CN112618532B - External medicine composition for improving hyperplasia of mammary glands - Google Patents

External medicine composition for improving hyperplasia of mammary glands Download PDF

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CN112618532B
CN112618532B CN202011613897.7A CN202011613897A CN112618532B CN 112618532 B CN112618532 B CN 112618532B CN 202011613897 A CN202011613897 A CN 202011613897A CN 112618532 B CN112618532 B CN 112618532B
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pharmaceutical composition
extraction
pinene
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CN112618532A (en
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赵华祥
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Poli Fragrant Medicine Technology Shanghai Co ltd
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Poli Fragrant Medicine Technology Shanghai Co ltd
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/14—Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/31—Extraction of the material involving untreated material, e.g. fruit juice or sap obtained from fresh plants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction

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Abstract

The invention provides an external pharmaceutical composition for improving hyperplasia of mammary glands, and particularly provides a pharmaceutical composition, which comprises the following components in part by weight: 40-55 parts of oleic acid, 30-40 parts of linoleic acid, 4-8 parts of palmitic acid, 1-5 parts of stearic acid, 0.5-5 parts of alpha-pinene, 0.5-4 parts of limonene, 0.5-3 parts of eucalyptol, 0.2-3 parts of anethole, 1-3 parts of 3-arborvitae and 1-2 parts of beta-pinene. The pharmaceutical composition can be applied to a patient with hyperplasia of mammary glands in a transdermal administration form, thereby improving or controlling the symptoms of the patient.

Description

External medicine composition for improving hyperplasia of mammary glands
Technical Field
The invention relates to the field of medicines, and particularly provides an external pharmaceutical composition for improving hyperplasia of mammary glands.
Background
The hyperplasia of mammary glands refers to hyperplasia of mammary epithelium and fibrous tissue, degenerative changes of mammary tissue ducts and mammary lobules on structure and growth of progressive connective tissue, and the pathogenesis of the hyperplasia of mammary glands is mainly due to endocrine hormone imbalance. Hyperplasia of mammary glands is the most common breast disease in women, and the incidence rate accounts for the first place of breast diseases. The incidence of the disease has been increasing year by year in recent years, and the age has been getting lower. About 70% to 80% of women have different degrees of hyperplasia of mammary glands, which is common in women 25-45 years old. The clinical manifestations are different characteristics in different age groups, and the main symptom of the disease is mammary swelling pain, which can affect both sides at the same time, but one side is heavier. The distending pain of the mammary gland before menstruation is obvious, the pain is relieved and gradually stopped immediately after menstruation, the pain reappears before next menstruation, and the whole breast has diffuse nodular sensation and is accompanied with tenderness. The main symptoms of women after age 35 are breast lumps, mild breast pain and tenderness, and are independent of the menstrual cycle. When the breast is touched by hand, the breast can touch nodules with different sizes, oblate shapes or irregular shapes and flexible textures, the boundaries are not clear, no adhesion is caused between the breast and the skin and deep tissues, and the breast can be pushed. After age 45, it often appears as a single or multiple loose cystic masses with clear borders, often accompanied by dull pain, distending pain, or burning sensations. Postmenopausal women have atrophic breast glands and more prominent cystic lesions. The severity of breast pain is not related to the presence or absence and extent of nodules, and pain can be spread to the axilla and the shoulders and back. A few patients may be accompanied by nipple discharge.
Currently, there is no suitable drug in the art for benign breast hyperplasia other than surgery. Therefore, there is an urgent need in the art to develop a novel pharmaceutical composition for treating or alleviating hyperplasia of mammary glands. Disclosure of Invention
The invention aims to provide a novel pharmaceutical composition for treating or relieving hyperplasia of mammary glands.
