Traditional Chinese medicine composition for reinforcing qi, nourishing blood and strengthening body resistance after tumor chemoradiotherapy and detection method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for reinforcing qi, nourishing blood and strengthening body resistance after tumor chemoradiotherapy and a detection method thereof. The traditional Chinese medicine composition is prepared from astragalus membranaceus, codonopsis pilosula, angelica sinensis, poria cocos, cistanche, caulis spatholobi, radix paeoniae alba, glossy privet fruit, eclipta, hairyvein agrimony, medlar, Chinese yam, radix rehmanniae, radix ophiopogonis, deer-horn glue, tortoise-shell glue, pericarpium citri reticulatae and liquorice. The optimal traditional Chinese medicine composition and dosage are screened out through a large number of experimental screening and clinical medication experience, treatment is conducted on the basis of syndrome differentiation, compatibility is reasonable, the effects of reinforcing qi, nourishing blood and strengthening the body resistance are achieved together, immunity is improved, and the traditional Chinese medicine composition can be used for tumor chemoradiotherapy and postoperative conditioning and treatment of symptoms such as anemia, bone marrow suppression, thrombocytopenia and elderly weakness. Content determination is carried out through TLC identification and HPLC, and a scientific basis is provided for guaranteeing the clinical quality and effectiveness of reinforcing qi, nourishing blood and strengthening body resistance.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition, and in particular to a traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening the healthy qi after tumor radiotherapy and chemotherapy, and its detection method and application. Background Art

[0002] The newly diagnosed cases of malignant tumors increase year by year, among which lung cancer, gastric cancer, breast cancer, etc. rank among the top, and cancer is rising rapidly among women and young people. At present, radiotherapy and chemotherapy are still the core of tumor treatment, but breakthroughs have been made in immunotherapy (PD-1 / PD-L1 inhibitors), targeted therapy (EGFR-TKI drugs) and cell therapy (CAR-T). The drug resistance mechanism of chemotherapy drugs in tumor cells is complex. Under the diversified development of the combination of traditional Chinese and Western medicine for tumors, its application value has been gradually recognized in clinical practice. The traditional Chinese medicine composition can significantly reduce the treatment side effects (such as nausea and myelosuppression caused by chemotherapy), promote postoperative recovery, improve the quality of life and prolong the survival period. The traditional Chinese medicine compound can regulate the immune system, inhibit the inflammatory response, regulate the body environment, enhance the body's anti-tumor ability, and reduce the risk of recurrence and metastasis.

[0003] Based on the characteristics of qi and blood deficiency syndrome, qi and blood insufficiency, weak resistance, poor prognosis, and weak physical recovery ability during the radiotherapy and chemotherapy of tumor patients, the present invention screens the composition of traditional Chinese medicine flavors. Summary of the Invention

[0004] Object of the Invention: The object of the present invention is to screen the composition and dosage of traditional Chinese medicine flavors through a large number of experiments and in combination with clinical medication experience, and use thin-layer chromatography and high-performance liquid chromatography to qualitatively identify and determine the content of active ingredients. The present invention has the effects of replenishing qi and blood, strengthening the healthy qi and consolidating the root, improving immunity, reducing adverse reactions such as myelosuppression, etc., and can improve the healing speed of tumor radiotherapy and chemotherapy.

[0005] Technical Solution: In order to achieve the above object, the technical solution adopted by the present invention is as follows: A traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening the healthy qi after tumor radiotherapy and chemotherapy, which is made from the following traditional Chinese medicine raw materials: Astragalus membranaceus, Codonopsis pilosula, Angelica sinensis, Poria cocos, Cistanche deserticola, Spatholobus suberectus, Paeonia lactiflora, Ligustrum lucidum, Eclipta prostrata, Agrimonia pilosa, Lycium barbarum, Dioscorea opposita, Rehmannia glutinosa, Ophiopogon japonicus, Cornu cervi colla, Plastrum testudinis, Citrus reticulata Blanco and Glycyrrhiza uralensis Fisch.

[0006] As a preferred embodiment, the above-mentioned traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening the healthy qi after tumor radiotherapy and chemotherapy is made from the following traditional Chinese medicine raw materials in parts by weight: 20 - 80 parts of Astragalus membranaceus, 15 - 60 parts of Codonopsis pilosula, 15 - 60 parts of Angelica sinensis, 15 - 45 parts of Poria cocos, 15 - 45 parts of Cistanche deserticola, 15 - 45 parts of Spatholobus suberectus, 15 - 45 parts of Paeonia lactiflora, 15 - 45 parts of Ligustrum lucidum, 15 - 45 parts of Eclipta prostrata, 15 - 45 parts of Agrimonia pilosa, 15 - 45 parts of Lycium barbarum, 15 - 45 parts of Dioscorea opposita, 15 - 45 parts of Rehmannia glutinosa, 15 - 60 parts of Ophiopogon japonicus, 10 - 30 parts of Cornu cervi colla, 10 - 30 parts of Plastrum testudinis, 5 - 15 parts of Citrus reticulata Blanco, 5 - 15 parts of Glycyrrhiza uralensis Fisch.

[0007] As a preferred embodiment, the traditional Chinese medicine composition for supplementing qi and nourishing blood and strengthening the healthy qi after tumor radiotherapy and chemotherapy described above is made from the following traditional Chinese medicine raw materials in parts by weight: 40 - 80 parts of Astragalus membranaceus, 30 - 60 parts of Codonopsis pilosula, 30 - 60 parts of Angelica sinensis, 30 - 45 parts of Poria cocos, 30 - 45 parts of Cistanche deserticola, 30 - 45 parts of Spatholobus suberectus, 30 - 45 parts of Paeonia lactiflora, 30 - 45 parts of Ligustrum lucidum, 30 - 45 parts of Eclipta prostrata, 30 - 45 parts of Agrimonia pilosa, 30 - 45 parts of Lycium barbarum, 30 - 45 parts of Dioscorea opposita, 30 - 45 parts of Rehmannia glutinosa, 30 - 60 parts of Ophiopogon japonicus, 15 - 30 parts of Cornu cervi colla, 15 - 30 parts of Plastrum testudinis, 10 - 15 parts of Citrus reticulata Blanco, 10 - 15 parts of Glycyrrhiza uralensis Fisch.

[0008] As a preferred embodiment, the traditional Chinese medicine composition for supplementing qi and nourishing blood and strengthening the healthy qi after tumor radiotherapy and chemotherapy described above is made from the following traditional Chinese medicine raw materials in parts by weight: 80 parts of Astragalus membranaceus, 60 parts of Codonopsis pilosula, 60 parts of Angelica sinensis, 45 parts of Poria cocos, 45 parts of Cistanche deserticola prepared with wine, 45 parts of Spatholobus suberectus, 45 parts of Paeonia lactiflora, 45 parts of Ligustrum lucidum prepared with wine, 45 parts of Eclipta prostrata, 45 parts of Agrimonia pilosa, 45 parts of Lycium barbarum, 45 parts of Dioscorea opposita stir - fried with bran, 45 parts of Rehmannia glutinosa, 60 parts of Ophiopogon japonicus, 30 parts of Cornu cervi colla from Dong'e, 30 parts of Plastrum testudinis from Dong'e, 15 parts of Citrus reticulata Blanco, 15 parts of roasted Glycyrrhiza uralensis Fisch.

