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CN104547585A - External traditional Chinese medicine composition and preparation for treating swelling and pain, cut wounds and skin ulcers - Google Patents

External traditional Chinese medicine composition and preparation for treating swelling and pain, cut wounds and skin ulcers Download PDF

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CN104547585A
CN104547585A CN201510020899.8A CN201510020899A CN104547585A CN 104547585 A CN104547585 A CN 104547585A CN 201510020899 A CN201510020899 A CN 201510020899A CN 104547585 A CN104547585 A CN 104547585A
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曾显美
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Abstract

本发明涉及治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物,该中药组合物由紫苏、薄荷、细辛、大黄、朴硝、荆芥、白芨、防风、苍术和甘草的原料药经加工制备而成,由该中药组合物和辅剂制成的外用制剂包括散剂、酊剂、喷雾剂、贴剂、糊剂以及软膏剂;本发明还涉及上述中药组合物以及制剂的制备方法。本发明的中药组合物用于治疗无名肿痛、刀口伤和皮肤溃烂,具有见效快,治愈率高,止痛效果明显、散瘀消肿作用强以及伤口愈合时间短的优点。The invention relates to an external Chinese medicine composition for treating swelling, pain, incision wound and skin ulcer. The Chinese medicine composition is processed from the raw materials of perilla, peppermint, asarum, rhubarb, nitrate, nepeta, bletilla striata, windproof, atractylodes and licorice The external preparation made from the traditional Chinese medicine composition and auxiliary agent includes powder, tincture, spray, patch, paste and ointment; the present invention also relates to the preparation method of the above traditional Chinese medicine composition and preparation. The traditional Chinese medicine composition of the invention is used for treating unknown swelling and pain, incision wound and skin ulcer, and has the advantages of quick effect, high cure rate, obvious analgesic effect, strong effect of dispelling blood stasis and reducing swelling, and short wound healing time.

Description

治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物及制剂Externally applied traditional Chinese medicine composition and preparation for treating swelling and pain, incision wound and skin ulcer

技术领域technical field

本发明属于药物制剂领域,特别涉及一种治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物及其制剂。The invention belongs to the field of pharmaceutical preparations, in particular to an external Chinese medicinal composition for treating swelling and pain, incision wounds and skin ulcers and preparations thereof.

背景技术Background technique

外伤是身体或物体由于外界物体的打击、碰撞或化学物质的侵蚀等造成的外部损伤;具体包括有枪弹、金刃、跌打损伤、持重努伤、烧烫伤、冻伤和虫兽伤等。对于各种外伤,不论伤口大小、深浅,都要进行及时正确的处理,若处理不当,会引起伤口出血、感染、化脓,严重会得破伤风,断肢,甚至威胁生命。伤口处理正确,能使其迅速愈合;反之,可能化脓感染,经久不愈,甚至因并发全身感染、气性坏疽、破伤风等危及生命。Trauma refers to external damage to the body or objects caused by blows, collisions, or erosion of chemical substances; specifically, it includes bullets, metal blades, bruises, serious injuries, burns, frostbite, and insect injuries. For all kinds of trauma, regardless of the size and depth of the wound, timely and correct treatment must be carried out. If the treatment is not done properly, the wound will cause bleeding, infection, suppuration, and in severe cases, tetanus, limb amputation, and even life-threatening. Correct wound treatment can make it heal quickly; on the contrary, it may be suppurative and infected, which will not heal for a long time, and even be life-threatening due to concurrent systemic infection, gas gangrene, and tetanus.

现有治疗外伤的外用药物,用于灭菌消毒的有酒精、碘酊、络合碘、双氧水、新吉尔灭等,用于消炎生肌的西药制剂有磺胺粉、磺胺软膏等,用于散淤止血并能生肌的中药油剂有万花油、红花油等,中药粉剂有云南白药。这些药物经过长期的临床应用实践证明,都有不同程度的疗效,具体疗效有的因人而异、有的因伤情而异。又如专利申请号为CN201010191973.X的申请文件公开了一种治疗外伤的外用药物及其制备方法,该药物是一种以茶籽油及三七、血竭、蒲黄、白及的中药浸液为主要原料,加入辅助原料组成的具有散淤、消肿、止血、止痛、消炎、生肌等功能的外用乳剂药物。专利申请号为CN201110032186.5的申请文件公开的一种治疗刀伤、烧伤及多种创伤的中药组合物,该中药组合物主要由麻柳树根皮叶和松树叶或松针组成,还可以含有红花、血竭、三七、白芷、杜仲、桃仁、当归、桂枝、乳香、木通,将其分别制成药粉和药酒,可用于治疗刀伤、烧伤、烫伤等多种创伤。Existing topical medicines for treating trauma include alcohol, tincture of iodine, complex iodine, hydrogen peroxide, and chlorophyll, etc. for sterilization, and western medicine preparations for anti-inflammatory and muscle-promoting include sulfonamide powder, sulfonamide ointment, etc., which are used for dispersing silt Chinese medicine oils that stop bleeding and promote muscle growth include Wanhua oil, safflower oil, etc., and Chinese medicine powders include Yunnan Baiyao. These medicines have been proved through long-term clinical practice that they all have different degrees of curative effect, some of which vary from person to person, and some of which vary from injury to condition. Another example is that the application document with the patent application number CN201010191973.X discloses a kind of externally used medicine for treating trauma and its preparation method. Liquid as the main raw material, adding auxiliary raw materials to form an external emulsion drug with functions such as dispersing silt, reducing swelling, stopping bleeding, relieving pain, reducing inflammation, and promoting muscle growth. Patent application number CN201110032186.5 discloses a traditional Chinese medicine composition for treating knife wounds, burns and various wounds. Drainage, Panax notoginseng, Angelica dahurica, Eucommia ulmoides, peach kernel, angelica, cinnamon stick, frankincense, and akebia, which are made into medicinal powder and medicinal wine respectively, which can be used to treat various wounds such as knife wounds, burns, and scalds.

但是上述药物大多存在疗效差、见效慢、止痛效果不够明显、散瘀消肿作用不强以及伤口愈合时间长等问题;而中药制备的外用药物中所用原料药成分药效单一,原料药种类较多,有的中药原料药与其他原料药没有发生协同作用,影响了中药组合物的整体疗效。此外,现有的中药组合物多数是将所用原料直接粉碎入药,没有对原料内的活性成分进行提取分离,非有效成分没有除去,杂质较多,使中药组合物的组方过大,不利于患者服用,进一步影响中药组合物的疗效。However, most of the above-mentioned medicines have problems such as poor curative effect, slow effect, insufficient analgesic effect, weak effect of dissipating blood stasis and detumescence, and long wound healing time; and the raw materials used in the external medicines prepared by traditional Chinese medicine have single drug effects, and the types of raw materials are relatively large. Many, some traditional Chinese medicine raw materials have no synergistic effect with other raw materials, which affects the overall curative effect of the traditional Chinese medicine composition. In addition, most of the existing traditional Chinese medicine compositions use the raw materials directly crushed into medicine, without extracting and separating the active ingredients in the raw materials, the non-effective ingredients are not removed, and there are many impurities, which makes the prescription of the traditional Chinese medicine composition too large, which is not conducive to Patient takes, further influences the curative effect of Chinese medicine composition.

