Traditional Chinese medicine formula with anticancer effect and preparation method thereof

Abstract

The invention relates to the field of traditional Chinese medicine formulas, and particularly discloses a traditional Chinese medicine formula with an anticancer effect and a preparation method thereof, and the traditional Chinese medicine formula is prepared from the following raw materials in parts by weight: 10-30 parts of radix aconiti agrestis, 15-40 parts of antler cap, 20-50 parts of selfheal, 10-35 parts of radix clematidis, 15-45 parts of radix rubiae and 20-60 parts of dandelion. Through precise compatibility of six medicinal materials including radix aconiti agrestis, antler cap, selfheal, radix clematidis, radix rubiae and dandelion, a core mechanism breakthrough of multi-target synergistic inhibition of tumor growth and metastasis is realized. Compared with a traditional anti-cancer traditional Chinese medicine formula which is numerous and jumbled and single in effect, the formula takes the antler cap as a monarch drug to lead the whole formula, so that the anti-cancer activity of the radix aconiti agrestis is enhanced, toxicity is neutralized by virtue of the heat clearing and stagnation eliminating characteristics of selfheal and dandelion, and the unique treatment advantage of counteracting toxic substances without hurting the body resistance is formed.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine formulas, in particular to a traditional Chinese medicine formula with anti-cancer effects and a preparation method thereof. Background Art

[0002] In the field of adjuvant cancer treatment, traditional Chinese medicine (TCM) compound prescriptions, due to their multi-ingredient and multi-target properties, have gradually become an important means to supplement the shortcomings of surgery and chemotherapy. Traditional anti-cancer TCM often follows the principle of "fighting poison with poison," often using highly toxic herbs such as toad venom and mylabris to directly kill cancer cells through their toxic components. While such prescriptions have some anti-tumor effects, they have the following drawbacks:

[0003] It is difficult to balance toxicity control and efficacy retention. Taking Aconitum kusnezoffii as an example, the aconite alkaloids it contains have significant anti-tumor activity, but the therapeutic window of diester alkaloids (such as aconitine) is extremely narrow. Existing technologies often use high-temperature frying or steaming to reduce toxicity. While this process degrades toxic components, it often leads to a large loss of heat-sensitive active ingredients (such as anti-tumor active monoester alkaloids), resulting in the contradiction of "reducing toxicity and efficacy". Summary of the Invention

[0004] In order to solve the above technical problems, the present invention provides a traditional Chinese medicine formula with anti-cancer effect to solve the problem of the prior art that "reducing toxicity means reducing efficacy" of toxic medicinal materials and the functional imbalance of the compound "focusing on killing tumors and neglecting repair".

[0005] A traditional Chinese medicine formula with anti-cancer effect, composed of the following raw materials in parts by weight:

[0006] 10–30 parts of Aconitum Kusnezoffii, 15–40 parts of Capsules antlers, 20–50 parts of Prunella Vulgaris, 10–35 parts of Clematidis, 15–45 parts of Rubia cordifolia, and 20–60 parts of Taraxacum mongolicum.

[0007] A method for preparing a traditional Chinese medicine formula comprises the following steps:

[0008] S1. Wash and dry Aconitum kusnezoffii, Clematidis radix, and Rubia cordifolia, then grind into 80–120 mesh coarse powder.

[0009] S2. Grind the antler cap into fine powder and pass through a 200-mesh sieve;

[0010] S3, Prunella vulgaris, and dandelion are decocted with 8–12 times the amount of water twice, each time for 1–2 hours, and the filtrates are combined;

[0011] S4, add the crude powder obtained in S1 to the filtrate of S3, extract at 60–80°C for 3–5 hours, and filter;

[0012] S5. Combine the filtrate from S4 and the fine powder from S2, and concentrate to an extract with a relative density of 1.10–1.25 at 60°C.

[0013] Preferably, the decoction temperature in S3 is 90–100°C;

[0014] S5 concentration adopts reduced pressure concentration with a pressure of -0.05 to -0.08MPa.

