CN1401365A - Chinese health medicine - Google Patents

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CN1401365A
CN1401365A CN 02131251 CN02131251A CN1401365A CN 1401365 A CN1401365 A CN 1401365A CN 02131251 CN02131251 CN 02131251 CN 02131251 A CN02131251 A CN 02131251A CN 1401365 A CN1401365 A CN 1401365A
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ginseng
health care
care products
health
products
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CN 02131251
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Chinese (zh)
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白礼西
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太极集团有限公司
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Abstract

A health-care Chinese medicine for resisting against radiation and regulating immunity is prepared from proanthocyanidin and American ginseng or ginseng in a ratio of 1:(0.01-100).

Description

一种中药保健药物 A traditional Chinese medicine health drugs

技术领域 FIELD

本发明涉及一种保健药物或食品,特别是以西洋参或人参和原花青素(葡萄籽或松树皮提取物)作为活性成分的保健药物或食品组合物。 The present invention relates to a health food or a pharmaceutical, in particular in American ginseng or ginseng and proanthocyanidins (grape seed or pine bark extract) as a health food or a pharmaceutically active ingredient composition.

人参为五加科多年生草本植物。 Ginseng Araliaceae perennial herb. 根部入药。 The roots of medicine. 性味甘、微苦,温。 Sweet, bitter, warm. 功效为大补元气,补脾益肺,生津止渴,益智安神。 Efficacy is nourishing vitality, Spleen Yifei, thirst, puzzle soothe the nerves. 用于气虚欲脱症,脾气不足,肺气亏虚,津伤口渴、消渴。 For Qi want off the disease, lack of temper, lung deficiency, fluid and thirst, diabetes.

人参和西洋参中含有类似的药物成分人参皂甙。 Ginseng and American ginseng contain ginsenosides similar pharmaceutical ingredient.

松树皮为松科属植物,具有驱风胜湿、祛瘀的特点,传统主要用于风湿骨病、跌打损伤等疾病的治疗。 Pinaceae plants as pine bark, has carminative wins wet, Quyu characteristics, mainly used for conventional treatment of diseases rheumatoid bone disease, traumatic injury. 松树皮提取物中含有原花青素,为一种纯天然抗氧化剂,高效的自由基清除剂和紫外线吸收剂具有改善心脑血管功能;降血压;降血脂;抗过敏作用;也可用作化妆品中防晒主剂。 Pine bark extract containing proanthocyanidins, as a natural anti-oxidants, radical scavengers and efficient ultraviolet absorber with improved cardiovascular function; lowering blood pressure; hypolipidemic; anti-allergic effect; also be used as cosmetic sunscreen main agent.

葡萄籽中也存在着人体内不能合成的天然物质,原花青素,它能有效清除体内多余的自由基,抗氧化能力是维生素E的50倍,维生素C的20倍。 Grape seeds also exist in the human body can not synthesize natural substances, proanthocyanidins, it can effectively remove excess free radicals, antioxidant capacity is 50 times that of vitamin E, vitamin C 20 times. 目前,其抗氧化能力已得到国际公认。 At present, the antioxidant capacity has been internationally recognized.

松树皮和葡萄籽中含有共同的成分原花青素。 Pine bark and grape seeds contain a common component of proanthocyanidins.

目前没有将松原花青素与人参或西洋参合用制成医药保健产品的报道。 The anthocyanins are currently no Matsubara or American ginseng and ginseng combination of reports made medicine and health products.

本发明惊奇的发现将原花青素与人参或西洋参联合应用具有更好的抗辐射、调节人体免疫功能的作用,两者相加使用具有协同作,而且原花青素来源充分,价格低廉,可以买到,本发明的药物或保健品具有优良的保健治疗作用。 The present invention surprisingly found that procyanidins in combination with ginseng or ginseng having a better resistance to radiation, regulating body immune function, having a synergistic two together, and the source of proanthocyanidins sufficient, inexpensive, commercially available, the present invention drugs or health products with excellent health treatment.

本发明的药物或保健品,有效成分为,原花青素(主要由葡萄籽或松树皮提取,可以直接购买得到,也可以从富含原花青素的其他药用植物中提取获得,可以是纯品,也可以是粗品,含量越高越好)和西洋参或人参的生药原料或提取物复合组成,其组成的重量比例为:原花青素与西洋参或人参的重量比为1∶0.01-100,其中的西洋参或人参的量可以是提取物的量,也可以是生药原料的量,优选的原花青素与西洋参或人参的重量比为1∶0.1-10,其中西洋参或人参的提取物经水或/和醇提、浓缩、干燥步骤制成,生药原料是西洋参或人参经干燥、粉碎制成,其中的原花青素是由葡萄籽或松树皮经水或/和醇提、浓缩、干燥制成。 Drugs or health products according to the invention, the active ingredient is proanthocyanidins (mainly extracted from grape seed or pine bark, can be purchased directly available, can also be obtained from other medicinal plant extracts rich in proanthocyanidins, may be pure, you can the crude product is, the higher the content the better), and American ginseng or ginseng crude drug extract or a composite material composition, the weight ratio of composition: by weight of proanthocyanidins and American ginseng or ginseng ratio 1:0.01-100, wherein ginseng or ginseng amount may be the amount of the extract may be a crude drug material in an amount of, preferably proanthocyanidins or ginseng American ginseng with a weight ratio of 0.1-10, wherein the ginseng or ginseng extract with water and / or alcohol extraction, concentration, the drying step is made, crude drug material is dried ginseng or ginseng, pulverized made, wherein the proanthocyanidins grape seed or pine bark is made with water and / or alcohol extraction, concentration, drying is made. 优选的原花青素的量为1-2重量份,西洋参或人参的量为2-6重量份,其中有效成分的重量也可以按生药计算,优选比例按生药计算为,葡萄籽或松树皮∶人参或西洋参=5-20∶1,该药物或保健品在需要时还可加入生理上可接受的载体。 The preferred amount of the procyanidin is 1-2 parts by weight, the amount of ginseng or ginseng is 2-6 parts by weight, wherein the weight of active ingredient may also be calculated as crude drugs, crude drugs preferred ratio is calculated, grape seed or pine bark: ginseng or = 5-20:1 ginseng, the pharmaceutical or health products may be added if necessary physiologically acceptable carrier.

