CN105169183A - A traditional Chinese medicine composition for treating decubitus and preparation method thereof - Google Patents

A traditional Chinese medicine composition for treating decubitus and preparation method thereof Download PDF

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CN105169183A
CN105169183A CN201510654917.8A CN201510654917A CN105169183A CN 105169183 A CN105169183 A CN 105169183A CN 201510654917 A CN201510654917 A CN 201510654917A CN 105169183 A CN105169183 A CN 105169183A
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chinese medicine
medicine composition
corydalis
decubitus
traditional chinese
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阚积香
王怀芬
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Linyi Caozhimei Pharmaceutical Technology Co ltd
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Abstract

The invention relates to a traditional Chinese medicine composition for treating bedsore and a preparation method thereof, belonging to the technical field of traditional Chinese medicines, and the traditional Chinese medicine composition comprises the following preparation raw materials: folium artemisiae argyi, rhizoma gastrodiae, rhizoma corydalis, herba houttuyniae, folium eucalypti globueli, centella asiatica, herba portulacae, frankincense, rhizoma ligustici wallichii, angelica sinensis, medlar, galangal, radix ampelopsis, garden burnet, fresh rehmannia and liquorice. The traditional Chinese medicine provided by the invention is reasonable in formula and strong in synergistic effect, has the effects of clearing away heat and toxic materials, promoting blood circulation to remove blood stasis, removing putrefaction toxin and promoting tissue regeneration and skin growth, can dredge blood vessels and meridians while removing putrefaction toxin, can accelerate the self metabolism of skin, enables toxin and bacteria to be rapidly discharged out of a sore, further enhances the immunity of an organism, enhances the resistance to bacteria and fungi, and avoids reinfection after wound healing.

Description

一种治疗褥疮的中药组合物及其制备方法A traditional Chinese medicine composition for treating decubitus and preparation method thereof

技术领域 technical field

本发明涉及一种治疗褥疮的中药组合物及其制备方法,属于中药技术领域。 The invention relates to a traditional Chinese medicine composition for treating decubitus and a preparation method thereof, belonging to the technical field of traditional Chinese medicines.

背景技术 Background technique

褥疮又名压疮(压迫性溃疡),是局部组织常期受压,持续缺血、缺氧、营养不良而致局部组织溃烂、坏死,是临床常见的并发症之一。中医称为“席疮”,乃因久病气血大亏,长期卧床,局部受压以致血气运行失常,经络阻塞,无以荣肤所致,如不及时救治,肉腐骨露合并感染,严重时引起败血症,导致死亡。 Bed sores, also known as pressure sores (compression ulcers), are chronic pressure on local tissues, resulting in local tissue ulceration and necrosis due to continuous ischemia, hypoxia, and malnutrition. It is one of the common clinical complications. Traditional Chinese medicine is called "Xi sore", which is caused by long-term illness, great loss of qi and blood, long-term bed rest, local pressure, resulting in abnormal blood and qi circulation, blockage of meridians and collaterals, and no skin. In severe cases, it can cause sepsis and lead to death.

与中成药相比,传统的西医换药时多应用消毒剂或抗生素,虽然能够有效的控制细菌,但也不可避免的抑制了创面细胞的健康再生,从而导致创面愈合非常慢,病情迁延不愈,影响患者的生活和工作。 Compared with Chinese patent medicines, traditional western medicine often uses disinfectants or antibiotics when changing dressings. Although it can effectively control bacteria, it also inevitably inhibits the healthy regeneration of wound cells, resulting in very slow wound healing and protracted disease. , affecting the life and work of patients.

中药治疗褥疮的主要原则是清热解毒、活血祛瘀、去腐生肌,促进坏死组织排出,加快肉芽组织生长,将坏死组织清除体外,改善创面周围组织的微循环,增加局部血流,同时能促进残存上皮细胞组织生长,祛腐生肌,激活机体内源性清创过程,表现为无痛清创,对正常组织无副作用,填充伤口窦道及腔隙,防止伤口塌陷,减轻疼痛,吸收伤口渗液。 The main principles of traditional Chinese medicine treatment of decubitus are to clear away heat and detoxify, activate blood circulation and remove blood stasis, remove putrefaction and promote muscle growth, promote the discharge of necrotic tissue, accelerate the growth of granulation tissue, remove necrotic tissue from the body, improve the microcirculation of tissues around the wound, increase local blood flow, and promote Residual epithelial cell tissue grows, removes putrefaction and promotes granulation, activates the body's endogenous debridement process, manifests as painless debridement, has no side effects on normal tissues, fills wound sinuses and cavities, prevents wound collapse, relieves pain, and absorbs wound exudate liquid.