发明内容Contents of the invention

为了解决上述技术问题,本发明提供一种起效快、疗程短、治愈率高的治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物及其制剂。In order to solve the above-mentioned technical problems, the present invention provides an external Chinese medicine composition for treating swelling and pain, incision wounds and skin ulcers and its preparation with quick onset, short course of treatment and high cure rate.

本发明具体技术方案如下:Concrete technical scheme of the present invention is as follows:

本发明提供一种治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物,所述外用中药组合物主要由下列重量份的原料药经加工制备而成:The invention provides an external Chinese medicine composition for treating swelling and pain, incision wounds and skin ulcers. The external Chinese medicine composition is mainly prepared by processing the following raw materials in parts by weight:

本发明所提供的治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物,该中药组合物具有散淤、消肿、止痛、止血、消炎、生肌等显著疗效,该药物见效快,有效率高达97.7%,且患者创伤面生肌快。The external Chinese medicine composition for treating swelling and pain, incision wounds and skin ulcers provided by the present invention has significant curative effects such as dispelling stasis, detumescence, pain relief, hemostasis, anti-inflammation, and muscle growth. As high as 97.7%, and the patient's wounded surface grows muscle quickly.

优选地,外用中药组合物主要由下列重量份的原料药经加工制备而成:Preferably, the traditional Chinese medicine composition for external use is mainly processed and prepared from the following raw materials in parts by weight:

更进一步合理优化本发明的配方,外用中药组合物主要由下列重量份的原料药经加工制备而成:Further rationally optimize the formula of the present invention, the traditional Chinese medicine composition for external use is mainly prepared by processing the raw materials of the following parts by weight:

为了服用及携带方便,本发明提供由治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物和辅剂制成的制剂,所述制剂包括散剂、酊剂、喷雾剂、贴膏剂、糊剂以及软膏剂,所述组合物和辅料的重量比为1:0.1-12。For the convenience of taking and carrying, the present invention provides preparations made of external Chinese medicine compositions and adjuvants for treating swelling, pain, incision wounds and skin ulcers, said preparations include powders, tinctures, sprays, plasters, pastes and ointments agent, the weight ratio of the composition and the auxiliary material is 1:0.1-12.

进一步的改进,本发明将外用中药组合物和辅料制成糊剂,所述辅料由以下重量份数的成分组成:50-60度的白酒或60-70度的医用酒精120份、苯甲酸钠3份。上述中药原料中注入白酒或医用酒精后,并常温放置3天,灭菌、装瓶即可;其中苯甲酸钠的使用可提高该药物制剂的存储期。As a further improvement, the present invention makes a paste from the traditional Chinese medicine composition for external use and auxiliary materials, and the auxiliary materials are composed of the following components in parts by weight: 120 parts of white wine of 50-60 degrees or 120 parts of medical alcohol of 60-70 degrees, sodium benzoate 3 share. After injecting white wine or medical alcohol into the above-mentioned traditional Chinese medicine raw materials, place them at room temperature for 3 days, then sterilize and bottle them; wherein the use of sodium benzoate can increase the storage period of the pharmaceutical preparations.

更进一步的改进,本发明将外用中药组合物和辅料制成软膏剂,所述辅料由以下重量分数的成分组成:硬脂酸20份、蜂蜡26份、十八醇15份、甘油20份、蔗糖脂肪酸酯1.5份、聚氧乙烯蓖麻油2份、苯扎溴铵1份、柠檬烯2.4份以及纯化水80份。As a further improvement, the present invention makes an ointment from the traditional Chinese medicine composition for external use and auxiliary materials, and the auxiliary materials are composed of the following components in weight fractions: 20 parts of stearic acid, 26 parts of beeswax, 15 parts of stearyl alcohol, 20 parts of glycerin, 1.5 parts of sucrose fatty acid ester, 2 parts of polyoxyethylene castor oil, 1 part of benzalkonium bromide, 2.4 parts of limonene and 80 parts of purified water.

该配方制备的软膏剂为乳剂型软膏,其中选取硬脂酸、蜂蜡和十八醇作为基质,提高药物活性成分的释药性和生物利用度;柠檬烯的使用进一步促进药物的透皮吸收;蔗糖脂肪酸酯起到乳化、粘合的作用,蔗糖脂肪酸酯和聚氧乙烯蓖麻油与中药组合物形成均匀分散体,该比例的蔗糖脂肪酸酯和山梨醇的混合物可显著提高软膏剂的稳定性;苯扎溴铵则是用做防腐作用。上述物质与中药组合物制成膏状,可提高软膏剂的含量均匀度,充分发挥中药组合物对各类外伤的治疗效果,显著提高疗效。The ointment prepared by this formula is an emulsion type ointment, in which stearic acid, beeswax and stearyl alcohol are selected as bases to improve the drug release and bioavailability of the active ingredients of the drug; the use of limonene further promotes the transdermal absorption of the drug; sucrose fat Ester plays the role of emulsification and adhesion, and sucrose fatty acid ester and polyoxyethylene castor oil form a uniform dispersion with the traditional Chinese medicine composition. The mixture of sucrose fatty acid ester and sorbitol in this ratio can significantly improve the stability of the ointment ; Benzalkonium bromide is used as a preservative. The above-mentioned substances and the traditional Chinese medicine composition are made into a paste, which can improve the content uniformity of the ointment, give full play to the therapeutic effect of the traditional Chinese medicine composition on various traumas, and significantly improve the curative effect.

本发明另一方面还提供了治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物的制备方法:将所述重量份的原料药分别粉碎成粗粉,将粗粉在60℃的烘箱内干燥240min,混合后将粗粉粉碎,过80目筛,并研磨成细粉,即为外用中药组合物。Another aspect of the present invention also provides a preparation method of an external Chinese medicine composition for treating swelling and pain, incision wounds and skin ulcers: the raw materials in parts by weight are respectively pulverized into coarse powder, and the coarse powder is dried in an oven at 60°C After 240 minutes, the coarse powder is crushed after mixing, passed through an 80-mesh sieve, and ground into a fine powder, which is a traditional Chinese medicine composition for external use.

