A traditional Chinese medicine formula for treating breast hyperplasia

Abstract

The present invention belongs to the field of pharmaceuticals, and specifically relates to a traditional Chinese medicine formula for treating breast hyperplasia. The formula is mainly composed of the following components: 10-15 grams of Naja naja, 10-15 grams of Prunella vulgaris, 8-10 grams of Clematidis, 10-15 grams of Rhizoma Australis, 8-10 grams of Radix Curcumae, and 8-10 grams of Rhizoma Curcumae. The formula uses Naja naja, Prunella vulgaris, Clematidis, Rhizoma Australis, Radix Curcumae, and Rhizoma Curcumae as raw materials, and has significant therapeutic effects, rapid effects, safe and reliable long-term use, and no toxic side effects.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine formula for treating breast hyperplasia. Background Art

[0002] Fibrocystic breast disease is a condition characterized by the proliferation and degeneration of breast tissue, with breast lumps and pain as the two main symptoms. According to surveys, approximately 70% of women experience varying degrees of fibrocystic breast disease. Currently, Western medicine typically treats fibrocystic breast disease with hormone receptor modulation therapy or surgical treatment. However, hormone therapy can cause menstrual irregularities or even amenorrhea; surgical treatment can leave scars that affect appearance. Furthermore, fibrocystic breast disease often recurs after surgery, requiring multiple and repeated surgeries, which can cause physical damage and significant psychological distress to patients. Existing Traditional Chinese Medicine (TCM) treatments for fibrocystic breast disease often utilize large amounts of blood-activating, qi-invigorating, and phlegm-resolving herbs. These aggressive, rapid-acting therapies often result in a loss of effectiveness, inevitably harming the body, and making them difficult to maintain for long-term use. Therefore, there is an urgent need to develop a new TCM formula for fibrocystic breast disease that is effective, fast-acting, safe, and reliable for long-term use, without toxic side effects, to address these deficiencies. Summary of the Invention

[0003] The technical problem to be solved by the present invention is achieved by the following technical solutions:

[0004] A traditional Chinese medicine formula for treating breast hyperplasia is mainly prepared from the following components: 10-15 grams of cobra, 10-15 grams of selfheal, 8-10 grams of clematis, 10-15 grams of atractylodes, 8-10 grams of turmeric, and 8-10 grams of zedoaria.

[0005] Preferably, a traditional Chinese medicine formula for treating breast hyperplasia is mainly composed of the following components: 15 grams of Naja, 15 grams of Prunella Vulgaris, 10 grams of Clematidis, 15 grams of August Zha, 10 grams of Curcuma, and 10 grams of Curcuma.

[0006] Preferably, the Chinese medicine formula for treating breast hyperplasia is prepared into an oral preparation.

[0007] Preferably, the oral preparation of the traditional Chinese medicine formula for treating breast hyperplasia is one of water decoction, oral liquid, granules, tablets, capsules and pills.

[0008] The present invention provides an application of the above-mentioned traditional Chinese medicine formula in preparing a medicine of the traditional Chinese medicine formula for treating breast hyperplasia.

[0009] Preferably, the present invention provides a traditional Chinese medicine preparation for treating breast hyperplasia, which is composed of the above-mentioned traditional Chinese medicine formula and pharmaceutically acceptable excipients.

[0010] Preferably, the dosage form of the traditional Chinese medicine preparation is ointment, granules, pills, powders, tablets, capsules or oral liquid.

[0011] Preferably, the pharmaceutically acceptable excipient is selected from at least one of a solvent, a diluent, a disintegrant, a precipitation inhibitor, a surfactant, a glidant, a binder, a lubricant, a dispersant, a suspending agent, an isotonic agent, a thickener, an emulsifier, a preservative, a stabilizer, a hydrating agent, an emulsification accelerator, a buffer, an absorbent, a colorant, a flavoring agent, a sweetener, an ion exchanger, a release agent, a coating agent, a flavoring agent or an antioxidant.

[0012] The pharmaceutical raw materials used in the present invention have the following pharmaceutical mechanisms:

[0013] Cobra: Sweet and salty in flavor, warm in nature; enters the liver and kidney meridians. It dispels wind, dredges the meridians, and relieves pain. It is commonly used for rheumatic pain, paralysis caused by stroke, and polio.

