Correlation Analysis of Traditional Chinese Medicines from Fungi Based on "Habit-Growth Environment-part-medicinal Properties" / 中国实验方剂学杂志

ObjectiveThe relevant laws among the biological characteristics， medicinal parts， growth environment， and medicinal properties and efficacy of traditional Chinese medicines （TCM） from fungi were excavated， so as to strengthen the theory of distinguishing symptoms for quality and provide a reference for the development and utilization of TCM from fungi. MethodThe medicinal parts， meridians for properties and tastes， heterotrophic mode， and efficacy of commonly used TCM from fungi were summarized. By consulting the Compendium of Materia Medica， Shennong Materia Medica， Flora of China， and literature， the TCM from fungi indexed in the 2020 edition of the Chinese Pharmacopoeia and some local pharmacopeias were checked. ResultA total of 28 common TCM from fungi were selected. Different TCMs from fungi have different meridians for properties and tastes， medicinal parts， habits， and growth environments. The relevant information was counted. Among the four properties， plain>cold>warm. Among the five tastes， sweet>bitter>light>pungent=salty. In terms of medicinal parts， fruiting body>sclerotia>complex>spermia=outer skin=other. In terms of meridians， lung>liver=heart>spleen=kidney>stomach. In terms of habits， parasitism>saprophysis>symbiosis=facultative parasitism=facultative saprophysis. ConclusionTCM from fungi are mainly parasitic and saprophytic， and the plain property and sweet taste the most. The meridians are mostly lung， heart， and liver. Nourishment and diuresis are the main efficacy. There is a certain correlation between the color， habit， medicinal parts， and growth environment of TCM from fungi and their properties， tastes， and efficacy， providing comprehensive literature reference and theoretical basis for their in-depth research， clinical use， and resource development.

Correlation of "Parts-components-properties" of Traditional Chinese Medicines from Latex-containing Plants / 中国实验方剂学杂志

ObjectiveTo investigate the correlation among the botanical characteristics， biological characteristics， chemical composition， and medicinal properties and efficacy of traditional Chinese medicines （TCM） from latex-containing plants， so as to strengthen the theory of "identifying symptoms for qualities" and provide a reference for the development and utilization of the latex-containing plant resources. MethodStatistics on the meridians for properties and tastes， efficacy， medicinal parts， family and genus， and chemical components of TCM from latex-containing plants were carried out. A total of 53 TCM from latex-containing plants included in the 2020 edition of the Chinese Pharmacopoeia were screened by mining the Chinese Botanical Journal， Chinese Materia Medica， Dictionary of Traditional Chinese Medicines， and related literature. In addition， their meridians for properties and tastes， medicinal parts， chemical components， and TCM classifications were summarized and statistically analyzed by using Excel 2013 and ChiPlot 2023.3.31 software. ResultIt was found that latex-containing plants were mainly distributed in one kingdom， one phylum， two classes， and 20 families， and most of the TCM from latex-containing plants belonged to Dicotyledonaceae under Angiosperms. In terms of properties and tastes， plain>cold>warm>cool>hot and bitter>pungent>sweet>sour>salty. In terms of meridians， liver>lung>kidney>spleen=large intestine=stomach>heart>bladder=gallbladder=small intestines. In terms of medicinal parts， roots （root， rhizomes， tuberous root， and root bark）>resin>seed>whole herb （whole herb and above-ground part）>stem （stem and branch）>fruit>leaf>flower=skin. In terms of research on chemical components， they were mostly glycosides. In terms of TCM classification， they were mostly medicines for activating blood circulation and removing blood stasis. ConclusionThe TCM from latex-containing plants is mainly plain， with a uniform warm and cold distribution. The tastes are mainly bitter and pungent， and the major meridians are the liver and lung. The roots and resins are mainly used as medicines. The components mostly contain glycosides， alkaloids， and volatile oils， and most of them are medicines for activating blood circulation and removing blood stasis， as well as for removing heat and toxins. There is a certain degree of correlation among the growth habits， medicinal parts， chemical components， and the properties， tastes， and efficacy of the TCM from latex-containing plants. It may provide a reference for resource development and utilization of TCM from latex-containing plants.

