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05 October 2017, Volume 2 Issue 4 Previous Issue    Next Issue
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Special Issue of Modern Chinese Herb
News and Comments: Have Phase Ⅲ clinical trials of Compound Danshen Dripping Pill “tragically failed”?
Cui-Hong Zhu, Xiong-Zhi Wu
Traditional Medicine Research. 2017, 2 (4)  
Abstract ( 604 )     PDF (232KB) ( 264 )  

Have Phase Ⅲ clinical trials of Compound Danshen Dripping Pill “tragically failed”?

Compound Danshen Dripping Pill (CDDP) is the traditional Chinese medicine that has been widely used in China for the treatment of diseases such as coronary heart disease, stenocardia, and myocardial ischemia. The application of the pills was submitted to the USA Food and Drug Administration (FDA) in 1997. It was also the first TCM to enter phase III clinical trials by the FDA. However, news about the failure of the phase III clinical trials of CDDP was recently reported.

   Lian-Da Li, a Chinese medicine pharmacology expert and an academician of the Chinese Academy of Engineering, pointed out that the phase III clinical trials of CDDP had tragically failed and described the heavy losses and painful lessons experienced. He also analyzed the four major causes of the failure. Soon, these remarks were shared. Tasly Pharmaceutical Group Limited immediately issued a notice to respond, which declared that the statistical results of the clinical trials (P = 0.06) did not meet the requirements stipulated in the phase III clinical scheme. However, the phase Ⅲ clinical trials of CDDP are not completed, but the remarks of Lian-Da Li are contrary to the fact. Tasly will continue to discuss with the FDA and obtain permission to add a 6-week confirmatory test to meet the application requirements of the FDA.

   Some insiders disagreed with Lian-Da Li’s actions; they believed that in drug development, a failure for anyone is a failure for everyone. It is important to provide encouragement, rather than to “kick a man when he is down”.

   This special issue of Modern Chinese Herb will focus on the latest research on the efficacy and safety of traditional Chinese medicine.

The role of Chinese herb in the treatment of disease: Science Fiction or Fact?

The clinical efficacy and safety of proprietary Chinese herb has become a huge concern to the public. There are still many weak points in this field, which makes post-marketing reappraisal necessary. The editorial by Ran Tian et al. introduced a new concept, “Precise proprietary Chinese medicine”, with six detailed steps to facilitate the post-marketing reappraisal. The insight provided by the authors is unique and novel. Ganduqing Granule is an approved natural traditional Chinese medicine in China (approved No. 2000-009). Mei Wei et al. discovered that Ganduqing Granule could balance the metabolic disorders related to lipids and bile acids as well as relieve oxidative stress in patients with chronic hepatitis B, which will help conduct the post-marketing reappraisal of Ganduqing Granule.

   Danchai formula was obtained from Danzhixiaoyao powder, which was first recorded in Neikezhaiyao in the Ming Dynasty of China (1368 A.D. - 1644 A.D.). This formula can be used to treat excessive immune response-related diseases, including immune rejection after organ transplantation, autoimmune diseases, and hypersensitivity.

   Tujinpi (Cortex Pseudolaricis) is obtained from the root bark of the pine plant Jinqiansong, a rare tree found only in China, which has been used in the treatment of eczema and fungal skin infections for centuries. The article by Yi-Teng Wang et al. presented the role of pseudolaric acid B isolated from Tujinpi in the amelioration of 2,4-dinitrofluorobenzene-induced atopic dermatitis-like skin lesions via the inhibition of the NLRP3 inflammasome. Different chemical compositions of plant-based medicine have different biological benefits in the human body. Dr. Dong and co-workers collected recent literature concerning Yuxingcao (Houttuynia cordata Thunb) and summarized the natural ingredients isolated from Yuxingcao, including composition, structure, and classification at the molecular level, through an evidence-based study. This was helpful to explain the anti-oxidant, anti-inflammatory, anti-bacterial, anti-viral and anti-cancer effects from the molecular target and molecular network levels. However, how to extract the compound efficiently and maintain the activity from natural medicine is a key for the modernization of Chinese medicine. Nan Nan et al. discussed various extraction methods for Gekko sulfated glycopeptide.

