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1.
Semina cienc. biol. saude ; 42(1): 71-80, jan./jun. 2021. Tab
Article in Portuguese | LILACS | ID: biblio-1247939

ABSTRACT

O mel de abelha é um produto de consumo relevante pela população devido aos seus fatores nutricionais e terapêuticos. A adulteração é um exemplo de como as características do mel podem ser afetadas, prejudicando os consumidores que desejam comprar produtos puros e de alta qualidade. Este trabalho teve como objetivo avaliar a qualidade físico-química do mel de abelha comercializado em Brasília, Distrito Federal. Foram obtidas 13 amostras de mel de abelhas: uma de um apicultor da região com certificação de produção (usada como controle negativo), seis de lojas de produtos naturais e hipermercados no centro de Brasília e seis de feira livre e pequenos estabelecimentos de uma região administrativa do Distrito Federal, das quais cinco não tinham o selo do Serviço de Inspeção Federal (SIF) na embalagem. Também foi usada uma amostra comercial de xarope de glicose como controle positivo. Para verificar a adulteração, foram adotados os testes de Lund, Fiehe e Lugol, bem como as análises de pH, acidez titulável e umidade, para serem comparados com os parâmetros de qualidade do mel estabelecidos pela legislação vigente. As análises verificaram a qualidade dos méis comercializados com o selo SIF, com algumas ressalvas para a possível alteração de temperatura. Já as que não possuíam selo, apenas uma foi aprovada nos testes de qualidade, porém sua venda não é regularizada. A maioria das amostras analisadas apresentaram resultados consistentes com os padrões exigidos pela legislação vigente, com maiores irregularidades na comercialização de méis em feira livre, mostrando a necessidade de maior controle de qualidade e inspeção de produtos não certificados.(AU)


Bee honey is a product of relevant consumption by the population due to its nutritional and therapeutic factors. Tampering is an example of how honey characteristics can be affected and harming consumers who want to buy a high quality and pure product. This work aimed to evaluate the physicochemical quality of bee honey commercialized in Brasília, Federal District. Thirteen samples of bee honey were obtained: one from a certified local beekeeper (used as a negative control), six from natural products and hypermarkets in central Brasília and six from street fair and small establishments in one of the administrative region of the Federal District, of which five did not have the seal of the Federal Inspection Service (SIF) on the packaging. Also, a sample of commercial glucose syrup was used as positive control. To verify tampering, the Lund, Fiehe and Lugol tests were adopted, as well as the pH, titratable acidity and humidity analysis, to be compared honey quality parameters established by the current legislation. The analyzes verified the quality of the honeys sold with SIF seal, with some restraints for the possible temperature changes. As for those that did not have a seal, only one passed the quality tests, but its sale is not regularized. Most of the samples analyzed showed results consistent with the standards requirements of the current legislation, with greater irregularities in the marketing of honey in street fair, showing the need for greater quality control and inspection of non-certified products.(AU)


Subject(s)
Animals , Bees , Quality Management , Honey , Quality Control , Product Packaging
2.
San Salvador; MINSAL; ene. 27. 2021. 50 p. ilus.
Non-conventional in Spanish | LILACS, BISSAL | ID: biblio-1177125

ABSTRACT

El presente documento establece los procedimientos de la Unidad de Aseguramiento de la Calidad/ Laboratorio de Control de Calidad, el desarrollo de cada una de las arreas que la conforman para realizar la evaluación de la calidad de los medicamentos e insumos médicos que son adquiridos a través de las diferentes compras del MINSAL, facilitando la ejecución de las mismas y contribuyendo a delimitar dichas actividades


This document establishes the procedures of the Quality Assurance Unit / Quality Control Laboratory, the development of each of the areas that make it up to carry out the evaluation of the quality of drugs and medical supplies that are acquired through of the different purchases of the MINSAL, facilitating their execution and helping to delimit said activities