[0014] Prunella Vulgaris: Pungent, bitter, and cold. Enters the Liver and Gallbladder Meridians. It clears the liver and purges heat, improves eyesight, and relieves swelling. It can be used to treat red, swollen, and painful eyes, nighttime eye pain, headaches, dizziness, scrofula, goiters, mastitis, breast abscesses, and breast tenderness.

[0015] Clematis root: Spicy and salty in flavor, warm in nature. It enters the bladder meridian. It dispels rheumatism and dredges the meridians. It is used for rheumatic pain, numbness of the limbs, muscle spasms, and difficulty flexing and extending.

[0016] August Zha: Sweet, cold. Enters the Liver, Spleen, and Kidney meridians. It soothes the liver and regulates Qi, promotes blood circulation, dissipates blood stasis, relieves pain, and promotes urination. It is used for liver and stomach pain, stomach heat, loss of appetite, thirst, low back pain, flank pain, hernia, menopause, and uterine prolapse.

[0017] Curcuma: Pungent, bitter, and cold. It enters the Liver, Heart, and Lung meridians. It promotes blood circulation and relieves pain, promotes qi and relieves depression, clears the heart and cools blood, and promotes bile secretion and reduces jaundice. It is used for chest and flank pain, chest pain, amenorrhea, dysmenorrhea, breast tenderness, coma due to febrile illness, epilepsy, vomiting and epistaxis due to blood heat, and jaundice and dark urine.

[0018] Due to the adoption of the above technical scheme, the present invention has the following beneficial effects: the present invention adopts cobra, selfheal, clematis, aconite, turmeric and zedoaria as raw materials, has considerable therapeutic effect, quick effect, is safe and reliable for long-term use, and has no toxic side effects. DETAILED DESCRIPTION

[0019] The following examples may help those skilled in the art to more fully understand the present invention, but shall not limit the present invention in any way.

[0020] A traditional Chinese medicine formula for treating breast hyperplasia is mainly prepared from the following components: 10-15 grams of cobra, 10-15 grams of selfheal, 8-10 grams of clematis, 10-15 grams of atractylodes, 8-10 grams of turmeric, and 8-10 grams of zedoaria.

[0021] Example 1

[0022] A traditional Chinese medicine formula for treating breast hyperplasia is mainly prepared from the following components: 15 grams of cobra, 15 grams of selfheal, 10 grams of clematis, 15 grams of atractylodes, 10 grams of turmeric, and 10 grams of zedoaria.

[0023] A method for preparing a traditional Chinese medicine formula for treating breast hyperplasia comprises the following steps:

[0024] (1) Preparation: Weigh the ingredients of the formula according to the weight ratio, rinse and dry the cobra, selfheal, clematis, atractylodes, turmeric, and zedoaria respectively;

[0025] (2) Decoction: Add 3-5 times the amount of water as the raw material, decoct over low heat for 30-40 minutes, filter, and obtain 200-300 ml of filtrate.

[0026] Comparative Example 1

[0027] 15 grams of black-striped snake, 15 grams of selfheal, 10 grams of clematis, 15 grams of atractylodes, 10 grams of turmeric, and 10 grams of zedoaria.

[0028] A method for preparing a traditional Chinese medicine formula for treating breast hyperplasia, (1) preparing: weighing the raw materials of the formula according to the weight ratio, washing and drying the dwarf snake, selfheal, clematis, radix aconitifolia, turmeric, and zedoaria respectively;

[0029] (2) Decoction: Add 3-5 times the amount of water as the raw material, decoct over low heat for 30-40 minutes, filter, and obtain 200-300 ml of comparative filtrate.

[0030] Experimental example

[0031] The therapeutic effect of the Chinese medicine formula of Example 1 on mammary hyperplasia in SD rats was investigated as follows:

[0032] 1. Experimental Animals: 50 non-pregnant female SD rats weighing 180-220 g were fed a pelleted diet and observed for one week before entering the experimental period. Ten of these rats were injected with normal saline (0.02 mL / kg) every two days for a total of 15 injections, serving as a blank group. The remaining 40 rats, representing Example 1, Comparative Example 1, a model group, and a positive control group, were injected with estradiol benzoate (0.3 mg / kg; Tianjin Jinyao Pharmaceutical Co., Ltd.) and progesterone (4 mg / kg; Tianjin Jinyao Pharmaceutical Co., Ltd.) into the thigh muscles every two days for a total of 15 injections to establish a model of mammary hyperplasia.