中国专利申请201510239732.0公开了一种用于治疗褥疮的中药药膏,该药膏由以下原料制得:黄柏10-12、血竭3-4、紫草2-4、黄芪8-10、白芷5-6、苍术2-4、当归8-10、党参4-5、白蔹2-4、制乳香5-6、没药9-10、川芎3-4、天花粉2-4、鹿角霜6-7、白芍4-6、炒山甲3-4、炒皂角刺1-3、红藤6-8、虎杖4-5、牡丹皮9-11、艾叶2-4、酒黄连4-5、制马钱子8-10、琥珀2-4、人面子叶2-4、以及大茶药根1-3。该药膏在治疗褥疮方面具有一定的疗效,但是该药物治疗褥疮疗程长,中药组方复杂,治疗成本高。 Chinese patent application 201510239732.0 discloses a traditional Chinese medicine ointment for treating decubitus. The ointment is made of the following raw materials: Cortex Phellodendri 10-12, Dried Blood 3-4, Comfrey 2-4, Astragalus 8-10, Angelica 5-6 , Atractylodes 2-4, Angelica 8-10, Codonopsis 4-5, Baishui 2-4, Frankincense 5-6, Myrrh 9-10, Chuanxiong 3-4, Trichosanthes 2-4, Antler Cream 6-7, Radix Paeoniae Alba 4-6, Stir-Fried Mountain Beetle 3-4, Stir-fried Saponaria thorn 1-3, Red Vine 6-8, Polygonum cuspidatum 4-5, Moutan Cortex 9-11, Artemisia argyi 2-4, Wine Coptis 4-5, Nuxychnium 8-10, amber 2-4, human face cotyledon 2-4, and big tea root 1-3. The ointment has a certain curative effect in treating bedsores, but the drug has a long course of treatment for bedsores, complex prescriptions of traditional Chinese medicines, and high treatment cost.

发明内容 Contents of the invention

为了解决现有技术中治疗褥疮的药物存在愈合慢、治疗时间长和治疗成本高的缺点,本发明的目的在于提供一种治疗褥疮的中药组合物,以解决上述问题。同时,本发明还提供该中药组合物的制备工艺。 In order to solve the shortcomings of slow healing, long treatment time and high treatment cost in the medicines for treating bedsores in the prior art, the object of the present invention is to provide a traditional Chinese medicine composition for treating bedsores to solve the above problems. At the same time, the invention also provides a preparation process of the traditional Chinese medicine composition.

本发明的中药组合物包括以下重量份数的制备原料:艾叶25-30、天麻10-19、延胡索4-10、鱼腥草10-15、桉叶15-22、积雪草8-25、马齿苋5-15、乳香13-19、川芎14-20、当归10-15、枸杞6-12、高良姜8-16、白蔹4-8、地榆4-8、鲜地黄10-16以及甘草6-14。 The traditional Chinese medicine composition of the present invention comprises the following preparation raw materials in parts by weight: Artemisia argyi 25-30, Tianma 10-19, Corydalis 4-10, Houttuynia 10-15, Eucalyptus 15-22, Centella asiatica 8-25, Purslane 5-15, Frankincense 13-19, Chuanxiong 14-20, Angelica 10-15, Lycium barbarum 6-12, Galangal 8-16, Scutellaria 4-8, Burnet 4-8, Fresh Rehmannia 10-16 and licorice 6-14.

进一步地,所述中药组合物包括以下重量份数的制备原料:艾叶25、天麻10、延胡索4、鱼腥草10、桉叶15、积雪草8、马齿苋5、乳香13、川芎14、当归10、枸杞6、高良姜8、白蔹4、地榆4、鲜地黄10以及甘草6。 Further, the traditional Chinese medicine composition includes the following preparation raw materials in parts by weight: Artemisia argyi 25, Gastrodia elata 10, Corydalis 4, Houttuynia cordata 10, Eucalyptus 15, Centella asiatica 8, purslane 5, frankincense 13, chuanxiong 14 , Angelica 10, wolfberry 6, galangal 8, white scorpion 4, Burnet 4, fresh rehmannia 10 and licorice 6.

进一步地,所述中药组合物包括以下重量份数的制备原料:艾叶30、天麻19、延胡索10、鱼腥草15、桉叶22、积雪草25、马齿苋15、乳香19、川芎20、当归15、枸杞12、高良姜16、白蔹8、地榆8、鲜地黄16以及甘草14。 Further, the traditional Chinese medicine composition includes the following preparation raw materials in parts by weight: Artemisia argyi 30, Tianma 19, Corydalis 10, Houttuynia 15, Eucalyptus 22, Centella asiatica 25, Purslane 15, Frankincense 19, Rhizoma Chuanxiong 20 , Chinese angelica 15, wolfberry 12, galangal 16, white scorpion 8, Burnet 8, fresh rehmannia 16 and licorice 14.

进一步地,所述中药组合物包括以下重量份数的制备原料:艾叶22、天麻14、延胡索6、鱼腥草12、桉叶18、积雪草18、马齿苋12、乳香15、川芎16、当归13、枸杞8、高良姜14、白蔹6、地榆5、鲜地黄14以及甘草10。 Further, the traditional Chinese medicine composition includes the following preparation raw materials in parts by weight: Artemisia argyi 22, Gastrodia elata 14, Corydalis 6, Houttuynia cordata 12, Eucalyptus 18, Centella asiatica 18, purslane 12, frankincense 15, chuanxiong 16 , Chinese angelica 13, wolfberry 8, galangal 14, white scorpion 6, Burnet 5, fresh rehmannia 14 and licorice 10.

进一步地,本发明的中药组合物优选制成散剂、软膏剂或凝胶剂,便于患者使用。 Furthermore, the traditional Chinese medicine composition of the present invention is preferably made into powder, ointment or gel, which is convenient for patients to use.