Subject(s)
Quality Control , Manuals as Topic , Quality Management
3.
Afr. J. Clin. Exp. Microbiol ; 22(4): 448-456, 2021.
Article in English | AIM | ID: biblio-1342108

ABSTRACT

Background: Risk assessment is the means of identifying and evaluating potential errors or problems that may occur in testing process. The aim of this study was to perform risk assessment of antimicrobial susceptibility testing (AST) process in clinical microbiology laboratories of Niamey, Niger Republic. Methodology: We conducted a descriptive cross-sectional study from October 1 to December 31, 2019, to evaluate AST performance in seven clinical microbiology laboratories at Niamey, the capital city of Niger republic. The evaluation focused on the determination of the criticality index (CI) of each critical point (frequency of occurrence of anomalies, severity of the process anomaly, and detectability of the anomaly during the process) in the AST process and the performance of the AST through an observation sheet using two reference strains; Escherichia coli ATCC 25922 and Staphylococcus aureus ATCC 29213. Results: The criticality index (CI) was greater than 6 for most of the critical points related to material, medium, equipment, method and labour for the AST process in all the laboratories. A range of 18-100% errors on the inhibition zone diameters of the reference strains were observed. Major and/or minor categorization (Sensitive S, Intermediate I and Resistance R) discrepancies were found at all the laboratories for either one or both reference strains. The antibiotics most affected by the S/I/R discrepancies were trimethoprim (100%), vancomycin (100%), amoxicillin (80%) and amoxicillin + clavulanic acid (70%). Conclusion: This study showed a deficiency in the control of critical control points that impacts the performance of the AST reported by the laboratories in Niger. Corrective actions are needed to improve the performance of AST in clinical microbiology laboratories in Niger


Subject(s)
Humans , Quality Control , Microbial Sensitivity Tests , Medical Laboratory Science , Microbiology , Critical Illness , Niger
4.
Article in Chinese | WPRIM | ID: wpr-879128

ABSTRACT

In the past few years, continuous manufacturing(CM) has been put forward by the FDA. Pharmaceutical enterprises are encouraged to promote the implementation of CM, which has become a hot research direction of pharmaceutical technology. In February 2019, the FDA issued a draft guideline for the implementation of CM, which greatly promoted the development of CM and provided reference for continuous manufacturing of traditional Chinese medicine(TCM). The production process of TCM is a complex system. With the innovation of production equipment and the promotion of automation and informatization of TCM production, the exis-ting policies, regulations and traditional production control capacity are difficult to meet the market demand for high-quality TCM pro-ducts. In this paper, we reviewed the new technologies and methods of quality control in accordance with the characteristics of TCM production by referring to modern manufacturing technology, information technology and quality control technology. Based on the "QbD" theory and "PAT" technology, process knowledge system(PKS), an advanced control strategy, was proposed to provide a reference for the implementation of CM in TCM production.


Subject(s)
Commerce , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality Control , Technology, Pharmaceutical
5.
Article in Chinese | WPRIM | ID: wpr-879120

ABSTRACT

Post-marketing evaluation of traditional Chinese medicine(TCM) is an important research stage in the life cycle of a drug, and the add-on-design is a common method for its post-marketing evaluation. This article introduces the basic concept of add-on-design, and points out that it is suitable for use based on the principles of medical ethics when the standard treatment should not be interrupted. The post-marketing evaluation of TCM should be carried out based on human experience and in compliance with regulations and ethics. The clinical values of TCM, such as the therapeutic effect for disease, improvement of disease symptoms, improvement in quality of life, as well as the synergism and toxicity attenuation of combined use of TCM and chemical drugs, should be fully reflected through the clinical trials designed with add-on-design. The key points of add-on-design are accurate clinical positioning, scientific estimation of sample size, and rigorous standard treatment. Standard treatment should be a recognized one, consistent and stable; appropriate and recognized efficacy indicators and targeted safety indicators should be selected; the design and operation of clinical research scheme should meet the requirements of randomization and blind method, with special emphasis on the production of qualified placebo. The add-on-design has the advantages that the rights and interests of the subjects are adequately protected. Besides, the research conclusions are easily put into clinical application. But there are also many difficulties, such as the influence of confounding bias, the "ceiling" effect of clinical efficacy, and the difficulty of interpretation of adverse events. Therefore, a rigorous research quality assu-rance system should be established, and the quality control of evaluation consistency of researchers should be emphasized to ensure strict quality control in the research process.


