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1.
China Journal of Chinese Materia Medica ; (24): 306-312, 2022.
Article in Chinese | WPRIM | ID: wpr-927972

ABSTRACT

A total of 18 batches of Zhuru Decoction samples were prepared. Chromatographic fingerprints were established for Zhuru Decoction and single decoction pieces, the content of which was then determined. The extraction rate ranges, content, and transfer rate ranges of puerarin, liquiritin, and glycyrrhizic acid, together with the common peaks and the similarity range of the fingerprints, were determined to clarify key quality attributes of Zhuru Decoction. The 18 batches of Zhuru Decoction samples had 25 common peaks and the fingerprint similarity higher than 0.95. Puerariae Lobatae Radix, Glycyrrhizae Radix et Rhizoma, and Zingiberis Rhizoma Recens had 21, 3, and 1 characteristic peaks, respectively. The 18 batches of samples showed the extraction rates within the range of 18.45%-25.29%. Puerarin had the content of 2.20%-3.07% and the transfer rate of 38.5%-45.9%; liquiritin had the content of 0.24%-0.85% and the transfer rate of 15.9%-37.5%; glycyrrhizic acid had the content of 0.39%-1.87% and the transfer rate of 16.2%-32.8%. In this paper, the quality value transmitting of substance benchmarks of Zhuru Decoction was analyzed based on chromatographic fingerprints, extraction rate, and the content of index components. A scientific and stable method was preliminarily established, which provided a scientific basis for the quality control and formulation development of Zhuru Decoction.


Subject(s)
Chromatography, High Pressure Liquid , Drugs, Chinese Herbal/standards , Glycyrrhizic Acid/analysis , Quality Control , Rhizome/chemistry
2.
China Journal of Chinese Materia Medica ; (24): 846-852, 2022.
Article in Chinese | WPRIM | ID: wpr-927968

ABSTRACT

The improvement of the harvest period standards is critical in the quality control of Chinese medicinal materials. The present study statistically analyzed the harvest period standards of plant medicinal materials in the 2020 edition of Chinese Pharmacopoeia(Vol.Ⅰ) and put forward the existing problems and suggestions based on herbal records and modern research to provide references for the improvement of the standards. According to the statistical analysis, in 499 types of plant medicinal materials, harvest period standards are recorded under 486 types, accounting for 97.4%, and are lacking in the remaining. Only one medicinal material(Stellariae Radix) is recorded with the standard of the harvest year. The standards of the harvest season and phenological period are recorded under 233 types, accounting for 46.7%. For 237 types, only harvest season is specified, accounting for 47.5%, and for 15 types, only harvest phenological period is specified, accounting for 3.0%. Among 222 types mainly derived from cultivation and 51 types from wild resources and cultivation, only 11 types are recorded with harvest period of cultivated products. Only Stellariae Radix is recorded with the harvest period standards for the wild and cultivated products separately. The harvest period standards of plant medicinal materials with different medicinal parts have certain rules to follow. The main problems about the harvest period standards are discovered. Specifically, no harvest period standards are recorded under 13 types of plant medicinal materials. Almost all perennial cultivated medicinal materials are not recorded with harvest year standard. No phenological period standard is found under 250 types of plant medicinal materials. There is no clear distinction between the harvest period standards of cultivated and wild products. The evidence for harvest period standards of 26 types of plant medicinal materials that can be harvested all year round is insufficient. As a result, it is proposed to strengthen basic research in response to the above-mentioned problems and improve the harvest period standards as soon as possible to ensure the quality of Chinese medicinal materials.


