Medicinal composition of plant aromatic essential oil and application of medicinal composition

By preparing plant aromatic essential oil pharmaceutical compositions containing β-caryophyllene, α-curtaine and caryophyllene oxide, the toxic and side effects of existing anti-tumor treatment methods are solved, and effective anti-tumor effects and immune regulation are achieved.

CN119868333APending Publication Date: 2025-04-25SHANGHAI INST OF PHARMA IND CO LTD +1
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Patent Information

Application Number
CN202311384280.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2023-10-24
Publication Date
2025-04-25

AI Technical Summary

Technical Problem

Existing anti-tumor treatment methods such as chemotherapy drugs have toxic side effects, and the synergistic effect of plant aromatic essential oils in anti-tumor applications has not been fully utilized.

Method used

A plant aromatic essential oil pharmaceutical composition is prepared, comprising beta-caryophyllene, alpha-curedene and caryophyllene oxide, and extracted by steam distillation and vapor phase separation method.

Benefits of technology

This pharmaceutical composition has a synergistic effect, can effectively inhibit tumor growth, reduce the secretion of inflammatory factors, increase the ratio of immune cells, have good anti-tumor effects and reduce toxic side effects.

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Abstract

The invention discloses a pharmaceutical composition of plant aromatic essential oil and application of the pharmaceutical composition. The invention provides a pharmaceutical composition. The pharmaceutical composition comprises beta-caryophyllene, alpha-humulene and caryophyllene oxide. The pharmaceutical composition provided by the invention can improve abnormal expression of inflammatory factors caused by tumors, inhibit release of inflammatory mediators, and play an anti-tumor role by regulating immunity.
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Description

Technical Field

[0001] The invention belongs to the field of biomedicine, and specifically relates to the preparation and anti-tumor application of a medicinal composition of aromatic essential oil. Background Art

[0002] Malignant tumors have always been a potential killer of human life and the main cause of death in China and developed countries, seriously endangering people's physical and mental health. At present, the global incidence and mortality of cancer are still growing rapidly. According to data released by the United Nations, there were about 19.3 million new cases of cancer in 2020 worldwide, including nearly 10 million cancer deaths. Among them, breast cancer replaced lung cancer as the most common cancer in the world, while lung cancer is still the main cause of cancer death.

[0003] Regarding the treatment of cancer, there are mainly radiotherapy, surgical treatment, chemotherapy, immunotherapy, etc. Among them, chemotherapy is an important means of anti-tumor treatment, and other treatment methods are often combined with chemotherapy to exert anti-tumor effects. While chemotherapy drugs produce good therapeutic effects, they also have a series of toxic side effects on the human body, mainly manifested in liver and kidney damage, cardiac toxicity, bone marrow suppression, nervous system damage, and tumor resistance.

[0004] A large number of in vitro cell molecular experiments have reported that the terpene components in many plant essential oils have certain anti-inflammatory immune activities and are considered to be useful for anti-tumor activities. From Zhu Liyun's review, it can be seen that the anti-tumor activities of more than 19 plant essential oils have been reported, such as lemongrass, sage, lavender, etc., among which limonene, menthol, β-elemene, etc. may be the main active ingredients. Among them, limonene limonene has an inhibitory effect on cancer cells such as colon cancer, breast cancer, gastric cancer, and skin cancer; β-elemene may inhibit gastric cancer cells, breast cancer cells, and hepatic stellate cells through the ERK signaling pathway Ras / MARK / ERK signaling pathway and ANGII receptor antagonism. Summary of the invention

[0005] The technical problem solved by the present invention is to provide a plant essential oil pharmaceutical composition and its application. The plant essential oil of the present invention contains active substances β-caryophyllene, α-humulene and caryophyllene oxide. Further, the plant essential oil of the present invention has one or more of the following advantages: the plant essential oil has a synergistic effect, has an anti-tumor effect, and has a good application prospect.

