CN114767743A - 含丹参的治疗心脑血管病中成药及中成药制剂的制备工艺 - Google Patents
含丹参的治疗心脑血管病中成药及中成药制剂的制备工艺 Download PDFInfo
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Abstract
本发明公开了含丹参的治疗心脑血管病中成药及中成药制剂的制备工艺，包括以下组分：丹参45份、冰片5份、茯苓23份、赤芍18份、琥珀13份、甘草18份、大血藤13份、赤小豆5份、辅料5份，其制备工艺包括如下步骤：将原料进行净制消除杂质，去除非用药部位，然后进行清洗，清洗后浸泡，沸水蒸；将处理后的原料切成片状；将片状原料经微波灭菌，干燥；将灭菌原料和辅料混合加热；将炮制后的原料切碎加入到提取罐中，加入两倍重量乙醇，煎煮30min，回流提取，提取过滤液并浓缩；浓缩液冷却后加入两倍重量乙醇充分搅拌，常温下静置20h；上清液离心处理，然后常温冷却过滤。本发明中成药及制剂的制备工艺原料易得，获得的制剂治疗效果优异，毒副作用小。
Description
技术领域
本发明涉及中成药技术领域，尤其涉及含丹参的治疗心脑血管病中成药及中成药制剂的制备工艺。
背景技术
造成心脑血管疾病的主要根源在于高脂血症、高血压症、高血糖和高血粘度。目前，人口老龄化，生活水平日益提高使得我国正进入心血管疾病爆发的“窗口期”，拥有心血管药物庞大的消费群体。
丹参的主要药用成份丹参酮≥0.25%，丹酚酸B≥3%，方城丹参（裕丹参）经检测丹参酮含量稳定在0.6%左右，是国家药典规定标准的2倍多；丹酚酸B含量在稳定在9.0%左右，是国家药典规定标准的3倍。丹参具有改善微循环，抗血小板聚集和抑制血栓形成，具有降血脂、降血糖、降血液粘稠度、抑制冠状粥样斑块形成，具有抗氧化作用，保护肝细胞，改善肾功能，抗菌、抗肿瘤、增加免疫力的功能，有利于延缓衰老，延年益寿，广泛用于治疗心脑血管病预防、治疗、保健。随着人类饮食结构的改变，心脑血管病将逐年增加，用于治疗心脑血管病的药品市场需求也必将随之增高，作为主要成分原料的丹参市场需求的增加是必然的。
目前治疗含丹参的心脑血管病药品多数含有较为名贵中药材，如人参、牛黄、麝香等，以及一些紧俏药材如三七等，其采购成本受国内节节上升的中药材价格的影响而有所提高，限制了药物的制备和应用；此外，现有的制备工艺获得的药物，还存在治疗效果不佳，毒副作用大等问题。
发明内容
本发明为了解决上述技术问题，提供含丹参的治疗心脑血管病中成药及中成药制剂的制备工艺，采用中药配方，原料易得，获得的制剂治疗效果优异，毒副作用小。
本发明含丹参的治疗心脑血管病中成药，按重量份数计，包括以下组分：丹参30-60份、冰片1-10份、茯苓20-25份、赤芍15-20份、琥珀10-15份、甘草15-20份、大血藤10-15份、赤小豆1-10份、辅料1-10份。
进一步，按重量份数计，包括以下组分：丹参45份、冰片5份、茯苓23份、赤芍18份、琥珀13份、甘草18份、大血藤13份、赤小豆5份、辅料5份。
进一步，所述辅料，按重量份数计，包括盐1-2份、姜1-2份、醋1-2份、灶心土1-2份、麦麸1-2份、黑豆1-2份、铁1-2份、沙1-2份、灰1-2份、酒1-2份、蜜1-2份、糖1-2份和石灰5-10份。
丹参具有改善微循环，抗血小板聚集和抑制血栓形成，具有降血脂、降血糖、降血液粘稠度、抑制冠状粥样斑块形成，具有抗氧化作用，保护肝细胞，改善肾功能，抗菌、抗肿瘤、增加免疫力的功能；冰片是由菊科艾纳香茎叶或樟科植物龙脑樟枝叶经水蒸汽蒸馏并重结晶而得，具有开窍醒神，清热散毒，明目退翳的功效；茯苓微寒活血化瘀通经止痛、养血安神、益精气、补肝肾、生津健脾；琥珀养血安神的功效；甘草、大血藤、赤小豆等中药共用可以增强活血化瘀、熄风止痉、凉血清心、祛风通络、补气养血、解郁安神的功效。
本发明含丹参的治疗心脑血管病中成药制剂的制备工艺，包括如下步骤：
