[Chemical composition and antioxidant activity of different parts of Prunella vulgaris by UPLC-Q-TOF-MS/MS and UPLC].

Prunellae Spica is the dried spica of Prunella vulgaris belonging to Labiatae and it is widely used in pharmaceutical and general health fields. As a traditional Chinese medicine cultivated on a large scale, it produces a large amount of non-medicinal parts, which are discarded because they are not effectively used. To analyze the chemical constituents in the different samples from spica, seed, stem, and leaf of P. vulgaris, and explore the application value and development prospect of these parts, this study used ultrahigh performance liquid chromatography-tandem quadrupoles time of flight mass spectrometry(UPLC-Q-TOF-MS/MS) to detect chemical constituents in different parts of P. vulgaris. As a result, 117 compounds were detected. Among them, 87 compounds were identified, including 32 phenolic acids, 8 flavonoids, and 45 triterpenoid saponins. Some new triterpenoid saponins containing the sugar chain with 4-6 sugar units were found. Further, multivariate statistical analysis was conducted on BPI chromatographic peaks of multiple batches of different parts, and the results showed that spica had the most abundant chemical constituents, including salviaflaside and linolenic acid highly contained in the seed and phenolic acids, flavonoids, and triterpenoid saponins in the stem and leaf. In general, the constituents in the spica were composed of those in the seed, stem, and leaf. UPLC was used to determine the content of 6 phenolic acids(danshensu, protocatechuic acid, protocatechuic aldehyde, caffeic acid, salviaflaside, and rosmarinic acid) in different parts. The content of other phenolic acids in the seed was generally lower than that in the spica except that of salviaflaside. The content of salviaflaside in the spica was higher than that in the stem and leaf, but the content of other phenolic acids in the spica was not significantly different from that in the stem. The content of protocatechuic aldehyde and caffeic acid in the spica was lower than that in the leaf. DPPH free radical scavenging method was used to detect the antioxidant activity of four parts, and there was no significant difference in the antioxidant activity between the spica and the stem and leaf, but that was significantly higher than the seed. Moreover, the antioxidant activity of these parts was correlated with the content of total phenolic acids. Based on the above findings, the stem and leaf of P. vulgaris have potential application value. Considering the traditional medication rule, it is feasible to use the whole plant as a medicine. Alternatively, salviaflaside, occurring in the seed, can be used as a marker compound for the quality evaluation of Prunellae Spica, if only using spica as the medicinal part of P. vulgaris, as described in the Chinese Pharmacopoeia(2020 edition).

A Comprehensive Analysis of Microflora and Metabolites in the Development of Ulcerative Colitis into Colorectal Cancer Based on the Lung-Gut Correlation Theory.

The lungs and large intestine can co-regulate inflammation and immunity through the lung-gut axis, in which the transportation of the gut microbiota and metabolites is the most important communication channel. In our previous study, not only did the composition of the gut microbiota and metabolites related to inflammation change significantly during the transition from ulcerative colitis (UC) to colorectal cancer (CRC), but the lung tissues also showed corresponding inflammatory changes, which indicated that gastrointestinal diseases can lead to pulmonary diseases. In order to elucidate the mechanisms of this lung-gut axis, metabolites in bronchoalveolar lavage fluid (BALF) and lung tissues were detected using UHPLC-Q-TOF-MS/MS technology, while microbiome characterization was performed in BALF using 16S rDNA sequencing. The levels of pulmonary metabolites changed greatly during the development of UC to CRC. Among these changes, the concentrations of linoleic acid and 7-hydroxy-3-oxocholic acid gradually increased during the development of UC to CRC. In addition, the composition of the pulmonary microbiota also changed significantly, with an increase in the Proteobacteria and an obvious decrease in the Firmicutes. These changes were consistent with our previous studies of the gut. Collectively, the microbiota and metabolites identified above might be the key markers related to lung and gut diseases, which can be used as an indication of the transition of diseases from the gut to the lung and provide a scientific basis for clinical treatment.

Nuciferine attenuates acute ischemic stroke in a rat model: a metabolomic approach for the mechanistic study.

