External medicine for hyperplasia of mammary glands and preparation method thereof

Abstract

The invention relates to the technical field of plasters, in particular to an external medicine for hyperplasia of mammary glands and a preparation method. The external medicine is prepared by decocting angelica sinensis, rheum officinale, coptis chinensis, radix paeoniae rubra, ligusticum wallichii, radix isatidis, thunberg fritillary bulb, arisaema cum bile, safflower carthamus, cortex moutan, peach kernel, oyster, mirabilite, gypsum, liquorice, frankincense, myrrh, borneol and oil azone with sesame oil, rosin and beewax. Chinese angelica, rhubarb, coptis chinensis, red paeony root, ligusticum wallichii, isatis root, arisaema cum bile, cortex moutan, oyster, mirabilite, gypsum and liquorice are decocted, extracted, filtered and concentrated to obtain fluid extract; refining sesame oil, rosin and beewax into base paste; and spraying the fluid extract into the base paste, adding powder of thunberg fritillary bulb, safflower, peach kernel, frankincense and myrrh, uniformly stirring, and adding borneol and oil azone to obtain the black plaster. The black plaster is used for treating internal diseases by external treatment and mainly used for treating hyperplasia of mammary glands, lobular hyperplasia of mammary glands, breast lumps, breast swelling pain and the like, the effective rate reaches 96% or above, and the cure rate reaches 90% or above.

Description

Technical Field

[0001] The present invention relates to the technical field of plaster patches, and particularly relates to an external medicine for mammary gland hyperplasia and a preparation method thereof. Background Art

[0002] Mammary gland hyperplasia is a common and frequently-occurring disease among women. It is a chronic non-inflammatory disease of the breast, accounting for approximately 75% of all breast diseases. Among women of childbearing age, about 40% of women suffer from mammary gland hyperplasia. Mammary gland hyperplasia actually has two forms: one is physiological mammary gland hyperplasia, which is a normal physiological change in women; the other is pathological hyperplasia, mostly caused by endocrine disorders. With the acceleration of the pace of life and the increase in work pressure, the incidence of mammary gland hyperplasia shows an increasing trend. Mammary gland hyperplasia has a great impact on women's physiology, emotions and other aspects of life, endangering women's physical and mental health.

[0003] At present, there are traditional Chinese medicine preparations for treating mammary gland hyperplasia on the market, such as Rupixiao, Rupixiao Pills, Tian Dong Su Tablets, Pingxiao Tablets, Nangpiling, etc. The treatment effects are different. The disadvantages are obvious gastrointestinal symptoms after oral administration, and most of them cause serious damage to liver and kidney functions after long-term use, with a high recurrence rate. And most of them are oral preparations with large side effects and are not suitable for long-term use. There is also a hormone therapy in Western medicine, using androgen for treatment to soften nodules and relieve symptoms. However, this treatment may exacerbate the imbalance of human hormones and is not suitable for routine application.

[0004] Plaster is an important part of traditional Chinese medicine and is a kind of external treatment method. It uses drugs and applies them to the surface of the patient's body, and exerts the functions of dredging meridians, promoting qi and removing stasis, opening orifices and penetrating bones, expelling wind and dispelling cold through the passage of meridians, so as to achieve a certain therapeutic purpose. The development of black plasters has a history of more than 1,600 years and has very definite curative effects in treating internal diseases with external treatments, and has been widely recognized by society.

[0005] Therefore, the present invention provides an external applied black plaster for treating mammary gland hyperplasia. The black plaster of the present invention is directly applied to the mammary gland hyperplasia tissue, with fast absorption, remarkable effect and no side effects, achieving a satisfactory effect of treating internal diseases with external treatments. Summary of the Invention

[0006] The purpose of the present invention is to provide an external medicine for mammary gland hyperplasia and a preparation method thereof, so as to solve the problems that the oral preparations on the market have large side effects and are not suitable for long-term use; the hormone therapy may exacerbate the imbalance of human hormones and is not suitable for routine application.

