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1.
Article in Chinese | WPRIM | ID: wpr-906499

ABSTRACT

In this paper, a comparative analysis is carried out on the policy of listed drugs in Australia, the policy of over-the-counter drugs in Japan, the policy related to the conversion of Chinese patent medicines to over-the-counter drugs, and the policy related to health food. The focus is on one of the possible situations for the registration of over-the-counter traditional Chinese medicines (TCMs), namely new prescription-composed over-the-counter TCMs. This paper discussed separately from the three parts of the scope of Chinese medicinal materials in the prescription medicines, the scope of indications, and the technical requirements, in order to provide references for the technical requirements related to the registration of over-the-counter TCMs. Recommendations on the marketing and registration of new prescription-composed over-the-counter TCMs:①It is recommended to formulate a list of medicinal materials for the use of Chinese herbal medicines, and consider including raw materials of health food. On this basis, a batch of safe Chinese medicinal materials/decoction pieces was added. And consider dynamic supervision, such as allowing the addition or recall of Chinese medicinal materials/decoction pieces in the list of medicinal materials. ②The scope of indications is recommended to consider the scope of indications for the conversion of Chinese patent medicines to over-the-counter TCMs in China, and the selection of medium-risk indications can reflect the characteristics and advantages of TCM treatment. ③Efficacy evaluation needs to provide high-quality scientific evidence, including clinical research data, and consider relaxing the requirements for non-clinical pharmacodynamic trials.

2.
Article in Chinese | WPRIM | ID: wpr-906315

ABSTRACT

With the publication of Registration and Classification of Traditional Chinese Medicine (TCM) and Application Data Requirements, the related management and technical documents of TCM with the same name and prescription need to be further studied and formulated. In this paper, the management mode and technical evaluation of TCM with the same name and prescription are discussed to provide reference for the formulation of management and technical documents of TCM with the same name and prescription. The issues to be discussed include which management mode to adopt, how to select the control drugs with the same name and prescription, whether the indication risk level should be divided, whether the indication should be limited to medium and low risk, and how to carry out the technical evaluation of similarity/consistency. From the perspective of technical document research and formulation, this paper mainly focuses on the technical level. However, there are still other theoretical possibilities in the management mode and technical evaluation of TCM with the same name and prescription. Therefore, this paper, as a preliminary summary of the management and technical evaluation of TCM with the same name and prescription, needs more scholars and industry experts to pay attention to and participate in this work.

3.
Article in Chinese | WPRIM | ID: wpr-905908

ABSTRACT

Objective:To establish ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) for simultaneous determination of six hepatotoxic pyrrolizidine alkaloids in Verbenae Herba, and to carry out preliminary risk assessment according to the research results. Method:An ACQUITY UPLC HSS T3 column (2.1 mm×100 mm, 1.8 μm) was used for analysis with 0.05% formic acid and 2.5 mmol·L<sup>-1</sup> ammonium formate in water (A)-0.05% formic acid and 2.5 mmol·L<sup>-1</sup> ammonium formate in acetonitrile (B) as mobile phase for gradient elution (0-12 min, 3%-8%B; 12-25 min, 8%-15%B; 25-26 min, 15%-3%B; 26-30 min, 3%B), the flow rate was 0.3 mL·min<sup>-1</sup>, the column temperature was 40 ℃, and the injection volume was 1 μL. MS system was operated by electrospray ionization (ESI) in the positive ion mode with multiple reaction monitoring mode. MS parameters of triple quadrupole and six analytes were optimized for qualitative and quantitative analysis. According to the determination results, the risk assessment was carried out by using margin of exposure (MOE) combined with transfer rate of hot water extraction. Result:Based on the instrument precision, linear range, repeatability, stability, recovery and other methodological validations, the results were in conformity with relevant standards of quantitative analysis. The linear ranges of intermedine, lycopsamine, intermedine <italic>N</italic>-oxide, lycopsamine<italic> N</italic>-oxide, echimidine<italic> N</italic>-oxide and echimidine were good (<italic>r</italic>≥0.999 0) between peak area and mass concentration in the ranges of 0.984-49.20, 0.994-49.70, 1.012-50.60, 1.032-51.60, 1.004-50.20, 1.016-50.80 µg·L<sup>-1</sup>, respectively. The average recoveries of these six analytes were 87.2%-94.2% with relative standard deviation (RSD)<4.0%. Their MOE values were >10 000. Conclusion:The UPLC-MS/MS established in this study is stable and feasible, which can provide scientific basis for the quality control and safety evaluation of hepatotoxic pyrrolizidine alkaloids in Verbenae Herba.

