CN113813344B - 一种治疗产妇关节痛、乳腺炎的组合物及其应用 - Google Patents
一种治疗产妇关节痛、乳腺炎的组合物及其应用 Download PDFInfo
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- CN113813344B CN113813344B CN202111141259.4A CN202111141259A CN113813344B CN 113813344 B CN113813344 B CN 113813344B CN 202111141259 A CN202111141259 A CN 202111141259A CN 113813344 B CN113813344 B CN 113813344B
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Abstract
本发明属于中药技术领域,尤其涉及一种治疗产妇乳腺炎的中药组合物,所述组合物的原料包括如下重量份数的组分:叶酸、黄芪、白芍、百合、熟地、夏枯草、菝葜、肉桂、茯苓、延胡索、洋甘菊提取物和淡竹叶提取物。其制备方法包括如下步骤:先将菝葜、百合、肉桂、白芍、黄芪加水进行水蒸气蒸馏提取,得挥发油和干膏粉1;然后将夏枯草、熟地、茯苓、延胡索加60‑70%乙醇回流提取得干膏粉2;最后将挥发油、干膏粉1、干膏粉2、洋甘菊提取物和淡竹叶提取物混合均匀,即得。该组合物对治疗盆腔***炎、产后关节痛、急性乳腺炎、缺乳等多种产后病功能均有较明显的改善作用。
Description
技术领域
本发明属于中药技术领域,尤其涉及一种治疗产妇关节痛、乳腺炎的中药组合物及其制备方法。
背景技术
产后病,也称月子病,月子病是指妇女在生产(包括小产)之后一个月内所受到的外感或内伤而引起的疾患,在月子里没有治愈而留下的病症。妇女在生产后,因筋骨腠理大开,身体虚弱,内外空疏,如果此时不慎使风寒侵入,或大怒大悲,或过多房事,都能引起月子病。临床表现:主要症状有全身肌肉关节麻木、疼痛、酸胀、怕风、怕冷、不耐劳累、屈伸不利为主要表现,严重者每当感受凉风之时就有凉风钻到骨头里的感觉,患者即使在暑热时节其患处也必须裹以厚被或棉衣才能感觉舒适。其症状特征是出凉汗、遇风、遇冷后症状加重,但受累关节和肌肉无红肿等典型的炎症表现。其他表现型尚有身体困乏、心烦急躁,失眠多梦等、部分患者尚有头痛、头晕、眼眶疼痛、眼睛干涩或多泪、视物模糊、体弱多病等征候。产后风湿看上去很像风湿病,但患病关节、肌肉无红肿,血沉、抗链球菌“O”以及产后风湿因子等常见的风湿病化验指标多正常,按常规抗风湿也无效果。此时如果治疗不及时或治疗不当,病邪长期滞留于体内,就会逐渐侵蚀腠理与筋骨经络组织,导致严重的筋骨病或形成难治脏腑病症。
产后病的病因:一是亡津失血,由于分娩用力、出汗和产伤或失血过多,使阴血骤虚,加之产后调养不慎,以致亡津失血,阳气浮散。二是瘀血内阻,产后元气亏虚,气血无力,气滞血虚;或产后百脉空虚,易感外邪,寒邪乘虚入体,血为寒凝,以导致恶露不畅,留而成瘀;或复因产前即有气郁血滞,以致瘀血内阻;或因产后余血浊液生瘀滞,或胞衣残留或感染邪毒,均可导致瘀血内阻,败血为患。三是外感六淫或饮食房劳所伤,产后气血俱伤,元气受损,正气减弱,即所谓“产后百脉空虚”,因身体虚弱,稍有感触,或产时、产后调理不慎,均可导致脏腑功能失常,变生百病。总之,产后病以“虚”、“瘀”为主,故有“产后多虚多瘀”之说。
