Pharmaceutical composition for treating hyperplasia of mammary glands and breast nodules and application thereof

Abstract

The invention discloses a pharmaceutical composition for treating hyperplasia of mammary glands and breast nodules and application of the pharmaceutical composition. The pharmaceutical composition is prepared from semen hyoscyami, rhizoma paridis, semen litchi, radix cynanchi paniculati, frankincense and herba asari. The preparation of the medicine is prepared by the following steps: crushing semen hyoscyami, rhizoma paridis, semen litchi, radix cynanchi paniculati, frankincense and herba asari into fine powder; extracting part of the fine powder by using a solvent extraction method, and concentrating into extract; and uniformly mixing the extract with the residual fine powder, and blending with vinegar paste to prepare the external preparation. The obtained medicine has the effects of promoting qi to activate blood, removing stasis and diminishing swelling, and relieving swelling and pain, and is used for diseases such as breast nodules and hyperplasia of mammary glands; the preparation is scientific and reasonable in formula compatibility, quick in effect, capable of treating both symptoms and root causes, low in recurrence rate and free of toxic and side effects.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a pharmaceutical composition for treating breast hyperplasia and breast nodules and an application thereof. Background Art

[0002] Breast hyperplasia and breast nodules are degenerative diseases caused by the proliferation of breast fiber and epithelial tissue. The clinical manifestations are mainly hard lumps on both or one side of the breast, often accompanied by pain. The condition of this disease is related to the menstrual cycle and emotional changes, and it is more common in women aged 25-44. Breast hyperplasia and breast nodules have the characteristics of high incidence, difficult to cure, and easy recurrence. In recent years, the incidence of breast hyperplasia has increased year by year, and the onset has a trend of younger age. This disease has a certain tendency to malignant transformation. Among them, patients with severe breast hyperplasia, atypical breast hyperplasia and cystic breast hyperplasia have a higher incidence of breast cancer, so we should be vigilant about this disease, diagnose it early, and treat it early.

[0003] At present, drug treatment is the main treatment for breast hyperplasia and breast nodules, generally oral chemical drugs or traditional Chinese medicine are used, and there are also surgical operations to treat breast masses. Commonly used chemical drugs include hormones, iodine traditional Chinese medicine preparations and tamoxifen, but these drugs can only relieve pain and have poor efficacy; commonly used traditional Chinese medicines include Xiaojieling, Rukuaixiao, Runing, Rukang Tablets, Xiaoyaosan, Danzhixiaoyaosan and other traditional Chinese medicine prescriptions, which have certain efficacy in the treatment of breast hyperplasia and breast nodules, but the medication cycle is long, the effect is poor, and it is easy to relapse, and the efficacy of drugs still needs to be improved. Summary of the invention

[0004] Based on this, it is necessary to provide a pharmaceutical composition and its application for treating breast hyperplasia and breast nodules to address the problems that the current drugs used to treat breast hyperplasia and breast nodules have poor therapeutic effects and unclear clinical mechanisms of action.

[0005] The present invention provides a pharmaceutical composition for treating breast hyperplasia and breast nodules, the pharmaceutical composition is composed of the following raw materials in parts by weight: 5-30 parts of Hyoscyamus chinensis, 5-30 parts of Paris polyphylla, 15-60 parts of litchi seed, 10-45 parts of Cynanchum paniculatum, 10-40 parts of frankincense, and 10-40 parts of Asarum. Preferably, the pharmaceutical composition is composed of the following raw materials in parts by weight: 10-20 parts of Hyoscyamus chinensis, 10-20 parts of Paris polyphylla, 20-50 parts of litchi seed, 15-35 parts of Cynanchum paniculatum, 15-30 parts of frankincense, and 15-30 parts of Asarum. More specifically, the pharmaceutical composition is composed of the following raw materials in parts by weight: 5 parts of Hyoscyamus chinensis, 5 parts of Paris polyphylla, 30 parts of litchi seed, 20 parts of Cynanchum paniculatum, 10 parts of frankincense, and 10 parts of Asarum.

