CN109432188A - 一种对化学性肝损伤有保护功能的组合物及其制备方法 - Google Patents
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Abstract
本发明是一种对化学性肝损伤有保护功能的组合物及其制备方法，组合物，具体组成成分及其质量百分比为：葛根提取物28.89％；丹参提取物24.44％；枳椇子提取物17.78％；五味子提取物11.11％；辅料17.78％。所述辅料的组成成分及其质量百分比为：微晶纤维素96.25％；硬脂酸镁3.75％。制备方法，具体步骤为：S1、过筛；S2、称重混合；S3、灌装、抛光和包装。本发明对化学性性肝损伤进行辅助修复，达到对肝损害的辅助保护功能；产品生产工艺科学合理，质量稳定、可控，为消费者提供了一个安全、有效、可靠、价廉的保健食品。
Description
技术领域
本发明涉及保健药品的领域，尤其涉及一种对化学性肝损伤有保护功能的组合物及其制备方法。
背景技术
化学性肝损伤，是由化学性肝毒性物质所造成的肝损伤。肝脏为人体消化系统中最大、最重要的消化腺体，具有重要的消化功能，是人体的主要代谢器官和防御器官，对体内外诸多有毒物质具有很强的生物转化及解毒功能。肝脏具有肝动脉和肝静脉双重血液供应。化学物质可通过胃肠道门静脉或体循环进入肝脏进行转化，因此肝脏容易受到化学物中的毒性物质损害。化学性肝损伤也包括酒精及某些药物引起的肝损伤，而且酒精性肝损伤也是目前最常见的。这些毒物在人群中普遍易感，潜伏期短，病变的过程与感染的剂量直接相关，可引起肝脏不同程度的肝细胞坏死、脂肪变形、肝硬化、胆汁淤积、肝纤维化、甚至肝癌。
肝损伤引发的肝脏疾病已成为常见病、多发病，更为严重的是其引发的肝功能衰竭和肝性脑病等，发病率和死亡率高，极大地威胁着人类的健康。开发安全有效的对化学性肝损伤辅助保护作用的保健食品非常迫切。
发明内容
本发明旨在解决现有技术的不足，而提供一种对化学性肝损伤有保护功能的组合物及其制备方法。
本发明为实现上述目的，采用以下技术方案：
一种对化学性肝损伤有保护功能的组合物，具体组成成分及其质量百分比为：
所述辅料的组成成分及其质量百分比为：
微晶纤维素96.25％；
硬脂酸镁3.75％。
所述葛根提取物为原料葛根经加工提取的干燥提取物；所述丹参提取物为原料丹参经加工提取的干燥提取物；所述枳椇子为原料枳椇子经加工提取所得干燥提取物；所述五味子提取物为原料五味子经加工提取所得干燥提取物。
上述对化学性肝损伤有保护功能的组合物的制备方法，具体步骤为：
S1、过筛
将葛根提取物、丹参提取物、枳椇子提取物、五味子提取物、微晶纤维素、硬脂酸镁分别过80目筛；
S2、称重混合
按照各物质的配方进行称重，称重好的各物质置于混合机中进行混合，混合 30分钟，得到混合粉末；
S3、灌装、抛光和包装
将混合粉末灌装填充到胶囊中，对胶囊表面进行抛光处理，并进行包装。
每粒胶囊中填充的混合粉末为0.45g。
本发明的有益效果是：本发明综合传统中医药的保健理论和现代医学对化学性肝损伤药理研究、发病机理相结合，选用具有清热解毒、活血化瘀、养肝护肝的天然植物葛根、丹参、枳椇子、五味子的提取物为原料，利用中药天然独特的保健功效，对化学性性肝损伤进行辅助修复，达到对肝损害的辅助保护功能。产品生产工艺科学合理，质量稳定、可控，为消费者提供了一个安全、有效、可靠、价廉的保健食品，对于中国居民的养生保健将起到重要的作用，同时具有较强的科学价值，和其他同类保健食品相比，具有一定的综合优势。
具体实施方式
下面结合具体实施例对本发明作进一步说明：
一种对化学性肝损伤有保护功能的组合物，具体组成成分及其质量百分比为：
所述辅料的组成成分及其质量百分比为：
微晶纤维素 96.25％；
硬脂酸镁 3.75％。
所述葛根提取物为原料葛根经加工提取的干燥提取物；所述丹参提取物为原料丹参经加工提取的干燥提取物；所述枳椇子为原料枳椇子经加工提取所得干燥提取物；所述五味子提取物为原料五味子经加工提取所得干燥提取物。
上述对化学性肝损伤有保护功能的组合物的制备方法，具体步骤为：
S1、过筛
将葛根提取物、丹参提取物、枳椇子提取物、五味子提取物、微晶纤维素、硬脂酸镁分别过80目筛；
S2、称重混合
按照各物质的配方进行称重，称重好的各物质置于混合机中进行混合，混合 30分钟，得到混合粉末；
S3、灌装、抛光和包装
将混合粉末灌装填充到胶囊中，对胶囊表面进行抛光处理，并进行包装。