Subject(s)
China , Drugs, Chinese Herbal/standards , Medicine, Chinese Traditional , Pharmacopoeias as Topic , Plants, Medicinal , Quality Control
3.
China Journal of Chinese Materia Medica ; (24): 127-133, 2022.
Article in Chinese | WPRIM | ID: wpr-927919

ABSTRACT

In light of related methods in Chinese Pharmacopoeia(2020 edition), this study established the quality standard for Lobeliae Chinensis Herba. The TLC identification method was established with silica gel GF_(254) thin layer plate, diosmin standard, linarin standard, and the reference material of Lobeliae Chinensis Herba. The loss on drying, total ash, acid-insoluble ash, and ethanol-soluble extracts of 18 batches of Lobeliae Chinensis Herba samples were determined according to the general principles in Chinese Pharmacopoeia. Then, HPLC was adopted in the establishment of characteristic chromatogram and content determination. The results showed that the established method can achieve good separation for diosmin, linarin, and lobetyolin. Based on the results of detection for 18 batches of Lobeliae Chinensis Herba samples, the draft quality standard was established, which was expected to provide reference for the revision of this medicinal herb in Chinese Pharmacopoeia.


Subject(s)
Chromatography, High Pressure Liquid , Drugs, Chinese Herbal/standards , Lobelia/chemistry , Plants, Medicinal/chemistry
4.
China Journal of Chinese Materia Medica ; (24): 334-342, 2022.
Article in Chinese | WPRIM | ID: wpr-927975

ABSTRACT

Fingerprints of 18 batches of substance benchmark of Shentong Zhuyu Decoction(SZD) were established by UPLC under the following conditions: Waters Sun Fire C_(18) column(3.0 mm×150 mm, 3.5 μm), column temperature of 35 ℃, gradient elution with mobile phase of acetonitrile(A)-0.1% phosphoric acid aqueous solution(B) at the flow rate of 0.4 mL·min~(-1), and detection by wavelength switching. A total of 16 common peaks were identified. The similarities among the fingerprints were calculated by Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(2012 Edition) and the result showed they were in the range of 0.911-0.988. Based on the 16 common peaks, cluster analysis(CA), principal component analysis(PCA), and partial least square discriminant analysis(PLS-DA) all categorized the 18 batches of samples into two groups(S1, S2, S5-S8, S14, and S17 in one group, and S1, S2, S5-S8, S14, and S17 in another), and 11 most influential components were screened. Five known components with great difference among samples(hydroxysafflor yellow A, ferulic acid, benzoic acid, ecdysone, and ammonium glycyrrhizinate) were determined. The combination of multi-component content determination and fingerprints can reflect the overall cha-racteristics of the primary standards of SZD, which is simple, feasible, reproducible, and stable. This study can serve as a reference for the quality control of the primary standards of SZD.


Subject(s)
Chromatography, High Pressure Liquid , Drugs, Chinese Herbal/standards , Quality Control
5.
China Journal of Chinese Materia Medica ; (24): 324-333, 2022.
Article in Chinese | WPRIM | ID: wpr-927974

ABSTRACT

To clarify the key quality attributes of substance benchmarks in Danggui Buxue Decoction(DBD), this study prepared 21 batches of DBD substance benchmarks, and established two methods for detecting their fingerprints, followed by the identification of peak attribution and similarity range as well as the determination of extract and transfer rate ranges and contents of index components ferulic acid, calycosin-7-O-β-D-glucoside, and astragaloside Ⅳ. The mass fractions and transfer rates of DBD substance benchmarks from different batches were calculated as follows: ferulic acid(index component in Angelicae Sinensis Radix): 0.037%-0.084% and 31.41%-98.88%; astragaloside Ⅳ(index component in Astragali Radix): 0.021%-0.059% and 32.18%-118.57%; calycosin-7-O-β-D-glucoside: 0.002%-0.023% and 11.51%-45.65%, with the extract rate being 18.4%-36.1%. The similarity of fingerprints among 21 batches of DBD substance benchmarks was all higher than 0.9. The quality control method for DBD substance benchmarks was preliminarily established based on the HPLC fingerprint analysis and index component determination, which has provided a basis for the subsequent development of DBD and the quality control of novel related preparations.


