WO2015172607A1 - 一种云南白药纳米乳以及制备方法 - Google Patents

一种云南白药纳米乳以及制备方法 Download PDF

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WO2015172607A1
WO2015172607A1 PCT/CN2015/074816 CN2015074816W WO2015172607A1 WO 2015172607 A1 WO2015172607 A1 WO 2015172607A1 CN 2015074816 W CN2015074816 W CN 2015074816W WO 2015172607 A1 WO2015172607 A1 WO 2015172607A1
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yunnan baiyao
nanoemulsion
filtrate
supernatant
yunnan
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张晓燕
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张晓燕
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Priority to EA201692062A priority Critical patent/EA032980B1/ru
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/894—Dioscoreaceae (Yam family)
    • A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers

Definitions

  • the invention belongs to the field of medicine and relates to a Yunnan Baiyao nanoemulsion, in particular to a transparent and stable Yunnan Baiyao nanoemulsion.
  • Yunnan Baiyao is known to the world to stop bleeding. Because it contains a variety of active ingredients, its pharmacological effects are complex, and there are many uses besides stopping bleeding.
  • Yunnan Baiyao has obvious curative effect on various hemorrhagic diseases, which can accelerate hemostasis and shorten the course of disease. Studies have shown that the pharmacological effects in this area are mainly to shorten the bleeding time and clotting time. Yunnan Baiyao can shorten the prothrombin time, increase the prothrombin content, and induce platelet aggregation and release. Hemostasis is also widely used, and it has a good therapeutic effect on traumatic bleeding, gastrointestinal bleeding, respiratory bleeding, hemorrhagic encephalopathy, gynecology, pediatrics, and ENT bleeding disorders.
  • Yunnan Baiyao has an inhibitory effect on the release of inflammatory substances, and is effective for improving microcirculation and changing vascular permeability. In the treatment of wounds, it can effectively treat local redness and heat pain, promote blood circulation and remove phlegm, and inhibit swelling. In addition, Yunnan Baiyao also has a bacteriostatic effect, which can prevent wound infection. At present, Yunnan Baiyao has various dosage forms, such as Yunnan Baiyao Powder, Yunnan Baiyao Capsule, Yunnan Baiyao Decoction, Yunnan Baiyao Ointment, Yunnan Baiyao Oral Liquid, and Yunnan Baiyao Aerosol.
  • Yunnan Baiyao is insoluble in water, Yunnan Baiyao, oral liquid, aerosol, etc. are easy to precipitate, poor stability, poor transdermal, low absorption rate, low bioavailability, thus affecting its therapeutic effect. And Yunnan Baiyao has certain toxic side effects.
  • the object of the present invention is to provide a Yunnan Baiyao nanoemulsion which is uniform in content, stable in quality, good in transdermal absorption, high in bioavailability, and simple in preparation.
  • the technical solution for achieving the above object of the invention is Yunnan Baiyao Nanoemulsion, which is characterized in that it is a raw material and method of the following weight ratio to form a nanoemulsion:
  • the oil described above is ethyl acetate; the surfactant described above is Tween-80 or castor oil polyoxyethylene ether (40), either of which.
  • Yunnan Baiyao 2 ⁇ 4g oil 10 ⁇ 55g, surfactant 10 ⁇ 55g, ethanol 20 ⁇ 102g, water 6 ⁇ 30g.
  • the oil described above is ethyl acetate; the surfactant described above is Tween-80 or castor oil polyoxyethylene ether (40), either of which.
  • Yunnan Baiyao 4g oil 50g, Tween-8050g, ethanol 102g, water 30g; the above oil is ethyl acetate.
  • non-toxic and biocompatible nonionic surfactants are selected for the selection of surfactants.
  • the nonionic surfactant is relatively stable in solution, is not easily affected by strong electrolytes, inorganic salts, and is not easily affected by acid and alkali, and has good compatibility with other surfactants, and has less hemolysis.
