CN103751360A - Pharmaceutical composition for treating breast distention and application thereof - Google Patents

Abstract

The invention relates to a pharmaceutical composition for treating breast swelling and its application. The composition is prepared from Chinese medicine extracts and auxiliary materials, wherein the Chinese medicine extracts are obtained by water extraction and alcohol precipitation of the following Chinese medicine raw materials in parts by weight: The filtrate is concentrated: 17-25 parts of Trichosanthes, 17-25 parts of Fern, 5-10 parts of orange leaves, 5-10 parts of orange cores, 8-16 parts of peanut shells, 15-22 parts of angelica, 8 parts of cocklebur -16 servings. Treating premenstrual breast distension with the medicine of the present invention can quickly disappear the symptoms, thereby avoiding the occurrence of uterine fibroids, hyperplasia of mammary glands and gynecological tumors caused by liver depression and Qi stagnation.

Description

A kind of pharmaceutical composition for treating breast swelling and its application

technical field

The invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a pharmaceutical composition for treating breast swelling, in particular to a pharmaceutical composition for premenstrual breast swelling and its application.

Background technique

Premenstrual breast swelling occurs before menstruation, usually 3-7 days before menstruation, and sometimes even occurs about half a month after menstruation, and disappears between 1-2 days after menstruation, but sometimes it disappears after menstruation. It will recur before menstruation next time, quite regularly and periodically. The degree of breast engorgement includes breast engorgement, nipple pain, breast engorgement with agglomeration, and breast engorgement with burning sensation.

Premenstrual breast swelling is rarely described in the gynecological books of the past dynasties, but more patients are seen in daily outpatient clinics. There are roughly two reasons for this: one is that breasts are considered to be a hidden place, and there are both pains and shyness The second is that the disease occurs before menstruation, and can disappear by itself after menstruation, so it is ignored. During the clinic, most of the patients with premenstrual breast distension have infertility. Few patients come to treat premenstrual breast distension.

The pathogenesis of premenstrual breast distension is mainly due to liver stagnation, the liver is the general's official, and the sexual desire is strong. If stimulated by emotions, the stagnation of qi is difficult to vent, and it invades the stomach, so the stagnation of the liver stagnates the stomach. Both meridians are affected, the nipple belongs to the liver, and the breast belongs to the stomach, so the symptoms include nipple pain and breast swelling. It can be confirmed that stagnation of liver qi and breast distention are closely related.

Contents of the invention

The object of the present invention is to provide a pharmaceutical composition for treating breast swelling. The medicinal composition is an ancestral secret prescription for treating mastopathy, and after long-term administration, it also has very good curative effect in treating breast distension, and is especially suitable for the treatment of patients with premenstrual breast distension.

The purpose of the present invention is achieved like this:

A pharmaceutical composition for treating breast swelling, prepared from Chinese medicine extracts and auxiliary materials, wherein the Chinese medicine extracts are concentrated from the filtrate of the following Chinese medicinal materials by weight: 25 parts, 17-25 parts of fern, 5-10 parts of orange leaves, 5-10 parts of orange cores, 8-16 parts of peanut shells, 15-22 parts of angelica, 8-16 parts of cocklebur.

Preferably, the pharmaceutical composition for treating breast distension as described above, wherein the Chinese medicine extract is concentrated from the filtrate of the following Chinese medicinal materials by weight: 19-22 parts of Trichosanthes trichosanthes, 19-22 parts of fern, 6-8 parts of orange leaves, 6-8 parts of orange cores, 10-14 parts of peanut shells, 17-19 parts of angelica, 10-14 parts of cocklebur.

Further preferably, the pharmaceutical composition for treating breast distension as described above, wherein the Chinese medicine extract is obtained by concentrating the filtrate of the following Chinese medicinal material raw materials by water extraction and alcohol precipitation: 20 parts of Trichosanthes trichosanthes, 20 parts of Fern , 7 parts of orange leaves, 7 parts of orange cores, 12 parts of peanut shells, 19 parts of angelica, 12 parts of cocklebur.

Still further preferably, the pharmaceutical composition for treating breast swelling as described above, wherein the pharmaceutical composition is a solid oral preparation; the solid oral preparation includes tablets, capsules and granules.

