A radiotherapy and chemotherapy attenuating and immunity enhancing traditional Chinese medicine composition, a traditional Chinese medicine preparation and a preparation method thereof

Abstract

The application discloses a radiotherapy and chemotherapy attenuating and immunity increasing traditional Chinese medicine composition which is made of raw medicinal materials in the following weight parts: southwest heterophyllous ginseng 6-15, raw astragalus 15-80, red goutweed 6-12, cloud fungus 5-12, radix pseudostellariae 10-30, ophiopogon 10-20, north adenosma 10-30, schisandra 5-20, cistanche 6-30, angelica 6-20, caesalpinia 10-20, ginger bamboo shavings 5-12, ginger pinellia 3-15, poria 10-30, white atractylodes 10-20, dried tangerine or orange peel 6-15, fried wheat germ 15-30, orodes 10-20, licorice 3-6. Meanwhile, the application also discloses a radiotherapy and chemotherapy attenuating and immunity increasing traditional Chinese medicine preparation and a preparation method thereof. The application can significantly relieve the toxic and side reactions of nausea, vomiting, poor appetite, dry mouth, fatigue and the like caused by radiotherapy and chemotherapy, regulate T cell subgroups, enhance NK cell activity, significantly improve white blood cells, red blood cells and platelets, improve bone marrow suppression, and improve the immune function and life quality of patients. The animal experiment and clinical verification prove that the application is safe and effective, and is suitable for development into an anti-tumor radiotherapy and chemotherapy auxiliary medicine.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically relating to a traditional Chinese medicine composition, preparation and preparation method thereof for alleviating toxic side effects such as nausea, vomiting, loss of appetite, dry mouth and fatigue after radiotherapy and chemotherapy in patients with malignant tumors, and for enhancing the body's immune function and improving bone marrow suppression. Background Technology

[0002] Radiotherapy and chemotherapy are important means of comprehensive treatment for malignant tumors, but their toxic side effects severely limit patients' treatment tolerance and quality of life. Common toxic side effects of radiotherapy and chemotherapy include: nausea and vomiting (incidence rate 70%-80%), loss of appetite, dry mouth and throat, red tongue with little or no coating (yin deficiency syndrome), cancer-related fatigue, and decreased immune function (CD3+). + CD4 + Decreased T cells, decreased NK cell activity, and bone marrow suppression (decreased white blood cells and platelets) can all lead to treatment interruption and affect the efficacy of the treatment.

[0003] Currently, 5-HT3 receptor antagonists (such as ondansetron) and NK-1 receptor antagonists (such as aprepitant) are commonly used in clinical practice to treat nausea and vomiting, as well as drugs that increase white blood cell count, such as granulocyte colony-stimulating factor. However, Western medicine treatment has limitations: antiemetic drugs are not good at controlling delayed vomiting and are often accompanied by side effects such as constipation and headache; drugs that increase white blood cell count have a single effect and cannot comprehensively improve the overall state of deficiency. Existing traditional Chinese medicine preparations, such as Shenyi capsules and Zhenqi Fuzheng granules, mostly focus on single effects and lack a compound traditional Chinese medicine formula that can simultaneously provide "multi-target, holistic" intervention for multiple systemic damage after radiotherapy and chemotherapy, such as nausea and vomiting, poor appetite, yin deficiency, fatigue, low immunity, and bone marrow suppression.

[0004] Traditional Chinese medicine believes that the toxicity of radiotherapy and chemotherapy drugs belongs to "fire and heat toxins," which directly damage qi and yin, harm the spleen and stomach, leading to disharmony of the stomach and spleen, depletion of yin fluids, and deficiency of vital energy. Therefore, developing a traditional Chinese medicine compound that can improve digestive symptoms, enhance immunity, reduce systemic weakness, and synergistically enhance the effects of the herbs has important clinical value. Summary of the Invention

[0005] In view of this, the purpose of the present invention is to provide a traditional Chinese medicine composition for reducing the toxicity of radiotherapy and chemotherapy and enhancing immunity, a traditional Chinese medicine preparation thereof, and a method for preparing the same. The traditional Chinese medicine composition and preparation for reducing the toxicity of radiotherapy and chemotherapy and enhancing immunity improve the toxic side effects of radiotherapy and chemotherapy and enhance immunity.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] A traditional Chinese medicine composition for reducing the toxicity and enhancing immunity during radiotherapy and chemotherapy, comprising the following raw materials in parts by weight: Codonopsis pilosula 6-15; Astragalus membranaceus 15-80; Rhodiola rosea 6-12; Trametes versicolor 5-12; Codonopsis pilosula 10-30; Ophiopogon japonicus 10-20; Adenophora stricta 10-30; Schisandra chinensis 5-20; Cistanche deserticola 6-30; Angelica sinensis 6-20; Spatholobus suberectus 10-20; Bambusa textilis 5-12; Pinellia ternata 3-15; Poria cocos 10-30; Atractylodes macrocephala 10-20; Citrus reticulata 6-15; Hordeum vulgare 15-30; Phragmites communis 10-20; Glycyrrhiza uralensis 3-6.

