The invention provides a double accessories Ribavirin for Injection freeze-dried powder injection, relates to the field of medicine preparation and preparation method, which mainly solves the problems of the prior art in Ribavirin for Injection freeze-dried powder production excipients production when the drying time is long, high drying temperature, large energy consumption, product clarity and color of the solution for the low pass rate of defects. The Ribavirin for Injection freeze-dried powder using double accessories, accessories including mannitol and hydroxyethyl starch 130/0.4, the main drug is Leigh Bhave Lin, in which Leigh Bhave Lin and accessories main drug in the weight ratio of 100:100 between 100:120, mannitol and hydroxyethyl starch 130/0.4 weight ratio of 100:70 100:90. The Ribavirin for Injection freeze-dried powder was prepared with the main drugs and the excipients. The Ribavirin for Injection freeze-dried powder injection has the advantages of stable quality, safety and effectiveness, simple production process, short drying time, low drying temperature, low energy consumption, and high qualified rate of product clarity and solution color.
【技术实现步骤摘要】
一种双辅料注射用利巴韦林冻干粉针剂
:本专利技术涉及医药制剂及制备方法领域,尤其涉及一种双辅料注射用利巴韦林冻干粉针剂及其制备方法。
技术介绍
:注射用利巴韦林冻干粉针剂主药利巴韦林是广谱强效的抗病毒药物,能抑制肌苷酸-5-磷酸脱氢酶,阻断肌苷酸转化为鸟苷酸,从而抑制病毒的RNA和DNA合成,对DNA病毒和RNA病毒均有抑制复制作用。利巴韦林配合长效干扰素治疗丙肝、人类呼吸道融合病毒(RSV),和某些出血热(WHO)的治疗。目前工业上生产注射用利巴韦林冻干粉针剂时用到的辅料分为以下几类:(1)多元醇类,如甘油、山梨醇、甘露醇、肌醇、侧金盏花醇、乙二醇、聚乙二醇等;(2)糖类,如右旋糖苷(葡聚糖)、13一环糊精、麦芽糊精、海藻糖、蔗糖、乳糖、麦芽糖、葡萄糖等;(3)氨基酸类,如谷氨酸钠、脯氨酸、赖氨酸和丙氨酸等;(4)无机盐类,如磷酸盐、碳酸钙、硫酸锰、乙酸钠等;(5)蛋白质及肽类,如粘多糖蛋白、酪蛋白、牛血清蛋白等。羟乙基淀粉130/0.4是对人体无毒无害的半合成大分子化合物,无药理活性,在医疗上大剂量使用时常作为血容量扩容剂,它临床使用已有50多年历史。市售的注 ...
【技术保护点】
一种双辅料注射用利巴韦林冻干粉针剂,其特征在于,包括主药和辅料,主药是利巴韦林,辅料为甘露醇和羟乙基淀粉130/0.4,该药剂以上述主药和辅料制备成注射用冻干粉针剂,其中主药与辅料的重量比为100:100‑100:120,甘露醇与羟乙基淀粉130/0.4的重量比为100:70‑100:90。
【技术特征摘要】
1.一种双辅料注射用利巴韦林冻干粉针剂,其特征在于,包括主药和辅料,主药是利巴韦林,辅料为甘露醇和羟乙基淀粉130/0.4,该药剂以上述主药和辅料制备成注射用冻干粉针剂,其中主药与辅料的重量比为100:100-100:120,甘露醇与...
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