4.
Article in Chinese | WPRIM | ID: wpr-905076

ABSTRACT

Objective:To conduct quality evaluation of Ginkgo Folium preparations by analyzing the national evaluation sampling test results, analyze the quality differences, and put forward suggestions for the improvement of quality standards and market supervision. Method:The contents of total flavonol glycosides and terpene lactones in Ginkgo Folium tablets and Ginkgo Folium capsules were determined according to the methods of determination in the 2015 edition of Chinese Pharmacopoeia (the first volume), and the contents of free flavonoids (quercetin, kaempferide and isorhamnetin) and sophoricoside in Ginkgo Folium preparations were determined according to related supplementary testing method of Ginkgo Folium tablets and Ginkgo Folium capsules issued by National Medical Products Administration. The quality differences of Ginkgo Folium preparations from different batches and different manufacturers were compared according to the contents of total flavonol glycosides, terpene lactones, free flavonoids and sophoricoside in 328 batches of Ginkgo Folium tablets and Ginkgo Folium capsules manufactured by 48 enterprises. Result:Quality of 328 batches of Ginkgo Folium tablets and Ginkgo Folium capsules was in accordance with the standard, but the contents of terpene lactones and total flavonol glycosides were all distributed in a wide range, and the quality of samples varied greatly among different enterprises. Conclusion:It is recommended that each enterprise should optimize the production process and strictly control the raw materials to ensure the consistency between different batches of samples.

5.
Article in Chinese | WPRIM | ID: wpr-888183

ABSTRACT

In this study, data of amino acids of Cordyceps samples from Qinghai and Tibet was analyzed with self-organizing map neural network. A model of XY-Fused network was established with the content of 8 major amino acids and total amino acids for the identification of geographical origins of Cordyceps from Qinghai and Tibet. It had the prediction accuracy of 83.3% for the test set. In addition, data mining indicated that methionine was a special kind of amino acid in Cordyceps which could serve as a marker to identify its geographical origins. On this basis, the content ratio of methionine to total amino acids was proposed to be a quantifiable indicator to distinguish Cordyceps from Qinghai and Tibet.


Subject(s)
Amino Acids , Cordyceps/genetics , Geography , Neural Networks, Computer , Tibet
6.
Article in Chinese | WPRIM | ID: wpr-888146

ABSTRACT

This study aims to develop a UPLC-MS/MS method for simultaneous determination of six pyrrolizidine alkaloids(PAs)--intermedine N-oxide(ImNO), lycopsamine N-oxide(LyNO), seneciphylline(Sp), seneciphylline N-oxide(SpNO), senecionine N-oxide(SnNO), and senkirkine(Sk) in different parts of Emilia sonchifolia. UPLC conditions are as follows: ACQUITY UPLC HSS T3 column(2.1 mm×100 mm, 1.8 μm), mobile phase consisting of 0.05% formic acid and 2.5 mmol·L~(-1) ammonium formate in water(A)-0.05% formic acid and 2.5 mmol·L~(-1) ammonium formate in acetonitrile(B) for gradient elution. MS conditions are as below: electrospray ionization(ESI) in the positive ion mode, multiple reaction monitoring(MRM), and the content of the six PAs was calculated with the external standard method. The results suggested the differences in the six PAs among different parts of E. sonchifolia. Sk was detected in all the four parts, with similar content. SnNO also existed in all the four parts, but the content in roots was significantly higher than that in other parts. Sp and SpNO were found in both roots and flowers, with the content higher in the former than in the later. ImNO and LyNO were only found in leaves, and the content was low. Among the six components detected, ImNO, LyNO, and SpNO were found and determined for the first time, which enriched the toxic components and laid a scientific basis for the quality and safety evaluation of E. sonchifolia.


