CN112237609A - 一种中药组合物在制备降血脂药物中的应用 - Google Patents
一种中药组合物在制备降血脂药物中的应用 Download PDFInfo
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Abstract
本发明提供一种中药组合物在制备降血脂药物中的应用，所述药物是由以下重量份比例的原料制成：酸枣6‑36份、桑椹6‑36份、灵芝2‑12份、百合1‑6份、山楂2‑12份、茯苓1‑6份、陈皮1‑6份、菊花2‑12份、荷叶1‑6份。本发明用于降血脂取得了良好的效果。且本发明配伍合理，简单易行，为纯中药制剂，不良反应小，可供病人长期使用。
Description
技术领域
本发明涉及一种中药组合物的新用途，具体地，涉及一种中药组合物在制备降血脂药物中的应用。
背景技术
血脂是血浆中的中性脂肪（甘油三酯）和类脂（磷脂、糖脂、固醇、类固醇）的总称，广泛存在于人体中。它们是生命细胞的基础代谢必需物质。一般说来，血脂中的主要成分是甘油三酯和胆固醇，其中甘油三酯参与人体内能量代谢，而胆固醇则主要用于合成细胞浆膜、类固醇激素和胆汁酸。高血脂是指血浆胆固醇、甘油三酯、总脂等血脂成分的浓度超过正常标准，主要危害是导致动脉粥样硬化，进而导致众多的相关疾病，其中最常见的一种致命性疾病就是冠心病，严重的高血脂症可导致急性胰腺炎，是另一致命性疾病。
高脂血症可分为原发性和继发性两类。原发性与先天性和遗传有关，是由于单基因缺陷或多基因缺陷，使参与脂蛋白转运和代谢的受体、酶或载脂蛋白异常所致，或由于环境因素(饮食、营养、药物)和通过未知的机制而致。继发性多发生于代谢性紊乱疾病(糖尿病、高血压、黏液性水肿、甲状腺功能低下、肥胖、肝肾疾病、肾上腺皮质功能亢进)，或与其他因素年龄、性别、季节、饮酒、吸烟、饮食、体力活动、精神紧张、情绪活动等有关。
高脂血症的临床表现主要是脂质在真皮内沉积所引起的黄色瘤和脂质在血管内皮沉积所引起的动脉硬化。尽管高脂血症可引起黄色瘤，但其发生率并不很高;而动脉粥样硬化的发生和发展又是一种缓慢渐进的过程。因此在通常情况下，多数患者并无明显症状和异常体征，不少人是由于其他原因进行血液生化检验时才发现有血浆脂蛋白水平升高。
目前，高血脂的治疗方法主要有以下几种：1.控制理想体重，许多流行病学资料显示，肥胖人群的平均血浆胆固醇和三酰甘油水平显著高于同龄的非肥胖者。除了体重指数(BMI)与血脂水平呈明显正相关外，身体脂肪的分布也与血浆脂蛋白水平关系密切。一般来说，中心型肥胖者更容易发生高脂血症。肥胖者的体重减轻后，血脂紊乱亦可恢复正常。2.运动锻炼，体育运动不但可以增强心肺功能、改善胰岛素抵抗和葡萄糖耐量，而且还可减轻体重、降低血浆三酰甘油和胆固醇水平。3.戒烟,吸烟可升高血浆胆固醇和三酰甘油水平。4.饮食治疗,血浆脂质主要来源于食物，通过控制饮食，可使血浆胆固醇水平降低5%～10%，同时有助于减肥。并使降脂药物发挥出最佳的效果。5.药物治疗，以降低血清三酰甘油为主的药物有贝特类和烟酸类,,但是该类药物治疗均有不同程度的不良反应。具有降血脂功效的中成药数目众多，但是效果一般，市场急需一种降血脂疗效确切、副作用小的中药制剂。
发明内容
本发明涉及一种中药组合物的新用途，具体地，涉及一种中药组合物在制备治疗降血脂药物中的应用。
本发明提供治疗降血脂的中药组合物，该中药组合物是由如下重量份的原料药制成的：酸枣6-36份、桑椹6-36份、灵芝2-12份、百合1-6份、山楂2-12份、茯苓1-6份、陈皮1-6份、菊花2-12份、荷叶1-6份。
优选的中药组合物由如下重量份的原料药制成：酸枣30-36份、桑椹30-36份、灵芝10-12份、百合5-6份、山楂10-12份、茯苓5-6份、陈皮5-6份、菊花10-12份、荷叶5-6份。
优选的中药组合物由如下重量份的原料药制成：酸枣30份、桑椹30份、灵芝10份、百合5份、山楂10份、茯苓5份、陈皮5份、菊花10份、荷叶5份。