Subject(s)
Chromatography, High Pressure Liquid/methods , Drugs, Chinese Herbal/standards , Quality Control
6.
China Journal of Chinese Materia Medica ; (24): 313-323, 2022.
Article in Chinese | WPRIM | ID: wpr-927973

ABSTRACT

Following the preparation of substance benchmarks in Huanglian Decoction from 18 batches, the method for detecting their characteristic spectra was established to identify the similarity range and peak attribution. The content and transfer rate ranges of the index components coptisine, palmatine, berberine, liquiritin, glycyrrhizic acid, 6-gingerol, and cinnamaldehyde and the extraction amount were combined for analyzing the quality value transfer from the Chinese medicinal pieces to substance benchmarks and clarifying the key quality attributes of substance benchmarks in Huanglian Decoction. The results showed that the substance benchmarks in Huang-lian Decoction of 18 batches exhibited good similarity in characteristic spectra(all greater than 0.98). There were 17 characteristic peaks identified in the substance benchmarks of Huanglian Decoction, including 10 from Coptidis Rhizoma, 3 from Glycyrrhizae Radix Et Rhizoma Praeparata Cum Melle(processed with water), 1 from Zingiberis Rhizoma, and 3 from Cinnamomi Ramulus. The contents and average transfer rates of the index components were listed as follows: coptisine 2.20-6.46 mg·g~(-1) and 18.50%±2.93%; palmatine 3.03-8.13 mg·g~(-1) and 26.56%±4.69%; berberine 7.71-22.29 mg·g~(-1) and 17.34%±3.00%; liquiritin 0.88-2.18 mg·g~(-1) and 9.88%±4.88%; glycyrrhizic acid 1.83-4.44 mg·g~(-1) and 8.50%±3.72%; 6-gingerol 0.56-1.43 mg·g~(-1) and 11.36%±2.37%; cinnamaldehyde 1.55-3.48 mg·g~(-1) and 19.02%±4.36%. The extraction amount of the substance benchmarks from the 18 batches was controlled at 10.65%-13.88%. In this paper, the quality value transfer of substance benchmarks in Huanglian Decoction was analyzed based on the characteristic spectra, the index component contents and the extraction amount, which has provided a basis for the subsequent development of Huanglian Decoction and the quality control of its related preparations.


Subject(s)
Chromatography, High Pressure Liquid , Drugs, Chinese Herbal/standards , Quality Control
7.
China Journal of Chinese Materia Medica ; (24): 1350-1356, 2020.
Article in Chinese | WPRIM | ID: wpr-1008578

ABSTRACT

To define the composition of relevant substances in Breviscapine for Injection, in order to improve the quality control of impurity, and ensure the clinical safety. The analysis and structural identification of relevant substances in different specifications and batches of Breviscapine for Injection powders were carried out by HPLC and UPLC-QTOF-MS. Three primary relevant substances, namely 5,6,7,3',4'-pentahydroxyflavone-7-O-glucuronide(3), 3,5,6,7,4'-pentahydroxyflavone-3-O-glucuronide(4) and scutellarein(10), as well as three minor impurities, namely 6-hydroxyapigenin-6-O-glucosyl-7-O-glucuronide(1), methoxylscutellarin(6) and apigenin-7-O-glucuronide(7) were structurally identified by matching retention time, UV spectra, and mass spectra with authentic compounds and MS fragmentation rules. The main relevant substances(3) and(4) were separated and purified by semi-preparative HPLC, and their structures were further confirmed by NMR data. The study defined relevant substances of Breviscapine for Injection, and provided reference for improving the quality control level of single impurity in breviscapine preparation.


Subject(s)
Apigenin/analysis , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal/standards , Flavonoids/chemistry , Glucuronides/analysis , Injections , Magnetic Resonance Spectroscopy , Mass Spectrometry , Quality Control
8.
China Journal of Chinese Materia Medica ; (24): 884-889, 2020.
Article in Chinese | WPRIM | ID: wpr-1008514