Subject(s)
Asteraceae , Chromatography, High Pressure Liquid , Chromatography, Liquid , Pyrrolizidine Alkaloids , Tandem Mass Spectrometry
7.
Article in Chinese | WPRIM | ID: wpr-887959

ABSTRACT

A determination method for bilirubin in cultured cow-bezoar was developed in this study, with which the bilirubin in 15 batches of samples was quantified. The samples were first processed with 10% oxalic acid solution for the conversion of bilirubin from conjugated to unconjugated, followed by the extraction with dichloromethane. Then the obtained sample solutions were analyzed at 450 nm by HPLC[chromatographic column: Agilent TC-C_(18)(4.6 mm × 250 mm, 5 μm); mobile phase: acetonitrile and 1% glacial acetic acid aqueous solution(95∶5); flow rate: 1.0 mL·min~(-1)]. The bilirubin content in the 15 batches of cultured cow-bezoar was ranged from 21.9% to 41.7% with the average of 32.4%. The proposed method is accurate and reliable, thus making it suitable for the quantitation of bilirubin in cultured cow-bezoar and its quality assessment and control.


Subject(s)
Animals , Bezoars , Bilirubin , Cattle , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Female
8.
Acta Pharmaceutica Sinica ; (12): 1797-1803, 2021.
Article in Chinese | WPRIM | ID: wpr-887024

ABSTRACT

This study aimed to establish a method for positioning six chromatographic peaks occurred in HPLC profile of Gastrodiae Rhizoma. The "liner calibration with two reference substances" (LCTRS) method was used to calculate the retention time so as to assist in positioning of chromatographic peaks in terms of the prediction accuracy of retention time and the coincidence rate of chromatographic column. A total of 24 C18 chromatographic columns from different brands and types available were used to determine the retention times of six components in Gastrodiae Rhizoma, then the average retention time of each component was obtained as standard retention time (SRT). Parishin E (peak 3) and Parishin A (peak 6) were simultaneously taken as reference substance to forecast the retention time of the other four components by using the LCTRS method. Four different C18 columns were employed to verify the method. Meanwhile, for the purpose of comparison, the relative retention time (RRT) method was applied to forecast the retention time, by using Parishin E as the single reference substance. The comparison between LCTRS and RRT methods indicated that the former was more accurate in predicting the retention time and more applicable in utilization of chromatographic columns. This study demonstrated that the LCTRS method shows the superior performance in positioning of chromatographic peak, and therefore has a good prospect of application.

9.
Acta Pharmaceutica Sinica ; (12): 1749-1756, 2021.
Article in Chinese | WPRIM | ID: wpr-887019

ABSTRACT

This paper reviews modern science and technology with regard to traditional Chinese medicine (TCM) research methods, quality control, and discusses the establishment and improvement of the evaluation system for TCM, focusing on the following issues: 1) How to incorporate the efficacy of TCM in the overall evaluation of TCM quality; 2) how to quantify the efficacy and properties of TCM; 3) how to understand the correlation between the efficacy and properties of TCM and its application; 4) how to reflect the specificity of the effective components in the overall evaluation of TCM quality; and 5) how to reflect the quality value transfer of effective components in the whole process of production and metabolism in vivo to the overall evaluation of TCM quality. The overall quality evaluation of TCM needs to better reflect its clinically safety and effectiveness. It is suggested to establish a clinical quality assessment method based on the content of the chemical components of TCM to explore and establish an overall evaluation method of TCM quality that reflects the efficacy of TCM and conforms with clinical practice.