In a first aspect of the present invention, there is provided a pharmaceutical composition comprising:
40-55 parts of oleic acid, 30-40 parts of linoleic acid, 4-8 parts of palmitic acid, 1-5 parts of stearic acid, 0.5-5 parts of alpha-pinene, 0.5-4 parts of limonene, 0.5-3 parts of eucalyptol, 0.2-3 parts of anethole, 1-3 parts of 3-arborvitae and 1-2 parts of beta-pinene.
In another preferred embodiment, the pharmaceutical composition further comprises:
0.01-2 parts of trans-caryophyllene, 0.01-2 parts of alpha-santalene, 0.01-2 parts of sabinene, 0.01-2 parts of ocimene and 0.01-1 part of p-cymene.
In another preferred embodiment, the pharmaceutical composition comprises:
45-55 parts of oleic acid, 32-39 parts of linoleic acid, 5-7 parts of palmitic acid, 2-4 parts of stearic acid, 1-3 parts of alpha-pinene, 1-3 parts of limonene, 1-3 parts of eucalyptol, 1-3 parts of anethole, 1-3 parts of 3-thujene and 1-2 parts of beta-pinene.
In another preferred embodiment, the pharmaceutical composition comprises:
trans-caryophyllene 0.5-1.5 weight parts, alpha-santalene 0.5-1.5 weight parts, sabinene 0.5-1.5 weight parts, ocimene 0.5-1.5 weight parts, and p-cymene 0.5-1.5 weight parts.
In a second aspect of the present invention, there is provided a process for the preparation of a pharmaceutical composition according to the first aspect of the present invention, said process comprising the steps of: 40-55 parts of oleic acid, 30-40 parts of linoleic acid, 4-8 parts of palmitic acid, 1-5 parts of stearic acid, 0.5-5 parts of alpha-pinene, 0.5-4 parts of limonene, 0.5-3 parts of eucalyptol, 0.2-3 parts of anethole, 1-3 parts of 3-arborvitae and 1-2 parts of beta-pinene, and uniformly mixing to obtain the required pharmaceutical composition.
In a third aspect of the present invention, there is provided a process for the preparation of a pharmaceutical composition according to the first aspect of the present invention, said process comprising the steps of:
s101: cleaning and crushing bay, fennel, red myrrh and black pine branches and leaves, and performing first extraction by adopting supercritical carbon dioxide;
s102: pulverizing basil, rose geranium and frankincense, uniformly mixing, performing second extraction by adopting a steam distillation method, filtering a product obtained after the second extraction, and collecting a second filtrate;
s103: mixing grape seeds and Morocco nuts, and extracting by cold pressing;
s104: and (3) uniformly mixing the products obtained in the step (S101), the step (S102) and the step (S103) to obtain the pharmaceutical composition.
In another preferred example, in step S101, the temperature of the supercritical carbon dioxide for the first extraction is 45-50 ℃, and the pressure of the gas flow is 12-18MPa.
In another preferred example, the first extraction time is 70-90min.
In another preferred embodiment, the flow rate of the supercritical carbon dioxide in the first extraction process is 28-32kg/h.
In another preferred example, in the step S102, the mass ratio of the added water to the pulverized solid product is 4 to 6:1.
In another preferred embodiment, the time for steam distillation extraction is 250-350min.
In another preferred example, in the step S103, the cold pressing is performed at a temperature of 5 to 10 ℃.
In another preferred embodiment, in step S103, the cold pressing process is performed at a pH of 7-8 ℃.
In a fourth aspect of the invention, there is provided the use of a pharmaceutical composition according to the first aspect of the invention for the manufacture of a medicament for the treatment of mammary gland hyperplasia.
In another preferred embodiment, the medicament is a transdermal administration preparation.
It is to be understood that within the scope of the present invention, the above-described features of the present invention and those specifically described below (e.g., in the examples) may be combined with each other to form new or preferred embodiments. Not to be repeated herein, depending on the space.