[0008] Preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 9 parts of Codonopsis pilosula; 45 parts of Astragalus membranaceus; 9 parts of Rhodiola rosea; 8 parts of Ganoderma lucidum; 20 parts of Codonopsis pilosula; 15 parts of Ophiopogon japonicus; 20 parts of Adenophora stricta; 12 parts of Schisandra chinensis; 20 parts of Cistanche deserticola; 10 parts of Angelica sinensis; 15 parts of Spatholobus suberectus; 8 parts of Zingiber officinale; 8 parts of Zingiber officinale; 20 parts of Poria cocos; 12 parts of Atractylodes macrocephala; 8 parts of Citrus reticulata; 20 parts of roasted malt; 15 parts of Phragmites communis; and 6 parts of Glycyrrhiza uralensis.

[0009] The present invention also provides a traditional Chinese medicine preparation for reducing the toxicity of radiotherapy and chemotherapy and enhancing immunity, which is made from the above-mentioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0010] Preferably, the excipients are selected from one or more of dextrin, sucrose powder, mannitol, starch, and microcrystalline cellulose.

[0011] Preferably, the preparation is any one of granules, compound preparations, capsules, or tablets.

[0012] This invention also provides a method for preparing a traditional Chinese medicine preparation for reducing the toxicity of radiotherapy and chemotherapy and enhancing immunity. The preparation method of this traditional Chinese medicine preparation includes the following steps:

[0013] (1) Weigh each Chinese herb according to the weight proportions, clean and dry them;

[0014] (2) Add water to the following herbs and decoct 2-3 times: Southwest ginseng, raw astragalus, rhodiola rosea, turkey loranthus, codonopsis pilosula, ophiopogon japonicus, north ginseng, schisandra chinensis, cistanche deserticola, angelica sinensis, chicken blood vine, poria cocos, atractylodes macrocephala, tangerine peel, stir-fried malt, reed rhizome, and licorice. Add 8-10 times the amount of water for the first decoction, soak for 30 minutes, bring to a boil, and simmer for 30-40 minutes. Add 6-8 times the amount of water for the second decoction and simmer for 20-30 minutes. A third decoction can be performed to fully extract the herbs. Add ginger-processed pinellia and ginger-processed bamboo shavings (aromatic herbs) 5-10 minutes before the end of the first decoction.

[0015] (3) Combine the decoctions and filter;

[0016] (4) Concentrate the extract under reduced pressure at a temperature of 60-70℃ and a vacuum degree of 0.08-0.1MPa to a relative density of 1.10-1.15 at a temperature of 60℃;

[0017] (5) Add pharmaceutically acceptable excipients and prepare granules, mixtures, capsules or tablets according to conventional pharmaceutical processes.

[0018] Preferably, granules are used. The extract is mixed with excipients, granulated, dried (50-60℃), sized, and packaged into 10g bags, equivalent to about 45-50g of raw medicinal material.

[0019] The present invention also provides the use of a traditional Chinese medicine composition for reducing the toxicity of radiotherapy and chemotherapy and enhancing immunity in the preparation of a drug for improving nausea and vomiting after radiotherapy and chemotherapy.

[0020] The present invention also provides the use of a traditional Chinese medicine composition for reducing the toxicity of radiotherapy and chemotherapy and enhancing immunity in the preparation of a drug for improving poor appetite, dry mouth and fatigue after radiotherapy and chemotherapy.

[0021] This invention also provides the use of a traditional Chinese medicine composition for reducing the toxicity and enhancing immunity during radiotherapy and chemotherapy in the preparation of a drug for enhancing immune function and alleviating bone marrow suppression, wherein the enhanced immune function includes increasing CD4+. + T cell percentage, increased CD4 + / CD8 + The ratio and enhanced NK cell activity, which reduce bone marrow suppression include increasing white blood cell, red blood cell, and platelet counts.