[0006] The present invention also provides a pharmaceutical preparation for treating breast hyperplasia and breast nodules, which is prepared from the pharmaceutical composition for treating breast hyperplasia and breast nodules described in any of the previous technical solutions. Preferably, the pharmaceutical preparation is an external preparation, which is prepared according to the following steps:

[0007] (1) Preparation of a pharmaceutical composition for treating breast hyperplasia and breast nodules:

[0008] ① Weigh henbane, paridis, litchi seeds, cynanchum, frankincense and asarum by weight, crush into fine powder and mix well;

[0009] ②Take 1 / 5-4 / 5 of the above fine powder, add 60-85% ethanol aqueous solution to reflux and extract 1-3 times, each time for 1-3 hours, filter, combine the filtrate, and concentrate under reduced pressure to an extract with a relative density of 1.0-1.3 (45°C);

[0010] ③ Combine the extract from step ② and the remaining fine powder from step ①, add 1-5 times the weight ratio of vinegar paste, mix well and set aside.

[0011] (2) Preparation of external preparations:

[0012] The drug obtained in step ③ is evenly coated on non-woven fabric or other backing materials, and cut into external patches or plasters.

[0013] Preferably, the pharmaceutical preparation is prepared by taking 1 / 5-3 / 5 of the fine powder, and extracting and concentrating it into an extract by a solvent extraction method. Preferably, the pharmaceutical preparation is added with 1-2 times the weight of vinegar paste and mixed evenly.

[0014] In addition, the present invention also provides the use of the pharmaceutical composition and pharmaceutical preparation for treating breast hyperplasia and breast nodules as described in any of the previous technical solutions in the preparation of drugs for treating breast hyperplasia and breast nodules.

[0015] The pharmaceutical composition for treating breast hyperplasia and breast nodules of the present invention is explained as follows:

[0016] In the pharmaceutical composition for treating breast hyperplasia and breast nodules of the present invention, the hyssop is bitter and pungent in taste and enters the heart, stomach and liver meridians. The pungent taste is good at opening and draining, and the bitter taste is good at descending, which is beneficial to dredging meridians and promoting smooth qi movement. The parsley has the effects of clearing away heat, detoxicating, reducing swelling and relieving pain. The two are used together, one dispersing and the other eliminating, to achieve the functions of promoting qi and blood circulation, dispersing nodules and reducing swelling. The two are monarch drugs; the litchi seed promotes qi and resolves nodules, dispels cold and relieves pain, and the cynanchum promotes qi and activates blood circulation, removes toxins and reduces swelling. The two are matched to strengthen the monarch drug in promoting qi and resolving nodules, so they are minister drugs; the frankincense is pungent and bitter in flavor and warm in nature. The pungent taste can disperse, the pungent fragrance can warm and promote circulation, the bitter taste can break, and the frankincense can enter both the blood and the qi, and has the functions of promoting blood circulation, reducing swelling and promoting tissue regeneration, promoting qi and activating blood circulation, reducing swelling and relieving pain, so it is an adjuvant drug; the asarum is pungent in nature and warm in nature. Xinnengsan can promote circulation. According to the Annotated Compendium of Materia Medica, it is mainly used to relieve gas, break up phlegm, open the chest, and relieve milk knots, so it can promote qi and eliminate knots. The various drugs in this drug combination are used together to regulate qi and blood, take both the symptoms and the root cause into consideration, and together they have the effects of softening and dispersing knots, promoting qi and blood circulation, and relieving swelling and pain.

[0017] Specifically, each drug substance has the following pharmacological properties:

[0018] Hyoscyamus niger L. is the dried mature seed of the Solanaceae plant. In summer and autumn, when the peel turns yellow, the fruit is picked, exposed to the sun, the seeds are beaten, the peel and stalks are sieved out, and the fruit is dried in the sun. It tastes bitter, pungent, and warm. It enters the heart, stomach, and liver meridians. It has the effects of promoting qi and blood circulation, dispersing stagnation and reducing swelling.

