CN112107665A - 一种降浊祛脂胶囊 - Google Patents
一种降浊祛脂胶囊 Download PDFInfo
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- CN112107665A CN112107665A CN201910532148.2A CN201910532148A CN112107665A CN 112107665 A CN112107665 A CN 112107665A CN 201910532148 A CN201910532148 A CN 201910532148A CN 112107665 A CN112107665 A CN 112107665A
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Abstract
本发明公开了一种降浊祛脂胶囊，所述降浊祛脂胶囊包括黄芪、枸杞子、郁金、绞股蓝、红曲五味原料组成，所述黄芪、枸杞子、郁金、绞股蓝、红曲的重量之比为20:6:10:15:20。本发明中黄芪为君，枸杞子、郁金为臣，绞股蓝、红曲为佐使，协同增效，具有化痰降浊，活血行气、健脾补肾，疏肝降浊的功效，对治疗痰瘀互阻型高脂血症效果尤其好。
Description
技术领域
本发明涉及医药技术领域，具体涉及一种降浊祛脂胶囊。
背景技术
高脂血症(Hyperlipidemia)是指多种原因引起的体内脂类代谢紊乱，血脂水平异常升高，包括胆固醇和甘油三酯(TG)异常升高的一种疾病。高脂血症可加重动脉粥样硬化进程，导致多种疾病的产生，尤其对心脑血管疾病的发生发展有着重要影响。近年来，随着人民生活水平的不断提高，高脂血症呈年轻化发展趋势，发病率逐年上升。以低密度脂蛋白胆固醇(LDL-C)或总胆固醇(TC)升高为特点的高脂血症是动脉粥样硬化性心血管疾病(atheroscleroticcardiovascular disease,ASCVD)发生发展的重要危险因素。降低LDL-C水平，可显著减少ASCVD的发病及相关死亡风险。其他类型的血脂水平异常升高与ASCVD发病危险也存在一定程度关联。因此，为降低ASCVD发生风险，降低以LDL-C升高为主的患者血脂水平成为首要目标。他汀作为降脂治疗的核心药物，可以有效降低LDL-C水平，其在心血管疾病一级预防及二级预防中发挥重要作用，能有效降低疾病的发生率及死亡率。他汀类药物耐受性和安全性总体较为良好，但个别患者仍会出现肌肉毒性、肝损害、认知障碍、糖尿病、白内障和肿瘤等方面的不良反应，尤其是中高剂量他汀长期服用，容易增加不良反应的风险。中医药在高脂血症的治疗中具有独特优势，有效性及安全性高，并有益于提高患者的依从性，在治疗高脂血症及预防心脑血管事件发生具有重要意义。
中医古籍中并无“高脂血症”这一病名，根据古籍中的相关论述，认为“痰湿”、“血寮”、“脂浊”等可都可归属于高脂血症的范畴。中医对高脂血症的认识最早可追溯到《黄帝内经》时期，《黄帝内经》提出“膏脂学说”，《灵枢·卫气失常》篇云：“脂者，其血清，气滑少。”《灵枢·五癃津液别》曰“五谷之津液，和合而为膏者。内渗于骨空，补益脑髓，而下流于阴股”。中医认为高脂血症发病与先天禀赋、饮食不节、劳逸失调、情志内伤等因素有关。其病因可分为内因和外因。外因主要包括过食肥甘厚腻，滋生痰湿，内困于脾，脾虚进一步影响气血津液运化，痰浊瘀阻于血脉；内因主要是脏腑功能失调。高脂血症的病机总属本虚标实，正虚为本，痰瘀为标。本虚以脾、肝、肾三脏亏虚为本，尤其以脾虚为主；标实包括气滞、血瘀、痰浊，以痰浊瘀阻脉络为主。脾虚导致运化功能失调，水液输布失司，内困于脾，聚湿生痰。痰浊内阻，进而影响脾运化功能，以致恶性循环。痰浊日久生瘀，痰瘀阻于脉络，形成高脂血症。因此，脏腑功能失调，脾气亏虚，痰浊瘀血阻滞脉络，是高脂血症的基本病机。
岭南处五岭之南，南濒大海，北枕五岭山脉，“四时常花，三冬无雪”，气候温暖、湿润，常见病以温病为主。珠三角地区常年受到暖湿气流影响，空气湿度较高。《岭南卫生方》提出“阳燠之气常泄”和“阴湿之气常盛”，总结了岭南地区人群以“湿”为主的体质特点。中医整体观把人体各脏腑及形体官窍视为一体，结构和功能上密不可分、互为协调，病理上相互影响。人生活在自然界和社会环境中，生理及病理变化必然受到自然和社会环境的影响。岭南地区人群长期处于湿热气候中，气体受湿热之邪侵袭，湿热交蒸于脾胃，最易伤脾。久之脾虚失运，水湿不布，聚湿生痰。此外，岭南地区受湿热气候影响，人们勤泳浴，喜食生冷、海鲜等滋腻之品，喜用药膳、凉茶等清热消暑之品，寒湿更易伤脾，致使脾胃运化功能失调。因此岭南人多有脾阳不足、痰湿阻滞的体质特点。生活习性及环境造就了岭南人独特的体质，即脾虚兼有痰湿。脾土喜燥恶湿，湿邪困阻脾胃，久之脾胃虚弱，运化功能减弱，则湿浊更甚，进而损伤脾阳。所谓“土厚火伏”、“内伤脾胃，百病由生”，脾虚易使肾阳难以潜藏，脾阳虚易致肾精虚损。同时，肝主疏泄，脾主运化，肝依赖于脾胃运化水谷精微，提供营养，才能保持疏泄功能的正常。若脾失健运，水湿内停，则肝疏泄不利，土壅木郁。因此，急需针对岭南地区人群开发有效治疗高脂血症的药物。