常见的产后疾病有:产后腹痛、产后血晕、产后发热、产后恶露不下、产后恶露不净、产后头痛、身痛、产后关节痛、产后尿频、产后小便失禁、产后自汗、产后盗汗、产后缺乳、产后贫血、产后外阴疾病等。这些疾病不仅严重影响产妇的情绪与健康,而且使产妇不能正常哺乳宝宝。很多妇女生产完后患上产后病的几率很高,病症严重,需要引起重视,对产后疾病做到早预防、早发生、早治疗,对于确保产妇和宝宝的健康都有十分重要的意义。
目前用于产后疾病的中药见效慢,适应症少。
中国发明专利申请CN101129494A公开了治疗产后缺乳的一种中药组合物,所述组合物的原料药包括:生白芍1.5~6份、夜交藤1.5~6、沙参1.5~6份、夏枯草1.0~4份、蒲公英1.0~4份、刘寄奴0.1~2份、制穿山甲0.1~2份、海桐皮0.1~2份、净洋甘菊提取物0.1~2份、王不留行0.1~2份、通草0.1~2份和防风0.1~2份。该组合物通过养阴清热,祛风通络来治疗女性产后缺乳;但是对女性产后关节痛的治疗作用并未有报道。
发明内容
针对现有技术存在的不足,本发明欲解决的问题是提供一种中药组合物,兼具治疗盆腔***炎、产后关节痛、急性乳腺炎、缺乳等多种产后病功能,遵循中医辨证施治的原则,配方各味药相辅相成,另外,还可抗疲劳,且产品具有十分良好的稳定性,并且安全可靠,食用方式方便快捷。
本发明的目的是通过以下技术方案实现的:
一种治疗产后关节痛及乳腺炎的组合物,所述组合物的原料包括如下组分:叶酸、黄芪、白芍、百合、熟地、夏枯草、菝葜、肉桂、茯苓、延胡索、洋甘菊提取物和淡竹叶提取物。
优选地,所述组合物的原料包括如下重量份数的组分:叶酸0.01~0.02份、黄芪5-10份、白芍10-20份、百合5~10份、熟地5-7份、夏枯草5~10份、菝葜5~10份、肉桂10~20份、茯苓5-10份、延胡索5-10份、洋甘菊提取物5-7份和淡竹叶提取物5-10份。
优选地,所述组合物的原料包括如下重量份数的组分:叶酸0.01份、黄芪7份、白芍15份、百合8份、熟地6份、夏枯草8份、菝葜7份、茯苓8份、肉桂15份、延胡索7份、洋甘菊提取物6份和淡竹叶提取物7份。
本发明的再一目的是提供一种上述组合物的制备方法,包括如下步骤:
(1)将夏枯草、熟地、菝葜、百合、茯苓、延胡索、白芍和黄芪粉碎,过筛,备用;
(2)将菝葜、百合、肉桂、白芍和黄芪加水进行水蒸气蒸馏提取,得挥发油,过滤浓缩,干燥得干膏粉1;
(3)将夏枯草、熟地、茯苓、延胡索加60-70%乙醇回流提取,过滤浓缩,干燥得干膏粉2;
(4)将挥发油、干膏粉1、干膏粉2、洋甘菊提取物、淡竹叶提取物和叶酸混合均匀,即得。
优选地,步骤(1)中所述过筛为过10-65目筛。
优选地,步骤(2)中加水的质量为步骤(2)总药材质量的6-10倍;优选地,所述干燥为减压干燥,温度为60℃。
优选地,步骤(2)中所述提取的时间为3-5h,所述提取次数为1次。
优选地,步骤(2)中所述干燥为减压干燥,温度为60℃;优选地,所述提取的时间为3-5h。
优选地,步骤(3)中加入60-70%乙醇的量为步骤(3)总药材质量的5-8倍,所述提取的时间为1-2h,所述提取的次数为1-3次。
本发明的再一目的是提供上述组合物在制备治疗产妇关节痛、***和乳腺炎的产品中的应用。
本发明的有益效果:
(1)本发明组合物采用特定的中药组合物与叶酸配伍,研究表明,其在治疗产妇急性乳腺炎方面具有明显的治愈作用对产后盆腔***炎具有明显的治疗作用,对子宫肿胀具有显著的抑制作用,对产妇关节痛具有极大的缓解作用,与此同时具有一定的产奶作用;
(2)本发明组合物经特定的清热解毒、利水渗湿及补气血的等中药进行配伍,并对配比进行严格的限定,达到了对产妇温和治疗乳腺炎、***和关节炎的作用。经试验证实熟地和洋甘菊提取物协同增效作用明显;
