抗(抑)菌劑有效成分名錄(征求意見稿)

1、附件1抗（抑）菌劑有效成分名錄（征求意見稿）本名錄規(guī)定了用于人體完整皮膚和黏膜的抗菌劑和抑菌劑 的有效成分清單，適用于直接用于人體完整皮膚、口腔黏膜和 陰道黏膜的抗菌劑和抑菌劑。二、名詞術(shù)語（一）抗菌劑 Antibacterial lotion直接接觸人體完整皮膚或黏膜（不包括用于人體足部、眼 睛、指甲、腋部、頭皮、頭發(fā)、鼻黏膜、肛腸等特定部位），具 有一定殺菌作用且殺滅率N90%，不以治療疾病或者改善皮膚、 黏膜的癥狀為目的的液體制劑。（二）抑菌劑 Bacteriostatic lotion直接接觸人體完整皮膚或黏膜（不包括用于人體足部、眼 睛、指甲、腋部、頭皮、頭發(fā)、鼻黏膜、肛腸等特定部位

2、），具 有一定抑菌作用且抑菌率N50%，不以治療疾病或者改善皮膚、 黏膜的癥狀為目的的液體制劑。（三）CAS編碼chem ical abstracts service number美國化學(xué)文摘服務(wù)社為化學(xué)物質(zhì)制定的登記號，該號是 檢索有多個(gè)名稱的化學(xué)物質(zhì)信息的重要工具，是某種物質(zhì)（化 合物、高分子材料、生物序列）、混合物或合金的唯一的數(shù)字 識(shí)別號碼。（四）有效成分 active ingredient在抗（抑）菌劑中，對微生物具有殺滅或抑制作用的物 質(zhì)。（五）禁用物質(zhì) prohibited substance在抗（抑）菌劑中禁止添加的物質(zhì)，包括化學(xué)類和生物類 物質(zhì)。三、成分清單非植物類抗（抑）菌

3、劑有效成分清單見下表抗（抑）菌劑有效成分清單及出處表編號中文名稱英文名稱CAS編碼11-漠-3-氯-5,5-二甲基乙內(nèi)酰脲（漠氯海因）1-bromo-3-chloro-5,5-dimethylhydantoin(bromochlorodimethylhydantoin)16079-88-222,2-亞甲基雙（3,4,6-三氯苯酚）（六氯酚）2,2-methylenebis(3,4,6-trichloro-phenol)(hexachlorophene)70-30-433-甲基-4-異丙基苯酚Isopropyl Methyl Phenol3228-02-244-氯-3 -甲酚Chlorocres

4、ol59-50-75苯酚Phenol108-95-26二甲基苯酚dimethyl phenol95-87-47甲酚Cresol1319-77-38間苯二酚Resorcin108-46-39鄰苯基苯酚Biphenyl-2-ol90-43-72 522 32 221001CO11 o獺 港形瑁(【)穌形尊二T【甌 -(HZ) -那番昔*害1 霄由二霄*霄馴813-213港詠琳琳獺w-M琴didecyl dimethylammonium chlorideoctadecyl dimethyl amine oxidedodecyl trimethyl ammonium bromidedodecyl tr

5、imethyl ammonium chloridepoly(diallyl dimethyl ammonium chloride)Ammonium Glycyrrhizatedimethyl dioctylammonium chlorideBenzethonium chlorideBenzalkonium BromideBenzalkonium chloridequaternary ammonium compounds, benzyl C12-C18 alkyl dimethyl, salts with 1,2-benzisothiazol -3 (2H)-one 1,1-dioxide (1

6、:1)quaternary ammonium compounds, benzyl C12-C16 alkyl dimethyl, chloridesquaternary ammonium compounds, benzyl C12-C14 alkyl dimethyl, chloridesquaternary ammonium compounds, C12-C14 alkyl(ethylphenyl) methyl) dimethyl, chloridesquaternary ammonium compounds, di-C8-CIO alkyl dimethyl, chlorideschlo

7、roxylenol7173-51-511119-94-4112-00-526062-79-31407-03-05538-94-3121-54-07281-04-163449-41-268424-85-185409-22-985409-23-068424-95-389-83-888-04-027雙癸基二甲基漠化皎didecyl dimethylammonium bromide2390-68-328西曲漠皎cetrimide8044-71-129度米芬Domiphen Bromide538-71-630六亞甲基四胺（烏洛托品）HexamethylenetetramineUrotropin/Meth