另外,本发明还提供了一种治疗褥疮的中药组合物的制备方法,包括以下步骤: In addition, the present invention also provides a preparation method of a Chinese medicine composition for treating decubitus, comprising the following steps:

S1:取天麻洗净,干燥后粉碎,过80-100目筛,加入天麻粗粉重量5-8倍量浓度为65-85%的乙醇,浸泡6-12小时,在60-70℃温度下超声提取两次,每次40-60分钟,超声频率为25-35kHz,过滤,合并滤液,滤液减压浓缩至60℃时相对密度为1.15-1.25的清膏,得天麻提取物; S1: Take Gastrodia elata, wash it, dry it, crush it, pass it through a 80-100 mesh sieve, add 5-8 times the weight of Gastrodia elata coarse powder, and add ethanol with a concentration of 65-85%, soak for 6-12 hours, and store it at a temperature of 60-70°C Ultrasonic extraction twice, 40-60 minutes each time, the ultrasonic frequency is 25-35kHz, filtering, combining the filtrate, and concentrating the filtrate under reduced pressure to a clear paste with a relative density of 1.15-1.25 at 60°C to obtain the Gastrodia elata extract;

S2:取艾叶、延胡索、鱼腥草、桉叶、积雪草、马齿苋、乳香、川芎、当归、枸杞、高良姜、白蔹、地榆、鲜地黄以及甘草粉碎混合,加上述粗粉总重量6-8倍量的浓度为70-80%乙醇,浸泡6-12小时,回流提取2-3次,每次2-6小时,过滤,合并滤液,减压蒸馏除去乙醇,在55-60℃条件下浓缩至相对密度为1.20-1.25的浓缩液; S2: Take mugwort leaves, Corydalis Corydalis, Houttuynia cordata, Eucalyptus leaves, Centella asiatica, purslane, frankincense, chuanxiong, angelica, wolfberry, galangal, white pomegranate, burnet, fresh rehmannia glutinosa and licorice, and mix them, add the above coarse powder The concentration of 6-8 times the total weight is 70-80% ethanol, soak for 6-12 hours, reflux extraction 2-3 times, each time for 2-6 hours, filter, combine the filtrates, and distill off the ethanol under reduced pressure. Concentrated to a concentrated solution with a relative density of 1.20-1.25 at 60°C;

S3:将步骤S1得到的天麻提取物与步骤S2得到的浓缩液混合,干燥,粉碎,即得。 S3: Mix the Gastrodia elata extract obtained in step S1 with the concentrated solution obtained in step S2, dry and pulverize to obtain.

本发明中药组合物中所用组分的来源、性味、归经及功效: The source, nature and flavor, meridian distribution and efficacy of the components used in the Chinese medicine composition of the present invention:

艾叶:本品为菊科植物艾的干燥叶;味苦,性温;归肝、脾、肾经;散寒止痛、温经止血。 Artemisia argyi: This product is the dry leaf of Artemisia argyi of Compositae; bitter in taste, warm in nature; returns to liver, spleen, and kidney meridians; dispels cold to relieve pain, warms meridians to stop bleeding.

天麻:兰科天麻属植物天麻的干燥块茎,味味、甘,性平,归肝经;息风止痉,平肝潜阳,祛风通络。 Gastrodia elata: the dry tuber of Gastrodia elata in the genus Gastrodia elata of Orchidaceae, tastes sweet, flat in nature, and returns to the liver meridian; relieves wind and spasm, calms the liver and subdues yang, dispels wind and dredges collaterals.

延胡索:本品为罂粟科植物延胡索的干燥块茎;味辛、苦,性温;归肝、脾经;活血,利气,止痛。 Corydalis Corydalis: This product is the dried tuber of Corydalis Corydalis of Poppyaceae; pungent, bitter, warm in nature; returns to liver and spleen meridians; promotes blood circulation, sharpens qi, and relieves pain.

鱼腥草:本品为三白草科植物蕺菜的干燥地上部分;味辛,微温;入肝、肺二经;清热解毒,利尿消肿。 Houttuynia cordata: This product is the dry aboveground part of the Sanbaiaceae plant Houttuynia cordata; acrid in taste, slightly warm; enters the liver and lung meridians; clears heat and detoxifies, diuretic and detumescence.

桉叶:本品为为桃金娘科植物蓝桉的叶;味苦,性温;归肺、胃、脾、肝经;疏风解表、清热解毒、化痰理气、杀虫止痒。 Eucalyptus leaf: This product is the leaf of Eucalyptus eucalyptus of Myrtaceae plant; bitter in taste, warm in nature; returns to lung, stomach, spleen, liver meridian; disperses wind and relieves exterior syndrome, clears heat and detoxification, reduces phlegm and regulates qi, kills insects and relieves itching.

积雪草:本品为伞形科植物积雪草的干燥全草;味苦,性寒;归肝、脾、肾经;清热利湿、解毒消肿。 Centella asiatica: This product is the dry whole herb of Centella asiatica; bitter in taste, cold in nature; returns to liver, spleen and kidney meridians; clears away heat and dampness, detoxifies and reduces swelling.

马齿苋:本品为马齿苋科植物马齿苋的干燥地上部分;味酸,性寒;归肝、大肠经;清热解毒、凉血止血。 Purslane: This product is the dry aerial part of Purslane, a plant of the family Portulaca oleracea; sour in taste and cold in nature; it returns to the liver and large intestine meridian; it can clear away heat and detoxify, cool blood and stop bleeding.