Potential efficacy and mechanism of eight mild-natured and bitter-flavored TCMs based on gut microbiota: A review / 中草药·英文版

The mild-natured and bitter-flavored traditional Chinese medicines (MB-TCMs) are an important class of TCMs that have been widely used in clinical practice and recognized as safe long-term treatments for chronic diseases. However, as an important class of TCMs, the panorama of pharmacological effects and the mechanisms of MB-TCMs have not been systemically reviewed. Compelling studies have shown that gut microbiota can mediate the therapeutic activity of TCMs and help to elucidate the core principles of TCM medicinal theory. In this systematic review, we found that MB-TCMs commonly participated in the modulation of metabolic syndrome, intestinal inflammation, nervous system disease and cardiovascular system disease in association with promoting the growth of beneficial bacteria Bacteroides, Akkermansia, Lactobacillus, Bifidobacterium, Roseburia as well as inhibiting the proliferation of harmful bacteria Helicobacter, Enterococcus, Desulfovibrio and Escherichia-Shigella. These alterations, correspondingly, enhance the generation of protective metabolites, mainly including short-chain fatty acids (SCFAs), bile acid (BAs), 5-hydroxytryptamine (5-HT), indole and gamma-aminobutyric acid (GABA), and inhibit the generation of harmful metabolites, such as proinflammatory factors trimethylamine oxide (TAMO) and lipopolysaccharide (LPS), to further exert multiplicative effects for the maintenance of human health through several different signaling pathways. Altogether, this present review has attempted to comprehensively summarize the relationship between MB-TCMs and gut microbiota by establishing the TCMs-gut microbiota-metabolite-signaling pathway-diseases axis, which may provide new insight into the study of TCM medicinal theories and their clinical applications.

Gain deeper insights into traditional Chinese medicines using multidimensional chromatography combined with chemometric approaches / 中草药·英文版

Traditional Chinese medicines (TCMs) possess a rich historical background, unique theoretical framework, remarkable therapeutic efficacy, and abundant resources. However, the modernization and internationalization of TCMs have faced significant obstacles due to their diverse ingredients and unknown mechanisms. To gain deeper insights into the phytochemicals and ensure the quality control of TCMs, there is an urgent need to enhance analytical techniques. Currently, two-dimensional (2D) chromatography, which incorporates two independent separation mechanisms, demonstrates superior separation capabilities compared to the traditional one-dimensional (1D) separation system when analyzing TCMs samples. Over the past decade, new techniques have been continuously developed to gain actionable insights from complex samples. This review presents the recent advancements in the application of multidimensional chromatography for the quality evaluation of TCMs, encompassing 2D-gas chromatography (GC), 2D-liquid chromatography (LC), as well as emerging three-dimensional (3D)-GC, 3D-LC, and their associated data-processing approaches. These studies highlight the promising potential of multidimensional chromatographic separation for future phytochemical analysis. Nevertheless, the increased separation capability has resulted in higher-order data sets and greater demands for data-processing tools. Considering that multidimensional chromatography is still a relatively nascent research field, further hardware enhancements and the implementation of chemometric methods are necessary to foster its robust development.

Role of Histone Methyltransferase in Fibrosis and Traditional Chinese Medicine Treatment： A Review / 中国实验方剂学杂志

Fibrosis， a tumor-like lesion between benign tissue and malignant tumor， mostly occurs in the liver， kidney， heart， lung， bone marrow and other organs and tissues. It can affect almost every organ and eventually induce multiple organ failure and cancers， seriously endangering human life. It will be of great importance to prevent cancer if the disease can be opportunely blocked in the fibrotic stage. The pathogenesis of fibrosis is still not completely clear. It is of great clinical significance to study the occurrence， development， and mechanism of fibrosis as well as to screen new therapeutic targets. Enhancer of zeste homolog 2 （EZH2） is mainly located in the nucleus and involved in the formation of the polycomb repressive complex 2. EZH2 is a methyltransferase which makes the lysine on position 27 of histone H3 （H3K27me3） undergo trimethyl modification induces gene silencing through classical or nonclassical actions， so as to inhibit or activate transcription. EZH2 plays a critical role in cell growth， proliferation， differentiation， and apoptosis， which is regulated by different targets and signaling pathways. EZH2 regulates the transformation of myofibroblasts and participates in the fibrosis of multiple organs. Recent studies have shown that EZH2 plays a role in fibrosis-related pathophysiological processes such as epithelial-mesenchymal transition， oxidative stress， and inflammation. EZH2 as the target of fibrosis， EZH2 inhibitors， and EZH2-related traditional Chinese medicine （TCM） formula and active compounds have gradually become hot research directions. EZH2 may be a powerful target for organ fibrosis. Exploring the structure， function， and distribution of EZH2， the role of EZH2 in fibrosis， the EZH2 inhibitors， and TCM formulas and active components targeting EZH2 has great meanings. This paper reviews the research progress in EZH2 and fibrosis， providing new ideas for the diagnosis， treatment， and drug development of fibrosis.

