicators in the observation group were also more obvious than those in the control group[(8.4±0.9)IgCFU/g ratio(6.4±0.9)IgCFU/g, (8.8±1.3)IgCFU/g ratio(7.9±1.3)IgCFU/g, (7.1±0.9)IgCFU/g ratio(8.0±1.1)IgCFU/g, (5.4±0.7)IgCFU/g ratio(6.9±0.9)IgCFU/g]( t=14.248, 4.339, 5.825, 12.753, P<0.05 for all). There was no significant difference in dialysis adequacy index between the two groups before treatment( P>0.05 for all). After 24 months of treatment, the levels of Scr, BUA, BUN and Cys-C in both groups decreased, and those of the observation group were lower than those of the control group[(471.5±50.5)μmol/L vs.(623.3±62.6)μmol/L, (17.5±0.5)mmol/L vs.(20.6±1.8)mmol/L, (16.4 ± 3.0)mmol/L vs.(22.5±2.0)mmol/L, (1.9±0.5)mg/L vs.(3.0±0.7)mg/L]( t=17.877, 14.976, 15.842, 11.749, P<0.05 for all). The incidence of endpoint events in the observation group was significantly lower than that in the control group(12.2% vs.2.2%, t=6.574, P<0.05 for all). Conclusions:After the treatment of Bifidobacterium triple viable bacteria in elderly peritoneal dialysis patients, the micro-inflammatory state of the patients was reduced, the nutritional status was improved, and the incidence of endpoint events was low, and has high clinical promotion and application value.

Comparative study on the methods to determine disintegration time of oral soluble films / 药学学报

Disintegration time is a key parameter that affects the palatability and compliance of oral soluble films. At present, there is no standard method to determine the disintegration time of oral soluble films. In this study, we compared the six methods (pharmacopoeial disintegration method, petri dish method, sponge surface method, slide frame and ball method, partially immersed into liquid (without weight attached) and partially immersed into liquid (with weight attached)) to determine the in vitro disintegration time of oral soluble films with different thickness, and evaluated the correlation with the in vivo disintegration time. The results showed that the repeatability and correlation of pharmacopoeial disintegration method and the partially immersed into liquid method (with weight attached) were excellent, with the endpoint of disintegration testing easy to determine. Partially immersed into liquid method (with weight attached), properly simulating the physiological condition in oral cavity, showed strong operability, good repeatability and in vitro-in vivo correlation, and was suitable for in vitro disintegration evaluation of oral soluble film dosage form. The adult sensory evaluation study was a research-based clinical trial conducted with informed consent from all subjects in accordance with the ethical requirements of Good Clinical Practice.

Significance of emerging clinical oncology endpoints in support of overall survival

Despite a better understanding of the pathophysiology and development of newer therapeutic options, cancer remains an area with several unmet needs. Although overall survival (OS) remains a gold standard endpoint for all cancer therapies, it poses challenges such as the requirement of a long?term follow?up, a higher number of patients, and a higher financial burden. Therefore, surrogate endpoints such as progression?free survival, time to progression, duration of response, and objective response rate are being investigated and used in oncology studies. Patient?related outcomes that measure the patient抯 overall health, quality of life, and satisfaction in the long term are crucial surrogate endpoints considered for drug approval. Surrogate endpoints shorten oncology clinical studies and accelerate the evaluation and implementation of newer therapies. Emerging surrogate endpoints such as biomarkers, immune?related response criteria, minimal residual disease, and pathological complete response are increasingly being considered in oncology trials. Validation of surrogate endpoints enables their substitution for OS and gain market approval. The selection of surrogate endpoints for an oncology trial depends on cancer type and stage, the purpose of treatment, and expected duration of survival for the relevant disease. With the advent of individualized approach and complex study designs, the field of oncology is currently undergoing a paradigm shift. The use of newer surrogate endpoints will aid in accelerating the drug development process, making patient care for oncology more accessible