发明内容
针对现有技术中的缺陷，本发明提供一种降浊祛脂胶囊。结合岭南地区人群脾肾亏虚，痰浊瘀滞的体质证候特点，标本同治，具有化痰降浊、活血行气的功效。
本发明通过如下技术方案实现：
一种降浊祛脂胶囊，包括黄芪、枸杞子、郁金、绞股蓝、红曲五味原料组成。
在其中一些实施例中，所述黄芪、枸杞子、郁金、绞股蓝、红曲的重量之比为20:6:10:15:20。
本发明还提供了降浊祛脂胶囊的制备方法，包括如下步骤：
A、将黄芪、枸杞子、绞股蓝三味原料加10-13倍量水，煎煮2-3次，每次煎煮1.3-1.7小时，合并煎液，过滤，滤液在70-80℃下减压浓缩，真空度为-0.06MPa～-0.08MPa，浓缩至在60℃测相对密度为1.2-1.3的浸膏；
B、将郁金、红曲二味原料加3-5倍量乙醇，回流提取2-3次，每次0.4-0.6小时，得提取液，过滤，合并滤液，滤液在70-80℃下减压浓缩，真空度为-0.06MPa～-0.08MPa，浓缩至在60℃测相对密度为1.1-1.2的浸膏；
C、将步骤(A)和步骤(B)浸膏合并，加入填充剂，混匀，70℃-80℃下减压干燥至干，真空度为-0.07MPa～-0.08MPa，干膏粉碎，过70-90目筛；
D、干膏粉加润湿剂润湿制软材，过10-15目筛制粒，70℃-75℃下减压干燥，整粒，加入润滑剂，混匀，制成胶囊，即得。
在其中一些实施例中，所述步骤(B)中乙醇的质量浓度为60％-80％。
在其中一些实施例中，所述步骤(C)中填充剂为二氧化硅，所述二氧化硅的添加量为10％-20％。干膏粘性大，干燥时加入二氧化硅解决了其难减压干燥的问题。
在其中一些实施例中，所述步骤(D)中润湿剂为乙醇，所述乙醇的质量浓度为90％-98％。
在其中一些实施例中，所述步骤(D)中乙醇的用量为干膏粉重量的30％-35％。
在其中一些实施例中，所述步骤(D)中润滑剂为硬脂酸镁，所述硬脂酸镁的添加量为0.25％-0.3％。润硬脂酸镁滑性强、抗粘附性好，作润滑剂，能较好的充填胶囊。
高脂血症病机为本虚标实，以脾肝肾三脏亏虚为本，痰浊瘀血阻络为标。痰浊和瘀血是导致高脂血症发病的重要因素，痰浊与瘀血能相互化生、转化。痰能致瘀，瘀可生痰，因此，化痰祛瘀是治疗高脂血症的主要治法。
脾失健运、肝气郁滞、肾失开合，均可导致痰浊的产生。脾主运化，水液的转输有赖于脾的运化功能正常。若脾气亏虚，水饮内停，聚湿生痰。同时，脂质难以运化转输，积聚成痰。痰浊日久，久病入络，形成血瘀，阻滞脉络，进而影响痰湿转运，痰瘀互结，发为本病。肝主疏泄，若肝气条达畅顺，则有助于促进脾胃运化，促进水谷精微的输布代谢。若肝失疏泄，一方面影响脾胃升清降浊功能，清气不升，浊阴不降，则痰浊内阻。另一方面，气机不利，易致血脉瘀阻，脉道瘀阻，痰湿不化，久之痰瘀互结。肾为先天之本，肾气不足，或肾阴、肾阳亏虚，均可导致痰浊、瘀血的产生。若肾阳不足，无力运化水湿，体内水湿停聚，痰浊内生。若肾阴亏虚，虚火内生，火热伤津，炼液为痰。
总之，脾、肝、肾三脏虚损均能导致痰浊、瘀血的产生。“痰”和“瘀”既是高脂血症的病理产物，亦是导致高脂血症发病的病理因素，二者贯穿疾病始终。痰浊日久，形成血瘀，血瘀脉道，凝滞成痰，因此，痰瘀互阻为高脂血症的主要病机特征，也是高脂血症的主要证型。治疗高脂血症，必须从痰瘀入手，痰瘀同治。单化痰则瘀血难祛，仅逐瘀则痰浊难化，只有化痰祛瘀二者兼顾，方能切中病机。
高脂血症病机总属本虚标实，本虚病变的脏腑主要为脾、肝、肾，尤以脾脏为关键，标实以痰浊瘀血为主，结合岭南地区人群症候特点，发明人认为痰瘀互阻为高脂血症一个常见证型，治疗方法应以健脾、化痰、降浊、活血等为主。本发明结合高脂血症病因病机特点，主治痰瘀互阻高脂血症，兼以补脾肾之气。气虚、气郁等气机失调均可导致痰湿内聚、瘀血内生等病理变化。痰瘀互阻又可阻碍气血运行，使脂浊内停，恶象循环。补益脾肾可激发气之运行，促进体内痰浊膏脂的排泄。本发明标本兼顾，化痰泻浊，以中医整体观的思想调节体内血脂异常的状态。
