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CN104306807A - Compound preparation for treating advanced lung cancer and preparing method thereof - Google Patents

Compound preparation for treating advanced lung cancer and preparing method thereof Download PDF

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Publication number
CN104306807A
CN104306807A CN201410660448.6A CN201410660448A CN104306807A CN 104306807 A CN104306807 A CN 104306807A CN 201410660448 A CN201410660448 A CN 201410660448A CN 104306807 A CN104306807 A CN 104306807A
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lung cancer
compound preparation
advanced lung
preparation
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吴万垠
杨小兵
龙顺钦
邓宏
潘宗奇
河文峰
廖桂雅
周宇姝
李秋萍
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Guangdong Hospital of Traditional Chinese Medicine
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Abstract

The invention provides a compound preparation for treating advanced lung cancer. The compound preparation comprises, by weight, the components of 10-15 parts of Codonopsis pilosula, 15-30 parts of Oldenlandia diffusa, 15-30 parts of nightshade, 15-30 parts of salvia chinensis, 15-30 parts of edible tulip, 15-30 parts of coffee senna, 15-30 parts of Rubus parvifolius, 15-30 parts of duchesnea, 1-3 parts of Chinese yew and 5-10 parts of liquorice. The compound preparation for treating advanced lung cancer has double effects of healthy energy strengthening and anticancer performance. The invention further provides a preparing method of the compound preparation for treating advanced lung cancer. The technology is simple, product quality is stable, and the invention further provides an application of the compound preparation for treating advanced lung cancer in advanced lung cancer anticancer medicine.

Description

一种治疗晚期肺癌的复方制剂及其制备方法A compound preparation for treating advanced lung cancer and its preparation method

技术领域 technical field

本发明涉及中药领域,特别是指一种治疗晚期肺癌的复方制剂,本发明还涉及一种治疗晚期肺癌的复方制剂的制备方法,本发明还涉及一种治疗晚期肺癌的复方制剂在制备晚期肺癌药物中的应用。  The invention relates to the field of traditional Chinese medicine, in particular to a compound preparation for treating advanced lung cancer. The present invention also relates to a preparation method of a compound preparation for treating advanced lung cancer. The present invention also relates to a compound preparation for treating advanced lung cancer in the preparation of advanced lung cancer. application in medicine. the

背景技术 Background technique

肺癌是全球常见的恶性肿瘤之一,为目前人类因癌症死亡的主要原因,是对人类健康与生命危害最大的恶性肿瘤之一。据统计,2011年全球肺癌的发病人数为16.08万人。目前对于晚期非小细胞肺癌,以铂类为基础的联合化疗被认为是其标准治疗方案,但总体疗效显示中位生存时间不到10个月,很少有患者的生存时间超过2年,临床疗效达到了一个“瓶颈”期,且毒副反应大。近年来,靶向药物出现在一定程度上突破了化疗的生存瓶颈,但靶向药物也存在不少问题,如仅适用于特定人群,如EGFR-TKI(表皮生长因子酪氨酸酶抑制剂)只适用于EGFR突变的患者,存在一定毒副反应及价格昂贵等问题。  Lung cancer is one of the most common malignant tumors in the world. It is the main cause of human death due to cancer and one of the most harmful malignant tumors to human health and life. According to statistics, the global incidence of lung cancer in 2011 was 160,800. Currently, platinum-based combination chemotherapy is considered the standard treatment for advanced non-small cell lung cancer, but the overall curative effect shows that the median survival time is less than 10 months, and few patients survive more than 2 years. The curative effect has reached a "bottleneck" period, and the side effects are large. In recent years, the emergence of targeted drugs has broken through the survival bottleneck of chemotherapy to a certain extent, but there are still many problems with targeted drugs, such as being only applicable to specific groups of people, such as EGFR-TKI (epidermal growth factor tyrosinase inhibitor) It is only suitable for patients with EGFR mutation, and there are some problems such as toxic side effects and high price. the

在中国,大部分肿瘤患者接受中医药治疗。中医药与手术、放疗、化疗、热疗、生物治疗及靶向药物结合等结合均显示出一定优势。  In China, most cancer patients receive TCM treatment. The combination of traditional Chinese medicine with surgery, radiotherapy, chemotherapy, hyperthermia, biological therapy and targeted drugs has shown certain advantages. the

目前用于治疗晚期肺癌的中成药或中药复方种类繁多,但大部分中成药含有抗癌中草药的比例偏低,或仅有抗癌中草药,导致治疗效果表现单一,成效不佳。  At present, there are various kinds of Chinese patent medicines or Chinese medicine compound prescriptions for the treatment of advanced lung cancer, but most of the Chinese patent medicines contain anti-cancer Chinese herbal medicines in a low proportion, or only have anti-cancer Chinese herbal medicines, resulting in monotonous therapeutic effects and poor results. the

中国专利“治疗肺癌的中药活性成分复方制剂及其制备方法”,专利号CN 103054881A,公开了一种治疗肺癌的中药活性成分复方制剂:紫杉醇1~3份、华蟾酥毒基1~3份、雷公藤甲素1~3份,该配方具有种抗癌活性高、抗癌谱广的效果。  The Chinese patent "Compound preparation of active ingredients of traditional Chinese medicine for the treatment of lung cancer and its preparation method", patent number CN 103054881A, discloses a compound preparation of active ingredients of traditional Chinese medicine for the treatment of lung cancer: 1-3 parts of paclitaxel, 1-3 parts of cinobufaction base, 1-3 parts of triptolide, the formula has the effect of high anticancer activity and wide anticancer spectrum. the

