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1.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 255-263, 2024.
Article in Chinese | WPRIM | ID: wpr-999183

ABSTRACT

Diabetic peripheral neuropathy(DPN) is a neurodegenerative disease of diabetes mellitus involving peripheral nervous system damage, which is characterized by axonal degenerative necrosis, Schwann cell apoptosis and demyelination of nerve myelin sheath as the main pathological features, this disease is highly prevalent and is a major cause of disability in diabetic patients. Currently, the pathogenesis of DPN may be related to oxidative stress, inflammatory response, metabolic abnormality, and microcirculation disorder. The treatment of DPN in modern medicine mainly starts from controlling blood glucose, nourishing nerves and improving microcirculation, which can only alleviate the clinical symptoms of patients, and it is difficult to fundamentally improve the pathological damage of peripheral nerves. Mitochondrial quality control refers to the physiological mechanisms that can maintain the morphology and functional homeostasis of mitochondria, including mitochondrial biogenesis, mitochondrial dynamics, mitochondrial oxidative stress and mitochondrial autophagy, and abnormal changes of which may cause damage to peripheral nerves. After reviewing the literature, it was found that traditional Chinese medicine(TCM) can improve the low level of mitochondrial biogenesis in DPN, maintain the balance of mitochondrial dynamics, inhibit mitochondrial oxidative stress and mitochondrial autophagy, and delay apoptosis of Schwann cells and neural axon damage, which has obvious effects on the treatment of DPN. With the deepening of research, mitochondrial quality control may become one of the potential targets for the research of new anti-DPN drugs, therefore, this paper summarized the research progress of TCM in treating DPN based on four aspects of mitochondrial quality control, with the aim of providing a theoretical research basis for the discovery of new drugs.

2.
Chinese Journal of Biologicals ; (12): 65-71, 2024.
Article in Chinese | WPRIM | ID: wpr-1006201

ABSTRACT

@#Objective To develop and verify a whole column imaging detection-capillary isoelectric focusing(WCID-CIEF)method for the determination of isoelectric point(pI)of pertactin(PRN).Methods The WCID-CIEF method for the determination of PRN antigen was developed by optimizing the parameters such as the focusing time and final concentration of samples in the WCID-CIEF process,and verified for the specificity,accuracy,repeatability,intermediate precision,durability and inter-batch consistency.Results The optimal focusing time of WCID-CIEF for the determination of PRN antigen pI was 1 min at 1 500 V and 3 min at 3 000 V. The optimal final concentration of PRN antigen was 300 μg/mL. The PRN antigen pI was about 6. 035,and the blank matrix showed no interference peak in the position of each peak of antigen. The method had good specificity,accuracy,repeatability,intermediate precision,durability and consistency among batches.Conclusion The developed WCID-CIEF method is suitable for the pI detection and charge heterogeneity analysis of PRN antigen,which can provide basis for the characterization of PRN antigen and reference for the quality control in the process of development and production of related vaccines.

3.
Chinese Journal of Biologicals ; (12): 1-7+16, 2024.
Article in Chinese | WPRIM | ID: wpr-1006189

ABSTRACT

@#Objective To analyze the trend of the hemagglutinin(HA) and ovalbumin contents in the lot release of influenza virus split vaccines in 2021,and evaluate the quality and quality control level of the vaccines.Methods The HA and ovalbumin content data of influenza virus split vaccines from two domestic enterprises in 2021 were collected and collated. The mean value and standard deviation were calculated according to the first 40 batches of data of the enterprise in the year,and the warning limit and action limit were established. The trend analysis of the above indexes was carried out to evaluate the stability and consistency of the product quality of the enterprise. Statistical data comparison and consistency analysis were made between the test results of the batch inspected by the lot release institution and the results of the enterprise.Results Through the retrospective data analysis of quadrivalent influenza virus split vaccines from two vaccine enterprises A and B,it was found that the content of H1N1 subtype HA and ovalbumin in the two enterprises and the content of Bv HA in the B enterprise had out of trend(OOT)situations,while the trend of other items was stable. The results of paired student's t test or Wilcoxon signed-rank test of the samples inspected by the lot release institution showed that except Bv subtype HA(t = 1. 094 and 0. 742 respectively)and ovalbumin(w =-64 and 36 respectively)contents showed no statistically significant difference(P > 0. 05),the HA contents of H1N1(t = 3. 862,w = 232),H3N2(t = 8. 225 and3. 473 respectively)and By(t = 5. 616 and 4. 934 respectively)of the two enterprises had significant differences(P <0. 05). The results of enterprises were generally higher than the lot release institution. Bland-Altman test analysis found that the consistency between the test data of enterprise A's HA content and the data of the lot release institution was better than that of enterprise B.Conclusion The stability and consistency of data trends of active ingredients and main impurity ingredients of quadrivalent influenza virus split vaccine batches in 2021 were generally good. The trend analysis can identify potential problems in vaccine production,and enterprises should carefully implement trend analysis and effectively monitor the product quality of vaccines.

