Composition for repairing immune injury as well as preparation method and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a composition for repairing immune injury and a preparation method and application thereof. The invention provides a composition for repairing immune injury. The composition comprises the following raw materials in parts by weight: 10-20 parts of astragalus membranaceus, 1-4 parts of schisandra chinensis, 2-6 parts of ginseng, 2-6 parts of radix ophiopogonis, 2-6 parts of pericarpium citri reticulatae, 2-6 parts of semen armeniacae amarae and 2-6 parts of angelica sinensis. The composition promotes immune recovery of mice with immune injury after chemotherapy and recovers the number of immune cells and bone marrow cells, so that the composition can be used for repairing immune injury caused by chemotherapy, and has good prospects in the aspects of preparation of drugs for regulating immunity or repairing immune injury and preparation of health-care foods beneficial to enhancing immunity.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a composition for repairing immune damage, its preparation method, and its uses. Background Technology

[0002] Chemotherapy is a common treatment for cancer, but while killing cancer cells, it also damages normal cells and the immune system. Damage to immune cells, in particular, leads to decreased immunity, increased risk of infection, and negatively impacts treatment effectiveness and quality of life. With the deepening research into the integration of traditional Chinese and Western medicine in cancer treatment, the role of traditional Chinese medicine in repairing chemotherapy-induced immune damage is receiving increasing attention. Modern pharmacological studies have shown that the active ingredients in traditional Chinese medicine can repair chemotherapy-induced immune damage through multiple mechanisms. Further research into the active ingredients and mechanisms of action of traditional Chinese medicine will clarify its role in tumor immunotherapy, potentially providing cancer patients with safer and more effective treatment options.

[0003] Although existing research has shown that single Chinese herbs or simple combinations thereof can regulate immune responses or repair immune damage caused by chemotherapy, the complexity of the active ingredients and mechanisms of action of Chinese herbs makes them difficult to fully analyze and explain using current technologies. Furthermore, the complexity of Chinese herbal combinations significantly impacts therapeutic efficacy. Therefore, how to scientifically combine Chinese herbal components based on their primary and secondary relationships to achieve the desired therapeutic effect is a major challenge currently facing the research field. Summary of the Invention

[0004] To address the problems of existing technologies, this invention provides a composition for repairing immune damage, its preparation method, and its uses.

[0005] This invention provides a composition comprising the following raw materials in parts by weight:

[0006] Astragalus membranaceus 10-20 parts, Schisandra chinensis 1-4 parts, Ginseng 2-6 parts, Ophiopogon japonicus 2-6 parts, Citrus reticulata 2-6 parts, Prunus armeniaca 2-6 parts, Angelica sinensis 2-6 parts.

[0007] Preferably, the composition comprises the following raw materials in parts by weight:

[0008] Astragalus membranaceus 15 parts, Schisandra chinensis 2 parts, Ginseng 3 parts, Ophiopogon japonicus 3 parts, Citrus reticulata 3 parts, Prunus armeniaca 3 parts, Angelica sinensis 3 parts.

[0009] The present invention provides a method for preparing the composition, which includes the following steps:

[0010] Step 1: Weigh out the raw materials astragalus, schisandra, ginseng, ophiopogon japonicus, tangerine peel, bitter almond and angelica according to the proportions;

[0011] Step 2: Boil the raw materials with water to obtain the final product.

[0012] Preferably, the decocting is performed 1-2 times.

[0013] Preferably, the process of adding water and decocting includes: adding 10 times the volume of water for the first time and decocting for 30-40 minutes; adding 8 times the volume of water for the second time and decocting for 30-40 minutes.

[0014] This invention provides the use of the composition in the preparation of medicaments for regulating immunity and / or repairing immune damage.

[0015] Preferably, the immune injury is chemotherapy-induced immune injury.

[0016] Preferably, the chemotherapy is paclitaxel treatment.

[0017] The present invention provides the use of the composition in the preparation of health food products that help enhance immunity.

[0018] The present invention provides a drug formulation which uses the composition as the active ingredient and adds pharmaceutically acceptable excipients or auxiliary ingredients.

[0019] Preferably, the preparation is a decoction, paste, granule, capsule, tablet, syrup, or pill.

