WO2016165495A1 - 一种治疗肺癌的外用药物及其制备方法 - Google Patents
一种治疗肺癌的外用药物及其制备方法 Download PDFInfo
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- lung cancer
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Classifications
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- 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)
- A61K36/902—Sparganiaceae (Bur-reed family)
Definitions
- the invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a topical medicine for treating lung cancer and a preparation method thereof.
- Lung cancer is one of the most malignant tumors with the fastest growth in morbidity and mortality and the greatest threat to population health and life.
- the incidence and mortality of lung cancer have been significantly increased in many countries.
- the incidence and mortality of lung cancer in males accounted for the first place among all malignant tumors.
- the etiology of lung cancer is still not completely clear.
- a large amount of data indicates that long-term large-scale smoking has a very close relationship with the occurrence of lung cancer.
- Previous studies have shown that the probability of lung cancer in a long-term large number of smokers is 10 to 20 times that of non-smokers. The younger the age of smoking, the higher the risk of lung cancer.
- Lung cancer has become a major killer of human health. According to domestic and foreign literature reports, the global incidence of lung cancer is as high as 205,020, accounting for about 14% of new tumor cases worldwide, with high incidence and high mortality. Under the influence of environmental pollution, smoking, ionizing radiation, occupational exposure and viral infection, the incidence and mortality of lung cancer have been rising, increasing at a rate of 0.5% per year, and with the increase in the number of young people smoking. Lung cancer is getting younger. According to the results of the death survey of residents of the Ministry of Health in China in 2008, lung cancer has replaced liver cancer as the first cause of malignant tumor death in China. Therefore, the diagnosis and treatment of lung cancer has attracted enough attention from the medical community.
- Lung cancer is divided into small cell lung cancer (SCLC, 20%) and non-small cell lung cancer (NSCLC, 80%), and its pathogenesis is complicated.
- SCLC small cell lung cancer
- NSCLC non-small cell lung cancer
- the treatment of lung cancer at home and abroad is mainly surgery, radiotherapy and chemotherapy, but these methods are easy to cause serious side effects on the normal organs of patients, and the prognosis and survival rate are poor.
- Traditional Chinese medicine featuring "Xie Xie Fu Zheng" has played a huge role in the treatment of lung cancer. The effect is not only consolidated, but also has little side effects and does not cause great harm to the body. It can be used together with chemotherapy to increase the effect and reduce toxicity.
- Patent 2005100156241 discloses an adjuvant treatment for advanced lung cancer, such as Astragalus, Codonopsis pilosulae, Radix Adenofolia, Ophiopogon japonicus, Agrimony, Gymnosperm, Sabina, Hedyotis diffusa, Fritillaria, Aster, Campanulaceae, Bitter Almond
- the licorice Chinese herbal medicine extract is made of raw materials.
- the invention has a large dosage and a long treatment period.
- An object of the present invention is a topical medicine for treating lung cancer, which comprises the following components: Ganoderma lucidum, Codonopsis, Atractylodes, natural bezoar, Ophiopogon japonicus, Scutellaria barbata, Quercetin, Trigonium, seaweed, Myrrh, Agrimony, Pinellia, Forsythia, Baiying, Sea Pumice and Bitter Almond.
- the drug also includes Cnidium, North Bean Root and Dandelion.
- the medicine is divided into parts by weight: 0.5-1 parts of Ganoderma lucidum, 2-3.5 parts of Codonopsis pilosula, 1-2 parts of Atractylodes macrocephala, 0.6-0.8 parts of natural bezoar, 1-1.5 parts of Ophiopogon japonicus, 2-3 parts of Scutellaria barbata L. 1-2 parts, 2.5-3 parts of triangles, 2.5-3.5 parts of seaweed, 1-2 parts of myrrh, 1-3 parts of Agrimony, 1-1.5 parts of Pinellia, 1.2-1.6 parts of Forsythia, Baiying 3 - 4 parts, 3-3.5 parts of sea pumice, 0.5-2 parts of bitter almond, 0.5-0.6 parts of Cnidium, 1-1.8 parts of B. chinensis and 1-2 parts of dandelion.
- the drug is divided into parts: 0.5 parts of Ganoderma lucidum, 3 parts of Codonopsis, 2 parts of Atractylodes, 0.7 parts of natural bezoar, 1 part of Ophiopogon japonicus, 2 parts of Scutellaria barbata L., 1.5 parts of quercetin, 2.5 parts of trigonyl, 3 parts of seaweed. 2 parts of myrrh, 2 parts of Agrimony, 1.5 parts of Pinellia, 1.5 parts of Forsythia, 4 parts of Baiying, 3 parts of sea pumice, 1 part of bitter almond, 0.5 part of Cnidium, 1.6 parts of North bean root and 2 parts of dandelion .
