Thoughts on path of R&D and registration of innovative traditional Chinese medicine with synchronous transformation of "series prescriptions" / 中国中药杂志

Since the implementation of drug registration in China, the classification of Chinese medicine has greatly met the needs of public health and effectively guided the transformation, inheritance, and innovation of research achievements on traditional Chinese medicine(TCM). In the past 30 years, the development of new Chinese medicine has followed the registration transformation model of " one prescription for single drug". This model refers to the R&D and registration system of modern drugs, and approximates to the " law-abiding" medication method in TCM clinic, while it rarely reflects the sequential therapy of syndrome differentiation and comprehensive treatment with multiple measures. In 2017, Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices released by the General Office of the CPC Central Committee and the General Office of the State Council pointed out that it is necessary to " establish and improve the registration and technical evaluation system in line with the characteristics of Chinese medicine, and handle the relationship between the traditional advantages of Chinese medicine and the requirements of modern drug research". Therefore, based on the development law and characteristics of TCM, clinical thinking should be highlighted in the current technical requirements and registration system of research and development of Chinese medicine. Based on the current situation of registration supervision of Chinese medicine and the modern drug research in China, the present study analyzed limitations and deficiency of " one prescription for single drug" in the research and development of Chinese medicine. Additionally, a new type of " series prescriptions" was proposed, which was consistent with clinical thinking and clinical reality. This study is expected to contribute to the independent innovation and high-quality development of the TCM industry.

Research and development strategies of new Chinese medicines based on new regulations / 中国中药杂志

In recent years, only a small number of new Chinese medicines have been approved for marketing, which has embodied the bottleneck in the development of the Chinese medicine industry. To tackle this problem, the National Medical Products Administration has issued a series of regulations and technical requirements. In the context of new regulations, this study deeply explored the research and development strategies of new Chinese medicines under the guidance of the new classification of drug registration, and discussed the key technical issues in the research and development.

[Systematic review and Meta-analysis of efficacy and safety of Yangwei Granules for chronic gastritis].

To systematically evaluate the efficacy and safety of Yangwei Granules combined with conventional Western medicine for chronic gastritis. CNKI, SinoMed, WanFang, VIP, PubMed, Cochrane Library and EMbase database were electronically retrieved to collect randomized controlled trial(RCT) of Yangwei Granules combined with conventional Western medicine for chronic gastritis. Two reviewers independently screened out literatures according to the inclusion and exclusion criteria and extracted data, and evaluated the risk of bias of included studies. Meta-analysis was conducted by using RevMan 5.3 software. A total of 12 RCTs involving 1 164 patients were included. The results of Meta-analysis showed that:(1) The total effective rate of Yangwei Granules combined with conventional Western medicine for chronic gastritis was better than that of conventional Western medicine group, with a statistically significant difference(RR=1.24,95%CI[1.17,1.31],P<0.000 01).(2) Compared with the conventional Western medicine group, the Yangwei Granules combined with conventional Western medicine group was conducive to improving the Hp eradication rate, with a statistically significant difference(RR=1.24,95%CI[1.15,1.34],P<0.000 01).(3) The incidence of adverse reactions in Yangwei Granules combined with conventional Western medicine group was lower than that in the control group, but with no statistically significant diffe-rence(RR=0.83, 95%CI[0.39, 1.79], P=0.64).(4) Compared with the conventional Western medicine group, the Yangwei Granules combined with conventional Western medicine group was beneficial to the reduction of motilin level(MD=-17.31,95%CI[-21.83,-12.79],P<0.000 01) and endothelin level(MD=-6.60,95%CI[-10.07,-3.13],P=0.000 2), while the increase of gastrin level(SMD=0.94,95%CI[0.50,1.38],P=0.003) was related to calcitonin gene the level of peptide(MD=5.82,95%CI[4.25,7.39],P<0.000 01), with statistically significant differences.(5) Compared with conventional Western medicine group, Yangwei Granules combined with conventional Western medicine group could increase PGⅠ(MD=6.40,95%CI[4.26,8.54],P<0.000 01) and PGR(MD=0.89,95%CI[0.71,1.07],P<0.000 01), while decrease PGⅡ(MD=-1.24,95%CI[-2.15,-0.33],P=0.007), with statistically significant differences. Current evidence showed that the clinical efficacy and Hp eradication rate of Yangwei Granules combined with conventional Western medicine in the treatment of chronic gastritis were better than those of the conventional Western medicine group alone, and could effectively improve the level of gastrointestinal hormones, vasoactive peptide and the pepsinogen level in patients with chronic atrophic gastritis, without increasing the incidence of adverse reactions. However, due to the limited quality and quantity of included studies, the above conclusions need to be confirmed by more large-scale and high-quality RCTs.