本发明还包括,本发明的药物或保健品在制备一种抗辐射和调节人体免疫功能的药物中的应用。 The present invention further includes, in the preparation of an anti-radiation and regulate immune function pharmaceutical drugs or health care products of the present invention.

本发明的药物或保健品,所述生理上可接受的载体可以是口服或外用制剂的各种材料,如:淀粉、蔗糖、乳糖、纤维素类衍生物、环糊精、β-环糊精、磷脂类材料、硬脂酸镁等。 Drugs or health care products of the present invention, the physiologically acceptable carrier may be oral or topical formulations of various materials, such as: starch, sucrose, lactose, cellulose derivatives, cyclodextrins, [beta] -cyclodextrin , phospholipid-based material, magnesium stearate.

本发明的药物或保健品,可以制成不同的剂型,优选的是口服剂型,这些剂型可以是,片剂、胶囊剂、口服液、口含剂、颗粒剂、冲剂、丸剂、散剂、混悬剂、粉剂、溶液剂、注射剂、栓剂、软膏剂、硬膏剂、霜剂、喷雾剂、滴剂、贴剂。 Drugs or health care products of the present invention, can be made into different dosage forms, preferably oral dosage form, these dosage forms may be tablets, capsules, oral, buccal, granules, granules, pills, powders, suspension , powders, solutions, injections, suppositories, ointments, plasters, creams, sprays, drops, patches.

本发明的药物或保健品,其中的有效成分原花青素和西洋参或人参可以通过通常的中药提取方法提取,如水提或醇提,水沉或醇沉,提取液经过浓缩、干燥、制成浸膏,粉碎后可制药,本发明的药物或保健品中的人参或西洋参也可直接粉碎制成人参粉或西洋参粉后配药,无需提取。 Drugs or health care products of the present invention, wherein the active ingredients proanthocyanidins or ginseng and American ginseng may be extracted by conventional extracting methods medicine, such as water stripping or alcohol extraction, ethanol precipitation, or heavy water, the extract was concentrated, dried to prepare extract, Pharmaceuticals may be crushed, drugs or health products ginseng or ginseng of the present invention can also be made directly pulverized ginseng powder, ginseng powder or after dispensing, without extracting. 将有效成分与生理上可接受的载体混合后按常规方法制成制剂即可制成本发明的药物或保健品。 The system cost can be formulated by conventional methods of the invention the active ingredient is mixed with the carrier in a physiologically acceptable pharmaceutical or health products.

具体说,本发明的药物或保健品有效成分原花青素的提取可以采用如下方法,对于松树皮中原花青素的提取可采用乙醇煮提,乙醇浓度为10-95%,分离分别采用水沉、醇沉方法分离,水为1-10倍量,乙醇浓度为70-95%,用量为1-10倍量。 In particular, pharmaceutical or health products extracted according to the present invention, the active ingredient procyanidin may be employed a method for the pine bark extract boiled Procyanidins can be mentioned ethanol, the ethanol concentration of 10-95%, were separated using heavy water, alcohol precipitation method separated, 1-10 times the amount of water, the ethanol concentration was 70 to 95%, in an amount of 1 to 10 times the amount. 葡萄籽提取物也可采用同样或类似方法制备。 Grape seed extract may also be prepared in the same or the like. 以下为工艺流程: Here is the process:

西洋参8倍量乙醇回流提取三次,滤液浓缩,回收乙醇,得稠膏,减压干燥,粉碎,80目过筛,得浸膏粉1。 Ginseng 8 times the amount of ethanol extracted three times, the filtrate was concentrated, recovering ethanol to give a thick paste, dried under reduced pressure, pulverized, sieved to 80 mesh to obtain a powder extract.

松树皮6倍量乙醇回流提取三次,滤液浓缩,得稠膏,水沉,过滤、浓缩,85%醇沉,过滤,减压干燥,粉碎,80目过筛,得浸膏粉2。 Bark 6 times the amount of ethanol extracted three times, the filtrate was concentrated to give a thick paste, heavy water, filtered, and concentrated to 85% alcohol, filtered and dried under reduced pressure, pulverized, sieved to 80 mesh to obtain extract powder 2.

浸膏粉1,浸膏粉2,乳糖,硬脂酸镁混合均匀,装胶囊,经质检,包装得成品。 Extract powder 1, 2 extract powder, lactose, magnesium stearate uniformly, encapsulating, quality inspection, packaging products.

同样的方法可制成人参和葡萄籽提取物的复方产品、人参和松树皮提取物的复方产品以及西洋参和葡萄籽提取物的复方产品。 The same method can be made ginseng and grape seed extract combination product, ginseng, and the pine bark extract and American ginseng Combinations Combinations and grape seed extract thereof.

本发明的药物或保健品,其有效成分原花青素和人参或西洋参提取物也可从市场上买到。 Drugs or health care products of the present invention, the active ingredient procyanidin extract and American ginseng or ginseng are also commercially available on the market. 买来的原料经过加工可制成本发明的药物或保健品。 Bought material being processed can be prepared pharmaceutical or health products of the invention.

本发明最优选的是胶囊剂,每粒胶囊含有原花青素50-100mg,西洋参或人参100-200mg。 The present invention is most preferred is a capsule, each capsule contains 50-100 mg of proanthocyanidins, ginseng or ginseng 100-200mg. 具体是每粒胶囊含有原花青素75mg,西洋参或人参150mg,药物可接受的载体76.5mg。 Specifically Each capsule contains proanthocyanidins 75mg, ginseng or ginseng 150mg, pharmaceutically acceptable carrier 76.5mg.

本发明的药物或保健品的制备方法是将原花青素和西洋参或人参以及生理上可接受的载体混合。 The method of preparing a pharmaceutical or health care products of the present invention are procyanidins ginseng and ginseng or carriers and physiologically acceptable.

本发明的药物或保健品,经过实验证实具有极好的抗辐射和免疫调节作用,以下为本发明的药物或保健品的实验例证。 Drugs or health care products of the present invention, experimentally confirmed to have excellent resistance to radiation and immunomodulatory effects, the experimental drug or illustration of the present invention the health care products.

