CN100455300C - Wild kiwifruit compound swallow tablet and preparation method thereof - Google Patents
Wild kiwifruit compound swallow tablet and preparation method thereof Download PDFInfo
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Abstract
本发明公开了一种野生猕猴桃复方吞咽片及其制备方法。该片剂由以下重量比的原料制成:野生猕猴桃(猫人参)30-120份,当归5-20份,黄芪10-40份,茯苓10-30份,西洋参1-5份。将五味材料按重量配分均匀混合,加水煎煮2-3次,每次1-3小时,合并煎液,滤过,滤液浓缩成稠膏,稠膏喷雾干燥、真空干燥或真空冷冻干燥成干膏,并粉碎过筛制成均匀粉末,加入辅料,混匀,制粒,干燥,压片,包衣,即得。本发明采用先进工艺,低成本高质量地制成携带、服用方便、疗效高的保健食品。具有益气养血、提高机体免疫力的功能。适用于身体虚弱、久病痊愈、癌症康复的免疫功能低下人群。同时,对正常体质人群也起到提高免疫力的预防保健作用。The invention discloses a compound swallowing tablet of wild kiwi fruit and a preparation method thereof. The tablet is made of the following raw materials in weight ratio: 30-120 parts of wild kiwi fruit (cat ginseng), 5-20 parts of angelica, 10-40 parts of astragalus, 10-30 parts of poria cocos and 1-5 parts of American ginseng. Mix the five-flavored ingredients evenly according to the weight distribution, add water and decoct 2-3 times, 1-3 hours each time, combine the decoction, filter, and concentrate the filtrate into a thick paste, which is spray-dried, vacuum-dried or vacuum-freeze-dried to dry paste, crushed and sieved to make uniform powder, added auxiliary materials, mixed evenly, granulated, dried, compressed into tablets, coated, and obtained. The invention adopts advanced technology to make the health food which is portable, convenient to take and high in curative effect with low cost and high quality. It has the functions of nourishing qi, nourishing blood and improving the body's immunity. It is suitable for immunocompromised people who are weak, recover from long-term illness, and recover from cancer. At the same time, it also plays a preventive and health-care role in improving immunity for people with normal physiques.
Description
技术领域 technical field
本发明涉及一种具有抗肿瘤、扶持正气、增强免疫能力功效,以一种野生猕猴桃(俗称猫人参)为主要原料的复方吞咽片——艾能片剂,和该片剂的制备方法及用途。The present invention relates to a compound swallowing tablet, Ai Neng tablet, which has the functions of anti-tumor, supporting healthy energy and enhancing immunity, and uses a wild kiwi fruit (commonly known as cat ginseng) as the main raw material, and the preparation method and use of the tablet .
背景技术 Background technique
亚健康状态是指人的机体虽然没有明确的疾病,但呈现出活力降低、适应力减退,介于健康与疾病之间的一种生理功能降低的状态。据世界卫生组织(WHO)一项全球性调查结果表明,全世界真正健康的人只占5%,诊断有病的人占20%,而有75%的人处于的亚健康状态。亚健康已经成为当今危害人类健康的头号隐形杀手,也是现代医学面临的难题之一。随着我国国民经济的发展和广大人民群众养生保健意识的不断增强,人们呼唤健康增益、疗效确切的天然保健食品,探询能够远离亚健康、永驻青春的有效药物。然而目前由于人们摄取动物性食品和精加工食品过多,加上工作节奏紧张、压力大,造成了“现代文明病”,如精力不济、情绪低迷、失眠多梦等。再者,现代化工业的发展,人们的生存环境日益恶化,空气、水源、粮食、水果、蔬菜等与人类生命关系密切的物质无不处于有害物质的包围中,这给人们带来了许多严重的损害,诸如基因突变、细胞老化(自由基增多),免疫应答减弱等,集中表现出如肿瘤患者增加、亚健康状态普遍化。因此,抗肿瘤、增强免疫力的有效保健食品倍受青睐。但是目前市面上的滋补产品多为状阳燥热药物,非长期病患者和体质虚弱者适用;迫切需要研究开发一种提高免疫功能,增强体质抗病能力,促进身体康复的作用平和的纯天然制剂。The sub-health state refers to a state in which the human body has reduced vitality and adaptability, although there is no definite disease. It is a state of reduced physiological function between health and disease. According to a global survey by the World Health Organization (WHO), only 5% of people in the world are truly healthy, 20% are diagnosed with diseases, and 75% are in a sub-health state. Sub-health has become the number one invisible killer that endangers human health today, and it is also one of the difficult problems facing modern medicine. With the development of our country's national economy and the continuous enhancement of the public's awareness of health care, people are calling for health-enhancing, natural health food with definite curative effects, and inquiring about effective drugs that can stay away from sub-health and keep youth forever. However, at present, people consume too much animal food and refined processed food, coupled with the tense pace of work and high pressure, resulting in "modern civilization diseases", such as lack of energy, depression, insomnia and dreaminess. Furthermore, with the development of modern industry, people's living environment is deteriorating day by day. Air, water, food, fruits, vegetables and other substances closely related to human life are surrounded by harmful substances, which has brought many serious damages to people. , such as gene mutations, cell aging (increased free radicals), weakened immune response, etc., such as the increase in tumor patients and the generalization of sub-healthy states. Therefore, effective health food for anti-tumor and immunity enhancement is favored. However, most of the nourishing products currently on the market are medicines for symptoms of yang and dryness, which are suitable for non-chronic patients and those with weak constitutions; there is an urgent need to research and develop a pure natural preparation that can improve immune function, enhance physical resistance to disease, and promote physical recovery. .
