CN117442697A - Traditional Chinese medicine composition for treating chronic obstructive pulmonary disease and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for treating chronic obstructive pulmonary disease and preparation method and application thereof Download PDFInfo
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- CN117442697A CN117442697A CN202311642139.1A CN202311642139A CN117442697A CN 117442697 A CN117442697 A CN 117442697A CN 202311642139 A CN202311642139 A CN 202311642139A CN 117442697 A CN117442697 A CN 117442697A
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- traditional chinese
- chronic obstructive
- pulmonary disease
- obstructive pulmonary
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Abstract
本发明公开了一种治疗慢性阻塞性肺病的中药组合物,由肉苁蓉、巴戟天、牛膝、杜仲、茯苓、人参、蛤蚧、黄芩、瓜蒌、丹参、当归、莪术、胆南星、半夏、杏仁、木香、枳实、陈皮、熟地黄、泽泻、车前子提取制备而成,能温补脾肾肺阳、清泄肺热、活血化瘀、祛风化痰、理气、泻浊利水,共同配伍治疗脾肾阳虚型慢性阻塞性肺病,本发明还公开了其制备方法和应用。The invention discloses a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, which is composed of Cistanche deserticola, Morinda officinalis, Achyranthes bidentata, Eucommia ulmoides, Poria cocos, ginseng, Gecko, Scutellaria baicalensis, Trichosanthes melon, Salvia miltiorrhiza, Angelica sinensis, Curcuma turmeric, Dannanxing, Pinellia ternata. , almond, costus, citrus aurantium, tangerine peel, rehmannia glutinosa, Alisma and plantain. It can warm and nourish the spleen, kidney and lung yang, clear lung heat, activate blood circulation and remove blood stasis, dispel wind and phlegm, regulate qi, purge turbidity and diuresis. The invention also discloses its preparation method and application for the treatment of chronic obstructive pulmonary disease of spleen and kidney yang deficiency type.
Description
技术领域Technical field
本发明属于中药组合物及制剂技术领域,具体涉及一种治疗慢性阻塞性肺病的中药组合物及其制备方法和应用。The invention belongs to the technical field of traditional Chinese medicine compositions and preparations, and specifically relates to a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease and its preparation method and application.
背景技术Background technique
慢性阻塞性肺病(COPD)是一组气流受限为特征的肺部疾病,气流受限不完全可逆,呈进行性发展,但是可以预防和治疗的疾病。在COPD的定义中采用了“气流受限”这一概念,而未用“气道阻塞”这一旧名称,是因为单纯肺气肿时,气道并无器质性阻塞性疾病,但由于肺泡组织的弹性降低,因而肺泡压降低,使得气流流速缓慢、受阻。尤其是吸烟的老年男性,多部分都患有此病,表现为咳嗽、咳痰、呼吸困难等。COPD主要累及肺部,但也可以引起肺外各器官的损害。中医命名为“肺胀”,中医认为慢性阻塞性肺病一般分为寒饮射肺、痰热壅肺、肺肾两虚、脾肾阳虚、寒痰内闭、熱痰内闭,因咳嗽、哮喘等证,日久不愈,发病后病情难缠难愈,其中脾肾阳虚最为常见,症状表现为胸闷气憋,呼多吸少,动则气喘,冷汗自出,四肢不温,畏寒神怯,小便清长或失禁,舌淡嫩胖,脉微细。Chronic obstructive pulmonary disease (COPD) is a group of lung diseases characterized by airflow limitation. The airflow limitation is not completely reversible and develops progressively, but it can be prevented and treated. The concept of "airflow limitation" is used in the definition of COPD instead of the old name "airway obstruction" because in simple emphysema, there is no organic obstructive disease in the airway, but due to The elasticity of the alveolar tissue decreases, thus lowering the alveolar pressure, making the air flow slow and blocked. Especially elderly men who smoke, most of them suffer from this disease, which is manifested by cough, sputum, difficulty breathing, etc. COPD mainly affects the lungs, but can also cause damage to various organs outside the lungs. Traditional Chinese medicine names it "lung distension". Traditional Chinese medicine believes that chronic obstructive pulmonary disease is generally divided into cold drinks shooting into the lungs, phlegm and heat blocking the lungs, lung and kidney deficiency, spleen and kidney yang deficiency, cold phlegm in the lungs, hot phlegm in the lungs, due to cough, Asthma and other syndromes will not heal over time. After the onset, the condition is difficult to treat and difficult to recover. Among them, spleen and kidney yang deficiency is the most common. Symptoms include chest tightness and suffocation, exhaling more and inhaling less, wheezing when moving, spontaneous cold sweats, lukewarm limbs, and fear. Cold and timid, long and clear urine or incontinence, pale tongue, tender and fat tongue, and thin pulse.
