硼酸(藥用輔料)

穩(wěn)定性和貯藏條件管理情況功能安全給藥途徑唯一成分標(biāo)識(shí)配伍禁忌來(lái)源

中文名稱	硼酸(藥用輔料)
中文同義詞	硼酸(藥用輔料)
英文名稱	Boric acid (medicinal excipients)
英文同義詞
CAS號(hào)
分子式
分子量	0
EINECS號(hào)
相關(guān)類別
Mol文件	Mol File
結(jié)構(gòu)式

硼酸(藥用輔料) 性質(zhì)

硼酸(藥用輔料) 用途與合成方法

穩(wěn)定性和貯藏條件

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

管理情況

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

功能

本品具有酸化、抑菌等作用。在藥劑中作pH值調(diào)節(jié)劑、抑菌防腐劑等。[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it is used as a mild antiseptic, with weak bacteriostatic and fungistatic properties, although it has generally been superseded by more effective and less toxic disinfectants.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]蕭三貫.最新國(guó)家藥用輔料標(biāo)準(zhǔn)手冊(cè)[M].中國(guó)醫(yī)藥科技電子出版社[2] Raymond C Rowe,Paul J Sheskey and Marian E Quinn[M].Handbook of Pharmaceutical Excipients, 6th Ed. RPS Publishing,UK

安全

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

給藥途徑

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://www.accessdata.fda.gov/scripts/cder/iig/getiigWEB.cfm

唯一成分標(biāo)識(shí)

R57ZHV85D4

配伍禁忌

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

來(lái)源

在自然界中存在有天然硼砂礦、硼砂（MgO，B2O3），一般用中和法和碳氨法可制成本品。中和法是將硼砂溶解，加入鹽酸和硫酸中和，經(jīng)結(jié)晶、分離、干燥而成。碳氨法是將硼砂粉與碳酸氫銨溶液混合后，加熱分解成硼酸銨液料，再經(jīng)脫氨而成[1]。[1]蕭三貫.最新國(guó)家藥用輔料標(biāo)準(zhǔn)手冊(cè)[M].中國(guó)醫(yī)藥科技電子出版社

安全信息

MSDS信息

硼酸(藥用輔料) 上下游產(chǎn)品信息