A traditional Chinese medicine composition, a preparation method thereof and application thereof in treating breast cancer

Abstract

The present application relates to the technical field of breast disease medicine, more particularly to a traditional Chinese medicine composition, a preparation method thereof and application thereof in treating breast cancer.The traditional Chinese medicine composition comprises the following raw materials: Huangqi, Mudanpi, Rougui, Kushen, Cheqianzi, Mahuang, Chuanxiong, Xiakucaocao, Shedanzi, Tusizi, Danggui, Jiuniuzhizi, Shudi, Baizhu, Pugongying.The various raw materials of the present application are reasonably matched, can produce a synergistic effect, have a good therapeutic effect on breast cancer, and can treat the symptoms and the root cause, attack and tonify, support the healthy qi and eliminate the pathogenic factor, reduce toxicity and increase efficacy, have a definite pharmacological effect, reduce the possibility of tumor metastasis, enhance the body immunity, and improve the life quality and survival rate of patients.The preparation method defined in the present application can extract the active ingredients in medicinal materials to the maximum extent, promote the pharmacological effect, and has a wide application prospect due to the natural components and small side effects.

Description

Technical Field

[0001] This invention relates to the field of breast disease drug technology, and more specifically to a traditional Chinese medicine composition, its preparation method, and its application in the treatment of breast cancer. Background Technology

[0002] The breast is a type of human organ. Due to differences in physical development and endocrine environment between men and women, breast diseases are more common in women. Breast cancer is one of the most prevalent diseases in women, and its pathological nature is a malignant tumor occurring in the glandular epithelial tissue of the breast. Studies have shown that breast cancer remains the malignant tumor with the highest incidence and mortality rate among women. Although treatment drugs are constantly being developed, the global incidence and mortality rates of breast cancer in women are still rising, making the search for more effective drugs a top priority in breast cancer treatment.

[0003] The main treatment for breast cancer is a comprehensive approach combining radical surgery with radiotherapy, chemotherapy, and endocrine therapy. Chemotherapy is often used as an adjuvant therapy, but postoperative complications are common, such as nausea and vomiting, phlebitis, hair loss, and bone marrow suppression. Currently, targeted therapies for breast cancer primarily target the PI3K / Akt / mTOR signaling pathway, CDK, PARP, and HER2, acting directly on the lesion site with relatively low toxicity to normal tissues and cells. However, they also have several drawbacks, such as high cost, the influence of drug specificity on clinical efficacy, and numerous adverse reactions. Furthermore, many oral medications have long treatment courses, only provide short-term relief, and are prone to recurrence, thus failing to alleviate patient suffering.

[0004] Therefore, how to obtain a traditional Chinese medicine composition, its preparation method, and its application in the treatment of breast cancer are problems that urgently need to be solved by those skilled in the art. Summary of the Invention

[0005] In view of this, the present invention provides a traditional Chinese medicine composition, its preparation method, and its application in the treatment of breast cancer.

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

[0007] A traditional Chinese medicine composition comprising the following ingredients: Astragalus membranaceus, Paeonia suffruticosa, Cinnamomum cassia, Sophora flavescens, Plantago asiatica, Ephedra sinica, Ligusticum chuanxiong, Prunella vulgaris, Cnidium monnieri, Cuscuta chinensis, Angelica sinensis, Ligustrum lucidum (processed), Rehmannia glutinosa (processed), Atractylodes macrocephala, and Taraxacum mongolicum.

[0008] Preferred ingredients, by weight, include: 270–300 parts Astragalus membranaceus, 270–300 parts Paeonia suffruticosa, 245–265 parts Cinnamomum cassia, 230–250 parts Sophora flavescens, 200–225 parts Plantago asiatica, 200–225 parts Ephedra sinica, 175–185 parts Ligusticum chuanxiong, 150–160 parts Prunella vulgaris, 110–130 parts Cnidium monnieri, 95–100 parts Cuscuta chinensis, 95–100 parts Angelica sinensis, 70–88 parts Ligustrum lucidum (processed with wine), 55–60 parts Rehmannia glutinosa (processed), 30–40 parts Atractylodes macrocephala, and 16–28 parts Taraxacum mongolicum.

