CN101862367A - 一种降脂减肥用决明子软胶囊及其制备方法 - Google Patents
一种降脂减肥用决明子软胶囊及其制备方法 Download PDFInfo
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Abstract
一种降脂减肥用决明子软胶囊，其特征在于：该软胶囊的内容物按重量份比由以下组分构成：决明子醇提浸膏粉10～60份，甘草水提浸膏粉2～10份，月见草油10～30份，沙棘籽油5～20份，蜂蜡2～10份；本发明内容物中的固体药物成分含量高，故功效更好，同时也有效地解决了水溶性和醇溶性固体物料在植物油中的分散问题。
Description
技术领域
本发明涉及决明子的提取物在制药领域中的应用，尤其涉及一种降脂减肥用决明子软胶囊及其制备方法。
背景技术
高脂血症是一种常见疾病，是人体脂质代谢失调所致。临床检验为血清胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白(LDL)过高；高密度脂蛋白(HDL)趋于下降或低于正常值。高脂血症易诱发冠心病、脑中风、高血压等心血管疾病，还可能引起胆结石、胰腺炎、老年痴呆等疾病。目前，随着经济的快速发展，人们的饮食结构发生很大变化，动物脂肪等高热量食物摄取率增高，再加上生活节奏加快所致的社会心理因素的变化，高脂血症人群增多，心脑血管疾病的发病率升高。同时，医学研究证明，高血脂往往伴随肥胖症。目前医学界正努力开发副作用小疗效好的降脂减肥药物，尤其从中医理论出发，研究病因，通过科学合理配伍组方制成中药制剂，达到标本兼治的目的，以实现降脂减肥的功效的研究最为之多。如：公开号为CN101698028A的“一种降脂减肥组合物及其制备方法”以及公开号为CN101524441的“一种降脂减肥的中药组合及其制备方法”等，然而上述降脂减肥中药组合物中，尤其是其胶囊剂中，存在胶囊剂内容物中的固体药物成分的含量较低，服药剂量较大，故而药物功效不高。同时，由于目前软胶囊技术的难点主要是内容物中药物成分含量，尤其是水溶性、醇溶性固体药物成分的含量提升难。也由于软胶囊剂的内容物所用分散媒介通常为植物油，水溶性及醇溶性物料在植物油中的溶解度极低，故难以分散，导致软胶囊剂型在水溶性和醇溶性固体药物上的应用受到很大制约。
发明内容
鉴于上述不足之处，本发明的目的在于提供一种内容物中的固体药物成分含量高、功效更好的降脂减肥用决明子软胶囊及其制备方法。
为了达到上述目的，本发明采取了以下技术方案：一种降脂减肥用决明子软胶囊，该软胶囊的内容物按重量份比由以下组分构成：
决明子醇提浸膏粉 10～60份
甘草水提浸膏粉 2～10份
月见草油 10～30份
沙棘籽油 5～20份
蜂蜡 2～10份
制备上述降脂减肥用决明子软胶囊的方法包括有以下步骤：
(1)决明子醇提浸膏粉的制备：将决明子粉碎后，加10～20倍量的95％乙醇进行回流提取，提取液经减压回收乙醇后，经喷雾干燥，得决明子乙醇提浸膏粉；
甘草水提浸膏粉的制备：将甘草切碎或粉碎成粗粉，加10～20倍量的水进行煮沸提取，提取液经减压浓缩、喷雾干燥，成甘草水提浸膏粉；
月见草油的制备：月见草油为柳叶菜科植物月见草、黄花月见草等种子的脂肪油。7-8月果实成熟时，晒干，压碎并筛去果壳，收集种子，用CO2超临界萃取方法取得月见草油；
沙棘籽油的制备：采用CO2超临界萃取方法提炼沙棘籽油；
