CN109010451A - A kind of little Jin aerosol and its preparation method and application - Google Patents

A kind of little Jin aerosol and its preparation method and application Download PDF

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Publication number
CN109010451A
CN109010451A CN201810948866.3A CN201810948866A CN109010451A CN 109010451 A CN109010451 A CN 109010451A CN 201810948866 A CN201810948866 A CN 201810948866A CN 109010451 A CN109010451 A CN 109010451A
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China
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parts
extract
aerosol
little jin
propellant
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Inventor
许润春
韩丽
曹波
张定堃
林俊芝
慈志敏
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Chengdu University of Traditional Chinese Medicine
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Chengdu University of Traditional Chinese Medicine
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/55Glands not provided for in groups A61K35/22 - A61K35/545, e.g. thyroids, parathyroids or pineal glands
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/24Mucus; Mucous glands; Bursa; Synovial fluid; Arthral fluid; Excreta; Spinal fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/62Leeches; Worms, e.g. cestodes, tapeworms, nematodes, roundworms, earth worms, ascarids, filarias, hookworms, trichinella or taenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/13Coniferophyta (gymnosperms)
    • A61K36/15Pinaceae (Pine family), e.g. pine or cedar
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232Angelica
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/32Burseraceae (Frankincense family)
    • A61K36/324Boswellia, e.g. frankincense
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/32Burseraceae (Frankincense family)
    • A61K36/328Commiphora, e.g. mecca myrrh or balm of Gilead
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/42Cucurbitaceae (Cucumber family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/714Aconitum (monkshood)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/14Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/20Antivirals for DNA viruses
    • A61P31/22Antivirals for DNA viruses for herpes viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/14Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4

Abstract

The present invention provides a kind of little Jin aerosols, it is made of the supplementary material that following weight matches: 60~70 parts of little Jin extract, 30~70 parts of propellant, 5~20 parts of cosolvent, 0.2~0.6 part of solubilizer, 1~3 part of film forming agent, 0.5~2 part of penetrating agent;Wherein, the little Jin extract is prepared by following weight proportion bulk pharmaceutical chemicals: 20~40 parts of Moschus, 130~170 parts of wild aconite root, 130~170 parts of semen momordicae, 130~170 parts of resina liquidamberis, 130~170 parts of pheretima, 130~170 parts of excrementum pteropi, 65~85 parts of olibanum, 65~85 parts of myrrh, 65~85 parts of Radix Angelicae Sinensis, 8~16 parts of capital ink.The present invention also provides the preparation method of the little Jin aerosol and purposes.Aerosol is made in the present invention, has the advantages of long action time, easy to use, good effect, easily storage.Little Jin extract aerosol provided by the invention, percutaneous dosing is rapid-action, can be in lesion part fast onset anti-inflammatory and analgesic effect, and safety and environmental protection, homogeneous stability, casts that performance is good, droplet dispersion is uniform.

Description

A kind of little Jin aerosol and its preparation method and application
Technical field
The present invention relates to a kind of little Jin aerosols and its preparation method and application.