10.
Article in Chinese | WPRIM | ID: wpr-879064

ABSTRACT

To analyze quality standards of cattle bile and sheep bile, and to discuss the related problems in the standards. The results showed that physical forms of the related medicinal materials of cattle bile and sheep bile were chaotic, and the technical methods adopted in the quality standards were generally backward. In addition, there were still problems that some medicinal material standards lacked necessary test items, which were especially obvious in the relevant medicinal material standards of sheep bile and brought difficulties to quality evaluation and control. We suggest that physical forms of cattle bile and sheep bile in quality standards should be determined, and inspection items should be completed. Based on mainstream analytical technology, some technical methods of these standards should be improved.


Subject(s)
Animals , Bile , Cattle , Reference Standards , Sheep , Steroids
11.
Acta Pharmaceutica Sinica ; (12): 1004-1009, 2020.
Article in Chinese | WPRIM | ID: wpr-821686

ABSTRACT

Inductively coupled plasma mass spectrometry (ICP-MS) was used to determine the content of cadmium (Cd) and arsenic (As) in earthworms. A physiologically-based extraction test (PBET) digestion in vitro /MDCK cell model was established to investigate the bioaccessibility of Cd and As in earthworms. The hazard index (HI) method and the margin of exposure (MOE) method were used to assess the risks of the total content and the bioaccessible content of Cd and As. The results showed that the total content of Cd and As in six batches of earthworms ranged from 8.319 to 33.606 mg·kg-1 and from 0.532 to 16.412 mg·kg-1, respectively. After uptake by MDCK cells, the bioaccessibility of Cd in earthworms ranged from 10.13% to 64.16%, and the bioaccessibility of As was from 2.72% to 46.57%. The results of risk assessment showed that before uptake by MDCK cells, the MOE values of As and HI values of Cd for all batches of earthworms were greater than 1, which suggests that the risks of As are acceptable but the risks of Cd are unacceptable. After transportation by MDCK cells, except for one batch of earthworms, the HI values of Cd in the other five batches were less than 1, which suggests that the risks are at a safe level. This study provides important technical support for a more objective and scientific assessment of the health risks of heavy metals in traditional Chinese medicines, and for a more scientific and reasonable standard limit of heavy metals.

12.
Acta Pharmaceutica Sinica ; (12): 2695-2701, 2020.
Article in Chinese | WPRIM | ID: wpr-837522

ABSTRACT

Heavy metals and other harmful elements in traditional Chinese medicines inflict serious damage on public health. Therefore, risk assessment of Chinese raw materials has gained increasing attention. To date, few reports have been published on the health risk assessment of heavy metals and harmful elements in Chinese patent medicines. To gain a comprehensive understanding of heavy metals and other harmful elements in Chinese patent medicines and to establish proper limits, residual Pb, Cd, As, Hg, Cu and Cr in 15 054 samples of 295 drugs was analyzed with regard to distribution and variation between elements and dosage forms. In addition, in accord with procedures including hazard identification, hazard characterization, exposure assessment and risk characterization, basic procedures and specific parameters for risk assessment of heavy metals and harmful elements in Chinese patent medicines were clarified based on the health risk assessment of 14 787 samples and 276 drugs. A method and equation for establishing residual limits is proposed. The results show that content and target hazard quotients (THQs) of the investigated elements in all samples showed a skewed distribution approaching 0. Content of Pb, As, Cu, Hg, Cd or Cr in the samples exceeded 100 mg·kg-1 and the content of Pb, As, or Cu in individual samples exceeded 1 000 mg·kg-1. THQs of 586 samples and four drugs were above 1. We believe that the health risk of Hg, Pb and As in Chinese patent medicines with dosage forms of pill, capsule, tablet and powder, especially those in raw powder preparations, warrant concern.