为更精细的提取中药组合物的活性成分,本发明提供了一种治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物的制备方法,包括如下步骤:For extracting the active ingredient of the traditional Chinese medicine composition more finely, the present invention provides a kind of preparation method of the external Chinese medicine composition for treating swelling and pain, incision wound and skin ulceration, comprising the following steps:

a)取所述重量份的朴硝用热水溶解,离心过滤,放冷析出晶体,粉粹过80目筛,得晶体粉末;a) dissolving the nitrate in said weight portion with hot water, centrifuging, cooling to precipitate crystals, pulverizing through an 80-mesh sieve to obtain crystal powder;

b)取所述重量份的细辛、大黄、荆芥和苍术加乙醇回流提取三次,第一次加10倍量90%的乙醇,回流提取3h;第二次加7倍量90%的乙醇,回流提取2h;第三次加4倍量90%的乙醇,回流提取1h;合并回流液,滤过,合并得溶液1;b) Take the Herba Asarum, Rhubarb, Schizonepeta and Atractylodes Rhizoma Atractylodis in said weight parts and add ethanol to reflux for three times, add 10 times the amount of 90% ethanol for the first time, and reflux for 3 hours; add 7 times the amount of 90% ethanol for the second time , reflux extraction for 2 hours; add 4 times the amount of 90% ethanol for the third time, reflux extraction for 1 hour; combine the reflux liquid, filter, and combine to obtain solution 1;

c)取所述重量份的紫苏、薄荷、防风、白芨和甘草进行水煎煮2次,第一次15倍量水煎煮4h,第二次10倍量水煎煮1.5h,合并滤液,温度为55℃条件下浓缩至相对密度为1.00-1.15g/ml,冷却,加60-70%乙醇,静置24h,滤过,滤液在温度为55℃条件下浓缩至相对密度为1.00-1.25g/ml的稠膏,加水至总量60%,静置20h,取上清液,即得溶液2;c) decoct the perilla, mint, windproof, bletilla striata and licorice for 2 times, the first time decoct 15 times the amount of water for 4 hours, the second time 10 times the amount of water for 1.5 hours, and combine the filtrates , concentrated at a temperature of 55°C to a relative density of 1.00-1.15g/ml, cooled, added 60-70% ethanol, stood for 24 hours, filtered, and the filtrate was concentrated at a temperature of 55°C to a relative density of 1.00- 1.25g/ml thick paste, add water to 60% of the total amount, let it stand for 20 hours, take the supernatant, and obtain solution 2;

d)将溶液1和溶液2混合均匀,在温度为50℃、压力为-0.05MPa条件下进行真空干燥,制得细粉;d) Mix solution 1 and solution 2 evenly, and vacuum-dry at a temperature of 50°C and a pressure of -0.05MPa to obtain a fine powder;

e)将步骤a)的晶体粉末、步骤d)的细粉混合均匀,即得治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物。e) mixing the crystal powder in step a) and the fine powder in step d) evenly to obtain an external Chinese medicine composition for treating swelling, pain, incision wound and skin ulcer.

本发明提供的中药组合物的制备方法可将各中药原料药内的有效成分提取出来,减少没有发挥作用的成分的用量,进一步提高了中药组合物的疗效,在实现在节约成本的同时,保持收率高、产品品质好、工艺简单等优点,适合工业化生产。The preparation method of the traditional Chinese medicine composition provided by the present invention can extract the active ingredients in each traditional Chinese medicine raw material medicine, reduce the dosage of ingredients that do not play a role, further improve the curative effect of the traditional Chinese medicine composition, and realize cost saving while maintaining It has the advantages of high yield, good product quality, simple process and the like, and is suitable for industrialized production.

另一方面,本发明还提供了软膏剂的制备方法,该方法包括如下步骤:On the other hand, the present invention also provides the preparation method of ointment, and this method comprises the steps:

a)制备外用中药组合物,备用;a) preparing a traditional Chinese medicine composition for external use, for subsequent use;

b)取所述重量份数的硬脂酸、蜂蜡、十八醇置水浴锅加热,温度70~90℃,搅拌至全熔,为油相;b) Take the stearic acid, beeswax and stearyl alcohol in the stated parts by weight, heat in a water bath at a temperature of 70-90° C., stir until fully melted, and form an oil phase;

c)取步骤a)的组合物和甘油、蔗糖脂肪酸酯、聚氧乙烯蓖麻油、苯扎溴铵、柠檬烯置水浴锅,溶解于纯化水中,加热至70~90℃,为水相;c) Take the composition of step a), glycerin, sucrose fatty acid ester, polyoxyethylene castor oil, benzalkonium bromide, and limonene in a water bath, dissolve in purified water, and heat to 70-90°C to form an aqueous phase;

d)将步骤b)中的油相缓缓倒入步骤c)的油相中,边加边搅拌,直至冷却45℃时,继续搅拌,灌装即得软膏剂。d) Slowly pour the oil phase in step b) into the oil phase in step c), and stir while adding, until it cools to 45°C, continue stirring, and fill to obtain an ointment.

进一步地,所述外用中药组合物在制备治疗淋巴结发炎、蜜蜂蛰伤、跌打损伤、刀口伤以及皮肤溃烂的药物中的应用。Further, the application of the traditional Chinese medicine composition for external use in the preparation of medicines for treating lymph node inflammation, bee stings, bruises, incision wounds and skin ulcers.

本发明所述原料药的来源如下:The source of crude drug of the present invention is as follows:

紫苏:唇形科紫苏属植物紫苏Perilla frutescens(L.)Britt.的带枝嫩叶。Perilla: The young leaves with branches of Perilla frutescens (L.) Britt.

薄荷:本品为唇形科薄荷属植物薄荷Mentha haplocalyx Briq.的干燥地上部分。Mint: This product is the dry aerial part of Mentha haplocalyx Briq.

细辛:本品为马兜铃科植物北细辛Asarum heterotropoides Fr.Schmidt var.mandshuricum(Maxim.)Kitag.、汉城细辛Asarum sieboldiiMiq.var.seoulense Nakai或华细辛Asarum sieboldii Miq.的干燥全草。Asarum: This product is the dry whole of Asarum heterotropoides Fr. Schmidt var. mandshuricum (Maxim.) Kitag., Asarum sieboldii Miq. var. seoulense Nakai or Asarum sieboldii Miq. Grass.

大黄:本品为蓼科植物掌叶大黄Rheum palmatum L.、唐古特大黄Rheum tanguticum Maxim.ex Balf.或药用大黄Rheum officinale Baill.的干燥根及根茎。Rhubarb: This product is the dry root and rhizome of Rheum palmatum L., Rheum tanguticum Maxim.ex Balf. or medicinal Rheum officinale Baill. of Polygonaceae.

朴硝:又名芒硝,是含有结晶水的硫酸钠的俗称;芒硝是由一种分布很广泛的硫酸盐矿物经加工精制而成的结晶体。Glauber's salt: also known as Glauber's salt, is a common name for sodium sulfate containing crystal water; Glauber's salt is a crystal that is processed and refined from a widely distributed sulfate mineral.

荆芥:本品为唇形科植物荆芥Schizonepeta tenuifolia Briq.的干燥地上部分。Nepeta: This product is the dry aerial part of Schizonepeta tenuifolia Briq.

白芨:本品为兰科植物白及Bletilla striata(Thunburcz)Reichb.f.的干燥块茎。Bletilla striata: This product is the dry tuber of the orchid plant Bletilla striata (Thunburcz) Reichb.f.

防风:本品为伞形科防风Saposhnikovia divaricate(Turcz.)Schischk.植物的根。Windproof: This product is the root of Saposhnikovia divaricate (Turcz.) Schischk. plant of Umbelliferae.

苍术:本品为菊科植物茅苍术Atractylodes lancea(Thunb.)DC.或北苍术Atractylodes chinensis(DC.)Koidz.的干燥根茎。Atractylodes: This product is the dry rhizome of Atractylodes lancea (Thunb.) DC. or Atractylodes chinensis (DC.) Koidz. of Compositae.

