Drug composition for preventing and / or treating breast cancer, preparation method and use thereof

Abstract

The present invention discloses a pharmaceutical composition for preventing and / or treating breast cancer, and its preparation method and use. The pharmaceutical composition is prepared from components including the following raw materials: 6-11 parts by weight of Cyperus rotundus, 5-11 parts by weight of Bolbostemma paniculatum, 12-16 parts by weight of Fritillaria thunbergii, 6-16 parts by weight of Paeonia lactiflora, 9-31 parts by weight of Astragalus membranaceus, 6-13 parts by weight of Ligustrum lucidum, 6-11 parts by weight of Epimedium brevicornu, 3-6 parts by weight of Olibanum, 3-6 parts by weight of Myrrha, 12-15 parts of Psoralea corylifolia and 0.9-1.3 parts by weight of Momordica cochinchinensis. The pharmaceutical composition of the present invention can prevent and / or treat breast cancer, and has fewer types of raw materials.

Description

Technical Field

[0001] The present invention relates to a pharmaceutical composition for preventing and / or treating breast cancer, and also relates to a preparation method and use thereof. Background Art

[0002] Breast cancer is one of the most common malignant tumors in women, and its clinical symptoms can be diverse. Common ones include: breast lumps, breast pain, nipple discharge, erosion or skin depression, axillary lymph node enlargement, etc. The primary focus of breast cancer can be well controlled through means such as surgery, chemotherapy, and endocrine therapy, and it rarely endangers life. However, the recurrence and metastasis of breast cancer are often the main causes of patient death. The treatment methods and drugs for breast cancer are still being explored, and there is an urgent need for drugs with good efficacy and few side effects to benefit more patients. Many scholars at home and abroad have focused on traditional Chinese medicine in China. In particular, preventing recurrence and metastasis in high-risk populations after surgery is a key area for the future integrated traditional Chinese and Western medicine treatment of breast cancer and also the future development trend of tumor prevention and treatment.

[0003] CN102178818A discloses a traditional Chinese medicine composition for treating breast cancer and its preparation method. The traditional Chinese medicine composition consists of an oral medicine and an external medicine. The weight parts of various raw materials in the oral medicine are as follows: 10 - 20 parts of Paeonia lactiflora Pall., 10 - 20 parts of Codonopsis pilosula (Franch.) Nannf., 10 - 20 parts of Astragalus membranaceus (Fisch.) Bunge, 10 - 20 parts of Angelica sinensis (Oliv.) Diels, 10 - 20 parts of Drynaria fortunei (Kunze) J. Sm., 10 - 20 parts of Prunella vulgaris L., 10 - 20 parts of Gentiana scabra Bunge, 10 - 20 parts of Lithospermum erythrorhizon Sieb. et Zucc., 10 - 20 parts of Atractylodes macrocephala Koidz., 10 - 20 parts of Garcinia hanburyi Hook.f., 10 - 20 parts of Scorpio, 10 - 20 parts of Poria cocos (Schw.) Wolf, 10 - 20 parts of Pheretima aspergillum (E. Perrier), 10 - 20 parts of Herba Salviae Chinensis Benth., 10 - 20 parts of Psoralea corylifolia L., 10 - 20 parts of Olibanum, 10 - 20 parts of Cyperus rotundus L., 10 - 20 parts of Paris vietnamensis (Takht.) H. Li.

[0004] CN105726714A discloses a traditional Chinese medicine preparation for treating breast cancer and its preparation method. The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials: 15 - 20 parts of Bupleurum chinense DC., 15 - 20 parts of Astragalus membranaceus (Fisch.) Bunge, 25 - 30 parts of Perilla frutescens (L.) Britt., 25 - 30 parts of Codonopsis pilosula (Franch.) Nannf., 25 - 30 parts of Prunella vulgaris L., 25 - 30 parts of Oyster, 25 - 30 parts of Trichosanthes kirilowii Maxim., 25 - 30 parts of Gypsum Fibrosum, 25 - 30 parts of Citrus reticulata Blanco cv. Chachiensis Hort., 25 - 30 parts of Paeonia lactiflora Pall., 25 - 30 parts of Vaccaria segetalis (Neck.) Garcke, 8 - 10 parts of Glycyrrhiza uralensis Fisch., 8 - 10 parts of Ziziphus jujuba Mill., 3 - 5 parts of Bufo bufo gargarizans Cantor skin, 3 - 5 parts of Achyranthes bidentata Blume, 3 - 5 parts of Panax notoginseng (Burkill) F. H. Chen ex C. H. Chow, 10 - 15 parts of Astragalus membranaceus (Fisch.) Bunge, 25 - 30 parts of Limonite, 10 - 15 parts of Endothelium Corneum Gigeriae Galli, 6 - 8 parts of Gardenia jasminoides Ellis, 6 - 8 parts of Calculus Bovis, 3 - 5 parts of Moschus, 3 - 5 parts of Olibanum, 3 - 5 parts of Myrrha.

