Chinese Herbal Medicine Products Research Articles

The Reutilization of Herbal Residues

How to dispose of herbal residues during the Chinese herbal medicine production and processing has become a problem that can not be ignored. This paper summarizes the way of reuse herbal residues in China, and discusses existing problem. Moreover, its suggested that Chinese Medicine enterprises should take road of sustainable development by rational utilization of herbal residues.

Establishing the Pharmaceutical Quality of Chinese Herbal Medicine: A Provisional BCS Classification

The Biopharmaceutical Classification System (BCS), which is a scientific approach to categorize active drug ingredient based on its solubility and intestinal permeability into one of the four classes, has been used to set the pharmaceutical quality standards for drug products in western society. However, it has received little attention in the area of Chinese herbal medicine (CHM). This is likely, in part, due to the presence of multiple active components as well as lack of standardization of CHM. In this report, we apply BCS classification to CHMs provisionally as a basis for establishing improved in vitro quality standards. Based on a top-200 drugs selling list in China, a total of 31 CHM products comprising 50 official active marker compounds (AMCs) were provisionally classified according to BCS. Information on AMC content and doses of these CHM products were retrieved from the Chinese Pharmacopoeia. BCS parameters including solubility and permeability of the AMCs were predicted in silico (ACD/Laboratories). A BCS classification of CHMs according to biopharmaceutical properties of their AMCs is demonstrated to be feasible in the current study and can be used to provide a minimum set of quality standards. Our provisional results showed that 44% of the included AMCs were classified as Class III (high solubility, low permeability), followed by Class II (26%), Class I (18%), and Class IV (12%). A similar trend was observed when CHMs were classified in accordance with the BCS class of AMCs. Most (45%) of the included CHMs were classified as Class III, followed by Class II (16%), Class I (10%), and Class IV (6%); whereas 23% of the CHMs were of mixed class due to the presence of multiple individual AMCs with different BCS classifications. Moreover, about 60% of the AMCs were classified as high-solubility compounds (Class I and Class III), suggesting an important role for an in vitro dissolution test in setting quality control standards ensuring consistent biopharmaceutical quality for the commercially available CHM products. That is, provisionally, more than half of the AMCs of the top-selling CHMs included in this study would be candidates for a bioequivalence (BE) biowaiver, based on WHO recommendations and EMEA guidelines. Thus a dissolution requirement on these AMCs would represent a significant advance in the pharmaceutical quality of CHM today.

Preparation and properties of several Chinese herbal residue/polylactic acid composites

Disposal of Chinese herbal residues (CHRs) during Chinese herbal medicine production and processing has become a problem that requires attention. In this study, CHRs were pretreated by steam explosion or pulverization and composites were prepared by mixing pretreated CHRs with polylactic acid. The mechanical properties of composites of CHRs pretreated by two different methods were compared, the main compositions of CHRs were analyzed, and the morphology of various CHRs and brittle fracture surfaces of composites were observed by scanning electron microscopy. The results show that the mechanical properties of the composites are closely related to the herbal species and pretreatment methods. The mechanical properties of CHR composites pretreated by steam explosion are superior to those pretreated by pulverization. Choosing CHRs with large fiber cell wall–lumen ratio, high lignin and cellulose contents, low contents of hetero cells and hemicellulose are helpful in making composites with good comprehensive performance.

A Chinese herbal medicine production of anxiolytic and cognitive enhancing effects in a rat model of posttraumatic stress disorder

Free and Easy Wanderer Plus (FEWP) is a traditional Chinese medicine that has been used to treat stress- and depression-related diseases in China. To study the effects of FEWP on post-traumatic stress disorder (PTSD), the present study investigated how chronic treatment with FEWP affected rodent behaviors in a modified single-prolonged stress and shock (SPS and S) model, which induces certain behavioral manifestations similar to those seen in PTSD patients. Locomotor activities (LMA), elevated Plus Maze (EPM), and Morris Water Maze (MWM) tests were used to determine its effects on general locomotion, anxiety and cognitive functions following traumatic exposure. The results showed that SPS and S impaired performance in MWM and produced anxiogenic-like effects in EPM, both of which were significantly ameliorated by chronic treatment of FEWP at doses of 5 and 10 mg/kg/d. The effects of FEWP were not due to changes in locomotion. The current findings provide strong evidence that FEWP may be a useful drug for treating PTSD. Key words: Single prolonged stress and shock, post-traumatic stress disorder, Morris water maze, open field, elevated plus maze.

