In recent years, the research on the prevention and treatment of chronic hepatitis B (CHB) in Chinese medicine has received increasing attention from the medical community at home and abroad, and many researchers have increasingly developed clinically effective classical prescriptions, effective prescriptions of famous doctors, and experimental prescriptions into in-hospital preparations or marketed ready-to-use drugs. These results have enriched and broadened the scope and types of drugs available for clinical treatment of CHB. However, reviewing the current status and research progress of proprietary Chinese medicines for the treatment of CHB, it is not difficult to find that, while good progress has been made and promising results have been achieved, the problems of numerous classifications of proprietary Chinese medicines and complicated prescriptions, diffuse and messy therapeutic directions, poor specificity of efficacy, and unclear microscopic targets of mechanism of action have, to a certain extent, affected the dominant direction of research on the prevention and treatment of CHB by proprietary Chinese medicines, and also easily confused or It is also easy to confuse or interfere with the clinical awareness of clinical use and the choice of drugs, and affects the progress and pace of the internationalization of proprietary Chinese medicines. Therefore, it is necessary to summarize, analyze, evaluate and discuss the current situation and research progress of clinical use of proprietary Chinese medicines for CHB. The author searched the research literature on the treatment of CHB with proprietary Chinese medicines from January 2004 to December 2009 through the “China Knowledge Network full-text journal database”, and the results showed that there were more than 1758 research papers discussing the efficacy of proprietary Chinese medicines on CHB and their mechanism of action, among which There are 568 listed proprietary Chinese medicines, 92 in-hospital preparations, 446 Chinese herbal extracts, 38 self-prepared proprietary medicines, and 614 other proprietary medicines not for the treatment of CHB but clinically effective. The search results of the listed Chinese patent medicines for the treatment of CHB by “China Pharmaceutical Network” show that there are 99 listed Chinese patent medicines with the effect of treating CHB, produced by 1190 pharmaceutical enterprises; 12 kinds of non-CHB treatment but clinically effective drugs, produced by 438 pharmaceutical enterprises; 16 kinds of drugs developed by Chinese medicine extracts, produced by 144 pharmaceutical enterprises. There are 16 kinds of drugs produced by 144 pharmaceutical enterprises; 43 kinds of in-hospital preparations; and 12 kinds of self-prepared proprietary drugs. There are 171 types of proprietary Chinese medicines for CHB on the China Knowledge Network and China Medicine Network, including 47 types of capsules, 35 types of tablets (including sugar-coated tablets), 34 types of granules (including bulk), 28 types of pills (including micro pills and honey pills), 17 types of oral liquids or syrups (including concoctions), 6 types of injections, 2 types of creams, and 1 type of patch and suppository each. In addition, there are still many manufacturers producing the same type, name of the phenomenon of patent medicines (such as hepatitis B Fuzheng capsule 123, liver protection tablets 122, hepatitis B detoxification capsule 121); its public or undisclosed drug composition of the compounded prescriptions, Chinese medicine, there are more than 200 flavors. The above-mentioned data reflect, to a certain extent, the remarkable and abundant achievements in the field of research and development of proprietary Chinese medicines for CHB in China, but on the other hand, the status quo of proprietary Chinese medicines with a wide variety of composition and repetitive names gives us the following thoughts: ① Does it reflect, to some extent, the relative lack of leading research direction in the field of proprietary Chinese medicines for CHB in China? (2) The main treatment and indications introduced in the manuals of more or less the same proprietary medicines have added a certain degree of blindness and difficulty to clinical practitioners in the application selection, and there is a danger that the prescriptions do not follow the evidence? (3) Many drugs lack the scope of selection of the indications of Chinese medicine, which seems to give the impression of emphasizing the identification of diseases rather than the identification of evidence, which is inevitably contrary to the traditional thinking of Chinese medicine and the basic features of diagnosis and treatment? ④ Numerous manufacturers produce the same variety of proprietary drugs, which reflects the high clinical efficacy and utilization rate of the drug, but also reflects the one-sided pursuit of individualized economic benefits of individual manufacturers, while ignoring the concept of scientific development concept of integrating scientific and technological resources and bringing into play the effectiveness of the group? Therefore, we believe that standardizing the classification of proprietary Chinese medicine treatment rules, integrating effective resources, group collaboration, scientific and technological research, selecting the key drugs, and developing the fist product of proprietary Chinese medicine for the treatment of CHB will help to improve the relatively confusing situation of the classification of proprietary Chinese medicine. 