CN109953997B - 一种替米考星制剂的制备方法 - Google Patents
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Abstract
本发明公开了一种替米考星制剂的制备方法,其包括如下工艺步骤:取聚乙二醇6000作为载体,加入载体质量1~3%的阴离子表面活性剂后于60℃恒温水浴中加热使其全部熔融,再边搅拌边加入替米考星原料药至完全融解,按质量计药载比为1:2,后迅速倒入预冷的不锈钢容器中,依次置于‑20℃冰箱中固化、35~40℃干燥箱中干燥,最后经研碎、过80目筛,得成品。本发明解决了现有替米考星制剂不溶于水、味苦、生物利用度低的问题,采用固体分散体技术制备得能够掩盖苦味、溶于水,生物利用度高的替米考星制剂,其方便饮水给药,可及时治疗疾病,从而能给养殖业带来更大的方便以及利益。
Description
技术领域
本发明涉及生物医药领域,特别涉及一种替米考星制剂的制备方法。
背景技术
替米考星是一种由泰乐菌素半合成的新型大环内酯类畜禽专用抗生素,对革兰氏阳性菌和部分革兰氏阴性菌、支原体、螺旋体等均有良好的抑制作用,对胸膜肺炎放线菌、巴氏杆菌具有比泰乐菌素更强的抗菌活性,与临床常用抗生素无交差耐药性。临床上主要用于动物呼吸道疾病和泌乳动物的乳腺炎,尤其在治疗猪呼吸道病综合征和猪繁殖与呼吸综合征时表现出显著的优越性。但替米考星具有一定的刺激性,替米考星主要采取内服和皮下注射方式给药,尤其对猪慎用注射给药,导致其在兽医临床上推广应用受到限制。
替米考星在水中极难溶解,具有较强的苦味,口服对胃部黏膜有刺激,生物利用度较低,市场上主要制剂是其磷酸盐,内服后易被胃酸破坏,吸收不完全,生物利用度低,体内半衰期短。在兽医临床上主要通过拌料给药,由于动物患病时易食欲不振,不能起到及时治疗疾病的作用。因此,提高替米考星的水溶性、生物利用度、靶向性,延长其在体内的半衰期,增强疗效,已成为当前替米考星高效利用研究的重要课题之一。
近几年来,微囊、微球、微丸、纳米乳、肠溶包衣颗粒、包合物、脂质体、固体分散体等新技术在替米考星制剂的研究中得到了应用,在一定程度上,提高了药物的溶解度,掩盖了替米考星的苦味,并且具有缓释,靶向的作用。但是替米考星靶向作用于肺泡巨噬细胞,本身就有靶向治疗的作用,并且对于一些急性病,缓释制剂并不能起到及时治疗的作用,大部分技术需要加入有机试剂,且用量较大,成本较高,且有时难以除尽,污染环境,目前,这些制剂新技术还未在实际的生产中得到应用。
发明内容
本发明的目的在于针对上述现有技术的不足,提供一种替米考星制剂的制备方法,其制备得的替米考星固体分散体载药量高、能够快速溶于水,对及时治疗疾病具有重要的临床应用价值。
本发明所采取的技术方案是:一种替米考星制剂的制备方法,其包括如下工艺步骤:取聚乙二醇6000作为载体,加入载体质量1~3%的阴离子表面活性剂后于60℃恒温水浴中加热使其全部熔融,再边搅拌边加入替米考星原料药至完全融解,按质量计药载比为1:2,后迅速倒入预冷的不锈钢容器中,依次置于-20℃冰箱中固化、35~40℃干燥箱中干燥,最后经研碎、过80目筛,得成品。
本发明采用熔融法制备替米考星固体分散体,无需加入有机试剂等助溶剂,区别于传统的溶剂法制备替米考星制剂,其具有较安全、无污染、制备方法简单、有利于大规模工业化生产的优点。
作为上述方案的进一步改进,所述阴离子表面活性剂为十二烷基硫酸钠。具体地,十二烷基硫酸钠具有较好的分散性能和助溶作用,使替米考星均匀的分散于载体中,形成分散均一的固体分散体,使替米考星固体分散体更快融解。
作为上述方案的进一步改进,所述搅拌的搅拌时间为2h。
作为上述方案的进一步改进,所述固化的固化时间为12h。
本发明的有益效果是:本发明解决了现有替米考星制剂不溶于水、味苦、生物利用度低的问题,采用固体分散体技术制备得能够掩盖苦味、溶于水,生物利用度高的替米考星制剂,其方便饮水给药,可及时治疗疾病,从而能给养殖业带来更大的方便以及利益。
具体实施方式
下面结合实施例对本发明进行具体描述,以便于所属技术领域的人员对本发明的理解。有必要在此特别指出的是,实施例只是用于对本发明做进一步说明,不能理解为对本发明保护范围的限制,所属领域技术熟练人员,根据上述发明内容对本发明作出的非本质性的改进和调整,应仍属于本发明的保护范围。同时下述所提及的原料未详细说明的,均为市售产品;未详细提及的工艺步骤或制备方法为均为本领域技术人员所知晓的工艺步骤或制备方法。
