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1.
China Pharmacy ; (12): 425-432, 2022.
Article in Chinese | WPRIM | ID: wpr-920458

ABSTRACT

OBJECTIVE To determi ne the contents of total fla vonoids i n Scutellaria barbata standard decoction ,evaluate in vitro antioxidant activity ,establish the fingerprint and conduct chemical pattern recognition analysis. METHODS The contents of total flavonoids in S. barbata standard decoction (calculated by scutellarein )were determined by ultraviet-visible spectrophotometry. In vitro antioxidant activity of S. barbata standard decoction was investigated by free radical scavenging tests of 1,1-diphenyl- 2-trinitrophenylhydrazine(DPPH)and 2,2′-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid )ammonium salt (ABTS);HPLC method was adopted. Using scutellarin as reference ,the fingerprints of 16 batches of S. barbata standard decoction were drawn and evaluated by Similarity Evaluation System of TCM Chromatogram Fingerprint (2004 A edition ),and the common peaks were determined;Pearson correlation analysis was carried out by using SPSS 24.0 software to screen substances with in vitro antioxidant activity. Taking them as variables ,cluster analysis and principal component analysis were carried out by using SPSS 24.0 and SIMCA 14.1 software. RESULTS The linear range of total flavonoids were 2.106-21.06 μg/mL(R2=0.999 3);RSDs of precision , reproducibility and stability tests (120 min)were all lower than 2%;the recovery was 100.62%(RSD=0.55%,n=6);the contents of total flavonoids were 0.634-1.053 mg/mL. Median inhibitory concentration (IC50) of DPPH radical scavenging experiment ranged 1.120-3.602 mg/mL,and IC 50 of ABTS radical scavenging e xperiment range d 0.684-1.327 mg/mL. The results of correlation analysis showed that the content of total flavonoids Δ 基金项目 :河北省高校省级重点学科建设项目 (No.冀教 in S. barbata standard decoction was negatively correlated 高〔2013〕4号);承德医学院自然科学研究计划项目(No.201824) *讲师,硕士。研究方向:中药质量控制 。电话:0314-2291186。 with the IC 50 of DPPH free radical and ABTS free radical E-mail:duyilongww@sina.com scavenging experiment ,and the correlation coefficients were # 通信作者 :教授,硕士。研究方向 :中药质量控制 。电话: -0.976 and -0.940 respectively(P<0.01). There were 18 0314-2291186。E-mail:phf2301@163.com common peaks in the fin gerprints of 16 batches of S. barbata 中国药房 2022年第33卷第4期 China Pharmacy 2022Vol. 33 No. 4 ·425· standard decoction ;the s imilarities were 0.964-0.997. A total of 4 common peaks were identified ,such as scutellarin (peak 8), scutellarein(peak 14),luteolin(peak 15),apigenin(peak 17).In the HPLC fingerprints of S. barbata standard decoction ,the peak areas of peak 3-4,8-9,12-15 and 17 were significantly negatively correlated with the IC 50 of DPPH free radical and ABTS free radical scavenging experiment (P<0.05). The results of cluster analysis showed that 16 batches of S. barbata standard decoction could be clustered into two categories ,of which S 2,S7-S8 and S 14-S16 were clustered into one category ,S1,S3-S6 and S 9-S13 were clustered into one category. By principal component analysis ,16 batches of S. barbata standard decoction were divided into two categories ,of which S 2,S4,S7 and S 14-S16 were clustered into one category ,and S 1,S3,S5-S6 and S 8-S13 were clustered into one. The comprehensive scores were high in the samples of S 4,S13,S15. CONCLUSIONS Established HPLC fingerprint and chemical pattern recognition analysis method can be used to evaluate the quality of S. barbata standard decoction ; peak 3-4,8-9,12-15 and 17 and total flavonoids are the potential material basis for S. barbata standard decoction to scavenge DPPH free radical and ABTS free radical.

