CN102631486B - Health care composition - Google Patents

发明内容 Contents of the invention

本发明为了弥补现有技术的不足，采用四种药食同源的中药材制成一种具有治疗阳痿功效和调节人体免疫力和抗疲劳的组合物，并且任选的通过将该组合物加工成供口服剂型的制剂。In order to make up for the deficiencies in the prior art, the present invention adopts four kinds of Chinese herbal medicines with the same source of medicine and food to make a composition which has the effect of treating impotence, regulating human immunity and anti-fatigue, and optionally processes the composition Formulations for oral dosage form.

本发明是通过如下技术方案实现的：The present invention is achieved through the following technical solutions:

一种保健组合物，由以下重量份数的原料组成：各组分的重量份数为：虫草2-50份、人参3-65份、藏红花3-60份、淫羊藿5-60份、海马5-65份。优选地，虫草4-30份、人参5-35份、藏红花4-35份、淫羊藿6-35份。A health care composition, which is composed of the following raw materials in parts by weight: the parts by weight of each component are: 2-50 parts of Cordyceps sinensis, 3-65 parts of ginseng, 3-60 parts of saffron, 5-60 parts of epimedium, Hippocampus 5-65 parts. Preferably, 4-30 parts of Cordyceps, 5-35 parts of ginseng, 4-35 parts of saffron, and 6-35 parts of epimedium.

优选地，各组分的重量配比为：虫草50份、人参65份、藏红花60份、淫羊藿60份。Preferably, the weight ratio of each component is: 50 parts of Cordyceps sinensis, 65 parts of ginseng, 60 parts of saffron, and 60 parts of epimedium.

优选地，各组分的重量配比为：虫草2份、人参3份、藏红花3份、淫羊藿5份。Preferably, the weight ratio of each component is: 2 parts of Cordyceps sinensis, 3 parts of ginseng, 3 parts of saffron and 5 parts of epimedium.

优选地，各组分的重量配比为：虫草30份、人参35份、藏红花35份、淫羊藿35份。Preferably, the weight ratio of each component is: 30 parts of Cordyceps sinensis, 35 parts of ginseng, 35 parts of saffron, and 35 parts of epimedium.

优选地，各组分的重量配比为：虫草4份、人参5份、藏红花4份、淫羊藿6份。Preferably, the weight ratio of each component is: 4 parts of Cordyceps sinensis, 5 parts of ginseng, 4 parts of saffron and 6 parts of epimedium.

上述各组分经挑选、清洗、沥干、粉碎、混合，即得组合物。或采用本领域常规的提取方法对上述各组分进行提取，提取液经干燥，混合，即得组合物。The above components are selected, washed, drained, pulverized and mixed to obtain the composition. Alternatively, the above-mentioned components are extracted by conventional extraction methods in the art, and the extracts are dried and mixed to obtain the composition.

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:

