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Volume 10, Issue 1, February 2008 Online English edition of the Chinese language journal Cite this article as: Mode Tradit Chin Med Mater Med, 2008, 10(1): 91–96
REVIEW
Overview on External Contamination Sources in Traditional Chinese Medicines
;XH-LDQ /LX'RQJMLQJ&KHQ6KLOLQ/LDR
Abstract: External contamination sources (pesticide residues, heavy metals, solvent residues, and aflatoxin) and measurements and restriction standards that were published in previous studies, along with the authors’ data were analyzed. It was found that the key to addressing the contamination is to place contamination source under control using mandatory standards. Key Words: Traditional Chinese medicines, pesticide residues, heavy metals, solvent residues, contamination control
1
Introduction
The traditional Chinese medicines (TCMs) are one part of the outstanding cultural heritages of China. TCMs have been contributing immensely to the disease prevention, cure, and health protection of people for thousands of years. To date, in the research of many important, complicated, and/or senile diseases with respect to nutrition and health, TCMs have been attracting increasing attention all over the world. With the large extent of Chinese medicines being used in foreign countries, safety in using these medicines has been paid corresponding attention. On one hand, the so-called "toxicity" issues have been exposed to the public frequently. On the other hand, other potential safety risks, such as the harmful pollutants, have also been given great attention, and these risks have posed as barriers in the export trade. The safety of the TCMs has become one of the important handicaps in the export trade, and it restricts the development and the internationalization of these medicines. With great attention having been paid to the safety of TCMs in the cure and health protection, there are many new understandings and stricter requirements on all the contaminated toxins in these traditional medicines. Corresponding to these requirements, the standards of the various techniques are becoming stricter. The pollutants in the TCMs face more challenges. Therefore, it is of utmost importance to strengthen the study of the exogenous pollutants in the medicines to ensure people's safety during medication and to promote the development of the international trade. This article will discuss and analyze the relative researches in the following aspects.
2 Current situation of the exogenous pollutants in TCMs The contamination in the medicines is the exogenous harmful substance that can be introduced in the whole
process, from the growth of the herbs and plants to the final procedure. The pollutants include residual pesticides, heavy metals, SO2 or other fumigants when processing or storage, Mold pollution by its toxins, organic solvent residues, and the printing ink that can also pollute the medicines when packing. Growth hormones and antibiotics that are absorbed during the breeding of the animal medicines with some illegally used adjuvant and additives, the adulteration in the TCMs, and the chemical components added illegally to the TCMs. All of them, which have become the potential safety risk in the production of the TCMs, should be strictly controlled and managed. At present, the pesticide residues, the heavy metals, mycotoxin, SO2, and organic solvents are the main pollutants in the TCMs and will be discussed in this article. 2.1 Pesticide residues in TCMs First, the pesticide residues in the TCMs, on one hand, are ingested from the growing environment of the herbs; on the other hand, these residues exist because of the abuse of the pesticides, such as using an overdose of the chemical pesticides, use of prohibited pesticides, and so on. Second, using the pesticides during storage, and fumigating with SO2 when preserving these medicines as prevention against insects and mildewing are also ways in which contamination occurs. Third, the use of adjuvant during processing is another reason for the pesticide contamination. The contamination of the pesticide residues is universal. The pesticide residues can be nearly detected in all the samples, among the residues, the detection rates of the organochlorine are high [1,2]. Shanghai College of Traditional Chinese Medicine did a general investigation on the pesticide residues in 300 kinds of TCMs [3]. The results showed that all the samples had the hexachlorocyclohexanes (BHC) residues. When comparing with herb medicine, the pesticide residues in the Chinese patent
Received date: 7 September 2007 * Corresponding author. Tel: +86-10-62895076; E-mail:
[email protected] Foundation item: Supported by the Ministry of Science and Technology of the People's Republic of China (No.2004DIB1J039) Copyright © 2008, World Science and Technology Press. Published by Elsevier BV. All rights reserved.