CN110292601B公开中药复方由以下中药材作为原料制成:陈皮、丁香、黄芪、香鳞毛蕨;所述中药材的配伍比例按照重量份数计算为:陈皮30~90份、丁香10~30份、黄芪10~20份、香鳞毛蕨8~14份;所述丁香、香鳞毛蕨采用水蒸气蒸馏法提取,所述陈皮、黄芪采用水煎煮提取。陈皮、丁香为君,黄芪为佐,香鳞毛蕨为佐使;或加入风箱树根、大肺筋草、穿根藤为臣具有抗炎、祛痰、平喘作用。在多种动物模型中显示出有益效果,对急性期慢性阻塞性肺病模型也具有改善作用。CN110742966B公开了一种治疗慢性阻塞性肺病的中药组合物,包括以下重量份数的各组分:蓝布正30~60份,山麦冬20~40份,天冬10~20份,川贝母10~20份,暴马子皮20~40份,满山红25~50份,玉竹10~30份,牛蒡子10~20份,当归5~20份,山药(炒)20~40份。此外,本发明还提供了一种治疗慢性阻塞性肺病的中药组合物的制备方法。本发明提供的中药组合物具有散结消肿、清肺祛痰、养阴润燥,生津止渴、宜肺透疹,切中慢性阻塞性肺病之病机,适用于患有慢性阻塞性肺病的患者。上述方法均没有针对证型进行辨证治疗。CN110292601B discloses a traditional Chinese medicine compound made of the following traditional Chinese medicines as raw materials: tangerine peel, cloves, astragalus, and Dryopteris; the compatibility ratio of the Chinese medicines is calculated in parts by weight: 30 to 90 parts of tangerine peel, 10 to 30 parts of cloves, 10 to 20 parts of astragalus and 8 to 14 parts of Dryopteris fragrans; the cloves and Dryopteris fragrans are extracted by steam distillation, and the tangerine peel and astragalus are extracted by decoction. Tangerine peel and clove are the main ingredients, astragalus is the auxiliary, and Dryopteris fragrans is the adjuvant; or bellows tree root, big lung muscle grass, and Chuangenvine are added to have anti-inflammatory, expectorant, and antiasthmatic effects. It has shown beneficial effects in a variety of animal models and also has an improvement effect on acute phase chronic obstructive pulmonary disease models. CN110742966B discloses a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, which includes the following components by weight: 30 to 60 parts of Lanbusheng, 20 to 40 parts of Ophiopogon japonicus, 10 to 20 parts of Asparagus Asparagus, and Sichuan Fritillaria 10 to 20 parts of mother's milk, 20 to 40 parts of Baomazi skin, 25 to 50 parts of mountain red, 10 to 30 parts of Polygonatum odoratum, 10 to 20 parts of burdock, 5 to 20 parts of angelica root, 20 to 40 parts of Chinese yam (fried) . In addition, the present invention also provides a preparation method of a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease. The traditional Chinese medicine composition provided by the present invention has the functions of dispersing stagnation and reducing swelling, clearing the lungs and eliminating phlegm, nourishing yin and moisturizing dryness, producing body fluids and quenching thirst, and is suitable for lungs and rashes. It cuts into the pathogenesis of chronic obstructive pulmonary disease and is suitable for patients suffering from chronic obstructive pulmonary disease. patient. None of the above methods provide syndrome differentiation treatment based on syndrome types.
发明内容Contents of the invention
本发明的第一目的在于提供一种治疗慢性阻塞性肺病的中药组合物;进一步提供该中药组合物之制剂,以及用途。The first object of the present invention is to provide a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease; and further provide preparations and uses of the traditional Chinese medicine composition.
本发明的第一目的是这样实现的,本发明所述治疗慢性阻塞性肺病的中药组合物,所述中药组合物由下列重量份的中药提取制备而成:肉苁蓉10-20份、巴戟天9-18份、牛膝9-18份、杜仲6-18份、茯苓6-18份、人参10-20份、蛤蚧5-15份、黄芩6-18份、瓜蒌15-25份、丹参15-25份、当归12-18份、莪术9-18份、胆南星6-18份、半夏10-20份、杏仁9-18份、木香6-18份、枳实12-18份、陈皮9-18份、熟地黄10-20份、泽泻6-18份、车前子5-15份。The first object of the present invention is achieved in this way. The traditional Chinese medicine composition for treating chronic obstructive pulmonary disease of the present invention is prepared by extracting and preparing the following traditional Chinese medicines in parts by weight: 10-20 parts of Cistanche deserticola, Morinda officinalis. 9-18 servings, Achyranthes bidentata 9-18 servings, Eucommia ulmoides 6-18 servings, Poria cocos 6-18 servings, Ginseng 10-20 servings, Gecko 5-15 servings, Scutellaria baicalensis 6-18 servings, Trichosanthes melon 15-25 servings, Salvia miltiorrhiza 15-25 parts, angelica 12-18 parts, zedoary 9-18 parts, gallbladder 6-18 parts, pinellia 10-20 parts, almond 9-18 parts, costus 6-18 parts, citrus aurantium 12-18 parts , 9-18 parts of tangerine peel, 10-20 parts of Rehmannia glutinosa, 6-18 parts of Alisma, and 5-15 parts of Plantago.
所述治疗慢性阻塞性肺病的中药组合物,所述中药组合物由下列重量份的中药提取制备而成:肉苁蓉15份、巴戟天15份、牛膝12份、杜仲12份、茯苓10份、人参15份、蛤蚧10份、黄芩12份、瓜蒌20份、丹参20份、当归15份、莪术12份、胆南星10份、半夏15份、杏仁12份、木香15份、枳实15份、陈皮15份、熟地黄15份、泽泻12份、车前子10份。The traditional Chinese medicine composition for treating chronic obstructive pulmonary disease is prepared by extracting and preparing the following traditional Chinese medicines in parts by weight: 15 parts of Cistanche deserticola, 15 parts of Morinda officinalis, 12 parts of Achyranthes bidentata, 12 parts of Eucommia ulmoides, and 10 parts of Poria cocos. , 15 parts of ginseng, 10 parts of gecko, 12 parts of skullcap, 20 parts of trichosanthes, 20 parts of salvia, 15 parts of angelica, 12 parts of zedoary, 10 parts of bile, 15 parts of pinellia, 12 parts of almond, 15 parts of woody root, tangerine 15 parts of real fruit, 15 parts of tangerine peel, 15 parts of Rehmannia glutinosa, 12 parts of Alisma, and 10 parts of Psyllium chinensis.
所述治疗慢性阻塞性肺病的中药组合物,所述慢性阻塞性肺病证型为脾肾阳虚型。According to the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, the syndrome type of chronic obstructive pulmonary disease is spleen and kidney yang deficiency type.