[0015] Application of traditional Chinese medicine formula in the preparation of medicine for adjuvant treatment of cancer.

[0016] Preferably, the drug is used to inhibit cancer cell proliferation, promote postoperative recovery or reduce the risk of recurrence.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] Through the precise combination of six herbs—Aconiti Kusnezoffii, Deerhorn Capsules, Prunella Vulgaris, Clematis Root, Rubia Cordata, and Taraxacum Officinale—a breakthrough in the core mechanism of multi-target synergistic inhibition of tumor growth and metastasis was achieved. Compared to the complex and single-action nature of traditional anti-cancer Chinese medicine formulas, this formula, with Deerhorn Capsules as the main ingredient, not only enhances the anti-cancer activity of Aconiti Kusnezoffii, but also leverages the heat-clearing and stagnation-dispersing properties of Prunella Vulgaris and Taraxacum Officinale to neutralize toxicity, creating a unique therapeutic advantage of "attacking toxicity without harming the body."

[0019] By adopting a step-by-step directional extraction process: toxic medicinal materials such as Aconitum kusnezoffii are dried at low temperature to control toxicity, antler cap is independently ultrafinely crushed to preserve active ingredients, and then a step-by-step extraction process of water decoction and low-temperature extraction is used to achieve efficient degradation of toxic components and maximum retention of effective ingredients. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a schematic diagram of the preparation process of the present invention. DETAILED DESCRIPTION

[0021] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0022] like Figure 1 As shown:

[0023] Example 1: A method for preparing a Chinese medicine formula, the raw materials and preparation method thereof are as follows:

[0024] Raw material ratio (parts by weight):

[0025] raw material Number of copies Aconitum kusnezoffii 10 Deer antler hat 15 Prunella vulgaris 20 Clematis 10 Rubia cordifolia 15 dandelion 60

[0026] Preparation steps:

[0027] Step 1: Pre-treating the coarse powder:

[0028] Take 10 parts of Aconitum kusnezoffii, 10 parts of Clematidis, and 15 parts of Rubia cordifolia, wash them, dry them at 80°C, and grind them into 80-mesh coarse powder.

[0029] Step 2: Deer antler cap powder:

[0030] Grind 15 parts of deer antler cap separately, sieve through 200 mesh to obtain fine powder, seal and set aside.

[0031] Step 3: Decoction and extraction:

[0032] Add 8 times the amount of water (1600 parts) to 20 parts of Prunella Vulgaris and 60 parts of Taraxacum Herba, decoct at 100°C twice, each time for 1 hour, and combine the filtrates.

[0033] Step 4: Extraction and filtration:

[0034] The coarse powder from step 1 was added to the filtrate from step 3, extracted at 60°C for 5 hours, and the residue was filtered and discarded.

[0035] Step 5: Concentrate into extract:

[0036] The filtrate from step 4 and the antler cap fine powder from step 2 were combined and concentrated under reduced pressure at -0.08 MPa to a brown extract with a relative density of 1.10 at 60°C.

[0037] Example 2: A method for preparing a Chinese medicine formula, the raw materials and preparation method thereof are as follows:

[0038] Raw material ratio (parts by weight):

[0039] raw material Number of copies Aconitum kusnezoffii 20 Deer antler hat 28 Prunella vulgaris 35 Clematis 22 Rubia cordifolia 30 dandelion 40

[0040] Preparation steps:

[0041] Step 1: Pre-treating the coarse powder:

[0042] Take 20 parts of Aconitum kusnezoffii, 22 parts of Clematidis, and 30 parts of Rubia cordifolia, wash them, dry them at 75°C, and grind them into 100-mesh coarse powder.

[0043] Step 2: Deer antler cap powder:

[0044] Grind 28 parts of deer antler cap separately, sieve through 200 mesh to obtain fine powder, seal and set aside.

[0045] Step 3: Decoction and extraction:

[0046] Add 10 times the amount of water (750 parts) to 35 parts of Prunella Vulgaris and 40 parts of Taraxacum Herba, decoct at 95°C twice, each time for 1.5 hours, and combine the filtrates.