  • the preparation of O/W type nanoemulsion requires the HLB value of the surfactant to be between 8 and 18. Considering the simplicity of the preparation process, the easy formation of the nanoemulsion and the stability of the prepared nanoemulsion.
  • a liquid nonionic surfactant having an HLB of between 10 and 15 is used.
  • the surfactant is Tween-80 or castor oil polyoxyethylene ether (40).
  • the interfacial tension can be further reduced, the flexibility and rigidity of the film can be increased, inserted into the interface film, the formation of a film having a small radius of curvature is promoted, and the nanoemulsion formation region is enlarged.
  • the present invention selects a stimulating small co-surfactant, mainly ethanol.
  • the present invention is based on the principle that the emulsion formed when the HLB of the surfactant required for emulsifying the oil phase is close to the surfactant, and the selected grease is ethyl acetate. This oil is liquid at normal temperature.
  • the preparation method of the Yunnan Baiyao nanoemulsion of the invention comprises the following steps:
  • HLB value of surfactant phase The surfactant is weighed according to the formulation ratio, and is compounded with the surface-supporting activity. The HLB value of the system is calculated and fully stirred. The HLB values of common emulsifiers can be found in some chemical handbooks, such as the Chemical Products Handbook of Chemical Press. Since the hydrophilic-lipophilic balance (HLB) value of the surfactant has additive properties, the HLB value of the surfactant can be determined by mass average method. For example, after mixing two surfactants A and B, the hydrophilic-lipophilic balance HLBAB value of the mixed surfactant is
  • HLBAB (WAHLBA+WBHLBB)/(WA+WB)
  • the appearance of the invention is a light yellow transparent liquid with good stability: the stability over time refers to the extent to which the appearance of the nanoemulsion preparation changes with time when stored under natural changing conditions at room temperature.
  • the nanoemulsion is long-lasting and transparent, and no turbidity or precipitation is found, indicating that the stability over time is good. This is an important indicator for evaluating nanoemulsion oral liquid. It shows that Yunnan Baiyao nanoemulsion has excellent stability.
  • the Yunnan Baiyao nano-milk of the invention has the functions of activating blood circulation and dissipating blood stasis, reducing swelling and relieving pain.
  • rheumatism numbness, joint pain, muscle soreness and frostbite.
  • hemorrhage vomiting blood, hemoptysis, blood in the stool, blood stasis, uterine bleeding, bronchial and tuberculosis hemoptysis, ulcer bleeding, sore swollen and soft tissue contusion, closed fracture, and skin Infectious disease. Yunnan Baiyao Nanoemulsion can also treat old bone injuries, old arthritis, and old pain.
  • Yunnan Baiyao Compared with Yunnan Baiyao Powder, Yunnan Baiyao Capsule, Yunnan Baiyao, Yunnan Baiyao Aerosol, Yunnan Baiyao Ointment, Yunnan Baiyao Oral Liquid and other other dosage forms of Yunnan Baiyao, the antibacterial and anti-inflammatory levels were significantly improved. Compared with all other dosage forms of Yunnan Baiyao, the therapeutic effect is greatly enhanced, and the external application and dosage are greatly reduced, and the side effects are greatly reduced.
  • the preparation method of the Yunnan Baiyao nanoemulsion of the present invention is further illustrated by the examples given by the inventors.
  • the patient's leg was bruised, and the Yunnan Baiyao nanoemulsion of the present invention was applied to the affected part. After a few seconds, the bruises disappeared obviously and the legs were no longer painful.
  • the same amount (medicine content) Yunnan Baiyao aerosol, Yunnan Baiyao, Yunnan Baiyao powder was applied to the affected area, and Yunnan white ointment was applied to the affected area. No brucella disappeared quickly. With Yunnan Baiyao aerosol, the leg pain is temporarily relieved, but after a while, it will still be painful again.
  • the Yunnan Baiyao nanoemulsion of the invention is greatly improved, and the therapeutic effect is greatly improved.