实验例一:免疫调节作用试验品为按实施例1制备的胶囊实验方法:脏器/体重比值测定连续灌胃25天后,颈椎脱处死动物,取出脾脏、胸腺,分析天平分别称出动物、脾脏、胸腺重量,按分式计算脏器/体重比值(以mg/10g表示),并进行统计学处理。 Experimental Example One: immunomodulatory effects by the test sample capsule prepared in the experimental procedure as in Example 1: Determination of the ratio of the organ / body weight 25 days after gavage, cervical off the animals were sacrificed and the spleen, thymus, respectively, said analytical balance in an animal, the spleen , thymus weight, organ / body weight ratio (expressed in mg / 10g), and by fractional statistical calculation.

迟发型变态反应(足跖增厚法)连续灌胃20天后,每只小鼠腹腔注射2%SRBC0.2ml免疫,继续灌胃4天后,测量左后足跖厚度,测量3次取平均值;然后在测量部位皮下注射20%(v/v)SRBC,每只20μl。 Delayed type hypersensitivity (Method footpad thickening) intragastrically 20 days were immunized by intraperitoneal injection of 2% SRBC0.2ml continue gavage for 4 days, the left hind paw thickness measured, averaged measured three times; then measurement site subcutaneous SRBC, each 20μl 20% (v / v). 注射后24小时、48小时分别测量左后足跖厚度,测量3次取平均值。 24 hours after injection, 48 hours were measured left hind footpad thickness is measured 3 times averaged. 计算攻击前后足跖夺取度的差值,以差值表示小鼠DTH的程度,并进行统计学处理。 Calculating a difference before and after the attack paw captured degrees, as the difference represents the degree of DTH in mice, and analyzed statistically.

血清深血素测定(血凝法)连续灌胃20天,每只小鼠腹腔注射2%SRBC0。2ml免疫,继续灌胃5天后,摘除眼球取血于离心管内,放置1小时,剥离,2000rpm离心10分钟,收集血清,用生理盐水将血清作倍比稀释,每份稀释12孔,将不同稀释度的血清置于血凝板中,每孔100μl,再加入0。5%SRBC悬液100μl,混匀,置湿盒37℃3小时后观察结果,记录每孔的凝集程度。 Deep blood serum hormone (hemagglutination) intragastrically for 20 days, each mouse was immunized by intraperitoneal injection of 2% SRBC0.2ml continued gavage 5 days, eyeballs were removed blood in a centrifuge tube, stand for 1 hour, stripping, 2000 rpm rpm for 10 minutes, the serum was collected with physiological saline serum for dilution, each dilution hole 12, different serum dilutions placed hemagglutination plate, 100 l per well, 0.5% SRBC suspension was added 100 l , mixing, after 37 ℃ 3 hours humidified chamber opposite observations, the degree of agglutination of each well was recorded. 按公式计算抗体积数,并进行统计学处理。 Anti calculated according to the formula volume number, and statistical processing.

小鼠腹腔巨噬细胞吞噬鸡红细胞实验(半体内法)连续灌胃25天后,于每只小鼠腹腔注射20%鸡红细胞悬液1ml,30分钟后,颈椎脱臼处死,将其固定在鼠板上,正中剪开腹壁皮肤,经腹腔注入生理盐水2ml,转动鼠板1分钟,吸出腹腔洗液1ml,平均滴于2张载坡片上,置湿盒37℃30分钟,取出在生理盐水中漂洗,晾干,固定,4%GiemsaPBS染色3分钟,蒸馏水漂洗晾干,镜检。 Mouse peritoneal macrophage phagocytosis of chicken erythrocytes experiments (ex vivo method) is continuously fed 25 days, injection of 1ml of 20% suspension of chicken erythrocytes in the abdominal cavity of each mouse after 30 minutes, killed by cervical dislocation, which is fixed to the mouse board upper, middle cut abdominal skin by intraperitoneal injection of saline 2ml, rotation mouse board 1 minute aspirated peritoneal wash 1ml, average drop onto two carrier slope sheet, opposing wet cassette 37 ℃ 30 minutes, remove the saline rinse, dry dry, fixing, 4% GiemsaPBS stained for 3 minutes, rinsed with distilled water to dry, microscopic examination. 按分式计算吞噬百分率及吞噬指数,并进行统计学处理。 Fractional calculated by phagocytic percentage and phagocytic index, and statistical analysis.