[0005] CN106362091A discloses a pharmaceutical composition for treating breast cancer. CN107375699A discloses a traditional Chinese medicine for treating breast cancer, which includes an oral formula and an external application formula. The traditional Chinese medicine in the above documents uses relatively many ingredients. Summary of the Invention

[0006] In view of this, the inventors of the present invention have found through in-depth research and experiments a pharmaceutical composition with fewer raw material types, which can have a good preventive and / or therapeutic effect on breast cancer.

[0007] On this basis, an object of the present invention is to provide a pharmaceutical composition for preventing and / or treating breast cancer.

[0008] Another object of the present invention is to provide a preparation method of the above-mentioned pharmaceutical composition.

[0009] Another object of the present invention is to provide a pharmaceutical preparation for preventing and / or treating breast cancer.

[0010] Another object of the present invention is to provide the pharmaceutical use of the above-mentioned pharmaceutical composition.

[0011] The present invention adopts the following technical solutions to achieve the above objects.

[0012] The present invention provides a pharmaceutical composition for preventing and / or treating breast cancer, which is prepared from components including the following raw materials:

[0013] Cyperus rotundus 6-11 parts by weight, Bolbostemma paniculatum 5-11 parts by weight, Fritillaria thunbergii 12-16 parts by weight, Paeonia lactiflora 6-16 parts by weight, Astragalus membranaceus 9-31 parts by weight, Ligustrum lucidum 6-13 parts by weight, Epimedium brevicornu 6-11 parts by weight, Olibanum 3-6 parts by weight, Myrrha 3-6 parts by weight, Psoralea corylifolia 12-15 parts by weight, and Momordica cochinchinensis 0.9-1.3 parts by weight.

[0014] According to the pharmaceutical composition of the present invention, preferably, the pharmaceutical composition is prepared from components including the following raw materials:

[0015] Cyperus rotundus 6-10 parts by weight, Bolbostemma paniculatum 5-10 parts by weight, Fritillaria thunbergii 12-15 parts by weight, Paeonia lactiflora 6-15 parts by weight, Astragalus membranaceus 9-30 parts by weight, Ligustrum lucidum 6-12 parts by weight, Epimedium brevicornu 6-10 parts by weight, Olibanum 3-5 parts by weight, Myrrha 3-5 parts by weight, Psoralea corylifolia 13-15 parts by weight, and Momordica cochinchinensis 0.9-1.2 parts by weight.

[0016] According to the pharmaceutical composition of the present invention, preferably, the pharmaceutical composition is only made of components of the following raw materials:

[0017] Cyperus rotundus 6 - 11 parts by weight, Bolbostemma paniculatum 5 - 11 parts by weight, Fritillaria thunbergii 12 - 16 parts by weight, Paeonia lactiflora 6 - 16 parts by weight, Astragalus membranaceus 9 - 31 parts by weight, Ligustrum lucidum 6 - 13 parts by weight, Epimedium brevicornu 6 - 11 parts by weight, Olibanum 3 - 6 parts by weight, Myrrha 3 - 6 parts by weight, Psoralea corylifolia 12 - 15 parts by weight, and Momordica cochinchinensis 0.9 - 1.3 parts by weight.

[0018] For the pharmaceutical composition according to the present invention, preferably, the pharmaceutical composition is made only from the following components of raw medicinal materials:

[0019] Cyperus rotundus 6 - 10 parts by weight, Bolbostemma paniculatum 5 - 10 parts by weight, Fritillaria thunbergii 12 - 15 parts by weight, Paeonia lactiflora 6 - 15 parts by weight, Astragalus membranaceus 9 - 30 parts by weight, Ligustrum lucidum 6 - 12 parts by weight, Epimedium brevicornu 6 - 10 parts by weight, Olibanum 3 - 5 parts by weight, Myrrha 3 - 5 parts by weight, Psoralea corylifolia 13 - 15 parts by weight, and Momordica cochinchinensis 0.9 - 1.2 parts by weight.

[0020] For the pharmaceutical composition according to the present invention, preferably, the pharmaceutical composition is made only from the following components of raw medicinal materials:

[0021] Cyperus rotundus 7 - 10 parts by weight, Bolbostemma paniculatum 6 - 10 parts by weight, Fritillaria thunbergii 13 - 15 parts by weight, Paeonia lactiflora 7 - 15 parts by weight, Astragalus membranaceus 10 - 30 parts by weight, Ligustrum lucidum 7 - 12 parts by weight, Epimedium brevicornu 7 - 10 parts by weight, Olibanum 4 - 5 parts by weight, Myrrha 4 - 5 parts by weight, Psoralea corylifolia 14 - 15 parts by weight, and Momordica cochinchinensis 1.0 - 1.2 parts by weight.

