CN100387265C - 一种减肥降脂的中药制剂 - Google Patents
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Abstract
一种减肥降脂的中药制剂，其活性成分是以下列配比的8种中药药材制备而成(重量份)：柴胡4—30份，青皮6—20份，三七2—10份，败酱草5—20份，淡豆豉10—20份，苍术5—20份，白矾0.5—1份，女贞子4—20份。该中药制剂为胶囊剂型。临床应用证明，该制剂安全有效，体重下降，总有效率为98.51%，血脂各项指标都有明显的下降，疗效显著，有助于提高患者的生活质量，减少各种因肥胖而产生的并发症，并具有养肝、保肝作用。
Description
技术领域：
本发明述及中药制剂，尤其是关于一种减肥降脂的中药制剂。
背景技术：
人们生活水平的提高，工作的繁忙，饮食的不均衡，使近年全球“肥胖一族”的人数剧增，肥胖已成为一项严重的健康问题，有资料显示，在发达国家的肥胖发病率在20-30％，太平洋诸岛中发生率更高。在中国，目前约有1亿左右的人受到肥胖症的困扰，尤其是现在肥胖儿童发病率的上扬趋势更是令人担扰。1986年中国儿童的肥胖发病率是5.2％，到1998年已达18％。不论国内国外，肥胖病都已成为当前最广泛的严重威胁人类健康的疾病之一。
肥胖是由于进食热量超过消耗量，多余的营养物质以脂肪的形式储存于体内而形成人体脂肪积聚过多，体重超过正常标准体重20％以上的一种病症。正常标准体重(kg)＝〔身高(cm)-100〕×0.9。肥胖不仅影响形体美，而且给生活带来不便，更重要是容易引起多种并发症，加速衰老和死亡。例如肝脏脂肪积聚过多形成脂肪肝，可引起肝功能减退。心脏内脂肪积聚过多，心脂肪垫增厚，影响心脏功能。腹部脂肪过多，致横膈增高，换气困难，影响呼吸运动和血液循环，常有疲乏、气促、便秘腹胀，不能耐受较重的体力活动，下肢浮肿也较常见。肥胖可造成机体的额外负担，使其氧耗量增加30～40％。常畏热多汗，使机体抵抗力降低。
审美标准的改变，更重要的是随着医学科技的进步，肥胖症给人类健康带来的问题引起人们的重视，1997年WHO正式宣布肥胖是一种疾病，将肥胖症列为仅次于吸烟和艾滋病的第三大慢性杀手。医学专家认为肥胖至少与数十种疾病有关，如各种心脑血管疾病、高血脂症、脂肪肝、糖尿病等。由于肝脏在脂肪代谢中所起的重要作用，由肥胖等因素导致的脂肪肝发病率亦是逐年升高，已占到平均人口的10％，在肥胖病人中可高达50％-60％，约25％的患者发生肝纤维化，1.5％-1.8％的患者发展为肝硬化，且发病人群日趋年轻化。因此，肥胖的控制和治疗对于脂肪肝的防治及慢性肝病进展和改善起着十分重要的作用。
由于肥胖流行率高，能引起严重的并发症，严重威胁人类健康，并难以治疗，故防治肥胖病已迫在眉睫，目前虽然减肥降脂产品种类繁多，但许多都具有一定的肝毒作用，故患者常面临降脂与保肝治疗相矛盾的困境。针对这一矛盾，我公司运用中医中药理论，总结多年临床经验，精选药物、优化组方，研究开发具有减肥降脂保肝作用的中药制剂。
发明内容：
本发明提供一种减肥降脂的中药制剂(商品名为疏肝脂胶囊，曾用名为复方玉芩胶囊)，该中药制剂是按中医中药理论，总结多年临床经验，精选药物、优化组方，研究开发具有疏肝消脂、清热化积、行气活血作用的新药。该中药制剂可用于治疗肥胖，脂肪肝引起的转氨酶升高和肝内脂肪浸润，高血脂等。