(3)本发明对提取方法进行研究,发现分步提取要比传统的水煎剂及其他提取方法效果要明显增强,其他水煎剂可能将原本药味中的药效成分反应丢失,本发明的分煎要比其他形式的分煎和合煎效果好。
具体实施方式
下面结合实施例对本发明技术方案作进一步说明。
实施例1
本实施例祛斑组合物的原料及组成为:叶酸0.01份、夏枯草5份、熟地5份、菝葜5份、百合5份、肉桂10份、茯苓5份、延胡索5份、洋甘菊提取物5份、白芍10份、淡竹叶提取物5份和黄芪5份。
本发明的制备方法步骤如下:
(1)夏枯草、熟地、菝葜、百合、茯苓、延胡索、白芍、黄芪粉碎,过筛,备用;
(2)将菝葜、百合、肉桂、白芍、黄芪加水进行水蒸气蒸馏提取5h,得挥发油,过滤浓缩,干燥得干膏粉1;
(3)将夏枯草、熟地、茯苓、延胡索加5倍量的70%乙醇回流提取3次,每次提取1h,过滤,60℃减压浓缩,干燥得干膏粉2;
(4)将挥发油、干膏粉1、干膏粉2、淡竹叶提取物、洋甘菊提取物和叶酸混合均匀,即得中药组合物。
实施例2
本实施例祛斑组合物的原料及组成为:叶酸0.01份、夏枯草10份、熟地7份、菝葜10份、百合10份、肉桂20份、茯苓10份、延胡索10份、洋甘菊提取物7份、白芍20份、淡竹叶提取物10份和黄芪10份。
本发明的制备方法步骤如下:
(1)将夏枯草、熟地、菝葜、百合、茯苓、延胡索、白芍、黄芪粉碎,过筛,备用;
(2)将菝葜、百合、肉桂、白芍、黄芪加水进行水蒸气蒸馏提取3h,得挥发油,过滤浓缩,干燥得干膏粉1;
(3)将夏枯草、熟地、茯苓、延胡索加60%乙醇回流提取2h,过滤浓缩,干燥得干膏粉2;
(4)将挥发油、干膏粉1、干膏粉2、淡竹叶提取物、洋甘菊提取物和叶酸混合均匀,即得中药组合物。
实施例3
本实施例祛斑组合物的原料及组成为:叶酸0.02份、夏枯草8份、熟地6份、菝葜7份、百合8份、肉桂15份、茯苓8份、延胡索7份、白芍15份、淡竹叶提取物7份、洋甘菊提取物7份、黄芪7份。
本发明的制备方法步骤如下:
(1)将夏枯草、熟地、菝葜、百合、茯苓、延胡索、白芍、黄芪粉碎,过筛,备用;
(2)将菝葜、百合、肉桂、白芍、黄芪加水进行水蒸气蒸馏提取5h,得挥发油,过滤浓缩,干燥得干膏粉1;
(3)将夏枯草、熟地、茯苓、延胡索加65%乙醇回流提取2次,每次1.5h,过滤,合并滤液,60℃减压浓缩至相对密度为1.10(60℃下),干燥得干膏粉2;
(4)将挥发油、干膏粉1、干膏粉2、淡竹叶提取物、洋甘菊提取物和叶酸混合均匀,即得中药组合物。
对比例1
本对比例与实施例3的区别为:将熟地替换为海桐皮、将菝葜替换为土鳖虫,将百合替换为沙参,其余与实施例3保持一致。
对比例2
本对比例与实施例3的区别为:将洋甘菊提取物去掉,将淡竹叶提取物调整为14份,其余与实施例3保持一致。
对比例3
本对比例与实施例3的区别为:将淡竹叶提取物去掉,将洋甘菊提取物调整为14份,其余与实施例3保持一致。
对比例4
本对比例采用实施例3的原料及配比,其制备方法如下:
(1)将夏枯草、熟地、菝葜、百合、茯苓、延胡索、白芍、黄芪粉碎,过筛,备用;
(2)将夏枯草、熟地、菝葜、百合、黄芪加水提取2次,每次提取2h,合并滤液,浓缩,干燥得干膏粉1;
(3)将茯苓、肉桂、白芍、延胡索加95%乙醇回流提取,过滤浓缩,干燥得干膏粉2;
(4)将挥发油、干膏粉1、干膏粉2、淡竹叶提取物、洋甘菊提取物和叶酸混合均匀,即得中药组合物。
效果例1本发明对金黄色葡萄球菌所致乳腺炎小鼠模型的抗炎作用
1.1动物分组及给药方式
6-8周龄雌性BALB/c小鼠,体重为40-45g,购于北京维通利华实验动物技术有限公司。按照随机数表法随机分组,分别为空白对照组、模型对照组、实施例1-3组、对比例1-4组。每组10只。实施例1-3与对比例1-4组灌胃给药,每天1次,连续给药7天,给药0.3g/kg,给药体积为0.1mL/10g。空白对照组、模型对照组分别给予等量的蒸馏水。
