CN103127272A - Chinese medicinal preparation for treating breast disease and preparation method thereof - Google Patents

Abstract

The invention discloses a Chinese medicinal preparation for treating a breast disease. The preparation is prepared from the following raw medicaments: Szechuan lovage rhizome, bupleurum, root of red-rooted salvia, red peony root, achyranthes root, self-heal, safflower, poria cocos, peach seeds, white atractylodes rhizome, corydalis tuber and licorice. A preparation method comprises the following steps of: crushing the corydalis tuber, soaking into ethanol, extracting, and filtering the extraction solution, wherein the extract and the medicinal residue are used later; soaking the safflower into ethanol, extracting, and filtering the extraction solution, wherein the extract and the medicinal residue are used later; boiling and extracting the medicinal residue of the corydalis tuber, the medicinal residue of the safflower and the rest raw medicaments, concentrating the extract, and soaking into ethanol to obtain an ethanol precipitation solution; reclaiming ethanol from the ethanol precipitation solution, the corydalis tuber extract and the safflower extract to obtain an extract; and drying the extract, crushing the extract into medicinal powder, and preparing the medicinal powder into powder, tablets, pills, capsules, granules and oral liquid according to conventional methods. By organically combining the traditional Chinese medicine and the modern preparation technology, the effect components of the preparation are stable and controllable. By adopting the unique extraction process, the active ingredients of the extract are preserved completely, the extraction rate is improved, the utilization rate of rare Chinese medicaments is improved, and the production cost is reduced.

Description

A kind of Chinese medicine preparation for the treatment of mastopathy and preparation method thereof

Technical field

The present invention relates to a kind of Chinese medicine preparation and preparation method thereof, specifically a kind of Chinese medicine preparation for the treatment of mastopathy and preparation method thereof.

Background technology

Mastopathy includes breast dysplasia, sagging, atrophy and cyclomastopathy, cyst of breast etc.Mastopathy is current women's commonly encountered diseases and frequently-occurring disease, and the sickness rate of mastopathy is 25-35% according to statistics.Breast is beginning of Puberty of Female and adult principal character sign, is also an important indicator of modern female build U.S., and healthy breast is not only the assurance that produces offspring, and is also the glamour place of healthy women.Modern female is being born the double liability of family and society, and each side pressure is large, easily causes the organism endocrine imbalance, and estrogen secretion reduces, and makes breast dysplasia or the atrophy in advance of some women.The traditional Chinese medical science thinks that mastopathy mostly is stagnation of QI due to depression of the liver, and dysfunction of the spleen in transportation accumulates in phlegm-damp and causes liver spleen two wounds, causes qi depression to blood stasis to form; Or deficiency of the liver and kindey, Chong and Ren channel disorder, knot in the yang deficiency phlegm-damp and causing.The method for the treatment of cystic hyperplasia of breast is mainly expectant treatment at present, and take oral drugs as main, the safety dispute of sex hormone drug treatment is always very large, and long-term taking has larger infringement to femaleness.

Summary of the invention

The object of the invention is to propose the technical scheme of a kind of Chinese medicine preparation that uses treatment mastopathy safe, evident in efficacy and preparation method thereof.

Technical scheme of the present invention is: a kind of Chinese medicine preparation for the treatment of mastopathy, and it is the medicament of being made by the crude drug of following weight proportioning:

Rhizoma Chuanxiong 150-250, Radix Bupleuri 100-200, Radix Salviae Miltiorrhizae 200-300, Radix Paeoniae Rubra 150-250, Radix Achyranthis Bidentatae 120-220, Spica Prunellae 200-300, Flos Carthami 100-200, Poria 150-250, Semen Persicae 120-220, Rhizoma Atractylodis Macrocephalae 200-300, Rhizoma Corydalis 100-200, Radix Glycyrrhizae 60-160.

Described medicament is powder, tablet, pill, capsule, granule and oral liquid.

