CN117860850A - Traditional Chinese medicine composition for improving advanced lung cancer and preparation method thereof - Google Patents

Abstract

The invention discloses a traditional Chinese medicine composition for improving advanced lung cancer and a preparation method thereof, wherein the traditional Chinese medicine composition comprises the following components: astragalus root, pilose asiabell root, schisandra fruit, glehnia root, dwarf lilyturf tuber, lily bulb, aster, platycodon root, thunberg fritillary bulb, white mulberry root-bark, reed rhizome, poria cocos, coix seed, cassia twig, chinese angelica, peach seed, red paeony root, chinese yam, immature bitter orange and liquorice. The preparation method comprises the following steps: mixing the above materials, and making into pill, powder, decoction or oral liquid. The prescription contains 20 medicines, has strict compatibility of monarch, minister, assistant and guide medicines and good medicine quantity, has the effects of tonifying qi and yin, removing blood stasis and expelling toxin, and can improve the symptoms of fatigue, cough, shortness of breath, insomnia, anorexia and pain of patients with advanced lung cancer, thereby improving the life quality of the patients, and is totally safe and free from toxic and side effects.

Description

Traditional Chinese medicine composition for improving advanced lung cancer and preparation method thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for improving advanced lung cancer and a preparation method thereof.

Background

Lung cancer belongs to the categories of lung accumulation, lump, cough, hemoptysis, chest pain and the like in traditional Chinese medicine. Currently, main treatment means of lung cancer comprise surgery, radiotherapy, chemotherapy and targeted therapy, and in recent years, targeted therapy becomes a focus of treating lung cancer, so great progress is made, but the effect of the combined targeted therapy scheme is still not very ideal. The occurrence and development of malignant tumors are considered from the whole view in traditional Chinese medicine, mainly due to deficiency of healthy qi, imbalance of yin and yang, viscera dysfunction, stagnation of pathogenic factors, qi stagnation and blood stasis, accumulation of phlegm and toxin, mutual cementation and accumulation of Yu Chengliu; aiming at lung cancer, the lung cancer is considered to have the pathogenesis characteristic of local excess and global deficiency.

Research shows that for the patients with advanced lung cancer which are unsuitable or not subjected to surgery, radiotherapy, chemotherapy and molecular targeted therapy, the pure traditional Chinese medicine treatment can play roles in controlling tumor, stabilizing illness state, improving life quality and prolonging life. At present, the traditional Chinese patent medicines are clinically obtained in batches, and the commonly used oral Chinese patent medicines recommended by the medical guidelines 2023 for the combination of traditional Chinese medicine and western medicine for lung cancer are mainly divided into four categories: (1) centralizing group: zhenqi Fuzheng capsule/granule, jianpi Yishen granule/granule; (2) eliminating pathogenic factors: pingxiao capsule/tablet, shenlian capsule/granule; (3) strengthening body resistance to eliminate pathogenic factors: jin Fukang oral liquid, YIFEIQINGHUA granule/paste, and Compound Mylabris Capsule; (4) traditional Chinese medicine extracts: wei Mai Ning capsule and Shen Yi capsule. The deficiency and excess of pathogenesis in advanced lung cancer traditional Chinese medicine are mixed, so that a simple Chinese herbal compound for strengthening body resistance and eliminating evil cannot accurately cut the pathogenesis; in the aspects of strengthening body resistance and eliminating pathogenic factors, jin Fukang oral liquid and lung-tonifying and heat-clearing and evil-dispelling particles/paste have the effects of tonifying qi and yin, clearing heat and detoxicating, and the late lung cancer is pathological in place, blood stasis is also formed, and local qi and blood circulation of the tumor is unsmooth, so that phlegm turbidity is formed, and the late lung cancer should be considered for activating blood and dissolving stasis, promoting diuresis and reducing phlegm; compound Mylabris capsules have the effects of removing blood stasis, eliminating toxin and sores, tonifying qi and nourishing yin, and have no lung-series menstruation-inducing medicine. The traditional Chinese medicine extract has single component, and has strict meaning which is not similar to the traditional Chinese medicine compound.

In conclusion, the traditional Chinese medicine compound for the advanced lung cancer group still has room for optimization and perfection. Therefore, the traditional Chinese medicine for improving the advanced lung cancer, which has reasonable formulation, definite curative effect and no toxic or side effect, is developed and developed, and the preparation method thereof has objective requirements.

Disclosure of Invention

In order to solve the problems of the traditional Chinese medicine compound related to the advanced lung cancer, the invention aims to provide a traditional Chinese medicine composition for improving the advanced lung cancer and a preparation method thereof.

The technical scheme adopted by the invention is as follows:

the traditional Chinese medicine composition for improving advanced lung cancer is characterized by comprising the following components in parts by weight:

1-120 parts of astragalus membranaceus, 1-50 parts of codonopsis pilosula, 1-50 parts of schisandra chinensis, 1-50 parts of radix glehniae, 1-50 parts of radix ophiopogonis, 1-50 parts of lily, 1-50 parts of aster, 1-50 parts of platycodon grandiflorum, 1-50 parts of fritillaria thunbergii, 1-50 parts of cortex mori, 1-50 parts of reed rhizome, 1-50 parts of poria cocos, 1-50 parts of semen coicis, 1-50 parts of cassia twig, 1-50 parts of angelica sinensis, 1-50 parts of peach kernel, 1-50 parts of radix paeoniae rubra, 1-50 parts of Chinese yam, 1-50 parts of immature bitter orange and 1-50 parts of liquorice.

