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caizhengjun

木虫 (著名写手)

[求助] FDA规定的十二烷基硫酸钠(月桂醇硫酸钠、SDS)的安全范围是多少?

求助FDA规定的十二烷基硫酸钠(月桂醇硫酸钠、SDS)的安全范围是多少?

[ 来自科研家族 药物制剂 ]
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libaoyu_123321

新虫 (初入文坛)

【答案】应助回帖

★ ★ ★
感谢参与,应助指数 +1
caizhengjun: 金币+2, ★★★很有帮助, 谢谢 2012-07-16 09:43:05
豆哥: 金币+1, 谢谢参与 2012-07-16 10:38:06
http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
这个是美国非活性物质数据库,里面收录的大多数辅料的用量情况
Search Results for: "Sodium Lauryl Sulfate"
INACTIVE
INGREDIENT6 ROUTE;DOSAGE FORM7 CAS
NUMBER8 UNII9 MAXIMUM
POTENCY10

--------------------------------------------------------------------------------

SODIUM LAURYL SULFATE BUCCAL/SUBLINGUAL; TABLET 151213 368GB5141J 1.1MG

--------------------------------------------------------------------------------

SODIUM LAURYL SULFATE DENTAL; GEL 151213 368GB5141J 1.47%

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SODIUM LAURYL SULFATE DENTAL; PASTE 151213 368GB5141J  

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SODIUM LAURYL SULFATE ORAL; CAPSULE 151213 368GB5141J 15MG

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SODIUM LAURYL SULFATE ORAL; CAPSULE (IMMED./COMP. RELEASE), HARD GELATIN 151213 368GB5141J 3.6MG

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SODIUM LAURYL SULFATE ORAL; CAPSULE, DELAYED ACTION 151213 368GB5141J 0.118MG

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SODIUM LAURYL SULFATE ORAL; CAPSULE, DELAYED ACTION, COATED, HARD GELATIN 151213 368GB5141J 2MG

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SODIUM LAURYL SULFATE ORAL; CAPSULE, ENTERIC COATED PELLETS 151213 368GB5141J 1.004MG

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SODIUM LAURYL SULFATE ORAL; CAPSULE, EXTENDED RELEASE 151213 368GB5141J 16.667MG

--------------------------------------------------------------------------------

SODIUM LAURYL SULFATE ORAL; CAPSULE, HARD GELATIN 151213 368GB5141J 6MG

--------------------------------------------------------------------------------

SODIUM LAURYL SULFATE ORAL; CAPSULE, SOFT GELATIN 151213 368GB5141J 24MG

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SODIUM LAURYL SULFATE ORAL; CAPSULE, SUSTAINED ACTION 151213 368GB5141J 1.6MG

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SODIUM LAURYL SULFATE ORAL; CAPSULE, SUSTAINED ACTION, HARD GELATIN 151213 368GB5141J 1.7MG

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SODIUM LAURYL SULFATE ORAL; DISPERSIBLE TABLET 151213 368GB5141J 8.4MG

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SODIUM LAURYL SULFATE ORAL; DROPS 151213 368GB5141J  

--------------------------------------------------------------------------------

SODIUM LAURYL SULFATE ORAL; GRANULE 151213 368GB5141J  

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SODIUM LAURYL SULFATE ORAL; POWDER, FOR SUSPENSION 151213 368GB5141J 0.066%

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SODIUM LAURYL SULFATE ORAL; SUSPENSION 151213 368GB5141J 0.15%

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SODIUM LAURYL SULFATE ORAL; TABLET 151213 368GB5141J 51.69MG

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SODIUM LAURYL SULFATE ORAL; TABLET (IMMED./COMP RELEASE), UNCOATED, HYPODERMIC 151213 368GB5141J 28.6MG

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SODIUM LAURYL SULFATE ORAL; TABLET (IMMED./COMP. RELEASE), COATED 151213 368GB5141J 1MG

