CN116850252A - 一种姜花跌打酒及其用途 - Google Patents
一种姜花跌打酒及其用途 Download PDFInfo
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- CN116850252A CN116850252A CN202310837557.XA CN202310837557A CN116850252A CN 116850252 A CN116850252 A CN 116850252A CN 202310837557 A CN202310837557 A CN 202310837557A CN 116850252 A CN116850252 A CN 116850252A
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Abstract
本发明属于中药制剂技术领域,具体涉及一种姜花跌打酒及其用途。本发明要解决的技术问题是为治疗跌打扭伤提供一种新选择。本发明的技术方案是一种姜花跌打酒,按重量份计,将以下药材:姜黄22.5份、红花6.25份、威灵仙25份、醋乳香6.25份、独活12.5份、制川乌6.25份、醋没药6.25份、制草乌6.25份、细辛6.25份,经酒提取得到。本发明提供了一种以红花为主要成分的药酒,能对跌打扭伤起到良好的治疗效果。
Description
技术领域
本发明属于中药制剂技术领域,具体涉及一种姜花跌打酒及其用途。
背景技术
骨伤后期肢体肿胀是跌打损伤或骨折患者常见的并发症,主要是骨伤部位的软组织出现的肿胀与充血现象,是骨科常见疾病症状,其发生主要与局部疼痛未得到缓解、毛细血管网通透性提高及肌肉痉挛等因素有关,对患者患肢骨伤的痊愈有不良影响,若未及时进行处理,会导致患者出现感染、深静脉血栓与局部坏死等较为严重的并发症,不但会延长骨折愈合时间,还会威胁到患者的生命健康,需要对骨伤后期的治疗引起高度重视。中医认为骨伤后期肢体肿胀属于“瘀血证”范畴,其发生主要与气滞血瘀及热毒内侵有关,治疗应该以行气止痛、活血化瘀为主。通过相关药物治疗可有效缓解患者的脾虚症状,对其水肿情况也具有较好的改善效果,在提升疗效的同时可加快肿胀消除速度,同时还可达到疏通经络与调解微循环的目的。
治疗跌打损伤的药品有很多,根据病程过程合理选择用药。初期:对于症状较轻,出血较少,创面浅的伤口,可自行先用生理盐水冲洗后,再敷以消肿止痛膏;对于肿痛剧烈者,宜活血化瘀,消肿止痛,常见的药有双氯芬酸钠、尼美舒利或洛索洛芬钠等,能够很好的起到消炎以及镇痛的作用。中期:跌打损伤的中期,通常患处肿痛减退,治疗应舒筋活血,当有瘀血不散时候,可借助中成药,如活血止痛胶囊或伤科跌打胶囊,具有化瘀止血,消肿止痛的作用,主要用于跌打损伤所致的瘀血肿痛。后期:后期常夹有风寒外邪、局部疼痛,活动欠利,治宜养血活络,祛风宣痹,补肝肾,外用解痉镇痛酊或采用中药熏洗,对于严重的跌打损伤还可以采用物理治疗,如红外线光疗、紫外线光疗或电疗等,还可用针灸、拔炎罐等。
目前临床上治疗骨折或跌打扭伤所致肿胀方法多种多样,骨伤患者后期出现肢体肿胀的概率较高,并且肢体肿胀较为严重且疼痛程度较为剧烈,要及时给予其有效治疗,能够加速其血液循环,预防静脉血栓。临床对骨伤后期肢体肿胀的治疗所选用的西药为甘露醇,虽具有一定效果,但单一用药不但导致病情无明显改善,还会导致患者出现水电解质失衡等较多副作用。另外常规西药治疗骨伤后期肢体肿胀主要以消除肿胀与改善微循环为主,进而有效减少感染与血栓的发生,同时还可降低相关并发症的发生率,但副作用较多,极易导致患者出现水电解质紊乱现象,对治疗效果造成影响。中医根据“痛则不通,通则不痛”的病机,中医的跌打损伤、风湿肿痛,是由血瘀、风寒、湿邪阻滞经络,至使血、气于体内运行不畅,其于体征表现为痛证。中医治疗当活血化瘀、消肿通络、行气止痛为治则。中药制剂根据其独特的治疗效果以及其副作用小等特点,在疾病治疗方面发挥越来越重要的作用。