[0022] For the pharmaceutical composition according to the present invention, preferably, the pharmaceutical composition is made only from the following components of raw medicinal materials:

[0023] Cyperus rotundus 10 parts by weight, Bolbostemma paniculatum 10 parts by weight, Fritillaria thunbergii 15 parts by weight, Paeonia lactiflora 15 parts by weight, Astragalus membranaceus 30 parts by weight, Ligustrum lucidum 12 parts by weight, Epimedium brevicornu 10 parts by weight, Olibanum 5 parts by weight, Myrrha 5 parts by weight, Psoralea corylifolia 15 parts by weight, and Momordica cochinchinensis 1.2 parts by weight.

[0024] The present invention also provides a preparation method of the pharmaceutical composition as described above, comprising the following steps:

[0025] 1) Crush and sieve each component of the raw medicinal materials separately;

[0026] 2) Mix the sieved components evenly in a mixer according to the parts by weight to obtain a traditional Chinese medicine mixture;

[0027] 3) Soak the traditional Chinese medicine mixture in 6 - 15 times the weight of water for 1 - 3 h, heat under reflux for extraction 1 - 3 times, each time for 30 min - 2 h, separate the solid and liquid to obtain a filtrate, concentrate the filtrate, and dry the concentrate to obtain the pharmaceutical composition.

[0028] According to the preparation method of the present invention, preferably, in step 3), the traditional Chinese medicine mixture is soaked in 6-10 times the weight of water for 1-2 h, heated under reflux for extraction 1-2 times, each time for 40 min-1.5 h, solid-liquid separated to obtain a filtrate, the filtrate is concentrated, and the concentrate is dried to obtain the pharmaceutical composition.

[0029] The present invention also provides a pharmaceutical preparation for preventing and / or treating breast cancer, and the pharmaceutical preparation comprises the above-mentioned pharmaceutical composition and a pharmaceutically acceptable excipient.

[0030] The present invention also provides the use of the above-mentioned pharmaceutical composition in the preparation of a drug for preventing and / or treating breast cancer.

[0031] According to the preferred technical solution of the present invention, the pharmaceutical composition of the present invention is only made of the following raw material medicine components: 6-10 parts by weight of Cyperus rotundus, 5-10 parts by weight of Bolbostemma paniculatum, 12-15 parts by weight of Fritillaria thunbergii, 6-15 parts by weight of Paeonia lactiflora, 9-30 parts by weight of Astragalus membranaceus, 6-12 parts by weight of Ligustrum lucidum, 6-10 parts by weight of Epimedium brevicornu, 3-5 parts by weight of Olibanum, 3-5 parts by weight of Myrrha, 13-15 parts by weight of Psoralea corylifolia, and 0.9-1.2 parts by weight of Momordica cochinchinensis.

[0032] The pharmaceutical composition of the present invention is obtained on the basis of years of clinical experience in the prevention and treatment of breast cancer, with concise medicine and obvious curative effect. Cell experiments prove that the pharmaceutical composition of the present invention has a satisfactory inhibition rate on various types of breast cancer cells, and at the same time has less harm to normal cells and good safety. Detailed implementation manners

[0033] The present invention will be further described below in conjunction with specific embodiments, but the protection scope of the present invention is not limited thereto.

[0034] <Pharmaceutical composition>

[0035] The pharmaceutical composition of the present invention is prepared from the following raw material medicine components: 6-11 parts by weight of Cyperus rotundus, 5-11 parts by weight of Bolbostemma paniculatum, 12-16 parts by weight of Fritillaria thunbergii, 6-16 parts by weight of Paeonia lactiflora, 9-31 parts by weight of Astragalus membranaceus, 6-13 parts by weight of Ligustrum lucidum, 6-11 parts by weight of Epimedium brevicornu, 3-6 parts by weight of Olibanum, 3-6 parts by weight of Myrrha, 12-15 parts by weight of Psoralea corylifolia, and 0.9-1.3 parts by weight of Momordica cochinchinensis. In this way, it can not only prevent and treat breast cancer, but also reduce toxicity and side effects at the same time.