2.
Article in Chinese | WPRIM | ID: wpr-879046

ABSTRACT

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


Subject(s)
Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Paeonia , Quality Control , Reference Standards
3.
Chinese Pharmaceutical Journal ; (24): 1103-1110, 2020.
Article in Chinese | WPRIM | ID: wpr-857659

ABSTRACT

OBJECTIVE: To prepare Cinnamomi Ramulus standard decoction according to the traditional decoction method, and study the preparation process and quality control of Cinnamomi Ramulus formula granules. METHODS: The standard decoctions of 16 batches of Cinnamomi Ramulus were prepared using decocting pot. The extracting rate, contents and transfer rates of cinnamic acid and cinnamaldehyde were calculated. The preparation process of Cinnamomi Ramulus dispensing granules was improved based on the parameters of standard decoction. The volatile oil was collected while extracting, and the β-cyclodextrin inclusion technology was applied in the granulation process. Based on the parameters of standard decoction, the quality standard of Cinnamomi Ramulus formula granules was established. RESULTS: The extracting rate of Cinnamomi Ramulus standard decoction was 3.58%-6.10%; the cinnamic acid content was 0.99%-2.59% and the transfer rate was 39.56%-62.28%; while the cinnamaldehyde content was 1.95%-4.69% and the transfer rate was 4.76%-7.85%. According to the standard decoction, 1 g of Cinnamomi Ramulus formula granules was equivalent to 14 g of pieces, containing cinnamic acid (0.50%-1.43%) and cinnamaldehyde (0.98%-3.50%). Six characteristic peaks in specific spectra were confirmed, including protocatechuic acid (1), coumarin (2), cinnamic acid (3), 2-methoxycinnamic acid (4), cinnamaldehyde (5) and 2-methoxycinnamaldehyde (6). CONCLUSION: In this study, the quality parameters of Cinnamomi Ramulus standard decoction are determined by traditional decocting pot. The strategy of establishing the preparation process and quality standard of Cinnamomi Ramulus formula granules based on standard decoction is proposed. It can provide reference for the research of Cinnamomi Ramulus dispensing granules and other Chinese medicine preparations containing volatile oil.

4.
Article in Chinese | WPRIM | ID: wpr-873206

ABSTRACT

This paper, taking the formulation of national drug standards for traditional Chinese medicine (TCM) dispensing granules as a case study, explores the improvement of the formation mechanism of national drug standards, and promotes the reform of streamline administration, delegate powers, and improve regulation and services of national standards management, so as to release the vitality of the research and development of standards of drug manufacturers. After nearly two decades of pilot production of TCM dispensing granules, a large number of researches and discussions have been conducted on the formulation of unified standards of TCM dispensing granules from manufacturing enterprises to national standard administration departments, it was found that this work was difficult on the basis of the original drug standard formation mechanism. The authors tried to improve and innovate the formation mechanism of national drug standards, to provide methods and ideas for the formulation and unification of national standards for TCM dispensing granules, and to provide references for the formulation of other national drug standards.

5.
Article in Chinese | WPRIM | ID: wpr-873133

ABSTRACT

Objective::To establish HPLC fingerprint spectra of the pieces, standard decoction, intermediates, dispensing granules of Rehmanniae Radix Praeparata, and assess the quality correlation among them, then to evaluate the scientificity and rationality of preparation process based on the yields of dry extract and the transfer rate of acteoside. Method::Fingerprints of several batches of the pieces, standard decoction, intermediates and dispensing granules of Rehmanniae Radix Praeparata were detected by HPLC, and the content of acteoside was determined according to the method of ChP 2015.The fingerprint chromatographic separation was carried out on Phenomenex Luna 100A C18(2) chromatographic column (4.6 mm×250 mm, 5 μm). The mobile phase was acetonitrile-0.1% phosphoric acid for gradient elution, with a flow rate of 1 mL·min-1, and the detection wavelength was 330 nm. At the same time, the correlation analysis of quality transmission during the preparation of dispensing granules was carried out based on the yields of dry extract and the transfer rates of acteoside. Result::The contents of acteoside pieces, standard decoction and intermediates were basically consistent. The yield of dry extracts of intermediates and dispensing granules, and the transmission rate of acteoside were all within the range of standard decoction, and basically consistent with standard decoction. There were 7 common peaks in all fingerprint spectra of 17 batches of pieces, 17 batches of standard decoction, 10 intermediates and 10 dispensing granules of Rehmanniae Radix Praeparata, with a good correlation. The 13 main chromatographic peaks in the dispensing granules were identified by UPLC-Q-TOF-MS analysis, and 4 of the 7 fingerprint common peaks were identified as 5-hydroxymethyl furfural, acteoside, isoacteoside and martynoside. Conclusion::The main chemical constituents of Rehmanniae Radix Praeparata pieces, standard decoction, intermediates and dispensing granules are basically identical. The established HPLC fingerprint method can be used for the quality control of preparation process of Rehmanniae Radix Praeparata dispensing granules.