13.
Article in Chinese | WPRIM | ID: wpr-828062

ABSTRACT

In this study, we aimed to establish a rat liver micro-tissue evaluation system to evaluate the hepatotoxicity of the main monomers in Polygonum multiflorum. Rat primary hepatocytes were isolated and purified by two-step in situ perfusion method to prepare hepatic parenchymal cells. The ultra-low adsorption plate and the inverted model were used to establish an in vitro hepatotoxicity evaluation system. After the system was established, the main monomer components(monanthone with emodin type, rhein, emodin, emodin-8-O-β-D-glucopyranoside, physcion) of P. multiflorum were selected for in vitro hepatotoxicity evaluation. This study showed that the primary cells of the liver can form liver micro-tissues in the low adsorption plate method and the mold perfusion method, with good liver structure and function, which can be used to evaluate the hepatotoxicity of the drug to be tested after long-term administration. The five monomers to be tested in P. multiflorum can significantly affect the proliferation of primary liver micro-tissues in rats in a dose-and time-dependent manner. The hepatotoxic effects were as follows: monanthone with emodin type > rhein > emodin > emodin-8-O-β-D-glucopyranoside > physcion. The results suggested that the emodin-type monoterpene and rhein might be the potential hepatotoxic components, while the metabolites of emodin-8-O-β-D-glucoside and emodin methyl ether showed more toxic risks. The rat primary hepatocyte micro-tissue model system established in this experiment could be used to achieve long-term drug administration in vitro, which was consistent with the clinical features of liver injury caused by long-term use of P. multiflorum. The experimental results provided important information and reference on the clinical application and toxic component of P. multiflorum.


Subject(s)
Animals , Chemical and Drug Induced Liver Injury , Emodin , Fallopia multiflora , Glucosides , Plant Extracts , Polygonum , Rats
14.
Article in Chinese | WPRIM | ID: wpr-873260

ABSTRACT

Objective::To establish the quality control method for multi-index content determination and fingerprint of salvianolic acids. Method::Agilent ZORBAX SB-C18 (4.6 mm×250 mm, 5μm) column was adopted, with 0.1%formic acid-water as mobile phase A and 0.1%formic acid-acetonitrile as mobile phase B for gradient elution (0-30 min, 20%-21.5%B; 30-35 min, 21.5%-25%B; 35-45 min, 25%-40%B; 45-50 min, 40%-95%B). The column temperature was set at 30 ℃, the flow rate was set at 1 mL·min-1, and the detection wavelength was set at 288 nm. Relative correction factors of caffeic acid, salvianolic acid E, rosmarinic acid, lithosperic acid, salvianolic acid B and salvianolic acid Y were determined by the concentration method. The content of each indicator component of the reference extract of salvianolic acid polyphenolic acid was determined and compared with the results of the monomer reference substance by the external standard method. At the same time, the fingerprint method was established. and the similarity evaluation was carried out on 10 batches of extracts. Result::Caffeic acid, salvianolic acid E, rosmarinic acid, lithospermic acid, salvianolic acid B, and salvianolic acid Y had a good linear relationship within the respective detection mass concentration ranges (r>0.999 9). The injection precision RSD was 0.1%-1.2%, the reproducible RSD was 1.2%-1.6%, and the recovery of the six components was 82.03%-98.68%. The stability of each component in the sample solution was good within 36 h. The relative correction factors for each indicator component were determined to be caffeic acid (2.92), salvianolic acid E (1.10), rosmarinic acid (1.61), lithosperic acid (1.07), salvianolic acid B (1.00), salvianolic acid Y (0.83). The effects of different methods, concentrations, instruments, columns, wavelengths were investigated, and the measured relative correction factors were found to be suitable. The results of the calibration factor method and the monomer standard reference substance method were less different. The HPLC fingerprints of the reference extract of salvianolic acids were established, and five common characteristic peaks were determined. The chromatographic peaks were confirmed according to the reference substance. The similarity of the fingerprints of the 10 batches of extracts was higher, and the quality difference was smaller. Conclusion::The multi-index content determination method and the fingerprint method established in this study are simple, rapid, accurate and reproducible, and can be used for quality control of Salviae miltiorrhizae Radix et Rhizoma polyphenolic acid reference extract.