乳香:本品为橄榄科乳香树属植物乳香树以其树干皮部伤口渗出的油胶树脂入药;味辛、苦,性温;入心、肝、脾经;活血止痛。 Frankincense: This product is the Oleum gum resin exuded from the bark wound of the Boswellia tree of the olive family. It is used as medicine. It is pungent, bitter, and warm in nature.

川芎:本品为伞形科植物川芎的干燥根茎;味辛,性温;归肝、胆、心包经;活血行气、祛风止痛。 Ligusticum Chuanxiong: This product is the dried rhizome of Ligusticum Chuanxiong of Umbelliferae; pungent in taste, warm in nature; returns to the liver, gallbladder, and pericardium meridians; promotes blood circulation and qi, dispels wind and relieves pain.

当归:本品为伞形科植物当归的干燥根;味甘,性温;归肝、心、脾经;补血活血、调经止痛、润肠通便。 Angelica: This product is the dried root of Angelica sinensis; sweet in taste and warm in nature; it returns to the liver, heart, and spleen meridian; it nourishes blood and activates blood circulation, regulates menstruation and relieves pain, moistens the intestines and relieves constipation.

枸杞:本品为茄科植物宁夏枸杞的干燥成熟果实;味甘,性平;归肝、肾经;滋补肝肾、益精明目。 Lycium barbarum: This product is the dried and mature fruit of Lycium barbarum Ningxia, a plant of the family Solanaceae; sweet in taste, flat in nature;

高良姜:本品为姜科植物高良姜的干燥根茎;味辛,性热;归脾、胃经;温胃散寒、消食止痛。 Galangal: This product is the dried rhizome of Zingiberaceae galangal; spicy in taste, hot in nature; returns to spleen and stomach meridian; warms stomach and dispels cold, relieves indigestion and relieves pain.

白蔹:本品为葡萄科植物白蔹的干燥块根;味苦、性微寒;归心、胃经;清热解毒、消痈散结。 Radix Scutellariae: This product is the dried root tuber of Rhizoma Radix Radix Vitis Potatoes; bitter in taste, slightly cold in nature; Guixin and Stomach Meridian; heat-clearing and toxic substances removing, eliminating carbuncle and dissipating stagnation.

地榆:本品为蔷薇科植物地榆或长叶地榆的干燥根;味苦,性微寒;入肝、大肠经;凉血止血、解毒敛疮。 Burnet: This product is the dry root of Burnet or Burnet longifolia of Rosaceae plant; bitter in taste, slightly cold in nature; enters the liver and large intestine meridian; cools blood to stop bleeding, detoxifies and suppresses sores.

鲜地黄:本品为为玄参科植物地黄的新鲜根茎;味甘苦,性微寒;入心、肝、肾经;清热、凉血、生津。 Fresh Rehmannia glutinosa: This product is the fresh rhizome of Rehmannia glutinosa of Scrophulariaceae; tastes sweet and bitter, slightly cold in nature; enters the heart, liver, and kidney channels; clears away heat, cools blood, and promotes body fluid.

甘草:本品为豆科植物甘草、胀果甘草或光果甘草的干燥根;味甘,性平;归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。 Licorice: This product is the dried root of leguminous plant licorice, bloated licorice or glabra; sweet in taste, flat in nature; heart, lung, spleen, stomach meridian; invigorating spleen and qi, clearing heat and detoxification, eliminating phlegm and relieving cough, relieving spasm and relieving pain , to reconcile the various medicines.

本发明中药组方的组方分析: The prescription analysis of Chinese medicine prescription of the present invention:

本发明中药组方是以艾叶、天麻、桉叶为君药,散寒止痛、疏风解表、清热解毒;以延胡索、鱼腥草、积雪草、马齿苋、乳香、川芎为臣药,解毒消肿、生肌、祛风止痛;以当归、枸杞、高良姜、白蔹、地榆、鲜地黄为佐药,补血活血、消食止痛、解毒敛疮;以甘草为使药,使诸药协同配合,相辅相成,共同达到解毒消肿、活血祛瘀、生肌长皮等功效,对褥疮有十分显著的治疗效果。 The traditional Chinese medicine prescription of the present invention is based on Artemisia argyi, Gastrodia elata, and eucalyptus leaves as monarch drugs, dispelling cold and relieving pain, dispelling wind and relieving the exterior, clearing away heat and detoxifying; Reducing swelling, promoting muscle growth, dispelling wind and relieving pain; using angelica, wolfberry, galangal, white scorpion, burnet, and fresh rehmannia root as adjuvant medicines, nourishing blood and promoting blood circulation, eliminating food and relieving pain, detoxifying and relieving sores; using licorice as an envoy to make all medicines synergize Cooperate and complement each other to achieve the effects of detoxification and swelling, blood circulation and blood stasis removal, muscle growth and skin growth, etc., and have a very significant therapeutic effect on bedsores.