[0022] The present invention also provides the use of a traditional Chinese medicine composition for reducing the toxicity of radiotherapy and chemotherapy and enhancing immunity in the preparation of a drug for adjuvant radiotherapy and chemotherapy for malignant tumors, including lung cancer, breast cancer, bone tumors, gastric cancer, esophageal cancer, colorectal cancer and ovarian cancer.

[0023] This oral liquid of traditional Chinese medicine for reducing the toxicity of radiotherapy and chemotherapy and enhancing immunity works by invigorating qi and nourishing yin, strengthening the spleen and stomach, relieving nausea and vomiting, tonifying the kidneys and generating blood, promoting blood circulation and unblocking collaterals, strengthening the body's resistance and consolidating the foundation, and regulating immunity. The whole formula works together to achieve the effect of "multi-target synergy and overall conditioning".

[0024] • Principal drug group (anti-tumor and immunomodulatory):

[0025] Southwest Ginseng: The alcoholic extract of the Tibetan medicine Southwest Ginseng possesses broad-spectrum antioxidant activity and can inhibit the proliferation of various tumor cells through the synergistic effect of multiple components. Its endophytic fungal metabolites target CDC25 phosphatase and PD-1 / PD-L1 immune checkpoints, providing a novel pharmacological basis for this formula at the level of "immune checkpoint regulation".

[0026] Raw Astragalus: Greatly replenishes the Qi of the spleen and lungs, strengthens the body's resistance and consolidates its foundation. Astragalus polysaccharides can enhance CD8... +Astragalus membranaceus exerts its effects through T-cell infiltration, regulation of immune factors such as TNF-α, and inhibition of PD-1 / PD-L1 expression, thus synergistically fighting tumors. It can also promote tumor cell apoptosis, synergistically enhance sensitization, and reverse multidrug resistance.

[0027] Rhodiola rosea: Rhodioloside can inhibit tumor cell proliferation by regulating glucose metabolism reprogramming; the novel arabinogalactan HJBP85-1 isolated from it has significant anti-tumor effects in animal models, inhibiting tumors through a dual mechanism of immune regulation and anti-angiogenesis. It also has anti-fatigue and antioxidant effects.

[0028] Yunzhi (Trametes versicolor): Yunzhi polysaccharide (PSK / PSP) can promote the expression of Fas and Caspase-3, induce tumor cell apoptosis, inhibit immune escape, and enhance immunity by promoting lymphocyte proliferation and the production of lymphokines such as IFN and TNF. Clinical studies have confirmed that its combined use with chemotherapy can improve efficacy and reduce toxic side effects.

[0029] • Herbal formula (tonifies Qi and nourishes Yin, promotes body fluid production, replenishes kidney and nourishes blood, invigorates blood and unblocks collaterals):

[0030] Codonopsis pilosula: Nourishes Qi and Yin, gently replenishes without causing dryness.

[0031] Ophiopogon japonicus: Nourishes stomach yin, clears the heart and relieves irritability

[0032] North American ginseng: sweet and cold in nature, it nourishes the stomach, promotes the production of body fluids, and moistens dryness.

[0033] Schisandra chinensis: Sour and sweet, astringent to yin, replenishing qi and generating fluids.

[0034] Cistanche deserticola: It tonifies kidney yang, nourishes essence and blood, and is warm and moistening without causing dryness. Modern research has confirmed that its polysaccharides can promote the proliferation of hematopoietic stem cells, counteract the decrease in white blood cells and platelets caused by chemotherapy, and activate macrophages and T lymphocytes, thereby increasing NK cell activity.

[0035] Angelica sinensis: It nourishes and invigorates blood, earning it the title of "holy medicine for nourishing blood." Angelica sinensis polysaccharides can directly stimulate the proliferation of bone marrow granulocyte-monocyte progenitor cells, promoting leukocyte production. Combined with raw Astragalus membranaceus, it forms "Angelica sinensis blood-nourishing decoction," a classic formula for boosting white blood cell count by simultaneously nourishing both qi and blood.

[0036] Chicken blood vine: Nourishes and invigorates blood, clears the meridians and relieves pain. Modern research has confirmed that chicken blood vine can significantly increase peripheral blood leukocytes, promote hematopoietic function, improve bone marrow suppression caused by radiotherapy and chemotherapy, and has good anti-inflammatory and antioxidant effects. When combined with angelica and cistanche, it synergistically enhances the blood-generating and invigorating effects.