研究认为肥胖病形成多由过食肥甘、膏粱厚味之品，加之久卧、久坐、活动过少，致“形不动则精不流，精不流则气郁”，“久卧伤气”，气虚气郁必使运化无力，转输失调，膏脂痰湿内聚，使人肥胖。或七情所伤，常致肝气郁滞，而使肝胆疏泄失于调畅，不仅影响脾之健运，气机之升降转输，而且胆汁不能正常泌输精汁，净浊化脂，则浊脂内聚而肥胖。由于脾肾气虚，肝胆失调，不仅造成膏脂、痰浊、水湿停蓄，也使气机失畅，脉道不利，而造成气滞或血瘀。因此，肥胖病的发病机理实为本虚标实，本为气虚，标为湿、痰、痰脂。轻度肥胖者一般无明显症状，中、重度患者多表现为肥胖，两下肢沉重感，活动时气促，体力劳动易疲倦，弯腰前屈困难，腰、腿痛，怕热多汗，嗜睡酣眠，多食善饥，月经不调，失眠，多梦，舌苔白或薄腻，脉弦细等。这些症状中医辨证为肝郁气滞、痰湿内阻、瘀血阻滞之症。故治疗上采用疏肝保肝、消脂化痰、清热化积、行气活血的方法。根据这一原则，本发明人研制开发了具有疏肝消脂、清热化积、行气活血作用的中药制剂来治疗肥胖及肥胖引起的相关病症。本方的优点在于泻实而不伤正，补虚而不护邪，在减肥降脂的同时不会产生腹泻症状，且辅以保肝养肝之品，来保护整个机体功能。
本发明中药制剂的活性成分是以下列配比的8种中药药材制备而成(重量份)：
柴胡4-30份 青皮6-20份 三七2-10份 败酱草5-20份
淡豆豉10-20份 苍术5-20份 白矾0.5-1份 女贞子4-20份
中药药材活性成份与药用载体按任意比例组成其中活性成份占重量比可以为0.1-99.9％，药用载体占重量比可以为99.9-0.1％，药用载体可以为淀粉、糊精、蛋白糖、蔗糖、微粉硅胶、炼蜜或其它常用载体。
本发明减肥降脂中药制剂包含8种中药药材活性成分，由于合适的配合，产生良好的协合作用，使本发明中药制剂有很好的疗效，这些组份的治疗作用如下所述：
柴胡、青皮，两药皆能疏泄肝气，如《中华本草》说：“柴胡能条达肝气而疏郁结。”又说：青皮“善疏肝胆之滞气。”两者配合同用使肝气调畅，脾气健运，胆汁分泌通畅，能净浊化脂，其功益著。
三七、败酱草能活血化瘀，如《中华本草》说：“三七善散瘀止痛，为治瘀血(疼痛)证之佳品。”又说：败酱草具有“活血祛瘀之功，(能)使血脉流通，通则不痛。”能协助柴胡、青皮达理气活血之功。
淡豆豉有宣郁功效，如《本草汇言》说：“王绍隆曰：此药乃宣郁之上剂也。凡病一切有形无形、壅胀满闷、停结不化，不能发越致痰者无不宜之。”有助柴胡、青皮行气解郁。
中医学认为人体脂肪沉积与痰湿蕴积密切攸关，如对肥胖症患者通常称为“痰湿之体”，治疗方法多从化除痰湿着手。制剂中用苍术，功能健脾燥湿。如《中华本草》说：苍术“功能燥湿以健脾运，凡湿困脾胃、胸痞腹胀、食欲不振、肢体倦怠者，是为必用之品。”而用白矾，则是取其有消痰之功，《本草纲目》说：“能治痰涎饮癖。”以上苍术、白矾，一重燥湿、一重消痰，两者合用，功能化除痰湿，既除脂肪沉积之因，又能改善湿阻所致食欲不振、疲乏身重之症。
女贞子能滋养肝阴，沈文彬《药论》指出其能“补肝血”，以增强消食积且保肝作用。
本发明中药制剂按常规操作制备成便于服用的胶囊剂，其制备方法如下：
按上述配方称取中药药材，加水煎煮二次，第一次煮2小时，第二次煮1小时，合并滤液，滤过，滤液浓缩至相对密度为1.1(80℃)，加入适量乙醇沉淀18小时，取上清液浓缩至相对密度为1.35(90℃)的稠膏，加入适量淀粉，制粒，干燥，拌入润滑剂适量，装入胶囊。