所述治疗慢性阻塞性肺病的中药组合物,所述中药组合物中中药提取后加入医学上可以接受的辅料,制备成汤剂、颗粒剂、丸剂、片剂、胶囊剂、膏剂、糖浆剂和粉剂中的任意一种。The traditional Chinese medicine composition for treating chronic obstructive pulmonary disease is prepared by adding medically acceptable auxiliary materials after extracting the traditional Chinese medicine, and preparing it into decoctions, granules, pills, tablets, capsules, ointments, syrups and Any kind of powder.
所述治疗慢性阻塞性肺病的中药组合物,所述颗粒剂由下列工艺制备:For the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, the granules are prepared by the following process:
(1)煎煮:将组方各药味按药水重量比1:10-15加水煎煮1-3次,每次30-60min,合并煎煮液;(1) Decoction: Add each medicinal flavor of the formula to water according to the weight ratio of 1:10-15 and decoct it 1-3 times, 30-60 minutes each time, and combine the decoction liquid;
(2)浓缩:将所得煎煮液在50-75℃,-0.02--0.06MPa真空度下浓缩成稠膏,稠膏50℃时密度为1.20g/ml;(2) Concentration: Concentrate the resulting decoction liquid into a thick paste at 50-75°C and -0.02--0.06MPa vacuum. The density of the thick paste at 50°C is 1.20g/ml;
(3)干燥:将稠膏于50-75℃,-0.02--0.06MPa真空度下干燥成干膏,备用;(3) Drying: dry the thick paste at 50-75°C and -0.02--0.06MPa vacuum to become a dry paste for later use;
(4)干膏粉碎并过100目筛得混合干膏粉,加入制粒辅料混匀,加入适量70-90%的乙醇,湿法制粒,干燥后即得颗粒剂。(4) Crush the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Add granulation auxiliary materials and mix well. Add an appropriate amount of 70-90% ethanol and perform wet granulation. After drying, granules are obtained.
所述治疗慢性阻塞性肺病的中药组合物,所述丸剂由下列工艺制备:According to the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, the pills are prepared by the following process:
(1)煎煮:将组方中各药味按组方量称量,并按药水重量比1:10-15加水煎煮1-3次,每次30-60min,合并煎煮液;(1) Decoction: Weigh each medicinal flavor in the formula according to the formula, add water and decoct 1-3 times according to the weight ratio of the medicinal solution 1:10-15, 30-60 minutes each time, and combine the decoction liquid;
(2)浓缩:将所得煎煮液在50-75℃,-0.02--0.06MPa真空度下浓缩成稠膏,稠膏50-60℃时密度为1.20-1.35g/ml;(2) Concentration: Concentrate the resulting decoction liquid into a thick paste at 50-75°C and -0.02--0.06MPa vacuum. The density of the thick paste at 50-60°C is 1.20-1.35g/ml;
(3)干燥:将稠膏于50-75℃,-0.02--0.06MPa真空度下干燥成干膏,备用;(3) Drying: dry the thick paste at 50-75°C and -0.02--0.06MPa vacuum to become a dry paste for later use;
(4)干膏粉碎并过100目筛得混合干膏粉,用水或30%及以下浓度乙醇泛丸,即得丸剂。(4) Crush the dry paste and pass it through a 100-mesh sieve to obtain mixed dry paste powder. Pellet it with water or ethanol with a concentration of 30% or less to obtain pills.
所述中药组合物在制备治疗脾肾阳虚型慢性阻塞性肺病药物中的应用。Application of the traditional Chinese medicine composition in preparing medicine for treating chronic obstructive pulmonary disease of spleen and kidney yang deficiency type.
上述药材均符合中国药典标准。The above medicinal materials all comply with Chinese Pharmacopoeia standards.
有益效果:Beneficial effects:
1、本发明通过如下治法治则进行治疗脾肾阳虚型慢性阻塞性肺病:一是由于脾阳不足,则津液转输无能,水津停滞,积而为饮,饮聚成痰,痰随气上逆,上干于肺,久则阻塞气道,呼吸不利;肾阳虚衰,下焦阴寒之气,挟水饮上逆于肺,可致咳喘气逆;肺主气,肾纳气,肺为气之主,肾为气之根,肺虚则清肃失司,肾虚则纳气无能,清气难入,浊气难出,故胸满喘促,动则气短,故采用温补脾肾肺阳;二是脾虚生痰,郁而化热,故采用清泄肺热,也防止温补脾肾肺阳过度;三是痰瘀相结肺胀咳逆,日久不愈,不仅损伤肺肾之气,而且势必导致瘀滞,盖气不煦则血不濡,而成气血瘀滞之证;脾为生痰之源,脾虚则痰生,痰瘀互结,络脉阻滞,则可出现痰涎壅盛、唇暗舌紫、手足青黑等证候。如《丹溪心法·咳嗽》说:“肺胀而嗽,或左或右不得眠,此痰夹瘀血碍气而病。”,故采用活血化瘀和祛风化痰之法;四是气根于肾,主于肺。咳喘日久,经年不擦,必伤肺气;由肺及肾,必致肺肾俱虚。肺不主气而气滞,肾不纳气而气逆,当升不升,当降不降,肺肾之气不能交相贯通,以致清气难入,浊气难出,滞于胸中,壅塞于肺而为膨膨胀满。如隋代巢元方《诸病源候论·气病诸候》说:“肺主于气,邪乘于肺则肺胀,胀则肺管不利,不利则气道塞,故气上喘逆。”亦有因年老体弱,下元虚惫,以致气不归根,逆而上冲,下虚上盛,使肺气胀满,发为本病,故采用理气之法,气顺而痰行;五是因为血不利则为水,导致肺、脾、肾之水液代谢功能失常,而致饮邪内停,凌心射肺,外溢肌肤,故采用泻浊利水之法。1. The present invention treats chronic obstructive pulmonary disease of spleen-kidney yang deficiency type through the following therapeutic principles: First, due to insufficient spleen yang, the transfer of body fluids is incompetent, water and body fluids are stagnant, and accumulation is caused by drinking, and drinking accumulates into phlegm, and phlegm follows the Qi. Upverse, the upper stem is in the lungs, which will block the airway for a long time and make breathing difficult; kidney yang is weak, and the yin and cold air in the lower burner, drinking water with the upper stem in the lungs, can cause coughing and dyspnea; the lungs govern qi, and the kidneys receive qi. The lungs are the masters of qi, and the kidneys are the roots of qi. If the lungs are deficient, purification will be lost, and if the kidneys are deficient, the qi will be unable to be received. It is difficult for clear qi to enter and for turbid qi to come out, so the chest will be full and short of breath, and movement will cause