硼酸
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生产批文：国药准字H20074137
符合标准：CP2015
英文名：Boric Acid
生产单位：南昌白云药业有限公司
- 包装规格：
- 小批量采购
供应商：上海泛科史康医药科技有限公司
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中文名称 硼酸
英文名称 Boric Acid
中文别名 正硼酸；焦硼酸
英文别名 Acidum boricum; boracic acid; boraic acid; Borofax; boron trihydroxide; E284; orthoboric acid; trihydroxyborene.
化学名称 硼酸
CAS号 10043-35-3
UNII(唯一标识码) R57ZHV85D4
分 子 式 H3BO3
分 子 量 61.83
结 构 式
分 类 pH值调节剂;抑菌防腐剂
用 途
本品具有酸化、抑菌等作用。在药剂中作pH值调节剂、抑菌防腐剂等。[1]
Boric acid is used as an antimicrobial preservative in eye drops,cosmetic products, ointments, and topical creams. It is also used as an antimicrobial preservative in foods.Boric acid and borate have good buffering capacity and are used to control pH; they have been used for this purpose in external
preparations such as eye drops.Boric acid has also been used therapeutically in the form of suppositories to treat yeast infections.In dilute concentrations it is used as a mild antiseptic, with weak bacteriostatic and fungistatic properties, although it has generally been superseded by more effective and less toxic disinfectants. [2]
[1]萧三贯.最新国家药用辅料标准手册[M].中国医药科技电子出版社
[2] Raymond C Rowe,Paul J Sheskey and Marian E Quinn[M].Handbook of Pharmaceutical Excipients, 6th Ed. RPS Publishing,UK
给药途径
耳用、眼用、外用[1]
[1]FDA. Inactive Ingredient Search for Approved Drug Product［EB/OL］.(2010-10-22)[2010-12-23].http://db.yaozh.com/fdafuliao
储存条件
Boric acid is hygroscopic and should therefore be stored in an air-tight, sealed container. The container must be labeled ‘Not for Internal Use’.
[1] Raymond C Rowe,Paul J Sheskey and Marian E Quinn[M].Handbook of Pharmaceutical Excipients, 6th Ed. RPS Publishing,UK
安 全 性
Boric acid is a weak bacteriostatic and antimicrobial agent, and has been used in topical preparations such as eye lotions, mouthwashesand gargles. It has also been used in US- and Japanese-approved intravenous products. Solutions of boric acid were formerly used to wash out body cavities, and as applications to wounds and ulcers, although the use of boric acid for these purposes is now regarded as inadvisable owing to the possibility of absorption.
Boric acid is not used internally owing to its toxicity. It is poisonous by ingestion and moderately toxic by skin contact. Experimentally it has proved
to be toxic by inhalation and subcutaneous routes, and moderately toxic by intraperitoneal and intravenous routes. Boric acid is absorbed from the gastrointestinal tract and from damaged skin, wounds, and mucous membranes, although it does not readily permeate intact skin. The main symptoms of boric acid poisoning are abdominal pain, diarrhea, erythematous rash involving both skin and mucous membrane, and vomiting. These symptoms may be followed by desquamation, and stimulation or depression of the central nervous system. Convulsions, hyperpyrexia, and renal tubular damage have been known to occur.
Death has occurred from ingestion of less than 5 g in young children, and of 5–20 g in adults. Fatalities have occurred most frequently in young children after the accidental ingestion of solutions of boric acid, or after the application of boric acid powder to abraded skin.
The permissible exposure limit (PEL) of boric acid is 15mg/m3 total dust, and 5mg/m3 respirable fraction for nuisance dusts.
LdLo (man, oral): 429mg/kg
LdLo (woman, oral): 200mg/kg
LdLo (infant, oral): 934mg/kg
LdLo (man, skin): 2.43 g/kg
LdLo (infant, skin): 1.20 g/kg
LD50 (mouse, oral): 3.45 g/kg
LD50 (mouse, IV): 1.24 g/kg
LD50 (mouse, SC): 1.74 g/kg
LD50 (rat, oral): 2.660 g/kg
LD50 (rat, IV): 1.33 g/kg
LD50 (rat, SC): 1.4 g/kg
[1] Raymond C Rowe,Paul J Sheskey and Marian E Quinn[M].Handbook of Pharmaceutical Excipients, 6th Ed. RPS Publishing,UK
禁 忌
Boric acid is incompatible with water, strong bases and alkali metals. It reacts violently with potassium and acid anhydrides. It also forms a complex with glycerin, which is a stronger acid than boric acid. [1]
[1] Raymond C Rowe,Paul J Sheskey and Marian E Quinn[M].Handbook of Pharmaceutical Excipients, 6th Ed. RPS Publishing,UK
来源与制备
在自然界中存在有天然硼砂矿、硼砂（MgO，B2O3），一般用中和法和碳氨法可制成本品。中和法是将硼砂溶解，加入盐酸和硫酸中和，经结晶、分离、干燥而成。碳氨法是将硼砂粉与碳酸氢铵溶液混合后，加热分解成硼酸铵液料，再经脱氨而成[1]。
[1]萧三贯.最新国家药用辅料标准手册[M].中国医药科技电子出版社
管理情况
Accepted for use as a food additive in Europe. Included in the FDA Inactive Ingredients Database (IV injections; ophthalmic preparations; (auricular) otic solutions; topical preparations). Reported in the EPA TSCA Inventory. In the UK, the use of boric acid in cosmetics and toiletries is restricted. Included in the Canadian List of Acceptable Non-medicinal Ingredients. [1]
[1] Raymond C Rowe,Paul J Sheskey and Marian E Quinn[M].Handbook of Pharmaceutical Excipients, 6th Ed. RPS Publishing,UK
信息来源 北京大学医学部
- 南昌白云药业有限公司成立于1989年，地处江西省南昌市青山湖区风景秀丽的赣江之滨，交通便利，厂区占工面积36000平方米，建筑面积15000平方米。 ??经过二十余载的发展，在外用溶液剂行业中第一家通过GMP认证，已成为一家集生产、研发为一体的高科技制药企业，现在大中专学历、工程技术人员占职工总数的35%，高级工程师、药剂师、大学本科生形成了坚强的技术骨干和管理力量，使企业日渐成为全国外用药及原料药生产基地，在全国同行业中名列前驱。 ??●先进的生产条件，严格的质量管理 ??公司生产设备先进，配套设施完备，建有通过国家GMP认证的标准化厂房和气相色谱仪等精密检验设置，已形成完善的QA、QC体系和级质量监督网，自原辅料采购、检验到生产、包装、入库、销信等环节严格执行国家药品生产质量管理规范和《中华人同共和国药品管理法》。
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