NK细胞活性测定(乳酸脱氢酶测定法)连续灌胃25天后,颈椎脱臼处死动物,取出脾脏,撕碎,过200目筛网后,用Hank's3次,用完全1640培养液配成5×106个/ml细胞悬液.将各只小鼠的细胞悬液取300μl分置于96孔培养板中,每孔100μl,每孔加靶细胞(YAC-1细胞,1×105个/ml)100μl,同时做靶细胞自然释放孔(靶细胞100μl+培养液100μl)及最大释放孔(靶细胞100μl+1%NP-40 100μl)各8孔,37℃5%CO2培养4小时,取出1500rpm离心5分钟。 NK cell activity assay (LDH assay) intragastrically for 25 days, animals were sacrificed by cervical dislocation, spleens were removed, shredded, over 200 mesh sieve, with Hank's3 times with 5 completely dubbed 1640 × 106 cells / ml cell suspension. the cell suspension of each mouse taken 300μl sub plated in 96 well culture plate, 100 l per well, was added to each well of target cells (YAC-1 cell, 1 × 105 cells / ml ) 100 l, while doing target cell spontaneous release hole (target cells 100μl + medium 100 l) and maximum release hole (target cells 100μl + 1% NP-40 100μl) each of 8 holes, 37 ℃ 5% CO2 for 4 hours, removed centrifuged at 1500rpm 5 minutes. 将各孔上清液100μl置于另一培养板中,每孔再加入100μl基质液,10分钟后加1mol/L HCl 30μl终止反应,在490nm处测定0.D.值,按公式计算NK细胞活性率,并进行统计学处理。 The supernatant of each well culture plate placed in another 100μl, 100μl per well of substrate solution was added and after 10 minutes was added 1mol / L HCl 30μl reaction was terminated, measured 0.D. of 490nm, according to a formula of NK cell activity , and for statistical analysis. 结果见下表:表1.对小鼠体重的影响(血清溶血素与迟发型变态反应测定组)组别 动物数 初始体重(g) 中期体重(g) 结束体重(g) 增重值(g) p值 (只) (—x±S) ±S--对照组 11 19.84±0.83 20.95±0.81 21.68±0.78 1.84±0.3537.5mg/kg.bw 11 19.64±0.75 20.69±0.85 21.47±0.98 1.83±0.40 >0.0575.0mg/kg.bw组 12 19.66±0.92 20.96±0.86 21.55±0.67 1.89±0.49 >0.05150.0mg/kg.bw 12 19.78±0.97 20.83±0.60 21.65±0.62 1.87±0.64 >0.05表2.对小鼠体重的影响(吞噬鸡红细胞试验组)组别 动物数 初始体重(g) 中期体重(g) 结束体重(g) 增重值(g) p值对照组 12 19.95±0.78 21.28±1.01 21.28±1.01 1.88±0.87 -37.5mg/kg.bw 11 19.62±0.88 21.13±0..96 21.56±1.00 1.94±0.65 >0.0575. The results in the table below: Table 1. Effects on body weight of mice (hemolysin and delayed hypersensitivity assay Group) Group Number of animals initial body weight (g) mid weight (g) End weight (g) weight gain value (g ) p value (only) (-x ± S) ± S-- group 11 19.84 ± 0.83 20.95 ± 0.81 21.68 ± 0.78 1.84 ± 0.3537.5mg / kg.bw 11 19.64 ± 0.75 20.69 ± 0.85 21.47 ± 0.98 1.83 ± 0.40 > 0.0575.0mg / kg.bw group 12 19.66 ± 0.92 20.96 ± 0.86 21.55 ± 0.67 1.89 ± 0.49> 0.05150.0mg / kg.bw 12 19.78 ± 0.97 20.83 ± 0.60 21.65 ± 0.62 1.87 ± 0.64> 0.05 table 2. small of rat body weight (test group chicken erythrocytes phagocytosis) group number of animals initial body weight (g) mid weight (g) end weight (g) weight gain value (g) P value control group 12 19.95 ± 0.78 21.28 ± 1.01 21.28 ± 1.01 1.88 ± 0.87 -37.5mg / kg.bw 11 19.62 ± 0.88 21.13 ± 0..96 21.56 ± 1.00 1.94 ± 0.65> 0.0575. 0mg/kg.bw 12 19.94±0.93 21.25±0.84 21.83±0.55 1.89±0.61 >0.05150.0mg/kg.bw 11 19.74±0.79 21.06±0.91 21.57±0.85 1.83±0.67 >0.05表3.对小鼠体重的影响(NK细胞活性测定组)组别 动物数 初始体重(g) 中期体重(g) 结束体重(g) 增重值(g) p值对照组 12 19.60±0.24 20.67±1.22 21.35±1.30 1.75±0.35 -37.5mg/kg.bw 11 19.62±0.70 20.70±0.97 21.28±1.88 1.66±0.56 >0.0575.0mg/kg.bw 11 19.77±0.82 20.71±0.79 21.60±0.75 1.83±0.62 >0.05150.0mg/kg.bw 12 19.76±0.80 20.86±0.81 21.39±0.94 1.64±0.54 >0.05*表示各剂量组与对照组的增重值比较表4.对小鼠脏器/体重比值的影响组别 动物数 脾脏/体重比值 P值* 胸腺/体重比 P值*(只) (mg/10g)对照组 11 48.72±0.98 - 0mg / kg.bw 12 19.94 ± 0.93 21.25 ± 0.84 21.83 ± 0.55 1.89 ± 0.61> 0.05150.0mg / kg.bw 11 19.74 ± 0.79 21.06 ± 0.85 1.83 ± 0.67> 0.05 Table 3. Effect 0.91 21.57 ± mice body weight (NK cell activity assay group) group number of animals initial body weight (g) mid weight (g) end weight (g) weight gain value (g) P value control group 12 19.60 ± 0.24 20.67 ± 1.22 21.35 ± 1.30 1.75 ± 0.35 - 37.5mg / kg.bw 11 19.62 ± 0.70 20.70 ± 0.97 21.28 ± 1.88 1.66 ± 0.56> 0.0575.0mg / kg.bw 11 19.77 ± 0.82 20.71 ± 0.79 21.60 ± 0.75 1.83 ± 0.62> 0.05150.0mg / kg.bw 12 19.76 ± 0.80 20.86 ± 0.81 21.39 ± 0.94 1.64 ± 0.54> 0.05 * represents the weighting value of each dose group and the control group comparison group of animals table 4. Effect of the number of mouse organ / body weight ratio spleen / body weight ratio P value * thymus / body weight ratio P value * (only) (mg / 10g) control group 11 48.72 ± 0.98 - 11.89±2.32 -37.5mg/kg.bw 11 51.45±7.07 >0.05 14.00±2.49 >0.0575.0mg/kg.bw组 12 51.63±5.53 >0.05 13.18±2.01 >0.05150.0mg/kg.bw 12 49.75±6.79 >0.05 12.65±2.34 >0.05*P1表示各剂量组与对照组脾脏/体重比值比较,P2值各剂量组与对照组胸腺/体重比值比较2.3对小鼠迟发型变态反应(DTH)的影响(表5)抗原攻击24小时后,37.5mg/kg.bw剂量与对照组小鼠相比,足跖肿胀度无显著性增高(P>0.05),75.0mg/kg.bw剂量\150.0mg/kg.bw剂量与对照组小鼠相比,足跖肿胀度均无显著性差异(P>0.05)。 11.89 ± 2.32 -37.5mg / kg.bw 11 51.45 ± 7.07> 0.05 14.00 ± 2.49> 0.0575.0mg / kg.bw Group 12 51.63 ± 5.53> 0.05 13.18 ± 2.01> 0.05150.0mg / kg.bw 12 49.75 ± 6.79> 0.05 12.65 ± 2.34> 0.05 * P1 represents in each dose group and the control group of spleen / body weight ratio comparison, P2 value of each dose group and the control group thymus / body weight ratio 2.3 comparison of Effects of delayed Type Hypersensitivity (DTH) in mice (table 5 ) 24 hours after antigen challenge, 37.5mg / kg.bw dose compared to control mice, paw swelling was not significantly increased (P> 0.05), 75.0mg / kg.bw dose \ 150.0mg / kg.bw doses compared to control mice, significant difference in paw swelling no (P> 0.05). 表5.对小鼠迟发型变态反应(DTH)的影响组别 动物数(只)足跖肿胀度(mm)P值* P值*24h 48h对照组 11 0.26±0.10 0.18±0.10 - -37.5mg/kg.bw 11 0.27±0.12 0.18±0.11 >0.05 >0.0575.0mg/kg.bw组 12 0.40±0.11 0.18±0.10 <0.05 >0.05150.0mg/kg.bw 12 0.37±0.11 0.19±0.09 <0.05 >0.05*P1表示各剂量组与对照组24小时足跖肿胀度比较,P2值各剂量组与对照组48小时足跖肿胀度比较表6.对小鼠血清溶血素抗体积数的影响组别 动物数(只) 抗体积数( P值*对照组 11 181.27±10.23 -37.5mg/kg.bw 11 180.45±9.18 >0.0575.0mg/kg.bw组12 181.17±12.16 >0.05150.0mg/kg.bw 12 198.00±15.67 <0.01*P表示各剂量组与对照组抗体积数比较表7.对小鼠腹腔巨噬细胞吞噬鸡红细胞能力的影响组别 Table 5. Effect of several groups of animals on delayed type hypersensitivity (DTH) Mice (only) Swelling (mm) P value * P * 24h 48h value of the control group 11 0.26 ± 0.10 0.18 ± 0.10 - -37.5mg /kg.bw 11 0.27 ± 0.12 0.18 ± 0.11> 0.05> 0.0575.0mg / kg.bw group 12 0.40 ± 0.11 0.18 ± 0.10 <0.05> 0.05150.0mg / kg.bw 12 0.37 ± 0.11 0.19 ± 0.09 <0.05> 0.05 * P1 shows a comparison of paw edema in each dose group and the control group 24 hours, P2 value of each dose group and the control group 48 hours swelling Effect comparison table group number number of anti-mouse serum volume 6. hemolysin animals (only) the number of anti-volume (P value * control group 11 181.27 ± 10.23 -37.5mg / kg.bw 11 180.45 ± 9.18> 12 181.17 ± 12.16 0.0575.0mg / kg.bw group> 0.05150.0mg / kg.bw 12 198.00 ± 15.67 <0.01 * P denotes each dose group and the control group, the number of anti-volume table 7. comparison of mouse peritoneal macrophage phagocytic ability group chicken erythrocytes 动物数 吞噬百分率(%) P1值* 吞噬指数 P2值*(只)对照组 12 28.33±6.22 - 0.99±0.20 -37.5mg/kg.bw 11 35.27±9.03 <0.05 1.42±0.27 <0.0175.0mg/kg.bw组12 35.96±6.52 <0.05 1.39±0.28 <0.01150.0mg/kg.bw 11 37.00±7.86 <0.05 1.53±0.26 <0.01*P1表示各剂量组与对照组吞噬百分率比较,P2值各剂量组与对照组吞噬指数比较 Number of animals phagocytosis percentage (%) P1 P2 phagocytic index value * * value (only) Control group 12 28.33 ± 6.22 - 0.99 ± 0.20 -37.5mg / kg.bw 11 35.27 ± 9.03 <0.05 1.42 ± 0.27 <0.0175.0mg / kg .bw group 12 35.96 ± 6.52 <0.05 1.39 ± 0.28 <0.01150.0mg / kg.bw 11 37.00 ± 7.86 <0.05 1.53 ± 0.26 <0.01 * P1 represents in each dose group and the control group, the percentage of phagocytic comparison, P2 and the value of each dose group phagocytic index in control group