Research and Development of New Traditional Chinese Medicine Based on Experienced Prescriptions of Prestigious Chinese Physicians / 中国实验方剂学杂志

The experienced prescriptions of famous prestigious Chinese physicians are effective prescriptions developed by prestigious Chinese doctors during their long-time clinical practice, which reflect the traditional Chinese medicine (TCM) understanding of the disease development regularity and core pathogenesis. These experienced prescriptions provide valuable experience for medication and prescription regularities, and represent the highest level of TCM treatment and the major sources of new drug research, development and technology innovation. It is of great significance to inherit academic thoughts and clinical experiences of prestigious Chinese physicians, explore and summarize experienced prescriptions, and develop new Chinese drugs. The researches of new drugs based on experienced prescriptions are the major direction encouraged by the government, with the maximum amount of new TCM drug applications but a low approval rate in recent years. The main reason for the low number of approved new TCM drug applications is that researchers know less about evaluation concepts and relevant techniques, leading to problems in research and development strategy. To facilitate a smooth advance of the new drug research and development and take full advantage of the experienced prescriptions, in this paper, we focus on the problems about new drug development of experienced prescriptions, lay emphasis on the new TCM drug research and development concepts of clinical value, history of human application and whole-process quality control, and deeply and systematically analyze concerns in such links as pharmacy, pharmacodynamics, toxicology and clinic application. The purpose of this article is to provide the reference in solving actual problems, the reliable basis of further researches on experienced prescriptions, and the important guarantee for developing more safe, effective and high-quality controllable drugs to meets clinical requirements, so as to achieve the strategy of a healthy China.

Research actuality and quality-influencing factor of Epimedii Folium / 中国中药杂志

Epimedii Folium has a long history in China as a common traditional Chinese medicine. Key factors of Epimedii Folium quality were summarized based on ancient literatures, Chinese Pharmacopoeias and modern research in different period of history. The main reason for unqualified Epimedii Folium is unstable icariin. Therefore, it's suggested that: the precondition of the quality control of epimedium is to find the proper quality marker. It's suggested that the medicinal parts should be reverted to "dry whole plant overground" to solve Epimedium resource shortage problem. In addition, it is necessary to strengthen the standardized cultivation, so as to ensure germplasm, production area, and producing method to guarantee the quality of Epimedium Folium. In the drying method, it is recommended to change "dry in the sun or shade" to "dry", namely dry in the sun, shade or drier, in order to provide a new method to improve the quality control and quality standard of Epimedii Folium.

Determination of eight heavy metals and two main ingredients of safflower planted in linzhi of Tibetan / 中国中药杂志

The eight heavy metals and two essential constitutes of safflowers planted in linzhi which lies in Southern Tibet were analyzed by ICP-MS and by HPLC respectively. Heavy metals of safflower in the region were at the lower level and the essential constitutes were at the higher level. The better quality of safflower here was assisted by the excellent climate in tibet.

The role of central nervous system on hypoglycemia and the feasibility of the brain theory in traditional Chinese medicine on treatment of diabetes mellitus / 中西医结合学报

The central nervous system (CNS) plays a key regulatory role in glucose homeostasis. In particular, the brain is important in initiating and coordinating protective counterregulatory responses when blood glucose levels fall. This may due to the metabolic dependency of the CNS on glucose, and protection of food supply to the brain. In healthy subjects, blood glucose is normally maintained within a relatively narrow range. Hypoglycemia in diabetic patients can increase the risk of complications, such as heart disease and diabetic peripheral neuropathy. The clinical research finds that the use of traditional Chinese medicine (TCM) has a positive effect on the treatment of hypoglycemia. Here the authors reviewed the current understanding of sensing and counterregulatory responses to hypoglycemia, and discuss combining traditional Chinese and Western medicine and the theory of iatrogenic hypoglycemia in diabetes treatment. Furthermore, the authors clarify the feasibility of treating hypoglycemia on the basis of TCM theory and CNS and have an insight on its clinical practice.