8、enamine100-97-031醋酸氯己定chlorhexidine Acetate56-95-132聚六亞甲基雙服鹽酸鹽poly (hexamethylenebiguanide)hydrochloride32289-58-033葡萄糖酸氯己定Chlorhexidine Gluconate Solution(Chlorhexidine digluconate)18472-51-034鹽酸聚六亞甲基服polyhexamethyleneguanidinehydrochloride57028-96-335苯甲酸Benzoic Acid65-85-036丙酸Propionic Acid79-09-4

9、37次氯酸Hypochlorous acid7790-92-338甘草酸Glycyrrhizic Acid1405-86-339甘草亭酸Glycyrrhetinic Acid471-53-440酪氨酸Tyrosine60-18-441檸檬酸citric acid77-92-942硼酸Boric Acid11113-50-143L-乳酸L-(+)-lactic acid79-33-444乳酸Lactic Acid50-21-545山梨酸Sorbic Acid22500-92-146H烯酸Undecylenic Acid112-38-947水楊酸Salicylic Acid69-72-748辛酸C

10、aprylic Acid124-07-249乙酸acetic acid64-19-750硬脂酰基甘草酸Stearyl Glycyrrhetinate13832-70-751苯甲酸鈉Sodium Benzoate532-32-152次氯酸鈣calcium hypochlorite7778-54-353次氯酸鈉Active chlorine released from sodium hypochlorite7681-52-954甘草酸二鉀Dipotassium Glycyrrhizate68797-35-355高鎰酸鉀Potassium Permanganate7722-64-756焦亞硫酸鈉So

11、dium Metabisulfite7681-57-457山梨酸鉀Potassium Sorbate509-00-0158H烯酸鋅Zinc Undecylenate557-08-459辛酸鈉Sodium Caprylate1984-06-160苯甲醇Benzyl Alcohol100-51-661三氯叔丁醇Chlorobutanol6001-64-562乙醇Alcohol (ethyl alcohol)64-17-563異丙醇Isopropyl alcohol67-63-064正丙醇Propan-l-ol71-23-865二氯異氧尿酸鈉sodium dichloroisocyanurat289

12、3-78-966二氧化氯chlorine dioxide10049-04-467三氯均二苯脈（三氯卡班）3,4,4-trichloro-carbanil id/triclo carban101-20-268三氯生Triclosan3380-34-569三氯異氧尿酸t(yī)richloroisocyanuric aicde87-90-170過氧化氫Hydrogen peroxide7722-84-171過氧乙酸Peracetic acid79-21-072苯甲基氯化物2-methylbenzhydryl chloride41870-52-473過氧苯甲酰Benzoyl Peroxide94-36-07

13、4甲紫Methylrosanilinium Chloride8004-87-375碘Iodine7553-56-276聚維酮碘Povidone Iodine25655-41-877羥苯節(jié)酯Benzyl Hydroxybenzoate94-18-878羥苯丙酯Propylparaben94-13-379羥苯丁酯Butylparaben94-26-880羥苯甲酯Methylparaben99-76-381羥苯乙酯Ethylparaben120-47-882羥苯丙酯鈉Sodium Propyl Parahydroxybenzoate35285-69-983羥苯甲酯鈉Sodium Methyl Par

14、ahydroxybenzoate5026-62-084羥基二氯二苯酰5-chloro-2-(4-chlorphenoxy)phenol(DCPP)3380-30-185硫磺Sulfur7704-34-986硫酸羥嗟詠Oxyquinoline Sulfate134-31-687尿囊素Allantoin97-59-688硼砂Borax1303-96-489氧化鋅Zinc Oxide1314-13-290乳酸依沙叩呢Ethacridine Lactate1837-57-691銀離子silver7440-22-492魚石脂Ichthammol8029-68-393溶菌酶lysozyme9001-63-294溶葡萄球菌酶lysostaphin9011-93-2四、禁用物質(zhì)抗（抑）菌劑中禁止添加列入中華人民共和國藥典（2015年版）（消毒防腐類藥物除外）的藥品及其同名原料；以 微生物、細(xì)胞、動(dòng)物或人源組織和體液等為起始原材