[0007] To achieve the above purpose, the present invention adopts the following technical scheme: An external medicine for mammary gland hyperplasia, wherein the external medicine is made into a paste by decocting the following raw materials in parts by weight with sesame oil, rosin and beeswax. The parts by weight of each raw material are:

[0008] 10 - 15 parts of Angelica sinensis, 10 - 30 parts of Rheum palmatum, 6 - 10 parts of Coptis chinensis, 6 - 15 parts of Paeonia lactiflora, 6 - 15 parts of Ligusticum wallichii, 10 - 30 parts of Isatis indigotica, 6 - 10 parts of Fritillaria thunbergii, 6 - 10 parts of Arisaema cum Bile, 6 - 10 parts of Carthamus tinctorius, 3 - 10 parts of Cortex Moutan, 6 - 10 parts of Prunus persica, 6 - 10 parts of Oyster, 10 - 30 parts of Mirabilite, 10 - 30 parts of Gypsum Fibrosum, 6 - 10 parts of Glycyrrhiza uralensis, 3 - 10 parts of Olibanum, 3 - 10 parts of Myrrh, 1 - 3 parts of Borneol, 1 - 5 parts of Azone;

[0009] The weight parts of the sesame oil are 50 - 100 parts, the weight parts of the rosin are 400 - 800 parts, and the weight parts of the beeswax are 10 - 30 parts.

[0010] A preparation method of an external medicine for mammary gland hyperplasia, comprising the following steps:

[0011] S1. Take Angelica sinensis, Rheum palmatum, Coptis chinensis, Paeonia lactiflora, Ligusticum wallichii, Isatis indigotica, Arisaema cum Bile, Cortex Moutan, Oyster, Mirabilite, Gypsum Fibrosum, and Glycyrrhiza uralensis, weigh and prepare them according to the weight components; add water, decoct by reflux extraction, filter, and concentrate the filtrate under reduced pressure to obtain a fluid extract;

[0012] S2. Weigh Fritillaria thunbergii, Carthamus tinctorius, Prunus persica, Olibanum, and Myrrh according to the weight components, and pulverize them for standby;

[0013] S3. Add the sesame oil to a pot for refining. After refining until it forms beads when dripping water, add rosin and beeswax, and continue refining until there are no bubbles to obtain a base paste;

[0014] S4. Spray the fluid extract from S1 into the base paste from S3, heat and continuously stir until the water evaporates completely, then add the pulverized medicinal powder from S2, stir evenly until the medicinal powder is completely dissolved, cool down, add Borneol and Azone, and stir evenly to obtain a black plaster;

[0015] S5. Drop the black plaster prepared in S4 into plaster patches, seal and package to obtain the black plaster patch of the external medicine of the present invention.

[0016] Further, in S1, the decoction is divided into a first decoction and a second decoction. The water addition amount for the first decoction is 8 - 10 weight parts, and the reflux extraction time is 50 - 60 min; the water addition amount for the second decoction is 6 - 8 weight parts, and the reflux extraction time is 30 - 40 min; filter after reflux extraction and combine the two filtrates, and then conduct reduced pressure concentration.

[0017] Further, in S1, the specific gravity of the fluid extract is 1.0 - 1.20 g / cm 3 .

[0018] Further, in S2, the particle size of each raw material medicine after pulverization is 80 - 100 mesh.

[0019] Further, in S4, the stirring intensity for each stirring is 40 - 50 rpm, the stirring time after adding the medicinal powder is 5 - 10 min; the temperature after cooling is controlled at 90 - 100 °C; the stirring time after adding borneol and oleic acid azone is 5 - 10 min.

[0020] Further, in S5, the mass of the black plaster dropped on each patch of the black plaster is 18 - 20 g.

[0021] Advantages of the present invention:

[0022] 1. The external medicine black plaster of the present invention treats internal diseases externally, enabling the Chinese medicine components to enter the meridians, acupoints and lesion sites through transdermal absorption, reaching the lesion sites directly, and having the effects of promoting blood circulation to remove blood stasis, soothing the liver and regulating qi, resolving phlegm and dissipating nodules, detumescence and relieving pain, dredging collaterals and opening orifices, and is mainly used for treating diseases such as mammary gland hyperplasia, mammary gland lobular hyperplasia, breast masses, breast distending pain, etc.