15.
Acta Pharmaceutica Sinica ; (12): 2162-2168, 2019.
Article in Chinese | WPRIM | ID: wpr-780350

ABSTRACT

Consistency in quality of traditional Chinese medicine granules is an important factor to ensure reproducible clinical efficacy. In this study rhubarb dispensing granules were utilized to construct an efficacious near-infrared spectroscopy (eNIRS) assay by combining NIRS and biopotency. A NIR method for assaying rhubarb dispensing particles was established, and information on different batches was collected. The diarrhea-inducing biopotency of rhubarb dispensing granules was determined based on a constipation model induced by diphenoxylate in mice. The animal protocol was approved by the Animal Ethic Committee​ of 302 Hospital of Chinese PLA People's Liberation Army (ID: IACUC-2019-0010). Ten anthraquinones were determined in rhubarb dispensing granules by UPLC. The correlation between NIR and biopotency was analyzed and five characteristic bands that correlated highly with bioactivity were identified, including 4 011-4 390, 4 859-5 461, 7 012-7 493, 10 992-11 312 and 11 871-12 489 cm-1. There were some differences in the main bands of different chemical constituents. In summary, five active bands based on NIRS were identified and found to be able to achieve rapid on-line detection of rhubarb dispensing granule quality. This research model may also provide reference for quality control of other Chinese medicine dispensing granules.

16.
Acta Pharmaceutica Sinica ; (12): 2074-2082, 2019.
Article in Chinese | WPRIM | ID: wpr-780288

ABSTRACT

We determined a component-target-disease network for Carthamus tinctorius L. and the key compounds, identified by topological analysis, were related to vasculitis, coronary heart and cerebrovascular disease. Based on these compounds, the chromatographic fingerprint of Carthamus tinctorius L. was established. Firstly, 132 compounds were obtained from TCMID and TCMSP databases. Their targets were predicted in the PharmMapp and HemMapper databases. CardioGenBase, Therapeutic Target Database and DisGeNET databases were used to collect targets of vasculitis, coronary heart disease and cerebrovascular disease. The corresponding relationships between component and target protein were established by mapping. Finally, the "component-target-disease" network was built with Cytoscape software. The core network and key nodes were analyzed with the Cytohubba plug-in. The results showed that the 24 key compounds were alpha-tocopherol, adenosine, quinone chalcone pigments such as hydroxysafflor yellow A, safflower yellow, quercetin, kaempferol and other flavonoids, organic acids such as stearic acid, linolenic acid, coumaric acid and cinnamic acid. This resulting chromatographic fingerprint of Carthamus tinctorius L. showed good consistency, and the core chemical compounds obtained by topological analysis of the network of "component-target-disease", could be used as quality control markers. Our research provides a new approach for the identification of quality control indicators in Chinese medicinal materials.

17.
Acta Pharmaceutica Sinica ; (12): 2083-2088, 2019.
Article in Chinese | WPRIM | ID: wpr-780284

ABSTRACT

The morphological identification, chemical component analysis, and DNA barcode determination were investigated on Genus Mentha (including Mentha haplocalyx Briq., Mentha piperita Linn., Mentha spicata Linn. and Mentha cultivated) in order to reveal the origin of Herba Mentha as a drug, and ensure the accuracy in clinic application. The morphological characters, chemical composition analysis by GC-MS/MS and DNA content measure by polymerase chain reaction (PCR) were reported in this study for inter- or intra- species divergence. Based on the morphology, axillary verticillasters was recognized as the typical character for Mentha haplocalyx Briq. Carvone was used as an index component for chemical composition analysis of Mentha spicata Linn. Gene clustering analysis divided 22 batches of samples into two molecular groups. Mentha haplocalyx Briq. is distinguishably different from Mentha spicata Linn. Mentha piperita Linn. and other cultivated plants were distributed between these two species. The results obtained by morphological identification, chemical composition analysis, and DNA barcode determination show good correlations, but each identification method has its limit. In view of the fact that hybridization of the plants in Genus Mentha is common, identification relying on only one method is not recommended.