本发明减肥降脂中药制剂的现代药理证明：
柴胡：能降低血清胆固醇和甘油三脂，并对肝脏损伤有保护作用。
三七：能明显降低甘油三脂，对肝脏损伤，也有保护作用。
女贞子：能降低血清胆固醇和甘油三脂，改善肝内脂质代谢，对肝脏同样有保护作用。
淡豆豉：淡豆豉中的菸酸能促进细胞的新陈代谢，并有血管扩张作用。
败酱草：能促进肝细胞再生，防止肝细胞变性，对肝脏有保护作用。
苍术：能促进肝蛋白的合成作用，实验研究表明苍术甙对小鼠、兔和犬均有降血糖作用，同时降低糖原和肝糖原，抑制糖原生成，使糖量降低，血乳酸含时增加。
本发明中药制剂胶囊减肥降脂的治疗效果
在临床应用中随机取201例肥胖患者，其中并发脂肪肝45例，并发高血脂27例，并发高血压12例，并发糖尿病3例。给予口服本发明胶囊，每日三次，每次3粒，治疗三个月，用药前后不改变原有的饮食习惯和运动情况。治疗三个月后：胸围平均减少2厘米，腰围减少3厘米，臀围减少2厘米，体重下降总有效率为98.51％，其中显效(体重下降＞5千克)194例(96.52％)；有效(体重下降＞3千克)4例(1.99％)；无效(体重下降＜3千克或体重未下降)3例(1.49％)。血脂治疗前后变化情况如下表1所示：
表1
表1显示本发明胶囊治疗后，肥胖症者的总胆固醇、甘油三脂、高密度脂蛋白、低密度脂蛋白都有明显的下降，效果良好。
本发明减肥降脂中药制剂具有疏肝消脂、清热化积、行气活血的功效，主要用于治疗气滞血瘀兼痰湿内阻的肥胖及肥胖引起的相关病症(脂肪肝、高脂血症等)，能起到减肥降脂、疏肝保肝作用。临床应用证明，该药安全、有效，对201例肥胖患者进行临床验证，体重下降总有效率为98.51％，血脂各项指标(总胆固醇、甘油三脂、低密度脂蛋白)都有明显的下降，疗效显著，有助于提高患者的生活质量，减少各种因肥胖而产生的并发症，降低死亡率。本发明胶囊制剂的优点在于减肥降脂疗效确切，与已有的中药减肥产品相比，独具养肝保肝作用，不会产生肝毒作用，且本品在服用阶段不会产生腹泻、厌食等症状，适合广泛的人群，有较强的竞争力和广阔的市场前景。
具体实施方式：
实施例1减肥降脂胶囊的制备
称取柴胡643g，青皮428g，三七214g，苍术428g，白矾21g，女贞子428g，败酱草428g和淡豆豉428g，生药总量约3000g左右，加水煎煮二次，第一次加10倍量的水煎煮2小时，第二次加8倍量的水煎煮1小时，合并滤液，滤过，滤液浓缩至相对密度为1.1(80℃)，加入2倍量乙醇沉淀18小时，取上清液浓缩至相对密度为1.35(90℃)的稠膏，加入适量淀粉，制粒，干燥，拌入硬脂酸镁适量，装入胶囊，制成1000粒，每粒胶囊0.3g，含生药量3g左右。
服用方法：口服，每日三次，每次2-3粒，每天剂量相当于生药18-27克。
实施例2减肥降脂胶囊的制备
称取柴胡201g，青皮798g，三七358g，苍术207g，白矾40g，女贞子198g，败酱草792g和淡豆豉412g，生药总量约3000g左右，加水煎煮二次，第一次加10倍量的水煎煮2小时，第二次加8倍量的水煎煮1小时，合并滤液，滤过，滤液浓缩至相对密度为1.1(80℃)，加入2倍量乙醇沉淀18小时，取上清液浓缩至相对密度为1.35(90℃)的稠膏，加入适量淀粉，制粒，干燥，拌入滑石粉适量，装入胶囊，制成1000粒，每粒胶囊0.3g，含生药量3g左右。