6.
Article in Chinese | WPRIM | ID: wpr-873029

ABSTRACT

Objective:There were 92 kinds of compound preparations containing Ophiopogonis Radix in the 2015 edition of Chinese Pharmacopoeia, but there was no effective method to identify these compound preparations. Because Ophiopogonis Radix and Liriopes Radix are similar in appearance, it is easy to be confused in application. The aim of this study was to set up a thin layer chromatography (TLC) to identify compound preparations containing Ophiopogonis Radix and distinguish Ophiopogonis Radix and Liriopes Radix in the forms of decoction pieces and standard decoction. Method:In this study, decoction pieces of Ophiopogonis Radix and Liriopes Radix were collected and separately prepared as standard decoction. TLC was used to qualitatively identify decoction pieces and standard decoction of Ophiopogonis Radix and Liriopes Radix, and compound preparations containing Ophiopogonis Radix. In the TLC, the lower solution of chloroform-methanol-water (65∶35∶10) was selected as the developing agent and 10% sulfuric acid ethanol solution as the chromogenic agent. Result:The resolution of this TLC was good. Decoction pieces, standard decoction and preparations of Ophiopogonis Radix had the same characteristic strips, which were two bright white fluorescent strips under ultraviolet lamp (365 nm). But these two characteristic strips were not existed in the TLC of decoction pieces and standard decoction of Liriopes Radix. The corresponding components of both of these two strips were identified as mixture containing saponins by LC-MSn, including ophiopogonin Ra, Tb, ophiopogonin D', borneol glycoside, ophiopogonin C and Liriope muscari baily saponins C. Conclusion:The established TLC method, which has significant advantages such as high specificity and sensitivity, can be applied to the characteristic identification of decoction pieces and standard decoction of Ophiopogonis Radix, the identification of compound preparations containing Ophiopogonis Radix, and the distinction of Ophiopogonis Radix and Liriopes Radix, thus serving as an effective method to qualitatively identify Ophiopogonis Radix and its compound preparations.

7.
Article in Chinese | WPRIM | ID: wpr-872928

ABSTRACT

Objective:To establish the quality evaluation methods of Asparagi Radix decoction pieces and its standard decoction. Method:Ten batches of Asparagi Radix standard decoction were prepared. High performance liquid chromatography-evaporative light scattering detection method (HPLC-ELSD) was established for the determination of protodioscin and protoneodioscin in Asparagi Radix decoction pieces and its standard decoction, and the fingerprint detection of Asparagi Radix decoction pieces with acetonitrile-water as mobile phase for gradient elution. UHPLC-LTQ-Orbitrap-MS/MS was used to identify ten main common peaks in the fingerprint with acetonitrile-0.1% formic acid solution as mobile phase for gradient elution, electrospray ionization (ESI) and positive and negative ion mode scanning were employed, the detection range was m/z 100-1 400. Result:The total content of protodioscin and protoneodioscin in Asparagi Radix decoction pieces was 0.41%-0.72%, and their total content in Asparagi Radix standard decoction was 0.33%-0.59%, the transfer rate of these two components was 73.6%-98.3%. The dry extract yield of the standard decoction was 59.0%-73.0%, and its pH was 4.9-5.6. There were 10 common peaks in the fingerprint, and all of them were saponins, including protoneodioscin, protodioscin, aspacochioside A and its isomer, methyl protodioscin, asparagoside F, (25R)-26-O-β-D-glucopyranosyl-furostan-5, 20-diene-3β, 26-diol-3-O-[α-L-rhamnopyranosyl (1→2)]-[β-D-glucopyranosyl (1→4)-α-L-rhamnopyranosyl (1→4)]-β-D-glucopyranoside, 26-O-β-D-glucopyranosyl-furostan-20 (22)-ene-3β, 26-diol-3-O-[α-L-rhamnopyranosyl (1→2)]-[α-L-rhamnopyranosyl (1→4)]-β-D-glucopyranoside, pseudodiosgenin, aspacochioside C. Conclusion:In this paper, the quality evaluation methods of Asparagi Radix decoction pieces and its standard decoction are established, and these methods are stable and feasible, which can provide reference for the quality control of pharmaceutical preparations containing Asparagi Radix.