[0020] The present invention also provides a health food product, which is obtained by adding excipients or auxiliary ingredients acceptable in the field of health food, with the composition as the active ingredient.

[0021] This invention provides the following explanation: Astragalus membranaceus is used in large quantities to replenish the Qi of the lungs and spleen, thus nourishing the source of Qi and blood. Combined with Angelica sinensis, it replenishes both Qi and blood, promoting the flow of Qi and blood, and ensuring the smooth circulation of Ying and Wei Qi. This embodies the principle that "tangible blood cannot be quickly generated, but intangible Qi must be urgently consolidated," and together they serve as the principal herbs. Ginseng is used as the assistant herb, greatly replenishing the original Qi and assisting the spleen and lungs to enhance its Qi-replenishing function. Ophiopogon japonicus nourishes Yin and generates fluids, while Schisandra chinensis astringes lung Qi, thus both replenishing Qi and Yin, ensuring the pulse is full, and implicitly embodying the principle of "generating the pulse." The meaning of "the formula" is to replenish qi and blood, and it can also be combined with angelica to astringe the pungent and drying properties of astragalus to prevent the heavy use of astragalus from damaging yin and depleting blood. Bitter almond promotes the downward movement of lung qi, and tangerine peel promotes qi circulation and dries dampness to smooth the middle jiao. This can make the whole formula replenish without stagnation, promote qi and blood circulation, help the depleted qi to rise, and allow the damaged blood to flow back. When the ying and wei are restored and the original qi is at peace, the essence can also be nourished and restored. Together, they serve as adjuvant and guiding herbs. In the end, the whole formula works together to replenish qi and blood, nourish yin and restore pulse.

[0022] Cancer patients already have insufficient vital energy due to the invasion of cancer cells, and chemotherapy further disrupts this energy. Therefore, cancer patients are in a state of severe deficiency of vital energy after chemotherapy. Treatment should focus on protecting vital energy while avoiding excessive nourishment, so as not to hinder the flow of qi and affect the distribution of essential nutrients. This formula heavily utilizes Astragalus membranaceus to replenish Qi and strengthen the exterior, combined with Angelica sinensis to promote the rise of Yang and the growth of Yin, nourishing blood and strengthening the defensive Qi. This helps the heart and lungs replenish and circulate Qi and blood, restoring the defensive Qi's fullness and ability to ward off pathogens. This embodies the principle that "tangible blood cannot be quickly generated, but intangible Qi must be urgently strengthened." Ginseng greatly replenishes the original Qi and nourishes the five internal organs, Ophiopogon japonicus nourishes Yin and generates fluids, and Schisandra chinensis consolidates fluids and astringes Qi, preventing the leakage of Qi and fluids, thus implying "blood generation." It also works with Angelica sinensis to astringe the pungent and dispersing properties of Astragalus membranaceus, preventing damage to Yin and blood. Bitter almond promotes the downward movement of lung Qi, while tangerine peel regulates Qi, strengthens the spleen, and dredges body fluids. This ensures the smooth flow of Qi, blood, fluids, and body fluids throughout the formula, replenishing without stagnation. This allows the dissipated Qi to rise, the damaged blood to flow back, the Ying and Wei Qi to be restored, and the original Qi to be at peace. The entire formula focuses on tonification, taking into account both Yin and Yang, and integrating tonification with circulation. This ensures that tonification is not stagnant and circulation is not harmful, achieving the effect of gently replenishing the body's vital energy and restoring its strength.

[0023] Beneficial effects: This invention provides a composition for repairing immune damage, which promotes immune recovery in mice after chemotherapy, restores the number of immune cells and bone marrow cells, and improves the indices of immune organs such as the spleen and thymus, thereby repairing immune damage caused by chemotherapy. It has great promise in the preparation of drugs that regulate immunity or repair immune damage, as well as in the preparation of health foods that help enhance immunity.

[0024] Obviously, based on the above description of the present invention, and according to common technical knowledge and conventional methods in the field, various other modifications, substitutions or alterations can be made without departing from the basic technical concept of the present invention.

