CN110227139A - 一种丹参强筋壮骨颗粒及其制备方法 - Google Patents

一种丹参强筋壮骨颗粒及其制备方法 Download PDF

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CN110227139A
CN110227139A CN201810180529.4A CN201810180529A CN110227139A CN 110227139 A CN110227139 A CN 110227139A CN 201810180529 A CN201810180529 A CN 201810180529A CN 110227139 A CN110227139 A CN 110227139A
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parts
radix
rhizoma
root
particle
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陈杰
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Shanghai Official Aitang Pharmaceutical Co Ltd
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Shanghai Official Aitang Pharmaceutical Co Ltd
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Abstract

本发明公开了一种丹参强筋壮骨颗粒及其制备方法，由39味药材组成，包括骨碎补、龙血竭、人参、杜仲、丹参、鸡血藤、何首乌、桑寄生、桂枝、地龙、枸杞、伸筋草、乳香、没药、当归、肉桂、黄精、川芎、黄芪、茯苓、续断、天麻、防风、熟地、独活、羌活、白芷、干姜、砂仁、川牛膝、五加皮、姜黄、土鳖、丁香、葛根、豨莶草、千斤拔、红花和三七；该配方以攻为主，寓攻于补；诸药配伍，共奏补肝肾，强腰膝，益气血之功，以收祛风散寒，活血祛瘀，通络止痛；则风、寒、湿邪、瘀血均能得除，经络得通，气血得行，瘀散肿消，诸痛可止。治疗骨质增生、肩周炎、中风偏瘫、风湿、跌打损伤、椎间盘突出。

Description

一种丹参强筋壮骨颗粒及其制备方法
技术领域
本发明涉及一种丹参强筋壮骨颗粒及其制备方法，属于医药领域。
背景技术
类风湿性关节炎是一种以关节病变为主的慢性全身自身免疫性疾病。主要临床表现为小关节滑膜所致的关节肿痛，继而软骨破坏、关节间隙变窄，晚期因严重骨质破坏、吸收导致关节僵直、畸形、功能障碍。在我国类风湿性关节炎的患病率为0.24-0.5％，女性多于男性，约2-3:1，任何年龄均可发病，以20-50岁最多。本病多为一种反复发作性疾病，致残率较高，预后不良，目前还没有很好的根治方法。
丹参强筋壮骨颗粒就是根据中医理论，按照古人治疗腰肌劳损的经验方，结合现代文献研究资料和自己积累的临床经验，组成的方剂，通过临床实践证实对患者确有一定的临床效果。
发明内容
本发明提供一种丹参强筋壮骨颗粒及其制备方法，具有益气养血，祛风除湿，活血止痛；用于气血不足，风湿瘀阻，关节僵硬变形，气短乏力；风湿、类风湿性关节炎，腰肌劳损，软组织损伤。
为了解决上述技术问题，本发明提供了如下的技术方案：