Further, the traditional Chinese medicine composition for improving advanced lung cancer is characterized by comprising the following components in parts by weight: the composite material consists of the following components in parts by weight: 10-60 parts of astragalus membranaceus, 10-50 parts of codonopsis pilosula, 5-50 parts of schisandra chinensis, 5-50 parts of radix glehniae, 5-50 parts of radix ophiopogonis, 5-50 parts of lily, 5-50 parts of aster, 5-50 parts of platycodon grandiflorum, 5-50 parts of fritillaria thunbergii, 5-50 parts of cortex mori, 5-50 parts of reed rhizome, 5-50 parts of poria cocos, 5-50 parts of semen coicis, 5-50 parts of cassia twig, 5-50 parts of angelica sinensis, 5-50 parts of peach kernel, 5-50 parts of radix paeoniae rubra, 5-50 parts of Chinese yam, 5-50 parts of immature bitter orange and 5-50 parts of liquorice.

Further, the traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 10-50 parts of astragalus membranaceus, 10-40 parts of codonopsis pilosula, 5-40 parts of schisandra chinensis, 10-40 parts of radix glehniae, 10-40 parts of radix ophiopogonis, 5-40 parts of lily, 5-40 parts of aster, 10-40 parts of platycodon grandiflorum, 5-40 parts of fritillaria thunbergii, 10-40 parts of cortex mori, 10-40 parts of reed rhizome, 10-40 parts of poria cocos, 10-40 parts of semen coicis, 5-40 parts of cassia twig, 10-40 parts of angelica sinensis, 10-40 parts of peach kernel, 10-40 parts of radix paeoniae rubra, 10-40 parts of Chinese yam, 5-40 parts of immature bitter orange and 5-40 parts of liquorice.

Further, the traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 45 parts of astragalus membranaceus, 30 parts of codonopsis pilosula, 10 parts of shizandra berry, 15 parts of glehnia root, 15 parts of dwarf lilyturf tuber, 10 parts of lily bulb, 10 parts of aster, 15 parts of platycodon root, 10 parts of fritillaria thunbergii, 10 parts of white mulberry root-bark, 20 parts of reed rhizome, 15 parts of poria cocos, 30 parts of coix seed, 10 parts of cassia twig, 15 parts of Chinese angelica, 15 parts of peach seed, 15 parts of red paeony root, 20 parts of Chinese yam, 10 parts of immature bitter orange and 5 parts of liquorice.

Further, the traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 30 parts of astragalus membranaceus, 15 parts of codonopsis pilosula, 5 parts of shizandra berry, 10 parts of glehnia root, 10 parts of dwarf lilyturf tuber, 5 parts of lily bulb, 10 parts of aster, 15 parts of platycodon root, 10 parts of fritillaria thunbergii, 15 parts of white mulberry root-bark, 20 parts of reed rhizome, 15 parts of poria cocos, 20 parts of coix seed, 10 parts of cassia twig, 15 parts of Chinese angelica, 10 parts of peach seed, 15 parts of red paeony root, 15 parts of Chinese yam, 10 parts of immature bitter orange and 5 parts of liquorice.

Further, the traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 45 parts of astragalus membranaceus, 30 parts of codonopsis pilosula, 10 parts of shizandra berry, 15 parts of glehnia root, 20 parts of dwarf lilyturf tuber, 10 parts of lily bulb, 10 parts of aster, 10 parts of platycodon root, 5 parts of fritillaria thunbergii, 10 parts of white mulberry root-bark, 15 parts of reed rhizome, 10 parts of poria cocos, 20 parts of coix seed, 5 parts of cassia twig, 10 parts of Chinese angelica, 10 parts of peach seed, 10 parts of red paeony root, 15 parts of Chinese yam, 5 parts of immature bitter orange and 5 parts of liquorice.

Further, the traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight:

30 parts of astragalus membranaceus, 15 parts of codonopsis pilosula, 5 parts of shizandra berry, 10 parts of glehnia root, 10 parts of dwarf lilyturf tuber, 5 parts of lily bulb, 5 parts of aster, 10 parts of platycodon root, 5 parts of fritillaria thunbergii, 10 parts of white mulberry root-bark, 15 parts of reed rhizome, 10 parts of poria cocos, 20 parts of coix seed, 5 parts of cassia twig, 10 parts of Chinese angelica, 10 parts of peach seed, 10 parts of red paeony root, 15 parts of Chinese yam, 5 parts of immature bitter orange and 5 parts of liquorice.

A preparation method of a traditional Chinese medicine composition for improving advanced lung cancer comprises the following steps: mixing the above materials, and making into pill, powder, decoction or oral liquid.