8.
Article in Chinese | WPRIM | ID: wpr-872807

ABSTRACT

The inheritance of traditional clinical value of famous classical formulae is an important direction for the development of traditional Chinese medicine industry.Compared with the previous research and development of new drugs, the management requirement of " material reference" was introduced into the famous classical formulae research, which is used as the reference of process optimization and quality control.The characteristics of compound preparation of famous classical formulae are also reflected in the core concept of " quality inheritance of classics" in the road of industrial development.How to implement the above requirements and concepts into product development and industrial production? There are many specific common problems to be solved in practical research.How to effectively establish the " material reference" of famous classical formulae of different dosage forms? How to use " material reference" to guide the process optimization of compound preparation of famous classical formulae? How to determine the daily dose of famous classical formulae? How to take effective measures in the selection of raw material to reduce quality fluctuation range? This paper discusses the key issues such as production process and quality evaluation from the following aspects.Firstly, the management regulations and research and development guidelines are analyzed, and the specific implementation methods are given.Then, the possible problems in the Requirements for Declaration Documents (Draft for Opinions) are pointed out, and relevant suggestions are given.Finally, based on the research experience of standard decoction and famous classical formulae in the laboratory, an example is given to provide reference for the development of compound preparation of famous classical formulae.

9.
Article in Chinese | WPRIM | ID: wpr-878821

ABSTRACT

UPLC-Q-TOF-MS technology was used to analyze the chemical constituents from classical prescription Huangqi Guizhi Wuwu Tang standard decoction. Acquity HSS T3 column(2.1 mm × 100 mm, 1.8 μm) was used as the chromatographic column, with 0.1% formic acid solution-0.1% formic acid acetonitrile as the mobile phase for gradient elution. The volume flow rate was 0.4 mL·min~(-1) and the column temperature was 40 ℃. Mass spectrometry data of Huangqi Guizhi Wuwu Tang standard decoction were collected in positive and negative ion modes. The chemical constituents from classical prescription Huangqi Guizhi Wuwu Tang standard decoction were analyzed and identified by Masslynx 4.1 software combined with SciFinder database, comparison with reference mate-rials, mass spectrometry data analysis and reference to relevant literature. A total of 110 compounds were analyzed and identified, including 33 flavonoids, 14 monoterpene glycosides, 8 triterpenoids, 8 gingerols, 17 phenylpropanoids, 12 organic acids, 7 amino acids and 11 other compounds. The results of this study provide an experimental basis for the further research on the substance basis and quality control of Huangqi Guizhi Wuwu Tang standard decoction.


Subject(s)
Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Flavonoids/analysis , Glycosides , Prescriptions , Reference Standards
10.
Article in Chinese | WPRIM | ID: wpr-846696

ABSTRACT

Objective: Comparing the differences between dispensing granule decoction (DGD), standard decoction (SD) and traditional decoction (TD) of Phellodendri Chinensis Cortex (PCC) prescription to evaluate the quality of commercially available dispensing granule (DG), and establish the relevant standards for SD, TD and evaluative methods for DG. Methods: Fingerprint was established by HPLC. A comprehensive comparative study was conducted on 35 samples of DGD (three batches from each of the five A-E manufacturers), SD (10 batches) and TD (10 batches) in seven categories from five aspects of chemical composition type, representative index component content, fingerprint similarity, total peak area sum and principal component analysis (PCA); Clinically recommended equivalent corrections were performed for DGD. Results: ① Twenty-one common peaks in SD and TD were preserved in the DGD fingerprint. ② The content of magnoflorine in manufacturer A of DGD was 34.3% lower than that of SD (P < 0.05); The content of magnoflorine in manufacturer C was 35.6% lower than SD (P < 0.01), and 37.0% lower than TD (P < 0.05); The content of phellodendrine hydrochloride in D manufacturer was 22.0% lower than SD (P < 0.05), and 27.5% lower than TD (P < 0.05), The content of berberine hydrochloride in D manufacturer was 20.8% lower than SD (P < 0.05), and 23.8% lower than TD (P < 0.05). There were no significant differences between the other manufacturers' components. ③ The average similarity of each DGD and SD was greater than 0.992 6, and the average similarity of each DGD and TD was greater than 0.991 2, with high component similarity. Using the normalization method, the total peak area of the 21 common peaks of SD was 1 unit, and the ratios of the seven types of samples were 0.90, 1.03, 0.69, 0.77, 0.73, 1.00, and 1.06. ⑤ PCA showed that the distance between the B manufacturer and SD and TD was close, and the difference was small. Using the 21 common peak information of SD as the standard, the peak area plus method was used to correct the clinical recommended equivalent of DG. It was recommended that manufacturers A, C, D, and E could be reduced from 1 g equivalent to 12 g of the original decoction pieces to 10.7, 8.3, 9.2, and 8.8 g, respectively. B manufacturer was not needed to be corrected, and still 1 g was equivalent to 10 g of the original decoction pieces. Conclusion: There are differences in the content of components between DGD, SD, and TD in the real world. There is no significant difference in the proportion of components and components. These overall basically consistent differences can be adjusted by correcting the clinical recommended equivalent, thus promoting clinical rational drug use.