发明内容
本发明要解决的技术问题是为治疗跌打扭伤提供一种新选择。
本发明的技术方案是一种姜花跌打酒,按重量份计,将以下药材:姜黄22.5份、红花6.25份、威灵仙25份、醋乳香6.25份、独活12.5份、制川乌6.25份、醋没药6.25份、制草乌6.25份、细辛6.25份,经酒提取得到。
具体的,所述提取为将上述药材用酒浸泡,然后去渣,即得。
其中,所述酒与药材的用量配比为:每97.5g药材用1150mL酒。
特别的,所述酒为米酒。
进一步的,所述米酒度数为28~52°。
优选的,所述米酒度数为40°。
进一步的,所述浸泡时间为15~45天。
优选的,所述浸泡时间为30天。
特别的,浸泡过程中搅拌至少一次。
具体的,所述去渣采用如下方式之一:100~200目筛网过滤或者离心。
进一步的,去渣后的液体加酒稀释,得到原液。
优选的,所述酒为米酒。
特别的,稀释后体积与药材的比例为:每97.5g药材稀释至1000mL。
更进一步的,所述稀释后原液,干燥,得到浸膏。
特别的,所述干燥为原液依次经烘干、减压干燥。
本发明还提供了所述姜花跌打酒在制备活血祛瘀、通络止痛的药物中的用途。
本发明还提供了所述姜花跌打酒在制备治疗跌打扭伤的药物中的用途。
本发明方中,诸药性味辛温,其中姜黄犹长活血行气,使瘀散滞通而痛解,通经止痛,用治风湿痹痛,跌打肿痛,为君药;红花活血通经,祛瘀止痛,并列君药;制川乌、制草乌、乳香、没药均有温经,活血行气,消肿生肌,散寒止痛作用,为臣药;细辛、独活为辛,温,祛风散寒,止痹痛,为佐药;威灵仙辛、咸、温,归膀胱经,祛风湿、通经络,用于风湿痹痛,肢体麻木,筋脉拘孪,屈伸不利,是为使药。诸药配伍具有活血化瘀、通络止痛的功效。
酒剂是在中医药理论指导下,结合中药的现代药理学知识,把中药和酒按一定比例加工融合,通过饮服或外涂能达到防治疾病目的的一种中药剂型。借酒疗疾的做法由来已久,最早见于《五十二病方》中,虽未明确记载各类药酒的功效及所主病证,但仍为后世医家应用药酒防治疾病做出了重要贡献。研究[1]表明,酒在改变药性、宣行药势、引药上行、增强药物疗效、降低药物毒性、矫味矫臭、防腐等方面发挥巨大作用。
本发明的有益效果:本发明提供了一种以红花为主要成分的药酒,具有活血祛瘀、通络止痛的功效,能对跌打扭伤起到良好的治疗效果。其次,本发明还提供了该药酒的制备方法,对方法中的各工艺参数进行了优化和选择。根据临床疗效总结报告,姜花跌打酒治疗骨伤导致的血瘀及肢体肿胀疼痛效果较好,可有效减轻患者的疼痛程度,缓解肢体肿胀程度,加快消肿速度与骨伤愈合速度,值得临床应用推广。此外,姜花跌打酒为中药外搽酒剂,药物可以通过皮肤吸收直达病所,起到活血化瘀、消肿止痛、舒筋活络之作用,且病人反馈效果良好,用药感觉舒适,费用低廉,简单方便,且不受跌打扭伤部位、地点的限制,病人普遍乐于接受。
附图说明
图1、羟基红花黄色素A标准曲线方程。
图2、姜花跌打酒全方、空白、阴性(缺红花)及标准品(羟基红花黄色素A)的色谱叠加图;从上到下依次为标准品、阴性、空白、全方。
图3、九种供试品溶液色谱叠加图;从上到下依次为52°/45d,40°/45d,28°/45d,52°/30d,40°/30d,28°/30d,52°/15d,45°/15d,40°/45d。
图4、三种供试品溶液色谱叠加图;从上到下依次为离心操作、过200目筛、过100目筛。
图5、三批姜花跌打酒供试品指标成分色谱峰叠加图;从上到下依次为03批、02批、01批。
具体实施方式
下述实施例中用到的实验仪器:
Agilent 1260高效液相色谱仪(包括梯度泵G1311C、自动进样器G1329B、柱恒温系统G1316A、紫外检测器DAD-G1315D、色谱工作站);色谱柱:Sharpsil-U C18(4.6mm×250mm,100A)色谱柱。
电热恒温鼓风干燥箱(厂家:上海精宏实验设备有限公司)。
下述实施例中用到的实验材料:
威灵仙(产地:广西,批号:201201,厂家:广州至信中药饮片);制川乌(产地:陕西,批号:2019070033,厂家:安徽盛海堂中药饮片有限公司);制草乌(产地:辽宁,批号:2019070023,厂家:安徽盛海堂中药饮片有限公司);醋乳香(产地:埃塞俄比亚,批号:2019090511,厂家:安徽盛海堂中药饮片有限公司);醋醋没药(产地:索马里,批号:2019100281,厂家:安徽盛海堂中药饮片有限公司);细辛(产地:辽宁,批号:200701,厂家:广州南北行中药饮片有限公司);独活(产地:湖北,批号:200401,厂家:广州南北行中药饮片有限公司);姜黄(产地:四川,批号:200201,厂家:广州南北行中药饮片有限公司);红花(产地:新疆,批号:210402,厂家:广州至信中药饮片);羟基红花黄色素A纯度:HPLC≥98%,批号:wkq21070209。
实施例1供试品溶液的制备
姜花跌打酒供试品制备:称取姜黄22.5g,红花6.25g,威灵仙25g,醋乳香6.25g,独活12.5g,制川乌6.25g,醋没药6.25g,制草乌6.25g,细辛6.25g加1150mL 40°米酒,浸泡30天,浸泡结束后用米酒补足体积至1000mL,过200目筛,取滤液用0.22μm微孔滤膜滤过,作为供试品溶液。
缺红花阴性供试品制备:称取姜黄22.5g,威灵仙25g,醋乳香6.25g,独活12.5g,制川乌6.25g,醋没药6.25g,制草乌6.25g,细辛6.25g加1150mL 40°米酒,浸泡30天,浸泡结束后补足体积至1000mL,过200目筛,取滤液用0.22μm微孔滤膜滤过,作为供试品溶液。
实施例2标准曲线绘制及检测限定量限考察
标准品溶液的制备:精密称量标准品羟基红花黄色素A 5mg,用甲醇定容到5mL容量瓶中,配置成浓度为1.00mg/mL的标准品溶液,备用。
标准曲线绘制及检测限定量限考察:精密称量标准品羟基红花黄色素A 5mg,用甲醇定容到5mL容量瓶中,配置成浓度为1.00mg/mL的标准品溶液,作为储备液备用,将对照品储备液依次稀释到5、10、20、40、80、160、320倍得不同浓度的标准品,过0.22μm微孔滤膜。按色谱条件进行测定,进样量为10μL,经HPLC检测。以峰面积为纵坐标(Y)、浓度为横坐标(X)绘制标准曲线,如图1和表1所示。
表1羟基红花黄色素A的相关参数
实施例3姜花跌打酒指标成分的指认
采用高效液相色谱法进行测定。羟基红花黄色素A的测定照高效液相色谱法(《中国药典》2020版(通则0512))测定。Sharpsil-U C18(4.6mm×250mm,100A)色谱柱;流动相体系:甲醇-乙腈-0.7%磷酸溶液(26︰2︰72);流动相A为甲醇,流动相B为乙腈,流动相C为0.7%磷酸溶液,等度洗脱,流速为1mL/min,柱温25℃,检测波长403nm,进样量:10μL。流动相洗脱程序见表2。
表2流动相洗脱程序
时间(min) | A% | B% | C% |
0 | 26 | 2 | 72 |
60 | 26 | 2 | 72 |
备注:柱前以初始流动相平衡10min。
取上述姜花跌打酒供试品溶液,缺红花阴性供试品溶液,羟基红花黄色素A标准品溶液以及空白溶剂,按照色谱条件进行测定,进样量为10μL,测定结果如下图2。结果显示:根据姜花跌打酒供试品溶液,缺红花阴性供试品溶液,羟基红花黄色素A标准品溶液以及空白溶剂的色谱峰比对确认,空白溶剂无干扰。缺红花阴性供试品溶液中无羟基红花黄色素A,表明姜花跌打酒全方中的指标成分色谱峰为羟基红花黄色素A。
