Traditional Chinese medicine composition as well as preparation method and application thereof in treating breast cancer

Abstract

The invention relates to the technical field of mastopathy drugs, in particular to a traditional Chinese medicine composition, a preparation method thereof and application of the traditional Chinese medicine composition in treatment of breast cancer. The traditional Chinese medicine composition is prepared from the following raw materials: radix astragali, cortex moutan, cortex cinnamomi, radix sophorae flavescentis, semen plantaginis, herba ephedrae, rhizoma chuanxiong, spica prunellae, fructus cnidii, semen cuscutae, radix angelicae sinensis, wine-processed fructus ligustri lucidi, radix rehmanniae preparata, rhizoma atractylodis The traditional Chinese medicine composition is reasonable in compatibility of various raw materials, can generate a synergistic effect, has a good treatment effect on breast cancer, treats both symptoms and root causes, combines purgation and tonification, can strengthen the body resistance to eliminate pathogenic factors, reduces toxicity and improves the effect, has a definite drug effect, reduces the possibility of tumor metastasis, enhances the immunity of the organism, and improves the living quality and survival rate of patients. According to the limited preparation method, active ingredients in the medicinal materials can be extracted to the maximum extent, pharmacological action is promoted to be played, the ingredients are natural, side effects are small, and wide application prospects are achieved.

Description

Technical Field

[0001] The invention relates to the technical field of breast disease drugs, and more specifically to a Chinese medicine composition and a preparation method thereof and application thereof in treating breast cancer. Background Art

[0002] The breast is a type of human organ. Due to the differences in the physical development structure and endocrine environment between men and women, breast diseases are more common in women. Breast cancer is also one of the most common diseases in women. Its pathological nature is a malignant tumor that occurs in the mammary gland epithelial tissue. Studies have pointed out that breast cancer is still the malignant tumor with the highest incidence and mortality rate in women. Although therapeutic drugs are constantly being developed, the incidence and mortality rate of breast cancer in women around the world are still rising. Finding more effective drugs has become a top priority for breast cancer treatment.

[0003] The treatment of breast cancer is mainly based on comprehensive treatment such as radical surgery combined with radiotherapy, chemotherapy and endocrine therapy. Chemotherapy is often used as an auxiliary treatment measure for patients, but postoperative complications are common, such as nausea and vomiting, phlebitis, hair loss, bone marrow suppression, etc. At present, targeted drugs for breast cancer mainly target P13K / Akt / mTOR signaling pathway, CDK, PARP, HER2, etc., which can directly act on the lesion site and have low toxicity to normal tissues and cells, but there are also many shortcomings, such as the high price of targeted drugs, the strength of drug specificity affecting the level of clinical benefits, and more adverse reactions. In addition, the course of treatment of many oral drugs is long, only effective in the short term, and prone to relapse, which is not conducive to alleviating the pain of patients.

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

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

[0006] In order to achieve the above object, the present invention adopts the following technical solution:

[0007] A Chinese medicine composition comprises the following raw materials: astragalus, peony bark, cinnamon bark, sophora flavescens, plantain seed, ephedra, ligusticum chuanxiong, selfheal, cnidium monnieri, dodder seed, angelica sinensis, privet fruit, rehmannia glutinosa, atractylodes macrocephala, and dandelion.

[0008] Preferably, the ingredients, by weight, include: 270-300 parts of astragalus, 270-300 parts of moutan bark, 245-265 parts of cinnamon bark, 230-250 parts of sophora flavescens, 200-225 parts of plantain seeds, 200-225 parts of ephedra, 175-185 parts of ligusticum chuanxiong, 150-160 parts of selfheal, 110-130 parts of cnidium monnieri, 95-100 parts of dodder seeds, 95-100 parts of angelica sinensis, 70-88 parts of ligustri lucidi, 55-60 parts of rehmannia glutinosa, 30-40 parts of atractylodes macrocephala, and 16-28 parts of dandelions.

[0009] Preferably, the composition, by weight, includes: 285 parts of astragalus, 285 parts of peony bark, 250 parts of cinnamon, 240 parts of sophora flavescens, 215 parts of plantain seeds, 210 parts of ephedra, 178 parts of ligusticum chuanxiong, 156 parts of selfheal, 125 parts of cnidium monnieri, 96 parts of dodder seeds, 98 parts of angelica sinensis, 76 parts of ligustri lucidi, 58 parts of rehmannia glutinosa, 35 parts of atractylodes macrocephala, and 24 parts of dandelions.