The preparation method of the compound granule of the present invention comprises the steps of: weighing and cleaning 17-25 parts of Trichosanthes mellifera, 17-25 parts of Osmanthus fern, 5-10 parts of orange leaves, 5-10 parts of orange cores, peanuts, Shell 8-16 parts, Angelica 15-22 parts and Xanthium 8-16 parts, combine, add water and decoct twice, add water for the first time to 10 times the weight of medicinal materials, decoct for 1.5h, add water for the second time 8 times the weight of the medicinal materials, decoct for 1.5h, combine the decoction, concentrate under reduced pressure at 0.07MPa, 60-70°C to an extract with a relative density of 1.15 at 65°C, add 95% (v/v) ethanol to make the extract containing The alcohol content reached 75% (v/v), stirred, stood still for 24 hours, filtered, and the filtrate was concentrated under reduced pressure at 0.07MPa and 65°C until the relative density was 1.25 at 65°C, and the ethanol was recovered to obtain a concentrated solution. Spray-dry the concentrated liquid (the conditions are that the inlet air temperature is 100°C, the outlet air temperature is 80°C, the material temperature is 80°C, the atomization pressure is 0.2 MPa, and the spray speed is 5ml/s.), crushed through a 80-mesh sieve , to obtain clear paste powder; take clear paste powder, dextrin according to the weight ratio of clear paste powder: dextrin=1:1-3, and measure an appropriate amount of 55% ethanol, wherein 55% ethanol means that the volume concentration is 55% Put the clear paste powder and dextrin into the tank mixer, stir for 20 minutes, slowly add 55% ethanol while stirring, until it is made into a soft material, granulate with a 12-mesh stainless steel sieve, 65-75°C Dry it for 2 hours, take it out, and let it cool to get the granules.

Through the research of a large number of clinical application examples, it is found that the effect of the pharmaceutical composition of the present invention in treating premenstrual breast distention is very significant. Therefore, the second object of the present invention is to provide a pharmaceutical use, that is, the application of the above-mentioned pharmaceutical composition in the preparation of a drug for treating breast distension; especially preferably the above-mentioned pharmaceutical composition in the preparation of a drug for the treatment of premenstrual breast distension Applications.

Compared with the prior art, the pharmaceutical composition involved in the present invention has the following advantages and progress: (1) Good curative effect. Using the drug of the present invention to treat premenstrual breast swelling can quickly eliminate symptoms, thereby avoiding the occurrence of uterine fibroids, breast hyperplasia and gynecological tumors caused by liver depression and qi stagnation; (2) high safety. Since the medicine of the invention is prepared from traditional Chinese medicinal materials, the toxicity is low, and the medicine is safer for patients.

Detailed ways

It should be noted that the sources of Chinese medicinal materials used in each embodiment of the present invention are as follows: Trichosanthes kirilowii Maxim. is a dried and mature fruit of Cucurbitaceae plant Trichosanthes kirilowii Maxim. Fern is selected from the dry whole herb of fern Botrychium virginianum (L.) Sw. Orange leaves are selected from the dry leaves of Citrus reticulata Blanco or its cultivars. The orange stone is selected from the dry mature seeds of Citrus reticulata Blanco or its cultivars of the Rutaceae plant. Peanut shells are selected from the pod shells of the fruits of Arachis hypogaea L. Angelica sinensis is selected from the dried roots of Angelica sinensis (Oliv.) Diels of the Umbelliferae plant. Xanthium is selected from the dry and mature fruit with involucre of Xanthium sibiricum Patr.

The following are specific examples of the present invention, and further describe the technical solution of the present invention, but the protection scope of the present invention is not limited to these examples. All changes or equivalent substitutions that do not depart from the concept of the present invention are included in the protection scope of the present invention.