shortness of breath. Therefore, warming and nourishing the spleen and kidneys are required. Lung yang; second, spleen deficiency produces phlegm, stagnation and heat, so clearing the lung heat can also prevent excessive warming and tonifying the spleen and kidney lung yang; third, phlegm and blood stasis combined with lung distension and coughing, which will not heal over time, will not only damage the lungs and kidneys Qi, and it will inevitably lead to stasis. If the Qi is not warm, the blood will not be wet, forming a syndrome of qi and blood stagnation; the spleen is the source of phlegm, and spleen deficiency will lead to phlegm, phlegm and blood stasis, and the collaterals will be blocked. Symptoms such as excessive phlegm and saliva, dark lips and purple tongue, and blue and black hands and feet appear. For example, "Danxi Heart Method Cough" says: "Coughing due to distended lungs, or inability to sleep on the left or right side, is caused by phlegm and blood stasis that hinders Qi." Therefore, the method of activating blood circulation and removing blood stasis and dispelling wind and phlegm is adopted; the fourth is Qi is rooted in the kidneys and governs the lungs. Coughing and wheezing for a long time, if left unchecked for many years, will definitely damage the lung qi; from the lungs and kidneys, it will lead to deficiency of both lungs and kidneys. The lungs do not control the qi and become stagnant; the kidneys do not accept the qi and the qi is reversed. When it rises, it does not rise; when it falls, it does not fall. The qi of the lungs and kidneys cannot communicate with each other, so that it is difficult for clear qi to enter and for turbid qi to come out, and it becomes stagnant in the chest. Congestion in the lungs causes swelling and fullness. For example, Chao Yuanfang's "Treatise on the Causes and Symptoms of Diseases: Treating Qi Diseases" of the Sui Dynasty said: "The lungs govern Qi. If evil multiplies in the lungs, the lungs will swell. If the lungs are swollen, the lungs will be unfavorable. If it is unfavorable, the airways will be blocked, so the Qi will be reversed. ." There are also cases where the lower Yuan is exhausted due to old age and frailty, so that the Qi does not return to the root, but rushes upward, causing the lower Qi to become swollen and full, causing the lung Qi to swell and become the primary disease. Therefore, the method of regulating Qi is adopted to make the Qi smooth and smooth. The fifth reason is that when the blood is unfavorable, it will be water, which will lead to abnormal water metabolism in the lungs, spleen, and kidneys, causing the internal stasis of drinking evil, causing the heart to irritate the lungs and overflow the skin, so the method of purging turbidity and diluting water is adopted.
本发明采用肉苁蓉、巴戟天、牛膝、杜仲温补脾肾,茯苓、人参补脾,蛤蚧补肺虚,而且能补肾而益精血,定喘止嗽,采用黄芩、瓜蒌清热化痰,上述中药肉苁蓉、巴戟天、牛膝、杜仲、茯苓、人参、蛤蚧、黄芩、瓜蒌共为君药;丹参、当归、莪术活血化瘀,胆南星、半夏、杏仁祛风化痰,共为臣药;木香、枳实、陈皮行气散结,理气,气顺而痰行,为佐药;熟地黄滋补肾水、泽泻、车前子宣泄肾浊以清之,为使药,全方温补脾肾肺阳、清泄肺热、活血化瘀、祛风化痰、理气、泻浊利水,共同配伍治疗脾肾阳虚型慢性阻塞性肺病。The present invention uses Cistanche deserticola, Morinda officinalis, Achyranthes bidentata and Eucommia ulmoides to warm and nourish the spleen and kidneys; Poria cocos and ginseng nourish the spleen; Gecko nourishes the lungs, and can nourish the kidneys, benefit essence and blood, relieve asthma and cough, and uses Scutellaria baicalensis and Trichosanthes melon to clear away heat and resolve phlegm. The traditional Chinese medicines Cistanche deserticola, Morinda officinalis, Achyranthes bidentata, Eucommia ulmoides, Poria cocos, ginseng, gecko, skullcap, and Trichosanthes melon are all monarch medicines; Salvia miltiorrhiza, Angelica sinensis, and Curcuma zedoary are activating blood circulation and removing blood stasis, and Dannanxing, Pinellia ternata, and almond are all ministerial medicines for dispelling wind and reducing phlegm. Medicines: Acosta, Citrus aurantium, and dried tangerine peel can promote qi and dissipate stagnation, regulate qi, smooth qi and eliminate phlegm. They are used as adjuvant medicines; Rehmannia glutinosa can nourish kidney water, Alisma, and Plantago seed can relieve kidney turbidity and clear it. The prescription warms the spleen, kidney and lung yang, clears away lung heat, activates blood circulation and removes blood stasis, dispels wind and phlegm, regulates qi, purges turbidity and diuresis, and can be used together to treat chronic obstructive pulmonary disease due to spleen and kidney yang deficiency.