  • the patient suffers from old arthritis, and the affected area is soaked with the Yunnan Baiyao nanoemulsion of the present invention, the joint pain is obviously alleviated or even disappeared, and the same amount (medicine amount) Yunnan Baiyao aerosol, Yunnan Baiyao and Yunnan Baiyao powder are externally applied to the affected area.
  • Yunnan white ointment applied to the affected area joint pain relief is not obvious. It is indicated that the present invention greatly improves the therapeutic effect.
  • the patient's leg was swollen and painful. Taking the Yunnan Baiyao nanoemulsion of the present invention was significantly less than the dosage of Yunnan Baiyao Oral Liquid and Yunnan Baiyao, and the medication cycle was short, and the treatment effect was significantly improved.
  • the patient was sprained in the footsteps. After soaking the affected area with the Yunnan Baiyao nanoemulsion of the present invention, the swelling quickly disappeared and the pain was relieved.
  • the Yunnan Baiyao aerosol, Yunnan Baiyao and Yunnan Baiyao powder were applied to the affected area once more than the equivalent amount (medicine content). Yunnan white ointment was applied to the affected area once, and the effect was not so obvious.
  • the Yunnan Baiyao nanoemulsion effect of the invention is significantly improved.

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Abstract

一种云南白药纳米乳，该纳米乳由下述重量百分比的原料制成：云南白药1～4g、油2.6～55g、表面活性剂2.5～55g、乙醇5～102g、水2～30g，所述油是乙酸乙酯，所述表面活性剂是吐温-80或者蓖麻油聚氧乙烯醚(40)。该云南白药纳米乳能提高云南白药在加工过程中的药物稳定性，增加透皮吸收水平，提高生物利用度，延缓其在体内的药物代谢时间。

Description

一种云南白药纳米乳以及制备方法 技术领域
本发明属于医药领域，涉及一种云南白药纳米乳，特别涉及一种透明稳定的云南白药纳米乳。
背景技术