[0006] The present invention solves the above-mentioned problems through the following technical solutions.

[0007] The present invention provides a pharmaceutical composition A, comprising: β-caryophyllene, α-humulene and caryophyllene oxide.

[0008] In some embodiments, the pharmaceutical composition A further comprises one or more of (-)-humulene epoxide II, α-bisabolol and (+)-delta-cadinene, cnidium-3,7(11)-diene, γ-ylang-ylangolene, hordein, β-serene, α-bergamotene, and bergamotene oxide.

[0009] In some embodiments, in the pharmaceutical composition A, the content of β-caryophyllene is preferably 10-35%; more preferably 15-30%; for example 26.49%.

[0010] In the pharmaceutical composition A, the content of α-humulene is preferably 5-20%, more preferably 10-15%, for example 12.11%.

[0011] In the pharmaceutical composition A, the content of caryophyllene oxide is preferably 8-20%, more preferably 10-15%, for example 11.65%.

[0012] In the pharmaceutical composition A, the content of the (-)-humulene epoxide II is preferably 3-5%, for example 3.76%.

[0013] In the pharmaceutical composition A, the content of α-bisabolol is preferably 2-5%, for example 3.27%.

[0014] In the pharmaceutical composition A, the content of (+)-δ-cadinene is preferably 2-5%, for example 3.24%.

[0015] In the pharmaceutical composition A, the content of cnidium monnieri-3,7(11)-diene is preferably 2-5%, for example 3.07%.

[0016] In the pharmaceutical composition A, the content of γ-ylang-ylangolene is preferably 2-4%, for example 2.91%.

[0017] The hordein content is preferably 2-4%, for example 2.83%.

[0018] The β-surene content is preferably 2-4%, for example 2.44%.

[0019] The α-bergamotene content is preferably 2-4%, for example 2.37%.

[0020] The content of bergamot oxide is preferably 1-3%, for example 1.88%.

[0021] In some embodiments, the pharmaceutical composition A satisfies one or more of the following:

[0022] (1) The active ingredients of the pharmaceutical composition A are derived from plant essential oils;

[0023] (2) The plant is industrial hemp flowers and leaves;

[0024] (3) The active ingredients of the pharmaceutical composition A are mainly sesquiterpenoid compounds.

[0025] In some embodiments, the active ingredients of the pharmaceutical composition A consist of active substances β-caryophyllene, α-humulene and caryophyllene oxide.

[0026] In some embodiments, the active ingredients of the pharmaceutical composition A include β-caryophyllene, α-humulene and caryophyllene oxide, (-)-humulene epoxide II, α-bisabolol and (+)-delta-cadinene, cnidium-3,7(11)-diene, γ-ylang-ylangolene, hordein, β-thurene, α-bergamotene and bergamotene oxide.

[0027] In some embodiments, the pharmaceutical composition A is prepared by the following method, which comprises the following steps: (1) extracting and collecting volatile oil from industrial hemp flower and leaf powder by steam distillation;

[0028] (2) The collected volatile oil is subjected to gas phase separation to obtain the pharmaceutical composition A.

[0029] Preferably, the solvent of the steam distillation method is water.

[0030] The distillation temperature of the steam distillation method is 150°C to 170°C; for example, 160°C.

[0031] The gas phase chromatographic column is a HP-5MSUI column.

[0032] The injection port temperature of the gas phase is 200°C to 280°C, for example 250°C.

[0033] The gas phase chromatographic column flow rate is 0.8 ml / min to 12 ml / min, for example 1 ml / min.

[0034] The gas phase chromatographic column split ratio is 1:1 to 3:1, for example 2:1.

[0035] More preferably, the gas phase is programmed to heat, and the method of programmed heating is preferably: initial temperature 60°C, maintained for 2 minutes; increased to 110°C at 20°C / min; then increased to 160°C at 2°C / min, maintained for 1 minute; and then increased to 280°C at 20°C / min, maintained for 3 minutes.