The Use of Lipoprotein-Associated Phospholipase A2 in a Chinese Population to Predict Cardiovascular Events / 生物医学与环境科学（英文）

Objective@#To explore associations between lipoprotein-associated phospholipase A2 (Lp-PLA2) and the risk of cardiovascular events in a Chinese population, with a long-term follow-up.@*Methods@#A random sample of 2,031 participants (73.6% males, mean age = 60.4 years) was derived from the Asymptomatic Polyvascular Abnormalities Community study (APAC) from 2010 to 2011. Serum Lp-PLA2 levels were determined by enzyme-linked immunosorbent assay (ELISA). The composite endpoint was a combination of first-ever stroke, myocardial infarction (MI) or all-cause death. Lp-PLA2 associations with outcomes were assessed using Cox models.@*Results@#The median Lp-PLA2 level was 141.0 ng/mL. Over a median follow-up of 9.1 years, we identified 389 events (19.2%), including 137 stroke incidents, 43 MIs, and 244 all-cause deaths. Using multivariate Cox regression, when compared with the lowest Lp-PLA2 quartile, the hazard ratios with 95% confidence intervals for developing composite endpoints, stroke, major adverse cardiovascular events, and all-cause death were 1.77 (1.24-2.54), 1.92 (1.03-3.60), 1.69 (1.003-2.84), and 1.94 (1.18-3.18) in the highest quartile, respectively. Composite endpoints in 145 (28.6%) patients occurred in the highest quartile where Lp-PLA2 (159.0 ng/mL) was much lower than the American Association of Clinical Endocrinologists recommended cut-off point, 200 ng/mL.@*Conclusion@#Higher Lp-PLA2 levels were associated with an increased risk of cardiovascular event/death in a middle-aged Chinese population. The Lp-PLA2 cut-off point may be lower in the Chinese population when predicting cardiovascular events.

Determination of Reference Values for Alpha-N-Acetylglucosaminidase Activities in Patients with Sanfilippo Type B Disease and Control Population in Colombia

Abstract Sanfilippo B is a lysosomal disorder characterized by the pathological accumulation of heparan sulfate. It is caused by mutations in the NAGLU gene that codes for the alpha-N-acetylglucosaminidase enzyme. The objective of this study was to determine the reference values and frequency of Sanfilippo B in Colombia through an enzyme analysis of leukocytes extracts. We aim to inform the community and the health system so that they can work in a preventive way, providing an early diagnosis of patients and thus providing an appropriate management of the symptoms. We carried out an endpoint assay that indirectly quantifies NAGLU activity through the cleavage of 4-methylumbelliferone from the 4-methylumbelliferyl-2-acetamido-2-deoxy-α-D-glucopyranoside substrate. The activity of 463 healthy volunteers (Range: 0.6 - 4 nmol/mg/h, Median: 1.69 +/- 0.73) as well as 462 patients referred for clinical suspicion, was calculated. From the last group, 7 cases turned out to be positive (Range: 0 - 0.24 nmol/mg/h, Median: 0.13 +/- 0.09). The cut-off point according to ROC analysis between affected patients and controls was 0.42 nmol/mg/h. To our knowledge, this study is the first in Colombia where an estimated frequency of Sanfilippo type B is calculated by providing enzyme activity ranges and a cut-off point.

Time to untreatable progression is an appropriate surrogate endpoint for overall survival in patients with hepatocellular carcinoma after transarterial chemoembolization