[0023] 2. The externally applied black plaster of the present invention has achieved good effects in clinical applications, with an effective rate of over 96% and a cure rate of over 90%. Description of the Drawings

[0024] Figure 1 is a flow chart of the preparation method of the external medicine of the present invention. Detailed Embodiments

[0025] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the drawings in the embodiments of the present invention.

[0026] The usage method of the external medicine black plaster of the present invention is as follows: Take it out from the packaging bag, heat it slightly, and apply it to the affected area. Apply it at night and remove it in the morning, one patch per day, and one week is a treatment course.

[0027] The formula of the external medicine black plaster of the present invention, based on the basic theory of traditional Chinese medicine and combined with modern Chinese medicine preparation techniques, extracts the effective active ingredients of Chinese medicine, increases the drug loading capacity of the black plaster, and ensures the long-term effectiveness of the drug effect; it has the effects of promoting blood circulation to remove blood stasis, soothing the liver and regulating qi, resolving phlegm and dissipating nodules, detumescence and relieving pain, dredging collaterals and opening orifices, and is mainly used for treating diseases such as mammary gland hyperplasia, mammary gland lobular hyperplasia, breast masses, breast distending pain, etc.

[0028] The external medicine black plaster of the present invention treats internal diseases externally, enabling the Chinese medicine components to enter the meridians, acupoints and lesion sites through transdermal absorption, reaching the lesion sites directly, so as to improve local blood circulation, dredge the meridians, strengthen the healthy qi and eliminate pathogenic factors, activate the immune functions of various tissue cells in the human body, regulate the functions of the meridians, zang-fu organs in the human body to balance, and achieve the comprehensive purposes of preventing diseases, treating diseases, strengthening the body and prolonging life.

[0029] Example 1

[0030] The black plaster of this embodiment is made by decocting the following raw materials in parts by weight with sesame oil, rosin, and beeswax into a paste. The weight components of each raw material are: 10 parts of Angelica sinensis, 10 parts of Rheum palmatum, 6 parts of Coptis chinensis, 6 parts of Paeonia lactiflora, 6 parts of Ligusticum chuanxiong, 10 parts of Isatis indigotica, 6 parts of Fritillaria thunbergii, 6 parts of Arisaema erubescens, 6 parts of Carthamus tinctorius, 3 parts of Paeonia suffruticosa, 6 parts of Prunus persica, 6 parts of Oyster, 10 parts of Mirabilite, 10 parts of Gypsum fibrosum, 6 parts of Glycyrrhiza uralensis, 3 parts of Olibanum, 3 parts of Myrrh, 1 part of Borneol, and 1 part of Azone.

[0031] The weight of sesame oil is 50 parts, the weight of rosin is 400 parts, and the weight of beeswax is 10 parts.

[0032] A preparation method of an external black plaster for treating hyperplasia of mammary glands is as follows:

[0033] (1) Weigh 10 parts of Angelica sinensis, 10 parts of Rheum palmatum, 6 parts of Coptis chinensis, 6 parts of Paeonia lactiflora, 6 parts of Ligusticum chuanxiong, 10 parts of Isatis indigotica, 6 parts of Arisaema erubescens, 3 parts of Paeonia suffruticosa, 6 parts of Oyster, 10 parts of Mirabilite, 10 parts of Gypsum fibrosum, and 6 parts of Glycyrrhiza uralensis according to the weight components and prepare them. For the first decoction, add 8 - 10 times the weight of water, reflux and extract for 50 - 60 minutes, filter the medicinal liquid. For the second decoction, add 6 - 8 times the weight of water, reflux and extract for 30 - 40 minutes, filter the medicinal liquid. Combine the two decoctions and cool to 60 - 80 °C for reduced pressure concentration to obtain a fluid extract with a relative density of 1 - 1.20 for standby.

[0034] (2) Weigh 6 parts of Fritillaria thunbergii, 6 parts of Carthamus tinctorius, 6 parts of Prunus persica, 3 parts of Olibanum, and 3 parts of Myrrh according to the weight components, crush them into fine powder of 80 - 100 meshes for standby.