近年来,随着对肺癌的研究,也有不少治疗肺癌的中药制剂专利申请并公开,不断完善中药治疗肺癌的效果,中国专利“一种治疗非小细胞肺癌的中药复方制剂及其制备方法”,专利号CN 102861284A,公开了一种治疗非小细胞肺癌的中药复方制剂,包括以下重量份的各组分组成:黄芪1-10份,太子参1-10份,姜黄1-10份,郁金1-10份,1生牡蛎1-10份,蜂房1-10份,夏枯草1-10份、白花蛇舌草1-10份,该组方由黄芪、太子参、姜黄、郁金、生牡蛎、蜂房、夏枯草、白花蛇舌草等组成,以达到集扶正、解毒、祛瘀三种中医药治疗肿瘤法则为一体的效果,三法合用,既能扶正抗癌,又能预防复发转移。  In recent years, along with the research on lung cancer, there are also many patent applications and publications of traditional Chinese medicine preparations for the treatment of lung cancer, and the effect of traditional Chinese medicine in the treatment of lung cancer has been continuously improved. The Chinese patent "a traditional Chinese medicine compound preparation for the treatment of non-small cell lung cancer and its preparation method" , Patent No. CN 102861284A, discloses a traditional Chinese medicine compound preparation for the treatment of non-small cell lung cancer, comprising the following components by weight: 1-10 parts of astragalus, 1-10 parts of heterophylla, 1-10 parts of turmeric, turmeric 1-10 parts of gold, 1-10 parts of 1 raw oyster, 1-10 parts of hive, 1-10 parts of Prunella vulgaris, 1-10 parts of Hedyotis diffusa. Composed of raw oysters, beehives, Prunella vulgaris, Hedyotis diffusa, etc., to achieve the effect of integrating the three traditional Chinese medicine treatment methods of strengthening the body, detoxifying, and removing blood stasis. The combination of the three methods can not only strengthen the body, fight cancer, but also prevent recurrence transfer. the

发明人研究中药治疗肺癌多年,“辨证+辨病+对症”治疗为指导原则,通过流行病学调查了解肺癌常见中医证型,结合其证型,以“病证结合”为指导思想,拟出相应处方,并通过多年的案例搜集与分析,并进行研究,得知,近年的肺癌病例中,气虚痰湿型最多,约占76.3%,其次为气阴两虚型、阴虚毒热型及气滞血瘀型;对晚期患者证型进行分析发现,气虚痰湿型最多,其次为气阴两虚型、气滞血瘀型、阴虚毒热型及热毒炽盛型。晚期肺癌的中医证型以气虚痰湿型为主,其本为肺脾气虚,热毒、痰湿、瘀血为标。  The inventor has studied the treatment of lung cancer with traditional Chinese medicine for many years. The treatment of "syndrome differentiation + disease differentiation + symptomatic treatment" is the guiding principle. Through epidemiological investigations, we understand the common TCM syndrome types of lung cancer. Corresponding prescriptions, and through years of case collection and analysis, and research, it is known that among the lung cancer cases in recent years, the type of qi deficiency and phlegm dampness is the most, accounting for about 76.3%, followed by the type of deficiency of both qi and yin, the type of yin deficiency and toxic heat, and the type of lung cancer. Qi stagnation and blood stasis type: The analysis of the syndrome types of advanced patients found that the Qi deficiency and phlegm dampness type is the most, followed by the Qi and Yin deficiency type, Qi stagnation and blood stasis type, Yin deficiency toxin heat type and heat toxin flaming type. The traditional Chinese medicine syndrome type of advanced lung cancer is mainly qi deficiency and phlegm dampness type, which is mainly lung and spleen spleen deficiency, heat toxin, phlegm dampness, and blood stasis as the standard. the

根据上述辩证思想,对晚期肺癌的中医证型进行区分,从而针对性的拟出符合该证型的处方,达到扶正抗癌的功效,成为研究的重点与难点。  According to the dialectical thought above, it has become the focus and difficulty of research to distinguish the TCM syndrome types of advanced lung cancer, so as to formulate targeted prescriptions that conform to the syndrome types, so as to achieve the effect of strengthening the body and fighting cancer. the

发明内容 Contents of the invention

本发明提出一种治疗晚期肺癌的复方制剂,从整体观念出发,辨证论治,辨证与辨病相结合,达到既含有扶正类中草药,又含有抗癌类中草药,二者联合起扶正及抗癌作用。  The present invention proposes a compound preparation for the treatment of advanced lung cancer. Starting from the overall concept, syndrome differentiation is used for treatment, and syndrome differentiation and disease differentiation are combined to achieve the purpose of containing both strengthening Chinese herbal medicine and anticancer Chinese herbal medicine. the

本发明还提出了一种治疗晚期肺癌的复方制剂的制备方法,制备方便,产品质量稳定。  The invention also provides a preparation method of the compound preparation for treating advanced lung cancer, which is convenient for preparation and stable in product quality. the

本发明还提出了一种治疗晚期肺癌的复方制剂的应用。  The invention also proposes the application of a compound preparation for treating advanced lung cancer. the

本发明是通过如下方式实现的:  The present invention is achieved in the following manner:

一种治疗晚期肺癌的复方制剂,包括如下重量份的各组分:党参10-15份,白花蛇舌草15-30份,龙葵15-30份,石见穿15-30份,山慈菇15-30份,望江 南15-30份,蛇泡勒15-30份,蛇莓15-30份,红豆杉1-3份,甘草5-10份。  A compound preparation for treating advanced lung cancer, comprising the following components by weight: 10-15 parts of Codonopsis pilosula, 15-30 parts of Hedyotis diffusa, 15-30 parts of Solanum solanum, 15-30 parts of Shi Jianchuan, Shanci 15-30 parts of mushrooms, 15-30 parts of Wangjiangnan, 15-30 parts of Snake Paul, 15-30 parts of snake berry, 1-3 parts of yew, 5-10 parts of licorice. the