[0009] Preferred ingredients, by weight, include: 285 parts Astragalus membranaceus, 285 parts Paeonia suffruticosa, 250 parts Cinnamomum cassia, 240 parts Sophora flavescens, 215 parts Plantago asiatica, 210 parts Ephedra sinica, 178 parts Ligusticum chuanxiong, 156 parts Prunella vulgaris, 125 parts Cnidium monnieri, 96 parts Cuscuta chinensis, 98 parts Angelica sinensis, 76 parts Ligustrum lucidum (processed), 58 parts Rehmannia glutinosa (processed), 35 parts Atractylodes macrocephala, and 24 parts Taraxacum mongolicum.

[0010] As having the same inventive concept as the above-described technical solution, this invention also claims protection for a method for preparing the above-described traditional Chinese medicine composition, comprising the following steps:

[0011] (1) Weigh each raw material according to the above-mentioned weight proportions;

[0012] (2) Dry Astragalus membranaceus, Paeonia suffruticosa, Cinnamomum cassia, Sophora flavescens, Plantago asiatica, Ephedra sinica, Ligusticum chuanxiong and Prunella vulgaris, put them into a ball mill and pulverize them. Pass them through a 180-240 mesh sieve to obtain powder. Mix the powder with an ethanol aqueous solution, sonicate it, and then reflux extract it. Filter it, combine the filtrates, concentrate it under reduced pressure, and freeze dry it to obtain extract A.

[0013] (3) Dry the Cnidium monnieri, Cuscuta chinensis, Angelica sinensis, Ligustrum lucidum, Rehmannia glutinosa, Atractylodes macrocephala, and Taraxacum mongolicum, put them into a ball mill and pulverize them. Pass them through a 180-240 mesh sieve to obtain powder. Soak the powder in water, then reflux extract, filter, combine the filtrates, centrifuge, concentrate the supernatant under reduced pressure, freeze dry, and obtain extract B.

[0014] (4) Mix extract A and extract B evenly and freeze-dry to obtain the traditional Chinese medicine composition.

[0015] Preferably, the mass-to-volume ratio of the powder and the ethanol aqueous solution in step (2) is 1:8-18 g / mL, and the volume concentration of the ethanol aqueous solution is 55-75%.

[0016] Preferably, the ultrasonic treatment time in step (2) is 60 to 120 minutes, the ultrasonic power is 150 to 200 W, and the ultrasonic frequency is 20 to 40 kHz.

[0017] Preferably, the reflux extraction in step (2) is performed 2 to 4 times, each time for 2 to 3 hours.

[0018] Preferably, in step (3), the mass-to-volume ratio of the powder to water is 1:8-12 g / mL, the soaking time is 1-3 h, and the reflux extraction is performed 2-4 times, each time for 1.5-2 h.

[0019] Preferably, the temperature for vacuum concentration is 50–60°C; the temperature for freeze drying is -60–-40°C, and the pressure is 90–100 Pa.

[0020] As having the same inventive concept as the above-described technical solution, this invention also seeks protection for the use of the above-described traditional Chinese medicine composition in the preparation of drugs for treating breast cancer.

[0021] Astragalus: replenishes qi and strengthens the exterior, promotes tissue regeneration and detoxification, enhances the body's immune function, and regulates endocrine function.

[0022] Peony bark: Clears heat and cools blood, promotes blood circulation and removes blood stasis, and relieves breast pain.

[0023] Cinnamon: Promotes blood circulation and removes blood stasis, clears the meridians, and is used for blood stasis and stagnation leading to masses and accumulations.

[0024] Sophora flavescens: Clears heat and dries dampness, enhances immune function.

[0025] Plantain seed: Clears heat and promotes diuresis, clears heat and detoxifies.

[0026] Ephedra: It promotes diuresis and reduces swelling, and breaks up hard masses and accumulations.