Background technique
Xiaojin pill first recorded in Qing Dynasty's Wang Hongxu " surgery card control Quan Shengji ", by Moschus, wild aconite root, semen momordicae, resina liquidamberis, Totally 10 taste medicines form for dragon, excrementum pteropi, olibanum, myrrh, Radix Angelicae Sinensis, capital ink, and formula is proper, significant in efficacy, easy to use.Effect dissipating bind Detumescence, blood-activating analgetic.For treating the cards such as scrofula, goiter, mammary cancer, breast illness caused by mental disorder stagnates, mammary gland disease effect is treated It is further preferred that.Pertinent literature shows that xiaojin pill can be used for neoplastic diseases, and terpene contained therein, alkaloid and polysaccharide can induce tumour Apoptosis adjusts MAPK access, inhibits the expression of relevant inflammatory factors and the increase of tumor microvessel density.Experiment shows Xiaojin pill has bacteriostasis to staphylococcus aureus, Escherichia coli, hemolytic streptococcus, Neisseria etc..Little Jin simultaneously Ball can improve state of blood stasis and inhibit tumour growth, and Small side effects work rapidly, persistent.Disappear in addition, xiaojin pill also has Inflammation, detumescence, treating tuberculosis, sedation-analgesia and the effect for improving immunity of organisms and disease resistance, can promote lump and scar to subtract Light or recession.Xiaojin pill wide indications.Clinically xiaojin pill is usually used in thyroid adenoma, thyroid cyst, multifocal neurological at present Fibroma, lymphosarcoma, lipoma, bone tumour, breast cancer, gastric cancer, lung cancer, thymus gland abdominal cavity inflammatory mass and abscess, band-like blister The early stage etc. of the diseases such as rash, Acne conglobata, mastofibroma, intestinal tuberculosis, tuberculosis of bone and joint.The above disease typically exhibits Often there is swollen, pain inflammatory performance in the swollen pathological characters having a pain firmly, part.It is obvious for anti-inflammatory Western medicine side effect.Traditional Chinese medicine There is significant in efficacy, the advantage of Small side effects in terms for the treatment of such disease.And xiaojin pill safety and low toxicity, treating both manifestation and root cause of disease, extensively It is welcome by patient.
However xiaojin pill is beaten powder and is used as medicine using primary crude drug, need to be smashed when taking, it is inconvenient to use, and cannot directly act on It breaks out and uses in lesion, it is difficult to reach the therapeutic effect of rapid relief of symptoms.
Application number: 201810489870.8, denomination of invention: a kind of little Jin rubber emplastrum and preparation method thereof and purposes, it should A kind of little Jin rubber emplastrum of disclosure of the invention is made: 6~7 parts of little Jin extract, natural rubber of the supplementary material that following weight matches 30~80 parts of glue, 40~60 parts of tackifier, 20~45 parts of softening agent, 50~120 parts of filler.The invention also discloses above-mentioned small Purposes of the golden rubber emplastrum in the drug that the proliferation of mammary gland, breast cancer, thyroid nodule, thyroid cancer are treated in preparation.The present invention Little Jin rubber emplastrum there is production and processing smoothly Painting effect be good, cream face smoothness is good (exquisiteness without blank spot), paste performance The advantages that excellent, stability is good, and removing is suitable for.
Currently, it is not yet reported that the purposes in the external drug of xiaojin pill externally treating herpes zoster is not more reported Xiaojin pill raw material is prepared into aerosol.
Summary of the invention
The present invention provides a kind of little Jin aerosols and its preparation method and application.
The present invention provides a kind of little Jin aerosols, it is made of the supplementary material that following weight matches:
60~70 parts of little Jin extract, 30~70 parts of propellant, 5~20 parts of cosolvent, 0.2~0.6 part of solubilizer, film forming 1~3 part of agent, 0.5~2 part of penetrating agent;
Wherein, the little Jin extract is prepared by following weight proportion bulk pharmaceutical chemicals:
20~40 parts of Moschus, 130~170 parts of wild aconite root, 130~170 parts of semen momordicae, 130~170 parts of resina liquidamberis, pheretima 130~170 parts, 130~170 parts of excrementum pteropi, 65~85 parts of olibanum, 65~85 parts of myrrh, 65~85 parts of Radix Angelicae Sinensis, capital ink 8~16 Part.
It is further preferred that it by following weight match supplementary material at:
62~68 parts of little Jin extract, 40~60 parts of propellant, 6~18 parts of cosolvent, 0.3~0.5 part of solubilizer, film forming 1.5~2.5 parts of agent, 1~1.5 part of penetrating agent.
It is further preferred that it is made of the supplementary material that following weight matches:
65 parts of little Jin extract, 50 parts of propellant, 9 parts of cosolvent, 0.4 part of solubilizer, 2 parts of film forming agent, 1 part of penetrating agent.
Wherein, the little Jin extract is prepared by the raw material of following weight proportion:
30 parts of Moschus, 150 parts of wild aconite root, 150 parts of semen momordicae, 150 parts of resina liquidamberis, 150 parts of pheretima, 150 parts of excrementum pteropi, cream 75 parts fragrant, 75 parts of myrrh, 75 parts of Radix Angelicae Sinensis, 12 parts of capital ink.