2.5对小鼠NK细胞活性的影响(表8)各剂量组分别与对照组小鼠组比,其NK细胞活性率均无显著性差异(P>0.05). Effect of 2.5 pairs of NK cell activity in mice (Table 8) in each dose group were compared with the control group mice, NK-cell activity No significant difference (P> 0.05).

表8.对小鼠NK细胞活性的影响组别 动物数(只) NK细胞活性率(%)( ) P值*对照组 12 9.19±6.20 - -37.5mg/kg.bw 11 13.80±8.42 >0.0575.0mg/kg.bw组 11 12.76±6.67 >0.05150.0mg/kg.bw 11 13.18±6.84 >0.05*P表不各剂量组与对照组NK细胞活性率比较实验例二:抗辐射作用实验方法1.选雌性昆明种小鼠、随机分为空白对照组、辐射对照组和三个试验组。 Table 8. Group No. of animals on the NK cell activity in mice (only) the rate of NK cell activity (%) () P value * Control Group 12 9.19 ± 6.20 - -37.5mg / kg.bw 11 13.80 ± 8.42> 0.0575 .0mg / kg.bw 11 12.76 ± 6.67 group> 0.05150.0mg / kg.bw 11 13.18 ± 6.84> 0.05 * P table comparative experiment not each dose group and the control group NK cell activity of two cases: a method of experimental anti-radiation . election female Kunming mice were randomly divided into blank control group, the radiation control group and three experimental groups. 试验组动物分别按推荐剂量450mg/人/目(7.5mg/kg..bw)的倍、20倍、30倍(75mg/kg..bw、225gm/kg.bw)每天灌胃一次,共30天,空白对照组、辐射对照组动物每天用蒸馏水灌胃。 Experimental animals were recommended dose human 450mg / mesh (7.5mg / kg..bw) doubling / 20-fold, 30-fold (75mg / kg..bw, 225gm / kg.bw) orally once a day for 30 day, the control group, the radiation control animals were fed daily with distilled water. 于灌胃后第三周将辐射对照组和三个试验组动物用60Cor射线进行辐照,每天一次、1.0GY/次、共10次。 In the third week after the administration of radiation control and three experimental groups of animals irradiated with radiation 60Cor, once daily, 1.0GY / times, a total of 10 times.