猫人参是一种野生猕猴桃资源,为民间常用草药。根据中药大词典记载:具有解毒消肿、祛风除湿的功效,临床用于治疗深部脓肿,骨髓炎,风湿痹痛,疮疡肿毒,肝硬化黄疸腹水等;另外,其对各类消化道肿瘤的疗效也得到了广泛的认可。近年来发现这种野生猕猴桃在抑制肿瘤生长,改善生命征象方面有独特的效果,已成为继藤梨(中华猕猴桃)根之后的又一个来自猕猴桃属的抗癌药源。尽管如此,到目前为止,还未见该植物的相关保健食品的报道。我们应用现代制药技术,克服诸多剂型的不足之处,制成吞咽片,不仅生产方便,又减少了处方中热敏性成分及挥发性成分的损失,保证疗效的同时,方便服用和携带。这对继承和发扬祖国医药遗产,具有重要意义。Cat ginseng is a kind of wild kiwi fruit resource, which is commonly used in folk herbal medicine. According to the Chinese Medicine Dictionary, it has the functions of detoxification, detumescence, wind and dampness, and it is clinically used to treat deep abscess, osteomyelitis, rheumatic arthralgia, sore swelling, liver cirrhosis, icteric ascites, etc.; Tumor efficacy has also been widely recognized. In recent years, it has been found that this wild kiwi fruit has a unique effect in inhibiting tumor growth and improving vital signs, and has become another source of anticancer drugs from the genus Actinidia after the root of vine pear (Actinidia sinensis). Nevertheless, up to now, also do not see the report of the relevant health food of this plant. We apply modern pharmaceutical technology to overcome the shortcomings of many dosage forms and make swallow tablets, which are not only convenient to produce, but also reduce the loss of heat-sensitive and volatile components in the prescription, ensuring the curative effect, and are convenient to take and carry. This is of great significance for inheriting and carrying forward the medical heritage of the motherland.
引证文献:Citations:
①.赵瑞芹,宋振峰,2002:亚健康问题的研究进展,国外医学·社会医学分册,19(1):10-13;①. Zhao Ruiqin, Song Zhenfeng, 2002: Research progress on sub-health problems, Foreign Medicine and Social Medicine Volume, 19(1): 10-13;
②.何静,2004:走出亚健康,远离“灰色”人生,科技文萃,7:82-87;②. He Jing, 2004: Get out of sub-health, stay away from "grey" life, Science and Technology Literature, 7: 82-87;
③.周兴兆,2000;唐福安论肺癌证治,浙江中医学院学报,24(2):45;③. Zhou Xingzhao, 2000; Tang Fuan on the syndrome and treatment of lung cancer, Journal of Zhejiang University of Traditional Chinese Medicine, 24(2): 45;
④.金瑞芝,王国强,1998;猫人参汤治疗膨胀例释,浙江中医杂志,33(1):35;④. Jin Ruizhi, Wang Guoqiang, 1998; Maorenshen Decoction in the treatment of swelling, Zhejiang Journal of Traditional Chinese Medicine, 33(1): 35;
⑤.来平凡,章红燕,2002;浙江地区习用中药猫人参研究进展,浙江中医学院学报,26(1):77-78。⑤. Lai Pingfan, Zhang Hongyan, 2002; Research progress of traditional Chinese medicine cat ginseng in Zhejiang, Journal of Zhejiang University of Traditional Chinese Medicine, 26(1): 77-78.
发明内容 Contents of the invention
本发明的目的为了克服以上技术的不足,提供了一种服用剂量小,生产、服用、携带方便的野生猕猴桃复方吞咽片及其制备方法。The purpose of the present invention is to overcome the deficiencies of the above technologies, and to provide a wild kiwi fruit compound swallow tablet and a preparation method thereof which are small in dosage and easy to produce, take and carry.
本发明是通过以下措施来实现的:The present invention is achieved through the following measures:
1.野生猕猴桃复方吞咽片(艾能片剂)及制备方法包括如下步骤:1. Wild kiwifruit compound swallowing tablet (Ai Neng tablet) and its preparation method comprise the following steps:
1.1野生猕猴桃复方吞咽片(艾能片剂)的配方组成1.1 The formula composition of wild kiwi fruit compound swallow tablet (Ai Neng tablet)
野生猕猴桃复方吞咽片的配方以重量份计为:The formula of the wild kiwi fruit compound swallowing tablet is calculated in parts by weight:
野生猕猴桃 30-120份Wild kiwi 30-120 parts
当归 5-20份Angelica 5-20 servings
黄芪 10-40份Astragalus 10-40 parts
茯苓 10-30份Poria cocos 10-30 parts
西洋参 1-5份。American ginseng 1-5 parts.
它的优选配方以重量份计为:Its preferred formula is calculated in parts by weight:
野生猕猴桃 60份Wild kiwi 60 servings
当归 10份Angelica 10 servings
黄芪 20份Astragalus 20 servings
茯苓 15份Poria cocos 15 parts
西洋参 1-5份。American ginseng 1-5 parts.
1.2野生猕猴桃复方吞咽片(艾能片剂)的制备工艺1.2 Preparation process of wild kiwifruit compound swallow tablet (Ai Neng tablet)
取处方中药材,用适宜的工艺提取制备成吞咽片,其制备工艺可采用下述工艺,也可采用其它适宜的工艺。Take the prescribed Chinese herbal medicines, extract and prepare them into tablets for swallowing by a suitable process, and the preparation process can adopt the following process or other suitable processes.
工艺一将五味药材按配分均匀混合,加水煎煮2-3次,每次1-3小时,合并煎液,滤过,滤液浓缩成稠膏,稠膏喷雾干燥/真空干燥/真空冷冻干燥成干膏,并粉碎过筛制成均匀粉末。加入适量辅料,混匀,制粒,干燥,压片,包衣,即得。Process 1 Mix the five herbs evenly according to the distribution, add water and decoct 2-3 times, 1-3 hours each time, combine the decoction, filter, and concentrate the filtrate into a thick paste, which is spray-dried/vacuum-dried/vacuum-freeze-dried into Dry paste, and crushed and sieved to make a uniform powder. Add appropriate amount of auxiliary materials, mix evenly, granulate, dry, compress into tablets, and coat.