The extract is ethanol extract.
The extract is to extract bulk pharmaceutical chemicals as solvent using 40% ethanol solution, solid-liquid ratio 1: 12, extraction time 3h.
Wherein, the propellant is one of tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane, dimethyl ether or more Kind;Preferably, the propellant is tetrafluoroethane;
The cosolvent is one of ethyl alcohol, isopropanol, propylene glycol and polyethylene glycol or a variety of;Preferably, described latent Solvent is propylene glycol;
The solubilizer is one of Tween 80, polysorbate40, poloxamer and paregal O or a variety of;Preferably, described Solubilizer is Tween 80;
The film forming agent is one of PVP K30 and povidone S630 or a variety of;Preferably, the film forming agent is poly- Tie up ketone K30.
The penetrating agent is one of azone and borneol or a variety of;Preferably, the penetrating agent is azone.
In addition to the aforementioned ingredients, aerosol combination of the present invention can also contain one or more other additives.The present invention The feature that the features described above or embodiment mentioned are mentioned can be in any combination.The revealed all features of patent specification can Be used in combination with any composition form, each feature disclosed in specification, can by it is any can provide it is identical, impartial or similar The alternative characteristics of purpose replace.Therefore except there is special instruction, revealed feature is only impartial or similar features generality Example.
The present invention also provides the preparation methods of the aerosol, it includes the following steps:
1) configuration of medical fluid: taking the little Jin extract of formula ratio, and formula is added after being concentrated to the medicinal extract that relative density is 1.1 Cosolvent, solubilizer, film forming agent, the penetrating agent of amount, shake up, static, and filtering adds 40% ethanol solution constant volume;
2) dispense: the liquid medicine quantitative that step 1) is configured is packed into aerosol bottle, gland;
3) filling of propellant: be filled with propellant in above-mentioned aerosol bottle to get.
The present invention also provides purposes of the aerosol in the drug of preparation treatment shingles zoster.
The present invention also provides the aerosols in preparation adjuvant treatment thyroid nodule and the drug of the proliferation of mammary gland Purposes.
Aerosol is made in the present invention, has the advantages of long action time, easy to use, good effect, easily storage.The present invention mentions The little Jin extract aerosol of confession, percutaneous dosing is rapid-action, can be in lesion part fast onset anti-inflammatory and analgesic effect, and safety collar Guarantor, homogeneous stability, projectile performance is good, droplet dispersion is uniform.
Obviously, above content according to the present invention is not being departed from according to the ordinary technical knowledge and customary means of this field Under the premise of the above-mentioned basic fundamental thought of the present invention, the modification, replacement or change of other diversified forms can also be made.
The specific embodiment of form by the following examples remakes further specifically above content of the invention It is bright.But the range that this should not be interpreted as to the above-mentioned theme of the present invention is only limitted to example below.It is all to be based on above content of the present invention The technology realized all belongs to the scope of the present invention.
Specific embodiment
It include Moschus 30g, wild aconite root 150g, semen momordicae 150g, resina liquidamberis in little Jin medicinal powder in the embodiment of the present invention 150g, pheretima 150g, excrementum pteropi 150g, olibanum 75g, myrrh 75g, Radix Angelicae Sinensis 75g, capital ink 12g.
The preparation of the little Jin aerosol of the present invention of embodiment 1
1, prepared by little Jin extract
40% ethanol water is used to extract as solvent in dry little Jin medicinal powder, solid-liquid ratio 1:12, extraction Time is 3h, by extracting solution be concentrated be made medicinal extract to get.