2.The efficacy of the treatment rules is multifarious, and the treatment direction is diffuse. Looking at the retrieved data and literature, it is not difficult to find that the Chinese medicine treatment rules for the treatment of CHB are mostly compounded, such as clearing heat and detoxifying, tonifying the liver and kidney, activating blood circulation and resolving blood stasis, strengthening the spleen and relieving dampness, nourishing Yin and softening the liver, draining the liver and Qi, resolving phlegm and dispersing knots, etc., often 2-3 methods are overlapping and compounded, and there are few independent treatments; in terms of “detoxification In terms of “detoxification” type of Chinese patent medicines, there are ① heat-clearing and detoxification (Beduo hepatic ning tablets, Hubei Zhongxin Pharmaceutical Co. Ltd.), ④ blood activation and detoxification (Chaoyang Pill, Beijing Vast Pharmaceutical Factory; Hepatofukang Honey Pill, Huaxia Hepatitis B Research Institute), ⑤ resolving blood stasis and detoxification (Fuxiangjia Soft Liver Tablets, Inner Mongolia Furei Chinese and Mongolian Medicine Technology Co. Ltd.; Longxie Granules, Jiangsu Provincial Hospital of Traditional Chinese Medicine), ⑧ dispel dampness and clear heat (liver toxin clear sugar-coated tablets, Meizhou City Hospital of Traditional Chinese Medicine), ⑨ support and detoxify (compound winter grass oral liquid, Changzhou Hospital of Infectious Diseases), ⑩ diarrhea and detoxify (liver toxin clear granules, Jilin Province Bowie Pharmaceutical Co. “There are also “removing cold toxin”, “clearing epidemic toxin” and mixed treatment of detoxification with other treatment methods, so the list is endless. Which is better and which is worse? What is the “ruler” of antidote drugs? What is the “minister”? What is the poison? What is the objective difference in evaluation? It is difficult for medical practitioners to make judgments, and researchers have not revealed it in microscopic terms, which is confusing. In addition, there are still descriptions of its main efficacy from the perspective of modern medicine, such as “lowering enzymes and reducing yellowing, reducing liver cell damage, and promoting recovery of liver function” (Ganixin capsule, Lianyungang Zhengda Tianqing Pharmaceutical Co., Ltd.), “stabilizing liver cell membranes, reducing liver cell damage, anti-fibrosis, and slowing down the progression of chronic hepatitis to cirrhosis. Ltd.), “lowering enzymes, lowering turbidity, adjusting the body’s immune function, improving metabolic disorders, liver disease symptoms and accelerating liver function recovery” (Hepatospeed Capsules, Harbin Songhe Pharmaceutical Co. “(Hepatitis Ling, Changshu Leiyun Shang Pharmaceutical Co., Ltd.), etc.; there are also a mixture of Chinese and Western effects, such as “clearing heat and detoxifying, activating blood circulation, lowering dampness, lowering glutathione transaminase “Ltd.), “protecting liver cells, clearing heat and dampness, reducing yellowing, detoxifying and lowering enzymes, immune regulation, anti-liver fibrosis” (Hepatitis B clearing and detoxifying tablets, Shandong Haisen Pharmaceutical Co. There are more than 100 different or the same or similar treatments described. As we all know, the principles of modern medicine for the treatment of CHB include five aspects, such as antiviral, immunomodulation, anti-inflammatory and liver-protective, anti-fibrosis and symptomatic treatment, and it is proposed that antiviral treatment is the key [1], while Chinese medicine, although it proposes “toxicity”, “stasis” and “dampness” for CHB “, “stasis”, “dampness”, “heat” and other major pathogenic theories for CHB [2], but there is a lack of relatively unified and standardized treatment direction in the legislation of treatment. It is true that the coexistence of multiple methods reflects to a certain extent the flexible and adaptable characteristics of TCM “different treatment for the same disease” and the advantages of multiple methods and different paths, but almost all the “eight methods” of TCM treatment are included in it, which shows the confusion of the direction of TCM treatment of CHB from another level. In addition, the mixture of Chinese and Western efficacy or the “progress” of the combination of Chinese and Western medicine, but the mixture of Chinese and Western medical theory of treatment system is also contrary to the basic characteristics of traditional Chinese medicine, and it will also confuse the clinicians and patients’ interpretation of drug efficacy instructions. Therefore, the author believes that the formulation of a framework for the therapeutic direction and treatment rules of proprietary Chinese medicines for the treatment of CHB, and the unification of the expression of the main treatment, efficacy, indications and scope of application, will help to standardize the classification of the treatment methods of proprietary Chinese medicines, clarify the therapeutic direction, standardize the drug descriptions, and clarify the clinical selection of medicines by physicians. The modern mechanism is not clear, and the target point of action is not yet clear. Traditional Chinese medicine has been using the “theory of yin and yang and the five elements”, the “eight syllabuses of evidence”, the “evidence of qi, blood