CN104306847A - Six-ingredient qi-tonifying capsule and preparation process thereof - Google Patents
Six-ingredient qi-tonifying capsule and preparation process thereof Download PDFInfo
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- CN104306847A CN104306847A CN201410491939.2A CN201410491939A CN104306847A CN 104306847 A CN104306847 A CN 104306847A CN 201410491939 A CN201410491939 A CN 201410491939A CN 104306847 A CN104306847 A CN 104306847A
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- pericarpium citri
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Classifications
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- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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Abstract
本发明提供一种六味补气胶囊,其成分包括:生晒参、炙黄芪、益智仁、玉竹、陈皮、肉桂,具体配方由以下重量份的原料药制成的药剂:生晒参5-15份、炙黄芪10-20份、益智仁1-10份、玉竹5-15份、陈皮1-10份、肉桂1-10份。其制备工艺包括如下步骤,1)将生晒参铺平在烘盘中,放入烘箱,控制温度为25-80℃,干燥、粉碎细粉备用;2)粗粉与炙黄芪、益智仁、玉竹、陈皮、肉桂加水煎煮提取三次。3)吸取煎煮药液的上清液,减压浓缩收膏,真空干燥,干浸膏粉碎,加入上生晒参细粉及适量糊精,用80%乙醇制粒,干燥,整粒,灭菌,充填,外包,送检,入库。本发明配伍合理,给药简单、方便,而且本发明提取方法科学合理,药效稳定。The invention provides a Liuwei Qi-tonifying capsule, the ingredients of which include: raw sun-dried ginseng, sun-dried astragalus root, Yizhiren, Polygonatum odoratum, tangerine peel, and cinnamon. -15 parts, 10-20 parts of Radix Astragalus, 1-10 parts of Yizhi Ren, 5-15 parts of Polygonatum Polygonatum, 1-10 parts of Chenpi, and 1-10 parts of Cinnamon. The preparation process includes the following steps: 1) spreading raw sun-dried ginseng on a baking tray, putting it into an oven, controlling the temperature at 25-80°C, drying and pulverizing fine powder for later use; , Polygonatum, Tangerine Peel, and Cinnamon are decocted and extracted three times. 3) Take the supernatant of the decocted medicinal liquid, concentrate it under reduced pressure to collect the extract, dry it in vacuum, crush the dry extract, add raw sun-dried ginseng fine powder and appropriate amount of dextrin, granulate with 80% ethanol, dry, and granulate, Sterilization, filling, outsourcing, inspection, storage. The invention has reasonable compatibility, simple and convenient administration, and the extraction method of the invention is scientific and reasonable, and the drug effect is stable.
Description
技术领域technical field
本发明涉及补气的中医药领域,具体为一种六味补气胶囊及其制备工艺。The invention relates to the field of traditional Chinese medicine for invigorating qi, in particular to a Liuwei qi invigorating capsule and a preparation process thereof.
背景技术Background technique
目前,治疗各种细菌发炎西医以抗菌消炎治疗,多缠绵难愈,是因为忽略了该病病机。此症若气血盛,则外感六邪淫毒或情志内伤也未必发病,反之则易发病。益气血旺而外邪不能感,气血衰而内正不能拒。明确指出了气血旺盛,则不易受感染而发病。此外,气血盛衰直接关系外科疾病发起,破溃,收口等,对整个病程长短有一定影响。如气虚则难于起发,血少则难于生肌收口。因此补气血、助恢复尤为重要。目前尚无治疗疮疡溃脓的专用中药,其往往都是中医大夫根据患者病情开出药方,并采用传统方法煎服,工艺简单,技术落后,药物效果难以保证。At present, Western medicine treats various bacterial inflammations with antibacterial and anti-inflammatory treatments, which are often lingering and difficult to heal, because the pathogenesis of the disease has been ignored. If the qi and blood are abundant in this disease, the exogenous six pathogenic poisons or internal emotional injuries may not be onset, and vice versa. When Qi and blood are prosperous, external evils cannot be sensed, and when qi and blood are weak, internal righteousness cannot be rejected. It is clearly pointed out that if the qi and blood are strong, it is not easy to be infected and get sick. In addition, the ups and downs of qi and blood are directly related to the initiation, ulceration, and closing of surgical diseases, which have a certain impact on the length of the entire disease process. If qi is deficient, it will be difficult to initiate, and if blood is low, it will be difficult to promote muscle growth and close the mouth. Therefore, it is particularly important to replenish qi and blood and help recovery. There is no special Chinese medicine for the treatment of sores, ulcers and pus at present, which are often prescribed by doctors of traditional Chinese medicine according to the patient's condition, and are decocted and taken in traditional ways. The process is simple, the technology is backward, and the drug effect is difficult to guarantee.