1.2金黄色葡萄球菌致乳腺炎动物模型的制备
分娩后7d的初产、泌乳母鼠,腹腔注射乌拉坦麻醉,对腹部乳腺进行75%酒精消毒。剪去***尖端约1mm左右,露出乳导管。用100μL微量注射器通过导管灌注金黄色葡萄球菌,每个乳腺注射100μL菌重悬液,以制造乳腺炎模型。其中金黄色葡萄球菌液浓度为2×108CFU/μL。
1.3本发明组合物对乳腺炎小鼠的抗炎作用
各组动物模型给药7天结束后,禁食16h。取乳腺组织,以质量体积比为1:5加入灭菌生理盐水,研磨成匀浆,取0.8ml匀浆液涂布于高盐甘露醇培养基上,37℃培养24h后用平板计数法测定金黄色葡萄球菌数,将其余匀浆液以10000r/min高速离心20mi,用ELISA检测其中肿瘤坏死因子(TNF-a)。
1.4结果与分析
(1)给药后各组乳腺组织中金黄色葡萄球菌含量及治疗乳腺炎的治愈率见表1。
表1组乳腺组织中金黄色葡萄球菌的含量
注:同一列不同字母之间差异具有显著性,P<0.05。
(2)各组小鼠乳腺组织中TNF-α含量的检测结果见表2。
表2乳腺组织中TNF-α含量
注:同一列不同字母之间差异具有显著性,P<0.05。
效果例2本发明组合物对雌性大鼠***的治疗作用
2.1动物分组及给药方式
雌性大鼠,体重为200±20g,购于北京维通利华实验动物技术有限公司,按照随机数表法随机分组,分别为空白组、模型组、实施例1-3组、对比例1-4组。每组10只。实施例1-3与对比例1-4组灌胃给药,每天1次,连续给药7天,给药0.2g/kg,给药体积为1mL/100g。空白对照组、模型对照组分别给予等量的蒸馏水。
2.2***大鼠模型制备
将除空白组以外的各组大鼠与下腹部剪一小口,暴露并固定子宫,用注射针尖刺伤右侧子宫内膜组织,并将大肠杆菌液0.2ml浓度为6×106注入子宫,缝合伤口,正常喂养两周后,灌胃给药,每日一次,连续7天。
2.3本发明组合物对雌性大鼠***的治疗作用
末次给药后禁食1天,处死动物,取两侧子宫,称重,并计算肿胀率和抑制率。
其中肿胀度为两侧子宫重量之差;肿胀率为肿胀度与左侧子宫的比值;抑制率为给药组和模型组肿胀率之差与模型组肿胀率的比值。结果见表3。
表3各组对大鼠***子宫肿胀抑制率的作用
组别 | 肿胀度mg | 肿胀率% | 抑制率% |
空白组 | - | - | - |
模型组 | 0.097±0.010<sup>a</sup> | 48.20±3.16<sup>a</sup> | - |
实施例1 | 0.021±0.036<sup>b</sup> | 10.57±1.61<sup>b</sup> | 78.07 |
实施例2 | 0.018±0.045<sup>b</sup> | 9.02±2.49<sup>b</sup> | 81.28 |
实施例3 | 0.016±0.027<sup>b</sup> | 8.33±3.46<sup>b</sup> | 82.71 |
对比例1 | 0.033±0.019<sup>c</sup> | 16.50±1.27<sup>c</sup> | 65.76 |
对比例2 | 0.028±0.017<sup>c</sup> | 14.00±1.33<sup>c</sup> | 70.95 |
对比例3 | 0.029±0.023<sup>c</sup> | 14.51±2.67<sup>c</sup> | 69.89 |
对比例4 | 0.031±0.035<sup>c</sup> | 15.64±5.07<sup>c</sup> | 67.55 |