[0009] As a preferred embodiment, the preparation method of the traditional Chinese medicine composition for supplementing qi and nourishing blood and strengthening the healthy qi after tumor radiotherapy and chemotherapy described above includes the following steps: Take Astragalus membranaceus, Codonopsis pilosula, Angelica sinensis, Poria cocos, Cistanche deserticola, Spatholobus suberectus, Paeonia lactiflora, Ligustrum lucidum, Eclipta prostrata, Agrimonia pilosa, Lycium barbarum, Dioscorea opposita, Rehmannia glutinosa, Ophiopogon japonicus, Cornu cervi colla, Plastrum testudinis, Citrus reticulata Blanco and Glycyrrhiza uralensis Fisch. according to the parts by weight, add 5 - 20 times the amount of water or ethanol for extraction 1 - 3 times, 0.5 - 2 hours each time, filter, combine the filtrates, and concentrate to obtain.

[0010] As a preferred embodiment, the preparation method of the traditional Chinese medicine composition for supplementing qi and nourishing blood and strengthening the healthy qi after tumor radiotherapy and chemotherapy described above includes the following steps: Take astragalus, codonopsis, angelica, tuckahoe, cistanche, millettia, white peony, glossy privet, eclipta, agrimony, wolfberry, yam, radix rehmanniae, ophiopogon, antler glue, tortoise shell glue, tangerine peel and liquorice by weight, add 10-20 times amount of water for decoction or ethanol reflux, percolation or ultrasonic extraction for 1-3 times, each time for 0.5-2 hours, filter, combine the filtrate and concentrate to obtain the product.

[0011] As a preferred embodiment, the above-mentioned detection method of the Chinese medicine composition for invigorating qi, nourishing blood and strengthening the body after tumor radiotherapy and chemotherapy comprises qualitative identification by thin layer chromatography and content determination; The described thin layer chromatography qualitative identification comprises the following steps: (1) Preparation of test solution Take astragalus, codonopsis, angelica, tuckahoe, cistanche, millettia, white peony, glossy privet, eclipta, agrimony, wolfberry, yam, raw rehmannia, ophiopogon, antler glue, tortoise shell glue, tangerine peel and liquorice by weight, add 10-20 times the amount of water to decoct or ethanol reflux, percolate or ultrasonic extraction 1-3 times, each time for 0.5-2 hours, filter, combine the filtrate, concentrate to obtain, accurately weigh the concentrate, put it into a stoppered conical bottle, add methanol, seal, ultrasonic extraction, stand at room temperature, filter with filter paper The filtrate was placed in an evaporating dish and evaporated to dryness. The residue was dissolved in water and placed in a separatory funnel. It was shaken and extracted with water-saturated n-butanol. The mixture was allowed to stand. The upper layer of liquid was taken. The n-butanol extract was combined and washed with sodium hydroxide solution in a separatory funnel. The mixture was allowed to stand. The upper layer of liquid was taken and placed in an evaporating dish. The n-butanol extract was evaporated to dryness. Methanol was added to the residue to dissolve it. The residue was transferred to a volumetric flask and fixed to volume. The mixture was allowed to stand. The residue was filtered with a 0.45 μm organic filter head and placed in a sample injection bottle as the test solution for Yangxue Fuzheng Recipe. (2) Preparation of reference solution Astragaloside IV, codonopsis arginine and verbascoside reference substances were taken respectively, accurately weighed, placed in a volumetric flask, and methanol was added to make up to volume, thereby preparing astragaloside IV, codonopsis arginine and verbascoside reference substance solutions respectively; (3) TLC identification (3.1) Identification of Astragaloside IV and Codonopsis pilosula Astragaloside IV reference solution, codonopsis pilosula reference solution, and Yangxue Fuzheng Fang test solution were respectively aspirated and spotted on the same silica gel G thin layer plate, and chloroform-methanol-water was used as the developing solvent. The plate was developed, taken out, air-dried, sprayed with sulfuric acid ethanol solution, and heated until the spots were clearly colored. In the chromatogram of the test sample, at the corresponding position of the chromatogram of the reference sample, spots of the same color appeared under sunlight; and fluorescent spots of the same color appeared under ultraviolet light. (3.2) Identification of Verbascoside Absorb the verbascose reference substance solution and the Yangxue Fuzheng formula test solution, and spot them on the same polyamide thin-layer plate respectively. Use methanol - acetic acid - water as the developing agent, develop, take out, dry in the air, and examine under an ultraviolet lamp; in the test solution chromatogram, at the position corresponding to the reference substance chromatogram, fluorescent spots of the same color appear.

[0012] As a preferred solution, for the detection method of a traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening the healthy qi after tumor radiotherapy and chemotherapy described above, the thin-layer chromatography qualitative identification includes the following steps (1) Preparation of test solution Weigh astragalus root, codonopsis pilosula, angelica sinensis, poria cocos, cistanche deserticola, millettia reticulata, white peony root, glossy privet fruit, eclipta prostrata, agrimony, wolfberry fruit, Chinese yam, rehmannia glutinosa, dwarf lilyturf tuber, deer horn glue, tortoise shell glue, tangerine peel and liquorice root according to the weight parts, add 10 - 20 times the amount of water to decoct or reflux with ethanol, percolate or extract by ultrasonic wave for 1 - 3 times, each time for 0.5 - 2 hours, filter, combine the filtrates, concentrate to obtain. Weigh the concentrate precisely, put it into a stoppered conical flask, add 100 mL of methanol, seal, extract by ultrasonic wave for 20 - 30 min, let it stand at room temperature for 0.5 - 1 h, filter through a funnel and filter paper, put the filtrate into an evaporating dish and evaporate to dryness, dissolve the residue with water, put it into a separating funnel, shake and extract with n-butanol saturated with water for 2 - 3 times, each time for 30 - 40 mL, let it stand for 0.5 - 1 h, take the upper layer liquid, combine the n-butanol extraction solutions, put them into a separating funnel, shake and wash with 1 - 5% sodium hydroxide solution for 30 - 40 mL for 1 - 3 times, let it stand for 0.5 - 1 h, take the upper layer liquid, put it into an evaporating dish and evaporate the n-butanol extraction solution to dryness, dissolve the residue with methanol, transfer it to a volumetric flask for constant volume, let it stand for 0.5 - 1 h, filter with a 0.45 μm organic filter head, and put it into an injection bottle as the Yangxue Fuzheng formula test solution; (2) Preparation of reference substance solution Take 0.00211 g of astragaloside IV reference substance, weigh it precisely, put it into a 10 mL volumetric flask, add methanol for constant volume to prepare an astragaloside IV reference substance solution with a concentration of 0.211 mg / mL, and that's it; Take 0.00225 g of lobetyolin reference substance, weigh it precisely, put it into a 10 mL volumetric flask, add methanol for constant volume to prepare a lobetyolin reference substance solution with a concentration of 0.225 mg / mL, and that's it; Take 0.00201 g of verbascoside reference substance, weigh it precisely, put it into a 10 mL volumetric flask, add methanol for constant volume to prepare a verbascoside reference substance solution with a concentration of 0.201 mg / mL, and that's it; (3) TLC identification (3.1) Identification of astragaloside IV and lobetyolin Respectively pipette 5 μL and 10 μL of astragaloside reference solution, lobetyolin reference solution and the test solution of Yangxue Fuzheng Prescription, spot them on the same silica gel G thin-layer plate respectively, use the lower layer solution of chloroform-methanol-water (volume ratio 13﹕7﹕2) placed overnight at below 10°C as the developing solvent, develop, take out, dry in air, spray with 10% sulfuric acid ethanol solution, heat at 105°C until the spots are clearly developed; in the chromatogram of the test sample, at the positions corresponding to the chromatogram of the reference substance, spots of the same color are shown under daylight; fluorescent spots of the same color are shown under ultraviolet light; (3.2)Identification of acteoside Pipette the acteoside reference solution and the test solution of Yangxue Fuzheng Prescription, pipette 5 μL and 10 μL of each solution respectively, spot them on the same polyamide thin-layer plate respectively, use methanol-acetic acid-water (volume ratio 2∶1∶7) as the developing solvent, develop, take out, dry in air, examine under ultraviolet lamp; in the chromatogram of the test sample, at the positions corresponding to the chromatogram of the reference substance, fluorescent spots of the same color are shown.