[0037] • Adjuvant herbs (for relieving nausea and vomiting, strengthening the spleen and improving appetite, clearing heat and promoting body fluid production):

[0038] Ginger and bamboo shavings: Clears heat and resolves phlegm, relieves nausea and vomiting.

[0039] Ginger-processed Pinellia: Dries dampness, resolves phlegm, relieves nausea and vomiting (ginger-processed to reduce toxicity)

[0040] Poria: Strengthens the spleen and eliminates dampness, calms the mind and soothes the nerves.

[0041] Atractylodes macrocephala: Strengthens the spleen and replenishes qi, dries dampness and harmonizes the middle jiao.

[0042] Dried tangerine peel: regulates qi and stomach, prevents greasiness.

[0043] Roasted malt: aids digestion, stimulates appetite, and soothes the liver.

[0044] Reed rhizome: Clears heat and promotes body fluid production, stops vomiting, and is good at clearing stomach heat. It is effective for dry mouth and nausea after radiotherapy and chemotherapy.

[0045] • Guiding herb: Licorice, which invigorates qi and harmonizes the middle jiao, harmonizes the effects of various herbs, and also has the effect of clearing heat and detoxifying.

[0046] The main indications for this oral liquid of traditional Chinese medicine for reducing the toxicity of radiotherapy and chemotherapy and enhancing immunity are as follows:

[0047] Functions: Tonifies Qi and Yin, strengthens the spleen and stomach, relieves nausea and vomiting, nourishes the kidneys and generates blood, invigorates blood circulation and unblocks collaterals, strengthens the body's resistance and consolidates the foundation, and enhances immunity.

[0048] Indications: Used for patients with malignant tumors experiencing the following symptoms after radiotherapy and chemotherapy: nausea and vomiting, especially after eating; loss of appetite; dry mouth and throat, thirst; fatigue, shortness of breath, and reluctance to speak (cancer-related fatigue); red tongue with little or no coating, and a thready, rapid pulse; and weakened immune function (CD3+). + CD4 + Decreased T cells and decreased NK cell activity; leukopenia, anemia, and thrombocytopenia (bone marrow suppression).

[0049] Traditional Chinese Medicine diagnosis: Qi and Yin deficiency syndrome, complicated by stomach qi rebellion, spleen and stomach weakness, kidney essence deficiency, and blood stasis.

[0050] Dosage and administration of this traditional Chinese medicine oral liquid for reducing toxicity and enhancing immunity during radiotherapy and chemotherapy: 1 sachet each time, twice a day, dissolved in warm water. It can be taken 1-2 days before chemotherapy, and continuously for 5-7 days during chemotherapy as one course of treatment; it can be taken throughout the entire course of radiotherapy.

[0051] Compared with the prior art, the present invention has the following beneficial effects:

[0052] 1. Multi-target comprehensive improvement of radiotherapy and chemotherapy toxic side effects: Simultaneously relieves the four core symptoms of nausea and vomiting, loss of appetite, dry mouth and fatigue, and improves leukopenia, anemia, thrombocytopenia and low immune function, covering the most common adverse reaction spectrum after radiotherapy and chemotherapy.

[0053] 2. A groundbreaking breakthrough in the combination of principal herbs: The combined use of four herbs—Southwest Ginseng, Yunzhi, Rhodiola Rosea, and Astragalus membranaceus—forms a "four-principal synergistic" immune-anti-tumor core. Southwest Ginseng targets the PD-1 / PD-L1 immune checkpoint, Yunzhi promotes the production of immune factors, and Astragalus membranaceus enhances CD8. +T cell infiltration, combined with the metabolic reprogramming and angiogenesis inhibition of Rhodiola rosea, constitutes a complete anti-tumor immune network from immune checkpoint inhibition, cellular immune activation, metabolic regulation to microenvironment remodeling.

[0054] 3. Innovative introduction of kidney-tonifying, blood-nourishing, and blood-activating herbal pairs: For the first time, Cistanche deserticola, Angelica sinensis, and Spatholobus suberectus are used in combination in an adjuvant formula for radiotherapy and chemotherapy. Cistanche deserticola warms the kidneys and replenishes essence to generate marrow, Angelica sinensis nourishes and activates blood, and Spatholobus suberectus nourishes blood and activates blood. The three herbs work synergistically to promote the recovery of bone marrow hematopoietic function through multiple pathways of "warming the kidneys, nourishing blood, and activating blood," significantly increasing white blood cells, red blood cells, and platelets. In conjunction with Astragalus membranaceus, a four-dimensional support system of "qi-blood-kidney-blood vessels" is formed, fundamentally improving the state of deficiency and stagnation after radiotherapy and chemotherapy.

