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2.
Shokuhin Eiseigaku Zasshi ; 60(4): 113-118, 2019.
Artigo em Japonês | MEDLINE | ID: mdl-31474652

RESUMO

We evaluated measurement uncertainty and performed internal quality control of an ELISA test for allergens in egg and milk, using control samples. For the evaluation of measurement uncertainty, the following three important factors were identified: 1) Differences in test-kit lots, 2) Different-day reproducibility, 3) Same-time reproducibility. A three-stage nested design was used, and the combined standard uncertainty of the three factors mentioned above was calculated based on the results obtained. Measurement uncertainty was defined as the expanded uncertainty obtained by multiplying the combined standard uncertainty by a coverage factor of two. As a result, the expanded uncertainty of egg was 1.9 µg/g when the total egg protein concentration was 13.4 µg/g, and the expanded uncertainty of milk was 1.8 µg/g when the total milk protein concentration was 13.5 µg/g. For the internal quality control, we first set the reference range of the measured value of the control sample, using the obtained combined standard uncertainty as an index. Each control sample was then measured for every test, and we concluded that the test was performed without any errors, when the result of the control sample was within the reference range. Second, the measured values of the control samples were plotted on a graph for continuous monitoring. This enabled us to check whether inspection accuracy was maintained. There were no large chronological changes and no major differences between the standard deviations of the control samples and the combined standard uncertainty in egg or milk. Therefore, it was determined that the dispersion was at an acceptable range and inspection accuracy was maintained.


Assuntos
Alérgenos/análise , Ovos/análise , Ensaio de Imunoadsorção Enzimática , Leite/química , Controle de Qualidade , Animais , Reprodutibilidade dos Testes , Incerteza
3.
Adv Exp Med Biol ; 1148: 55-80, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31482494

RESUMO

Therapeutic enzymes are a commercially minor but clinically important area of biopharmaceuticals. An array of therapeutic enzymes has been developed for a variety of human diseases, including leukaemia and enzyme-deficiency diseases such as Gaucher's disease. Production and testing of therapeutic enzymes is strictly governed by regulatory bodies in each country around the world, and batch-to-batch consistency is crucially important. Manufacture of a batch starts with the fermentation or cell culture stage. After expression of the therapeutic enzyme in a cell culture bioreactor, robust and reproducible protein purification, or downstream processing (DSP) of the target product, is critical to ensuring safe delivery of these medicines. Modern processing technology, including the use of disposable processing equipment, has greatly improved the DSP development pathway in terms of robustness and speed to clinic. Once purified, the drug substance undergoes rigorous quality control (QC) testing according to current regulatory guidance, to enable release to the clinic and patient. QC testing is conducted to ensure the safety, purity, identity, potency and strength of the medicinal product, requiring multiple analytical methods that are rigorously validated and monitored for robust performance. Several case studies, including L-asparaginase and asfotase alfa, are discussed to illustrate the methods described herein.


Assuntos
Enzimas/biossíntese , Enzimas/farmacologia , Controle de Qualidade , Produtos Biológicos , Reatores Biológicos , Fermentação , Humanos
5.
Ceska Slov Farm ; 68(3): 91-94, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31431018

RESUMO

Content tolerance limits should respect the acceptable variation in the content of the active substance or excipient from its production and the variability of the results of the analytical procedure prescribed to determine the content by the appropriate pharmacopoeia. This usually prevails in the active substances and excipients. They should be derived statistically based on the precision of the prescribed analytical method determined by the interlaboratory test. Calculations from published precision characteristics show that some tolerance intervals for the active substance content are probably too narrow in Ph. Eur. This can lead to erroneous decisions about their quality.