[0033] 2. Experimental drugs: Take the filtrate prepared in Example 1 and set aside.

[0034] Rupixiao tablets (Liaoning Haohushi Pharmaceutical (Group) Co., Ltd., national medicine standard Z20121823) were crushed and dissolved in water to form a 20 mg / mL solution, which was used as the test drug for rats in the positive control group.

[0035] 3. Experimental procedure: The rats after modeling were randomly divided into 4 groups (Example 1 group, Comparative Example 1 group, model group and positive control group). The Example 1 group was given the filtrate of Example 1 by oral gavage once a day, 10 mL each time; the Comparative Example 1 group was given the comparison filtrate of Comparative Example 1 by oral gavage once a day, 10 mL each time; the positive control group was given Rupixiao solution by oral gavage once a day, 10 mL each time; the blank group and the model group were given 10 mL of normal saline once a day. After continuous oral gavage for one month, the rats were fasted for 24 hours after the last administration, and then the rat breast diameter and nipple height were measured with a vernier caliper. The results are shown in Table 1.

[0036] Group Breast diameter (mm) Nipple height (mm) Blank group 1.02±0.13 1.24±0.22 Model Group 1.89±0.12 2.27±0.43 Positive drug group 1.29±0.18 1.86±0.16 Comparative Example 1 1.27±0.42 1.89±0.41 Example 1 group 1.12±0.17 1.16±0.24

[0037] Table 1 Breast diameter and nipple height of rats in each group

[0038] As can be seen from table 1 data, there is a significant difference between the model group and the blank group, which illustrates that modeling is successful. Positive control group, compared with the model group, has significant differences in breast diameter and nipple height, proving that Rupixiao tablets can effectively improve the breast swelling problem that hyperplasia of the breast brings. Embodiment 1 group, compared to model group and Comparative Example 1, has significant differences in breast diameter and nipple height, proving that the embodiment of the present invention 1 can also suppress hyperplasia of the breast, and the effect of embodiment 1 is obviously better than Comparative Example 1 group simultaneously, effectively improves the breast swelling problem that hyperplasia of the breast brings, and effect is better than positive control group, i.e. Rupixiao tablets.

[0039] At the same time, it can be seen that the therapeutic effect of cobra as a raw material is better than that of garter snake as a raw material. Although garter snake and cobra belong to the same snake family, garter snake is obviously not as effective as cobra in regulating menstrual disorders. This shows that not any snake can achieve the effect achieved by the Chinese medicine formula for treating breast hyperplasia of the present invention.

[0040] During the above experiment, no mice in the experimental groups died, and after administration, the mice showed normal appearance, fur color, luster, social behavior, reactions, feeding, and excretion, indicating that the composition of the present invention is safe and reliable.

[0041] Although the present invention has been described in detail above using general descriptions and specific embodiments, it will be apparent to those skilled in the art that modifications and improvements may be made based on the present invention. Therefore, such modifications and improvements, which do not depart from the spirit of the present invention, are intended to be within the scope of protection claimed herein.

Claims

1. A Chinese medicine composition for treating breast hyperplasia, characterized in that: The invention is prepared from the following components: 10-15g of cobra, 10-15g of selfheal, 8-10g of clematis, 10-15g of atractylodes, 8-10g of turmeric, and 8-10g of zedoaria.

2. A Chinese medicine composition for treating mammary hyperplasia according to claim 1, characterized in that, It is made from the following ingredients: 15 grams of cobra, 15 grams of selfheal, 10 grams of clematis, 15 grams of august thrush, 10 grams of turmeric, and 10 grams of zedoaria.

3. A Chinese medicine composition for treating mammary hyperplasia according to any one of claims 1-2, characterized in that, The Chinese medicine composition is prepared into an oral preparation.

4. A Chinese medicine composition for treating mammary hyperplasia according to claim 3, characterized in that, The oral preparation is one of water decoction, oral liquid, granule, tablet, capsule and pill.

5. A method for preparing a Chinese medicine composition for treating breast hyperplasia according to claim 4, characterized in that: The following steps are involved: (1) Preparation: Weigh the ingredients of the formula according to the weight ratio, rinse and dry the cobra, selfheal, clematis, atractylodes, turmeric, and zedoaria respectively; (2) Decoction: Add 3-5 times the amount of water as the raw material, decoct over low heat for 30-40 minutes, filter, and obtain 200-300 ml of filtrate.