A traditional Chinese medicine composition for preventing and treating breast diseases and its preparation method

Abstract

The present invention discloses a traditional Chinese medicine composition for preventing and treating breast diseases, which is a preparation prepared from raw medicinal materials with the following weight ratios: 10-25 parts of ground beetle, 2-5 parts of centipede, 10-25 parts of iron leaf, and 10-30 parts of Oldenlandia diffusa. The clinical efficacy results show that the traditional Chinese medicine composition of the present invention has a significant effect on preventing and treating breast diseases. After patients take it for 2-4 courses of treatment, the symptoms can be alleviated or even completely cured, greatly reducing the treatment burden and providing a new drug option for clinical prevention and treatment of breast diseases.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine composition for preventing and treating breast diseases and a preparation method thereof, belonging to the field of medicine. Background Art

[0002] Breast diseases are a class of frequently-occurring diseases that endanger the physical and mental health of women. Clinically common types of diseases include mastitis, breast hyperplasia, breast fibroadenoma, breast cysts, breast cancer, etc. If such diseases are not treated in a timely manner or treated improperly, malignant transformation may occur, and in severe cases, even life-threatening may result. In recent years, due to reasons such as the improvement of living standards, less exercise, environmental pollution, and increased stress, people's endocrine disorders and immune decline have led to an increasing annual incidence of breast diseases, and the trend is towards younger age.

[0003] At present, there is no effective treatment for breast diseases. Modern medicine believes that the incidence of breast hyperplasia is mainly related to endocrine hormone disorders and mental factors, especially related to the disorder of hypothalamus-pituitary-gonadal hormones. Since this disease is caused by endocrine disorders, the sensitivity of the diseased tissue to drugs is poor, the mass disappears slowly, the treatment time is long, and sometimes it takes six months to one year for internal medications such as Xiaojindan, Rupixiao, and Tamoxifen Citrate Tablets to take effect. If timely treatment is not carried out or there is an obvious tendency to canceration, only simple mastectomy can be performed, bringing great pain to patients.

[0004] Therefore, providing a drug with definite curative effect for preventing and treating breast diseases has become an urgent problem to be solved. Summary of the Invention

[0005] The purpose of the present invention is to provide a traditional Chinese medicine composition for preventing and treating breast diseases and a preparation method thereof.

[0006] The present invention provides a traditional Chinese medicine composition for preventing and treating breast diseases, which is a preparation prepared from raw materials of the following weight ratios: 10-25 parts of ground beetle, 2-5 parts of centipede, 10-25 parts of sago cycas leaves, and 10-30 parts of oldenlandia diffusa.

[0007] Furthermore, it also contains raw materials of the following weight ratios: 12-30 parts of green tangerine peel, 15-30 parts of cyperus rotundus, 15-30 parts of Corydalis yanhusuo, 12-40 parts of caudate rehmannia root, 10-30 parts of semen vaccariae, 8-25 parts of sargentodoxa cuneata, and 12-30 parts of salvia miltiorrhiza.

[0008] Still further, it also contains raw materials of the following weight ratios: 10-20 parts of fructus aurantii carpophylum, 15-50 parts of prunella vulgaris fruits, and 12-40 parts of spina gleditsiae.

[0009] Preferably, it is a preparation prepared from the following raw medicinal materials in the following weight ratios: Eupolyphaga seu Steleophaga 10-25 parts, Scolopendra 2-5 parts, Cycas revoluta Thunb. leaves 10-25 parts, Hedyotis diffusa Willd. 10-30 parts, Pericarpium Citri Reticulatae Viride 12-30 parts, Rhizoma Cyperi 15-30 parts, Rhizoma Corydalis 15-30 parts, Caulis Spatholobi 12-40 parts, Semen Vaccariae 10-30 parts, Caulis Sargentodoxae 8-25 parts, Radix Salviae Miltiorrhizae 12-30 parts, Fructus Akebiae 10-20 parts, Spica Prunellae 15-50 parts, Spina Gleditsiae 12-40 parts.

[0010] More preferably, it is a preparation prepared from the following raw medicinal materials in the following weight ratios: Eupolyphaga seu Steleophaga 20 parts, Scolopendra 3 parts, Cycas revoluta Thunb. leaves 15 parts, Hedyotis diffusa Willd. 20 parts, Pericarpium Citri Reticulatae Viride 25 parts, Rhizoma Cyperi 30 parts, Rhizoma Corydalis 15 parts, Caulis Spatholobi 15 parts, Semen Vaccariae 15 parts, Caulis Sargentodoxae 10 parts, Radix Salviae Miltiorrhizae 15 parts, Fructus Akebiae 12 parts, Spica Prunellae 15 parts, Spina Gleditsiae 20 parts.