Effects and mechanisms of traditional Chinese medicines on functional dyspepsia: A review / 中草药·英文版

Functional dyspepsia (FD) is a common and frequently occurring disease in clinic. With the influence of environmental factors, social factors and dietary factors, the incidence rate of FD in the general population is yearly increasing. Traditional Chinese medicine has a long history and far-reaching influence in the treatment of FD. It can prevent and treat FD in the form of multiple-components, targets and channels, with obvious effect and prominent advantages. This article starts with the common syndrome types of FD, and discusses the research progress of single Chinese medicine, effective ingredients and the mechanism of traditional Chinese medicines in treating FD, in order to provide a theoretical basis for the treatment of FD with traditional Chinese medicines.

Traditional Chinese medicines for non-small cell lung cancer: Therapies and mechanisms / 中草药·英文版

The most common subtype of lung cancer is non-small cell lung cancer (NSCLC), which has a poor prognosis and seriously threatens the health of human beings. The multidisciplinary comprehensive treatment model has gradually become the mainstream of NSCLC treatment. Traditional Chinese medicine (TCM) can be used effectively either as an adjunctive therapy or alone throughout the NSCLC therapy, which has a significant impact on survival, quality of life, and reduction of toxicity. Therefore, this paper reviewed the theoretical basis, the latest clinical application, and combined treatment mechanisms in order to explore the advantage stage of TCM treatment and the synergistic therapeutic mechanisms.

Progress in research methods or strategies of compatibility mechanism of traditional Chinese medicine prescriptions / 中国药房

Compound formulas of traditional Chinese medicines （TCM）， also known as prescription in clinic， refers to a form of medication in which several TCMs are selectively combined according to the certain compatibility principles and the needs of patient’s condition， based on syndrome differentiation and treatment. At present， the methods and strategies for investigating the compatibility mechanisms of TCM prescriptions mainly focus on the following two aspects: analysis of pharmacological substances （including chemical composition analysis of TCM， ingredients of TCM analysis in blood， and pharmacokinetic analysis） and pharmacological signaling pathways analysis （involving network pharmacology analysis， signal pathway indicator detection， and metabolomics analysis）. In future research， the compatibility relationships of TCM prescriptions should be explored according to the principles of “Qiqing Hehe”，“ Shengjiang Fuchen”，“ Junchen Zuoshi”， and “Siqi Wuwei”. The regularity of TCM prescriptions compatibility should be shown in the change regularity of chemical components， pharmacokinetics， pharmacological pathways， and chemical compositions of various ratios of TCMs. Based on the insurance of holistic efficacy of TCM prescriptions， the underlying mechanisms of compatibility should be uncovered， which will provide references for the optimization of clinical applications of prescriptions and new directions for the creation of innovative TCM prescriptions.

Research progress in pathogenesis and traditional Chinese medicines treatment of ischemic stroke-related headache / 中国中药杂志

Headache is a common clinical complication of ischemic stroke. As a precursor of stroke, headache occurs repeatedly in the convalescent period of ischemic stroke, leading to secondary stroke and seriously hindering patients' rehabilitation. Currently, it is believed that the pathogenesis of ischemic stroke-related headache is associated with the abnormal release of vasoactive substances, high platelet aggregation, and stimulation of intracranial pain-sensitive structures. The active ingredients in traditional Chinese medicines(TCM) with the effects of activating blood to resolve stasis and clearing heat to release exterior can protect brain tissue and relieve headache by reducing the release of inflammatory cytokines, alleviating antioxidant stress, inhibiting neuronal apoptosis and so on. This paper introduces the research progress in the potential mechanism and TCM treatment of ischemic stroke-related headache, aiming to provide reference for further research and drug development of this complication.