ABSTRACT

To establish a content determination method for quality control of the pieces and standard decoction of honey-fried Descurainiae Semen. Standard decoction of honey-fried Descurainiae Semen was prepared with standardized process, and high performance liquid chromatography coupled with diode-array detector(HPLC-DAD) was used to detect its characteristic fingerprint and determine the content of quercetin-3-O-β-D-glucose-7-O-β-D-gentiobioside. In addition, the transfer rate, dry extract rate and pH value were calculated. The results showed that the established method had a high accuracy. The content of quercetin-3-O-β-D-glucose-7-O-β-D-gentiobioside in 13 batches of standard decoction was 0.03-0.12 mg·mL~(-1); the transfer rate was 13.4%-23.1%; the rate of extracts was 1.9%-5.5%, and the pH was between 5.4-5.9. The similarity coefficients were all greater than 0.85, indicating good homogeneity for the different batches of decoction. There were 7 common peaks in the characteristic chromatogram, one of which was quercetin-3-O-β-D-glucose-7-O-β-D-gentiobioside. In this paper, the established content determination and quality evaluation method for Descurainiae Semen pieces and decoction was simple, rapid and reproducible, providing reference for the quality control of honey-fried Descurainiae Semen pieces, standard decoction and its preparations.


Subject(s)
Brassicaceae/chemistry , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal/standards , Glucosides/analysis , Honey , Quality Control , Quercetin/analogs & derivatives
9.
China Journal of Chinese Materia Medica ; (24): 715-719, 2020.
Article in Chinese | WPRIM | ID: wpr-1008495

ABSTRACT

Dao-di herbs is one of the characteristics of traditional Chinese medicine different from other ethnic medicine. Sichuan province is rich in varieties and resources of Dao-di herbs, and its development scale and benefits are not obvious in recent decades due to the lag of standards behind the development of the times and objective needs. From the point of view of the whole process and the whole industrial chain, the significance of standardization system for quality assurance, healthy development of the industry, and development of the industry of Sichuan Dao-di herbs are presented in this paper. At present, Sichuan has made every effort to promote the construction and practice of the standardization system for Sichuan Dao-di herbs, to promote the rapid and high-quality development of Dao-di herbs industry in Sichuan.


Subject(s)
China , Drugs, Chinese Herbal/standards , Medicine, Chinese Traditional , Plants, Medicinal/chemistry
10.
China Journal of Chinese Materia Medica ; (24): 709-714, 2020.
Article in Chinese | WPRIM | ID: wpr-1008494

ABSTRACT

Guided by the basic theory of traditional Chinese medicine and using modern scientific methods, Dao-di herbs pharmacology studies the nature, performance, interaction with the body and its clinical application.It is a bridge between the basic research and clinical application of Dao-di herbs. It can objectively describe the law of efficacy of Dao-di herbs, scientifically explain the mechanism of efficacy of Dao-di herbs, explore and establish the standards and methods of Dao-di herbs based on biological effect and clinical efficacy, and provide scientific basis for the special properties, pharmacology and clinical value of Dao-di herbs.Furthermore, we put forward a new idea of building the standard of Dao-di herbs based on the curative effect rather than the origin.The Dao-di herbs standard should come from the systematic research of traditional Dao-di herbs producing areas and form a new characteristic system, through the extraction of environmental, genetic, character, chemical, pharmacological and other characteristics.This standard originates from the tradition, but it is higher than the tradition. It may not have the origin meaning of strict administrative division, but it can better reflect the pharmacological characteristics and excellent clinical value of Dao-di herbs.


Subject(s)
China , Drugs, Chinese Herbal/standards , Medicine, Chinese Traditional , Plants, Medicinal/chemistry
11.
China Journal of Chinese Materia Medica ; (24): 119-123, 2020.
Article in Chinese | WPRIM | ID: wpr-1008446