[0011] Furthermore, it is a preparation prepared from the crude drug powder of each raw medicinal material in the following weight ratios, the extract of water or organic solvent, and adding pharmaceutically acceptable excipients or auxiliary components.

[0012] Even further, the said preparation is an oral preparation.

[0013] Even further, the said preparation is powder, granule, pill, tablet, capsule or oral liquid.

[0014] The present invention provides a preparation method of the said traditional Chinese medicine composition, including the following steps: weighing the raw medicinal materials in each weight ratio, directly powdering, or extracting with water or organic solvent, and then adding pharmaceutically acceptable excipients or auxiliary components to obtain.

[0015] The present invention provides the use of the said traditional Chinese medicine composition in the preparation of drugs for treating and / or preventing breast diseases.

[0016] Furthermore, the said drug is a drug for treating and / or preventing mammary gland hyperplasia and breast cancer.

[0017] The present invention provides a traditional Chinese medicine composition for preventing and treating breast diseases. In the raw material formula, Eupolyphaga seu Steleophaga, Scolopendra, Hedyotis diffusa Willd., and Cycas revoluta Thunb. leaves promote blood circulation to remove blood stasis, clear heat and detoxify and inhibit cancer, and are the monarch drugs of this formula; Pericarpium Citri Reticulatae Viride, Rhizoma Cyperi, Rhizoma Corydalis, Caulis Sargentodoxae, Semen Vaccariae, Caulis Spatholobi, and Radix Salviae Miltiorrhizae soothe the liver and relieve depression, activate blood circulation and soften hardness, and are the minister drugs; the adjuvant drugs Fructus Akebiae and Spica Prunellae disperse and soften hardness, and the guiding drug Spina Gleditsiae guides the drugs to reach the liver. The above-mentioned various drugs cooperate with each other to jointly present the effects of promoting blood circulation to remove blood stasis, soothing the liver and regulating qi, dispersing and inhibiting cancer. The clinical efficacy results show that the traditional Chinese medicine composition of the present invention has a significant effect on preventing and treating breast diseases. After patients take it for 2-4 courses of treatment, the symptoms can be relieved or even completely cured, greatly reducing the treatment burden and providing a new drug option for clinical prevention and treatment of breast diseases.

[0018] Obviously, based on the above content of the present invention, and in accordance with the common general technical knowledge and conventional means in the art, without departing from the above basic technical concept of the present invention, various other forms of modifications, substitutions or changes can be made.

[0019] The following is a further detailed description of the above content of the present invention through specific embodiments in the form of examples. However, this should not be construed as limiting the scope of the above subject matter of the present invention to the following examples. All technologies implemented based on the above content of the present invention fall within the scope of the present invention. Specific Embodiments

[0020] The raw materials and equipment used in the specific embodiments of the present invention are all known products and are obtained by purchasing commercially available products.

[0021] Example 1 Preparation of the Traditional Chinese Medicine Composition of the Present Invention

[0022] Weigh 20 g of Eupolyphaga seu Steleophaga, 3 g of Scolopendra, 15 g of Cycas revoluta Thunb., 20 g of Hedyotis diffusa Willd., 25 g of Pericarpium Citri Reticulatae Viride, 30 g of Rhizoma Cyperi, 15 g of Corydalis yanhusuo W. T. Wang, 15 g of Caulis Spatholobi, 15 g of Semen Vaccariae, 10 g of Caulis Sargentodoxae, 15 g of Radix Salviae Miltiorrhizae, 12 g of Fructus Akebiae, 15 g of Spica Prunellae, 20 g of Spina Gleditsiae, pulverize them, and pass through a 100-mesh sieve. The obtained raw material powder is reserved for use.

[0023] Manual seedling making: At the 1 / 4 position of a clean and dry bamboo plaque, use a brush to smear a little water evenly to moisten the plaque surface, sprinkle a small amount of the above-mentioned medicinal powder on the wet plaque surface, hold the plaque with both hands, rotate the bamboo plaque to make all the medicines moist, then gently brush them down successively with a brush (that is, gently adjust them with the tip of the brush), rotate the bamboo plaque, move the moistened small particles to the other side (the dry part of the plaque), sprinkle a little fine medicinal powder, and shake the bamboo plaque to make all the small particles evenly adhere to the medicinal powder and shake them to another place. Then add a small amount of water to the original water-coated place, move the powder-coated particles to the water-coated place to roll, make them all adhere to the water, then turn to another dry place, sprinkle fine medicinal powder, and rotate the bamboo plaque again to make all the wet particles roll with the medicinal powder. Repeat such operations many times until relatively dense small round grains (such as about 0.5 - 1 mm in diameter) are formed. When they do not stick to the plaque, the plaque mold is completed. After selection for uniformity, further increase the size for shaping.