[0019] Paris polyphylla is the dried rhizome of Paris polyphylla Smith var. yunnanensis (Franch.) Hand.-Mazz. or Paris polyphylla Smith var. chinensis (Franch.) Hara, a plant of the Liliaceae family. It is harvested in autumn, the fibrous roots are removed, washed, and dried in the sun. It tastes bitter and slightly cold. It enters the liver meridian. It has the effects of clearing away heat and detoxification, reducing swelling and relieving pain, and cooling the liver and calming convulsions.

[0020] Litchi kernels are the dried mature seeds of the plant Litchi chinensis Sonn. of the Sapindaceae family. Ripe fruits are picked in summer, the peel and fleshy aril are removed, washed and dried in the sun. It tastes sweet and slightly bitter, and is warm in nature. It enters the liver and kidney meridians. It has the effects of promoting qi and dispersing stagnation, dispelling cold and relieving pain.

[0021] Cynanchum paniculatum (Bge.) Kitag. is a dried root and rhizome of the Apocynaceae plant. It is harvested in autumn, removed of impurities, and dried in the shade. It tastes spicy and is warm in nature. It enters the liver and stomach meridians. It has the effects of dispelling wind and relieving pain, detoxifying and reducing swelling.

[0022] Frankincense is a resin exuded from the bark of Boswellia carterii Birdw. and Boswelliabhaw-dajiana Birdw., both of which are plants of the same genus. It is pungent, bitter and warm in nature and flavor. It enters the heart, liver and spleen meridians. It has the effects of promoting blood circulation, relieving pain, reducing swelling and promoting tissue regeneration.

[0023] Asarum is the dried root and rhizome of Asarum heterotropoides Fr.Schmidtvar.mandshuricum (Maxim.)Kitag., Asarum sieboldii Miq.var.seou1enseNakai or Asarum sieboldii Miq. of the Aristolochiaceae family. It is dug up in summer when the fruit is ripe or in early autumn, and the above-ground parts and mud and sand are removed, and then dried in the shade. It tastes spicy and warm. It enters the lung, heart and kidney meridians. It has the effects of dispelling cold, expelling wind and relieving pain, and warming the lungs and eliminating phlegm.

[0024] Vinegar paste is a substance made of aged vinegar that has been stored for many years and becomes viscous as the water evaporates. It has the effects of clearing away heat and detoxifying, promoting blood circulation and removing blood stasis, reducing swelling and relieving pain.

[0025] Compared with the prior art, the beneficial effects of the present invention include:

[0026] (1) The pharmaceutical composition of the present invention has good effects in treating breast hyperplasia and breast nodules; it has obvious effects in treating redness, swelling, heat and pain in body surgery, has rapid effects, treats both the symptoms and the root cause, has a low recurrence rate, and has no toxic side effects;

[0027] (2) The pharmaceutical composition for treating breast hyperplasia and breast nodules of the present invention is inexpensive and easily accepted by patients. DETAILED DESCRIPTION

[0028] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0029] Example 1

[0030] A medicinal external patch for treating breast hyperplasia and breast nodules is prepared from the following raw materials in parts by weight: 5 parts of Hyoscyamus chinensis, 5 parts of Paris polyphylla, 15 parts of litchi seeds, 10 parts of Cynanchum wilfordii, 10 parts of frankincense and 10 parts of asarum.

[0031] The preparation method comprises the following steps:

[0032] (1) Weigh henbane, paridis, litchi seeds, cynanchum chinense, frankincense and asarum according to the prescribed weight proportions, grind into fine powder, and mix evenly;

[0033] (2) Take 1 / 5 of the above fine powder, add 80% ethanol solution and reflux extract twice, each time for 1 hour, filter, combine the filtrate, and concentrate under reduced pressure to an extract with a relative density of 1.2 (45°C);

[0034] (3) combining the extract from step (2) with the remaining fine powder from step (1), adding 1 times the weight ratio of vinegar paste, and blending evenly;

[0035] (4) The drug obtained in step (3) is evenly coated on a non-woven fabric, and the non-woven fabric is cut into pieces to prepare the topical patch for treating breast hyperplasia and breast nodules.