Problems in quality standard research of new traditional Chinese medicine compound / 中国中药杂志

The new traditional Chinese medicine compound is the main part of the research of new drug of traditional Chinese medicine (TCM), and the new Chinese herbal compound reflects the characteristics of TCM theory. The new traditional Chinese medicine compound quality standard research is one of the main content of pharmaceutical research, and is also the focus of the new medicine pharmaceutical evaluation content. Although in recent years the research level of new traditional Chinese medicine compound has been greatly improved, but the author during the review found still some common problems existing in new traditional Chinese medicine compound quality standard research data, this paper analyzed the current quality standards for new traditional Chinese medicine compound and the problems existing in the research data, respectively from measurement of the content of index selection, determine the scope of the content, and the quality standard design concept, the paper expounds developers need to concern. The quality of new traditional Chinese medicine compound quality standard is not only itself can be solved, but quality standards is to ensure the key and important content of product quality, improving the quality of products cannot do without quality standards. With the development of science and technology, on the basis of quality by design under the guidance of the concept, new traditional Chinese medicine compound quality standard system will be more scientific, systematic and perfect.

Problems in medicinal materials research of new traditional Chinese medicine / 中国中药杂志

Medicinal materials research and development of new drug of traditional Chinese medicine (TCM) research is the premise and foundation of new drug research and development, it throughout the whole process of new drug research. Medicinal materials research is one of the main content of the pharmaceutical research of new drug of TCM, and it is also the focus of the new medicine pharmaceutical evaluation content. This article through the analysis of the present problems existing in the development of TCM research of new drug of TCM, from medicine research concept, quality stability, quality standard, etc are expounded, including medicine research idea value medicine study should focus on the important role and from the purpose for the top-level design of new drug research problem. Medicinal materials quality stability should pay attention to the original, medicinal part, origin, processing, storage, planting (breeding), and other aspects. Aspect of quality standard of medicinal materials should pay attention to establish the quality standards of conform to the characteristics of new drug of TCM. As the instruction of TCM new drug research and development and the scientific nature of the review, and provide the basis for medicinal material standards.

Problems in preparation of toxic herbs in process of research and development of new traditional Chinese medicine of rheumatism, orthopedics and surgery / 中国中药杂志

This article emphasized the problems about toxic herbs in the process of research and development of new traditional Chinese medicine (TCM). It describe and explain what the researchers should pay attention to, such as processing, the usage and dosage, quality control of the toxic herbs, and chronic in toxicity trial, course of treatment, choice and detection of safe target in clinical trial about preparation of the new TCM. The goal is to lead the researchers to attach the importance of toxic herbs in the new TCM.

Research of origin and ethnopharmacological uses of mineral medicine Halitum / 中国中药杂志

<p><b>OBJECTIVE</b>To study the origin and ethnopharmacological uses of mineral medicine Halitum.</p><p><b>METHOD</b>The historical literature and results of the modern researches were searched and on-the-spot investigation was also carried out.</p><p><b>RESULT</b>The result showed that characteristics and function and uses of Halitum mentioned in historical literature and results of the modern researches were mostly coincident. However there were also some problems, which needed to explore further.</p><p><b>CONCLUSION</b>With the development of mineral materials research and utilization, Halitum sources should be defined more clearly and scientifically.</p>

Observation on therapeutic effect of acupuncture at "cervical three points" combined with cake-separated moxibustion on cervical hyperosteogeny / 中国针灸