[0036] The present invention also provides a pharmaceutical composition B, characterized in that it comprises the aforementioned pharmaceutical composition A and an active substance Y.

[0037] In some embodiments, the active substance Y is paclitaxel.

[0038] In some embodiments, the pharmaceutical composition B satisfies one or more of the following conditions:

[0039] (1) In the pharmaceutical composition B, the content of the pharmaceutical composition A is 20 mg / kg to 150 mg / kg; preferably 25 mg / kg, 50 mg / kg or 100 mg / kg;

[0040] (2) The mass ratio of the pharmaceutical composition A to the active substance Y is 3:1 to 6:1; preferably 5:1 or 5:2;

[0041] (3) In the pharmaceutical composition B, the active ingredients consist of the pharmaceutical composition A and the active substance Y;

[0042] (4) In the pharmaceutical composition B, the pharmaceutical composition A and the active substance Y are administered simultaneously or separately.

[0043] The present invention also provides a use of the pharmaceutical composition A or the pharmaceutical composition B as described above in the preparation of a drug, wherein the drug is used to inhibit tumor growth or to treat and / or prevent cancer.

[0044] In some embodiments, the medicament is for treating and / or preventing thymic atrophy.

[0045] In some embodiments, the medicament is for treating and / or preventing an enlarged spleen.

[0046] In some embodiments, the drug is used to increase the level of CD4+, CD8+ T cells.

[0047] In some embodiments, the drug is used to increase the CD4+ / CD8+ T cell ratio.

[0048] In some embodiments, the medicament is for immunomodulation.

[0049] In some embodiments, the medicament is for reducing the secretion of inflammatory cytokines.

[0050] In some embodiments, the cancer may be lung cancer.

[0051] In some embodiments, the thymic atrophy may be caused by cancer.

[0052] In some embodiments, the enlarged spleen may be caused by cancer.

[0053] In some embodiments, the treatment and / or prevention of tumors is by reducing the secretion of inflammatory cytokines.

[0054] In some embodiments, the proinflammatory cytokine may be one or more of IL-6 and TNF-α.

[0055] The present invention also provides a use of the above-mentioned pharmaceutical composition A or pharmaceutical composition B in the preparation of an inhibitor, wherein the inhibitor is used to inhibit the expression of inflammatory factors.

[0056] In some embodiments, the proinflammatory cytokine may be one or more of IL-6 and TNF-α.

[0057] As used herein, the term "treat" refers to therapeutic treatment. When referring to a specific condition, treatment means: (1) ameliorating one or more biological manifestations of the disease or condition, (2) interfering with (a) one or more points in the biological cascade that leads to or causes the condition.

[0058] The term "pharmaceutical composition" as used herein refers to a composition containing specified active ingredients that can be prepared into the same dosage form.

[0059] The term "subject" as used herein refers to any animal that is about to or has been administered the compound or composition according to the embodiments of the present invention, preferably a mammal, and most preferably a human. As used herein, the term "mammal" includes any mammal. Examples of mammals include, but are not limited to, cattle, horses, sheep, pigs, cats, dogs, mice, rats, rabbits, guinea pigs, monkeys, humans, etc., with humans being the most preferred.

[0060] On the basis of being in accordance with the common sense in the art, the above-mentioned preferred conditions can be arbitrarily combined to obtain the preferred embodiments of the present invention.

[0061] Unless otherwise specified, the reagents and raw materials used in the present invention are commercially available.

