Added substances Many of added substances to injection are a antibacterial preservatives, buffers ■ solubilizers, a antioxidants, and other pharmaceutical adjuncts
Added substances Many of added substances to injection are antibacterial preservatives, buffers, solubilizers, antioxidants, and other pharmaceutical adjuncts
For the following preservatives, the indicated maximum limits prevail for use in a parenteral product unless otherwise directed: I for agents containing mercury and the cationic, surface-active compounds, 0.01%, ■ for agents like chlorobutanol(氯代丁醇), cresol(甲酚), and phenol(〔苯酚),0.5%; I for sulfur dioxide as an antioxidant or for an equivalent amount of the sulfite(亚硫酸盐) bisulfite, or metabisulfite of potassium or sodium,0.2%.(亚硫酸氢盐或钾和钠的焦亚硫酸盐)
For the following preservatives, the indicated maximum limits prevail for use in a parenteral product unless otherwise directed: for agents containing mercury and the cationic, surface-active compounds, 0.01%; for agents like chlorobutanol（氯代丁醇）, cresol（甲酚）, and phenol（苯酚）, 0.5%; for sulfur dioxide as an antioxidant, or for an equivalent amount of the sulfite（亚硫酸盐）, bissulfite, or metabisulfite of potassium or sodium, 0.2%. （亚硫酸氢盐或钾和钠的焦亚硫酸盐）
The air within an injectable product is frequently replaced with an inert gas, such as nitrogen, to enhance the stability of the product
The air within an injectable product is frequently replaced with an inert gas, such as nitrogen, to enhance the stability of the product
常用的附加剂 (1)pH调节剂盐酸、氢氧化钠、碳酸氢钠 枸橼酸缓冲液、酒石酸缓冲液和磷酸盐缓 冲液等 2)表面活性剂聚山梨酯类(常用聚山梨 酯80)、聚氧乙烯蓖麻油、泊洛沙姆188, 卵磷脂等,作为增溶、润湿、乳化剂使用。 (3)助悬剂PVP、明胶、甲基纤维素、羧 甲基纤维素钠等,用于混悬型注射剂
常用的附加剂 （1）pH调节剂 盐酸、氢氧化钠、碳酸氢钠、 枸橼酸缓冲液、酒石酸缓冲液和磷酸盐缓 冲液等。 （2）表面活性剂 聚山梨酯类（常用聚山梨 酯80）、聚氧乙烯蓖麻油、泊洛沙姆188、 卵磷脂等，作为增溶、润湿、乳化剂使用。 （3）助悬剂 PVP、明胶、甲基纤维素、羧 甲基纤维素钠等，用于混悬型注射剂
(4)延缓氧化的附加剂 抗氧剂常用亚硫酸钠、亚硫酸氢钠、焦亚 硫酸钠、硫代硫酸钠;螯合剂常用EDTA钠 盐;惰性气体常用二氧化碳或氮气。 (5)等渗调节剂 常用氯化钠、葡萄糖。 (6)局部止痛剂 苯甲醇、三氯叔丁醇、盐酸普鲁卡因、利 多卡因
（4）延缓氧化的附加剂 抗氧剂常用亚硫酸钠、亚硫酸氢钠、焦亚 硫酸钠、硫代硫酸钠；螯合剂常用EDTA钠 盐；惰性气体常用二氧化碳或氮气。 （5）等渗调节剂 常用氯化钠、葡萄糖。 （6）局部止痛剂 苯甲醇、三氯叔丁醇、盐酸普鲁卡因、利 多卡因