CN100350933C - Externally applied medicament for treating mammary gland disease and its preparing method - Google Patents

Abstract

The present invention relates to a medical composition for treating breast diseases and a method for the preparation thereof, which discloses an external applying breast nodule disease eliminating agent and a method for the preparation thereof. The breast nodule disease eliminating agent uses dandelions, spatholobus stems, aucklandia roots, antlers, kelp, radixes, tree peony bark, notoginseng, trichosanthes root powder, red peony roots, seaweed, iron powder, salt, etc., as raw materials. Solid state ingredients are dried and pulverized, wherein the salt, water, wood powder and acetic acid are firstly and uniformly mixed, and after the mixture of the salt, water, wood powder and acetic acid is statically placed for a time period, the mixture is uniformly mixed with other ingredients. The mixture is stored and activated for 24 hours under a sealing state, and the external applying preparation wrapped by an air leaking bag is used. The present invention has the advantages of direct effect, exact treating effect, no pain, no stimulation, colorless, tasteless, no pollution, little side effect, small size, convenient and comfortable use, cheap price, simple preparing process, convenient industrial production, and excellent and wide applying prospect.

Description

Nodules of the breast is pressed agent and preparation method thereof

Technical field the present invention relates to a kind of pharmaceutical composition for the treatment of mastopathy and preparation method thereof, but especially a kind of nodules of the breast of external is pressed agent and preparation method thereof.

The technical background cystic hyperplasia of breast is the able-bodied common clinical of a kind of women of having a strong impact on, frequently-occurring disease, reports abroad in the history inspection that 58～98% women has this disease in various degree.With the quickening pace of modern life, the enhancing of competitive spirit, the change of dietary structure, sickness rate rises year by year, occupies the first place of whole mastopathy, accounts for 60～70%, is onset peak with 30～49 years old.Cystic hyperplasia of breast often shows as mammary gland tumor and periodicity mastalgia, the traditional Chinese medical science belongs to " nodules of the breast " category, be that a kind of non-inflammation, non-tumor become, the probability that suffers from breast cancer is 3～5 times of general women, thereby some scholar thinks that also primary disease belongs to precancerous lesion, makes that the control of primary disease in recent years receives much attention.

At present, operation is the more definite Therapeutic Method of cystic hyperplasia of breast, but because of it brings the frightened and human body misery of psychology to patient, operation influences the function and the outward appearance of mammary gland, and Most patients is reluctant to accept.Hormoness such as Progesterone for oral administration, estrogen, testosterone propionate, tamoxifen, Ergolactin easily cause endocrine regulation, and curative effect is difficult to be consolidated, and side effect is big.Method uncertain therapeutic efficacies such as fine needle aspiration, intracapsular injection, infrared ray, low-frequency pulse are decided, bother and take effect slow, and certain misery is arranged.

Motherland's traditional medicine has accumulated rich experience to the treatment of primary disease, RUPIXIAO be exactly a kind ofly have hard masses softening and resolving, the Chinese medicine of the effect of the eliminating carbuncle of invigorating blood circulation, heat-clearing and toxic substances removing, be widely used in treatment nodules of the breast caking, acute mastitis from the beginning of, cystic hyperplasia of breast and mastitis early stages, the RUPIXIAO that the Pharmacopoeia of the People's Republic of China (version was an one in 2000) is included is made up of Cornu Cervi, Herba Taraxaci, Thallus Laminariae (Thallus Eckloniae), Radix Trichosanthis, Caulis Spatholobi etc.RUPIXIAO generally is to make oral tablet at present, the method treatment disease that employing is for oral administration.

Adopt the research report of Chinese medicine decoction, tablets and other formulations treatment cystic hyperplasia of breast existing a lot, but adopt the research of external therapy of Chinese herb treatment cystic hyperplasia of breast increasing in recent years, as methods such as outer varnish, unguentum, medicated powder or mass external application, ultrathin pad pasting, transdermic absorbent, medicine medicated bras.But uses such as outer varnish, unguentum, medicated powder or mass external application are inconvenient, local excitation is big, abnormal smells from the patient is dense, easily pollute clothes; Ultrathin pad pasting, transdermic absorbent, medicine medicated bra etc. are health product, and drug effect is worth discussion, and to the having relatively high expectations of preparation technology, cost is also high again.Therefore seek effective, inexpensive, convenient, attractive in appearance, side effect is little, the long-term easily method of accepting of patient is unusual necessity still.