(2)取上述配方量的决明子醇提浸膏粉，用两倍该浸膏粉重量的95％乙醇溶解，加入配方量50％的蜂蜡，75℃水浴加热，使蜂蜡溶解，得决明子乙醇蜂蜡混合液；另将剩余配方量50％的蜂蜡与月见草油共热，使蜂蜡溶解，待油蜡液冷却至60℃以下，在不断搅拌下，缓缓将上述决明子乙醇蜂蜡混合液加入，不停搅拌，再加入上述配方量的甘草水提浸膏粉，继续搅拌并以循环水冷却，待温度降至50℃左右，加入上述配方量的沙棘籽油，继续搅拌，得流动性均质性较好的膏状体软胶囊内容物，在40℃以下按常规方法压制软胶囊即得。
本发明配方中：决明子醇提浸膏粉为君。决明子醇提浸膏粉具有降血压、降血脂、保肝及抑菌等活性；
而沙棘籽油的活性成分就有103种(其中脂溶性维生素6种，脂肪酸22种，脂类42种，黄酮和酚类33种)，沙棘籽油被定为“宇航日餐必需品”，在国际上，沙棘籽油被称为“油料黄金”。沙棘油是一类天然植物产品，可使高血脂患者的血清甘油三酯(TG)和胆固醇(TC)两种指标下降，使血清高密度脂蛋白(HDL)升高，从而调节血脂，预防心脑血管病的发生。有助决明子醇提浸膏粉降脂之功效，故为臣药。
月见草油具降血脂及抗动脉粥样硬化、减肥作用；为佐药。
甘草水提浸膏粉补脾益气，清热解毒，祛痰止咳，有调和诸药之功效，故为使药。
诸药合用，具补脾益气、降脂减肥之功效。
本发明的有益效果在于：
(1).选用中药材为原料，提取各有效组份符合药政法规，利用各味中药的综合作用来
达到降脂减肥之功效，无毒无害，可长期服用。
(2).本发明内容物中的固体药物成分含量高，故功效更好。
(3).本发明则有效地解决了水溶性和醇溶性固体物料在植物油中的分散问题：A、决明子的醇提物与蜂蜡在乙醇中经加热溶解后，可形成高浓度，但粘滞性较低的液体，主要是利用蜂蜡可溶于热乙醇的特点，使决明子醇提物、蜂蜡、乙醇三者形成均质性较好的液体(决明混合液)。B、将决明混合液在不停冷却搅拌下，缓缓加入到月见草与蜂蜡形成的蜡油中。是利用决明混合液与月见草蜡油可以共溶的原理，在搅拌下，再加入甘草水提浸膏粉，随着混合液中乙醇的不断挥发，以及温度的不断下降，析出的决明子醇提物以极细的微粒被蜂蜡不断包埋，形成均质性较好的膏体。此时再加入沙棘籽油稀释膏体，即得流动性极佳的软胶囊内容物，易于胶囊压制成型。
具体实施方式
实施例1
决明子醇提浸膏粉的制备：将决明子粉碎后，加10～20倍量的95％乙醇进行回流提取，提取液经减压回收乙醇后，经喷雾干燥，得决明子乙醇提浸膏粉；甘草水提浸膏粉的制备：将甘草切碎或粉碎成粗粉，加10～20倍量的水进行煮沸提取，提取液经减压浓缩、喷雾干燥，成甘草水提浸膏粉；
月见草油的制备：月见草油为柳叶菜科植物月见草、黄花月见草等种子的脂肪油。7-8月果实成熟时，晒干，压碎并筛去果壳，收集种子，用CO2超临界萃取方法取得月见草油；
沙棘籽油的制备：采用CO2超临界萃取方法提炼沙棘籽油；
取决明子浸膏粉
决明子醇提浸膏粉 10～60份
甘草水提浸膏粉 2～10份
月见草油 10～30份
沙棘籽油 5～20份
蜂蜡 2～10份
取决明子醇提浸膏粉1000g，用2000g95％乙醇溶解，加入100g的蜂蜡，75℃水浴加热，使蜂蜡溶解，得决明子乙醇蜂蜡混合液；另将100g的蜂蜡与月见草油1000g共热，使蜂蜡溶解，待油蜡液冷却至60℃以下，在不断搅拌下，缓缓将上述决明子乙醇蜂蜡混合液加入，不停搅拌，再加入200g甘草水提浸膏粉，继续搅拌并以循环水冷却，待温度降至50℃左右，加入500g沙棘籽油，继续搅拌，得流动性均质性较好的膏状体软胶囊内容物，在40℃以下按常规方法压制软胶囊即得降脂减肥用决明子软胶囊(500mg/粒)。