[0035] (3) Add 50 parts of sesame oil to the pot for refining. After refining until the water droplets form beads, add 400 parts of rosin and 10 parts of beeswax and continue to refine until there are no bubbles. Test its softening point at 50 - 60 °C, piercing strength at 60 - 80 N, and viscosity at 25 °C room temperature at 8000 mPa·s - 15000 mPa·s. The base paste is made.

[0036] (4) Spray the above fluid extract into the base paste, heat and stir at 40 - 50 rpm until the water evaporates completely, then add the above - crushed fine powder, stir evenly to completely dissolve the medicinal powder. When the temperature drops to 90 - 100 °C, add 1 part of Borneol and 1 part of Azone, stir evenly, and the prepared black plaster is obtained.

[0037] (5) Place the prepared black plaster on a dropping machine and drop it into plaster patches of 18 - 20 grams per patch, then seal and package.

[0038] Example 2

[0039] The black plaster of this embodiment is made by decocting the following raw materials in parts by weight with sesame oil, rosin, and beeswax into a paste. The weight components of each raw material are: 12 parts of angelica, 15 parts of rhubarb, 8 parts of coptis, 8 parts of red peony root, 8 parts of chuanxiong, 15 parts of isatis root, 8 parts of fritillaria thunbergii, 8 parts of arisaema cum bile, 8 parts of safflower, 5 parts of moutan bark, 8 parts of peach kernel, 8 parts of oyster, 15 parts of mirabilite, 15 parts of gypsum fibrosum, 8 parts of licorice, 5 parts of frankincense, 5 parts of myrrh, 1.5 parts of borneol, and 2 parts of oleic acid azone.

[0040] The weight of sesame oil is 80 parts, the weight of rosin is 650 parts, and the weight of beeswax is 15 parts.

[0041] A preparation method of an external-use black plaster for treating hyperplasia of mammary glands is as follows:

[0042] (1) Weigh and prepare 12 parts of angelica, 15 parts of rhubarb, 8 parts of coptis, 8 parts of red peony root, 8 parts of chuanxiong, 15 parts of isatis root, 8 parts of arisaema cum bile, 5 parts of moutan bark, 8 parts of oyster, 15 parts of mirabilite, 15 parts of gypsum fibrosum, and 8 parts of licorice according to the weight components; add 8 - 10 times the weight of water for the first decoction, reflux and extract for 50 - 60 minutes, filter the medicinal liquid, add 6 - 8 times the weight of water for the second decoction, reflux and extract for 30 - 40 minutes, filter the medicinal liquid; combine the two medicinal liquids and concentrate under reduced pressure at 60 - 80 °C to obtain a fluid extract with a relative density of 1.0 - 1.20 for standby.

[0043] (2) Weigh 8 parts of fritillaria thunbergii, 8 parts of safflower, 8 parts of peach kernel, 5 parts of frankincense, and 5 parts of myrrh according to the weight components, crush them into fine powder of 80 - 100 mesh for standby.

[0044] (3) Add 80 parts of sesame oil to the pot for refining. After refining until it forms beads when dripping water, add 650 parts of rosin and 15 parts of beeswax and continue to refine until there are no bubbles. Test its softening point at 50 - 60 °C, the puncture strength at 60 - 80 N, and the viscosity at 8000 mPa·s - 15000 mPa·s at room temperature of 25 °C. The base paste is then made.

[0045] (4) Spray the above-mentioned fluid extract into the base paste, heat and stir at 40 - 50 rpm until the water evaporates completely, then add the above-mentioned crushed fine powder, stir evenly until the medicinal powder is completely dissolved. When the temperature drops to 90 - 100 °C, add 1.5 parts of borneol and 2 parts of oleic acid azone, and stir evenly to obtain the well-boiled black plaster.

[0046] (5) Place the well-boiled plaster on a dropping machine and drop it into plaster patches of 18 - 20 grams per patch, then seal and package.

