通用名

BP：Croscarmellose Sodium

JP：Crosmellosum natricum conexum

PhEur：Maydis oleum raffinatum

USPNF：Croscarmellose Sodium

别名

交联CMC-Na；交联SCMC

化学名和CAS注册号

cellulose，carboxymethyl ether，sodium salt，crosslinked [74811-65-7]

分子式  分子量

交联羧甲纤维素钠是羧甲纤维素钠的交联聚合物。

见羧甲纤维素钠。

制造工艺

纤维素碱的制备可将来源于木浆或棉纤维的纤维素在氢氧化钠溶液中浸渍。然后将碱化纤维素与一氯醋酸钠反应得到羧甲纤维素钠。待取代反应完成，且全部氢氧化钠耗尽后，过量的一氯醋酸钠缓慢水解为羟基乙酸。羟基乙酸将部分羧甲基钠基团转化为游离酸，并催化交联生成交联羧甲纤维素钠。随后用醇水提取交联羧甲纤维素钠,除去残留的氯化钠和羟基乙酸钠。纯化后的交联羧甲纤维素钠的纯度大于99.5%。可以将交联羧甲纤维素钠磨碎，降低聚合物纤维的长度，从而改善其流动性。

类别

片剂、胶囊剂的崩解剂。

制剂应用

交联羧甲纤维素钠在口服剂型中用作胶囊剂、片剂和颗粒剂的崩解剂。

片剂中，交联羧甲纤维素钠适用于直接压片和湿法制粒压片工艺。湿法制粒时，交联羧甲纤维素钠可分别于润湿阶段或干燥阶段加入（颗粒内加和颗粒外加），这样可以最好发挥崩解剂的毛细管和溶胀作用。交联羧甲纤维素钠用作崩解剂时，浓度可达5%，但通常直接压片工艺中的用量为2%，湿法制粒压片时为3%。见表Ⅰ。

表Ⅰ：交联羧甲纤维素钠的应用

性状

交联羧甲纤维素钠为无臭、白色或灰白色粉末。

药典标准

见表Ⅱ。

表Ⅱ：交联羧甲纤维素钠的药典标准

一般性质

黏合指数：0.0456

脆碎指数：0.1000

溶解度：不溶于水，但当与水接触后，交联羧甲纤维素钠体积迅速溶胀至原体积的4~8倍。

比表面积：0.81~0.83 m²/g

稳定性和贮藏条件

交联羧甲纤维素钠稳定，但具吸湿性。

以交联羧甲纤维素钠为崩解剂、采用直接压片工艺制备的模型片，30℃贮存14个月后，其溶出度无显著改变。

交联羧甲纤维素钠应置于密闭容器中，于阴凉、干燥处贮存。

配伍禁忌

无论是湿法制粒或直接压片工艺，含有吸湿性辅料（例如山梨醇）可造成崩解剂（如交联羧甲纤维素钠）的效率稍微降低。

交联羧甲纤维素钠与强酸，或者铁或其他金属（例如铝、汞、锌）的可溶性盐有配伍禁忌。

安全性

交联羧甲纤维素钠主要用作口服制剂的崩解剂，通常认为无毒、无刺激性。大量口服可能有缓泻作用，但固体制剂处方中的用量不大可能导致这一问题。

英国，交联羧甲纤维素钠允许应用于营养保健品中。

由于其类似物质羧甲纤维素钠达到起效的必需剂量不足以危害健康，因此，WHO未规定其作为食品填加剂的日允许摄取量。

另见羧甲纤维素钠。

操作注意事项

遵守材料操作的环境及数量相应的常规注意事项。交联羧甲纤维素钠对眼有刺激性；建议对眼睛采取保护措施。

法规

收载于FDA《非活性组分指南》（口服胶囊剂和片剂）。英国已许可用于非注射用制剂中。

同类物质

羧甲纤维素钙；羧甲纤维素钠。

注释

交联羧甲纤维素钠一般取代度（DS）为0.7。

Mingtai is a leading worldwide pharmaceutical excipient and food ingredient manufacturer since1972, devoted to improving its quality in all aspects. Under the leadership of Mingtai's founder – Mr. Mark Chen, President since 1972, and now joined by the 2nd generation – Peter Chen, Chief Operating Officer, the quest by the organization for the highest quality standards has not wavered and continues to be the business philosophy. 
The quality of Mingtai's products has gained the acceptance and recognition of worldwide users. The pharmaceutical grades are critical ingredients in solid dosage forms (such as tablets and capsules) due to their functional roles as tablet binders and disintegrants. Mingtai's product range also includes hydrocolloids derived from natural sources which are used as stabilizers, viscosity enhancers and texture modifiers in pharmaceutical liquid dosage forms and in various food systems. ISO-9000 and ISO-14000 certification of our quality and environmental management systems, IPEC's audit of our GMP compliance and customer's satisfaction are testaments to Mingtai's global quality standards.

Plant automation and the most advanced manufacturing equipment allow us provide tailor-made services such as customized products and packages. In joint research programs with renowned local or worldwide academic organizations and cooperative projects with companies in the pharmaceutical and food industries, Mingtai seeks to further advance the knowledge and range of product applications.

Mingtai has established an efficient worldwide network of more than 70 distribution partners, thus taking advantage of the synergies of an efficient global manufacturer / supplier and the presence of local knowledge from the distributors to capture growth opportunities and eventually provide the best services to the customers.

Continuing improvement, innovation and product diversification will enable us to continue to grow in this market and better serve our valued customers.