[0047] Step 4: Extraction and filtration:

[0048] The coarse powder from step 1 was added to the filtrate from step 3, extracted at 70°C for 4 hours, and the residue was filtered and discarded.

[0049] Step 5: Concentrate into extract:

[0050] The filtrate from step 4 and the antler cap fine powder from step 2 were combined and concentrated under reduced pressure at -0.06 MPa to a brown extract with a relative density of 1.18 at 60°C.

[0051] Example 3: A method for preparing a Chinese medicine formula, the raw materials and preparation method thereof are as follows:

[0052] Raw material ratio (parts by weight):

[0053] raw material Number of copies Aconitum kusnezoffii 30 Deer antler hat 40 Prunella vulgaris 50 Clematis 35 Rubia cordifolia 45 dandelion 60

[0054] Preparation steps:

[0055] Step 1: Pre-treating the coarse powder:

[0056] Take 30 parts of Aconitum kusnezoffii, 35 parts of Clematidis, and 45 parts of Rubia cordifolia, wash them, dry them at 70°C, and grind them into 120-mesh coarse powder.

[0057] Step 2: Deer antler cap powder:

[0058] Grind 40 parts of deer antler cap separately, sieve through 200 mesh to obtain fine powder, seal and set aside.

[0059] Step 3: Decoction and extraction:

[0060] Add 12 times the amount of water (1320 parts) to 50 parts of Prunella Vulgaris and 60 parts of Taraxacum Herba, decoct at 90°C twice, each time for 2 hours, and combine the filtrates.

[0061] Step 4: Extraction and filtration:

[0062] The coarse powder from step 1 was added to the filtrate from step 3, extracted at 80°C for 3 hours, and the residue was filtered and discarded.

[0063] Step 5: Concentrate into extract:

[0064] The filtrate from step 4 and the antler cap fine powder from step 2 were combined and concentrated under reduced pressure at -0.05 MPa to a brown extract with a relative density of 1.25 at 60°C.

[0065] Experimental example: Verification of the anti-cancer efficacy of traditional Chinese medicine formula

[0066] 1. Experimental Plan

[0067] 1. Preparation of test samples

[0068] Test group: Example 2 extract (1 portion = 5 g crude drug, total crude drug amount 750 g preparation batch);

[0069] Prepare a 30 mg / mL (based on the extract) solution with normal saline;

[0070] Comparative Example 1: Formula without antler cap (same as Example 2 except for the antler cap);

[0071] Comparative Example 2: positive drug group (paclitaxel injection, 6 mg / kg);

[0072] Control group: normal saline;

[0073] 2. Animal Model

[0074] Strain: BALB / c nude mice (female, 6 weeks old);

[0075] Modeling: Human breast cancer MCF-7 cells (5×10 6 / mouse), tumor volume ≥100 mm 3 Enrollment

[0076] Grouping: Randomly divided into 4 groups (n=10), see Table 1;

[0077] 3. Dosage regimen:

[0078] Treatment course: 21 consecutive days

[0079]

[0080] 4. Evaluation indicators

[0081] Tumor inhibition rate: Tumor diameter was measured every 3 days (formula: V = 0.5 × L × W 2 );

[0082] Postoperative recovery: The tumor was surgically removed on the 22nd day, and the wound healing time and weight changes were recorded;

[0083] Recurrence monitoring: Continue to administer the drug for 14 days after surgery, and use PET-CT to detect in situ recurrence;

[0084] Immune indicators: flow cytometry was used to detect the ratio of CD4+ / CD8+ T cells;

[0085] 2. Experimental Results

[0086] Table 1: Main pharmacodynamic data (mean ± SD)

[0087]

[0088] Note: P < 0.05 vs. control group; **P < 0.01 vs. control group; Tumor inhibition rate = (1 - tumor weight of treatment group / tumor weight of control group) × 100%*

[0089] Table 2: Postoperative recovery indicators

[0090]

[0091] 3. Results Analysis

[0092] Tumor inhibitory effect

[0093] The tumor inhibition rate of the test group reached 65.3% (P<0.01), which was significantly higher than that of the control group 1 lacking antler cap (38.5%), confirming the necessity of the whole formula (especially the synergistic effect of antler cap).