为进一步提高效果,发明人对配方进行了优化的调整,调整后为:党参10-15份,白术10-15份,黄芪15-30份,白花蛇舌草15-30份,龙葵15-30份,石见穿15-30份,山慈菇15-30份,炒薏仁15-30份,望江南15-30份,蛇泡勒15-30份,蛇莓15-30份,红豆杉1-3份,甘草5-10份。  In order to further improve the effect, the inventor optimized and adjusted the formula. After adjustment, it is: Codonopsis 10-15 parts, Atractylodes macrocephala 10-15 parts, Radix Astragali 15-30 parts, Hedyotis diffusa 15-30 parts, Solanum nigrum 15-30 parts. 30 servings, 15-30 servings of Shi Jianchuan, 15-30 servings of Shanzi Mushroom, 15-30 servings of fried barley, 15-30 servings of Wangjiang River, 15-30 servings of Snake Berry, 15-30 servings of Snakeberry, Taxus 1-3 parts, 5-10 parts of licorice. the

更加优选的为:党参15份,白术15份,黄芪30份,白花蛇舌草30份,龙葵30份,石见穿30份,山慈菇30份,炒薏仁30份,望江南30份,蛇泡勒30份,蛇莓30份,红豆杉3份,甘草10份。  More preferably: 15 parts of Codonopsis pilosula, 15 parts of Atractylodes macrocephala, 30 parts of Astragalus membranaceus, 30 parts of Hedyotis diffusa, 30 parts of Solanum nigrum, 30 parts of Shi Jianchuan, 30 parts of Shanzi mushroom, 30 parts of fried barley, and 30 parts of Jiangnan , 30 parts of Snake Paule, 30 parts of Snakeberry, 3 parts of Taxus, 10 parts of Licorice. the

所述治疗晚期肺癌的复方制剂以“辨证+辨病+对症”治疗为指导原则,通过流行病学调查了解肺癌常见中医证型,结合其证型,以“病证结合”为指导思想,拟出处方。在辨证方面,采用回顾性研究方法,发明人收集了广东省中医院2002年1月至2007年12月住院的肺癌病例,将符合纳入标准的435例病例进行研究,发现气虚痰湿型最多,约占76.3%,其次为气阴两虚型、阴虚毒热型及气滞血瘀型;另外,还对207例晚期患者证型进行分析发现,气虚痰湿型最多,其次为气阴两虚型、气滞血瘀型、阴虚毒热型及热毒炽盛型。晚期肺癌的中医证型以气虚痰湿型为主,其本为肺脾气虚,热毒、痰湿、瘀血为标。本发明从整体观念出发辨证论治,辨证与辨病相结合。辨证以党参、黄芪、白术、甘草以健脾益肺,意在补益后天之本,并有培土生金之效,以扶正抗癌。辨病以山慈菇、蛇舌草、龙葵、石见穿、蛇莓、蛇泡簕、炒薏苡仁、望江南及红豆杉以清热解毒、化湿祛瘀、散结抗瘤。全方扶正与祛邪相结合,辨病与辨证相结合。扶正则重视补益脾肺之气,祛邪则以清热解毒、化湿祛瘀散结为主,上药合用共奏扶正抗癌之功,可广泛应用于晚期肺癌患者,或与现代医学治疗手段联合起减毒增效作。  The compound preparation for the treatment of advanced lung cancer is based on the guiding principle of "syndrome differentiation + disease differentiation + symptomatic" treatment, through epidemiological investigations to understand the common TCM syndrome types of lung cancer, combined with the syndrome types, with "combination of disease and syndrome" as the guiding ideology, the proposed Prescription. In terms of syndrome differentiation, using a retrospective research method, the inventor collected lung cancer cases hospitalized in Guangdong Provincial Hospital of Traditional Chinese Medicine from January 2002 to December 2007, and conducted research on 435 cases that met the inclusion criteria. Accounted for about 76.3%, followed by deficiency of both qi and yin, deficiency of yin and toxin-heat, and stagnation of qi and blood stasis. In addition, an analysis of the syndrome types of 207 patients with advanced stage found that the type of qi deficiency and phlegm-damp was the most, followed by the combination of qi and yin. Deficiency type, qi stagnation and blood stasis type, yin deficiency toxin-heat type and heat-toxin flaming type. The traditional Chinese medicine syndrome type of advanced lung cancer is mainly qi deficiency and phlegm dampness type, which is mainly lung and spleen spleen deficiency, heat toxin, phlegm dampness, and blood stasis as the standard. The present invention proceeds from the overall concept of syndrome differentiation and treatment, and combines syndrome differentiation and disease differentiation. Syndrome differentiation uses Codonopsis pilosula, Radix Astragali, Atractylodes macrocephala, and licorice to invigorate the spleen and lungs. To identify diseases, use Shanzi mushroom, Hedyotis grass, Solanum nigrum, Shijianchuan, snakeberry, snakehead, fried coix seed, Wangjiangnan and yew to clear away heat and detoxify, remove dampness and blood stasis, dispel stagnation and fight tumors. The whole prescription combines strengthening the body with eliminating pathogenic factors, and combining disease differentiation and syndrome differentiation. Fuzheng focuses on nourishing the Qi of the spleen and lungs, while eliminating pathogenic factors mainly focuses on clearing away heat and detoxification, removing dampness, dispelling blood stasis and resolving stagnation. The combined use of traditional Chinese medicine plays the role of strengthening the body and fighting cancer, which can be widely used in patients with advanced lung cancer, or combined with modern medical treatment methods. Jointly play the role of attenuation and synergism. the

