CN111202757A - 一种穿心莲软胶囊的制备方法 - Google Patents
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Abstract
本发明涉及一种穿心莲软胶囊的制备方法,包括(1)穿心莲提取物的制备:取穿心莲药材1000g,用85%乙醇热浸提取2次,每次2h,合并提取液,滤过,滤液回收乙醇,浓缩至适量,干燥得浸膏,备用;(2)软胶囊制备:取大豆油与蜂蜡混匀,加热至约70℃使蜂蜡完全熔融,搅拌冷却至35℃以下,加入穿心莲浸膏粉,搅拌均匀,胶体研磨均匀,抽真空消去气泡,备用;取明胶‑甘油‑水(100∶20~40∶100),加入水浴式化胶罐,搅拌,熔融,保温1h,抽真空无明显气泡,过80目筛网,放入胶桶保温(≥60℃),静置2~6h。在18~26℃、相对湿度不超过50%的环境下用软胶囊压制机,填入上述物料,压制出软胶囊。在25℃、相对湿度25%~30%条件下,干燥16h,即得。该方法操作简便,制备的软胶囊稳定可靠。
Description
技术领域
本发明涉及一种软胶囊的制备方法,具体涉及一种穿心莲软胶囊的制备方法。
背景技术
穿心莲为爵床科穿心莲属穿心莲的干燥地上部分,具有清热解毒、凉血消肿的功效。临床上用于感冒发热、咽喉肿痛、口舌生疮、顿咳劳嗽、泄泻痢疾、热淋涩痛、痈肿疮疡、毒蛇咬伤等。
穿心莲片为穿心莲单味药材经加工制成的片剂,一直是《中国药典》收载品种并广泛应用于临床。穿心莲有效成分有穿心莲内酯、去氧穿心莲内酯、脱水穿心莲内酯等,其中脱水穿心莲内酯为主要有效成分,具有抗炎、解热作用,临床用于呼吸道及肠道感染性疾病有较好疗效。但是穿心莲内酯类化合物难溶于水,其片剂在临床应用中溶出度较低,影响疗效。
发明内容
本发明旨在提供一种穿心莲软胶囊,该剂型具有生物利用度高、吸收迅速、稳定性好、
便于服用等优点。
穿心莲软胶囊的制备方法,包括以下步骤:
(1)穿心莲提取物的制备:取穿心莲药材1000g,用85%乙醇热浸提取2次,每次2h,合并提取液,滤过,滤液回收乙醇,浓缩至适量,干燥得浸膏,备用;
(2)软胶囊制备:取大豆油与蜂蜡混匀,加热至约70℃使蜂蜡完全熔融,搅拌冷却至35℃以下,加入穿心莲浸膏粉,搅拌均匀,胶体研磨均匀,抽真空消去气泡,备用;取明胶-甘油-水(100∶20~40∶100),加入水浴式化胶罐,搅拌,熔融,保温1h,抽真空无明显气泡,过80目筛网,放入胶桶保温(≥60℃),静置2~6h。在18~26℃、相对湿度不超过50%的环境下用软胶囊压制机,填入上述物料,压制出软胶囊。在25℃、相对湿度25%~30%条件下,干燥16h,即得。
所述步骤(2)中,明胶-甘油-水比例为100::20~40:100,在18~26℃,环境下压制出软胶囊,并控制相对湿度25%~30%进行干燥。
下面将结合具体实施方式进一步说明本发明,但本发明要求保护的范围并不局限于下列实施方式。
具体实施方式:
实施例1:
(1)穿心莲提取物的制备:取穿心莲药材1000g,用85%乙醇热浸提取2次,每次2h,合并提取液,滤过,滤液回收乙醇,浓缩至适量,干燥得浸膏,备用;(2)软胶囊制备:取大豆油与蜂蜡混匀,加热至约70℃使蜂蜡完全熔融,搅拌冷却至35℃以下,加入穿心莲浸膏粉,搅拌均匀,胶体研磨均匀,抽真空消去气泡,备用;取明胶-甘油-水(100∶20∶100),加入水浴式化胶罐,搅拌,熔融,保温1h,抽真空无明显气泡,过80目筛网,放入胶桶保温(≥60℃),静置2h。在18℃、相对湿度不超过50%的环境下用软胶囊压制机,填入上述物料,压制出软胶囊。在25℃、相对湿度25%条件下,干燥16h,即得。
实施例2
(1)穿心莲提取物的制备:取穿心莲药材1000g,用85%乙醇热浸提取2次,每次2h,合并提取液,滤过,滤液回收乙醇,浓缩至适量,干燥得浸膏,备用;(2)软胶囊制备:取大豆油与蜂蜡混匀,加热至约70℃使蜂蜡完全熔融,搅拌冷却至35℃以下,加入穿心莲浸膏粉,搅拌均匀,胶体研磨均匀,抽真空消去气泡,备用;取明胶-甘油-水(100∶50∶100),加入水浴式化胶罐,搅拌,熔融,保温1h,抽真空无明显气泡,过80目筛网,放入胶桶保温(≥60℃),静置4h。在22℃、相对湿度不超过50%的环境下用软胶囊压制机,填入上述物料,压制出软胶囊。在25℃、相对湿度28%条件下,干燥16h,即得。
实施例3
(1)穿心莲提取物的制备:取穿心莲药材1000g,用85%乙醇热浸提取2次,每次2h,合并提取液,滤过,滤液回收乙醇,浓缩至适量,干燥得浸膏,备用;(2)软胶囊制备:取大豆油与蜂蜡混匀,加热至约70℃使蜂蜡完全熔融,搅拌冷却至35℃以下,加入穿心莲浸膏粉,搅拌均匀,胶体研磨均匀,抽真空消去气泡,备用;取明胶-甘油-水(100∶40∶100),加入水浴式化胶罐,搅拌,熔融,保温1h,抽真空无明显气泡,过80目筛网,放入胶桶保温(≥60℃),静置6h。在26℃、相对湿度不超过50%的环境下用软胶囊压制机,填入上述物料,压制出软胶囊。在25℃、相对湿度30%条件下,干燥16h,即得。
Claims (2)
1.一种穿心莲软胶囊的制备方法,包括:
(1)穿心莲提取物的制备:取穿心莲药材1000g,用85%乙醇热浸提取2次,每次2h,合并提取液,滤过,滤液回收乙醇,浓缩至适量,干燥得浸膏,备用;
(2)软胶囊制备:取大豆油与蜂蜡混匀,加热至约70℃使蜂蜡完全熔融,搅拌冷却至35℃以下,加入穿心莲浸膏粉,搅拌均匀,胶体研磨均匀,抽真空消去气泡,备用;取明胶-甘油-水(100∶20~40∶100),加入水浴式化胶罐,搅拌,熔融,保温1h,抽真空无明显气泡,过80目筛网,放入胶桶保温(≥60℃),静置2~6h。在18~26℃、相对湿度不超过50%的环境下用软胶囊压制机,填入上述物料,压制出软胶囊。在25℃、相对湿度25%~30%条件下,干燥16h,即得。
2.根据权利要求2所述的穿心莲软胶囊制备方法,其特征在于:所述步骤(2)中,明胶-甘油-水比例为100::20~40:100,在18~26℃,环境下压制出软胶囊,并控制相对湿度25%~30%进行干燥。
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