实施例
1、实验试剂与药品
替米考星原料药、PEG6000、十二烷基硫酸钠
2、制备固体分散体
取载体PEG6000置于烧杯中,加入载体质量1~3%的十二烷基硫酸钠,60℃水浴加热使其熔融,加入替米考星原料药,边加边搅拌,使替米考星原料药完全融于介质中,继续搅拌至一定时间。从水浴中取出烧杯,迅速倒入预冷的不锈钢托盘中,然后转移至-20℃的冰箱固化,取出置35~40℃鼓风干燥箱干燥,从托盘中取出,研碎,过80目筛,密封避光保存得本发明的替米考星制剂成品。
3、筛选方法
体外溶出度测定:按《中华人民共和国兽药典》2015年版一部附录160第二法(桨法)测试药物溶出度。
取替米考星原药、本发明的替米考星制剂成品适量(相当于替米考星原药100mg),溶出介质为经脱气处理的蒸馏水900mL,温度37℃,转速100r/min,分别与2、5、10、15、20、30、45和60min定量取样5mL,同时补充等量同温介质5mL,经0.22μm微孔滤膜过滤,高效液相色谱法分别测定峰面积,计算出不同时间样品液的浓度,求算药物的累积溶出度。
4、制备工艺筛选(正交试验)
表1正交试验设计因素和水平表
水平因素 | 药载比 | 搅拌时间(h) | 固化时间(h) |
1 | 1∶1 | 1 | 4 |
2 | 1∶2 | 2 | 8 |
3 | 1∶3 | 3 | 12 |
表2正交试验设计表
表3 1h内累积溶出度表(%)
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | |
2min | 17.09 | 15.56 | 17.26 | 17.03 | 16.71 | 16.57 | 28.32 | 20.68 | 22.61 |
5min | 32.50 | 28.86 | 29.27 | 30.01 | 31.52 | 29.97 | 46.71 | 37.27 | 36.65 |
10min | 49.57 | 45.33 | 46.45 | 46.47 | 47.75 | 46.03 | 63.64 | 55.01 | 54.07 |
15min | 60.01 | 57.48 | 59.41 | 60.46 | 59.18 | 57.81 | 73.13 | 66.17 | 64.79 |
20min | 68.23 | 65.60 | 68.43 | 68.52 | 67.24 | 65.95 | 79.57 | 74.16 | 73.03 |
30min | 78.06 | 78.25 | 79.15 | 80.45 | 77.90 | 77.30 | 85.83 | 82.70 | 81.78 |
45min | 84.75 | 84.10 | 86.36 | 88.79 | 85.71 | 85.51 | 88.76 | 88.35 | 86.86 |
60min | 89.69 | 90.38 | 94.28 | 95.10 | 94.85 | 94.33 | 91.69 | 94.66 | 89.86 |
根据正交试验结果分析,A2>A3>A1,B2>B3>B1,C3>C1>C2,最优制备工艺为A2B2C3,即药载比1:2,搅拌时间2h,固化时间12h。
上述实施例为本发明的优选实施例,凡与本发明类似的工艺及所作的等效变化,均应属于本发明的保护范畴。
Claims (1)
1.一种替米考星制剂的制备方法,其特征在于包括如下工艺步骤:取聚乙二醇6000作为载体,加入载体质量1~3%的阴离子表面活性剂后于60℃恒温水浴中加热使其全部熔融,再边搅拌边加入替米考星原料药至完全融解,按质量计药载比为1:2,后迅速倒入预冷的不锈钢容器中,依次置于-20℃冰箱中固化、35~40℃干燥箱中干燥,最后经研碎、过80目筛,得成品;
所述搅拌的搅拌时间为2h;所述固化的固化时间为12h;
所述替米考星制剂是固体分散剂;
所述阴离子表面活性剂为十二烷基硫酸钠。
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