原料处理：将丹参、冰片、茯苓、赤芍、琥珀、甘草、大血藤、赤小豆进行净制消除杂质，去除非用药部位，然后进行清洗，清洗后浸泡1h，然后沸水蒸1h，得到处理后的原料；
切制：将处理后的原料切成片状，得到片状原料；
灭菌：将片状原料经微波灭菌，然后在30-40℃温度下干燥，得到灭菌原料；
炮制：将灭菌原料和辅料混合，然后在20-30℃温度下加热30min，得到炮制原料；
浓缩：将炮制后的原料切碎加入到提取罐中，加入两倍重量乙醇，煎煮30min，回流提取，提取过滤液并浓缩，得到浓缩液，浓缩温度为10℃；
静置分层：浓缩液冷却后加入两倍重量乙醇，充分搅拌，常温下静置20h，得到分层溶液；
过滤离心：将分层溶液的上清液去除，回收乙醇，回收乙醇后的上清液离心处理，然后常温冷却、过滤，过滤后得到治疗心脑血管病中成药制剂。
进一步，所述炮制步骤中，辅料加入前进行前处理，辅料中的盐、姜、醋、灶心土、麦麸、黑豆、铁、沙、灰、酒、蜜、糖进行锻炼，辅料中的石灰进行消毒。
进一步，所述盐、姜、醋、灶心土、麦麸、黑豆、铁、沙、灰、酒、蜜、糖进行锻炼的设备为煅药机，煅药温度为150℃，煅药时间为1h。
进一步，所述浓缩和静置分层步骤中，所述乙醇的浓度为70％。
进一步，所述切制步骤中，采用转盘式切药机进行切药。
进一步，所述浓缩步骤中，所述提取罐为多功能提取、浓缩设备，提取时间为12h
本发明与现有技术相比，具有如下的优点和有益效果：
1、本发明含丹参的治疗心脑血管病中成药及中成药制剂的制备工艺，采用中药配方，标本兼治、治补同步、毒副作用小；
2、本发明含丹参的治疗心脑血管病中成药及中成药制剂的制备工艺，其配方组份易于获得，相比现有的治疗心脑血管病中成药，成本较低，由于原料易于获得，能够更容易实现产业化生产；
3、本发明含丹参的治疗心脑血管病中成药及中成药制剂的制备工艺，制剂制备时，先进行前处理，进行浸泡蒸煮，使药材质地***，便于切制，易于加工；将原料切成片状，增大与溶剂接触面积，缩短煎煮时间，便于调剂，提高疗效；将灭菌原料和辅料混合加热，改变药性，提高疗效，引药归经；辅料中的盐、姜、醋、灶心土、麦麸、黑豆、铁、沙、灰、酒、蜜、糖进行锻炼，辅料中的石灰进行消毒，降低毒副作用；
4、本发明含丹参的治疗心脑血管病中成药及中成药制剂的制备工艺，低温浓缩，使提取液在真空减压状态下，只需较低的温度即可浓缩至规定的相对密度，有效地保留了药物的有效成分；
5、本发明含丹参的治疗心脑血管病中成药及中成药制剂的制备工艺，提取工艺简单易操作，可对乙醇进行回收利用，节约能源，提取完全彻底，缩短生产时间40%以上，节约能源约40%左右。
具体实施方式
下面结合实施例对本发明进行进一步描述。以下实施例仅为本发明的几个具体实施例，但本发明的设计构思并不局限于此，凡利用此构思对本发明进行非实质性的改动，均应属于侵犯本发明保护范围的行为。
实施例1
含丹参的治疗心脑血管病中成药，按重量份数计，包括以下组分：丹参30份、冰片1份、茯苓20份、赤芍15份、琥珀10份、甘草15份、大血藤10份、赤小豆1份、辅料1份。
更具体地，所述辅料，按重量份数计，包括盐1-2份、姜1-2份、醋1-2份、灶心土1-2份、麦麸1-2份、黑豆1-2份、铁1-2份、沙1-2份、灰1-2份、酒1-2份、蜜1-2份、糖1-2份和石灰5-10份。
实施例2
含丹参的治疗心脑血管病中成药，按重量份数计，包括以下组分：丹参60份、冰片10份、茯苓25份、赤芍20份、琥珀15份、甘草20份、大血藤15份、赤小豆10份、辅料10份。
更具体地，所述辅料，按重量份数计，包括盐1-2份、姜1-2份、醋1-2份、灶心土1-2份、麦麸1-2份、黑豆1-2份、铁1-2份、沙1-2份、灰1-2份、酒1-2份、蜜1-2份、糖1-2份和石灰5-10份。
实施例3
含丹参的治疗心脑血管病中成药，按重量份数计，包括以下组分：丹参45份、冰片5份、茯苓23份、赤芍18份、琥珀13份、甘草18份、大血藤13份、赤小豆5份、辅料5份。