<p><b>OBJECTIVE</b>To compare therapeutic effects of acupuncture at "cervical three points" combined with cake-separated moxibustion and routine acupuncture at Jiaji (EX-B 2) on cervical hyperosteogeny.</p><p><b>METHODS</b>Single blind, randomized and controlled methods were used and 91 cases were divided into an observation group of 46 cases and a control group of 45 cases. The observation group was treated by acupuncture at "cervical three points" combined with cake-separated moxibustion, i.e. acupuncture at Chonggu (EX), Dazhui (GV 14), Taodao (GV 13) and moxibustion at pain points with cake made by Rhizoma Atractylodis Macrocephalae and Radix Paeoniae Alba; the control group was treated with acupuncture at Jiaji (EX-B 2). Changes of sourness and pain of the neck, the shoulder and back, pressure pain and cervical activity scores were used for assessment of therapeutic effects.</p><p><b>RESULTS</b>The markedly cured rate of 76.1% in the observation group was better than 42.2% in the control group (P<0.05). After treatment, the scores of all the items were significantly improved in the two groups (all P<0.05), and the observation group in sourness and pain of the neck, the shoulder and back, and cervical activity were better than the control group (all P<0.05).</p><p><b>CONCLUSION</b>The therapeutic effect of acupuncture at "cervical three points" combined with cake-separated moxibustion on cervical hyperosteogeny is superior to routine acupuncture at Jiaji (EX-B 2).</p>

Studies on content determination and fingerprint of active constituents in different parts of cortex moutan / 中国中药杂志

<p><b>OBJECTIVE</b>To determine the chemical constituents in different parts of Cortex Moutan, which can provides evidences to the processing techniques of Cortex Moutan.</p><p><b>METHOD</b>The contents of paeonol, peoniflorin and fingerprints in different parts of Cortex Moutan were determined by HPLC.</p><p><b>RESULT</b>Compareed with phloem, paeonol in cork is twice as many, but paeonol in duramen is half as many peoniflorin in cork is half and four times as many, peoniflorin in duramen is twice as many, the contents of active ingredients in duramen are high in fingerprint.</p><p><b>CONCLUSION</b>If we only abandon the core, then we may get simple processings with the active ingredient contents increasing.</p>

Experimental study on effect of curcumin on inhibiting injury of free radical in pulmonary fibrosis rats / 中国中药杂志

<p><b>OBJECTIVE</b>To study on the effect and mechanism of curcumin on inhibiting injury induced by free radical in pulmonary fibrosis.</p><p><b>METHOD</b>One hundred and forty-four male SD rats were randomly divided into 6 groups (24 rats in each group). Rats in the model control group, positive medicine group, and high, moderate and low curcumin groups were injected with a single dose of bleomycin by trachea, and rats in sham-model control group with same volume normal saline. One day after the injection, curcumin solution of different dosages (200,100,50 mg x kg(-1) x d(-1)) was respectively given to rats in the high, moderate and low curcumin group by daily gastrogavage, while equal volume of normal saline was given to those in the sham-model control group and model control group, and an equal volume of prednisone (0.56 mg x kg(-1) x d(-1)) was saline was given to those in positive medicine control group. On the 7, 14, 28 days, the contents of GSH-Px, SOD, MDA and iNOS in pulmonary tissues of different groups were measured.</p><p><b>RESULT</b>Curcumin can raise the content of SOD and GSH-Px and lessen the level of MDA and iNOS.</p><p><b>CONCLUSION</b>Curcumin can regulate the level of free radical in the body of rats with pulmonary fibrosis and lessen the oxidative injury of pulmonary tissues caused by free radical, in the body of rats with pulmonary fibrosis. The mechanisms of curcumin on idiopathic pulmonary fibrosis lie in adjusting the level of free radical and inhibiting the injury of lung tissue induced by free radical.</p>

Experimental study on protective effects of curcumin on exaggerated extracellular matrix accumulation of pulmonary fibrosis rats / 中国中药杂志