Subject(s)
Drugs, Chinese Herbal , Humans , Marketing , Medicine, Chinese Traditional , Quality Control , Quality of Life
6.
Article in Chinese | WPRIM | ID: wpr-879089

ABSTRACT

Traditional Chinese medicine(TCM) injections boast a definite efficacy and have been widely used in clinic. However, the problems in medication safety have been attracted increasing attention. Pharmacokinetics is of significance to guiding TCM injection administration regimen design and improving safety and effectiveness in clinical use. In recent years, with the improvement of ideas, technology and methods of TCM studies, the pharmacokinetic studies of TCM injections have been broadly performed, with a notable progress. This paper reviewed the advance in pharmacokinetics studies of TCM injections in recent ten years, which mainly focused on pre-clinical concentration-time course, distribution, metabolism and excretion in vivo based on analysis techniques, pharmacokinetic interactions of constitutes, impact of pathological state, pharmacokinetic interactions between TCM injection and chemical drugs, and clinical pharmacokinetics studies of TCM injections, in the expectation of providing reference for studies on quality control, product development and rational clinical use of TCM injections.


Subject(s)
Drugs, Chinese Herbal , Injections , Medicine, Chinese Traditional , Quality Control
7.
Article in Chinese | WPRIM | ID: wpr-879082

ABSTRACT

Since "the implementation of good clinical practice"(GCP), especially after 2015, the overall quality of new drug cli-nical trials in China has made significant progress, but compared with developed countries, there are still some obvious quality problems in clinical trials in China. Clinical trials of new drugs of traditional Chinese medicine are an important part of clinical trials of new drugs in China. In addition to some common problems in all clinical trials, there are also some special quality problems. In terms of security data, such as the collection of human safety data is not standardized, the management and judgment of unexpected serious adverse reactions(SUSAR) were not professional and timely, the relationship between adverse events and trial drug was not fully judged by investigator, In terms of effective data, such as primary efficacy outcome of the scale cannot be traced, TCM syndrome data cannot meet the requirements of "source data" in the revised GCP and the quality of traditional Chinese medicine placebo is not high, in terms of overall quality system construction, the sponsors and research institutions have not established a quality assurance system that conforms to the characteristics of new drug research of traditional Chinese medicine, etc. The quality of clinical trials of new drugs of traditional Chinese medicine is based on the current GCP and ICH-GCP in China, we should also consider the characteristics of clinical trials of new traditional Chinese medicine drugs, and formulate targeted quality control measures according to the characteristics of these new drugs of traditional Chinese medicine, to improve the overall quality of clinical trials of new drugs of traditional Chinese medicine in China, which has important strategic significance for promoting the research and development of new drugs of traditional Chinese medicine in China.


Subject(s)
China , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , Quality Control
8.
Article in Chinese | WPRIM | ID: wpr-879078

ABSTRACT

Collecting and summarizing human use experience(HUE) data, forming high-quality data and evidences that can be used for evaluation are the key links of HUE research on traditional Chinese medicine(TCM). The collection, collation and summary of human experience data were discussed in this paper. It is pointed out that the collection of HUE should be focus on the source of prescription of new traditional Chinese medicines, and be summarized based on dialectical thinking, experience in medication, characte-ristics of prescription and clinical application. The collected contents include prescription, process, clinical location and applicable population, efficacy data and safety data, etc. The methods include interview, clinical data summary and data mining. When the data formed based on HUE information is used as drug registration information, it is necessary to ensure that the data source is legal and compliant, and the ownership of intellectual property is clear.Data sources should meet the requirements of medical ethics. To avoid conflict of interest, data analysis should be conducted by an independent third party. It is necessary to develop the quality control measures of HUE data to ensure the data traceability, integrity, consistency and accuracy, and avoid data bias.The data of HUE should include the key data such as accurate clinical location and applicable population, recognized clinical efficacy and safety.After the formation of HUE, the statistical analysis plan of empirical data of human use should be formulated. Through strict data processing, statistical analysis and clinical interpretation, HUE can be produced for evaluation.