现在,中国专利补气益血胶囊(公布号CN102266423A),本发明以黄芪、人参、白术、茯苓、熟地黄、白芍、当归、金银花、川芎、炙甘草为原料药,经干燥、粉碎成细粉,过筛、混匀等工常规工艺制得;以及中国专利一种中药补气养身胶囊(公布号CN103845570A),采用以下技术配方与生产方法,其特征在于:黄芪20克,山药20克,何首乌20克,党参5克,炙甘草2.5克,熟地7.5克,白芍5克,当归7.5克,川芎3克,单味采用超临界萃取工艺方法提取浓缩浸膏,干燥,打粉,拌均匀杀菌,装入胶囊包装即成成品。此两种药剂不仅配伍复杂,而且药物有效成分提取工艺不科学,药效不稳定,不易被患者所接受。Now, the Chinese patent Buqi Yixue Capsules (publication number CN102266423A), the present invention uses astragalus, ginseng, Atractylodes macrocephala, Poria cocos, rehmannia glutinosa, white peony root, angelica, honeysuckle, Chuanxiong, Zhigancao as raw materials, dried and crushed into fine powder, sieved, mixed and other conventional processes; and a Chinese patented Chinese medicine qi nourishing capsule (publication number CN103845570A), which adopts the following technical formula and production method, is characterized in that: Astragalus 20 grams, Chinese yam 20 grams , Polygonum multiflorum 20 grams, Codonopsis 5 grams, Radix Glycyrrhizae 2.5 grams, Rehmannia glutinosa 7.5 grams, Paeoniae Alba 5 grams, Angelica sinensis 7.5 grams, Ligusticum chuanxiong 3 grams, single flavor extract concentrated extract by supercritical extraction process, dry, powder, mix well Sterilize and pack into capsules to complete the finished product. Not only the compatibility of these two medicines is complicated, but also the extraction process of the active ingredients of the medicine is unscientific, the efficacy of the medicine is unstable, and it is not easy to be accepted by patients.
发明内容Contents of the invention
本发明所解决的技术问题在于提供一种六味补气胶囊及其制备工艺,以解决上述背景技术中的问题。The technical problem to be solved by the present invention is to provide a Liuwei Qi-tonifying capsule and its preparation process, so as to solve the above-mentioned problems in the background technology.
本发明所解决的技术问题采用以下技术方案来实现:一种六味补气胶囊,其成分包括:生晒参、炙黄芪、益智仁、玉竹、陈皮、肉桂,具体配方由以下重量份的原料药制成的药剂:生晒参5-15份、炙黄芪10-20份、益智仁1-10份、玉竹5-15份、陈皮1-10份、肉桂1-10份。The technical problem solved by the present invention is realized by the following technical solutions: a Liuwei Qi-tonifying capsule, whose ingredients include: raw sun-dried ginseng, sun-dried astragalus root, Yizhi kernel, Polygonatum odoratum, Tangerine peel, and cinnamon, and the specific formula is composed of the following parts by weight: Medicine made from raw materials: 5-15 parts of raw sun-dried ginseng, 10-20 parts of Sun-roasted Astragalus membranaceus, 1-10 parts of Yizhiren, 5-15 parts of Polygonatum odoratum, 1-10 parts of tangerine peel, and 1-10 parts of cinnamon.
各组分的优选重量份数为:The preferred parts by weight of each component are:
生晒参10份、炙黄芪15份、益智仁6份、玉竹10份、陈皮6份、肉桂3份。10 parts of raw sun-dried ginseng, 15 parts of roasted astragalus, 6 parts of Yizhiren, 10 parts of Polygonatum odoratum, 6 parts of tangerine peel, and 3 parts of cinnamon.
各组分的优选重量份数为:The preferred parts by weight of each component are:
生晒参5份、炙黄芪10份、益智仁1份、玉竹5份、陈皮1份、肉桂1份。5 parts of raw sun-dried ginseng, 10 parts of roasted astragalus, 1 part of Yizhiren, 5 parts of Polygonatum odoratum, 1 part of tangerine peel, and 1 part of cinnamon.
各组分的优选重量份数为:The preferred parts by weight of each component are:
生晒参15份、炙黄芪20份、益智仁10份、玉竹15份、陈皮10份、肉桂10份。15 parts of raw sun-dried ginseng, 20 parts of roasted astragalus, 10 parts of Yizhiren, 15 parts of Polygonatum odoratum, 10 parts of tangerine peel, and 10 parts of cinnamon.
本发明所用到的原料药可从普通中药店购买得到,其规格符合国家中药材标准即可。The raw materials used in the present invention can be purchased from ordinary Chinese medicine stores, and its specifications can meet the national standards for Chinese medicinal materials.
本发明的另一个目的是提供一种制备本发明中药药剂的方法,包括如下步骤,Another object of the present invention is to provide a method for preparing the traditional Chinese medicine of the present invention, comprising the following steps,
1)按处方所述重量份数称取各味原料药;1) Weigh each raw material drug according to the weight and number of parts stated in the prescription;
2)将生晒参铺平在烘盘中,放入烘箱,控制温度为25-80℃,干燥、粉碎细粉备用;2) Spread the raw sun-dried ginseng on a baking tray, put it into an oven, control the temperature at 25-80°C, dry and pulverize it into fine powder for later use;
3)粗粉与炙黄芪、益智仁、玉竹、陈皮、肉桂加水煎煮提取三次。第一次加重量比10倍量水,煎煮1.5小时;第二、三次加重量比8倍量水,煎煮1.0小时,合并提取液滤过,静置48小时。3) Coarse powder is decocted with sunburned astragalus, Yizhiren, Polygonatum odoratum, tangerine peel, and cinnamon in water for three times. Add 10 times the weight ratio of water for the first time, decoct for 1.5 hours; add 8 times the weight ratio of water for the second and third times, decoct for 1.0 hours, combine the extracts, filter, and let stand for 48 hours.