4.
Journal of Pharmaceutical Practice ; (6): 1-5, 2024.
Article in Chinese | WPRIM | ID: wpr-1005419

ABSTRACT

Sprays have gained significant attention and widespread use due to their numerous advantages, including rapid action, safety, and convenience. They are widely used in various fields such as dermatology, respiratory disease treatment, wound repair, and central nervous system targeted drug delivery. With the in-depth research of new drugs and modern pharmaceutics, the development ideas of sprays are more diverse, and the application scenarios are increasingly extensive. In this review the clinical application status of sprays and the latest research progress were summarized. Then the quality control parameters were briefly introduced,which provided reference for the research and development of sprays.

5.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 12-20, 2024.
Article in Chinese | WPRIM | ID: wpr-1005248

ABSTRACT

In the quality control of Chinese medicine, the detection of active components and toxic and harmful components are two important links. Although conventional methods such as high performance liquid chromatography and liquid chromatography-mass spectrometry can accurately quantify the above substances, they have shortcomings such as complicated operation, high costs, inability of detection at any time, difficult detection of insoluble and macromolecular substances. Enzyme-linked immunosorbent assay (ELISA) can adsorb antigens or antibodies on the surface of solid carriers and realize qualitative or quantitative analysis of targets by using the specific reactions of antigens and antibodies. This method is praised for the simple operation, high sensitivity, strong specificity, simple requirements for experimental equipment, a wide application range, and low costs. In recent years, ELISA has been widely used in the quality control of Chinese medicine, especially in the content determination of mycotoxins represented by aflatoxin and the qualitative and quantitative analysis of active components. ELISA plays an increasingly important role with its unique advantages, providing new methods and ideas for the rapid quality examination of large quantities of Chinese medicines. This paper reviews the research progress in ELISA for the quality control of Chinese medicine in recent years and prospects its technical development and application prospects, aiming to provide reference and research ideas for further using this method to ensure the quality, safety, and controllability of Chinese medicine.

6.
Chinese Journal of Rehabilitation Theory and Practice ; (12): 125-140, 2024.
Article in Chinese | WPRIM | ID: wpr-1013369

ABSTRACT

ObjectiveTo analyze the medical services, quality and safety of rehabilitation medicine departments in general hospitals and rehabilitation hospitals in 2021 in perspectives of structure, segment and outcome quality. MethodsWe analyzed the data from National Clinical Improvement System of the National Health Commission, involving 9 328 hospitals, including all secondary and above general hospitals and rehabilitation hospitals, as well as traditional Chinese Medicine hospitals and integrated traditional Chinese and Western medicine hospitals in 2021. A total of 2 513 sampling hospitals that equipped with rehabilitation wards were included. ResultsAmong the 9 328 general hospitals surveyed this year, only 2 713 had rehabilitation wards. In general hospitals, the average number of physicians per bed in 56.77% hospitals, the average number of rehabilitation therapists per bed in 80.36% hospitals, and the average number of nurses per bed in 53.53% hospitals did not meet the national requirements, and the average number of rehabilitation medical personnel per bed in rehabilitation medicine departments in different regions was significantly different. The rates of early rehabilitation intervention were 13.45%, 20.67% and 29.74% respectively in department of orthopedics, department of neurology and intensive care units in general hospitals. The average improvement rate of activities of daily living of discharged patients was 77.87% in rehabilitation department of general hospitals, and 69.01% in rehabilitation hospitals. ConclusionIn 2021, professional medical services, quality and safety of rehabilitation medicine in China have improved steadily. However, most general hospitals in China still have not configured the rehabilitation wards, and there are problems such as the total number of rehabilitation medical personnel in the country does not meet the requirements, early rehabilitation intervention is significantly insufficient, and the implementation of important evaluation and therapies is deficient. The effect of rehabilitation still needs to improve. It is necessary to continuously promote capacity building of the medical rehabilitation to improve the quality of medical rehabilitation services.