甘草:本品为豆科植物甘草Glycyrrhiza uralensis Fisch.、胀果甘草Glycyrrhiza inflata Bat.或光果甘草Glycyrrhiza glabra L.的干燥根。Licorice: This product is the dry root of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. of the leguminous plant Glycyrrhiza uralensis Fisch.

本发明所提供的中药组合物是申请人研制开发的一种纯中药治疗外伤的药剂,该中药组合物的散剂“特消散”已大量生产且广泛运用于临床治疗。The traditional Chinese medicine composition provided by the present invention is a kind of pure traditional Chinese medicine medicine for treating trauma developed by the applicant. The powder of the traditional Chinese medicine composition "Texiaosan" has been mass-produced and widely used in clinical treatment.

本发明的中药组合物主要用于无名肿毒(例如:淋巴结发炎,蜜蜂蛰伤、跌打损伤等)、刀口伤、皮肤溃烂等症;其特点为:见效快,治愈率高,止痛效果明显、散瘀消肿作用强以及伤口愈合时间短。The traditional Chinese medicine composition of the present invention is mainly used for diseases such as nameless swollen toxins (for example: lymph node inflammation, bee stings, bruises, etc.), incision wounds, and skin ulcers; it is characterized by quick results, high cure rate, and obvious analgesic effect , Dispersing blood stasis and detumescence is strong and wound healing time is short.

具体实施方式Detailed ways

实施例1外用中药组合物Embodiment 1 external use Chinese medicine composition

一种治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物,该外用中药组合物由下列重量份的原料药经加工制备而成:An external Chinese medicine composition for treating swelling and pain, incision wounds and skin ulcers. The external Chinese medicine composition is prepared by processing the following raw materials in parts by weight:

紫苏15g        薄荷10g       细辛8g      大黄15gPerilla 15g Mint 10g Asarum 8g Rhubarb 15g

朴硝16g        荆芥12g       白芨15g     防风12gPu Nitrate 16g Nepeta 12g Baiji 15g Fangfeng 12g

苍术9g      甘草9g。Cangzhu 9g, licorice 9g.

制备方法:Preparation:

a)取所述重量份的朴硝用热水溶解,离心过滤,放冷析出晶体,粉粹过80目筛,得晶体粉末;a) dissolving the nitrate in said weight portion with hot water, centrifuging, cooling to precipitate crystals, pulverizing through an 80-mesh sieve to obtain crystal powder;

b)取所述重量份的细辛、大黄、荆芥和苍术加乙醇回流提取三次,第一次加10倍量90%的乙醇,回流提取3h;第二次加7倍量90%的乙醇,回流提取2h;第三次加4倍量90%的乙醇,回流提取1h;合并回流液,滤过,合并得溶液1;b) Take the Herba Asarum, Rhubarb, Schizonepeta and Atractylodes Rhizoma Atractylodis in said weight parts and add ethanol to reflux for three times, add 10 times the amount of 90% ethanol for the first time, and reflux for 3 hours; add 7 times the amount of 90% ethanol for the second time , reflux extraction for 2 hours; add 4 times the amount of 90% ethanol for the third time, reflux extraction for 1 hour; combine the reflux liquid, filter, and combine to obtain solution 1;

c)取所述重量份的紫苏、薄荷、防风、白芨和甘草进行水煎煮2次,第一次15倍量水煎煮4h,第二次10倍量水煎煮1.5h,合并滤液,温度为55℃条件下浓缩至相对密度为1.00-1.15g/ml,冷却,加60-70%乙醇,静置24h,滤过,滤液在温度为55℃条件下浓缩至相对密度为1.00-1.25g/ml的稠膏,加水至总量60%,静置20h,取上清液,即得溶液2;c) decoct the perilla, mint, windproof, bletilla striata and licorice for 2 times, the first time decoct 15 times the amount of water for 4 hours, the second time 10 times the amount of water for 1.5 hours, and combine the filtrates , concentrated at a temperature of 55°C to a relative density of 1.00-1.15g/ml, cooled, added 60-70% ethanol, stood for 24 hours, filtered, and the filtrate was concentrated at a temperature of 55°C to a relative density of 1.00- 1.25g/ml thick paste, add water to 60% of the total amount, let it stand for 20 hours, take the supernatant, and obtain solution 2;

d)将溶液1和溶液2混合均匀,在温度为50℃、压力为-0.05MPa条件下进行真空干燥,制得细粉;d) Mix solution 1 and solution 2 evenly, and vacuum-dry at a temperature of 50°C and a pressure of -0.05MPa to obtain a fine powder;

e)将步骤a)的晶体粉末、步骤d)的细粉混合均匀,即得治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物。e) mixing the crystal powder in step a) and the fine powder in step d) evenly to obtain an external Chinese medicine composition for treating swelling, pain, incision wound and skin ulcer.

实施例2外用中药组合物Embodiment 2 external use Chinese medicine composition

一种治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物,该外用中药组合物由下列重量份的原料药经加工制备而成:An external Chinese medicine composition for treating swelling and pain, incision wounds and skin ulcers. The external Chinese medicine composition is prepared by processing the following raw materials in parts by weight:

紫苏25g          薄荷16g       细辛2g      大黄5gBasil 25g Mint 16g Asarum 2g Rhubarb 5g

朴硝28g          荆芥20g       白芨6g      防风5gPu Nitrate 28g Nepeta 20g Bletilla striata 6g Fangfeng 5g

苍术16g          甘草3g。Cangzhu 16g, licorice 3g.

制备方法:将所述重量份的原料药分别粉碎成粗粉,将粗粉在60℃的烘箱内干燥240min,混合后将粗粉粉碎,过80目筛,并研磨成细粉,即为外用中药组合物。Preparation method: respectively pulverize the crude drug in said parts by weight into coarse powder, dry the coarse powder in an oven at 60°C for 240 minutes, pulverize the coarse powder after mixing, pass through an 80-mesh sieve, and grind into a fine powder for external use Chinese medicine composition.

实施例3外用中药组合物Embodiment 3 external use Chinese medicine composition

一种治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物,该外用中药组合物由下列重量份的原料药经加工制备而成:An external Chinese medicine composition for treating swelling and pain, incision wounds and skin ulcers. The external Chinese medicine composition is prepared by processing the following raw materials in parts by weight:

制备方法:按实施例1所述方法制备。Preparation method: prepared according to the method described in Example 1.

实施例4外用中药组合物Embodiment 4 external use Chinese medicine composition

一种治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物,该外用中药组合物由下列重量份的原料药经加工制备而成:An external Chinese medicine composition for treating swelling and pain, incision wounds and skin ulcers. The external Chinese medicine composition is prepared by processing the following raw materials in parts by weight:

制备方法:按实施例2所述方法制备。Preparation method: prepared according to the method described in Example 2.

实施例5外用中药组合物Embodiment 5 external use Chinese medicine composition

一种治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物,该外用中药组合物由下列重量份的原料药经加工制备而成:An external Chinese medicine composition for treating swelling and pain, incision wounds and skin ulcers. The external Chinese medicine composition is prepared by processing the following raw materials in parts by weight:

制备方法:按实施例1所述方法制备。 Preparation method: prepared according to the method described in Example 1.