Chemical reaction mechanism of decoction of traditional Chinese medicines: a review / 中国中药杂志

Complicated chemical reactions occur in the decoction of traditional Chinese medicines(TCMs) which features complex components, influencing the safety, efficacy, and quality controllability of TCMs. Therefore, it is particularly important to clarify the chemical reaction mechanism of TCMs in the decoction. This study summarized eight typical chemical reactions in the decoction of TCMs, such as substitution reaction, redox reaction, isomerization/stereoselective reaction, complexation, and supramolecular reaction. With the "toxicity attenuation and efficiency enhancement" of aconitines and other examples, this study reviewed the reactions in decoction of TCMs, which was expected to clarify the variation mechanisms of key chemical components in this process and to help guide medicine preparation and safe and rational use of medicine in clinical settings. The current main research methods for chemical reaction mechanisms of decoction of TCMs were also summed up and compared. The novel real-time analysis device of decoction system for TCMs was found to be efficient and simple without the pre-treatment of samples. This device provides a promising solution, which has great potential in quantity evaluation and control of TCMs. Moreover, it is expected to become a foundational and exemplary research tool, which can advance the research in this field.

Review of traditional Chinese medicines in ameliorating neuropsychiatric diseases by improving the levels of monoamine neurotransmitters via gut microbiota regulation / 中国中药杂志

The degeneration of monoaminergic system and the reduction of monoamine neurotransmitters(MNTs) are associated with the occurrence of a variety of neuropsychiatric diseases, becoming the key indicators for clinical diagnosis and treatment. Recent studies suggested gut microbiota could influence the occurrence, development, and treatment of neuropsychiatric diseases by directly or indirectly regulating the synthesis and metabolism of MNTs. Rich clinical experience has been accumulated in the amelioration and treatment of neuropsychiatric diseases by traditional Chinese medicines. The traditional oral administration method demonstrates obvious advantages in regulating gut microbiota. It provides a new idea for explaining the pharmacodynamic material basis and mechanism of traditional Chinese medicines in ameliorating neuropsychiatric disease by improving the levels of MNTs via gut microbiota regulation. Focusing on three common neuropsychiatric diseases including Alzheimer's disease, Parkinson's disease, and major depression, we summarized the pathways of gut microbiota in regulating the levels of MNTs and the paradigms of traditional Chinese medicines in ameliorating neuropsychiatric diseases via the "bacteria-gut-brain axis", aiming to provide ideas for the development of drugs and treatment schemes.

Bioinformatics analysis and validation of key genes in transformation of idiopathic membranous nephropathy to end-stage renal disease and traditional Chinese medicines for prevention and treatment / 中国中药杂志

This study used bioinformatics analysis to screen out key genes involved in the transformation of idiopathic membranous nephropathy to end-stage renal disease and to predict targeted Chinese herbs and medicines and active ingredients with preventive and curative effects. The GSE108113 microarray of idiopathic membranous nephropathy and GSE37171 microarray of were downloaded from the comprehensive gene expression database, and 8 homozygous differentially expressed genes for the transformation of idiopathic membranous nephropathy into end-stage renal disease of were screened out by R software. GraphPad Prism was used to verify the expression of homozygous differentially expressed genes in GSE115857 microarray of idiopathic membranous nephropathy and GSE66494 microarray of chronic kidney disease, and 7 key genes(FOS, OGT, CLK1, TIA1, TTC14, CHORDC1, and ANKRD36B) were finally obtained. The Gene Ontology(GO) analysis was performed. There were 209 functions of encoded proteins, mainly involved in regulation of RNA splicing, cytoplasmic stress granule, poly(A) binding, etc. Thirteen traditional Chinese medicines with the effect of preventing the transformation of idiopathic membranous nephropathy to end-stage renal disease were screened out from Coremine Medical database, including Ginseng Radix et Rhizoma, Lycopi Herba, and Gardeniae Fructus, which were included in the Chinese Pharmacopoeia(2020 edition). The active ingredient quercetin mined from Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform(TCMSP) had ability to dock with the key gene FOS-encoded protein molecule, which provided targets and research ideas for the development of new traditional Chinese medicines.