Summary of the invention the purpose of this invention is to provide a kind of nodules of the breast that is mainly used in treatment cystic hyperplasia of breast, cyclomastopathy, acute mastitis and presses agent, adopt the form of therapy disease of external application, the toxic and side effects of avoiding oral medication to bring, be easy to be accepted by the patient, and cheap, have an excellent curative.

Another object of the present invention provides the preparation method that this nodules of the breast is pressed agent.

Solution of the present invention is based on the composition of RUPIXIAO in the Pharmacopoeia of the People's Republic of China, according to the different qualities of each flavor Chinese medicine and the characteristics of external, suitably adjust and form and consumption proportion, be equipped with suitable heat-generation system again, to reach excellent curative.

It is the medicament of being made by the following weight proportion raw material that nodules of the breast provided by the invention is pressed agent:

Herba Taraxaci 3～8 Caulis Spatholobis 3～8 Radix Aucklandiae 3～8 Cornu Cervis 1～4

Thallus Laminariae (Thallus Eckloniae) 1～4 Radix Rhapontici 1～4 Cortex Moutan 1～4 Radix Notoginseng 1～4

Radix Trichosanthis 1～2 Radix Paeoniae Rubra 1～2 Sargassum 1～2 Radix Scrophulariae 0～2

Spica Prunellae 0～2 Fructus Forsythiae 1～2 Flos Carthami 0～2 Borneolum Syntheticum 0～3

Sal 10～20 iron powders 200～300 active carbons 20～30 wood powders 30～50

Water 100～130 acetic acid 0～15

The formula optimization weight proportion scope of preparation medicine of the present invention is:

Herba Taraxaci 4～7 Caulis Spatholobis 4～7 Radix Aucklandiae 4～7 Cornu Cervis 2～3

Thallus Laminariae (Thallus Eckloniae) 2～3 Radix Rhapontici 2～3 Cortex Moutans 2～3 Radix Notoginseng 2～3

Radix Trichosanthis 1～2 Radix Paeoniae Rubra 1～2 Sargassum 1～2 Radix Scrophulariae 1～2

Spica Prunellae 1～2 Fructus Forsythiae 1～2 Flos Carthami 1～2 Borneolum Syntheticum 1～3

Sal 10～15 iron powders 250～280 active carbons 25～30 wood powders 40～50

Water 105～120 acetic acid 5～15

The optimum weight proportioning of medicine of the present invention is:

Herba Taraxaci 5 Caulis Spatholobis 5 Radix Aucklandiae 5 Cornu Cervis 2.5

Thallus Laminariae (Thallus Eckloniae) 2.5 Radix Rhapontici 2.5 Cortex Moutans 2.5 Radix Notoginseng 2.5

Radix Trichosanthis 1 Radix Paeoniae Rubra 1 Sargassum 1 Radix Scrophulariae 1

Spica Prunellae 1 Fructus Forsythiae 1 Flos Carthami 1 Borneolum Syntheticum 1

Sal 12 iron powders 269 active carbons 26 wood powders 42

Water 115 acetic acid 8

Above-mentioned each component is made medicine production method of the present invention is:

1, will dewater, each the component drying beyond the acetic acid is crushed to 30～120 orders;

2, get Sal, water, wood powder and acetic acid mix homogeneously, left standstill 12～20 hours, make mixture A;

3,, under sealing state, store and activate 24 hours promptly with the mixture A and all the other the component mix homogeneously that make.

The temperature equalization that granular size is pressed agent to the nodules of the breast that makes after wherein pulverizing in the step 1 has direct influence, and granularity is good with 30～80 orders.

The nodules of the breast that makes is pressed the external preparation that permeation bag parcel is adopted in agent, and the breathable paper bag of packing into, cloth bag, plastic bag or other Fibre Bag can use.As product, generally can reinstall in the sealing bag by 50 grams/packed infiltrating behind the airbag.During use, outer bag is opened, taken out inner bag, the shake inner bag places the affected part to get final product to beginning heating.This is pressed agent and can keep generating heat about 20 hours 45～55 ℃ of mean temperatures.Each 1 bag, change every day 1 time, 12～18 days be-recovery period.