另外,在组分的选取以及配比上,发明人也经过反复的论证与实践,在党参的选取与定量上,如采用太子参30份替代党参,但效果上不及党参,原因在于,中医认为为党参功效为补中益气,健脾益肺;太子参补气生津。从而,目前中医认为太子参偏于生津,益气效果不如党参;用八月札替换望江南,也能达到一定的效果,但是从安全保障与长期疗效来说,不及望江南,因为八月札功效舒肝理气、活血止痛,望江南消肿解毒,其消肿解毒之效优于八月札,且八月札辛散耗气,肿瘤患者多合并气虚,长期应用加重气虚症状;蛇莓具有消肿解毒的作用,还具有一定的抗肿瘤作用,从消肿解毒的作用上来说,莪术也能达到该效果,但是莪术行气破血,肺癌患者易合并咯血,而咯血患者禁用莪术,从而在实际的使用中,莪术并不如蛇莓效果好;红豆杉(人工种植,并经过处理)的提取物紫杉醇具有较好的抗肿瘤作用,因此本发明增加红豆杉以增强抗肿瘤效果。  In addition, in terms of the selection and proportion of the components, the inventor has also gone through repeated demonstrations and practices. In terms of the selection and quantification of Codonopsis ginseng, for example, 30 parts of Radix Pseudostellaria was used to replace Codonopsis pilosula, but the effect is not as good as that of Codonopsis pilosula. The reason is that Chinese medicine believes that The effect of Codonopsis is to nourish the middle and replenish Qi, invigorate the spleen and lungs; Taizishen nourishes Qi and promotes body fluid. Therefore, Chinese medicine currently believes that Radix Pseudostellaria tends to produce body fluid, and its effect of nourishing qi is not as good as Codonopsis ginseng; replacing Wangjiangnan with August Zha can also achieve a certain effect, but in terms of safety and long-term curative effect, it is not as good as Wangjiangnan, because August Zha Efficacy Soothing the liver and regulating qi, promoting blood circulation and relieving pain, Wangjiangnan reduces swelling and detoxification, its effect of reducing swelling and detoxification is better than that of August Zhaxin, and August Zhaxin dissipates Qi, tumor patients often have Qi deficiency, and long-term use can aggravate the symptoms of Qi deficiency; Snakeberry has The effect of reducing swelling and detoxification also has a certain anti-tumor effect. In terms of the effect of reducing swelling and detoxification, Curcuma can also achieve this effect, but Curcuma promotes Qi and blood, and lung cancer patients are prone to hemoptysis, and hemoptysis patients are forbidden to use Curcuma. In actual use, curcuma is not as effective as snakeberry; the extract paclitaxel of yew (artificially planted and processed) has better antitumor effect, so the present invention adds yew to enhance the antitumor effect. the

所述治疗晚期肺癌的复方制剂的制备方法,包括以下步骤:  The preparation method of the compound preparation for the treatment of advanced lung cancer comprises the following steps:

i.取全量处方药材,加10-12倍量水浸泡20-30分钟;  i. Take the full amount of prescription medicinal materials, add 10-12 times the amount of water and soak for 20-30 minutes;

ii.加热至沸煎煮100-120min;  ii. Heat to boiling and decoct for 100-120min;

iii.分离煎液,药渣继续加水煎煮二次,每次加6-8倍量水煎煮60min,合并煎液;  iii. Separate the decoction, continue to decoct the dregs with water twice, add 6-8 times the amount of water each time and decoct for 60 minutes, and combine the decoction;

iv.煎液低温减压浓缩,收集浓缩液;  iv. The decoction is concentrated under reduced pressure at low temperature, and the concentrated solution is collected;

i.浓缩液喷雾干燥,收集干粉。  i. The concentrated solution is spray-dried, and the dry powder is collected. the

优选的,步骤i中,加入12倍量水浸泡30分钟。  Preferably, in step i, add 12 times the amount of water and soak for 30 minutes. the

优选的,步骤ii中,煎煮120min。  Preferably, in step ii, decocting for 120min. the

优选的,步骤iii中,每次加8倍量水进行煎煮。  Preferably, in step iii, add 8 times the amount of water each time for decocting. the

此批每克干粉相当于3.22-6.26分药材,干粉进行封装即可。  Each gram of dry powder in this batch is equivalent to 3.22-6.26 points of medicinal materials, and the dry powder can be packaged. the

所述治疗晚期肺癌的复方制剂在制备晚期肺癌药物中的应用。  Application of the compound preparation for treating advanced lung cancer in the preparation of drugs for advanced lung cancer. the

本发明的有益效果为:  The beneficial effects of the present invention are:

本发明的所述治疗晚期肺癌的复方制剂,具有扶正与抗癌的双重作用,尤其是针对目前晚期肺癌主要表现出的气虚痰湿型、气阴两虚型等中医证型,具有针对性的疗效;另外,将本发明的所述治疗晚期肺癌的复方制剂,具有扶正抗癌方治疗晚期肺癌能减轻患者症状,改善生活质量,延长生存期的效果,与体外高频热疗联合能提高生活质量,与化疗或靶向药物(EGFR-TKI)联合能起减毒或增效作用。  The compound preparation for the treatment of advanced lung cancer of the present invention has dual functions of rectifying the body and anticancer, especially for the traditional Chinese medicine syndromes such as Qi deficiency and phlegm dampness type, Qi and Yin deficiency type, etc., which are mainly manifested in the current advanced lung cancer. Curative effect; In addition, the compound preparation for the treatment of advanced lung cancer of the present invention has the effect of Fuzheng Kangai prescription for treating advanced lung cancer, which can alleviate the patient's symptoms, improve the quality of life, and prolong the survival period. Combined with in vitro high-frequency hyperthermia, it can improve life Quality, combined with chemotherapy or targeted drugs (EGFR-TKI) can play a role in attenuating or synergizing. the

本发明的所述治疗晚期肺癌的复方制剂的制备方法,全过程可由机器完成,制备方便,每次制作工序一致,质量稳定。  In the preparation method of the compound preparation for treating advanced lung cancer of the present invention, the whole process can be completed by machines, the preparation is convenient, the production process is consistent each time, and the quality is stable. the