2、采用烟熏结合气管注射脂多糖构建大鼠慢阻肺模型,本发明实施例1样品对血清TNF-a均具有降低趋势,对肺脏系数均用降低作用,提示本发明对慢性阻塞性肺病具有一定的治疗作用。2. A rat model of chronic obstructive pulmonary disease was constructed by using smoke combined with tracheal injection of lipopolysaccharide. The samples in Example 1 of the present invention all had a decreasing trend in serum TNF-a and had a decreasing effect on lung coefficients, suggesting that the present invention has a positive effect on chronic obstructive pulmonary disease. It has certain therapeutic effect.
3、针对门诊收治疗慢性阻塞性肺病患者共100例,本发明实施例1提供的颗粒剂,临床试验结果表明总有效率高达90%,临床痊愈率42%,显效率36%,而对照组总有效率为74%,临床痊愈率24%,显效率26%,这就表明本发明中药组合物治疗脾肾阳虚型慢性阻塞性肺病的疗效优于常规的治疗方法。临床观察结果表明,治疗组的50例患者服用本发明中药组合物后,无明显毒副作用,服用安全可靠。3. A total of 100 patients with chronic obstructive pulmonary disease were treated in outpatient clinics. The clinical test results of the granules provided in Example 1 of the present invention showed that the total effective rate was as high as 90%, the clinical recovery rate was 42%, and the effective rate was 36%, while the control group The total effective rate was 74%, the clinical recovery rate was 24%, and the effective rate was 26%. This shows that the traditional Chinese medicine composition of the present invention is more effective than conventional treatment methods in treating chronic obstructive pulmonary disease with spleen and kidney yang deficiency. Clinical observation results show that after the 50 patients in the treatment group took the traditional Chinese medicine composition of the present invention, there were no obvious toxic or side effects, and it was safe and reliable to take.
具体实施方式Detailed ways
下面结合具体实施方式,进一步阐述本发明。应理解,这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解,在阅读了本发明记载的内容之后,本领域技术人员可以对本发明作各种改动或修改,但这些等价形式同样落于本申请所附权利要求书所限定的范围。The present invention will be further described below in conjunction with specific embodiments. It should be understood that these examples are only used to illustrate the invention and are not intended to limit the scope of the invention. In addition, it should be understood that after reading the content described in the present invention, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms also fall within the scope defined by the appended claims of this application.
实施例1:取肉苁蓉15g、巴戟天15g、牛膝12g、杜仲12g、茯苓10g、人参15g、蛤蚧10g、黄芩12g、瓜蒌20g、丹参20g、当归15g、莪术12g、胆南星10g、半夏15g、杏仁12g、木香15g、枳实15g、陈皮15g、熟地黄15g、泽泻12g、车前子10g,由下列工艺制备:Example 1: Take 15g of Cistanche deserticola, 15g of Morinda officinalis, 12g of Achyranthes bidentata, 12g of Eucommia ulmoides, 10g of Poria cocos, 15g of ginseng, 10g of Gecko, 12g of skullcap, 20g of Trichosanthes trichosanthes, 20g of Salvia miltiorrhiza, 15g of Angelica sinensis, 12g of Curcuma, 10g of Dannanxing, half 15g Xia Xia, 12g almonds, 15g Koesin, 15g Citrus aurantium, 15g tangerine peel, 15g Rehmannia glutinosa, 12g Alisma, 10g Plantago, prepared by the following process:
(1)煎煮:将组方各药味按药水重量比1:10加水煎煮2次,每次45min,合并煎煮液;(1) Decoction: Add each medicinal flavor of the formula to water at a potion weight ratio of 1:10 and decoct it twice, 45 minutes each time, and combine the decoction liquid;
(2)浓缩:将所得煎煮液在65℃,-0.05MPa真空度下浓缩成稠膏,稠膏50℃时密度为1.20g/ml;(2) Concentration: Concentrate the resulting decoction liquid into a thick paste at 65°C and -0.05MPa vacuum. The density of the thick paste at 50°C is 1.20g/ml;
(3)干燥:将稠膏于65℃,-0.05MPa真空度下干燥成干膏,备用;(3) Drying: dry the thick paste at 65°C and -0.05MPa vacuum to become a dry paste for later use;
(4)干膏粉碎并过100目筛得混合干膏粉,加入制粒辅料混匀,加入适量80%的乙醇,湿法制粒,干燥后即得颗粒剂。(4) Crush the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Add granulation auxiliary materials and mix well. Add an appropriate amount of 80% ethanol and perform wet granulation. After drying, granules are obtained.
实施例2:取肉苁蓉10g、巴戟天18g、牛膝9g、杜仲18g、茯苓6g、人参20g、蛤蚧5g、黄芩18g、瓜蒌15g、丹参25g、当归12g、莪术18g、胆南星6g、半夏20g、杏仁9g、木香18g、枳实12g、陈皮18g、熟地黄10g、泽泻18g、车前子5g,由下列工艺制备:Example 2: Take 10g of Cistanche deserticola, 18g of Morinda officinalis, 9g of Achyranthes bidentata, 18g of Eucommia ulmoides, 6g of Poria cocos, 20g of ginseng, 5g of Gecko, 18g of skullcap, 15g of Trichosanthes trichosanthes, 25g of Salvia miltiorrhiza, 12g of Angelica sinensis, 18g of Curcuma, 6g of Dannanxing, half 20g of Xia Xia, 9g of almonds, 18g of Acosta, 12g of Citrus aurantium, 18g of tangerine peel, 10g of Rehmannia glutinosa, 18g of Alisma and 5g of Plantago, prepared by the following process:
(1)煎煮:将组方各药味按药水重量比1:12加水煎煮1次,每次60min,合并煎煮液;(1) Decoction: Add each medicinal flavor of the formula to water at a potion weight ratio of 1:12 and decoct once for 60 minutes each time, and combine the decoction liquid;
(2)浓缩:将所得煎煮液在50℃,-0.06MPa真空度下浓缩成稠膏,稠膏50℃时密度为1.20g/ml;(2) Concentration: Concentrate the resulting decoction liquid into a thick paste at 50°C and -0.06MPa vacuum. The density of the thick paste at 50°C is 1.20g/ml;
(3)干燥:将稠膏于50℃,-0.06MPa真空度下干燥成干膏,备用;(3) Drying: dry the thick paste at 50°C and -0.06MPa vacuum to become a dry paste for later use;
(4)干膏粉碎并过100目筛得混合干膏粉,加入制粒辅料混匀,加入适量70-90%的乙醇,湿法制粒,干燥后即得颗粒剂。(4) Crush the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Add granulation auxiliary materials and mix well. Add an appropriate amount of 70-90% ethanol and perform wet granulation. After drying, granules are obtained.