11.
Article in Chinese | WPRIM | ID: wpr-846427

ABSTRACT

Objective: To establish an HPLC fingerprint spectrum of for decoction pieces-, standard decoction- and dispensing granules of Astragali Radix, and evaluate the correlation among them. Methods: HPLC method was used to determine the content of 7-hydroxy- 4'-methoxy isoflavone, calycosin-7-glucoside, calycosin, and ononin in decoction pieces-, standard decoction- and dispensing granules of Astragali Radix. The common pattern of the three fingerprints was established and the correlation was evaluated through the control fingerprint spectrum. Results: The average contents of 7-hydroxy-4'-methoxy isoflavone, calycosin-7-glucoside, calycosin, and ononin in 20 batches of decoction pieces were 0.097, 0.482, 0.142, and 0.237 mg/g, respectively; The average content of these four index components in the standard decoction were 0.116, 0.912, 0.214, and 0.434 mg/g, respectively; The average content of these four index components in the dispensing granules were 0.088,, 0.623,, 0.160, and 0.289 mg/g, respectively. There were six common peaks in all fingerprint spectra of 20 batches of decoction pieces-, standard decoction- and dispensing granules of Astragali Radix. The similarity between dispensing granules and standard decoction was 0.980, indicating that the components difference between them was very small. Conclusion: The study establishes an HPLC fingerprint spectrum, and itwhich reflects the whole picture of multi-component of decoction pieces-, standard decoction- and dispensing granules of Astragali Radix. It provides reference value for the identification and quality control of Astragalus dispensing granules of Astragalus Radix.

12.
Article in Chinese | WPRIM | ID: wpr-846390

ABSTRACT

Objective: To study the law of quality value transmitting of Artemisiae Scopariae Herba (ASH) standard decoction. Methods: Fifteen batches of ASH standard decoction were prepared. Fingerprints of these 15 batches standard decoction and its raw pieces were determined by HPLC, the control fingerprints were established, the common peaks were calibrated and the similarity was evaluated. Components of common peaks were identified by Q-TOF/MS and the contents of components confirmed by reference substance were determined. The common peaks transfer number, peak area ratio, index components transfer rate and extraction rate were used to analyze the quality value transfer rule of standard decoction. Results: The similarity of fingerprints of ASH and its standard decoction were greater than 0.9, 16 and 15 common peaks were calibrated respectively, and the transfer rate of the common peaks number was 93.75%. Thirteen components of the common peaks were confirmed by reference substance, including 1-caffeoylquinic acid, neochlorogenic acid, chlorogenic acid, caffeic acid, cryptochlorogenic acid, p-hydroxyacetophenone, 1,3-dicaffeoylquinic acid, rutin, hyperoside, isoquercetin, 3,4-dicaffeoylquinic acid, 3,5-dicaffeoylquinic acid, 4,5-dicaffeoylquinic acid. Caffeoylquinic acid glucoside and a di-C-glycoside named apigenin 6,8-di-C-β-D-glucoside were first detected in ASH. The ratio of the common peaks area of ASH standard decoction to that of ASH raw pieces showed a good positive linear relationship with the components transfer rate. The average transfer rates of neochlorogenic acid, cryptochlorogenic acid, 1,3-dicaffeoylquinic acid and 3,4-dicaffeoylquinic acid were more than 100%, while the average transfer rates of chlorogenic acid and 3,5-dicaffeoylquinic acid were only 47.59% and 22.33% respectively, suggesting that the organic acid components may be transformed into each other during the preparation of standard decoction, and part of chlorogenic acid may be transformed into cryptochlorogenic acid and neochlorogenic acid; 3,5-dicaffeoylquinic acid may be partially converted into 1,3-dicaffeoylquinic acid and 3,4-dicaffeoylquinic acid. The average transfer rates of rutin and hyperoside were 31.36% and 28.36%, respectively, and that of other components were between 50% and 70%. The average extraction rate of standard decoction was 19.76%. Conclusion: The laws of quality value transmitting of ASH standard decoction revealed in this study laid a foundation for the establishment of the material reference of ASH formula granules and the classic prescriptions containing ASH.