[0062] The positive and progressive effects of the present invention are: the present invention provides a new plant aromatic oil pharmaceutical composition obtained from industrial hemp and having multiple active substances. Furthermore, the pharmaceutical composition of the present invention has one or more of the following advantages: (1) the pharmaceutical composition has a synergistic effect; (2) it can be used to inhibit tumor growth; (3) it inhibits tumor growth by inhibiting the secretion of inflammatory factors; (4) it has no cytotoxicity to cancer cells; and (5) it has good application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] Figure 1 Total ion current obtained by GC-MS analysis of industrial hemp volatile oil

[0064] Figure 2 This is the tumor growth curve of lung cancer-bearing mice after administration of industrial hemp volatile oil

[0065] Figure 3Effect of industrial hemp volatile oil on the level of inflammatory factor IL-6 in lung cancer-bearing mice

[0066] Figure 4 Effect of industrial hemp volatile oil on the level of inflammatory factor TNF-α in lung cancer-bearing mice DETAILED DESCRIPTION

[0067] The present invention is further described below by way of examples, but the present invention is not limited to the scope of the examples. The experimental methods in the following examples without specifying specific conditions are carried out according to conventional methods and conditions, or selected according to the product specifications.

[0068] Example 1 Preparation method of industrial hemp volatile oil

[0069] Weigh industrial hemp flower and leaf powder (raw materials provided by Yunnan Hangu Biotechnology Co., Ltd.), place it in a round-bottom flask, add pure water at a solid-liquid ratio of 8 mg / L, set the electric heating mantle to heat at 160°C and extract by steam distillation for 5 hours, collect the volatile oil, and store it in a sealed, light-proof refrigerator at 4°C.

[0070] Example 2 GC-MS analysis of industrial hemp volatile oil

[0071] Chromatography-mass spectrometry conditions: HP-5MS UI column (0.250mm×30m×0.25μm); carrier gas is high-purity helium; direct injection; injection port temperature is 250℃; transfer line temperature is 260℃; column flow rate is 1ml / min; split ratio is 2:1, ionization mode is EI, scanning range (m / z) is 50-600, and acquisition mode is full scan mode. The program temperature rise method is: initial temperature is 60℃, maintained for 2min; increased to 110℃ at 20℃ / min; then increased to 160℃ at 2℃ / min, maintained for 1min; then increased to 280℃ at 20℃ / min, maintained for 3min.

[0072] Total ion current ( Figure 1 ) were compared with reference substances and searched in the NIST database to identify the chemical components. The main components are shown in Table 1, accounting for 76% of the total peak area.

[0073] Table 1 Main chemical components of industrial hemp volatile oil

[0074]

[0075] Example 3 Study on the anti-tumor effect of industrial hemp volatile oil

[0076] (1) Lewis lung cancer cells (derived from the Pharmacological Evaluation Research Center of China Pharmaceutical Industry Research Institute) were cultured in DMEM complete medium (DMEM high glucose medium + 10% FBS + 1% double antibody) and placed in a constant temperature incubator (37°C, 5% CO 2 ) and change the medium regularly.

[0077] (2) 70 SPF C57BL / 6 mice weighing 18-22 g (purchased from Shanghai Shengchang Biotechnology Co., Ltd.) were selected for 1 week of adaptive feeding (temperature 20-28°C, light-dark cycle 12 h). After one week, 10 mice were randomly selected as the control group: blank control group.

[0078] (3) Modeling: Adjust the cell concentration to 2×10 7 60 C57BL / 6 mice were selected and inoculated with 0.2 mL of cell suspension in the right forelimb axilla after disinfection.

[0079] (4) Grouped drug administration: 24 hours after cell inoculation, the mice were randomly divided into 6 groups, which were marked as model control group, Model: lung cancer model group, 0.2 ml of 3% Tween 80 saline, ip, once a day; PTX-L: paclitaxel 5 mg / kg, ip, once every 3 days; PTX-H: paclitaxel 10 mg / kg, ip, once every 3 days; HEO-L: industrial hemp volatile oil 25 mg / kg, ip, once a day; HEO-M: industrial hemp volatile oil 50 mg / kg, ip, once a day; HEO-H: industrial hemp volatile oil group 100 mg / kg, ip, once a day. Drug treatment lasted for two weeks.