Lotus leaves have the dual identity of medicine and food homology as included in the Chinese Pharmacopoeia. Nuciferine is the major bioactive component which is highly abundant in the leaves of Nelumbo nucifera Gaertn. Nuciferine has been shown to potentially improve energy metabolism and protect neurons in cerebral ischemia. However, the mechanisms underlying the protective effects of nuciferine on acute ischemic stroke (AIS) are still unclear. Metabolomics was used for uncovering the underlying therapeutic mechanism of nuciferine in AIS with the help of 1H NMR. The rat model of AIS was generated by the occlusion of the middle cerebral artery (MCAO). After treatment with nuciferine, several indexes of oxidative stress and inflammation, such as total antioxidant capacity (T-AOC), total glutathione/oxidized glutathione (GSH/GSSG), malondialdehyde (MDA), superoxide dismutase (SOD), tumor necrosis factor-α (TNF-α) and interleukin-1ß (IL-1ß) were significantly improved, and some metabolic biomarkers (histidine, glycine, glycerol, serine, tyrosine, lysine, choline, etc.) were significantly regulated. Bioinformatic analysis demonstrated that these biomarkers and the derived genes (myeloperoxidase, catalase, etc.), fatty acid and amino acid metabolisms and 9 key metabolic pathways were involved in the nuciferine activity, which indicated the potential therapeutic mechanisms of nuciferine in AIS.

Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review.

The Chinese Pharmacopoeia 2020 edition was reviewed and approved by the National Medical Products Administration and the National Health Commission of the People's Republic of China in July 2020. The current edition was officially implemented on December 30, 2020. The general chapters of the Chinese Pharmacopoeia discuss the general testing methods and guidelines, which are the common requirements and basis for the implementation of drug standards in the Chinese Pharmacopoeia. Owing to adherence to the principles of scientificity, versatility, operability, and sustainable development, there is an improvement in the general chapters of the 2020 edition over those of the previous editions. Further, the application of advanced and mature analytical techniques has expanded, the development of testing methods for exogenous pollutants in traditional Chinese medicines has been strengthened, and technical requirements are now better harmonized with international standards. The updated edition provides technical and methodological support to ensure safety, effectiveness, and control of pharmaceuticals in China and will play an important and active role in encouraging the application of advanced technologies, improving the quality control of medicines, and strengthening the means of drug regulation in China. This review provides a comprehensive introduction of the main features of and changes to the general chapters in the Chinese Pharmacopoeia 2020 edition and aims to provide reference for its correct understanding and accurate implementation.

Development of the general chapters of the Chinese Pharmacopoeia 2020 edition:A review / 药物分析学报

The Chinese Pharmacopoeia 2020 edition was reviewed and approved by the National Medical Products Administration and the National Health Commission of the People's Republic of China in July 2020.The current edition was officially implemented on December 30,2020.The general chapters of the Chinese Pharmacopoeia discuss the general testing methods and guidelines,which are the common re-quirements and basis for the implementation of drug standards in the Chinese Pharmacopoeia.Owing to adherence to the principles of scientificity,versatility,operability,and sustainable development,there is an improvement in the general chapters of the 2020 edition over those of the previous editions.Further,the application of advanced and mature analytical techniques has expanded,the development of testing methods for exogenous pollutants in traditional Chinese medicines has been strengthened,and technical requirements are now better harmonized with international standards.The updated edition provides technical and methodological support to ensure safety,effectiveness,and control of pharmaceuticals in China and will play an important and active role in encouraging the application of advanced technolo-gies,improving the quality control of medicines,and strengthening the means of drug regulation in China.This review provides a comprehensive introduction of the main features of and changes to the general chapters in the Chinese Pharmacopoeia 2020 edition and aims to provide reference for its correct understanding and accurate implementation.

The cardiac protection of Baoyuan decoction via gut-heart axis metabolic pathway.