2.末次辐照后3天取血并处死一批动物测定血清超氧化物歧化酶(SOD)活性(黄嘌噙氧化酶法)、外周血白细胞数(WBC),取胸骨骨髓按《食品安全性毒理学评价程序和方法》中微核实验规定方法制片、染色、镜检;另一批动物留作观察第一次辐照后30天存活率及平均存活时间。 2. After irradiation of the last three days bled and the serum superoxide dismutase (SOD) activity of the animals were sacrificed batch (xanthine oxidase hold in the mouth), the number of peripheral blood (WBC) leukocytes, sternum marrow taken by the "Food Safety toxicological evaluation procedures and methods "micronucleus test method specified producer, staining, microscopy; another group of animals put on probation for the first 30 days post-irradiation survival rate and average survival time. 结果见下表(试验组为给以本发明实施例1的方法制造的药剂,称为睫灵胶囊):表1睫灵胶囊对小鼠体重的影响初始体重 中期体重 结束体重组别 剂量 —— —— ——(mg/kg..bw) 动物数 体重 动物数 体重 动物数 体重(只) (g) (只) (g) (只) (g)空白对照 0 30 21.0±1.1 30 28.0±1.7 29 31.4±2.5辐射对照 0 30 20.9±1.1 30 28.3±3.0 20 26.3±4.3*睫灵胶囊 75 30 20.9±1.1 30 27.8±2.4 29 26.5±3.4*150 30 20.9±1.0 30 27.0±2.5 16 24.3±3.9*225 30 20.9±1.1 30 27.0±2.6 20 25.8±3.4* The results in the table below (test group as a pharmaceutical method of Example 1 produced given embodiment of the present invention, referred to eyelashes Capsules): Table 1 Effect on eyelashes Capsules initial body weight of mice mid dose group body weight end - - - (mg / kg..bw) number of animals number of animals body weight of animal body weight number (only) (g) (only) (g) (only) (g) the control 0 30 21.0 ± 1.1 30 28.0 ± 1.7 29 31.4 ± 2.5 radiation control 0 30 20.9 ± 1.1 30 28.3 ± 3.0 20 26.3 ± 4.3 * eyelashes capsules 75 30 20.9 ± 1.1 30 27.8 ± 2.4 29 26.5 ± 3.4 * 150 30 20.9 ± 1.0 30 27.0 ± 2.5 16 24.3 ± 3.9 * 225 30 20.9 ± 1.1 30 27.0 ± 2.6 20 25.8 ± 3.4 *

末次辐照后部分动物死亡。 After the last portion irradiated animals died. *:p<0.01(与空白对照组比较)辐射对照组及三个实验剂量组小鼠结束时体重均显著低于空白对照组(p<0.01),三个睫灵胶囊剂量组与辐射对照组之间无显著差异。 *: P <0.01 (compared with control group) at the end of the radiation dose control group and three experimental groups of mice body weight were significantly lower than the control group (p <0.01), three eyelashes Capsules radiation dose group and the control group There was no significant difference between.

表2对小鼠外周血细胞数的影响组别 剂量 动物数 白细胞数(mg/kg.bw) (只) (X109/L)空白对照 0 12 7.94±1.61辐射对照 0 12 0.41±0.28*▲睫灵胶囊 75 12 0.99±0.23*▲150 12 0.66±0.46*▲225 12 0.91±0.46*▲*:p<0.01(与空白对照组比较):▲:p<0.01(与辐射对照组比较)受辐照各组小鼠外周血白细胞数均显著低于空白对照组(:p<0.01),睫灵胶囊三个剂量组小鼠白细胞数显著高于辐射对照组(:p<0.01),即睫灵胶囊对受辐射小鼠白细胞数有升高作用。 Table Effect Group Number of animals Number of doses Number of leukocytes in peripheral blood cells of mouse 2 (mg / kg.bw) (only) (X109 / L) Blank Control 0 12 7.94 ± 1.61 Control Radiation 0 12 0.41 ± 0.28 * ▲ spirit eyelashes capsule 75 12 0.99 ± 0.23 * ▲ 150 12 0.66 ± 0.46 * ▲ ± 0.46 * ▲ * 225 12 0.91: p <0.01 (comparison with control group): ▲: (comparison of the radiation control) p <0.01 irradiated groups of mice the number of peripheral blood leukocytes were significantly lower than control group (: p <0.01), white blood cell count eyelashes capsules three dose group was significantly higher than the control group of radiation (: p <0.01), i.e. eyelashes capsules on irradiated mice had elevated white blood cell count effect.

表3睫灵胶囊对受辐照小鼠超氧化物歧化酶(SOD)活性的影响组别 剂量 动物数 白细胞数(mg/kg.bw) (只) (NU/ml血清)空白对照 0 11 486.43±58.02辐射对照 0 11 389.71±50.37*睫灵胶囊 75 11 411.93±58.83*150 11 447.00±36.60▲225 11 462.25±42.88▲::p<0.01(与空白对照组比较):▲:::p<0.01(与辐射对照组比较)辐射对照组、睫灵胶囊75mg/kg.bw剂量组小鼠血清超氧化物歧化酶活性显著低于空白对照组(:p<0.01),150mg/kg.bw、225mg/kg.bw剂量组小鼠超氧化物歧化酶活性显著高于辐射对照组(:p<0.05),即睫灵胶囊能增加受辐照小鼠血清超氧化物歧化酶活性。 Table 3 Capsule eyelashes irradiated mice and superoxide dismutase (SOD) Effect Group number of animals number of doses of active leukocytes (mg / kg.bw) (only) (NU / ml serum) by the control 011 486.43 radiation ± 58.02 control 0 11 389.71 ± 50.37 * eyelashes capsules 75 11 411.93 ± 58.83 * 150 11 447.00 ± 36.60 ▲ 225 11 462.25 ± 42.88 ▲ :: p <0.01 (comparison with control group): ▲ ::: p < 0.01 (compared to control radiation) of radiation control group, eyelashes capsules 75mg / serum SOD activity kg.bw dose group was significantly lower than the control group (: p <0.01), 150mg / kg.bw, superoxide dismutase activity 225mg / kg.bw dose group was significantly higher than the control group of radiation (: p <0.05), i.e. eyelashes capsules can increase SOD activity of serum of irradiated mice.

表4睫灵胶囊对受辐照小鼠平均存活时间的影响组别 剂量 动物数 平均存活时间(mg/kg..bw) (只) (天)空白对照 0 15 29.0±3.9辐射对照 0 15 12.1±3.5*睫灵胶囊 75 15 21.8±4.7*▲150 15 13.9±1.6225 15 13.5±4.8p<0.01(与空白对照组比较):▲p<0.01(与辐射对照组比较注:表中存活时间为第1次辐照后天数,未死动物存活时间以第1次辐照后30天计。 Table 4 Capsule eyelashes number average survival time by group dose irradiated mice Effect animal mean survival time (mg / kg..bw) (only) (days) blank 0 15 29.0 ± 3.9 015 12.1 Radiation Control capsules eyelashes ± 3.5 * 75 15 21.8 ± 4.7 * ▲ 150 15 13.9 ± 1.6225 15 13.5 ± 4.8p <0.01 (comparison with the control group): ▲ p <0.01 (comparison with the control group, the radiation NOTE: table survival time 1st days after irradiation, dead animal survival time to 30 days after the first radiation meter.