[0027] Chuanxiong (Ligusticum striatum): promotes qi circulation, relieves stagnation, invigorates blood, relieves pain, dispels wind and dampness.

[0028] Prunella vulgaris: dissipates nodules and reduces swelling, promotes blood circulation and removes blood stasis.

[0029] Cnidium monnieri: It dries dampness and dispels wind, kills parasites and relieves itching, and warms the kidneys and strengthens yang.

[0030] Cuscuta: Nourishes the liver and kidneys, strengthens muscles and bones.

[0031] Angelica sinensis: Nourishes and invigorates blood, regulates menstruation and relieves pain.

[0032] Wine privet fruit: Nourishes the liver and kidneys, and replenishes essence and blood.

[0033] Rehmannia glutinosa: Nourishes blood and yin, replenishes essence and marrow.

[0034] Atractylodes macrocephala: strengthens the spleen and replenishes qi, and unblocks the meridians.

[0035] Dandelion: Reduces swelling and lumps, alleviates inflammation, and relieves symptoms of swelling and pain.

[0036] As can be seen from the above technical solution, compared with the prior art, the present invention discloses a traditional Chinese medicine composition, its preparation method, and its application in the treatment of breast cancer, which has the following beneficial effects:

[0037] (1) The combination of various raw materials in this invention is reasonable and can produce a synergistic effect. It has a good therapeutic effect on breast cancer, treating both the symptoms and the root cause, and combining attack and supplementation. It can strengthen the body's resistance and eliminate pathogens, reduce toxicity and increase efficacy. The efficacy is definite, reducing the possibility of tumor metastasis, enhancing the body's immunity, and improving the patient's quality of life and survival rate.

[0038] (2) The preparation method specified in this invention can extract the active ingredients in the medicinal materials to the greatest extent, promote the pharmacological effect, and the ingredients are natural with few side effects, and have broad application prospects. Detailed Implementation

[0039] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0040] Example 1

[0041] A traditional Chinese medicine composition, by weight, comprises: 270 parts Astragalus membranaceus, 270 parts Paeonia suffruticosa, 245 parts Cinnamomum cassia, 230 parts Sophora flavescens, 200 parts Plantago asiatica, 200 parts Ephedra sinica, 175 parts Ligusticum chuanxiong, 150 parts Prunella vulgaris, 110 parts Cnidium monnieri, 95 parts Cuscuta chinensis, 95 parts Angelica sinensis, 70 parts Ligustrum lucidum (processed with wine), 55 parts Rehmannia glutinosa (processed), 30 parts Atractylodes macrocephala, and 16 parts Taraxacum mongolicum.

[0042] The preparation method of the above-mentioned traditional Chinese medicine composition includes the following steps:

[0043] (1) Weigh each raw material according to the above-mentioned weight proportions;

[0044] (2) Astragalus membranaceus, Paeonia suffruticosa, Cinnamomum cassia, Sophora flavescens, Plantago asiatica, Ephedra sinica, Ligusticum chuanxiong and Prunella vulgaris were dried, pulverized in a ball mill, and passed through a 180-mesh sieve to obtain powder. The powder was mixed with an ethanol aqueous solution, ultrasonically treated, and then refluxed for extraction. The mixture was filtered, the filtrates were combined, concentrated under reduced pressure, and freeze-dried to obtain extract A.

[0045] (3) Dry the Cnidium monnieri, Cuscuta chinensis, Angelica sinensis, Ligustrum lucidum, Rehmannia glutinosa, Atractylodes macrocephala, and Taraxacum mongolicum, put them into a ball mill and pulverize them. Pass them through a 180-mesh sieve to obtain powder. Soak the powder in water, then reflux extract, filter, combine the filtrates, centrifuge, concentrate the supernatant under reduced pressure, freeze dry, and obtain extract B.

[0046] (4) Mix extract A and extract B evenly and freeze-dry to obtain the traditional Chinese medicine composition.