BACKGROUND: Gut-heart axis has emerged as a novel concept to provide new insights into the complex mechanisms of heart failure (HF) and offer new therapeutic targets. Cardiac hypertrophy (CH) is one of the etiological agents contributing to the development of HF. Baoyuan Decoction (BYD), a traditional Chinese medicine (TCM) formula, exhibits unambiguous effects on treating CH and preventing HF. Previously, we have reported that BYD-targeted endogenous metabolites are potentially linked to gut microbiota metabolism, but the contribution of gut microbiota and metabolic interaction to the cardioprotective efficacy of BYD remains to be elucidated. PURPOSE: To investigate whether the gut microbiota plays a key role in anti-CH effects of BYD. STUDY DESIGN: A comprehensive strategy via incorporating pharmacodynamics, microbiomics, metabolomics, and microflora suppression model was adopted to investigate the links between the microbiota-host metabolic interaction and BYD efficacy in CH rats. METHOD: Firstly, the efficacy evaluation of BYD in treating chronic isoproterenol (ISO)-induced CH rats was performed by using multiple pharmacodynamic approaches. Then, the fecal metabolomics and 16S rRNA sequencing techniques were used to obtain the microbial and metabolic features of BYD against CH. After that, the potential gut-heart axis-based mechanism of BYD against CH was predicted by bioinformatic network analysis and validated by multiple molecular biology approaches. Finally, the antibiotics (AB)-induced gut microbiota suppression was employed to investigate whether the anti-CH effects of BYD is associated with the gut microflora. RESULTS: The fecal microbial communities and metabolic compositions were significantly altered in ISO-induced CH rats, while BYD effectively ameliorated the CH-associated gut microbiota dysbiosis, especially of Firmicutes and Bacteroidetes, and time-dependently alleviated the disturbance of fecal metabolome and reversed the changes of key CH and gut microbiota-related metabolites, such as short/medium chain fatty acids, primary/secondary bile acids, and amino acids. The mechanism study showed that the anti-CH effect of BYD was related to inhibition of the derivatives of arginine and tryptophan and their downstream pro-hypertrophic, pro-inflammatory, and pro-oxidant signaling pathways. The following microflora suppression test showed that BYD-mediated myocardial protection was decreased either in pharmacodynamics or in metabolic modulation. CONCLUSION: This study demonstrates that the protection of BYD against CH is partially gut microbiota dependent, and the regulatory effects of gut metabolism-related tryptophan and arginine derivatives is an important cardioprotection mechanism of BYD.

[Comparative study on standard decoctions of Ophiopogonis Radix and Liriopes Radix].

Standard decoction is the core of the pharmacodynamics for water-soluble substance of Chinese materia medica. Its research is of great significance to the research and development of some single ingredients and the classical prescriptions,and it is the only way to transform traditional medication experience into industrial products. In this article,standard decoction research strategies were used for the comparison analysis of Ophiopogonis Radix from Zhejiang province(ZMD),Ophiopogonis Radix from Sichuan province(CMD),and Liriopes Radix(SMD). Regularities were present among different grades of CMD; potential quality markers and pH differences associated with SO2 residues were also found. Finally,the extract powder of Ophiopogonis Radix prepared by mass production process was analyzed and validated,and the results showed that the standard system could be used for the quality control of intermediates and final products. In conclusion,this study can provide reference for the clinical application of Ophiopogonis Radix medicines and provide testing method for higher quality with higher price.

[Research on evaluation criteria over quality as core index of high grade Chinese patent medicine].

"One drug was produced by many companies" is common in Chinese patent medicines. The quality and price of products from different manufacturers varies widely, and the efficacy is inconsistency. In order to ensure the quality of Chinese patent medicines and promote "Healthy national program" implementation, it is necessary to study the current status of Chinese patent medicines and carry out the evaluation criteria over quality as the core management of high grade Chinese patent medicines, which is set up to reflect the evaluation strategy and method of Chinese patent medicines from raw material, production, quality control, reevaluation and competitive power to the whole chain of brand construction. It aims to reveal the quality discrepancy from different manufacturers over the same Chinese patent medicines. The research and application will select a serials of high grade quality products, and provide reference basis for the scientific and reasonable price formation mechanism of Chinese patent medicines and purchasing drugs by centralized bidding, guide healthy competition in the market and promote the implementation of "healthy China 2030 program".

[Influence and countermeasure of technical barriers to trade on traditional Chinese medicine industry].

The authors proposed remedial measures for traditional Chinese medicine (TCM) products export faced with technical barriers to trade (TBT) according to analyzing the impact of TBT on TCM product export with economic theories, and putting forward countermeasures based on evaluation researches. TBT can be effectively coped with by the joint efforts of government, enterprises and industry association. Not only TBT can be broken through but also TCM product export can be expanded by the coordination and cooperation of our country and the society.

[Overview on quantitative analysis of multi-components by single-marker].

Based on the previous literatures, the overview on the history and recent advance of the quantitative analysis of multi-components by single-marker (QAMS) was summarized. The key questions of QAMS were also highlighted. It could be considered as a feasible method for the quality control of Traditional Chinese Medicines.

Quantitative determination of 10 phenylpropanoid and lignan compounds in Lancea tibetica by high-performance liquid chromatography with UV detection.