Detailed Description
The inventor provides an external pharmaceutical composition for improving or relieving hyperplasia of mammary glands through long-term and intensive research. The pharmaceutical composition has scientific proportioning, is safe without toxic and side effects, and has excellent effect of improving the symptoms of hyperplasia of mammary glands. The pharmaceutical composition provided by the invention has the advantages of obvious curative effect, good stability, convenience in use and wide application value. Based on the above findings, the inventors have completed the present invention.
External pharmaceutical composition
The invention provides an external pharmaceutical composition, which comprises the following raw material components in parts by weight: 45-55 parts of oleic acid, 30-40 parts of linoleic acid, 4-8 parts of palmitic acid, 1-5 parts of stearic acid, 1-3 parts of alpha-pinene, 1-3 parts of limonene, 1-3 parts of eucalyptol, 1-3 parts of anethole, 1-3 parts of 3-thujene, 1-2 parts of beta-pinene, 0-2 parts of trans-caryophyllene, 0-2 parts of alpha-santalene, 0-2 parts of sabinene, 0-2 parts of ocimene and 0-1 part of p-cymene.
In a further embodiment of the invention, comprising: 50 parts of oleic acid, 35 parts of linoleic acid, 7 parts of palmitic acid, 3 parts of stearic acid, 2 parts of alpha-pinene, 1 part of limonene, 1 part of eucalyptol, 1 part of anethole, 1 part of 3-arborvitae, 1 part of beta-pinene, 1 part of trans-caryophyllene, 1 part of alpha-santalene, 1 part of sabinene, 1 part of ocimene and 1 part of p-cymene.
In addition, for the pharmaceutical composition of the present invention, the pharmaceutical composition can be obtained by directly purchasing each raw material component in the pharmaceutical composition and then mixing them uniformly; can also be prepared by the following method provided by the invention.
The invention provides a preparation method of a pharmaceutical composition, which comprises the following steps:
s101: cleaning branches and leaves of laurel, fennel, red myrrh and black pine, crushing, and performing first extraction by using supercritical carbon dioxide, wherein the temperature of the first extraction is 48 ℃, the pressure is 15.80MPa, the time is 80min, and the flow rate of the supercritical carbon dioxide is 30kg/h.
S102: pulverizing basil, rose geranium and frankincense, uniformly mixing, performing second extraction by adopting a steam distillation method, filtering a product obtained after the second extraction, and collecting a second filtrate; wherein, the time of steam distillation is 300min, and the mass ratio of the added water to the crushed product is 5:1.
S103: cold pressing grape seeds and Argania morocca to extract; in a preferred embodiment, the cold pressing method has a pH of 7 to 8 and a temperature of 5 to 10 ℃.
S104: and (3) uniformly mixing the products obtained in the step (S101), the step (S102) and the step (S103) to obtain the pharmaceutical composition.
The pharmaceutical composition of the present invention may be administered in the form of a topical formulation, for example, by transdermal administration to the affected area. In the using process, the medicine can directly penetrate into the subcutaneous blood capillary from the corneal layer of the skin and the accessory structure of the skin, is convenient and simple to use and has good safety. In a preferred embodiment, in using the pharmaceutical composition of the invention, the pharmaceutical composition is applied directly to the breast area and massaged until absorption.
Compared with the prior art, the invention has the main advantages that:
(1) The pharmaceutical composition disclosed by the invention is safe, has no toxic or side effect, and has excellent effects of resisting inflammation, sterilizing and enhancing the immunity of a human body. The composition prepared by the method provided by the invention has the advantages of obvious curative effect, quick response, good stability, convenience in use and wide application value.
(2) By adopting the preparation method of the pharmaceutical composition provided by the invention, active ingredients of the raw material medicines can be retained to the maximum extent, and meanwhile, the active ingredients in the raw material medicines can be fully released, so that the finally prepared pharmaceutical composition has excellent effect.