[0080] The relative volume of the tumor was recorded from the 7th day after inoculation, and the tumor growth curve was drawn. Figure 2 :

[0081] Tumor relative volume V = 1 / 2ab 2 , (a is the long diameter of the mouse tumor, b is the short diameter)

[0082] (5) After inoculation, the mice’s living and eating conditions, body weight, and tumor growth at the inoculation site were observed daily. Blood was collected from the eye sockets 24 hours after the last administration, and the mice were killed by cervical dislocation. The tumor, spleen, and thymus tissues were removed and weighed, and the immune organ index and tumor inhibition rate were calculated. Flow cytometry was used to analyze the distribution of spleen immune cell subsets CD4+T cells and CD8+T cells.

[0083] Thymus index = thymus weight / mouse body weight

[0084] Spleen index = spleen weight / mouse body weight.

[0085] Tumor inhibition rate = (average tumor weight of the control group - average tumor weight of the experimental group) / average tumor weight of the control group × 100%

[0086] (6) After blood was drawn, the serum was collected by centrifugation and the expression levels of inflammatory factors IL-6 and TNF-α were detected according to the instructions of the ELISA kit.

[0087] (7) All data were processed using GraphPad Prism7.

[0088] (8) Compared with the model group, each group had different degrees of tumor inhibition effect. Compared with the blank group, the thymus index of the model group was significantly decreased (P<0.01), and the spleen index was significantly increased (P<0.01). Compared with the model group, there was no significant difference in the organ indexes of the PTX group, the thymus index of the low-dose HEO group was significantly increased (P<0.01), and the spleen index was significantly decreased (P<0.01). There was no significant difference in the organ indexes of the medium-dose HEO group, and the spleen index of the high-dose HEO group was significantly decreased (P<0.01). The specific results are shown in Table 2.

[0089] Table 2 Effects of industrial hemp volatile oil on immune organ index and tumor inhibition rate in lung cancer-bearing mice

[0090]

[0091]

[0092] ###-p<0.001, VS. blank control group; **-p<0.01, VS. model group; ***-p<0.001, VS. model group; @ -P<0.05, @@ -p<0.01, @@@ -p<0.001, VS. high-dose paclitaxel group; PTX-H+HEO-L group represents high-dose paclitaxel + low-dose volatile oil group, and PTX-H+HEO-M group represents high-dose paclitaxel + medium-dose volatile oil group.

[0093] (9) Compared with the blank group, the levels of CD4+T cells and CD8+T cells in the model group were significantly decreased (P<0.01), and the CD4+ / CD8+ ratio was significantly decreased (P<0.01); compared with the model group, the levels of CD4+T cells and CD8+T cells in the high-dose group of the experimental drug HEO were significantly increased, and the CD4+ / CD8+ ratio was significantly increased (P<0.01), while the CD4+ and CD8+ levels in the medium-dose group did not show significant changes, but the CD4+ / CD8+ ratio was significantly increased (P<0.01). See Table 3.

[0094] Table 3 Splenic lymphocyte subset analysis results ( n=6)

[0095]

[0096] ###-p<0.001, VS. blank control group; *-P<0.05; **-p<0.01, VS. model group; ***-p<0.001, VS. model group; @ -P<0.05, @@ -p<0.01, @@@ -p<0.001, VS. high-dose paclitaxel group; PTX-H+HEO-L group represents high-dose paclitaxel + low-dose volatile oil group, and PTX-H+HEO-M group represents high-dose paclitaxel + medium-dose volatile oil group.

[0097] (10) Compared with the blank group, the IL-6 and TNF-α levels of the mice in the model group were significantly increased (P < 0.05); compared with the model group, the IL-6 levels of the PTX-H group, HEO-L group, HEO-M group, and HEO-H group were significantly decreased (P < 0.01), and the TNF-α levels of the HEO-L group, HEO-M group, and HEO-H group were significantly decreased (P < 0.01). For details, see Figure 3 , Figure 4 (#-p<0.05, VS.Control group; *-p<0.05, VS.Model group; **-p<0.01, VS.Model group; ***-p<0.01, VS.Model group).