2, supplementary material is weighed
65 parts of little Jin extract
9 parts of propylene glycol
0.4 part of Tween 80
50 parts of tetrafluoroethane
2 parts of PVP K30
1 part of azone
3, preparation method
1) configuration of medical fluid: taking the little Jin extract of formula ratio, and formula is added after being concentrated to the medicinal extract that relative density is 1.1 The cosolvent (propylene glycol) of amount, the solubilizer (Tween 80) of formula ratio, the film forming agent (PVP K30) of formula ratio and formula ratio Penetrating agent (azone) shakes, and 40% ethanol solution constant volume is added to 100ml in static, filtering;
2) dispense: the liquid medicine quantitative that step 1) is configured is packed into aerosol bottle, gland;
3) filling of propellant: be filled with the propellant (tetrafluoroethane) of formula ratio in above-mentioned aerosol bottle to get.
The preparation of the little Jin aerosol of the present invention of embodiment 2
1, prepared by little Jin extract
30% ethanol water is used to extract as solvent in dry little Jin medicinal powder, solid-liquid ratio 1:10, extraction Time is 2h, by extracting solution be concentrated be made medicinal extract to get.
2, supplementary material is weighed
60 parts of little Jin extract
5 parts of propylene glycol
0.2 part of Tween 80
30 parts of tetrafluoroethane
1 part of PVP K30
0.5 part of azone
3, preparation method
1) configuration of medical fluid: taking the little Jin extract of formula ratio, and formula is added after being concentrated to the medicinal extract that relative density is 1.1 The cosolvent (propylene glycol) of amount, the solubilizer (Tween 80) of formula ratio, the film forming agent (PVP K30) of formula ratio and formula ratio Penetrating agent (azone) shakes, and 40% ethanol solution constant volume is added to 100ml in static, filtering;
2) dispense: the liquid medicine quantitative that step 1) is configured is packed into aerosol bottle, gland;
3) filling of propellant: be filled with the propellant (tetrafluoroethane) of formula ratio in above-mentioned aerosol bottle to get.
The preparation of the little Jin aerosol of the present invention of embodiment 3
1, prepared by little Jin extract
50% ethanol water is used to extract as solvent in dry little Jin medicinal powder, solid-liquid ratio 1:15, extraction Time is 4h, by extracting solution be concentrated be made medicinal extract to get.
2, supplementary material is weighed
70 parts of little Jin extract
20 parts of propylene glycol
0.6 part of Tween 80
70 parts of tetrafluoroethane
3 parts of PVP K30
2 parts of azone
3, preparation method
1) configuration of medical fluid: taking the little Jin extract of formula ratio, and formula is added after being concentrated to the medicinal extract that relative density is 1.1 The cosolvent (propylene glycol) of amount, the solubilizer (Tween 80) of formula ratio, the film forming agent (PVP K30) of formula ratio and formula ratio Penetrating agent (azone) shakes, and 40% ethanol solution constant volume is added to 1000ml in static, filtering;
2) dispense: the liquid medicine quantitative that step 1) is configured is packed into aerosol bottle, gland;
3) filling of propellant: be filled with the propellant (tetrafluoroethane) of formula ratio in above-mentioned aerosol bottle to get.
The preparation of the little Jin aerosol of the present invention of embodiment 4
1, prepared by little Jin extract
40% ethanol water is used to extract as solvent in dry little Jin medicinal powder, solid-liquid ratio 1:14, extraction Time is 4h, by extracting solution be concentrated be made medicinal extract to get.
2, supplementary material is weighed
62 parts of little Jin extract
6 parts of propylene glycol
0.3 part of Tween 80
40 parts of tetrafluoroethane
1.5 parts of PVP K30
1 part of azone
3, preparation method
1) configuration of medical fluid: taking the little Jin extract of formula ratio, and formula is added after being concentrated to the medicinal extract that relative density is 1.1 The cosolvent (propylene glycol) of amount, the solubilizer (Tween 80) of formula ratio, the film forming agent (PVP K30) of formula ratio and formula ratio Penetrating agent (azone) shakes, and 40% ethanol solution constant volume is added to 100ml in static, filtering;
2) dispense: the liquid medicine quantitative that step 1) is configured is packed into aerosol bottle, gland;
3) filling of propellant: be filled with the propellant (tetrafluoroethane) of formula ratio in above-mentioned aerosol bottle to get.