更具体地，所述辅料，按重量份数计，包括盐1-2份、姜1-2份、醋1-2份、灶心土1-2份、麦麸1-2份、黑豆1-2份、铁1-2份、沙1-2份、灰1-2份、酒1-2份、蜜1-2份、糖1-2份和石灰5-10份。
上述实施例1-3可按照下述工艺制备，制备工艺，包括如下步骤：
原料处理：将丹参、冰片、茯苓、赤芍、琥珀、甘草、大血藤、赤小豆进行净制消除杂质，去除非用药部位，然后进行清洗，清洗后浸泡1h，然后沸水蒸1h，得到处理后的原料；
切制：将处理后的原料切成片状，得到片状原料；
灭菌：将片状原料经微波灭菌，然后在30-40℃温度下干燥，得到灭菌原料；
炮制：将灭菌原料和辅料混合，然后在20-30℃温度下加热30min，得到炮制原料；
浓缩：将炮制后的原料切碎加入到提取罐中，加入两倍重量乙醇，煎煮30min，回流提取，提取过滤液并浓缩，得到浓缩液，浓缩温度为10℃；
静置分层：浓缩液冷却后加入两倍重量乙醇，充分搅拌，常温下静置20h，得到分层溶液；
过滤离心：将分层溶液的上清液去除，回收乙醇，回收乙醇后的上清液离心处理，然后常温冷却、过滤，过滤后得到治疗心脑血管病中成药制剂。
更具体地，所述炮制步骤中，辅料加入前进行前处理，辅料中的盐、姜、醋、灶心土、麦麸、黑豆、铁、沙、灰、酒、蜜、糖进行锻炼，辅料中的石灰进行消毒。
更具体地，所述盐、姜、醋、灶心土、麦麸、黑豆、铁、沙、灰、酒、蜜、糖进行锻炼的设备为煅药机，煅药温度为150℃，煅药时间为1h。
更具体地，所述浓缩和静置分层步骤中，所述乙醇的浓度为70％。
更具体地，所述切制步骤中，采用转盘式切药机进行切药。
更具体地，所述浓缩步骤中，所述提取罐为多功能提取、浓缩设备，提取时间为12h。
实验例
为了验证本发明含丹参的治疗心脑血管病中成药制剂的功效，选取150名患有心脑血管疾病的患者，平均分成三组，其中A组为50名每日服用本发明中成药制剂，服用规则与现有技术中治疗心脑血管病中成药制剂服用规则相同；其中B组为50名每日服用现有技术中成药制剂，制剂为江西华太药业有限公司生产的脑得生片；其中C组为50名服用西药药物进行治疗，西药药物为广州悦康生物制药有限公司生产的悦康；治疗时间为28天。
诊断依据：心脑彩超、心电图、CT片、MRI 片的相关检查；西医临床症状；中医辨证：心脾两虚、心肾不交、心火亢盛肝阳上火、气滞血瘀、气血亏虚、肝肾阴虚；
诊断标准：
治愈：各种中西医临床症状正常，辅助检查结果支持治愈。
显效：各种中西医临床症状明显改善，辅助检查结果支持显效。
有效：部分中西医临床症状改善，辅助检查结果支持有效。
无效：各种中西医临床症状无改善。
治疗28天后，对150名患者的状况进行测评，测评结果如表1。
表1 各药物治疗测评效果
| 组\效果 | 治愈 | 显著疗效 | 有效疗效 | 无效 | 总有效率 |
| A | 40 | 6 | 2 | 2 | 96% |
| B | 41 | 5 | 1 | 3 | 94% |
| C | 42 | 6 | 1 | 1 | 98% |
综上所述，本发明含丹参的治疗心脑血管病中成药制剂对治疗心脑血管病有明显的效果，与现有中成药和西药效果相当，但本发明中成药制剂原料易得、低廉，能够降低成本，适合产业化生产，且采用中药配方，标本兼治、治补同步、毒副作用小。
以上所述的具体实施方式，对本发明的目的、技术方案和有益效果进行了进一步详细说明，所应理解的是，以上所述仅为本发明的具体实施方式而已，并不用于限定本发明的保护范围，凡在本发明的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
Claims (9)
1.含丹参的治疗心脑血管病中成药，其特征在于，按重量份数计，包括以下组分：丹参30-60份、冰片1-10份、茯苓20-25份、赤芍15-20份、琥珀10-15份、甘草15-20份、大血藤10-15份、赤小豆1-10份、辅料1-10份。