- the preparation method of the external medicine for treating lung cancer comprises the following steps:
- the solvent extracted under reflux was ethanol and ethyl acetate; the volume ratio of ethanol to ethyl acetate was 5:1.
- the stirring speed is 500 rpm/min or more.
- the speed of the cooling is 1 ° C / min or more.
- the invention adopts the leading small molecule cutting technology, and the ultrafine pulverization can pulverize the ganoderma lucidum into fine particles.
- the obtained product has a small particle size, and the active ingredient in the drug is sufficiently released in the form of small molecules. It does not contain large sections of plant fiber that are difficult to absorb through the skin, and the product does not contain heavy metals.
- the drug can be directly applied to the affected area, and the active ingredient can be directly transdermally absorbed without a carrier, and can be quickly targeted to reach the affected part. After reflux extraction, the functional ingredients in Ganoderma lucidum can be effectively extracted, and the dregs can be decoctioned to maximize the nutrients in Ganoderma lucidum.
- the pharmaceutical composition of the present invention produces a synergistic effect, and can function to prevent tumors, inhibit growth of cancer cells, and kill cancer cells.
- the invention can also significantly increase the number of white blood cells in the patient and improve immunity.
- the invention has no toxic and side effects, is suitable for long-term use, and eradicates diseases.
- Patent 12005100156241 is taken as comparative example 1.
- mice of 6-8 weeks old, 10 rats in each group were intraperitoneally injected with 3,4-benzopyrene-corn oil solution at a dose of 10 mg/kg body weight to induce lung cancer. They were divided into three groups: Example 1 group, Example 2 group, and Comparative group 1 at a dose of 0.5 mg/kg body weight for 150 days. The mice were sacrificed by cervical dislocation, and formalin was injected into the lungs to calculate the number of nodules on the surface of the lungs.