实施例2
按上述方法制得决明子醇提浸膏粉，甘草水提浸膏粉，月见草油，沙棘籽油。
取决明子醇提浸膏粉3500g，用7000g95％乙醇溶解，加入300g的蜂蜡，75℃水浴加热，使蜂蜡溶解，得决明子乙醇蜂蜡混合液；另将300g的蜂蜡与月见草油2000g共热，使蜂蜡溶解，待油蜡液冷却至60℃以下，在不断搅拌下，缓缓将上述决明子乙醇蜂蜡混合液加入，不停搅拌，再加入600g甘草水提浸膏粉，继续搅拌并以循环水冷却，待温度降至50℃左右，加入1250g沙棘籽油，继续搅拌，得流动性均质性较好的膏状体软胶囊内容物，在40℃以下按常规方法压制软胶囊即得降脂减肥用决明子软胶囊(500mg/粒)。
实施例3
按上述方法制得决明子醇提浸膏粉，甘草水提浸膏粉，月见草油，沙棘籽油。
取决明子醇提浸膏粉6000g，用12000g95％乙醇溶解，加入500g的蜂蜡，75℃水浴加热，使蜂蜡溶解，得决明子乙醇蜂蜡混合液；另将500g的蜂蜡与月见草油3000g共热，使蜂蜡溶解，待油蜡液冷却至60℃以下，在不断搅拌下，缓缓将上述决明子乙醇蜂蜡混合液加入，不停搅拌，再加入1000g甘草水提浸膏粉，继续搅拌并以循环水冷却，待温度降至50℃左右，加入2000g沙棘籽油，继续搅拌，得流动性均质性较好的膏状体软胶囊内容物，在40℃以下按常规方法压制软胶囊即得降脂减肥用决明子软胶囊(500mg/粒)。
本发明是通过加速胆固醇和脂肪的代谢，增强肝脏代谢能力而发挥作用的。主要成分为豆科植物决明子的降胆固醇活性成分以及沙棘籽油中的降低密度β-脂蛋白成分。每天4-6粒(500mg/粒)的用量，坚持2个月以上，可收到明显效果。
目前对本发明进行了如下实验：
现将100名人体总胆固醇高于7.76m mol/l，低密度脂蛋白高于4.80mmol/l，体重超过标准体重的20％(标准体重的算法：男性标准体重＝(身高cm-80cm)×70％；女性标准体重＝(身高cm-70cm)×60％)的人进行临床试验。
将选出的100名患者根据年龄的不同按照表一进行分类，按照年龄差异分成：30～40组：10人，41～50组：42人，51～60组：36人，61～70组：12人。
表一：
服用本发明提供的降脂减肥用决明子软胶囊(服用实施例2所制得的胶囊)，每天4粒(500mg/粒)的用量，坚持服用4个月。在实验过程中，停止服用其他降脂减肥类药物。
评判比较
治疗功能差异用的统计处理：
表三统计比较：
其中：
康复是指：人体总胆固醇为2.9-6.00mmol/l，低密度脂蛋白2.7-3.36mmol/l，体重为标准体重±5％；
显效是指：人体总胆固醇为6.00-7.00mmol/l，低密度脂蛋白3.36-4.00mmol/l，体重为标准体重±15％；
无效是指没有改变。
临床观察显示将该发明用于降脂减肥，总有效率90％。治疗前后作血、尿、便常规及肝肾功能检查，未见异常变化，用药过程中未发现该药物有明显的不良反应。试验表明该发明治疗肥胖和高血脂疗效显著，无毒副作用。
典型病例：
病例l：患者谢XX，男性，年龄65岁，身高1.70米，体重76kg，胆固醇7.76mmol/l，低密度脂蛋白4.80mmol/l。经服用本发明制备的降脂减肥用决明子软胶囊(服用实施例1所制得的胶囊)，每日一次，每次4粒，4个月后检查，总胆固醇降为6.07mmol/l，低密度脂蛋白降为3.70mmol/l，体重降为68kg。