   We hope that this issue will stimulate the readers to conduct further studies in the field of Chinese herb. The editor kindly thanks the authors for their manuscripts contributions to this special issue.


Xiong-Zhi Wu

Editor Group of TMR

 

Post-marketing Reappraisal
How to establish precise proprietary Chinese medicine in post-marketing reappraisal?
Tian Ran, Dai Liang, Shang Hong-Cai, Li You-Ping, Bian Zhao-Xiang
Traditional Medicine Research. 2017, 2 (4): 155-160.   https://doi.org/10.12032/TMR201708054
Abstract ( 435 )   HTML ( 48 )     PDF (313KB) ( 276 )  

Highlights

This paper introduced a new concept “precise proprietary Chinese medicine” with six detailed steps to facilitate the post-marketing reappraisal.

Editor’s Summary

The post-marketing reappraisal of Chinese medicine is a systematic project rather than a pile of simply isolated research about the drug efficacy and safety.

Abstract

The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern. The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine. In this paper, we propose a reappraisal protocol called “precise proprietary Chinese medicine” to precisely i) define the therapeutic aim; ii) design the protocol; iii) control the quality of proprietary Chinese medicine; iv) implement the protocol in the trial; v) study the mechanism-of-action of the proprietary Chinese medicine and vi) describe the indications of the proprietary Chinese medicine. We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.

Effect of Ganduqing Granule on metabolic disorder and liver dysfunction in patients with chronic hepatitis B
Liu You-Ping, Li Bo, Wang Xiao-Dong, Mi Shao-Ping, Liu En-Ze, Wei Mei
Traditional Medicine Research. 2017, 2 (4): 161-168.   https://doi.org/10.12032/TMR201708055
Abstract ( 524 )   HTML ( 17 )     PDF (513KB) ( 286 )  

Highlights

Ganduqing Granule could adjust the metabolic disorder of lipids, bile acids, and relieve the oxidative stress in patients with chronic hepatitis B.

Editor’s Summary

Ganduqing Granule is an approved natural traditional Chinese medicine compound for hepatitis in China (Approved No. 2000-009).

Abstract

Objective: This study investigated the potential mechanisms of Ganduqing Granule (GDQG) in improving the liver function in patients with chronic hepatitis B (CHB). Methods: Plasma samples from 30 healthy volunteers and 30 patients with CHB before and after the treatment with GDQG were measured for the alterations in liver function and metabolites, using the method of ultra-high-performance liquid chromatography coupled with time-of-flight mass spectrometry. Results: Patients with CHB developed severe liver dysfunction, which was associated with the higher plasma levels of 8 metabolites when compared with those of the normal control (P < 0.05). Interestingly, after treatment with GDQG for 3 weeks, the 8 metabolites were significantly reduced (P < 0.05). Among them, glycochenodeoxycholate-3-sulfate, glycochenodeoxycholic acid-3-glucuronide, taurochenodeoxycholic acid, and 7b-hydroxy-3-oxo-5b-cholanoic acid were associated with the metabolism of bile acids, while 3b, 16a-dihydroxyandrostenone sulfate, lysophosphatidylcholine (C18:3), and lysophosphatidylethanolamine (C22:1) were related to the metabolism of lipids. 2,6-Diamino-4-hydroxy-5-N-methylformamidopyrimidine was related to hepatic oxidative stress. Meanwhile, liver damage in patients was greatly reduced. Conclusion: Treatment with GDQG has improved liver function of patients with CHB through the possible mechanism of adjusting the metabolic disorders related to lipids, bile acids, and oxidative stress.