本发明的有益效果体现在：本发明中黄芪为君，枸杞子、郁金为臣，绞股蓝、红曲为佐使，协同增效，具有化痰降浊，活血行气、健脾补肾，疏肝降浊的功效，对治疗痰瘀互阻型高脂血症效果尤其好。
附图说明
为了更清楚地说明本发明具体实施方式或现有技术中的技术方案，下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍。
图1为降浊祛脂胶囊的工艺流程图；
图2为治疗前后两组TC水平比较；
图3为治疗前后两组TG水平比较；
图4为治疗前后两组LDL-C水平比较；
图5为治疗前后两组HDL-C水平比较。
具体实施方式
下面将结合附图对本发明技术方案的实施例进行详细的描述。以下实施例仅用于更加清楚地说明本发明的技术方案，因此只作为示例，而不能以此来限制本发明的保护范围。
需要注意的是，除非另有说明，本申请使用的技术术语或者科学术语应当为本发明所属领域技术人员所理解的通常意义。
本发明中黄芪为豆科植物蒙古黄芪Astragalus membranaceus(Fisch.)Bge.Var.mongholicus(Bge.)Hsiac干燥根的炮制加工品。黄芪的化学成分主要成分含有皂苷类、黄酮类、氨基酸、多糖，其中，黄芪皂苷Ⅳ(亦称黄芪甲苷)是一种羊毛酯醇形的四环三萜皂苷，是黄芪的主要有效成分，为黄芪药材的定性定量指标。此外，黄芪中还含有生物碱、甾醇类物质、叶酸、亚麻酸、亚油酸、尼克酸、核黄素、维生素P及铁、锰、锌、铷等14种微量元素。黄芪味甘，性微温，归肺、脾经。功效为益气固表、利尿排毒。主治气虚乏力、食少便溏、中气下陷等。《本草备要》记载其“温分肉、实腠理、泻阴火、解肌热，益元气、温三焦、壮脾胃，为补药之长”。黄芪既能补益脾肾正气之亏，又善行血导气、排毒除滞，是为君药。现代多项药理研究亦证明黄芪具有多种确切的药理作用，如增强机体免疫力、改善机体功能状态、增强心肌收缩力、调节血压、血糖等作用，对高脂血症治疗作用显著。同时，黄芪还具有抗氧化及延缓衰老的作用。文献《黄芪对冠心病合并血脂异常的疗效观察》中，刘亚辉将56例冠心病合并有高脂血症的患者随机分为治疗组和对照组，两组患者均予硝酸甘油静滴，治疗组患者加予黄芪注射液静滴。结果显示黄芪注射液能显著降低患者血清胆固醇P＜0.01)，对甘油三酯、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇均有不同程度的改善(P＜0.05)。表明黄芪能有效调节高脂血症患者血脂水平。
枸杞子为茄科植物宁夏枸杞Lycium barbarum L.的干燥成熟果实的炮制加工品。据文献报道，枸杞子的主要成分包括生物碱、黄酮类成分、枸杞多糖、类胡萝卜素、挥发油类成分、有机酸等。枸杞味甘，具有滋养肝肾、补益精气等作用，它能有效调节血脂，抑制动脉粥样硬化的形成。另外，枸杞中内含丰富人体内必须的微量元素，如钙、磷、铁。这些物质对细胞内的生长分化、细胞间的信息交流、神经系统的激动性和传导性都具有重要作用。这些作用将维持组织的整体性和渗透屏障功能。实验表明，枸杞水提取液能降低高脂血症大鼠血清中TC、TG含量和LDL-C/HDL-C比值，提高HDL-C含量和HDL-C/TC比值，有显著的降脂功能，对预防动脉粥样硬化具有积极作用。
郁金为姜科植物姜黄Curcuma longa L.干燥块根的炮制加工品。其主含挥发油类、姜黄素类、多糖类及微量元素等成分，郁金中有效成分挥发油主要为倍半萜类化合物，包括莪术酮、吉马酮、莪术烯、姜黄二酮等。
绞股蓝为葫芦科植物绞股蓝Gynostemma pentaphyllum(Thunberg)Makino的干燥地上部分炮制加工品。据文献报道，绞股蓝的主要成分有：皂苷类、多糖、黄酮及黄酮苷类化合物、甾醇类化合物、氨基酸、微量元素等。绞股蓝中富含18种氨基酸，其中8种是人体必需的氨基酸以及丰富的蛋白质和多种维生素。同时人体必需的微量元素(铜、铁、锌、锰、钻、镍、铬、铝、硒及锶、锂)的含量均较高。此外，还有报道分离得到丙二酸、苯甲醇葡萄糖苷、甜味素(phyllodulein)、木脂素等。绞股蓝，味苦酸，性偏寒，其主要功效为祛痰化瘀、养心健脾、益气和血、清热解毒。现代药理学表明绞股蓝有降脂、抗动脉粥样硬化等作用。绞股蓝总苷片能有效调节血脂、保护血管内皮细胞膜及抗血小板聚集和释放，具有延缓、防止动脉粥样硬化斑块发展的作用。众多临床研究及实验证明绞股蓝具有良好的调脂作用。绞股蓝总皂苷能降低大鼠血清TC、TG、LDL-C和调节HDL-C水平，同时具有抗脂质过氧化作用，用于治疗高脂血症疗效显著。文献《绞股蓝复方制剂治疗高脂血症的临床疗效》中徐洪用绞股蓝复方制剂治疗高脂血症患者，将临床上100例患者随机分为治疗组和对照组各50例，治疗组予绞股蓝复方制剂，对照组予普伐他汀片调脂治疗。30天后观察发现治疗组患者的有效率高于对照组(P＜0.05)，绞股蓝复方制剂能有效降低血脂异常患者TC、TG和LDL-C水平，同时能有效提高患者HDL-C水平，临床上治疗高脂血症疗效显著。
