CN116850247A - 一种治疗高尿酸血和痛风的中药组合物制备方法及组合物 - Google Patents

一种治疗高尿酸血和痛风的中药组合物制备方法及组合物 Download PDF

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CN116850247A
CN116850247A CN202311019025.1A CN202311019025A CN116850247A CN 116850247 A CN116850247 A CN 116850247A CN 202311019025 A CN202311019025 A CN 202311019025A CN 116850247 A CN116850247 A CN 116850247A
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gout
hyperuricemia
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赵汝君
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Abstract

本发明所提供的一种治疗高尿酸血症和/或痛风的中药组合物的制备方法，通过先将乳香、没药、细辛以及黑顺片四味药，进行水蒸气提取，分别得到挥发油和水相提取物，最后再将剩余的十二味药材进行水提取，合并提取物后，所得的提取物改善了毒性较大的问题，且保留了原有的药效，有清热解毒、消肿排脓、凉血止血的功效，对高尿酸血症与痛风患者更具有针对性，增强了受损关节处的消肿抗炎，具有标本兼治、疗效显著、副作用小、服用方便、价格经济等优点，生产工艺简单高效，利于工业化生产。

Description

一种治疗高尿酸血和痛风的中药组合物制备方法及组合物
技术领域
本发明中药技术领域，具体涉及一种治疗高尿酸血和痛风的中药组合物制备方法及组合物。
背景技术
高尿酸血症，是尿酸合成增加和(或)尿酸排泄减少引起的一种代谢性疾病，不仅是急性关节炎、痛风石、肾结石和尿酸性肾病最主要的生化基础，而且与多种传统心血管疾病的危险因素如高龄、男性、肥胖、脂代谢紊乱、酗酒等并存，并与多种心血管疾病，如脑卒中、冠心病、痛风、糖尿病、心功能衰竭、慢性肾脏疾病等密切相关，严重威胁人类的健康。
痛风，是由于长期高尿酸血症导致尿酸盐沉淀于关节和软组织而形成的一组异质性、代谢类疾病。痛风的临床表现为反复发作的急性关节炎、痛风石沉淀、痛风性慢性关节炎和关节畸形，常累及肾脏，易引起慢性间质性肾炎、肾结石等。
目前针对痛风的治疗主要以西药为主，包括秋水仙碱、别嘌呤醇、非布司他、苯溴马隆等。其中，秋水仙碱是治疗痛风急性发作的首选药，能显著缓解痛风引起的症状，但80％的患者在治疗剂量下会出现恶心、腹泻、呕吐、肠胃不适等症状，停药后易出现“反跳”，不宜长期使用；别嘌呤醇和非布司他是通过抑制XO，阻断次黄嘌呤向黄嘌呤的尿酸转化的原理，降低血尿酸浓度，抑制痛风的，使用后可能会引起不同程度的肝肾损伤及不良反应，如肾功能衰竭、史蒂文斯-约尔逊综合征等；苯溴马隆是一种促尿酸排泄类药物，其作用机制主要是抑制尿酸盐在近曲小管的主动再吸收，增加尿酸盐的排泄而降低血中尿酸浓度，促进尿酸盐溶解；苯溴马隆，曾被认为是最有潜力的促尿酸排泄剂，但由于具有潜在的肝毒性而被欧洲一些国家限制使用，而在国内仍作为促尿酸排泄的主要药物在临床广泛使用。
发明人在研究中发现，常规的中药进行水提的过程中，即水煮，过滤，离心，提取，然后干燥粉碎，会产生一定的毒性，这种毒性在动物实验的过程中出现动物死亡的现象。
因此，亟需研制一种不具有毒性的治疗高尿酸血和痛风的中药组合物制备方法及组合物。
发明内容
本发明提供一种治疗高尿酸血症和/或痛风的中药组合物的制备方法，可达到清热养阴、活血祛湿、化痰降浊、活血化瘀的功效，制备所得的中药组合物既改善了毒性又保留了药效。
为实现上述目的，本发明采用的技术方案是：
一种治疗高尿酸血症和/或痛风的中药组合物的制备方法，包括以下步骤：
S1、按重量份称量乳香、没药、细辛以及黑顺片，加入10倍量水，水蒸气蒸馏提取7-10h，得一次水相提取液和挥发油，将挥发油使用β-环糊精包结，冷藏过滤，低温干燥，粉碎，得包结物；