Xue Jian et al. / Mode Tradit Chin Med Mater Med, 2008, 10(1), 91-96
medicine is very low; some Chinese patent medicine such as the Ganoderma spore powder capsules, had been detected with 0.35 mgkg-1 of BHC residues. The reason is that there are a large amount of the pesticide residues in the rude medicine, but there are no suitable processes for extracting them. Because of the biological chain accumulation, some animal medicines may contain more residual pesticides, such as the Hirudo that had been detected with 0.45 mg·kg-1 of dichloro-diphenyl-trichloroethane (DDT) residues [4]. Others, such as the organophosphorus and carbamate pesticides, because of the unstable ester bond in their chemical structures, and the residual period being shorter, they can be easily degraded. Therefore, these pesticides can be scarcely detected in the TCMs. The distribution of the pesticides in the medicinal plant varies according to the origins, the kind of the medicine, and medicinal parts. For the underground parts, the chance of being contaminated is very large [5]. Statistical analysis showed that the total BHC, DDT, and pentachloronitrobenzene (PCNB) residues in a relatively large number of samples of the American ginseng, Radix ginseng [6], Radix Notoginseng, and so on, exceeds 0.1 mg·kg-1. The contamination of the SO2 can be found in those TCMs that can be easily ruined by the insects or whose color turns dark. It was reported in one article that in the samples of the Rhizoma Gastrodiae, 0.56 mg·kg-1 of the SO2 was detected [7]. 2.2 Heavy metals contamination in TCMs One reason for the heavy metals contamination in TCMs is the environment (including atmosphere, soil, and water background), another reason is the course of collection, transporting, and processing. The heavy metals contamination also has something to do with the medicinal plants inherit characteristics, their active absorption function, and the enriching ability of the heavy metals [8]. But some traditional Chinese mineral medicines contain some heavy metal elements, such as Lithargyrum containing Pb, Cinnabaris containing Hg, and Realgar containing As. If used in prescriptions, they can cause the heavy metals to exceed the limited standard in the body, but all of these are for special use. According to Chinese medical science theory, this method of using is called Poisonous Drugs Treating Poisoning. The specific researches on the mechanism and the toxicology should be done, but it is beyond the scope of the discussion of the heavy metal contamination in this article. In China, some of the TCMs were contaminated by the heavy metals. For example, in the determination of heavy metal elements in five beneficial TCMs [9], the content of the Pb in part of the Radix Codonopsis samples is 83.1 mg·kg-1, the As in the Radix Angelicae Sinensis is 23.5 mg·kg-1; all of them exceeds the standard limits prescribed in the pharmacopeia. The distributions of the heavy metals in the TCMs are different. For instance, the Spica Prunellae [10] contains Pb, Cd, Hg and As, and the leaves are seriously contaminated by Pb and Hg, but the roots contain
more Cd. In the Concha Ostreae, the main heavy metal contamination is Cd [11], in the Pheretima asiatica it is As and Pb [12]. Because Hirudo grows in water, it can be contaminated by many heavy metals and pesticide residues [13]. But some Scorpio samples are seriously contaminated by Hg [14]. 2.3 Mycotoxin contamination in TCMs First, the TCMs contaminated by mycotoxin are mainly relevant to the species and habitat. The TCMs that are rich in oil or tend to mold, such as coix lacryma-jobi, Fructus Alpiniae Oxyphyllae, Semen Platycladi, and so on, can be easily contaminated. Second, the mycotoxin contamination is relevant to the dosage form. For example, as Qu requires fermentation, it is easy to mold. Third, because the herbs are not processed or dried in time or are preserved improperly, they mold. There are many kinds of mycotoxin, such as fusarial toxin, aflatoxins, ochratoxin, citreoviridin, penicillic acid, and so on. Among them, the aflatoxins are more extensive and most poisonous. Therefore, significant studies on the aflatoxins are being made in recent years. The TCMs are contaminated by the aflatoxins in varying degrees. It was reported that in the determination of the aflatoxins in the seven kinds of TCMs [15], the results showed the massa medicata fermentata and its preparations Yueju Baohe Wan and Feier Pian had been seriously contaminated by the aflatoxins. The content of the aflatoxins in massa medicata fermentata is 0.2 mg·kg-1. There was another report in Korea about the determination of the 85 kinds of nuts, the results were that there were 31 kinds of nuts that exceed the standard limits [16]. 