工艺二将野生猕猴桃用60-95%的食用酒精提取2-3次,每次1.5-2小时,合并提取液,滤过,回收乙醇,得浸膏备用;茯苓加水浸提,浸出液滤过,滤液备用;当归、黄芪、西洋参与上述野生猕猴桃药渣一起加水煎煮2-3次,每次1-3小时,合并煎液,滤过,滤液混合野生猕猴桃浸膏及茯苓滤液,浓缩成稠膏,稠膏喷雾干燥、真空干燥或真空冷冻干燥成干膏,并粉碎过筛制成均匀粉末,加入辅料,混匀,制粒,干燥,压片,包衣,即得。Process 2: Extract wild kiwi fruit with 60-95% edible alcohol for 2-3 times, each time for 1.5-2 hours, combine the extracts, filter, recover ethanol, and obtain the extract for later use; add water to extract the poria cocos, filter the extract, The filtrate is used for later use; Chinese angelica, astragalus, and western ginseng are added to the above-mentioned wild kiwi fruit dregs and decocted with water for 2-3 times, 1-3 hours each time, the decoction is combined, filtered, and the filtrate is mixed with wild kiwi fruit extract and Poria cocos filtrate, and concentrated to thicken Paste, thick paste is spray-dried, vacuum-dried or vacuum-freeze-dried into a dry paste, crushed and sieved to make a uniform powder, added with auxiliary materials, mixed evenly, granulated, dried, compressed into tablets, coated, and obtained.
1.3制备野生猕猴桃复方吞咽片(艾能片剂)的辅料及具体工艺1.3 Excipients and specific process for preparing wild kiwifruit compound swallow tablet (Ai Neng tablet)
工艺中药材粉碎成粗粉/切成饮片,通常为过5-50目的粗粉/切成饮片,最佳为过20-40目粗粉。The medicinal materials in the process are crushed into coarse powder/cut into decoction pieces, usually coarse powder over 5-50 mesh/cut into decoction pieces, preferably coarse powder over 20-40 mesh.
工艺中稠膏在添加辅料前最终粉碎为80-160目的细粉,最佳为超微粉碎成200-300目的细粉。In the process, the thick paste is finally pulverized into a fine powder of 80-160 mesh before adding auxiliary materials, and it is best to be superfinely pulverized into a fine powder of 200-300 mesh.
工艺中采用的醇提方法,醇提条件为:用60-95%的食用酒精为溶剂,可采用加热回流法或渗麓法或其它适宜的方法提取,最佳为以70%的食用酒精加热回流提取2次,每次2小时。The alcohol extraction method adopted in the process, the alcohol extraction conditions are: use 60-95% edible alcohol as solvent, and can be extracted by heating reflux method or infiltration method or other suitable methods, the best is heating with 70% edible alcohol Reflux extraction 2 times, 2 hours each time.
工艺中采用的水提方法,水提条件为:温浸(50℃-90℃)5-12小时后,煎煮2-3次,加水量第一次为药量的6-15倍量,第二、三次为药量的4-12倍量,每次0.5-4小时;最佳为8倍量水煮沸后,80℃温浸5小时,煎煮3次,加水量分别为药量的10、8、8倍,时间分别为2、2、1小时。药渣加入同煎时,可于第二次煎煮时加入。The water extraction method adopted in the process, the water extraction conditions are: after warm soaking (50°C-90°C) for 5-12 hours, decocting 2-3 times, the amount of water added for the first time is 6-15 times the amount of medicine, The second and third times are 4-12 times the amount of medicine, 0.5-4 hours each time; the best is 8 times the amount of water boiled, soaked at 80 ° C for 5 hours, decocted 3 times, and the amount of water added is respectively the amount of medicine 10, 8, 8 times, the time is 2, 2, 1 hour respectively. When the medicinal dregs are added to the same decoction, they can be added during the second decoction.
工艺中提取物的干燥可采用真空干燥或喷雾干燥或其它适宜方法。真空干燥温度控制在50℃-80℃;最佳为60℃。喷雾干燥为将提取液浓缩成相对密度为1.05-1.15(60℃)的浓缩液,喷雾干燥,进风温度为100℃-200℃,出风温度为50℃-150℃;最佳相对密度为1.08-1.10(60℃),进风温度为150℃-170℃,出风温度为80℃-100℃。The drying of the extract in the process can adopt vacuum drying or spray drying or other suitable methods. The vacuum drying temperature is controlled at 50°C-80°C; the optimum is 60°C. Spray drying is to concentrate the extract into a concentrated solution with a relative density of 1.05-1.15 (60°C), spray drying, the inlet air temperature is 100°C-200°C, and the outlet air temperature is 50°C-150°C; the best relative density is 1.08-1.10 (60°C), the inlet air temperature is 150°C-170°C, and the outlet air temperature is 80°C-100°C.
工艺中浓缩采用减压浓缩/薄膜浓缩/真空薄膜浓缩或其它适宜方法。Concentration in the process adopts vacuum concentration/film concentration/vacuum film concentration or other suitable methods.
工艺中滤过可采用常规滤过,离心,超滤或其它适宜的方法。Filtration in the process can adopt conventional filtration, centrifugation, ultrafiltration or other suitable methods.
工艺中所得的片剂可用适宜的包衣材料包衣,如胃溶型薄膜衣预混剂(欧巴代)、羟丙基纤维素或其它适宜的材料。The tablets obtained in the process can be coated with suitable coating materials, such as gastric-soluble film coating premix (Opadry), hydroxypropyl cellulose or other suitable materials.