实施例3:取肉苁蓉20g、巴戟天9g、牛膝18g、杜仲6g、茯苓18g、人参10g、蛤蚧15g、黄芩6g、瓜蒌25g、丹参15g、当归18g、莪术9g、胆南星18g、半夏10g、杏仁18g、木香6g、枳实18g、陈皮9g、熟地黄20g、泽泻6g、车前子15g,由下列工艺制备:Example 3: Take 20g of Cistanche deserticola, 9g of Morinda officinalis, 18g of Achyranthes bidentata, 6g of Eucommia ulmoides, 18g of Poria cocos, 10g of ginseng, 15g of Gecko, 6g of skullcap, 25g of Trichosanthes trichosanthes, 15g of Salvia miltiorrhiza, 18g of Angelica sinensis, 9g of Curcuma, 18g of Dannanxing, half Xia Xia 10g, almond 18g, costus 6g, citrus aurantium 18g, tangerine peel 9g, rehmannia glutinosa 20g, Alisma 6g, plantain 15g, prepared by the following process:
(1)煎煮:将组方各药味按药水重量比1:15加水煎煮3次,每次30min,合并煎煮液;(1) Decoction: Add each medicinal flavor of the formula to water at a potion weight ratio of 1:15 and decoct it 3 times, 30 minutes each time, and combine the decoction liquid;
(2)浓缩:将所得煎煮液在75℃,-0.02MPa真空度下浓缩成稠膏,稠膏50℃时密度为1.20g/ml;(2) Concentration: Concentrate the resulting decoction liquid into a thick paste at 75°C and -0.02MPa vacuum. The density of the thick paste at 50°C is 1.20g/ml;
(3)干燥:将稠膏于75℃,-0.06MPa真空度下干燥成干膏,备用;(3) Drying: dry the thick paste at 75°C and -0.06MPa vacuum to become a dry paste for later use;
(4)干膏粉碎并过100目筛得混合干膏粉,加入制粒辅料混匀,加入适量90%的乙醇,湿法制粒,干燥后即得颗粒剂。(4) Crush the dry paste and pass it through a 100-mesh sieve to obtain a mixed dry paste powder. Add granulation auxiliary materials and mix well. Add an appropriate amount of 90% ethanol and perform wet granulation. After drying, granules are obtained.
实施例4:取肉苁蓉15g、巴戟天15g、牛膝12g、杜仲12g、茯苓10g、人参15g、蛤蚧10g、黄芩12g、瓜蒌20g、丹参20g、当归15g、莪术12g、胆南星10g、半夏15g、杏仁12g、木香15g、枳实15g、陈皮15g、熟地黄15g、泽泻12g、车前子10g,由下列工艺制备:Example 4: Take 15g of Cistanche deserticola, 15g of Morinda officinalis, 12g of Achyranthes bidentata, 12g of Eucommia ulmoides, 10g of Poria cocos, 15g of ginseng, 10g of Gecko, 12g of skullcap, 20g of Trichosanthes trichosanthes, 20g of Salvia miltiorrhiza, 15g of Angelica sinensis, 12g of Curcuma, 10g of Dannanxing, half 15g Xia Xia, 12g almonds, 15g Koesin, 15g Citrus aurantium, 15g tangerine peel, 15g Rehmannia glutinosa, 12g Alisma, 10g Plantago, prepared by the following process:
(1)煎煮:将组方中各药味按组方量称量,并按药水重量比1:12加水煎煮2次,每次45min,合并煎煮液;(1) Decoction: Weigh each medicinal flavor in the formula according to the formula, add water and decoct it twice with a potion weight ratio of 1:12, 45 minutes each time, and combine the decoction liquid;
(2)浓缩:将所得煎煮液在6℃,-0.05MPa真空度下浓缩成稠膏,稠膏50-60℃时密度为1.25g/ml;(2) Concentration: Concentrate the resulting decoction liquid into a thick paste at 6°C and -0.05MPa vacuum. The density of the thick paste at 50-60°C is 1.25g/ml;
(3)干燥:将稠膏于65℃,-0.05MPa真空度下干燥成干膏,备用;(3) Drying: dry the thick paste at 65°C and -0.05MPa vacuum to become a dry paste for later use;
(4)干膏粉碎并过100目筛得混合干膏粉,用水或30%及以下浓度乙醇泛丸,即得丸剂。(4) Crush the dry paste and pass it through a 100-mesh sieve to obtain mixed dry paste powder. Pellet it with water or ethanol with a concentration of 30% or less to obtain pills.