ABSTRACT

Astragali Radix is commonly used as bulk medicinal materials. Chinese Pharmacopoeia contains about 150 compound preparations of Astragali Radix, but the sample preparation method under the determination of Astragali Radix content in Chinese Pharmacopoeia is tedious and time-consuming, not convenient for the test of a large number of samples. Therefore, it is of great significance to simplify the sample preparation method and improve the practicability of the method for the quality control of Astragali Radix and its preparations. In this study, ultrasonic extraction method was used instead of heated reflux extraction, and solid phase extraction method was used to enrich and prepare the samples. A set of practical quality evaluation method was established for Astragali Radix slices and standard decoction, greatly shortening the sample preparation time and improving the accuracy of the method. The results of Astragali Radix standard decoction analysis showed that the transfer rate of calycosin 7-O-β-D-glucospyranoside,(96.5±28.7)%, had great variation, which was found to be related to the conversion of mulberry isoflavone glucoside into calycosin 7-O-β-D-glucospyranoside during the preparation of standard decoction. The transfer rates were(59.4±14.4)% and(101.3±12.3)% for calycosin and astragaloside Ⅳ respectively, which were relatively stable. Therefore, it is suggested that Astragali Radix slices and water decoction preparations should be evaluated by using calycosin and astragaloside Ⅳ as the quality evaluation index. The results provide a scientific and practical method for quality control of Astragali Radix slices and its standard decoction, and also provide scientific evidence for quality evaluation of the preparations.


Subject(s)
Astragalus Plant/chemistry , Astragalus propinquus , Drugs, Chinese Herbal/standards , Glucosides/analysis , Plant Roots/chemistry , Quality Control , Solid Phase Extraction
12.
China Journal of Chinese Materia Medica ; (24): 92-97, 2020.
Article in Chinese | WPRIM | ID: wpr-1008442

ABSTRACT

Pyrrolizidine alkaloids(PAs) are a kind of natural toxins, which can cause severe hepatotoxicity, pulmonary toxicity, genotoxicity, neurotoxicity, embryotoxicity and even death. Therefore, international organizations and countries such as World Health Organization have paid great attention to herbal medicines and preparations containing PAs. PAs are widely distributed in Chinese herb medicines and contained in hundreds of traditional Chinese medicine preparations. The content of adonifoline, the main PAs in Senecionis Scandentis Herba, shall be less than 0.004% in herbal medicines as described in Chinese pharmacopeia. However, there is no guidance in preparations which contain Senecionis Scandentis Herba. In this study, 14 preparations were analyzed by an UPLC-MS method. Among them, 8 preparations were found to contain adonifoline much higher than the content limits of such countries as Germany, Netherlands and New Zealand. And the highest contents of adonifoline were found in Qianbai Biyan Tablets and Qianbai Biyan Capsules, which are officially recorded in Chinese Pharmacopeia. The contents of adonifoline varied in different batches of the same preparations. The highest content was 156.10 μg·g~(-1) Qianbai Biyan Tablets, whose daily intake of adonifoline was up to 1 030.26 μg according to the recommended dosage of the preparation. Our results showed the potential risk of these preparations, and the content limit of adonifoline shall be inspected Chinese medicine preparations containing Senecionis Scandentis Herba.


Subject(s)
Chromatography, Liquid , Drugs, Chinese Herbal/standards , Lactones/analysis , Medicine, Chinese Traditional , Pyrrolizidine Alkaloids/analysis , Senecio/chemistry , Tandem Mass Spectrometry
13.
China Journal of Chinese Materia Medica ; (24): 352-360, 2020.
Article in Chinese | WPRIM | ID: wpr-1008344

ABSTRACT

In this paper, some quality problems of mineral medicine Calamina and calcined Calamina have been discussed after determination and analysis of the quality parameters of a large number of market samples, and the countermeasures are put forward. According to the XRD results, as well as the results of tests included in Chinese Pharmacopoeia(2015 edition), the authenticity of Calamina and calcined Calamina samples were identified. The content of zinc oxide in samples were determined by the method of determination in Chinese Pharmacopoeia. Individually, inductively coupled plasma mass spectrometry(ICP-MS), inductively coupled plasma atomic emission spectrometry(ICP-AES) and atomic fluorescence spectrometry(AFS) methods were used for the determination of impurity elements and harmful elements in Calamina and calcined Calamina samples. Four kinds of impurity elements of magnesium(Mg), iron(Fe), aluminum(Al), calcium(Ca) and five harmful elements such as lead(Pb), cadmium(Cd), arsenic(As), copper(Cu), mercury(Hg) were measured. The study showed that: ① Fake Calamina products on the market were overflowing; ② The mineral origin of the mainstream Calamina in the market is inconsistent with that stipulated in Chinese Pharmacopoeia(2015 edition); ③ The contents of harmful elements Pb and Cd in Calamina and calcined Calamina are generally higher, while the contents of harmful elements As and Cu in some inferior Calaminae are higher; ④ Parts of calcined Calamina were improperly or inadequately processed. In view of these quality problems, the countermeasures are put forward as follows: ① It is suggested that hydrozincite should be approved as the mineral source of Calamina, and be included by Chinese Pharmacopoeia; ② Strengthen the research on the specificity of Calamina identification methods to improve the quality control level; ③ Strengthen the research on the processing of Calamina, and formulate the limit standards for the content of Pb and Cd in Calamina; ④ Carry out research on the artificial synthesis of Calamina and calcined Calamina, in order to cope with the current shortage of Calamina resources and ensure the sustainable development of Calamina medicinal materials.