and fluids”, and the “evidence of internal organs” for the mechanism of efficacy. and “internal organs”, as well as the theories of “four gases and five tastes”, “elevation and sinking”, and “drug attribution” of Chinese medicine. With the development of modern Chinese medicine science, the analysis of the mechanism of action of traditional Chinese medicine no longer stays in the perspective of traditional Chinese medicine theory, but has leapfrogged to modern pharmacological methods, and even gradually aligned with western medicine chemical drug research methods. Many listed proprietary drugs must have undergone pharmacodynamics, pharmacokinetics, determination of the main active ingredients, quality standards and formulation process standards, as well as efficacy tests that must be conducted in clinical trials, and most of them have confirmed their effects and efficacy through modern pharmacology, and proprietary Chinese medicines for CHB are no exception. Modern medicine for CHB virus drugs mainly include interferon and nucleoside analogues (such as lamivudine, adefovir, entecavir or telbivudine), etc. The main components and chemical structure formula of these drugs are clear, and their absorption pathways and time, blood concentration, metabolism organs and metabolites, and clearance half-life time in the body are also very clear, so the pharmacological mechanisms and targets of action are relatively clear. For example, lamivudine has been significantly described in the drug description: lamivudine can be metabolized in HBV-infected cells and normal cells to produce lamivudine triphosphate (L-TP), which is embedded in viral DNA in the form of cyclic adenosine phosphate through HBV polymutase, resulting in the suspension of DNA strand synthesis, thus achieving anti-HBV effects. The Chinese patent medicines already contain the meaning of traditional Chinese medicine efficacy in the drug naming, such as hepatitis B heat detoxification capsule (Jilin Xiuquan Pharmaceutical), Sutor hepatitis B complex soft capsule (Shenzhen Jiatai Pharmaceutical Co., Ltd.), hepatitis B Jian tablets (Qinghai Sanpu Pharmaceutical), hepatitis B Ning punch (Changsha Jiuzitang Pharmaceutical Factory), hepatitis B Fuzheng capsule (Wuhan Jianmin Group Suizhou Pharmaceutical) and so on, but most of the Chinese patent medicines in the instructions are only to clear heat and detoxify, to However, most of the Chinese patent medicines are only described in the manual as clearing heat and detoxifying, dredging liver and Qi, activating blood circulation, nourishing kidney and liver …… and other traditional Chinese medicine efficacy and indications, lacking the introduction and description of its mechanism of action, and even lacking clear ingredients, absorption and metabolic pathways in the body, thus only describing the modern efficacy of the drug from the macroscopic effects, such as liver protection, enzyme reduction, antiviral, etc., but through what kind of substances and the microscopic mechanism of action. However, the microscopic targets of what substances and mechanisms of action are difficult to be clearly revealed. Since entering the 21st century, the internationalization of TCM has been accelerated, and TCM is gaining more and more attention and interest from foreign medical circles, and its products are gradually moving towards the international market. This means that for the first time, the safety and efficacy as well as the quality control standards of Chinese proprietary medicines have been recognized by the FDA, the most stringent drug regulatory agency in the world. But unfortunately, Chinese medicine is still accepted by some people internationally as “alternative medicine”, and most Chinese medicines and their products can only be used as “food additives” to get out of the country, which is an insurmountable “threshold”. Although this insurmountable “threshold” is related to the different medical systems and different exotic cultures in the East and the West, the author believes that it is related to the difficulty of clarifying the active ingredients, the metabolic processes and the microscopic targets of the action of proprietary Chinese medicines. Therefore, we believe that how to clarify the active ingredients, effective parts and reveal the microscopic targets of action of proprietary Chinese medicines for the treatment of CHB, and objectively elaborate their mechanism of action will be an important issue to be solved in the field of proprietary Chinese medicine research, which is of great significance to promote and accelerate the speed and pace of proprietary Chinese medicines to the international market. 