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SODIUM LAURYL SULFATE ORAL; TABLET (IMMED./COMP. RELEASE), FILM COATED 151213 368GB5141J 0.98MG

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SODIUM LAURYL SULFATE ORAL; TABLET (IMMED./COMP. RELEASE), UNCOATED, CHEWABLE 151213 368GB5141J 5MG

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SODIUM LAURYL SULFATE ORAL; TABLET, COATED 151213 368GB5141J 5.2MG

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SODIUM LAURYL SULFATE ORAL; TABLET, DELAYED ACTION 151213 368GB5141J 1MG

--------------------------------------------------------------------------------

SODIUM LAURYL SULFATE ORAL; TABLET, DELAYED ACTION, ENTERIC COATED 151213 368GB5141J 8.09MG

--------------------------------------------------------------------------------

SODIUM LAURYL SULFATE ORAL; TABLET, EXTENDED RELEASE 151213 368GB5141J 51.69MG

--------------------------------------------------------------------------------

SODIUM LAURYL SULFATE ORAL; TABLET, FILM COATED 151213 368GB5141J 12MG

--------------------------------------------------------------------------------

SODIUM LAURYL SULFATE ORAL; TABLET, MULTILAYER, EXTENDED RELEASE 151213 368GB5141J 0.8MG

--------------------------------------------------------------------------------

SODIUM LAURYL SULFATE ORAL; TABLET, ORALLY DISINTEGRATING 151213 368GB5141J 0.5MG

--------------------------------------------------------------------------------

SODIUM LAURYL SULFATE ORAL; TABLET, SUSTAINED ACTION 151213 368GB5141J 20.62MG

--------------------------------------------------------------------------------

SODIUM LAURYL SULFATE ORAL; TABLET, SUSTAINED ACTION, COATED 151213 368GB5141J 10.5MG

--------------------------------------------------------------------------------

SODIUM LAURYL SULFATE ORAL-28; TABLET 151213 368GB5141J 0.65MG

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SODIUM LAURYL SULFATE RESPIRATORY (INHALATION); CAPSULE 151213 368GB5141J  

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SODIUM LAURYL SULFATE SUBLINGUAL; TABLET 151213 368GB5141J 0.02MG

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SODIUM LAURYL SULFATE TOPICAL; EMULSION, CREAM 151213 368GB5141J 2.5%

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SODIUM LAURYL SULFATE TOPICAL; LOTION 151213 368GB5141J 0.5%

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SODIUM LAURYL SULFATE TOPICAL; OINTMENT 151213 368GB5141J 1%

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SODIUM LAURYL SULFATE TOPICAL; SHAMPOO 151213 368GB5141J  

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SODIUM LAURYL SULFATE TOPICAL; SHAMPOO, SUSPENSION 151213 368GB5141J 40%

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SODIUM LAURYL SULFATE TOPICAL; SPONGE 151213 368GB5141J  

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SODIUM LAURYL SULFATE VAGINAL; EMULSION, CREAM 151213 368GB5141J 0.333%

--------------------------------------------------------------------------------

SODIUM LAURYL SULFATE VAGINAL; INSERT 151213 368GB5141J 5MG

--------------------------------------------------------------------------------




Update Frequency: Quarterly
Data Through: June 29, 2012
Database Last Updated: July 13, 2012
2楼2012-07-16 09:18:11
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libaoyu_123321

新虫 (初入文坛)

【答案】应助回帖

★ ★
caizhengjun: 金币+2, 审评中心的数据和辅料大全一致,谢谢! 2012-07-16 09:42:52
好人做到底,再给个中文的
这个是CDE刚刚开通的辅料数据库
http://www.cde.org.cn/drugInfo.do?method=fuliaoView&flId=127
里面也收录了这个辅料,可供参考
3楼2012-07-16 09:21:03
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901024@

新虫 (初入文坛)

“(十二)烷基硫酸钠”的含量应不低于90%(FDA,§172.822,2000)。
LD50 1288mg/kg(大鼠,经口)。
笑口常开
4楼2012-07-16 09:44:03
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