本发明一种丹参强筋壮骨颗粒，原料的重量组分为：骨碎补：2-5份；龙血竭：0.1-2份；人参：1-3份；杜仲：2-5份；丹参：1-4份；鸡血藤：2-4份；何首乌：1-4份；桑寄生：1-4份；桂枝：8-15份；地龙：2-5份；枸杞：1.2-3份；伸筋草：1-4份；乳香： 0.3-1.5份；没药：0.1-1份；当归：1-2份；肉桂：0.1-1.5份；黄精：8-15份；川芎： 0.5-2份；黄芪：3-8份；茯苓：1-4份；续断：1-4份；天麻：1-3份；防风：0.1-2份；熟地：0.5-3份；独活：0.5-3份；羌活：0.1-1份；白芷：2-4份；干姜：0.3-1.5份；砂仁：0.3-2份；川牛膝：0.6-1.6份；五加皮：2-4份；姜黄：9-19份；土鳖：0.1-1 份；丁香：0.8-2份；葛根：5-10份；豨莶草：0.6-2份；千斤拔：0.1-1.6份；红花：2.5-4份；三七：1-3份。
作为本发明的一种优选方案：原料的重量组分为：骨碎补：2.9份；龙血竭：0.2份；人参：2份；杜仲：2.9份；丹参：1.8份；鸡血藤：2.9份；何首乌：2.9份；桑寄生： 1.8份；桂枝：9.9份；地龙：2.9份；枸杞：2份；伸筋草：1.8份；乳香：1份；没药： 0.2份；当归：1.2份；肉桂：0.6份；黄精：9.9份；川芎：2份；黄芪：5.9份；茯苓： 2.9份；续断：2.9份；天麻：2份；防风：1份；熟地：2份；独活：0.6份；羌活：0.6 份；白芷：2.9份；干姜：0.6份；砂仁：0.6份；川牛膝：1份；五加皮：2.9份；姜黄： 9.9份；土鳖：0.6份；丁香：1份；葛根：6份；豨莶草：1.8份；千斤拔：1份；红花： 2.9份；三七：2份；
本发明提供一种丹参强筋壮骨颗粒的制备方法，包括配料S1、提取S2、浓缩S3、制粒S4、干燥S5、整粒S6、总混S7、检验S8和包装S9；该方法的步骤如下：
S1：首先根据需要的比例选取骨碎补、龙血竭、人参、杜仲、丹参、鸡血藤、何首乌、桑寄生、桂枝、地龙、枸杞、伸筋草、乳香、没药、当归、肉桂、黄精、川芎、黄芪、茯苓、续断、天麻、防风、熟地、独活、羌活、白芷、干姜、砂仁、川牛膝、五加皮、姜黄、土鳖、丁香、葛根、豨莶草、千斤拔、红花和三七；并这39味药材按配比的配料配置10 份，称重复核后，备用；
S2：称取S1中的39味药材中的1份重量加入多功能提取罐内,加水煎煮两次：第一次加水5-10份量，煎煮1.5-2.5小时；第二次加水4-8份量，煎煮1-2小时；合并两次提取液，注入浓缩罐；
S3：将提取S2中提取液合并煎液,滤液浓缩至相对密度为1.28g/ml-1.32g/ml(50℃热测)的浸膏；
S4：取S3中制得的浸膏1份，加淀粉适量，分别加入槽式混合机内，充分混合均匀后，封闭，开启混合15-30分钟后，用10-15目筛制粒；
S5：将S4中制得的湿颗粒，置于卧式沸腾干燥机进行干燥，干燥温度控制在55℃ -65℃，颗粒含水量控制在6％以内。干燥后颗粒，置洁净容器内；
S6：取S5中干燥的颗粒，置整粒机整粒，分选10～60目间的颗粒，称重后用洁净的中转袋密封；产生的细粉和大颗粒称量后标示，按《尾料管理规程》处理；
S7：将同一批次或分次制得的S6中所有整好的颗粒，参照《二维运动混合机岗位操作规程》充分混合20-40分钟，转入中间站待验；
S8：对S7中混合的颗粒，其中将合格的颗粒，填写请检单，由QA取样，检验，待取得半成品检验合格后，方可转移至下道工序进行分装；
S9：分为内包装和外包装。
作为本发明制备方法的一种优选方案：提取S2的提取方法为：
A1：首先根据需要选取15g骨碎补、1g龙血竭、10g人参、15g杜仲、9g丹参、15g 鸡血藤、15g何首乌、桑寄生：9g；桂枝：50g；地龙：15g；枸杞：10g；伸筋草：9g；乳香：5g；没药：1g；当归：6g；肉桂：3g；黄精：50g；川芎：10g；黄芪：30g；茯苓： 15g；续断：15g；10g天麻：；5g防风；10g熟地；3g独活、3g羌活、15g白芷；3g干姜、3g砂仁、5g川牛膝、15g五加皮；50g姜黄；3g土鳖；5g丁香、30g葛根、9g豨莶草、5g千斤拔、15g红花和10g三七；
A2：并将A1配比的配料加入多功能提取罐内,加水煎煮两次；
A3：对于A2中第一次煎煮时加5倍量的水，煎煮为2小时；
A4：对于A3中经过一次煎煮的配料进行第二次煎煮，煎煮时加水4倍量，煎煮1.5小时；
