CN106421431A - 一种参芪斛胶囊 - Google Patents
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Abstract
本发明公开一种参芪斛胶囊，其铁皮石斛和西洋参通过一次渗漉、两次水提、然后喷雾干燥得到铁皮石斛提取物和西洋参提取物；黄芪经过三次水提、然后喷雾干燥得到黄芪提取物，铁皮石斛提取物13重量份，西洋参提取物72重量份，黄芪提取物43重量份，在加入淀粉172重量份混合均匀，装入空胶囊即可。与现有技术相比，本发明通过通过无数次试验最终确定铁皮石斛、黄芪、西洋参三者的合理配伍，在该配伍中，铁皮石斛对黄芪和西洋参起到协同作用，提高了二者的药理效果，且工艺过程能最大咸度提高提取的活性成分。
Description
技术领域
本发明涉及一种中药，也涉及保健食品，具体涉及一种参芪斛胶囊。
背景技术
糖尿病(diabetes meilitus,DM)是一种由于胰岛素绝对或相对分泌不足而导致的以慢性血葡萄糖水平增高为特征的一种常见内分泌代谢性疾病。近年来，DM的发病率和患病率在全球范围内呈现逐年升高的趋势，己成为严重威胁人类健康与生活质量的世界性公告卫生问题。DM不仅仅表现为长期慢性的血糖升高，还可伴有多种并发症。其中心血管并发症已经成为DM并发症中致残率和致死率最高、危害最大的并发症。
中医是我国的传统医学，在中国的历史发展中发挥了无可替代的作用。近年来，中医在治疗糖尿病的领域亦发挥着重要的、独特的、不可替代的作用。国家药品管理局目前已有收录的治疗糖尿病的中成药制剂及部分中成药制剂，如参芪消渴胶囊、参芪降糖颗粒等。
参芪降糖颗粒临床用于治疗气阴两虚、脾肾不足型糖尿病，取得了较好疗效。其成分有人参(茎叶)皂甙、五味子、黄芪、山药、地黄、覆盆子、麦冬、茯苓、天花粉、泽泻、枸杞子，未有铁皮石斛入药。
铁皮石斛性味功效：味甘，性微寒。生津养胃；滋阴清热；润肺益肾；明目强腰。具有良好的药理作用，生津作用：铁皮石斛具有生津作用，主要表现为促进腺体分泌和脏器运动；降血糖作用：铁皮石斛可降低链脲霉素诱发糖尿血糖值；增强机体免疫力：铁皮石斛颗粒可促进荷瘤动物巨噬细胞的吞噬功能，增强T淋巴细胞的增殖和分化及NK细胞的活性，并能明显提高荷瘤动物的血清溶血素值，提示TPSH无论是对非特异性免疫功能，或是特异性细胞免疫以及体液免疫功能，均有一定的提高作用。
发明人发现，铁皮石斛、黄芪、西洋参三者在一定比例下具有更好的调节血糖水平的作用，并且无毒副作用。并且良好的剂型更能保证人体的吸收。
发明内容
本发明的目的是克服现有技术的不足，提供一种参芪斛胶囊。本发明采用的技术方案是：
一种参芪斛胶囊，其特征在于：通过如下步骤制备：
1)将体积分数为70％的乙醇溶液浸没粉碎的铁皮石斛3～4小时，利用塔式结构的渗漉装置收集渗漉液，减压浓缩，喷雾干燥，得第一石斛提取物；
2)将步骤1)渗漉过的铁皮石斛碎转入蒸球中，加入可浸没其高度的纯化水，武火烧开，文火慢煎一小时，共两次，合并煎液；减压浓缩，喷雾干燥，得第二石斛提取物；
3)合并步骤1)的第一石斛提取物和步骤2)的第二石斛提取物得到铁皮石斛提取物；
4)将体积分数为70％的乙醇溶液浸没切片的西洋参2～3小时，利用塔式结构的渗漉装置收集渗漉液，减压浓缩，喷雾干燥，得第一西洋参提取物；
5)将步骤5)渗漉过的西洋参片转入蒸球中，加入可浸没其高度的纯化水，武火烧开，文火慢煎一小时，共三次，合并煎液；减压浓缩，喷雾干燥，得第二西洋参提取物；
6)合并步骤4)的第一西洋参提取物和步骤2)的第二西洋参提取物得到西洋参提取物；
