CN102631496B - Traditional Chinese medicine composition capable of improving immunity and resisting fatigue - Google Patents
Traditional Chinese medicine composition capable of improving immunity and resisting fatigue Download PDFInfo
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Abstract
本发明涉及一种提高人体机体免疫力、抗疲劳的保健品组合物,本组合物的有效组分由人参、藏红花、海马和螺旋藻组成。本发明具有增强机体免疫能力和抗疲劳、强身健体和舒筋活络之功效,疗效显著,作用温和。The invention relates to a health product composition for improving human body immunity and anti-fatigue. The effective components of the composition are composed of ginseng, saffron, hippocampus and spirulina. The invention has the effects of enhancing the body's immune ability and anti-fatigue, strengthening the body and relaxing tendons and activating collaterals, with remarkable curative effect and mild effect.
Description
技术领域 technical field
本发明涉及一种具有协同提高人体免疫力、抗疲劳和舒筋活络功能的中药组合物。The invention relates to a traditional Chinese medicine composition which has the functions of synergistically improving human immunity, anti-fatigue and relaxing tendons and activating collaterals.
技术背景 technical background
随着社会经济的不断发展,人们生活水平的日益提高,人们对健康的管住程度逐渐增加,生活在现今的都是,我们每个人的健康都容易收到许多外部威胁,包括空气污染、视频污染、环境污染、工作压力、经济压力、细菌病毒、饮食不当等等。再者,由于都市工作、生活节奏的变化,很容易使人产生慢性疲劳,即亚健康状态,所有这些不利健康的因素,通常会令人精神不能集中、记忆力衰退、经常怠倦、提早衰老。因此提高自身免疫力,增强对抗各种不利健康因素的能力至关重要。With the continuous development of social economy and the improvement of people's living standards, people's control over their health is gradually increasing. In today's world, each of us is vulnerable to many external threats to our health, including air pollution, video Pollution, environmental pollution, work pressure, economic pressure, bacteria and viruses, improper diet and so on. Furthermore, due to urban work and changes in the rhythm of life, it is easy to cause chronic fatigue, that is, a sub-health state. All these unhealthy factors usually cause people to be unable to concentrate, memory decline, frequent slackening, and premature aging. Therefore, it is very important to improve self-immunity and enhance the ability to resist various adverse health factors.
目前市面上的用于增强机体免疫力的保健品种类繁多,但作用效果参差不齐。At present, there are many kinds of health care products on the market for enhancing the body's immunity, but the effects are uneven.
发明内容 Contents of the invention
本发明要解决的技术问题是:本发明的目的是提供一种增强机体免疫力、抗疲劳和舒筋活络功能的中药组合物。通过以人参、藏红花、海马和螺旋藻为主要中药材,通过相互的协同增效作用,以期提高抗病能力,增强免疫效果,缓解体力疲劳和舒筋活络功能的工程。The technical problem to be solved by the present invention is: the purpose of the present invention is to provide a traditional Chinese medicine composition that enhances the immunity of the body, resists fatigue and relaxes tendons and activates collaterals. With ginseng, saffron, hippocampus and spirulina as the main Chinese medicinal materials, through mutual synergistic effect, it is expected to improve disease resistance, enhance immune effect, relieve physical fatigue and relax tendons and activate collaterals.
为解决上述技术问题,本发明提供一种具有协同提高人体免疫力、抗疲劳和舒筋活络的保健品组合物,其特征在于所述的组合物包含有效组分一种具有协同增效提高人体机体免疫力、抗疲劳和具有舒筋活络功能的保健品组合物,其特征在于所述的组合物包含人参、藏红花、海马、螺旋藻。有效组分中按重量份计:人参4-65份,藏红花2-55份,海马5-60份,螺旋藻5-65份。优选,人参8-50份,藏红花4-40份,海马7-45份,螺旋藻7-50份。In order to solve the above-mentioned technical problems, the present invention provides a health product composition that synergistically improves human immunity, anti-fatigue, and relaxes tendons and collaterals. The health product composition for body immunity, anti-fatigue and function of relaxing tendons and activating collaterals is characterized in that the composition contains ginseng, saffron, hippocampus and spirulina. The effective components are calculated by weight: 4-65 parts of ginseng, 2-55 parts of saffron, 5-60 parts of hippocampus, and 5-65 parts of spirulina. Preferably, 8-50 parts of ginseng, 4-40 parts of saffron, 7-45 parts of hippocampus, and 7-50 parts of spirulina.
优选,各组分的重量配比为:人参65份,藏红花55份,海马60份,螺旋藻65份。Preferably, the weight ratio of each component is: 65 parts of ginseng, 55 parts of saffron, 60 parts of hippocampus, and 65 parts of spirulina.
