CN106176645A - 知柏地黄丸及其制备方法 - Google Patents
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Abstract
本发明公开了一种知柏地黄丸及其制备方法，所述知柏地黄丸，包括下述重量份的原料制备而成：知母75‑85份、熟地黄310‑330份、黄柏75‑85份、山茱萸150‑170份、山药150‑170份、牡丹皮110‑130份、茯苓110‑130份、泽泻110‑130份。本发明知柏地黄丸，具有滋阴降火的功效，可用于治疗阴虚火旺、潮热盗汗、口干咽痛、耳鸣遗精、小便短赤的症状，同时具有成本合理、毒副作用小，服用方便、疗效短的特点，本发明可进行批量生产，适宜人群广泛，具有极高的推广价值。
Description
技术领域
本发明涉及中药制剂技术领域，具体涉及一种知柏地黄丸及其制备方法。
背景技术
中医认为，潮热盗汗，口干咽痛，头晕耳鸣，梦遗滑精，小便短赤等症状，为肾阴虚、相火妄动、“虚火”上升引起，而非“实火”，因此不能使用清热泻火的方法治疗。肾中虚火由肾阴虚引起，中医称为“阴不制阳”，因此正确的解决方法是，滋补肾阴，使阴液不再亏虚，阴阳归于平衡，则虚火自消。
知柏地黄丸，以六味地黄丸为基础方，配以知母滋阴清热泻火，黄柏清泻下焦之火，八药合用共同发挥滋阴清热之功，阴液足，虚火清，从而达到标本兼治的目的。但现有技术制备的知柏地黄丸稳定性较差，且不易长时间存放。
发明内容
针对现有技术中存在的上述不足，本发明所要解决的技术问题之一是提供一种知柏地黄丸。
本发明的解决的技术问题之二是提供一种知柏地黄丸的制备方法。
本发明目的是通过如下技术方案实现的：
一种知柏地黄丸，包括下述重量份的原料制备而成：知母75-85份、熟地黄310-330份、黄柏75-85份、山茱萸150-170份、山药150-170份、牡丹皮110-130份、茯苓110-130份、泽泻110-130份。
一种知柏地黄丸，由下述重量份的原料制备而成：知母75-85份、熟地黄310-330份、黄柏75-85份、山茱萸150-170份、山药150-170份、牡丹皮110-130份、茯苓110-130份、泽泻110-130份、矫味剂0.1-1份、保鲜剂0.5-3.5份。
优选地，所述的矫味剂为蒜糖醇、麦芽四糖醇、D-山梨醇中一种或多种的混合物。
更优选地，所述的矫味剂由蒜糖醇、麦芽四糖醇、D-山梨醇混合而成，所述蒜糖醇、麦芽四糖醇、D-山梨醇的质量比为(1-3)：(1-3)：(1-3)。
优选地，所述的保鲜剂为杨梅素、芝麻素、异荭草素中一种或多种的混合物。
更优选地，所述的保鲜剂由杨梅素、芝麻素、异荭草素混合而成，所述杨梅素、芝麻素、异荭草素的质量比为(1-3)：(1-3)：(1-3)。
本发明还提供了上述知柏地黄丸的制备方法，包括以下步骤：
(1)取泽泻、茯苓、知母、黄柏、熟地黄混合粉碎至20-200目，得到混合药材，加入混合药材重量10-30倍水煎煮2-4小时，过滤，得到一次滤液和一次滤渣，将一次滤渣再加入混合药材重量10-30倍的水煎煮1-3小时，过滤，得到二次滤液和二次滤渣，合并一次滤液和二次滤液，滤液浓缩成密度为1.30-1.35g/mL(20℃)的稠膏；
(2)将总重量二分之一的牡丹皮、总重量二分之一的山茱萸以75wt％乙醇为溶剂，溶剂加入量为牡丹皮、山茱萸二者重量之和的10倍，浸渍24小时后浓缩成密度为1.31g/mL(20℃)的稠膏；
(3)取山药、剩余总重量二分之一的山茱萸及剩余总重量二分之一的牡丹皮粉碎至100-300目，再与步骤(1)和步骤(2)的稠膏混匀制丸，干燥即得。
具体的，在本发明中：
知母，拉丁学名：Anemarrhena asphodeloides Bunge，也叫毛知母，多年生草本植物，根状茎。
熟地黄，拉丁文名：Rehmannia glutinosa(Gaetn.)Libosch.ex Fisch.et Mey，又名：生地、怀庆地黄、熟地。
黄柏，拉丁学名：Cortex Phellodendri Chinensis，是芸香科黄檗属落叶乔木，树皮内层经炮制后入药。
山茱萸，拉丁学名：Cornusofficinalis，山茱萸科落叶灌木或小乔木，其成熟果实为中药。
山药，拉丁学名：Dioscorea opposita，别名怀山药、淮山药、土薯、山薯、山芋、玉延。
