Safety Limit Test of Heavy Metals and Pesticide Residues in the Zhuang Ethnic Medcine Herba Polygoni

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  Abstract [Objectives] This study was conducted to determine the contents of such five heavy metals as lead (Pb), cadmium (Cd), arsenic (As), mercury (Hg) and copper (Cu) and the contents of nine kinds of organochlorine pesticide residues including total BHC (α-BHC, β-BHC, γ-BHC, δ-BHC) and total DDT (pp -DDE, pp-DDD, op-DDT, pp-DDT) and pentachloronitrobenzene in the Zhuang medicine Herba Polygoni Chinensis from 13 producing areas.
  [Methods]The five heavy metals were determined in accordance with the second method of general rule 2341, the inductively coupled plasma mass spectrometry method, in part 4 of the 2020 edition of Chinese Pharmacopoeia; and the nine organochlorines were determined in accordance with the first method of general rule 2341, organochlorine pesticide residue determination method (chromatography), in part 4 of the 2020 edition of Chinese Pharmacopoeia.
  [Results] In the Herba Polygoni Chinensis from 13 origins, the lead contents were in the range of 0.50-3.28 mg/kg; the cadmium contents were in the range of 0.06-4.21 mg/kg; the arsenic contents were in the range of 0.16-6.9 mg/kg; the copper contents were in the range of 10.5-45.1 mg/kg; the mercury contents were in the range of 0.00-0.003 mg/kg; and the nine organochlorines including the total benzene hexachloride (α-BHC, β-BHC, γ-BHC, δ-BHC), total DDT (pp-DDE, pp-DDD, op-DDT, pp-DDT) and pentachloronitrobenzene were all not detected. Referring to part 4 of the 2020 edition of Chinese Pharmacopoeia, the Cu and As of the Herba Polygoni Chinensis produced in Hezhou exceeded the standards, the Cu of the Herba Polygoni Chinensis produced in Wuzhou exceeded the standard, and the As of the Herba Polygoni Chinensis produced in Yulin City and Guilin City exceeded the standard.
  [Conclusions]This study provides safety limit test data for the development and utilization of Herba Polygoni Chinensis of the Zhuang medicine.
  Key words Different producing areas; Zhuang medicine Herba Polygoni Chinensis; Heavy metals; Pesticide residues
  Received: January 28, 2021  Accepted: March 30, 2021
  Supported by Development of Huotanmu Capsules, a New Zhuang Ethnic Medicine for the Treatment of Hepatitis B (20183046-1); Collaborative Innovation Center  of  Zhuang and Yao Ethnic Medicine (GJKY [2013] 20); Guangxi Key Laboratory of Zhuang and Yao Ethnic Medicines (GKJZ [2014] 32); Guangxi Key Discipline: Zhuang Pharmacology (GJKY [2013] 16); First-class Discipline in Guangxi of Traditional Chinese Pharmacology (Direction of Ethnic Medicine) (GJKY [2018] 12).   Fengfeng XIE (1989-), female, P. R. China, research asistant, PhD, devoted to research about pharmacy and industry of fine chemicals.
  *Corresponding author.
   In order to improve the safety and effective control of drugs, the 2020 edition of Chinese Pharmacopoeia further strengthens the control of safety evaluation indexes such as heavy metals and harmful elements and banned pesticide residues in medicinal pieces. The "0212 General Rules for the Verification of Medicinal Materials and Decoction Pieces" (Part 4) was revised, stipulating that banned agrochemicals (33 prohibited agrochemicals) shall not be detected in botanical medicinal materials and decoction pieces, and a fifth method "Method for the determination of banned agrochemical residues in medicinal materials and decoction pieces (plants)" was added to the "2341 Methods for Determination of Agrochemical Residues". The "9302 Guidelines for the Establishment of Limits for Hazardous Residues in Traditional Chinese Medicines" was revised, adding a fifth item "Guidelines for the Consistency Limits of Heavy Metals and Hazardous Elements in Traditional Chinese Medicines (Plants)"[1]. And compared with the 2015 edition of Chinese Pharmacopoeia, the limits for heavy metals and harmful elements in the new version of the pharmacopoeia are revised from "Lead shall not exceed 5 mg/kg; cadmium shall not exceed 0.3 mg/kg; arsenic shall not exceed 2 mg/kg; mercury shall not exceed 0.2 mg/kg; copper must not exceed 20 mg/kg" to "Lead must not exceed 5 mg/kg; cadmium must not exceed 1 mg/kg; arsenic must not exceed 2 mg/kg; mercury must not exceed 0.2 mg/kg; copper must not exceed 20 mg/kg", and the number of heavy metals and harmful elements tested has been increased from 17 to 28. The 11 newly added varieties are Angelicae Dahuricae Radix, Angelicae Sinensis Radix, Radix Puerariae, Polygonati Rhizoma, Radix Ginseng, Notoginseng Radix Et Rhizoma, Fructus Gardeniae, Persicae Semen, Semen Ziziphi Spinosae, Corni Fructus and Cordyceps sinensis, all of which are Chinas bulk medicinal materials. It can be seen that China has been continuously strengthening the safety control requirements of Chinese medicinal materials and improving the controllability of drug quality.