红曲为曲霉科真菌紫色红曲菌等菌种接种于煮至半熟的梗米上，经培育的红曲米Monascus purpureus Went..红曲的主要成分有：茯苓化学成分主要为多糖和三萜类成分、还含有树胶、蛋白质、脂肪酸、甾醇、酶等成分。日本远藤章首次从红色红曲霉菌(M.ruber)发酵产物中分离到Monacolin k(即Lovastatin，洛伐他汀)。到目前为止，从红曲霉菌发酵代谢产物中分离到Monacolin J、Monacolin L、Monacolin M等10种Monacolin k的类似物质，统称为Monacolins。此类成分为3-羟基-3-甲戊二酰辅酶A(HMG-CoA)还原酶的特异性抑制剂，被认为是当前最有前途的血脂调节药物。
本发明根据各药的成分，结合临床汤剂用药经验，拟定提取工艺为黄芪、枸杞子、绞股蓝等三味加水煎煮，郁金、红曲二味加乙醇回流提取，再与适量辅料混合干燥，湿法制粒，充填胶囊，即得。
对黄芪、枸杞子、绞股蓝三味水提浸膏和郁金、红曲二味醇提浸膏80℃单独干燥与混合干燥情况做试验，结果如下表1所示：
表1
结论：试验结果提示，水提浸膏易干燥；醇提浸膏难干燥。因此考虑将水提浸膏、醇提浸膏加二氧化硅混合干燥。
二氧化硅比表面积大、分散性好，将其与水提浸膏、醇提浸膏混匀，在添加量为5％、10％、15％、20％、25％，80℃减压干燥的情况下，测试其效果，见表2。
表2
| 试验号 | 二氧化硅用量 | 干燥情况 |
| 1 | 5％ | 较难干燥，干膏较难收集 |
| 2 | 10％ | 较易干燥，干膏易收集、粉碎 |
| 3 | 15％ | 易干燥，干膏易收集、粉碎 |
| 4 | 20％ | 易干燥，干膏易收集、粉碎 |
| 5 | 25％ | 较难干燥，干膏较难收集 |
结论：试验结果表明，添加量为10％-20％的二氧化硅，与水提浸膏、醇提浸膏混匀，80℃减压干燥是可行的。添加量太少(5％)或者太多(25％)，对混合水提、醇提浸膏的干燥都难易达到干燥效果。
不同用量润湿剂对颗粒成型影响较大，故测试乙醇的合理使用量。
取混合干膏(水提浸膏、醇提浸膏和20％二氧化硅混合干燥)，粉碎，过80目筛，与适量二氧化硅混合均匀，分别用不同量乙醇制粒，70℃下干燥，整粒，观察颗粒成型情况，结果见表3。
表3
结论：根据试验结果可知，当乙醇的用量小于30％时，其颗粒粘性小，不易成型，颗粒均匀，较细；当乙醇的用量大于35％时，其颗粒粘性较大，粘结成块，颗粒不均匀，较大。所以，乙醇的用量在30％-35％时，对颗粒的成型和粒度都较好。
不同用量润滑剂对颗粒流动性影响较大，故测试硬硬酸镁的合理使用量。
取颗粒分别加入0.25％、0.30％、0.50％的硬硬酸镁混匀，以颗粒休止角为指标，考察颗粒流动性，结果见表4。
表4
| 试验号 | 硬脂酯镁用量(％) | 休止角 |
| 1 | 未加 | 45.2° |
| 2 | 0.25 | 38.0° |
| 3 | 0.30 | 38.1° |
| 4 | 0.50 | 41.3° |
结论：试验结果表明，试验2、试验3休止角小于40°，颗粒流动性满足生产需求，当硬脂酯镁的用量小于0.25％或者大于0.3％，休止角都大于40°，其颗粒流动性不满足生产需求。
本发明以胶囊的形式装载药物，将药物颗粒装在胶囊壳中与外界隔离，避开了水分、空气、光线的影响，不受压力因素影响，有利于药物分散、溶出和吸收，其生物利用度将高于丸剂、片剂，再者胶囊剂具有剂量准确、质量稳定可控、易吞服、应用广泛等优点，故本发明制成胶囊剂。
在制备工艺中，本发明采用减压干燥的方式干燥浸膏，中药浸膏的一般干燥方式主要包括常压干燥、减压干燥、喷雾干燥等。采用常压干燥一般温度较高，水分蒸发慢，耗时长，效率低，对热敏性成分损耗较大；喷雾干燥属于对流型干燥，热效率比较低，而且成本费用比较高；而减压干燥需要的温度低，速度快，减少了物料与空气的接触，避免污染或氧化变质，干燥后产品呈松脆海绵状，易于粉碎，适于浸膏及热敏性或高温下易氧化物料的干燥。
实施例1
一种降浊祛脂胶囊，由1000g黄芪、300g枸杞子、500g郁金、750g绞股蓝、1000g红曲五味原料制成。其制备方法，包括如下步骤：
A、将黄芪、枸杞子、绞股蓝三味原料加13倍量水，煎煮2次，每次煎煮1.7小时，合并煎液，过滤，滤液在70℃下减压浓缩，真空度为-0.08MPa，浓缩至在60℃测相对密度为1.2的浸膏；