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

[0011] (1) Weighing each raw material according to the above weight parts;

[0012] (2) drying astragalus, peony bark, cinnamon bark, sophora flavescens, plantago seed, ephedra, ligusticum chuanxiong, and prunella vulgaris, grinding them in a ball mill, passing through a 180-240 mesh sieve to obtain a powder, mixing the powder with an ethanol aqueous solution, ultrasonically treating the mixture, performing reflux extraction, filtering, combining the filtrates, concentrating under reduced pressure, and freeze-drying to obtain extract A;

[0013] (3) drying Cnidium monnieri, Cuscuta australis, Angelica sinensis, Ligustrum lucidum, Rehmannia glutinosa, Atractylodes macrocephala, and Taraxacum officinale, grinding them in a ball mill, passing through a 180-240 mesh sieve to obtain a powder, soaking the powder in water, and then performing reflux extraction, filtering, combining the filtrates, centrifuging, concentrating the obtained supernatant under reduced pressure, and freeze-drying to obtain extract B;

[0014] (4) The extract A and the extract B are mixed evenly, and freeze-dried to obtain a Chinese medicine composition.

[0015] Preferably, the mass 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 min, 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 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 of the reduced pressure concentration is 50 to 60°C; the temperature of the freeze drying is -60 to -40°C, and the pressure is 90 to 100Pa.

[0020] As an inventive concept identical to the above technical solution, the present invention also requests protection for the use of the above traditional Chinese medicine composition in the preparation of drugs for treating breast cancer.

[0021] Astragalus: replenishes Qi and strengthens the exterior, removes toxins and promotes tissue regeneration, improves the body's immune function, and regulates endocrine function.

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

[0023] Cinnamon: promotes blood circulation and removes blood stasis, dredges meridians, and is used for blood stasis and accumulation leading to symptoms of mass.

[0024] Sophora flavescens: clears away heat and dampness, enhances immune function.

[0025] Plantago seed: clears away heat and dampness, clears heat and detoxifies.

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

[0027] Chuanxiong: promotes qi and relieves depression, promotes blood circulation and relieves pain, dispels wind and dampness.

[0028] Prunella Vulgaris: dispels stagnation and reduces swelling, promotes blood circulation and removes blood stasis.

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

[0030] Cuscuta: nourishes the liver and kidneys, strengthens the tendons and bones.

[0031] Angelica: replenishes blood, promotes blood circulation, regulates menstruation and relieves pain.

[0032] Ligustrum lucidum: nourishes the liver and kidneys, and replenishes the essence and blood.

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

[0034] Atractylodes macrocephala: strengthens the spleen and replenishes Qi, dredges the meridians.

[0035] Dandelion: reduces swelling and resolves lumps, reduces inflammation, and relieves symptoms of swelling and pain.

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

[0037] (1) The various raw materials of the present invention are reasonably compatible and can produce a synergistic effect. They have a good therapeutic effect on breast cancer, treat both the symptoms and the root causes, and can strengthen the body and eliminate evil, reduce toxicity and increase efficacy. The drug efficacy is definite, the possibility of tumor metastasis is reduced, the body's immunity is enhanced, and the patient's quality of life and survival rate are improved.

[0038] (2) The preparation method defined in the present invention can extract the active ingredients in the medicinal materials to the greatest extent, promote the pharmacological effects, and has natural ingredients, few side effects, and has broad application prospects. DETAILED DESCRIPTION

[0039] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. 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 work are within the scope of protection of the present invention.

[0040] Example 1

[0041] A Chinese medicine composition comprises, by weight: 270 parts of astragalus, 270 parts of moutan bark, 245 parts of cinnamon bark, 230 parts of sophora flavescens, 200 parts of plantain seeds, 200 parts of ephedra, 175 parts of ligusticum chuanxiong, 150 parts of selfheal, 110 parts of cnidium monnieri, 95 parts of dodder seeds, 95 parts of angelica sinensis, 70 parts of ligustri lucidi, 55 parts of rehmannia glutinosa, 30 parts of atractylodes macrocephala, and 16 parts of dandelion.

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

[0043] (1) Weighing each raw material according to the above weight parts;

[0044] (2) drying astragalus, peony bark, cinnamon bark, sophora flavescens, plantago seed, ephedra, ligusticum chuanxiong, and prunella vulgaris, grinding them in a ball mill, passing through a 180-mesh sieve to obtain a powder, mixing the powder with an ethanol aqueous solution, ultrasonically treating the mixture, performing reflux extraction, filtering, combining the filtrates, concentrating under reduced pressure, and freeze-drying to obtain extract A;

[0045] (3) drying Cnidium monnieri, Cuscuta australis, Angelica sinensis, Ligustrum lucidum, Rehmannia glutinosa, Atractylodes macrocephala, and Taraxacum officinale, grinding them in a ball mill, passing through a 180-mesh sieve to obtain a powder, soaking the powder in water, and then performing reflux extraction, filtering, combining the filtrates, centrifuging, concentrating the obtained supernatant under reduced pressure, and freeze-drying to obtain Extract B;

[0046] (4) The extract A and the extract B are mixed evenly, and freeze-dried to obtain a Chinese medicine composition.