云南白药为世人所知得多是止血的功效，由于它含有多种活性成分，药理作用复杂，除止血之外还有多种用途。
云南白药对于多种出血性疾病都有明显的疗效，可以加速止血、缩短病程。有研究表明，这方面的药理作用主要是缩短出血时间和凝血时间，云南白药能使凝血酶原时间缩短，增加凝血酶原含量，并能诱导血小板的聚集和释放。止血方面也应用十分广泛，对于创伤出血、消化道出血、呼吸道出血、出血性脑病，妇科、小儿科、五官科出血性疾病都有很好的治疗效果。
云南白药对炎症物质的释放有抑制作用，对于改善微循环、改变血管通透性等方面都有效用。在治疗创伤中，能有效的治疗局部的红肿热痛，活血化瘀，抑制肿胀。此外云南白药还有抑菌的作用，能够防止创伤的感染。现在云南白药有多种剂型，云南白药粉、云南白药胶囊、云南白药酊、云南白药膏、云南白药口服液、云南白药气雾剂等。
但是，云南白药不溶于水，云南白药酊、口服液、气雾剂等易沉淀，稳定性差，透皮性差，吸收率低，生物利用度低，从而影响了其治疗效果。并且云南白药有一定的毒副作用。
发明内容
针对上述现有技术中存在的问题与缺陷，本发明的目的在于提供一种含量均匀准确、质量稳定、透皮吸收好，生物利用度高，且制备简便的云南白药纳米乳。
实现上述发明目的的技术方案是云南白药纳米乳，其特征在于它是以下重量比的原料和方法制成纳米乳：
云南白药1～4g、油2.6～55g、表面活性剂2.5～55g、乙醇5～102g、水2～30g。
上面所述油是乙酸乙酯；上面所述表面活性剂是吐温-80或者蓖麻油聚氧乙烯醚(40)，两种其中任何一种。
将上述各组分按以下步骤制备：
(1)将云南白药中加入5～100倍乙醇，提取并静置24～48小时。用吸管或者真空抽取 抽取上清液，并将上清液用滤纸或者过滤机过滤形成过滤液1。将抽取上清液后留下的药渣和残液用滤纸或者过滤机过滤，形成过滤液2。将过滤液1、过滤液2合并，形成总过滤液。
(2)按照配方比例，将乙酸乙酯，吐温-80或者蓖麻油聚氧乙烯醚(40)、总滤液、水混合，搅拌，形成澄清透明黄色的云南白药纳米乳。
本发明的云南白药纳米乳，其特征在于各原料的重量配比的优先范围是：
云南白药2～4g、油10～55g、表面活性剂10～55g、乙醇20～102g、水6～30g。
上面所述油是乙酸乙酯；上面所述表面活性剂是吐温-80或者蓖麻油聚氧乙烯醚(40)，两种其中任何一种。
本发明的云南白药纳米乳，其特征在于各原料的重量配比的最佳配方是：
云南白药4g、油50g、吐温-8050g、乙醇102g、水30g；上面所述油是乙酸乙酯。
本发明在表面活性剂的选择上，选用无毒性和生物相容性好的非离子型表面活性剂。非离子型表面活性剂在溶液中比较稳定，不易受强电解质、无机盐类的影响，也不易受酸碱的影响，并且与其他表面活性剂的相容性好，溶血作用较小。理论上，O/W型纳米乳状液的制备需要表面活性剂的HLB值介于8～18之间，考虑到制备工艺的简单性，即纳米乳的易形成性和制备出来的纳米乳的稳定性，本发明选用HLB介于10～15之间的液态非离子型表面活性剂。表面活性剂为吐温-80或者蓖麻油聚氧乙烯醚(40)。
为了调整表面活性剂的亲水亲油值(HLB),能进一步降低界面张力，增大膜的柔性和刚性，插到界面膜中，促进曲率半径很小的膜的形成，扩大纳米乳形成区域，本发明选择刺激性小的助表面活性剂，主要有乙醇。
本发明根据当乳化油相所需的表面活性剂的HLB与表面活性剂相近时，所形成的乳状液稳定的原则,选用的油脂为乙酸乙酯。此油常温下呈液态。
本发明的云南白药纳米乳的制备方法，具体包括步骤如下：
(1)表面活性剂相的配制按配方比例称取表面活性剂，与助表面活性按比例复配，计算该体系的HLB值，充分搅拌均匀。常见乳化剂的HLB值可以在一些化工手册中查到，如化工出版社的《化学产品手册》。由于表面活性剂的亲水亲油平衡(HLB)值具有加合性，可用质量平均法求出表面活性剂的HLB值。例如，两种表面活性剂A、B混合后，其混合表面活性剂的亲水亲油平衡HLBAB值为
HLBAB＝(WAHLBA+WBHLBB)/(WA+WB)