病例2：患者马XX，女性，年龄50岁，身高1.58米，体重65kg，胆固醇7.98mmol/l，低密度脂蛋白5.02mmol/l服用本发明制备的降脂减肥用决明子软胶囊(服用实施例3所制得的胶囊)(每日一次，每次4粒，4个月后检查，总胆固醇降为6.02mmol/l，低密度脂蛋白降为3.510mmol/l，体重降为61.5kg。
Claims (2)
1.一种降脂减肥用决明子软胶囊，其特征在于：该软胶囊的内容物按重量份比由以下组分构成：
决明子醇提浸膏粉 10～60份
甘草水提浸膏粉 2～10份
月见草油 10～30份
沙棘籽油 5～20份
蜂蜡 2～10份
2.一种如权利要求1所述的降脂减肥用决明子软胶囊的制备方法，其特征在于：该方法包括有以下步骤：
(1)决明子醇提浸膏粉的制备：将决明子粉碎后，加10～20倍量的95％乙醇进行回流提取，提取液经减压回收乙醇后，经喷雾干燥，得决明子乙醇提浸膏粉；
甘草水提浸膏粉的制备：将甘草切碎或粉碎成粗粉，加10～20倍量的水进行煮沸提取，提取液经减压浓缩、喷雾干燥，成甘草水提浸膏粉；
月见草油的制备：月见草油为柳叶菜科植物月见草、黄花月见草等种子的脂肪油。7-8月果实成熟时，晒干，压碎并筛去果壳，收集种子，用CO2超临界萃取方法取得月见草油；
沙棘籽油的制备：采用℃O2超临界萃取方法提炼沙棘籽油；
(2)取上述配方量的决明子醇提浸膏粉，用两倍该浸膏粉重量的95％乙醇溶解，加入配方量50％的蜂蜡，75℃水浴加热，使蜂蜡溶解，得决明子乙醇蜂蜡混合液；另将剩余配方量50％的蜂蜡与月见草油共热，使蜂蜡溶解，待油蜡液冷却至60℃以下，在不断搅拌下，缓缓将上述决明子乙醇蜂蜡混合液加入，不停搅拌，再加入上述配方量的甘草水提浸膏粉，继续搅拌并以循环水冷却，待温度降至50℃左右，加入上述配方量的沙棘籽油，继续搅拌，得流动性均质性较好的膏状体软胶囊内容物，在40℃以下按常规方法压制软胶囊即得。
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| WO2012003768A1 (zh) * | 2010-07-05 | 2012-01-12 | Ma Jianzhong | 一种降脂减肥用决明子软胶囊及其制备方法 |
| US8859006B2 (en) | 2010-07-05 | 2014-10-14 | Jianzhong Ma | Semen cassiae soft capsule for reducing fat and losing weight and preparation method thereof |
| CN105616481A (zh) * | 2016-03-03 | 2016-06-01 | 广东福寿仙生物科技有限公司 | 一种降血脂中西药制剂及其制备方法 |
Also Published As
| Publication number | Publication date |
|---|---|
| US20130099403A1 (en) | 2013-04-25 |
| US8859006B2 (en) | 2014-10-14 |
| CN101862367B (zh) | 2011-09-07 |
| WO2012003768A1 (zh) | 2012-01-12 |
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