优选各组分的重量配比为:人参4份,藏红花2份,海马5份,螺旋藻5份。Preferably, the weight ratio of each component is: 4 parts of ginseng, 2 parts of saffron, 5 parts of hippocampus, and 5 parts of spirulina.
优选各组分的重量配比为:人参8份,藏红花4份,海马7份,螺旋藻7份。Preferably, the weight ratio of each component is: 8 parts of ginseng, 4 parts of saffron, 7 parts of hippocampus, and 7 parts of spirulina.
优选,各组分的重量配比为:人参50份,藏红花40份,海马45份,螺旋藻50份。Preferably, the weight ratio of each component is: 50 parts of ginseng, 40 parts of saffron, 45 parts of hippocampus, and 50 parts of spirulina.
本发明采用的各组分的药用及保健性能为:The medicinal and health-care properties of each component that the present invention adopts are:
人参:本发明中所涉及的人参是指伞形目五加科人参族人参属的一种多年生草本植物的总称,包括红参、白参、西洋参(花旗参)、条参、党参以及太子参等。本发明中的人参包含经过加工提炼后人参提取物、经研磨粉碎后人参精粉或者是人参生长过程中的各种形态。具有甘微苦,性温,入脾、肺经,大补元气,固脱生津,安神。治劳伤虚损,食少,倦怠,反胃吐食,大便滑泄,虚咳喘促,自汗暴脱,惊悸,健忘,眩晕头痛,阳痿,尿频,消渴,妇女崩漏,小儿慢惊,及久虚不复,一切气血津液不足之症。Ginseng: The ginseng involved in the present invention refers to the general name of a kind of perennial herb of the genus Panax of the Araliaceae Panax family of Umbelliferae, including red ginseng, white ginseng, American ginseng (American ginseng), bar ginseng, Codonopsis ginseng and heterophylla wait. The ginseng in the present invention includes ginseng extract after processing and refining, ginseng fine powder after grinding and crushing or various forms during the growth process of ginseng. Has sweet and slightly bitter, warm in nature, enters the spleen and lung meridians, greatly invigorates vital energy, solidifies and promotes fluid production, and calms the nerves. Treatment of fatigue, fatigue, lack of appetite, lassitude, nausea and vomiting, slippery stool, cough and shortness of breath, spontaneous sweating, palpitations, forgetfulness, dizziness and headache, impotence, frequent urination, thirst, metrorrhagia in women, chronic shock in children , and long-term deficiency, all symptoms of insufficient qi, blood and body fluid.
藏红花:本发明所涉及到的藏红花(又称番红花、西红花),是一种百合目鸢尾科番红花属的多年生花卉。本发明中的藏红花包含研磨粉碎后的藏红花精粉、通过各种工艺加工获得藏红花提取物或者是藏红花的其他加工形态。临床上藏红花用于治疗人体多种慢性疾病,通过其活血化瘀、抗菌消炎的功效,增强机体耐力,增强淋巴细胞增殖反应,以此来提高机体细胞免疫和体液免疫,起到调整人体气机运行,平衡人体阴阳的作用。Saffron: Saffron (also known as Saffron, Saffron) involved in the present invention is a perennial flower of the genus Saffron in the family Iridaceae. The saffron in the present invention includes ground and pulverized saffron powder, saffron extract obtained through various processes, or other processed forms of saffron. Clinically, saffron is used to treat a variety of chronic diseases in the human body. Through its effects of promoting blood circulation, removing blood stasis, antibacterial and anti-inflammatory effects, it can enhance the body's endurance and enhance the lymphocyte proliferation response, so as to improve the body's cellular immunity and humoral immunity, and play a role in adjusting the body's Qi mechanism. Run, balance the role of Yin and Yang in the human body.
海马:属于鱼纲,海龙目,海马属动物的总称,属于硬骨鱼。海马是一种经济价值较高的名贵中药,含氨基酸及蛋白质、脂肪酸、甾体和无机元素。其性甘、温,入肝、肾经,补肾壮阳,调气活血,治阳痿,遗尿,虚喘,难产,疔疮肿毒,并具有强身健体、补肾壮阳、舒筋活络、消炎止痛、镇静安神、止咳平喘等药用功能,特别是对于治疗神经系统的疾病更为有效。Seahorse: It belongs to the class of fish, the order of sea dragons, and the general name of animals in the genus hippocampus, which belongs to bony fish. Hippocampus is a famous and precious traditional Chinese medicine with high economic value, containing amino acids, proteins, fatty acids, steroids and inorganic elements. It is sweet and warm in nature, enters the liver and kidney meridians, nourishes the kidney and strengthens yang, regulates qi and activates blood circulation, treats impotence, enuresis, dyspnea due to deficiency, dystocia, boils and swollen toxins, and has the functions of strengthening the body, tonifying the kidney and strengthening yang, relaxing tendons and activating collaterals, reducing inflammation and relieving pain, Medicinal functions such as calming the nerves, relieving cough and relieving asthma, are especially effective in treating diseases of the nervous system.