A5：合并两次提取液，开始浓缩。
与现有技术相比，本发明的有益效果是：该颗粒的处方是在中医药理论指导下组方，具有益气养血，祛风除湿，活血止痛之功能。全方以攻为主，寓攻于补；诸药配伍，共奏补肝肾，强腰膝，益气血之功，以收祛风散寒，活血祛瘀，通络止痛；则风、寒、湿邪、瘀血均能得除，经络得通，气血得行，瘀散肿消，诸痛可止。治疗骨质增生、肩周炎、中风偏瘫、风湿、跌打损伤、椎间盘突出。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例，基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
本发明的理论依据为：
杜仲、桑寄生、续断、骨碎补、五加皮、天麻、豨莶草、千斤拔、鸡血藤和伸筋草可补肝肾，强筋骨，舒筋活络，祛风除湿，通经止痛，用于治疗风寒湿引起的痹痛证；防风、白芷和葛根祛风散寒除湿，捜风通络止痛；独活、川牛膝、桂枝和羌活可祛风湿、止痹痛，且独活祛风止痛，川牛膝补肝肾，强筋骨，逐瘀通经，引血(药)下行，二药善治下部之痹痛；桂枝温通经脉，羌活祛风除湿，散寒止痛，二药合用，善治上部之痹痛，四药同为引经药，相得益彰，使药物直达周身上下；龙血竭、三七、丹参、土鳖虫、乳香、没药、当归、川芎和红花可起到活血祛瘀、温经散寒和通络止痛的作用；姜黄不仅可活血化瘀，还起到行气止痛，肉桂、干姜和丁香温里以振奋阳气，散寒以通脉止痛；且气得热则行，血得热则流，以增强上述诸药之散寒除湿、活血化瘀之力，则瘀结通而疼痛止。
人参、黄芪和茯苓益气健脾以化生气血，熟地、枸杞、何首乌和黄精补肝肾、益精血，与人参、黄芪、茯苓同用，气血并补，与祛风散寒药合用，有扶正祛邪之功，邪去而正不伤之意；且诸多风药，性偏温燥，易伤津血，当归、赤芍、川芎与熟地、枸杞子、何首乌、黄精等合用，养血活血，柔筋止痛，使风药祛风而不伤血，即所谓“疏风必先养血”，寓养血于疏风之中，使风药不至过于温燥；砂仁行气调中，醒脾和胃，治脘腹痞胀，胃呆食滞，使人参、熟地等补益气血之药补而不滞；
全方以攻为主，寓攻于补；诸药配伍，共奏补肝肾，强腰膝，益气血之功，以收祛风散寒，活血祛瘀，通络止痛；则风、寒、湿邪、瘀血均能得除，经络得通，气血得行，瘀散肿消，诸痛可止。治疗骨质增生、肩周炎、中风偏瘫、风湿、跌打损伤、椎间盘突出。
现取丹参强筋壮骨颗粒三批中试样品生产技术的数据，分别对试样品去编号为：20150401、20150402和20150403，试样品检测结果的相关技术数据如下：
表1：试样品检测结果
表2：试产品微生物限度检测结果
上述三批中试样品经检测，其水分、装量差异、微生物限度检查均符合中国药典2010 年版一部附录颗粒剂项下规定。
表3：中试验数据汇总表
上述3批茯苓温肾益发颗粒中试样品工艺稳定性好，产品质量可靠，根据以上结果，说明该生产工艺是稳定的、成熟的，达到了试验目的。
最后应说明的是：以上仅为本发明的优选实施例而已，并不用于限制本发明，尽管参照前述实施例对本发明进行了详细的说明，对于本领域的技术人员来说，其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (4)

1.一种丹参强筋壮骨颗粒，其特征在于，原料的重量组分为：骨碎补：2-5份；龙血竭：0.1-2份；人参：1-3份；杜仲：2-5份；丹参：1-4份；鸡血藤：2-4份；何首乌：1-4份；桑寄生：1-4份；桂枝：8-15份；地龙：2-5份；枸杞：1.2-3份；伸筋草：1-4份；乳香：0.3-1.5份；没药：0.1-1份；当归：1-2份；肉桂：0.1-1.5份；黄精：8-15份；川芎：0.5-2份；黄芪：3-8份；茯苓：1-4份；续断：1-4份；天麻：1-3份；防风：0.1-2份；熟地：0.5-3份；独活：0.5-3份；羌活：0.1-1份；白芷：2-4份；干姜：0.3-1.5份；砂仁：0.3-2份；川牛膝：0.6-1.6份；五加皮：2-4份；姜黄：9-19份；土鳖：0.1-1份；丁香：0.8-2份；葛根：5-10份；豨莶草：0.6-2份；千斤拔：0.1-1.6份；红花：2.5-4份；三七：1-3份。