The preparation of the little Jin aerosol of the present invention of embodiment 5
1, prepared by little Jin extract
40% ethanol water is used to extract as solvent in dry little Jin medicinal powder, solid-liquid ratio 1:14, extraction Time is 3h, by extracting solution be concentrated be made medicinal extract to get.
2, supplementary material is weighed
68 parts of little Jin extract
18 parts of propylene glycol
0.5 part of Tween 80
60 parts of tetrafluoroethane
2.5 parts of PVP K30
1.5 parts of azone
3, preparation method
1) configuration of medical fluid: taking the little Jin extract of formula ratio, and formula is added after being concentrated to the medicinal extract that relative density is 1.1 The cosolvent (propylene glycol) of amount, the solubilizer (Tween 80) of formula ratio, the film forming agent (PVP K30) of formula ratio and formula ratio Penetrating agent (azone) shakes, and 40% ethanol solution constant volume is added to 100ml in static, filtering;
2) dispense: the liquid medicine quantitative that step 1) is configured is packed into aerosol bottle, gland;
3) filling of propellant: be filled with the propellant (tetrafluoroethane) of formula ratio in above-mentioned aerosol bottle to get.
Clinical efficacy of the invention is verified below by test example:
1 present invention treatment shingles zoster clinical efficacy verification test of test example
1, subjects
Patients with Herpes Zoster 120 that outpatient service is accepted for medical treatment are collected, treatment group is divided into using random digits table and control group is each 60.Wherein treatment group male patient 15, female patient 45, the course of disease 8~2 years, the age 15~40 years old;Control group male Patient 17, female patient 43, the course of disease 10 months~2 years, the age 14~42 years old.The data such as two groups of genders, the course of disease, ages without Significant difference is comparable.
Patient is included in standard: the age 18~45 years old, meeting the diagnostic criteria of shingles zoster, to this research informed consent, disease History data and questionnaire are filled in completely.
Exclusion criteria: pain caused by other reasons merges other Medicine and Surgery serious diseases, disagrees participation research, disease History data is imperfect, questionnaire fills in not comprehensive person.
2, medication
Treatment group and control group are handled as follows respectively in addition to carrying out shingles zoster conventional therapy:
Treatment group: little Jin extract aerosol 2ml (every 1ml medical fluid prepared by the embodiment of the present invention 1 is sprayed outside treatment group affected part It is equivalent to primary crude drug 6.61g), three times a day.The course for the treatment of 15 days, continuously treat 2 courses for the treatment of.
Control group: the blank aerosol without little Jin extract of equivalent is sprayed outside control group affected part, three times a day.The course for the treatment of 15 It, continuously treats 2 courses for the treatment of.
3, criterion of therapeutical effect
Cure: patient's fash disappears with feeling of pain;
Improve: patient's deflorescence is more than 30%, and feeling of pain is greatly lowered compared with pre-treatment;
Invalid: fash or feeling of pain without alleviation or deteriorate.
4, treatment results
Treatment results are shown in Table 1.
1 little Jin treatment by aerosol herpes zoster group of table is compared with control group curative effect
Group Number of cases It cures It improves In vain Total effective rate Obvious adverse reaction example
Treatment group 60 21 30 9 85% 0
Control group 60 5 19 36 40% 0
Experimental result explanation: treatment group's total effective rate is 85%, and control group total effective rate is only 40%, and treatment group fullys recover from an illness More number is essentially 6 times of control group, illustrates that little Jin aerosol of the invention can be used for treating shingles zoster, and curative effect is obvious.
2 present invention adjuvant treatment proliferation of mammary gland of test example and thyroid nodule clinical efficacy verification test
1, subjects
Choose proliferation of mammary gland patient 200, the age 45~60 years old, the course of disease 9 months~2 years.It is randomly divided into two groups, every group 100 people, respectively test group and control group.
Choose thyroid nodule patient 200, the age 38~55 years old, the course of disease 5 months~1 year.It is randomly divided into two groups, every group 100 people, respectively test group and control group.
2, medication
Treatment group: spray prepared by the embodiment of the present invention 1 while carrying out corresponding illness conventional therapy, outside treatment group affected part Little Jin extract aerosol 2ml (every 1ml medical fluid is equivalent to primary crude drug 6.61g), three times a day.The course for the treatment of 15 days, continuously treat 3 A course for the treatment of.