2.4 Organic solvents residues in TCMs During the processing of the traditional Chinese medicinal herbals or the preparations, such as the extraction of the effective constituents, organic solvents are unavoidably used. There will be a few organic solvents residues in the extract, similar to macroporous resins [17]. Therefore, the chance of the organic solvents residues in the extraction TCMs will be much greater than no extraction’s. Moreover, because of the requirement of the form of medication, the organic solvents are introduced in the production during the processing of the TCMs [18]. The wrapping of the TCMs can bring many conveniences for transport and storage; at the same time it can also bring peculiar foreign matters, such as the organic solvents, printing ink, and so on, which can be diffused or absorbed in the surface of the TCMs during the storage to become potential risks [19]. At present, numerous articles [20, 21] reported the researches on the organic solvents in the synthetic medicines and their raw material. But concerning organic solvents residues in the TCMs and the preparation reports are relatively fewer; they only determine organic solvent residues in few TCMs, such as the Radix Bupleuri Soft Capsules [22] and Andrographolide Microcapsules[18].
Xue Jian et al. / Mode Tradit Chin Med Mater Med, 2008, 10(1), 91-96
In addition, if using the macroporous adsorptive resins, the temporary residues detected should include benzene, methylbenzene, dimethyl benzene, benzene vinyl, diolefine, and diethylbenzene (diethyl).
3 Determination method of exogenous pollutants in TCMs For the determination of these pollutants, the following techniques are applied For analysis of pesticide residues, gas chromatography (GC), gas chromatography–mass spectrometry technique (GC-MS), and the liquid chromatography-multimass spectrometry (LC-MS-MS) techniques are mainly used; For the analysis of heavy metals, the atomic absorption spectrum (AAS) and the inductively coupled plasma mass spectrometry (ICP-MS) techniques are mainly used; For the determination of aflatoxins the high-performance liquid chromatography (HPLC) and the liquid chromatography-multimass spectrometry (LC-MSMS) techniques are mainly used; Finally for the determination of organic solvent residues, the gas chromatography (GC) and the gas chromatography-mass spectrometry technique (GC-MS) are mainly used. All of these appliances are available in the institutes in China. For the determination of pollutants in samples of foodstuff, fruits, water resources, and geology, there are also many mature methods that can be referred to. There are many related articles, therefore, the problems in the determination can be solved easily. But concerning TCMs, their samples are more complicated than other ordinary samples. Therefore, the research on the preprocessing before the determination should be strongly emphasized. Although there are many advanced equipments, if the pollutants cannot be extracted totally or the samples contain many interferential foreign matters, the accuracy of the results will be seriously affected. According to the domestic related article, it can be found that the articles on the methods of research are mainly the repeat of the current experiments. On the contrary, the studies on the analysis on the specific kind of the TCMs are rare. For example, the standards on the limits of the organochlorine pesticides in the Chinese Pharmacopeia (2005 edition) only regulate the Radix Glycyrrhizae and Radix Astragali; it means that the assay method is only suitable for these two TCMs. It is impossible to use the method in all the TCMs. The authors of this study did a contrasting study on the application of the method in certain animal medicines and some medicines that contain lipin; the results showed 30̣ 50% lower readings. Therefore, the researches on the determination of the pollutants, especially on pesticide residues and the aflatoxins, should aim at the different kinds of TCMs according to their characteristics, texture, the content of fat and water, the kinds of the secondary metabolites and the
characteristics of the pollutants. This is followed with systemic and in-depth studies on them. Only in this manner can one find the most suitable methods to avoid the incidents that the TCMs are qualified for domestic use but disqualified for export (sometimes the reason is that the standard of limits is different).