[0013] As a preferred scheme, the detection method of a traditional Chinese medicine composition for replenishing qi, nourishing blood and strengthening the healthy qi after tumor radiotherapy and chemotherapy described above is characterized in that the content determination method comprises the following steps (1)Preparation of test solution Take astragalus membranaceus, codonopsis pilosula, angelica sinensis, poria cocos, cistanche deserticola, spatholobus suberectus, white peony root, glossy privet fruit, eclipta prostrata, agrimonia pilosa, wolfberry fruit, Chinese yam, rehmannia glutinosa, ophiopogon japonicus, deer horn glue, tortoise shell glue, dried tangerine peel and liquorice root according to the weight parts, add 10 - 20 times the amount of water to decoct or reflux with ethanol, percolate or extract by ultrasonic for 1 - 3 times, each time for 0.5 - 2 hours, filter, combine the filtrates, concentrate to obtain, accurately weigh the concentrate, transfer it to a stoppered conical flask, add 100 mL of methanol, seal, extract by ultrasonic for 20 - 30 min, let stand at room temperature for 0.5 - 1 h, filter through a funnel and filter paper, place the filtrate in an evaporating dish and evaporate to dryness, dissolve the residue with water, transfer it to a separating funnel, shake and extract with n-butanol saturated with water for 2 - 3 times, each time for 30 - 40 mL, let stand for 0.5 - 1 h, take the upper layer liquid, combine the n-butanol extracts, in the separating funnel, shake and wash with 1 - 5% sodium hydroxide solution for 30 - 40 mL for 1 - 3 times, let stand for 0.5 - 1 h, take the upper layer liquid, place it in an evaporating dish and evaporate the n-butanol extract to dryness, dissolve the residue with methanol, transfer it to a volumetric flask and make up the volume, let stand for 0.5 - 1 h, filter with a 0.45 μm organic filter head, and place it in an injection vial as the test solution of Yangxue Fuzheng Prescription; (2)Preparation of reference solution Accurately weigh the reference substances of acteoside, codonopsispiloside, nobiletin, and formononetin, place them in a volumetric flask, make up to the mark with methanol, shake well, and prepare a mixed reference substance solution containing 0.0603 mg / mL acteoside, 0.2302 mg / mL codonopsispiloside, 0.201 mg / mL nobiletin, and 0.0742 mg / mL formononetin; (3) Respectively aspirate the reference substance solution and the test solution and inject them into a high-performance liquid chromatograph, and determine the contents of acteoside, codonopsispiloside, nobiletin, and formononetin in the test substance according to the external standard single-point method; The liquid chromatography conditions for step (3) are as follows: Chromatographic column: Purospher STAR LP RP-18 endcapped, mobile phase: acetonitrile and 0.1% phosphoric acid water, gradient elution, diode array detector, detection wavelength: 245 nm, column temperature 30 °C, flow rate 1.0 mL / min, injection volume: 10 μL, and the gradient elution program is as follows in the table: Procedure Time min Acetonitrile volume % 1 0 5 2 10 5 3 40 20 4 115 45 5 122 52 6 145 64 7 155 74 8 160 5 9 165 5 。

[0014] The traditional Chinese medicine composition for replenishing qi, nourishing blood, and strengthening the healthy qi provided by the present invention can be used for the conditioning after radiotherapy, chemotherapy, and surgery for tumor diseases, the treatment of symptoms such as anemia, myelosuppression, thrombocytopenia, and weakness in the elderly.

[0015] The traditional Chinese medicine composition for replenishing qi, nourishing blood, and strengthening the healthy qi provided by the present invention has a particularly specific formula rule: In the formula, astragalus membranaceus is sweet, warm, and neutral in nature, and is good at replenishing qi and nourishing blood; angelica sinensis is sweet, tonifying, pungent, dispersing, warm, and promoting blood circulation, and is good at nourishing blood and promoting blood circulation. The two herbs are combined, with qi flourishing and blood being generated, aiming at the effect of replenishing qi and generating blood, and they are used as the monarch herbs together; codonopsis pilosula helps astragalus membranaceus to replenish qi, and wolfberry fruit and rehmannia glutinosa help angelica sinensis to nourish blood, and they are used as the minister herbs together; millettia reticulata can activate blood circulation and nourish blood, agrimonia pilosa can tonify deficiency, cistanche deserticola and deer horn glue can tonify the kidney, assist yang, and strengthen the healthy qi; glossy privet fruit and eclipta prostrata have the effects of tonifying the liver and kidney, nourishing yin and stopping bleeding, white peony root is sour, bitter, slightly cold, can nourish blood and benefit yin, soothe the liver and relieve pain, and roasted licorice root is sweet, warm, can tonify the middle-jiao and relieve spasm, and the two herbs are used together to achieve the effect of generating yin from sour and sweet, regulating the liver and spleen, and relieving spasm and pain; tortoise shell glue is made into a paste, and can also nourish blood and strengthen the healthy qi, and is used as an assistant and guiding herb; xylitol is used for flavoring and made into a paste. The whole formula is combined to achieve the effect of replenishing qi, nourishing blood, and strengthening the healthy qi.

[0016] Beneficial effects: The present invention has the following technical advantages: 1. The present invention screens out the best composition and dosage of traditional Chinese medicine flavors through a large number of experiments and clinical medication experience. The whole formula is syndrome differentiated and treated, and the compatibility is reasonable, achieving the effect of replenishing qi, nourishing blood, and strengthening the healthy qi, improving immunity, reducing adverse reactions such as myelosuppression and thrombocytopenia, and can improve the healing speed of tumor radiotherapy and chemotherapy.