The preparation of embodiment 1 Chinese medicine granules

Weigh and clean 2kg of Trichosanthes, 2kg of Fern, 0.7kg of orange leaves, 0.7kg of orange core, 1.2kg of peanut shells, 1.9kg of angelica and 1.2kg of cocklebur, combine them, add water to decoct twice, and add water for the first time The amount is 10 times the weight of the medicinal material, decocted for 1.5 hours, and the second time adding water is 8 times the weight of the medicinal material, decocted for 1.5 hours, combined the decoction, concentrated under reduced pressure at 0.07MPa, 60-70 °C to 65 °C For the extract with a density of 1.15, add 95% (v/v) ethanol to make the alcohol content reach 75% (v/v), stir, let stand for 24 hours, filter, and concentrate the filtrate under reduced pressure at 0.07MPa and 65°C The relative density is 1.25 when it reaches 65°C, and the ethanol is recovered to obtain a concentrated solution, which is spray-dried (conditions are that the inlet air temperature is 100°C, the outlet air temperature is 80°C, the material temperature is 80°C, and the atomization pressure is 0.2 MPa, the spray speed is 5ml/s.), crushed through an 80 mesh sieve to obtain the clear cream powder; according to the weight ratio of clear cream powder: dextrin = 1:3, take clear cream powder, dextrin, and measure Appropriate amount of 55% ethanol, wherein 55% ethanol refers to the ethanol aqueous solution with a volume concentration of 55%, put the clear cream powder and dextrin into the tank mixer, stir for 20 minutes, and slowly add 55% ethanol while stirring until the preparation into a soft material, granulated with a 12-mesh stainless steel sieve, dried at 65-75°C for 2 hours, taken out, and allowed to cool to obtain the granules, which are packed in 10g bags. the

The preparation of embodiment 2 Chinese medicine granules

Weigh clean Trichosanthes 2.5kg, Ferns 1.7kg, Orange Leaf 1kg, Tangerine Pit 0.7kg, Peanut Shell 1.5kg, Angelica 1.5kg and Xanthium 1.6kg, combine them, add water to decoct twice, the first time Add water to 10 times the weight of the medicinal material, decoct for 1.5 hours, add water for the second time to 8 times the weight of the medicinal material, decoct for 1.5 hours, combine the decoction, and concentrate under reduced pressure at 0.07MPa and 60-70 °C to 65 °C For the extract with a relative density of 1.15, add 95% (v/v) ethanol to make the alcohol content reach 75% (v/v), stir, let stand for 24 hours, filter, and depressurize the filtrate at 0.07MPa and 65°C Concentrate to a relative density of 1.25 at 65°C, and recover ethanol to obtain a concentrated solution, which is then spray-dried (conditions are that the inlet air temperature is 100°C, the outlet air temperature is 80°C, the material temperature is 80°C, and the atomization pressure is 0.2 MPa, and the spray speed is 5ml/s.), crushed through an 80 mesh sieve to obtain clear cream powder; take clear cream powder, dextrin, and the amount Take an appropriate amount of 55% ethanol, wherein 55% ethanol refers to an ethanol aqueous solution with a volume concentration of 55%, put the clear cream powder and dextrin into the tank mixer, stir for 20 minutes, and slowly add 55% ethanol while stirring, until Made into soft material, granulated with 12-mesh stainless steel sieve, dried at 65-75°C for 2 hours, taken out, allowed to cool to obtain the granules, packed in 10g per bag.

The preparation of embodiment 3 Chinese medicine granules

Weigh and clean 1.8kg of trichosanthes, 2kg of fern, 0.5kg of orange leaves, 1kg of orange core, 0.8kg of peanut shells, 2kg of angelica and 1.5kg of cocklebur, combine them, add water to decoct twice, add water for the first time 10 times the weight of the medicinal materials, decoct for 1.5 hours, add water for the second time to 8 times the weight of the medicinal materials, decoct for 1.5 hours, combine the decoction, 0.07MPa, 60-70 ℃ reduced pressure concentration to 65 ℃ relative density 1.15 extract, add 95% (v/v) ethanol to make the alcohol content reach 75% (v/v), stir, let stand for 24 hours, filter, and concentrate the filtrate under reduced pressure at 0.07MPa and 65°C to obtain The relative density is 1.25 at 65°C, and the ethanol is recovered to obtain a concentrated solution, which is spray-dried (conditions are that the inlet air temperature is 100°C, the outlet air temperature is 80°C, the material temperature is 80°C, and the atomization pressure is 0.2 MPa, the spray speed is 5ml/s.), crushed through an 80 mesh sieve to obtain the cream powder; according to the weight ratio of cream powder: dextrin = 1:3, weigh the cream powder, dextrin, and measure an appropriate amount 55% ethanol, where 55% ethanol refers to the ethanol aqueous solution with a volume concentration of 55%, put the clear paste powder and dextrin into the tank mixer, stir for 20 minutes, slowly add 55% ethanol while stirring, until the prepared Soft materials are granulated with a 12-mesh stainless steel sieve, dried at 65-75°C for 2 hours, taken out, and cooled to obtain the granules, which are packed in 10g bags.