优选的中药组合物由如下重量份的原料药制成：酸枣36份、桑椹36份、灵芝10份、百合6份、山楂12份、茯苓6份、陈皮6份、菊花12份、荷叶6份。
本发明所述中药组合物的活性成分由以下步骤制成：
(1)按照原料药重量比例称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎 煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60℃ 热测时相对密度为1.20-1.25的清膏，加乙醇静置、醇沉、过滤，滤液减压 回收乙醇至无醇味，减压浓缩至60℃热测时相对密度1.02-1.06的流浸膏，干燥，即得活性成分。
本发明所述中药组合物的制剂剂型为胶囊剂、片剂、丸剂、口服液、软胶囊、微丸、滴丸。
本发明所述的口服液的制备方法是由以下步骤制成：
(1)按照原料药重量比例称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热 煎煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至 60℃热测时相对密度为1.20-1.25的清膏，加乙醇静置、醇沉、过滤，滤液 减压回收乙醇至无醇味，减压浓缩至60℃热测时相对密度1.02-1.06的流浸膏，备用；
(3)将步骤(2)所得流浸膏中加入药学上所接收的防腐剂，调解PH值 至规定范围，加水调解浓度，搅匀、静置、滤过、灌封、灭菌，即得。
经试验证实本发明药物组合物用于降血脂取得了良好的效果。且本发明配伍合理，简单易行，为纯中药制剂，不良反应小，可供病人长期使用。
为证实本发明药物降血脂的疗效，用按实施例1制得的口服液（以下称本发明药物）以及对比例1-3制备的药物，进行以下临床试验研究：
试验例
1 高脂血症动物模型
1.1 原理：用含有胆固醇、蔗糖、猪油、胆酸钠的饲料喂养动物可形成脂代谢紊乱动物模型，再给予动物受试样品，可检测受试样品对高脂血症的影响，并可判定受试样品对脂质的吸收、脂蛋白的形成、脂质的降解或排泄产生的影响。
仪器及试剂：解剖器械、分光光度计，自动生化分析仪，胆固醇、胆酸钠、血清总胆固醇（TC）、甘油三酯（TG）、低密度脂蛋白胆固醇（LDL-C），高密度脂蛋白胆固醇（HDL-C）测定试剂盒。本发明药物（石家庄以岭药业股份有限公司提供）
1.3 动物选择及饲料
1.3.1 健康成年雄性SD大鼠，适应期结束时，体重180-220g，每组10只。
1.3.2 模型饲料：在维持饲料中添加20.0％蔗糖、15％猪油、1.2％胆固醇、0.2％胆酸钠，适量的酪蛋白、磷酸氢钙、石粉等。模型饲料的水分、粗蛋白、粗脂肪、粗纤维、粗灰分、钙、磷、钙、磷均要达到维持饲料的国家标准。
剂量分组及受试样品给予时间
实验设本发明药物三个剂量组、对比例三组、空白对照组和模型对照组，受试样品给予时间为30天。
实验步骤
1.5.1适应期：于屏障系统下大鼠喂饲维持饲料观察5－7天。
1.5.2造模期：按体重随机分成2组，10只大鼠给予维持饲料作为空白对照组，70只给予模型饲料作为模型对照组。每周称量体重1次。模型对照组给予模型饲料1周后，空白对照组和模型对照组大鼠不禁食采血（眼内眦或尾部），采血后尽快分离血清，测定血清TC、TG、LDL-C 、HDL-C水平。根据TC水平将模型对照组随机分成7组，分别为对比例1组、对比例2组、对比例3组、本发明药物低、中、高3个剂量组和模型对照组。
1.5.3受试样品给予
分组后，本发明药物三个剂量组每天经口给药，三个对比例组分别给予对比例1-3制备的药物，空白对照组和模型对照组同时给予同体积的相应溶剂，空白对照组继续给予维持饲料，模型对照组及三个剂量组继续给予模型饲料，并定期称量体重，于实验结束时不禁食采血，采血后尽快分离血清，测定血清TC、TG、LDL-C 、HDL-C水平。
观察指标：试验结束时（第31天）不禁食采血，分离血清，得到TC、TG、LDL-C 、HDL-C水平。
数据处理和结果判定