7.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 148-155, 2024.
Article in Chinese | WPRIM | ID: wpr-1013351

ABSTRACT

ObjectiveTo establish a rapid and stable liquid chromatography-mass spectrometry(LC-MS) for simultaneous analysis of 17 chemical components in Gnaphalium affine aboveground parts with flowers, so as to provide experimental basis for improving the quality standard of this herb. MethodUltra performance liquid chromatography-quadrupole/electrostatic field orbitrap mass spectrometry(UPLC-Q-Exactive Orbitrap MS) was used for the quantitative analysis of 17 constituents in 15 batches of G. affine from different origins, the separation was performed on an ACQUITY UPLC® BEH C18 column(2.1 mm×100 mm, 1.7 μm) with the mobile phase of methanol(A)-0.1% formic acid aqueous solution(B) for gradient elution(0-1.0 min, 8%A; 1.0-4.0 min, 8%-26%A; 4.0-9.0 min, 26%A; 9.0-14.0 min, 26%-34%A; 14.0-14.5 min, 34%-45%A; 14.5-15.0 min, 45%-60%A; 15.0-18.0 min, 60%-90%A; 18.0-19.0 min, 90%A; 19.0-19.01 min, 90%-8%A; 19.01-20.0 min, 8%A), the flow rate was 0.3 mL·min-1, the column temperature was 40 ℃ and the injection volume was 2 μL. And the electrospray ionization was used with full scanning in both positive and negative ion modes, and the scanning range was m/z 100-1 000. ResultThe established method has been verified by the methodology and could be used for the simultaneous quantification of 17 components in G. affine. The content ranges of the 17 components(quinic acid, gallic acid, protocatechuic acid, neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, caffeic acid, 1,3-O-dicaffeoylquinic acid, isochlorogenic acid A, isoquercitrin, 1,5-O-dicaffeoylquinic acid, apigenin-7-O-glucoside, astragalin, isochlorogenic acid C, luteolin, apigenin and hispidulin) in 15 batches of G. affine samples was 39.60-179.12, 0.17-0.84, 2.41-8.38, 4.33-31.50, 13.63-180.38, 2.43-14.75, 1.16-19.68, 0.49-5.63, 55.77-445.16, 0.23-10.26, 62.04-530.10, 1.11-18.01, 11.36-90.61, 12.22-65.98, 7.22-69.84, 3.37-45.65, 0.30-2.59 μg·g-1, respectively. The content of organic acids was higher than that of flavonoids in G. affine, and the contents of 1,5-O-dicaffeoylquinic acid, isochlorogenic acid A, quinic acid and chlorogenic acid were higher. Meanwhile, the content of flavonoids in the samples from Guizhou was higher than that from Jiangsu, while the content of organic acids in the samples from Jiangsu was higher than that from Guizhou. ConclusionThe established method can be used for the rapid and accurate determination of 17 components in G. affine, which clarifies the content range of the main components in this herb, and can provide a reference for the selection of quality control markers of G. affine.

8.
Chinese Journal of Radiological Health ; (6): 61-67, 2024.
Article in Chinese | WPRIM | ID: wpr-1012772

ABSTRACT

Objective To provide a theoretical basis for radiation health supervision through an analysis of the situation of computed tomography (CT) equipment quality control and CT room radiological protection in Guangdong Province, China in recent years. Methods We collected the data of 392 times of CT quality control and radiological protection testing by a third-party radiological health technical service institution in Guangdong Province from 2019 to 2021. We analyzed the levels of CT-owning hospitals, CT manufacturers, CT quality control test results, and the pass rate of radiation protection tests. Results The examined CT scanners were from different levels of hospitals in Guangdong Province, and were manufactured by nine major CT equipment manufacturers at home and abroad. The pass rate of CT room radiological protection was 99.88%, and the ambient dose equivalent rates of five monitoring points exceeded the limit, with four at the control room door and one at the shield wall of the room. The overall pass rate of CT equipment quality control was 99.49%, and the non-conforming parameters were the accuracy of positioning light and the deviation of reconstructed slice thickness. Conclusion In recent years, CT equipment quality control and room radiation protection in Guangdong Province have been at a high level.