B、将郁金、红曲二味原料加3倍量60％乙醇，回流提取3次，每次0.4小时，得提取液，过滤，合并滤液，滤液在80℃下减压浓缩，真空度为-0.06MPa，浓缩至在60℃测相对密度为1.2的浸膏；
C、将步骤(A)和步骤(B)浸膏合并，加入二氧化硅，二氧化硅的用量为浸膏重量的10％，混匀，70℃下减压干燥至干，真空度为-0.08MPa，干膏粉碎，过70目筛；
D、干膏粉加90％乙醇润湿制软材，乙醇的用量为干膏粉重量的35％，过15目筛制粒，70℃下减压干燥，整粒，加入硬脂酸镁，硬脂酸镁的用量为颗粒重量的0.28％，混匀，制成胶囊，即得。
实施例2
一种降浊祛脂胶囊，由200g黄芪、60g枸杞子、100g郁金、150g绞股蓝、200g红曲五味原料制成。其制备方法，包括如下步骤：
A、将黄芪、枸杞子、绞股蓝三味原料加10倍量水，煎煮3次，每次煎煮1.3小时，合并煎液，过滤，滤液在80℃下减压浓缩，真空度为-0.06MPa，浓缩至在60℃测相对密度为1.3的浸膏；
B、将郁金、红曲二味原料加5倍量80％乙醇，回流提取2次，每次0.6小时，得提取液，过滤，合并滤液，滤液在70℃下减压浓缩，真空度为-0.08MPa，浓缩至在60℃测相对密度为1.1的浸膏；
C、将步骤(A)和步骤(B)浸膏合并，加入二氧化硅，二氧化硅的用量为浸膏重量的20％，混匀，80℃下减压干燥至干，真空度为-0.07MPaa，干膏粉碎，过90目筛；
D、干膏粉加98％乙醇润湿制软材，乙醇的用量为干膏粉重量的30％，过10目筛制粒，75℃下减压干燥，整粒，加入硬脂酸镁，硬脂酸镁的用量为颗粒重量的0.25％，混匀，制成胶囊，即得。
实施例3
一种降浊祛脂胶囊，由416.7g黄芪、125g枸杞子、208.3g郁金、312.5g绞股蓝、416.7g红曲五味原料制成。其制备方法，包括如下步骤：
A、将黄芪、枸杞子、绞股蓝三味原料加12倍量水，煎煮3次，每次煎煮1.5小时，合并煎液，过滤，滤液在75℃下减压浓缩，真空度为-0.07MPa，浓缩至在60℃测相对密度为1.2的浸膏；
B、将郁金、红曲二味原料加4倍量70％乙醇，回流提取3次，每次0.5小时，得提取液，过滤，合并滤液，滤液在80℃下减压浓缩，真空度为-0.07MPa，浓缩至在60℃测相对密度为1.2的浸膏；
C、将步骤(A)和步骤(B)浸膏合并，加入二氧化硅，二氧化硅的用量为浸膏重量的15％，混匀，70℃下减压干燥至干，真空度为-0.07MPa，干膏粉碎，过80目筛；
D、干膏粉加95％乙醇润湿制软材，乙醇的用量为干膏粉重量的33％，过14目筛制粒，70℃下减压干燥，整粒，加入硬脂酸镁，硬脂酸镁的用量为颗粒重量的0.3％，混匀，制成胶囊，即得。
疗效验证：对本发明降浊祛脂胶囊效果进行试验分析
一、方法
从广州中医药大学第一附属医院筛选共60例符合纳入标准的痰瘀互阻型高脂血症患者作为研究对象，采用随机、单中心、阳性药对照、开放性临床研究设计，随机将60例患者分为治疗组(实施例3降浊祛脂胶囊)及对照组(血脂康胶囊组)，两组患者各30例。治疗组予以服用降浊祛脂胶囊，一日2次，1次2粒，早晚饭后服用，由广州中医药大学第一附属医院药房提供。对照组予以服用血脂康胶囊，一日2次，1次2粒，早晚饭后服用，由北京大维信生物科技有限公司生产，国药准字：Z10950029。入组前对患者进行健康教育，患者在用药期间应尽量减少饱和脂肪酸及胆固醇等摄入，保持适当运动。疗程共4周，观察主要疗效指标包括患者血脂水平(TC、TG、LDL-C、HDL-C)、血脂总体疗效、中医证候积分等，同时治疗前后完善体温、脉搏、呼吸、血压等生命体征检测，完善血、尿、粪常规、肝肾功能、心电图等检查。4周疗程结束后进行数据统计与分析，所有资料用SPSS 22.0统计软件处理。
注：①纳入标准：(1)同意参加本临床试验，并且签署知情同意书的受试者；(2)年龄范围为18～75岁，性别不限；(3)符合高脂血症诊断标准者，受试者血清TC≥5.2mmol/L和(或)TG≥1.7mmol/L；(4)符合中医辩证诊断标准者，由2名及以上的主治中医师临床诊断确定；(5)已停用相关调脂药物2周及以上。
②痰瘀互阻证：主症：眩晕、倦怠乏力、肢体麻木、胸痛；次症：头重如裹、头痛、胸闷、恶心呕吐、形体肥胖、肌肤甲错、食少多寐；舌脉象：舌淡暗或舌质紫暗，舌尖边有瘀点、瘀斑，苔腻。脉滑或脉涩。若具备主症≥2项，兼具备次症≥1项(或主症≥1项，次症≥2项)，结合舌脉，即可诊断为痰瘀互阻证。
③统计分析：所有资料应用SPSS 22.0统计软件处理。计数资料采用四格表资料设计的卡方检验衡量组间差异；计量资料采用