每粒胶囊中填充的混合粉末为0.45g。
本产品葛根提取物、丹参提取物、枳椇子提取物、五味子提取物、微晶纤维素、硬脂酸镁分别过80目筛后，置混合机中进行混合，混合的均匀程度直接影响到产品的质量。为了保证混合粉混合均匀，并提高生产效率，对混合时间进行了实验考查：以混合粉中标志性成分葛根素作为考察指标，在混合至第10、20、 30、40分钟时分别从混合机中混合粉的四角及中间的部位取样，按照GB/T 22251-2008中规定的测定方法测定取样样品中指标性成分葛根素的含量，并计算 RSD值，以此判定混合粉混合均匀程度，最终确定混合时间，具体的筛选结果见下表：
混合粉混合均匀度验证试验结果
从表中可以看出，混合到30分钟时，已经达到了混合均匀的目的(RSD＜ 3％)，将混合时间定为30分钟，合理可行。
混合粉的流动性直接影响着所填充胶囊剂量的准确性，为了保证混合粉的流动性，进行混合粉休止角的测定：
取本品混合粉3份，分别经口径7cm的长颈漏斗流下，并呈圆锥形状，测其休止角的结果见下表：
混合粉休止角的测定
结论：本品混合粉的休止角为39.2°(＜45°)，说明混合粉的流动性较好，可以直接胶囊填充。
本配方是综合中药具有活血化瘀、清肝解毒、强肝益肝的护肝作用的植物原料，根据中药治疗肝损伤作用机理、治则来组方，配方主要由葛根提取物、丹参提取物、枳椇子提取物和五味子提取物组成。葛根提取物清肝解毒、生津除烦，能显著降低乙醇诱发肝损伤小鼠丙二醛(MDA)含量，升高肝脏线位体(GSH) 水平功效作用；丹参提取物活血祛瘀，疏肝止痛，能降低自由基的产生，抑制 GSH的消耗，增强体内抗氧化防御能力，丹参能很好地保护肝细胞膜系统，提高其稳定性；枳椇子提取物可凉血、润燥止渴、养阴生津。枳椇子可加快乙醇代谢，显著提高谷胱甘肽过氧化物酶(GSH)的活力，显著降低乙醇诱发肝损伤小鼠丙二醛(MDA)含量；五味子提取物收敛固涩、益气生津，是常用的保肝护肝的原料，五味子提取物有助于肝细胞蛋白质的合成，使线粒体恢复和增加，相应的酶活性增高，肝细胞得以恢复和再生，降低血清谷丙转氨酶作用，方中各种成分合力达到对肝损伤的辅助保护功能。
用量方面，本产品所用原料均是卫生部、国家食品药品监督管理局批准认可使用的保健食品原料，用量上主要参考《中华人民共和国药典》和相关政策法规的要求，中国药典记载用量主要是作为治疗用量，不宜作为保健食品的功能与安全的有效保障，且药典用量可以理解为单味药用量，而保健食品组方多运用传统的中医养生理论和经验，复配制成，再加上药品是短期用于治疗用途，而保健食品是要长期自行选择食用，因此各原料的用量相应也会偏低。
以0.23g/kg·BW、0.45g/kg·BW、0.90g/kg·BW剂量的组合物胶囊内容物灌胃小鼠30天，各组动物生长活动良好，各组动物增重与模型对照组相比，差异无统计学意义(P>0.05)；高剂量组肝匀浆中MDA浓度及高剂量组TG浓度均低于模型对照组；高剂量组的脂肪变性评分低于模型对照组，且差异有统计学意义(P<0.05)。根据《保健食品检验与评价技术规范》(2003年版)辅助保护化学性肝损伤功能结果判定标准，组合物胶囊具有对动物酒精性肝损伤辅助保护作用功能。
以1.12、2.25、4.50g/kg·BW(分别相当于人拟用剂量的25倍、50倍、100 倍)的组合物胶囊掺入饲料中喂饲大鼠30天，在试验期间，各组动物体重、增重、食物利用率及脏体比值与对照组比较，差异均无统计学意义(P>0.05)；血液学指标、生化指标均在本检测单位正常值范围内；大体解剖未见异常，未发现与受试样品相关的病理组织学改变。本品经大鼠30天喂养试验未见明显的毒性作用。
组合物胶囊对两种性别大、小鼠经口急性毒性(MTD)均大于20.0g/kg·BW，根据《保健食品检验与评价技术规范》(2003年版)急性毒性分级标准，本样品属无毒级；三项遗传毒性试验(Ames试验、小鼠骨髓细胞微核试验和小鼠精子畸形试验)结果均为阴性。
本产品各原料无配伍禁忌。各原料用量低于药典用量也体现了其较为安全的一面。而且本产品经过安全性评价试验(急性毒性试验、三项遗传毒性试验、30 天喂养试验)证明本品属无毒级，无毒副作用，动物功能试验证明本品有确切的对化学性肝损伤有辅助保护的功效作用，故据此可以说明本品配方安全、有效。