[0036] Preferably, the pharmaceutical composition of the present invention is prepared from components comprising the following raw medicinal materials: Cyperus rotundus 6-10 parts by weight, Bolbostemma paniculatum 5-10 parts by weight, Fritillaria thunbergii 12-15 parts by weight, Paeonia lactiflora 6-15 parts by weight, Astragalus membranaceus 9-30 parts by weight, Ligustrum lucidum 6-12 parts by weight, Epimedium brevicornu 6-10 parts by weight, Olibanum 3-5 parts by weight, Myrrha 3-5 parts by weight, Psoralea corylifolia 12-15 parts by weight, and Momordica cochinchinensis 0.9-1.2 parts by weight. More preferably, the pharmaceutical composition of the present invention is prepared from components comprising the following raw medicinal materials: Cyperus rotundus 7-10 parts by weight, Bolbostemma paniculatum 6-10 parts by weight, Fritillaria thunbergii 13-15 parts by weight, Paeonia lactiflora 7-15 parts by weight, Astragalus membranaceus 10-30 parts by weight, Ligustrum lucidum 7-12 parts by weight, Epimedium brevicornu 7-10 parts by weight, Olibanum 4-5 parts by weight, Myrrha 4-5 parts by weight, Psoralea corylifolia 13-15 parts by weight, and Momordica cochinchinensis 1.0-1.2 parts by weight.

[0037] In certain embodiments, the pharmaceutical composition of the present invention is made only from components of the following raw medicinal materials: Cyperus rotundus 6-11 parts by weight, Bolbostemma paniculatum 5-11 parts by weight, Fritillaria thunbergii 12-16 parts by weight, Paeonia lactiflora 6-16 parts by weight, Astragalus membranaceus 9-31 parts by weight, Ligustrum lucidum 6-13 parts by weight, Epimedium brevicornu 6-11 parts by weight, Olibanum 3-6 parts by weight, Myrrha 3-6 parts by weight, Psoralea corylifolia 12-15 parts by weight, and Momordica cochinchinensis 0.9-1.3 parts by weight.

[0038] In some other embodiments, the pharmaceutical composition of the present invention is made only from components of the following raw medicinal materials: Cyperus rotundus 6-10 parts by weight, Bolbostemma paniculatum 5-10 parts by weight, Fritillaria thunbergii 12-15 parts by weight, Paeonia lactiflora 6-15 parts by weight, Astragalus membranaceus 9-30 parts by weight, Ligustrum lucidum 6-12 parts by weight, Epimedium brevicornu 6-10 parts by weight, Olibanum 3-5 parts by weight, Myrrha 3-5 parts by weight, Psoralea corylifolia 13-15 parts by weight, and Momordica cochinchinensis 0.9-1.2 parts by weight.

[0039] In still some other embodiments, the pharmaceutical composition of the present invention is made only from components of the following raw medicinal materials: Cyperus rotundus 7-10 parts by weight, Bolbostemma paniculatum 6-10 parts by weight, Fritillaria thunbergii 13-15 parts by weight, Paeonia lactiflora 7-15 parts by weight, Astragalus membranaceus 10-30 parts by weight, Ligustrum lucidum 7-12 parts by weight, Epimedium brevicornu 7-10 parts by weight, Olibanum 4-5 parts by weight, Myrrha 4-5 parts by weight, Psoralea corylifolia 14-15 parts by weight, and Momordica cochinchinensis 1.0-1.2 parts by weight.

[0040] According to a specific embodiment of the present invention, the pharmaceutical composition of the present invention is made only from components of the following raw medicinal materials: Cyperus rotundus 10 parts by weight, Bolbostemma paniculatum 10 parts by weight, Fritillaria thunbergii 15 parts by weight, Paeonia lactiflora 15 parts by weight, Astragalus membranaceus 30 parts by weight, Ligustrum lucidum 12 parts by weight, Epimedium brevicornu 10 parts by weight, Olibanum 5 parts by weight, Myrrha 5 parts by weight, Psoralea corylifolia 15 parts by weight, and Momordica cochinchinensis 1.2 parts by weight.

[0041] Breast cancer is mainly caused by emotional disorders, stagnation of liver qi, blockage of meridians, stagnation of qi movement, endogenous phlegm turbidity and stasis of blood, which transform into heat and toxins over time; or disharmony between thoroughfare and conception vessels, deficiency of qi and blood, endogenous phlegm turbidity, blockage of qi movement and blood circulation, and accumulation over a long time. Under the long-term action of etiological factors such as the lurking pathogens of the six exogenous factors and the stagnant toxins of the seven emotions, the visceral functions of the body are affected, and over time, the viscera accumulate toxins without being transformed, leading to "endogenous cancer toxins".