虫草：本发明中所涉及的虫草是指麦角菌科的真菌(虫草菌)与幼虫在特殊条件下形成的菌虫结合体，包括：冬虫夏草、亚香棒虫草、凉山虫草、新疆虫草、分枝虫草、藿克虫草、蛹虫草、武夷山虫草、龙洞虫草、张家界虫草、大塔顶虫草、多壳虫草、柔柄虫草、下垂虫草、江西虫草、四川虫草、尖头虫草、巴恩虫草、贵州虫草、赤水虫草、革翅目虫草、拟布班克虫草、珊瑚虫草、娄山虫草、鼠尾虫草、绿核虫草、泽地虫草、茂兰虫草、布氏虫草、高雄山虫草、淡黄蛹虫草、球头虫草、金龟子虫草、螳螂虫草、沫蝉虫草、柄壳虫草、拟茂兰虫草、细虫草、发丝虫草、金针虫虫草、日本虫草、辛克莱虫草、喙壳虫草、拟暗绿虫草、峨眉虫草、粉被虫草、大邑虫草、叉尾虫草、桫椤虫草、蜻蜒虫草、蚁虫草、罗伯茨虫草、九州虫草、细柱虫草、戴氏虫草、变形虫草、稻子山虫草、双梭孢虫草、古尼虫草等。本发明中的虫草包含虫草研磨粉碎后的虫粉、经过加工提炼后虫草提取物，或者是虫草各个生长过程中的存在形态。虫草具有补肺肾、止咳嗽、益虚损、养精气之功能。据临床研究报道，冬虫夏草具有十大功能具有养肺阴，补肾阳、止咳化痰、抗癌防老的功效，为平补阴阳之品，诸无所忌(男女老少都能吃，是适合人群最广的补品，而且不需要忌嘴，对身体大有补益，补精髓益肺肾，而且药性温和，不似人参会使人产生燥热，有人参之益而无人参之害)。可用于肺痨咳血，阳痿遗精等症。Cordyceps: The Cordyceps involved in the present invention refers to the combination of fungi (Cordyceps fungi) and larvae formed under special conditions, including: Cordyceps, Huoke Cordyceps, Cordyceps militaris, Wuyishan Cordyceps, Longdong Cordyceps, Zhangjiajie Cordyceps, Datatop Cordyceps, multi-shell Cordyceps, soft handle Cordyceps, drooping Cordyceps, Jiangxi Cordyceps, Sichuan Cordyceps, pointed Cordyceps, Bahn Cordyceps, Guizhou Cordyceps, Cordyceps Chishui, Cordyceps dermatoptera, Cordyceps spp., Cordyceps Cordyceps, Loushan Cordyceps, Cordyceps sage, Cordyceps green nucleus, Cordyceps marshland, Cordyceps maolan, Cordyceps brucei, Cordyceps kaohsiung, light yellow Cordyceps militaris, Ballhead Cordyceps, Scarab Cordyceps, Mantis Cordyceps, Mollia Cordyceps, Pelium Cordyceps, Pseudomonas Cordyceps, Fine Cordyceps, Hair Silkworms, Golden Needle Cordyceps, Japanese Cordyceps, Sinclair Cordyceps, Beaked Cordyceps, Pseudogreen Cordyceps , Cordyceps Emei, Cordyceps pink, Dayi Cordyceps, Cordyceps fork, Cordyceps spinosa, Cordyceps dragonfly, Ant caterpillar fungus, Cordyceps Roberts, Cordyceps Kyushu, Cordyceps lentilis, Cordyceps dai's, Amoeba, Cordyceps rice mountain, Thielavia bispodium Cordyceps, Cordyceps guni, etc. The Cordyceps in the present invention includes ground and crushed Cordyceps powder, processed and refined Cordyceps extract, or the existing forms of Cordyceps in each growth process. Cordyceps has the functions of invigorating the lungs and kidneys, relieving coughs, benefiting deficiency, and nourishing essence. According to clinical research reports, Cordyceps sinensis has ten functions, including nourishing lung yin, nourishing kidney yang, relieving cough and reducing phlegm, anti-cancer and anti-aging effects. It is a wide range of supplements, and does not need to be taboo, it is very beneficial to the body, tonifies the essence, nourishes the lungs and kidneys, and has mild medicinal properties, unlike ginseng that can cause dryness and heat, there are benefits of ginseng but no harm of ginseng). It can be used for tuberculosis and hemoptysis, impotence and nocturnal emission embolism.

人参：为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。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: A general term for a perennial herb of the genus Panax in the Araliaceae family of the Araliaceae family, including red ginseng, white ginseng, American ginseng (American ginseng), bar ginseng, Codonopsis ginseng, and heterophylla. 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. 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.

淫羊藿：本发明所涉及到的淫羊藿，可以是小檗科植物淫羊藿、箭叶淫羊藿、柔毛淫羊藿，或朝鲜淫羊藿的干燥叶。本发明中的淫羊藿藏包含研磨粉碎后的淫羊藿粉、经过提炼的淫羊藿苷、淫羊藿苷I、淫羊藿A等。淫羊藿具有补肾阳，强筋骨，祛风湿的功效，能提高机体免疫功能；能扩张周血管，改善微循环，增加血流量，增加冠脉流量。Epimedium: the Epimedium involved in the present invention can be the dried leaves of Epimedium Berberidaceae, Epimedium sagitta, Epimedium pilosa, or Epimedium korean. Epimedium in the present invention includes ground and pulverized Epimedium powder, refined icariin, icariin I, epimedium A and the like. Epimedium has the functions of invigorating kidney yang, strengthening muscles and bones, dispelling rheumatism, and improving the immune function of the body; it can expand peripheral blood vessels, improve microcirculation, increase blood flow, and increase coronary flow.