本发明综合传统中医药的保健理论和现代医学对化学性肝损伤药理研究、发病机理相结合，选用具有清热解毒、活血化瘀、养肝护肝的天然植物葛根、丹参、枳椇子、五味子的提取物为原料，利用中药天然独特的保健功效，对化学性性肝损伤进行辅助修复，达到对肝损害的辅助保护功能。产品生产工艺科学合理，质量稳定、可控，为消费者提供了一个安全、有效、可靠、价廉的保健食品，对于中国居民的养生保健将起到重要的作用，同时具有较强的科学价值，和其他同类保健食品相比，具有一定的综合优势。
上面结合具体实施例对本发明进行了示例性描述，显然本发明具体实现并不受上述方式的限制，只要采用了本发明的方法构思和技术方案进行的各种改进，或未经改进直接应用于其它场合的，均在本发明的保护范围之内。
Claims (5)
1.一种对化学性肝损伤有保护功能的组合物，其特征在于，具体组成成分及其质量百分比为：
2.根据权利要求1所述的一种对化学性肝损伤有保护功能的组合物，其特征在于，所述辅料的组成成分及其质量百分比为：
微晶纤维素 96.25％；
硬脂酸镁 3.75％。
3.根据权利要求2所述的一种对化学性肝损伤有保护功能的组合物，其特征在于，所述葛根提取物为原料葛根经加工提取的干燥提取物；所述丹参提取物为原料丹参经加工提取的干燥提取物；所述枳椇子为原料枳椇子经加工提取所得干燥提取物；所述五味子提取物为原料五味子经加工提取所得干燥提取物。
4.一种如权利要求3所述的对化学性肝损伤有保护功能的组合物的制备方法，其特征在于，具体步骤为：
S1、过筛
将葛根提取物、丹参提取物、枳椇子提取物、五味子提取物、微晶纤维素、硬脂酸镁分别过80目筛；
S2、称重混合
按照各物质的配方进行称重，称重好的各物质置于混合机中进行混合，混合30分钟，得到混合粉末；
S3、灌装、抛光和包装
将混合粉末灌装填充到胶囊中，对胶囊表面进行抛光处理，并进行包装。
5.根据权利要求4所述的一种对化学性肝损伤有保护功能的组合物的制备方法，其特征在于，每粒胶囊中填充的混合粉末为0.45g。
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| CN113694104A (zh) * | 2021-07-23 | 2021-11-26 | 江苏大学 | 一种对化学性肝损伤有保护作用、促进肝脏再生的中药组合物、制备方法及其用途 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102188513A (zh) * | 2011-05-25 | 2011-09-21 | 遵义陆圣康源科技开发有限责任公司 | 对化学性肝损伤具有辅助保护功能的药物组合物 |
| CN106214773A (zh) * | 2016-07-29 | 2016-12-14 | 神威药业集团有限公司 | 一种对化学性肝损伤有辅助保护功能的组合物及其制备方法 |
| CN108066473A (zh) * | 2018-02-05 | 2018-05-25 | 贵州师范大学 | 对化学性肝损伤有保护作用的制剂及其制备方法 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102188513A (zh) * | 2011-05-25 | 2011-09-21 | 遵义陆圣康源科技开发有限责任公司 | 对化学性肝损伤具有辅助保护功能的药物组合物 |
| CN106214773A (zh) * | 2016-07-29 | 2016-12-14 | 神威药业集团有限公司 | 一种对化学性肝损伤有辅助保护功能的组合物及其制备方法 |
| CN108066473A (zh) * | 2018-02-05 | 2018-05-25 | 贵州师范大学 | 对化学性肝损伤有保护作用的制剂及其制备方法 |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110420264A (zh) * | 2019-07-16 | 2019-11-08 | 江苏康缘药业股份有限公司 | 一种中药组合物及其制备方法和应用 |
| CN110420264B (zh) * | 2019-07-16 | 2021-10-08 | 江苏康缘药业股份有限公司 | 一种中药组合物及其制备方法和应用 |
| CN113694104A (zh) * | 2021-07-23 | 2021-11-26 | 江苏大学 | 一种对化学性肝损伤有保护作用、促进肝脏再生的中药组合物、制备方法及其用途 |
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