螺旋藻:属于蓝藻门、蓝藻纲、藻殖段目、颤藻科、螺旋藻属中的一类低等植物,主要包括极大螺旋藻、钝顶螺旋藻。本发明中的螺旋藻包含经过加工提炼后螺旋藻提取物或者是螺旋藻的其他加工形态。苦咸,寒,入脾、肺、肾经,抗菌,抗辐射,降低胆固醇,增强免疫力。Spirulina: It belongs to a class of lower plants in Cyanophyta, Cyanophyceae, Spirulina, Oscillatoriaceae, and Spirulina, mainly including Spirulina maxima and Spirulina platensis. The spirulina in the present invention contains processed and refined spirulina extract or other processed forms of spirulina. Bitter and salty, cold, enters the spleen, lung, and kidney meridian, antibacterial, anti-radiation, lowers cholesterol, and enhances immunity.
本发明中“协同提高”的定义可以理解为几种药材组合后,其药效相对于单独使用时的提高;药效更为持久;组合物在新的防治或保健领域产生意想不到的效果。The definition of "synergistic improvement" in the present invention can be understood as the combination of several medicinal materials, the improvement of their drug effect compared to when used alone; the drug effect is more durable; the composition produces unexpected effects in new prevention or health care fields.
本发明的组分中,人参大补元气、劳伤虚损,安神益智。藏红花味甘性平,散郁开结,抗疲劳,解郁安神。海马具有强身健体、提高免疫机能、舒筋活络、镇静安神功能。螺旋藻具有增强机体免疫功能,提高有效性。Among the components of the present invention, ginseng greatly invigorates the vital energy, relieves fatigue and insufficiency, calms the nerves and improves intelligence. Saffron is sweet in taste and flat in nature, dissipates stagnation and relieves knots, resists fatigue, relieves stagnation and calms the nerves. The hippocampus has the functions of strengthening the body, improving immune function, relaxing tendons and activating collaterals, and calming the nerves. Spirulina can enhance the immune function of the body and improve the effectiveness.
发明人通过试验发现,本发明的组合物在提高人体免疫力、抗疲劳的病理上具有显著的协同增效作用,如本发明的组合物具有提高人体免疫力、抗疲劳的功效外,同时具有舒筋活络的功效。本发明的组合物对人体某些机能的有益作用效果是单剂所无法比拟的。The inventors have found through experiments that the composition of the present invention has a significant synergistic effect on improving human immunity and anti-fatigue pathology, such as the composition of the present invention. The effect of relaxing tendons and activating collaterals. The beneficial effect of the composition of the present invention on certain functions of the human body is incomparable to that of a single dose.
本发明的组合物,可以直接研磨成粉或经过本领域常规提取技术如水提醇沉法或醇提水沉法的提取精制作为治疗的组合物的活性成分。所述活性成分可以与药学上可接受的载体或赋形剂组合制成各种药学剂型,如呈多颗粒状的片剂、颗粒剂、胶囊,或口服液等。根据使用需要,本发明的组合物也可以加工成缓释制剂或速释制剂。其中所述的药学可接受的载体或赋形剂根据不同的剂型而选择。所用的这些载体或赋形剂对于制药领域的普通技术人员是可以决定的。The composition of the present invention can be directly ground into powder or extracted and refined by conventional extraction techniques in the field such as water extraction and alcohol precipitation method or alcohol extraction and water precipitation method as the active ingredient of the therapeutic composition. The active ingredients can be combined with pharmaceutically acceptable carriers or excipients to prepare various pharmaceutical dosage forms, such as multi-granular tablets, granules, capsules, or oral liquids. According to the needs of use, the composition of the present invention can also be processed into sustained-release preparations or immediate-release preparations. The pharmaceutically acceptable carriers or excipients mentioned therein are selected according to different dosage forms. These carriers or excipients to be used can be determined by those of ordinary skill in the pharmaceutical art.
口服液的制备方法,可以但不仅局限于下列一种,如将有效组分混合后,加水煎煮,将煎煮液过滤,得到溶液,将所得溶液浓缩得到浸膏,然后所得浸膏溶于浸膏重量5-10倍重量的浓度为按照重量计95%的乙醇水溶液中,搅拌混合,定量分装,得到口服液制剂。The preparation method of the oral liquid can be, but not limited to, the following one, such as mixing the effective components, adding water to decoct, filtering the decoction to obtain a solution, concentrating the obtained solution to obtain an extract, and then dissolving the obtained extract in The concentration of the extract is 5-10 times of the weight by weight in 95% ethanol aqueous solution, stirred and mixed, and quantitatively distributed to obtain the oral liquid preparation.