2.根据权利要求1述的一种丹参强筋壮骨颗粒，其特征在于，原料的重量组分为：骨碎补：2.9份；龙血竭：0.2份；人参：2份；杜仲：2.9份；丹参：1.8份；鸡血藤：2.9份；何首乌：2.9份；桑寄生：1.8份；桂枝：9.9份；地龙：2.9份；枸杞：2份；伸筋草：1.8份；乳香：1份；没药：0.2份；当归：1.2份；肉桂：0.6份；黄精：9.9份；川芎：2份；黄芪：5.9份；茯苓：2.9份；续断：2.9份；天麻：2份；防风：1份；熟地：2份；独活：0.6份；羌活：0.6份；白芷：2.9份；干姜：0.6份；砂仁：0.6份；川牛膝：1份；五加皮：2.9份；姜黄：9.9份；土鳖：0.6份；丁香：1份；葛根：6份；豨莶草：1.8份；千斤拔：1份；红花：2.9份；三七：2份；
3.根据权利要求1所述的一种丹参强筋壮骨颗粒的制备方法，其特征在于，包括配料S1、提取S2、浓缩S3、制粒S4、干燥S5、整粒S6、总混S7、检验S8和包装S9；该方法的步骤如下：
S1：首先根据需要的比例选取骨碎补、龙血竭、人参、杜仲、丹参、鸡血藤、何首乌、桑寄生、桂枝、地龙、枸杞、伸筋草、乳香、没药、当归、肉桂、黄精、川芎、黄芪、茯苓、续断、天麻、防风、熟地、独活、羌活、白芷、干姜、砂仁、川牛膝、五加皮、姜黄、土鳖、丁香、葛根、豨莶草、千斤拔、红花和三七；并这39味药材按配比的配料配置10份，称重复核后，备用；
S2：称取S1中的39味药材中的1份重量加入多功能提取罐内,加水煎煮两次：第一次加水5-10份量，煎煮1.5-2.5小时；第二次加水4-8份量，煎煮1-2小时；合并两次提取液，注入浓缩罐；
S3：将提取S2中提取液合并煎液,滤液浓缩至相对密度为1.28g/ml-1.32g/ml(50℃热测)的浸膏；
S4：取S3中制得的浸膏1份，加淀粉适量，分别加入槽式混合机内，充分混合均匀后，封闭，开启混合15-30分钟后，用10-15目筛制粒；
S5：将S4中制得的湿颗粒，置于卧式沸腾干燥机进行干燥，干燥温度控制在55℃-65℃，颗粒含水量控制在6％以内。干燥后颗粒，置洁净容器内；
S6：取S5中干燥的颗粒，置整粒机整粒，分选10～60目间的颗粒，称重后用洁净的中转袋密封；产生的细粉和大颗粒称量后标示，按《尾料管理规程》处理；
S7：将同一批次或分次制得的S6中所有整好的颗粒，参照《二维运动混合机岗位操作规程》充分混合20-40分钟，转入中间站待验；
S8：对S7中混合的颗粒，其中将合格的颗粒，填写请检单，由QA取样，检验，待取得半成品检验合格后，方可转移至下道工序进行分装；
S9：分为内包装和外包装。
4.根据权利要求3所述的一种丹参强筋壮骨颗粒的制备方法，其特征在于，提取S2的提取方法为：
A1：首先根据需要选取15g骨碎补、1g龙血竭、10g人参、15g杜仲、9g丹参、15g鸡血藤、15g何首乌、桑寄生：9g；桂枝：50g；地龙：15g；枸杞：10g；伸筋草：9g；乳香：5g；没药：1g；当归：6g；肉桂：3g；黄精：50g；川芎：10g；黄芪：30g；茯苓：15g；续断：15g；10g天麻：；5g防风；10g熟地；3g独活、3g羌活、15g白芷；3g干姜、3g砂仁、5g川牛膝、15g五加皮；50g姜黄；3g土鳖；5g丁香、30g葛根、9g豨莶草、5g千斤拔、15g红花和10g三七；
A2：并将A1配比的配料加入多功能提取罐内,加水煎煮两次；
A3：对于A2中第一次煎煮时加5倍量的水，煎煮为2小时；
A4：对于A3中经过一次煎煮的配料进行第二次煎煮，煎煮时加水4倍量，煎煮1.5小时；
A5：合并两次提取液，开始浓缩。
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