Compared with the prior art, the invention has the beneficial effects that: the invention reclassifying and summarizing the pathogenesis of advanced lung cancer, and providing that the main symptoms are 'deficiency of both qi and yin, stasis and toxin accumulation', treating 'qi-tonifying yin, stasis-resolving and toxin-expelling', and according to the law cube 'lung-nourishing toxin-expelling prescription', 20 medicines in the whole prescription are used for nourishing lung qi through monarch medicines of astragalus and dangshen; through ministerial drugs of shizandra berry, glehnia root, dwarf lilyturf tuber and lily bulb, the qi is benefited and yin is nourished; radix Asteris, radix Platycodi, bulbus Fritillariae Thunbergii, cortex Mori, radix Paeoniae alba, with effects of relieving cough, eliminating phlegm, purging lung qi, and relieving asthma; rhizoma phragmitis, poria cocos and coix seed have the effects of clearing heat and promoting diuresis, and relieving swelling and expelling pus; ramulus Cinnamomi, radix Angelicae sinensis, semen Persicae, and radix Paeoniae Rubra with effects of warming channel, dredging collaterals, promoting blood circulation, and removing blood stasis; chinese yam and immature bitter orange can strengthen and protect spleen and stomach; licorice root, radix Glycyrrhizae Praeparata regulates the drugs. In addition, jie Geng and Gui Zhi can disperse lung qi, lu Gen and sang Bai Pi descend lung qi and guide all the drugs into the lung. The lung and large intestine are both exterior-interior-related, so Zhi Shi and Tao ren can unblock the large intestine. Can improve the symptoms of fatigue, cough, shortness of breath, insomnia, anorexia, pain and the like of patients with advanced lung cancer by clinical application, and has the advantages of good curative effect and treatment of both symptoms and root causes.

Drawings

FIG. 1 is a comparison of two sets of baseline data.

Figure 2 comparison of objective efficacy of tumors before and after treatment.

Figure 3 is a graph showing the integral of symptoms in TCM before and after treatment.

Figure 4 rate of improvement of symptoms in TCM before and after treatment.

Figure 5 adverse event occurrence.

Detailed Description

The invention will be further illustrated with reference to specific examples.

Example 1

A traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 1 part of astragalus membranaceus, 1 part of codonopsis pilosula, 1 part of schisandra chinensis, 1 part of glehnia root, 1 part of dwarf lilyturf tuber, 1 part of lily bulb, 1 part of aster, 1 part of platycodon grandiflorum, 1 part of fritillaria thunbergii, 1 part of white mulberry root-bark, 1 part of reed rhizome, 1 part of poria cocos, 1 part of coix seed, 1 part of cassia twig, 1 part of angelica sinensis, 1 part of peach seed, 1 part of red paeony root, 1 part of Chinese yam, 1 part of immature bitter orange and 1 part of liquorice.

Selecting the above raw materials, oven drying, sterilizing with ultraviolet rays, pulverizing into fine powder, sieving with 100 mesh sieve, packaging into nonwoven fabric decocting bags, and weighing 100g per bag.

Example 2

A traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 60 parts of astragalus membranaceus, 50 parts of codonopsis pilosula, 50 parts of shizandra berry, 50 parts of glehnia root, 50 parts of dwarf lilyturf tuber, 50 parts of lily bulb, 50 parts of aster, 50 parts of platycodon root, 50 parts of fritillaria thunbergii, 50 parts of white mulberry root-bark, 50 parts of reed rhizome, 50 parts of poria cocos, 50 parts of coix seed, 50 parts of cassia twig, 50 parts of Chinese angelica, 50 parts of peach seed, 50 parts of red paeony root, 50 parts of Chinese yam, 50 parts of immature bitter orange and 50 parts of liquorice.

Selecting the above raw materials, oven drying, sterilizing with ultraviolet rays, pulverizing into fine powder, sieving with 100 mesh sieve, packaging into nonwoven fabric decocting bags, and weighing 100g per bag.

Example 3

A traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 10 parts of astragalus membranaceus, 10 parts of codonopsis pilosula, 5 parts of shizandra berry, 10 parts of glehnia root, 10 parts of dwarf lilyturf tuber, 5 parts of lily bulb, 5 parts of aster, 10 parts of platycodon root, 5 parts of fritillaria thunbergii, 10 parts of white mulberry root-bark, 10 parts of reed rhizome, 10 parts of poria cocos, 10 parts of coix seed, 5 parts of cassia twig, 10 parts of Chinese angelica, 10 parts of peach seed, 10 parts of red paeony root, 10 parts of Chinese yam, 5 parts of immature bitter orange and 5 parts of liquorice.

Selecting the above raw materials, oven drying, sterilizing with ultraviolet rays, pulverizing into fine powder, sieving with 100 mesh sieve, packaging into nonwoven fabric decocting bags, and weighing 100g per bag.