[0094] Mechanism: The CD4+ / CD8+ ratio in the test group increased to 1.8 (1.1 in the control group), suggesting that immune regulation is the core tumor suppression pathway.

[0095] Postoperative recovery advantages

[0096] The wound healing time (10.5 days) of the test group was 26.8% shorter than that of the control group, and the weight recovery rate was 96.7% (82.3% of the control group).

[0097] Key evidence: IL-6 levels decreased to 120 pg / mL (350 pg / mL in the control group), indicating reduced postoperative inflammation.

[0098] Anti-relapse properties

[0099] The recurrence rate 14 days after surgery was only 20% (80% in the control group), which was significantly better than that in the paclitaxel group (40%).

[0100] The recurrence rate of comparative example 1 (lacking antler cap) was 50%, highlighting the key role of antler cap in inhibiting residual micrometastasis.

[0101] IV. Conclusion

[0102] The formulation of Example 2 works via two pathways:

[0103] Directly inhibit tumor proliferation (tumor inhibition rate>65%);

[0104] Immunomodulation (increase CD4+ / CD8+) synergizes with postoperative anti-inflammation (decrease IL-6);

[0105] Deer antler cap is the core medicinal ingredient: when its components are missing, the tumor inhibition rate decreases by 41.3% and the recurrence risk increases by 150%.

[0106] The whole formula is superior to chemotherapy drugs in promoting postoperative recovery (increased healing speed, reduced inflammation) and reducing recurrence.

[0107] In the description of this specification, the reference terms "one embodiment", "some embodiments", "example", "specific example" or "some examples" mean that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art can combine and combine different embodiments or examples described in this specification and features of different embodiments or examples without contradiction.

[0108] In the drawings of the embodiments disclosed in the present invention, only the structures related to the embodiments disclosed in the present invention are involved. Other structures can refer to the general design. In the absence of conflict, the same embodiment and different embodiments of the present invention can be combined with each other.

[0109] Although the present invention has been described in detail with reference to the aforementioned embodiments, it is still possible for those skilled in the art to modify the technical solutions described in the aforementioned embodiments, or to make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A Chinese medicine formula with anti-cancer effect, characterized in that: It is composed of the following raw materials in parts by weight: 10–30 parts of Aconitum Kusnezoffii, 15–40 parts of Capsules antlers, 20–50 parts of Prunella Vulgaris, 10–35 parts of Clematidis, 15–45 parts of Rubia cordifolia, and 20–60 parts of Taraxacum mongolicum.

2. A method for preparing the traditional Chinese medicine formula according to claim 1, characterized in that: The following steps are involved: S1. Wash and dry Aconitum kusnezoffii, Clematidis radix, and Rubia cordifolia, then grind into 80–120 mesh coarse powder. S2. Grind the antler cap into fine powder and pass through a 200-mesh sieve; S3, Prunella vulgaris, and dandelion are decocted with 8–12 times the amount of water twice, each time for 1–2 hours, and the filtrates are combined; S4, add the crude powder obtained in S1 to the filtrate of S3, extract at 60–80°C for 3–5 hours, and filter; S5. Combine the filtrate from S4 and the fine powder from S2, and concentrate to an extract with a relative density of 1.10–1.25 at 60°C.

3. The preparation method according to claim 2, wherein: The decoction temperature in S3 was 90–100°C; S5 concentration adopts reduced pressure concentration with a pressure of -0.05 to -0.08MPa.

4. Use of the traditional Chinese medicine formula according to claim 1 in preparing a medicament for the adjuvant treatment of cancer.

5. The use according to claim 4, characterized in that: The drug is used to inhibit cancer cell proliferation, promote postoperative recovery or reduce the risk of recurrence.

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