[0055] 4. An organic fusion of anti-nausea and appetite-stimulating effects with yin-nourishing and fluid-generating properties: Ginger-processed Pinellia ternata, ginger-processed bamboo shavings, and stir-fried malt precisely intervene in nausea and vomiting; reed rhizome clears heat, generates fluids, and stops vomiting; Ophiopogon japonicus and Adenophora stricta nourish stomach yin; Schisandra chinensis is sour and sweet, astringent to yin. The entire formula not only controls gastrointestinal reactions but also protects stomach qi, improving the patient's quality of life.

[0056] 5. Unique mechanism of polysaccharide synergistic effect: Polysaccharide components such as Rhodiola rosea polysaccharide, Trametes versicolor polysaccharide, Astragalus membranaceus polysaccharide, Poria cocos polysaccharide, and Cistanche deserticola polysaccharide form a "multi-target polysaccharide synergistic" combination, which plays an important synergistic role in anti-tumor, immune enhancement, and hematopoietic promotion.

[0057] 6. The unique value of chicken blood vine: Chicken blood vine can both replenish blood and promote blood circulation, improve the hypercoagulable state of blood after radiotherapy and chemotherapy, promote drug absorption and circulation, and complements angelica. Detailed Implementation

[0058] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0059] Example 1 (Granules)

[0060] Prescription (for 2800g granules):

[0061] The raw materials are as follows: 90 g of Codonopsis pilosula (Southwest China); 450 g of Astragalus membranaceus (raw); 90 g of Rhodiola rosea; 80 g of Ganoderma lucidum (Yun Zhi); 200 g of Codonopsis pilosula (Pseudostellaria heterophylla); 150 g of Ophiopogon japonicus; 200 g of Adenophora stricta (Northern Ginseng); 120 g of Schisandra chinensis; 200 g of Cistanche deserticola; 100 g of Angelica sinensis; 150 g of Spatholobus suberectus; 80 g of Zingiber officinale (processed with ginger); 80 g of Zingiber officinale (processed with ginger); 200 g of Poria cocos; 120 g of Atractylodes macrocephala; 80 g of Citrus reticulata peel; 200 g of roasted malt; 150 g of Phragmites communis rhizome; and 60 g of Glycyrrhiza uralensis.

[0062] The preparation method of traditional Chinese medicine preparations for reducing the toxicity of radiotherapy and chemotherapy and enhancing immunity is as follows:

[0063] (1) Clean and dry the above-mentioned medicinal materials.

[0064] (2) Add water to the following herbs and decoct twice: add 10 times the amount of water for the first time, soak for 30 minutes, decoct for 40 minutes, add ginger Pinellia and ginger Bamboo Shavings 8 minutes before the end of the decoction; add 8 times the amount of water for the second time, decoct for 25 minutes.

[0065] (3) Combine the decoctions and filter.

[0066] (4) The filtrate was concentrated under reduced pressure at a temperature of 65℃ and a vacuum degree of 0.09MPa to a clear paste with a relative density of 1.12 (60℃).

[0067] (5) Add 200g of dextrin and 300g of sucrose powder, mix well, granulate, dry (60℃), granulate, and package into 100 bags, each bag containing 20g.

[0068] Example 2 (Mixed Solution)

[0069] Prescription (increase proportionally):

[0070] The raw materials are as follows: 150 g of Codonopsis pilosula; 800 g of Astragalus membranaceus; 120 g of Rhodiola rosea; 120 g of Ganoderma lucidum; 300 g of Pseudostellaria heterophylla; 200 g of Ophiopogon japonicus; 300 g of Adenophora stricta; 200 g of Schisandra chinensis; 300 g of Cistanche deserticola; 200 g of Angelica sinensis; 200 g of Spatholobus suberectus; 120 g of Zingiber officinale; 150 g of Zingiber officinale; 300 g of Poria cocos; 200 g of Atractylodes macrocephala; 150 g of Citrus reticulata peel; 300 g of roasted malt; 200 g of Phragmites communis rhizome; and 60 g of Glycyrrhiza uralensis.

[0071] The preparation method of traditional Chinese medicine preparations for reducing the toxicity of radiotherapy and chemotherapy and enhancing immunity is as follows:

[0072] (1) Clean and dry the above-mentioned medicinal materials.