Example 4

A traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 50 parts of astragalus membranaceus, 40 parts of codonopsis pilosula, 40 parts of shizandra berry, 40 parts of glehnia root, 40 parts of dwarf lilyturf tuber, 40 parts of lily bulb, 40 parts of aster, 40 parts of platycodon root, 40 parts of fritillaria thunbergii, 40 parts of white mulberry root-bark, 40 parts of reed rhizome, 40 parts of poria cocos, 40 parts of coix seed, 40 parts of cassia twig, 40 parts of Chinese angelica, 40 parts of peach seed, 40 parts of red paeony root, 40 parts of Chinese yam, 40 parts of immature bitter orange and 40 parts of liquorice.

Selecting the above raw materials, oven drying, sterilizing with ultraviolet rays, pulverizing into fine powder, sieving with 100 mesh sieve, packaging into nonwoven fabric decocting bags, and weighing 100g per bag.

Example 5

A traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 45 parts of astragalus membranaceus, 30 parts of codonopsis pilosula, 10 parts of shizandra berry, 15 parts of glehnia root, 15 parts of dwarf lilyturf tuber, 10 parts of lily bulb, 10 parts of aster, 15 parts of platycodon root, 10 parts of fritillaria thunbergii, 10 parts of white mulberry root-bark, 20 parts of reed rhizome, 15 parts of poria cocos, 30 parts of coix seed, 10 parts of cassia twig, 15 parts of Chinese angelica, 15 parts of peach seed, 15 parts of red paeony root, 20 parts of Chinese yam, 10 parts of immature bitter orange and 5 parts of liquorice.

Selecting the above raw materials, oven drying, sterilizing with ultraviolet rays, pulverizing into fine powder, sieving with 100 mesh sieve, packaging into nonwoven fabric decocting bags, and weighing 100g per bag.

Example 6

A traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 30 parts of astragalus membranaceus, 15 parts of codonopsis pilosula, 5 parts of shizandra berry, 10 parts of glehnia root, 10 parts of dwarf lilyturf tuber, 5 parts of lily bulb, 10 parts of aster, 15 parts of platycodon root, 10 parts of fritillaria thunbergii, 15 parts of white mulberry root-bark, 20 parts of reed rhizome, 15 parts of poria cocos, 20 parts of coix seed, 10 parts of cassia twig, 15 parts of Chinese angelica, 10 parts of peach seed, 15 parts of red paeony root, 15 parts of Chinese yam, 10 parts of immature bitter orange and 5 parts of liquorice.

Selecting the above raw materials, oven drying, sterilizing with ultraviolet rays, pulverizing into fine powder, sieving with 100 mesh sieve, packaging into nonwoven fabric decocting bags, and weighing 100g per bag.

Example 7

A traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 45 parts of astragalus membranaceus, 30 parts of codonopsis pilosula, 10 parts of shizandra berry, 15 parts of glehnia root, 20 parts of dwarf lilyturf tuber, 10 parts of lily bulb, 10 parts of aster, 10 parts of platycodon root, 5 parts of fritillaria thunbergii, 10 parts of white mulberry root-bark, 15 parts of reed rhizome, 10 parts of poria cocos, 20 parts of coix seed, 5 parts of cassia twig, 10 parts of Chinese angelica, 10 parts of peach seed, 10 parts of red paeony root, 15 parts of Chinese yam, 5 parts of immature bitter orange and 5 parts of liquorice.

Selecting the above raw materials, oven drying, sterilizing with ultraviolet rays, pulverizing into fine powder, sieving with 100 mesh sieve, packaging into nonwoven fabric decocting bags, and weighing 100g per bag.

Example 8

A traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 30 parts of astragalus membranaceus, 15 parts of codonopsis pilosula, 5 parts of shizandra berry, 10 parts of glehnia root, 10 parts of dwarf lilyturf tuber, 5 parts of lily bulb, 5 parts of aster, 10 parts of platycodon root, 5 parts of fritillaria thunbergii, 10 parts of white mulberry root-bark, 15 parts of reed rhizome, 10 parts of poria cocos, 20 parts of coix seed, 5 parts of cassia twig, 10 parts of Chinese angelica, 10 parts of peach seed, 10 parts of red paeony root, 15 parts of Chinese yam, 5 parts of immature bitter orange and 5 parts of liquorice.

Selecting the above raw materials, oven drying, sterilizing with ultraviolet rays, pulverizing into fine powder, mixing, sieving with 100 mesh sieve, packaging into nonwoven fabric decocting bag, and weighing 100g per bag.

Example 9

A traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 30 parts of astragalus membranaceus, 15 parts of codonopsis pilosula, 5 parts of shizandra berry, 10 parts of glehnia root, 10 parts of dwarf lilyturf tuber, 5 parts of lily bulb, 5 parts of aster, 10 parts of platycodon root, 5 parts of fritillaria thunbergii, 10 parts of white mulberry root-bark, 15 parts of reed rhizome, 10 parts of poria cocos, 20 parts of coix seed, 5 parts of cassia twig, 10 parts of Chinese angelica, 10 parts of peach seed, 10 parts of red paeony root, 15 parts of Chinese yam, 5 parts of immature bitter orange and 5 parts of liquorice.

Selecting the above materials, oven drying, sterilizing with ultraviolet rays, pulverizing into fine powder, mixing, sieving with 100 mesh sieve, adding ethanol as binder, adding starch as filler, making into granule with Chinese medicinal pill machine, each granule weighing 0.5g, and filling into medicinal bottles of 200 granules.