[0047] The mass-to-volume ratio of the powder and the ethanol aqueous solution in step (2) is 1:8 g / mL, and the volume concentration of the ethanol aqueous solution is 55%.

[0048] The ultrasonic treatment in step (2) lasts for 60 minutes, with an ultrasonic power of 150W and an ultrasonic frequency of 20kHz.

[0049] The reflux extraction in step (2) is performed twice, each time for 2 hours.

[0050] In step (3), the mass-to-volume ratio of powder to water is 1:8 g / mL, the soaking time is 1 h, and the reflux extraction is performed twice, each time for 1.5 h.

[0051] The temperature for vacuum concentration is 50°C; the temperature for freeze drying is -40°C and the pressure is 90 Pa.

[0052] Example 2

[0053] A traditional Chinese medicine composition, by weight, comprises: 300 parts Astragalus membranaceus, 300 parts Paeonia suffruticosa, 265 parts Cinnamomum cassia, 250 parts Sophora flavescens, 225 parts Plantago asiatica, 225 parts Ephedra sinica, 185 parts Ligusticum chuanxiong, 160 parts Prunella vulgaris, 130 parts Cnidium monnieri, 100 parts Cuscuta chinensis, 100 parts Angelica sinensis, 88 parts Ligustrum lucidum (processed with wine), 60 parts Rehmannia glutinosa (processed), 40 parts Atractylodes macrocephala, and 28 parts Taraxacum mongolicum.

[0054] The preparation method of the above-mentioned traditional Chinese medicine composition includes the following steps:

[0055] (1) Weigh each raw material according to the above-mentioned weight proportions;

[0056] (2) Astragalus membranaceus, peony bark, cinnamon, sophora flavescens, plantain seed, ephedra, chuanxiong rhizome, and prunella vulgaris were dried, pulverized in a ball mill, and passed through a 240-mesh sieve to obtain powder. The powder was mixed with an ethanol aqueous solution, ultrasonically treated, and then refluxed for extraction. The mixture was filtered, the filtrates were combined, concentrated under reduced pressure, and freeze-dried to obtain extract A.

[0057] (3) Dry the Cnidium monnieri, Cuscuta chinensis, Angelica sinensis, Ligustrum lucidum, Rehmannia glutinosa, Atractylodes macrocephala, and Taraxacum mongolicum, put them into a ball mill and pulverize them. Pass them through a 240-mesh sieve to obtain powder. Soak the powder in water, then reflux extract, filter, combine the filtrates, centrifuge, concentrate the supernatant under reduced pressure, freeze dry, and obtain extract B.

[0058] (4) Mix extract A and extract B evenly and freeze-dry to obtain the traditional Chinese medicine composition.

[0059] The mass-to-volume ratio of the powder and the ethanol aqueous solution in step (2) is 1:18 g / mL, and the volume concentration of the ethanol aqueous solution is 75%.

[0060] The ultrasonic treatment in step (2) lasts for 120 minutes, with an ultrasonic power of 200W and an ultrasonic frequency of 40kHz.

[0061] The reflux extraction in step (2) is performed 4 times, each time for 3 hours.

[0062] In step (3), the mass-to-volume ratio of powder to water is 1:12 g / mL, the soaking time is 3 h, and the reflux extraction is performed 4 times, each time for 2 h.

[0063] The temperature for vacuum concentration is 60°C; the temperature for freeze drying is -60°C and the pressure is 100 Pa.

[0064] Example 3

[0065] A traditional Chinese medicine composition, by weight, comprises: 285 parts Astragalus membranaceus, 285 parts Paeonia suffruticosa, 250 parts Cinnamomum cassia, 240 parts Sophora flavescens, 215 parts Plantago asiatica, 210 parts Ephedra sinica, 178 parts Ligusticum chuanxiong, 156 parts Prunella vulgaris, 125 parts Cnidium monnieri, 96 parts Cuscuta chinensis, 98 parts Angelica sinensis, 76 parts Ligustrum lucidum (processed with wine), 58 parts Rehmannia glutinosa (processed), 35 parts Atractylodes macrocephala, and 24 parts Taraxacum mongolicum.