Subject(s)
Data Collection , Drugs, Chinese Herbal , Humans , Medicine, Chinese Traditional , Prescriptions , Quality Control
9.
Article in Chinese | WPRIM | ID: wpr-879073

ABSTRACT

Assessment of the status property(boiling time) is a challenge for the quality control of extraction process in pharmaceutical enterprises. In this study, the pilot extraction process of Phellodendron chinense was used as the research carrier to develop an online near-infrared(NIR) quality control method based on the status property(boiling time). First, the NIR spectra of P. chinense were collected during the two pilot-scale extraction processes, and the status property(boiling time) was assessed by observing the state of bubbles in the extraction tank using a transparent window during the extraction process, which was then used as a reference standard. Based on the moving block standard deviation(MBSD) algorithm, the assessment model using online NIR spectra for boiling time during extraction process was established. In addition, the model was optimized as follows: standard normal variable(SNV) for spectral pretreatment, modeling band of 800-2 200 nm, and window size of 4. The results showed that, with 0.002 0 as the MBSD model threshold, the boiling time can be accurately assessed using online NIR spectra during extraction process. Furthermore, the principal component analysis-moving block standard deviation(PCA-MBSD) model was developed by our group to reduce the influence of online NIR spectral noise and background signal on the model, and the number of principal components was optimized into 2 in the PCA-MBSD model. The results showed that, with 0.000 075 as the PCA-MBSD model threshold, the boiling time can be accurately assessed using online NIR spectra during extraction process, with improved reliability. This study can provide a assessment method for boiling time during extraction process using online NIR spectra, which can replace the empirical judgment in manual observation, and realize the digitalization of the extraction process for big brand traditional Chinese medicine.


Subject(s)
Medicine, Chinese Traditional , Principal Component Analysis , Quality Control , Reproducibility of Results , Spectroscopy, Near-Infrared
10.
Article in Chinese | WPRIM | ID: wpr-879072

ABSTRACT

The physical properties of powder and granules are the critical quality attributes for the process control of Suhuang Zhike Capsules, a big brand traditional Chinese medicine. This paper took the production of 25 batches of real-world Suhuang Zhike Capsules dry extract powder and granules intermediates as the research object. Firstly, a method for testing the physical properties of Suhuang Zhike Capsules powder and granules with 19 physical indicators was established. The results showed that the granules of dry extract powder after granulation had a smaller particle size, wider particle size distribution range and poor fluidity, which easily caused the problem of over-limit capsule loading. Secondly, correlation analysis, principal component analysis and cluster analysis were used for mathematical statistics. The correlation analysis showed that the density of dry extract powder could affect the chroma and fluidity. At the same time, the particle size in the granules had a stronger effect on the chroma and fluidity than the density. The study also found that the particle size and hygroscopicity of dry extract powder were potentially key physical properties that affected the physical properties of granules. Furthermore, the results of principal component analysis and cluster analysis showed that the consistency of the physical properties between the dry extract powder and intermediate granules was relatively poor. To this end, similarity analysis was carried out, and the quality control method of powder and granules based on physical fingerprint was established. The results showed that the physical fingerprint similarity of 25 batches of dry extract powder was 0.639-0.976, and the physical fingerprint similarity of the gra-nules was 0.716-0.983. With the similarity of 0.85 as the threshold, the batches with abnormal physical properties could be identified. In this study, the process quality control method of Suhuang Zhike Capsules based on the physical properties of powder and granules was established finally, which realized the identification of abnormal batches, and provided a reference for the process quality control of Suhuang Zhike Capsules.