[0047] The mass 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 time in step (2) is 60 min, the ultrasonic power is 150 W, and the ultrasonic frequency is 20 kHz.

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

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

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

[0052] Example 2

[0053] A Chinese medicine composition comprises, by weight: 300 parts of astragalus, 300 parts of peony bark, 265 parts of cinnamon bark, 250 parts of sophora flavescens, 225 parts of plantain seeds, 225 parts of ephedra, 185 parts of ligusticum chuanxiong, 160 parts of selfheal, 130 parts of cnidium monnieri, 100 parts of dodder seeds, 100 parts of angelica sinensis, 88 parts of ligustri lucidi, 60 parts of rehmannia glutinosa, 40 parts of atractylodes macrocephala, and 28 parts of dandelion.

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

[0055] (1) Weighing each raw material according to the above weight parts;

[0056] (2) drying astragalus, peony bark, cinnamon bark, sophora flavescens, plantago seed, ephedra, ligusticum chuanxiong, and prunella vulgaris, grinding them in a ball mill, passing through a 240-mesh sieve to obtain a powder, mixing the powder with an ethanol aqueous solution, ultrasonically treating the mixture, performing reflux extraction, filtering, combining the filtrates, concentrating under reduced pressure, and freeze-drying to obtain extract A;

[0057] (3) drying Cnidium monnieri, Cuscuta australis, Angelica sinensis, Ligustrum lucidum, Rehmannia glutinosa, Atractylodes macrocephala, and Taraxacum officinale, grinding them in a ball mill, passing through a 240-mesh sieve to obtain a powder, soaking the powder in water, and then performing reflux extraction, filtering, combining the filtrates, centrifuging, concentrating the obtained supernatant under reduced pressure, and freeze-drying to obtain Extract B;

[0058] (4) The extract A and the extract B are mixed evenly, and freeze-dried to obtain a Chinese medicine composition.

[0059] The mass 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 time in step (2) is 120 min, the ultrasonic power is 200 W, and the ultrasonic frequency is 40 kHz.

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

[0062] In step (3), the mass volume ratio of the 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 of the reduced pressure concentration is 60°C; the temperature of the freeze drying is -60°C and the pressure is 100Pa.

[0064] Example 3

[0065] A Chinese medicine composition comprises, by weight: 285 parts of astragalus, 285 parts of moutan bark, 250 parts of cinnamon bark, 240 parts of sophora flavescens, 215 parts of plantain seeds, 210 parts of ephedra, 178 parts of ligusticum chuanxiong, 156 parts of selfheal, 125 parts of cnidium monnieri, 96 parts of dodder seeds, 98 parts of angelica sinensis, 76 parts of ligustri lucidi, 58 parts of rehmannia glutinosa, 35 parts of atractylodes macrocephala, and 24 parts of dandelion.

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

[0067] Comparative Example 1

[0068] A Chinese medicine composition, which differs from Example 3 in that 285 parts of astragalus and 285 parts of peony bark are replaced by 570 parts of astragalus, and the rest are the same.

[0069] Comparative Example 2

[0070] A Chinese medicine composition, which differs from Example 3 in that 285 parts of astragalus and 285 parts of peony bark are replaced with 570 parts of peony bark, and the rest are the same.

[0071] Comparative Example 3

[0072] A Chinese medicine composition, which is different from Example 3 in that Astragalus is removed and the rest is the same as Example 3.

[0073] Comparative Example 4

[0074] A Chinese medicine composition, which is different from Example 3 in that astragalus and peony bark are removed, and the rest are the same.

[0075] Comparison document 5

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

[0077] Animal experiments

[0078] 80 SPF female SD Kunming rats weighing 150±10g were selected. After adaptive feeding for 1 week, 70 of the rats were implanted with 0.2ml of 3*10 7 The remaining 10 rats were treated with 0.2 ml of phosphate buffered saline in the same way as the blank group. The tumor size was measured and recorded. When the overall tumor volume of the rat reached 150 ± 10 mm 3 Afterwards, 70 rats were randomly divided into 7 groups, including: Example 1-3 groups, Comparative Example 1-3 groups, and model group; 10 rats in each group were gavaged with the corresponding drugs, and the dose was 5g of Chinese medicine composition / kg. The model group and the blank group were given an equal volume of normal saline. The drug was administered once every two days for 20 consecutive days. On the 21st day, all rats were killed and blood was collected through the abdominal aorta. The collected plasma was placed in a procoagulant tube and allowed to stand for 30 minutes, and then centrifuged at 3500r / min for 15 minutes to obtain serum. Tumor markers carbohydrate chain antigen (CA15-3) and carcinoembryonic antigen (CEA) were detected using an electrochemiluminescence immunoassay. The results are shown in Table 1.