Subject(s)
Arsenic , Cadmium , Copper , Drug Combinations , Drugs, Chinese Herbal/standards , Ferric Compounds/standards , Iron , Lead , Medicine, Chinese Traditional , Mercury , Minerals , Quality Control , Trace Elements/analysis , Zinc Oxide/standards
14.
China Journal of Chinese Materia Medica ; (24): 5446-5450, 2019.
Article in Chinese | WPRIM | ID: wpr-1008419

ABSTRACT

The purpose of this study was to investigate the feasibility of the salvianolic acids reference extract for quality control for Salvia miltiorrhiza and salvianolic acids for injection. An Agilent ZORBAX SB-C18( 4. 6 mm×250 mm,5 μm) column was used with mobile phase consisting of 0. 1% formic acid-water and 0. 1% formic acid-acetonitrile in gradient elution procedure. The column temperature was 30 ℃; the flow rate was 1 m L·min-1; and the detection wavelength was 288 nm. The content of rosmarinic acid,lithospermic acid and salvianolic acid B in S. miltiorrhiza was determined by using the salvianolic acids reference extract as control substance. The content of caffeic acid,salvianolic acid E,rosmarinic acid,lithospermic acid,salvianolic acid B,and salvianolic acid Y in the salvianolic acids for injection was also determined. The linear relationship between chemicals was good( r>0. 998 9),and the injection precision RSD was 0. 30%-0. 90%. The sexual RSD is between 1. 4% and 3. 0%,and the RSD of the reproducibility of the extract is between 2. 1% and 5. 2%. The recovery rate of the three components in S. miltiorrhiza was 96. 80%-99. 20%,and the recovery rate of the six components in salvianolic acids for injection was 88. 90%-107. 5%. The solution of S. miltiorrhiza and salvianolic acids for injection were stable within 48 h. A total of 8 batches of S. miltiorrhiza and injection were determined by the reference extract,and the difference was smaller than that measured by the monomer control. This study preliminarily verified that the salvianolic acids reference extract can be used as a substitute for the monomer control for the quality control of S. miltiorrhiza and salvianolic acids for injection.


Subject(s)
Alkenes/analysis , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal/standards , Polyphenols/analysis , Quality Control , Reproducibility of Results , Salvia miltiorrhiza/chemistry
15.
China Journal of Chinese Materia Medica ; (24): 5421-5428, 2019.
Article in Chinese | WPRIM | ID: wpr-1008415