辐射对照组及睫灵胶囊三个剂量组小鼠受辐照后的平均存活时间显著短于空白对照组(:p<0.01),75mg/kg.bw剂量组小鼠受辐照后的平均存活时间显著长于辐射对照组p<0.01)即睫灵胶囊可增加受辐照小鼠的平均存活时间。 Radiation control group and three dose groups Capsule eyelashes by average survival time of mice after irradiation significantly shorter than the control group (: p <0.01), 75mg / kg.bw dose group by the mean survival after irradiation irradiation time significantly longer than the control group p <0.01) increased by capsule i.e. eyelashes average survival time of mice irradiated.

表5睫灵胶对小鼠受辐照后30天存活率的影响组别 剂量 观察动物数 30天存活动物数 存活率(mg/kg..bw) (只) (只) (%)空白对照 0 15 14 93.3辐射对照 0 15 0 0.0*睫灵胶囊 75 15 2 13.3*150 15 0 0.0*225 15 0 0.0*p<0.01(与空白对照组比较):注:表中存活率为第1次辐照后30天的存活率。 Table 5 glue eyelashes spirit animals were observed for the number of doses 30 day survival of irradiated mice impact group number of animals surviving 30 days survival rate (mg / kg..bw) (only) (only) (%) Blank Control radiation control 93.3 01514 0150 0.0 * eyelashes capsules 75 15 2 13.3 * 150 15 0 0.0 * 225 15 0 0.0 * p <0.01 (comparison with control group): Note: the table is a survival 1st 30-day survival after irradiation. 受辐照各组小鼠在第一次受辐照后30天存活率均显著低于空白对照组(p<0.01),睫灵胶囊三个剂量组小鼠受辐照后30天存活率与辐射对照组无显著差异(p<0.05),即睫灵胶囊对受辐射小鼠30天存活率无增加作用。 Groups of mice irradiated survival at 30 days after the first 30 days after the irradiation by the survival rate was significantly lower than control group (p <0.01), eyelashes Capsules three doses of irradiated mice with no significant difference (p <0.05) of radiation control group, i.e., no effect of increased survival of irradiated mice 30 days capsule eyelashes. 睫灵胶囊对小鼠骨髓细胞微核率的影响受辐照各组小鼠骨髓嗜多染红细胞微核率均显著高于空白对照组(p<0.01),睫灵胶囊三个剂量组小鼠骨髓嗜多染红细胞微核率显著低于辐射对照组(p<0.01),并有较好的剂量反应关系。 Effect eyelashes capsule on micronucleus rate of mouse bone marrow cells irradiated in each group in mouse bone marrow cell micronucleus rate significantly higher than the control group (p <0.01), eyelashes Capsules three dose groups of mice bone marrow cell micronucleus rate of the control group was significantly lower than the radiation (p <0.01), and has a good dose-response relationship. 即睫灵胶囊有降低受辐射小鼠骨髓嗜多染红细胞微核率的作用(见表6)表6睫灵胶囊对小鼠骨髓细胞微核率的影响组别 剂量 动物数 嗜多红细胞数 微核数 微核率(mg/kg.bw) (只) (个/只) (个) (%0)空白对照 0 10 1000 1.5±0.8 1.5辐射对照 0 10 1000 27.8±4.3* 27.8睫灵胶囊 75 10 1000 20.9±2.6*▲20.9150 10 1000 14.6±2.0*▲14.6225 10 1000 8.2±1.2*▲8.2*:p<0.01(与空白对照组比较),▲p<0.01(与辐射对照组比较)以本品发明的保健药物组合物进行的安全性评价,结果如下:急性毒性试验:对大、小鼠的急毒经口LD均大于10000mg/kg.bw,判属实际无毒类;Ames试验、小鼠骨髓细胞微核试验和小鼠精子畸形试验三项遗传毒性试验均为阴性结果,即无致突变作 Capsules i.e. eyelashes irradiated lowering effect in mouse bone marrow cell micronucleus rate (see Table 6) Table 6 Number of Capsules eyelashes Micronucleus Marrow Cells Group Effect polychromatic erythrocyte Number of animals dose micro Audit micronucleus rate (mg / kg.bw) (only) (/ animal) (a) (0%) blank control 0 10 1000 1.5 ± 0.8 1.5 radiation control 0 10 1000 27.8 ± 4.3 * 27.8 75 capsule eyelashes 10 1000 20.9 ± 2.6 * ▲ 20.9150 10 1000 14.6 ± 2.0 * ▲ 14.6225 10 1000 8.2 ± 1.2 * ▲ 8.2 *: p <0.01 (compared with control group), (compared with the radiation control group) ▲ p <0.01 in the present safety evaluation of health product pharmaceutical composition of the invention is carried out, the results are as follows: acute toxicity test: large, acute oral LD ​​mice were greater than 10000mg / kg.bw, nonpoisonous sentence belongs; Ames test, a small mouse micronucleus test of bone marrow cells and sperm abnormality test three genotoxicity tests were negative results, i.e. for non-mutagenic 用。 use. 长期毒性试验:取大白鼠50只,按750mg/kg.bw相当于人用药量的100倍),连续港灌胃给药90天,均未异常,处死动物后基动物的脏器肉眼观察、以及心、肝、脾、肺肾等脏器病理切片观察也未见异常。 Long-term toxicity test: Take rats 50, 100 times the dosage of human by 750mg / kg.bw), continuous oral administration port 90 days, no abnormality, the animals were sacrificed animal organ group was visually observed, organs and histopathological examinations heart, liver, spleen, lung and kidney, also no exception. 结果表明本发明的药物无毒性。 The results show that the medicament of the present invention is non-toxic. 本发明的其他的配方的产品也具有上述实验中的相同作用,如它们的毒性很小,都具有免疫调节和防辐射作用,都可通过口服,每日三次,每次1-5粒胶囊。 Other product formulations of the present invention also has the same effect of the above experiments, such as their low toxicity, have immunomodulatory effect and radiation, can be administered orally, three times a day, 1-5 capsules every time.