[0036] Example 2

[0037] A pharmaceutical composition for treating breast hyperplasia and breast nodules is prepared from the following raw materials in parts by weight: 15 parts of Hyoscyamus chinensis, 15 parts of Paris polyphylla, 30 parts of litchi seeds, 25 parts of Cynanchum wilfordii, 20 parts of frankincense and 20 parts of Asarum.

[0038] The preparation method of the above-mentioned pharmaceutical composition for treating breast hyperplasia and breast nodules comprises the following steps:

[0039] (1) Weigh henbane, paridis, litchi seeds, cynanchum chinense, frankincense and asarum according to the prescribed weight proportions, grind into fine powder, and mix evenly;

[0040] (2) Take 4 / 5 of the above fine powder, add 60% ethanol solution and reflux extract twice, each time for 1.5 hours, filter, combine the filtrate, and concentrate under reduced pressure to an extract with a relative density of 1.3 (45°C);

[0041] (3) Combine the extract from step (2) and the remaining fine powder from step (1), add 3 times the weight of the vinegar paste, and mix well;

[0042] (4) The drug obtained in step (3) is evenly coated on a non-woven fabric, and the non-woven fabric is cut into pieces to prepare the topical patch for treating breast hyperplasia and breast nodules.

[0043] Example 3

[0044] A pharmaceutical composition for treating breast hyperplasia and breast nodules is prepared from the following raw materials in parts by weight: 25 parts of Hyoscyamus chinensis, 20 parts of Paris polyphylla, 45 parts of litchi seeds, 25 parts of Cynanchum wilfordii, 30 parts of frankincense and 20 parts of Asarum.

[0045] The preparation method of the above-mentioned pharmaceutical composition for treating breast hyperplasia and breast nodules comprises the following steps:

[0046] (1) Weigh henbane, paridis, litchi seeds, cynanchum chinense, frankincense and asarum according to the prescribed weight proportions, grind into fine powder, and mix evenly;

[0047] (2) Take 3 / 5 of the above fine powder, add 60% ethanol solution and reflux extract once, each time for 3 hours, filter, combine the filtrate, and concentrate under reduced pressure to an extract with a relative density of 1.3 (45°C);

[0048] (3) combining the extract from step (2) with the remaining fine powder from step (1), adding 5 times the weight of the vinegar paste, and blending evenly;

[0049] (4) The drug obtained in step (3) is evenly coated on a backing material, and cut into pieces to prepare the external plaster for treating breast hyperplasia and breast nodules.

[0050] Example 4

[0051] A pharmaceutical composition for treating breast hyperplasia and breast nodules is prepared from the following raw materials in parts by weight: 30 parts of Hyoscyamus chinensis, 20 parts of Paris polyphylla, 45 parts of litchi seeds, 25 parts of Cynanchum wilfordii, 40 parts of frankincense and 20 parts of Asarum.

[0052] The preparation method of the above-mentioned pharmaceutical composition for treating breast hyperplasia and breast nodules comprises the following steps:

[0053] (1) Weigh henbane, paridis, litchi seeds, cynanchum chinense, frankincense and asarum according to the prescribed weight proportions, grind into fine powder, and mix evenly;

[0054] (2) Take 4 / 5 of the above fine powder, add 60% ethanol solution and reflux extract 3 times, each time for 1 hour, filter, combine the filtrate, and concentrate under reduced pressure to an extract with a relative density of 1.1 (45°C);

[0055] (3) Combine the extract from step (2) and the remaining fine powder from step (1), add 3 times the weight of the vinegar paste, and mix well;

[0056] (4) The drug obtained in step (3) is evenly coated on a non-woven fabric, and the non-woven fabric is cut into pieces to prepare the topical patch for treating breast hyperplasia and breast nodules.

[0057] Example 5

[0058] A pharmaceutical composition for treating breast hyperplasia and breast nodules is prepared from the following raw materials in parts by weight: 5 parts of Hyoscyamus chinensis, 5 parts of Paris polyphylla, 30 parts of litchi seeds, 20 parts of Cynanchum wilfordii, 10 parts of frankincense and 10 parts of asarum.