[0079] It can be seen that the tumor increase volume, CA15-3 amount, and CEA amount after treatment of the present invention are significantly reduced, and the treatment effect of breast cancer is good, among which the prescription of Example 3 is the best. The comparative example curative effect is greatly reduced, especially when comparative example 4 does not contain astragalus and peony bark, the inhibitory effect on tumor is the worst. It is proved that the astragalus and peony bark in the raw materials of the present invention have a synergistic effect under a suitable ratio, which is very critical to the overall prescription and has a significant anti-tumor effect. At the same time, the raw materials of comparative example 5 are complete and still have a certain inhibitory effect, but without ultrasonic treatment, the content of effective ingredients is low, and the therapeutic effect is not good. Ultrasonic treatment can effectively extract the active ingredients in the medicinal materials and promote the formula to exert pharmacological effects.

[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, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0083] The above description of the disclosed embodiments enables one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to one 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 present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A Chinese medicine composition, characterized in that: The invention comprises the following raw materials: astragalus, peony bark, cinnamon bark, sophora flavescens, plantain seed, ephedra, ligusticum chuanxiong, herba prunellae, fructus cnidium, fructus dodder, angelica sinensis, fructus ligustri lucidi, rehmannia glutinosa, atractylodes macrocephala, and dandelion.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention comprises, by weight, 270-300 parts of astragalus, 270-300 parts of moutan bark, 245-265 parts of cinnamon bark, 230-250 parts of sophora flavescens, 200-225 parts of plantain seed, 200-225 parts of ephedra, 175-185 parts of ligusticum chuanxiong, 150-160 parts of selfheal, 110-130 parts of cnidium monnieri, 95-100 parts of dodder seed, 95-100 parts of angelica sinensis, 70-88 parts of ligustri lucidi, 55-60 parts of rehmannia glutinosa, 30-40 parts of atractylodes macrocephala, and 16-28 parts of dandelion.

3. The Chinese medicine composition according to any one of claims 1-2, characterized in that: The ingredients include, by weight: 285 parts of astragalus, 285 parts of peony bark, 250 parts of cinnamon, 240 parts of sophora flavescens, 215 parts of plantain seeds, 210 parts of ephedra, 178 parts of ligusticum chuanxiong, 156 parts of selfheal, 125 parts of cnidium monnieri, 96 parts of dodder seeds, 98 parts of angelica sinensis, 76 parts of ligustri lucidi, 58 parts of rehmannia glutinosa, 35 parts of atractylodes macrocephala, and 24 parts of dandelions.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The following steps are involved: (1) Weighing each raw material according to the above weight parts; (2) drying astragalus, peony bark, cinnamon bark, sophora flavescens, plantago seed, ephedra, ligusticum chuanxiong, and prunella vulgaris, grinding them in a ball mill, passing through a 180-240 mesh sieve to obtain a powder, mixing the powder with an ethanol aqueous solution, ultrasonically treating the mixture, performing reflux extraction, filtering, combining the filtrates, concentrating under reduced pressure, and freeze-drying to obtain extract A; (3) drying Cnidium monnieri, Cuscuta australis, Angelica sinensis, Ligustrum lucidum, Rehmannia glutinosa, Atractylodes macrocephala, and Taraxacum officinale, grinding them in a ball mill, passing through a 180-240 mesh sieve to obtain a powder, soaking the powder in water, and then performing reflux extraction, filtering, combining the filtrates, centrifuging, concentrating the obtained supernatant under reduced pressure, and freeze-drying to obtain extract B; (4) The extract A and the extract B are mixed evenly, and freeze-dried to obtain a Chinese medicine composition.

5. The method for preparing the Chinese medicine composition according to claim 4, characterized in that: The mass 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%.

6. The method for preparing the Chinese medicine composition according to claim 4, characterized in that: 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.

7. The method for preparing the Chinese medicine composition according to claim 4, characterized in that: The reflux extraction in step (2) is performed 2 to 4 times, each time for 2 to 3 hours.

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

9. The method for preparing the Chinese medicine composition according to claim 4, characterized in that: The temperature of the reduced pressure concentration is 50 to 60°C; the temperature of the freeze drying is -60 to -40°C, and the pressure is 90 to 100Pa.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in preparing a drug for treating breast cancer.