实施例4提取工艺研究
米酒度数、浸泡时间考察
为提高实验效率,采用正交实验,参考L9(32)正交表,选择米酒度数、浸泡时间两个因素中三个水平组合,具体试验内容如下表3。
表3 L9(32)正交表
试验 | 米酒度数 | 浸泡时(天) |
1 | 28 | 15 |
2 | 28 | 30 |
3 | 28 | 45 |
4 | 40 | 15 |
5 | 40 | 30 |
6 | 40 | 45 |
7 | 52 | 15 |
8 | 52 | 30 |
9 | 52 | 45 |
备注:样品制备均平行制备2份。
根据实施例3的色谱条件,分别精密吸取10μL供试品溶液,经HPLC测定得出最佳工艺参数。检测结果见图3、表4和表5。另取适量药液,经水浴锅烘干,减压干燥得到浸膏,计算浸膏得率,结果见表5。
表4九种供试品溶液指标成分含量测定比较
表5九种供试品溶液浸膏得率比较
本试验依据正交试验表进行试验,考察米酒度数(A)、浸泡时间(B)对姜花跌打酒提取的影响,通过对得膏率和羟基红花黄色素A指标成分的含量分析,优化最佳提取工艺。
分别对每次试验各因素的第1水平的实验结果求和,即得Ⅰ;再对每次试验各因素的第2水平的实验结果求和,即得Ⅱ;对每次试验各因素的第3水平的实验结果求和,即得III。各水平平均值的最大值与最小值差即为R(极差),R值越大,所对应的因素越重要。得膏率和各指标成分结果(表6和表7)如下。
表6羟基红花黄色素A正交试验结果分析
结果(表6)显示:RB>RA,表明浸泡时间对羟基红花黄色素A的含量影响最大,其次为米酒度数。米酒度数:Ⅱ>Ⅲ>Ⅰ,浸泡时间:Ⅲ>Ⅰ≈Ⅱ,综合考虑经济效益与提取效率,羟基红花黄色素A的最优化提取工艺为:米酒度数为40°,浸泡30天。
表7得膏率正交实验结果分析
结果(表7)显示:RB>RA,表明浸泡时间对得膏率影响最大,其次为米酒度数,浸泡时间:Ⅲ≈Ⅱ>Ⅰ,米酒度数:Ⅲ≈Ⅱ>Ⅰ,综合考虑经济效益与提取效率,得膏率的最优化提取工艺为:米酒度数为40°,浸泡30天。
实施例5过滤工艺优化
称取姜黄22.5g,红花6.25g,威灵仙25g,醋乳香6.25g,独活12.5g,制川乌6.25g,醋没药6.25g,制草乌6.25g,细辛6.25g加1150ml 40°米酒,浸泡30天,浸泡结束后补足体积至1000mL,得到原液,分别取100mL过200目筛/100目筛/离心过滤,取滤液用0.22μm微孔滤膜滤过,作为供试品溶液。样品均平行制备2份。根据色谱条件,分别精密吸取10μL供试品溶液,经HPLC测定计算各指标成分含量(每克药材含指标成分质量,单位:mg/g),结果见图4和表8。另取适量药液,经水浴锅烘干,减压干燥得到浸膏,计算浸膏得率,结果见表9。
表8三种过滤方式指标成分含量测定比较
表9三种过滤方式浸膏得率比较
结果显示,100目筛网和200目筛网过滤的指标成分含量及浸膏得率均高于离心过滤,其中100目网筛过滤与200目网筛过滤指标成分含量及浸膏得率相近。建议选择100目或200目网筛作为过滤方法,具体药筛规格选择以实际生产为准。
实施例6中试产品-姜花跌打酒三批样品最优工艺验证
供试品溶液制备:称取姜黄2250g,红花625g,威灵仙2500g,醋乳香625g,独活1250g,制川乌625g,醋没药625g,制草乌625g,细辛625g加115000mL 40°米酒,浸泡30天,浸泡结束后补足体积至100000mL,过200目筛,取部分滤液用0.22μm微孔滤膜滤过,作为供试品溶液。备注:以上试验平行做三批(三批产品的信息见表10)。测定采用HPLC(表11),具体操作参数与实施例3同。