Assuntos
Excipientes/normas , Controle de Qualidade
6.
Zhongguo Shi Yan Xue Ye Xue Za Zhi ; 27(4): 1287-1290, 2019 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-31418394

RESUMO

OBJECTIVE: To investigate the methods for verifying and comparing performance of HIV testing methods and procedure analysis in blood station laboratories so as to meet the requirements of ISO15189 accreditation. METHODS: The performance of HIV test was verified by the automatic ELISA analyzer, the intra- and inter-assay precision was analyzed and evaluated by intra- and inter-assay repeat tests, the compliance rate was verified by the test results of the standard serum plate and the external quality assessment from the Ministry of Health in the past 2 years, the limit of detection was verified through continuous dilution of a known amount of reference serum for internal quality control, the status of the instrument was evaluated by testing one HIV-negative specimen, one HIV-negative with other positive markers, one strong HIV-positive specimen and two weak HIV-positive specimens. RESULTS: The intra- and inter-assay precisions were 5.12% and 16.81% respectively, the compliance rate of the serum plate test was 100%, the compliance of the external quality assessment results was 100%, the limits of detection for HIV was 1.42 NCU/ml, and the consistency of the detection systems was 100%. CONCLUSION: The analytical performance of the HIV test methods and procedures accords with the requirements of the reagent instructions, the comparison of the test systems meets the verification requirements.


Assuntos
HIV , Programas de Rastreamento , Ensaio de Imunoadsorção Enzimática , Controle de Qualidade , Testes Sorológicos
7.
Int J Nanomedicine ; 14: 5435-5448, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31409997

RESUMO

Background: Ramipril (RMP) suffers from poor aqueous solubility along with sensitivity to mechanical stress, heat, and moisture. The aim of the current study is to improve RMP solubility and stability by designing solid self-nanoemulsifying drug delivery system (S-SNEDDS) as tablet. Methods: The drug was initially incorporated in different liquid formulations (L-SNEDDS) which were evaluated by equilibrium solubility, droplet size, and zeta potential studies. The optimized formulation was solidified into S-SNEDDS powder by the adsorbent Syloid® and compressed into a self-nanoemulsifying tablet (T-SNEDDS). The optimized tablet was evaluated by drug content uniformity, hardness, friability, disintegration, and dissolution tests. Furthermore, pure RMP, optimized L-SNEDDS, and T-SNEDDS were enrolled in accelerated and long-term stability studies. Results: Among various liquid formulations, F5 L-SNEDDS [capmul MCM/transcutol/HCO-30 (25/25/50%w/w)] showed relatively high drug solubility, nano-scaled droplet size, and high negative zeta potential value. The optimized SNEDDS solidification with Syloid® at ratio (1:1) resulted in a compressible powder with an excellent flowability. The optimized tablet (T-SNEDDS) showed accepted content uniformity, hardness, friability, and disintegration time (<15 minutes). The optimized L-SNEDDS, S-SNEDDS, and T-SNEDDS showed superior enhancement of RMP dissolution compared to the pure drug. Most importantly, T-SNEDDS showed significant (P<0.05) improvement of RMP stability compared to the pure drug and L-SNEDDS in both accelerated and long-term stability studies. Conclusion: RMP-loaded T-SNEDDS offers a potential oral dosage form that provides combined improvement of RMP dissolution and chemical stability.


Assuntos
Sistemas de Liberação de Medicamentos , Emulsões/química , Nanopartículas/química , Ramipril/farmacologia , Administração Oral , Adsorção , Disponibilidade Biológica , Varredura Diferencial de Calorimetria , Liberação Controlada de Fármacos , Estabilidade de Medicamentos , Dureza , Nanopartículas/ultraestrutura , Tamanho da Partícula , Controle de Qualidade , Solubilidade , Eletricidade Estática , Comprimidos/química , Fatores de Tempo , Difração de Raios X
8.
Br J Radiol ; 92(1102): 20190355, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31317765

RESUMO

OBJECTIVE: The accuracy of dose delivery for intensity modulated radiotherapy (IMRT) treatments should be determined by an accurate quality assurance procedure. In this work, we used artificial neural networks (ANNs) as an application for the pre-treatment dose verification of IMRT fields based two-dimensional-fluence maps acquired by an electronic portal imaging device (EPID). METHODS: The ANN must be trained and validated before use for the pretreatment dose verification. Hence, 60 EPID fluence maps of the anteroposterior prostate and nasopharynx IMRT fields were used as an input for the ANN (feed forward type), and a dose map of those fluence maps that were acquired by two-dimensional Array Seven29TM as an output for the ANN. RESULTS: After the training and validation of the neural network, the analysis of 20 IMRT anteroposterior fields showed excellent agreement between the ANN output and the dose map predicted by the treatment planning system. The average overall global and local γ field pass rate was greater than 90% for the prostate and nasopharynx fields, with the 2 mm/3% criteria. CONCLUSION: The results indicated that the ANN can be used as a fast and powerful tool for pretreatment dose verification, based on an EPID fluence map. ADVANCES IN KNOWLEDGE: In this study, ANN is proposed for EPID based dose validation of IMRT fields. The proposed method has good accuracy and high speed in response to problems. Neural network show to be low price and precise method for IMRT fields verification.