9.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 197-205, 2024.
Article in Chinese | WPRIM | ID: wpr-1012709

ABSTRACT

With the increasing incidence of diabetes mellitus in recent years, cardiomyopathy caused by diabetes mellitus has aroused wide concern and this disease is characterized by high insidiousness and high mortality. The early pathological changes of diabetic cardiomyopathy (DCM) are mitochondrial structural disorders and loss of myocardial metabolic flexibility. The turbulence of mitochondrial quality control (MQC) is a key mechanism leading to the accumulation of damaged mitochondria and loss of myocardial metabolic flexibility, which, together with elevated levels of oxidative stress and inflammation, trigger changes in myocardial structure and function. Qi deficiency and stagnation is caused by the loss of healthy Qi, and the dysfunction of Qi transformation results in the accumulation of pathogenic Qi, which further triggers injuries. According to the theory of traditional Chinese medicine (TCM), DCM is rooted in Qi deficiency of the heart, spleen, and kidney. The dysfunction of Qi transformation leads to the generation and lingering of turbidity, stasis, and toxin in the nutrient-blood and vessels, ultimately damaging the heart. Therefore, Qi deficiency and stagnation is the basic pathologic mechanism of DCM. Mitochondria, similar to Qi in substance and function, are one of the microscopic manifestations of Qi. The role of MQC is consistent with the defense function of Qi. In the case of MQC turbulence, mitochondrial structure and function are impaired. As a result, Qi deficiency gradually emerges and triggers pathological changes, which make it difficult to remove the stagnant pathogenic factor and aggravates the MQC turbulence. Ultimately, DCM occurs. Targeting MQC to treat DCM has become the focus of current research, and TCM has the advantages of acting on multiple targets and pathways. According to the pathogenesis of Qi deficiency and stagnation in DCM and the modern medical understanding of MQC, the treatment should follow the principles of invigorating healthy Qi, tonifying deficiency, and regulating Qi movement. This paper aims to provide ideas for formulating prescriptions and clinical references for the TCM treatment of DCM by targeting MQC.

10.
Organ Transplantation ; (6): 191-199, 2024.
Article in Chinese | WPRIM | ID: wpr-1012488

ABSTRACT

Since the 20th century, organ transplantation has become a breakthrough technology to effectively save the lives of patients with end-stage organ failure, which has significantly enhanced the quality of life of patients. Organ donation is an important source of organ transplantation. Improving the quality of donor organ procurement is the key to promote the translation of donor organs and improve the prognosis of organ transplantation recipients. The United States, Spain and other countries have put forward a series of policies and standards in the quality management and control of donor organ procurement and achieved positive results. In this article, related concepts of medical quality management and control, advanced strategies and models of international donor organ procurement quality management, and quality control measures of Organ Procurement Organization, donors and donor organs were reviewed, aiming to provide reference for establishing a quality management and control system of donor organs with "Chinese characteristics" and advancing high-speed and high-quality development of donor organ procurement.

11.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 215-224, 2024.
Article in Chinese | WPRIM | ID: wpr-1011461