- Example 1 Example 2 Comparative example 1 Number of pulmonary nodules 4 5 twenty four
- Example 1 and Example 2 of the present invention are significantly less than that of Comparative Example 1, which can effectively inhibit the growth of lung cancer cells and achieve the purpose of preventing and treating lung cancer.
- the A549 lung cancer cells in logarithmic growth phase were dissociated, resuspended, cultured in 48-well plum plates, and 200 ⁇ l of culture medium was added to each well at a dose of 0.5/ml.
- the growth inhibitory effects of Example 1, Example 2 and Comparative Example 1 on tumor cells were measured.
- Example 1 Example 2 Comparative example 1 Tumor cell growth inhibition rate 82.5% 79.6% 63.1%
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Abstract
一种治疗肺癌的外用药物及其制备方法，所述药物的原料包括灵芝、党参、白术、天然牛黄、麦冬、半枝莲、槲皮素、三棱、海藻、没药、仙鹤草、半夏、连翘、白英、海浮石、和苦杏仁；所述药物的原料还可以包括蛇床子、北豆根、和蒲公英。
Description
本发明属于中医药技术领域，具体涉及一种治疗肺癌的外用药物及其制备方法。
肺癌是发病率和死亡率增长最快，对人群健康和生命威胁最大的恶性肿瘤之一。近50年来许多国家都报道肺癌的发病率和死亡率均明显增高，男性肺癌发病率和死亡率均占所有恶性肿瘤的第一位，女性发病率占第二位，死亡率占第二位。肺癌的病因至今尚不完全明确，大量资料表明，长期大量吸烟与肺癌的发生有非常密切的关系。已有的研究证明：长期大量吸烟者患肺癌的概率是不吸烟者的10～20倍，开始吸烟的年龄越小，患肺癌的几率越高。
肺癌已成为威胁人类健康的一大杀手。据国内外文献报道，全球肺癌的新发病例高达205020，约占全球各种肿瘤新发病例的14％，具有高发率和高死亡率的特点。在环境污染、吸烟、电离辐射、职业暴露和病毒感染等因素的多方面影响下，肺癌的发病率及死亡率一直处于上升状态，每年以0.5％的速度增加，且随着青少年吸烟人数的增加，肺癌日趋年轻化。据2008年我国卫生部居民死亡调查结果显示，肺癌已代替肝癌成为我国首位恶性肿瘤死因。因此，肺癌的诊断和治疗引起医学界的足够重视。
肺癌分为小细胞肺癌(SCLC，20％)和非小细胞肺癌(NSCLC，80％)，其发病原因复杂。目前国内外肺癌的治疗以手术和放疗、化疗为主，但这些方法易对患者的正常器官造成较大的副作用，患者预后和存活率较差。以“祛邪扶正”为特色的传统中药在治疗肺癌方面发挥了巨大作用，其疗
效不仅巩固，而且毒副作用小，对机体不会造成大的伤害，与化疗并用可起到增效减毒的作用。因此从中药和天然药物中寻找和开发高效低毒的抗肺癌药物是肿瘤学研究的热点和难点。专利2005100156241公开了一种晚期肺癌的辅助治疗药物，以黄芪、党参、北沙参、麦冬、仙鹤草、拳参、败酱草、白花蛇舌草、川贝母、紫菀、桔梗、苦杏仁、甘草中药材提取物为原料制成的。该发明用药剂量大，治疗周期长。现有技术中的方法虽然有很多种，但是很难找到行之有效的方法。
发明内容
本发明的一个目的是一种治疗肺癌的外用药物，所述药物包含以下组分：灵芝、党参、白术、天然牛黄、麦冬、半枝莲、槲皮素、三棱、海藻、没药、仙鹤草、半夏、连翘、白英、海浮石和苦杏仁。
所述药物还包括蛇床子、北豆根和蒲公英。
所述药物按重量份为：灵芝0.5-1份、党参2-3.5份、白术1-2份、天然牛黄0.6-0.8份、麦冬1-1.5份、半枝莲2-3份、槲皮素1-2份、三棱2.5-3份、海藻2.5-3.5份、没药1-2份、仙鹤草1-3份、半夏1-1.5份、连翘1.2-1.6份、白英3-4份、海浮石3-3.5份、苦杏仁0.5-2份、蛇床子0.5-0.6份、北豆根1-1.8份和蒲公英1-2份。