ABSTRACT

By preparing 10 batches of the material reference of Linggui Zhugan Decoction,the methodology of the characteristic spectrum of the material reference was created. The creaming rate range,the contents and the transfer rate range of cinnamaldehyde,glycyrrhizin and glycyrrhizic acid,the characteristic peaks and the similarity range of the characteristic spectrum of Linggui Zhugan Decoction were determined to clarify key quality attributes of the material reference of Linggui Zhugan Decoction. In the 10 batches of the material reference of Linggui Zhugan Decoction,the similarity of characteristic spectrum was higher than 0. 9. Furthermore,after summarizing the characteristic peak information,we knew that Fuling had two characteristic peaks,Guizhi had six characteristic peaks,Baizhu had two characteristic peaks and Gancao had 11 characteristic peaks. The average creaming rate of the material reference of the ten batches was( 12. 13 ± 0. 35) %. The average content of cinnamaldehyde was 0. 32%,the average transfer rate was 10. 69%,the content of cinnamaldehyde in the different batches was between 0. 22% and 0. 42%,and the transfer rate was between 7. 48% and13. 90%. The average content of glycyrrhizin was 0. 84%,the average transfer rate was 50. 39%,the content of glycyrrhizin in the different batches was between 0. 42% and 1. 26%,and the transfer rate was between 35. 27% and 65. 51%. The average content of glycyrrhizic was 1. 88%,the average transfer rate was 40. 74%,the content of glycyrrhizic in the different batches was between 0. 94% and2. 82%,and the transfer rate was between 28. 52% and 52. 96%. In this paper,the quality value transmitting of substance benchmarks of Linggui Zhugan Decoction was analyzed by the combination of characteristic spectrum,creaming rate and the content of index component. A scientific and stable method was preliminarily established,which provided scientific basis for the quality control and formulation development of Linggui Zhugan Decoction.


Subject(s)
Chromatography, High Pressure Liquid , Drugs, Chinese Herbal/standards , Glycyrrhiza , Glycyrrhizic Acid/analysis , Plant Extracts/standards , Quality Control
16.
China Journal of Chinese Materia Medica ; (24): 5269-5276, 2019.
Article in Chinese | WPRIM | ID: wpr-1008393

ABSTRACT

According to the requirements for developing the quality control technology in Chinese medicine( CM) manufacturing process and the practical scenarios in applying a new generation of artificial intelligence to CM industry,we present a method of constructing the knowledge graph( KG) for CM manufacture to solve key problems about quality control in CM manufacturing process.Based on the above,a " pharmaceutical industry brain" model for CM manufacture has been established. Further,we propose founding the KG-based methodology for quality control in CM manufacturing process,and briefly describe the design method,system architecture and main functions of the KG system. In this work,the KG for manufacturing Shuxuening Injection( SXNI) was developed as a demonstration study. The KG version 1. 0 platform for intelligent manufacturing SXNI has been built,which could realize technology leap of the quality control system in CM manufacturing process from perceptual intelligence to cognitive intelligence.


Subject(s)
Artificial Intelligence , Drug Industry/standards , Drugs, Chinese Herbal/standards , Medicine, Chinese Traditional/standards , Pattern Recognition, Automated , Quality Control , Technology, Pharmaceutical
17.
China Journal of Chinese Materia Medica ; (24): 4034-4042, 2019.
Article in Chinese | WPRIM | ID: wpr-1008323

ABSTRACT

This study aims to compare the internal chemical composition and appearance indifferent growth patterns and years of Saposhnikovia divaricata decoction pieces,which was applied to explore the effect of growth patterns and years on its quality. The appearance characteristic data of 55 batches of different growth patterns and years of S. divaricata were collected using PANTONE color card.High performance liquid chromatography( HPLC) was used to determine the contents of prim-O-glucosyl-cinmifugin,cimifugin,4-O-β-D-glucosyl-5-O-methylvisamminol and sec-O-glucosylhamaudol. The content of alcohol soluble extract and water-soluble extract were determined by hot-dip method. The content of volatile oil was determined by steam distillation. The correlation between growth patterns and years and the contents of 4 chromones,extracts and volatile oil were analyzed by modern statistical methods. Also,the method of comprehensively evaluating the quality of Chinese herbal pieces was developed by combining the growth patterns and years,appearance and chemical indexes. MTT assay was used to evaluate the effects on the survival rate of RAW264. 7 cells at four different concentrations of chromones and LPS was used to stimulate well-growing RAW264. 7 cells to establish an inflammatory model. The contents of NO and TNF-α in cell supernatant were detected by NO test kit and ELISA method. The contents of alcohol soluble extracts and water-soluble extracts in different growth patterns and years are: wild products<perennial cultivation<annual cultivation; the contents of volatile oil are: wild products>perennial cultivation>annual cultivation; the contents of four chromones are: wild products>perennial cultivation and annual cultivation. There was no significant difference between the sum of the two indexes in the Pharmacopoeia of perennial cultivation and wild products. 4 chromones showed no toxicity to RAW264. 7 cells at 5 mg·L-1. The release of NO and TNF-α was inhibited by 4 chromones and the anti-inflammatory effect of cimifugin was the best. In summary,there are obvious differences in appearance characteristics,internal quality and effects between different growth patterns and years. It showed that the wild products were superior to the perennial cultivation and the perennial cultivation was superior to the annual cultivation. In order to alleviate the shortage of wild S. divaricata resources,it is suggested that the Chinese Pharmacopoeia standard should increase the character of decoction pieces of perennial cultivation,and properly raise the limit requirement of the sum of the two indexes in the Chinese Pharmacopoeia to ensure the clinical demands and effect.