13.
Article in Chinese | WPRIM | ID: wpr-846326

ABSTRACT

Objective: To establish HPLC fingerprint of Eriobotryae Folium standard decoction and compare quality difference between raw and honey processed Eriobotryae Folium standard decoction, which can provide a reference for its quality control. Methods: An HPLC-DAD method was utilized. The mobile phase was acetonitrile-0.4% phosphoric acid setting for gradient elution. The HPLC fingerprints of 20 batches of standard decoction of raw and honey processed Eriobotryae Folium were established. The contents of neochlorogenic acid, chlorogenic acid, and cryptochlorogenic acid were determined simultaneously. Similarity and cluster analysis were chosen to evaluate the quality of standard decoction of raw and honey processed Eriobotryae Folium. Results: Both of the fingerprint and the contents of three kinds of chlorogenic acids of Eriobotryae Folium standard decoction had significant difference before and after the Eriobotryae Folium being processed by honey. Two chromatographic peaks were increased newly in honey processed Eriobotryae Folium. The No.1 peak refers to component of 5-hydroxymethylfurfural. The average contents of neochlorogenic acid, chlorogenic acid and cryptochlorogenic acid in raw Eriobotryae Folium standard decoction were 4.300, 4.306, and 5.432 mg/g respectively. The result of contents showed a significantly decrease in honey processed Eriobotryae Folium standard decoction. Their contents were 3.295, 3.460, and 4.118 mg/g respectively. The reduction rate of them were 23.29%, 19.06%, and 23.92% respectively. Conclusion: The method is concise and durable. It could not only be utilized to evaluate the quality of standard decoction of Eriobotryae Folium before and after processed by honey, but also to identify the quality differences of them. The study could be used for quality control of standard decoction of raw and honey processed Eriobotryae Folium, identify the quality difference of them and also provide a reference for quality control of their preparations.

14.
Article in Chinese | WPRIM | ID: wpr-846265

ABSTRACT

Objective: To establish an HPLC characteristic fingerprint of substance benchmark (standard decoction) of classical famous prescription of Jichuan Decoction (JD), and provide reference for the quality study of substance benchmark of JD. Methods: JD standard decoction was prepared according to the ancient method, 15 batches JD standard decoction were determined by HPLC. The similarity analysis and characteristic peak analysis of 15 batches JD were carried out by the "Similarity Evaluation System for Chromatographic Fingerprint of Chinese Materia Medica 2012 version". Results: A total of 18 common characteristic peaks were screened by automatic matching method, peaks 1 and 3 were from Angelicae Sinensis Radix and Cimicifugae Rhizoma, peaks 2, 5, 6, 7, 9, 11 and 13 were from Cistanches Herba, peaks 4, 12, 14, 15 and 17 from were Cimicifugae Rhizoma, peaks 8, 10 and 18 from Aurantii Fructus, and peak 16 was from Angelicae Sinensis Radix. Seven characteristic components were identified by the reference substance, including caffeic acid (peak 1), echinacoside (peak 2), ferulic acid (peak 3), isoferulic acid (peak 4), mullein glycoside (peak 6), naringin (peak 8) and neohesperidin (peak 10). The similarities of 15 batches substance benchmark of JD were greater than 0.9. Conclusion: The HPLC method established for substance benchmark of JD is simple, accurate, stable and sensitive. It can be used for the quality study for JD substance benchmark, and provides a reference for the transformation and development of JD for modern preparations.