实施例5:取肉苁蓉15g、巴戟天15g、牛膝12g、杜仲12g、茯苓10g、人参15g、蛤蚧10g、黄芩12g、瓜蒌20g、丹参20g、当归15g、莪术12g、胆南星10g、半夏15g、杏仁12g、木香15g、枳实15g、陈皮15g、熟地黄15g、泽泻12g、车前子10g,由下列工艺制备:Example 5: Take 15g of Cistanche deserticola, 15g of Morinda officinalis, 12g of Achyranthes bidentata, 12g of Eucommia ulmoides, 10g of Poria cocos, 15g of ginseng, 10g of Gecko, 12g of skullcap, 20g of Trichosanthes trichosanthes, 20g of Salvia miltiorrhiza, 15g of Angelica sinensis, 12g of Curcuma, 10g of Dannanxing, half 15g Xia Xia, 12g almonds, 15g Koesin, 15g Citrus aurantium, 15g tangerine peel, 15g Rehmannia glutinosa, 12g Alisma, 10g Plantago, prepared by the following process:
(1)煎煮:将组方中各药味按组方量称量,并按药水重量比1:12加水煎煮2次,每次45min,合并煎煮液;(1) Decoction: Weigh each medicinal flavor in the formula according to the formula, add water and decoct it twice with a potion weight ratio of 1:12, 45 minutes each time, and combine the decoction liquid;
(2)浓缩:将所得煎煮液在6℃,-0.05MPa真空度下浓缩成稠膏,稠膏50-60℃时密度为1.25g/ml;(2) Concentration: Concentrate the resulting decoction liquid into a thick paste at 6°C and -0.05MPa vacuum. The density of the thick paste at 50-60°C is 1.25g/ml;
(3)干燥:将稠膏于65℃,-0.05MPa真空度下干燥成干膏,备用;(3) Drying: dry the thick paste at 65°C and -0.05MPa vacuum to become a dry paste for later use;
(4)干膏粉碎并过100目筛得混合干膏粉,用水和蜂蜜,做成糖浆剂。(4) Crush the dry paste and pass it through a 100-mesh sieve to mix the dry paste powder with water and honey to make a syrup.
实施例6:对慢性阻塞性肺病模型大鼠的抗炎作用和肺脏脏器系数影响Example 6: Anti-inflammatory effect and impact on lung organ coefficients in chronic obstructive pulmonary disease model rats
1.实验动物分组1. Grouping of experimental animals
清洁级健康Wistar大鼠30只,雌雄各半,鼠龄10~12周,体重(230±20)g,适应性饲养7d后,笼内饲养,室温(25±1)℃,给予充足食物和饮水,每日12h白天/黑夜循环,随机分为空白组、模型组、给药组,每组10只。Thirty clean-grade healthy Wistar rats, half male and half, 10 to 12 weeks old, weighing (230±20) g, were reared adaptively for 7 days and then raised in cages at room temperature (25±1)°C, with sufficient food and Drinking water, 12h day/night cycle every day, randomly divided into blank group, model group and medication group, with 10 animals in each group.
2.采用烟熏结合气管注射脂多糖构建大鼠慢阻肺模型2. Use smoke combined with tracheal injection of lipopolysaccharide to construct a rat COPD model
分组大鼠放入密闭箱内,给予过滤嘴香烟(焦油量11mg,烟碱量0.8mg,CO量14mg),以5%烟雾浓度进行烟熏,2次/d,0.5h/次,2次间隔时间为8h,共60d。第10d、20d、40d不给予烟熏,气管内注入脂多糖(200μg/200μL)。空白对照组大鼠放入密闭箱内但不进行烟熏,时间、间隔同慢阻肺模型组,第10d、20d、40d气管内注入等量生理盐水。给药组大鼠每日烟熏前30min规定剂量灌胃给药(实施例1所述中药颗粒剂)。除在密闭箱内时间外,三组大鼠在相同环境中饲养,10周造模完成。Rats were grouped into a closed box and given filtered cigarettes (tar content 11 mg, nicotine content 0.8 mg, CO content 14 mg), smoked at a smoke concentration of 5%, 2 times/d, 0.5h/time, 2 times apart. The time is 8h, a total of 60d. On the 10th, 20th, and 40th day, no smoke was given, and lipopolysaccharide (200 μg/200 μL) was injected into the trachea. The rats in the blank control group were placed in a closed box but not smoked. The time and intervals were the same as those in the COPD model group. On the 10th, 20th and 40th days, the same amount of normal saline was injected into the trachea. The rats in the administration group were administered intragastrically at a prescribed dose 30 minutes before smoking every day (the traditional Chinese medicine granules described in Example 1). Except for the time in the closed box, the three groups of rats were raised in the same environment, and the modeling was completed in 10 weeks.
实验结束各组存活动物称重,采血,离心分离血清,Elisa法测定血清中TNF-a含量。采血完毕处死各组存活动物,取肺脏称量肺脏湿重,计算肺脏系数。肺脏系数(%)=100*肺脏湿重/动物体重。各组大鼠肺脏系数及血清TNF-a含量,结果见表1。At the end of the experiment, the surviving animals in each group were weighed, blood was collected, and the serum was separated by centrifugation. The TNF-a content in the serum was measured by Elisa method. After blood collection, the surviving animals in each group were killed, the lungs were taken, the lung wet weight was measured, and the lung coefficient was calculated. Lung coefficient (%)=100*lung wet weight/animal weight. The lung coefficient and serum TNF-a content of rats in each group are shown in Table 1.
表1各组大鼠肺脏系数及血清TNF-a含量Table 1 Lung coefficient and serum TNF-a content of rats in each group
*与模型组相比p<0.05;**与模型组相比p<0.01。*p<0.05 compared with the model group; **p<0.01 compared with the model group.
3.结论:实施例1样品对血清TNF-a具有降低作用,对肺脏系数有降低作用,提示本发明对慢性阻塞性肺病具有一定的治疗作用。3. Conclusion: The sample of Example 1 has a reducing effect on serum TNF-a and the lung coefficient, indicating that the present invention has a certain therapeutic effect on chronic obstructive pulmonary disease.