进行统计描述。若组内指标呈正态分布时，采用配对样本t检验，呈非正态分布，采用配对设计秩和检验；组间指标的比较，正态分布采用独立样本t检验，非正态分布采用成组设计两样本比较秩和检验。以P＜0.05为有显著性统计学意义，P＜0.01为有高度显著统计学意义。
二、疗效性指标
1、主要疗效指标
(1)血脂指标(TC、TG、LDL-C、HDL-C)；
(2)综合疗效评价标准：(见表5)
表5
2、次要疗效指标
(1)中医证候评分(治疗前后各评分一次)：中医证候评分标准参照《中药新药治疗高脂血症的临床研究指导原则》(2002版)制定；
(2)中医证候疗效判定标准：(见表6)
表6
三、病例收集情况
临床试验期间共收集病例60例，研究过程中5例出现脱落。其中治疗组2例脱落，1例脱落原因为患者依从性差，未规律服用药物。1例脱落原因为患者失访，未能判定临床疗效；对照组3例脱落，1例脱落原因为患者依从性差，未规律服用药物。2例脱落原因为患者失访，未能判定临床疗效。(见表7)
表7两组脱落病例情况比较
| 病例类别 | 治疗组 | 对照组 | 合计 |
| 纳入病例数 | 30 | 30 | 60 |
| 完成病例数 | 28 | 27 | 55 |
| 剔除病例数 | 0 | 0 | 0 |
| 脱落病例数 | 2 | 3 | 5 |
四、临床疗效比较
1、治疗前血脂水平比较
治疗前两组患者血脂水平比较，各项指标(TC、TG、LDL-C、HDL-C)均无统计学意义(P＞0.05)，表明治疗前组间患者的血脂水平无显著差异，具有可比性。(见表8)
表8两组治疗前血脂水平比较(mmol/L，
)
| 观察项目 | 例数 | 治疗组 | 对照组 | t | p |
| TC | 30 | 6.05±0.50 | 6.11±0.53 | -0.423 | 0.674 |
| TG | 30 | 2.31±1.01 | 2.37±1.03 | -0.245 | 0.807 |
| LDL-C | 30 | 4.05±0.43 | 4.12±0.63 | -0.506 | 0.615 |
| HDL-C | 30 | 1.26±0.29 | 1.29±0.36 | -0.304 | 0.763 |
2、两组治疗前后TC水平比较
两组治疗前后TC水平比较。组内比较，经配对样本t检验，治疗组患者TC水平较治疗前显著下降(t＝7.054，P＝0.000＜0.01)，对照组患者TC水平亦下降明显(t＝6.125，P＝0.000＜0.01)，表明两组治疗均能有效降低患者TC水平(见图2)。组间比较，治疗前后两组TC差值比较，经独立样本t检验，t＝-0.080，P＝0.936＞0.05，差异无统计学意义，表明治疗组与对照组降低患者TC疗效相当。(见表9)
表9两组治疗前后TC比较(mmol/L，
)
3、两组治疗前后TG水平比较
两组治疗前后TG水平比较。组内比较，经配对样本t检验，治疗组患者TG水平较治疗前显著下降(t＝4.540，p＝0.000＜0.01)，对照组患者TG水平较治疗前亦下降明显(t＝3.333，p＝0.003＜0.01)，表明两组治疗均能有效降低患者TG水平(见图3)。组间比较，治疗前后两组TG差值比较，经独立样本t检验，t＝1.359，P＝0.180＞0.05，差异无统计学意义，表明治疗组与对照组降低患者TG疗效相当。(见表10)
表10两组治疗前后TG比较(mmol/L，
)
4、两组治疗前后LDL-C水平比较
两组治疗前后LDL-C水平比较。组内比较，经配对样本t检验，治疗组患者LDL-C水平较治疗前显著下降(t＝4.804，P＝0.000＜0.01)，对照组患者LDL-C水平亦较治疗前明显下降(t＝5.953，P＝0.000＜0.01)，表明两组治疗均能有效降低患者LDL-C水平(见图4)。组间比较，治疗前后两组LDL-C差值比较，经秩和检验，Z＝-0.775，P＝0.439＞0.05，差异无统计学意义，表明治疗组与对照组降低患者LDL-C疗效相当。(见表11)
表11两组治疗前后LDL-C比较(mmol/L，
)
5、两组治疗前后HDL-C水平比较
两组治疗前后HDL-C水平比较。组内比较，经配对样本t检验，治疗组患者HDL-C水平较治疗前明显升高(t＝-3.612，P＝0.001＜0.01)。经秩和检验，对照组患者HDL-C水平较治疗前亦明显上升(Z＝-3.798，P＝0.000＜0.01)，表明两组治疗均能有效升高患者HDL-C水平(见图5)。组间比较，治疗前后两组HDL-C差值比较，经独立样本t检验，t＝-0.030，P＝0.976＞0.05，差异无统计学意义，表明治疗组与对照组升高患者HDL-C疗效相当。(见表12)
