硼酸(药用辅料)

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,UKAccepted 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it is used as a mild antiseptic, with weak bacteriostatic and fungistatic properties, although it has generally been superseded by more effective and less toxic disinfectants.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,UKBoric 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.cfmR57ZHV85D4Boric 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