Interactions between gut microbiota and berberine,a necessary procedure to understand the mechanisms of berberine / 药物分析学报

Berberine(BBR),an isoquinoline alkaloid,has been found in many plants,such as Coptis chinensis Franch and Phellodendron chinense Schneid.Although BBR has a wide spectrum of pharmacological effects,its oral bioavailability is extremely low.In recent years,gut microbiota has emerged as a cynosure to un-derstand the mechanisms of action of herbal compounds.Numerous studies have demonstrated that due to its low bioavailability,BBR can interact with the gut microbiota,thereby exhibiting altered pharma-cological effects.However,no systematic and comprehensive review has summarized these interactions and their corresponding influences on pharmacological effects.Here,we describe the direct interactive relationships between BBR and gut microbiota,including regulation of gut microbiota composition and metabolism by BBR and metabolization of BBR by gut microbiota.In addition,the complex interactions between gut microbiota and BBR as well as the side effects and personalized use of BBR are discussed.Furthermore,we provide our viewpoint on future research directions regarding BBR and gut microbiota.This review not only helps to explain the mechanisms underlying BBR activity but also provides support for the rational use of BBR in clinical practice.

Regulatory effect of traditional Chinese medicines on signaling pathways of process from chronic atrophic gastritis to gastric cancer / 中草药·英文版

Chronic atrophic gastritis (CAG), a common disease of digestive system, is an extremely important cause of gastric cancer (GC). The occurrence and development of CAG involves the abnormality of multiple signaling pathways. Traditional Chinese medicines (TCMs) has the advantages of mild action, multi-target and small adverse reaction, etc., which broadens the way for the treatment of the disease, and TCMs can play a therapeutic role by regulating multiple signaling pathways. In this review, based on the related experiments of TCMs and Chinese herbal compounds in recent years, the related literatures were searched and 10 kinds of signaling pathways involved were summarized, in order to provide a reference for further research on reversing or delaying the progress of CAG and preventing gastric cancer.

Post-infectious cough of different syndromes treated by traditional Chinese medicines: A review / 中草药·英文版

The application of traditional Chinese medicines (TCMs) has a history of more than 2000 years, which have the characteristics of multi-component, multi-target, and high safety. Post-infectious cough (PIC) is a respiratory disease with high incidence. It belongs to subacute cough and accounts for as much as 40%–50%. Cough is the main clinical manifestation of PIC. PIC seriously affects people's life quality because of complex etiology, long-term course of disease, treatment difficulties and other characteristics. Western medicines are based on the principle of symptomatic treatment, so they are often difficult to control PIC fundamentally. These factors could due to that PIC is prolonged and unable to heal repeatedly. TCMs have obvious advantages in treating PIC, with accurate curative effects, less side effects and adverse reactions and are effective in improving PIC-related symptoms and indicators, enhancing patients' life quality and reducing pain. TCMs, guided by holistic concept and syndrome differentiation, advocate determine treatment on the basis of pattern types, and have remarkable clinical treatment effects. As for TCMs etiology, pathogenesis and syndrome types of PIC, TCM scholars have not yet reached a unified standard. However, most of them think that wind pathogen can cause PIC alone, or it can be combined with other evils, which might be the main mechanism of PIC. This paper discusses the advantages and limitations of TCMs in PIC treatment from etiology, pathogenesis, distribution of syndrome types and treatment of TCMs. This article focuses on the treatment methods and pharmacodynamic material basis of wind pathogen, providing ideas in treating PIC of TCMs clinically and innovative drug development.

Progress in the design and quality control of placeboes for clinical trials of traditional Chinese medicine / 中西医结合学报

In recent years, new preparations of traditional Chinese medicines (TCMs) have been developed, increasing the need for their clinical trials. Using placeboes rather than control drugs is increasingly popular in clinical trials of TCMs, as the therapeutic effects of the tested TCMs can be more properly judged. The basic attributes of TCM placeboes include similarity, safety, applicability and controllability. In particular, it is necessary to have similarities in appearance, color, smell and taste between the tested TCMs and placeboes. This is quite difficult for some TCMs due to their distinctive smell and taste. On the other hand, according to the TCM theory on homology of medicine and food, many foods also have certain bioactivities, potentially further complicating the selection of materials for TCM placeboes. In this review, firstly, studies on the special smell and taste of TCMs were introduced. Then, the preparation quality evaluation processes for TCM placeboes were summarized and discussed, based on the relevant literature published in recent years and the research results from our own lab. This review will facilitate the further research and development of TCM placeboes.