工艺中所用的辅料可以是卵磷脂、木糖醇、蔗糖、β-环糊精、羟丙基-β-环糊精,山梨醇、硬脂酸镁或其它适宜的辅料中的一种或多种混合使用,约占总配方量的15%~45%。The auxiliary materials used in the process can be one or more of lecithin, xylitol, sucrose, β-cyclodextrin, hydroxypropyl-β-cyclodextrin, sorbitol, magnesium stearate or other suitable auxiliary materials Mixed use, accounting for about 15% to 45% of the total formula.
2.野生猕猴桃复方吞咽片(艾能片剂)的质量标准控制包括功效成分检测、稳定性试验、卫生学检验、毒理学实验和药理学评估。2. The quality standard control of Wild Kiwi Fruit Compound Swallow Tablets (Ai Neng Tablets) includes functional component testing, stability testing, hygienic testing, toxicological testing and pharmacological evaluation.
在功效成分检测上,要求粗多糖含量≥3%,总皂甙含量≥2%;在稳定性试验中,要求样品经37℃-40℃温度和75%相对湿度条件下保温3个月,各指标符合国家保健食品的相关规定;在卫生学检验中,要求样品的各指标符合国家保健食品的相关规定;毒理学实验表明,艾能片剂的Ames试验、小鼠微核试验、精子畸形试验均为阴性;大、小鼠急性毒性、长期毒性实验均未见毒性反应;在药理学评估中,野生猕猴桃复方吞咽片(艾能片剂)无论对正常体质还是免疫力低下的缺陷体质都能显著地提供机体免疫功能。In the detection of functional components, it is required that the content of crude polysaccharides is ≥ 3%, and the content of total saponins is ≥ 2%; in the stability test, the samples are required to be kept at a temperature of 37°C-40°C and a relative humidity of 75% for 3 months. It complies with the relevant regulations of the national health food; in the hygienic inspection, each index of the sample is required to meet the relevant regulations of the national health food; the toxicology experiment shows that the Ames test, mouse micronucleus test and sperm abnormality test of the Aineng tablet are all It was negative; no toxic reaction was seen in the acute toxicity and long-term toxicity experiments of rats and mice; in the pharmacological evaluation, the wild kiwi fruit compound swallowing tablet (Ai Neng tablet) can significantly affect the normal constitution and the defective constitution with low immunity. To provide the body's immune function.
3.野生猕猴桃复方吞咽片(艾能片剂)的功效3. The efficacy of wild kiwifruit compound swallowing tablet (Ai Neng tablet)
本发明的野生猕猴桃复方吞咽片(艾能片剂)数药合用,起到抗肿瘤、增强免疫力之功效。The wild kiwifruit compound swallow tablet (Ai Neng tablet) of the present invention is used in combination with several medicines to have the effects of anti-tumor and enhancing immunity.
野生猕猴桃(猫人参)作为我国东南部地方性草药,在民间有悠久的药用历史。为此,《地方药材标准》(浙江省卫生厅,1994)中收载了此药,为该药的开发研究和综合利用奠定了基础。实验研究表明:用猫人参为主的方药治疗以肝癌为主的各种消化道肿瘤,临床疗效明显,猫人参具有提高病人生存质量及延长生存期的功效。Wild kiwifruit (cat ginseng), as an endemic herb in southeastern my country, has a long history of medicinal use among the people. For this reason, this medicine has been included in the "Local Medicinal Material Standards" (Zhejiang Provincial Department of Health, 1994), which has laid a foundation for the development, research and comprehensive utilization of this medicine. Experimental studies have shown that cat ginseng-based prescriptions can be used to treat various digestive tract tumors mainly liver cancer, and the clinical curative effect is obvious. Cat ginseng can improve the quality of life and prolong the survival period of patients.
野生猕猴桃在我国作为滋身补体和防疾治病的民间草药由来已久。它具有健胃、治疗消化不良,具有解毒消肿、祛风除湿的功效;临床用于治疗深部脓肿,骨髓炎,风湿痹痛,疮疡肿毒,肝硬化黄疸腹水等,民间常用于治疗各类消化道肿瘤。近年来发现其在抑制肿瘤生长,改善生命征象方面也有独特的效果。可治多种疾病,消肿排淤,能溶解死细胞,并使人体中亚硝酸氯类致癌物质分解,调中理气,因此可以起到解热除烦、生津润燥、保健长寿、治疗消化不良,食欲不振等病症的作用。近年来众多学者对野生猕猴桃植物各部位的药理活性进行了研究,发现如猕猴桃多糖等一些成分具有降血脂、抗脂质过氧化、清除活性氧自由基、抑制肿瘤细胞,提高免疫功能等方面的药理活性,是一种有效的免疫调节剂。Wild kiwi fruit has a long history in my country as a folk herbal medicine for nourishing the body and preventing and treating diseases. It has the functions of invigorating the stomach, treating indigestion, detoxifying, reducing swelling, expelling wind and dehumidification; it is clinically used to treat deep abscess, osteomyelitis, rheumatic arthralgia, sores and swelling, liver cirrhosis, jaundice and ascites, etc. Gastrointestinal tumors. In recent years, it has been found that it also has unique effects in inhibiting tumor growth and improving vital signs. It can cure a variety of diseases, reduce swelling and expel silt, dissolve dead cells, and decompose chlorine nitrite carcinogens in the human body, adjust the middle and regulate Qi, so it can relieve heat and annoyance, promote body fluid and moisten dryness, maintain health and longevity, and treat digestion Bad, loss of appetite and other diseases. In recent years, many scholars have studied the pharmacological activity of various parts of wild kiwifruit plants, and found that some ingredients such as kiwifruit polysaccharides have the effects of lowering blood fat, resisting lipid peroxidation, scavenging active oxygen free radicals, inhibiting tumor cells, and improving immune function. Pharmacological activity, is an effective immunomodulator.