与现有技术相比,本发明的中药组合物在治疗褥疮方面具有清热解毒、活血祛瘀、清除腐毒和生肌长皮的功效,在清除腐毒的同时疏通血脉经络,可以加快皮肤的自身代谢,使毒素和细菌能够快速排出疮口,同时进一步增强机体免疫力,增强对细菌、真菌的抵抗力,避免伤口愈合后再度感染。并且本发明提供的制备方法简便易行、适用范围广、毒副作用小、易于推广应用。 Compared with the prior art, the traditional Chinese medicine composition of the present invention has the effects of clearing away heat and detoxification, promoting blood circulation and removing blood stasis, removing putrefaction and promoting muscle growth in treating bedsores. Self-metabolism, so that toxins and bacteria can be quickly discharged from the sores, and at the same time further enhance the body's immunity, enhance the resistance to bacteria and fungi, and avoid re-infection after the wound has healed. Moreover, the preparation method provided by the invention is simple and easy to implement, has a wide application range, has little toxic and side effects, and is easy to popularize and apply.

具体实施方式 Detailed ways

本领域技术人员应理解,以下实施例中所公开的技术代表本发明人发现的在本发明的实践中发挥良好作用的技术。然而,在所公开的具体实施方案中可以做出许多改变,并仍然获得相同或相似的结果,而不脱离本发明的精神和范围。 It should be appreciated by those of skill in the art that the techniques disclosed in the examples which follow represent techniques discovered by the inventors to function well in the practice of the invention. However, many changes can be made in the specific embodiments which are disclosed and still obtain a like or similar result without departing from the spirit and scope of the invention.

实施例1Example 1

本发明实施例1中药组合物包括以下重量份数的制备原料:艾叶25、天麻10、延胡索4、鱼腥草10、桉叶15、积雪草8、马齿苋5、乳香13、川芎14、当归10、枸杞6、高良姜8、白蔹4、地榆4、鲜地黄10以及甘草6。 The traditional Chinese medicine composition of Example 1 of the present invention includes the following preparation raw materials in parts by weight: Artemisia argyi 25, Gastrodia elata 10, Corydalis 4, Houttuynia cordata 10, Eucalyptus 15, Centella asiatica 8, purslane 5, frankincense 13, chuanxiong 14 , Angelica 10, wolfberry 6, galangal 8, white scorpion 4, Burnet 4, fresh rehmannia 10 and licorice 6.

制备方法: Preparation:

S1:取天麻洗净,干燥后粉碎,过80目筛,加入天麻粗粉重量5倍量浓度为65%的乙醇,浸泡6小时,在60℃温度下超声提取两次,每次40分钟,超声频率为25kHz,过滤,合并滤液,滤液减压浓缩至60℃时相对密度为1.15的清膏,得天麻提取物; S1: Take Gastrodia elata, wash it, dry it, crush it, pass it through a 80-mesh sieve, add 65% ethanol in an amount 5 times the weight of Gastrodia elata coarse powder, soak for 6 hours, and extract it twice by ultrasonic at 60°C for 40 minutes each time. The ultrasonic frequency is 25kHz, filter, combine the filtrates, and concentrate the filtrates under reduced pressure to a clear paste with a relative density of 1.15 at 60°C to obtain the Gastrodia elata extract;

S2:取艾叶、延胡索、鱼腥草、桉叶、积雪草、马齿苋、乳香、川芎、当归、枸杞、高良姜、白蔹、地榆、鲜地黄以及甘草粉碎混合,加上述粗粉总重量6倍量的浓度为70%乙醇,浸泡6小时,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,在55℃条件下浓缩至相对密度为1.20的浓缩液; S2: Take mugwort leaves, Corydalis Corydalis, Houttuynia cordata, Eucalyptus leaves, Centella asiatica, purslane, frankincense, chuanxiong, angelica, wolfberry, galangal, white pomegranate, burnet, fresh rehmannia glutinosa and licorice, and mix them, add the above coarse powder The concentration of 6 times the total weight is 70% ethanol, soak for 6 hours, reflux extraction twice, each time for 2 hours, filter, combine the filtrate, remove ethanol by distillation under reduced pressure, and concentrate at 55°C to a concentrated concentration with a relative density of 1.20 liquid;

S3:将步骤S1得到的天麻提取物与步骤S2得到的浓缩液混合,干燥,粉碎,加入相应的辅料,制成散剂。 S3: Mix the Gastrodia elata extract obtained in step S1 with the concentrated solution obtained in step S2, dry, pulverize, and add corresponding auxiliary materials to make a powder.

实施例2Example 2

本发明实施例2中药组合物包括以下重量份数的制备原料:艾叶30、天麻19、延胡索10、鱼腥草15、桉叶22、积雪草25、马齿苋15、乳香19、川芎20、当归15、枸杞12、高良姜16、白蔹8、地榆8、鲜地黄16以及甘草14。 The Chinese medicine composition of Example 2 of the present invention includes the following preparation raw materials in parts by weight: Artemisia argyi 30, Tianma 19, Corydalis 10, Houttuynia 15, Eucalyptus 22, Centella asiatica 25, Purslane 15, Olibanum 19, Rhizoma Chuanxiong 20 , Chinese angelica 15, wolfberry 12, galangal 16, white scorpion 8, Burnet 8, fresh rehmannia 16 and licorice 14.

制备方法如实施例1类似,制成凝胶剂。 The preparation method is similar to that of Example 1 to prepare a gel.