[0098] In summary, the present invention shows that industrial hemp volatile oil has anti-tumor effects. It mainly reduces the expression levels of inflammatory factors IL-6 and TNF-α, alleviates thymus atrophy and spleen enlargement in tumor-bearing mice, and increases the ratio of immune cells CD4+ / CD8+ to produce immunomodulatory effects to exert anti-tumor effects. The present invention provides a new choice for industrial hemp volatile oil as an anti-tumor drug candidate.

[0099] Example 4 Study on the anti-tumor effect of industrial hemp volatile oil combined with paclitaxel

[0100] (1) In the case of Example 3, the additional groups are a high-dose paclitaxel + low-dose volatile oil group (PTX-H + HEO-L: paclitaxel 10 mg / kg, ip, once / 3 days; HEO 25 mg / kg, ip, once / 1 day) and a high-dose paclitaxel + medium-dose volatile oil group (PTX-H + HEO-M: paclitaxel 10 mg / kg, ip, once / 3 days; HEO 50 mg / kg, ip, once / 1 day). The experimental process is the same as that of Example 3.

[0101] (2) Compared with the model group, the combined drug groups all had different degrees of tumor inhibition effects, but the statistical analysis results showed that the combination of the two drugs had no significant synergistic effect;

[0102] (3) Compared with the high-dose paclitaxel PTX-H group, the spleen index of the high-dose PTX combined with low-dose HEO group was significantly reduced (P<0.01); see Table 2. Compared with the high-dose paclitaxel PTX-H group, the combined drug group could significantly increase the CD4+ / CD8+ ratio (P<0.05), see Table 3.

Claims

1. A pharmaceutical composition A, characterized in that: It contains: β-caryophyllene, α-humulene and caryophyllene oxide.

2. The pharmaceutical composition A according to claim 1, characterized in that The pharmaceutical composition A also includes one or more of (-)-humulene epoxide II, α-bisabolol and (+)-delta-cadinene, cnidium-3,7(11)-diene, γ-ylang-ylangolene, hordein, β-serene, α-bergamotene and bergamotene oxide.

3. The pharmaceutical composition A according to claim 2, characterized in that: The pharmaceutical composition A satisfies one or more of the following conditions: (1) The β-caryophyllene content is preferably 10-35%; more preferably 15-30%; for example 26.49%; (2) The α-humulene content is preferably 5 to 20%; more preferably 10 to 15%; for example 12.11%; (3) The content of caryophyllene oxide is preferably 8-20%; more preferably 10-15%; for example 11.65%; (4) The content of (-)-humulene epoxide II is preferably 3 to 5%, for example 3.76%. (5) The content of α-bisabolol is preferably 2-5%, for example 3.27%. (6) The (+)-δ-cadinene content is preferably 2-5%, for example 3.24%. (7) The content of cnidium-3,7(11)-diene is preferably 2 to 5%, for example 3.07%. (8) The γ-ylangolene content is preferably 2-4%, for example 2.91%. (9) The hordein content is preferably 2-4%, for example 2.83%. (10) The β-serene content is preferably 2-4%, for example 2.44%. (11) The α-bergamotene content is preferably 2-4%, for example 2.37%. (12) The content of bergamot oxide is preferably 1-3%, for example 1.88%.

4. The pharmaceutical composition A according to claim 3, characterized in that: The pharmaceutical composition A satisfies one or more of the following conditions: (1) The active ingredients of the pharmaceutical composition A are derived from plant essential oils; (2) The plant is industrial hemp flowers and leaves; (3) The active ingredients of the pharmaceutical composition A are mainly sesquiterpenoid compounds.