[0024] Increasing the size for shaping: After the mold is made, rotate the bamboo plaque repeatedly, and alternately add water and powder, and continuously rotate the medicinal plaque. The whole basic operation is to knead the dough and knock it over alternately to enhance the hardness and roundness of the pill grains until the pill grains are gradually increased in size and shaped.

[0025] Select the pills, cover the surface, and dry (below 60 degrees. When drying, the temperature should be gradually increased and continuously turned over to avoid generating yin and yang surfaces), and the pill form of the traditional Chinese medicine composition of the present invention is obtained.

[0026] Example 2 Preparation of the Traditional Chinese Medicine Composition of the Present Invention

[0027] Weigh 10g of Eupolyphaga sinensis, 5g of Scolopendra subspinipes, 25g of Cyperus rotundus, 10g of Hedyotis diffusa, 12g of Citrus aurantium, 15g of Cyperus rotundus, 30g of Corydalis yanhusuo, 40g of Radix Angelicae Sinensis, 10g of Vaccariae segetalis, 25g of Sargentophyllae, 30g of Salvia miltiorrhiza, 20g of Fructus Akebiae, 50g of Prunella Vulgaris, and 40g of Gleditsia sinensis, grind them, pass through a 100-mesh sieve, and the obtained raw material powder is set aside.

[0028] Mechanical demolding: Sprinkle the powder in the coating pan, spray water into the coating pan while it is rotating, so that all the powder becomes wet small particles, then add a small amount of fine powder, continue to roll for a certain period of time to make the small particles solid and dense, then spray water and sprinkle powder, repeat this operation to form a regular pill mold, and continue to shape after screening, (or first pour an appropriate amount of water into the pan, then add an appropriate amount of powder, evenly spread it in the entire pan, and then gently brush it from the opposite direction with a brush to get a loose lump, gently rub it with your hands to break the large ones, and continue to repeat the operation to form a pill mold.

[0029] Enlarging and shaping: After the mold is made, the bamboo plaque is rotated repeatedly, and water and powder are added alternately, and the medicine plaque is continuously rotated. The whole basic action is to knead the ball, knock it over, and do it alternately to enhance the hardness and roundness of the pellets until the pellets are gradually enlarged and shaped.

[0030] Select pills, cover the surface, and dry (below 60 degrees, the temperature should be gradually increased during drying, and the pills should be turned over continuously to avoid the generation of yin and yang sides), to obtain the Chinese medicine composition pills of the present invention.

[0031] The beneficial effects of the present invention are demonstrated by clinical experiments as follows.

[0032] Experimental Example 1 Clinical trial of the Chinese medicine composition of the present invention in preventing and treating breast diseases

[0033] 3000 patients with breast hyperplasia were treated using the Chinese medicine composition pills of the present invention prepared according to Example 1.

[0034] Take pill of the present invention for 2 courses of treatment (20 days / course of treatment), 3 times a day, 6 grams each time.

[0035] Treatment criteria for breast hyperplasia: refer to the "Diagnosis, Diagnosis and Therapeutic Effect Evaluation Criteria for Breast Hyperplasia" discussed and revised by the Breast Disease Professional Committee of the Chinese Society of Traditional Chinese Medicine Surgery in 2002.

[0036] Evaluation criteria for the efficacy of breast hyperplasia: refer to the "Diagnosis, Diagnosis and Therapeutic Effect Evaluation Criteria for Mammary Hyperplasia" discussed and revised by the Breast Disease Professional Committee of the Chinese Society of Traditional Chinese Medicine Surgery in 2002.

[0037] Clinical experimental results show that after 3,000 patients were treated with the Chinese medicine composition of the present invention, the total effective rate was 97%, among which the symptoms and signs of 2,790 patients completely disappeared, and the cure rate was as high as 93%.

[0038] In addition, the traditional Chinese medicine composition of the present invention can prevent actively proliferating cells from turning into cancer cells; can reverse the changes of grade III-IV nuclear atypia cells; and can prevent the further development of breast hyperplasia of type 4A and type 4C diagnosed by B-ultrasound into cancer. After follow-up of 5 to 10 years for the above-mentioned breast hyperplasia patients, none of them developed cancer.

[0039] The above clinical trial results show that the traditional Chinese medicine composition of the present invention has definite curative effect on breast hyperplasia, with a cure rate as high as 93%, and can also significantly reduce the incidence of breast cancer.

[0040] Experimental Example 2 Efficacy of Typical Cases of Breast Diseases

[0041] Typical Case 1

[0042] Name: Jiang xx, Gender: Female, Age: 32 years old, Occupation: Teacher, Marital Status: Married

[0043] Date of consultation: June 4, 2001

[0044] Chief complaint: Bilateral breast masses with pain for more than 5 years.