[0066] The preparation method is the same as in Example 2.

[0067] Comparative Example 1

[0068] A traditional Chinese medicine composition differs from Example 3 in that 285 parts of Astragalus membranaceus and 285 parts of Paeonia suffruticosa are replaced with 570 parts of Astragalus membranaceus, while the rest are the same.

[0069] Comparative Example 2

[0070] A traditional Chinese medicine composition differs from Example 3 in that 285 parts of Astragalus membranaceus and 285 parts of Paeonia suffruticosa are replaced with 570 parts of Paeonia suffruticosa, while the rest remains the same.

[0071] Comparative Example 3

[0072] A traditional Chinese medicine composition differs from Example 3 in that Astragalus membranaceus is removed, while the rest are the same.

[0073] Comparative Example 4

[0074] A traditional Chinese medicine composition differs from Example 3 in that Astragalus membranaceus and Paeonia suffruticosa are removed, while the rest are the same.

[0075] Comparison document 5

[0076] A traditional Chinese medicine composition differs from Example 3 in that the ultrasonic treatment is not performed in step (2) of the preparation method, but the rest are the same.

[0077] Animal experiments

[0078] Eighty SPF-grade, female SD Kunming rats, weighing 150±10g, were acclimatized for one week. Then, 0.2ml of fat pads containing 3*10 g of fat were implanted into the left fourth pair of mammary glands of 70 rats. 7 Ten rats were given phosphate-buffered saline (PBSS) to treat 4 T1 cells, while the remaining 10 rats served as a control group and were treated with 0.2 ml of PBSS in the same manner. Tumor size was measured and recorded. The overall tumor volume of the rats was defined as 150 ± 10 mm. 3 Seventy rats were then randomly divided into seven groups: Examples 1-3, Comparative Examples 1-3, and a model group; each group consisted of ten rats. Each group was administered the corresponding drug via gavage at a dose of 5g of the herbal composition / kg. The model group and the control group received an equal volume of physiological saline. The drugs were administered twice daily for 20 consecutive days. On day 21, all rats were sacrificed, and blood was collected from the abdominal aorta. The collected plasma was placed in a coagulation-promoting tube and allowed to stand for 30 minutes before being centrifuged at 3500 rpm for 15 minutes to obtain serum. Tumor markers CA15-3 and carcinoembryonic antigen (CEA) were detected using an electrochemiluminescence immunoassay analyzer. The results are shown in Table 1.

[0079] It is evident that the tumor volume, CA15-3 levels, and CEA levels significantly decreased after treatment with this invention, demonstrating good efficacy in treating breast cancer. The formulation in Example 3 showed the best results. The efficacy of the comparative examples was significantly reduced, especially in Comparative Example 4, which lacked Astragalus and Moutan Cortex, exhibiting the worst tumor-inhibiting effect. This proves that Astragalus and Moutan Cortex in the raw materials of this invention have a synergistic effect when used in appropriate proportions, which is crucial to the overall formulation and results in a significant anti-tumor effect. While Comparative Example 5, with all its raw materials present, still showed some inhibitory effect, the lack of ultrasonic treatment resulted in a lower content of active ingredients and poor therapeutic efficacy. Ultrasonic treatment can effectively extract the active ingredients from the medicinal materials, promoting the pharmacological effects of the formulation.

[0080] Table 1: Effect Test

[0081] Group <![CDATA[Tumor increased volume (mm 3 )]]> CA15-3 (U / mL) CEA (U / mL) Blank group 0 0 0 Model group 128 0.81 0.69 Example 1 16 0.24 0.16 Example 2 13 0.17 0.14 Example 3 10 0.14 0.09 Comparative Example 1 19 0.31 0.21 Comparative Example 2 24 0.35 0.27 Comparative Example 3 53 0.54 0.43 Comparative Example 4 76 0.65 0.54 Comparative Example 5 31 0.46 0.32