4)吸取煎煮药液的上清液,减压浓缩收膏,真空干燥,干浸膏粉碎,加入上生晒参细粉及适量糊精,用80%乙醇制粒,干燥,整粒,灭菌,充填,外包,送检,入库。4) Take the supernatant of the decocted medicinal liquid, concentrate under reduced pressure to collect the extract, dry it in vacuum, crush the dry extract, add fine powder of sun-dried ginseng and appropriate amount of dextrin, granulate with 80% ethanol, dry, and granulate, Sterilization, filling, outsourcing, inspection, storage.
所述步骤3中干燥温度为25-80℃。The drying temperature in step 3 is 25-80°C.
1、药理分析:本发明是发明人根据自己多年的行医经验,结合祖国中医学精髓辩证组方而得,通过药物的归经作用调理机体阴阳平衡,扶正固本、改善久病耗气,肺气亏虚,卫外失职,水液运行失常,成痰成喘,肾不纳气、肾气亏虚,则腰酸耳鸣,动则气喘等症状,从而达到彻底治愈的目的。1. Pharmacological analysis: The present invention is obtained by the inventor based on his many years of medical practice experience, combined with the dialectical formula of the essence of traditional Chinese medicine in the motherland. Through the meridian-tropic effect of drugs, the balance of yin and yang in the body can be adjusted, the body can be strengthened, the body can be strengthened, and the long-term illness can be improved. Deficiency of qi, dereliction of duty by guards, abnormal flow of water and liquid, phlegm and wheezing, kidney insufficiency, deficiency of kidney qi, waist soreness, tinnitus, asthma and other symptoms when moving, so as to achieve the goal of complete cure.
生晒参:别名人参,味甘、微苦,性温,滋补,安神,宁心,主治心悸征忡,久病体虚,心衰,气短喘促,口渴多汗,唇厥,面色苍白,大汗肢冷,呼吸微弱,脾胃久虚,精华内耗,呕吐泄泻。人参中含有13种以上皂苷,其总皂苷称为人参皂苷RX(ginsenosideRX),单体有人参皂苷Ro、Ra、Rb1……等。皂苷是人参生物活性的基本物质,此外尚含有多种氨基酸、糖类、β-榄香烯、人参炔醇、人参酸、维生素、黄酮类等成分。人参可使家兔红细胞、白细胞和血红蛋白增加,白细胞中以单核细胞增加较多。可减轻辐射对造血系统的损伤,能增强机体对有害刺激的防御能力,对物理、化学、生物等各种有害刺激有非特异的抵抗能力,此外还有强心、调节血压、调节糖和物质代谢、抗疲劳、抗衰老等作用。Raw sun-dried ginseng: alias ginseng, sweet, slightly bitter, warm in nature, nourishing, calming the nerves, calming the mind, mainly treating palpitations, chronic illness and physical weakness, heart failure, shortness of breath, thirst and hyperhidrosis, lip verge, pale complexion, Profuse sweating, cold limbs, weak breathing, prolonged deficiency of spleen and stomach, internal consumption of essence, vomiting and diarrhea. Ginseng contains more than 13 kinds of saponins, the total saponins are called ginsenoside RX (ginsenoside RX), and the monomers include ginsenosides Ro, Ra, Rb1...etc. Saponin is the basic substance of ginseng's biological activity. In addition, it also contains a variety of amino acids, sugars, β-elemene, panaxynol, ginseng acid, vitamins, flavonoids and other ingredients. Ginseng can increase red blood cells, white blood cells and hemoglobin in rabbits, and among the white blood cells, monocytes increase more. It can reduce radiation damage to the hematopoietic system, enhance the body's defense against harmful stimuli, and have non-specific resistance to physical, chemical, biological and other harmful stimuli. In addition, it can strengthen the heart, regulate blood pressure, and regulate sugar and substances. Metabolism, anti-fatigue, anti-aging and other effects.
炙黄芪:性味:甘,微温,归肺、脾、肝、肾经,主治黄芪有补气固表、止汗脱毒、生肌、利尿、退肿之功效。用于治疗气虚乏力,中气下陷,久泻脱肛,便血崩漏,表虚自汗,痈疽难溃,久溃不敛,血虚萎黄,内热消渴,慢性肾炎,蛋白尿,糖尿病等。炙黄芪益气补中,生用固表托疮。Sun-roasted Astragalus: Nature and flavor: sweet, slightly warm, returns to the lung, spleen, liver, and kidney meridian, and cures mainly Astragalus has the effects of invigorating qi and strengthening the exterior, antiperspirant and detoxification, promoting muscle growth, diuresis, and detumescence. It is used to treat qi deficiency and fatigue, depression of middle qi, chronic diarrhea and prolapse of the anus, bloody stool and metrorrhagia, surface deficiency and spontaneous sweating, carbuncle and gangrene, chronic ulceration, blood deficiency and chlorosis, internal heat and thirst, chronic nephritis, proteinuria, diabetes, etc. Sun-roasted Astragalus nourishes qi and invigorates the middle, and is used to strengthen the surface and support sores.
