CN109329943A - 一种含大鲵油的缓释滴丸 - Google Patents
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Abstract
本发明公开了一种含大鲵油的缓释滴丸，它是按重量比1∶1∶1混合大鲵油、茶籽油和杜仲籽油，将上述混合物，再配以所选择的基质，置于加热容器内边搅拌边加热，待完全熔融，再加入薄荷素油并充分搅拌均匀，得到含有大鲵油、茶籽油和杜仲籽油的混合物和基质的药物组合物混合液；由滴丸机收缩成滴丸既得。本发明所指含大鲵油缓释滴丸具有吸收快、生物利用度高的特点，长期服用之，能够增强中枢神经功能，提高人体免疫力，促进血液活力，消除疲劳、增强记忆力。
Description
技术领域
本发明涉及保健品领域，具体地说，是提供一种含大鲵油缓释滴丸及其制备方法。
背景技术
大鲵是世界上现存最大的也是最珍贵的两栖动物，俗称娃娃鱼，是国家二类保护水生野生动物，是农业产业化和特色农业重点开发品种。大鲵营养丰富，含有优质蛋白质、丰富的氨基酸和微量元素，价值极高，被誉为“水中人参”，是高级滋补保健品。大鲵肉蛋白中含有17种氨基酸，其中8种是人体必需的氨基酸，总氨基酸含量为91.92％，必需氨基酸含量为39.69％，远高过了猪肉和牛肉，同时大鲵还是一种传统的名贵中药，李时珍的《本草纲目》中就有“鳞目、滋阴补肾、补血行气治痴疾”的记载。大鲵肉具有补血行气、延年益寿，增强人体免疫功能，防癌健体等多种特殊功效。为了促进大鲵资源保护和大鲵人工繁养产业化的推广，国家有关部门已批准人工繁养的子二代大鲵可以进行加工和销售。
现有技术中，专利200910226619.3公开的“一种大鲵油软胶囊、制备方法及其用途”，是由大鲵油、棕榈油、大豆色拉油、单硬脂酸甘油酯、维生素E、山梨酸钾和丙二醇酯混合，制成软胶囊剂，由于大鲵油中不饱和脂肪酸DHA、EPA具有见光易分解的特性，该发明制备的软胶囊剂具有被光分解的风险；专利201310029335.1公开了一种大鲵油包合片的制备方法及其产品，该发明将大鲵油通过β-环糊精包合制成片剂，然后通过不透光包衣材料进行包衣，该发明虽然可以有效防止大鲵油中的不饱和脂肪酸DHA、EPA被光分解，但由于片剂本身的工艺特点，制备过程中容易出现裂片、松片、黏冲、片重差异、崩解迟缓、溶出超限、含量不均一等问题，现有剂型中，滴丸剂具有工艺条件易于控制、质量稳定、剂量准确等特点，另外，现有产品服用量大，次数多，不便于外出携带或者老人等人群使用，因此，将大鲵油制备成缓释滴丸剂具有重要的意义。
发明内容
为了解决现有技术的不足之处，本发明提供一种含大鲵油缓释滴丸及其制备方法，该缓释滴丸质量稳定、剂量准确，能减少服药次数、维持血药浓度平稳。
本发明的技术方案为：一种含大鲵油的缓释滴丸，按照重量份计算，由以下原料药及辅料配比制备而成：
1)按1∶1∶1混合的大鲵油、茶籽油和杜仲籽油的混合物；
2)基质——聚乙二醇2000～20000、硬脂酸、硬脂酸钠、甘油明胶、硬脂酸聚烃氧40酯、虫胶、聚氧乙烯单硬脂酸脂、聚醚、羧甲基淀粉钠、十二烷基硫酸钠等可药用载体其中的一种或两种以上的混合物；
3)配比(以g或kg为单位，按照重量份计)，大鲵油、茶籽油和杜仲籽油的混合物∶基质＝1∶1～1∶5。
[制备方法]
1)按照配方所给出的比例，准确称取各药物原料和基质，将所称取的各药物原料和基质置于加热容器内边搅拌边加热，待完全熔融，再加入薄荷素油并充分搅拌均匀，得到含有大鲵油、茶籽油和杜仲籽油的混合物和基质的药物组合物混合液；
2)采用滴丸机，并调整滴丸机的温度控制系统，使滴丸机的滴头温度加热并保持在(50～90)℃，冷凝剂的温度冷却并保持在(-5～40)℃；
3)待滴丸机滴头和冷凝柱内冷凝剂的温度分别稳定处于以上第2步所要求的温度状态时，将含有薄荷素油和基质的药物混合液置于滴丸机的滴头储料桶内，以适当的速度通过滴头滴入冷凝剂中。
冷凝剂可以是液体石蜡、甲基硅油、植物油中的任意一种；
4)由滴丸机出口将收缩成型的滴丸取出，去掉表面冷凝剂，干燥即得。
本发明所指含大鲵油缓释滴丸具有吸收快、生物利用度高的特点，还具有增加药物稳定性以及延效作用，大鲵机体中含有70多种天然活性生物，在食用、药物、化妆品、健康食品等方面有着独特的研发价值，还能促进人体生理活性，改善人体细胞代谢水平，促进人体蛋白质合成，提高人体免疫功能，增强人体抗病能力。