15.
Article in Chinese | WPRIM | ID: wpr-846146

ABSTRACT

Objective: To study the content variation and chemical composition of Siwu Decoction between mixed decoction and single decoction comprehensively, and then explore variation rule of Siwu Decoction by different decocting methods based on material basis. Methods: Components of Siwu Decoction were identified by LC-MS/MS and an UPLC wavelength switching method for simultaneously determining the contents of multiple compounds in Siwu Decoction was established based on the idea of TCM chemistry holography. The mixed and single decoction samples were prepared and tested. Experimental data was compared to analyze material basis differences and variation rule of Siwu Decoction by different decocting methods. Results: A total of 72 compounds were identified and assigned, 18 compounds were quantitative detected and all of 18 analytes showed good linearity (R2 ≥ 0.999) within the test range. The relative standard deviations of the precision, repeatability and stability were not exceeding 2.0%, and the recoveries were in the range of 97%-105%. Analysis of Siwu Decoction samples showed dissolution of ligustilide, 3-n- butylphthalide, catechin, gallic acid and paeoniflorin was affected by the change of solvent volume and dissolution of aucubin, catechin, oxypaeoniflorin, paeoniflorin and acteoside were higher in mixed decoction than single decoction obviously. Compared to single decoction, the kinds of compounds in mixed decoction did not change significantly but the content showed notable variety. Conclusion: Through the study of chemistry holography, the composition and content of compounds in TCM mixed decoction and herbs single decoction can be compared and analyzed comprehensively to provide a new perspective for the study on the rule of TCM decoction and dissolution. TCM chemistry holography study may become a useful exploration of the TCM quality study.

16.
Article in Chinese | WPRIM | ID: wpr-823973

ABSTRACT

A sensitive, fast and comprehensive method for the quality assessment of Semen Ziziphi Spinosae (SZS) standard decoction with characterization of its chemical components was developed and validated. UPLC-Q/TOF-MS/MS system was used to identify thirty-six chemical components of SZS standard de-coction which included nucleosides, phenolic acids, alkaloids, and flavonoids. Furthermore, a UPLC-PDA method was validated to simultaneously determine adenosine, protocatechuic acid, magnoflorine, ca-techin, protocatechin, vicenin II, spinosin, kaempferol-3-rutinoside, and 6'''-feruloylspinosin which re-present four species of characteristic compounds. The qualitative method had been validated according to Chinese Pharmacopoeia (2015 edition) in terms of lineary, repeatability, recovery and stability for all analytes, with the results showing good precision, accuracy and stability. In conclusion, the method using UPLC combined with MS and PDA provided a novel way for the standardization and identification of SZS standard decoction, and also offered a basis for qualitative analysis and quality assessment of the pre-parations for SZS standard decoction.

17.
Article in Chinese | WPRIM | ID: wpr-851442

ABSTRACT

Objective To study the dry extract rate, determination and transfer rate of maker compounds, and fingerprint of standard decoction of ginger juice Magnoliae Officinalis Cortex (GJMOC) and provide a reference for the preparation and quality assessment of its dispensing granules by establishing 16 batches of standard decoction of GJMOC. Methods A total of 16 batches of GJMOC standard decoctions were prepared following literature requirements. The quantitative analysis method of magnolol and honokiol was according to Chinese Pharmacopoeia (2015 edition). The transfer rate of total magnolol and honokiol and extraction rate were calculated. the pH value was determined and HPLC fingerprint was established under a flow rate of 1 mL/min and eluted with a mobile phase of acetonitrile (A)-0.1% phosphoric acid solution (B) in a gradient mode (0-15 min, 12%-16% A; 15-30 min, 16%-28% A; 30-42 min, 28%-74% A; 42-55 min, 74%-80% A). The column temperature was set at 40℃ and the detection wavelength was 294 nm. Results By measuring the of 16 batches of standard decoction, the transfer rate of the sum of magnolol and honokiol ranged from 6.5% to 12.0%, the extraction rate was at a range of 3.41% to 7.14% and pH value was 4.63 to 5.43. The Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine (2012A) was used to analyze and compare the fingerprints, and seven common peaks were determined and four were identified including magnoloside B (peak 1), magnoloside A (peak 2), honokiol (peak 6), and magnolol (peak 7). The similarity among 16 batches of standard decoction of GJMOC was evaluated, and the similarity was all greater than 0.69. Moreover, this study established an HPLC fingerprint analysis method of GJMOC standard decoction. Conclusion The preparation method established in this study is stable and feasible, and the analysis method shows good precision, stability, and repeatability in fingerprint analysis and it is suitable for evaluating the quality of standard decoction of GJMOC.