片剂的制备方法是将有效组分混合物过筛,在与制备片剂常用的助剂粉碎、充分混合均匀后,过40-80目筛网,通过压片将干粉直接机压制成片剂。The preparation method of the tablet is to sieve the active component mixture, pulverize and fully mix with the commonly used auxiliary agent for preparing the tablet, pass through a 40-80 mesh sieve, and directly press the dry powder into a tablet by tablet pressing.
胶囊制剂的制备工艺可以为,将有效组分混合物过筛,在与制备片剂常用的助剂粉碎、充分混合均匀后,过40-80目筛网,通过制粒,干燥,整粒等工序后灌囊,抛光,包装,即得成品。The preparation process of the capsule preparation can be as follows: sieve the mixture of active components, pulverize and fully mix with the auxiliary agents commonly used in the preparation of tablets, pass through a 40-80 mesh sieve, and pass through granulation, drying, granulation and other processes After filling, polishing and packaging, the finished product is obtained.
本发明的有益效果是:The beneficial effects of the present invention are:
本发明药物组合物具有益气固表,提高机体免疫力作用,本发明药物不温不燥,具有健脾益胃、舒筋活络、散湿除痹、增强免疫力、抗疲劳、抗病毒、强壮身体之功效,疗效显著,作用温和,无毒副作用。该药物的生产工艺简单、易于服用,是一种理想的提高人体免疫、抗疲劳的药物。The pharmaceutical composition of the present invention has the functions of replenishing qi and consolidating the surface, and improving the immunity of the body. The effect of strengthening the body, the curative effect is remarkable, the effect is mild, and there is no toxic side effect. The medicine has a simple production process and is easy to take, and is an ideal medicine for improving human immunity and anti-fatigue.
优选实施方案的详细描述DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
以下实施例说明了本发明的各方面内容。他们仅用以说明,并不限定本发明的范围。The following examples illustrate aspects of the invention. They are for illustration only and do not limit the scope of the present invention.
实施例1:含有人参与藏红花、海马和螺旋藻苷的胶囊剂Example 1: Capsules containing ginseng, saffron, hippocampus and spirulina
人参65克,藏红花55克,海马60克,螺旋藻65克。65 grams of ginseng, 55 grams of saffron, 60 grams of hippocampus, and 65 grams of spirulina.
将上述中药加水浸泡40分钟,水面高于原料重要,加入水总量为总药量的8倍,沸后小火沸态,维持液面高于原料中药高度,煎煮2小时,过滤取滤液,再加入总药量的6倍的水,沸后小火沸态,维持液面高于原料中药高度,煎煮2小时,过滤合并两次滤液,经减压浓缩(压力0.06MPa,温度65℃)至干膏,粉碎,经300目筛,加入总重量2%的硬脂酸镁,装入胶囊即可。Soak the above traditional Chinese medicine in water for 40 minutes, the water level is higher than the raw material, the total amount of water added is 8 times of the total medicine amount, after boiling, it is in a low heat boiling state, keep the liquid level higher than the raw material Chinese medicine, decoct for 2 hours, filter to get the filtrate , then add 6 times the water of the total amount of medicine, after boiling, keep the liquid level higher than the height of the raw material traditional Chinese medicine, decoct for 2 hours, filter and merge the filtrate twice, concentrate under reduced pressure (pressure 0.06MPa, temperature 65 ℃) to dry paste, pulverize, through a 300 mesh sieve, add 2% magnesium stearate of total weight, and pack into capsules.
实施例2:含有人参与藏红花、海马和螺旋藻的片剂Example 2: Tablets containing ginseng, saffron, hippocampus and spirulina
人参4克,藏红花2克,海马5克,螺旋藻5克。4 grams of ginseng, 2 grams of saffron, 5 grams of hippocampus, and 5 grams of spirulina.
将上述中药材干燥粉碎成粗粉,以50-60%的乙醇为溶媒在60-70℃回流提取,提取液在出去乙醇后,低温浓缩成稠浸膏,干燥,粉碎成细粉,过筛,混匀,制粒,压制成片剂。Dry and pulverize the above-mentioned Chinese herbal medicines into coarse powder, use 50-60% ethanol as a solvent to reflux extract at 60-70°C, after the ethanol is removed from the extract, concentrate at low temperature to form a thick extract, dry, pulverize into fine powder, and sieve , mixed, granulated, compressed into tablets.