实施例3Example 3

本发明实施例3中药组合物包括以下重量份数的制备原料:艾叶22、天麻14、延胡索6、鱼腥草12、桉叶18、积雪草18、马齿苋12、乳香15、川芎16、当归13、枸杞8、高良姜14、白蔹6、地榆5、鲜地黄14以及甘草10。 The traditional Chinese medicine composition of Example 3 of the present invention includes the following preparation raw materials in parts by weight: Artemisia argyi 22, Gastrodia elata 14, Corydalis 6, Houttuynia cordata 12, Eucalyptus 18, Centella asiatica 18, purslane 12, frankincense 15, chuanxiong 16 , Chinese angelica 13, wolfberry 8, galangal 14, white scorpion 6, Burnet 5, fresh rehmannia 14 and licorice 10.

制备方法如实施例1类似,制成软膏剂。 The preparation method is similar to that of Example 1, and an ointment is made.

药效学实验Pharmacodynamic experiment

一、本发明中药组合物治疗豚鼠褥疮模型试验 One, Chinese medicine composition of the present invention treats guinea pig decubitus model test

1.试验材料: 1. Test material:

1.1试验动物:雄性豚鼠,体重(275±25)g,由南京医科大学动物实验中心提供。 1.1 Experimental animals: male guinea pigs, body weight (275±25) g, provided by Animal Experiment Center of Nanjing Medical University.

1.2试验药品:实施例3制备的治疗褥疮的软膏,马应龙麝香痔疮膏,国药准字为:Z42021920,购于马应龙药业集团股份有限公司。 1.2 Experimental drug: the ointment for treating bedsore prepared in Example 3, Mayinglong Musk Hemorrhoid Ointment, approved by the Chinese Medicine: Z42021920, was purchased from Mayinglong Pharmaceutical Group Co., Ltd.

2.建立动物模型:对36只豚鼠进行麻醉、皮肤消毒,以俯卧位固定,在靠近背部脊柱的左侧切开一长约3cm的口子,植入经高压灭菌的4.0cmx2.5cmx0.05cm不锈钢钢板,缝合切口,并包扎伤口,用绷带固定。豚鼠术后单笼喂养,观察ld。24h后用4.0cm×2.5cm×1.0cm磁铁压迫创面(5h/d),休息12h循环1次,总压迫时间10h,记录褥疮的形成面积与分度等级。将动物单独分笼,喂养及管理条件一致。 2. Establishment of animal models: 36 guinea pigs were anesthetized, skin sterilized, fixed in a prone position, a 3cm long incision was made on the left side near the back spine, and a 4.0cmx2.5cmx0.05cm autoclaved guinea pig was implanted. Stainless steel plate, the incision was sutured, and the wound was bandaged and fixed with a bandage. Guinea pigs were fed in a single cage after operation, and ld was observed. After 24 hours, a 4.0cm×2.5cm×1.0cm magnet was used to compress the wound surface (5h/d), rest for 12h and cycle once, and the total compression time was 10h. The formation area and graduation grade of bedsores were recorded. The animals were separated into individual cages, and the feeding and management conditions were the same.

3.试验方法:豚鼠褥疮模型形成后第2天,将豚鼠随机分为3组,每组12只,分别为正常组、阳性对照组和实施例3组,各组处理如下: 3. Test method: on the second day after the formation of the guinea pig decubitus model, the guinea pigs were randomly divided into 3 groups, 12 in each group, respectively normal group, positive control group and embodiment 3 groups, and each group was processed as follows:

正常组:用0.9%氯化钠清洗伤口后,不做其他处理; Normal group: After cleaning the wound with 0.9% sodium chloride, no other treatment was done;

阳性对照组:用0.9%氯化钠清洗伤口后,将马应龙麝香痔疮膏涂于伤口处; Positive control group: After cleaning the wound with 0.9% sodium chloride, apply Mayinglong Musk Hemorrhoid Ointment to the wound;

实施例3组:用0.9%氯化钠清洗伤口后,将实施例3制备的含有艾叶的治疗褥疮的软膏涂于伤口处; Example 3 group: After cleaning the wound with 0.9% sodium chloride, the ointment for treating decubitus prepared in Example 3 containing Artemisia argyi was applied to the wound;

上述操作每天涂抹1次,用药14天后判断效果。 The above operation is applied once a day, and the effect is judged after 14 days of medication.

4.观察指标: 4. Observation indicators:

根据褥疮分期标准,治愈为伤口消失,表皮愈合;好转为伤口缩小80%,肉芽新鲜,生长好,水肿消退,渗液少;无效为伤口缩小50%,肉芽生长不良或有脓性渗液。 According to the staging standard of decubitus ulcer, the cure means that the wound disappears and the epidermis heals; the improvement means that the wound shrinks by 80%, the granulation is fresh, grows well, the edema subsides, and there is less exudate;

5.试验结果: 5. Test results:

表1豚鼠褥疮治疗效果及愈合天数比较 Table 1 Comparison of treatment effect and healing days of decubitus in guinea pigs

注:与正常组比较,▲▲P<0.01。 Note: Compared with the normal group, ▲▲ P<0.01.

由表1可知,使用本发明实施例3制备的治疗褥疮的软膏在10天左右伤口基本愈合,而且治愈率达到83.3%,无效率为0,证明本发明制备的褥疮软膏对褥疮具有显著的治疗效果。 As can be seen from Table 1, using the ointment for the treatment of decubitus prepared by the embodiment of the present invention 3, the wound is basically healed in about 10 days, and the cure rate reaches 83.3%, and the invalid rate is 0, which proves that the decubitus ointment prepared by the present invention has significant treatment for decubitus Effect.