Example 4 Experimental Study of Chinese Medicine Granules in Treating Premenstrual Breast Distension

43 cases of patients with premenstrual breast distension, the clinical manifestations began to appear breast distension and pain 3-7 days or 10-15 days before menstruation, and even the pain could not touch the clothes. Organic changes, or soft bean-sized nodules in 1-2 quadrants, can be moved when pushed, and painful when pressed; often accompanied by mental depression, chest and hypochondrium distension, irritability, abdominal distension and pain, Irregular menstruation, more or less menstrual flow, profuse leukorrhea, dark red tongue or petechiae on the sides, stringy and slippery pulse; all symptoms disappear or relieve after menstruation, and change regularly with the menstrual cycle, repeating itself. Among all the patients, 25 were unmarried aged 22-28, and 18 were married and unpregnant aged 26-34; the disease course was as short as 2 months and as long as 10 years. After the test started, all patients took 2 bags of traditional Chinese medicine granules (prepared according to the prescription and process of Example 1 of the present invention) every day, one bag each in the morning and evening, and took it from 15 days after menstruation to the end of menstruation, and 15 days was a course of treatment , and even served 3 courses of treatment. According to the following curative effect evaluation standards, the drug efficacy was counted: cured: the symptoms disappeared, the nodules disappeared, and no recurrence was found after a follow-up visit of 3 menstrual cycles; effective: the symptoms basically disappeared, or occasionally there was a slight feeling of breast swelling, and the nodules became soft and shrunk; invalid: Symptoms do not go away or breast fullness increases, or nodules increase. Test results: Among the 43 patients with premenstrual breast swelling, 34 cases were cured, 8 cases were effective, and 1 case was ineffective. the

Claims (7)

1. a pharmaceutical composition for the treatment of breast swelling, prepared from Chinese medicine extracts and adjuvant materials, is characterized in that said Chinese medicine extracts are concentrated from the filtrate of the following weight parts of Chinese medicine raw materials through water extraction and alcohol precipitation: 17-25 parts of trichosanthes, 17-25 parts of fern, 5-10 parts of orange leaves, 5-10 parts of orange cores, 8-16 parts of peanut shells, 15-22 parts of angelica, 8-16 parts of cocklebur. 2. The pharmaceutical composition for treating breast distention according to claim 1, wherein said Chinese medicine extract is concentrated from the filtrate of Chinese herbal medicine raw materials in following weight portions through water extraction and alcohol precipitation: 19-22 parts of Trichosanthes , 19-22 parts of fern, 6-8 parts of orange leaves, 6-8 parts of orange cores, 10-14 parts of peanut shells, 17-19 parts of angelica, 10-14 parts of cocklebur. 3. The pharmaceutical composition for treating breast distention according to claim 2 is characterized in that said Chinese medicine extract is formed by concentrating the filtrate of the following Chinese herbal medicine raw materials by water extraction and alcohol precipitation: 20 parts of Trichosanthes trichosanthes, fern fern 20 parts of Osmunda, 7 parts of orange leaves, 7 parts of orange cores, 12 parts of peanut shells, 19 parts of angelica, 12 parts of cocklebur. 4. The pharmaceutical composition for treating breast distension according to claim 1, 2 or 3, characterized in that: the pharmaceutical composition is a solid oral preparation. 5. The pharmaceutical composition for treating breast distention according to claim 4, characterized in that: the solid oral preparation is tablet, capsule or granule. 6. The application of the pharmaceutical composition described in claim 1 or 2 or 3 in the preparation of the medicine for the treatment of breast swelling. 7. The application of the pharmaceutical composition described in claim 1 or 2 or 3 in the preparation of the medicine for the treatment of premenstrual breast distension.