[0082] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0083] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A traditional Chinese medicine composition for treating breast cancer, characterized in that, Made from the following ingredients by weight: 270–300 parts Astragalus membranaceus, 270–300 parts Paeonia suffruticosa, 245–265 parts Cinnamomum cassia, 230–250 parts Sophora flavescens, 200–225 parts Plantago asiatica, 200–225 parts Ephedra sinica, 175–185 parts Ligusticum chuanxiong, 150–160 parts Prunella vulgaris, 110–130 parts Cnidium monnieri, 95–100 parts Cuscuta chinensis, 95–100 parts Angelica sinensis, 70–88 parts Ligustrum lucidum (processed with wine), 55–60 parts Rehmannia glutinosa (processed), 30–40 parts Atractylodes macrocephala, and 16–28 parts Taraxacum mongolicum. The preparation method of the traditional Chinese medicine composition is as follows: (1) Weigh each raw material according to the above-mentioned weight proportions; (2) Dry Astragalus membranaceus, Paeonia suffruticosa, Cinnamomum cassia, Sophora flavescens, Plantago asiatica, Ephedra sinica, Ligusticum chuanxiong and Prunella vulgaris, put them into a ball mill and pulverize them. Pass them through a 180-240 mesh sieve to obtain powder. Mix the powder with an ethanol aqueous solution, sonicate it, and then reflux extract it. Filter it, combine the filtrates, concentrate it under reduced pressure, and freeze dry it to obtain extract A. (3) Dry the Cnidium monnieri, Cuscuta chinensis, Angelica sinensis, Ligustrum lucidum, Rehmannia glutinosa, Atractylodes macrocephala, and Taraxacum mongolicum, put them into a ball mill and pulverize them. Pass them through a 180-240 mesh sieve to obtain powder. Soak the powder in water, then reflux extract, filter, combine the filtrates, centrifuge, concentrate the supernatant under reduced pressure, freeze dry, and obtain extract B. (4) Mix extract A and extract B evenly and freeze-dry to obtain the traditional Chinese medicine composition.

2. The traditional Chinese medicine composition for treating breast cancer according to claim 1, characterized in that, Made from the following ingredients by weight: 285 parts Astragalus membranaceus, 285 parts Paeonia suffruticosa, 250 parts Cinnamomum cassia, 240 parts Sophora flavescens, 215 parts Plantago asiatica, 210 parts Ephedra sinica, 178 parts Ligusticum chuanxiong, 156 parts Prunella vulgaris, 125 parts Cnidium monnieri, 96 parts Cuscuta chinensis, 98 parts Angelica sinensis, 76 parts Ligustrum lucidum (processed), 58 parts Rehmannia glutinosa (processed), 35 parts Atractylodes macrocephala, and 24 parts Taraxacum mongolicum.

3. The traditional Chinese medicine composition for treating breast cancer according to claim 1, characterized in that, The mass-to-volume ratio of the powder and the ethanol aqueous solution in step (2) is 1:8-18 g / mL, and the volume concentration of the ethanol aqueous solution is 55-75%.

4. The traditional Chinese medicine composition for treating breast cancer according to claim 1, characterized in that, The ultrasonic treatment time in step (2) is 60-120 min, the ultrasonic power is 150-200 W, and the ultrasonic frequency is 20-40 kHz.

5. The traditional Chinese medicine composition for treating breast cancer according to claim 1, characterized in that, The reflux extraction in step (2) is performed 2 to 4 times, each time for 2 to 3 hours.

6. The traditional Chinese medicine composition for treating breast cancer according to claim 1, characterized in that, In step (3), the mass-to-volume ratio of powder to water is 1:8-12 g / mL, the soaking time is 1-3 h, and the reflux extraction is performed 2-4 times, each time for 1.5-2 h.

7. The method for preparing the traditional Chinese medicine composition for treating breast cancer according to claim 1, characterized in that, The temperature for vacuum concentration is 50–60°C; the temperature for freeze drying is -60–-40°C, and the pressure is 90–100 Pa.