[0047] Example 3

[0048] The black plaster of this embodiment is made by decocting the following raw materials in parts by weight with sesame oil, rosin, and beeswax into a paste. The weight components of each raw material are: 15 parts of Angelica sinensis, 20 parts of Rheum palmatum, 10 parts of Coptis chinensis, 12 parts of Paeonia lactiflora, 12 parts of Ligusticum chuanxiong, 20 parts of Isatis indigotica, 10 parts of Fritillaria thunbergii, 10 parts of Arisaema erubescens, 10 parts of Carthamus tinctorius, 10 parts of Paeonia suffruticosa, 10 parts of Prunus persica, 10 parts of Oyster, 20 parts of Mirabilite, 20 parts of Gypsum Fibrosum, 10 parts of Glycyrrhiza uralensis, 8 parts of Olibanum, 8 parts of Myrrh, 2 parts of Borneol, and 3 parts of Oleic acid azone.

[0049] The weight of sesame oil is 100 parts, the weight of rosin is 850 parts, and the weight of beeswax is 20 parts.

[0050] A preparation method of an externally applied black plaster for treating hyperplasia of mammary glands is as follows:

[0051] (1) Weigh 15 parts of Angelica sinensis, 20 parts of Rheum palmatum, 10 parts of Coptis chinensis, 12 parts of Paeonia lactiflora, 12 parts of Ligusticum chuanxiong, 20 parts of Isatis indigotica, 10 parts of Arisaema erubescens, 10 parts of Paeonia suffruticosa, 10 parts of Oyster, 20 parts of Mirabilite, 20 parts of Gypsum Fibrosum, and 10 parts of Glycyrrhiza uralensis according to the weight components and prepare them. For the first decoction, add 8 - 10 times the weight of water, reflux and extract for 50 - 60 minutes, and filter the medicinal liquid. For the second decoction, add 6 - 8 times the weight of water, reflux and extract for 30 - 40 minutes, and filter the medicinal liquid. Combine the two medicinal liquids and concentrate under reduced pressure at 60 - 80 °C to obtain a fluid extract with a relative density of 1.0 - 1.20 for standby.

[0052] (2) Weigh 10 parts of Fritillaria thunbergii, 10 parts of Carthamus tinctorius, 10 parts of Prunus persica, 8 parts of Olibanum, and 8 parts of Myrrh according to the weight components, crush them into fine powder of 80 - 100 mesh for standby.

[0053] (3) Add 100 parts of sesame oil to the pot for refining. After refining until it forms beads when dripping water, add 850 parts of rosin and 20 parts of beeswax and continue refining until there are no bubbles. Test its softening point at 50 - 60 °C, piercing strength at 60 - 80 N, and viscosity at 25 °C normal temperature at 8000 mPa·s - 15000 mPa·s. The base paste is made.

[0054] (4) Spray the above fluid extract into the base paste, heat and stir at 40 - 50 rpm until the water evaporates completely, then add the above - crushed fine powder, stir evenly to make the medicinal powder completely dissolve. When the temperature drops to 90 - 100 °C, add 2 parts of Borneol and 3 parts of Oleic acid azone, and stir evenly to obtain the well - decocted black plaster.

[0055] (5) Place the well - decocted plaster on a dropping machine and drop it into plaster patches of 18 - 20 grams per patch, then seal and package.

[0056] Example 4

[0057] Clinical practice was carried out on the black plaster patch of the present invention. During the process, a treatment group and a control group were selected. In the treatment group, the black plaster patch of the present invention was used, and in the control group, a placebo patch (the base paste of the present invention as the ingredient) was used. There were 168 cases in each of the treatment group and the control group, and informed consent forms were signed.

[0058] Table 1 Information data table of the treatment group and the control group

[0059]

[0060] The same application method was adopted for the treatment group and the control group, that is, it was applied externally to the affected area for 8 hours every day, and the treatment continued for 14 days.

[0061] The relevant treatment indicators were: pain relief rate (VAS (self-perceived pain) score decreased by ≥ 50%), change in the diameter of breast masses (ultrasound measurement), serum hormone levels (E2, PRL, P), and quality of life score (SF-36 scale), etc.

[0062] The efficacy data were recorded as follows:

[0063] Table 2 Efficacy data record table

[0064]

[0065] The adverse events were recorded as follows:

[0066] Table 3 Adverse event record table

[0067]

[0068] The follow-up results were recorded as follows:

[0069] Table 4 Follow-up result record table

[0070]

[0071] It can be seen that the externally applied black plaster of the present invention has achieved good effects in clinical applications, with an effective rate of over 96% and a cure rate of over 90%.