4 Limited standards of the exogenous pollutants in TCMs On one hand, the phenomenon that some pollutants seriously contaminate the TCM, is owing to the people's significant lack of precautionary that can be taken during the production processing of the TCMs, on the other hand, it is also owing to the lack of the complete related standards. The following (Table) are the related standards of the TCMs in China and abroad. There are no conclusive standards of limits of the aflatoxins in TCMs in China. The permissive standards of the aflatoxins in foods such as the corn, peanut oil, peanut and its preparations, cannot exceed 20 mg·kg-1; in rice and other vegetable oils, aflatoxins cannot exceed 10 mg·kg-1, in other foodstuffs such as beans and fermented food, it cannot exceed 5 mg·kg-1. Aflatoxins should not be found in baby milk substitute food. Standards of limits for organic solvent residues are not mentioned in the Chinese Pharmacopeia (Part I), but in the datum of the new drug approval in China, the standards of limits of the organic residues such as the benzene, methylbenzene, dimethyl benzene, benzene vinyl, diolefine and diethylbenzene(diethyl) cannot exceed the national standard in China or the general international standards. Moreover, the standards of limits of the residual organic solvents in the American Pharmacopeia and Japanese Pharmacopoeia are consistent with the regulation in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). According to the Table, it can be concluded that compared with the developed countries, the formulation of standards of limits of the pollutants in the TCMs in China is later. For this reason, it failed to keep pace with the requirements of the development. The main differences are that the total number of the standards of limits is inadequate, only a few types of pollutants are covered, and the kinds of the pesticides that have been regulated by the standards are few. Therefore, they cannot form a system. The herbal medicine standards of the European Union have covered all kinds of pollutants. The Japanese Pharmacopoeia not only regulates the standards of limits of the pesticide residues in the TCMs, but it also regulates the applicability of the types of TCMs. In contrast, only 9–10 kinds of organochlorine pesticides and five kinds of heavy metals were regulated in the Chinese Pharmacopoeia
Xue Jian et al. / Mode Tradit Chin Med Mater Med, 2008, 10(1), 91-96
Table
Maximum limited standards of heavy metals and the pesticide residues in different regions (mg·kg-1)
Pollutant
ChP1
Total heavy metals
WM/T 2-20042
Hong Kong
20.0
Korea4
Singapore5
30.0
US codex
JP3
10-20
Pb
5.0
5.0
5.0
5.0
20.0
As
2.0
2.0
2.0
3.0
5.0
3.0
Hg
0.2
0.2
0.2
0.2
0.5
3.0
Cd
0.3
0.3
0.3
0.3
5.0
Cu
20.0
2.0
0.2
0.1
0.3
0.2
Total BHC
Europe codex6
20.0 2.0
150.0 0.3
0.3
0.2 0.2
Total DDT
0.2
0.1
1.0
0.1
1.0
1.0
PNCB
0.1
0.1
1.0
0.1
1.0
1.0
Parathion
0.5
0.5
0.5
Methyl parathion
0.2
0.2
0.2
Methidathion
0.2
0.2
0.2
Malathion
1.0
1.0
Fenvalerate
1.5
1.5
1.0
1.0
Cypermethrin Lindane
0.6
Endrin
0.05
0.6
Pyrethrin
3.0
Dieldrin
3.0
0.01
HCB
0.1
Heptachlor
0.05
Chlordan
0.05
Aflatoxin Dichloromethane
0.6 0.05
0.005 600
Ethylene glycol 1,2-ethylene chloride
0.020
0.002
600
600
620
620
5.0
1,1-ethylene chloride
8.0
Trichloroethane
1500
5.0 8.0 1500
Methanol
3000
3000
Dimethyl benzene
2170
2170
Chloroform
60
N-hexane Methylbenzene
890
Benzene
2.0
Carbon tetrachloride
60
60
290
290
890
890
2.0
2.0
4.0
4.0
Notes: 1.
In the Chinese Pharmacopoeia, the standards of limits only specify Radix Astragali and Radix Glycyrrhizae, and the five heavy metals are only specified for six TCMs that are: Radix Glycyrrhizae, Radix Astragali, Radix Salviae Miltiorrhizae, Radix Paeoniae Alba, American ginseng, Flos Lonicerae
2. 3.