ABSTRACT

As a Chinese saying goes, "good Chinese medicinal material makes good medicine", the quality of Chinese herbal medicines is related to the development prospect of Chinese medicine industry in China. With the rapid development of new technologies such as traceability methods and monitoring instruments, it is imperative to integrate and innovate traditional Chinese herbal medicines with new-generation information technology in view of the quality problems existing in the current production and circulation of Chinese herbal medicines, and it is of great significance for the construction of traceability system to ensure the quality and safety of Chinese herbal medicines and to promote the industry of Chinese herbal medicines to move towards high-quality development. This paper reviews the development history of the traceability system of Chinese herbal medicines in China, takes the influencing factors of the quality of Chinese herbal medicines as the entry point, and proposes that the construction of the traceability system should satisfy the traceability requirements of the characteristics of Chinese herbal medicines and their traditional medication experience. By analyzing the influencing factors of the quality of Chinese herbal medicines, it is pointed out that focusing on the influencing factors to build a traceability system is of great significance for targeting the problematic links at a later stage and exploring the interrelationship between environmental factors and the quality of Chinese herbal medicines. Based on the previous explorations, the author summarizes the system framework, functional modules and practical applications of the traceability system of Chinese herbal medicines, and looks forward to the development of a traceability system with risk early warning function and expert decision-making function in its functional development. Finally, based on the factors affecting the quality of Chinese herbal medicines, the author puts forward several thoughts on construction of the traceability system, and makes an in-depth analysis and puts forward a solution for the current situation that a unified, standardized and universal traceability system has not yet been built, with a view to providing ideas and references for the construction of traceability system of Chinese herbal medicines.

12.
Chinese Herbal Medicines ; (4): 27-41, 2024.
Article in English | WPRIM | ID: wpr-1010752

ABSTRACT

Traditional Chinese medicines (TCMs) possess a rich historical background, unique theoretical framework, remarkable therapeutic efficacy, and abundant resources. However, the modernization and internationalization of TCMs have faced significant obstacles due to their diverse ingredients and unknown mechanisms. To gain deeper insights into the phytochemicals and ensure the quality control of TCMs, there is an urgent need to enhance analytical techniques. Currently, two-dimensional (2D) chromatography, which incorporates two independent separation mechanisms, demonstrates superior separation capabilities compared to the traditional one-dimensional (1D) separation system when analyzing TCMs samples. Over the past decade, new techniques have been continuously developed to gain actionable insights from complex samples. This review presents the recent advancements in the application of multidimensional chromatography for the quality evaluation of TCMs, encompassing 2D-gas chromatography (GC), 2D-liquid chromatography (LC), as well as emerging three-dimensional (3D)-GC, 3D-LC, and their associated data-processing approaches. These studies highlight the promising potential of multidimensional chromatographic separation for future phytochemical analysis. Nevertheless, the increased separation capability has resulted in higher-order data sets and greater demands for data-processing tools. Considering that multidimensional chromatography is still a relatively nascent research field, further hardware enhancements and the implementation of chemometric methods are necessary to foster its robust development.

13.
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1535404

ABSTRACT

Introducción: La calidad de los datos facilita garantizar la fiabilidad de los estudios observacionales. Objetivo: Describir el aseguramiento y el control de calidad para mantener la fiabilidad y la validez del dato en un estudio de cohorte. Métodos: Presentar el manejo de datos implementado dentro de un seguimiento de enfermos renales crónicos cuya exposición fue un programa de protección renal comparado con el tratamiento convencional y su asociación con desenlaces clínicos. Se evaluó el cambio en la frecuencia de errores después de implementar el plan y la reproducibilidad del ingreso de registros a las bases de datos. Resultados: Se documentó una disminución progresiva en los errores cometidos en la captación de datos. El valor de Kappa entre los recolectores de la información para las variables clínicas más importantes fue 0,960 para la depuración de creatinina 150 mg/dL; 0,730 para la alteración del sedimento urinario; 0,956 para la asignación de estadio al ingreso. Los coeficientes de correlación intraclase para la identificación de las cifras de presión arterial sistólica fue 0,996; para la de presión arterial diastólica 0,993 y para los niveles de creatinina sérica al diagnóstico 0,995. Discusión: La calidad de los datos comienza con el reconocimiento de los retos y dificultades que implica su responsable captación, de ahí el aporte de la estandarización de los procesos y el personal que los lleve a cabo en forma idónea. Estudios evidencian que muchos procesos de mejora surgen en el desarrollo de la investigación sin protocolos preestablecidos. Conclusión: La reducción en la proporción y el tipo de error durante el proceso de captación de datos se debe a su identificación temprana y la corrección de instructivos, del instrumento de control de diligenciamiento y de la capacitación continua del personal. El análisis mostró una buena concordancia interevaluador.