Ethnic and Regional Medicine
Pseudolaric acid B extracted from the Chinese medicinal herb Cortex Pseudolaricis ameliorates DNFB-induced atopic dermatitis-like skin lesions in BALB/c mice
Wang Yi-Teng, Zhang Min, Liu Mei-Lun, Zhang Li-Ming, Chen Hong, Li Tan
Traditional Medicine Research. 2017, 2 (4): 169-175.   https://doi.org/10.12032/TMR201708056
Abstract ( 541 )   HTML ( 14 )     PDF (498KB) ( 321 )  

Highlights

Pseudolaric acid B significantly ameliorated the development of atopic dermatitis-like clinical symptoms and effectively suppressed the infiltration of inflammatory cells by inhibiting the expression of the NLRP3 in?ammasome and IL-1β in skin lesions, and downregulating serum IgE levels.

Editor’s Summary

Tujinpi (Cortex Pseudolaricis) is obtained from the root bark of the pine plant Jinqiansong, a rare tree that is only found in China. It was first recorded in Bencaogangmushiyi published in 1765 A.D. (Qing Dynasty of China).

Abstract

Objective: Pseudolaric acid B (PB) is a newly identified diterpenoid isolated from Tujinpi (Cortex Pseudolaricis). In the present study, we aimed to explore the anti-inflammatory effects of PB on atopic dermatitis (AD), as well as the molecular mechanisms underlying its effects. Methods: BALB/c mice treated with 2,4-dinitrofluorobenzene were orally administered with PB (10 mg?kg-1?d-1). After evaluating the AD score, serum levels of IgE and the mRNA expression of NLRP3 inflammasome and IL-1β were measured by ELISA and qRT-PCR respectively. Results: The results showed that PB treatment significantly ameliorated the development of AD-like clinical symptoms and effectively suppressed the infiltration of inflammatory cells. Furthermore, PB inhibited the expression of NLRP3 in?ammasome and IL-1β in skin lesions, and downregulated serum IgE levels. Conclusion: The anti-inflammatory properties of PB were demonstrated using the 2,4-dinitrofluorobenzene-induced mouse model of AD-like skin lesions. Our study highlighted the potential use of PB as a novel therapeutic agent for the treatment of inflammation-associated skin diseases.

Modernization of Traditional Medicine
Systematic analysis of components and contents in Houttuynia cordata Thunb
Dong Xin-Yi, Jin Yi, Yang Li-Ping
Traditional Medicine Research. 2017, 2 (4): 176-188.   https://doi.org/10.12032/TMR201708053
Abstract ( 726 )   HTML ( 12 )     PDF (3391KB) ( 371 )  

Highlights

This study provided a basis for further study on molecular mechanisms of anti-bacterial, anti- inflammatory and anti-oxidant effects of Yuxingcao (Houttuynia cordata Thunb).

Editor’s Summary

Yuxingcao (Houttuynia cordata Thunb, HCT) was first recorded as herb in Mingyibielu, which was published in the third century A.D. (Han Dynasty of China). This study is helpful to explain the anti-infectious mechanism of HCT from the molecular network levels of anti-bacteria, anti- inflammation and anti-oxidant.

Abstract

Objective: This study aims to provide the material basis for the molecular mechanism of Yuxingcao (Houttuynia cordata Thunb, HCT) through the method of evidence-based study to summarize the natural constituents isolated from HCT. Methods: We searched CNKI, Wanfang, VIP, Pubmed and relevant conference compilations. The keywords were “Yuxingcao or Houttuynia cordata Thunb” and “components” or “ingredients” or “constituent” or “volatile oil” or “flavonoids” or “terpene” or “content”, both in Chinese and English. According to the inclusion and exclusion criteria, the reported compositions and contents have been summarized, and SPSS software was used to draw the boxplot of contents. Results: A total of 603 natural compounds in 11 categories were obtained from pooled articles. In the diverse components, the number of aliphatic compounds (n = 259) and terpenoids (n = 158) are more than those of flavonoids (n = 26), alkaloids (n = 42) and aromatics (n = 42). While, in the part of volatile oils of HCT, the largest components are aliphatic compounds (mainly distributed on the ground) and terpenoids (mainly distributed in the underground). Although, methyl n-nonylketone is distributed in the whole herb plant, a large proportion is present in the underground parts. As for non-volatiles, the flavonoid content (mainly distributed on the ground) was the highest, among which quercetin and its glycosyl derivatives were the prominent. Conclusion: The results of this study provide a more comprehensive material basis for the further study of HCT. It is also helpful to explain the mechanisms of anti-oxidant, anti-inflammatory, anti-bacterial, anti-viral and anti-cancer effects from the molecular target and molecular network levels.