Assuntos
Redes Neurais (Computação) , Aceleradores de Partículas , Dosagem Radioterapêutica , Radioterapia de Intensidade Modulada , Humanos , Aprendizado de Máquina , Masculino , Neoplasias Nasofaríngeas/diagnóstico por imagem , Neoplasias Nasofaríngeas/radioterapia , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/radioterapia , Controle de Qualidade
9.
Food Chem ; 298: 125067, 2019 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-31260989

RESUMO

An ultra-high performance supercritical fluid chromatography-photodiode array detection-mass spectrometry (UHPSFC-MS) method for quality control of Piper longum L. has been developed and optimized. Hexane/isopropanol (70/30, v/v) was determined as the final injection solvent and methanol as the organic modifier. A design-of-experimental (DoE) approach was used to optimize column temperature, back-pressure and the gradient slope simultaneously using Trefoil CEL1 column. The back-pressure, temperature, flow rate were set at 130 bar, 32.5 °C and 1.0 mL/min, respectively. Positive electrospray ionization was used in the single ion monitoring mode. The 12 analytes were analyzed within 8 min using the optimized conditions. The linearities of the standard calibrations were satisfactory with coefficients of determination (R2) > 0.995. The recovery measured varied from 96.34% to 105.00% with relative standard deviation (RSD) ≤ 4.68%. The method was sensitive, reliable and effective, and successfully applied to simultaneous determination of 12 compounds in 28 batches of P. longum.


Assuntos
Alcaloides/química , Cromatografia com Fluido Supercrítico/métodos , Piper/química , Alcaloides/isolamento & purificação , Benzodioxóis/química , Benzodioxóis/isolamento & purificação , Cromatografia Líquida de Alta Pressão , Cromatografia com Fluido Supercrítico/normas , Frutas/química , Frutas/metabolismo , Limite de Detecção , Espectrometria de Massas , Metanol/química , Piper/metabolismo , Piperidinas/química , Piperidinas/isolamento & purificação , Alcamidas Poli-Insaturadas/química , Alcamidas Poli-Insaturadas/isolamento & purificação , Análise de Componente Principal , Controle de Qualidade , Solventes/química , Temperatura Ambiente
10.
Zhongguo Zhong Yao Za Zhi ; 44(13): 2742-2747, 2019 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-31359685

RESUMO

The processing of Mongolian medicine,which is called " mort harl" in Mongolian language,refers to a traditional processing technology to " tame" some toxic,aggressive,ineffective or inconvenient Mongolian medicines,so as to make it " compliant" to clinical needs. It is the summary of long-term experience in drug preparation by Mongolian medicine experts,one of the bridges for the dialectical unity of Mongolian medicine,the essential content in evaluation of the clinical efficacy of Mongolian medicine and the study of Mongolian medicine modernization,and also the important soft power carrier of " intangible cultural heritage" and " grassland culture" in Inner Mongolia autonomous region. In this study,the processing history,purpose,crafts,mechanism,processing standards and quality standards of Mongolian medicine were explained,and some suggestions were proposed for the problems of the Mongolian medicine processing and development: focus on the basic theory of Mongolian medicine and the clinical experience of Mongolian medicine in the development of traditional Mongolian medicine processing; strengthen the literature research on the processing method of Mongolian medicine; establish comprehensive and systematic Mongolian medicine concocts standards and quality standards; enhance the research and development of special processing equipment and process quality control instruments for Mongolian medicine; and strengthen the training of professional technicians,the protection of copyright in Mongolian medicine processing,and scientific research on Mongolian medicine processing. In the inheritance of the tradition,the latest achievements of modern scientific development can be also absorbed to provide reference for the further development of traditional Mongolian medicine processing technology.