Described a kind of preparation method for the treatment of the Chinese medicine preparation of cystic hyperplasia of breast, concrete preparation method is:

(1) get Rhizoma Corydalis and be crushed to the 30-50 order, doubly measure (w/v) with concentration 90% ethanol 8-10 and soak more than 48 hours, extracted 3 times each l hour, extract 80-85 ℃ of temperature, filter merge extractive liquid,, extracting solution is standby, and medicinal residues are standby;

(2) get Flos Carthami and doubly measure (w/v) with 90% ethanol 8-10 and soak more than 48 hours, extracted 3 times each l hour, extract 80-85 ℃ of temperature, the filtration merge extractive liquid,, extracting solution is standby, and medicinal residues are standby;

(3) Rhizoma Corydalis medicinal residues Flos Carthami medicinal residues and all the other 10 herbal medicine water boils are extracted 2 times, each 2 hours, extracting solution was concentrated into sticky shape, with 90% soak with ethanol 2 times, was alcohol deposit fluid;

(4) alcohol deposit fluid reclaims ethanol together with Rhizoma Corydalis extracting solution Flos Carthami extracting solution, is extractum;

(5) extractum is put 75 ℃ of oven dry of baking oven, pulverized, crossing at least 200 mesh sieves is medicated powder.

The preparation of examining is made as powder, tablet, pill, capsule, granule and oral liquid according to a conventional method for the medicated powder with step (5).

The present invention mainly debates according to Chinese medicine the principle that disease treats, collect many doctor chiefs, extensively adopting fights receives the strange medicine wonderful recipe in ethnic mimority area, and based on pathogenetic understanding and the Therapeutic Principle of modern medicine to mastopathy, forms through the clinical practice summary of diagnosis and treatment case for a long time.Chinese medicine is thought, qi depression to blood stasis, and body fluid is not all right, is tuberculosis for a long time.Modern medicine thinks, women's newborn mastopathy is that hormonal system and multiple visceral dysfunction or function descend and the general performance that causes.The present invention is tonifying Qi and lifting yang, dispersing the stagnated live-QI to relieve the stagnation of QI, dredge the meridian passage, blood circulation promoting and blood stasis dispelling, heat-clearing and toxic substances removing, Chong and Ren Meridians regulating, hard masses softening and resolving, invigorating the spleen and replenishing QI, nourishing YIN for suppressing the hyperactive YANG in the medicament selection principle.The Chinese medicine that the present invention selects has respectively blood circulation promoting and blood stasis dispelling, and regulating the flow of vital energy is stagnant, heat-clearing and toxic substances removing, the principle that enhancing immunity, hard masses softening and resolving, antineoplastic action, these medicines are pressed monarch organically combines, each medicine is adjusted endocrine function synergism, and immunity is improved.Rhizoma Chuanxiong energy blood-activating and qi-promoting, wind-expelling pain-stopping.The Radix Bupleuri dispersing the stagnated live-QI to relieve the stagnation of QI.Chinese angelica blood supplementing is invigorated blood circulation, the promoting the circulation of blood regulating menstruation.Rhizoma Atractylodis Macrocephalae wet dissipation eliminating impediment.The Rhizoma Corydalis promoting blood circulation to remove blood stasis is regulated the flow of vital energy, pain relieving.Radix Salviae Miltiorrhizae, property is bitter, tepor, enter the conscience warp, have blood circulation promoting and blood stasis dispelling, evacuation of pus, the effect of pain relieving has blood circulation promoting and blood stasis dispelling and will suppress cell and gather, and makes the cell component state that falls apart, the permeability of blood vessel is strengthened, improved blood circulation, all medicines share, long memorial liver and qi altogether, the merit of blood circulation promoting and blood stasis dispelling heat-clearing and toxic substances removing has been regulated the functional status of internal organs, meridians and QI and blood, regulate endocrine balance, improved immunity.The present invention forms for pure Chinese drug preparation commonly used, uses safety, and toxic and side effects is little. and preparation of the present invention is oral agents, every day 3 times, each 9-12 gram, 10 days is a course for the treatment of, and common 1-2 course for the treatment of is effective, and pertinacious disease needs 3-4 the course for the treatment of.The present invention adopts pure Chinese medicine conditioning physical function, and nourishing lung, spleen, stomach, kidney accelerate blood circulation of breast, promote breast development.The raw material that the present invention adopts is common Chinese medicine, has no side effect, and taking convenience, instant effect, curative effect is high.The present invention mainly is applicable to the treatment of the diseases such as breast dysplasia, mastoptosis, mastatrophy and cyclomastopathy, before can also being used for the treatment of menstrual period, menstrual period distending pain of the breast; For mastatrophy, obvious curative effects is arranged.The present invention is esy to use, safe and reliable, but the life-time service that has no side effect.