(3) The preparation method of the pharmaceutical composition provided by the invention has the advantages of stable process, high yield, good quality, low energy consumption, wide raw materials and simple and economical process; the production can be finished by adopting the existing equipment, the equipment requirement is reduced, and the environmental pollution is zero.
(4) The pharmaceutical composition provided by the invention is convenient to use, can be directly smeared on the breast part, and can achieve excellent curative effect after being absorbed by massage.
The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. The experimental procedures, in which specific conditions are not noted in the following examples, are generally carried out under conventional conditions or conditions recommended by the manufacturers. Unless otherwise indicated, percentages and parts are by weight.
In the following examples, oleic acid, linoleic acid, palmitic acid, stearic acid, α -pinene, limonene, eucalyptol, anethole, 3-thujene, β -pinene, trans-caryophyllene, α -santalene, sabinene, ocimene, and p-cymene are chemically pure commercially available reagents.
The laurel, fennel, myrrh, pine, basil, rose geranium, frankincense, grape seed and argan nut used in the following examples all meet the relevant regulations under each herb item in the text of the chinese pharmacopoeia (2015 edition). Before feeding, the material objects are identified to accord with the names of the materials, and the quality of the materials accords with the standard. Wherein the essential oil is extracted from stem and leaf of flos Pelargonii Graveolentis, leaf of herba Ocimi, seed of fructus Foeniculi, and branch parts of laurel, pinus nigra and Frankia latifolia.
Example 1
The pharmaceutical composition of this embodiment comprises: 50 parts of oleic acid, 35 parts of linoleic acid, 7 parts of palmitic acid, 3 parts of stearic acid, 2 parts of alpha-pinene, 1 part of limonene, 1 part of eucalyptol, 1 part of anethole, 1 part of 3-arborvitae, 1 part of beta-pinene, 1 part of trans-caryophyllene, 1 part of alpha-santalene, 1 part of sabinene, 1 part of ocimene and 1 part of p-cymene: the raw material components are uniformly mixed to obtain the medicinal composition, and the medicinal composition is placed in a brown bottle for later use.
Example 2
The pharmaceutical composition of this embodiment comprises: 48 parts of oleic acid, 37 parts of linoleic acid, 7 parts of palmitic acid, 3 parts of stearic acid, 2 parts of alpha-pinene, 2 parts of limonene, 2 parts of eucalyptol, 1 part of anethole, 1 part of 3-arborvitae, 1 part of beta-pinene, 1 part of sabinene, 1 part of ocimene and 1 part of p-cymene: the raw material components are uniformly mixed to obtain the medicinal composition, and the medicinal composition is placed in a brown bottle for later use.
Example 3
The pharmaceutical composition of this embodiment comprises: 48 parts of oleic acid, 33 parts of linoleic acid, 6 parts of palmitic acid, 3 parts of stearic acid, 3 parts of alpha-pinene, 2 parts of limonene, 2 parts of eucalyptol, 1 part of anethole, 1 part of 3-arborvitae, 1 part of beta-pinene, 1 part of trans-caryophyllene, 1 part of alpha-santalene and 1 part of sabinene: the raw material components are uniformly mixed to obtain the medicinal composition, and the medicinal composition is placed in a brown bottle for later use.
Example 4
The pharmaceutical composition of this embodiment comprises: 46 parts of oleic acid, 39 parts of linoleic acid, 6 parts of palmitic acid, 2 parts of stearic acid, 3 parts of alpha-pinene, 1 part of limonene, 1 part of eucalyptol, 1 part of anethole, 2 parts of 3-arborvitae, 2 parts of beta-pinene, 1 part of trans-caryophyllene, 1 part of ocimene and 1 part of p-cymene: the raw material components are uniformly mixed to obtain the medicinal composition, and the medicinal composition is placed in a brown bottle for later use.