[0059] The preparation method of the above-mentioned pharmaceutical composition for treating breast hyperplasia and breast nodules comprises the following steps:

[0060] (1) Weigh henbane, paridis, litchi seeds, cynanchum chinense, frankincense and asarum according to the prescribed weight proportions, grind into fine powder, and mix evenly;

[0061] (2) Take 4 / 5 of the above fine powder, add 60% ethanol solution and reflux extract 3 times, each time for 1.5 hours, filter, combine the filtrate, and concentrate under reduced pressure to an extract with a relative density of 1.2 (45°C);

[0062] (3) Combine the extract from step (2) and the remaining fine powder from step (1), add 4 times the weight of the vinegar paste, and mix well;

[0063] (4) The drug obtained in step (3) is evenly coated on a backing material, and cut into pieces to prepare the external plaster for treating breast hyperplasia and breast nodules.

[0064] Example 6

[0065] A pharmaceutical composition for treating breast hyperplasia and breast nodules is prepared from the following raw materials in parts by weight: 10 parts of Hyoscyamus chinensis, 30 parts of Paris polyphylla, 60 parts of litchi seeds, 45 parts of Cynanchum wilfordii, 20 parts of frankincense and 40 parts of Asarum.

[0066] The preparation method of the above-mentioned pharmaceutical composition for treating breast hyperplasia and breast nodules comprises the following steps:

[0067] (1) Weigh henbane, paridis, litchi seeds, cynanchum chinense, frankincense and asarum according to the prescribed weight proportions, grind into fine powder, and mix evenly;

[0068] (2) Take 4 / 5 of the above fine powder, add 60% ethanol solution and reflux extract 3 times, each time for 1.5 hours, filter, combine the filtrate, and concentrate under reduced pressure to an extract with a relative density of 1.2 (45°C);

[0069] (3) Combine the extract from step (2) and the remaining fine powder from step (1), add 4 times the weight of the vinegar paste, and mix well;

[0070] (4) The drug obtained in step (3) is evenly coated on a non-woven fabric, and the non-woven fabric is cut into pieces to prepare the topical patch for treating breast hyperplasia and breast nodules.

[0071] Example 7

[0072] Effect evaluation test for treating breast hyperplasia and breast nodules

[0073] The pharmaceutical composition for treating breast hyperplasia and breast nodules of the present invention is a clinical prescription of traditional Chinese medicine, which has been clinically used for many years and has good clinical efficacy. The specific clinical effects are as follows:

[0074] 1 Clinical Data

[0075] The preferred embodiments of the present invention have been verified in a large-scale test of 100 people.

[0076] 2. Efficacy evaluation

[0077] Recovery: All clinical symptoms disappeared, and no pathological changes were found in the follow-up examination six months after stopping the medication and one year later:

[0078] Markedly effective: All clinical symptoms disappeared, and pathological changes tended to be cured after reexamination six months after stopping the drug;

[0079] Ineffective: Although clinical symptoms improved, pathological changes did not improve significantly.

[0080] The preferred embodiments of the present invention have been verified in a large-scale test of 100 people. After taking the medicine (the method of application is: one patch per person per day), it has the effects of promoting qi and blood circulation, dispersing nodules and reducing swelling, and relieving swelling and pain. It has a good therapeutic effect on breast hyperplasia and breast nodules, with a cure rate of more than 85% and a significant efficacy of more than 95%.

[0081] Typical case 1:

[0082] Zhang, female, 50 years old, bilateral breast glandular layer thickening, internal structure disorder, uneven echo; a low echo area was seen in the glandular layer near the nipple at 9 o'clock on the right breast, with a range of about 3×5mm, clear boundaries and regular shape. A low echo nodule was seen in the glandular layer near the outer edge of the right breast at 10 o'clock, with a size of about 7×8mm, irregular shape, and large lobed shape. After using the external preparation of the pharmaceutical composition of the present invention, all the lumps disappeared after 2 weeks, and no recurrence has been seen since follow-up.