Foreign Trade of green herbs and extracts from the import and export standards The applicability of the limited standards of the pesticides ķ Organic chlorine pesticides: This is applied for TCMs:(the Health pesticide residues in the drug industry standards) Radix Astragali, Radix Polygalae, Radix Glycyrrhizae, cinnamon, Herba Asari, Fructus Corni, folium perillae, Fructus Jujubae, Pericarpium Citri Reticulatae, Folium Eriobotryae, and Cortex Moutan For the Chinese drugs preparation:(Chinese medicine preparations, and the Health and pesticide residues in the industry standard) the applicability includes the Chinese medicine preparations of: Radix Astragali, Radix Polygalae, Radix Glycyrrhizae, cinnamon, Herba Asari, Fructus Corni, folium perillae, Fructus Jujubae, Pericarpium Citri Reticulatae, Folium Eriobotryae, Cortex Moutan, Radix Ginseng, Radix Ginseng Rubra, and Folium Sennae. ĸ Organophosphorus Pesticides: The applicability includes the Chinese medicine preparations of Radix Polygalae, Fructus Corni, folium perillae, and Pericarpium Citri Reticulatae. Ĺ Permethrin Pesticides: the applicability includes the preparations of Radix Polygalae, folium perillae, Fructus Jujubae, Pericarpium Citri Reticulatae, and Cortex Moutan. (To be continued)
Xue Jian et al. / Mode Tradit Chin Med Mater Med, 2008, 10(1), 91-96
Notes (continued) 4.
Korea (the Publicity Office of Drug Safety)
ķ Except the standard of limits of the pesticide residues in the above-mentioned TCMs, there are other kinds of pesticides. There are corresponding regulations on standard of limits for the different types of the residual pesticides in different medicines. ĸ The regulations on the standards of limits of the heavy metals, Hg, Cd and Pb are only suitable for the botanical crude drugs. Besides the botanical crude drugs, the regulations on the standards of limits of As is also suitable for the Cornu Cervi Pantotrichum. 5. 6.
Singapore [1995 Drug resolution (Ban on the sale and supply) (amendment)] It is regulated in the European Pharmacopoeia that except the pesticides mentioned above, there are other 34 kinds of pesticides that should be limited in the herbal medicine, including chlordane, Sapecron, dimpylate, dichlorvos, and so on. The American Pharmacopeia also regulates 34 kinds of pesticides.
and the exporting standard for green traditional Chinese medicines with the determination methods and the standards of limits of the aflatoxin were regulated. As for other pollutants, there is no regulation. The standards referred to in China are only limited to a few of species, such as Radix Glycyrrhizae, Radix Astragali, Radix Ginseng (GB/T 15517.1), Fructus lycii (GB/T 18672-2002), and Radix Notoginseng (GB 19086-2003), the green herbal medicines that are exported, the extracts, and so on .