[0017] 2. The present invention conducts TLC identification and HPLC content determination. First, through a large number of experiments, the present invention has screened out the optimal preparation method for the test sample solution. This preparation method for the test sample has the advantage of being shared by multiple inspection methods. For example, in TLC identification, there are respective methods for the TLC identification of Astragali Radix and Codonopsis Radix in the pharmacopoeia, and the preparation methods for their test sample solutions are significantly different. In particular, the preparation of the test sample solution for Codonopsis Radix requires filtration through a macroporous chromatographic column, and there are also two kinds of developing agents for the two. However, the preparation method for this test sample is simple and easy to operate, and only one kind of developing agent is needed to simultaneously identify the marker components astragaloside IV and codonopside in Astragali Radix and Codonopsis Radix, achieving the savings of reagents, improvement of efficiency, and reduction of detection costs. For example, "Shandong Ejiao Ointment" in the pharmacopoeia also contains Astragali Radix and Codonopsis Radix. Under the TLC detection item, the two herbs are separately detected by TLC. The preparation method for this test sample and the thin-layer developing agent save reagents, improve efficiency, and reduce detection costs compared with Shandong Ejiao Ointment).

[0018] In addition, the present invention has screened out the optimal TLC chromatographic conditions through experiments, including the developing agent and color development conditions for the thin-layer chromatographic identification of astragaloside IV and codonopside. In addition, the chromatographic conditions for HPLC content determination have been screened out through experiments, including the composition of the mobile phase and the gradient elution method, etc. The present invention can simultaneously determine the contents of acteoside, codonopside, nobiletin, and formononetin, providing a scientific basis for ensuring the clinical quality and effectiveness of replenishing qi and nourishing blood and strengthening the healthy qi. Description of the Drawings

[0019] Figure 1 It is a thin-layer chromatographic identification diagram of astragaloside IV and codonopside under ultraviolet light of 366 nm.

[0020] Figure 2 is a thin-layer chromatographic identification diagram of acteoside under ultraviolet light of 366 nm.

[0021] Figure 3 It is a chromatogram of the mixed reference substance.

[0022] Figure 4 It is the control fingerprint chromatogram of the sample of the prescription for nourishing blood and strengthening healthy qi of the present invention.

[0023] Figure 5 It is a chromatogram of the single reference substance of acteoside of the present invention.

[0024] Figure 6 It is a chromatogram of the single reference substance of codonopside of the present invention.

[0025] Figure 7 It is a chromatogram of the single reference substance of formononetin of the present invention.

[0026] Figure 8 It is a chromatogram of the single reference substance of nobiletin of the present invention. Detailed Embodiments

[0027] The present invention will be further illustrated below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. After reading the present invention, various equivalent modifications made by those skilled in the art to the present invention fall within the scope defined by the appended claims of this application.

[0028] Example 1 1. A traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening the healthy qi after radiotherapy and chemotherapy for tumors, which is made from the following traditional Chinese medicine raw materials in parts by weight: Astragalus membranaceus 80g, Codonopsis pilosula 60g, Angelica sinensis 60g, Poria cocos 45g, Cistanche deserticola processed with wine 45g, Spatholobus suberectus 45g, Paeonia lactiflora 45g, Ligustrum lucidum processed with wine 45g, Eclipta prostrata 45g, Agrimonia pilosa 45g, Lycium barbarum 45g, Dioscorea opposita stir-fried with bran 45g, Rehmannia glutinosa 45g, Ophiopogon japonicus 60g, Dong'e deer horn glue 30g, Dong'e tortoise shell glue 30g, Citrus reticulata Blanco 15g, Honey-fried Licorice Root 15g.

[0029] 2. A preparation method of a traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening the healthy qi after radiotherapy and chemotherapy for tumors, comprising the following steps: Take Astragalus membranaceus 80g, Codonopsis pilosula 60g, Angelica sinensis 60g, Poria cocos 45g, Cistanche deserticola processed with wine 45g, Spatholobus suberectus 45g, Paeonia lactiflora 45g, Ligustrum lucidum processed with wine 45g, Eclipta prostrata 45g, Agrimonia pilosa 45g, Lycium barbarum 45g, Dioscorea opposita stir-fried with bran 45g, Rehmannia glutinosa 45g, Ophiopogon japonicus 60g, Dong'e deer horn glue 30g, Dong'e tortoise shell glue 30g, Citrus reticulata Blanco 15g, Honey-fried Licorice Root 15g according to parts by weight. First, add 15 times the weight of the Chinese medicinal materials of water and decoct for 1 hour, filter to obtain a filtrate. Then add 10 times the weight of water to the filter residue and decoct for 1 hour, filter to obtain a filtrate. Then add 8 times the weight of water to the filter residue and decoct for 0.5 hour, filter, and combine the filtrates of the 3 times, and concentrate to obtain the extract of the prescription for nourishing blood and strengthening the healthy qi.

[0030] 3. Thin-layer identification method (1) Preparation of test solution Take 6g of the Yangxue Fuzheng Fang extract prepared above, accurately weigh it, put it into a 100mL stoppered conical flask, add 100mL of methanol, seal it, and extract it by ultrasonic (temperature 20℃, power 250W, frequency 100hz) for 20min, let it stand at room temperature (10℃) for 0.5h, filter it through a funnel filter paper, evaporate the filtrate in an evaporating dish, dissolve the residue in 40mL of water, put it into a 125mL separatory funnel, and shake it with water-saturated n-butanol for 2 times, each time 40mL, let it stand for 0.5h, take the upper layer of liquid, combine the n-butanol extract, put it in a 125mL separatory funnel, shake and wash once with 40mL of 1% sodium hydroxide solution, let it stand for 0.5h, take the upper layer of liquid, put it in an evaporating dish, evaporate the n-butanol extract to dryness, add 2mL of methanol to dissolve the residue, transfer it to a 2mL volumetric flask to make up the volume, let it stand for 0.5h, filter it with a 0.45μm organic filter head, and put it in a sampling bottle as the test solution of Yangxue Fuzheng Decoction.

[0031] (2) Preparation of reference solution Take 0.00211 g of astragaloside IV reference substance, weigh it accurately, put it in a 10 mL volumetric flask, add methanol to make up to volume, and prepare a 0.211 mg / mL astragaloside IV reference substance solution.

[0032] Take 0.00225 g of dangshen glycoside reference substance, accurately weigh it, put it in a 10 mL volumetric flask, add methanol to make up to volume, and prepare a 0.225 mg / mL dangshen glycoside reference substance solution.

[0033] Take 0.00201 g of verbascoside reference substance, accurately weigh it, put it in a 10 mL volumetric flask, add methanol to make up to volume, and prepare 0.201 mg / mL verbascoside reference substance solution.