Aims: The aim of the study was to determine whether the time to progression (TTP) or time to untreatable progression (TTUP) is an appropriate surrogate endpoint for overall survival (OS) in patients with hepatocellular carcinoma (HCC) after transarterial chemoembolization (TACE). Materials and Methods: Eighty-four patients with Barcelona clinic liver cancer (BCLC) stage B or C HCC underwent TACE. The correlations of TTP and TTUP with OS were evaluated after a log transformation of the indicated values. After identifying independent prognostic factors of TTP, TTUP, and OS, the partial correlations of TTP and TTUP with OS were analyzed in all patients and subgroups. Subsequently, the prognostic value of TTP and TTUP was compared by the multivariate survival analysis of OS. Results: Both the BCLC stage and tumor number were correlated with TTP and TTUP. In addition, the BCLC stage, initial treatment failure, and sorafenib administration were associated with OS. In all patients, the correlation coefficients of TTP and TTUP with OS were 0.559 and 0.789, respectively. Adjustment for independent prognostic factors yielded partial correlation coefficients which were 0.433 and 0.697, respectively. Furthermore, OS was found to be associated with TTUP (P = 0.003; hazard ratio: 0.253; 95% confidence interval: 0.10–0.63) but not with TTP. Conclusion: Untreatable progression is more representative of clinical progression in patients with HCC who underwent TACE. In the current study, TTUP is a more appropriate surrogate endpoint for OS than TTP. Future studies should explore whether untreatable progression is a valuable endpoint event in clinical trials or an indicator of the need for second-line therapy

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.

Judgment on decocting endpoint of decoction in "Treatise on Febrile Diseases" and "Treatise on Differentiation and Treatment of Epidemic Febrile Disease" / 中草药

The time of decocting plays an important role in ensuring the clinical efficacy of Chinese medicine decoction and the quality of traditional Chinese medicine, but from ancient times to the present, the judgment of the endpoint of Chinese medicine decoction has always been a technical problem. In this paper, the decocting time and the judgment methods in the Chinese medicine classics "Treatise on Febrile Diseases" and "Treatise on Differentiation and Treatment of Epidemic Febrile Disease" were analyzed. Certain laws of decocting time were found. It was demonstrated that the main factors affecting the decocting time were the disease, the efficacy of the prescriptions, the drug properties, and the characteristics of the medicine, etc. Combined with modern research results, the judgment method of the endpoint of traditional Chinese medicine decoction was expounded, hoping to seek a reasonable scientific basis for the boiling time of Chinese medicine decoction and the extraction process of modern Chinese medicine preparation, and provide a theoretical basis for ensuring the clinical efficacy of Chinese medicine decoction and the quality of Chinese medicine preparations.

Statistical consideration in the design of COVID-19 clinical trials in emergency / 中国临床药理学与治疗学

The outbreak of coronavirus disease 2019 (COVID-19) led to the first-level response to major public health emergencies in China. To explore the therapy of COVID-19, hundreds of clinical studies were conducted. For major public health emergencies, it is important to find out the effective drug and therapeutic regimen as soon as possible for the control of disease, which raises the claim of timeliness to the trials conducted in emergency, especially to the registered clinical trials. This paper discusses the choice of clinical endpoint and related questions in the design of clinical trials in emergency from the statistical perspective.

Bowel Sound Signal Identifcation of Whole Abdomen Based on Voice Endpoint Detection / 中国医疗器械杂志

Bowel sounds are one of the important physiological signals of the body,and different bowel sounds can reflect different gastrointestinal states.In this paper,long time bowel sound data is obtained with wearable full belly bowel sound recorder which is independent designed.After adaptive noise cancellation and wavelet threshold denoising,voice endpoint detection method based on short-time energy is used to identify effective bowel sounds.Experiments and results show that the sound recorder is simple and reliable.Through processing,analysis and endpoint detection algorithm,the recognition accuracy of effective bowel sounds is high,which has certain clinical practicality and research significance.