The Rhizoma Corydalis Flos Carthami is principal agent of the present invention, is also rare Chinese medicine.Water-soluble substances and pure soluble substance are arranged in the main effective ingredient in the Rhizoma Corydalis Flos Carthami, and this two flavor generally adopts water extraction in pharmacy at present, but also contains Alcohol soluble composition in the Rhizoma Corydalis Flos Carthami, adopts simple water extraction, and many Alcohol soluble compositions will be run off.The present invention adopts two kinds of solvents to extract respectively, makes extraction more complete, can keep like this effective ingredient of Rhizoma Corydalis Flos Carthami more fully.We show with the experimental data that identical Rhizoma Corydalis Flos Carthami raw material adopts distinct methods to extract: technique of the present invention not only makes the extraction yield higher, and the effective ingredient of medicine keeps more complete, has reduced production cost, and is specifically as shown in table 1:

Table 1 distinct methods extracts the yield contrast

?	Extracting method	Total yield %
			The traditional method for extracting Rhizoma Corydalis	Alcohol extraction	22.3
The traditional method for extracting Rhizoma Corydalis	Water extraction	19.1
			Method of the present invention	Alcohol extraction+water extraction	26.2
The traditional method for extracting Flos Carthami	Alcohol extraction	23，2
			The traditional method for extracting Flos Carthami	Water extraction	18.6
Method of the present invention	Alcohol extraction+water extraction	27.4

The present invention examines or check from the many aspects such as advantageous feature of raw material reasonability, consumption safety, raw material, filters out this formula.Characteristics of the present invention are unique formula, and unique technique has been taked in the extraction of main Chinese medicinal materials, make extraction ratio improve, and the product effective ingredient is preserved fully.The present invention adopts the first alcohol extraction of Rhizoma Corydalis Flos Carthami, and the preparation technology of rear water extraction can improve the content of effective ingredient greatly.The present invention organically combines traditional Chinese medicine and modern preparation technique, makes the product efficacy stable components controlled, and the present invention adopts unique extraction process, the effective ingredient of extract is kept fully, extraction ratio improves, and the utilization rate of rare Chinese medicine is improved greatly, has reduced production cost.

Clinical trial data:

1, mastoptosis, mastatrophy

Mastoptosis, atrophy patient 100 examples, Normal-weight, appetite is normal, age 28-45 year, all gave birth to a son, breast feeding 3-12 month, after ablactation, mammary gland began sagging, atrophy.Breast examination: breast extends out, sagging, and cutis laxa can be touched a small amount of mammary gland, belongs to slight or moderate atrophy.Take medicine of the present invention 3 times every day, each 3 grams, pharmaceutical dosage form is loose, sheet, ball, capsule, and 20 days is a course for the treatment of, and common 1-3 course for the treatment of is effective, and pertinacious disease needs 4-5 the course for the treatment of.Most begin to swell at 8-10 days rear udder attachments, breast has inflated sense, without pain, checks after 40-80 days, and it is strong, full that mammary contour becomes, and obviously improve the breast position, and what can touch the bulk mammary gland tissue is 33 examples; It is large that mammary contour becomes, the slightly raising of breast position, and can touch the fritter mammary gland tissue is 48 examples what increase; Mammary contour changes little, and the fritter mammary gland tissue is unconverted is 19 examples.Take medicine and be showed no the patient 1-4 the course for the treatment of and gastrointestinal upset or toxic and side effects occur.On inspection, main organs is without obvious change.