Subject(s)
Animals , Mice , Apiaceae/growth & development , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal/standards , Nitric Oxide/metabolism , Oils, Volatile/analysis , Tumor Necrosis Factor-alpha/metabolism
18.
China Journal of Chinese Materia Medica ; (24): 4026-4033, 2019.
Article in Chinese | WPRIM | ID: wpr-1008322

ABSTRACT

An analysis method was established by UPLC fingerprint and then applied to simultaneous determination of multiple compounds in Gardeniae Fructus from different areas in China. Samples were separated on a Waters Acquity UPLC BEH C18( 2. 1 mm×50 mm,1. 7 μm) column with 0. 1% formic acid-water and acetonitrile solution as gradient mobile phase at a flow rate of 0. 4 m L·min-1 at various wavelengths. The similarity of samples was over 0. 95 with ″Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine( 2012 edition) ″. The UPLC common fingerprints for 32 batches were established with 19 common peaks identified. The samples were divided into 3 groups analyzed by HCA and PCA. Five components were identified as the main compositions which caused the differences of chemical constituents in the samples from different areas with partial least squares discriminant analysis( PLS-DA). The content of the total components in each area was Zhejiang > Fujian > Jiangxi > Sichuan. This method was accurate and viable,could be used to evaluate the quality of Gardeniae Fructus.


Subject(s)
China , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal/standards , Fruit/chemistry , Gardenia/chemistry , Phytochemicals/analysis
19.
China Journal of Chinese Materia Medica ; (24): 3994-3999, 2019.
Article in Chinese | WPRIM | ID: wpr-1008317

ABSTRACT

In recent years,the development and application of classical famous prescriptions have attracted much attention. However,the differences between ancient and modern conditions lead to difficulties in carrying out practical work. In this paper,with Houpu Wenzhong Decoction as an example,the key technologies of boiling granularity,water addition,boiling time and sample pretreatment methods were investigated on the basis of sufficient literature research. The experimental results showed that there was no significant difference in the concentration of index components between those with different granularity( 2 mm and 3-5 mm) and different decocting time( 30 min and 60 min),but the extraction rate of index components was relatively high when the granularity of powder was 2 mm and decocting time was 30 min. With the increase of water content,the concentration of index components and the extraction rate were increased in varying degrees. A certain proportion of methanol aqueous solution was used as the resolvent before content determination of the reference sample of Houpu Wenzhong Decoction,which could take into account both the spectral information of water-soluble components and fat-soluble components in the prescription,and help to display the overall information of the prescription' s chemical components more comprehensively. At the same time,the boiling and dispersing classical prescriptions in the Catalogue of Ancient Classical Prescriptions( the first batch) were collected and summarized in this study; the key influencing factors of decocting process were analyzed from different angles,and preliminary research suggestions were put forward,so as to provide a certain direction and reference for the establishment of quality standard of Houpu Wenzhong Decoction,as well as for the development,research and clinical application of boiling and dispersing classical prescriptions.


Subject(s)
Drugs, Chinese Herbal/standards , Powders , Prescriptions
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