二、本发明中药组合物的临床试验 Two, the clinical trial of Chinese medicine composition of the present invention

1.临床研究对象: 1. Clinical research object:

选取120例患有褥疮的临床志愿患者,其中男80例,女40例,年龄45-85岁,患者在治疗前疮面直径1-30cm,溃疡期85例,深度溃疡期35例;将120例患者随机分为2组,分别为治疗组和对照组,每组60人。两组患者性别、年龄、病情程度及临床表现经统计学处理差异无显著性,具有可比性。 Select 120 clinical volunteer patients with decubitus ulcers, including 80 males and 40 females, aged 45-85 years old, the diameter of the sores was 1-30cm before treatment, 85 cases were in the ulcer stage, and 35 cases were in the deep ulcer stage; The patients were randomly divided into two groups, a treatment group and a control group, 60 people in each group. There was no significant difference in gender, age, disease severity and clinical manifestations between the two groups, and they were comparable.

2.试验药物及试验方法: 2. Test drugs and test methods:

治疗组:涂抹本发明实施例3制备的治疗褥疮的软膏,每天换药1次,每次0.52-1.04g,连续观察14天。 Treatment group: apply the ointment for treating decubitus prepared in Example 3 of the present invention, change the dressing once a day, 0.52-1.04 g each time, and observe continuously for 14 days.

对照组:创面周围皮肤用75%酒精消毒,创面用0.1%新洁尔灭清洁,尽量剪除坏死组织,然后敷以紫草油纱布,以无菌纱布覆盖包扎,其他与观察组相同。 Control group: the skin around the wound was disinfected with 75% alcohol, the wound was cleaned with 0.1% bromogeramine, and the necrotic tissue was cut off as much as possible, then covered with comfrey oil gauze, covered with sterile gauze, and the rest were the same as the observation group.

3.疗效标准: 3. Efficacy standard:

参照中医药管理局实施的《中医病证诊断疗效标准》并结合本研究的具体情况拟定。 It was formulated with reference to the "Diagnostic and Curative Criteria for Syndrome Diagnosis and Efficacy of Traditional Chinese Medicine" implemented by the Administration of Traditional Chinese Medicine and combined with the specific situation of this study.

痊愈:创口愈合,无炎性渗出,疮面缩小,有新生肉芽组织生成及上皮组织覆盖; Healing: the wound is healed, without inflammatory exudation, the sore surface shrinks, and new granulation tissue is formed and covered by epithelial tissue;

有效:创口感染控制,疮面缩小>80%,有肉芽组织生成,但创口未完全愈合; Effective: Wound infection is controlled, the sore surface shrinks >80%, granulation tissue is formed, but the wound is not completely healed;

无效:治疗前后创口对比无明显改善,未见肉芽生长,创面缩小<40%。 Ineffective: There was no significant improvement in the comparison of the wound before and after treatment, no granulation growth was seen, and the wound shrank <40%.

4.试验结果: 4. Test results:

表1两组临床疗效比较(%) Table 1 Comparison of clinical efficacy between the two groups (%)

5.试验结论: 5. Test conclusion:

试验结果显示,本发明制备的治疗褥疮的软膏在治疗褥疮方面具有显著的效果,痊愈率达到83.3%,总有效率达到96.7%,明显优于对照组的效果。临床试验结果表明,本发明制备的治疗褥疮的软膏在治疗褥疮方面具有显著的技术优势,可以作为临床治疗褥疮药物推广应用。 The test results show that the ointment for treating bedsores prepared by the present invention has a significant effect in treating bedsores, with a cure rate of 83.3% and a total effective rate of 96.7%, which is significantly better than that of the control group. The results of clinical trials show that the ointment for treating bedsores prepared by the invention has significant technical advantages in treating bedsores, and can be popularized and applied as a medicine for clinical treatment of bedsores.

Claims (6)