18.
Acta Pharmaceutica Sinica ; (12): 354-359, 2019.
Article in Chinese | WPRIM | ID: wpr-780099

ABSTRACT

Though red yeast rice (RYR) has been used as medicine for centuries, few study has been reported about its biological activities related to traditional medicinal application and marketed RYR showed poor consistency in quality. In this study, with comprehensive investigation of their production processes and field acquisition samples including those from genuine producing area, an ultra performance liquid chromatographic (UPLC) method was firstly established to discriminate RYR for different applications based on their secondary metabolites fingerprint. It was performed on a CAPCELL CORE AQ column (100 mm×4.6 mm, 2.7 μm), with PDA (range: 200-650 nm, extracted: 237 nm) and ELSD detection. The mobile phase used was water (A) and acetonitrile (B) both containing 0.1% formic acid at gradient elution (0-15 min, 50% B→85% B (linear); 15-16 min, 85 % B→50% B (linear) and maintained until 21 min), with a flow rate of 0.5 mL∙min-1. The method established was fully validated in agreement with guidelines of Chinese Pharmacopeia. Common metabolites were found in RYR for same application and the fingerprints of RYR for food coloring or brewing from various manufacturers had similarities above 0.90. Meanwhile, significant differences were observed among the fingerprints for various applications and discrimination could be achieved by principal component analysis (PCA). Lovastatin was absence in RYRs for food coloring or brewing, and the fingerprint of traditional medicinal RYR was similar to that of RYR for brewing. However, standardization was required for RYR containing lovastatin because of their significant differences from various manufacturers in fingerprints and lovastatin content. The results demonstrated the feasibility to discriminate RYR for different applications by the secondary metabolites fingerprint method established in this study, which provides a scientific basis to investigate the relationship between biological activities of medicinal RYR and their corresponding secondary metabolites, and further aid their quality standardization and improvement.

19.
Acta Pharmaceutica Sinica ; (12): 348-353, 2019.
Article in Chinese | WPRIM | ID: wpr-780098

ABSTRACT

To determine relative molecular weight of astragalus polysaccharides (APs), we used Shodex GS620 gel permeation chromatographic column and differential refraction detector (GPC-RI) with dextran as a reference. Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF-MS) and GPC combined with multi-angle laser light scattering detection (GPC-MALLS) were also used.GPC-RI measure showed four peaks of APs, with the Mw of 1 380 000, 231 000, 18 000, and 480, respectively. Three main peaks were found by GPC-RI-MALLS with the Mw as 1 148 000, 180 000, and 43 000, respectively. Strong signals in 155 000 and 18 000 were detected by MALDI-TOF-MS, which also indicated the sugar moieties of the APs as hexoses. From our study, we found that the GPC-RI method with universal correction is most suitable for Mw determination of the APs. Nevertheless, the three methods should be combined and contrasted with each other to obtain accurate information in research of polysaccharides from Chinese medicine.

20.
Article in Chinese | WPRIM | ID: wpr-777457

ABSTRACT

For the discussion of the source, preparation and quality problems of Indigo Naturalis, the historical tradition and reality were summarized by literature survey and producing area investigation. Besides some quality problems, potential safety hazards were found out in some samples from market tested. Because lime could not be dislodged enough from Indigo Naturalis in the process of purification, the samples of Indigo Naturalis contained too much lime and showed strong alkalinity. It was suggested that the quality standard of Indigo Naturalis should be revised and revised and some detection projects and methods should be added into the standard. In addition, we suggested that the production access of Indigo Naturalis should be further defined.


Subject(s)
Drugs, Chinese Herbal , Reference Standards , Indigofera , Chemistry , Plants, Medicinal , Chemistry
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