服用方法：口服，每日三次，每次2-3粒，每天剂量相当于生药18-27克。
实施例3减肥降脂胶囊的制备
称取柴胡628g，青皮188g，三七63g，苍术471g，白矾16g，女贞子534g，败酱草628g和淡豆豉473g，生药总量约3000g左右，加水煎煮二次，第一次加10倍量的水煎煮2小时，第二次加8倍量的水煎煮1小时，合并滤液，滤过，滤液浓缩至相对密度为1.1(80℃)，加入2倍量乙醇沉淀18小时，取上清液浓缩至相对密度为1.35(90℃)的稠膏，加入适量淀粉，制粒，干燥，拌入硬脂酸镁适量，装入胶囊，制成1000粒，每粒胶囊0.3g，含生药量3g左右。
服用方法：口服，每日三次，每次2-3粒，每天剂量相当于生药18-27克。
实施例4治疗病例
一女性患者，52岁，素体肥胖，近5年来尤为明显，日渐影响日常生活，不能胜任体力劳动及体育运动，出现动则气喘，以及汗出、头晕等症，曾至区中心医院检查：血脂各项指标均显著增高，诊断为“肥胖症”、“高血脂”。虽多次通过节食及服用降脂减肥茶等治疗，但效果均不明显。就诊时行动不便，肢体困重，时觉乏力、气急，怕热多汗，大便溏，舌红苔薄黄腻，脉细滑。查体：形体肥胖，身高156cm，体重76.8kg，腰围108cm，血脂指标：总胆固醇10.78mmol/L，甘油三脂6.6mmol/L，β脂蛋白6.1mmol/L。给予口服本发明胶囊每日3次，每次3粒，治疗3个月后体重减至70.4kg，腰围104cm，血脂各项指标均下降至：总胆固醇7.4mmol/L，甘油三脂4.7mmol/L，β脂蛋白3.9mmol/L，且服药期间未发生腹泻、厌食等不良反应。
实施例5治疗病例
一男性患者，64岁，肥胖伴中上腹胀满不适十余年，近两周病情加重，两周来自觉中上腹作胀，进食后尤甚，嗳气泛恶，有饱胀感，乏力，素体肥胖，平日一般不喜运动，少活动，嗜睡，稍事活动或劳动后易疲劳无力，喜食甜食、油炸、高脂肪食物，嗜好烟酒，大便粘腻不畅，中山医院查得B超示：肝内脂肪中度浸润，诊为“肥胖症”、“脂肪肝”。就诊时查体：体形肥胖，身高175cm，体重101kg，腰围116cm，血脂指标：总胆固醇9.96mmol/L，甘油三脂4.6mmol/L，高密度脂蛋白0.94mmol/L低密度脂蛋白4.07mmol/L。给予口服本发明胶囊每日3次，每次3粒，经服用6周后，体重即下降3.6kg，各项症状有所缓解，继续服用10周后，体重下降10kg，腰围缩小6.6cm，症状基本消失，血脂各项指标下降至正常范围，B超示：肝内脂肪轻度浸润，且服药期间未发生腹泻、厌食等不良反应。
Claims (2)
1.一种减肥降脂的中药制剂，其特征在于所述中药制剂的活性成分是以下列重量份配比的8种中药药材制备而成，柴胡4-30份，青皮6-20份，三七2-10份，败酱草5-20份，淡豆豉10-20份，苍术5-20份，白矾0.5-1份和女贞子4-20份。
2.如权利要求1所述减肥降脂的中药制剂，其特征在于所述中药制剂为胶囊剂型。
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| 调肝脂胶囊治疗脂肪肝65例疗效观察. 刘小楠，李志君.河北中医，第24卷第4期. 2002 * |
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