" pressing " is ancient xeothermic deposited external treatment, and pressing agent is a kind of external preparation by thermotherapy of motherland's traditional medicine.The present invention changes the RUPIXIAO tablet into external and presses the agent dosage form, by its slow heat production transdermal effect, make the Chinese medicine drug effect of promoting flow of QI and blood, detoxicating and resolving stagnation of pathogens, hardness softening and stasis-eliminating, sick institute can go directly, with promoting flow of QI and blood, hard masses softening and resolving, warm lactogenesis network, the pain relieving addiction that disappears is particularly useful for cystic hyperplasia of breast, cyclomastopathy, acute cyclomastopathy.Clinical trial obtains satisfied effect.The present invention is through 54 examples, 20～51 years old age, and the patients clinical application result of 34.2 years old mean age, total effective rate reaches 100%, and various safety observation index such as liver, renal function, routine blood test, electrocardiogram etc. all prove without any side effects.This group patient diagnostic criteria and observation of curative effect standard are all with reference to instructing Rulemaking, result such as following table about the clinical research of new Chinese medicine treatment cystic hyperplasia of breast in the Ministry of Public Health " new Chinese medicine clinical research guideline ":

Clinical drug of the present invention uses the result to show, following advantage is arranged: it is direct that this nodules of the breast is pressed the agent effect, determined curative effect, temperature control is steadily constant, be suitable for placing the front and be unlikely to cause and scald and uncomfortable, no pain, non-stimulated, side effect is little, can avoid corrective surgery the psychology of fear and postoperative to influence the function and the outward appearance of mammary gland, colorless and odorless is pollution-free, and volume is little, and is easy to use comfortable, the patient easily accepts and adheres to, and cheap, preparation technology is simple, is easy to suitability for industrialized production, have good social effect and economic benefit, have a extensive future.

Preferred forms is following with specific embodiment explanation the present invention, but the present invention is not limited to this.

Embodiment 1

Take by weighing raw material (kilogram) by following proportioning:

Herba Taraxaci 5 Caulis Spatholobis 5 Radix Aucklandiae 5 Cornu Cervis 2.5

Thallus Laminariae (Thallus Eckloniae) 2.5 Radix Rhapontici 2.5 Cortex Moutans 2.5 Radix Notoginseng 2.5

Radix Trichosanthis 1 Radix Paeoniae Rubra 1 Sargassum 1 Radix Scrophulariae 1

Spica Prunellae 1 Fructus Forsythiae 1 Flos Carthami 1 Borneolum Syntheticum 1

Sal 12 iron powders 269 active carbons 26 wood powders 42

Water 115 acetic acid 8

Production method is as follows:

With Herba Taraxaci, Caulis Spatholobi, the Radix Aucklandiae, Cornu Cervi, Thallus Laminariae (Thallus Eckloniae), Radix Rhapontici, Cortex Moutan, Radix Notoginseng, Radix Trichosanthis, Radix Paeoniae Rubra, Sargassum, Radix Scrophulariae, Spica Prunellae, Fructus Forsythiae, Flos Carthami, Borneolum Syntheticum, iron powder, active carbon, Sal drying and crushing to 30～60 orders, wood powder directly adopts industrial wood dust (about 30～60 orders of granularity) earlier; Get Sal, water, wood powder and acetic acid mix homogeneously, left standstill 15 hours, make mixture A; With mixture A and all the other the component mix homogeneously that makes, under sealing state, store and activate 24 hours promptly, with the Fibre Bag packing that microvoid is arranged, reuse plastic sealing bag packing.