益智仁:味辛;性温,归脾;肾经,温脾止泻摄涎;暖肾缩尿固精,温里药,主治脾胃虚寒;呕吐;泄泻;腹中冷育;口多唾涎;肾虚遗尿;尿频;遗精;白浊。《纲目》:益智,行阳退阴之药也。三焦、命门气弱者宜之。接杨士源《直指方》云:心看脾之母,进食,不止于和脾,火能生士,当使心药入脾胃药中,庶几相得。故古人进食药中,多用益智,土中益火也。Yizhiren: pungent in taste; warm in nature, returns to the spleen; kidney meridian, warms the spleen, relieves diarrhea and catches saliva; warms the kidney, reduces urination and solidifies essence, warms the interior medicine, mainly treats spleen and stomach deficiency and cold; vomiting; diarrhea; cold in the abdomen; mouth Excessive salivation; kidney deficiency enuresis; frequent urination; nocturnal emission; white turbidity. "Compendium": Yizhi, the medicine for promoting yang and retreating yin. Sanjiao and Mingmen are suitable for those with weak qi. Take Yang Shiyuan's "Zhizhi Fang" saying: "The heart looks at the mother of the spleen. Eating food is not limited to harmonizing the spleen. Fire can beget the soul. You should put the medicine for the heart into the medicine for the spleen and stomach, and you can get it together." Therefore, the ancients used medicines to improve intelligence and fire in soil.
玉竹:甘;平,归肺;胃经,滋阴润肺;养胃生津,补益药;润燥药,主治燥咳;劳嗽;热病阴液耗伤之咽干口渴;内热消渴;阴虚外感;头昏眩晕;筋脉挛痛。《纲目》:萎蕤,性平,味甘,柔润可食。故朱肱《南阳活人书》治风温自汗身重,语言难出,用萎蕤汤以之为君药。予每用治虚劳寒热及一切不足之症,用代参、耆,不寒不燥,大有殊功。不止于去风热湿毒而已,此昔人所未阐者也。主风温自汗灼热,及劳疟寒热,脾胃虚乏,男子小便频数,失精,一切虚损。Polygonatum Polygonatum: sweet; flat, returns to the lung; stomach meridian, nourishes yin and moistens the lung; nourishes the stomach and promotes body fluid, tonic medicine; moisturizer, mainly treats dry cough; cough due to fatigue; dry throat and thirst caused by yin fluid consumption in febrile disease; internal heat disappears Thirst; Exogenous syndrome due to yin deficiency; dizziness and dizziness; muscle spasms and pains. "Compendium": wilted, flat in nature, sweet in taste, soft and edible. Therefore, Zhu Gong's "Nanyang Living Book" treats wind, temperature, self-sweating, heavy body, and difficulty in speaking, and uses Weirui Decoction as the king's medicine. Every time I use it to treat asthenia, cold, heat, and all insufficiencies, I use ginseng and qi instead, and it is neither cold nor dry, which has a great effect. It is not limited to removing wind-heat and damp-dampness, which has not been explained by people in the past. Main wind temperature, spontaneous sweating and scorching heat, malaria, cold and heat, deficiency of spleen and stomach, frequent urination in men, loss of sperm, and all depletion.
陈皮:性温,味苦、辛,主治理气健脾.燥湿化痰。用于胸脘胀满,食少吐泻,咳嗽痰多。含橙皮苷(hesperdin),川陈皮素(nobiletin),新橙皮苷(neohesperidin),柠檬蒎(limonene),α-、β-蒎烯(α-,β-pinene)等。橙皮苷可抑制实验性胃溃疡,降低毛细血管通透性,因此具有调整肠胃功能以及抗炎作用;陈皮挥发油具有祛痰、平喘、促进消化液分泌和排除肠内积气等作用。此外还有扩张冠状动脉、降低血压和利胆等作用。Tangerine peel: warm in nature, bitter and pungent in taste, mainly governing qi and invigorating the spleen, drying dampness and resolving phlegm. It is used for fullness in the chest cavity, vomiting and diarrhea due to lack of food, and cough with excessive phlegm. Contains hesperdin, nobiletin, neohesperidin, limonene, α-, β-pinene (α-, β-pinene), etc. Hesperidin can inhibit experimental gastric ulcer and reduce capillary permeability, so it can adjust gastrointestinal function and anti-inflammation; tangerine peel volatile oil has the functions of eliminating phlegm, relieving asthma, promoting the secretion of digestive juice and eliminating intestinal gas. In addition, it also has the effects of expanding coronary arteries, lowering blood pressure and promoting choleresis.
肉桂:辛;甘;热,归肾;脾;心;肝经,补火助阳;引火归源;散寒止痛;温经通脉,止痛药;助阳药,主治肾阳不足;命门火畏寒肢冷;腰膝酸软;阳痿遗精;小便不利或频数;短气喘促;浮肿尿少诸证;命门火衰;火不归源;戴阳;格阳;及上热下寒;面赤足冷;头晕耳鸣;口舌糜破;脾肾虚寒;脘腹冷痛;食减便溏;www.med126.com肾虚腰痛;寒湿痹痛;寒疝疼痛;宫冷不孕;痛经经闭;产后瘀滞腹痛;阴疽流注;或虚寒痈疡脓成不溃;或溃后不敛。《本经》:主上气咳逆,结气喉痹吐吸,利关节,补中益气。《别录》:主心痛,胁风,胁痛,温筋,通脉,止烦、出汗。主温中,利肝肺气,心腹寒热、冷疾,霍乱转筋,头痛,腰痛,止唾,咳嗽,鼻能;能堕胎,坚骨节,通血脉,理疏不足;宣导百药,无所畏。Cinnamon: pungent; sweet; heat, returning to the kidney; spleen; heart; liver meridian, tonifying fire and supporting yang; drawing fire back to its source; dispelling cold and relieving pain; Cold and cold limbs; soreness of the waist and knees; impotence and nocturnal emission; dysuria or frequent urination; shortness of breath and shortness of breath; edema and oliguria; decline of vital fire; fire not returning to source; wearing yang; grid yang; upper heat and lower cold; bare feet Cold; dizziness and tinnitus; broken mouth and tongue; deficiency and coldness of spleen and kidney; cold and pain in the abdomen; food loss and loose stool; Stomach stasis abdominal pain; Yin gangrene outflow; or deficient cold carbuncle pus into pus; or ulceration does not converge. "Herbal Classic": It is mainly used to control upper Qi and cough, block Qi and throat numbness, spit and inhale, sharpen joints, invigorate the middle and replenish Qi. "Bie Lu": main heartache, hypochondriac, hypochondriac pain, warming tendons, dredging pulse, relieving restlessness, sweating. Main temperature, benefit liver and lung qi, cold and heat in trusted subordinates, cold disease, cholera tendons, headache, low back pain, stop saliva, cough, nasal energy; can abort, strengthen joints, unblock blood vessels, and relieve deficiency; promote hundreds of medicines, no dreaded.