18.
Article in Chinese | WPRIM | ID: wpr-851332

ABSTRACT

Objective: To prepare standard decoction of Alismatis Rhizoma (AR) and establish its quality evaluation system, and provide reference for the development of dispensing granules of AR. Methods: A total of 18 batches of AR decoction pieces were collected to prepare standard decoction of AR according to the standard process. Quality evaluation system of standard decoction of AR was established with pH value, dry extract rate, fingerprint similarity and transfer rate of alisol B 23-acetate as indexes. Results: The mass fraction of alisol B 23-acetate in AR decoction pieces was 0.057%—0.267% with the average value of 0.156%, water content was 9.2%—12.8% with the average value of 10.44%; the pH value of standard decoction of AR was 4.11—5.60, dry extract rate was 10.25%—17.09%; transfer rate of alisol B 23-acetate from decoction pieces to standard decoction was 10.49%—17.49%. Conclusion: The established quality evaluation method is stable and feasible, which is suitable for the development and quality evaluation of standard decoction of AR, which can provide reference for the development of dispensing granules of AR and related classic formulas.

19.
Article in Chinese | WPRIM | ID: wpr-850798

ABSTRACT

The decoction of Chinese materia medica (CMM) is the most commonly used CMM compound dosage form by CMM doctors, and it is also the longest and most widely used preparation in the history of CMM. The medicinal materials are raw materials for decoction pieces. Decoction pieces are raw materials for preparing extracts and constituting CMM prescriptions and CMM prescription formulas. They also reflect the importance of inheriting and developing CMM. Based on the standard decoction of CMM decoction pieces, it is an important strategy for scientific development to scientifically understand the quality of decoction and improve the evaluation theory and method of decoction of pharmacopoeia and Chinese patent medicine. This article is to carry out the standard decoction of CMM decoction pieces under the guiding by the CMM theory and clinical application research. On the basis of the theory and method of CMM quality markers to study, we discuss the influences of decoction pieces and decoction process, form the marked quality evaluation system, not only to ensure the drug safety and efficacy of CMM prescription, but also to meet the standard of the quality and standard of “medicinal-materials” - “decoctions” - “Chinese patent drug”, and to understand their differences and value for promoting national supervision level on CMM decoction pieces and ensure people’s safety and effective. It is also helpful to understand the significance of standard decoction in the production of traditional Chinese medicine decoction pieces, the inheritance and research of traditional Chinese medicine formula granules and classic famous prescription.

20.
Article in Chinese | WPRIM | ID: wpr-850773

ABSTRACT

Objective: To establish an HPLC method for the fingerprint analysis and content determination of standard decoction of Angelicae Sinensis Radix (ASR), and to provide an effective method to ensure the quality of standard decoction of ASR. Methods: Fingerprint of standard decoction of ASR was established by HPLC. The similarity evaluation combined with cluster analysis (CA), principal component analysis (PCA), and partial least squares discriminant analysis (PLS-DA) were applied to explore chromatographic peak of main affecting the quality of standard decoction of ASR, and to determine the contents of ferulic acid, ligustilide H, ligustilide I, ligustilide and tryptophan. All samples were analyzed by Kromasil C18 column (250 mm × 4.6 mm, 5 μm) maintained at 35 ℃ and eluted with acetonitrile-0.1% formic acid at the flow rate of 1.2 mL/min, and the detection wavelength was 280 nm. Results: There were 17 common peaks in the HPLC fingerprint of established standard decoction of ASR, and the similarity of 15 batches of standard decoction of ASR was between 0.788 and 0.983. The samples were broadly divided into three categories by CA and PCA. Seven markers were verified by PLS-DA, and peaks 8, 17, 10, and 12 were identified as ferulic acid, ligustilide, ligustilide I, and ligustilide H, respectively. In quantitative analysis, the five components showed good regression (r2 > 0. 999 0) with linear range, the content respectively was 0.041%-5.596% in ferulic acid, 0.026%-1.583% in ligustilide H, 0.201%-6.461% in ligustilide I, 0.126%-4.942% in ligustilide, and 0.481%-2.753% in tryptophan, and the average recoveries were in the range of 99.43%-104.35%. Conclusion: The analysis method established in this experiment is stable, reliable, and repeatable, which can provide reference for the quality evaluation of standard decoction of ASR.

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