S2、将步骤S1中所得的一次水相提取液过滤浓缩，冷却至室温后离心，得离心液；
S3、按重量份数称取丹参、蒲公英、紫花地丁、茯苓、独活、土茯苓、桃仁、红花、鸡血藤、赤芍、川牛膝及地龙，加入10倍量水煎煮2-3次，合并每次煎煮后的煎液，过滤，将滤液与步骤S2中的离心液合并，浓缩得浸膏，减压干燥，粉碎，加入步骤S1中所得的包结物，混匀制粒，干燥即得。
优选的，步骤S2中，所述滤液浓缩至相对密度为1.00～1.05。
优选的，步骤S3中，所述滤液和离心液混匀后浓缩至相对密度为1.25～1.30。
优选的，所述步骤S3中加入步骤S1中所得的包结物，还包括甜味剂和β-环糊精。
优选的，步骤S1中，粉碎的目数为150-400目；步骤S3中，粉碎的目数为150-400目。
优选的，所述乳香为醋制乳香。
优选的，所述桃仁为燀桃仁。
一种如上任一项所述的制备方法制备所得的高尿酸血症和/或痛风的中药组合物，按重量份计，由以下组分组成：丹参10-20份、蒲公英10-20份、紫花地丁7-17份、茯苓10-20份、独活5-15份、土茯苓10-20份、燀桃仁10-20份、红花10-20份、鸡血藤5-15份、醋乳香10-20份、没药10-20份、赤芍10-20份、黑顺片10-20份、细辛7-17份、川牛膝10-20份、地龙5-15份。
上述发明所获得的配方其药理作用为：
丹参：具有活血化瘀、祛瘀止血、舒经通络之功效；蒲公英：具有利尿排毒、平抑肝阳、消炎抗菌之功效，该两味药为君药，能使周身之气通而不滞；
紫花地丁：具有清热解毒、凉血止血之功效；茯苓：具有利水渗湿、健脾和胃、养心安神之功效；独活：具有祛风除湿、通痹止痛、解表之功效；土茯苓：具有清热解毒、除湿、通利关节之功效，该四味药为臣药，可清热解毒，具有辅助君药起治疗作用；
燀桃仁：具有活血祛瘀，缓解气血淤滞引起的痛症和不适之功效；红花：具有活血通经、散瘀止痛之功效；鸡血藤：具有补血行血，通经活络之功效；醋乳香：具有活血止痛、通经之功效；没药：具有消肿生肌、理气止疼、活血祛瘀之功效；赤芍：具有清热凉血、化瘀止痛之功效；黑顺片：具有回阳救逆、补火助阳、散寒止痛之功效；细辛：具有解表散寒、祛风止痛、温肺化饮之功效，该八味药组合为佐药，可活血止痛，配合君药臣药治疗兼证；
川牛膝：具有活血祛瘀、通利关节、利尿通淋之功效；地龙：具有清热息风、通经活络、清肺平喘之功效，该两味药为使药，具有排除淤堵，清热通利，调和诸药的作用。
本申请具有以下优点：
1、本发明所提供的一种治疗高尿酸血症和/或痛风的中药组合物的制备方法，通过先将乳香、没药、细辛以及黑顺片四味药，进行水蒸气提取，分别得到挥发油和水相提取物，最后再将剩余的十二味药材进行水提取，合并提取物后，所得的提取物改善了毒性较大的问题，且保留了原有的药效，有清热解毒、消肿排脓、凉血止血的功效，对高尿酸血症与痛风患者更具有针对性，增强了受损关节处的消肿抗炎，具有标本兼治、疗效显著、副作用小、服用方便、价格经济等优点，生产工艺简单高效，利于工业化生产。
2、本发明提供的一种治疗高尿酸血症和/或痛风的中药组合物具有很好的镇痛降尿酸作用，能改善患者关节疼痛、关节压痛、关节急性红肿和关节活动受限情况，疗效显著。
具体实施方式
下面结合实施例1-3对本发明的技术方案进行说明。
实施例1
一种治疗高尿酸血症和/或痛风的中药组合物的制备方法，包括以下步骤：
S1、按重量份数称量乳香、没药、细辛以及黑顺片，加入10倍量水，水蒸气蒸馏提取7-10h，得一次水相提取液和挥发油，将挥发油使用β-环糊精包结，冷藏过滤，低温干燥，粉碎，得包结物；
S2、将步骤S1中所得的一次水相提取液过滤浓缩，冷却至室温后离心，得离心液；
S3、按重量份数称取丹参、蒲公英、紫花地丁、茯苓、独活、土茯苓、桃仁、红花、鸡血藤、赤芍、川牛膝及地龙，加入10倍量水煎煮2-3次，合并每次煎煮后的煎液，过滤，将滤液与步骤S2中的离心液合并，浓缩得浸膏，减压干燥，粉碎，加入步骤S1中所得的包结物，混匀制粒，干燥即得痛风颗粒膏粉。
临床测试方法：
(1)痛风颗粒膏粉对次黄嘌呤法高尿酸血症大鼠模型的药效实验
为表明本发明药物对高尿酸血症及痛风的治疗效果，采用实施例1制备的痛风颗粒膏粉对大鼠进行持续给药3天，并对次黄嘌呤(200mg/kg，ip)致高尿酸血症模型的大鼠血清尿酸水平的影响-注射次黄瞟吟，分别于给予造模药后0.5、1h取血测定血清尿酸。实验结果如下表1、表2、表3所示。