实施例3:含有人参与藏红花、海马和螺旋藻苷的胶囊剂Example 3: Capsules containing ginseng, saffron, hippocampus and spirulina
人参8克,藏红花4克,海马7克,螺旋藻7克。8 grams of ginseng, 4 grams of saffron, 7 grams of hippocampus, and 7 grams of spirulina.
将上述中药材干燥粉碎成细粉,过筛,混匀,装入硬将囊壳,制得本发明的中药组合物。The above-mentioned Chinese medicinal materials are dried and pulverized into fine powder, sieved, mixed evenly, and packed into hard capsule shells to obtain the traditional Chinese medicine composition of the present invention.
实施例4:含有人参与藏红花、海马和螺旋藻苷的口服液Embodiment 4: Oral liquid containing ginseng saffron, hippocampus and spirulina
人参50克,藏红花40克,海马45克,螺旋藻50克。50 grams of ginseng, 40 grams of saffron, 45 grams of hippocampus, and 50 grams of spirulina.
将上述组分混合后,加水煎煮,将煎煮液过滤,得到溶液,将所得溶液浓缩得到浸膏,然后所得浸膏溶于浸膏重量5-10倍重量的浓度为按照重量计95%的乙醇水溶液中,搅拌混合,定量分装,得到口服液制剂。After mixing the above components, add water to decoct, filter the decoction to obtain a solution, concentrate the obtained solution to obtain an extract, and then dissolve the obtained extract in 5-10 times the weight of the extract to a concentration of 95% by weight ethanol aqueous solution, stirred and mixed, and quantitatively distributed to obtain oral liquid preparations.
实施例5:含有人参与藏红花、海马和螺旋藻的片剂Example 5: Tablets containing ginseng, saffron, hippocampus and spirulina
人参18克,藏红花10克,海马25克,螺旋藻20克18 grams of ginseng, 10 grams of saffron, 25 grams of hippocampus, 20 grams of spirulina
将上述中药材干燥粉碎成粗粉,以50-60%的乙醇为溶媒在60-70℃回流提取,提取液在出去乙醇后,低温浓缩成稠浸膏,干燥,粉碎成细粉,过筛,混匀,制粒,压制成片剂。Dry and pulverize the above-mentioned Chinese herbal medicines into coarse powder, use 50-60% ethanol as a solvent to reflux extract at 60-70°C, after the ethanol is removed from the extract, concentrate at low temperature to form a thick extract, dry, pulverize into fine powder, and sieve , mixed, granulated, compressed into tablets.
试验实施例1:本发明对小鼠免疫功能的影响试验Test Example 1: The present invention's impact test on mouse immune function
1、检测产品:实施例1、实施例2、实施例3、实施例4和实施例5的产品为样品。1. Testing products: the products of embodiment 1, embodiment 2, embodiment 3, embodiment 4 and embodiment 5 are samples.
2、检测用动物:小鼠、大鼠,雌雄各半。2. Animals for testing: mice, rats, half male and half male.
3、检验依据:卫生部《保健食品检验与评价技术规范》(2003版)3. Inspection basis: Ministry of Health "Technical Specifications for Inspection and Evaluation of Health Food" (2003 Edition)
4、检测项目:4. Test items:
4.1体重,胸腺/体重比值,脾脏/体重比值4.1 Body weight, thymus/body weight ratio, spleen/body weight ratio
4.2comA诱导的小鼠脾淋巴细胞转化实验(MTT法)4.2 comA-induced mouse spleen lymphocyte transformation experiment (MTT method)
4.3二硝基氟苯诱导的小鼠迟发性变态反应(DTH)4.3 Dinitrofluorobenzene-induced delayed hypersensitivity (DTH) in mice
4.4抗体生成细胞检测(Jerne改良玻片法)4.4 Detection of antibody-producing cells (Jerne's modified slide method)
4.5血清溶血素试验4.5 Serum hemolysin test
4.6小鼠碳廓清试验4.6 Carbon clearance test in mice
4.7小鼠腹腔巨噬细胞吞噬鸡红细胞实验(滴片法)4.7 Mouse peritoneal macrophages phagocytosis experiment of chicken red blood cells (drop method)
4.8NK细胞活性测定4.8 NK cell activity assay
5、检测结果及判定5. Test results and judgment
5.1实验动物的体重,胸腺/体重比值,脾脏/体重比值的检测结果表明,在本试验条件下,所实样品在500、1000、3000mg\kg(分别相当于成人每日每千克体重推荐摄入量的5倍、10倍、30倍)剂量时,五组样品对动物的体重,胸腺/体重比值,脾脏/体重比值均未见明显影响。5.1 The test results of body weight, thymus/body weight ratio and spleen/body weight ratio of experimental animals show that under the conditions of this test, the actual samples are 500, 1000, 3000 mg/kg (respectively equivalent to the recommended daily intake per kilogram of body weight for adults) During 5 times, 10 times, 30 times of dosage) dosage, five groups of samples have no obvious influence on the body weight of animal, thymus/body weight ratio, spleen/body weight ratio.