式中WA，WB——混合物表面活性剂A、B的质量；
HLBA，HLBB——表面活性剂A、B的HLB值。
(2)油相的配制根据表面活性剂相的HLB值，选择油，调其比例，使其乳化所需的HLB值与表面活性剂相的HLB相近。
(3)将云南白药中加入5～100倍乙醇，提取并静置24～48小时。用吸管或者真空抽取上清液，并将上清液用滤纸或者过滤机过滤形成过滤液1。将抽取上清液后留下的药渣和残液用滤纸或者过滤机过滤，形成过滤液2。将过滤液1、过滤液2合并，形成总过滤液。按照配方比例，将乙酸乙酯，吐温-80或者蓖麻油聚氧乙烯醚(40)、总滤液、水混合，搅拌，形成澄清透明黄色的云南白药纳米乳。
本发明外观为淡黄色透明液体，具有很好的稳定性：经时稳定性是指纳米乳制剂在室温自然变化条件下贮藏时，外观随时间延长而发生变化的程度。该纳米乳持久透明，未发现浑浊或沉淀，则说明经时稳定性好。这是评价纳米乳口服液的一个重要指标。说明云南白药纳米乳稳定性极好。
本发明的云南白药纳米乳活血散瘀，消肿止痛。用于跌打损伤，风湿麻木、筋骨及关节疼痛，肌肉酸痛及冻伤。用于跌打损伤，瘀血肿痛，吐血、咳血、便血、痔血、崩漏下血，支气管及肺结核咳血，溃疡病出血，疮疡肿毒及软组织挫伤，闭合性骨折，以及皮肤感染性疾病。云南白药纳米乳还能治疗陈旧性骨伤、陈旧性关节炎、陈旧性疼痛。比云南白药粉、云南白药胶囊、云南白药酊、云南白药气雾剂、云南白药膏、云南白药口服液等云南白药全部其他剂型相比，抑菌抗炎水平有显著提高。比云南白药全部其他剂型治疗效果大大增强，外敷、服用量都大幅度减少，毒副作用大大减轻。
本发明的云南白药纳米乳，与现有技术相比，具有以下优点：
1)热力学稳定性高。制备时操作比较简单,不分相、不沉淀,贮存稳定性提高；
2)透光性好,任何不均匀性或沉淀物的存在易被发现，感观品质提高；
3)防腐性能提高,因为分散相液体比较小,能防止细菌的侵入,同时增加一些有效成份的溶解度；
4)具有良好的增溶作用，可以有效的提高难溶性药物的溶解度；
5)能提高云南白药溶解性，从而提高了其生物利用度；
6)方法工艺简单,适合规模化生产。
7)延缓了药物的代谢时间，起到缓释作用。
8)具有良好透皮性，大大增加了云南白药的透皮吸收水平。
具体实施方式
以下通过发明人给出的实施例来进一步阐述本发明云南白药纳米乳的制备方法。
实施例1
精确称取云南白药1.079g，加入5.016g乙醇，提取并静置24～48小时。用吸管抽取上清液，并将上清液用过滤纸过滤形成过滤液1。将抽取上清液后留下的药渣和残液用过滤纸过滤，形成过滤液2。将过滤液1、过滤液2合并，形成总过滤液。将乙酸乙酯2.603g，吐温-80 2.508g、总滤液、水2g混合，搅拌，形成澄清透明黄色的云南白药纳米乳。
实施例2
精确称取云南白药1.048g，加入20g乙醇，提取并静置24～48小时。用吸管抽取上清液，并将上清液用过滤纸过滤形成过滤液1。将抽取上清液后留下的药渣和残液用过滤纸过滤，形成过滤液2。将过滤液1、过滤液2合并，形成总过滤液。将乙酸乙酯10g，吐温-80 10g、总滤液、水6g混合，搅拌，形成澄清透明黄色的云南白药纳米乳。
实施例3
精确称取云南白药2g，加入60g乙醇，提取并静置24～48小时。用吸管抽取上清液，并将上清液用过滤纸过滤形成过滤液1。将抽取上清液后留下的药渣和残液用过滤纸过滤，形成过滤液2。将过滤液1、过滤液2合并，形成总过滤液。将乙酸乙酯32g，吐温-80 32g、总滤液、水25g混合，搅拌，形成澄清透明黄色的云南白药纳米乳。
实施例4
精确称取云南白药1.010g，加入100g乙醇，提取并静置24～48小时。用吸管抽取上清液，并将上清液用过滤纸过滤形成过滤液1。将抽取上清液后留下的药渣和残液用过滤纸过滤，形成过滤液2。将过滤液1、过滤液2合并，形成总过滤液。将乙酸乙酯55g，吐温-80 55g、总滤液、水30g混合，搅拌，形成澄清透明黄色的云南白药纳米乳。
实施例5