Introduction: Data quality makes it easier to ensure that observational studies are reliable. Objective: To describe assurance and quality control to maintain data reliability and validity in a cohort study. Methodology: We present the data management strategies implemented in a study that followed patients of chronic kidney disease who were in a renal protection program and compared them with those undergoing conventional treatment to observe its association with clinical outcomes. We assessed the changes in error frequency after implementing the plan along with the reproducibility of the strategies for entering records into the databases. Results: We documented a progressive decrease of data collection errors. The Kappa values among data collectors for the most important variables were: 0.960 for creatinine clearance 150 mg/dl; 0.730 for urinary sediment alteration and 0.956 for stage allocation upon admission. The intraclass correlation coefficient for the identification of systolic blood pressure was 0.996; for diastolic blood pressure, the coefficient was 0.993 and for serum creatinine levels at diagnosis, the value was 0.995. Discussion: Data quality begins with the recognition of the challenges and difficulties involved in responsible data collection, hence the contribution of standardized processes and personnel to carry them out in a suitable manner. Studies show that many improvement processes arise in the development of research without pre-established protocols. Conclusion: The reduction in error ratio and type during the data collection process are the result of the early identification of erroneously entered or missing data, the correction of the guidelines for completing forms as well as of the instruments for detecting errors and continuous training of the staff. The analysis showed good inter-rater reliability.

14.
Rev. mex. anestesiol ; 46(2): 87-92, abr.-jun. 2023. tab, graf
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1508624

ABSTRACT

Resumen: Introducción: El diferimiento quirúrgico desde el inicio de la pandemia COVID-19 representa un riesgo para la salud de los pacientes y un reto para las instituciones sanitarias. La métrica de indicadores de productividad en quirófano, como la tasa de diferimiento quirúrgico, nos brindará información para planear estrategias basadas en evidencia científica que nos permitan mejorar la calidad de la atención. Objetivo: Determinar la tasa de diferimiento quirúrgico durante la pandemia COVID-19. Material y métodos: Se realizó un estudio, retrospectivo, descriptivo y transversal en el que se analizaron 297 pacientes cuyas cirugías fueron diferidas durante el período comprendido del 11 de marzo de 2020 al 10 de marzo de 2021. Para el análisis de variables se efectuó estadística descriptiva, utilizando medidas de tendencia central y dispersión, frecuencias simples y proporciones. Adicionalmente se realizó un diagrama de Pareto. La información fue procesada con SPSS v-25.0. Resultados: La proporción de diferimiento fue de 7.34%; 20.92% de las causas fueron atribuidas al paciente, 31.65% a causas médicas y 47.49% fueron logístico-administrativas. Conclusión: Las causas de diferimiento quirúrgico establecidas son evitables y revelan fracasos en los procesos logístico-administrativos que requieren planes de mejora continua.


Abstract: Introduction: Surgical deferral since the beginning of the COVID-19 pandemic represents a risk to the health of patients and a challenge for health institutions. The metric of productivity indicators in the operating room, such as the surgical deferral rate, will provide us with information to plan strategies based on scientific evidence that allow us to improve the quality of care. Objective: To determine the surgical deferral rate during the COVID-19 pandemic. Material and methods: A retrospective, descriptive and cross-sectional study was carried out in which 297 patients whose surgeries were deferred during the period from March 11, 2020 to March 10, 2021 were analyzed. Descriptive statistics were employed, using measures of central tendency and dispersion, simple frequencies and proportions. Additionally, a Pareto diagram was made. The information was processed with SPSS v-25.0. Results: The deferral rate was 7.34%. 20.92% of the causes were attributed to the patient, 31.65% to medical causes and 47.49% logistic-administrative. Conclusion: The established causes of surgical deferral are avoidable and reveal failures in the logistical-administrative processes that require continuous improvement plans.