[0034] (3) TLC identification (3.1) Identification of Astragaloside IV and Codonopsis pilosula Take 5 and 10 μL of the above astragaloside reference solution, codonopsis pilosula reference solution, and Yangxue Fuzheng Fang test solution, respectively, and spot them on the same silica gel G thin layer plate (10cm×10cm), use chloroform-methanol-water (13﹕7﹕2) and place the lower layer solution overnight below 10℃ as the developing agent, develop, take out, dry, spray with 10% sulfuric acid ethanol solution, and heat at 105℃ until the spots are clearly colored. In the chromatogram of the test sample, at the corresponding position of the chromatogram of the reference sample, spots of the same color appear under sunlight; if Figure 1As shown, fluorescent spots showing the same color under ultraviolet light. The first spot is the solution of astragaloside IV reference substance, with a sample application volume of 5 μL. The second spot is the solution of astragaloside IV reference substance, with a sample application volume of 10 μL. The third spot is the solution of lobetyolin reference substance, with a sample application volume of 5 μL. The fourth spot is the solution of lobetyolin reference substance, with a sample application volume of 10 μL. The fifth spot is the test solution of Yangxue Fuzheng Prescription (G003 - YXFZ, production date 2024.09.24), with a sample application volume of 5 μL. The sixth spot is the test solution of Yangxue Fuzheng Prescription (G003 - YXFZ, production date 2024.09.24), with a sample application volume of 10 μL. The seventh spot is the test solution of Yangxue Fuzheng Prescription (G003 - YXFZ, production date 2024.09.14), with a sample application volume of 5 μL. The eighth spot is the test solution of Yangxue Fuzheng Prescription (G003 - YXFZ, production date 2024.09.14), with a sample application volume of 10 μL. The ninth spot is the test solution of Yangxue Fuzheng Prescription (G003 - YXFZ, production date 2024.09.10), with a sample application volume of 5 μL. The tenth spot is the test solution of Yangxue Fuzheng Prescription (G003 - YXFZ, production date 2024.09.10), with a sample application volume of 10 μL.

[0035] (3.2)Identification of acteoside Absorb the above - mentioned acteoside reference substance solution and the test solution of Yangxue Fuzheng Prescription. For each solution, 5 μL and 10 μL are respectively absorbed and spotted on the same polyamide thin - layer plate (8 cm×8 cm). Using methanol - acetic acid - water (2∶1∶7) as the developing solvent, develop, take out, air - dry, and examine under an ultraviolet lamp. In the chromatogram of the test sample, at the position corresponding to the chromatogram of the reference substance, as Figure 2 , fluorescent spots showing the same color are presented.

[0036] 4. Content determination (1)Experimental equipment (1.1)Experimental instruments The full - wavelength scanning (200 - 800 nm) high - performance liquid chromatography system of Shimadzu Corporation, Japan, including a full - automatic online degassing system, a full - automatic injection system Prominence SIL - 20A, a diode array detector SPD - M20A, and an automatic temperature - controlled column oven CTO - 20A, a KQ3200DB type numerically controlled ultrasonic cleaner (Kunshan Ultrasonic Instrument Co., Ltd.), a BP121S electronic analytical balance (SARTORIUS).

[0037] (1.2)Drugs and reagents Acteoside, lobetyolin, nobiletin, formononetin reference substances are purchased from the National Institutes for Food and Drug Control; n - butanol, methanol, sodium hydroxide (analytical grade); phosphoric acid (analytical grade); acetonitrile (chromatographic grade); water (ultrapure water).

[0038] (1.3) Preparation of test solution Take 6g of the Yangxue Fuzheng Fang extract prepared above, accurately weigh it, put it into a 100mL stoppered conical flask, add 100mL of methanol, seal it, and extract it by ultrasonic (temperature 20℃, power 250W, frequency 100hz) for 20min, let it stand at room temperature (10℃) for 0.5h, filter it through a funnel filter paper, evaporate the filtrate in an evaporating dish, dissolve the residue in 40mL of water, put it into a 125mL separatory funnel, and shake it twice with water-saturated n-butanol. Take 40 mL each time, let it stand for 0.5 h, take the upper layer of liquid, combine it with the n-butanol extract, put it in a 125 mL separatory funnel, shake and wash it once with 40 mL of 1% sodium hydroxide solution, let it stand for 0.5 h, take the upper layer of liquid, put it in an evaporating dish and evaporate the n-butanol extract to dryness, add 2 mL of methanol to dissolve the residue, transfer it to a 2 mL volumetric flask to make up the volume, let it stand for 0.5 h, filter it with a 0.45 μm organic filter head, and put it in a sampling bottle as the test solution of Yangxue Fuzheng Decoction.

[0039] (1.4) Preparation of reference solution Accurately weigh verbascoside, codonopsis glycoside, nobiletin, and formononetin reference substances, place in a volumetric flask, dilute to the mark with methanol, shake well, and prepare a mixed reference substance solution containing 0.0603 mg / mL verbascoside, 0.2302 mg / mL codonopsis glycoside, 0.201 mg / mL nobiletin, and 0.0742 mg / mL formononetin.

[0040] Accurately weigh the verbascoside reference substance, place it in a volumetric flask, dilute to the mark with methanol, and shake well to prepare a 0.201 mg / mL verbascoside single reference substance solution.

[0041] Accurately weigh the dangshen glycoside reference substance, place it in a volumetric flask, dilute to the mark with methanol, shake well, and prepare a 0.225 mg / mL dangshen glycoside single reference substance solution.

[0042] Accurately weigh the Nobiletin reference substance, place it in a volumetric flask, dilute to the mark with methanol, shake well, and prepare a 0.410 mg / mL Nobiletin single reference substance solution.

[0043] Accurately weigh the formononetin reference substance, place it in a volumetric flask, dilute to the mark with methanol, shake well, and prepare a 0.740 mg / mL formononetin single reference substance solution.

[0044] (1.5) The above reference solutions and test solutions were respectively injected into the HPLC, and the contents of verbascoside, codonopsis pilosula, nobiletin and formononetin in the test samples were determined according to the external standard one-point method; as shown in Table 1: Table 1 Content of each compound Compound Verbascoside Lobetyolin Nobiletin Formononetin Content (mg / mL) 0.272 0.457 0.892 0.374 The liquid chromatography conditions are as follows: Chromatographic column: Purospher STAR LP RP-18 endcapped, mobile phase: acetonitrile and 0.1% phosphoric acid in water, gradient elution, diode array detector, detection wavelength: 245 nm, column temperature 30 °C, flow rate 1.0 mL / min, injection volume: 10 μL. The gradient elution program is shown in Table 2 below: Table 2 Gradient elution method Procedure Time (min) Acetonitrile volume (%) 1 0 5 2 10 5 3 40 20 4 115 45 5 122 52 6 145 64 7 155 74 8 160 5 9 165 5 The detection method for the fingerprint spectrum of Yangxue Fuzheng Prescription. There are 8 peaks in the fingerprint spectrum, and their retention times are 46.279 min for peak 1, 48.616 min for peak 2, 55.570 min for peak 3, 59.240 min for peak 4, 90.935 min for peak 5, 104.035 min for peak 6, 109.719 min for peak 7, and 138.209 min for peak 8. Among them, peak 1 is acteoside, peak 3 is lobetyolin, peak 5 is formononetin, and peak 6 is nobiletin.