所述药物按重量份为：灵芝0.5份、党参3份、白术2份、天然牛黄0.7份、麦冬1份、半枝莲2份、槲皮素1.5份、三棱2.5份、海藻3份、没药2份、仙鹤草2份、半夏1.5份、连翘1.5份、白英4份、海浮石3份、苦杏仁1份、蛇床子0.5份、北豆根1.6份和蒲公英2份。
所述治疗肺癌的外用药物的制备方法，包括以下步骤：
(1)对灵芝进行超微粉碎，过100目筛，回流提取两次，得到提取
液和灵芝药渣；
(2)取水50份和黄原胶5份，混合加热至100℃；
(3)取硬脂酸甘油酯5份、角鲨烷3份和硬脂醇聚醚4份混合加热至90℃；
(4)将步骤(2)和步骤(3)所得溶液混合，取步骤(1)的灵芝药渣，与权利要求1灵芝以外的药物组分混合、搅拌，煎煮1小时以上，得到的药汤与步骤(1)的提取液混合，混合温度为60℃；
(5)混合后降温，风干，灌装，得到成品。
所述回流提取的溶剂为乙醇和乙酸乙酯；乙醇和乙酸乙酯的体积比为5:1。
所述搅拌的转速为500rpm/min以上。
所述降温的速度为1℃/min以上。
本发明采用了领先的小分子切割技术，超微粉碎能将灵芝粉碎成微小颗粒。利用小分子切割技术，得到的产品粒径微小，药物中的有效成分以小分子的形式充分地释放出来。不含有难以透皮吸收的大段植物纤维，同时本产品不含重金属。药物可直接外敷于患处，有效成分能够无需载体直接透皮吸收，快速靶向到达患处。经过回流提取后，能够有效的将灵芝中的功效成分提取出来，再煎煮药渣，最大程度的获得灵芝中的营养成分。本发明中的药物组合物产生了协同作用，能起到预防肿瘤，抑制癌细胞生长进而杀灭癌细胞的作用。本发明还能明显增加患者体内白细胞的数目，提高免疫力。同时，本发明无毒副作用，适宜长期服用，根除疾病。
实施例1
(1)对灵芝0.5份进行超微粉碎，过100目筛，回流提取两次，溶剂为乙醇和乙酸乙酯；乙醇和乙酸乙酯的体积比为5:1，得到提取液和灵芝药渣；
(2)取水50份和黄原胶5份，混合加热至100℃；
(3)取硬脂酸甘油酯5份、角鲨烷3份和硬脂醇聚醚4份混合加热至90℃；
(4)将步骤(2)和步骤(3)所得溶液混合，取步骤(1)的灵芝药渣，与党参3份、白术2份、天然牛黄0.7份、麦冬1份、半枝莲2份、槲皮素1.5份、三棱2.5份、海藻3份、没药2份、仙鹤草2份、半夏1.5份、连翘1.5份、白英4份、海浮石3份、苦杏仁1份、蛇床子0.5份、北豆根1.6份和蒲公英2份混合、搅拌，搅拌转速为500rpm/min，煎煮1小时，得到的药汤与步骤(1)的提取液混合，混合温度为60℃；
(5)混合后降温，降温的速度为1℃/min，风干，灌装，得到成品。
实施例2
(1)对灵芝0.5份进行超微粉碎，过100目筛，回流提取两次，溶剂为乙醇和乙酸乙酯；乙醇和乙酸乙酯的体积比为5:1，得到提取液和灵芝药渣；
(2)取水50份和黄原胶5份，混合加热至100℃；
(3)取硬脂酸甘油酯5份、角鲨烷3份和硬脂醇聚醚4份混合加热至90℃；
(4)将步骤(2)和步骤(3)所得溶液混合，取步骤(1)的灵芝药渣，与党参3.5份、白术1份、天然牛黄0.6份、麦冬1.5份、半枝莲2份、槲皮素2份、三棱3份、海藻2.5份、没药1份、仙鹤草1份、半夏
1.5份、连翘1.2份、白英3份、海浮石3.5份、苦杏仁0.5份、蛇床子0.5份、北豆根1.8份和蒲公英2份混合、搅拌，搅拌转速为600rpm/min，煎煮100分钟，得到的药汤与步骤(1)的提取液混合，混合温度为60℃；
(5)混合后降温，降温的速度为1.5℃/min，风干，灌装，得到成品。
实施例3
(1)对灵芝0.8份进行超微粉碎，过100目筛，回流提取两次，溶剂为乙醇和乙酸乙酯；乙醇和乙酸乙酯的体积比为5:1，得到提取液和灵芝药渣；
(2)取水50份和黄原胶5份，混合加热至100℃；
(3)取硬脂酸甘油酯5份、角鲨烷3份和硬脂醇聚醚4份混合加热至90℃；
(4)将步骤(2)和步骤(3)所得溶液混合，取步骤(1)的灵芝药渣，与党参2份、白术2份、天然牛黄0.8份、麦冬1份、半枝莲3份、槲皮素1份、三棱2.5份、海藻3.5份、没药2份、仙鹤草3份、半夏1份、连翘1.6份、白英4份、海浮石3份、苦杏仁2份、蛇床子0.6份、北豆根1份和蒲公英1份混合、搅拌，搅拌转速为700rpm/min，煎煮1.5小时，得到的药汤与步骤(1)的提取液混合，混合温度为60℃；
(5)混合后降温，降温的速度为2℃/min，风干，灌装，得到成品。
实施例4
(1)对灵芝0.6份进行超微粉碎，过100目筛，回流提取两次，溶剂为乙醇和乙酸乙酯；乙醇和乙酸乙酯的体积比为5:1，得到提取液和灵芝药渣；
(2)取水50份和黄原胶5份，混合加热至100℃；
(3)取硬脂酸甘油酯5份、角鲨烷3份和硬脂醇聚醚4份混合加热至90℃；