实施例6外用中药组合物Embodiment 6 external use Chinese medicine composition

一种治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物,该外用中药组合物由下列重量份的原料药经加工制备而成:An external Chinese medicine composition for treating swelling and pain, incision wounds and skin ulcers. The external Chinese medicine composition is prepared by processing the following raw materials in parts by weight:

制备方法:按实施例1所述方法制备。Preparation method: prepared according to the method described in Example 1.

实施例7糊剂Example 7 Paste

实施例1所制备的中药组合物    100gChinese medicine composition prepared by embodiment 1 100g

辅料:50~60度白酒           105gAccessories: 50-60% liquor 105g

      苯甲酸钠               2.5gSodium Benzoate 2.5g

制备方法:Preparation:

a)将制备好的外用中药组合物、白酒及苯甲酸钠按重量组分比称重,备用;a) weighing the prepared external Chinese medicine composition, white wine and sodium benzoate according to the weight component ratio, and set aside;

b)向组合物中加入所述重量份的白酒,搅拌均匀,并常温放置3天,灭菌、装瓶,即得外用糊剂。b) adding said white wine in the composition by weight, stirring evenly, and standing at room temperature for 3 days, sterilizing and bottling to obtain the paste for external use.

实施例8糊剂Example 8 Paste

实施例1所制备的中药组合物    100gChinese medicine composition prepared by embodiment 1 100g

辅料:50~60度白酒           105gAccessories: 50-60% liquor 105g

      苯甲酸钠               2.5gSodium Benzoate 2.5g

制备方法:Preparation:

a)将制备好的外用中药组合物、白酒及苯甲酸钠按重量组分比称重,备用;a) weighing the prepared external Chinese medicine composition, white wine and sodium benzoate according to the weight component ratio, and set aside;

b)向组合物中加入所述重量份的白酒,搅拌均匀,得溶液1;b) adding the white wine in said weight portion to the composition, and stirring evenly to obtain solution 1;

c)向组合物溶液1中加入所述重量份的苯甲酸钠,搅拌均匀,并常温放置3天,灭菌、装瓶,即得外用糊剂。c) Add the sodium benzoate in said weight portion to the composition solution 1, stir evenly, and place at room temperature for 3 days, sterilize, bottle, and obtain the paste for external use.

实施例9糊剂Example 9 Paste

实施例1所制备的中药组合物    100gChinese medicine composition prepared by embodiment 1 100g

辅料:60~70度医用酒精       120gExcipients: 60-70% medical alcohol 120g

      苯甲酸钠               3gSodium Benzoate 3g

制备方法:Preparation:

a)将制备好的外用中药组合物、医用酒精及苯甲酸钠按重量组分比称重,备用;a) weighing the prepared traditional Chinese medicine composition for external use, medical alcohol and sodium benzoate according to the weight component ratio, and set aside;

b)向组合物中加入所述重量份的医用酒精,搅拌均匀,得溶液1;b) adding the medical alcohol in the weight part to the composition, and stirring evenly to obtain solution 1;

c)向溶液1中加入所述重量份的苯甲酸钠,搅拌均匀,并常温放置3天,灭菌、装瓶,即得外用糊剂。c) Add the sodium benzoate in said weight portion to solution 1, stir evenly, and place at room temperature for 3 days, sterilize, bottle, and obtain the paste for external use.

实施例10软膏剂Embodiment 10 ointment

制备方法:Preparation:

a)制备外用中药组合物,备用;a) preparing a traditional Chinese medicine composition for external use, for subsequent use;

b)取所述重量份数的硬脂酸、蜂蜡、十八醇置水浴锅加热,温度70~90℃,搅拌至全熔,为油相;b) Take the stearic acid, beeswax and stearyl alcohol in the stated parts by weight, heat in a water bath at a temperature of 70-90° C., stir until fully melted, and form an oil phase;

c)取步骤a)的组合物和甘油、蔗糖脂肪酸酯、聚氧乙烯蓖麻油、苯扎溴铵、柠檬烯置水浴锅,溶解于纯化水中,加热至70~90℃,为水相;c) Take the composition of step a), glycerin, sucrose fatty acid ester, polyoxyethylene castor oil, benzalkonium bromide, and limonene in a water bath, dissolve in purified water, and heat to 70-90°C to form an aqueous phase;

d)将步骤b)中的油相缓缓倒入步骤c)的油相中,边加边搅拌,直至冷却45℃时,继续搅拌,灌装即得软膏剂。d) Slowly pour the oil phase in step b) into the oil phase in step c), and stir while adding, until it cools to 45°C, continue stirring, and fill to obtain an ointment.

实施例11软膏剂Embodiment 11 ointment

制备方法:Preparation:

a)制备外用中药组合物,备用;a) preparing a traditional Chinese medicine composition for external use, for subsequent use;

b)取所述重量份数的硬脂酸、蜂蜡、十八醇置水浴锅加热,温度70~90℃,搅拌至全熔,为油相;b) Take the stearic acid, beeswax and stearyl alcohol in the stated parts by weight, heat in a water bath at a temperature of 70-90° C., stir until fully melted, and form an oil phase;

c)取步骤a)的组合物和甘油、苯扎溴铵、柠檬烯置水浴锅,溶解于纯化水中,加热至70~90℃,为水相;c) Take the composition of step a), glycerin, benzalkonium bromide, and limonene in a water bath, dissolve in purified water, and heat to 70-90°C to form an aqueous phase;

d)将步骤b)中的油相缓缓倒入步骤c)的油相中,边加边搅拌,直至冷却45℃时,继续搅拌,灌装即得软膏剂。d) Slowly pour the oil phase in step b) into the oil phase in step c), and stir while adding, until it cools to 45°C, continue stirring, and fill to obtain an ointment.

实施例12贴剂Embodiment 12 patch

制备方法:Preparation:

a)制备外用中药组合物,备用;a) preparing a traditional Chinese medicine composition for external use, for subsequent use;

b)在加入适量可溶性淀粉、甘油和尼泊金酯加适量纯化水调成糊状,利用涂布机将糊状药物均匀的涂布在无纺布上,加热烘干后,覆盖离型纸或离型膜后压片成型;最后进行分切、检验并进行包装,即得贴剂。b) After adding an appropriate amount of soluble starch, glycerin and paraben and an appropriate amount of purified water to make a paste, use a coating machine to evenly coat the paste drug on the non-woven fabric, heat and dry, and cover the release paper or a release film, and then pressed into tablets; finally cut, inspected and packaged to obtain a patch.

实施例13喷剂Example 13 Spray

实施例5所制备的组合物    100gThe composition prepared in embodiment 5 100g

制备方法:将粉碎过筛后的组合物装入喷雾瓶,为每瓶20ml,即为喷剂。Preparation method: put the crushed and sieved composition into a spray bottle, 20ml per bottle, which is the spray.