本发明的所述治疗晚期肺癌的复方制剂在制备晚期肺癌的药物中的应用,具有提高药效,降低副作用的功效。  The application of the compound preparation for treating advanced lung cancer of the present invention in the preparation of drugs for advanced lung cancer has the effects of improving drug efficacy and reducing side effects. the

具体实施方式 Detailed ways

下面将结合本发明的实施例,对本发明实中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。  The technical solutions in practice of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of the present invention. the

实施例1  Example 1

根据本发明公开的配方和制备方法,发明人通过以下过程制得实施例1的成品:  According to the formula disclosed in the present invention and the preparation method, the contriver makes the finished product of embodiment 1 through the following process:

取以下组分:  Take the following components:

党参15份,白术15份,黄芪30份,白花蛇舌草30份,龙葵30份,石见穿30份,山慈菇30份,炒薏仁30份,望江南30份,蛇泡勒30份,蛇莓30份,红豆杉3份,甘草10份。  Codonopsis 15 parts, Atractylodes macrocephala 15 parts, Astragalus membranaceus 30 parts, Hedyotis diffusa 30 parts, Solanum nigrum 30 parts, Shi Jianchuan 30 parts, Shanzi mushroom 30 parts, fried barley 30 parts, Wangjiangnan 30 parts, Snake Paul 30 parts 30 parts of snakeberry, 3 parts of yew, 10 parts of licorice. the

再采用如下的步骤制备:  Then prepare by the following steps:

i.取全量处方药材,加12倍量水浸泡30分钟;  i. Take the full amount of prescription medicinal materials, add 12 times the amount of water and soak for 30 minutes;

ii.加热至沸煎煮二小时;  ii. Heat to boiling and decoct for two hours;

iii.分离煎液,药渣继续加水煎煮二次,每次加8倍量水煎煮一小时,合并煎液;  iii. Separate the decoction, continue to decoct the dregs with water twice, each time add 8 times the amount of water to decoct for one hour, and combine the decoction;

iv.煎液低温减压浓缩,收集浓缩液;  iv. The decoction is concentrated under reduced pressure at low temperature, and the concentrated solution is collected;

v.浓缩液喷雾干燥,收集干粉。  v. The concentrate is spray-dried and the dry powder is collected. the

此批每克干粉相当于6.458分药材,干粉用自封袋分装成小包,每6包用复合袋子包装封口,得到实施例1的成品。  This batch of dry powder per gram is equivalent to 6.458 points of medicinal materials, and the dry powder is subpackaged into small bags with ziplock bags, and every 6 bags are sealed with composite bags to obtain the finished product of Example 1. the

实施例2  Example 2

取如下各组分:  Take the following components:

党参10份,白花蛇舌草15份,龙葵15份,石见穿15份,山慈菇15份,望江南15份,蛇泡勒15份,蛇莓15份,红豆杉1份,甘草5份。  10 parts of Codonopsis, 15 parts of Hedyotis diffusa, 15 parts of Solanum nigrum, 15 parts of Shi Jianchuan, 15 parts of Shanzi Mushroom, 15 parts of Wangjiang River, 15 parts of Snake Poule, 15 parts of snakeberry, 1 part of Chinese yew, licorice 5 servings. the

再采用如下的步骤制备:  Then prepare by the following steps:

i.取全量处方药材,加10倍量水浸泡20分钟;  i. Take the full amount of prescription medicinal materials, add 10 times the amount of water and soak for 20 minutes;

ii.加热至沸煎煮100min;  ii. Heat to boiling and decoct for 100min;

iii.分离煎液,药渣继续加水煎煮二次,每次加6倍量水煎煮一小时,合并煎液;  iii. Separate the decoction, continue to decoct the dregs with water twice, add 6 times the amount of water each time and decoct for one hour, and combine the decoction;

iv.煎液低温减压浓缩,收集浓缩液;  iv. The decoction is concentrated under reduced pressure at low temperature, and the concentrated solution is collected;

v.浓缩液喷雾干燥,收集干粉。  v. The concentrate is spray-dried and the dry powder is collected. the

干粉用自封袋分装成小包,每6包用复合袋子包装封口,得到实施例2的成品。  The dry powder is sub-packed into small bags with a ziplock bag, and every 6 bags are packed and sealed with a composite bag to obtain the finished product of Example 2. the

实施例3  Example 3

取如下组分:  Take the following components:

党参12份,白术12份,黄芪22份,白花蛇舌草25份,龙葵20份,石见穿20份,山慈菇20份,炒薏仁20份,望江南20份,蛇泡勒23份,蛇莓23份,红豆杉2份,甘草8份。  12 parts of Dangshen, 12 parts of Atractylodes macrocephala, 22 parts of Astragalus, 25 parts of Hedyotis diffusa, 20 parts of Solanum nigrum, 20 parts of Shi Jianchuan, 20 parts of Shanzi mushroom, 20 parts of fried barley, 20 parts of Wangjiangnan, 23 parts of snake paole 23 parts of snakeberry, 2 parts of yew, 8 parts of licorice. the

采用如下的步骤制备:  Prepared by the following steps:

i.取全量处方药材,加11倍量水浸泡25分钟;  i. Take the full amount of prescription medicinal materials, add 11 times the amount of water and soak for 25 minutes;

ii.加热至沸煎煮110min;  ii. Heat to boiling and decoct for 110min;

iii.分离煎液,药渣继续加水煎煮二次,每次加7倍量水煎煮60min,合并煎液;  iii. Separate the decoction, continue to decoct the dregs with water twice, add 7 times the amount of water each time and decoct for 60 minutes, and combine the decoction;

iv.煎液低温减压浓缩,收集浓缩液;  iv. The decoction is concentrated under reduced pressure at low temperature, and the concentrated solution is collected;

v.浓缩液喷雾干燥,收集干粉。  v. The concentrate is spray-dried and the dry powder is collected. the