(4)将步骤(2)和步骤(3)所得溶液混合，取步骤(1)的灵芝药渣，与党参2.5份、白术1.8份、天然牛黄0.65份、麦冬1.2份、半枝莲2.3份、槲皮素1份、三棱2.9份、海藻3.4份、没药1.6份、仙鹤草2.5份、半夏1.4份、连翘1.5份、白英3.2份、海浮石3份、苦杏仁1.5份、蛇床子0.6份、北豆根1.6份和蒲公英1.4份混合、搅拌，搅拌转速为550rpm/min，煎煮80分钟，得到的药汤与步骤(1)的提取液混合，混合温度为60℃；
(5)混合后降温，降温的速度为1.8℃/min，风干，灌装，得到成品。
实施例5
(1)对灵芝1份进行超微粉碎，过100目筛，回流提取两次，溶剂为乙醇和乙酸乙酯；乙醇和乙酸乙酯的体积比为5:1，得到提取液和灵芝药渣；
(2)取水50份和黄原胶5份，混合加热至100℃；
(3)取硬脂酸甘油酯5份、角鲨烷3份和硬脂醇聚醚4份混合加热至90℃；
(4)将步骤(2)和步骤(3)所得溶液混合，取步骤(1)的灵芝药渣，与党参3份、白术2份、天然牛黄0.6份、麦冬1.4份、半枝莲2.5份、槲皮素2份、三棱3份、海藻3份、没药1.5份、仙鹤草1.5份、半夏1份、连翘1.3份、白英3.5份、海浮石3.5份、苦杏仁1.5份、蛇床子0.6份、北豆根1份和蒲公英1.5份混合、搅拌，搅拌转速为650rpm/min，煎煮1.5小时，得到的药汤与步骤(1)的提取液混合，混合温度为60℃；
(5)混合后降温，降温的速度为2℃/min，风干，灌装，得到成品。
以专利2005100156241为对比例1。
取6-8周龄的A/J小鼠，每组10只，以10mg/kg体重的剂量每日腹腔注射3,4-苯并芘-玉米油溶液，诱导发生肺癌。分为三组：实施例1组、实施例2组和对比例1组，给药剂量为0.5mg/kg体重，持续给药150天。脱颈处死小鼠，向肺部注射福尔马林，计算肺表面结节数。
表1
| 实施例1 | 实施例2 | 对比例1 | |
| 肺表面结节数 | 4 | 5 | 24 |
由表1可知，本发明的实施例1和实施例2肺表面结节数显著少于对比例1，可以有效抑制肺癌细胞的生长，达到防治肺癌的目的。
取对数生长期A549肺癌细胞，使其脱壁，重悬细胞，于48孔梅花板中培养，每孔加入培养液200ul，给药剂量为0.5/ml。测定实施例1、实施例2和对比例1对肿瘤细胞的生长抑制作用。
表2
| 实施例1 | 实施例2 | 对比例1 | |
| 肿瘤细胞生长抑制率 | 82.5％ | 79.6％ | 63.1％ |
由表2可知，实施例1和实施例2的肿瘤细胞生长抑制率显著高于对比例1，能够有效抑制A549肺癌细胞的增殖活性。
上述详细说明是针对本发明其中之一可行实施例的具体说明，该实施例并非用以限制本发明的专利范围，凡未脱离本发明所为的等效实施或变更，均应包含于本发明技术方案的范围内。
Claims (8)
- 一种治疗肺癌的外用药物，其特征在于，所述药物包含以下组分：灵芝、党参、白术、天然牛黄、麦冬、半枝莲、槲皮素、三棱、海藻、没药、仙鹤草、半夏、连翘、白英、海浮石和苦杏仁。
- 如权利要求1所述的治疗肺癌的外用药物，其特征在于，所述药物还包括蛇床子、北豆根和蒲公英。
- 如权利要求1所述的治疗肺癌的外用药物，其特征在于，所述药物按重量份为：灵芝0.5-1份、党参2-3.5份、白术1-2份、天然牛黄0.6-0.8份、麦冬1-1.5份、半枝莲2-3份、槲皮素1-2份、三棱2.5-3份、海藻2.5-3.5份、没药1-2份、仙鹤草1-3份、半夏1-1.5份、连翘1.2-1.6份、白英3-4份、海浮石3-3.5份、苦杏仁0.5-2份、蛇床子0.5-0.6份、北豆根1-1.8份和蒲公英1-2份。
- 如权利要求1所述的治疗肺癌的外用药物，其特征在于，所述药物按重量份为：灵芝0.5份、党参3份、白术2份、天然牛黄0.7份、麦冬1份、半枝莲2份、槲皮素1.5份、三棱2.5份、海藻3份、没药2份、仙鹤草2份、半夏1.5份、连翘1.5份、白英4份、海浮石3份、苦杏仁1份、蛇床子0.5份、北豆根1.6份和蒲公英2份。
- 如权利要求1所述治疗肺癌的外用药物的制备方法，其特征在于，包括以下步骤：(1)对灵芝进行超微粉碎，回流提取两次，得到提取液和灵芝药渣；(2)取水50份和黄原胶5份，混合加热至100℃；(3)取硬脂酸甘油酯5份、角鲨烷3份和硬脂醇聚醚4份混合加热 至90℃；(4)将步骤(2)和步骤(3)所得溶液混合，取步骤(1)的灵芝药渣，与权利要求1的灵芝以外的药物组分混合、搅拌，煎煮1小时以上，得到的药汤与步骤(1)的提取液混合，混合温度为60℃；(5)混合后降温，风干，灌装，得到成品。
- 如权利要求5所述治疗肺癌的外用药物的制备方法，其特征在于，所述回流提取的溶剂为乙醇和乙酸乙酯；乙醇和乙酸乙酯的体积比为5:1。
- 如权利要求5所述治疗肺癌的外用药物的制备方法，其特征在于，所述搅拌的转速为500rpm/min以上。
- 如权利要求5所述治疗肺癌的外用药物的制备方法，其特征在于，所述降温的速度为1℃/min以上。
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