Assuntos
Medicina Tradicional da Mongólia , China , Controle de Qualidade , Padrões de Referência
11.
Zhongguo Zhong Yao Za Zhi ; 44(13): 2748-2752, 2019 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-31359686

RESUMO

Traditional Chinese medicine( TCM) glues,including leather glues,horn glues,nail glues and bone glues,have a long application history and unique characteristics. In recent years,their market demand has increased year by year because of their remarkable curative efficacy and nourishing effects,which leads to insufficient supply of raw material resources,and widespread use of fake and inferior products,seriously affecting the reputation of TCM glues and drug safety. In this context,the establishment of a more specific quality detection method for the TCM glues according to their specific characteristics can effectively improve the quality control level,promote rational use,and have a far-reaching impact on the industrial development of TCM glues. In this paper,the classification of TCM glues,as well as the production and application status of their representative( Ejiao) were briefly introduced; the papers on quality control technologies of TCM glues,including traditional identification experience,authenticity identification,physical property determination,protein,peptide and amino acid contents determination,element analysis,biological evaluation,and brand protection technology of TCM glues,were reviewed,and their advantages and disadvantages were summarized and analyzed comprehensively.Based on the specific characteristics of TCM glues,such as complex material basis,unclear pharmacodynamic components and different production processes,it was proposed in this paper to research and develop information-rich,convenient,fast,and non-destructive analytical techniques for the quality control of TCM glues and brand protection of famous products,thus promoting the healthy development of TCM glues industry.


Assuntos
Adesivos , Medicina Tradicional Chinesa , Controle de Qualidade , Pesquisa
12.
Zhongguo Zhong Yao Za Zhi ; 44(13): 2762-2767, 2019 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-31359688

RESUMO

In order to understand the difference of contents of coelonin,batatasin Ⅲ and 3'-O-methylbatatasin Ⅲ in 60 different sources of Bletilla striata planted under the same conditions. UPLC method was used and the analysis was performed on a Waters ACQUITY UPLC BEH C18 column( 2. 1 mm×100 mm,1. 7 µm),eluted with acetonitril-0. 1% formic acid solution by gradient. The flow rate was 0. 208 m L·min-1,the detection wavelength was 270 nm,the column temperature was 35 ℃ and the injection volume was 4µL. Under the above chromatographic conditions,the three components can be separated well with good linearity in the range of 0. 156-5. 000 mg·L-1. The average contents of coelonin,batatasin Ⅲ and 3'-O-methylbatatasin Ⅲ were( 0. 116 ± 0. 071) %,( 0. 386 ±0. 185) % and( 0. 086±0. 034) %,respectively. After planting for two years under the same conditions,there was no significant difference in chemical composition among different sources and varieties,but the contents of the three components had some regional differences,which indicated that the western region was higher than the eastern region,while the contents of coelonin and batatasin Ⅲ in B.sinensis were slightly higher than those in B. striata. The chromatographic method above is simple,stable and reproducible,and can be used for quantitative analysis of three components. The content analysis of different sources of B. striata can provide reference for future B. striata breeding and quality control.


Assuntos
Medicamentos de Ervas Chinesas/química , Orchidaceae/química , Cromatografia Líquida de Alta Pressão , Controle de Qualidade
13.
Zhongguo Zhong Yao Za Zhi ; 44(9): 1729-1733, 2019 May.
Artigo em Chinês | MEDLINE | ID: mdl-31342693

RESUMO

To establish a quality constant evaluation system of Alismatis Rhizoma decoction pieces,in order to provide reference for regulating the market circulation of this decoction pieces. A total of 18 batches of Alismatis Rhizoma decoction pieces were collected from different pharmaceutical factories,and the morphological parameters of each sample were tested. The content of alisol B 23-acetate in Alismatis Rhizoma decoction pieces was determined by HPLC in the 2015 edition of Chinese Pharmacopoeia,and the parameters such as quality constant and relative quality constant were calculated. The quality constant range of 18 batches of Alismatis Rhizoma decoction pieces was 0. 390-2. 076. If 18 batches of Alismatis Rhizoma decoction pieces were divided into 3 grades,taking 80% of the maximum quality constant as first grade,50% to 80% as second grade,and the rest as third grade,then the quality constant of firstgrade samples was ≥1. 66,the quality constant of second-grade samples was ≥1. 04 and <1. 66,and the quality constant of third-grade samples was <1. 04. The established quality constant evaluation method is objective and feasible,which can be used to classify the grade of Alismatis Rhizoma decoction pieces and provide a reference method to control the quality of this decoction pieces.