7)将粉碎后黄芪装入蒸球中，加入可浸没其高度的纯化水，武火烧开，文火慢煎一小时，共三次，合并煎液；减压浓缩，喷雾干燥，得黄芪提取物；
8)取步骤3)的铁皮石斛提取物13重量份，步骤6)的西洋参提取物72重量份，步骤7)的黄芪提取物43重量份，在加入淀粉172重量份混合均匀，装入空胶囊即可。
进一步地，所述的渗漉液是在常温下，以3～10mL/秒的流速收集的，收集时间为24～48小时；所述的减压浓缩是在常温下进行，压力-0.08MPa、时间1～3小时，浓缩到比重为1.03；所述的喷雾干燥的温度在100-200℃。
与现有技术相比，本发明通过通过无数次试验最终确定铁皮石斛、黄芪、西洋参三者的合理配伍，在该配伍中，铁皮石斛对黄芪和西洋参起到协同作用，提高了二者的药理效果，且工艺过程能最大咸度提高提取的活性成分。
具体实施方式
一种参芪斛胶囊，其特征在于：通过如下步骤制备：
1)将体积分数为70％的乙醇溶液浸没粉碎的铁皮石斛3～4小时，利用塔式结构的渗漉装置收集渗漉液，减压浓缩，喷雾干燥，得第一石斛提取物；
2)将步骤1)渗漉过的铁皮石斛碎转入蒸球中，加入可浸没其高度的纯化水，武火烧开，文火慢煎一小时，共两次，合并煎液；减压浓缩，喷雾干燥，得第二石斛提取物；
3)合并步骤1)的第一石斛提取物和步骤2)的第二石斛提取物得到铁皮石斛提取物；
4)将体积分数为70％的乙醇溶液浸没切片的西洋参2～3小时，利用塔式结构的渗漉装置收集渗漉液，所述的渗漉液是在常温下，以3～10mL/秒的流速收集的，收集时间为24～48小时；在常温下进行减压浓缩，压力-0.08MPa、时间1～3小时，浓缩到比重为1.03，在100-200℃温度下喷雾干燥，得第一西洋参提取物；
5)将步骤5)渗漉过的西洋参片转入蒸球中，加入可浸没其高度的纯化水，武火烧开，文火慢煎一小时，共三次，合并煎液；减压浓缩，喷雾干燥，得第二西洋参提取物；
6)合并步骤4)的第一西洋参提取物和步骤2)的第二西洋参提取物得到西洋参提取物；
7)将粉碎后黄芪装入蒸球中，加入可浸没其高度的纯化水，武火烧开，文火慢煎一小时，共三次，合并煎液；减压浓缩，喷雾干燥，得黄芪提取物；
8)取步骤3)的铁皮石斛提取物13重量份，步骤6)的西洋参提取物72重量份，步骤7)的黄芪提取物43重量份，在加入淀粉172重量份混合均匀，装入空胶囊即可。
使用本发明制备的胶囊与参芪降糖颗粒进行比较测试，测试数共10人，均为二型糖尿病患者：
第1-3天，按照患者通常服用的剂量的服用参芪降糖颗粒，检测服用前及服用1小时后血糖水平如下表；
第4-6天，按照患者通常服用的剂量的一半服用本发明的胶囊，检测服用前及服用1小时后血糖水平如下表；
| 第1天 | 第2天 | 第3天 | 第4天 | 第5天 | 第6天 | |
| 患者1 | 16.4/8.2 | 15.4/9.1 | 17.6/7.8 | 18.0/6.2 | 17.9/5.1 | 14.6/6.1 |
| 患者2 | 13.4/6.4 | 14.5/7.5 | 16.3/6.3 | 16.7/4.3 | 18.9/4.5 | 17.3/5.0 |
| 患者3 | 20.5/9.2 | 17.3/8.1 | 19.6/9.8 | 18.4/7.2 | 17.5/9.1 | 18.6/6.7 |
| 患者4 | 11.4/4.2 | 14.6/6.1 | 12.7/5.8 | 12.3/3.2 | 14.6/4.1 | 13.5/3.9 |
| 患者5 | 15.4/7.4 | 14.6/7.1 | 12.6/6.8 | 16.4/5.5 | 14.2/6.6 | 11.7/6.5 |