[0073] (2) Add water to the following herbs and decoct twice: add 8 times the amount of water for the first time, soak for 30 minutes, decoct for 30 minutes, add ginger Pinellia and ginger Bamboo Shavings 5 ​​minutes before the end of the decoction; add 6 times the amount of water for the second time, decoct for 30 minutes.

[0074] (3) Combine the decoctions and filter.

[0075] (4) The filtrate was concentrated under reduced pressure at a temperature of 70°C and a vacuum of 0.1 MPa to obtain a clear paste with a relative density of 1.10 (60°C).

[0076] (5) Add 200g of dextrin and 300g of sucrose powder, mix well, then add 0.3% sodium benzoate as a preservative, add water to adjust to 1g of raw drug per milliliter, fill into the container, and the mixture is obtained.

[0077] Example 3 (Capsule)

[0078] Prescription (reduced proportionally):

[0079] The raw materials are as follows: 60 g of Codonopsis pilosula (Southwest China); 150 g of Astragalus membranaceus (raw); 60 g of Rhodiola rosea; 50 g of Ganoderma lucidum (Yun Zhi); 100 g of Codonopsis pilosula (Pseudostellaria heterophylla); 100 g of Ophiopogon japonicus; 100 g of Adenophora stricta (Northern Ginseng); 50 g of Schisandra chinensis; 60 g of Cistanche deserticola; 60 g of Angelica sinensis; 100 g of Spatholobus suberectus; 50 g of Zingiber officinale (ginger-processed bamboo shavings); 30 g of Zingiber officinale (ginger-processed Pinellia ternata); 100 g of Poria cocos; 100 g of Atractylodes macrocephala; 60 g of Citrus reticulata peel; 150 g of stir-fried malt; 100 g of Phragmites communis rhizome; and 30 g of Glycyrrhiza uralensis.

[0080] The preparation method of traditional Chinese medicine preparations for reducing the toxicity of radiotherapy and chemotherapy and enhancing immunity is as follows:

[0081] (1) Clean and dry the above-mentioned medicinal materials.

[0082] (2) Add water to the following herbs and decoct three times: first, add 9 times the amount of water, soak for 30 minutes, decoct for 35 minutes, add ginger-processed Pinellia ternata and ginger-processed Bambusa textilis 10 minutes before the end of the decoction; second, add 8 times the amount of water and decoct for 20 minutes; a third decoction can also be carried out to fully extract the herbs.

[0083] (3) Combine the decoctions and filter.

[0084] (4) The filtrate was concentrated under reduced pressure at a temperature of 60℃ and a vacuum degree of 0.08MPa to a thick paste with a relative density of 1.15 (60℃), and then vacuum dried (60℃) to obtain a dry paste.

[0085] (5) Grind the raw drug through a 100-mesh sieve, add an appropriate amount of starch, mix well, granulate, and fill into capsules, each capsule containing 0.5g, which is equivalent to 2g of raw drug.

[0086] Pharmacodynamic experiments

[0087] Experiment 1: Effects on a chemotherapy-induced vomiting model mouse

[0088] A cisplatin-induced mouse vomiting model was used (n=10 / group). Results: The number of vomiting episodes in the medium and high dose groups of this invention was significantly lower than that in the control group (p<0.01), while there was no significant difference between the high dose group and the ondansetron group. The vomiting latency period increased from 18.5 min in the control group to 45.2 min in the high dose group (p<0.01). Conclusion: This invention can significantly reduce chemotherapy-induced vomiting.

[0089] Experiment 2: Effects on the immune function of immunosuppressed mice

[0090] Cyclophosphamide-induced immunosuppressive mouse model. Results showed that this invention significantly increased spleen index, thymus index, and CD4+. + / CD8 + The ratio increased (from 0.92 to 1.62, p < 0.01), and NK cell activity was enhanced (from 18.5% to 28.6%, p < 0.01). Conclusion: This invention can reverse cyclophosphamide-induced immunosuppression.

[0091] Experiment 3: Effects on peripheral blood counts after radiotherapy and chemotherapy

[0092] Cyclophosphamide-induced myelosuppression mouse model (n=10 / group). Mice were randomly divided into a model group, a positive drug group (recombinant human granulocyte colony-stimulating factor), and low, medium, and high dose groups of this invention. A blank control group was also included. Peripheral blood leukocytes, erythrocytes, and platelets were measured 14 days after administration.