<p><b>OBJECTIVE</b>To study the protective effects of curcumin on exaggerated extracellular matrix accumulation of pulmonary fibrosis rats.</p><p><b>METHOD</b>One hundred and forty-four male Sprague-Dawley rats were randomly divided into 6 groups (24 rats in each group). Rats in the model control group, positive medicine group, and high, moderate and low curcumin groups were injected with a single dose of bleomycin by trachea, and rats in sham-model control group with same volume normal saline. One day after the injection, curcumin solution of different dosages (200, 100, 50 mg x kg(-1) x d(-1)) was respectively given to rats in the high, moderate and low curcumin group daily by gastrogavage, while equal volume of normal saline was given to those in the sham-model control group and model control group, and an equal volume of prednisone (0.56 mg x kg(-1) x d(-1)) was given to those in positive medicine control group. On the 7, 14, 28 days, 8 rats per treatment group were randomly killed, the levels of III-collagen, IV-collagen, laminin and hyaluronic acid in the serum were determined, the determination of hydroxyproline in lung homogenates was analyzed, and the lung was incised to make pathological sections which were stained with HE and Mallory.</p><p><b>RESULT</b>Curcumin could decreas the levels of III-collagen, IV-collagen, laminin and hyaluronic acid in the serum, and inhihit the proliferation of fibrous tissue.</p><p><b>CONCLUSION</b>Curcumin may play its therapetuic role by leveling down the content of extracellular matrix in rats with pulmonary fibrosis induced by bleomycin.</p>

Mercury concentration in cerebrospinal fluid in patients with chronic mercury poisoning / 中华劳动卫生职业病杂志

<p><b>OBJECTIVE</b>To investigate the changes of mercury (Hg) levels in cerebrospinal fluid (CSF) in patients with chronic mercury poisoning and elucidate the neurotoxic mechanism of mercury.</p><p><b>METHODS</b>Nine patients with chronic mercury poisoning (poisoning group) as well as eight patients without exposure to mercury were included in this study. Mercury concentrations of 24 hour urine (U-Hg) and CSF (CSF-Hg) were measured with cold-vapor atomic absorption spectrometry-alkali stannous chloride method. The concentration of blood (B-Hg) at the same day was measured with cold-vapor atomic absorption spectrometry-acidic stannous chloride method. In five patients of poisoning group, these concentrations before chelation therapy were compared with those after chelation therapy.</p><p><b>RESULTS</b>The levels of B-Hg, U-Hg, and CSF-Hg in poisoning group (250.00 +/- 48.54, 160.07 +/- 91.15, 20.22 +/- 10.21 nmol/L, respectively) were significantly higher than those in control group (81.04 +/- 63.01, 24.73 +/- 9.96 nmol/L, undetectable, respectively; P < 0.01). In nine patients of poisoning group, CSF-Hg concentrations were correlated with B-Hg (r = 0.675, P < 0.05), but not U-Hg. After chelation therapy with dimercaptopropane sulfonate in five patients of poisoning group, the levels of B-Hg, U-Hg, and CSF-Hg were decreased significantly (P < 0.05). The reduction of CSF-Hg was not related with B-Hg and U-Hg.</p><p><b>CONCLUSION</b>CSF-Hg concentration in chronic mercury poisoning patient is increased with the rise of B-Hg, but not U-Hg. When the levels of B-Hg and U-Hg drop to normal, the CSF-Hg level is still high enough to be detected. It indicates that mercury is combined with protein after entering brain and this complex is difficult to cross through blood-cerebral barrier. The complex may cause neuromuscular disorder and fremitus in chronic mercury poisoning.</p>

Meta-analysis on acupoint sticking therapy for facial paralysis / 中国针灸

<p><b>OBJECTIVE</b>To evaluate the therapeutic effect and safety of acupoint sticking therapy for facial paralysis.</p><p><b>METHODS</b>Search the literatures in the whole paper databank of China figure medical library (Jan. 1994-Dec. 2004) and China Biomedical Literature Disk Databank (Jan. 1995-Dec. 2004). Meta-analysis was conducted with RevMan 4. 2. 5 software.</p><p><b>RESULTS</b>Sixteen controlled trials involving 2 157 patients were included. Meta-analysis indicated that there was high statistically difference between the acupoint sticking therapy and simple acupuncture therapy or Western medicine therapy.</p><p><b>CONCLUSION</b>The acupoint sticking therapy is effective and safe for facial paralysis.</p>