Assuntos
Alisma/química , Medicamentos de Ervas Chinesas/normas , Cromatografia Líquida de Alta Pressão , Controle de Qualidade , Rizoma/química
14.
Zhongguo Zhong Yao Za Zhi ; 44(9): 1734-1738, 2019 May.
Artigo em Chinês | MEDLINE | ID: mdl-31342694

RESUMO

The specifications of Chinese herbal medicines naturally form and exist in the circulation and use of Chinese herbal medicines.Buyers and sellers negotiate price by quality. With the increasing demand for public health care,the cultivation,processing methods and circulation of Chinese herbal medicines have changed. Under the mode of pursuing output and short-term benefits,the traditional grade evaluation method has been difficult to apply to the current quality status of the pieces. Bran stir-baked Aurantii Fructus is a genuine medicinal material in Jiangxi province. It is widely used,but the quality level of bran stir-baked Aurantii Fructus on the market is not uniform. Quality constant method was used in this paper for grading the Chinese herbal slices of bran stir-baked Aurantii Fructus. Sixteen batches of different quality samples were collected and tested,and finally,eleven qualified batches of them were chosen as researcher objects. The results showed that the relative quality constant ranged from 2. 52 to 5. 60. The relative quality constant was ≥4. 48 for first grade bran stir-baked Aurantii Fructus,2. 80-4. 48 for the second grade pieces,and <2. 80 for the third grade pieces. The grades evaluation method for bran stir-baked Aurantii Fructus established in this paper included both appearance and index composition. The results were objective,accurate,quantitative,applicable,and the method was simple to operate and easy to popularize. This study showed that the quality constant method could be applied to the grade evaluation of bran stir-baked Aurantii Fructus,providing a reference for the grade evaluation of fruit-type decoction pieces.


Assuntos
Citrus/química , Medicamentos de Ervas Chinesas/normas , Frutas/química , Controle de Qualidade
15.
Zhongguo Zhong Yao Za Zhi ; 44(9): 1739-1743, 2019 May.
Artigo em Chinês | MEDLINE | ID: mdl-31342695

RESUMO

Grade of Chinese medicine slices is the most clear and most direct way to characterize the quality of Chinese medicine slices,also the basis of realizing " good quality and good prices",and it can guarantee the industry health development. Therefore,grade evaluation of Chinese medicine slices( GECMS) is highly valued and has grown rapidly in the industry. In recent years,due to the comprehensive and measureable features,the Chinese medicine quality constant evaluation method has been gradually recognized and applied.The paper is to establish a method of grades evaluation of Glycyrrizae Radix et Rhizoma Praeparata Cum Melle( GRRPCM) based on the Chinese medicine quality constant. 20 batches of samples were collected from Chinese herbal slices enterprises and 14 batches of qualified samples were selected to determine their external morphological indexes and inner quality indexes,then their Chinese medicine quality constants were calculated and the grades were determined. The results revealed that the relative quality constant of these samples ranged from 0. 70 to 14. 08,with a percentage quality constant from 4. 95 to 100. 00. If these samples were divided into three grades: the relative quality constant shall be ≥11. 27 or percentage quality constant ≥80. 03 for the first grade; the relative quality constant shall be <11. 27 but ≥7. 04,or percentage quality constant <80. 03 and ≥49. 99 for the second grade; while for the third grade,the relative quality constant shall be <7. 04 or the percentage quality constant <49. 99. This research indicates that Chinese quality constant can be used to objectively grade the herbal slices,providing reference for grades standard development of complex processing slices. In addition,the connotation of GECMS that has evaluate the mass discrepancy is discussed for expanding application.