5. The pharmaceutical composition A according to claim 4, characterized in that The active ingredients of the pharmaceutical composition A consist of active substances β-caryophyllene, α-humulene and caryophyllene oxide.

6. The pharmaceutical composition A according to claim 4, characterized in that: The active ingredients of the pharmaceutical composition A include β-caryophyllene, α-humulene and caryophyllene oxide, (-)-humulene epoxide II, α-bisabolol and (+)-delta-cadinene, cnidium-3,7(11)-diene, γ-ylang-ylangolene, hordein, β-thulene, α-bergamotene and bergamotene oxide.

7. The pharmaceutical composition A according to any one of claims 1 to 6, characterized in that: The pharmaceutical composition A is prepared by the following method, which comprises the following steps: (1) extracting and collecting volatile oil from industrial hemp flower and leaf powder by steam distillation; (2) subjecting the collected volatile oil to gas phase separation to obtain the pharmaceutical composition A according to any one of claims 1 to 6; Preferably, the solvent of the steam distillation method is water; And / or, the distillation temperature of the steam distillation method is 150°C to 170°C; for example, 160°C; And / or, the gas phase chromatographic column is a HP-5MSUI column; And / or, the gas phase injection port temperature is 200°C to 280°C; for example, 250°C; And / or, the gas phase chromatographic column flow rate is 0.8 ml / min to 12 ml / min; for example, 1 ml / min; And / or, the gas phase chromatographic column split ratio is 1:1 to 3:1; for example, 2:1; More preferably, the gas phase is programmed to heat, and the method of programmed heating is preferably: initial temperature 60°C, maintained for 2 minutes; increased to 110°C at 20°C / min; then increased to 160°C at 2°C / min, maintained for 1 minute; and then increased to 280°C at 20°C / min, maintained for 3 minutes.

8. A pharmaceutical composition B, characterized in that: It comprises the pharmaceutical composition A as claimed in claims 1 to 7 and an active substance Y; wherein it satisfies one or more of the following conditions: (1) The active substance Y is paclitaxel; (2) In the pharmaceutical composition B, the content of the pharmaceutical composition A is 20 mg / kg to 150 mg / kg; preferably 25 mg / kg, 50 mg / kg or 100 mg / kg; (3) The mass ratio of the pharmaceutical composition A to the active substance Y is 3:1 to 6:1; preferably 5:1 or 5:2; (4) In the pharmaceutical composition B, the active ingredients consist of the pharmaceutical composition A and the active substance Y; (5) In the pharmaceutical composition B, the pharmaceutical composition A and the active substance Y are administered simultaneously or separately.

9. Use of the pharmaceutical composition A according to claims 1 to 7 or the pharmaceutical composition B according to claim 8 in the preparation of a drug for inhibiting tumor growth or treating and / or preventing cancer; and / or, the medicament is used for treating and / or preventing thymic atrophy; and / or, the medicament is for treating and / or preventing splenomegaly; And / or, the drug is used to increase the level of CD4+ and CD8+ T cells; And / or, the drug is used to increase the CD4+ / CD8+ T cell ratio; and / or, the drug is used for regulating immunity; and / or, the drug is used to reduce the secretion of inflammatory cytokines; And / or, the tumor may be lung cancer; And / or, the thymic atrophy may be caused by cancer; And / or, the enlarged spleen may be caused by cancer; and / or, the treatment and / or prevention of the tumor is by reducing the secretion of inflammatory cytokines; And / or, the inflammatory cytokine may be one or more of IL-6 and TNF-α.

10. A pharmaceutical composition A as described in claims 1-7 or a pharmaceutical composition B as described in claim 8, wherein the pharmaceutical composition A or the pharmaceutical composition B is used in the preparation of an inhibitor, wherein the inhibitor is used to inhibit the expression of inflammatory factors, preferably, the inhibitor is used to inhibit the expression of one or more inflammatory factors of IL-6 and TNF-α.