2.根据权利要求1所述含丹参的治疗心脑血管病中成药，其特征在于，按重量份数计，包括以下组分：丹参45份、冰片5份、茯苓23份、赤芍18份、琥珀13份、甘草18份、大血藤13份、赤小豆5份、辅料5份。
3.根据权利要求2所述含丹参的治疗心脑血管病中成药，其特征在于，所述辅料，按重量份数计，包括盐1-2份、姜1-2份、醋1-2份、灶心土1-2份、麦麸1-2份、黑豆1-2份、铁1-2份、沙1-2份、灰1-2份、酒1-2份、蜜1-2份、糖1-2份和石灰5-10份。
4.根据权利要求3所述含丹参的治疗心脑血管病中成药的制剂制备工艺，其特征在于，包括如下步骤：
原料处理：将丹参、冰片、茯苓、赤芍、琥珀、甘草、大血藤、赤小豆进行净制消除杂质，去除非用药部位，然后进行清洗，清洗后浸泡1h，然后沸水蒸1h，得到处理后的原料；
切制：将处理后的原料切成片状，得到片状原料；
灭菌：将片状原料经微波灭菌，然后在30-40℃温度下干燥，得到灭菌原料；
炮制：将灭菌原料和辅料混合，然后在20-30℃温度下加热30min，得到炮制原料；
浓缩：将炮制后的原料切碎加入到提取罐中，加入两倍重量乙醇，煎煮30min，回流提取，提取过滤液并浓缩，得到浓缩液，浓缩温度为10℃；
静置分层：浓缩液冷却后加入两倍重量乙醇，充分搅拌，常温下静置20h，得到分层溶液；
过滤离心：将分层溶液的上清液去除，回收乙醇，回收乙醇后的上清液离心处理，然后常温冷却、过滤，过滤后得到治疗心脑血管病中成药制剂。
5.根据权利要求4所述中成药制剂的制备工艺，其特征在于，所述炮制步骤中，辅料加入前进行前处理，辅料中的盐、姜、醋、灶心土、麦麸、黑豆、铁、沙、灰、酒、蜜、糖进行锻炼，辅料中的石灰进行消毒。
6.根据权利要求5所述中成药制剂的制备工艺，其特征在于，所述盐、姜、醋、灶心土、麦麸、黑豆、铁、沙、灰、酒、蜜、糖进行锻炼的设备为煅药机，煅药温度为150℃，煅药时间为1h。
7.根据权利要求4所述中成药制剂的制备工艺，其特征在于，所述浓缩和静置分层步骤中，所述乙醇的浓度为70％。
8.根据权利要求4所述中成药制剂的制备工艺，其特征在于，所述切制步骤中，采用转盘式切药机进行切药。
9.根据权利要求4所述中成药制剂的制备工艺，其特征在于，所述浓缩步骤中，所述提取罐为多功能提取、浓缩设备，提取时间为12h。
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| CN101085003A (zh) * | 2006-06-08 | 2007-12-12 | 天津天士力制药股份有限公司 | 含丹参、赤芍和冰片或苏合香的中药组合物及其制剂 |
| CN104367630A (zh) * | 2014-11-10 | 2015-02-25 | 成都果睿医药科技有限公司 | 一种含有西洋参的治疗心脑血管疾病的药物组合物 |
| CN104435664A (zh) * | 2014-11-11 | 2015-03-25 | 成都果睿医药科技有限公司 | 一种含有赤小豆的治疗心脑血管疾病的药物组合物 |
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| CN101085003A (zh) * | 2006-06-08 | 2007-12-12 | 天津天士力制药股份有限公司 | 含丹参、赤芍和冰片或苏合香的中药组合物及其制剂 |
| CN104367630A (zh) * | 2014-11-10 | 2015-02-25 | 成都果睿医药科技有限公司 | 一种含有西洋参的治疗心脑血管疾病的药物组合物 |
| CN104435664A (zh) * | 2014-11-11 | 2015-03-25 | 成都果睿医药科技有限公司 | 一种含有赤小豆的治疗心脑血管疾病的药物组合物 |
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