Example 10

A traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 30 parts of astragalus membranaceus, 15 parts of codonopsis pilosula, 5 parts of shizandra berry, 10 parts of glehnia root, 10 parts of dwarf lilyturf tuber, 5 parts of lily bulb, 5 parts of aster, 10 parts of platycodon root, 5 parts of fritillaria thunbergii, 10 parts of white mulberry root-bark, 15 parts of reed rhizome, 10 parts of poria cocos, 20 parts of coix seed, 5 parts of cassia twig, 10 parts of Chinese angelica, 10 parts of peach seed, 10 parts of red paeony root, 15 parts of Chinese yam, 5 parts of immature bitter orange and 5 parts of liquorice.

Placing the above materials into a decocting pot, adding 1500ml of drinking water, soaking for 30min, decocting with strong fire to boil, decocting with slow fire for 40-60min, and the rest about 300ml.

Example 11

A traditional Chinese medicine composition for improving advanced lung cancer comprises the following components in parts by weight: 30 parts of astragalus membranaceus, 15 parts of codonopsis pilosula, 5 parts of shizandra berry, 10 parts of glehnia root, 10 parts of dwarf lilyturf tuber, 5 parts of lily bulb, 5 parts of aster, 10 parts of platycodon root, 5 parts of fritillaria thunbergii, 10 parts of white mulberry root-bark, 15 parts of reed rhizome, 10 parts of poria cocos, 20 parts of coix seed, 5 parts of cassia twig, 10 parts of Chinese angelica, 10 parts of peach seed, 10 parts of red paeony root, 15 parts of Chinese yam, 5 parts of immature bitter orange and 5 parts of liquorice.

The raw materials are processed through the following steps: (1) taking: weighing the following raw materials in parts by weight: 30 parts of astragalus membranaceus, 15 parts of codonopsis pilosula, 5 parts of shizandra berry, 10 parts of glehnia root, 10 parts of dwarf lilyturf tuber, 5 parts of lily bulb, 5 parts of aster, 10 parts of platycodon root, 5 parts of thunberg fritillary bulb, 10 parts of white mulberry root-bark, 15 parts of reed rhizome, 10 parts of poria cocos, 20 parts of coix seed, 5 parts of cassia twig, 10 parts of Chinese angelica, 10 parts of peach seed, 10 parts of red paeony root, 15 parts of Chinese yam, 5 parts of immature bitter orange and 5 parts of liquorice;

(2) extracting: uniformly mixing the medicines to form a mixture, adding water with the weight which is 6-7 times of that of the mixture into the mixture, soaking for 0.5-1 h, decocting for 1-2 h, filtering to obtain a first filtrate and medicine residues, adding water with the weight which is 3-4 times of that of the medicine residues into the medicine residues, decocting for 0.5-1 h, filtering to obtain a second filtrate, finally cooling the mixed solution obtained by combining the first filtrate and the second filtrate, standing for 20-26 h, removing sediment, and taking supernatant for later use;

(3) concentrating: concentrating the supernatant obtained in the step (2) to thick paste with the relative density of 1.5-2.0;

(4) granulating: sequentially adding maltodextrin, sucrose, microcrystalline cellulose and ethanol into the thick paste prepared in the step (3), and uniformly mixing to prepare wet particles;

(5) and (3) drying: drying the wet particles prepared in the step (4) at 65-75 ℃;

(6) finishing: finishing the granules dried in the step (5) by using a 15-20 mesh sieve, and then sieving the granules by using a 40-50 mesh sieve to remove fine powder to obtain granules;

(7) and (5) subpackaging: and (3) packaging the granules prepared in the step (6) into packaging bags according to the specified mass to obtain the finished product.

The invention is not limited to the alternative embodiments described above, but any person may derive other various forms of products in the light of the present invention. The above detailed description should not be construed as limiting the scope of the invention, which is defined in the claims and the description may be used to interpret the claims.

1. Clinical data

1.1 diagnostic and syndrome differentiation criteria

The Western diagnosis standard refers to the standard of the "Chinese medical society lung cancer clinical diagnosis and treatment guide (2021 edition)", and the Chinese medicine differentiation standard refers to the differentiation type standard in the "Chinese medicine New medicine clinical study guiding principle (trial)".

1.2 inclusion criteria

1. Cell or histological diagnosis of non-small cell lung cancer; 2. pathological stage (III-IV), 3. Non-operative tumor bearing patients, first line treatment efficacy was assessed as disease progression-free, including complete remission (complete response, CR), partial Remission (PR), stable Disease (SD); 4. age 18-75 years old; 5. the eastern tumor cooperative group (ECOG) score of 0-2 points in the United states; 6. is in line with the syndrome of deficiency of both qi and yin and internal stagnation of stagnant toxin; 7. the expected lifetime is more than or equal to 3 months, 8. Sign the informed consent.

1.3 exclusion criteria

1. Pregnant or lactating women, mental patients, 2. Combination of serious and uncontrolled organic lesions or infections such as decompensated heart, lung and kidney failure, 3. Participation in other clinical trials, 4. Study of drug allergy.