Subject(s)
Capsules , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Powders , Quality Control
11.
Article in Chinese | WPRIM | ID: wpr-879071

ABSTRACT

The chemical properties of characteristic components are significant to the manufacturing quality control of big brand traditional Chinese medicine. In this study, the Huangjing Zanyu Capsules were used as the research carrier to determine the content of five characteristic components including icraiin, emodin, schisandrin A, 2,3,5,4'-tetrahydroxystilbene-2-O-β-D-glucoside, and osthole simultaneously by high-performance liquid chromatography(HPLC). The results showed that the chemical properties of five cha-racteristic components had a good linear relationship(r>0.999 9) within the quantitative range; the relative standard deviations(RSD) was 0.11%-2.0% and 0.25%-2.8% respectively for intra-day and inter-day precision; the RSD of repeatability was 1.8%-2.6%; the RSD of stability within 48 hours was 0.19%-2.8%, and the average recovery rate was 95.52%-100.1%, all meeting the requirements of pharmaceutical quantitative analysis. Additionally, the interval estimation method was used to directly reflect the distribution of samples with abnormal chemical properties of characteristic components, and the results showed ten samples were detected beyound the 95% control line of confidence level. Multivariate statistical process control(MSPC) method was used to monitor the abnormal samples of Huangjing Zanyu Capsules collectively, and the results showed that two samples were beyond the 95% control line of Hotelling's T~2 and three samples beyond the 95% control line of squared prediction error(SPE), indicating consistent quality control of Huangjing Zanyu Capsules. In conclusion, the proposed method is not only accurate and efficient but also a compensation for the traditional single-component quality control method, providing a scientific basis for the quality control in manufacturing process of Huangjing Zanyu Capsules. Furthermore, it could also serve as a reference method for the quality control in manufacturing big brand traditional Chinese medicine.


Subject(s)
Capsules , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality Control
12.
Article in Chinese | WPRIM | ID: wpr-879070

ABSTRACT

The physical properties of ginkgo leaves extract(GLE) are the critical quality attributes for the control of the manufacturing process of ginkgo leaves preparations. In this study, 53 batches of GLE with different sources from the real world were used as the objects to carry out the research from 3 levels. First, based on micromeritics evaluation method, a total of 29 physical attribute quality parameters in five dimensions were comprehensively characterized, with a total of 1 537 data points. Further, with use of physical fingerprinting technology combined with similarity evaluation, the powder physical properties of 53 batches of GLE showed obvious differences from an overall perspective, and the similarity of the physical fingerprints was 0.876 to 1.000. Secondly, hierarchical clustering analysis(HCA) and principal component analysis(PCA) models were constructed to realize the reliable identification and differentiation of real-world materials produced by GLE from different sources. Multivariate statistical process control(MSPC) model was used to create GLE material Hotelling T~2 and squared prediction error(SPE) control charts. It was found that the SPE score of B_(21) powder exceeded the 99% confidence control limit by 22.495 9, and the SPE scores of A_1 and C_(10) powder exceeded the 95% confidence control limit by 16.099 2, realizing the determination of abnormal samples in the materials of GLE from the production in real world. Finally, the physical quality control method of GLE in the production process of ginkgo leaves preparations was established in this study, providing a reference for the quality control methods of ginkgo leaves preparations in their manufacturing process.


