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    Home > Medical News > Medical World News > The standard for determination of mercury and arsenic element forms and valence states of Chinese medicinal materials in the 2020 edition of the Chinese Pharmacopoeia is planned to be upgraded

    The standard for determination of mercury and arsenic element forms and valence states of Chinese medicinal materials in the 2020 edition of the Chinese Pharmacopoeia is planned to be upgraded

    • Last Update: 2019-12-19
    • Source: Internet
    • Author: User
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    Wen Di Di Si Nan On December 18, 2019, centering closely on the overall goal of the 13th five year plan for national drug safety, taking the establishment of "the most rigorous standard" as the criterion and benchmarking against the international advanced standards, the State Pharmacopoeia Commission issued 2322 "determination of mercury, arsenic element forms and their valence states" (the third draft for comments) on its website, with a publicity period of one month, which is of far-reaching significance to the traditional Chinese medicine industry Due to the success of traditional Chinese medicine Because of its complexity, the current standard is difficult to evaluate the quality of drugs comprehensively and find potential quality problems This paper reviews the knowledge of mercury and arsenic speciation and their valence determination In terms of the control of heavy metals and harmful elements in traditional Chinese medicine, most national pharmacopoeia have mainly formulated residue standards such as mercury and arsenic The 2015 edition of China Pharmacopoeia has technically realized the simultaneous detection of many heavy metals and harmful elements It is also the first time to explore and formulate the forms and prices of mercury and arsenic elements according to the characteristics of different pharmacological and toxic effects of heavy metals in different valence states It can be said that the state-of-the-art international experience and scientific concepts have been used for reference in the detection level of heavy metals and harmful elements, and more attention has been paid to the unified coordination with the International Pharmaceutical General technical standards According to the work schedule of China Pharmacopoeia 2020 edition, the first, second and third drafts of 2322 mercury and arsenic speciation and valence determination method have been solicited on the official website of the National Pharmacopoeia Committee in November 2018, may 2019 and December 2019 respectively for public opinions from all walks of life According to the characteristics of different pharmacological and toxic effects of heavy metals in different valence states, they have different pharmacological and toxic effects , gradually revised and improved the determination method of mercury and arsenic forms and their valence states It can be said that in the detection level of heavy metals and harmful elements, after revision and improvement, China's pharmacopoeia 2020 edition can reach the international advanced level The revised contents of the first draft are indicated The revised contents of the second draft are indicated The revised contents of the third draft are indicated High performance liquid chromatography inductively coupled plasma mass spectrometry (HPLC-ICP-MS) was used to determine the speciation and valence of mercury and arsenic in the sample Because the pretreatment method of element form and valence analysis is closely related to the sample, if there are special requirements for the preparation method of test solution, they shall be specified under the item of variety It was determined by high performance liquid chromatography inductively coupled plasma mass spectrometry (general rule 0412) Octadecylsilane bonded silica gel was used as the filling agent (); methanol-0.01mol/l ammonium acetate solution (containing 0.12% L-cysteine, pH value adjusted by ammonia to 7.5) (8:92) was used as the mobile phase; the flow rate was 1.0ml/min Inductively coupled plasma mass spectrometry (ICP-MS) was used to detect the co axial atomizer The isotope was 202hg, and the normal mode or collision pool reaction mode was selected according to the interference The resolution of three different forms of mercury should be greater than 1.5 Speciation and valence of mercury 1 Mercuric chloride (divalent mercury); 2 Methylmercury; 3 Ethyl mercury Take appropriate amount of base mercury reference, weigh accurately, and add 8% methanol to make a solution containing 100ng (all calculated by mercury) per 1ml Take a proper amount of the stock solution of the reference precisely, add 8% methanol to prepare a series of solutions containing 0.5ng, 1ng, 5ng, 10NG and 20ng (all calculated by mercury) per 1ml respectively (: unless otherwise specified, weigh accurately, add an appropriate amount of artificial gastric juice or artificial intestinal fluid, put it in a 37 ℃ water bath for ultrasonic treatment for an appropriate time, shake it well, take an appropriate amount, leave it for about hours, take an appropriate amount of middle-level solution, filter it with a microporous filter membrane (10 μ m), precisely measure an appropriate amount of continuous filtrate, dilute it to a certain volume with 0.125mol/l