[0025] The following detailed embodiments further illustrate the above-described content of the present invention. However, this should not be construed as limiting the scope of the present invention to the following examples. All technologies implemented based on the above-described content of the present invention fall within the scope of the present invention. Attached Figure Description Detailed Implementation

[0026] In the following examples and experimental cases, reagents and raw materials not specifically described are all commercially available products.

[0027] Example 1: A composition for repairing immune damage

[0028] This embodiment provides a composition for repairing chemotherapy-induced immune damage, with the following formulation:

[0029] Astragalus membranaceus 30g, Schisandra chinensis 4g, Ginseng 6g, Ophiopogon japonicus 6g, Citrus reticulata peel 6g, Prunus armeniaca 6g, Angelica sinensis 6g, total 64g.

[0030] The preparation method includes the following steps:

[0031] Weigh the above-mentioned raw materials according to the formula, grind them into the coarsest powder, and decoct them twice. For the first decoction, soak them in 10 times the amount of water for 1 hour, decoct for 40 minutes, filter, add 8 times the amount of water to the residue, decoct for 40 minutes, filter, combine the filtrates, and concentrate for later use.

[0032] In other embodiments, the simmering time can be adjusted within the range of 30 to 40 minutes each time.

[0033] Comparative Example 1 Composition

[0034] Formula: Astragalus membranaceus 53.3g, Angelica sinensis 10.7g, total 64g.

[0035] The preparation method is the same as in Example 1.

[0036] Comparative Example 2 Composition

[0037] Formula: Schisandra chinensis 9.2g, ginseng 13.7g, Ophiopogon japonicus 13.7g, tangerine peel 13.7g, bitter almond 13.7g, total 64g.

[0038] The preparation method is the same as in Example 1.

[0039] The difference in formulation between Example 1 and Comparative Examples 1-2 is as follows:

[0040] (1) The formula of Example 1 is based on the control example 1, with the addition of Schisandra chinensis, ginseng, Ophiopogon japonicus, tangerine peel and bitter almond.

[0041] (2) The formula of Example 1 is based on the control example 2, with the addition of Astragalus membranaceus and Angelica sinensis.

[0042] The following experimental examples demonstrate the beneficial effects of the present invention.

[0043] Experimental Example 1: Composition for Repairing Chemotherapy-Induced Immune Damage

[0044] I. Experimental Materials

[0045] The test drugs were the compositions prepared in Example 1, Control Example 1, and Control Example 2. All the Chinese medicinal materials contained in the compositions were purchased from Sichuan Xinhehua Traditional Chinese Medicine Pieces Co., Ltd. Granulocyte colony-stimulating factor (G-CSF, batch number: C002) was used as a positive control, and paclitaxel (paclitaxel, catalog number: 33069-62-4) was used to establish a chemotherapy-induced immune injury model. The experimental animals were SPF-grade 7-week-old female BALB / c mice (weighing 19±1g), purchased from Speford (Beijing) Biotechnology Co., Ltd. II. Experimental Methods

[0046] Animal pharmacodynamic experiments

[0047] Mice were first given an acclimatization diet for one week. Then, mice were administered the corresponding extracts via gavage to the mice in Examples 1, 1, and 2. The normal control group, PTX model control group, and positive control group were administered the same volume of physiological saline via gavage. From days 11 to 13, concurrently with the gavage administration, the PTX model control group, Examples 1, 1, 2, and positive control group were intraperitoneally injected with paclitaxel at a dose of 25 mg / kg / day for three consecutive days to establish a mouse model of chemotherapy-induced immune damage. The normal control group received the same volume of solvent. Simultaneously, the positive control group was intraperitoneally injected with G-CSF at a dose of 100 μg / kg / day from days 11 to 14. To investigate the immune-improving effect of this composition on mice with chemotherapy-induced immune damage, complete blood counts, bone marrow cell counts, and thymus and spleen indices were measured.

[0048] (1) Blood cell count detection

[0049] Approximately 50 μL of blood was collected from the mandibular vein of mice and placed in a 1.5 mL EP tube containing anticoagulant. The number of various blood cells was detected using an animal blood cell analyzer.