本发明在中药材选择和配伍上符合中医辨证理论,其中,补气药辅以温阳以助补气之功,补气伍以理气以期补而不滞。肺为娇脏,佐以养阴以使温而不燥,健脾以期培土生金,补肾以期肺肾同补。两方合用,共奏益气化痰、止咳平喘之功,治疗效果显著,且无毒副作用,达到了中药配伍中相辅相成的目的。The selection and compatibility of Chinese herbal medicines in the present invention conform to the syndrome differentiation theory of traditional Chinese medicine. Among them, the qi invigorating medicine is supplemented with warming yang to help invigorate qi, and the qi invigorating agent is used to regulate qi so as to invigorate and not stagnate. The lung is a delicate viscera, it is supplemented by nourishing yin to make it warm but not dry, invigorating the spleen in order to cultivate soil and produce metal, and nourishing the kidney in order to nourish the lung and kidney at the same time. Combined use of the two prescriptions can benefit qi and reduce phlegm, relieve cough and relieve asthma, and the therapeutic effect is remarkable without toxic and side effects, achieving the goal of complementing each other in the compatibility of traditional Chinese medicines.
2、用法与用量:2. Usage and dosage:
本发明药物的用药量取决于病人的年龄、体重、健康状况等因数。使用指导:每次口服3-4颗胶囊,每天2次。The dosage of the medicament of the present invention depends on factors such as the patient's age, body weight, and health status. Instructions for use: Oral 3-4 capsules each time, 2 times a day.
3、本发明组合物进行了大量的动物急性毒性试验、动物长期毒性试验以及治疗疾病的大量临床试验,对该药投入治疗疾病的使用环节提供了科学而客观的依据。其试验方法和试验结果分别如下:3. The composition of the present invention has undergone a large number of animal acute toxicity tests, animal long-term toxicity tests and a large number of clinical trials for treating diseases, which provides a scientific and objective basis for the use of the drug in the treatment of diseases. The test methods and test results are as follows:
1)对本发明制备的颗粒剂进行动物急性毒性试验:1) Carry out animal acute toxicity test to the granule prepared by the present invention:
药物:本发明所用到的原料药从普通中药店购买得到,其规格符合国家中药材标准。Medicines: The raw materials used in the present invention are purchased from ordinary Chinese medicine stores, and their specifications meet the national standards for Chinese medicinal materials.
试验动物:小白鼠,体重在50g左右,雌雄随机选择,由市场购买。Experimental animals: small white mice, weighing about 50 g, male and female are randomly selected, purchased from the market.
方法和结果:取小白鼠10只,按每只每天服用8克,连续喂服7天,小鼠活动正常,无毒性反应,无死亡。表明药剂无急性毒性,临床用药剂量安全。Methods and results: 10 mice were taken, and each mouse was given 8 grams per day for 7 consecutive days. The mice had normal activities, no toxic reaction, and no death. It shows that the medicament has no acute toxicity, and the clinical dosage is safe.
2)对本发明制备的汤剂进行动物长期毒性试验:2) Carry out animal long-term toxicity test to the decoction prepared by the present invention:
试验动物:大白鼠,体重在120-130g,雌雄随机选择,由市场购买。Experimental animals: white rats, weighing 120-130 g, male and female were randomly selected, purchased from the market.
方法和结果:取大白鼠20只,分成2组,每组10只,其中第1组作为给药组,按每只每天服用5克,第2组喂服相同重量的普通食物为对照组,对比观察90天,测体重,于最后一次给药后24小时断头处死,测血、尿常规、肝功能、肾功能,取心、肾等内脏,观察组织形态的变化,观察剂量的作用,观察饮食、活动的变化,实验证明给药组与对照组比较无显著变化,均无毒性反应,是一种安全的药物。Methods and results: Take 20 rats and divide them into 2 groups, 10 rats in each group. Among them, the first group is used as the administration group, and each rat takes 5 grams per day, and the second group is fed with the same weight of common food as the control group. Contrast observation for 90 days, measure body weight, execute by decapitation 24 hours after the last administration, measure blood, urine routine, liver function, kidney function, take heart, kidney and other viscera, observe changes in tissue morphology, observe the effect of dose, The changes in diet and activity were observed, and the experiment proved that the drug administration group had no significant changes compared with the control group, and there was no toxic reaction, so it was a safe drug.