[0042] In the present invention, Cyperus rotundus has the effects of soothing the liver and relieving depression, regulating qi and harmonizing the middle, and is designed for the main causes of emotional disorders and stagnation of liver qi in breast cancer; Paeonia lactiflora enters the liver meridian, softens the liver and relieves spasm, and restrains the warm-dispersing property of Cyperus rotundus; the two Fritillariae, namely Bolbostemma paniculatum and Fritillaria thunbergii, Bolbostemma paniculatum is slightly cold in nature and bitter in taste, with the functions of dissipating binds, reducing swelling and detoxifying, Fritillaria thunbergii is cold in nature and bitter in taste, clearing heat and resolving phlegm, dissipating binds and detoxifying. The two are used together, mainly attacking the dissipation of binds and resolving phlegm, and concurrently resolving heat toxins; Momordica cochinchinensis is bitter, slightly sweet, cool in nature, dissipating binds and reducing swelling, attacking toxins and treating sores. Its medicinal power is single and strong, but the dosage should not be excessive. When Momordica cochinchinensis is used together with the two Fritillariae, it can strongly dissipate binds and detoxify. Olibanum and Myrrha have strong effects of promoting qi and activating blood circulation. One is partial to regulating qi, and the other is partial to activating blood circulation, jointly exerting the effects of promoting qi and activating blood circulation and removing stasis; Astragalus membranaceus is sweet, slightly warm in nature, replenishing qi and lifting yang, benefiting the defensive qi and strengthening the exterior; Ligustrum lucidum is sweet, bitter, cool in nature, nourishing the liver and kidney, focusing on nourishing kidney yin, while Epimedium brevicornu and Psoralea corylifolia focus on nourishing kidney yang. The four herbs are used together to nourish kidney yin, kidney yang and the defensive qi on the body surface at the same time, taking into account both the interior and the exterior, and comprehensively enhancing the healthy qi of the human body. All the herbs are used together to jointly exert the effects of soothing the liver and regulating qi, dissipating binds and detoxifying, promoting blood circulation and removing stasis, strengthening the healthy qi and eliminating pathogenic factors.

[0043] The pharmaceutical composition of the present invention is obtained on the basis of many years of clinical experience in the prevention and treatment of breast cancer. Clinically, it can effectively delay or control the metastasis of the lesion, extend the survival period of breast cancer patients; it shows almost no toxicity and has unique advantages in aspects such as long-term sustainability and good effects. Cell experiments prove that the pharmaceutical composition of the present invention has a satisfactory inhibition rate on various types of breast cancer cells, and at the same time causes less damage to normal cells and has good safety.

[0044] <Preparation method>

[0045] The present invention also provides a preparation method of the pharmaceutical composition as described above, including the following steps:

[0046] 1) Crush and sieve each raw material drug component separately;

[0047] 2) Mix the sieved components evenly in a mixer according to the weight parts to obtain a traditional Chinese medicine mixture;

[0048] 3) Soak the traditional Chinese medicine mixture in 6-15 times the weight of water for 1-3 hours, heat under reflux and extract 1-3 times, each time for 30 minutes to 2 hours, separate the solid and liquid to obtain a filtrate, concentrate the filtrate, and dry the concentrate to obtain the pharmaceutical composition.

[0049] When soaking, the amount of water used is 6 to 15 times the weight of the traditional Chinese medicine mixture, preferably 6 to 12 times, more preferably 6 to 10 times, and still more preferably 8 to 9 times. The soaking time can be 1 to 3 hours, preferably 1 to 2 hours, more preferably 1.5 to 2 hours.

[0050] Perform heating under reflux extraction 1 to 3 times, preferably 1 to 2 times. The time for each heating under reflux extraction can be 30 minutes to 2 hours, preferably 40 minutes to 1.5 hours, more preferably 1 to 1.5 hours.

[0051] The drying method can be those conventional in the art, and preferably freeze-drying method is adopted. According to the preferred embodiment of the present invention, the freeze-drying temperature is lower than -35°C.

[0052] <Pharmaceutical Preparation and Use>

[0053] The present invention also provides a pharmaceutical preparation for preventing and / or treating breast cancer, which pharmaceutical preparation comprises the above-mentioned pharmaceutical composition and pharmaceutically acceptable excipients. The dosage form of the preparation is not limited, and for example, it can be tablets, pills, capsules, granules, etc.

[0054] The present invention also provides the use of the above-mentioned pharmaceutical composition in the preparation of a drug for preventing and / or treating breast cancer.

[0055] Example 1

[0056] Crush and sieve each raw material drug component separately. Mix the sieved components evenly in a mixer according to the weight parts to obtain a traditional Chinese medicine mixture. Among them, each component is: 10 parts by weight of Cyperus rotundus, 10 parts by weight of Bolbostemma paniculatum, 15 parts by weight of Fritillaria thunbergii, 15 parts by weight of Paeonia lactiflora, 30 parts by weight of Astragalus membranaceus, 12 parts by weight of Ligustrum lucidum, 10 parts by weight of Epimedium brevicornu, 5 parts by weight of Olibanum, 5 parts by weight of Myrrha, 15 parts by weight of Psoralea corylifolia, 1.2 parts by weight of Momordica cochinchinensis.

[0057] Example 2

[0058] Soak the traditional Chinese medicine mixture obtained by the method of Example 1 with 8 times the weight of water for 2 hours, then perform heating under reflux extraction for 1 hour, then filter, concentrate the obtained filtrate under reduced pressure to obtain a concentrate, and lyophilize the concentrate to obtain a pharmaceutical composition.