Guideline Recommendation for Endpoints Used in Clinical Trials for Functional Dyspepsia / 대한소화기학회지

Functional dyspepsia is a disease, in which there is no organic lesion but chronic and repetitive postprandial fullness, early satiation, epigastric pain, and epigastric burning. Functional dyspepsia is not life-threatening but its symptoms are relapsing and remitting and persist over a lifetime, limiting the social life and reducing the quality of life. Therefore, the treatment for acute relapsing period may help improve the short-term symptoms. Continuous medication may be needed to improve the long-term symptoms. Research designs to demonstrate the short-term efficacy of therapeutic agents may differ from clinical trials to demonstrate long-term efficacy. There are many difficulties in clinical trial design, implementation, and screening because there are no international standards of clinical trials for functional dyspepsia. The purpose of this guideline recommendation is to develop a standard for clinical trials, such as clinical trial subjects and evaluation methods, in the development of therapeutic agents for functional dyspepsia. The ultimate aim is to enhance the safety and efficacy of therapeutic agents for functional dyspepsia and promote the development of new therapeutic agents.

An endpoint-detection algorithm of surface electromyography insensitive to electrocardiogram interference / 生物医学工程学杂志

Surface electromyography (sEMG) has been widely used in the study of clinical medicine, rehabilitation medicine, sports, etc., and its endpoints should be detected accurately before analyzing. However, endpoint detection is vulnerable to electrocardiogram (ECG) interference when the sEMG recorders are placed near the heart. In this paper, an endpoint-detection algorithm which is insensitive to ECG interference is proposed. In the algorithm, endpoints of sEMG are detected based on the short-time energy and short-time zero-crossing rates of sEMG. The thresholds of short-time energy and short-time zero-crossing rate are set according to the statistical difference of short-time zero-crossing rate between sEMG and ECG, and the statistical difference of short-time energy between sEMG and the background noise. Experiment results on the sEMG of rectus abdominis muscle demonstrate that the algorithm detects the endpoints of the sEMG with a high accuracy rate of 95.6%.

Prevention and Treatment of Traditional Chinese Medicine for Heart Failure Caused by Coronary Heart Disease Based on Endpoint Events: Ideas and Methods of Evidence-Based Optimization / 世界科学技术-中医药现代化

Objective: This paper analyzed the present clinical researches of traditional Chinese medicine (TCM) in the treatment of heart failure caused by coronary heart disease and discusses the ideas and methods of evidence-based optimization. Methods: PubMed, EMBASE, Cochrane Library, CNKI, WanFang, VIP and CBM were searched to screen the clinical studies of TCM for treating heart failure caused by coronary heart disease. The problems and solutions were discussed by evaluating the risk of bias of the studies and analyzing the outcomes compared with the Cochrane systematic reviews of chronic heart failure. Results: A total of 32 clinical researches were included and the methodological quality of the studies was generally low. In addition, few studies assessed the endpoint events, mortality and readmission, as the primary outcomes in their trials, which is significantly different from the outcomes concerned in the Cochrane systematic reviews. Conclusion: It is really critical to improve the methodological quality of the trials and to choose the endpoint events as the primary outcomes in the evidence-based optimization of the prevention and treatment of TCM for heart failure caused by coronary heart disease Chinese medicine.

Rapid Judgement of Blending Endpoint of Jingqi Shuangshen Capsules and Content Determination of Astragaloside Ⅳ by AOTF-NIR / 中国药房

OBJECTIVE:To establish the method for rapid judgement of blending endpoint of Jingqi shuangshen capsules and content determination of astragaloside Ⅳ. METHODS:AOTF-NIR combined with principal component analysis and Moving Block Standard Deviation method was used to identify the blending endpoint. First derivative combined with savitzky-golay filter method were used to spectrum pretreatment. The partial least square method was used to establish quantitative analysis model of the content of astragaloside Ⅳin mixed endpoint sample. The content of astragaloside Ⅳ in mixed endpoint sample was determined by HPLC-ELSD to validate the model. RESULTS:Methodology validation of content determination of astragaloside Ⅳ in mixed material sample and mixed endpoint sample was in line with the requirements. NIR monitoring results showed that the product reached the blending endpoint after 30 min. The results of NIR monitoring were generally consistent with the results of HPLC-ELSD. The principal component dimension of the quantitative model was 9;determination coefficients was 0.954 9;Root Mean Square of Calibration of the model was 0.039 2;Root Mean Square Error of Prediction of the model was 0.042 6. Predicted average value of astragaloside Ⅳ by NIR was 11.74 mg/g,and measured average value of astragaloside Ⅳ by HPLC-ELSD was 11.38 mg/g;average deviation was 3.16%. CONCLUSIONS:AOTF-NIR can rapidly judge the blending endpoint sample of Jingqi shuangshen capsules,rapidly determine the content of astragalosideⅣin mixed endpoint material,improve the quality control level of blending process and shorten blending cycle.