5.2comA诱导的小鼠脾淋巴细胞转化实验(MTT法)结果表明,在本实验条件下,各剂量组光密度差值与溶剂对照组值比较,均无统计学显著性差异(P>0.05)。提示样品无增强小鼠淋巴细胞增殖能力。5.2comA-induced mouse spleen lymphocyte transformation experiment (MTT method) showed that under the experimental conditions, there was no statistically significant difference between the optical density difference of each dose group and the solvent control group (P>0.05) . It suggested that the sample did not enhance the proliferation ability of mouse lymphocytes.
5.3二硝基氟苯诱导的小鼠迟发性变态反应(DTH)结果表明,在本实验条件下,各剂量组光密度差值与溶剂对照组值比较,均无统计学显著性差异(P>0.05)。提示样品具有增强二硝基氟苯引起的小鼠迟发性变态反应作用。试验剂量组为阳性,提示样品可增强小鼠细胞免疫功能。5.3 The results of delayed hypersensitivity (DTH) in mice induced by dinitrofluorobenzene showed that under the experimental conditions, the difference in optical density of each dose group was compared with the value of the solvent control group, and there was no statistically significant difference (P >0.05). It is suggested that the sample has the effect of enhancing the delayed allergic reaction induced by dinitrofluorobenzene in mice. The test dose group was positive, suggesting that the sample can enhance the cellular immune function of mice.
5.4抗体生成细胞检测(Jerne改良玻片法)结果表明,在本试验条件下,各剂量组溶血空斑数均高于溶剂对照组值,且低、中剂量组有统计学显著差异(P<0.05),提示样品具有增强小鼠产生抗体生产细胞的能力。5.4 The results of antibody-producing cell detection (Jerne's modified glass slide method) showed that under the test conditions, the number of hemolytic plaques in each dose group was higher than that of the solvent control group, and there was a statistically significant difference between the low and middle dose groups (P< 0.05), suggesting that the sample has the ability to enhance the ability of mice to produce antibody-producing cells.
5.5血清溶血素试验结果表明,在本实验条件下,各剂量组小鼠血清半数溶血值与溶剂对照组值比较,均无统计学显著差异(P>0.05)。提示样品无增强小鼠产生血清溶血素的能力。一项试验的剂量组为阳性,提示样品可增强小鼠体液免疫功能。5.5 The results of the serum hemolysin test showed that under the experimental conditions, there was no statistically significant difference between the half hemolysis value of the mouse serum in each dose group and the value of the solvent control group (P>0.05). It suggested that the sample did not enhance the ability of mice to produce serum hemolysin. The dosage group of one test was positive, suggesting that the sample can enhance the humoral immune function of mice.
5.6小鼠碳廓清试验结果表明,在本实验条件下,各剂量组小鼠的吞噬植树A与溶剂对照组值比较,均无统计学显著性差异(P>0.05)。提示样品五增强碳廓清能力的作用。5.6 The results of mouse carbon clearance test showed that, under the experimental conditions, there was no statistically significant difference between the phagocytosis plant A of mice in each dose group and the solvent control group (P>0.05). Prompt the function of sample five to enhance the carbon clearance ability.
5.7小鼠腹腔巨噬细胞吞噬鸡红细胞实验(滴片法)结果表明,在本试验条件下,各个样品及各剂量组小鼠的单核-巨噬细胞吞噬百分率及吞噬指数与溶剂对照组值比较,均无统计学显著性差异(P>0.05)。提示样品五增强小鼠腹腔巨噬细胞吞噬能力的作用。试验结果均为阴性,提示样品无增强小鼠单核-巨噬细胞吞噬功能。5.7 The results of mouse peritoneal macrophage phagocytosis chicken erythrocyte experiment (drop method) show that under the test conditions, the mononuclear-macrophage phagocytosis percentage and phagocytosis index of mice in each sample and each dosage group are the same as those of the solvent control group. There was no statistically significant difference (P>0.05). Prompt the role of sample five in enhancing the phagocytic ability of mouse peritoneal macrophages. The test results were all negative, suggesting that the sample did not enhance the phagocytic function of mouse monocyte-macrophages.