Claims (10)

  1. 1.一种具有抗幅射和调节人体免疫功能作用的中药药物或保健品,其特征在于,其有效成份由原花青素和西洋参或人参制成,原花青素与西洋参或人参的重量比为1∶0.01-100,该药物或保健品还可含有生理上可接受的载体。 A radiation having a anti-regulate immune function and effect of Chinese medicines or health care products, characterized in that the active ingredients of ginseng or ginseng former anthocyanins and prepared, the weight ratio of proanthocyanidin with ginseng or ginseng is 1:0.01- 100, the drug or health products may also contain a physiologically acceptable carrier.
  2. 2.权利要求1的药物或保健品,其中的西洋参或人参的量可以是它们的提取物的量,也可以是生药原料的量,原花青素与西洋参或人参的重量比为1∶0.1-10。 2. A pharmaceutical or health products as claimed in claim 1, wherein the amount of ginseng or ginseng may be an amount extracts thereof, or may be the amount of crude drug material, the weight ratio of proanthocyanidin with ginseng or ginseng is 0.1-10.
  3. 3.权利要求2的药物或保健品,其中西洋参或人参的提取物经醇提、浓缩、干燥步骤制成,生药原料是西洋参或人参经干燥、粉碎制成,其中的原花青素由葡萄籽或松树皮经醇提、浓缩、干燥制成。 Drugs or health care products of claim 2, wherein the ginseng American ginseng extract or alcohol extract was concentrated, the drying step is made, crude drug material is dried ginseng or ginseng, pulverized made, wherein the grape seed proanthocyanidins or pine percutaneous ethanol extract, concentrated and dried to prepare.
  4. 4.权利要求1-3的任意一项药物或保健品,其中原花青素的量为1-2重量份,西洋参或人参的量为2-6重量份。 1-3 or any of a medicament according to claim health care products, wherein the amount of proanthocyanidin is 1-2 parts by weight, the amount of ginseng or ginseng is 2-6 parts by weight.
  5. 5.权利要求1-4的任意一项药物或保健品,其特征在于,所述药物或保健品为片剂、胶囊剂、口服液、口含剂、颗粒剂、冲剂、丸剂、散剂、混悬剂、粉剂、溶液剂、注射剂、栓剂、软膏剂、硬膏剂、霜剂、喷雾剂、滴剂、贴剂。 1-4 or any of a medicament according to claim health care products, wherein said pharmaceutical or health products are tablets, capsules, oral, buccal, granules, granules, pills, powders, mixed suspending agents, powders, solutions, injections, suppositories, ointments, plasters, creams, sprays, drops, patches.
  6. 6.权利要求5的药物或保健品是胶囊剂。 Medicament according to claim 5 or health care products is a capsule.
  7. 7.权利要求3的药物或保健品,其特征在于,其中有效成分的重量比例按生药计算为,葡萄籽或松树皮∶人参或西洋参=5-20∶1。 Drugs or health care products according to claim 3, characterized in that, wherein the weight ratio of active ingredient is calculated by crude drugs, grape seed or pine bark: = 5-20:1 American ginseng or ginseng.
  8. 8.权利要求1-7的任意一项药物或保健品的制备方法,其特征在于,将原花青素和西洋参或人参以及药物可接受的载体混合。 1-7 or in any process for the preparation of a medicament according to claim health care products, wherein the procyanidins and American ginseng or ginseng and a pharmaceutically acceptable carrier.
  9. 9.权利要求1-7的任意一项药物或保健品在制备一种抗幅射和调节人体免疫功能作用的药物中的应用。 1-7 of a medicament for any health care products or in the manufacture of an anti-radiation effect and regulate immune function of a medicament as claimed in claim 9.
  10. 10.权利要求6的药物或保健品,其中每粒胶囊含有原花青素50-100mg,西洋参100-200mg。 10. The pharmaceutical or health products as claimed in claim 6, wherein each capsule contains 50-100 mg of proanthocyanidins, ginseng 100-200mg.
CN 02131251 2002-09-19 2002-09-19 Chinese health medicine CN1401365A (en)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102198195A (en) * 2011-05-25 2011-09-28 遵义陆圣康源科技开发有限责任公司 Antioxidative medicinal composition
CN102258195A (en) * 2011-08-15 2011-11-30 通化腾龙生物科技有限公司 Green Senate Health Products
CN102631482A (en) * 2012-05-12 2012-08-15 赵全成 Chinese medicinal composition for preventing and treating diabetes and complications
CN102657334A (en) * 2012-05-14 2012-09-12 青岛海隆达生物科技有限公司 Hard capsules taking grape seed extracts as raw materials and preparation method for hard capsules
CN102669657A (en) * 2012-04-20 2012-09-19 苏州爱斯欧蒂生物科技有限公司 Immunity-improving health product
CN102716272A (en) * 2012-06-27 2012-10-10 乔树宏 Traditional Chinese medicine composition for senescence delaying and antifatigue as well as soft capsule and preparation method of traditional Chinese medicine composition

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102198195A (en) * 2011-05-25 2011-09-28 遵义陆圣康源科技开发有限责任公司 Antioxidative medicinal composition
CN102258195A (en) * 2011-08-15 2011-11-30 通化腾龙生物科技有限公司 Green Senate Health Products
CN102669657A (en) * 2012-04-20 2012-09-19 苏州爱斯欧蒂生物科技有限公司 Immunity-improving health product
CN102631482A (en) * 2012-05-12 2012-08-15 赵全成 Chinese medicinal composition for preventing and treating diabetes and complications
CN102631482B (en) 2012-05-12 2014-01-08 赵全成 Chinese medicinal composition for preventing and treating diabetes and complications
CN102657334A (en) * 2012-05-14 2012-09-12 青岛海隆达生物科技有限公司 Hard capsules taking grape seed extracts as raw materials and preparation method for hard capsules
CN102716272A (en) * 2012-06-27 2012-10-10 乔树宏 Traditional Chinese medicine composition for senescence delaying and antifatigue as well as soft capsule and preparation method of traditional Chinese medicine composition

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