在该组合物中，淫羊藿为君药，主要用于补肾壮阳、活血调气、强身健体、消炎止痛、强筋骨、祛风湿；虫草、藏红花同为臣药，发挥补气补血、补肾益精、增强免疫、抗疲劳和平衡人体阴阳的作用。人参为佐药，主要为补精益气，补肾壮阳和增强身体耐受能力。本发明的组合物，以补肾壮阳、补气血、调节免疫能力为治则，诸药合用共凑补肾益精、壮阳强体、养血润燥和提高免疫、抗疲劳之效，具有良好的治疗、保健效果。In this composition, Epimedium is the monarch drug, which is mainly used for invigorating the kidney and strengthening yang, promoting blood circulation and regulating qi, strengthening the body, reducing inflammation and relieving pain, strengthening muscles and bones, and dispelling rheumatism; Yijing, enhance immunity, anti-fatigue and balance the role of human yin and yang. Ginseng is an adjuvant drug, mainly for nourishing essence and Qi, tonifying kidney and aphrodisiac, and enhancing body tolerance. The composition of the present invention is based on the principles of tonifying kidney and strengthening yang, nourishing qi and blood, and regulating immunity. The combined use of various medicines has the effects of tonifying kidney and essence, strengthening yang and strengthening body, nourishing blood and moistening dryness, improving immunity, and anti-fatigue. Treatment, health effects.

由于该组合物中的五种有效成分均属于药食同源的材料，因而该组合物也可以作为营养保健品，或者用于制备营养保健品的用途。Since the five active ingredients in the composition belong to materials with the same source of medicine and food, the composition can also be used as a nutraceutical or for preparing a nutraceutical.

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、改善人体微循环、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，是一种理想的治疗阳痿和提高人体免疫、抗疲劳的保健品、药物。The pharmaceutical composition of the present invention has the functions of nourishing qi and consolidating the surface, and improving the immunity of the body. The medicine of the present invention is neither warm nor dry, and has the functions of invigorating the spleen and stomach, improving the microcirculation of the human body, dispelling dampness and eliminating numbness, enhancing immunity, anti-fatigue, and anti-virus , 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 health care product and medicine for treating impotence, improving human immunity and anti-fatigue.

(四)具体实施方式及实施例(4) Specific implementation methods and examples

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：含有虫草与人参、藏红花和淫羊藿苷的胶囊剂Example 1: Capsules Containing Cordyceps with Ginseng, Saffron and Icariin

虫草50克、人参65克、藏红花60克、淫羊藿60克。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。Cordyceps 50 grams, ginseng 65 grams, saffron 60 grams, epimedium 60 grams. 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：含有虫草、人参、藏红花和淫羊藿苷的片剂Example 2: Tablets Containing Cordyceps, Ginseng, Saffron and Icariin

虫草2克、人参3克、藏红花3克、淫羊藿5克。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。2 grams of Cordyceps, 3 grams of ginseng, 3 grams of saffron, 5 grams of epimedium. 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：含有虫草、人参、藏红花和淫羊藿苷的胶囊剂Example 3: Capsules Containing Cordyceps, Ginseng, Saffron and Icariin

虫草30克、人参35克、藏红花35克、淫羊藿35克。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。Cordyceps 30 grams, ginseng 35 grams, saffron 35 grams, epimedium 35 grams. 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：含有虫草、人参、藏红花和淫羊藿苷的口服液Example 4: Oral liquid containing Cordyceps, ginseng, saffron and icariin

虫草5克，人参35克，藏红花10克，淫羊藿苷15克。5 grams of Cordyceps, 35 grams of ginseng, 10 grams of saffron, 15 grams of icariin.

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：含有虫草、人参、藏红花、淫羊藿的片剂Example 5: Tablets Containing Cordyceps, Ginseng, Saffron, and Epimedium

虫草10克，人参12克，藏红花15克，淫羊藿60克。10 grams of Cordyceps, 12 grams of ginseng, 15 grams of saffron, 60 grams of epimedium.