2, cyclomastopathy

Cyclomastopathy patient's 100 examples, age 18-45 year, the course of disease 30 days to 8 years, there are 78 examples for one-sided mammary gland, 1-4 lump to be arranged in this group case, lump and surrounding tissue adhesion, clear border take local lump and distending pain as cardinal symptom, and has the molybdenum target breast to take the photograph sheet and the inspection of near infrared ray breast examining device is diagnosed as foundation.The patient takes medicine of the present invention 3 times every day, and pharmaceutical dosage form is oral liquid, each 10-20 milliliter, and 10 days is an outer course for the treatment of, and common 1-2 course for the treatment of is effective, and pertinacious disease needs 3-4 the course for the treatment of.Took the photograph sheet and the inspection of near infrared ray breast examining device by the molybdenum target breast in 30-40 days, distending pain of the breast disappears, and what nodule in the breast limbered up, lump disappears fully is 28 examples; Distending pain of the breast disappears, and nodule in the breast limbers up, and what the lump major part disappeared is 52 examples; Distending pain of the breast disappears, and nodule in the breast limbers up, and what the lump fraction disappeared is 15 examples; Distending pain of the breast slightly alleviates, and nodule in the breast changes little, and what lump did not have disappearance substantially is 5 examples.Take medicine and be showed no the patient 1-4 the course for the treatment of and gastrointestinal upset or toxic and side effects occur.On inspection, main organs is without obvious change.

3, breast dysplasia

Breast dysplasia 50 examples, most asthenic body, body weight is lighter, and appetite is normal, and in age 20-45 year, most menstruations are undesired, and quantity is on the low side.There are 87 life to cross a son, breast feeding 3-12 month.13 people did not give birth to.Breast examination: breast is less than normal or less, can touch a small amount of mammary gland, and most congenital malformations that belong to will also have produce the day after tomorrow.Take medicine of the present invention 3 times every day, each 3 grams, drug dose is loose, sheet, ball, capsule, 20 days is an outer course for the treatment of, and common 1-2 course for the treatment of is effective, and pertinacious disease needs 3-4 the course for the treatment of, majority begins to swell at 10-15 days rear udder attachments, and the sensation breast is grown up, without pain, check after 20-40 days, menstruation is tending towards normally, and the breast inflated sense is remarkable, and it is large that mammary contour obviously becomes, strong, full, what can touch the bulk mammary gland tissue is 18 row; Breast expands significantly, and mammary contour becomes greatly a little, and what can touch the fritter mammary gland tissue is 28 examples; Breast has inflated sense, and profile variation is little, and what can touch the fritter mammary gland tissue is 4 examples.

The specific embodiment

A kind of preparation method for the treatment of the Chinese medicine preparation of mastopathy, the parameter of each formula sees Table 2, and concrete steps are as follows:

(1) by weight for raw material of Chinese medicine,

Rhizoma Chuanxiong 150-250, Radix Bupleuri 100-200, Radix Salviae Miltiorrhizae 200-300, Radix Paeoniae Rubra 150-250, Radix Achyranthis Bidentatae 120-220, Spica Prunellae 200-300, Flos Carthami 100-200, Poria 150-250, Semen Persicae 120-220, Rhizoma Atractylodis Macrocephalae 200-300, Rhizoma Corydalis 100-200, Radix Glycyrrhizae 60-160;

(2) get Rhizoma Corydalis and be crushed to the 30-50 order, doubly measure (w/v) with concentration 90% ethanol 8-10 and soak more than 48 hours, extracted 3 times each l hour, extract 80-85 ℃ of temperature, filter merge extractive liquid,, extracting solution is standby, and medicinal residues are standby;

(3) get Flos Carthami and doubly measure (w/v) with 90% ethanol 8-10 and soak more than 48 hours, extracted 3 times each l hour, extract 80-85 ℃ of temperature, the filtration merge extractive liquid,, extracting solution is standby, and medicinal residues are standby;

(4) Rhizoma Corydalis medicinal residues Flos Carthami medicinal residues and all the other 10 herbal medicine water boils are extracted 3 times, each 2 hours, extracting solution was concentrated into sticky shape, with 90% soak with ethanol 2 times, was alcohol deposit fluid;

(5) alcohol deposit fluid reclaims ethanol together with Rhizoma Corydalis extracting solution Flos Carthami extracting solution, is extractum;

(6) extractum is put 75 ℃ of oven dry of baking oven, pulverized, crossing at least 200 mesh sieves is medicated powder;

(7) medicated powder with step (6) is made as powder, tablet, pill, capsule, granule and oral liquid according to a conventional method.