[0059] Comparative Example 1

[0060] The difference from Example 2 is only that 128.2 parts by weight of Cyperus rotundus alone is used instead of the traditional Chinese medicine mixture. The obtained freeze-dried product is Cyperus rotundus extract.

[0061] Comparative Example 2

[0062] The difference from Example 2 is only that 128.2 parts by weight of Fritillaria thunbergii alone are used to replace the traditional Chinese medicine mixture. The freeze-dried product obtained is Fritillaria thunbergii extract.

[0063] Comparative Example 3

[0064] The difference from Example 2 is only that 128.2 parts by weight of Paeonia lactiflora alone are used to replace the traditional Chinese medicine mixture. The freeze-dried product obtained is Paeonia lactiflora extract.

[0065] Comparative Example 4

[0066] The difference from Example 2 is only that 128.2 parts by weight of Astragalus membranaceus alone are used to replace the traditional Chinese medicine mixture. The freeze-dried product obtained is Astragalus membranaceus extract.

[0067] Comparative Example 5

[0068] The difference from Example 2 is only that 128.2 parts by weight of Glossy Privet Fruit alone are used to replace the traditional Chinese medicine mixture. The freeze-dried product obtained is Glossy Privet Fruit extract.

[0069] Comparative Example 6

[0070] The difference from Example 2 is only that 128.2 parts by weight of Olibanum alone are used to replace the traditional Chinese medicine mixture. The freeze-dried product obtained is Olibanum extract.

[0071] Comparative Example 7

[0072] The difference from Example 2 is only that 128.2 parts by weight of Myrrh alone are used to replace the traditional Chinese medicine mixture. The freeze-dried product obtained is Myrrh extract.

[0073] Comparative Example 8

[0074] The difference from Example 2 is only that 128.2 parts by weight of Momordica cochinchinensis alone are used to replace the traditional Chinese medicine mixture. The freeze-dried product obtained is Momordica cochinchinensis extract.

[0075] Experimental Example

[0076] 1. Experimental materials

[0077] Complete medium: RPMI-1640 (C11875500BT, Gibco), DMEM (10-013-CV, CORNING) containing 10% fetal bovine serum (FBS) (35-081-cv, CORNING) and double antibiotics (Pen Strep) (15140-122, Gibco). The MTT solution was purchased from Beijing Lamboride Biotechnology Co., Ltd., and the batch number was 0793-1g-1. Human breast cancer cells MDA-MB-231, MCF-7 and LO2 were all purchased from the Cell Center of the Institute of Basic Medicine, Chinese Academy of Medical Sciences, and the SK-BR-3 cell line was purchased from ATCC.

[0078] 2. Experimental methods

[0079] 2.1 Process the freeze-dried products of Example 2 and the comparative examples

[0080] Specific steps: Dissolve the freeze-dried sample with complete medium (DMEM / 1640 basal medium, 10% fetal bovine serum, 1% double antibiotics) to a mother liquor concentration of 50 mg·ml -1 . After filtering with a 0.22 μm microporous membrane, store it in a refrigerator at 4°C for subsequent verification of drug efficacy.

[0081] 2.2 IC 50 and the test of cell proliferation inhibition rate

[0082] 2.2.1 Determination method of IC 50

[0083] Determination method and calculation formula: Use a multimode microplate detection system to measure the OD value of each well at a wavelength of 490 nm; calculation method: Use graphpad prism8.0 for calculation.

[0084] 2.2.2 Determination method of cell proliferation inhibition rate

[0085] Digest MDA-MB-231, MCF-7, SK-BR-3, and LO2 cells in the logarithmic growth phase. After digestion, gently pipette to make a single-cell suspension. After dilution, count with a cell counting plate and then dilute the cell density to 2.5×10 4 cells / mL. After mixing, inoculate 100 μL into each well of a 96-well plate and place it in a cell culture incubator for 24 h to allow it to adhere completely. Then aspirate the old medium for drug administration treatment.

[0086] 50 mg·ml -1The drug composition of Example 2 and the mother liquor of each single drug extract of each comparative example were diluted with RPMI1640 / DMEM complete medium into a working solution of 5 mg / mL (the concentration here refers to the crude drug concentration), and then further diluted with RPMI1640 / DMEM complete medium into working solutions of each concentration (4 mg / mL, 3 mg / mL, 2 mg / mL, 1 mg / mL respectively). Five replicate wells were set for each concentration, and three blank wells were set to reduce the influence of background. After culturing for 24 h, 48 h, and 72 h respectively, the old drug-containing medium was aspirated. Under the condition of avoiding light, 100 μL of 10% MTT solution diluted with basic medium was added to each well, and then it was placed in an incubator at 37 °C for 4 h. After the incubation was completed, the MTT solution in the 96-well plate was aspirated, and 150 μL of DMSO solution was added to each well under the condition of avoiding light. It was placed on a horizontal shaker in the dark and shaken for 5 - 10 min until the purple crystals were completely dissolved. The OD value of each well at a wavelength of 490 nm was measured with a multimode microplate detection system, and the cell proliferation inhibition rate was calculated.