5
Control of the exogenous pollutants in TCMs
The existence of the exogenous pollutants in the TCMs not only influences the quality of the medicine, but also constrains the exports. The most serious problem is that the pollutants in the TCMs are harmful to human beings. For this reason, it is urgent to investigate the source and the pathway of the contamination so that the ways can be found to remove or reduce the pollutants in the TCMs or to prevent the TCMs being contaminated. It was reported that [23] washing the ginseng with the liquefied detergent to remove pesticide residues could easily reduce the pesticide residues in it. The supercritical carbon dioxide extraction technique [24] can also clean the residual pesticides in the TCMs, such as the benzene hexachloride, lindan, etc. As for the heavy metals, it was reported that the supercritical carbon dioxide extraction can extract heavy metal ions to clean up the heavy metals in the TCMs with sodium diethyl dithiocarbamate as complexant [25]. It was reported that some heavy metals in the TCMs’ water decoction can be removed by using chitosan [26]. Moreover, taking advantage of the difference of ion enrichment effect and the ion adsorption of the macroporous chelating resins can also remove the heavy metal ions during the crude extract of the TCMs [27]. The removal methods of the aflatoxins used in the foodstuff and the feedstuff include heat treatment, poaching, filling, adding adsorbent, alkali dissolution, and so on [28]. But all these methods have their limitations such as eluting effect not being good or introducing the second contamination of the organic solvents. In a word, by using both the removal techniques of the pollutants, the organic solvent extraction and the supercritical carbon dioxide extraction, may lose the effective components of some part of the medicines when removing the pollutants. And all these methods require a great amount of labor,
material, and financial resources, which means the raising cost of TCMs’ production. The main source of the pesticide residues and the heavy metals is the composition of the soil. Therefore, what should be solved first is the reparation of the soil that is contaminated. It was reported that the BHC-A and CDS-1degrading bacteria can repair the soil that was contaminated by the benzene hexachloride and the carbofuran [29]. After sprayed for 15 days, the pesticides degraded to the normal level in accordance with the ecological environment standard. It was reported that using the phytoremediation techniques to solve the heavy metals contamination can not only reduce the content of the heavy metals in soil, but also protect ecological environment [30]. In order to reduce the content of the mycotoxin in the TCMs, the store condition of the Qu and seed categories of TCMs, which are easy to get moldy in the high temperature and humidity regions or storeroom and special attention should be paid to this. In order to prevent pollution from mycotoxin to the TCMs, storage conditions should be improved to inhibit the growth of the mold [31]. This can be achieved by controlling the temperature and the humidity of the storage environment, storing under the condition of oxygen deficiency, keeping in the ventilation, and maintaining low temperature sites, and so on. In addition, the low-residual biological pesticides should be used during cultivation, and the pesticides should have high efficiency, low toxicity, broad-spectrum, safety, and low-cost and/or should exhibit biological activity [32]. The quality of the chemical fertilizer should be strictly controlled to avoid the heavy metals exceeding the limits to affect the quality of the TCMs. During the process of storage, transport, processing, and packaging, procedures should be regularized in order to avoid the heavy metals polluting the TCMs.
6
Conclusions
From the above-mentioned discussions, it can get the concluded that there are many kinds of exogenous pollutants in TCMs, though the degrees and the pathways of the contamination are different. They can affect the quality, pharmacodynamic action, and the safe use of the TCMs. Therefore, the exogenous pollutants in TCMs are one of the key points that affect the development of the TCM industry and need to be solved urgently. Based on the analysis of this issue, it is not difficult to
Xue Jian et al. / Mode Tradit Chin Med Mater Med, 2008, 10(1), 91-96
understand that, whatever the pollutant is, the first thing is to study the approach and the regularity of the contamination, then to control the source of the contamination. Only in this manner, the issue of the contamination can be fundamentally solved. The measures include controlling the use of the pesticides, not planting the herbs in places where the environment was contaminated by the pesticide residues and heavy metals seriously, controlling the feedstuff during the breeding process strictly, conserving the TCMs mold easily by utilizing air-conditioning system, modified atmosphere, using radiation techniques to avoid contamination by the mycotoxin, and avoiding the use of poisonous solvents or cleaning them up after using. All of these can improve the quality of TCMs. At the same time, the researches on the determination of the pollutants and the formulation of standards of limits are also the key points to solve the problem of the exogenous pollutants. At present, there are few relevant standards of limits on the pollutants in TCMs in China, therefore, not enough attention is being given to this problem by relevant authorities. The problem is only realized when the TCMs are rejected by the countries importing to. When this happens, nothing could be done except accept the reality. In fact, because of the constraints experienced during exports of TCMs, people began to realize the problems of the exogenous pollutants in the TCMs. As the country is the origin of these traditional medicines, China should strengthen the researches on the standards of limits and the determination of the harmful pollutants. Only working hard on these researches, it maybe possible to solve the problems as quickly as possible to pierce through the technical barriers of other countries, enhance the competitive ability of the TCMs in the world market and speed up the process of the globalization.
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