另外,组方中的黄芪具有补气、强健体质的作用;茯苓可健脾胃、宁心安神;当归能补血和血,润燥滑肠;西洋参益肺阴、清虚火。依据中医组方原理,进行合理科学配伍,使得整个方剂起到清热解毒、利咽散结;补气、补血;润养骨髓,调节机体免疫功能的功效。In addition, astragalus in the formula has the effect of invigorating qi and strengthening the body; poria cocos can strengthen the spleen and stomach, calm the mind and calm the nerves; angelica can nourish blood and blood, moisturize dryness and smooth the intestines; According to the principles of traditional Chinese medicine prescriptions, reasonable and scientific compatibility is carried out, so that the whole prescription can clear away heat and detoxify, relieve throat and relieve stagnation, nourish qi and blood, moisten and nourish bone marrow, and regulate the immune function of the body.
因此,本发明的野生猕猴桃复方吞咽片(艾能片剂)具有如下优点:有一定的抗肿瘤、增强免疫力的功效,安全无毒副作用,适用于身体虚弱、久病痊愈、癌症康复及免疫功能低下人群,同时,对正常体质人群也起到提高免疫力的预防保健作用;并且制备方法简单,适用于工业化生产而药物成分不损失,克服了服用方法繁琐、频繁的缺点,口服剂量相对较小,能迅速发挥作用。Therefore, the wild kiwifruit compound swallow tablet (Ai Neng tablet) of the present invention has the following advantages: it has certain anti-tumor and immunity-enhancing effects, is safe and has no side effects, and is suitable for weak health, long-term illness recovery, cancer recovery and immunity. People with low function, at the same time, also play a preventive and health-care role in improving immunity for people with normal physique; and the preparation method is simple, suitable for industrial production without loss of drug ingredients, overcomes the shortcomings of cumbersome and frequent taking methods, and the oral dosage is relatively low. Small and works quickly.
具体实施方式 Detailed ways
下述实例用以进一步说明本发明,可供参考,但并不由此限制本发明范围。Following example is in order to further illustrate the present invention, for reference, but does not limit the scope of the present invention thus.
实施例1:将五味药材分别净选,除去杂质,检验合格备用;称取野生猕猴桃(猫人参)12.0公斤,当归2.0公斤,黄芪4.0公斤,茯苓3.0公斤,西洋参0.5公斤,分别粉碎成粗粉,均匀混合备用;药材粗粉加水温浸(60℃)12小时后,水煎三次,加水量分别为药量的10、8、8倍,时间分别为2、2、1小时;合并煎液,滤过,滤液浓缩至相对密度为1.05-1.15(60℃)的浓缩液,喷雾干燥,收集得到干膏粉2.9公斤,超微粉碎成200目的均匀细粉;加入20%木糖醇粉末,以纯水喷雾,沸腾制粒(进风温度75℃;喷水量5R/MIN;干燥终点50℃);颗粒加入0.5%硬脂酸镁,混合、整粒、压片、包衣(进风温度70~75℃、排风温度45~55℃);即得本发明得片剂,片重控制0.5g±5%/片。Embodiment 1: The five kinds of medicinal materials are cleaned separately, remove impurities, and pass the test for later use; weigh 12.0 kg of wild kiwi fruit (cat ginseng), 2.0 kg of angelica, 4.0 kg of astragalus, 3.0 kg of poria cocos, and 0.5 kg of American ginseng, and grind them into coarse powder respectively , mixed evenly for later use; after soaking the coarse powder of medicinal materials in water (60°C) for 12 hours, decocting in water three times, the amount of water added was 10, 8, and 8 times of the amount of medicine, and the time was 2, 2, and 1 hour respectively; the decoction was combined , filter, and the filtrate is concentrated to a concentrated solution with a relative density of 1.05-1.15 (60° C.), spray-dried, and collects 2.9 kilograms of dry cream powder, which is superfinely pulverized into a uniform fine powder of 200 meshes; adding 20% xylitol powder, Spray with pure water, boil to granulate (air inlet temperature 75°C; water spray volume 5R/MIN; drying end point 50°C); Temperature 70~75 ℃, exhaust air temperature 45~55 ℃); That is to get the tablet of the present invention, tablet weight control 0.5g±5%/tablet.
用法和用量:口服,1日3次,每次1-2片。Usage and dosage: Take orally, 3 times a day, 1-2 tablets each time.
实施例2:将五味药材分别净选,除去杂质,检验合格备用;称取野生猕猴桃(猫人参)3.0公斤,当归0.5公斤,黄芪1.0公斤,茯苓1.0公斤,西洋参0.1公斤,分别粉碎成粗粉,均匀混合备用;药材粗粉加水温浸(60℃)12小时后,水煎三次,加水量分别为药量的10、8、8倍,时间分别为2、2、1小时;合并煎液,滤过,滤液浓缩至相对密度为1.05-1.15(60℃)的浓缩液,喷雾干燥,收集得到干膏粉2.9公斤,超微粉碎成200目的均匀细粉;加入35%甘露醇粉末,充分混匀,用2%PVPk30(50%乙醇溶液)制软材,以纯水喷雾,沸腾制粒(进风温度75℃;喷水量5R/MIN;干燥终点50℃);颗粒加入2.5%硬脂酸镁,混合、整粒、压片、包衣(进风温度70~75℃、排风温度45~55℃);即得本发明得片剂,片重控制0.5g±5%/片。Embodiment 2: The five kinds of medicinal materials are cleaned separately, remove impurities, and pass the test for later use; weigh 3.0 kg of wild kiwi fruit (cat ginseng), 0.5 kg of angelica, 1.0 kg of astragalus, 1.0 kg of poria cocos, and 0.1 kg of American ginseng, and grind them into coarse powder respectively , mixed evenly for later use; after soaking the coarse powder of medicinal materials in water (60°C) for 12 hours, decocting in water three times, the amount of water added was 10, 8, and 8 times of the amount of medicine, and the time was 2, 2, and 1 hour respectively; the decoction was combined , filter, and the filtrate is concentrated to a concentrated solution with a relative density of 1.05-1.15 (60° C.), spray-dried, and collects 2.9 kilograms of dry cream powder, which is superfinely pulverized into a uniform fine powder of 200 meshes; add 35% mannitol powder, fully Mix well, use 2% PVP k30 (50% ethanol solution) to make soft material, spray with pure water, boil and granulate (inlet air temperature 75°C; water spray volume 5R/MIN; drying end point 50°C); add 2.5% of the granules Magnesium stearate, mixing, granulation, tabletting, coating (inlet air temperature 70~75 ℃, exhaust air temperature 45~55 ℃); obtain the tablet of the present invention, tablet weight control 0.5g±5%/ piece.