牡丹皮，为毛茛科植物牡丹Paeonia suffruticosa Andr.的干燥根皮。
泽泻，拉丁学名：Alisma plantago-aquatica Linn.，多年生水生或沼生草本。
茯苓，拉丁学名：Wolfiporia cocos，又称玉灵、茯灵、万灵桂、茯菟。是拟层孔菌科真菌茯苓的干燥菌核。
蒜糖醇，CAS号：488-44-8。
麦芽四糖醇，CAS号：66767-99-5。
D-山梨醇，CAS号：50-70-4。
杨梅素，CAS号：529-44-2。
芝麻素，CAS号：607-80-7。
异荭草素，CAS号：4261-42-1。
本发明知柏地黄丸，具有滋阴降火的功效，可用于治疗阴虚火旺、潮热盗汗、口干咽痛、耳鸣遗精、小便短赤的症状，同时具有成本合理、毒副作用小，服用方便、疗效短的特点，本发明可进行批量生产，适宜人群广泛，具有极高的推广价值。
具体实施方式
下面结合实施例对本发明做进一步的说明，以下所述，仅是对本发明的较佳实施例而已，并非对本发明做其他形式的限制，任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更为同等变化的等效实施例。凡是未脱离本发明方案内容，依据本发明的技术实质对以下实施例所做的任何简单修改或等同变化，均落在本发明的保护范围内。
实施例1
知柏地黄丸原料：知母80份、熟地黄320份、黄柏80份、山茱萸160份、山药160份、牡丹皮120份、茯苓120份、泽泻120份、矫味剂0.45份、保鲜剂1.5份。
所述的矫味剂由蒜糖醇、麦芽四糖醇、D-山梨醇按质量比为1：1：1搅拌混合均匀得到。
所述的保鲜剂由杨梅素、芝麻素、异荭草素按质量比为1：1：1搅拌混合均匀得到。
上述知柏地黄丸的制备方法，包括以下步骤：
(1)取泽泻、茯苓、知母、黄柏、熟地黄混合粉碎至100目，得到混合药材，加入混合药材重量15倍水在96℃下煎煮3小时，采用180目滤布过滤，得到一次滤液和一次滤渣，将一次滤渣再加入混合药材重量15倍的水在96℃下煎煮2小时，采用180目滤布过滤，得到二次滤液和二次滤渣，合并一次滤液和二次滤液，滤液浓缩成密度为1.31g/mL(20℃)的稠膏；
(2)将总重量二分之一的牡丹皮(即60重量份)、总重量二分之一的山茱萸(即80重量份)以75wt％乙醇为溶剂，溶剂加入量为牡丹皮、山茱萸二者重量之和的10倍，浸渍24小时后浓缩成密度为1.31g/mL(20℃)的稠膏；
(3)取山药、剩余总重量二分之一的山茱萸(即80重量份)及剩余总重量二分之一的牡丹皮(即60重量份)粉碎至300目，再与步骤(1)和步骤(2)的稠膏混匀制丸，在60℃下干燥6小时。得到实施例1的知柏地黄丸。
实施例2
与实施例1基本相同，区别仅仅在于：所述的矫味剂由麦芽四糖醇、D-山梨醇按质量比为1：1搅拌混合均匀得到。得到实施例2的知柏地黄丸。
实施例3
与实施例1基本相同，区别仅仅在于：所述的矫味剂由蒜糖醇、D-山梨醇按质量比为1：1搅拌混合均匀得到。得到实施例3的知柏地黄丸。
实施例4
与实施例1基本相同，区别仅仅在于：所述的矫味剂由蒜糖醇、麦芽四糖醇按质量比为1：1搅拌混合均匀得到。得到实施例4的知柏地黄丸。
实施例5
与实施例1基本相同，区别仅仅在于：所述的保鲜剂由芝麻素、异荭草素按质量比为1：1搅拌混合均匀得到。得到实施例5的知柏地黄丸。
实施例6
与实施例1基本相同，区别仅仅在于：所述的保鲜剂由杨梅素、异荭草素按质量比为1：1搅拌混合均匀得到。得到实施例6的知柏地黄丸。
实施例7
与实施例1基本相同，区别仅仅在于：所述的保鲜剂由杨梅素、芝麻素按质量比为1：1搅拌混合均匀得到。得到实施例7的知柏地黄丸。
测试例1
将实施例1-7制备的知柏地黄丸，置于25℃，相对湿度85％环境下保藏半年，然后进行大肠杆菌(ATYCC 25922)菌落总数测试，参照GBT 4789.2-2008食品卫生微生物学检验菌落总数测定。具体测试结果见表1。
表1：菌落总数测试表cfu/g
| 大肠杆菌菌落总数，CFU/g | |
| 实施例1 | 304 |
| 实施例2 | 587 |
| 实施例3 | 595 |
| 实施例4 | 591 |
| 实施例5 | 713 |
| 实施例6 | 716 |
| 实施例7 | 713 |