2. Method of

2.1 methods of treatment

80 patients all enter a maintenance stage after 2-4 cycles of chemotherapy after the treatment effect evaluation and the disease stabilization, and enter groups according to the willingness of the patients. The treatment group (lung nourishing and toxin expelling prescription) and the control group (lung benefiting and clearing granule) are treated for 1 course of treatment for 45 days.

The control medicine group is prepared from YIFEIQINGHUASHENG granule, chinese medicinal preparation Z20050851, and is administered orally, 2 bags at a time, 3 times a day, and after meals. The experimental pharmaceutical group was prepared by using the powder of the present invention (prepared in example 8), 1 bag each time, 3 times per day, and taking after decocting in a health preserving kettle.

2.2 Observation index and method

2.2.1 objective tumor efficacy according to: RECIST (Response Evaluation Criteria in Solid Tumor) criteria are classified as Complete Response (CR), partial Response (PR), stable Disease (SD), lesion progression (Progressive Disease, PD), cr+pr is active, cr+pr+sd is Disease control. CR refers to the disappearance of all target lesions, PR refers to the 30% decrease in the sum of the maximum single diameters of tumors, and is maintained for more than 4 weeks. PD refers to the increase of 20% in the sum of the maximum single diameters of tumors or the appearance of new lesions. All other lesions were classified as stable SD, and SD was judged to have undergone at least 2 cycles of chemotherapy.

2.2.2 symptom score in TCM: before and after treatment for 45 days, two groups of symptoms of fatigue, cough, shortness of breath, insomnia, appetite and pain are evaluated by a 4-level scoring method, wherein each group of symptoms are 0-3 points, and the symptoms are lighter when the score is lower, namely no, light, moderate and severe. According to the classification and quantification table of the symptoms of the primary lung cancer, the Chinese medicine integral improvement rate= (integral before treatment-integral after treatment)/integral before treatment multiplied by 100 percent is effective, the integral improvement rate of the symptoms is reduced by more than or equal to 70 percent, the integral improvement rate of the symptoms is reduced by more than or equal to 30 percent, and the integral improvement rate of the symptoms is ineffective, wherein the integral is unchanged or is reduced by less than 30 percent according to the Chinese medicine new medicine clinical study guidelines (trial run) of the national medicine administration (Chinese medical science and technology Press, 2002).

2.2.3 security observations: including general conditions of patients, blood, urine and stool, liver function, kidney function, electrocardiogram, adverse events and adverse reactions, etc.

2.3 Statistical method

SPSS 26.0 statistical software is adopted to analyze and process data, and the comparison of the two groups of baseline data adopts t test and chi-square test according to metering data and counting data respectively. The tumor control rate between the two groups is tested by Z, the integral of Chinese medicine symptoms is tested by t, the improvement rate of Chinese medicine symptoms is tested by chi-square, and the occurrence of adverse events is testedThe use of Fisher's exact test was performed,Pa difference of < 0.05 is statistically significant.

3. Results

3.1 cases were from 80 cases diagnosed by a fifth hospital affiliated with the university of Zhongshan in Zhuhai, guangdong province, 2021, 10 months to 2023, with a random number into 2 groups of 40 cases each, namely: treatment group and control group, average age of treatment group (57.88) years, average age of control group (58.48) years, general clinical data of two groups of ages, disease course, etc. are statistically processed,P>0.05, the difference was statistically insignificant and comparable (FIG. 1).

3.2 comparison of objective efficacy of tumor

After being evaluated by RECIST standard, the effective rate of two groups of 45d maintenance treatments is respectively 2.50% and 0.00% after being tested by chi-square, and the statistical significance is achievedP<0.05 The disease control rate is 72.50 percent and 57.50 percent respectively, and the difference has statistical significance through statistical inspectionP< 0.05) (fig. 2).

3.3 integral comparison of clinical symptoms of traditional Chinese medicine

3.3.1 before and after treatment, the symptom score of the two groups of Chinese medicine symptom score comparison treatment group 45d is reduced, and compared with the symptom score of the treatment group before treatment, the difference has statistical significanceP =0.000), the integral decreases after the treatment of the control group, and the difference is statistically significant compared with the difference before the treatmentP=0.000), the difference between the integral of the two groups of clinical symptoms before treatment is not statistically significantP =0.899), with comparability. The integral comparison of the two groups of symptoms after treatment, the integral of the clinical symptoms of the treatment group is lower than that of the control group, and the difference has statistical significanceP=0.001) (fig. 3).

3.3.2 Integrated comparison of the two groups of Chinese symptoms before and after treatment after 45d treatment, the improvement rate of the Chinese symptoms of the two groups of curative effects has statistical significanceP =0.021). The effective rate of the treatment group for improving the symptoms of the traditional Chinese medicine is 65.00% (26/40), and the effective rate of the control group is 37.50% (15/40) (FIG. 4).

3.4 Comparison of patient safety in two groups

There were 10 patients in total with adverse events, 8 in the control group and 2 in the treatment group. The occurrence rate of the two groups of adverse events has no statistical significanceP=0.087), but not as a wholeThe incidence of adverse events was lower in the treated group than in the control group (fig. 5).