精确称取云南白药1.048g，加入20g乙醇，提取并静置24～48小时。用吸管抽取上清液，并将上清液用过滤纸过滤形成过滤液1。将抽取上清液后留下的药渣和残液用过滤纸过滤，形成过滤液2。将过滤液1、过滤液2合并，形成总过滤液。将乙酸乙酯10g，蓖麻油聚氧乙烯醚(40)10g、总滤液、水30g混合，搅拌，形成澄清透明黄色的云南白药纳米乳。
实施例6
精确称取云南白药2g，加入50g乙醇，提取并静置24～48小时。用吸管抽取上清液，并将上清液用过滤纸过滤形成过滤液1。将抽取上清液后留下的药渣和残液用过滤纸过滤，形成过滤液2。将过滤液1、过滤液2合并，形成总过滤液。将乙酸乙酯26g，吐温-80 26g、总滤液、水20g混合，搅拌，形成澄清透明黄色的云南白药纳米乳。
实施例7
精确称取云南白药4g，加入102g乙醇，提取并静置24～48小时。用吸管抽取上清液，并将上清液用过滤纸过滤形成过滤液1。将抽取上清液后留下的药渣和残液用过滤纸过滤，形成过滤液2。将过滤液1、过滤液2合并，形成总过滤液。将乙酸乙酯50g，吐温-80 50g、总滤液、水30g混合，搅拌，形成澄清透明黄色的云南白药纳米乳。
治疗效果
治疗实验1
患者腿部瘀伤，将本发明云南白药纳米乳涂于患处，几秒钟后，淤青明显消失，腿部不再疼痛。用等量(含药量)云南白药气雾剂、云南白药酊、云南白药粉外敷于患处，用云南白药膏贴于患处，未见淤青明显迅速消失。用云南白药气雾剂，腿部疼痛暂时减轻，但过一段时间后，仍然会再次疼痛。说明本发明云南白药纳米乳，大大提高了治疗效果。
治疗实验2
患者患有陈旧性关节炎，用本发明云南白药纳米乳浸泡患处，关节疼痛明显减轻，甚至消失，用等量(含药量)云南白药气雾剂、云南白药酊、云南白药粉外敷于患处，用云南白药膏贴于患处，关节疼痛缓解不明显。说明本发明极大的提高了治疗效果。
治疗实验3
患者腿部肿痛，服用本发明云南白药纳米乳，比服用云南白药口服液、云南白药酊的用量大幅度减小，服药周期短，治疗效果显著提高。
治疗实验4
患者脚步扭伤，用本发明云南白药纳米乳浸泡患处一次后，肿胀迅速消失，疼痛减轻，比等量(含药量)云南白药气雾剂、云南白药酊、云南白药粉外敷于患处一次，用云南白药膏贴于患处一次，未见效果如此明显。本发明云南白药纳米乳效果显著提高。
治疗实验5
患者长期输液，手背青肿，手上的血管出现硬化。用本发明云南白药纳米乳涂抹一次，青肿迅速消失，血管硬化恢复。等量(含药量)云南白药气雾剂、云南白药酊、云南白药粉外敷于患处，没有如此明显效果。云南白药纳米乳的治疗效果明显提高。

Claims (3)

  1. 一种云南白药纳米乳，其特征在于它是以下重量比的原料和方法制成纳米乳：
    Figure PCTCN2015074816-appb-100001
    上面所述油是乙酸乙酯；上面所述表面活性剂是吐温-80或者蓖麻油聚氧乙烯醚(40)，两种其中任何一种；
    将上述各组分按以下步骤制备：
    将云南白药中加入5～100倍乙醇，提取并静置24～48小时，抽取上清液，并将上清液过滤形成过滤液1，将抽取上清液后留下的药渣和残液过滤，形成过滤液2，将过滤液1、过滤液2合并，形成总过滤液，按照配方比例，将乙酸乙酯，吐温-80或者蓖麻油聚氧乙烯醚(40)、总滤液、水混合，搅拌，形成澄清透明黄色的云南白药纳米乳。
  2. 根据权利要求1所述的云南白药纳米乳，其特征在于各原料的重量配比的优先范围是：
    Figure PCTCN2015074816-appb-100002
    上面所述油是乙酸乙酯；上面所述表面活性剂是吐温-80或者蓖麻油聚氧乙烯醚(40)，两种其中任何一种。
  3. 根据权利要求1所述的云南白药纳米乳，其特征在于各原料的重量配比的最佳配方是：
    Figure PCTCN2015074816-appb-100003
    上面所述油是乙酸乙酯。
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