  The medicinal materials conventionally used by various nationalities recorded in the 2020 edition of Chinese Pharmacopoeia are mainly derived from Tibetan, Mongolian, Uygur, and Dai[2], with a total of 16 species, namely Fructus Podophylli, Fructus Terminaliae Billericae, Fructus Phyllanthi, Herba Lamiophlomis, Herba Lagotis, Acori Calami Rhizoma, Pterocephali Herba, Herba Cissampelotis, Fructus Choerospondiatis, Malvae Fructus, Aconiti Kusnezoffii Folium, Fructus Hippophae, Saussureae Involucratae Herba, Herba Cichorii, Semen Nigellae, and Entadae Semen among which eight are traditional Tibetan medicinal materials, four are traditional Mongolian medicinal materials, three are Uyghur traditional medicinal materials, one is Dai traditional medicinal material, and one is unspecified ethnic customary medicinal material (Entadae Semen). Furthermore, the Fructus Hippophae is called "the traditional medicinal materials of Tibetan and Mongolian nationality". No medicinal materials commonly used by Zhuang people are included. Therefore, striving for Zhuang medicine to enter the national standard is a huge challenge for the future development of Zhuang medicine.   The heavy metal limits and pesticide residue limits for Chinas traditional Chinese medicine and traditional medicine of ethnic minorities have been continuously improved. With the publication of the new edition of the pharmacopoeia, the control requirements for the safety indexes of traditional Chinese medicine and traditional medicine of ethnic minorities continue to increase. In recent years, national policies and policies of the Guangxi Zhuang Autonomous Region have played a huge role in promoting Guangxi ethnic medicine, especially Zhuang medicine. To give full play to the unique advantages of Zhuang Medicine and support the Guangxi Zhuang Medicine brand, safety control is the first condition. In this study, through the determination of heavy metal limits and pesticide residues of the Zhuang medicine Herba Polygoni Chinensis from 13 production areas in Guangxi, it is proposed to put forward some prospects for the safety index control of Guangxi Zhuang medicine: ① In order to ensure the control standards for harmful substances in Zhuang medicinal materials, it is necessary to strengthen the risk assessment of heavy metals, harmful elements and pesticide residues in medicinal materials, establish a tracking system for controlling the generation of harmful substances from sources, and evaluate the planting environments includes soil, water and air. ②   Fast, simple and economical analysis methods not only reduce the cost of investment, but also facilitate market monitoring. For example, rapid pesticide residue detectors and ion immunoassay method have been further developed to effectively improve the detection efficiency and meet the needs of grassroots or on-site detection. ③ Local standards for the limits of harmful substances in Zhuang medicine can be formualted. On the basis of Chinese Pharmacopoeia, combining Guangxis unique Karst landform and the growth environment of various herbal medicines and their own enrichment capacities, local standards suitable for Zhuang medicine can be comprehensively formulated to clarify the limits of harmful substances.
  In this study, only the medicinal material samples from 13 cities in Guangxi were measured. Whether it can be used as a basis for the formulation of the quality standardd of the Zhuang medicine Herba Polygoni Chinensis still needs further study. The number of samples needs to be further expanded, and at least one batch of samples should be collected from each city, so as to ensure that the sample quantity is representative. Meanwhile, the soil and water sources of each production area should be monitored to eliminate the capacity of medicinal materials to accumulate heavy metals, so as to formulate standardized and reliable limits.   References
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  [2] WANG QL. Chinese pharmacopoeia (2010 Edition): Statistics and analysis of traditional Chinese medicinal materials[J]. Chinese Journal of Experimental Traditional Medical Formulae, 2013, 19(12): 345-347. (in Chinese)
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  [4] Food and Drug Administration of Guangxi Zhuang Autonomous Region. Quality standards for Zhuang medicine in Guangxi Zhuang autonomous region (volume I)[M]. Nanning: Guangxi Science & Technology Publishing House Co., Ltd., 2008. (in Chinese)
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  [7] GAO Y, ZHU H. Study on the liver-protective effect of alcohol extracts from Polygonum chinense[J]. West China Journal of Pharmaceutical Sciences, 2012, 27(3): 283-284. (in Chinese)
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  [9] CAI JJ, ZENG CY, MEI QX. Experimental study on the antipyretic and jaundice-removing effect of the water extract of Polygonum chinense L. [J]. Journal of Chinese Medicinal Materials,2016,39(12): 2871-2874. (in Chinese)
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