5.8NK细胞活性测定结果表明,在本试验条件下,各剂量组小鼠的NK细胞活性均高于溶剂对照组值,且高剂量组有统计学显著性差异(P<0.05),提示样品具有增强小鼠的NK细胞活性的作用。5.8 NK cell activity assay results show that under this test condition, the NK cell activity of mice in each dose group is higher than the solvent control group value, and the high dose group has a statistically significant difference (P<0.05), suggesting that the sample has Enhanced NK cell activity in mice.
综合以上试验结果,根据保健食品增强免疫力功能评价标准,本发明组方5个样品均具有增强免疫力的功能。Based on the above test results, according to the evaluation standard of immunity-enhancing function of health food, all 5 samples of the prescription of the present invention have the function of enhancing immunity.
试验实施例2:本发明对改善人体免疫功能的临床疗效Test Example 2: The present invention improves the clinical curative effect of human immune function
儿童:免疫功能低下,易感冒,平均每月两次以上,或一年内患有肺炎两次以上的患者。Children: immunocompromised, prone to colds, more than twice a month on average, or patients with pneumonia more than twice a year.
老年病人:患多种慢性疾病,诊断为肺气虚证的患者。Elderly patients: patients suffering from a variety of chronic diseases and diagnosed with lung qi deficiency.
2、服药方法及疗程:2. Medication method and course of treatment:
口服本发明实施例1-5实施例的制剂。对照:藏红花单剂胶囊、螺旋藻单剂胶囊The preparations of Examples 1-5 of the present invention were taken orally. Control: saffron single-dose capsule, spirulina single-dose capsule
成人:每次3例,每日3次。Adult: 3 cases each time, 3 times a day.
6岁以下儿童:每次1粒,每日2-3次。Children under 6 years old: 1 capsule each time, 2-3 times a day.
6岁以上儿童:每次2粒,每次2-3次。Children over 6 years old: 2 capsules each time, 2-3 times each time.
以上病人均以一个月为一疗程,其治疗1-3个疗程。All the above patients take one month as a course of treatment, and the treatment takes 1-3 courses of treatment.
3、观察方法:3. Observation method:
进行血、尿、便常规化验和心、肺功能检查,并观察:发热、恶寒,鼻部症状,咽部症状及全身情况以及查体温,咽扁桃体,舌象脉象,指纹等变化,分别进行疗效评价。Conduct blood, urine, and stool routine tests and heart and lung function tests, and observe: fever, aversion to cold, nasal symptoms, pharyngeal symptoms, and general conditions, as well as changes in body temperature, pharyngeal tonsils, tongue and pulse, fingerprints, etc., respectively. Efficacy evaluation.
4、疗效评价4. Efficacy evaluation
表一本发明方剂改善人体免疫功能的临床观察Table 1 Clinical Observation of Prescriptions of the Invention Improving Human Immune Function
本发明药物副作用:服药期间少数患者口干,便干外,均无任何不良反应,停药或减量、口感,便干症状消失。Side effects of the medicine of the present invention: during the period of taking the medicine, a small number of patients have dry mouth and dry stools, and there is no adverse reaction, and the symptoms of drug withdrawal or reduction, taste, and dry stools disappear.
试验实施例3:本发明对小鼠抗疲劳的影响试验Experimental example 3: the present invention is to the impact test of anti-fatigue of mouse
本发明制剂(实施例1、实施例2、实施例3、实施例4、实施例5)经江苏省疾病防控中心对小鼠抗疲劳影响试验。小鼠90只随机等分为六组,按表2所示剂量灌胃给药,每日1次,连续10日,正常对照组及模型组给予等体积蒸馏水,体积均为20ml/kg。并于试验开始第一天。于末次给药后1小时,将动物放入15±1℃的游泳槽中,观察小鼠放入水中沉至水底再无力浮起的时间为持续游泳时间。结果见表2.由表2结果可见,本发明的组合物可明显延长小鼠低温持续游泳时间。The formulations of the present invention (Example 1, Example 2, Example 3, Example 4, Example 5) have been tested by the Jiangsu Provincial Center for Disease Control and Prevention on mice's anti-fatigue effects. Ninety mice were randomly divided into six groups, administered by intragastric administration according to the dosage shown in Table 2, once a day, for 10 consecutive days, and the normal control group and model group were given equal volumes of distilled water, both with a volume of 20ml/kg. And on the first day of the test. One hour after the last administration, the animals were placed in a swimming tank at 15±1°C, and the time for observing the mice to sink to the bottom of the water and then float up weakly was defined as the continuous swimming time. The results are shown in Table 2. As can be seen from the results in Table 2, the composition of the present invention can obviously prolong the duration of low temperature swimming in mice.