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)。提示五组样品具有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). It is suggested that the five groups of samples have the effect of enhancing 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1-4实施例的制剂。对照：人参胶囊；虫草胶囊；虫草+人参胶囊(虫草∶人参＝1∶1)；人参+淫羊藿苷胶囊(藏红花∶淫羊藿苷＝1∶1)。The preparations of Examples 1-4 of the present invention were taken orally. Control: Ginseng Capsules; Cordyceps Capsules; Cordyceps + Ginseng Capsules (Cordyceps: Ginseng = 1:1); Ginseng + Icariin Capsules (Saffron: Icariin = 1:1).

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 mice

利用本发明制剂(实施例1、实施例2、实施例3、实施例4、实施例5)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。Utilize the preparation of the present invention (Example 1, Example 2, Example 3, Example 4, Example 5) to test the effects of anti-fatigue on mice. 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：本发明对男性阳痿患者的临床治疗Experimental example 4: the present invention is to the clinical treatment of male impotence patient

(1)临床资料(1) Clinical data

2009年至今，本发明人利用实施例1、实施例2、实施5制得的制剂对326例阳痿患者进行临床观察治疗，其中，年龄20-30岁，67例；31-40岁，73例，41-50岁，79例，51-60岁，61例，60岁以上46例。阳痿原因：精神性阳痿48例，肾病所致阳痿45例，肝病所致阳痿32例，内分泌性阳痿41例，性功能减退(低下)者61例，心因性阳痿26例，动脉硬化性阳痿31例，不明原因阳痿42例。对照药剂：淫羊藿苷胶囊、虫草+淫羊藿苷胶囊(1∶1)。Since 2009, the present inventor has used the preparations prepared in Example 1, Example 2, and Implementation 5 to conduct clinical observation and treatment of 326 impotence patients, among them, 67 cases aged 20-30 years old; 73 cases aged 31-40 years old , 41-50 years old, 79 cases, 51-60 years old, 61 cases, 46 cases over 60 years old. Causes of impotence: 48 cases of mental impotence, 45 cases of impotence caused by kidney disease, 32 cases of impotence caused by liver disease, 41 cases of endocrine impotence, 61 cases of hypogonadism (low) sexual function, 26 cases of psychogenic impotence, arteriosclerotic impotence 31 cases, 42 cases of unexplained impotence. Control drug: icariin capsule, Cordyceps + icariin capsule (1:1).

(2)治疗方法(2) Treatment method

本发明所述组合物，温水内服，一日三次，每次3-6g，饭后服用。根据患者病情轻重计算治疗时间，轻度患者服用3个月，重病患者连服6个月。The composition of the present invention is taken orally with warm water, three times a day, 3-6g each time, after meals. The treatment time is calculated according to the severity of the patient's condition. Mild patients take it for 3 months, and severe patients take it for 6 months.

(3)疗效判定标准(3) Judgment criteria for curative effect

治愈：治疗期过后，阴茎勃起大于90度，性交成功率大于等于80％。Curing: After the treatment period, the penis erection is greater than 90 degrees, and the success rate of sexual intercourse is greater than or equal to 80%.

显效：治疗期过后，阴茎勃起大于90度，性交成功率大于等于50％。Significant effect: After the treatment period, the penis erection is greater than 90 degrees, and the success rate of sexual intercourse is greater than or equal to 50%.

有效：治疗期过后，勃起情况有所改善，，性交成功率大于等于30％。Effective: After the treatment period, the erection situation has improved, and the success rate of sexual intercourse is greater than or equal to 30%.

无效：用药前后各项指标均无改善。Invalid: There is no improvement in all indicators before and after treatment.

(4)临床结果(4) Clinical results

临床试验表明，本发明对阳痿患者具有优异的治疗效果，对于年龄小于50岁的患者总有效率达到90％以上，随着年龄的增加治疗效果也随之降低，但与对照比较仍有较好的疗效。Clinical trials show that the present invention has an excellent therapeutic effect on impotence patients, and the total effective rate reaches over 90% for patients younger than 50 years old. The therapeutic effect also decreases with age, but it is still better than the control. Efficacy.