用法和用量:口服,1日3次,每次1-2片。Usage and dosage: Take orally, 3 times a day, 1-2 tablets each time.
实施例3:将五味药材分别净选,除去杂质,检验合格备用;称取野生猕猴桃(猫人参)10.0公斤,当归1.8公斤,黄芪3.5公斤,茯苓3.0公斤,西洋参0.5公斤,分别粉碎成粗粉备用;取猫人参粗粉,用70%的食用酒精加热回流提取2次,每次2小时,合并提取液,滤过,回收乙醇,得浸膏备用;茯苓粗粉加水温浸,浸出液滤过,滤液备用;当归、黄芪、西洋参粗粉与上述猫人参药渣一起加水煎煮3次,时间分别为2、2、1小时,合并煎液,滤过,滤液与上述猫人参浸膏及茯苓滤液合并,浓缩至相对密度为1.05-1.15(60℃)的浓缩液,真空冷冻干燥得干膏1.5公斤,超微粉碎至200目;加入35%甘露醇粉末,充分混匀,用2%PVPk30(50%乙醇溶液)制软材,以纯水喷雾,沸腾制粒(进风温度75℃;喷水量5R/MIN;干燥终点50℃);颗粒加入2.5%硬脂酸镁,混合、整粒、压片、包衣(进风温度70~75℃、排风温度45~55℃);即得本发明得片剂,片重控制0.5g±5%/片。Embodiment 3: The five kinds of medicinal materials are cleaned separately, remove impurities, and pass the test for later use; Weigh 10.0 kg of wild kiwi fruit (cat ginseng), 1.8 kg of angelica, 3.5 kg of astragalus, 3.0 kg of poria cocos, and 0.5 kg of American ginseng, and grind them into coarse powder respectively Standby; take cat ginseng coarse powder, heat and reflux with 70% edible alcohol to extract twice, each time for 2 hours, combine the extracts, filter, recover ethanol, and obtain the extract for later use; soak the coarse powder of Poria cocos in warm water, and filter the extract , the filtrate is ready for use; the coarse powder of angelica, astragalus, American ginseng and the above-mentioned cat ginseng dregs are decocted with water for 3 times, the time is 2, 2, and 1 hour respectively, and the decoction is combined, filtered, and the filtrate is mixed with the above-mentioned cat ginseng extract and Poria cocos The filtrates were combined, concentrated to a concentrated solution with a relative density of 1.05-1.15 (60°C), vacuum freeze-dried to obtain a dry paste of 1.5 kg, and ultrafinely pulverized to 200 mesh; add 35% mannitol powder, mix well, and use 2% PVP K30 (50% ethanol solution) made of soft material, sprayed with pure water, boiling granulation (inlet air temperature 75°C; water spray volume 5R/MIN; drying end point 50°C); add 2.5% magnesium stearate to the granules, mix, Sizing, tableting, coating (inlet air temperature 70-75°C, exhaust air temperature 45-55°C); that is, the tablet of the present invention is obtained, and the tablet weight is controlled at 0.5g±5%/tablet.
用法和用量:口服,1日3次,每次1-2片。Usage and dosage: Take orally, 3 times a day, 1-2 tablets each time.
实施例4:将五味药材分别净选,除去杂质,检验合格备用;称取野生猕猴桃(猫人参)4.0公斤,当归0.6公斤,黄芪1.5公斤,茯苓1.0公斤,西洋参0.3公斤,分别粉碎成粗粉备用;取猫人参粗粉,用70%的食用酒精加热回流提取2次,每次2小时,合并提取液,滤过,回收乙醇,得浸膏备用;茯苓粗粉加水温浸,浸出液滤过,滤液备用;当归、黄芪、西洋参粗粉与上述猫人参药渣一起加水煎煮3次,时间分别为2、2、1小时,合并煎液,滤过,滤液与上述猫人参浸膏及茯苓滤液合并,浓缩至相对密度为1.05-1.15(60℃)的浓缩液,真空冷冻干燥得干膏1.5公斤,超微粉碎至200目;加入20%木糖醇粉末,以纯水喷雾,沸腾制粒(进风温度75℃;喷水量5R/MIN;干燥终点50℃)。颗粒加入0.5%硬脂酸镁,混合、整粒、压片、包衣(进风温度70~75℃、排风温度45~55℃)。即得本发明得片剂,片重控制0.5g±5%/片。Embodiment 4: The five kinds of medicinal materials are cleaned separately, remove impurities, and pass the inspection for later use; Weigh 4.0 kg of wild kiwi fruit (cat ginseng), 0.6 kg of angelica, 1.5 kg of astragalus, 1.0 kg of poria cocos, and 0.3 kg of American ginseng, and grind them into coarse powder respectively Standby; take cat ginseng coarse powder, heat and reflux with 70% edible alcohol to extract twice, each time for 2 hours, combine the extracts, filter, recover ethanol, and obtain the extract for later use; soak the coarse powder of Poria cocos in warm water, and filter the extract , the filtrate is ready for use; the coarse powder of angelica, astragalus, American ginseng and the above-mentioned cat ginseng dregs are decocted with water for 3 times, the time is 2, 2, and 1 hour respectively, and the decoction is combined, filtered, and the filtrate is mixed with the above-mentioned cat ginseng extract and Poria cocos The filtrates are combined, concentrated to a concentrated solution with a relative density of 1.05-1.15 (60°C), vacuum freeze-dried to obtain 1.5 kg of dry paste, and ultrafinely pulverized to 200 mesh; add 20% xylitol powder, spray with pure water, and boil to prepare grains (inlet air temperature 75°C; water spray volume 5R/MIN; drying end point 50°C). The granules are added with 0.5% magnesium stearate, mixed, granulated, tabletted and coated (inlet air temperature 70-75°C, exhaust air temperature 45-55°C). Promptly get the tablet of the present invention, tablet weight control 0.5g ± 5%/tablet.