试验例1稳定性试验Test Example 1 Stability Test

加速试验accelerated test

取本发明实施例10和实施例11的软膏剂,分别随机分成3批,分别编号为样品1、样品2、样品3、样品4、样品5和样品6,将以上6批样品均在40℃±2℃下,相对湿度为75%±5%的条件下放置6个月,在试验期间1个月、2个月、3个月、6个月末分别取样一次,按中国药典中的规定,检测升麻素苷的性状、含量(标示量%)、溶出度及有关物质(%)。Get the ointment of embodiment 10 of the present invention and embodiment 11, divide into 3 batches respectively at random, number respectively as sample 1, sample 2, sample 3, sample 4, sample 5 and sample 6, above 6 batches of samples are all heated at 40 ℃ Store at ±2°C and relative humidity of 75%±5% for 6 months, take samples at the end of the test period at 1 month, 2 months, 3 months, and 6 months respectively, according to the regulations in the Chinese Pharmacopoeia, The properties, content (marked amount %), dissolution rate and related substances (%) of acteoside were detected.

从结果可看出本发明实施例10所提供的软膏剂,经加速试验结果可知,放置6个月后,所述软膏的性状、含升麻素苷的量、溶出度及有关物质均未发生明显的变化;而实施例11的软膏放置6个月后,软膏色泽加深,并且升麻素苷的含量下降,溶出不均匀,有关物质的量显著增加;表明实施例10的软膏剂与实施例11相比,稳定性更高,即添加了蔗糖脂肪酸酯、聚氧乙烯蓖麻油成分提高了软膏的成型性和稳定性。As can be seen from the results, the ointment provided by the embodiment of the present invention 10 can be known through accelerated test results, after placing for 6 months, the properties of the ointment, the amount containing acteoside, dissolution rate and related substances did not occur. Obvious change; and after the ointment of embodiment 11 was placed 6 months, the color of the ointment deepened, and the content of acteoside declined, and the stripping was uneven, and the amount of related substances increased significantly; it was shown that the ointment of embodiment 10 and embodiment Compared with 11, the stability is higher, that is, the addition of sucrose fatty acid ester and polyoxyethylene castor oil improves the formability and stability of the ointment.

5.3长期试验5.3 Long-term test

另取5.2中的6批样品均于温度25℃±2℃下,相对湿度为60%±10%的条件下放置12个月,每3个月取样一次,分别于0个月、1个月、3个月、6个月、9个月、12个月取样,检测软膏剂的性状、升麻素苷的含量(标示量%)、溶出度及有关物质(%)。In addition, the 6 batches of samples in 5.2 were placed at a temperature of 25°C±2°C and a relative humidity of 60%±10% for 12 months, and samples were taken every 3 months, at 0 months and 1 month respectively. , 3 months, 6 months, 9 months, and 12 months, samples were taken to detect the properties of the ointment, the content of acteoside (marked amount %), dissolution rate and related substances (%).

从结果可看出本发明实施例10所提供的软膏剂,经长期试验结果可知,放置12个月后,所述软膏的性状、含升麻素苷的量、溶出度及有关物质均未发生明显的变化;而实施例11的软膏色泽加深,并且升麻素苷的含量显著下降,溶出不均匀,有关物质的量显著增加;表明蔗糖脂肪酸酯、聚氧乙烯蓖麻油成分提高了软膏的成型性和稳定性。From the results, it can be seen that the ointment provided by Example 10 of the present invention, through long-term test results, after being placed for 12 months, the properties of the ointment, the amount containing acteoside, dissolution rate and related substances did not occur. Obvious change; And the ointment color and luster of embodiment 11 is deepened, and the content of acteoside significantly descends, and dissolution is uneven, and the amount of related substance significantly increases; Show that sucrose fatty acid ester, polyoxyethylene castor oil composition have improved the ointment formability and stability.

试验例2临床试验Test Example 2 Clinical Trial

2.1诊断标准2.1 Diagnostic criteria

根据《中西医学诊断学》所记载,无名肿痛、刀口伤和皮肤溃烂。According to the records in "Diagnostics of Chinese and Western Medicine", nameless swelling and pain, incision wound and skin ulceration.

2.2试验病例2.2 Test case

收治患者共152例,年龄均在15-50岁之间;均经检查确诊,无名肿痛患者62例、刀口伤患者46例和皮肤溃烂患者44例;其中无名肿痛患者具体包括淋巴结发炎、蜜蜂蛰伤、跌打损伤症状。A total of 152 patients were admitted, all aged between 15 and 50 years old; all of them were confirmed by examination, 62 patients with unknown swelling and pain, 46 patients with incision wounds and 44 patients with skin ulcers; among them, patients with unknown swelling and pain specifically included lymph node inflammation, Symptoms of bee stings and bruises.

2.3分组及给药2.3 Grouping and administration

将62例无名肿痛患者随机分成治疗组38例,对照组24例;将46例刀口伤患者随机分成治疗组26例,对照组20例;将44例皮肤溃烂患者随机分成治疗组24例,对照组20例。62 patients with nameless swelling and pain were randomly divided into a treatment group of 38 cases and a control group of 24 cases; 46 patients with incision wounds were randomly divided into a treatment group of 26 cases and a control group of 20 cases; 44 patients with skin ulcers were randomly divided into a treatment group of 24 cases. 20 cases in the control group.

以上无名肿痛治疗组均给予本发明实施例1制成的中药组合物,用法为直接将组合物粉末撒在伤口处,记录疗程为15天,用法2次/日;刀口伤和皮肤溃烂治疗组均给予本发明实施例7制成的糊剂,记录疗程为15天,用法2次/日;对照组均给予红花油涂抹,每日2次,记录疗程15天。The above unknown swelling and pain treatment group is given the traditional Chinese medicine composition made in Example 1 of the present invention. The usage is to directly sprinkle the powder of the composition on the wound. The recorded course of treatment is 15 days, and the usage is 2 times/day; incision wound and skin ulceration treatment All groups were given the paste made by Example 7 of the present invention, and the recorded course of treatment was 15 days, and the usage was 2 times/day; the control group was given safflower oil smear, twice a day, and the recorded course of treatment was 15 days.

2.4观察方法2.4 Observation method

每例患者均全部记录病史,体征,诊断,疼痛部位及性质和有关的物理、生理检查。For each patient, the medical history, signs, diagnosis, location and nature of pain and related physical and physiological examinations were all recorded.

2.5疗效评定标准2.5 Evaluating Criteria for Efficacy

痊愈:治疗后病症全部消失,达到临床治愈标准;Cured: After treatment, all the symptoms disappeared and reached the clinical cure standard;

显效:治疗后病情体征明显改善;Significantly effective: After treatment, the symptoms and signs of the condition are obviously improved;

有效:治疗后病情体征有所改善;Effective: After treatment, the symptoms and signs of the disease have improved;

无效:治疗前后无变化。Ineffective: no change before and after treatment.

2.6治疗分析2.6 Treatment Analysis

将患者临床资料经整理分析,将治疗组与对照组在痊愈、显效、有效和无效四个标准中进行比较,通过t检验来验证治疗组和对照组之间的差异。After collation and analysis of the clinical data of the patients, the treatment group and the control group were compared in the four criteria of recovery, markedly effective, effective and ineffective, and the difference between the treatment group and the control group was verified by t test.