 

The crude drug of each formula of table 2 is detailed

Sequence number

Title

Formula 1

Formula 2

Formula 3

Formula 4

Formula 5

1

Rhizoma Chuanxiong

2.0㎏

2.5㎏

1.5㎏

2.5㎏

2.5㎏

2

Radix Bupleuri

1.5㎏

1.3㎏

1.0㎏

2.0㎏

1.9㎏

3

Radix Salviae Miltiorrhizae

2.5㎏

3.0㎏

2.0㎏

2.8㎏

2.3㎏

4

Radix Paeoniae Rubra

2.5㎏

1.7㎏

1.5㎏

2.0㎏

2.8㎏

5

Radix Achyranthis Bidentatae

1.5㎏

1.8㎏

2.2㎏

2.0㎏

1.2㎏

6

Spica Prunellae

2.8㎏

2.5㎏

3.0㎏

2.0㎏

2.2㎏

7

Flos Carthami

1.8㎏

1.5㎏

2.0㎏

1.2㎏

1.0㎏

8

Poria

2.5㎏

2.0㎏

2.3㎏

1.8㎏

1.5㎏

9

Semen Persicae

1.7㎏

1.5㎏

2.2㎏

2.0㎏

1.2㎏

10

The Rhizoma Atractylodis Macrocephalae

2.3㎏

2.8㎏

2.5㎏

2.0㎏

3.0㎏

11

Rhizoma Corydalis

1.0㎏

1.8㎏

1.2㎏

1.5㎏

2.0㎏

12

Radix Glycyrrhizae

0.8㎏

0.6㎏

1.0㎏

1.2㎏

1.6㎏

Claims (4)

1. a Chinese medicine preparation for the treatment of mastopathy, is characterized in that, it is the medicament of being made by the crude drug of following weight proportioning:

Rhizoma Chuanxiong 150-250, Radix Bupleuri 100-200, Radix Salviae Miltiorrhizae 200-300, Radix Paeoniae Rubra 150-250, Radix Achyranthis Bidentatae 120-220, Spica Prunellae 200-300, Flos Carthami 100-200, Poria 150-250, Semen Persicae 120-220, Rhizoma Atractylodis Macrocephalae 200-300, Rhizoma Corydalis 100-200, Radix Glycyrrhizae 60-160.

2. a kind of Chinese medicine preparation for the treatment of mastopathy as claimed in claim 1, is characterized in that, described medicament is powder, tablet, pill, capsule, granule and oral liquid.

3. a kind of preparation method for the treatment of the Chinese medicine preparation of cystic hyperplasia of breast as claimed in claim 1, is characterized in that, concrete preparation method is:

(1) get Rhizoma Corydalis and be crushed to the 30-50 order, doubly measure (w/v) with concentration 90% ethanol 8-10 and soak more than 48 hours, extracted 3 times each l hour, extract 80-85 ℃ of temperature, filter merge extractive liquid,, extracting solution is standby, and medicinal residues are standby;

(2) get Flos Carthami and doubly measure (w/v) with 90% ethanol 8-10 and soak more than 48 hours, extracted 3 times each l hour, extract 80-85 ℃ of temperature, the filtration merge extractive liquid,, extracting solution is standby, and medicinal residues are standby;

(3) Rhizoma Corydalis medicinal residues Flos Carthami medicinal residues and all the other 10 flavor crude drug water boils are extracted 2 times, each 2 hours, extracting solution was concentrated into sticky shape, with 90% soak with ethanol 2 times, was alcohol deposit fluid;

(4) alcohol deposit fluid reclaims ethanol together with Rhizoma Corydalis extracting solution Flos Carthami extracting solution, is extractum;

(5) extractum is put 75 ℃ of oven dry of baking oven, pulverized, crossing at least 200 mesh sieves is medicated powder.

4. the preparation method of the Chinese medicine preparation for the treatment of cystic hyperplasia of breast as claimed in claim 3, is characterized in that, described preparation is made as powder, tablet, pill, capsule, granule and oral liquid according to a conventional method for the medicated powder with step (5).