表12两组治疗前后HDL-C比较(mmol/L，
)
6、血脂总体疗效比较
两组患者治疗前后血脂指标总体疗效比较，治疗组总有效率为78.6％，对照组有效率为81.5％，经Mann-WhitneyU秩和检验，P＝0.643＞0.05，表明两组血脂水平总体疗效无显著差异。(见表13)
表13两组患者血脂指标疗效比较(例％)
7、中医证候积分比较
治疗前后两组患者的中医证候积分组间比较，治疗组患者治疗前中医证候总积分(25.68±7.077)，治疗后中医证候总积分(12.14±3.969)，平均积分下降了13.54±6.374分。治疗前后中医证候总积分比较，P＝0.000＜0.01，表明经治疗后，治疗组患者中医临床症状及体征等较治疗前显著改善。对照组患者治疗前中医证候总积分(27.33±7.141)，治疗后中医证候总积分(17.78±6.110)，平均积分下降了9.56±6.767分。对照组组内比较P＝0.000＜0.01，差异具有显著统计意义。治疗组与对照组相比，经独立样本t检验，治疗前两组患者中医证候总积分比较，t＝-0.863，P＝0.392＞0.05，无统计学意义，具有可比性。治疗后，两组患者中医证候总积分比较，t＝-4.040，P＝0.000＜0.01，差异具有显著统计学意义。组间分析，治疗前后积分差值进行分析，通过秩和检验，Z＝-2.563，P＝0.010＜0.05，即两组患者治疗后组间比较差异有统计学意义，治疗组中医证候积分的改善程度优于对照组。(见表14)
表14两组患者中医证候积分比较(分)
| 组别 | 例数 | 治疗前总积分 | 治疗后总积分 | 差值 | P(组内比较) |
| 治疗组 | 28 | 25.68±7.077 | 12.14±3.969 | 13.54±6.374 | 0.000 |
| 对照组 | 27 | 27.33±7.141 | 17.78±6.110 | 9.56±6.767 | 0.000 |
| P(组间比较) | 0.392 | 0.000 | 0.010 |
8、中医证候疗效比较
两组患者中医证候疗效比较，治疗组总有效率92.9％，对照组总有效率59.3％，经Mann-WhitneyU秩和检验，P＝0.012＜0.05，表明两组间患者中医证候疗效存在差异，治疗组在改善中医证候方面明显优于对照组。(见表15)
表15两组患者中医证候疗效比较(例％)
两组患者治疗后均未出现不良事件，治疗前后完善血、尿、大便常规、肝肾功能及心电图等检查，均无明显异常。
五、结果
1.两组患者治疗前后血脂总体疗效比较，治疗组临床控制2例，显效13例，有效7例，无效6例，总有效率78.6％。对照组临床控制4例，显效11例，有效7例，无效5例，总有效率81.5％。两组比较P＞0.05，降浊祛脂茶与血脂康胶囊均能有效改善患者血脂，总体疗效无明显差异。
2.经治疗后，治疗组与对照组TC、TG、LDL-C水平均较治疗前显著下降(P＜0.01)，HDL-C较治疗前明显升高(P＜0.01)，说明降浊祛脂胶囊与血脂康胶囊均能改善患者血脂水平。组间分析，对两组治疗前后血脂水平差值进行比较(P＞0.05)，差异无统计学意义。表明降浊祛脂胶囊与血脂康胶囊在改善患者血脂水平方面疗效相当。
3.在中医证候改善方面，两组患者中医证候总积分治疗后均较治疗前明显下降，P＜0.01，表明降浊祛脂胶囊与血脂康胶囊能有效改善患者中医症状、体征。两组组间比较，降浊祛脂胶囊在改善患者眩晕、头重、倦怠乏力、胸闷等中医症状方面优于血脂康胶囊，P＜0.05。
4.两组患者中医证候疗效比较，治疗组临床控制1例，显效4例，有效21例，无效2例，总有效率92.9％；对照组临床控制0例，显效3例，有效13例，无效11例，总有效率59.3％，P＜0.05，表明两组间患者中医证候疗效存在差异，治疗组在改善中医证候方面优于对照组。两组患者经治疗后均未出现不良反应。
结论：降浊祛脂胶囊能改善痰瘀互阻型高脂血症患者的血脂水平，同时能有效改善患者的中医证候评分，临床应用安全有效，值得推广应用。
最后应说明的是：以上各实施例仅用以说明本发明的技术方案，而非对其限制；尽管参照前述各实施例对本发明进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分或者全部技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本发明各实施例技术方案的范围，其均应涵盖在本发明的权利要求和说明书的范围当中。
Claims (8)