Assuntos
Medicamentos de Ervas Chinesas/normas , Glycyrrhiza/química , Medicina Tradicional Chinesa , Raízes de Plantas/química , Controle de Qualidade , Rizoma/química
16.
Zhongguo Zhong Yao Za Zhi ; 44(9): 1744-1749, 2019 May.
Artigo em Chinês | MEDLINE | ID: mdl-31342696

RESUMO

The quality constant evaluation method was applied in the grade evaluation of Scrophulariae Radix pieces. Nineteen batches of Scrophulariae Radix were measured for the appearance index. Harpagide and harpagoside were taken as index components for the content determination. The traditional grading standard and the modern quality control index were combined to calculate the quality constant and grade Scrophulariae Radix pieces. The results showed that the quality constants ranged between 156. 75 and 491. 65; according to the percentage mass constants,more than 80% were graded as first-class pieces,50%-80% were graded as second-class pieces,and the rest were graded as third-class pieces. The quality constants of first-class Scrophulariae Radix were >393. 32,that of second-class Scrophulariae Radix was between 245. 83 and 393. 32,and that of third-class Scrophulariae Radix was < 245. 83. The study shows that this method can objectively,reasonably and effectively classify Scrophulariae Radix pieces,and further promote and apply the evaluation method of slice model quality constant to prove the rationality,scientificity and practicability.


Assuntos
Medicamentos de Ervas Chinesas/normas , Scrophularia/química , Raízes de Plantas/química , Controle de Qualidade
17.
Zhongguo Zhong Yao Za Zhi ; 44(9): 1750-1754, 2019 May.
Artigo em Chinês | MEDLINE | ID: mdl-31342697

RESUMO

The grade of Gastrodia elata pieces is evaluated by quality constant evaluation method.Fifteen batches of G. elata pieces collected were measured for their appearance and morphological indexes. The contents of gastrodin,p-hydroxybenzyl alcohol,barrisoside A,B and E were taken as index components for the content determination. The traditional grading standards were combined with modern quality control indicators,and the quality constants were calculated to grade the pieces.The results showed that the quality constants of 15 batches of G. elata ranged between 143. 3 and 1 027. 3. If the percentage mass constant( ≥80%) was the first grade,the percentage mass constant between 50%-80% indicated the second grade,and the remaining percentage mass constant indicated the third grade. The quality constant of the first gradepieces was sality,that of the second grade pieces ranged between 513. 0-821. 0,and that of the third grade pieces was <513. 0. On the basis of the study for the grading method of quality constants,and the natural morphology and cutting characteristics of the pieces,a grading model for the quality constants of the pieces cut along texture was established,which made the method scientific,rational as well as " personalized". The model method is applied in grading G. elata pieces,so as to specify the grading method,further enrich the study data of the grading evaluation of G. elata pieces and provide a useful reference for the grading evaluation of G. elata pieces. Meanwhile,the grading method of mass constants could be further applied and promoted to prove its rationality,scientificity and practicability.


Assuntos
Medicamentos de Ervas Chinesas/normas , Gastrodia/química , Controle de Qualidade
18.
Zhongguo Zhong Yao Za Zhi ; 44(9): 1755-1759, 2019 May.
Artigo em Chinês | MEDLINE | ID: mdl-31342698

RESUMO

Quality constant is a kind of grading evaluation method of traditional Chinese medicine pieces based on the combination of traditional knowledge and modern quality control. This method has been successfully applied in the grading evaluation of Glycyrrizae Radix et Rhizome pieces and traditional Chinese medicine pieces,and with a positive influence in the industry. With Dachuanxiong Formula for example,different grades of Ligusticum chuanxiong and Gastrodia elata pieces formed high-quality,moderate and qualified Dachuanxiong Formula on the basis of the grading evaluation of the pieces,and the pharmacodynamics method was used to evaluate its efficacy. The results showed that the maximum vascular diastolic rates of Dachuanxiong Formula in the three grades were( 80. 3±5. 2) %,( 67. 0±6. 1) %and( 60. 3±6. 5) %,and the strength of pharmacodynamics was positively correlated with the grade of L. chuanxiong and G. elata pieces.The quality constant technique can objectively and quantitatively classify single decoctions,and has important correlations and prompts for the efficacy of traditional Chinese medicine prescriptions composed of these pieces,with important significance in promoting hierarchical management of the industry,implementing better price for high quality and defining high quality and superior effect.