表2.本发明的制剂对小鼠游泳时间的影响Table 2. Effect of formulation of the present invention on mouse swimming time
试验结果表明,本发明的制剂可显著延长小鼠低温持续游泳时间。表明本发明对小鼠具有抗疲劳的能力。The test results show that the preparation of the invention can significantly prolong the continuous swimming time of mice at low temperature. Show that the present invention has anti-fatigue ability to mice.
试验实施例4:本发明用于舒筋活络的临床治疗试验Test Example 4: The present invention is used for the clinical treatment test of relaxing muscles and tendons and activating collaterals
本发明用于舒筋活络的适应症:筋络、筋膜、筋腱、骨伤、腰腿痛等,脱位复位调理时服用。通过消化系统吸收渗透到机体局部器官、组织的病灶,产生药理效应,达到活血化瘀、消肿止痛、舒筋理气、续筋接骨的功效,从而对筋络、筋膜、筋腱、骨伤、腰腿痛等病灶治疗有很好的疗效;利用本发明实施例1和实施2制得的药剂,经临床使用158例,其中颈椎病45例,骨折41例,运动扭伤72例,均取得良好效果,有效率为92.7%,良好为77.5%,患者均无不良反应。具体举例如下:The present invention is used for the indications of relaxing muscles and tendons and activating collaterals: tendons, fascia, tendons, bone injuries, lumbago and leg pain, etc., and it is taken when dislocation is reset and recuperated. Through the digestive system, it penetrates into the lesions of the local organs and tissues of the body, produces pharmacological effects, and achieves the effects of promoting blood circulation and removing blood stasis, reducing swelling and pain, relaxing tendons and regulating qi, and reconnecting tendons and bones, thereby treating tendons, fascia, tendons, and bone injuries , lumbago and leg pain and other focus treatment have good curative effect; Utilize the medicament that the embodiment of the present invention 1 and implement 2 to make, through clinical use 158 examples, wherein cervical spondylosis 45 examples, fracture 41 examples, sports sprain 72 examples, all obtained Good effect, the effective rate is 92.7%, the good rate is 77.5%, and all patients have no adverse reactions. Specific examples are as follows:
1、熊女士,45岁,被自行车撞伤右大腿髋部,X线检查,右股骨粗隆间骨折、筋膜脱落,其远端向内后移位,局部肿胀严重。用实施例1的制剂治疗3个疗程后,患者能扶拐下床练习走路,2个半月经X线检查已有大量的骨痂形成,病人可丢拐走路。随访观察2年无后遗症。1. Ms. Xiong, 45 years old, was hit by a bicycle and injured her right thigh and hip. X-ray examination showed that the right femoral intertrochanteric fracture and fascia fell off. The distal end shifted inward and backward, and the local swelling was severe. After 3 courses of treatment with the preparation of Example 1, the patient can get out of bed with crutches and practice walking. After 2 and a half menstrual X-ray examinations, a large amount of bone callus has formed, and the patient can walk without crutches. There was no sequelae in the follow-up observation for 2 years.
2、吴先生,37岁,胸闷头昏,呼吸急促,经颈椎CT确诊为颈椎3-6骨质增生、颈3-4椎间盘突出。用实施例3的制剂使用一个疗程后症状明显减轻,服用2个月后缓解,续服1个月后,病状消失,至今未复发。2. Mr. Wu, 37 years old, suffered from chest tightness, dizziness, and shortness of breath. He was diagnosed with cervical vertebra 3-6 hyperosteogeny and cervical 3-4 intervertebral disc herniation by cervical CT. After using the preparation of Example 3 for a course of treatment, the symptoms were significantly relieved, relieved after taking 2 months, and continued after 1 month, and the symptoms disappeared, so far no recurrence.
3、刘小姐,27岁,擦窗户从阳台摔下,病症为臂骨折、筋络伤,患者左臂不能活动。将骨折块复位后并用石膏固定,用实施例2的制剂每日早晚两次,坚持1个月后患者停止治疗,进行功能锻炼,2个月后左臂愈合。3. Ms. Liu, 27 years old, fell from the balcony while cleaning the window. The symptoms were arm fracture and tendon injury. The patient's left arm could not move. After the fracture block was reset and fixed with plaster, the preparation of Example 2 was used twice a day in the morning and evening. After persisting for 1 month, the patient stopped the treatment and carried out functional exercises. After 2 months, the left arm healed.
4、武先生,19岁,打篮球时被同学碰撞,膝关节扭伤,双膝疼痛、肿胀,用实施例4的处方制剂3个疗程后诸症状消失,随访1年半未见复发。4. Mr. Wu, 19 years old, was hit by a classmate when playing basketball, and his knee joint was sprained, and both knees were painful and swollen. After 3 courses of treatment with the prescription preparation of embodiment 4, all symptoms disappeared, and no recurrence was found in follow-up for 1 and a half years.
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