Residual status, toxicity, and analytical method of banned pesticides in traditional Chinese medicines / 中国中药杂志

A total of 33 pesticides have been banned from Chinese medicinal materials and decoction pieces(plants) according to Chinese Pharmacopoeia(2020 edition). According to the chemical structures, they are mainly divided into seven categories: organophosphorus compounds, organochlorines, carbamates, amidines, sulfonylureas, phenylpyrazoles, and ethers. These banned pesticides exhibit neurotoxicity, reproductive toxicity, immune system toxicity, teratogenicity, carcinogenesis, and mutagenesis, seriously damaging human and animal health. They affect not only the quality and safety of traditional Chinese medicines and resulting products, but also their competitiveness in the international market. Due to the numerous varieties of traditional Chinese medicines and their complex substrates, it is necessary to establish a universal and highly sensitive method for pesticide residue detection. This review systematically summarized the residual status, toxicity, and analytical methods of banned pesticides in traditional Chinese medicines, and forecasted the prospects of different analytical techniques, so as to provide reference for further safety and risk assessment of banned pesticide residues in traditional Chinese medicines, thus ensuring the safe production of traditional Chinese medicines.

Challenges and strategies in progress of drug delivery system for traditional Chinese medicine Salviae Miltiorrhizae Radix et Rhizoma (Danshen) / 中草药·英文版

Traditional Chinese medicines (TCMs), with a history of thousands of years, are widely used clinically with effective treatment. However, the drug delivery systems (DDSs) for TCMs remains major challenges due to the characteristics of multi-components including alkaloids, flavones, anthraquinones, glycosides, proteins, volatile oils and other types. Therefore, the novel preparations and technology of modern pharmaceutics is introduced to improve TCM therapeutic effects due to instability and low bioavailability of active ingredients. Salviae Miltiorrhizae Radix et Rhizoma, the radix and rhizomes of Salvia miltiorrhiza Bunge (Danshen in Chinese), is a well known Chinese herbal medicine for protecting the cardiovascular system, with active ingredients mainly including lipophilic tanshinones and hydrophilic salvianolic acids. In this review, this drug is taken as an example to present challenges and strategies in progress of DDSs for TCMs. This review would also summary the characteristics of active ingredients in it including physicochemical properties and pharmacological effects. The purpose of this review is to provide inspirations and ideas for the DDSs designed from TCMs by summarizing the advances on DDSs for both single- and multi-component from Danshen.

Targeting immunometabolism by active ingredients derived from traditional Chinese medicines for treatment of rheumatoid arthritis / 中草药·英文版

Rheumatoid arthritis (RA), the most common inflammatory arthropathy word wild, is a systemic autoimmune disease that mainly affects the synovium of joints with a high disability rate. Metabolic mis-regulation has emerged as a fundamental pathogenesis of RA linked to immune cell dysfunction, while targeting immunometabolism provides a new and effective approach to regulate the immune responses and thus alleviate the symptom of RA. Recently, natural active compounds from traditional Chinese medicines (TCMs) have potential therapeutic effects on RA and regulating immunometabolism. In this review, in addition to updating the connection between cellular metabolism and cell function in immune cells of RA, we summarized that the anti-inflammatory mechanisms of the potential natural compounds from TCM by targeting metabolic reprogramming of immune cells, and discusses them as a rich resource for providing the new potential paradigm for the treatment of RA.

Formulation of technical guidelines in line with characteristics and principles of traditional Chinese medicine changes to improve quality of such preparations--interpretation of Technical guidelines for the study of pharmaceutical changes in traditional Chinese medicines / 中国中药杂志

In leading the high-quality development of Chinese medicine preparations, it is an important link to formulate the scientific, reasonable, and feasible guidelines for the change of Chinese medicines in accordance with the change characteristics and principles of the Chinese medicines is an important work to promote the Technical guidelines for the study of pharmaceutical changes in traditional Chinese medicines was formed by a broad consensus based on the characteristics and research results of the pharmaceutical changes in Traditional Chinese Medicines(TCM)with the principles of science and risk management. This guideline has clarified the basic principles and requirements for the evaluation of changes in TCM, specified the research and verification work of common change scenarios, defined the boundaries of changes in TCM, and proposed to encourage the use of new technologies, new methods, and new excipients that meet product characteristics. It will definitely promote the quality improvement and the secondary development of TCM. In this article, the revision background and main content of the guideline were introduced, and the main features of the Guideline were analyzed, in order to provide references for the industry.