Assuntos
Medicamentos de Ervas Chinesas/normas , Gastrodia/química , Glycyrrhiza/química , Ligusticum/química , Medicina Tradicional Chinesa , Raízes de Plantas/química , Controle de Qualidade , Rizoma/química
19.
Zhongguo Zhong Yao Za Zhi ; 44(9): 1842-1849, 2019 May.
Artigo em Chinês | MEDLINE | ID: mdl-31342711

RESUMO

This study is to establish a qualitative method for rapid identification of bile acids in Suis Fellis Pulvis based on UHPLC-LTQ-Orbitrap-MS technology,and an HPLC-ELSD internal standard method for the quantitative determination of two glycine-conjugated BAs in Suis Fellis Pulvis.The chromatographic separation of the UHPLC-LTQ-Orbitrap-MS qualitative analysis was achieved on a Waters Acquity UPLC HSS T_3column(2.1 mm×100 mm,1.8µm),with 0.2%formic acid aqueous solution(A)-acetonitrile(B)as mobile phase ingradient elution.Electrospray ionization(ESI)source was applied and operated in negative ion mode.Quantitative analysis was performed at 30℃on a Diamonsil-C_(18)column(4.6 mm×250 mm,5µm).The mobile phase consisted of 0.2%formic acid solution and acetonitrile with gradient elution and the flow rate was 1.0 m L·min~(-1).An ELSD was used with a nitrogen flow-rate of1.4 L·min~(-1)at a drift tube temperature of 60℃and the gain was 1.A total of 14 bile acids in Suis Fellis Pulvis were characterized based on the accurate mass measurements,fragmentation patterns,chromatographic retention times,and reference materials.For the quantitative analysis method,the glycohyodeoxycholic acid and glycochenodeoxycholic acid had good linear relationship in the range of26.52-265.20 mg·L~(-1)(r=0.999 8)and 19.84-198.40 mg·L~(-1)(r=0.999 1),respectively.The average recoveries(n=6)were104.1%and 103.1%,and the RSD were 2.0%and 2.4%.The UHPLC-LTQ-Orbitrap-MS technology provides a fast and efficient qualitative analysis method for identification of bile acids in Suis Fellis Pulvis.The HPLC-ELSD internal standard method is accurate and reliable,which has reference value for the quality control of Suis Fellis Pulvis.


Assuntos
Ácidos Cólicos/análise , Suínos , Animais , Cromatografia Líquida de Alta Pressão , Controle de Qualidade
20.
Zhongguo Zhong Yao Za Zhi ; 44(9): 1850-1856, 2019 May.
Artigo em Chinês | MEDLINE | ID: mdl-31342712

RESUMO

As known,simultaneous determination of various chemical indicators is one of the future trends in quality control of traditional Chinese medicines because of the extremely complex chemical compositions. This project is to screen the quality markers that can accurately control the quality of the Bufonis Venenum by exploring the intrinsic correlation of components. In this study,venom of Bufo bufo gargarizans from 17 different sources were used as research samples,and the contents of 7 bufogenin were determined by HPLC-DAD. Then,the data obtained were analyzed by Spearman correlation analysis and principal component analysis( PCA). In addition,a stepwise regression analysis was used to establish a predictive model for the contents of the seven bufogenin components( independent variable) and the total contents of the bufogenin( dependent variable). The results indicated that there is a significant positive correlation between the contents of telocinobufagin and cinobufotalin,and there is a significant positive correlation between the contents of bufalin,cinobufagin and resibufogenin. In contrast,the contents of telocinobufagin and cinobufotalin are negatively correlated with the contents of bufalin,cinobufagin and resibufogenin. However,the correlation between gamabufotalin and bufotalin and other components are not obvious. Furthermore,further study found that there is a correlation between the sum of the contents of bufalin,cinobufagin and telocinobufagin and the total contents of the bufogenin. In fact,the application of bufalin,cinobufagin and telocinobufagin as the quality control indicators of the Bufonis Venenum can better reflect the quality characteristics of the Bufonis Venenum compared with the previous quality control indicators. The conclusions will provide a reference for the revision of the quality standards of the Bufonis Venenum.


Assuntos
Venenos de Anfíbios/química , Bufanolídeos/análise , Bufo bufo , Animais , Cromatografia Líquida de Alta Pressão , Medicina Tradicional Chinesa , Controle de Qualidade
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