CN101856333B - 头孢孟多酯钠冻干粉针制剂及其制备方法 - Google Patents
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Abstract
本发明涉及一种头孢孟多酯钠冻干粉针制剂，由头孢孟多酯钠冻干粉针原料药，按使用剂量包装得到；所述头孢孟多酯钠冻干粉针原料药由下法得到：将头孢孟多酯钠原料药用水溶解，用0.22μm-1.0μm的膜过滤，将滤液置于冻干机冷冻干燥得到。本发明采用过滤的方法，减少原料药中头孢孟多的含量，并使头孢孟多酯钠达95％以上，冷冻干燥，得到新的原料药，直接按使用剂量分装，得到头孢孟多酯钠冻干粉针制剂。得到的制剂溶解性好，各项指标符合药典要求，不含碳酸钠，不会产生二氧化碳，解决了使用中的问题。本发明所得的头孢孟多酯钠冻干粉针，稳定性好，溶解速度快，仅含微量的头孢孟多，不影响溶解性，不需要加入碳酸钠，直接分装制剂。
Description
技术领域
本发明涉及一种头孢孟多酯钠冻干粉针制剂，本发明还涉及这种冻干粉针制剂的制备方法。
背景技术
头孢孟多酯钠化学式为7-D-(2-甲酰氧苯乙酰胺)-3[(1-甲基-1H-四唑-5基)巯甲基]-3头孢烯-4-羧酸钠盐，分子式为C19H17N6NaO6S2，为第二代头孢菌素，应用于敏感的革兰阴性菌所致的呼吸道、泌尿生殖系、皮肤和软组织、骨和关节、咽耳鼻喉等部位感染以及腹膜炎、败血症等。对胆道和肠道感染有较好疗效。
目前，头孢孟多酯钠多为注射用粉针制剂，其中含有少量的头孢孟多，因此需要在制剂中加入碳酸钠作为助溶剂，配制注射液时会产生大量的二氧化碳，给使用带来不方便。
虽然，肌肉和皮下注入空气对人不会造成致命的危害。但多量空气迅速进入血循环或溶解于血液内的气体迅速游离形成气泡，阻塞血管所引起的栓塞。前者为空气栓塞，多发生于静脉破裂后空气的进入，如头颈、胸壁和肺的创伤性手术以及分娩时，若迅速进入静脉的空气量超过100ml可导致心力衰竭；后者(即溶解于血液内的气体迅速游离形成气泡)为高气压环境急速转到低气压环境的减压过程中发生的气体栓塞，故又称减压病。
发明内容
本发明的目的在于克服上述现有背景技术的不足之处而提供一种头孢孟多酯钠冻干粉针制剂。本发明得到的头孢孟多酯钠冻干粉针制剂，降低了头孢孟多的含量，纯度高，不需要在制剂中加入碳酸钠，使用方便。
本发明的另一目的在于提供一种上述头孢孟多酯钠冻干粉针制剂的制备方法。
本发明的目的是通过如下措施来达到的：头孢孟多酯钠冻干粉针剂，由头孢孟多酯钠冻干粉针原料药，按使用剂量包装得到；所述头孢孟多酯钠冻干粉针原料药由下法得到：将头孢孟多酯钠原料药用水溶解，用0.22μm-1.0μm的膜过滤，将滤液置于冻干机冷冻干燥得到。
头孢孟多酯钠冻干粉针剂的制备方法，包括如下步骤：头孢孟多酯钠原料药用水溶解，用滤膜过滤，置于冻干机冷冻干燥，得头孢孟多酯钠冻干粉针原料药，按使用剂量分装，得到头孢孟多酯钠冻干粉针制剂。
在上述技术方案中，所述滤膜为孔径为0.22μm-1.0μm。
在上述技术方案中，所述滤膜为孔径为0.22μm-0.45μm。
本发明采用过滤的方法，减少原料药中头孢孟多的含量，并使头孢孟多酯钠达95％以上，冷冻干燥，得到新的原料药，直接按使用剂量分装，得到头孢孟多酯钠冻干粉针制剂。得到的制剂溶解性好，各项指标符合药典要求，不含碳酸钠，不会产生二氧化碳，解决了使用中的问题。
本发明所得的头孢孟多酯钠冻干粉针，稳定性好，溶解速度快，仅含微量的头孢孟多，不影响溶解性，不需要加入碳酸钠，直接分装制剂。
头孢孟多酯钠冻干粉针的有关特性研究
1、头孢孟多含量
取以上制备的头孢孟多酯钠冻干粉针与原料药对照，按药典要求的方法检测头孢孟多的含量，结果见表1，本专利制备的样品中头孢孟多的含量仅为0.31％，而对照品中头孢孟多的含量为7.8％，药典规定不能大于9.5％。