[0093] Results: In this invention, the medium and high dose groups significantly increased white blood cell count (from 2.26 ± 0.35 × 10⁻⁶). 9 / L increased to 4.85±0.58×10 9 / L and 5.62±0.62×10 9 / L, p<0.01), increased platelet count (from 245±32×10 9 / L increased to 385±45×10 9 / L and 412±38×10 9 The formula contained Cistanche deserticola (p < 0.01) and also had a certain effect on increasing red blood cells. Compared with the formula without Cistanche deserticola, Angelica sinensis, and Spatholobus suberectus, the addition of these ingredients increased the white blood cell count by more than 35% (p < 0.05). Conclusion: This invention has a clear effect on resisting bone marrow suppression and increasing white blood cells and platelets. The addition of Spatholobus suberectus further enhances its blood-activating and hematopoietic effects.

[0094] Experiment 4: Acute Toxicity Experiment

[0095] A maximum dose experiment was conducted in mice. The mice were administered the maximum concentration of the granules of this invention (4 g / ml of raw drug) at 0.4 ml / 10 g body weight via gavage, three times within 24 hours, for a total dose of 480 g / kg of raw drug (approximately 200 times the clinical equivalent dose). After 14 days of continuous observation, no mice died, and there were no significant abnormalities in general behavior, diet, or weight. Conclusion: This invention has good safety and no toxic side effects.

[0096] Typical Cases

[0097] Case 1: Ms. Li, 52 years old, underwent chemotherapy (AC regimen) after breast cancer surgery. On the second day after chemotherapy, she experienced severe nausea and vomiting (6-8 times daily), was completely unable to eat, had a dry mouth and tongue, and was extremely weak (ECOG score 3). Her tongue was red and without coating, and her white blood cell count dropped to 2.3 × 10⁻⁶. 9 / L. One sachet of the granules of this invention (Example 1) was administered twice daily, in small, frequent doses. One day after administration, vomiting decreased to twice daily, and small amounts of liquid food could be consumed; vomiting ceased after three days, and appetite significantly improved; after seven days, the fatigue score decreased to ECOG 1 point, and the white blood cell count rose to 3.8 × 10⁻⁶. 9 / L. Immune marker: CD4 + / CD8 + The ratio increased from 0.9 to 1.4, and NK cell activity increased from 11% to 19%. The patient continued to take the medication in subsequent chemotherapy cycles without experiencing any more severe gastrointestinal reactions and successfully completed 6 cycles of chemotherapy.

[0098] Case 2: Mr. Wang, male, 58 years old, underwent chemotherapy after lung cancer surgery (cisplatin + etoposide regimen). During the first cycle of chemotherapy, he experienced severe nausea and vomiting (5-6 times daily), vomiting immediately after eating, dry mouth and throat, red tongue with little coating, and fatigue. He was given the granules of this invention, one sachet each time, twice daily, starting one day before chemotherapy. On the second day after taking the medication, the vomiting decreased to 1-2 times daily, and he could consume liquids; on the fifth day, the vomiting stopped, his appetite significantly improved, his mental state improved, and he successfully completed chemotherapy.

[0099] Case 3: Ms. Zhao, 45 years old, underwent chemotherapy (paclitaxel + carboplatin) after ovarian cancer surgery. Her white blood cell count dropped to 1.9 × 10⁻⁶ after chemotherapy. 9 / L, fatigue, nausea, poor appetite, and sallow complexion. After taking the granules of this invention for 7 days, the white blood cell count rose to 3.5 × 10. 9 / L, nausea disappeared, appetite increased, and physical strength improved. After continuing to take it for 2 weeks, platelet count also returned to normal.

[0100] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for reducing the toxicity of radiotherapy and chemotherapy and enhancing immunity, characterized in that, This herbal composition for reducing the toxicity and enhancing immunity during radiotherapy and chemotherapy is made from the following raw materials in parts by weight: Codonopsis pilosula 6-15; Astragalus membranaceus 15-80; Rhodiola rosea 6-12; Ganoderma lucidum 5-12; Pseudostellaria heterophylla 10-30; Ophiopogon japonicus 10-20; Adenophora stricta 10-30; Schisandra chinensis 5-20; Cistanche deserticola 6-30; Angelica sinensis 6-20; Spatholobus suberectus 10-20; Bambusa textilis 5-12; Pinellia ternata 3-15; Poria cocos 10-30; Atractylodes macrocephala 10-20; Citrus reticulata 6-15; Hordeum vulgare 15-30; Phragmites communis 10-20; Glycyrrhiza uralensis 3-6.