Optimized extraction and purification technology of Gekko sulfated glycopeptide based on its anticancer activities
Nan Nan, Liu Chang, Xu Jing, Meng Li-Na, Liu Xiao-Hui, Wu Xiong-Zhi, Chen Dan, Zhou Jing
Traditional Medicine Research. 2017, 2 (4): 189-197.   https://doi.org/10.12032/TMR201708057
Abstract ( 377 )   HTML ( 7 )     PDF (378KB) ( 249 )  

Highlights

The best extraction method of Gekko sulfated glycopeptide is water extraction. The optimal deproteinization method is an enzymatic hydrolysis- trichloroacetic acid method.

Editor’s Summary

Gekko was first mentioned for eliminating stagnation in Bencaogangmu, which was published in 1578 A.D. (Ming Dynasty of China).

Abstract

Objective: To optimize the extraction and purification technologies of Gekko sulfated glycopeptide based on the content of glycopeptide, removal ratio of proteins, and anticancer activities. Methods: Different extraction methods, namely, water extraction, ultrasonic extraction, enzymatic hydrolysis-water extraction, and enzymatic hydrolysis-ultrasonic extraction were considered to determine the best extraction method. Single factor and orthogonal experiments were performed to determine the optimum extracting conditions. Sevage, enzymatic hydrolysis-Sevage, trichloroacetic acid (TCA), TCA-Sevage and enzymatic hydrolysis-TCA methods were tested to determine the best deproteinization method. The glycopeptide content and protein removal ratio were analyzed by the phenol-sulfuric acid and Coomassie Brilliant Blue methods. Results: Gekko sulfated glycopeptide obtained by water extraction could inhibit the proliferation of HepG2 and SKBR3, as well as promote that of lymphocytes. The glycopeptide content was 4.049% in the optimal extracting condition of a triple decoction extraction for 1 hour each time with a material to solvent ratio of 1:15. The enzymatic hydrolysis-TCA method was found to be the optimal deproteinization method, with a protein removal ratio of 50.46%, glycopeptide content of 14.27%, and inhibitory ratio on human HepG2 cells of 49.06%. Conclusion: This extraction and purification technique for Gekko sulfated glycopeptide is reasonable, feasible, and provides a scientific basis for industrial production.

Empirical Formula Research
Effects of Danchai formula on regulation of immunologic function
Chen Dan
Traditional Medicine Research. 2017, 2 (4): 198-201.   https://doi.org/10.12032/TMR201708058
Abstract ( 361 )   HTML ( 8 )     PDF (422KB) ( 289 )  

Highlights

Danchai formula can be used to treat excessive immune response-related diseases, including immune rejection after organ transplantation, autoimmune diseases, and hypersensitivity.

Editor’s Summary

Danchai formula was obtained from Danzhixiaoyao powder, which was first recorded in Neikezhaiyao in the Ming Dynasty of China (1368 A.D. - 1644 A.D.) and used to disperse stagnated liver Qi and clear heat, as well as invigorate the spleen and nourish the blood.

Abstract

The traditional formula of Danchai was provided by associate professor Dan Chen of Tianjin Medical University, which consisted of Chaihu (Radix Bupleuri) 9 g, Baishao (Radix Paeoniae Alba) 9 g, Yujin (Radix Curcumae) 30 g, Mudanpi (Cortex moutan Radicis) 9 g, and Gancao (Radix glycyrrhizae) 6 g. After soaking in water for 20 min, the herbs were decocted with medium heat to boiling and for 15 min with low heat. The liquid was poured out and decocted again by adding water. The decoction is mixed and consumed orally 30 min after meals, twice per day. Danchai formula can be used to treat excessive immune response-related diseases, including immune rejection after organ transplantation, autoimmune diseases, and hypersensitivity.

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