实施例7:临床研究Example 7: Clinical Study
1.临床资料:自2019年起本院门诊收治疗慢性阻塞性肺病患者共100例。其中男性67例,女性33例,年龄45-74岁,经中医诊断为脾肾阳虚型,症状表现为胸闷气憋,呼多吸少,动则气喘,冷汗自出,四肢不温,畏寒神怯,小便清长或失禁,舌淡嫩胖,脉微细。1. Clinical data: Since 2019, our outpatient clinic has treated a total of 100 patients with chronic obstructive pulmonary disease. Among them, there were 67 males and 33 females, aged 45-74 years old. They were diagnosed by traditional Chinese medicine as spleen and kidney yang deficiency. Symptoms include chest tightness and shortness of breath, more breathing and less breathing, asthma when moving, spontaneous cold sweats, lukewarm limbs, and fear. Cold and timid, long and clear urine or incontinence, pale tongue, tender and fat tongue, and thin pulse.
2.随机分为两组,即治疗组和对照组进行干预研究,治疗组服用本发明实施例1制备出的颗粒剂(每日用量:肉苁蓉15g、巴戟天15g、牛膝12g、杜仲12g、茯苓10g、人参15g、蛤蚧10g、黄芩12g、瓜蒌20g、丹参20g、当归15g、莪术12g、胆南星10g、半夏15g、杏仁12g、木香15g、枳实15g、陈皮15g、熟地黄15g、泽泻12g、车前子10g),对照组服用苏子降气丸(吉林紫鑫般若药业有限公司生产,国药准字Z20063628,批号:20190508),每次6克(一次1袋),每日1-2次。2. Randomly divide into two groups, namely the treatment group and the control group for intervention research. The treatment group takes the granules prepared in Example 1 of the present invention (daily dosage: Cistanche deserticola 15g, Morinda officinalis 15g, Achyranthes bidentata 12g, Eucommia ulmoides 12g , Poria 10g, ginseng 15g, Gecko 10g, skullcap 12g, Trichosanthes melon 20g, Salvia miltiorrhiza 20g, Angelica sinensis 15g, Curcuma zedoary 12g, Dananxing 10g, Pinellia 15g, almond 12g, Agarwood 15g, Citrus aurantium 15g, Tangerine peel 15g, Rehmannia glutinosa 15g, Alisma 12g, Plantago 10g), the control group took Suzi Jiangqi Pills (produced by Jilin Zixin Prajna Pharmaceutical Co., Ltd., national drug approval number Z20063628, batch number: 20190508), 6 grams each time (1 bag at a time) , 1-2 times a day.
3.疗效标准:痊愈:无呼吸困难,无咳嗽,无痰咳出,肺部啰音消失;显效:无呼吸困难,咳嗽次数明显减少,痰量明显减少,肺部啰音明显减少或者消失;有效:呼吸困难减轻,咳嗽次数减少,痰量略有减少,肺部啰音略有减少;无效:体征均无明显改善,甚或加重。3. Efficacy standards: recovery: no dyspnea, no cough, no phlegm coughed up, and pulmonary rales disappear; marked effect: no dyspnea, the number of coughs is significantly reduced, the amount of sputum is significantly reduced, and the pulmonary rales are significantly reduced or disappeared; Effective: dyspnea is relieved, the number of coughs is reduced, the amount of sputum is slightly reduced, and the rales in the lungs are slightly reduced; Ineffective: the physical signs are not significantly improved, or even worsened.
4.结果见表2。4. The results are shown in Table 2.
表2本发明治疗脾肾阳虚型慢性阻塞性肺病的临床疗效Table 2 Clinical efficacy of the present invention in treating chronic obstructive pulmonary disease of spleen and kidney yang deficiency type
5.结论:从表2可以看出,两组患者临床痊愈率、显效率、总有效率疗效比较,均P<0.05,有显著性差异,本发明实施例1提供的颗粒剂,临床试验结果表明总有效率高达90%,临床痊愈率42%,显效率36%,而对照组总有效率为74%,临床痊愈率24%,显效率26%,这就表明本发明中药组合物治疗脾肾阳虚型慢性阻塞性肺病的疗效优于常规的治疗方法。临床观察结果表明,治疗组的50例患者服用本发明中药组合物后,无明显毒副作用,服用安全可靠。综上所述,本发明中药组合物对脾肾阳虚型慢性阻塞性肺病患者具有疗效显著、无毒副作用小的优点,其制备工艺安全,稳定。这也进一步说明,本发明中药组合物具有良好的市场应用前景。5. Conclusion: It can be seen from Table 2 that the clinical recovery rate, significant efficiency, and total effective rate of the two groups of patients are all P<0.05, and there is a significant difference. The clinical test results of the granules provided in Example 1 of the present invention It shows that the total effective rate is as high as 90%, the clinical recovery rate is 42%, and the effective rate is 36%, while the total effective rate of the control group is 74%, the clinical recovery rate is 24%, and the effective rate is 26%. This shows that the traditional Chinese medicine composition of the present invention treats the spleen. The efficacy of chronic obstructive pulmonary disease with kidney-yang deficiency is better than conventional treatments. Clinical observation results show that after the 50 patients in the treatment group took the traditional Chinese medicine composition of the present invention, there were no obvious toxic or side effects, and it was safe and reliable to take. In summary, the traditional Chinese medicine composition of the present invention has the advantages of significant curative effect on patients with chronic obstructive pulmonary disease of spleen and kidney yang deficiency type, no toxic side effects, and its preparation process is safe and stable. This also further illustrates that the traditional Chinese medicine composition of the present invention has good market application prospects.
尽管已经示出和描述了本发明的实施例,对于本领域的普通技术人员而言,可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型,本发明的范围由所附权利要求及其等同物限定。Although the embodiments of the present invention have been shown and described, those of ordinary skill in the art will understand that various changes, modifications, and substitutions can be made to these embodiments without departing from the principles and spirit of the invention. and modifications, the scope of the invention is defined by the appended claims and their equivalents.
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