结果以均数±标准差（x±s）表示，数据处理采用SPSS19.0统计软件进行单因素方差分析和卡方检验。
辅助降低血脂功能结果判定：模型对照组和空白对照组比较，血清甘油三酯升高，血清总胆固醇或低密度脂蛋白胆固醇升高，差异均有显著性，判定模型成立。各剂量组与模型对照组比较，任一剂量组血清总胆固醇或低密度脂蛋白胆固醇降低，且任一剂量组血清甘油三酯降低，差异均有显著性，同时各剂量组血清高密度脂蛋白胆固醇不显著低于模型对照组，可判定该受试样品辅助降低血脂功能动物实验结果阳性。
结果
1.8.1 对大鼠体重的影响
八组大鼠体重均表现逐渐增长趋势，与空白对照组比较，模型组大鼠体重明显增加（P＜0.05或P＜0.01），说明高脂饲料可能导致大鼠体重增加；与模型组比较，3个对比例、3个剂量组动物体重均未见显著性差异（P＞0.05），表明本发明药物对大鼠的体重无显著影响，具体见表1。
1.8.2 对大鼠血脂的影响
综上所述，对比例1、2、3对于TC、TG、LDL-C、HDLC的影响与模型组比较均无显著性差异，而本发明药物的三个剂量组均具有降血脂的效果，其中中剂量组和高剂量组对TC、TG、LDL-C含量降低与模型组比较具有显著的差异，说明本发明药物具有显著的降血脂的效果，且对于大鼠的体重无显著的影响。
具体实施方式
实施例1：
原料药配方为：酸枣30g 桑椹30g 灵芝10g 百合5g 山楂10g 茯苓5g 陈皮5g菊花10g 荷叶5g；
制备方法：
(1)按照处方量称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎 煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60 ℃热测时相对密度为1.20-1.25的清膏，加95％乙醇调节浓度至75％，4℃以 下静置24小时，过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏，备用；
(3)将步骤(2)所得流浸膏中加入苯甲酸钠0.1％，调解PH值至规定范围， 加水至100ml，搅匀、静置、滤过、灌封、灭菌，即得。
实施例2：
原料药配方为：酸枣36g 桑椹36g 灵芝10g 百合6g 山楂12g 茯苓6g 陈皮6g菊花12g 荷叶6g
制备方法：
(1)按照处方量称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎 煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60 ℃热测时相对密度为1.20-1.25的清膏，加95％乙醇调节浓度至75％，4℃以 下静置24小时，过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏，备用；
(3)将步骤(2)所得流浸膏干燥、粉碎、制粒，按常规方法压成100片片剂。
对比例1
原料药配方为：酸枣30g 桑椹30g 灵芝10g 百合5g 神曲10g 茯苓5g 陈皮5g菊花10g 荷叶5g；
制备方法：
(1)按照处方量称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎 煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60 ℃热测时相对密度为1.20-1.25的清膏，加95％乙醇调节浓度至75％，4℃以 下静置24小时，过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏，备用；
(3)将步骤(2)所得流浸膏中加入苯甲酸钠0.1％，调解PH值至规定范围， 加水至100ml，搅匀、静置、滤过、灌封、灭菌，即得。
对比例 2
原料药配方为：酸枣30g 桑椹30g 灵芝10g 百合5g 山楂10g 茯苓5g 陈皮5g野菊花10g 荷叶5g；
制备方法：