表1头孢孟多含量检测结果：
2、头孢孟多酯钠冻干粉针的溶解性
取以上制备的头孢孟多酯钠冻干粉针与原料药对照，按药典要求做溶液的澄清度、可见异物、不溶性微粒检测，均符合药典标准。
取以上制备的头孢孟多酯钠冻干粉针与原料药及原料药+碳酸钠对照，比较三者的溶解速度，结果如表2，本发明制备的头孢孟多酯钠冻干粉针原料药的溶解性明显提高。
表2溶解速度比较
| 溶解速度 | |
| 本发明制备样品 | 30s |
| 市售原料药 | 大于30min |
| 市售原料药+碳酸钠 | 57s |
3、头孢孟多酯钠冻干粉针的稳定性
取本发明方法制备的头孢孟多酯钠冻干粉针进行高湿试验，并与市购头孢孟多酯钠粉针做对照，于40℃下置相对湿度为75％的恒温恒湿箱中，放置10天，分别于第2、4、6、8、10天取样检定，结果与0天样品检验结果比较。结果见表1
表1在40℃，湿度为75％条件下的稳定性、吸湿性，澄清度试验结果：
4、头孢孟多酯钠冻干粉针制剂
取以上制备的头孢孟多酯钠冻干粉针制剂与市售头孢孟多酯钠粉针制剂对照。质量均符合药典要求。在溶解的时候，本发明制备的制剂迅速溶解，不产生气泡。而市售头孢孟多酯钠粉针制剂溶解时产生大量的气泡。
具体实施方式
头孢孟多酯钠冻干粉针剂，它是将头孢孟多酯钠冻干粉针原料药，按使用剂量包装，得到头孢孟多酯钠冻干粉针制剂；所述头孢孟多酯钠冻干粉针原料药的制备方法为：将头孢孟多酯钠原料药用水溶解，用0.22μm-1.0μm的膜过滤，将滤液置于冻干机冷冻干燥得到。
头孢孟多酯钠冻干粉针剂的制备方法，包括如下步骤：头孢孟多酯钠原料药用水溶解，用滤膜过滤，置于冻干机冷冻干燥，得头孢孟多酯钠冻干粉针原料药，按使用剂量分装，得到头孢孟多酯钠冻干粉针制剂。所述滤膜为孔径为0.22μm-1.0μm。所述滤膜为孔径为0.22μm-0.45μm(优选方案)。
实施例1
称取头孢孟多酯钠原料200g，置于100ml烧杯中，加入50ml水溶解。用0.45μm的膜过滤，滤液冻干，得头孢孟多酯钠冻干粉针。25s内完全溶解于注射用水中。
实施例2
称取头孢孟多酯钠原料2000g，置于1000ml烧杯中，加入500ml水溶解。用0.22μm的膜过滤，滤液冻干，得头孢孟多酯钠冻干粉针。20s内完全溶解于注射用水中。
实施例3
称取头孢孟多酯钠原料2000g，置于1000ml烧杯中，加入500ml水溶解。用1.0μm的膜过滤，滤液冻干，得头孢孟多酯钠冻干粉针。30s内完全溶解于注射用水中。
实施例3
称取头孢孟多酯钠冻干粉针若干，粉碎后过60目筛，在无菌室内100级条件下，按装量要求进行无菌分装，即得药品注射用头孢孟多酯钠冻干粉针。装量可以是但不仅仅是0.5g、1g、2g每瓶。
实施例4
头孢孟多酯钠冻干粉针的冻干工艺如下，但不仅限于如下方案：
药液迅速冻结到-40℃，然后冷凝器降温至-50℃，抽真空至10Pa以下，开始升温，第一阶段：-40℃～-30℃，时间8小时，第二阶段：-30℃～0℃，时间6小时，第三阶段：0℃～30℃，时间7小时。30℃后继续保温3小时。
Claims (2)
1.头孢孟多酯钠冻干粉针剂的制备方法，其特征在于，包括如下步骤：将头孢孟多酯钠用水溶解，用0.22μm-1.0μm滤膜过滤，将滤液置于冻干机冷冻干燥，得头孢孟多酯钠冻干粉针原料药，然后按使用剂量分装，得到头孢孟多酯钠冻干粉针制剂；所述冷冻干燥条件为：将滤膜冻结到-40℃，然后冷凝器降温至-50℃，抽真空至10Pa以下，开始升温，第一阶段：-40～-30℃，时间8小时，第二阶段：-30℃～0℃，时间6小时，第三阶段：0℃～30℃，时间7小时；30℃后继续保温3小时。
2.根据权利要求1所述的制备方法，其特征在于所述滤膜孔径为0.22μm-0.45μm。
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