The invention provides a double accessories Matrine 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 Matrine 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 Matrine for Injection freeze-dried powder using double accessories, accessories including mannitol and hydroxyethyl starch 130/0.4, which is the main drug of matrine, matrine and excipients main drug weight ratio 100:100 between 100:120, mannitol and hydroxyethyl starch 130/0.4 weight ratio of 100:70 100:90. The Matrine for Injection freeze-dried powder was prepared with the main drugs and the excipients. The Matrine 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】
一种双辅料的注射用苦参碱冻干粉针剂
：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的注射用苦参碱冻干粉针剂及其制备方法。
技术介绍
：注射用苦参碱冻干粉针剂主药苦参碱是由豆科植物苦参的干燥根、植株、果实经乙醇等有机溶剂提取制成的，是一种生物碱。其主要成分有苦参碱、槐果碱、氧化槐果碱、槐定碱等多种生物碱，以苦参碱、氧化苦参碱含量最高。氧化苦参素碱的抗乙型和丙型肝炎病毒效应氧化苦参素碱在体外和在动物模型中显示对HBV有强有力的抗病毒活性，在人体内同样具有抗HBV作用，用于使慢性肝炎患者的丙氨酸氨基转移酶及胆红素恢复正常。目前工业上生产注射用苦参碱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...
【技术保护点】
一种双辅料注射用苦参碱冻干粉针剂，其特征在于，包括主药和辅料，主药是苦参碱，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苦参碱冻干粉针剂，其特征在于，包括主药和辅料，主药是苦参碱，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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