15.
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1535126

ABSTRACT

Objetivo: Optimizar el control interno de calidad de RT-PCR en tiempo real para detección cualitativa de SARS-CoV-2, utilizando los valores Cq de controles negativos y positivos. Material y método: Estudio prospectivo-longitudinal. La muestra estuvo constituida por 143 valores Cq para los controles negativos de alicuotado y extracción, así como para el control positivo. Se analizó la distribución normal de los valores Cq mediante la prueba de Anderson-Darling (AD) y se aplicaron pruebas de aleatoriedad. Se calculó límites de control a partir de 51 valores Cq, para luego, mediante gráficas de control, monitorizar 92 valores Cq obtenidos desde noviembre del 2020 hasta marzo del 2021. Se evaluó aceptación de lote e índices Cpk como indicadores de optimización. Los cálculos se hicieron con el programa Minitab. Resultados: Se aceptaron los lotes de valores Cq y se obtuvieron índices Cpk superiores a 1.33 para los tres tipos de control. Discusión: No existen estudios publicados que apliquen control estadístico de calidad a la detección cualitativa de SARS-CoV-2. Conclusiones: Es posible utilizar los valores Cq de los controles para optimizar el control interno de calidad de RT-PCR en tiempo real para detección cualitativa de SARS-CoV-2, como si se tratara de una técnica de tipo cuantitativo.


Objective: To optimize the internal quality control of real-time RT-PCR for the qualitative detection of SARS-CoV-2, using the Cq values ​​of negative and positive controls. Material and method : Prospective-longitudinal study. The sample consisted of 143 Cq values for the negative aliquot and extraction controls, as well as for the positive control. The normal distribution of Cq values ​​was analyzed using the Anderson-Darling (AD) test and randomness tests were applied. Control limits were calculated from 51 Cq values, and then, using control charts, to monitor 92 Cq values ​​obtained from November 2020 to March 2021. Lot acceptance and Cpk indices were evaluated as optimization indicators. The calculations were made with the Minitab program. Results: The batches of Cq values ​​were accepted and Cpk indices higher than 1.33 were obtained for the three types of control. Discussion : There are no published studies that apply statistical quality control to the qualitative detection of SARS-CoV-2. Conclusions : It is possible to use the Cq values ​​of the controls to optimize the internal quality control of real-time RT-PCR for qualitative detection of SARS-CoV-2, as if it were a quantitative technique.

16.
Acta Pharmaceutica Sinica ; (12): 2047-2058, 2023.
Article in Chinese | WPRIM | ID: wpr-999118

ABSTRACT

The in vitro transcribed (IVT) mRNA technology has progressed rapidly and the application of mRNA vaccines in the COVID-19 pandemic made it become the most talked-about topic. Compared with protein drugs, IVT mRNA has a lower cost; it can be modular produced and its sequence can be modified easily, so it has a broad application prospect. However, due to its short history, mRNA drugs face the problem of lacking sufficient clinical data, and there is no quality control standard for mRNA drugs except mRNA vaccines. We overview the sequence design, delivery vectors, administration, application prospect and safety considerations of mRNA drugs. We also discussed the quality control of mRNA drugs briefly.

17.
Acta Pharmaceutica Sinica ; (12): 2771-2776, 2023.
Article in Chinese | WPRIM | ID: wpr-999011

ABSTRACT

The quality control of Chinese patent medicines containing animal-derived crude drugs is relatively difficult, because the effective constituents of most animal-derived crude drugs remain unknown. Even if there are relevant methods, they are usually qualitative, and quantitative indicators are either lacking or have poor specificity. This paper has proposed to use molecular quantitative technology to control the quality of Chinese patent medicines containing animal-derived crude drugs. In this study, a molecular quantitative method based on fluorescence quantitative PCR was established for the determination of Jinqian Baihua She in Jinlong Capsule. The method has good specificity, sensitivity, and repeatability. There is a good linear relationship between the content of DNA fragments and the CT (cycle threshold) value. The content of the Bungarus multicinctus-specific fragment in Jinlong Capsule is 24.1-46.6 IU·mg-1. It is suggested that the content of the specific fragment of Jinqian Baihua She should not be less than 19.3 IU·mg-1 as one of the quality control criteria of Jinlong Capsule. The study can provide a reference for the quality control of Chinese patent medicines containing animal-derived crude drugs.