[0045] 5. Methodology investigation 5.1 Precision investigation Take 6 g of the Yangxue Fuzheng Prescription sample, and prepare the test solution according to the above-mentioned test sample preparation method. Inject continuously 6 times, with an injection volume of 10 μL each time. Detect according to the above chromatographic conditions, and measure its HPLC chromatogram. Examine the 8 common fingerprint peaks in the chromatogram. The results show that the RSD of the retention times of the common fingerprint peaks are all less than 0.9%, and the RSD of the peak areas of the common peaks are all less than 0.8%, indicating that the instrument precision is good.

[0046] 5.2 Stability investigation Take 6 g of the Yangxue Fuzheng Prescription sample, and prepare the test solution according to the above-mentioned test sample preparation method. Inject according to the above chromatographic conditions at 0, 4, 8, 12, 16, and 24 h respectively, record the chromatogram, and examine the 8 common fingerprint peaks in the chromatogram. The results show that the RSD of the retention times of the common fingerprint peaks are all less than 1.2%, and the RSD of the peak areas of the common peaks are all less than 1.4%, indicating that the test solution has good stability within 24 h.

[0047] 5.3 Repeatability investigation Take 6 portions of 6 g each of the Yangxue Fuzheng Prescription sample, and prepare the test solution according to the above-mentioned test sample preparation method. Measure respectively, record the chromatogram, and examine the 8 common fingerprint peaks in the chromatogram. The results show that the RSD of the retention times of the common fingerprint peaks are all less than 1.9%, and the RSD of the peak areas of the common peaks are all less than 2.0%, indicating that the method has good repeatability.

[0048] Example 2 1. A traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening healthy qi after radiotherapy and chemotherapy for tumors, which is made from the following traditional Chinese medicine raw materials in parts by weight: Astragalus membranaceus 40g, Codonopsis pilosula 30g, Angelica sinensis 30g, Poria cocos 25g, Cistanche deserticola processed with wine 25g, Spatholobus suberectus 25g, Paeonia lactiflora 25g, Ligustrum lucidum processed with wine 25g, Eclipta prostrata 25g, Agrimonia pilosa 25g, Lycium barbarum 25g, Dioscorea opposita stir-fried with bran 25g, Rehmannia glutinosa 25g, Ophiopogon japonicus 30g, Dong'e deer horn glue 15g, Dong'e tortoise shell glue 15g, Citrus reticulata Blanco 10g, Glycyrrhiza uralensis Fisch. processed with honey 10g.

[0049] 2. A preparation method of a traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening healthy qi after radiotherapy and chemotherapy for tumors, comprising the following steps: Weigh Astragalus membranaceus 40g, Codonopsis pilosula 30g, Angelica sinensis 30g, Poria cocos 25g, Cistanche deserticola processed with wine 25g, Spatholobus suberectus 25g, Paeonia lactiflora 25g, Ligustrum lucidum processed with wine 25g, Eclipta prostrata 25g, Agrimonia pilosa 25g, Lycium barbarum 25g, Dioscorea opposita stir-fried with bran 25g, Rehmannia glutinosa 25g, Ophiopogon japonicus 30g, Dong'e deer horn glue 15g, Dong'e tortoise shell glue 15g, Citrus reticulata Blanco 10g, Glycyrrhiza uralensis Fisch. processed with honey 10g according to parts by weight. First, add water 12 times the weight of the Chinese medicinal materials and decoct for 1 hour, filter to obtain a filtrate. Then add water 8 times the weight of the residue and decoct for 0.5 hour, filter to obtain a filtrate. Then add water 8 times the weight of the residue again and decoct for 0.5 hour, filter. Combine the filtrates of the three times and concentrate to obtain the product.

[0050] 3. The thin-layer chromatography identification and content determination methods are the same as those in Example 1.

[0051] Example 3 1. A traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening healthy qi after radiotherapy and chemotherapy for tumors, which is made from the following traditional Chinese medicine raw materials in parts by weight: Astragalus membranaceus 20g, Codonopsis pilosula 15g, Angelica sinensis 15g, Poria cocos 15g, Cistanche deserticola 15g, Spatholobus suberectus 15g, Paeonia lactiflora 15g, Ligustrum lucidum 15g, Eclipta prostrata 15g, Agrimonia pilosa 15g, Lycium barbarum 15g, Dioscorea opposita 15g, Rehmannia glutinosa 15g, Ophiopogon japonicus 15g, deer horn glue 10g, tortoise shell glue 10g, Citrus reticulata Blanco 5g, Glycyrrhiza uralensis Fisch. 5g.

[0052] 2. A preparation method of a traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening healthy qi after radiotherapy and chemotherapy for tumors, comprising the following steps: Take 20 g of Astragalus membranaceus, 15 g of Codonopsis pilosula, 15 g of Angelica sinensis, 15 g of Poria cocos, 15 g of Cistanche deserticola, 15 g of Spatholobus suberectus, 15 g of Paeonia lactiflora, 15 g of Ligustrum lucidum, 15 g of Eclipta prostrata, 15 g of Agrimonia pilosa, 15 g of Lycium barbarum, 15 g of Dioscorea opposita, 15 g of Rehmannia glutinosa, 15 g of Ophiopogon japonicus, 10 g of Cornu cervi colla, 10 g of Plastrum testudinis, 5 g of Citrus reticulata Blanco pericarpium, and 5 g of Glycyrrhiza uralensis Fisch. by weight. Decoct and extract with 10 times the weight of the Chinese medicinal materials for 1 hour for the first time, filter to obtain the filtrate. Add 10 times the amount of water to the filter residue and decoct and extract for 1 hour, filter to obtain the filtrate. Add 8 times the amount of water to the filter residue and decoct and extract for 0.5 hour, filter. Combine the filtrates of the three times and concentrate to obtain the product.

[0053] 3. The TLC identification and content determination methods are the same as those in Example 1.

[0054] Example 4 Experiment on enhancing immune function 1. Experimental method: Take 20 adult rabbits weighing about 2.0 - 2.5 kg, with half males and half females. Randomly divide them into a control group and an observation group. The rabbits in the observation group are only fed with feed. For the observation group: Add the extract prepared by the method of Example 1 of the present invention at a dose of 2 g / Kg to the feed for feeding. Before administration and at the 2nd week and 4th week after administration, each animal is bled from the heart. The anticoagulated blood is used for cell immunity and the separated serum is used for humoral immunity observation experiments.

[0055] 2. Experimental results Mix anti-rabbit IgG serum with buffer agar, pour into a plate and punch holes. Add 10 μl of sample to each hole. Use a mixed serum of 10 normal rabbits as a normal control. Make a standard curve with the reference serum. After adding the sample, measure the diameter of the precipitation circle after 24 hours, and calculate the IgG content according to the standard curve. The specific experimental results are shown in Table 3 below.