4. The small knot:

the experimental medicine can control the disease progression and improve the symptoms of fatigue, cough, shortness of breath, insomnia, appetite and pain of patients, and has no adverse reactions such as gastrointestinal reaction, anaphylactic reaction and the like.

Typical cases:

case 1: aged x, male, 58 years, 25 days of diagnosis in 2023, 5 months, clinical diagnosis: left lung portal central small cell carcinoma (T4N 1M1c IVB stage). Checking: NSE 76.6 ng/ml, CEA 220ng/ml. The symptoms are as follows: patients complain of unsmooth cough, little yellow phlegm, pain in the right side, shoulder and back, tiredness, lazy speaking, purple lips, poor appetite, dark purple tongue with ecchymosis and thready and rapid pulse. Diagnosis of traditional Chinese medicine: the recipe 15 bags for nourishing lung and expelling toxin is prepared by treating lung qi and yin deficiency, stasis toxin and internal accumulation. After the lung nourishing and toxin expelling powder is taken, the cough of the patient is relieved, and the appetite of the patient is slightly improved. The decoction is 15 doses of lung nourishing and toxin expelling decoction. After the lung nourishing and toxin expelling decoction is taken, the cough of the patient is obviously relieved, the debilitation is improved, the shoulder and back pain is not complained, and the appetite is good. Review: nerve Specific Enolase (NSE): 59.40 ng/ml, carcinoembryonic antigen (CEA): 85.20ng/ml.

Case 2: li, women, 39 years, 2023, 6, 21 days visit, clinical diagnosis: differentiated invasive adenocarcinoma (cT 3N3M1a, IVA stage) in right lung. Checking: CEA:150ng/ml. The symptoms are as follows: cough, cough with white and sticky phlegm, chest distress, shortness of breath, fatigue, lazy speaking, difficulty in falling asleep, constipation, pale purple tongue and thready and astringent pulse. Diagnosis of traditional Chinese medicine: the recipe 15 bags for nourishing lung and expelling toxin is prepared by treating lung qi and yin deficiency, stasis toxin and internal accumulation. After the lung nourishing and toxin expelling powder is taken, the patient complains about cough, chest distress and shortness of breath are relieved, and the stool is slightly improved. The decoction is 15 doses of lung nourishing and toxin expelling decoction. After the lung nourishing and toxin expelling decoction is taken, the cough of the patient is obviously relieved, the debilitation is improved, chest distress and shortness of breath are not complained, and the stool is normal and can sleep. Review: CEA:14.2ng/ml.

Case 3: bradykinin, 74 years, 2023, 7 months, 10 days visit, clinical diagnosis: left lung cancer multiple metastasis (T4N 3M1a, IVA stage). Checking: NSE 43.70 ng/ml, cytokeratin 19 fragment (CTFRA 21-1): 80.50 ng/ml. The symptoms are as follows: cough, tired and lazy speaking, dry mouth, constipation, swelling and pain of the right forearm, stagnant tongue and thready pulse. Diagnosis of traditional Chinese medicine: the recipe 15 bags for nourishing lung and expelling toxin is prepared by treating lung qi and yin deficiency, stasis toxin and internal accumulation. After the lung nourishing and toxin expelling powder is taken, the cough of the patient is relieved, and the stool is 1 to 2 times a day. The decoction is 15 doses of lung nourishing and toxin expelling decoction. After taking the lung nourishing and toxin expelling decoction, the cough of the patient is relieved, the hypodynamia is obviously improved, the mouth is not complained to be dry, the stool is 1 time a day, and the frequency and the degree of the right forearm swelling and pain are reduced. Review: NSE 10.10 ng/ml, cytokeratin 19 fragment (CTFRA 21-1): 8.41 ng/ml.

Note that: in typical cases, lung nourishing and toxin expelling powder is prepared according to example 8; a decoction for nourishing lung and expelling toxin is prepared according to example 10.

Claims (8)

1. A traditional Chinese medicine composition for improving advanced lung cancer is characterized in that: the composite material consists of the following components in parts by weight:

1-120 parts of astragalus membranaceus, 1-50 parts of codonopsis pilosula, 1-50 parts of schisandra chinensis, 1-50 parts of radix glehniae, 1-50 parts of radix ophiopogonis, 1-50 parts of lily, 1-50 parts of aster, 1-50 parts of platycodon grandiflorum, 1-50 parts of fritillaria thunbergii, 1-50 parts of cortex mori, 1-50 parts of reed rhizome, 1-50 parts of poria cocos, 1-50 parts of semen coicis, 1-50 parts of cassia twig, 1-50 parts of angelica sinensis, 1-50 parts of peach kernel, 1-50 parts of radix paeoniae rubra, 1-50 parts of Chinese yam, 1-50 parts of immature bitter orange and 1-50 parts of liquorice.