18.
China Pharmacy ; (12): 2057-2062, 2023.
Article in Chinese | WPRIM | ID: wpr-987131

ABSTRACT

Since the Guangdong alliance launched the centralized procurement of Chinese patent medicine, manufacturers have engaged in fierce price competition to obtain the qualification for selection. In order to ensure that manufacturers have lowered the price without decreasing quality, the evaluation criteria for the quality of Chinese patent medicine is constructed on the basis of the characteristics of traditional Chinese medicine. The evaluation criteria consist of the production process and therapeutic effect evaluation. The evaluation indicators involve raw materials, processing and clinical use covering the whole life cycle of Chinese patent medicine. The evaluation of production process includes 3 secondary indicators (the quality of traditional Chinese medicine, the quality of traditional Chinese medicine decoction pieces and the quality of Chinese patent medicines) and 13 tertiary indicators (standardized production, quality inspection, processing specifications, technical processes, safety risk control, etc.), which fully reflect the quality control of key links in the production of Chinese patent medicine. The therapeutic effect evaluation includes 5 secondary indicators (theoretical origin of formulation, proactive research by production enterprises, evidence-based medical evidence, clinical use, and technological embodiment) and 18 tertiary indicators (theoretical sources, post-market effectiveness re- evaluation, clinical guidelines, expert consensus, etc.) to assess the quality and efficacy of Chinese patent medicine from multiple perspectives and levels. This study is a useful supplement to the scheme of centralized procurement of Guangdong alliance, which can not only provide data support for selecting “low-cost and high-quality” Chinese patent medicine, but also provide information reference for hospitals to make procurement decisions.

19.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 176-184, 2023.
Article in Chinese | WPRIM | ID: wpr-953938

ABSTRACT

Safety is the core of the quality of Chinese materia medica products, and microbial pollution caused by medicinal materials, decoction pieces, intermediate products and others can bring certain impact on the quality and safety of Chinese materia medica products. The reasons for this are not only the problems of medicinal materials themselves, but also the exogenous pollution introduced in the production process. How to effectively use microbial detection technology and establish an appropriate microbial quality control strategy in the whole process of Chinese materia medica production is of great significance to improve the quality of Chinese materia medica products. Therefore, the authors put forward a microbial quality control strategy in the whole process of Chinese materia medica production based on the guidance of quality by design (QbD) concept, emphasizing the scientific linkage between the internal and external microbial quality control systems to jointly ensure the quality of products in all aspects. Among them, the internal microbial quality control system includes the control of the whole chain of Chinese materia medica-decoction pieces-intermediate products-excipitents-packaging materials-final products, which should be carried out by stages and characteristics, while the external microbial quality control system includes the control of personnel-equipment and facilities-pharmaceutical water-environment, emphasizing the principle of quality risk management and the development of monitoring programs, aiming to closely integrate microbial quality risk management with the production process of Chinese materia medica products, and to classify and develop microbial control strategies in order to minimize the impact of contaminating microorganisms and effectively guarantee the quality of Chinese materia medica products.

20.
China Pharmacy ; (12): 62-66, 2023.
Article in Chinese | WPRIM | ID: wpr-953719

ABSTRACT

OBJECTIVE To determine the contents of 11 components in Xueli zhike syrup, establish its chemometric method and provide reference for its quality control. METHODS HPLC method was established to simultaneously determine the contents of amygdalin, deapi-platycoside E, platycoside E, platycodin D3, euscaphic acid, tormentic acid, maslinic acid, corosolic acid, praeruptorin A, praeruptorin B and praeruptorin E in 12 batches of Xueli zhike syrup. The quality evaluation of 12 batches of samples was performed by chemometrics. RESULTS The 11 components had good linear relationships within their respective ranges (r≥0.999 1); RSDs of precision, reproducibility and stability (24 h) tests were all lower than 2.00%. The average recovery rates ranged 96.90%-100.01% (RSDs were all lower than 2.00%). Cluster analysis showed that 12 batches of samples were clustered into 3 groups. Principal component analysis showed that the first two principal components could represent 88.53% information of 11 components in Xueli zhike syrup. Partial least squares-discrimination analysis showed that euscaphic acid, amygdalin and praeruptorin A were the main potential markers affecting the quality of Xueli zhike syrup. CONCLUSIONS The established method can be used to control the quality of Xueli zhike syrup.

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