将所得的目标样品,经水浴锅浓缩至粘稠状后经电热恒温鼓风干燥箱干燥至恒重所得工艺制备的浸膏,精密称重,计算得率。
表10三批中试产品信息
表11含量测定结果
表12三批样品浸膏得率比较
从图5、表11和表12可知,姜花跌打酒的最优配置工艺为:称取姜黄2250g,红花625g,威灵仙2500g,醋乳香625g,独活1250g,制川乌625g,醋没药625g,制草乌625g,细辛625g加115000mL 40°米酒,浸泡30天,浸泡结束后补足体积至100000mL,过滤,分装,即得。
实施例7采用本发明姜花跌打酒治疗扭伤
观察病例共120例,均为2015年4月至2019年6月收治的跌打扭伤导致的血瘀、肢体肿胀患者,其中2015年23例,2016年25例,2017年25例,2018年22例,2019年25例。
给予姜花跌打酒外擦治疗,观察患者治疗后疼痛程度、肿胀消退状况。临床疗效判定主要依据症状评分情况制定临床疗效评价标准(表13)。(1)痊愈:患者疼痛、肿胀、瘀斑、功能障碍等症状、体征积分下降95%以上;(2)显效:患者疼痛、肿胀、瘀斑、功能障碍等症状、体征积分下降70~95%;(3)有效:患者疼痛、肿胀、瘀斑、功能障碍等症状、体征积分下降30~69%;(4)无效:患者疼痛、肿胀、瘀斑、功能障碍等症状、体征积分下降<30%。总有效率=痊愈率+显效率+有效率。
表13症状积分评估标准
视觉模拟评分(VAS)评估患者的疼痛程度,0~10分。0分表示无疼痛感,10分表示疼痛剧烈、患者已经到达疼痛忍受的边缘。临床观察表明,姜花跌打酒患者通过外擦姜花跌打酒,达到行气活血、散瘀止痛的功效,依据症状评分情况制定临床疗效评价标准,姜花跌打酒能够减轻患者VAS疼痛程度及肿胀程度,其中痊愈10例,显效53例,有效50例,无效7例,总治疗有效率94%。
Claims (16)
1.一种姜花跌打酒,其特征在于:按重量份计,将以下药材:姜黄22.5份、红花6.25份、威灵仙25份、醋乳香6.25份、独活12.5份、制川乌6.25份、醋没药6.25份、制草乌6.25份、细辛6.25份,经酒提取得到。
2.根据权利要求1所述姜花跌打酒,其特征在于:所述提取为将上述药材用酒浸泡,然后去渣,即得。
3.根据权利要求1所述姜花跌打酒,其特征在于:所述酒与药材的用量配比为:每97.5g药材用1150mL酒。
4.根据权利要求1所述姜花跌打酒,其特征在于:所述酒为米酒。
5.根据权利要求4所述姜花跌打酒,其特征在于:所述米酒度数为28~52°。
6.根据权利要求5所述姜花跌打酒,其特征在于:所述米酒度数为40°。
7.根据权利要求2所述姜花跌打酒,其特征在于:所述浸泡时间为15~45天。
8.根据权利要求7所述姜花跌打酒,其特征在于:所述浸泡时间为30天。
9.根据权利要求2所述姜花跌打酒,其特征在于:浸泡过程中搅拌至少一次。
10.根据权利要求2所述姜花跌打酒,其特征在于:所述去渣采用如下方式之一:100~200目筛网过滤或者离心。
11.根据权利要求2所述姜花跌打酒,其特征在于:去渣后的液体加米酒稀释,得到原液。
12.根据权利要求11所述姜花跌打酒,其特征在于:稀释后体积与药材的比例为:每97.5g药材稀释至1000mL。
13.根据权利要求12所述姜花跌打酒,其特征在于:所述稀释后原液,干燥,得到浸膏。
14.根据权利要求13所述姜花跌打酒,其特征在于:所述干燥为原液依次经烘干、减压干燥。
15.权利要求1~14任一项所述姜花跌打酒在制备活血祛瘀、通络止痛的药物中的用途。
16.权利要求1~14任一项所述姜花跌打酒在制备治疗跌打扭伤的药物中的用途。
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