4、诊断标准4. Diagnostic criteria
1)临床诊断:具有咳嗽,咳痰色白,喘息气短,动则加重,神疲乏力,腰酸耳鸣,舌质淡苔白,脉沉、弱或滑临床症状。1) Clinical diagnosis: clinical symptoms of cough, white sputum, wheezing, aggravated by movement, fatigue, backache and tinnitus, pale tongue with white coating, deep, weak or slippery pulse.
2)为了验证临床疗效,本组方在安徽中医药大学第一附属医院进行试用,随机选取其中50例病人。2) In order to verify the clinical efficacy, this prescription was tested in the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, and 50 patients were randomly selected.
3)治疗方法:按照本发明药物比例制成0.4克的胶囊,每次服用3-4颗胶囊,每天2次。3) Therapeutic method: make 0.4 gram capsules according to the medicine ratio of the present invention, take 3-4 capsules each time, 2 times a day.
4)疗效判定:4) Judgment of curative effect:
痊愈:气虚临床症状完全改善;Recovery: the clinical symptoms of qi deficiency are completely improved;
显效:气虚临床症状显著改善;Significantly effective: the clinical symptoms of qi deficiency are significantly improved;
有效:气虚临床它症状有改变,偶有不适,能接受;Effective: clinical symptoms of qi deficiency have changed, occasionally discomfort, acceptable;
无效:治疗后症状、体征与治疗前相比无任何改变;Ineffective: no change in symptoms and signs after treatment compared with before treatment;
具体治疗结果参见表1。The specific treatment results are shown in Table 1.
表1Table 1
5、注意事项:5. Matters needing attention:
1.饮食宜清淡,忌酒及辛辣、生冷、油腻食物。1. The diet should be light, avoid alcohol and spicy, cold and greasy food.
2.严格按用法用量服用。2. Take it strictly according to the usage and dosage.
3.对该药品及酒精过敏者禁用,过敏体质者慎用。3. For those who are allergic to this product and alcohol, those with allergies should use it with caution.
4.该药品性状发生改变时禁止使用。4. It is forbidden to use this product when its properties change.
5.请将该药品放在儿童不能接触的地方。5. Please keep this product out of the reach of children.
6.如正在使用其他药品,使用该药品前请咨询医师或药师。6. If you are using other medicines, please consult your physician or pharmacist before using this product.
与已公开技术相比,本发明存在以下优点:本发明配伍合理,给药简单、方便,而且本发明提取方法科学合理,药效稳定。Compared with the disclosed technology, the present invention has the following advantages: reasonable compatibility, simple and convenient administration, scientific and reasonable extraction method and stable drug effect.
具体实施方式Detailed ways
为了使本发明的技术手段、创作特征、工作流程、使用方法达成目的与功效易于明白了解,下面将结合本发明实施例,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。In order to make it easy to understand the technical means, creative features, work flow, and use methods of the present invention to achieve the purpose and effect, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the The described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.
实施例1Example 1
取生晒参10克将生晒参铺平在烘盘中,放入烘箱,控制温度为80℃,干燥、粉碎细粉备用;粗粉中加入炙黄芪15克、益智仁6克、玉竹10克、陈皮6克、肉桂3克,之后加水煎煮提取三次。第一次加重量比10倍量水,煎煮1.5小时;第二、三次加重量比8倍量水,煎煮1.0小时,合并提取液滤过,静置48小时,之后吸取煎煮药液的上清液,减压浓缩收膏,真空干燥,干浸膏粉碎,加入上生晒参细粉及适量糊精,用80%乙醇制粒,干燥、干燥温度为80℃,整粒,灭菌,充填,外包,送检,入库。Take 10 grams of raw sun-dried ginseng, spread the raw sun-dried ginseng on a baking tray, put it in an oven, control the temperature at 80°C, dry and pulverize the fine powder for later use; add 15 grams of sun-dried astragalus, 6 grams of Yizhiren, 10 grams of bamboo, 6 grams of tangerine peel, 3 grams of cinnamon, and then add water to decoct and extract three times. Add 10 times the weight ratio of water for the first time, decoct for 1.5 hours; add 8 times the weight ratio of water for the second and third times, decoct for 1.0 hours, combine the extract and filter, let stand for 48 hours, and then absorb the decoction liquid The supernatant was concentrated under reduced pressure to collect the extract, vacuum-dried, the dry extract was crushed, added the above raw sun-dried ginseng fine powder and an appropriate amount of dextrin, granulated with 80% ethanol, dried, and the drying temperature was 80°C, granulated, and extinguished. Bacteria, filling, outsourcing, inspection, storage.
病例1Case 1
王某某,男,60岁;肺功能、6分钟步行距离、血常规、生化等检测单位:安徽省中医院。Wang Moumou, male, 60 years old; lung function, 6-minute walking distance, blood routine, biochemical and other testing units: Anhui Provincial Hospital of Traditional Chinese Medicine.