表1：痛风颗粒膏粉(给药3天,ig)对次黄嘌呤致高尿酸血症模型大鼠血清尿酸水平的影响-注射次黄嘌呤0.5小时后采血
表2：痛风颗粒膏粉(给药3天,ig)对次黄嘌呤致高尿酸血症模型大鼠血清尿酸水平的影响-注射次黄嘌呤1小时后采血
由表1和表2可得，低剂量与高剂量，两组均有统计学显著差异，P<0.01，当前试验方案经过重复验证，受试物降尿酸颗粒剂对次黄嘌呤诱导的尿酸升高有明显的抑制作用。
(2)痛风颗粒膏粉对酵母粉+腺嘌呤喂饲法诱导高尿酸血症大鼠模型药效实验
为表明本发明药物对高尿酸血症及痛风的治疗效果，采用含酵母粉和腺嘌呤饲料喂饲法建立高尿酸模型，并实施例1制备的痛风颗粒膏粉对大鼠进行持续给药28天，分别于给予给药13天、28天取血测定血清尿酸。实验结果如表3所示。
由表3可得，高剂量组在28天时具有有统计学显著差异，P<0.01，当前试验方案经过重复验证，受试物降尿酸颗粒剂对酵母粉+腺嘌呤喂饲法诱导的尿酸升高有明显的抑制作用。
(3)痛风颗粒膏粉对治疗鹌鹑高尿酸血症药效实验
为表明本发明药物对高尿酸血症及痛风的治疗效果，采用鹌鹑建立高尿酸模型(鹌鹑具有鸟类嘌呤代谢的基本特征，由于体内缺乏尿酸酶，尿酸是嘌呤代谢的最终产物，与人类的嘌呤代谢路径相似，所以能在较大程度上模拟人类的高尿酸血症)，并实施例1制备的痛风颗粒膏粉对大鼠进行持续给药28天，分别于给予给药14天、28天取血测定血清尿酸。实验结果如表3所示。
表4：
实验期间，受试动物活动良好，无动物死亡，体重各组较为接近，从实验结果可以看出，给予受试药物28天后，各受试药物组出现血清尿酸水平显著下降，其中低剂量组降低幅度为16.7％、中剂量组15.1％、高剂量组28.1％、阳性药物组27.4％，其中高剂量组和阳性药物组较为接近，与模型对照组相比，两组均有统计学差异，P<0.05，当试前验方案经过重复验证，受试物降尿酸颗粒剂对鹌鹑高尿酸血症模型，具有降尿酸作用。
(5)痛风颗粒膏粉的长期毒性实验
为表明本发明药物在治疗高尿酸血症及痛风过程中的安全性，实施例1制备的痛风颗粒膏粉以15、30、60g/kg/天的剂量每天重复灌胃给予SD大鼠，连续给药28天，动物临床观察未见与药物相关的死亡及异常反应，体重、摄食量、体温、眼科检查、尿液检查、凝血功能指标均未见与给药相关的明显异常变化。各剂量组动物可见末次药后次日全部或部分红系相关指标和白细胞分类指标RBC、HGB、HCT降低，Retic(×1012/L，％)、Neut(×109/L，％)升高；各组部分动物可见末次药后次日粒细胞系统增生减低以及恢复期4周结束红细胞系统增生减低、形态无异常，其余未见明显异常。30、60g/kg/天/剂量组试验期间还可见TBil的升高，肝脏以及60g/kg/天/剂量组肾脏的脏器重量/脏体比/脏脑比等指标轻微增加。病理组织学检查各组分别有3/20、2/19、4/20、17/20的动物可见脾脏红髓髓外造血，0/10、0/10、6/10、8/10的雌性动物可见肝脏小叶中央肝细胞肥大；停药4周后病变均可恢复。实验期间，受试动物活动良好，无动物死亡，体重各组较为接近，从实验结果可以看出，各受试药物组出现血清尿酸水平显著下降，其中低剂量组降低幅度为16.7％、中剂量组15.1％、高剂量组28.1％、阳性药物组27.4％，其中高剂量组和阳性药物组较为接近，与模型对照组相比，两组均有统计学差异，P<0.05，当试前验方案经过重复验证，受试物降尿酸颗粒剂对鹌鹑高尿酸血症模型，有一定的降尿酸作用。
本发明所提供的一种治疗高尿酸血症和/或痛风的中药组合物的制备方法，通过先将乳香、没药、赤芍以及黑顺片四味药，进行水蒸气提取，分别得到挥发油和水相提取物，最后再将剩余的十二味药材进行水提取，合并提取物后，所得的提取物改善了毒性较大的问题，且保留了原有的药效，有清热解毒、消肿排脓、凉血止血的功效，对高尿酸血症与痛风患者更具有针对性，增强了受损关节处的消肿抗炎，具有标本兼治、疗效显著、副作用小、服用方便、价格经济等优点，生产工艺简单高效，利于工业化生产。
以上所述仅为本申请的较佳实施例而已，并不用以限制本申请，凡在本申请的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本申请的保护范围之内。

