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[药品研发] 有谁知道人体每日允许的EDTA摄入量是多少?

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药徒
发表于 2016-8-28 08:46:22 | 显示全部楼层 |阅读模式

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如题,有谁知道人体每日允许的EDTA摄入量是多少,或是药品中允许EDTA的残留量是多少?

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http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm  发表于 2016-8-29 10:08
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药徒
 楼主| 发表于 2016-8-29 09:51:55 | 显示全部楼层
红茶. 发表于 2016-8-28 12:38
FAO /WHO每日允许摄入量:0-2.5mg/kg体重

出处在哪?

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http://apps.who.int/food-additives-contaminants-jecfa-database/search.aspx  发表于 2016-8-29 11:41
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药师
发表于 2016-8-29 16:15:25 | 显示全部楼层
附上一个美国HOSPIRA公司关于EDEA2钠注射剂的安全资料。HOSPIRA 赫升瑞是世界领先的注射药物和输注技术供应商,现已被辉瑞收在麾下。

Edetate_Disodium_091911.pdf

87.9 KB, 下载次数: 173

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太感谢您了!  详情 回复 发表于 2017-2-5 09:12

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药徒
发表于 2016-8-29 10:39:58 | 显示全部楼层
本帖最后由 yaodaidongli 于 2016-8-29 10:46 编辑

FAO /WHO有一系列的文件啊
比如这个WHO_TRS_751
大家搜搜啊,有2M多
用户级别太低,传个封面大家看看 WHO_TRS751.pdf (26.98 KB, 下载次数: 97)

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有没有关于注射剂中允许的量?  详情 回复 发表于 2016-8-29 13:00
谢谢!  详情 回复 发表于 2016-8-29 12:58
搜了一下,吓到了(多如牛毛):http://www.who.int/foodsafety/publications/jecfa-reports/en/  发表于 2016-8-29 11:25
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药徒
发表于 2016-8-28 08:54:03 | 显示全部楼层
人每天还要摄取这个?没听说过…

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做清洁验证可能会要考虑这个的,同学。  详情 回复 发表于 2016-8-28 12:26
不是“需要”,是“允许”。  详情 回复 发表于 2016-8-28 09:06
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药徒
 楼主| 发表于 2016-8-28 09:06:49 | 显示全部楼层
阿炳1987 发表于 2016-8-28 08:54
人每天还要摄取这个?没听说过…

不是“需要”,是“允许”。
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药士
发表于 2016-8-28 12:26:45 | 显示全部楼层
阿炳1987 发表于 2016-8-28 08:54
人每天还要摄取这个?没听说过…

做清洁验证可能会要考虑这个的,同学。

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[attachimg]542813[/attachimg] 禁止嘚瑟!违令者,阉啦!!!  详情 回复 发表于 2016-8-28 15:59
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药士
发表于 2016-8-28 12:38:25 | 显示全部楼层
FAO /WHO每日允许摄入量:0-2.5mg/kg体重

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出处在哪?  详情 回复 发表于 2016-8-29 09:51
出处。否则问到时让检查员看论坛?  发表于 2016-8-29 08:50
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药徒
发表于 2016-8-28 15:59:09 | 显示全部楼层
红茶. 发表于 2016-8-28 12:26
做清洁验证可能会要考虑这个的,同学。

               QQ图片20160828155739.png
      禁止嘚瑟!违令者,阉啦!!!
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药徒
发表于 2016-8-28 21:18:00 | 显示全部楼层
清洁验证必备啊
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药师
发表于 2016-8-29 09:04:41 | 显示全部楼层
EDTA是一个很安全药品,属于维生素和补充剂之列,每日用量不超过3克。

http://www.webmd.com/vitamins-supplements/ingredientmono-1032-EDTA.aspx?activeIngredientId=1032&activeIngredientName=EDTA

Find a Vitamin or Supplement
EDTA
Other Names: Acide éthylènediaminetétracétique, Calcium Disodium Edathamil, Calcium Disodium EDTA, Calcium Disodium Edetate, Calcium Disodium Versenate, Calcium Edetate, Calcium EDTA, Chelation Therapy, Disodium Edathamil, Disodium Edetate, Disodium EDTA,

EDTA is a prescription medicine, given by injection into the vein (intravenously) or into the muscle (intramuscularly).

It is UNSAFE to use more than 3 grams of EDTA per day, or to take it longer than 5 to 7 days. Too much can cause kidney damage, dangerously low calcium levels, and death.

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非常感谢!  详情 回复 发表于 2016-8-29 09:52

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药徒
 楼主| 发表于 2016-8-29 09:52:18 | 显示全部楼层
yc20160802 发表于 2016-8-29 09:04
EDTA是一个很安全药品,属于维生素和补充剂之列,每日用量不超过3克。

http://www.webmd.com/vitamins-s ...

非常感谢!
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发表于 2016-8-29 10:46:04 | 显示全部楼层


Human Toxicity Excerpts:

/SIGNS AND SYMPTOMS/ Rapid intravenous administration of Na2EDTA causes hypocalcemic tetany. However, a slow infusion (15 mg/min) administered to a normal individual elicits no symptoms of hypocalcemia because of the ready availability of extracirculatory stores of calcium.
[Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1868] **PEER REVIEWED**

/CASE REPORTS/ ... Investigators have stated that EDTA is not a contact sensitizer. /These investigators/ reported that no positive reactions were observed when EDTA was included in the North American Contact Dermatitis Group's screening tray for several years, and that EDTA did not cross-react in 100 patients with ethylenediammne hydrochloride sensitivity.
[Cosmetic Ingredient Expert Review Panel; Final Report on the Safety Assessment of EDTA, Calcium, Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA, Trisodium EDTA, HEDTA, and Trisodium HEDTA. International Journal of Toxicology 21 (S2): 95-142 (2002)] **PEER REVIEWED**