Example 5
The pharmaceutical composition of this embodiment comprises: 48 parts of oleic acid, 35 parts of linoleic acid, 7 parts of palmitic acid, 3 parts of stearic acid, 3 parts of alpha-pinene, 3 parts of limonene, 1 part of eucalyptol, 1 part of anethole, 1 part of 3-thujene, 1 part of beta-pinene, 1 part of trans-caryophyllene, 1 part of alpha-santalene, 1 part of sabinene and 1 part of p-cymene by weight: the raw material components are uniformly mixed to obtain the medicinal composition, and the medicinal composition is placed in a brown bottle for later use.
Example 6
The pharmaceutical composition of this embodiment comprises: 47 parts by weight of oleic acid, 36 parts by weight of linoleic acid, 5 parts by weight of palmitic acid, 2 parts by weight of stearic acid, 2 parts by weight of alpha-pinene, 3 parts by weight of limonene, 2 parts by weight of eucalyptol, 1 part by weight of anethole, 1 part by weight of 3-arborvitae, 1 part by weight of beta-pinene, 1 part by weight of trans-caryophyllene, 1 part by weight of alpha-santalene and 1 part by weight of p-cymene: the raw material components are uniformly mixed to obtain the medicinal composition, and the medicinal composition is placed in a brown bottle for later use.
Example 7
(1) Cleaning branches and leaves of laurel, fennel, red myrrh and black pine, pulverizing, collecting 1000g, and extracting with supercritical carbon dioxide under 15.80 Mpa. During the extraction process, the temperature in the holding system is 48 ℃, and the flow rate of the supercritical carbon dioxide is 30kg/h. After 80min of extraction, the introduction of supercritical carbon dioxide was stopped and the product was collected.
(2) Pulverizing herba Ocimi, flos Pelargonii Graveolentis and Olibanum, mixing, adding 100g into a distillation device, adding 450ml water, and performing steam distillation at 30 deg.C for extraction. After 300min, the heating was removed and the distillate was collected.
(3) Squeezing grape seed and Morocco nut to allow oil to flow out, standing the obtained liquid for 48 hr, collecting upper layer oil, and maintaining the temperature at 8 deg.C during squeezing.
(4) And (3) uniformly mixing the products obtained in the steps (1), (2) and (3) to obtain the pharmaceutical composition, and placing the pharmaceutical composition in a brown bottle for later use.
Example 8
(1) Cleaning branches and leaves of laurel, fennel, red myrrh and black pine, pulverizing, collecting 1000g, and introducing supercritical carbon dioxide at 17.50Mpa for supercritical carbon dioxide extraction. During the extraction process, the temperature in the maintaining system is 48 ℃, and the flow rate of the supercritical carbon dioxide is 29kg/h. After 85min of extraction, the introduction of supercritical carbon dioxide was stopped and the product was collected.
(2) Pulverizing herba Ocimi, flos Pelargonii Graveolentis and Olibanum, mixing, adding 100g into a distillation device, adding 450ml water, and performing steam distillation at 30 deg.C for extraction. After 250min, the heating was removed and the distillate was collected.
(3) Squeezing grape seed and Morocco nut to allow oil to flow out, standing the obtained liquid for 48 hr, collecting upper oil, and maintaining the temperature at 7 deg.C during squeezing.
(4) And (4) uniformly mixing the products obtained in the steps (1), (2) and (3) to obtain a pharmaceutical composition, and placing the pharmaceutical composition in a brown bottle for later use.
Example 9
(1) Cleaning branches and leaves of laurel, fennel, red myrrh and black pine, pulverizing, collecting 1000g, and extracting with supercritical carbon dioxide under 16.50 Mpa. During the extraction process, the temperature in the maintaining system is 48 ℃, and the flow rate of the supercritical carbon dioxide is 31kg/h. After 80min of extraction, the introduction of supercritical carbon dioxide was stopped and the product was collected.
(2) Pulverizing herba Ocimi, flos Pelargonii Graveolentis and Olibanum, mixing, adding 100g into a distillation device, adding 500ml water, and performing steam distillation at 30 deg.C for extraction. After 320min, the heating was removed and the distillate was collected.