[0045] Current medical history: The patient went to the pathology department of the Affiliated Hospital of Southwest Medical University several times for cytological examination, which showed: right breast tumor-like hyperplasia with some actively proliferating cells. The patient had taken dozens of bottles of Xiaojindan, Rupixiao, Tamoxifen Citrate Tablets and many other drugs. The condition became more and more serious. The patient was afraid of canceration and was very anxious. The patient had a sallow complexion, red tongue with yellow coating, and taut and tense pulse.

[0046] Palpation: There was a mass about 2.5 cm in size at the 10 o'clock position of the right breast, hard in texture, irregular in shape, unclear in boundary, not adhered to the chest wall, and the skin was slightly sunken.

[0047] Diagnosis: Rupi (right breast tumor-like hyperplasia, left breast hyperplasia)

[0048] Treatment: Administer 8 courses (20 days / course) of the pills of the present invention, 3 times a day, 6 grams each time; instruct the patient to keep a happy mood.

[0049] A total of 8 courses were taken. After B-ultrasound examination by the Affiliated Hospital of Southwest Medical University, it showed: no abnormal changes in both breasts. After 15 years of follow-up, no recurrence was found.

[0050] Typical Case 2

[0051] Name: Lin XX, Gender: Female, Age 36 years old, Occupation: Farmer, Marital Status: Married

[0052] Date of consultation: November 23, 2015

[0053] Chief complaint: Bilateral breast distending pain for more than 3 months, aggravated for more than 1 week

[0054] History of present illness: The patient underwent a B-ultrasound examination at the Affiliated Hospital of Southwest Medical University, which showed: a solid mass in the right breast: classified as US-Bl-RADS 4A (further examination is recommended).

[0055] Upon observing the patient, it was found that the patient had a sallow complexion. During the interview, it was learned that the patient also suffered from moderate anemia. The tongue was pale with white coating, and the pulse was floating and weak. Palpation: There was a mass about 1.2 cm in size at about 8 o'clock in the right breast. The shape was irregular, the boundary was unclear, the surface of the mass was not smooth, the texture was tough, and it was less mobile.

[0056] Treatment: Administer 2 courses (20 days per course) of the pills of the present invention, 3 times a day, 6 grams each time.

[0057] Instruct the patient to keep a happy mood.

[0058] After taking the medicine for 2 courses, a B-ultrasound examination at the Affiliated Hospital of Southwest Medical University showed: bilateral breast US-BL-RADS 1 class.

[0059] In summary, the traditional Chinese medicine composition of the present invention has a significant effect in preventing and treating breast diseases. After the patient takes 2 to 4 courses, the symptoms can be relieved or even completely cured, greatly reducing the treatment burden and providing a new drug option for the clinical prevention and treatment of breast diseases.

Claims

1. A traditional Chinese medicine composition for preventing and treating breast diseases, characterized in that: It is a preparation prepared from raw medicinal materials with the following weight ratios: 20 parts of Eupolyphaga seu Steleophaga, 3 parts of Scolopendra, 15 parts of Cycas revoluta Thunb. leaves, 20 parts of Hedyotis diffusa Willd., 25 parts of Pericarpium Citri Reticulatae Viride, 30 parts of Rhizoma Cyperi, 15 parts of Rhizoma Corydalis, 15 parts of Caulis Spatholobi, 15 parts of Semen Vaccariae, 10 parts of Caulis Sargentodoxae, 15 parts of Radix Salviae Miltiorrhizae, 12 parts of Fructus Akebiae, 15 parts of Spica Prunellae, 20 parts of Spina Gleditsiae 2. The traditional Chinese medicine composition according to claim 1, wherein: a preparation prepared from the crude drug powder of raw medicinal materials with each weight ratio, extracts of water or organic solvents, and adding pharmaceutically acceptable excipients or auxiliary components.

3. The traditional Chinese medicine composition according to claim 2, wherein: The preparation mentioned above is an oral preparation.

4. The Chinese medicine composition according to claim 3, characterized in that: The preparation mentioned above is powder, granule, pill, tablet, capsule or oral liquid.

5. A preparation method of the traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that: It includes the following steps: weighing the raw medicinal materials with each weight ratio, directly powdering them, or extracting them with water or organic solvents, and then adding pharmaceutically acceptable excipients or auxiliary components to obtain the product.

6. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a drug for treating and / or preventing breast diseases.

7. The use according to claim 6, characterized in that: The drug mentioned above is a drug for treating and / or preventing mammary gland hyperplasia and breast cancer.