1.一种治疗褥疮的中药组合物,其特征在于,所述中药组合物包括以下重量份数的制备原料:艾叶25-30、天麻10-19、延胡索4-10、鱼腥草10-15、桉叶15-22、积雪草8-25、马齿苋5-15、乳香13-19、川芎14-20、当归10-15、枸杞6-12、高良姜8-16、白蔹4-8、地榆4-8、鲜地黄10-16以及甘草6-14。 1. A Chinese medicine composition for the treatment of decubitus, characterized in that, said Chinese medicine composition comprises the following preparation raw materials in parts by weight: Artemisia argyi 25-30, Gastrodia elata 10-19, Corydalis 4-10, Houttuynia cordata 10-15 , Eucalyptus 15-22, Centella asiatica 8-25, Purslane 5-15, Frankincense 13-19, Chuanxiong 14-20, Angelica 10-15, Lycium barbarum 6-12, Galangal 8-16, Radix 4 -8, Burnet 4-8, Fresh Rehmannia 10-16 and Licorice 6-14. 2.如权利要求1所述的治疗褥疮的中药组合物,其特征在于,所述中药组合物包括以下重量份数的制备原料:艾叶25、天麻10、延胡索4、鱼腥草10、桉叶15、积雪草8、马齿苋5、乳香13、川芎14、当归10、枸杞6、高良姜8、白蔹4、地榆4、鲜地黄10以及甘草6。 2. the Chinese medicine composition for the treatment of decubitus as claimed in claim 1, is characterized in that, described Chinese medicine composition comprises the preparation raw material of following parts by weight: Folium Artemisiae Argyi 25, Tianma 10, Corydalis Corydalis 4, Houttuynia cordata 10, Eucalyptus 15. Centella Asiatica 8, Purslane 5, Frankincense 13, Ligusticum Chuanxiong 14, Angelica 10, Lycium barbarum 6, Galangal 8, Pollen 4, Burnet 4, Fresh Rehmannia glutinosa 10 and Licorice 6. 3.如权利要求1所述的治疗褥疮的中药组合物,其特征在于,所述中药组合物包括以下重量份数的制备原料:艾叶30、天麻19、延胡索10、鱼腥草15、桉叶22、积雪草25、马齿苋15、乳香19、川芎20、当归15、枸杞12、高良姜16、白蔹8、地榆8、鲜地黄16以及甘草14。 3. the Chinese medicine composition for the treatment of decubitus as claimed in claim 1, is characterized in that, described Chinese medicine composition comprises the preparation raw material of following parts by weight: Folium Artemisiae Argyi 30, Tianma 19, Corydalis Corydalis 10, Houttuynia cordata 15, Eucalyptus 22. Centella asiatica 25, Purslane 15, Frankincense 19, Rhizoma Chuanxiong 20, Angelica 15, Lycium barbarum 12, Galangal 16, Radish 8, Burnet 8, Fresh Rehmannia glutinosa 16 and Licorice 14. 4.如权利要求1所述的治疗褥疮的中药组合物,其特征在于,所述中药组合物包括以下重量份数的制备原料:艾叶22、天麻14、延胡索6、鱼腥草12、桉叶18、积雪草18、马齿苋12、乳香15、川芎16、当归13、枸杞8、高良姜14、白蔹6、地榆5、鲜地黄14以及甘草10。 4. the Chinese medicine composition for the treatment of decubitus as claimed in claim 1, is characterized in that, described Chinese medicine composition comprises the preparation raw material of following parts by weight: Folium Artemisiae Argyi 22, Tianma 14, Corydalis Corydalis 6, Houttuynia cordata 12, Eucalyptus 18. Centella asiatica 18, purslane 12, frankincense 15, chuanxiong 16, angelica 13, wolfberry 8, galangal 14, white pomegranate 6, Burnet 5, fresh rehmannia glutinosa 14 and licorice 10. 5.如权利要求1-4任一项所述的治疗褥疮的中药组合物,其特征在于:所述中药组合物被制成散剂、软膏剂或凝胶剂。 5. The Chinese medicine composition for treating decubitus as claimed in any one of claims 1-4, characterized in that: said Chinese medicine composition is made into powder, ointment or gel. 6.一种制备如权利要求1-4任一项所述的治疗褥疮的中药组合物的方法,其特征在于包括下述步骤: 6. A method for preparing the Chinese medicine composition for the treatment of decubitus as described in any one of claims 1-4, is characterized in that comprising the steps: S1:取天麻洗净,干燥后粉碎,过80-100目筛,加入天麻粗粉重量5-8倍量浓度为65-85%的乙醇,浸泡6-12小时,在60-70℃温度下超声提取两次,每次40-60分钟,超声频率为25-35kHz,过滤,合并滤液,滤液减压浓缩至60℃时相对密度为1.15-1.25的清膏,得天麻提取物; S1: Take Gastrodia elata, wash it, dry it, crush it, pass it through a 80-100 mesh sieve, add 5-8 times the weight of Gastrodia elata coarse powder, and add ethanol with a concentration of 65-85%, soak for 6-12 hours, and store it at a temperature of 60-70°C Ultrasonic extraction twice, 40-60 minutes each time, the ultrasonic frequency is 25-35kHz, filtering, combining the filtrate, and concentrating the filtrate under reduced pressure to a clear paste with a relative density of 1.15-1.25 at 60°C to obtain the Gastrodia elata extract; S2:取艾叶、延胡索、鱼腥草、桉叶、积雪草、马齿苋、乳香、川芎、当归、枸杞、高良姜、白蔹、地榆、鲜地黄以及甘草粉碎混合,加上述粗粉总重量6-8倍量的浓度为70-80%乙醇,浸泡6-12小时,回流提取2-3次,每次2-6小时,过滤,合并滤液,减压蒸馏除去乙醇,在55-60℃条件下浓缩至相对密度为1.20-1.25的浓缩液; S2: Take mugwort leaves, Corydalis Corydalis, Houttuynia cordata, Eucalyptus leaves, Centella asiatica, purslane, frankincense, chuanxiong, angelica, wolfberry, galangal, white pomegranate, burnet, fresh rehmannia glutinosa and licorice, and mix them, add the above coarse powder The concentration of 6-8 times the total weight is 70-80% ethanol, soak for 6-12 hours, reflux extraction 2-3 times, each time for 2-6 hours, filter, combine the filtrates, and distill off the ethanol under reduced pressure. Concentrated to a concentrated solution with a relative density of 1.20-1.25 at 60°C; S3:将步骤S1得到的天麻提取物与步骤S2得到的浓缩液混合,干燥,粉碎,即得。 S3: Mix the Gastrodia elata extract obtained in step S1 with the concentrated solution obtained in step S2, dry and pulverize to obtain.
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