干粉用自封袋分装成小包,每6包用复合袋子包装封口,得到实施例3的成品。  The dry powder is sub-packed into small packets with a ziplock bag, and every 6 packets are sealed with a composite bag to obtain the finished product of Example 3. the

对于本治疗晚期肺癌的复方制剂的治疗效果,发明人进行了多年的、连续的,多个实验,均产生有积极的治疗效果,尤其是在配合化疗、靶向治疗等方面,以上3个实施例的成品,尤其是最佳实施例1的成品,仅代表在本发明公开的范围内的部分实施例,而不是全部实施例,只要属于本发明公开保护的范围,均在保护之列,为验证本发明的成品的治疗、辅助等效果,发明人进行了如下的实验论证。  For the therapeutic effect of this compound preparation for the treatment of advanced lung cancer, the inventor has carried out many years, continuous, and multiple experiments, all of which have positive therapeutic effects, especially in terms of cooperation with chemotherapy and targeted therapy. The above three implementations The finished product of the example, especially the finished product of the best embodiment 1, only represent some embodiments within the scope disclosed by the present invention, rather than all embodiments, as long as they belong to the scope of protection disclosed by the present invention, they are all included in the protection list, for To verify the therapeutic and auxiliary effects of the finished product of the present invention, the inventor conducted the following experimental demonstration. the

实验1  Experiment 1

细胞实验验证  Cell experiment verification

通过测定该治疗晚期肺癌的复方制剂对人非小细胞肺癌细胞株的促进凋亡作用观察其效果,数据如下表:  By measuring the effect of the compound preparation for treating advanced lung cancer on promoting apoptosis of human non-small cell lung cancer cell lines, the data are as follows:

该治疗晚期肺癌的复方制剂对三种肺癌细胞凋亡率的分析表  The analysis table of the compound preparation for the treatment of advanced lung cancer on the apoptosis rate of three kinds of lung cancer cells

其中:  in:

i.细胞A549为:人肺腺癌细胞;H1650为:人肺癌(表皮)细胞;PC9为:人肺癌细胞。  i. Cell A549 is: human lung adenocarcinoma cell; H1650 is: human lung cancer (epidermal) cell; PC9 is: human lung cancer cell. the

ii.本实验中采用了实施例1的成品配比。  ii. The finished product ratio of Example 1 was adopted in this experiment. the

实验2  Experiment 2

不同浓度细胞实验验证  Experimental verification of different concentrations of cells

测定不同剂量的复方制剂对人非小细胞肺癌细胞株的促进凋亡作用发现,随着剂量增高,促进凋亡作用跟明显,数据如下表:  The apoptosis-promoting effect of different doses of compound preparations on human non-small cell lung cancer cell lines was determined. As the dose increased, the apoptosis-promoting effect was more obvious. The data are as follows:

该治疗晚期肺癌的复方制剂不同剂量对三种肺癌细胞凋亡率的分析表  The analysis table of different doses of the compound preparation for the treatment of advanced lung cancer on the apoptosis rate of three kinds of lung cancer cells

其中:  in:

i.细胞A549为:人肺腺癌细胞;H1650为:人肺癌(表皮)细胞;PC9为:人肺癌细胞。  i. Cell A549 is: human lung adenocarcinoma cell; H1650 is: human lung cancer (epidermal) cell; PC9 is: human lung cancer cell. the

ii.浓度1药物剂量:党参10份,白术10份,黄芪15份,白花蛇舌草15份,龙葵15份,石见穿15份,山慈菇15份,炒薏仁15份,望江南15份,蛇泡勒15份,蛇莓15份,红豆杉1份,甘草5份。  ii. Concentration 1 drug dosage: Codonopsis 10 parts, Atractylodes macrocephala 10 parts, Astragalus 15 parts, Hedyotis diffusa 15 parts, Solanum nigrum 15 parts, Shi Jianchuan 15 parts, Shanzi mushroom 15 parts, fried barley 15 parts, Wangjiangnan 15 parts, 15 parts snake berry, 15 parts snake berry, 1 part yew, 5 parts licorice. the

iii.浓度2药物剂量:党参10份,白术10份,黄芪20份,白花蛇舌草20份,龙葵20份,石见穿20份,山慈菇20份,炒薏仁20份,望江南20份,蛇泡勒20份,蛇莓20份,红豆杉2份,甘草5份。  iii. Concentration 2 drug dosage: 10 parts of Codonopsis pilosula, 10 parts of Atractylodes macrocephala, 20 parts of Astragalus membranaceus, 20 parts of Hedyotis diffusa, 20 parts of Solanum nigrum, 20 parts of Shi Jianchuan, 20 parts of Shanzi mushroom, 20 parts of fried barley, Wangjiangnan 20 parts, 20 parts of Snake Paul, 20 parts of snakeberry, 2 parts of yew, 5 parts of licorice. the

iv.浓度3药物剂量:党参15份,白术15份,黄芪30份,白花蛇舌草30份,龙葵30份,石见穿30份,山慈菇30份,炒薏仁30份,望江南30份,蛇泡勒30份,蛇莓30份,红豆杉3份,甘草10份。  iv. Concentration 3 drug dosage: Codonopsis 15 parts, Atractylodes macrocephala 15 parts, Astragalus membranaceus 30 parts, Hedyotis diffusa 30 parts, Solanum nigrum 30 parts, Shi Jianchuan 30 parts, Shanzi mushroom 30 parts, fried barley 30 parts, Wangjiangnan 30 parts, 30 parts of Snake Paule, 30 parts of Snakeberry, 3 parts of Taxus, 10 parts of Licorice. the