用法和用量:口服,1日3次,每次1-2片。Usage and dosage: Take orally, 3 times a day, 1-2 tablets each time.
以上述方法制得的野生猕猴桃复方吞咽片(艾能片剂)进行质量标准控制,结果如下:The wild kiwi fruit compound swallow tablet (Ai Neng tablet) that makes with above-mentioned method carries out quality standard control, and the result is as follows:
1.野生猕猴桃复方吞咽片(艾能片剂)功效成分检测、稳定性和卫生学检验1. Testing, Stability and Hygienic Testing of Functional Components of Wild Kiwi Fruit Compound Swallow Tablets (Ai Neng Tablets)
按照《中国药典》(2000版)和卫生部《保健食品检验与评价技术规范》(2003版)的要求进行相关测试,结果表明:野生猕猴桃复方吞咽片(艾能片剂)中粗多糖含量≥3%,总皂甙含量≥2%;在稳定性检验中,样品经37℃-40℃温度和75%相对湿度条件下保温3个月,各指标(功效成分、水分、灰分、蛋白质、重金属和微生物等)均符合国家保健食品的相关规定;在卫生学检验中,样品的各指标(功效成分、水分、灰分、蛋白质、重金属和微生物等)符合国家保健食品的相关规定。According to the requirements of "Chinese Pharmacopoeia" (2000 edition) and "Health Food Inspection and Evaluation Technical Specifications" (2003 edition) of the Ministry of Health, relevant tests were carried out. 3%, the total saponin content ≥ 2%; in the stability test, the samples were kept at 37°C-40°C and 75% relative humidity for 3 months, and the indicators (functional ingredients, moisture, ash, protein, heavy metal and Microorganisms, etc.) are in line with the relevant regulations of the national health food; in the hygienic inspection, the indicators of the sample (functional ingredients, moisture, ash, protein, heavy metals and microorganisms, etc.) are in line with the relevant regulations of the national health food.
2.野生猕猴桃复方吞咽片(艾能片剂)毒理学实验2. Toxicology experiment of wild kiwifruit compound swallow tablet (Ai Neng tablet)
第一、二阶段毒性试验The first and second stage toxicity test
按照卫生部《保健食品检验与评价技术规范》(2003版)的要求,对野生猕猴桃复方吞咽片(艾能片剂)进行第一、二阶段毒性试验。试验结果表明:第一阶段大、小鼠急性经口毒性半数致死量(LD50),雌雄两性均大于1000mg/kg体重,按急性毒性分级标准判定,该样品属实际无毒类;第二阶段Ames试验结果为阴性;小鼠骨髓细胞微核试验和小鼠精子畸形试验结果均为阴性。这说明,野生猕猴桃复方吞咽片(艾能片剂)未显示有致突变性。In accordance with the requirements of the "Technical Specifications for Health Food Inspection and Evaluation" (version 2003) issued by the Ministry of Health, the first and second stages of toxicity tests were carried out on wild kiwifruit compound swallow tablets (Ai Neng tablets). The test results show that: in the first stage, the median lethal dose (LD 50 ) of acute oral toxicity in rats and mice was greater than 1000 mg/kg body weight for both sexes, and judged by the acute toxicity grading standard, the sample was actually non-toxic; in the second stage The results of Ames test were negative; the results of mouse bone marrow cell micronucleus test and mouse sperm abnormality test were negative. This shows that wild kiwifruit compound swallowing tablet (Ai Neng tablet) does not show mutagenicity.
大鼠30天喂养试验30-day feeding test in rats
按照卫生部《保健食品检验与评价技术规范》(2003版)的要求,对野生猕猴桃复方吞咽片(艾能片剂)进行大鼠30天喂养试验。试验结果表明:设野生猕猴桃复方吞咽片(艾能片剂)低、中、高三个剂量组,分别相当于人推荐摄入量的25倍、50倍和100倍,大鼠30天喂养试验三剂量组各项指标均未见明显毒性反应。In accordance with the requirements of the "Technical Specifications for Health Food Inspection and Evaluation" (2003 edition) issued by the Ministry of Health, a 30-day feeding test was carried out on wild kiwi fruit compound swallow tablets (Ai Neng tablets). The test results show that: there are three dose groups of wild kiwifruit compound swallow tablet (Ai Neng tablet), which are respectively 25 times, 50 times and 100 times the recommended human intake, and the rats were fed for 30 days. There was no obvious toxic reaction in each index in the dosage group.