2. The traditional Chinese medicine composition for reducing the toxicity and enhancing immunity during radiotherapy and chemotherapy according to claim 1, characterized in that, This herbal composition for reducing the toxicity and enhancing immunity during radiotherapy and chemotherapy is made from the following raw materials in parts by weight: Codonopsis pilosula 9g; Astragalus membranaceus 45g; Rhodiola rosea 9g; Ganoderma lucidum 8g; Codonopsis pilosula 20g; Ophiopogon japonicus 15g; Adenophora stricta 20g; Schisandra chinensis 12g; Cistanche deserticola 20g; Angelica sinensis 10g; Spatholobus suberectus 15g; Bambusa textilis 8g; Pinellia ternata 8g; Poria cocos 20g; Atractylodes macrocephala 12g; Citrus reticulata 8g; Hordeum vulgare 20g; Phragmites communis 15g; Glycyrrhiza uralensis 6g.

3. A traditional Chinese medicine preparation for reducing the toxicity and enhancing immunity during radiotherapy and chemotherapy, characterized in that, It is made from the traditional Chinese medicine composition as described in claim 1 or 2 and pharmaceutically acceptable excipients.

4. A traditional Chinese medicine preparation for reducing the toxicity and enhancing immunity during radiotherapy and chemotherapy according to claim 3, characterized in that, The excipients are selected from one or more of dextrin, sucrose powder, mannitol, starch, and microcrystalline cellulose.

5. A traditional Chinese medicine preparation for reducing the toxicity and enhancing immunity during radiotherapy and chemotherapy according to claim 3 or 4, characterized in that, The preparation is any one of granules, mixtures, capsules, or tablets.

6. A method for preparing a traditional Chinese medicine preparation for reducing the toxicity and enhancing immunity during radiotherapy and chemotherapy, characterized in that, The radiotherapy and chemotherapy toxicity reduction and immunity enhancement traditional Chinese medicine preparation according to any one of claims 3 to 5, and its preparation method includes the following steps: (1) Weigh each Chinese herb according to the weight proportions, clean and dry them; (2) Add water to the following herbs and decoct 2-3 times: Southwest ginseng, raw astragalus, rhodiola rosea, turkey loranthus, codonopsis pilosula, ophiopogon japonicus, north ginseng, schisandra chinensis, cistanche deserticola, angelica sinensis, chicken blood vine, poria cocos, atractylodes macrocephala, tangerine peel, stir-fried malt, reed rhizome, and licorice. Add 8-10 times the amount of water for the first decoction, soak for 30 minutes, bring to a boil, and simmer for 30-40 minutes. Add 6-8 times the amount of water for the second decoction and simmer for 20-30 minutes. A third decoction can be performed to fully extract the herbs. Add ginger-processed pinellia and ginger-processed bamboo shavings (aromatic herbs) 5-10 minutes before the end of the first decoction. (3) Combine the decoctions and filter; (4) Concentrate the extract under reduced pressure at a temperature of 60-70℃ and a vacuum degree of 0.08-0.1MPa to a relative density of 1.10-1.15 and a temperature of 60℃; (5) Add pharmaceutically acceptable excipients and prepare granules, mixtures, capsules or tablets according to conventional pharmaceutical processes.

7. The use of the radiotherapy and chemotherapy toxicity-reducing and immunity-enhancing traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for improving nausea and vomiting after radiotherapy and chemotherapy.

8. The use of the radiotherapy and chemotherapy toxicity reduction and immunity enhancement traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicine for improving poor appetite, dry mouth and fatigue after radiotherapy and chemotherapy.

9. The use of the radiotherapy and chemotherapy toxicity-reducing and immunity-enhancing traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for enhancing immune function and alleviating bone marrow suppression, wherein the enhanced immune function includes increasing CD4+. + T cell percentage, increased CD4 + / CD8 + The ratio and enhanced NK cell activity, which reduce bone marrow suppression include increasing white blood cell, red blood cell, and platelet counts.

10. The use of the radiotherapy and chemotherapy toxicity-reducing and immunity-enhancing traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for adjuvant radiotherapy and chemotherapy of malignant tumors, wherein the malignant tumors include lung cancer, breast cancer, bone and soft tissue tumors, gastric cancer, esophageal cancer, colorectal cancer and ovarian cancer.