2.7结果2.7 Results

治疗组和对照组的患者均给药15天;两组药对无名肿痛、刀口伤和皮肤溃烂的治疗效果比较分别见表1-3。Patients in the treatment group and the control group were administered for 15 days; the comparison of the therapeutic effects of the two groups of medicines on inexplicable swelling and pain, incision wounds and skin ulcers is shown in Table 1-3, respectively.

表1 治疗组和对照组对无名肿痛治疗效果比较Table 1 Comparison of therapeutic effect on innominate swelling and pain between treatment group and control group

治疗组与对照组相比较具有显著性差异(Pa<0.01);There was a significant difference between the treatment group and the control group (P a <0.01);

表2 治疗组和对照组对刀口伤治疗效果比较Table 2 Comparison of therapeutic effect on incision wound between treatment group and control group

治疗组与对照组相比较具有显著性差异(Pa<0.05);There was a significant difference between the treatment group and the control group (P a <0.05);

表2 治疗组和对照组对皮肤溃烂治疗效果比较Table 2 Comparison of therapeutic effects on skin ulcers between the treatment group and the control group

治疗组与对照组相比较具有差异性(Pa<0.05);There was a difference between the treatment group and the control group (P a <0.05);

2.8临床观察验证2.8 Clinical observation verification

本发明提供的治疗肿痛、刀口伤和皮肤溃烂的组合物及其糊剂对淋巴结发炎、蜜蜂蛰伤、跌打损伤、刀口伤以及皮肤溃烂具有显著的疗效,约61%的患者伤口在治疗后消失,无疤痕遗留;治疗总有效率达到97.7%。本发明的组合物在验证其疗效过程中,未发现任何不良反应及毒副作用,且止痛效果明显、散瘀消肿作用强以及伤口愈合时间短。The composition for treating swelling and pain, incision wound and skin ulcer and paste thereof provided by the present invention have significant curative effect on lymph node inflammation, bee sting, bruises, incision wound and skin ulcer, and about 61% of patients' wounds are cured after treatment. After disappearing, no scar remains; the total effective rate of treatment reaches 97.7%. During the verification of the curative effect of the composition of the present invention, no adverse reactions and side effects are found, and the analgesic effect is obvious, the effect of dispelling blood stasis and reducing swelling is strong, and the wound healing time is short.

典型病例Typical cases

黄某,女,23岁,淋巴结部位疼痛,发觉不适10天左右;经检查,为淋巴结发炎,将本发明的组合物糊状涂抹于伤口处,每日2次,使用2小时后疼痛减轻,3天后,肿胀消失。Huang, female, 23 years old, had pain in the lymph node and felt discomfort for about 10 days; after inspection, it was lymph node inflammation, and the composition of the present invention was applied to the wound in paste form, 2 times a day, and the pain was relieved after 2 hours of use. After 3 days, the swelling disappeared.

高某,男,35岁,群蜂蜇伤,受伤部位为头、面、颈、上肢,蛰伤创面达数十处,在受伤后48h内出现酱油色尿、肝损伤、溶血等症状,出现头晕、头痛、恍惚、烦躁等神经性系统症状;局部创面处理后,使用本发明组合物的糊状,每日3次,使用3天后结痂,临床症状消失、肝肾功能正常;停止用药,待12天后,创面消失,痊愈。Gao, male, 35 years old, was stung by swarms of bees. The injured parts were the head, face, neck, and upper limbs. Dizziness, headache, trance, irritability and other nervous system symptoms; after local wound treatment, use the paste of the composition of the present invention, 3 times a day, scab after 3 days of use, clinical symptoms disappear, liver and kidney function is normal; stop medication, After 12 days, the wound disappeared and healed.

宋某,男,29岁,开摩托车摔跤导致脸部和手臂擦伤,伤口红肿出血,第1天有用酒精稍微擦拭,然后涂红药水,但一直流液体出来,第3天开始化脓红肿,未见好转,使用本发明的粉末撒在患处,每日3次,日渐好转,结痂后停止用药,15天后治愈。Song, male, 29 years old, wrestled with a motorcycle and caused abrasions on his face and arms. The wound was red, swollen and bleeding. On the first day, he wiped it with alcohol a little, and then applied red lotion, but the liquid continued to flow out. On the third day, he began to suppurate, red and swell. Did not take a turn for the better, use powder of the present invention to sprinkle on affected part, every day 3 times, take a turn for the better day by day, stop medication after incrustation, cure after 15 days.

董某,女,43岁,刀切伤手,止血后伤口周围红肿,涂万花油2天后无明显效果,使用本发明的粉末,每天涂抹于患处,每日3次,治疗使用2天后,红肿消失,15天后结痂伤口掉落,治愈。Dong, female, 43 years old, cut her hand with a knife, redness and swelling around the wound after hemostasis, no obvious effect after being coated with wanhua oil for 2 days, use the powder of the present invention, apply it to the affected part every day, 3 times a day, after 2 days of treatment, The redness and swelling disappeared, and the scab wound fell off after 15 days and was cured.

王某,女,38岁,手指之间的部分会出现溃烂,瘙痒严重,后发展为手指甲周围也出现溃烂红肿,涂抹一些药膏后无明显减轻症状;使用本发明组合物,将组合物粉末撒在溃烂部位,组合物糊状涂抹于红肿部位,每日3次,2天后瘙痒消失,使用10天后,溃烂创面消失。Wang, female, 38 years old, festered between the fingers, severe itching, and later developed ulceration, redness and swelling around the fingernails. After applying some ointments, the symptoms were not significantly relieved; using the composition of the present invention, the composition powder Sprinkle it on the festered part, smear the composition paste on the red and swollen part, 3 times a day, the itching disappears after 2 days, and the festered wound disappears after 10 days of use.

Claims (10)