[0050] (2) Bone marrow cell count detection

[0051] Under aseptic conditions, the hind limbs of mice were harvested, and the femur and tibia were separated after muscle removal (one femur and one tibia from each mouse). The cartilage at both ends was removed to expose the medullary cavity. The cells were slowly rinsed with PBS until the bones turned white. The rinsing fluid was collected, centrifuged at 1000 rpm for 4 min at 4°C, and the supernatant was discarded. 1 mL of erythrocyte lysis buffer was added to lyse the erythrocytes for 2 min. Lysis was terminated by adding 400 μL of DMEM medium. The cell clumps were dispersed and filtered through a 70 μm sieve. The cells were centrifuged at 1000 rpm for 4 min at 4°C, and the supernatant was discarded. Finally, the cells were resuspended in 1 mL of PBS and counted.

[0052] (3) Organ index: Take the spleen and thymus of mice, wash the surface blood stains with pre-cooled PBS, absorb the surface moisture with filter paper, weigh the organs of each group, and calculate the organ index (organ weight / mouse body weight).

[0053] (4) Statistical analysis was performed using GraphPad Prism 10.1.2 software. Variables were expressed as mean ± standard deviation. The results were obtained using one-way ANOVA, with *p<0.05, **p<0.01, ***p<0.001, and ****p<0.0001.

[0054] III. Experimental Results

[0055] 1. Hematological and bone marrow examination results

[0056] The results are shown in Table 1. The results indicate that paclitaxel (PTX) treatment successfully established a mouse model of immune damage following chemotherapy, characterized by a significant decrease in the number of peripheral blood leukocytes and lymphocytes, accompanied by a reduction in the total number of bone marrow cells, suggesting significant suppression of hematopoietic function. After intervention with the composition described in Example 1, all of the above indicators were significantly improved, indicating that the composition can alleviate PTX-induced immune damage and promote the recovery of hematopoiesis and immune function. Moreover, the improvement effect of the composition described in Example 1 was superior to that of the compositions in Comparative Example 1 or Comparative Example 2 at the same dosage, demonstrating that the principal drug and other components have a synergistic effect in repairing immune damage.

[0057] All data were analyzed using GraphPad Prism 10.1.2 software. Differences between groups were analyzed using one-way ANOVA, with significance levels set at *p<0.05, **p<0.01, ***p<0.001, and ****p<0.0001; # indicates comparison with the blank control group, and * indicates comparison with the PTX model group.

[0058] Table 1. Effects of the composition on immune cells and hematopoietic cells in mice with paclitaxel-induced immune injury ( n=6)

[0059] Group <![CDATA[White blood cell count (x10 9 / L)]]> <![CDATA[Number of lymphocytes (x10 9 / L)]]> <![CDATA[Bone marrow cell count (x10 6 / mL)]]> Blank control group 7.02±1.44 5.55±1.28 2.59±0.51 PTX model control group <![CDATA[4.47±1.54 ## ]]> <![CDATA[3.25±1.38 ## ]]> <![CDATA[1.76±0.66 ### ]]> Positive control group 15.3±2.01**** 4.72±0.92 2.96±0.22**** Example 1 8.93±1.28**** 7.33±1.05**** 3.1±0.29**** Comparative Example 1 7.40±2.00** 5.87±1.62** 2.62±0.24*** Comparative Example 2 6.83±1.04* 6.10±1.24*** 2.46±0.15**

[0060] Note: Compared with the blank control group ## This indicates that p < 0.01. ### * indicates p < 0.001; compared with the model control group, * indicates p < 0.05, ** indicates p < 0.01, *** indicates p < 0.001, and **** indicates p < 0.0001.

[0061] The results above show that the composition of the present invention can exert a significant immune recovery effect, and the principal drug and other components produce a synergistic effect.

[0062] 2. Results of thymus and spleen index tests

[0063] The spleen, as an important peripheral immune organ, is a crucial storage and activation site for immune cells such as B cells and T cells; the thymus, on the other hand, is a key central immune organ for T cell differentiation and maturation. Both play a vital role in maintaining immune homeostasis.

[0064] The results are shown in Table 2. After paclitaxel modeling, the thymus and spleen indices decreased significantly, indicating that chemotherapy caused atrophy of immune organs and impaired immune function; the composition treatment in Example 1 significantly restored the spleen and thymus indices, indicating that it has the effect of improving chemotherapy-induced immunosuppression and promoting the repair of immune organs.