An HPLC method was developed for simultaneous determination of one phenylpropanoid glycoside, verbascoside (1), and nine lignans, including lantibeside (2), phillyrin (3), lantibeside B (4), lantibeside C (5), tibeticoside A (6), styraxjaponoside C (7), sylvatesmin (8), (+)-piperitol (9), and horsfieldin (10), from the Tibetan medicinal plant Lancea tibetica Hook. F. et Thoms. The analysis was performed within 45 min. The extraction method was optimized with different solvent systems. The HPLC method was validated for linearity, repeatability, accuracy, limits of detection, and limits of quantification. The limits of detection and limits of quantification of 10 analytes were found to be less than 0.1 and 0.5 µg/mL, respectively. The RSD for intra- and inter-day analyses was less than 4.2 %, and the recovery efficiency was 90-105 %. The method was used to analyze different populations of L. tibetica collected in China. HPLC profiles showed that the concentrations of analytes were different in samples collected from different areas of China. Verbascoside was the dominant component in three out of five plant samples; compounds 2, 3, 6, and 8 accounted for over 62 % yields in total lignan contents. The method is useful for identification, quality assurance, and quality control of L. tibetica and its related products.

High-performance liquid chromatographic method for the determination and pharmacokinetic study of dehydrotumulosic acid in the plasma of rats having taken the traditional chinese medicinal preparation Ling-Gui-Zhu-Gan decoction.

A high-performance liquid chromatographic method for the determination of dehydrotumulosic acid in plasma of rats having been administrated orally with the traditional Chinese medicinal preparation Ling-Gui-Zhu-Gan decoction was developed. Plasma samples taken from rats were acidified with hydrochloric acid and extracted with ethyl acetate. Separation of the main effective constituent dehydrotumulosic acid was accomplished on a C(18) stationary phase and a mobile phase of methanol-acetonitrile-2% glacial acetic acid (13:12:10, v/v), with a UV detector setting at 242 nm. After validation, the method was used for preliminary investigation of the pharmacokinetic profiles of dehydrotumulosic acid administrated in Ling-Gui-Zhu-Gan decoction.

The isolation, identification and determination of dehydrotumulosic acid in Poria cocos.

Poria cocos (Fuling), a popular Chinese medicinal (CM) herb of fungal origin, has been included in many combinations with other CM herbs for its traditionally claimed activities of inducing diuresis, excreting dampness, invigorating the spleen and tranquilizing the mind and its modern pharmacological use of modulating the immune system of the body. Dehydrotumulosic acid, one of the effective constituents of Fuling, was isolated from the chloroform-soluble material of ethanol extract of the fungus. After further purification by a high-performance liquid chromatographic method on a C18 column, the purified constituent was identified using modern analytical techniques, such as UV, 13C-NMR and EI-MS. A reversed-phase high-performance liquid chromatographic method has been developed for the determination of dehydrotumulosic acid in Poria cocos. The determination can be accomplished in less than 50 min using methanol-acetonitrile-2% glacial acetic acid as the mobile phase at a flow rate of 1.0 mL/min, with a UV detector setting at 242 nm and testosterone propionate used as an internal standard. This assay for dehydrotumulosic acid is simple, rapid and with good reproducibility.

An HPLC method for the determination and pharmacokinetic study of cinnamic acid in the plasma of rats having taken the traditional Chinese medicinal preparation Ling-Gui-Zhu-Gan decoction.

A high-performance liquid chromatographic method for the determination and pharmacokinetic study of cinnamic acid in the plasma of rats after having been administrated orally with the traditional Chinese medicinal (TCM) preparation Ling-Gui-Zhu-Gan decoction is established. Plasma samples taken from rats are acidified with hydrochloric acid and extracted with ethyl acetate. Separation of the main effective constituent cinnamic acid is accomplished on a C18 stationary phase and a mobile phase of methanol-acetonitrile-2% glacial acetic acid (10:22:70, v/v) with a UV detector setting at 254 nm. After validation, the method is used to take a limited view of pharmacokinetic profiles of the TCM preparation of the Ling-Gui-Zhu-Gan decoction.

[Study on the compatibility of composite herbal medicines of the lingguizhugan decoction].

OBJECTIVE: To study the compatibility of composite herbal medicines of the Ling Gui Zhu Gan Decoction. METHOD: Ethanol extract test solutions of the different combinations were prepared according to the orthogonal layout L16(4(5)). Pharmacologic experiments, such as the time of surviving of mice in shortage of oxygen in regular air pressure, the antagonizing effect on arrhythmia induced by chloroform and diuresis were carried out with the solutions. Variance analysis, canonical correlation and stepwise regression analysis were applied to interrelate the amount of each drug and the pharmacologic data. RESULT: The results confirmed that Fuling and Guizhi are the basis, while Baizhuand Gancao are the adjuvans, which is conformed to the theory of TCM. CONCLUSION: This study provides a significant try for studying the compatibility of composite herbal medicines.