/CASE REPORTS/ /The/ sensitivity to EDTA 2% in vaseline in 465 individuals (235 men and 230 women) that "most often" suffered from eczema /was reported/. EDTA caused one positive patch test reaction. No additional details were available.
[Cosmetic Ingredient Expert Review Panel; Final Report on the Safety Assessment of EDTA, Calcium, Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA, Trisodium EDTA, HEDTA, and Trisodium HEDTA. International Journal of Toxicology 21 (S2): 95-142 (2002)] **PEER REVIEWED**

/CASE REPORTS/ Three cases of ethylenediamine tetraacetic acid (EDTA)-induced leukoagglutination noted on peripheral blood films are reported. Two cases of EDTA-induced agglutination of benign lymphocytes, and one case of EDTA-induced mature neutrophil satellitosis about immature neutrophil were observed. EDTA-induced agglutination of malignant lymphoid cells has been reported in blood films from patients with malignant lymphoma and chronic lymphocytic leukemia. /These/ two cases are the first reported instances of EDTA-induced agglutination of benign lymphocytes. EDTA-induced agglutination of neutrophils is a well recognized, but uncommon event. This case was unusual because mature neutrophils were rosetted about a central immature granulocyte and no agglutination of mature neutrophils was noted.
[Deol I et al; Am J Clin Pathol 103 (3): 338-40 (1995)] **PEER REVIEWED** PubMed Abstract

/GENOTOXICITY/ In studies using ... human lymphocytes, ... EDTA caused chromosomal breakage by the chelation of divalent calcium ... ions and depleted heavy metal ions from the chromosome.
[Cosmetic Ingredient Expert Review Panel; Final Report on the Safety Assessment of EDTA, Calcium, Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA, Trisodium EDTA, HEDTA, and Trisodium HEDTA. International Journal of Toxicology 21 (S2): 95-142 (2002)] **PEER REVIEWED**

/ALTERNATIVE and IN VITRO TESTS/ ...Total loss of /human/ sperm motility was achieved at a concentration of about 5 mg/mL of EDTA. EDTA decreased in vitro percentage of motile sperm as a function of exposure time. It completely impeded sperm penetration into cervical mucus at a concentration much lower than that for 100% inhibition of sperm motility. In the presence of extra calcium, the first-order rate constant for immobilization of sperm was reduced by 38.9-55.6% of control and was inversely proportional to calcium concentration. After EDTA exposure, calcium ion concentration in semen was reduced as a function of EDTA concentration. A decrease of 65% in calcium ion concentration was the threshold at which total loss of sperm motility occurred.
[Lee CH et al; J Pharm Sci 85 (6): 649-54 (1996)] **PEER REVIEWED** PubMed Abstract

/OTHER TOXICITY INFORMATION/ ...Editic acid [ethylenediaminetetraacetic acid (EDTA)] increases the absorption of some toxicants by increasing intestinal permeability. ...While lead and many other heavy metal ions are not absorbed readily from the GI tract, EDTA and other chelators increase the lipid solubility and thus the absorption of complexed ions. Thus, it is important not to give a chelator orally when excess metal is still present in the GI tract after oral ingestion.
[Klaassen, C.D. (ed). Casarett and Doull's Toxicology. The Basic Science of Poisons. 6th ed. New York, NY: McGraw-Hill, 2001., p. 113] **PEER REVIEWED**

/OTHER TOXICITY INFORMATION/ All known pharmacological effects of EDTA result from formation of chelates with divalent and trivalent metal /ions/ in the body.
[Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1868] **PEER REVIEWED**

/OTHER TOXICITY INFORMATION/ ... The free acid or the sodium salt of ... /ethylenediamine tetraacetic acid/ are rather toxic ... the less toxic calcium disodium form ... is more frequently used.
[International Labour Office. Encyclopedia of Occupational Health and Safety. Vols. I&II. Geneva, Switzerland: International Labour Office, 1983., p. 443] **PEER REVIEWED**

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谢谢!  详情 回复 发表于 2016-8-29 12:51
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药徒
 楼主| 发表于 2016-8-29 12:51:13 | 显示全部楼层
xiaodong5296 发表于 2016-8-29 10:46
Human Toxicity Excerpts:

/SIGNS AND SYMPTOMS/ Rapid intravenous administration of Na2EDTA ca ...

谢谢!
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药徒
 楼主| 发表于 2016-8-29 12:58:48 | 显示全部楼层
yaodaidongli 发表于 2016-8-29 10:39
FAO /WHO有一系列的文件啊
比如这个WHO_TRS_751
大家搜搜啊,有2M多

谢谢!
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药徒
 楼主| 发表于 2016-8-29 13:00:58 | 显示全部楼层
yaodaidongli 发表于 2016-8-29 10:39
FAO /WHO有一系列的文件啊
比如这个WHO_TRS_751
大家搜搜啊,有2M多

有没有关于注射剂中允许的量?
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药徒
发表于 2016-9-1 11:01:54 | 显示全部楼层
论英语学习的重要性
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药徒
发表于 2016-9-1 13:09:39 | 显示全部楼层
前几年申报好象不允许用EDTA-2NA,由于依地酸二钠可与钙离子结合成可溶的络合物引起钙的减少,静脉制剂中使用依地酸二钠会导致血钙下降。。。因此多用钙钠
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大师
发表于 2016-9-6 10:58:27 | 显示全部楼层
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药徒
 楼主| 发表于 2016-9-6 16:23:21 | 显示全部楼层
roadman 发表于 2016-9-6 10:58
http://www.cde.org.cn/drugInfo.do?method=fuliaoView&flId=65
http://www.cde.org.cn/drugInfo.do?metho ...

非常感谢!
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