[0056] Table 3

[0057] Note: * P<0.05 and **P<0.01 are compared with before administration As can be seen from the experimental results in Table 3, compared with before administration, the IgG content in the serum of rabbits after two weeks of feeding with the extract of the traditional Chinese medicine composition prepared by the present invention has a significant increase (P<0.05), and the increase in IgG content in the serum after four weeks of administration is more obvious (P<0.01). The above experimental results show that the traditional Chinese medicine composition provided by the invention can significantly increase the IgG content in the serum and has a good effect of enhancing immunity.

Claims

1. A traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening the healthy qi after radiotherapy and chemotherapy for tumors, characterized in that, It is made from the following traditional Chinese medicine raw materials: Astragalus membranaceus, Codonopsis pilosula, Angelica sinensis, Poria cocos, Cistanche deserticola, Spatholobus suberectus, Paeonia lactiflora, Ligustrum lucidum, Eclipta prostrata, Agrimonia pilosa, Lycium barbarum, Dioscorea opposita, Rehmannia glutinosa, Ophiopogon japonicus, Cornu cervi colla, Plastrum testudinis, Citrus reticulata Blanco and Glycyrrhiza uralensis Fisch.

2. The traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening healthy qi after tumor radiotherapy and chemotherapy according to claim 1, wherein, It is made from the following traditional Chinese medicine raw materials in parts by weight: Astragalus membranaceus 20 - 80 parts, Codonopsis pilosula 15 - 60 parts, Angelica sinensis 15 - 60 parts, Poria cocos 15 - 45 parts, Cistanche deserticola 15 - 45 parts, Spatholobus suberectus 15 - 45 parts, Paeonia lactiflora 15 - 45 parts, Ligustrum lucidum 15 - 45 parts, Eclipta prostrata 15 - 45 parts, Agrimonia pilosa 15 - 45 parts, Lycium barbarum 15 - 45 parts, Dioscorea opposita 15 - 45 parts, Rehmannia glutinosa 15 - 45 parts, Ophiopogon japonicus 15 - 60 parts, Cornu cervi colla 10 - 30 parts, Plastrum testudinis 10 - 30 parts, Citrus reticulata Blanco 5 - 15 parts, Glycyrrhiza uralensis Fisch. 5 - 15 parts.

3. The traditional Chinese medicine composition for supplementing qi and nourishing blood and strengthening healthy qi after radiotherapy and chemotherapy for tumors according to claim 2, wherein It is made from the following traditional Chinese medicine raw materials in parts by weight: Astragalus membranaceus 40 - 80 parts, Codonopsis pilosula 30 - 60 parts, Angelica sinensis 30 - 60 parts, Poria cocos 30 - 45 parts, Cistanche deserticola 30 - 45 parts, Spatholobus suberectus 30 - 45 parts, Paeonia lactiflora 30 - 45 parts, Ligustrum lucidum 30 - 45 parts, Eclipta prostrata 30 - 45 parts, Agrimonia pilosa 30 - 45 parts, Lycium barbarum 30 - 45 parts, Dioscorea opposita 30 - 45 parts, Rehmannia glutinosa 30 - 45 parts, Ophiopogon japonicus 30 - 60 parts, Cornu cervi colla 15 - 30 parts, Plastrum testudinis 15 - 30 parts, Citrus reticulata Blanco 10 - 15 parts, Glycyrrhiza uralensis Fisch. 10 - 15 parts.

4. The traditional Chinese medicine composition for supplementing qi and nourishing blood and strengthening healthy qi after radiotherapy and chemotherapy for tumors according to claim 3, wherein, It is made from the following traditional Chinese medicine raw materials in parts by weight: Astragalus membranaceus 80 parts, Codonopsis pilosula 60 parts, Angelica sinensis 60 parts, Poria cocos 45 parts, Cistanche deserticola processed with wine 45 parts, Spatholobus suberectus 45 parts, Paeonia lactiflora 45 parts, Ligustrum lucidum processed with wine 45 parts, Eclipta prostrata 45 parts, Agrimonia pilosa 45 parts, Lycium barbarum 45 parts, Dioscorea opposita stir - fried with bran 45 parts, Rehmannia glutinosa 45 parts, Ophiopogon japonicus 60 parts, Cornu cervi colla from Dong'e 30 parts, Plastrum testudinis from Dong'e 30 parts, Citrus reticulata Blanco 15 parts, Glycyrrhiza uralensis Fisch. stir - fried 15 parts.

5. A method for preparing a traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening healthy qi after radiotherapy and chemotherapy for tumors, according to any one of claims 1 to 4, characterized in that, It includes the following steps: Take Astragalus membranaceus, Codonopsis pilosula, Angelica sinensis, Poria cocos, Cistanche deserticola, Spatholobus suberectus, Paeonia lactiflora, Ligustrum lucidum, Eclipta prostrata, Agrimonia pilosa, Lycium barbarum, Dioscorea opposita, Rehmannia glutinosa, Ophiopogon japonicus, Cornu cervi colla, Plastrum testudinis, Citrus reticulata Blanco and Glycyrrhiza uralensis Fisch. according to the parts by weight, add 5 - 20 times the amount of water or ethanol for extraction 1 - 3 times, each time for 0.5 - 2 hours, filter, combine the filtrates, and concentrate to obtain.

6. The preparation method of a traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening healthy qi after tumor radiotherapy and chemotherapy according to claim 5, characterized in that, It includes the following steps: Take Astragalus membranaceus, Codonopsis pilosula, Angelica sinensis, Poria cocos, Cistanche deserticola, Spatholobus suberectus, Paeonia lactiflora, Ligustrum lucidum, Eclipta prostrata, Agrimonia pilosa, Lycium barbarum, Dioscorea opposita, Rehmannia glutinosa, Ophiopogon japonicus, Cornu cervi colla, Plastrum testudinis, Citrus reticulata Blanco and Glycyrrhiza uralensis Fisch. according to the parts by weight, add 10 - 20 times the amount of water for decoction or ethanol reflux, percolation or ultrasonic extraction 1 - 3 times, each time for 0.5 - 2 hours, filter, combine the filtrates, and concentrate to obtain.