Subject(s)
Drugs, Chinese Herbal , Ginkgo biloba , Medicine, Chinese Traditional , Plant Extracts , Plant Leaves , Powders , Quality Control
13.
Article in Chinese | WPRIM | ID: wpr-879069

ABSTRACT

Spatial distribution uniformity is the critical quality attribute(CQA) of Ginkgo Leaves Tablets, a variety of big brand traditional Chinese medicine. The evaluation of the spatial distribution uniformity of active pharmaceutical ingredients(APIs) in Ginkgo Leaves Tablets is important in ensuring their stable and controllable quality. In this study, hyperspectral imaging technology was used to construct the spatial distribution map of API concentration based on three prediction models, further to realize the visualization research on the spatial distribution uniformity of Ginkgo Leaves Tablets. The region of interest(ROI) was selected from each Ginkgo Leaves Tablet, with length and width of 50 pixels, and a total of 2 500 pixels. Each pixel had 288 spectral channels, and the number of content prediction data could reach 1×10~5 for a single sample. The results of the three models showed that the Partial Least Squares(PLS) model had the highest prediction accuracy, with calibration set determination coefficient R_(pre)~2 of 0.987, prediction set determination coefficient R_(pre)~2 of 0.942, root mean square error of calibration(RMSEC) of 0.160%, and root mean square error of prediction(RMSEP) of 0.588%. The classical least-squares(CLS) model had a greater prediction error, with the RMSEP of 0.867%. Multivariate Curve Resolution-Alternating Least Square(MCR-ALS) model showed the worst predictive ability among the three models, and it couldn't realize content prediction. Based on the prediction results of PLS and CLS models, the spatial distribution map of APIs concentration was obtained through three-dimensional data reconstruction. Furthermore, histogram method was used to evaluate the spatial distribution uniformity of API. The data showed that the spatial distribution of APIs in Ginkgo Leaves Tablets was relatively uniform. The study explored the feasibility of visualization of spatial distribution of Ginkgo Leaves Tablets based on three models. The results showed that PLS model had the highest prediction accuracy, and MCR-ALS model had the lowest prediction accuracy. The research results could provide a new strategy for the visualization method of quality control of Ginkgo Leaves Tablets.


Subject(s)
Calibration , Ginkgo biloba , Least-Squares Analysis , Medicine, Chinese Traditional , Plant Leaves , Quality Control , Spectroscopy, Near-Infrared , Tablets
14.
Article in Chinese | WPRIM | ID: wpr-879068

ABSTRACT

Identification of critical quality attribute(CQA) is crucial in quality control of Tongren Niuhuang Qingxin Pills(TRNHQXP). In this study, 661 active components in TRNHQXP were selected by liquid chromatography-mass spectrometry(LC-MS) and network pharmacology based on reported data and TCMSP, BATMAN-TCM, and TCMID databases, as well as mass spectrometry data, and 1 413 targets of the active components were obtained through SwissTargetPrediction. The 152 potential targets obtained from the intersection of predicted targets with 456 stroke targets underwent functional enrichment analysis by Metascape. The 27 Chinese medicinals in TRNHQXP were divided into four sets according to efficacies. Thirty-seven key targets in the blood-activating and stasis-resolving set and 41 in the tonifying set were screened out. On the basis of these potential key targets, 137 potential key CQA of TRNHQXP for stroke were reversely predicted. This study revealed the possible mechanism of TRNHQXP in treating stroke and established a modular identification method for the potential CQA of big brand traditional Chinese medicine(TCM) based on efficacies and chemical properties. Consequently, the CQA of TRNHQXP were identified by this method, which has provided a reference for the following experimental studies of CQA.


Subject(s)
Chromatography, Liquid , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality Control
15.
Article in Chinese | WPRIM | ID: wpr-879067

ABSTRACT

Texture sensory attributes are the key items in quality control of Chinese medicinal honeyed pills. The purpose of this study is to develop a quality control method for assessing the texture sensory attributes of Chinese medicinal honeyed pills based on real-world Tongren Niuhuang Qingxin pilular masses and finished products. First, parameters of texture profile analysis(TPA) were optimized through single factor and central composite design(CCD) experiments to establish a detection method for texture sensory attri-butes of Tongren Niuhuang Qingxin Pills. The results showed that the established detection method was stable and reliable, with the optimal parameters set up as follows: deformation percentage of 70%, detection speed at 30 mm·min~(-1), and interval time of 15 s. Furthermore, 540 data points yielded form six texture sensory attributes of pills from 30 batches were subjected to multivariate statistical process control(MSPC) with Hotelling T~2 and squared prediction error(SPE) control charts to establish the quality control method of Tongren Niuhuang Qingxin Pills. This study is expected to provide a reference for improving the quality control system of Chinese medicinal honeyed pills.


Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality Control
16.
Article in Chinese | WPRIM | ID: wpr-879065

ABSTRACT

The spatial distribution uniformity of valuable medicines is the critical quality attribute in the process control of Tongren Niuhuang Qingxin Pills. With the real world sample of the mixed end-point powder of Tongren Niuhuang Qingxin Pills as the research object, hyperspectral imaging technology was used to collect a total of 32 400 data points with a size of 180 pix×180 pix. Spectral angle matching(SAM), classical least squares and mixed tuned matched filtering(MTMF) were used to identify the spatial distribution of rare medicines. MTMF model showed higher identification accuracy, therefore the spatial distribution of the blended intermediates was identified based on the MTMF model. The histogram method was also used to evaluate the spatial distribution uniformity of rare medicines. The results showed that the standard deviation was 4.78, 6.5, 3.48, 1.96, and 3.00 respectively for artificial bezoar, artificial musk, Borneol, Antelope horn and Buffalo horn; the variance was 22.8, 42.3, 12.1, 3.82, and 9.00, and the skewness was 1.26, 1.71, 0.06,-0.86, and 1.04, respectively. The final results showed that the most even blending was achieved in concentrated powder of Borneol, Antelope horn and Buffalo horn, followed by artificial bezoar, and last artificial musk. A visualization method was established for quality attributes of distribution uniformity in blending process of Tongren Niuhuang Qingxin Pills. It could provide evidences of quality control methods in the mixing process of big brand traditional Chinese medicine.


Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Powders , Quality Control
17.
Article in Chinese | WPRIM | ID: wpr-879046

ABSTRACT

The extract rates, multicomponent content and fingerprint were determined in this study to investigate the quality diffe-rence between standard decoction of raw Paeoniae Radix Alba and fried Paeoniae Radix Alba. UPLC fingerprint was established for 17 batches of standard decoction of raw and fried Paeoniae Radix Alba, and the contents of gallic acid, catechin, albiflorin, paeoniflorin and benzoyl paeoniflorin were determined. The peak areas of standard decoction were analyzed by the independent t-test and orthogonal partial least squares discriminant analysis. There was no significant difference in extract rates between the standard decoction of raw and fried Paeoniae Radix Alba. After fried processing, the content of albiflorin increased by 0.26%, while the contents of gallic acid, catechin, paeoniflorin and benzoyl paeoniflorin decreased by 13.04%, 27.97%, 10.30% and 18.79% respectively. There were 14 common peaks in the fingerprint of standard decoction of raw Paeoniae Radix Alba, and 16 common peaks in the fried Paeoniae Radix Alba. Peak 1 and peak 3 were new ones after processing, among which the peak 3 was 5-hydroxymethylfurfural. The results showed that peak 1, peak 3, peak 11 and peak 15 were the key compounds to distinguish standard decoction of raw and fried Paeoniae Radix Alba. In conclusion, this method is stable and can be used for the study of quantity transfer and quality control in the preparation process of standard decoction, granules and other dosage forms for raw and fried Paeoniae Radix Alba, providing reference for the identification of raw and fried Paeoniae Radix Alba and related preparations.