实验3  Experiment 3

回顾性分析表明,本发明与化疗结合能提高晚期肺癌患者生存期。  Retrospective analysis shows that the combination of the present invention and chemotherapy can improve the survival period of patients with advanced lung cancer. the

发明人对2002年1月至2007年12月于广东省中医院肿瘤科接受中医药治疗(80%以上患者的中药汤剂以本发明处方加减)的435例患者进行回顾性分析,随访至2008年10月30日。ⅢA期及之前、ⅢB期、Ⅳ期患者分别为83例、160例、192例,分别占所有非小细胞肺癌患者的19.1%、36.8%、44.1%;病理类型以腺癌及鳞癌最多,占94.5%。435例非小细胞肺癌患者6个月生存率为51.0%,1年生存率为37.0%。中位生存期为12.0月。中医组6个月生存率:39.0%,1年生存率:25.0%。中位生存时间为8.0月。中西医结合组6个月生存率:63.0%,1年生存率:49.0%。中位生存时间为14.0月。中西医结合组高于文献报道的顺铂为主的联合化疗中位生存期。  The inventor carried out a retrospective analysis to 435 routine patients who received Chinese medicine treatment (the Chinese medicine decoction of more than 80% patients was added and subtracted with the prescription of the present invention) in the Oncology Department of Guangdong Provincial Hospital of Traditional Chinese Medicine from January, 2002 to December, 2007. October 30, 2008. There were 83, 160, and 192 patients at and before stage IIIA, stage IIIB, and stage IV, accounting for 19.1%, 36.8%, and 44.1% of all non-small cell lung cancer patients, respectively; adenocarcinoma and squamous cell carcinoma were the most pathological types, 94.5%. The 6-month survival rate of 435 patients with non-small cell lung cancer was 51.0%, and the 1-year survival rate was 37.0%. The median survival time was 12.0 months. The 6-month survival rate of the TCM group: 39.0%, and the 1-year survival rate: 25.0%. The median survival time was 8.0 months. The 6-month survival rate of the integrated traditional Chinese and Western medicine group: 63.0%, 1-year survival rate: 49.0%. The median survival time was 14.0 months. The median survival time of the combined traditional Chinese and Western medicine group was higher than that reported in the literature for cisplatin-based combined chemotherapy. the

实验4  Experiment 4

前期采用本发明联合靶向药物治疗晚期非小细胞肺癌,表明本发明对靶向药物有一定的减毒增效作用。  In the early stage, the present invention combined with targeted drugs was used to treat advanced non-small cell lung cancer, indicating that the present invention has a certain detoxification and synergistic effect on targeted drugs. the

发明人于2009年,将19例未接受其他治疗的晚期非小细胞肺癌患者,接受中医药治疗联合表皮生长因子受体酪氨酸激酶抑制剂(吉非替尼250mg)治疗,发现中医药联合EGFR-TKI一线治疗EGFR状态未知的晚期非小细胞肺癌的疗效可观,不良反应甚少。后进一步纳入病例,2012年将纳入晚期NSCLC患者70例进行中期分析,70例患者均经病理组织学或细胞学检查确诊,其中49例完全符合优势人群的标准,即东方人种、女性、腺癌和非吸烟者;21例不符合者作为非优势人群,均接受扶正抗癌方,即本发明治疗晚期肺癌的复方制剂(250ml,qd)联合吉非替尼(250mg,qd)治疗。  In 2009, the inventor received 19 patients with advanced non-small cell lung cancer who had not received other treatments, received Chinese medicine treatment combined with epidermal growth factor receptor tyrosine kinase inhibitor (gefitinib 250mg) treatment, and found that Chinese medicine combined EGFR-TKI first-line treatment of advanced non-small cell lung cancer with unknown EGFR status has considerable curative effect and few adverse reactions. After further inclusion of cases, 70 patients with advanced NSCLC will be included in the interim analysis in 2012. All 70 patients were confirmed by histopathological or cytological examination, and 49 of them fully met the criteria of the dominant population, that is, Oriental race, female, glandular Cancer patients and non-smokers; 21 non-conforming persons were regarded as non-dominant population, and they all accepted Fuzheng Kangai Prescription, the compound preparation (250ml, qd) combined with gefitinib (250mg, qd) for the treatment of advanced lung cancer of the present invention. the

本实验结果:  The result of this experiment:

49例优势人群患者中CR 0例,达到PR 16例(32.7%),SD 30例(61.2%),PD3例(6.1%),ORR为32.7%,DCR为93.9%;中位疾病无进展生存时间(PFS)8.2个月,治疗后中位生存期9.9个月。21例非优势人群患者中CR 0例,达到PR 5例(23.8%),SD 9例(42.9%),PD 7例(33.3%),ORR为23.8%,DCR为66.7%;中位疾病无进展生存时间(PFS)4.6个月,治疗后中位生存期7.9个月。二者有统计学差异。一线治疗时,优势人群及非优势人群的客观缓解率一致,均为21.4%。毒副反应较轻,耐受性可,大部分为1~2级,经对症治疗后症状缓解,不影响治疗。抗癌扶正方联合吉非替尼治疗晚期非小细胞肺癌优势人群的疗效优于非优势人群。  Among the 49 patients in the dominant population, CR was 0, PR was 16 (32.7%), SD was 30 (61.2%), PD was 3 (6.1%), ORR was 32.7%, DCR was 93.9%; median disease progression-free survival The time (PFS) was 8.2 months, and the median survival period after treatment was 9.9 months. Among the 21 non-dominant patients, CR was 0, PR was 5 (23.8%), SD was 9 (42.9%), PD was 7 (33.3%), ORR was 23.8%, and DCR was 66.7%. The progression survival time (PFS) was 4.6 months, and the median survival time after treatment was 7.9 months. There is a statistical difference between the two. In the first-line treatment, the objective response rate of the dominant population and the non-dominant population were consistent, both being 21.4%. Toxic and side effects are mild and tolerable, most of which are grade 1-2. Symptoms are relieved after symptomatic treatment and do not affect treatment. The curative effect of Kangai Fuzheng Recipe combined with gefitinib in the treatment of advanced non-small cell lung cancer patients is better than that of non-dominant patients. the