| 患者6 | 16.5/7.4 | 13.4/6.1 | 13.6/7.9 | 18.0/5.2 | 17.9/4.3 | 14.6/5.3 |
| 患者7 | 14.4/8.4 | 14.5/7.4 | 15.3/6.6 | 15.7/5.3 | 16.9/5.7 | 16.3/6.3 |
| 患者8 | 18.5/9.2 | 17.4/9.1 | 19.4/8.8 | 17.4/6.2 | 16.7/8.1 | 18.6/7.3 |
| 患者9 | 19.4/4.2 | 17.6/6.1 | 18.3/5.8 | 15.3/4.2 | 16.6/6.1 | 16.5/5.0 |
| 患者10 | 23.4/7.4 | 22.6/7.1 | 19.6/6.8 | 20.4/7.5 | 18.2/8.6 | 16.7/9.4 |
从上表可以看出，一半剂量的本发明的胶囊能达到相同乃至优于市售参芪降糖颗粒所能达到的降糖效果。
Claims (2)
1.参芪斛胶囊，其特征在于：通过如下步骤制备：
1)将体积分数为70％的乙醇溶液浸没粉碎的铁皮石斛3～4小时，利用塔式结构的渗漉装置收集渗漉液，减压浓缩，喷雾干燥，得第一石斛提取物；
2)将步骤1)渗漉过的铁皮石斛碎转入蒸球中，加入可浸没其高度的纯化水，武火烧开，文火慢煎一小时，共两次，合并煎液；减压浓缩，喷雾干燥，得第二石斛提取物；
3)合并步骤1)的第一石斛提取物和步骤2)的第二石斛提取物得到铁皮石斛提取物；
4)将体积分数为70％的乙醇溶液浸没切片的西洋参2～3小时，利用塔式结构的渗漉装置收集渗漉液，减压浓缩，喷雾干燥，得第一西洋参提取物；
5)将步骤5)渗漉过的西洋参片转入蒸球中，加入可浸没其高度的纯化水，武火烧开，文火慢煎一小时，共三次，合并煎液；减压浓缩，喷雾干燥，得第二西洋参提取物；
6)合并步骤4)的第一西洋参提取物和步骤2)的第二西洋参提取物得到西洋参提取物；
7)将粉碎后黄芪装入蒸球中，加入可浸没其高度的纯化水，武火烧开，文火慢煎一小时，共三次，合并煎液；减压浓缩，喷雾干燥，得黄芪提取物；
8)取步骤3)的铁皮石斛提取物13重量份，步骤6)的西洋参提取物72重量份，步骤7)的黄芪提取物43重量份，在加入淀粉172重量份混合均匀，装入空胶囊即可。
2.权利要求1所述的一种参芪斛胶囊，其特征在于：所述的渗漉液是在常温下，以3～10mL/秒的流速收集的，收集时间为24～48小时；所述的减压浓缩是在常温下进行，压力-0.08MPa、时间1～3小时，浓缩到比重为1.03；所述的喷雾干燥的温度在100-200℃。
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| CN108042716A (zh) * | 2017-12-28 | 2018-05-18 | 金华寿仙谷药业有限公司 | 一种辅助降血糖的中药制剂产品 |
| CN112870299A (zh) * | 2021-03-15 | 2021-06-01 | 重庆新兴医院有限公司 | 一种辅助降血糖的中药组合物及其制备方法 |
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| CN108042716A (zh) * | 2017-12-28 | 2018-05-18 | 金华寿仙谷药业有限公司 | 一种辅助降血糖的中药制剂产品 |
| CN112870299A (zh) * | 2021-03-15 | 2021-06-01 | 重庆新兴医院有限公司 | 一种辅助降血糖的中药组合物及其制备方法 |
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