[0072] The present invention is not limited to the above-mentioned optimal implementation manner. Anyone can obtain various other forms of products under the inspiration of the present invention. However, no matter what changes are made in its shape or structure, as long as it has a technical solution that is the same as or similar to the present application, it falls within the protection scope of the present invention.

Claims

1. A drug for external use for breast hyperplasia, characterized in that: The external medicine is prepared by boiling the following raw materials in parts by weight with sesame oil, rosin and beeswax into a paste, wherein the weight parts of each raw material are: 10-15 parts of Chinese Angelica, 10-30 parts of Rhubarb, 6-10 parts of Coptis chinensis, 6-15 parts of Red Peony Root, 6-15 parts of Chuanxiong, 10-30 parts of Isatis Root, 6-10 parts of Fritillaria thunbergii, 6-10 parts of Arisaema cinerea, 6-10 parts of Carthamus tinctorius, 3-10 parts of Cortex Moutan, 6-10 parts of Semen persicae, 6-10 parts of Oyster, 10-30 parts of Sodium Sulfate, 10-30 parts of Gypsum, 6-10 parts of Licorice, 3-10 parts of Olibanum, 3-10 parts of Myrrh, 1-3 parts of Borneol, 1-5 parts of Oleazone; The weight portion of the sesame oil is 50-100 parts, the weight portion of the rosin is 400-800 parts, and the weight portion of the beeswax is 10-30 parts.

2. The method for preparing a medicament for external use for breast hyperplasia according to claim 1, characterized in that: The following steps are involved: S1. Take angelica, rhubarb, coptis root, red peony root, ligusticum chuanxiong, isatis root, strychnos nux vomica, moutan bark, oyster, mirabilite, gypsum, and liquorice, weigh and prepare the components by weight; add water, decoct and reflux to extract, filter, and concentrate the filtrate under reduced pressure to obtain a fluid extract; S2. Weigh the Fritillaria thunbergii, safflower, peach kernel, frankincense and myrrh according to their weight components, and crush them for later use; S3, add sesame oil into the pot for refining, and after refining until water drops into beads, add rosin and beeswax, and continue to refine until there is no foam, and refine into a base paste; S4, spray the S1 fluid extract into the S3 base cream, heat and stir continuously until the water evaporates completely, then add the S2 crushed powder, stir evenly to completely dissolve the powder, cool down, add borneol and oleazone, stir evenly to obtain a black plaster; S5, dripping the black plaster prepared in S4 into a plaster patch, sealing the bag and packaging to obtain the external-use black plaster patch of the present invention.

3. The method for preparing a medicament for external use for breast hyperplasia according to claim 2, characterized in that: In the S1, the decoction is divided into a primary decoction and a secondary decoction. The amount of water added in the primary decoction is 8 to 10 parts by weight, and the reflux extraction time is 50 to 60 minutes; the amount of water added in the secondary decoction is 6 to 8 parts by weight, and the reflux extraction time is 30 to 40 minutes; after the reflux extraction, the two filtrates are filtered and combined, and then concentrated under reduced pressure.

4. The method for preparing a medicament for external use for breast hyperplasia according to claim 2, characterized in that: In the S1, the specific gravity of the fluid extract is 1.0-1.20 g / cm 3 .

5. The method for preparing a medicament for external use for breast hyperplasia according to claim 2, characterized in that: In the S2, the particle size of each raw material drug after crushing is 80-100 mesh.

6. The method for preparing a medicament for external use for breast hyperplasia according to claim 2, characterized in that: In the S4, the stirring intensity of each stirring is 40-50 rpm, the stirring time after the addition of the powder is 5-10 min; the temperature after cooling is controlled to 90-100° C.; the stirring time after adding borneol and oleamide is 5-10 min.

7. The method for preparing a medicament for external use for breast hyperplasia according to claim 2, characterized in that: In the above-mentioned S5, the mass of the drip black plaster on each black plaster is 18-20 g.

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