比较实施例1与实施例2-4，实施例1(蒜糖醇、麦芽四糖醇、D-山梨醇复配)防腐性能明显优于实施例2-4(蒜糖醇、麦芽四糖醇、D-山梨醇中任意二者复配)；比较实施例1与实施例5-7，实施例1(杨梅素、芝麻素、异荭草素复配)防腐性能明显优于实施例5-7(杨梅素、芝麻素、异荭草素中任意二者复配)。
测试例2
对实施例1-7制备的知柏地黄丸进行稳定性测试。
本发明知柏地黄丸中包含的毛蕊花糖苷是熟地黄的指标性成分。将实施例1-7制备的知柏地黄丸分别用铝塑复合膜袋密封包装，将它们置于38℃温度下放置3个月，测定各试样中3月时的毛蕊花糖苷相对于该试样0月时的残余含量。测试方法参照文献边宝林等《5种不同药材中毛蕊花糖苷的含量比较》。具体结果见表2。
表2：稳定性测试结果表单位：％
比较实施例1与实施例2-4，实施例1(蒜糖醇、麦芽四糖醇、D-山梨醇复配)稳定性能明显优于实施例2-4(蒜糖醇、麦芽四糖醇、D-山梨醇中任意二者复配)；比较实施例1与实施例5-7，实施例1(杨梅素、芝麻素、异荭草素复配)稳定性能明显优于实施例5-7(杨梅素、芝麻素、异荭草素中任意二者复配)。
Claims (7)
1.一种知柏地黄丸，其特征在于，包括下述重量份的原料制备而成：知母75-85份、熟地黄310-330份、黄柏75-85份、山茱萸150-170份、山药150-170份、牡丹皮110-130份、茯苓110-130份、泽泻110-130份。
2.一种知柏地黄丸，其特征在于，由下述重量份的原料制备而成：知母75-85份、熟地黄310-330份、黄柏75-85份、山茱萸150-170份、山药150-170份、牡丹皮110-130份、茯苓110-130份、泽泻110-130份、矫味剂0.1-1份、保鲜剂0.5-3.5份。
3.如权利要求2所述的知柏地黄丸，其特征在于：所述的矫味剂为蒜糖醇、麦芽四糖醇、D-山梨醇中一种或多种的混合物。
4.如权利要求3所述的知柏地黄丸，其特征在于：所述的矫味剂由蒜糖醇、麦芽四糖醇、D-山梨醇混合而成，所述蒜糖醇、麦芽四糖醇、D-山梨醇的质量比为(1-3)：(1-3)：(1-3)。
5.如权利要求2-4中任一项所述的知柏地黄丸，其特征在于：所述的保鲜剂为杨梅素、芝麻素、异荭草素中一种或多种的混合物。
6.如权利要求5所述的知柏地黄丸，其特征在于：所述的保鲜剂由杨梅素、芝麻素、异荭草素混合而成，所述杨梅素、芝麻素、异荭草素的质量比为(1-3)：(1-3)：(1-3)。
7.如权利要求1-6中任一项所述的知柏地黄丸的制备方法，其特征在于，包括以下步骤：
(1)取泽泻、茯苓、知母、黄柏、熟地黄混合粉碎至20-200目，得到混合药材，加入混合药材重量10-30倍水煎煮2-4小时，过滤，得到一次滤液和一次滤渣，将一次滤渣再加入混合药材重量10-30倍的水煎煮1-3小时，过滤，得到二次滤液和二次滤渣，合并一次滤液和二次滤液，滤液浓缩成密度为1.30-1.35g/mL的稠膏；
(2)将总重量二分之一的牡丹皮、总重量二分之一的山茱萸以75wt％乙醇为溶剂，溶剂加入量为牡丹皮、山茱萸二者重量之和的10倍，浸渍24小时后浓缩成密度为1.31g/mL的稠膏；
(3)取山药、剩余总重量二分之一的山茱萸及剩余总重量二分之一的牡丹皮粉碎至100-300目，再与步骤(1)和步骤(2)的稠膏混匀制丸，干燥即得。
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107158357A (zh) * | 2017-07-31 | 2017-09-15 | 朱克兰 | 一种治疗耳鸣的中药组合物及其制备方法 |
| CN111265629A (zh) * | 2020-04-13 | 2020-06-12 | 史国勤 | 一种治疗痛风的中药组合物 |
| CN116019891A (zh) * | 2023-01-13 | 2023-04-28 | 荆州市中医医院(荆州市沙市中医医院) | 一种治疗耳鸣耳聋的中药膏方及其制备方法 |
| CN116019891B (zh) * | 2023-01-13 | 2023-10-27 | 荆州市中医医院(荆州市沙市中医医院) | 一种治疗耳鸣耳聋的中药膏方及其制备方法 |
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