3.野生猕猴桃复方吞咽片(艾能片剂)药理学实验3. Pharmacological experiment of wild kiwifruit compound swallow tablet (Ai Neng tablet)
按照卫生部《保健食品检验与评价技术规范》(2003版)的要求,对野生猕猴桃复方吞咽片(艾能片剂)在正常小鼠中的药理学评价进行如下试验:ConA诱导的小鼠脾淋巴细胞转化试验,小鼠血清溶血素测定,抗体生成细胞检测(溶血空斑数),和NK细胞活性测定。设野生猕猴桃复方吞咽片(艾能片剂)低、中、高三个剂量组连续三十天喂食,分别相当于人推荐摄入量的5倍、10倍和30倍,同时设阴性对照组(蒸馏水)。试验结果表明,与阴性对照组比较,中、高剂量组均能提高ConA诱导的小鼠脾淋巴细胞的增殖能力,且差异显著(q检验,p<0.05);高剂量组能提高小鼠NK细胞活性,差异显著(q检验,p<0.05);中剂量组能提高小鼠溶血空斑数,差异有显著性(q检验,p<0.05);中剂量组能提高小鼠血清溶血素,差异有显著性(q检验,p<0.05)。因此,认为野生猕猴桃复方吞咽片(艾能片剂)对正常体质具有增强免疫力的功能。(见表1)According to the requirements of the "Technical Specifications for Health Food Inspection and Evaluation" (2003 edition) issued by the Ministry of Health, the pharmacological evaluation of wild kiwi fruit compound swallow tablets (Ai Neng tablets) in normal mice was tested as follows: ConA-induced mice spleen Lymphocyte transformation test, determination of mouse serum hemolysin, detection of antibody-producing cells (number of hemolytic plaques), and determination of NK cell activity. Set wild kiwifruit compound swallowing tablet (Ai Neng tablet) three dosage groups to feed continuously for 30 days, which are respectively equivalent to 5 times, 10 times and 30 times of human recommended intake, and set negative control group ( distilled water). The test results showed that, compared with the negative control group, both the middle and high dose groups could improve the proliferation ability of ConA-induced mouse spleen lymphocytes, and the difference was significant (q test, p<0.05); the high dose group could improve the NK Cell viability, significant difference (q test, p<0.05); middle dose group can improve mouse hemolytic plaque number, difference has significance (q test, p<0.05); middle dose group can improve mouse serum hemolysin, The difference was significant (q test, p<0.05). Therefore, it is believed that wild kiwifruit compound swallowing tablet (Ai Neng tablet) has the function of enhancing immunity to normal constitution. (See Table 1)
按照卫生部《保健食品检验与评价技术规范》(2003版)的要求,对野生猕猴桃复方吞咽片(艾能片剂)在缺陷小鼠中的药理学评价进行如下试验:ConA诱导的小鼠脾T淋巴细胞转化试验,小鼠血清溶血素测定,和巨噬细胞吞噬功能测定。设野生猕猴桃复方吞咽片(艾能片剂)低、中、高三个剂量组连续三十天喂食,分别相当于人推荐摄入量的5倍、10倍和30倍,同时设阴性对照组(蒸馏水)。试验结果表明,与肿瘤对照组比较,低、中剂量组均能显著提高ConA诱导的小鼠脾T淋巴细胞的增殖能力(q检验,p<0.001~0.01);低、中、高三个剂量组均能显著提高小鼠血清溶血素,差异有显著性(q检验,p<0.001);低剂量组能提高小鼠巨噬细胞吞噬活性,差异显著(q检验,p<0.05)。因此,认为野生猕猴桃复方吞咽片(艾能片剂)对免疫力低下体质具有增强免疫力的功能。(见表2)According to the requirements of the Ministry of Health "Technical Specifications for Health Food Inspection and Evaluation" (2003 edition), the pharmacological evaluation of wild kiwifruit compound swallow tablets (Ai Neng tablets) in deficient mice was carried out as follows: ConA induced mouse spleen T lymphocyte transformation test, mouse serum hemolysin assay, and macrophage phagocytosis assay. Set wild kiwifruit compound swallowing tablet (Ai Neng tablet) three dosage groups to feed continuously for 30 days, which are respectively equivalent to 5 times, 10 times and 30 times of human recommended intake, and set negative control group ( distilled water). The test results showed that, compared with the tumor control group, both the low and middle dose groups could significantly improve the proliferation ability of ConA-induced mouse splenic T lymphocytes (q test, p<0.001~0.01); the low, medium and high dose groups Both can significantly increase serum hemolysin in mice, the difference is significant (q test, p<0.001); the low dose group can improve the phagocytic activity of mouse macrophages, the difference is significant (q test, p<0.05). Therefore, it is believed that wild kiwi fruit compound swallowing tablet (Ai Neng tablet) has the function of enhancing immunity for those with low immunity. (See Table 2)
表1Table 1
野生猕猴桃复方吞咽片(艾能片剂)对正常小鼠的药理学评价Pharmacological Evaluation of Wild Kiwi Fruit Compound Swallow Tablet (Ai Neng Tablet) on Normal Mice
*表示q检验,与阴性对照比较p<0.05。 * indicates q test, p<0.05 compared with the negative control.
表2Table 2
野生猕猴桃复方吞咽片(艾能片剂)对S180荷瘤小鼠药理学实验Pharmacological Experiment of Wild Kiwi Fruit Compound Swallow Tablet (Ai Neng Tablet) on S 180 Tumor-bearing Mice
*、**、***表示q检验,与肿瘤对照比较p<0.05、0.01、0.001。 * , ** , *** represent q test, p<0.05, 0.01, 0.001 compared with tumor control.
以上结果分别经浙江省疾病预防控制中心、浙江省中医药研究院权威验证。结果表明:野生猕猴桃复方吞咽片(艾能片剂)有很好的药理活性,具有提高人体免疫力之功效,且安全无毒副作用。The above results were verified by Zhejiang Provincial Center for Disease Control and Prevention and Zhejiang Provincial Academy of Traditional Chinese Medicine. The results show that: wild kiwi fruit compound swallow tablet (Ai Neng tablet) has good pharmacological activity, has the effect of improving human immunity, and is safe and has no side effects.
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