[0083] Typical case 2:

[0084] Chen, female, 32 years old, bilateral breast glandular layer thickening, internal structure disorder, uneven echo, no abnormal blood flow. A low-echo nodule was found in the glandular layer at 11-12 o'clock on the right breast, about 8.0×3.2mm in size, with smooth edges. Multiple low-echo nodules were found in the glandular layer of the left breast, the largest of which was located at 12-1 o'clock, about 13.0×6.1mm in size, with smooth edges. A cystic nodule was found in the glandular layer at 5-6 o'clock on the right breast, about 4.2×2.5mm in size, with smooth edges. After using the pharmaceutical composition of the present invention, the swelling and lumps disappeared completely after 3 weeks, and there has been no recurrence since follow-up.

[0085] Typical case 3:

[0086] Li, female, 44 years old, bilateral breast glandular layer thickening, internal structure disorder, uneven echo; a low echo area was seen in the glandular layer near the nipple at 10 o'clock on the right breast, with a range of about 6×4mm, clear boundaries and regular shape. A low echo nodule was seen in the glandular layer near the outer edge of the right breast at 9 o'clock, with a size of about 13×8mm, irregular shape, and large lobed. After using the pharmaceutical composition of the present invention, all the lumps disappeared after 4 weeks, and no recurrence has been seen since follow-up.

[0087] The specific implementation of the present invention described above does not constitute a limitation on the protection scope of the present invention. Any other corresponding changes and modifications made based on the technical concept of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A pharmaceutical composition for treating breast hyperplasia and breast nodules, characterized in that: The composition is composed of the following raw materials in parts by weight: 5-30 parts of Hyoscyamus chinensis, 5-30 parts of Paris polyphylla, 15-60 parts of litchi seeds, 10-45 parts of Cynanchum wilfordii, 10-40 parts of frankincense and 10-40 parts of Asarum.

2. A pharmaceutical composition for treating breast hyperplasia and breast nodules according to claim 1, characterized in that: The composition is preferably composed of the following raw materials in parts by weight: 10-20 parts of Hyoscyamus chinensis, 10-20 parts of Paris polyphylla, 20-50 parts of litchi seeds, 15-35 parts of Cynanchum wilfordii, 15-30 parts of frankincense and 15-30 parts of Asarum.

3. A pharmaceutical composition for treating breast hyperplasia and breast nodules according to claim 1, characterized in that: The composition is preferably composed of the following raw materials in parts by weight: 5 parts of Hyoscyamus chinensis, 5 parts of Paris polyphylla, 30 parts of litchi seeds, 20 parts of Cynanchum wilfordii, 10 parts of frankincense and 10 parts of Asarum.

4. A pharmaceutical composition for treating breast hyperplasia and breast nodules according to any one of claims 1 to 3, characterized in that: The composition is prepared into an external preparation medicine.

5. A pharmaceutical composition for treating breast hyperplasia and breast nodules according to claim 4, characterized in that: The external preparation is prepared according to the following steps: ① Weigh henbane, paridis, litchi kernel, cynanchum chinense, frankincense and asarum according to weight ratio, crush into fine powder and mix evenly; ②Take 1 / 5-4 / 5 of the above fine powder, add 60-85% ethanol aqueous solution to reflux and extract 1-3 times, each time for 1-3 hours, filter, combine the filtrate, and concentrate under reduced pressure to an extract with a relative density of 1.0-1.3 (45°C); ③ Combine the extract from step ② and the remaining fine powder from step ①, add 1-5 times the weight ratio of vinegar paste, mix well, and set aside; ④ The drug obtained in step ③ is evenly coated on non-woven fabric or other backing materials, and cut into external patches or plasters.

6. A pharmaceutical composition for treating breast hyperplasia and breast nodules according to claim 5, characterized in that: In step ②, preferably 1 / 5-3 / 5 of the fine powder is taken.

7. A pharmaceutical composition for treating breast hyperplasia and breast nodules according to claim 5, characterized in that: In the step ③, 1-2 times by weight of vinegar paste is preferably added and mixed evenly.

8. Use of a pharmaceutical composition for treating breast hyperplasia and breast nodules as claimed in any one of claims 1 to 4 in the preparation of a medicament for preventing and / or treating breast hyperplasia and breast nodules.