(1)按照处方量称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎 煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60 ℃热测时相对密度为1.20-1.25的清膏，加95％乙醇调节浓度至75％，4℃以 下静置24小时，过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏，备用；
(3)将步骤(2)所得流浸膏中加入苯甲酸钠0.1％，调解PH值至规定范围， 加水至100ml，搅匀、静置、滤过、灌封、灭菌，即得。
对比例3
原料药配方为：酸枣30g 桑椹30g 百合5g 山楂10g 茯苓5g 陈皮5g 菊花10g荷叶5g；
制备方法：
(1)按照处方量称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎 煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60℃热测时相对密度为1.20-1.25的清膏，加95％乙醇调节浓度至75％，4℃以 下静置24小时，过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测 时相对密度1.02-1.06的流浸膏，备用；
(3)将步骤(2)所得流浸膏中加入苯甲酸钠0.1％，调解PH值至规定范围， 加水至100ml，搅匀、静置、滤过、灌封、灭菌，即得。
Claims (7)
1.一种中药组合物在制备降血脂药物中的应用，其特征在于该中药组合物是由如下重量份的原料药制成的：酸枣6-36份、桑椹6-36份、灵芝2-12份、百合1-6份、山楂2-12份、茯苓1-6份、陈皮1-6份、菊花2-12份、荷叶1-6份。
2.根据权利要求1所述的应用，其特征在于所述中药组合物由如下重量份的原料药制成：酸枣30-36份、桑椹30-36份、灵芝10-12份、百合5-6份、山楂10-12份、茯苓5-6份、陈皮5-6份、菊花10-12份、荷叶5-6份。
3.根据权利要求1所述的应用，其特征在于所述中药组合物由如下重量份的原料药制成：酸枣30份、桑椹30份、灵芝10份、百合5份、山楂10份、茯苓5份、陈皮5份、菊花10份、荷叶5份。
4.根据权利要求1所述的应用，其特征在于所述中药组合物由如下重量份的原料药制成：酸枣36份、桑椹36份、灵芝10份、百合6份、山楂12份、茯苓6份、陈皮6份、菊花12份、荷叶6份。
5.根据权利要求1-4中任一项所述的应用，其特征在于所述中药组合物的活性成分由以下步骤制成：
(1)按照原料药重量比例称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60℃热测时相对密度为1.20-1.25的清膏，加乙醇静置、醇沉、过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测时相对密度1.02-1.06的流浸膏，干燥，即得活性成分。
6.根据权利要求1-4任一所述的应用，其特征在于所述中药组合物的制剂剂型为胶囊剂、片剂、丸剂、口服液。
7.根据权利要求6所述的应用，其特征在于所述的口服液的制备方法是由以下步骤制成：
(1)按照原料药重量比例称取中药材，净选；
(2)将上述净选后药材混匀，粗粉，加9倍量水，浸泡1小时，加热煎煮2次，第一次1.5小时，第二次1小时，滤过，合并滤液，减压浓缩至60℃热测时相对密度为1.20-1.25的清膏，加乙醇静置、醇沉、过滤，滤液减压回收乙醇至无醇味，减压浓缩至60℃热测时相对密度1.02-1.06的流浸膏，备用；
(3)将步骤(2)所得流浸膏中加入药学上所接收的防腐剂，调解PH值至规定范围，加水调解浓度，搅匀、静置、滤过、灌封、灭菌，即得。
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