7. A detection method for a traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening healthy qi after radiotherapy and chemotherapy for tumors, according to any one of claims 1 to 4, characterized in that, It includes thin - layer chromatography qualitative identification and content determination; The thin - layer chromatography qualitative identification includes the following steps: (1) Preparation of test solution Take the extract of the traditional Chinese medicine composition prepared according to Claim 6, accurately weigh it, put it into a stoppered conical flask, add methanol, seal it, extract it by ultrasonic wave, let it stand at room temperature, filter it through a funnel and filter paper, place the filtrate in an evaporating dish and evaporate it to dryness, dissolve the residue in water, put it into a separating funnel, shake and extract it with n-butanol saturated with water, let it stand, take the upper layer liquid, combine the n-butanol extraction liquid, put it into a separating funnel, shake and wash it with sodium hydroxide solution, let it stand, take the upper layer liquid, place it in an evaporating dish and evaporate the n-butanol extraction liquid to dryness, dissolve the residue in methanol, transfer it to a volumetric flask and make up the volume, let it stand, filter it with a 0.45 μm organic filter head, and put it into a sample vial as the test solution of Yangxue Fuzheng Prescription; (2)Preparation of reference substance solution Respectively take astragaloside IV, lobetyolin and acteoside reference substances, accurately weigh them, put them into a volumetric flask, make up the volume with methanol, and prepare astragaloside IV, lobetyolin and acteoside reference substance solutions respectively; (3)TLC identification (3.1)Identification of astragaloside IV and lobetyolin Respectively suck astragaloside IV reference substance solution, lobetyolin reference substance solution and the test solution of Yangxue Fuzheng Prescription, and spot them on the same silica gel G thin layer plate respectively. Use chloroform-methanol-water as the developing agent, develop, take out, dry in air, spray with sulfuric acid ethanol solution, and heat until the spots are clearly colored; in the test solution chromatogram, at the corresponding positions of the reference substance chromatogram, the spots show the same color under daylight; the fluorescent spots show the same color under ultraviolet light; (3.2)Identification of acteoside Suck acteoside reference substance solution and the test solution of Yangxue Fuzheng Prescription, and spot them on the same polyamide thin layer plate respectively. Use methanol-acetic acid-water as the developing agent, develop, take out, dry in air, and examine under ultraviolet lamp; in the test solution chromatogram, at the corresponding positions of the reference substance chromatogram, the fluorescent spots show the same color.

8. A detection method for a traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening healthy qi after radiotherapy and chemotherapy for tumors, characterized in that, The thin layer chromatography qualitative identification described above includes the following steps (1)Preparation of test solution Take the extract of the traditional Chinese medicine composition prepared according to Claim 6, accurately weigh it, put it into a stoppered conical flask, add 100 mL of methanol, seal it, extract it by ultrasonic wave for 20 - 30 min, let it stand at room temperature for 0.5 - 1 h, filter it through a funnel and filter paper, place the filtrate in an evaporating dish and evaporate it to dryness, dissolve the residue in water, put it into a separating funnel, shake and extract it with n-butanol saturated with water for 2 - 3 times, 30 - 40 mL each time, let it stand for 0.5 - 1 h, take the upper layer liquid, combine the n-butanol extraction liquid, put it into a separating funnel, shake and wash it with 30 - 40 mL of 1 - 5% sodium hydroxide solution for 1 - 3 times, let it stand for 0.5 - 1 h, take the upper layer liquid, place it in an evaporating dish and evaporate the n-butanol extraction liquid to dryness, dissolve the residue in methanol, transfer it to a volumetric flask and make up the volume, let it stand for 0.5 - 1 h, filter it with a 0.45 μm organic filter head, and put it into a sample vial as the test solution of Yangxue Fuzheng Prescription; (2)Preparation of reference substance solution Take 0.00211 g of astragaloside IV reference substance, accurately weigh it, put it into a 10 mL volumetric flask, make up the volume with methanol, and prepare an astragaloside IV reference substance solution with a concentration of 0.211 mg / mL, thus obtaining; Take 0.00225 g of the reference substance of lobetyolin, accurately weigh it, place it in a 10 mL volumetric flask, add methanol to volume, and prepare a reference substance solution of lobetyolin with a concentration of 0.225 mg / mL, thus obtaining; Take 0.00201 g of the reference substance of acteoside, accurately weigh it, place it in a 10 mL volumetric flask, add methanol to volume, and prepare a reference substance solution of acteoside with a concentration of 0.201 mg / mL, thus obtaining; (3)TLC identification (3.1)Identification of astragaloside IV and lobetyolin Respectively pipette 5 μL and 10 μL of the reference substance solution of astragaloside IV, the reference substance solution of lobetyolin, and the test solution of Yangxue Fuzheng Formula onto the same silica gel G thin-layer plate. Use the lower layer solution of chloroform - methanol - water (volume ratio 13﹕7﹕2) placed overnight at below 10°C as the developing agent, develop, take out, dry in air, spray with 10% sulfuric acid ethanol solution, and heat at 105°C until the spots are clearly visible; in the test solution chromatogram, at the positions corresponding to the reference substance chromatogram, the spots show the same color under daylight; and show the same color fluorescence spots under ultraviolet light; (3.2)Identification of acteoside Pipette the reference substance solution of acteoside and the test solution of Yangxue Fuzheng Formula, respectively pipette 5 μL and 10 μL of each solution, and place them on the same polyamide thin-layer plate. Use methanol - acetic acid - water (volume ratio 2∶1∶7) as the developing agent, develop, take out, dry in air, and examine under an ultraviolet lamp; in the test solution chromatogram, at the positions corresponding to the reference substance chromatogram, the fluorescence spots show the same color.

9. The detection method of a traditional Chinese medicine composition for replenishing qi and nourishing blood and strengthening healthy qi after radiotherapy and chemotherapy for tumors, characterized in that, The content determination method described above includes the following steps (1)Preparation of the test solution Take the extract of the traditional Chinese medicine composition prepared in claim 6, accurately weigh it, place it in a stoppered conical flask, add 100 mL of methanol, seal it, ultrasonically extract for 20 - 30 min, let it stand at room temperature for 0.5 - 1 h, filter through a funnel and filter paper, place the filtrate in an evaporating dish and evaporate to dryness, dissolve the residue in water, transfer it to a separating funnel, shake and extract with water-saturated n-butanol for 2 - 3 times, 30 - 40 mL each time, let it stand for 0.5 - 1 h, take the upper layer liquid, combine the n-butanol extracts, place it in a separating funnel, shake and wash with 30 - 40 mL of 1 - 5% sodium hydroxide solution for 1 - 3 times, let it stand for 0.5 - 1 h, take the upper layer liquid, place it in an evaporating dish and evaporate the n-butanol extract to dryness, dissolve the residue in methanol, transfer it to a volumetric flask and make up the volume, let it stand for 0.5 - 1 h, filter with a 0.45 μm organic filter head, and place it in an injection vial as the test solution of Yangxue Fuzheng Formula; (2)Preparation of the reference substance solution Accurately weigh the reference substances of acteoside, lobetyolin, nobiletin, and formononetin, place them in a volumetric flask, add methanol to the scale and shake well to prepare a mixed reference substance solution containing 0.0603 mg / mL of acteoside, 0.2302 mg / mL of lobetyolin, 0.201 mg / mL of nobiletin, and 0.0742 mg / mL of formononetin; (3)Respectively pipette the reference substance solution and the test solution into a high performance liquid chromatograph, and determine the contents of acteoside, lobetyolin, nobiletin, and formononetin in the test sample according to the external standard single point method; The liquid chromatography conditions for step (3) described above are: Chromatographic column: Purospher STAR LP RP-18 endcapped, mobile phase: acetonitrile and 0.1% phosphoric acid aqueous solution, gradient elution, diode array detector, detection wavelength: 245 nm, column temperature 30 °C, flow rate 1.0 mL / min, injection volume: 10 μL, the gradient elution program is as follows: 。 10. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of an adjuvant drug for treating after tumor radiotherapy and chemotherapy.

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