Embodiment 2

Take by weighing raw material (kilogram) by following proportioning:

Herba Taraxaci 6 Caulis Spatholobis 4 Radix Aucklandiae 5 Cornu Cervis 2

Thallus Laminariae (Thallus Eckloniae) 3 Radix Rhapontici 2 Cortex Moutans 1 Radix Notoginseng 1

Radix Trichosanthis 1.5 Radix Paeoniae Rubra 2 Sargassums 2 Fructus Forsythiaes 1.5

Flos Carthami 0.5 Borneolum Syntheticum 1.5 Sal 15 iron powders 280

Active carbon 25 wood powders 35 water 120 acetic acid 5

Production method is as follows:

With Herba Taraxaci, Caulis Spatholobi, the Radix Aucklandiae, Cornu Cervi, Thallus Laminariae (Thallus Eckloniae), Radix Rhapontici, Cortex Moutan, Radix Notoginseng, Radix Trichosanthis, Radix Paeoniae Rubra, Sargassum, Radix Scrophulariae, Spica Prunellae, Fructus Forsythiae, Flos Carthami, Borneolum Syntheticum, iron powder, active carbon, Sal drying and crushing to 60～100 orders, wood powder directly adopts industrial wood dust (about 30～60 orders of granularity) earlier; Get Sal, water, wood powder and acetic acid mix homogeneously, left standstill 18 hours, make mixture A; With mixture A and all the other the component mix homogeneously that makes, under sealing state, store and activate 24 hours promptly, with the Fibre Bag packing that microvoid is arranged, reuse plastic sealing bag packing.

Claims (6)

1, a kind of nodules of the breast is pressed agent, it is characterized in that the medicament of being made by the following weight proportion raw material:

Herba Taraxaci 3～8 Caulis Spatholobis 3～8 Radix Aucklandiae 3～8 Cornu Cervis 1～4

Thallus Laminariae (Thallus Eckloniae) 1～4 Radix Rhapontici 1～4 Cortex Moutan 1～4 Radix Notoginseng 1～4

Radix Trichosanthis 1～2 Radix Paeoniae Rubra 1～2 Sargassum 1～2 Radix Scrophulariae 0～2

Spica Prunellae 0～2 Fructus Forsythiae 1～2 Flos Carthami 0～2 Borneolum Syntheticum 0～3

Sal 10～20 iron powders 200～300 active carbons 20～30 wood powders 30～50

Water 100～130 acetic acid 0～15.

2, press agent according to the nodules of the breast of claim 1, it is characterized in that wherein the weight proportion of each raw material is:

Herba Taraxaci 4～7 Caulis Spatholobis 4～7 Radix Aucklandiae 4～7 Cornu Cervis 2～3

Thallus Laminariae (Thallus Eckloniae) 2～3 Radix Rhapontici 2～3 Cortex Moutans 2～3 Radix Notoginseng 2～3

Radix Trichosanthis 1～2 Radix Paeoniae Rubra 1～2 Sargassum 1～2 Radix Scrophulariae 1～2

Spica Prunellae 1～2 Fructus Forsythiae 1～2 Flos Carthami 1～2 Borneolum Syntheticum 1～3

Sal 10～15 iron powders 250～280 active carbons 25～30 wood powders 40～50

Water 105～120 acetic acid 5～15.

3, press agent according to the nodules of the breast of claim 2, it is characterized in that wherein the weight proportion of each raw material is:

Herba Taraxaci 5 Caulis Spatholobis 5 Radix Aucklandiae 5 Cornu Cervis 2.5

Thallus Laminariae (Thallus Eckloniae) 2.5 Radix Rhapontici 2.5 Cortex Moutans 2.5 Radix Notoginseng 2.5

Radix Trichosanthis 1 Radix Paeoniae Rubra 1 Sargassum 1 Radix Scrophulariae 1

Spica Prunellae 1 Fructus Forsythiae 1 Flos Carthami 1 Borneolum Syntheticum 1

Sal 12 iron powders 269 active carbons 26 wood powders 42

Water 115 acetic acid 8.

4, press agent according to the arbitrary nodules of the breast of claim 1～3, it is characterized by the external preparation of permeation bag parcel.

5, press the preparation method of agent according to the arbitrary nodules of the breast of claim 1～3, its feature comprises the steps:

1, will dewater, each the component drying beyond the acetic acid is crushed to 30～120 orders;

2, get Sal, water, wood powder and acetic acid mix homogeneously, left standstill 12～20 hours, make mixture A;

3,, under sealing state, store and activate 24 hours promptly with the mixture A and all the other the component mix homogeneously that make.

6, according to the method for claim 5, the grain graininess after it is characterized in that pulverizing in the step 1 wherein is 30～80 orders.