[0087] Cell survival rate = [(experimental group - blank group) / (control group - blank group)] * 100%;

[0088] Cell proliferation inhibition rate = 100% - cell survival rate.

[0089] 3. Experimental results

[0090] 3.1 IC 50 Measurement results

[0091] The IC 50 of the drugs in Example 2 and the comparative examples in MDA-MB-231 cells and MCF-7 cells 50 The results are shown in Table 1. In Table 1, IC 50 -MD represents the IC 50 in MDA-MB-231 cells, and IC 50 -MC represents the IC 50 in MCF-7 cells; the unit of IC

[0092] Table 1

[0093]

[0094] 3.2 Measurement results of cell proliferation inhibition rate

[0095] 3.2.1 The experimental results of the cell proliferation inhibition rates of the drug compositions of Example 2 and Comparative Examples 1 - 8 on breast cancer cell lines MDA-MB-231 cells, MCF-7 cells, and SK-BR-3 cells, as well as human normal liver cells LO2 cells are shown in Tables 2, 3, 4, and 5 respectively.

[0096] Table 2

[0097]

[0098] Table 3

[0099]

[0100] Table 4

[0101]

[0102] Table 5

[0103]

[0104] As can be seen from Table 2 and Table 5, when the administration concentration of the pharmaceutical composition of the present invention is 5 mg / mL, the pharmaceutical composition of the present invention has a very significant inhibitory effect on MDA-MB-231 cells, reaching 99.17%. Among the single components, Comparative Example 3 (Paeonia lactiflora extract), Comparative Example 6 (Boswellia carterii extract), and Comparative Example 7 (Commiphora myrrha extract) also have good inhibitory effects, but at the same time, these individual component extracts have obvious inhibitory effects on normal cells LO2 cells and have relatively high toxicity.

[0105] As can be seen from Table 3 and Table 5, Comparative Example 3 (Paeonia lactiflora extract), Comparative Example 6 (Boswellia carterii extract), Comparative Example 7 (Commiphora myrrha extract), and Comparative Example 8 (Momordica cochinchinensis extract) have good inhibitory effects on MCF-7 cells, but at the same time, these individual component extracts have obvious inhibitory effects on normal cells LO2 cells and have relatively high toxicity. Therefore, they cannot be used alone as drugs for preventing and treating breast cancer. The pharmaceutical composition of the present invention can not only have a significant inhibitory effect on breast cancer cells, but also have a relatively weak inhibitory effect on normal cells, that is, relatively low toxicity. Therefore, the pharmaceutical composition of the present invention can be used for the preparation of drugs for preventing and / or treating breast cancer.

[0106] As can be seen from Table 4 and Table 5, Comparative Example 3 (Paeonia lactiflora extract), Comparative Example 6 (Boswellia carterii extract), Comparative Example 7 (Commiphora myrrha extract), and Comparative Example 8 (Momordica cochinchinensis extract) have good inhibitory effects on SK-BR-3 cells, but at the same time, these individual component extracts have obvious inhibitory effects on normal cells LO2 cells and have relatively high toxicity. Therefore, they cannot be used alone as drugs for preventing and treating breast cancer. The pharmaceutical composition of the present invention can not only have a significant inhibitory effect on breast cancer cells, but also have a relatively weak inhibitory effect on normal cells, that is, relatively low toxicity. Therefore, the pharmaceutical composition of the present invention can be used for the preparation of drugs for preventing and / or treating breast cancer.

[0107] In summary, the pharmaceutical composition of the present invention has a significant inhibitory effect on human breast cancer cells of each subtype, and has a relatively small inhibitory effect on the proliferation of normal cells, is safe to use, and is suitable for preparing drugs for preventing and / or treating breast cancer.

[0108] The present invention is not limited to the above embodiments, and any variations, improvements, and substitutions that can be conceived by those skilled in the art without departing from the essence of the present invention fall within the scope of the present invention.

Claims

1. A pharmaceutical composition for treating breast cancer, characterized in that, the pharmaceutical composition is prepared from the following raw materials: Cyperus rotundus 6-11 parts by weight, Bolbostemma paniculatum 5-11 parts by weight, Fritillaria thunbergii 12-16 parts by weight, Paeonia lactiflora 6-16 parts by weight, Astragalus membranaceus 9-31 parts by weight, Ligustrum lucidum 6-13 parts by weight, Epimedium brevicornu 6-11 parts by weight, Olibanum 3-6 parts by weight, Myrrha 3-6 parts by weight, Psoralea corylifolia 12-15 parts by weight and Momordica cochinchinensis 0.9-1.3 parts by weight.