1.一种治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物,其特征在于,所述外用中药组合物由下列重量份的原料药经加工制备而成:1. an external Chinese medicine composition for the treatment of swelling and pain, incision wound and skin ulceration, characterized in that, said external Chinese medicine composition is prepared by processing the bulk drug of the following parts by weight: 2.如权利要求1所述的治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物,其特征在于,所述外用中药组合物由下列重量份的原料药经加工制备而成:2. the external Chinese medicine composition for the treatment of swelling and pain as claimed in claim 1, incision wound and skin ulceration, is characterized in that, described external Chinese medicine composition is prepared through processing by the crude drug of following weight part: 3.如权利要求2所述的治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物,其特征在于,所述外用中药组合物由下列重量份的原料药经加工制备而成:3. the external Chinese medicine composition for the treatment of swelling and pain as claimed in claim 2, incision wound and skin ulceration, is characterized in that, described external Chinese medicine composition is prepared through processing by the crude drug of following weight part: 4.由权利要求1-3中任一项所述的治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物和辅料制备的制剂,其特征在于,所述制剂包括散剂、酊剂、喷雾剂、贴剂、糊剂以及软膏剂,所述外用中药组合物和辅料的重量比为1:0.1-12。4. the preparation prepared by the external Chinese medicine composition and auxiliary materials for the treatment of swelling and pain, incision wound and skin ulceration described in any one of claims 1-3, is characterized in that, described preparation comprises powder, tincture, spray, Patches, pastes and ointments, the weight ratio of the traditional Chinese medicine composition for external use and auxiliary materials is 1:0.1-12. 5.如权利要求4所述的制剂,其特征在于,所述制剂为糊剂,所述辅料由以下重量份数的成分组成:50~60度的白酒或60~70度的医用酒精100-120份、苯甲酸钠2-3份。5. The preparation according to claim 4, wherein the preparation is a paste, and the auxiliary material is composed of the following parts by weight: 50-60 degrees of white wine or 60-70 degrees of medical alcohol 100- 120 parts, 2-3 parts of sodium benzoate. 6.如权利要求4所述的制剂,其特征在于,所述制剂为软膏剂,所述辅料由以下重量分数的成分组成:硬脂酸20份、蜂蜡26份、十八醇15份、甘油20份、蔗糖脂肪酸酯1.5份、聚氧乙烯蓖麻油2份、苯扎溴铵1份、柠檬烯2.4份以及纯化水80份。6. The preparation according to claim 4, wherein the preparation is an ointment, and the adjuvant is composed of the following components by weight fraction: 20 parts of stearic acid, 26 parts of beeswax, 15 parts of stearyl alcohol, glycerin 20 parts, 1.5 parts of sucrose fatty acid ester, 2 parts of polyoxyethylene castor oil, 1 part of benzalkonium bromide, 2.4 parts of limonene and 80 parts of purified water. 7.一种如权利要求1-3中任一项所述的治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物的制备方法,所述方法为:将所述重量份的原料药分别粉碎成粗粉,将粗粉在60℃的烘箱内干燥240min,混合后将粗粉粉碎,过80目筛,并研磨成细粉,即为外用中药组合物。7. a preparation method of the external Chinese medicine composition for the treatment of swelling and pain, incision wound and skin ulceration as described in any one of claims 1-3, said method is: the crude drug of described weight part is pulverized respectively into a coarse powder, dry the coarse powder in an oven at 60°C for 240 minutes, mix and crush the coarse powder, pass through an 80-mesh sieve, and grind into a fine powder, which is a traditional Chinese medicine composition for external use. 8.一种如权利要求1-3中任一项所述的治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物的制备方法,所述方法包括以下步骤:8. a preparation method of the external Chinese medicine composition for the treatment of swelling and pain, incision wound and skin ulceration as described in any one of claims 1-3, said method may further comprise the steps: a)取所述重量份的朴硝用热水溶解,离心过滤,放冷析出晶体,粉粹过80目筛,得晶体粉末;a) dissolving the nitrate in said weight portion with hot water, centrifuging, cooling to precipitate crystals, pulverizing through an 80-mesh sieve to obtain crystal powder; b)取所述重量份的细辛、大黄、荆芥和苍术加乙醇回流提取三次,第一次加10倍量90%的乙醇,回流提取3h;第二次加7倍量90%的乙醇,回流提取2h;第三次加4倍量90%的乙醇,回流提取1h;合并回流液,滤过,合并得溶液1;b) Take the Herba Asarum, Rhubarb, Schizonepeta and Atractylodes Rhizoma Atractylodis in said weight parts and add ethanol to reflux for three times, add 10 times the amount of 90% ethanol for the first time, and reflux for 3 hours; add 7 times the amount of 90% ethanol for the second time , reflux extraction for 2 hours; add 4 times the amount of 90% ethanol for the third time, reflux extraction for 1 hour; combine the reflux liquid, filter, and combine to obtain solution 1; c)取所述重量份的紫苏、薄荷、防风、白芨和甘草进行水煎煮2次,第一次15倍量水煎煮4h,第二次10倍量水煎煮1.5h,合并滤液,温度为55℃条件下浓缩至相对密度为1.00-1.15g/ml,冷却,加60-70%乙醇,静置24h,滤过,滤液在温度为55℃条件下浓缩至相对密度为1.00-1.25g/ml的稠膏,加水至总量60%,静置20h,取上清液,即得溶液2;c) decoct the perilla, mint, windproof, bletilla striata and licorice for 2 times, the first time decoct 15 times the amount of water for 4 hours, the second time 10 times the amount of water for 1.5 hours, and combine the filtrates , concentrated at a temperature of 55°C to a relative density of 1.00-1.15g/ml, cooled, added 60-70% ethanol, stood for 24 hours, filtered, and the filtrate was concentrated at a temperature of 55°C to a relative density of 1.00- 1.25g/ml thick paste, add water to 60% of the total amount, let it stand for 20 hours, take the supernatant, and obtain solution 2; d)将溶液1和溶液2混合均匀,在温度为50℃、压力为-0.05MPa条件下进行真空干燥,制得细粉;d) Mix solution 1 and solution 2 evenly, and vacuum-dry at a temperature of 50°C and a pressure of -0.05MPa to obtain a fine powder; e)将步骤a)的晶体粉末、步骤d)的细粉混合均匀,即得治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物。e) mixing the crystal powder in step a) and the fine powder in step d) evenly to obtain an external Chinese medicine composition for treating swelling, pain, incision wound and skin ulcer. 9.一种如权利要求6所述的制剂的制备方法,其特征在于,所述方法包括以下步骤:9. a preparation method of the preparation as claimed in claim 6, is characterized in that, described method comprises the following steps: a)制备外用中药组合物,备用;a) preparing a traditional Chinese medicine composition for external use, for subsequent use; b)取所述重量份数的硬脂酸、蜂蜡、十八醇置水浴锅加热,温度70~90℃,搅拌至全熔,为油相;b) Take the stearic acid, beeswax and stearyl alcohol in the stated parts by weight, heat in a water bath at a temperature of 70-90° C., stir until fully melted, and form an oil phase; c)取步骤a)的组合物和甘油、蔗糖脂肪酸酯、聚氧乙烯蓖麻油、苯扎溴铵、柠檬烯置水浴锅,溶解于纯化水中,加热至70~90℃,为水相;c) Take the composition of step a), glycerin, sucrose fatty acid ester, polyoxyethylene castor oil, benzalkonium bromide, and limonene in a water bath, dissolve in purified water, and heat to 70-90°C to form an aqueous phase; d)将步骤b)中的油相缓缓倒入步骤c)的油相中,边加边搅拌,直至冷却45℃时,继续搅拌,灌装即得软膏剂。d) Slowly pour the oil phase in step b) into the oil phase in step c), and stir while adding, until it cools to 45°C, continue stirring, and fill to obtain an ointment. 10.如权利要求1-3中任一项所述的治疗肿痛、刀口伤和皮肤溃烂的外用中药组合物,其特征在于,所述外用中药组合物在制备治疗淋巴结发炎、蜜蜂蛰伤、跌打损伤、刀口伤以及皮肤溃烂的药物中的应用。10. the external Chinese medicine composition for the treatment of swelling and pain, incision wound and skin ulceration as described in any one of claim 1-3, it is characterized in that, described external Chinese medicine composition is in preparation treatment lymph node inflammation, bee sting, Application in medicine for bruises, knife wounds and skin ulcers.
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