注:同一列不同字母之间差异具有显著性,P<0.05。
效果例3本发明组合物治疗女性产后关节痛的临床研究
试验样品:实施例3组,对比例4组;
试验设计及分组:选择自愿参加的产后关节痛志愿者50名,年龄24-38岁。分组时尽可能考虑影响结果的主要因素如户外活动情况、性别、年龄等,进行均衡性检验,以保证组间的可比性。
试验方法:各组志愿者口服实施例3和对比例4制备的本发明组合物,2g/次,一日一次,连续服用1个月,试用期间不改变原来的饮食习惯。
功效指标:
治愈:服药结束后,关节可以自由活动,身体各关节及腰背未有痛感;
有效:关节痛、腰痛相比服药前明显缓解;
无效:关节痛、腰痛相比服药前未有改善。
结果分析:各组志愿者关节痛改善情况见表4。
表4:各组志愿者关节痛改善情况
上述详细说明是针对本发明其中之一可行实施例的具体说明,该实施例并非用以限制本发明的专利范围,凡未脱离本发明所为的等效实施或变更,均应包含于本发明技术方案的范围内。
Claims (9)
1.一种治疗产后关节痛及乳腺炎的组合物,其特征在于,所述组合物的原料由如下重量份数的组分组成:叶酸0.01~0.02份、黄芪5-10份、白芍10-20份、百合5~10份、熟地5-7份、夏枯草5~10份、菝葜5~10份、肉桂10~20份、茯苓5-10份、延胡索5-10份、洋甘菊提取物5-7份和淡竹叶提取物5-10份;
所述的组合物的制备方法,包括如下步骤:
(1)将夏枯草、熟地、菝葜、百合、茯苓、延胡索、白芍和黄芪分别粉碎,过筛,备用;
(2)将菝葜、百合、肉桂、白芍和黄芪加水进行水蒸气蒸馏提取,得挥发油,提取液过滤浓缩,干燥得干膏粉1;
(3)将夏枯草、熟地、茯苓、延胡索加60-70%乙醇回流提取,提取液过滤浓缩,干燥得干膏粉2;
(4)将挥发油、干膏粉1、干膏粉2、洋甘菊提取物、淡竹叶提取物和叶酸混合均匀,即得。
2.根据权利要求1所述的组合物,其特征在于,所述组合物的原料由如下重量份数的组分组成:叶酸0.01份、黄芪7份、白芍15份、百合8份、熟地6份、夏枯草8份、菝葜7份、肉桂15份、茯苓8份、延胡索7份、洋甘菊提取物6份和淡竹叶提取物7份。
3.根据权利要求1-2任意一项所述的组合物的制备方法,包括如下步骤:
(1)将夏枯草、熟地、菝葜、百合、茯苓、延胡索、白芍和黄芪分别粉碎,过筛,备用;
(2)将菝葜、百合、肉桂、白芍和黄芪加水进行水蒸气蒸馏提取,得挥发油,提取液过滤浓缩,干燥得干膏粉1;
(3)将夏枯草、熟地、茯苓、延胡索加60-70%乙醇回流提取,提取液过滤浓缩,干燥得干膏粉2;
(4)将挥发油、干膏粉1、干膏粉2、洋甘菊提取物、淡竹叶提取物和叶酸混合均匀,即得。
4.根据权利要求3所述的制备方法,其特征在于,步骤(1)中所述过筛为过10-65目筛。
5.根据权利要求3所述的制备方法,其特征在于,步骤(2)中加水的质量为步骤(2)总药材质量的6-10倍;所述干燥为减压干燥,温度为60℃。
6.根据权利要求3所述的制备方法,其特征在于,步骤(2)中所述提取的时间为3-5h,所述提取次数为1次。
7.根据权利要求3所述的制备方法,其特在于,步骤(2)中所述浓缩为减压浓缩,温度为60℃。
8.根据权利要求3所述的制备方法,其特征在于,步骤(3)中加入60-70%乙醇的量为步骤(3)总药材质量的5-8倍,所述提取的时间为1-2h,所述提取的次数为1-3次。
9.根据权利要求1-2任意一项所述的组合物在制备治疗产妇关节痛、***和乳腺炎的药品中的应用。
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