A duplex endpoint PCR assay for rapid detection and differentiation of leptospira strains

Abstract INTRODUCTION: This study aimed to develop a duplex endpoint PCR assay for rapid detection and differentiation of Leptospira strains. METHODS: Primers were designed to target the rrs (LG1/LG2) and ligB (LP1/LP2) genes to confirm the presence of the Leptospira genus and the pathogenic species, respectively. RESULTS: The assay showed 100% specificity against 17 Leptospira strains with a limit of detection of 23.1pg/µl of leptospiral DNA and sensitivity of 103 leptospires/ml in both spiked urine and water. CONCLUSIONS: Our duplex endpoint PCR assay is suitable for rapid early detection of Leptospira with high sensitivity and specificity.

Development and Application of Surrogate Endpoints in FDA's Drug Review Process / 中国药学杂志

OBJECTIVE: To figure out the regulatory models and concepts of FDA in drug review process that promotes surrogate endpoints development. METHODS: This paper made a thorough research to the FDA regulations, guidance documents and guidelines and literatures, and through historical retrospective of surrogate endpoints used in clinical drug trials and regulatory acceptance, interpretation of FDA's established development model in scientific use of surrogates, combined with the status quo surrogate endpoints in the field of serious diseases as cancer, AIDS, diabetes. RESULTS AND CONCLUSION: Then conclusion of FDA's experience in promoting regulation and utility of surrogate endpoints is summed up, including the development of guidelines to promote common understanding of specific use of surrogates; combining a variety of programs promote the development of surrogate endpoints; and using a risk-based classification in favor of the allocation of resources.

Establishment of near-infrared on-line monitoring model and determination of endpoint in frying process of Hordei Fructus Germinatus / 中国中药杂志

Hordei Fructus Germinatus has been always used by "stir-frying" as a traditional medicine and the endpoint judgment of "fragrant" and "yellow" has been the focus and difficulty in frying process research. In this study, a quantitative calibration model between index components and NIRS was established in order to rapidly detect the contents of reducing sugar, total amino acids, total flavonoids, A420 and moisture; besides, an endpoint judgment method of frying process was put forward based on the "component change rate". Near-infrared spectra of samples with different frying time were collected, and a quantitative analysis model based on near-infrared spectroscopy was established to optimize the parameters such as spectral pretreatment and modeling band. HCA and PLS-DA were used to study the relationship between component and "stir-frying", and the endpoint of frying process was determined. The established calibration model had a good performance that the correlation coefficients between the predicted results and the actual measured values were both more than 0.9, with predicted relative deviations less than 10%. Hordei Fructus Germinatus with different frying time was divided into 4 categories by HCA analysis. PLS-DA analysis showed that total reducing sugar had a significant contribution to distinguishing the Hordei Fructus Germinatus of different frying time. When the change rate of total reducing sugar was 80%, it could judge that the endpoint of frying had been obtained. Results showed that NIRS could not only quickly and accurately determine the contents of reducing sugar, total amino acid, total flavonoid, A420 and moisture in Hordei Fructus Germinatus samples of different frying time, but also judge the endpoint of frying in the process. This study provided a new method for the evaluation and endpoint judgment of "stir-frying" process in research of traditional Chinese medicine.

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..