1.一种降浊祛脂胶囊，其特征在于，所述降浊祛脂胶囊包括黄芪、枸杞子、郁金、绞股蓝、红曲五味原料组成。
2.根据权利要求1所述的降浊祛脂胶囊，其特征在于，所述黄芪、枸杞子、郁金、绞股蓝、红曲的重量之比为20:6:10:15:20。
3.如权利要求1或2所述的降浊祛脂胶囊的制备方法，其特征在于，包括如下步骤：
A、将黄芪、枸杞子、绞股蓝三味原料加10-13倍量水，煎煮2-3次，每次煎煮1.3-1.7小时，合并煎液，过滤，滤液在70-80℃下减压浓缩，真空度为-0.06MPa～-0.08MPa，浓缩至在60℃测相对密度为1.2-1.3的浸膏；
B、将郁金、红曲二味原料加3-5倍量乙醇，回流提取2-3次，每次0.4-0.6小时，得提取液，过滤，合并滤液，滤液在70-80℃下减压浓缩，真空度为-0.06MPa～-0.08MPa，浓缩至在60℃测相对密度为1.1-1.2的浸膏；
C、将步骤(A)和步骤(B)浸膏合并，加入填充剂，混匀，70℃-80℃下减压干燥至干，真空度为-0.07MPa～-0.08MPa，干膏粉碎，过70-90目筛；
D、干膏粉加润湿剂润湿制软材，过10-15目筛制粒，70℃-75℃下减压干燥，整粒，加入润滑剂，混匀，制成胶囊，即得。
4.根据权利要求3所述的降浊祛脂胶囊的制备方法，其特征在于，所述步骤(B)中乙醇的质量浓度为60％-80％。
5.根据权利要求3所述的降浊祛脂胶囊的制备方法，其特征在于，所述步骤(C)中填充剂为二氧化硅，所述二氧化硅的添加量为10％-20％。
6.根据权利要求3所述的降浊祛脂胶囊的制备方法，其特征在于，所述步骤(D)中润湿剂为乙醇，所述乙醇的质量浓度为90％-98％。
7.根据权利要求3所述的降浊祛脂胶囊的制备方法，其特征在于，所述步骤(D)中乙醇的用量为干膏粉重量的30％-35％。
8.根据权利要求3所述的降浊祛脂胶囊的制备方法，其特征在于，所述步骤(D)中润滑剂为硬脂酸镁，所述硬脂酸镁的添加量为0.25％-0.3％。
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1376394A (zh) * | 2001-03-23 | 2002-10-30 | 阎永建 | 一种适于脑力劳动者饮用的保健茶 |
| CN102172373A (zh) * | 2011-01-12 | 2011-09-07 | 涂传荣 | 一种具有降血脂作用的中药制剂 |
| CN103417601B (zh) * | 2012-05-18 | 2016-09-28 | 北京北大维信生物科技有限公司 | 一种具有调节血脂作用的药物组合物及其用途 |
| CN106138164A (zh) * | 2015-03-23 | 2016-11-23 | 倪京满 | 一种具有调血脂功能的中药复方制剂 |
-
2019
- 2019-06-19 CN CN201910532148.2A patent/CN112107665A/zh active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1376394A (zh) * | 2001-03-23 | 2002-10-30 | 阎永建 | 一种适于脑力劳动者饮用的保健茶 |
| CN102172373A (zh) * | 2011-01-12 | 2011-09-07 | 涂传荣 | 一种具有降血脂作用的中药制剂 |
| CN103417601B (zh) * | 2012-05-18 | 2016-09-28 | 北京北大维信生物科技有限公司 | 一种具有调节血脂作用的药物组合物及其用途 |
| CN106138164A (zh) * | 2015-03-23 | 2016-11-23 | 倪京满 | 一种具有调血脂功能的中药复方制剂 |
Non-Patent Citations (5)
| Title |
|---|
| 关志宇: "《药物制剂辅料与包装材料》", 31 January 2017 * |
| 刘雅敏等: "《药物制剂常用辅料》", 31 January 1994 * |
| 卓烔梅: "基于PPAR-α探讨降浊调脂方调节高脂血症大鼠脂质代谢的作用机制", 《中国优秀博硕士学位论文全文数据库(硕士) ，医药卫生科技辑》 * |
| 郭群等: "心乐灵对各类脂蛋白的影响", 《安徽中医临床杂志》 * |
| 陈卫卫: "《药剂学》", 31 January 2014 * |
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