Claims (8)

1.一种治疗高尿酸血症和痛风的中药组合物的制备方法，其特征在于，包括以下步骤：
S1、按重量份称量乳香、没药、细辛以及黑顺片，加入10倍量水，水蒸气蒸馏提取7-10h，得一次水相提取液和挥发油，将挥发油使用β-环糊精包结，冷藏过滤，低温干燥，粉碎，得包结物；
S2、将步骤S1中所得的一次水相提取液过滤浓缩，冷却至室温后离心，得离心液；
S3、按重量份数称取丹参、蒲公英、紫花地丁、茯苓、独活、土茯苓、桃仁、红花、鸡血藤、赤芍、川牛膝及地龙，加入10倍量水煎煮2-3次，合并每次煎煮后的煎液，过滤，将滤液与步骤S2中的离心液合并，浓缩得浸膏，减压干燥，粉碎，加入步骤S1中所得的包结物，混匀制粒，干燥即得。
2.根据权利要求1所述的高尿酸血症和痛风的中药组合物的制备方法，其特征在于：步骤S2中，所述滤液浓缩至相对密度为1.00～1.05。
3.根据权利要求1所述的高尿酸血症和痛风的中药组合物的制备方法，其特征在于：步骤S3中，所述滤液和离心液混匀后浓缩至相对密度为1.25～1.30。
4.根据权利要求1所述的高尿酸血症和痛风的中药组合物的制备方法，其特征在于：所述步骤S3中加入步骤S1中所得的包结物，还包括甜味剂和β-环糊精。
5.根据权利要求1所述的高尿酸血症和痛风的中药组合物的制备方法，其特征在于：步骤S1中，粉碎的目数为150-400目；步骤S3中，粉碎的目数为150-400目。
6.根据权利要求1所述的高尿酸血症和痛风的中药组合物的制备方法，其特征在于：所述乳香为醋制乳香。
7.根据权利要求1所述的高尿酸血症和痛风的中药组合物的制备方法，其特征在于：所述桃仁为燀桃仁。
8.一种如权利要求1-7任一项所述的制备方法制备所得的高尿酸血症和痛风的中药组合物，其特征在于：按重量份计，由以下组分组成：丹参10-20份、蒲公英10-20份、紫花地丁7-17份、茯苓10-20份、独活5-15份、土茯苓10-20份、燀桃仁10-20份、红花10-20份、鸡血藤5-15份、醋乳香10-20份、没药10-20份、赤芍10-20份、黑顺片10-20份、细辛7-17份、川牛膝10-20份、地龙5-15份。
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