The invention discloses a lyophilized powder injection of Vonimirin hydrochloride and a preparation method thereof. The lyophilized liquid of Vonimirin hydrochloride is prepared by removing pyrogen from the original powder of Vonimirin hydrochloride and an excipient after dissolving and proportioning the raw powder with water for injection, and then the lyophilized powder is prepared by freeze-drying steps of pre-freezing, sublimation drying and analytic drying. After injection, covering and testing, we finished the finished product of freeze-dried hydrochloric acid. The appearance of the finished product is white and loose, and it is quickly dissolved into clear liquid after adding water for injection, and its solubility is good. At 40 + 2 C, RH75% + 5%, the quality was stable for 6 months. The invention is simple and stable, the process is stable and reliable, the dosage of the dosage form is accurate, and is suitable for industrial production.
【技术实现步骤摘要】
一种盐酸沃尼妙林冻干粉针剂及其制备方法
本专利技术涉及一种盐酸沃尼妙林冻干粉针剂及其制备方法,属于兽用抗菌药物制剂
技术介绍
盐酸沃尼妙林是一种新型兽用抗菌药物,其抗菌广、耐药性低,对关节炎霉形体、牛鼻霉形体、鸡毒霉形体、鸡败血性霉形体、肺炎霉形体、链球菌、金黄色葡萄球菌、放线杆菌、巴氏杆菌、猪痢疾短螺旋体及结肠菌毛样螺旋体等霉形体、细菌及螺旋体都有良好的抗菌活性。目前,该药已被欧公体批准用于预防好治疗由猪痢疾短螺旋体感染引起的猪痢疾和肺炎支原体感染引起的猪地方性肺炎。现有盐酸沃尼妙林兽用制剂主要为预混剂型,其制备过程中影响因素多、成本高、经济效益差。由于通过拌料服用,药物的浪费量大,难以达到药物的有效治疗浓度。且盐酸沃尼妙林味苦、刺激性大、吸湿性极强、稳定性相对较差,已有报道指出其在猪的治疗中,偶尔会出现不良反应,不利于动物疾病的治疗。通过药物剂型改造能够合理利用已有抗菌药物、充分发挥药物药效。冻干粉针剂由于采用冷冻干燥法,对于热敏性药物可提高其稳定性,且提高药效,与盐酸沃尼妙林特性及用药要求相符,但目前尚未见有相关技术解决方案。
技术实现思路
本专利技术的目的在于提供一种盐酸沃尼妙林冻干粉针剂及其制备方法,采用注射用水溶解配比后的沃尼妙林原粉与赋形剂,去除热原后制得盐酸沃尼妙林冻干原液,再通过预冻、升华干燥和解析干燥等冷冻干燥处理步骤制得冻干粉剂,加塞、轧盖、检验后制得盐酸沃尼妙林冻干粉针剂成品。成品外观呈白色疏松块状,加注射用水后迅速溶解成澄明液体,复溶性好。在40±2℃、RH75%±5%的条件下,放置6个月,质量稳定。本专利技术简单易行、工艺 ...
【技术保护点】
1.一种盐酸沃尼妙林冻干粉针剂,其特征在于,包括沃尼妙林和赋形剂,两者质量份数比为1:9~9:1。
【技术特征摘要】
1.一种盐酸沃尼妙林冻干粉针剂,其特征在于,包括沃尼妙林和赋形剂,两者质量份数比为1:9~9:1。2.根据权利要求1所述的盐酸沃尼妙林冻干粉针剂,其特征在于,所述沃尼妙林原粉采用盐酸沃尼妙林原粉或酒石酸沃尼妙林原粉。3.根据权利要求1所述的盐酸沃尼妙林冻干粉针剂,其特征在于,所述赋形剂为甘露醇或右旋糖酐40或无水葡萄糖或乳糖或任意两种的组合。4.一种制备权利要求1所述盐酸沃尼妙林冻干粉针剂的方法,其特征在于,包括以下步骤:S1.按照权利要求1所述的质量份数比称量盐酸沃尼妙林和赋形剂于配置容器中,加入注射用水搅拌至完全溶解后,调节溶液pH值为3.0~6.0,再次加入注射用水搅拌均匀,去除溶液热原并除菌后,得到冻干原液;S2.将步骤S1制得的冻干原液灌装于西林瓶中,半加塞,在-20℃~-40℃下预冻处理2h~4h,冻结后,抽真空至10Pa,以每小时2℃~4℃的速度升温至-10℃~-15℃,升华干燥处理10h~15h,再次以每小时5℃~10℃的速度升温...
【专利技术属性】
技术研发人员:侯东,
申请(专利权)人:四川通达动物保健科技有限公司,
类型:发明
国别省市:四川,51
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