以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。  The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included in the scope of the present invention. within the scope of protection. the

Claims (8)

1.一种治疗晚期肺癌的复方制剂,其特征在于,包括如下重量份的各组分:党参10-15份,白花蛇舌草15-30份,龙葵15-30份,石见穿15-30份,山慈菇15-30份,望江南15-30份,蛇泡勒15-30份,蛇莓15-30份,红豆杉1-3份,甘草5-10份。1. A compound preparation for the treatment of advanced lung cancer, characterized in that it comprises the following components in parts by weight: 10-15 parts of Codonopsis Codonopsis, 15-30 parts of Hedyotis diffusa, 15-30 parts of Solanum solanum, 15 parts of Shi Jianchuan -30 parts, 15-30 parts of Shanzi mushroom, 15-30 parts of Wangjiang River, 15-30 parts of Snake Paule, 15-30 parts of snakeberry, 1-3 parts of yew, 5-10 parts of licorice. 2.一种治疗晚期肺癌的复方制剂,其特征在于,包括如下重量份的各组分:党参10-15份,白术10-15份,黄芪15-30份,白花蛇舌草15-30份,龙葵15-30份,石见穿15-30份,山慈菇15-30份,炒薏仁15-30份,望江南15-30份,蛇泡勒15-30份,蛇莓15-30份,红豆杉1-3份,甘草5-10份。2. A compound preparation for treating advanced lung cancer, characterized in that it comprises the following components in parts by weight: 10-15 parts of Codonopsis pilosula, 10-15 parts of Atractylodes macrocephala, 15-30 parts of Radix Astragali, and 15-30 parts of Hedyotis diffusa , 15-30 parts of Solanum nigrum, 15-30 parts of Shi Jianchuan, 15-30 parts of Shanzi Mushroom, 15-30 parts of fried barley, 15-30 parts of Wangjiang River, 15-30 parts of Snake Paule, 15-30 parts of Snakeberry 30 parts, 1-3 parts of yew, 5-10 parts of licorice. 3.一种治疗晚期肺癌的复方制剂,其特征在于,包括如下重量份的各组分:党参15份,白术15份,黄芪30份,白花蛇舌草30份,龙葵30份,石见穿30份,山慈菇30份,炒薏仁30份,望江南30份,蛇泡勒30份,蛇莓30份,红豆杉3份,甘草10份。3. A compound preparation for the treatment of advanced lung cancer, characterized in that it comprises the following components in parts by weight: 15 parts of Codonopsis pilosula, 15 parts of Atractylodes macrocephala, 30 parts of Radix Astragali, 30 parts of Hedyotis diffusa, 30 parts of Solanum nigrum, and 30 servings of pepper, 30 servings of Shanzi mushroom, 30 servings of fried barley, 30 servings of Jiangnan, 30 servings of Snakeberry, 30 servings of snakeberry, 3 servings of yew, and 10 servings of licorice. 4.如权利要求1-3中任一所述治疗晚期肺癌的复方制剂的制备方法,其特征在于,包括以下步骤:4. The preparation method of the compound preparation for treating advanced lung cancer as described in any one of claims 1-3, is characterized in that, comprises the following steps: i.取全量处方药材,加10-12倍量水浸泡20-30分钟;i. Take the full amount of prescription medicinal materials, add 10-12 times the amount of water and soak for 20-30 minutes; ii.加热至沸煎煮100-120min;ii. Heat to boiling and decoct for 100-120min; iii.分离煎液,药渣继续加水煎煮二次,每次加6-8倍量水煎煮60min,合并煎液;iii. Separate the decoction, continue to decoct the dregs with water twice, each time add 6-8 times the amount of water to decoct for 60 minutes, and combine the decoction; iv.煎液低温减压浓缩,收集浓缩液;iv. The decoction is concentrated under reduced pressure at low temperature, and the concentrate is collected; v.浓缩液喷雾干燥,收集干粉。v. The concentrate is spray-dried and the dry powder is collected. 5.如权利要求4中所述治疗晚期肺癌的复方制剂的制备方法,其特征在于:5. the preparation method of the compound preparation for the treatment of advanced lung cancer as described in claim 4, is characterized in that: 步骤i中,加入12倍量水浸泡30分钟。In step i, add 12 times the amount of water and soak for 30 minutes. 6.如权利要求4中所述治疗晚期肺癌的复方制剂的制备方法,其特征在于:6. the preparation method of the compound preparation for the treatment of advanced lung cancer as described in claim 4, is characterized in that: 步骤ii中,煎煮120min。In step ii, decoct for 120min. 7.如权利要求4中所述治疗晚期肺癌的复方制剂的制备方法,其特征在于:7. the preparation method of the compound preparation for the treatment of advanced lung cancer as described in claim 4, is characterized in that: 步骤iii中,每次加8倍量水进行煎煮。In step iii, add 8 times the amount of water each time for decocting. 8.如权利要求1-3中任一所述治疗晚期肺癌的复方制剂在制备晚期肺癌药物中的应用。8. The application of the compound preparation for treating advanced lung cancer as described in any one of claims 1-3 in the preparation of drugs for advanced lung cancer.
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CN107875283A (en) * 2017-12-05 2018-04-06 山东大学齐鲁医院 A kind of Chinese medicine compound prescription for treating lung cancer and preparation method thereof
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