hydrochloric acid solution, shake it well, and then it is obtained Prepare blank solution by the same method A series of standard curve solutions and test sample solutions were respectively aspirated 20-100 μ L by the determination method, and then injected into the liquid chromatograph for determination Taking the peak area of different forms or valence mercury in series of standard curve solutions as the ordinate and the concentration as the abscissa, draw the standard curve and calculate the content of different forms or valence mercury in the test solution It was determined by high performance liquid chromatography inductively coupled plasma mass spectrometry (general rule 0412) The carrier of polystyrene divinylbenzene copolymer was used to bond trimethylammonium anion exchange material or equivalent material as filler (250 × 4.1mm; 10 μ m); 0.025mol/l ammonium dihydrogen phosphate solution (adjust pH value to 8.0 with ammonia water) was used as mobile phase a, and water as mobile phase B, and gradient elution was carried out according to the following table; the flow rate was 1.0ml/min Inductively coupled plasma mass spectrometry (ICP-MS) with a coaxial atomizer was used for the detection 75as isotope was selected for the determination, and the collision pool reaction mode was selected or the appropriate correction equation was selected according to the requirements of different instruments for correction The resolution of six different forms of arsenic should meet the requirements, and the resolution of arsenicone, betaine and Arsenious Acid should not be less than 1.0 Form and valence of arsenic 1 Arsenic choline; 2 Arsenic betaine; 3 Arsenite (trivalent arsenic) 4 Dimethylarsenic acid; 5 Dimethylarsenic acid; 6 Arsenic acid (pentavalent arsenic) Take appropriate amount of arsenious acid, arsenic acid, monomethyl arsenic, dimethyl arsenic, arsenicone and arsenical betaine, weigh them precisely, and add water to make a reference solution containing 2.0 μ g (all calculated as arsenic) per 1ml Take a proper amount of the stock solution of the reference precisely, add 0.02mol/l disodium ethylenediamine tetraacetate solution to make a solution containing 1ng, 5ng, 20ng, 50NG, 100ng, 200ng and 500ng (all calculated as arsenic) series concentrations per 1ml, and shake it up Unless otherwise specified, A series of standard curve solutions and test sample solutions were respectively aspirated 20-100 μ L by the determination method, and then injected into the liquid chromatograph for determination Take the peak area of different forms or valence arsenic in the series of standard curve solutions as the ordinate and the concentration as the abscissa, draw the standard curve and calculate the content of different forms or valence arsenic in the test solution [note] ① Before use, all glass instruments shall be soaked in 20% nitric acid solution (V / V) for 24 hours or other appropriate methods to avoid interference ② Under the condition of meeting the applicability of the system, it is not necessary to prepare 3 kinds of mercury or 6 kinds of arsenic form and valence series standard curve solutions for each determination Only the series standard curve solutions of mercury or arsenic form and valence need to be analyzed can be prepared according to the actual situation ③ In the analysis of mercury speciation and valence state, the column efficiency of Hg2 + was lost quickly because of the influence of the incompletely capped silicon hydroxyl in the column It is suggested to use the chromatographic column with high end coverage, and if necessary, at a certain injection interval, to use the valve switching technology to wash the chromatographic column with high proportion of organic phase, and then continue the analysis ⑦ The limit of mercury, arsenic form or valence state in the test article shall conform to the provisions of each variety According to the regulatory needs and the international advanced standards, the State Pharmacopoeia Commission released 2322 "determination method of mercury and arsenic forms and their valence states" (the third draft for comments), which included the test methods with strong specificity, good discrimination and high maturity into the standard, and reasonably upgraded the determination standard of mercury and arsenic forms and their valence states The upgrading of the standard promotes the international development of Chinese herbal medicine Standardization development will play a better leading role in promoting the international influence and competitiveness of traditional Chinese medicine products and promoting the international trade of traditional Chinese medicine products The State Food and drug administration has made it clear that good drugs are all over the world, and inferior drugs are hard to move forward It has once again sounded an alarm for the quality supervision of the traditional Chinese medicine industry The preparation and revision of the 2020 edition of the Chinese Pharmacopoeia are more grounded, closely linked with the actual supervision, and meet the regulatory needs in a timely manner, fully reflecting the main function of the pharmacopoeia standard, that is, encouraging good drugs, eliminating inferior drugs, identifying the true and the false, judging the good and better For regulatory services,
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