(3) Squeezing grape seed and Morocco nut to allow oil to flow out, standing the obtained liquid for 48 hr, collecting upper oil, and maintaining the temperature at 7.5 deg.C during squeezing.
(4) And (3) uniformly mixing the products obtained in the steps (1), (2) and (3) to obtain the pharmaceutical composition, and placing the pharmaceutical composition in a brown bottle for later use.
Example 10
(1) Cleaning branches and leaves of laurel, fennel, red myrrh and black pine, pulverizing, collecting 1000g, and extracting with supercritical carbon dioxide under 15.80 Mpa. During the extraction process, the temperature in the maintaining system is 48 ℃, and the flow rate of the supercritical carbon dioxide is 30kg/h. After 75min of extraction, the introduction of supercritical carbon dioxide was stopped and the product was collected.
(2) Pulverizing herba Ocimi, flos Pelargonii Graveolentis and Olibanum, mixing, adding 100g into a distillation device, adding 550ml water, and performing steam distillation at 30 deg.C for extraction. After 330min, the heating was removed and the distillate was collected.
(3) Squeezing grape seed and Morocco nut to allow oil to flow out, standing the obtained liquid for 48 hr, collecting upper oil, and maintaining the temperature at 8 deg.C during squeezing.
(4) And (3) uniformly mixing the products obtained in the steps (1), (2) and (3) to obtain the pharmaceutical composition, and placing the pharmaceutical composition in a brown bottle for later use.
Test example
1. Component determination
The ingredients of the pharmaceutical compositions of examples 1 to 10 were examined by GC-MS and the main ingredients in the examples are listed in the following table:
TABLE 1
Figure 445049DEST_PATH_IMAGE002
Figure 893348DEST_PATH_IMAGE004
2. Toxicity test
50 female white Swiss mice with the weight of 18-22g are selected and divided into 10 groups, each group comprises 5 mice, the back is unhaired to expose the outer skin, the unhairing range is 2cm multiplied by 2cm, the 1 st group and the 10 th group are respectively coated with the pharmaceutical composition prepared in the invention from the example 1 to the example 10, the administration dose is 5g, and the continuous administration is carried out for 30 days. During the administration period and 1 week after the withdrawal, the mice were observed for growth state and active diet, and indices such as hematology, blood biochemistry, organ organization, and urinary routine were identified. All mice survive healthily during and after the administration process, which suggests that the pharmaceutical composition of the invention has no obvious toxic or side effect.
The mice were sacrificed and dissected, and the hemogram, liver function and organ tissue status were observed, which was not different from the normal index of Swiss mice. Experiments prove that the pharmaceutical composition provided by the invention is nontoxic and safe and reliable in medication.
3. Effect testing
100 volunteers with hyperplasia of mammary glands were collected, and each patient was diagnosed clinically to have symptoms of mammary gland pain, nodules or lumps with different degrees. Prior to dosing, each patient was subjected to breast ultrasound and archived.
Each patient was randomized into 10 groups of 10. Groups 1 to 10 the pharmaceutical compositions of examples 1 to 10 of the present invention were applied, respectively, and at the time of use, the pharmaceutical compositions were applied to the surface of the breast and massaged until absorption. The application is continued for 3 months, 2 times daily (once in the morning and evening), 3g each time.
After trial for 1 month, 2 months and 3 months respectively, the patient is subjected to breast ultrasound examination again, the shape, size and number of the breast nodules suffered by the patient are observed, and compared with the examination results before using each example, the treatment effect evaluation criteria are as follows:
the method has the following advantages: a reduction in breast nodule mass or a reduction in the number of nodules.
Controllable: breast nodule masses did not enlarge and did not increase in number.
And (4) invalidation: breast nodule masses are enlarged or increased in number.