(一)血液检查报告(1) Blood test report
(二)、肺功能测定(2) Pulmonary function test
(三)、临床症状体征评分(2011-11-27):14分(3), clinical symptoms and signs score (2011-11-27): 14 points
(四)、6分钟步行距离321米(4), 6 minutes walking distance 321 meters
患者于2011年11月27日检查后开始按照疗程服用本发明的六味补气胶囊,于2012年11月25日再次接受检查,治疗效果显著,临床检查指标如下:The patient began to take the Liuwei Buqi capsule of the present invention according to the course of treatment after the examination on November 27, 2011, and was examined again on November 25, 2012. The therapeutic effect was remarkable, and the clinical examination indicators were as follows:
(一)实验室检查报告(1) Laboratory inspection report
(二)、肺功能测定(2) Pulmonary function test
(三)、临床症状体征评分(2012-11-25):8分(3), clinical symptoms and signs score (2012-11-25): 8 points
(四)、6分钟步行距离521米(4), 6 minutes walking distance 521 meters
实施例2Example 2
取生晒参5克将生晒参铺平在烘盘中,放入烘箱,控制温度为70℃,干燥、粉碎细粉备用;粗粉中加入炙黄芪10克、益智仁1克、玉竹5克、陈皮1克、肉桂1克,之后加水煎煮提取三次。第一次加重量比10倍量水,煎煮1.5小时;第二、三次加重量比8倍量水,煎煮1.0小时,合并提取液滤过,静置48小时,之后吸取煎煮药液的上清液,减压浓缩收膏,真空干燥,干浸膏粉碎,加入上生晒参细粉及适量糊精,用80%乙醇制粒,干燥、干燥温度为80℃,整粒,灭菌,充填,外包,送检,入库。Take 5 grams of raw sun-dried ginseng, spread the raw sun-dried ginseng on a baking tray, put it in an oven, control the temperature at 70°C, dry and pulverize the fine powder for later use; 5 grams of bamboo, 1 gram of tangerine peel, 1 gram of cinnamon, and then add water to decoct and extract three times. Add 10 times the weight ratio of water for the first time, decoct for 1.5 hours; add 8 times the weight ratio of water for the second and third times, decoct for 1.0 hours, combine the extract and filter, let stand for 48 hours, and then absorb the decoction liquid The supernatant was concentrated under reduced pressure to collect the extract, vacuum-dried, the dry extract was crushed, added the above raw sun-dried ginseng fine powder and an appropriate amount of dextrin, granulated with 80% ethanol, dried, and the drying temperature was 80°C, granulated, and extinguished. Bacteria, filling, outsourcing, inspection, storage.
病例2Case 2
吕某某,男,67岁;肺功能、6分钟步行距离、血常规、生化等检测单位:安徽省中医院。Lu Moumou, male, 67 years old; lung function, 6-minute walking distance, blood routine, biochemical and other testing units: Anhui Provincial Hospital of Traditional Chinese Medicine.
(一)实验室检查项目(1) Laboratory inspection items
(二)、肺功能测定(2) Pulmonary function test
(三)、临床症状体征评分(2011-11-27):14分(3), clinical symptoms and signs score (2011-11-27): 14 points
(四)、6分钟步行距离307米(4), 6 minutes walking distance 307 meters
患者于2011年11月27日检查后开始按照疗程服用本发明的六味补气胶囊,于2012年11月25日再次接受检查,治疗效果显著,临床检查指标如下:The patient began to take the Liuwei Buqi capsule of the present invention according to the course of treatment after the examination on November 27, 2011, and was examined again on November 25, 2012. The therapeutic effect was remarkable, and the clinical examination indicators were as follows:
(一)实验室检查项目:(1) Laboratory inspection items:
(二)、肺功能测定(2) Pulmonary function test
(三)、临床症状体征评分(2011-11-27):9分(3), clinical symptoms and signs score (2011-11-27): 9 points
(四)、6分钟步行距离460米(4), 6 minutes walking distance 460 meters
实施例3Example 3
取生晒参15克将生晒参铺平在烘盘中,放入烘箱,控制温度为60℃,干燥、粉碎细粉备用;粗粉中加入炙黄芪20克、益智仁10克、玉竹15克、陈皮10克、肉桂10克,之后加水煎煮提取三次。第一次加重量比10倍量水,煎煮1.5小时;第二、三次加重量比8倍量水,煎煮1.0小时,合并提取液滤过,静置48小时,之后吸取煎煮药液的上清液,减压浓缩收膏,真空干燥,干浸膏粉碎,加入上生晒参细粉及适量糊精,用80%乙醇制粒,干燥、干燥温度为70℃,整粒,灭菌,充填,外包,送检,入库。Take 15 grams of raw sun-dried ginseng, spread the raw sun-dried ginseng on a baking tray, put it in an oven, control the temperature at 60°C, dry and pulverize the fine powder for later use; 15 grams of bamboo, 10 grams of tangerine peel, 10 grams of cinnamon, and then add water to decoct and extract three times. Add 10 times the weight ratio of water for the first time, decoct for 1.5 hours; add 8 times the weight ratio of water for the second and third times, decoct for 1.0 hours, combine the extract and filter, let stand for 48 hours, and then absorb the decoction liquid The supernatant was concentrated under reduced pressure to collect the extract, vacuum dried, the dry extract was crushed, added the above raw sun-dried ginseng fine powder and an appropriate amount of dextrin, granulated with 80% ethanol, dried, and the drying temperature was 70°C, granulated, extinguished Bacteria, filling, outsourcing, inspection, storage.
病例3Case 3
黄某某,男,70岁;肺功能、6分钟步行距离、血常规、生化等检测单位:安徽省中医院。Huang Moumou, male, 70 years old; lung function, 6-minute walking distance, blood routine, biochemical and other testing units: Anhui Provincial Hospital of Traditional Chinese Medicine.