Metal concentrations of Chinese herbal medicine products in the United States

SUMMARY We determined arsenic, lead, mercury and cadmium concentrations in Chinese herbal medicinessold in the United States by medical use parts. 54 kinds of herbal products including 9 medicaluse parts (radix, rhizoma, cortex, pericarpium, fructus, lignum, semen, folium, and herba) wereanalyzed using inductively coupled plasma-mass spectrometry for arsenic, lead and cadmium,and using mercury analyzer for mercury. Arsenic (median concentration, 0.25 mg/g), mercury(0.20 mg/g), lead (3.78 mg/g) and cadmium (0.39 mg/g) were detected in 71%, 54%, 35%, and18% of 143 herbal medicine samples, respectively. A total of 27% and 12% of 143 productsanalyzed contained mercury and cadmium above the regulatory standards. Herba and folium(leaves of herbal plants) were the most contaminated parts from metals, whereas pericarpium,lignum and semen (outer layers and seeds) were less contaminated. This study suggests thatmetal contamination is different by medical use parts. Our findings provide further evidence thatefforts to protect people using traditional remedies from metal intoxication should be made toenforce the regulatory standards.Key words: Chinese herbal medicine; Metals; Toxicity

Can Product‐by‐Process Patent Claims Provide Protection for Modernized Chinese Herbal Medicine?

The rising importance of Chinese herbal medicine (CHM) in alleviating human suffering has created a potential niche for East Asian countries in the profitable global pharmaceutical market. However, modern CHM that involves modern biomedical technologies presents new issues regarding the proper degree and methods of protection that apply to these products or inventions. Pharmaceutical industries most commonly seek patent protection, which offers different types of protections for different types of inventions. This article explores whether product‐by‐process patent claims provide proper protection to CHM product inventions and the likely implications of such an approach. It concludes that product‐by‐process patent claims may offer proper protection for CHM product inventions at the current status quo but might be an inadequate approach when the industry matures in the future.

The analysis of heavy metals in Chinese herbal medicine by flow injection–mercury hydride system and graphite furnace atomic absorption spectrometry

Simple and robust atomic absorption spectrometry (AAS) analytical methods were developed to determine the contents of arsenic (As), lead (Pb) and mercury (Hg) contained in Chinese herbal medicine products or Chinese proprietary medicine. To develop AAS analytical methods to determine the contents of the toxic heavy metals in herbal medicine, and thus monitor them according to the regulated content limits to ensure the quality and safety of herbal products. A flow injection-mercury hydride system technique was used for the quantitation of As and Hg, and a graphite furnace technique was used for the analysis of Pb. Limits of detection (LOD) for the three toxic heavy metals were found to be 0.3 ppb for As, 0.1 ppb for Pb and 0.5 ppb for Hg. Eight samples of 'Yin Qiao Jie Du' tablets available on the market were selected as the model herbal medicine for analysis. The developed analytical methods are sensitive enough to detect these heavy metals to meet regulated guidelines. No trace amounts of Hg were found in the test samples due to the fact that the Hg level is less than the LOD. However, variable amounts of As (135.0-5349.3 ppb) and Pb (22.5-968.3 ppb) were found in all products.

Patent Protection for Chinese Herbal Medicine Product Invention in Taiwan

Taiwan has aimed to develop a local Chinese herbal medicine (CHM) industry targeting the global market. The main patent issues concern whether the inventions constitute patentable subject matter, and their patentability. Currently, it is difficult for CHM inventions to comply with patent standards developed in conjunction with the Western pharmaceutical industry. Despite its increasing prominence, thus far, Taiwan is the only country in the world to address specifically the characteristics of herbal medicines. Based on examining currently available literature and conducting interviews with patent examiners and CHM professors in Taiwan, this article compares CHM with Western and indigenous medicines. This article assesses the inefficiencies of the current patent law and explains the necessity for the new examination guideline. It is concluded that this new examination guideline will meet the needs of the CHM industry.

Improving the quality of randomized controlled trials in Chinese herbal medicine, Part Ⅲ: quality control of Chinese herbal medicine used in randomize

To discuss quality control of Chinese herbal medicine (CHM) in randomized controlled trials (RCTs), and to provide suggestions for improving this aspect in future clinical study in this therapeutic area. A search of the Cochrane Library was conducted to identify RCTs of CHM. Quality control information reported in those RCTs was then assessed independently. The search yielded a total of 167 RCTs of CHM for a variety of conditions. A total of 11 CHM preparations were used in those RCTs. Only one trial discussed quality control of the CHM interventions used. Issues affecting the safety and efficacy of CHM products used in RCTs were discussed including standardization of raw herbal materials, processing methods, screening for product contamination, and effects of combination products. The overall quality of reporting of RCTs of CHM was poor, reflecting the need for improvements in reporting future clinical trials in this area. To improve quality control of CHM used in RCTs in future, we recommend developing and implementing guidelines such as Good Agricultural Practice (GAP) for Chinese crude drugs, and current Good Manufacturing Practice (GMP) specific to CHM products. Chemical analyses of individual herbs of CHM and combination products are also recommended to provide reference standards for quality control.