The results of the use are shown in table 2 below. The results show that the pharmaceutical compositions of examples 1-10 improved the breast nodule problem in patients after use, and that the breast nodule mass of most patients decreased or disappeared after 3 months of use.
TABLE 2 changes in the status of breast nodules in patients following administration of the pharmaceutical composition of the present invention
Figure 469823DEST_PATH_IMAGE006
All documents referred to herein are incorporated by reference into this application as if each were individually incorporated by reference. Furthermore, it should be understood that various changes and modifications of the present invention can be made by those skilled in the art after reading the above teachings of the present invention, and these equivalents also fall within the scope of the present invention as defined by the appended claims.

Claims (7)

1. A pharmaceutical composition, comprising:
40-55 parts of oleic acid, 30-40 parts of linoleic acid, 4-8 parts of palmitic acid, 1-5 parts of stearic acid, 0.5-5 parts of alpha-pinene, 0.5-4 parts of limonene, 0.5-3 parts of eucalyptol, 0.2-3 parts of anethole, 1-3 parts of 3-arborvitae and 1-2 parts of beta-pinene;
and the pharmaceutical composition further comprises:
trans-caryophyllene 0.01-2 weight parts, alpha-santalene 0.01-2 weight parts, sabinene 0.01-2 weight parts, ocimene 0.01-2 weight parts, p-cymene 0.01-1 weight parts;
and the pharmaceutical composition is prepared by the following method:
s101: cleaning and crushing bay, fennel, red myrrh and black pine branches and leaves, and performing first extraction by adopting supercritical carbon dioxide; in the step S101, the temperature of the supercritical carbon dioxide for the first extraction is 45-50 ℃, and the airflow pressure is 12-18MPa;
s102: pulverizing basil, rose geranium and frankincense, uniformly mixing, performing second extraction by adopting a steam distillation method, filtering a product obtained after the second extraction, and collecting a second filtrate;
s103: mixing grape seeds and Morocco nuts, and extracting by cold pressing;
s104: and (3) uniformly mixing the products obtained in the step (S101), the step (S102) and the step (S103) to obtain the pharmaceutical composition.
2. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises:
45-55 parts of oleic acid, 32-39 parts of linoleic acid, 5-7 parts of palmitic acid, 2-4 parts of stearic acid, 1-3 parts of alpha-pinene, 1-3 parts of limonene, 1-3 parts of eucalyptol, 1-3 parts of anethole, 1-3 parts of 3-thujene and 1-2 parts of beta-pinene.
3. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition comprises:
trans-caryophyllene 0.5-1.5 weight parts, alpha-santalene 0.5-1.5 weight parts, sabinene 0.5-1.5 weight parts, ocimene 0.5-1.5 weight parts, and p-cymene 0.5-1.5 weight parts.
4. A process for preparing a pharmaceutical composition according to claim 1, comprising the steps of:
s101: cleaning and crushing laurel, fennel, red myrrh and black pine branches and leaves, and performing first extraction by adopting supercritical carbon dioxide; in step S101, the temperature of the supercritical carbon dioxide for the first extraction is 45-50 ℃, and the pressure of the gas flow is 12-18MPa;
s102: pulverizing basil, rose geranium and frankincense, uniformly mixing, performing second extraction by adopting a steam distillation method, filtering a product obtained after the second extraction, and collecting a second filtrate;
s103: mixing grape seeds and Morocco nuts, and extracting by cold pressing;
s104: and (3) uniformly mixing the products obtained in the step (S101), the step (S102) and the step (S103) to obtain the pharmaceutical composition.
5. The method of claim 4, wherein in step S102, the mass ratio of the added water to the crushed solid product is 4-6:1.
6. The method of claim 4, wherein the cold pressing is performed at a temperature of 5 to 10 ℃ in step S103.
7. Use of a pharmaceutical composition according to claim 1 for the preparation of a medicament for the treatment of mammary gland hyperplasia.
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