混合物中各物料的药理作用又相辅相成。因此，长期服用之，能够增强中枢神经功能，提高人体免疫力，促进血液活力，消除疲劳、增强记忆力，预防多发病和常见病；有助于高血压、心律失常、冠心病、急性心肌梗塞、脑血栓等疾病的恢复，对糖尿病有一定辅助治疗作用；对感冒、骨质疏松、癌症等有预防作用；对一些过敏症状、哮喘等有缓解作用；还具有滋阴补肾，补血行气、护肤养颜、延缓衰老之功效。
另外本发明混合物产品方便贮藏、运输、分销、配送，从加工生产到人们食用，各个环节的费用都很低，容易普及，对提高大众的健康水平具重要意义。
具体实施方式
以下通过实施例对本发明做进一步的说明：
以下实施例用于说明本发明，但不用来限制本发明的范围。若未特别指明，实施例中所用的技术手段为本领域技术人员所熟知的常规手段，所用原料均为市售商品。
1.将大鲵脂肪组织经通入热蒸气加热，挤压、过滤、离心，得到大鲵粗油；将大鲵粗油加热到50-70℃，加入磷酸溶液进行酸炼；酸炼所得大鲵油原料再加热到50-95℃，加入烧碱溶液，停留10-30分钟后，静置；在常温下加入活性炭，搅拌10-60分钟脱色、除臭，离心、过滤去渣，得到上清油液，再经冷却即得大鲵油产品。
2.以杜仲种籽为原料连续提取生物活性成分的方法，包括：
(1)利用超临界纯净CO2或高纯CO2从杜仲仁干燥粉中提制高亚麻酸杜仲籽油的方法；
(2)以水、甲醇或乙醇为提取剂，通过加热提取、减压浓缩、大孔树脂分离及柱色谱法等从中提取杜仲籽油。
3.将原料茶树籽与硅胶颗粒混合均匀，然后进行炒制至茶树籽破裂率达到85％以上；将茶树籽连同硅胶颗粒在30分钟内速冻成冰渣；将冰渣解冻，并将解冻后的茶树籽颗粒与硅胶颗粒进行分离，然后将分离得到的茶树籽颗粒送入压榨机内压榨得到茶树籽压榨液；向茶树籽压榨液加入5～10倍茶树籽压榨液体积的石油醚进行萃取、静置、分离，得到茶籽油。
4.基质——聚乙二醇2000、4000、6000、8000、10000、2000、硬脂酸、硬脂酸钠、甘油明胶、硬脂酸聚烃氧40酯、虫胶、聚氧乙烯单硬脂酸脂、聚醚、羧甲基淀粉钠、十二烷基硫酸钠等可药用载体；
5.配比(以g或kg为单位，按照重量份计)，大鲵油、茶籽油和杜仲籽油的混合物∶基质＝1∶1～1∶5；
[制备方法]
1)按照配方所给出的比例，准确称取各药物原料和基质，将所称取的各药物原料和基质置于加热容器内边搅拌边加热，待完全熔融，再加入薄荷素油并充分搅拌均匀，得到含有大鲵油、茶籽油和杜仲籽油的混合物和基质的药物组合物混合液；
2)采用滴丸机，并调整滴丸机的温度控制系统，使滴丸机的滴头温度加热并保持在(50～90)℃，冷凝剂的温度冷却并保持在(-5～40)℃；
3)待滴丸机滴头和冷凝柱内冷凝剂的温度分别稳定处于以上第2步所要求的温度状态时，将含有薄荷素油和基质的药物组合物混合液置于滴丸机的滴头储料桶内，以适当的速度通过滴头滴入冷凝剂中。
冷凝剂可以是液体石蜡、甲基硅油、植物油中的任意一种；
4)由滴丸机出口将收缩成型的滴丸取出，去掉表面冷凝剂，干燥即得。
Claims (1)
1.一种含大鲵油的缓释滴丸，其特征在于，按照重量份计算，由以下原料药及辅料配比制备而成：
1)按1∶1∶1混合的大鲵油、茶籽油和杜仲籽油的混合物；
2)基质——聚乙二醇2000～20000、硬脂酸、硬脂酸钠、甘油明胶、硬脂酸聚烃氧40酯、虫胶、聚氧乙烯单硬脂酸脂、聚醚、羧甲基淀粉钠、十二烷基硫酸钠等可药用载体其中的一种或两种以上的混合物；
3)配比(以g或kg为单位，按照重量份计)，大鲵油、茶籽油和杜仲籽油的混合物∶基质＝1∶1～1∶5；
[制备方法]
1)按照配方所给出的比例，准确称取各药物原料和基质，将所称取的各药物原料和基质置于加热容器内边搅拌边加热，待完全熔融，再加入薄荷素油并充分搅拌均匀，得到含有大鲵油、茶籽油和杜仲籽油的混合物和基质的药物组合物混合液；
2)采用滴丸机，并调整滴丸机的温度控制系统，使滴丸机的滴头温度加热并保持在(50～90)℃，冷凝剂的温度冷却并保持在(-5～40)℃；
3)待滴丸机滴头和冷凝柱内冷凝剂的温度分别稳定处于以上第2步所要求的温度状态时，将含有薄荷素油和基质的药物混合液置于滴丸机的滴头储料桶内，以适当的速度通过滴头滴入冷凝剂中；
冷凝剂可以是液体石蜡、甲基硅油、植物油中的任意一种；
4)由滴丸机出口将收缩成型的滴丸取出，去掉表面冷凝剂，干燥即得。
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