4. Toxic side effects are unknown, and the corresponding research is lacking The “Huangdi Neijing” “Suwen? The five permanent political theory” contains the following statement: “often poisonous cure, ten to its seven …… non-toxic cure, ten to its nine”, meaning that Chinese medicine has a harsh and peaceful medicinal properties, conventional drugs, but also have a certain degree of toxicity, the use of attention should be paid to the disease that stop Even non-toxic drugs should not be abused. In the past decade, the toxic side effects of Chinese medicines and their preparations have gradually been widely emphasized, and the Drug Evaluation Center of the State Food and Drug Administration and the National Center for Adverse Drug Reaction Detection created the journal China Pharmacovigilance in 2004, in which the adverse reactions of proprietary Chinese medicines have been reported one after another, such as Jiang’s earlier report of chronic arsenic poisoning caused by Niuhuang detoxification tablets in this publication [3], indicating that the national level has The toxic side effects of pCms should not be ignored. Recently, many scholars have also summarized their research on the side effects of pCms [4-5], which has gradually changed the erroneous view that pCms are “safe and non-toxic”. In addition, “Yinjianhuang injection” (Shanxi Taixing Pharmaceutical Co., Ltd.), which was once considered effective for viral hepatitis, was discontinued by the Ministry of Health in 2008 due to four adverse reactions in newborns and one death in Zhidan County Hospital in Shaanxi Province [6], so it can be seen that there are also serious adverse events of proprietary Chinese medicines for the treatment of CHB. Some scholars collated the instructions of proprietary Chinese medicines and found that the adverse reactions were mostly described as “minor gastrointestinal reactions” and “allergic reactions”, and some only wrote “not yet clear”, and the description of contraindications was even simpler. The description of contraindications is even simpler, such as “contraindicated for those who are allergic to this product or have serious adverse reactions” [6], which can hardly reflect the scope and degree of adverse reactions caused by toxic side effects. Almost all chemical drugs in Western medicine have “adverse reactions”, “contraindications”, “precautions”, “for pregnant women and nursing mothers”, “for children “, “for children”, “for the elderly”, “drug interactions”, “drug overdose “, “Pharmacological Toxicology-Clinical Safety Data”, etc., indicating that they have all undergone rigorous relevant studies, only the listed Chinese medicines have undergone acute and chronic toxicity tests on experimental animals and clinical phase I safety evaluation and adverse event monitoring in phase II-III clinical trials, but microscopic studies on their toxic side effects are still relatively absent. However, microscopic studies on their toxic effects are still relatively absent, and there is a lack of research information similar to that of chemical drugs. Recently, some scholars have gradually proposed [6-8] that the relevant authorities should increase the inspection of the implementation of GMP in drug manufacturers and improve the unified standards of drug instructions; enterprises should strengthen the improvement process of drugs and improve the quality control standards; relevant institutions should accelerate the research on toxic active pharmacological components of pCms, conduct research on the detection technology of illegal additives, and strengthen the research on the contraindications of compounding, dietary contraindications and contraindications The clinical application of pCms should be rationalized, and the monitoring and research on adverse reactions and drug interactions should be strengthened; and the research on the material basis, mechanism of action, clinical manifestations, detoxification measures, first aid methods and prevention measures of poisoning should be gradually improved. Therefore, the author believes that objective evaluation and description of the toxic side effects of proprietary Chinese medicines for the treatment of CHB, improvement of relevant research data, and standardization of the format and content of the instructions for efficacy, main treatment, indications, adverse reactions, contraindications, precautions ……, etc. will help to standardize and standardize proprietary Chinese medicine products and gradually move toward internationalization. In conclusion, in the field of research on the prevention and treatment of CHB in Chinese medicine, the continuous research and development of proprietary Chinese medicine has achieved fruitful results in broadening the therapeutic ideas and seeking new methods and new drugs. Nowadays, with the rapid development of modern science and technology, the pace of Chinese medicine towards standardization and internationalization has been accelerated. We believe that we should unify the classification of CHB Chinese patent medicines, clarify the leading therapeutic directions, standardize the content of drug instructions and their expressions, strengthen the improvement of preparation process, improve the quality control standards, further clarify the effective parts and active ingredients, improve the pharmacological and toxicological research data, and reveal and elaborate the microscopic targets of drug action mechanism. We believe that with the continuous efforts of Chinese medicine and related disciplines in China and the in-depth research on CHB clinical, pharmacology, pharmacology, medicinal chemistry and preparation, as well as the further implementation of standardization and standardization of research on proprietary Chinese medicine, the proprietary Chinese medicine preparation for the treatment of CHB will be active in the international research field of CHB prevention and treatment and clinical “stage The further implementation of the standardization and standardization of the research on Chinese patent medicines will make the Chinese patent preparations for the treatment of CHB active in the international research field and clinical “stage” of CHB.