2. The traditional Chinese medicine composition for improving advanced lung cancer according to claim 1, wherein the traditional Chinese medicine composition is characterized in that: the composite material consists of the following components in parts by weight: 10-60 parts of astragalus membranaceus, 10-50 parts of codonopsis pilosula, 5-50 parts of schisandra chinensis, 5-50 parts of radix glehniae, 5-50 parts of radix ophiopogonis, 5-50 parts of lily, 5-50 parts of aster, 5-50 parts of platycodon grandiflorum, 5-50 parts of fritillaria thunbergii, 5-50 parts of cortex mori, 5-50 parts of reed rhizome, 5-50 parts of poria cocos, 5-50 parts of semen coicis, 5-50 parts of cassia twig, 5-50 parts of angelica sinensis, 5-50 parts of peach kernel, 5-50 parts of radix paeoniae rubra, 5-50 parts of Chinese yam, 5-50 parts of immature bitter orange and 5-50 parts of liquorice.

3. The traditional Chinese medicine composition for improving advanced lung cancer according to claim 2, wherein the traditional Chinese medicine composition is characterized in that: the composite material consists of the following components in parts by weight: 10-50 parts of astragalus membranaceus, 10-40 parts of codonopsis pilosula, 5-40 parts of schisandra chinensis, 10-40 parts of radix glehniae, 10-40 parts of radix ophiopogonis, 5-40 parts of lily, 5-40 parts of aster, 10-40 parts of platycodon grandiflorum, 5-40 parts of fritillaria thunbergii, 10-40 parts of cortex mori, 10-40 parts of reed rhizome, 10-40 parts of poria cocos, 10-40 parts of semen coicis, 5-40 parts of cassia twig, 10-40 parts of angelica sinensis, 10-40 parts of peach kernel, 10-40 parts of radix paeoniae rubra, 10-40 parts of Chinese yam, 5-40 parts of immature bitter orange and 5-40 parts of liquorice.

4. The traditional Chinese medicine composition for improving lung cancer according to claim 2, which is characterized in that: the composite material consists of the following components in parts by weight: 45 parts of astragalus membranaceus, 30 parts of codonopsis pilosula, 10 parts of shizandra berry, 15 parts of glehnia root, 15 parts of dwarf lilyturf tuber, 10 parts of lily bulb, 10 parts of aster, 15 parts of platycodon root, 10 parts of fritillaria thunbergii, 10 parts of white mulberry root-bark, 20 parts of reed rhizome, 15 parts of poria cocos, 30 parts of coix seed, 10 parts of cassia twig, 15 parts of Chinese angelica, 15 parts of peach seed, 15 parts of red paeony root, 20 parts of Chinese yam, 10 parts of immature bitter orange and 5 parts of liquorice.

5. The traditional Chinese medicine composition for improving lung cancer according to claim 2, which is characterized in that: the composite material consists of the following components in parts by weight: 30 parts of astragalus membranaceus, 15 parts of codonopsis pilosula, 5 parts of shizandra berry, 10 parts of glehnia root, 10 parts of dwarf lilyturf tuber, 5 parts of lily bulb, 10 parts of aster, 15 parts of platycodon root, 10 parts of fritillaria thunbergii, 15 parts of white mulberry root-bark, 20 parts of reed rhizome, 15 parts of poria cocos, 20 parts of coix seed, 10 parts of cassia twig, 15 parts of Chinese angelica, 10 parts of peach seed, 15 parts of red paeony root, 15 parts of Chinese yam, 10 parts of immature bitter orange and 5 parts of liquorice.

6. The traditional Chinese medicine composition for improving lung cancer according to claim 2, which is characterized in that: the composite material consists of the following components in parts by weight: 45 parts of astragalus membranaceus, 30 parts of codonopsis pilosula, 10 parts of shizandra berry, 15 parts of glehnia root, 20 parts of dwarf lilyturf tuber, 10 parts of lily bulb, 10 parts of aster, 10 parts of platycodon root, 5 parts of fritillaria thunbergii, 10 parts of white mulberry root-bark, 15 parts of reed rhizome, 10 parts of poria cocos, 20 parts of coix seed, 5 parts of cassia twig, 10 parts of Chinese angelica, 10 parts of peach seed, 10 parts of red paeony root, 15 parts of Chinese yam, 5 parts of immature bitter orange and 5 parts of liquorice.

7. The traditional Chinese medicine composition for improving lung cancer according to claim 2, which is characterized in that: the composite material consists of the following components in parts by weight: 30 parts of astragalus membranaceus, 15 parts of codonopsis pilosula, 5 parts of shizandra berry, 10 parts of glehnia root, 10 parts of dwarf lilyturf tuber, 5 parts of lily bulb, 5 parts of aster, 10 parts of platycodon root, 5 parts of fritillaria thunbergii, 10 parts of white mulberry root-bark, 15 parts of reed rhizome, 10 parts of poria cocos, 20 parts of coix seed, 5 parts of cassia twig, 10 parts of Chinese angelica, 10 parts of peach seed, 10 parts of red paeony root, 15 parts of Chinese yam, 5 parts of immature bitter orange and 5 parts of liquorice.

8. A method for preparing a traditional Chinese medicine composition for improving advanced lung cancer according to any one of claims 1-7, which is characterized by comprising the following steps: mixing the above materials, and making into pill, powder, decoction or oral liquid.