(一)实验室检查项目(1) Laboratory inspection items
(二)、肺功能测定(2) Pulmonary function test
(三)、临床症状体征评分(2011-11-27):12分(3), clinical symptoms and signs score (2011-11-27): 12 points
(四)、6分钟步行距离315米(4), 6 minutes walking distance 315 meters
患者于2011年10月29日检查后开始按照疗程服用本发明的六味补气胶囊,于2012年10月20日再次接受检查,治疗效果显著,临床检查指标如下:The patient began to take the Liuwei Buqi capsule of the present invention according to the course of treatment after the examination on October 29, 2011, and was examined again on October 20, 2012. The therapeutic effect was remarkable, and the clinical examination indicators were as follows:
(一)、实验室检查项目(1) Laboratory inspection items
(二)、肺功能测定(2) Pulmonary function test
(三)、临床症状体征评分(2011-11-27):7分(3), clinical symptoms and signs score (2011-11-27): 7 points
(四)、6分钟步行距离465米(4), 6 minutes walking distance 465 meters
实施例4Example 4
取生晒参10克将生晒参铺平在烘盘中,放入烘箱,控制温度为60℃,干燥、粉碎细粉备用;粗粉中加入炙黄芪15克、益智仁5克、玉竹8克、陈皮5克、肉桂5克,之后加水煎煮提取三次。第一次加重量比10倍量水,煎煮1.5小时;第二、三次加重量比8倍量水,煎煮1.0小时,合并提取液滤过,静置48小时,之后吸取煎煮药液的上清液,减压浓缩收膏,真空干燥,干浸膏粉碎,加入上生晒参细粉及适量糊精,用80%乙醇制粒,干燥、干燥温度为70℃,整粒,灭菌,充填,外包,送检,入库。Take 10 grams of raw sun-dried ginseng, spread the raw sun-dried ginseng on a baking tray, put it in an oven, control the temperature at 60°C, dry and pulverize the fine powder for later use; 8 grams of bamboo, 5 grams of tangerine peel, and 5 grams of cinnamon, and then add water to decoct and extract three times. Add 10 times the weight ratio of water for the first time, decoct for 1.5 hours; add 8 times the weight ratio of water for the second and third times, decoct for 1.0 hours, combine the extract and filter, let stand for 48 hours, and then absorb the decoction liquid The supernatant was concentrated under reduced pressure to collect the extract, vacuum dried, the dry extract was crushed, added the above raw sun-dried ginseng fine powder and an appropriate amount of dextrin, granulated with 80% ethanol, dried, and the drying temperature was 70°C, granulated, and extinguished. Bacteria, filling, outsourcing, inspection, storage.
病例4Case 4
韩某某,男,58岁;肺功能、6分钟步行距离、血常规、生化等检测单位:安徽省中医院。Han Moumou, male, 58 years old; lung function, 6-minute walking distance, blood routine, biochemical and other testing units: Anhui Provincial Hospital of Traditional Chinese Medicine.
(一)实验室检查项目(1) Laboratory inspection items
(二)、肺功能测定(2) Pulmonary function test
(三)、临床症状体征评分(2011-11-27):13分(3), clinical symptoms and signs score (2011-11-27): 13 points
(四)、6分钟步行距离289米(4), 6 minutes walking distance 289 meters
患者于2011年10月29日检查后开始按照疗程服用本发明的六味补气胶囊,于2012年11月25日再次接受检查,治疗效果显著,临床检查指标如下:The patient began to take Liuwei Buqi Capsules of the present invention according to the course of treatment after the examination on October 29, 2011, and was examined again on November 25, 2012. The therapeutic effect was remarkable, and the clinical examination indicators were as follows:
(一)实验室检查项目(1) Laboratory inspection items
(二)、肺功能测定(2) Pulmonary function test
(三)、临床症状体征评分(2011-11-27):9分(3), clinical symptoms and signs score (2011-11-27): 9 points
(四)、6分钟步行距离430米。(4), 6 minutes walking distance of 430 meters.
以上显示和描述了本发明的基本原理、主要特征及本发明的优点。本行业的技术人员应该了解,本发明不受上述实施例的限制,上述实施例和说明书中描述的只是说明本发明的原理,在不脱离本发明精神和范围的前提下,本发明还会有各种变化和改进,这些变化和改进都落入要求保护的本发明范围内。本发明的要求保护范围由所附的权利要求书及其等效物界定。The basic principles, main features and advantages of the present invention have been shown and described above. Those skilled in the industry should understand that the present invention is not limited by the above-mentioned embodiments, and what described in the above-mentioned embodiments and the description only illustrates the principles of the present invention, and the present invention will also have other functions without departing from the spirit and scope of the present invention. Variations and improvements are possible, which fall within the scope of the claimed invention. The claimed scope of the present invention is defined by the appended claims and their equivalents.
Claims (7)
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| CN116421680A (en) * | 2023-04-18 | 2023-07-14 | 纳元(宁波)生物医药科技有限公司 | Micro-traditional Chinese medicine for treating cough caused by lung-spleen qi deficiency and application method thereof |
| CN116509973A (en) * | 2023-06-21 | 2023-08-01 | 安徽中医药大学第一附属医院(安徽省中医院) | Pharmaceutical composition for treating chronic obstructive pulmonary disease and application thereof |
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| CN116421680A (en) * | 2023-04-18 | 2023-07-14 | 纳元(宁波)生物医药科技有限公司 | Micro-traditional Chinese medicine for treating cough caused by lung-spleen qi deficiency and application method thereof |
| CN116509973A (en) * | 2023-06-21 | 2023-08-01 | 安徽中医药大学第一附属医院(安徽省中医院) | Pharmaceutical composition for treating chronic obstructive pulmonary disease and application thereof |
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