2. The pharmaceutical composition according to claim 1, characterized in that, the pharmaceutical composition is prepared from the following raw materials: Cyperus rotundus 6-10 parts by weight, Bolbostemma paniculatum 5-10 parts by weight, Fritillaria thunbergii 12-15 parts by weight, Paeonia lactiflora 6-15 parts by weight, Astragalus membranaceus 9-30 parts by weight, Ligustrum lucidum 6-12 parts by weight, Epimedium brevicornu 6-10 parts by weight, Olibanum 3-5 parts by weight, Myrrha 3-5 parts by weight, Psoralea corylifolia 13-15 parts by weight and Momordica cochinchinensis 0.9-1.2 parts by weight.

3. The pharmaceutical composition according to claim 1, characterized in that, the pharmaceutical composition is prepared from the following raw materials: Cyperus rotundus 6-11 parts by weight, Bolbostemma paniculatum 5-11 parts by weight, Fritillaria thunbergii 12-16 parts by weight, Paeonia lactiflora 6-16 parts by weight, Astragalus membranaceus 9-31 parts by weight, Ligustrum lucidum 6-13 parts by weight, Epimedium brevicornu 6-11 parts by weight, Olibanum 3-6 parts by weight, Myrrha 3-6 parts by weight, Psoralea corylifolia 12-15 parts by weight and Momordica cochinchinensis 0.9-1.3 parts by weight.

4. The pharmaceutical composition according to claim 1, characterized in that, the pharmaceutical composition is prepared from the following raw materials: Cyperus rotundus 6-10 parts by weight, Bolbostemma paniculatum 5-10 parts by weight, Fritillaria thunbergii 12-15 parts by weight, Paeonia lactiflora 6-15 parts by weight, Astragalus membranaceus 9-30 parts by weight, Ligustrum lucidum 6-12 parts by weight, Epimedium brevicornu 6-10 parts by weight, Olibanum 3-5 parts by weight, Myrrha 3-5 parts by weight, Psoralea corylifolia 13-15 parts by weight and Momordica cochinchinensis 0.9-1.2 parts by weight.

5. The pharmaceutical composition according to claim 4, characterized in that, the pharmaceutical composition is prepared from the following raw materials: Cyperus rotundus 7-10 parts by weight, Bolbostemma paniculatum 6-10 parts by weight, Fritillaria thunbergii 13-15 parts by weight, Paeonia lactiflora 7-15 parts by weight, Astragalus membranaceus 10-30 parts by weight, Ligustrum lucidum 7-12 parts by weight, Epimedium brevicornu 7-10 parts by weight, Olibanum 4-5 parts by weight, Myrrha 4-5 parts by weight, Psoralea corylifolia 14-15 parts by weight and Momordica cochinchinensis 1.0-1.2 parts by weight.

6. The pharmaceutical composition according to claim 1, characterized in that, the pharmaceutical composition is prepared from the following raw materials: Cyperus rotundus 10 parts by weight, Bolbostemma paniculatum 10 parts by weight, Fritillaria thunbergii 15 parts by weight, Paeonia lactiflora 15 parts by weight, Astragalus membranaceus 30 parts by weight, Ligustrum lucidum 12 parts by weight, Epimedium brevicornu 10 parts by weight, Olibanum 5 parts by weight, Myrrha 5 parts by weight, Psoralea corylifolia 15 parts by weight and Momordica cochinchinensis 1.2 parts by weight.

7. The preparation method of the pharmaceutical composition according to any one of claims 1-6, characterized in that, it comprises the following steps: 1) Crushing and sieving each raw material component respectively; 2) Mix the sieved components evenly in a mixer according to the weight parts to obtain a traditional Chinese medicine mixture; 3) Soak the traditional Chinese medicine mixture in 6 to 15 times the weight of water for 1 to 3 hours, heat under reflux for extraction 1 to 3 times, each time for 30 minutes to 2 hours, separate the solid and liquid to obtain a filtrate, concentrate the filtrate, and dry the concentrate to obtain a pharmaceutical composition.

8. According to the preparation method described in claim 7, wherein, in step 3), soak the traditional Chinese medicine mixture in 6 to 10 times the weight of water for 1 to 2 hours, heat under reflux for extraction 1 to 2 times, each time for 40 minutes to 1.5 hours, separate the solid and liquid to obtain a filtrate, concentrate the filtrate, and dry the concentrate to obtain a pharmaceutical composition.

9. A pharmaceutical preparation for treating breast cancer, wherein, the pharmaceutical preparation is made from the pharmaceutical composition according to any one of claims 1 to 6 and pharmaceutically acceptable excipients.

10. Use of the pharmaceutical composition according to any one of claims 1 to 6 in the preparation of a drug for treating breast cancer.

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