Subject(s)
Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Paeonia , Quality Control , Reference Standards
18.
Article in Chinese | WPRIM | ID: wpr-879031

ABSTRACT

It is the core of the development for Chinese patent medicine enterprises to cultivate large varieties of Chinese patent medicine, and the selection of potential "seed" products is the prerequisite for the cultivation strategy. By constructing the evaluation model from multiple dimensions of value and risk, we can conduct specialized evaluation of Chinese patent medicines to effectively, professionally and objectively select the "seed" products with large variety cultivation potential. In this paper, the establishment of a multidimensional evaluation system would be discussed from the aspects of drug naming and prescription composition, safety risk and supply guarantee of raw materials and medicinal materials, competition situation, access to policy catalogue, scientific and technological support, clinical evidence and recognition, systematical and standardized collection of information on product instructions, quality standards, policy catalogue, scientific and technological literature, market competition and clinical application of Chinese patent medicines. Through the objective evaluation index and the range of objective index, the multi-dimensional evaluation model on values and risks of Chinese patent medicine products was discussed. Based on this model, a batch of Chinese patent medicine products can be quickly and comprehensively analyzed, and quantitative comparison can be formed among different types and fields of products. According to the evaluation results of the model and the comprehensive evaluation of experts, high-quality "seed" products can be selec-ted, laying a solid foundation for the next step of large variety cultivation. With use of this model, we can further clarify the external competitive advantages and internal priority levels of each product, and provide support for enterprises to optimize product structure and improve product strategic layout.


Subject(s)
China , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese Traditional , Nonprescription Drugs/adverse effects , Quality Control
19.
Article in Chinese | WPRIM | ID: wpr-878946

ABSTRACT

To verify the appropriate preparation process of extracts for the solid substance benchmark of Linggui Zhugan Decoction. The extracts were prepared by different preparation processes, namely the traditional process(process 1), the extract combined with volatile oil separated from traditional process extract liquid(process 2), the modern secondary reflux extraction process(process 3) and the process that volatile oil was extracted first, then prepared according to the traditional process, and combined with extract(process 4); based on the characteristic spectrum, index components of cinnamaldehyde, glycyrrhizin, ammonium glycyrrhizinate, cinnamic acid, and the dry extract rate of process 1, the differences and similarities of four extracts were compared. The results showed that the similarity of the characteristic spectrum of process 2, process 4 and process 1 were all greater than 0.97, while there was no significant difference for the content of 4 quality control components and dry extract rate; the similarity of the characteristic spectrum of process 3 and process 1 was 0.91, the absolute peak area of 13 out of 21 peaks and the relative peak area of 7 peaks increased significantly, and the content of 3 out of 4 quality control components and dry extract rate also significantly increased. In conclusion, the material standards of extracts by the process 2 and 4 are consistent with that of the traditional process, so the two processes are suitable.


Subject(s)
Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Glycyrrhizic Acid , Oils, Volatile , Quality Control , Reference Standards
20.
Article in Chinese | WPRIM | ID: wpr-878945

ABSTRACT

By preparing 15 batches of Zhenwu Decoction substance benchmarks,the characteristic map,index component content and paste-forming rate were determined to define the peak attribution,similarity range,paste-forming rate range,paeoniflorin and6-gingerol content range and transfer rate range. The similarity between the substance benchmark characteristic map and the control map R generated from the 15 batches of substance benchmarks was higher than 0. 970. There were 19 characteristic peaks in total. By further summarization of the characteristic peaks,it could be seen that tuckahoe had 3 characteristic peaks,white peony root had 10 characteristic peaks,atractylodes had 3 characteristic peaks,ginger had 1 characteristic peak,and Aconite root had 3 characteristic peaks; among them,white peony root and aconite root had 1 common peak. The contents and transfer rates of the 15 batches were0. 50%-0. 93 and 16. 11%-26. 20%; those for 6-gingerol were 0. 018 2%-0. 033 9% and 13. 16%-24. 10%,respectively. The pasteforming rate ranged from 10. 00% to 14. 85%. In this study,the transfer process of substance benchmark value of classic formula Zhenwu Decoction was analyzed based on the characteristic map,the paste-forming rate and the content of the index components; a scientific and stable substance benchmark quality evaluation method was preliminarily established to provide a basis for subsequent development of classic formula Zhenwu Decoction and quality control of relevant preparations.


Subject(s)
Benchmarking , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Quality Control
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