[0065] Moreover, the composition described in Example 1 was more effective than the compositions of Comparative Example 1 or Comparative Example 2 at the same dosage in repairing the spleen index and thymus index, demonstrating that the principal drug and other components have a synergistic effect in repairing immune damage.

[0066] Table 2 Effects of the composition on paclitaxel-induced immune organs ( n=6)

[0067] Group Spleen index (mg / g) Thymus index (mg / g) Blank control group 4.87±0.31 2.51±0.446 PTX model control group <![CDATA[4.12±0.68 ## ]]> <![CDATA[0.93±0.30 #### ]]> Positive control group <![CDATA[6.48±0.60 **** ]]> 1.10±0.30 Example 1 <![CDATA[4.97±0.29 ** ]]> <![CDATA[1.47±0.60 * ]]> Comparative Example 1 <![CDATA[4.85±0.49 * ]]> 1.07±0.22 Comparative Example 2 3.93±0.24 1.34±0.29

[0068] Note: Compared with the blank control group ## This indicates that p < 0.01. #### * indicates p < 0.0001; compared with the model control group, * indicates p < 0.05, ** indicates p < 0.01, *** indicates p < 0.001, and **** indicates p < 0.0001.

[0069] The above results indicate that the principal drug and other components of the composition of the present invention have a synergistic effect, which can promote the immune recovery of mice with immune damage after chemotherapy, restore the number of immune cells and bone marrow cells, regulate spleen index and thymus index, thereby repairing immune damage caused by chemotherapy.

[0070] The results of the above embodiments and comparative examples show that the present invention provides a composition for repairing immune damage, comprising the following raw materials in parts by weight: 10-20 parts Astragalus membranaceus, 1-4 parts Schisandra chinensis, 2-6 parts Panax ginseng, 2-6 parts Ophiopogon japonicus, 2-6 parts Citrus reticulata peel, 2-6 parts Prunus armeniaca, and 2-6 parts Angelica sinensis. This composition can significantly promote the recovery of immune function in mice with immune damage after chemotherapy, manifested by an increase in the number of immune cells and bone marrow cells, and a return to normal spleen and thymus indices, thereby effectively repairing immune damage caused by chemotherapy. This composition has broad application prospects in the preparation of drugs for regulating immune function or repairing immune damage, as well as in the development of health foods that enhance immunity.

Claims

1. A composition, characterized in that, The ingredients include the following parts by weight: Astragalus membranaceus 10-20 parts, Schisandra chinensis 1-4 parts, Ginseng 2-6 parts, Ophiopogon japonicus 2-6 parts, Citrus reticulata 2-6 parts, Prunus armeniaca 2-6 parts, Angelica sinensis 2-6 parts.

2. The composition according to claim 1, characterized in that, The ingredients include the following parts by weight: Astragalus membranaceus 15 parts, Schisandra chinensis 2 parts, Ginseng 3 parts, Ophiopogon japonicus 3 parts, Citrus reticulata 3 parts, Prunus armeniaca 3 parts, Angelica sinensis 3 parts.

3. The method for preparing the composition according to claim 1, characterized in that, Includes the following steps: Step 1: Weigh out the raw materials astragalus, schisandra, ginseng, ophiopogon japonicus, tangerine peel, bitter almond and angelica according to the proportions; Step 2: Boil the raw materials with water to obtain the final product.

4. Use of the composition of claim 1 in the preparation of a medicament for regulating immunity and / or repairing immune damage.

5. The use according to claim 4, characterized in that: The immune damage mentioned refers to immune damage caused by chemotherapy.

6. The use according to claim 5, characterized in that: The chemotherapy was paclitaxel treatment.

7. Use of the composition of claim 1 in the preparation of a health food that helps enhance immunity.

8. A medicament comprising a formulation having the composition of claim 1 as the active ingredient and the addition of pharmaceutically acceptable excipients or auxiliary ingredients.

9. The medicament according to claim 8, characterized in that: The preparations include decoctions, ointments, granules, capsules, tablets, syrups, and pills.

10. A health food product, which is obtained by adding excipients or auxiliary ingredients acceptable in the field of health food products, using the composition of claim 1 as the active ingredient.