Control group: extracting without little Jin for equivalent is sprayed while carrying out corresponding illness conventional therapy, outside control group affected part The blank aerosol of object, three times a day.One the course for the treatment of 15 days, continuously treat 3 courses for the treatment of.
3, therapeutic effect
Whether mitigated with pain as foundation, treatment results are as shown in table 2.
2 little Jin aerosol of the table adjuvant treatment proliferation of mammary gland is with thyroid nodule treatment group compared with control group curative effect
Experimental result explanation: under the booster action of little Jin aerosol of the present invention, the effective of the proliferation of mammary gland treats in treatment group Rate is 37%, and the effective percentage for treating thyroid nodule is 49%;And control group is without the auxiliary of little Jin aerosol of the present invention, treatment The effective percentage of the proliferation of mammary gland is only 14%, and the effective percentage for treating thyroid nodule is only 17%.The effective percentage for the treatment of group is essentially 2 times of control group illustrate that little Jin aerosol of the invention can be used for the adjuvant treatment of the proliferation of mammary gland and thyroid nodule.
The quick anti-inflammatory and antalgic Curative effect experiment of the external medication of 3 present invention of test example
1, anti-inflammatory Curative effect experimental method
Take normal ICR mouse, 25~28g of weight, male.3 groups are randomly divided into, every group of 10 mouse.Blank mouse ear The equal not drug containing aerosol of dosage is sprayed on two sides, and little Jin aerosol group mouse ear two sides is sprayed the equal little Jin of dosage and extracted Object aerosol (prepared by embodiment 1), xiaojin pill group Mouse oral is converted into the same dose of xiaojin pill suspensions.Medication 1 is small Shi Hou, two sides before and after being applied to the left front ear of mouse with 50 μ l dimethylbenzene, puts to death mouse after causing inflammation 1h, cuts left and right along auricle base line Two ears remove round auricle, electronic balance weighing, electronic balance weighing, with small at same position respectively with punch (diameter 9mm) The difference of mouse or so auricular concha weight calculates swelling percentage as auricular concha swelling degree.
Swelling percentage=(left auricular concha weight-auris dextra shell weight)/auris dextra shell weight * 100%
2, anti-inflammatory Curative effect experimental result
Experimental result is shown in Table 3.
The influence (mean ± S) of 3 little Jin aerosol of table and xiaojin pill paraxylene induced mice ear swelling
The experimental results showed that ear swelling rate caused by the dimethylbenzene of xiaojin pill group mouse is significantly lower than blank group, little Jin aerosol Ear swelling rate caused by the dimethylbenzene of agent group mouse is significantly lower than blank group and xiaojin pill group, illustrates xiaojin pill and little Jin gas of the present invention Mist agent can mitigate ear swelling caused by mouse dimethylbenzene, but little Jin aerosol of the present invention mitigate ear swelling caused by mouse dimethylbenzene compared with Xiaojin pill is more efficient, it may be assumed that little Jin aerosol of the invention, percutaneous dosing is rapid-action, can be anti-inflammatory in lesion part fast onset Effect.
3, analgesia effect confirmatory experiment method
Take ICR mouse, 17~21g of weight or so, half male and half female.It is randomly divided into 3 groups, every group 10.Mouse peritoneal face is equal Make depilation processing.Blank group spray dosage it is certain without little Jin extract aerosol, it is certain that little Jin aerosol group sprays dosage Aerosol containing little Jin, xiaojin pill group intragastric administration on mice is converted into the xiaojin pill suspension of equal dose.After medication 30min, each group 0.5% acetic acid 0.2ml/ of mouse peritoneal injection only, observes the writhing response animal that each group mouse occurs in 15min after injecting acetic acid Several and writhing response number.
4, analgesia effect confirmatory experiment result
Experimental result is shown in Table 4.
The influence (mean ± S) of 4 little Jin aerosol of table and xiaojin pill to acetic acid induced mice pain reaction
The experimental results showed that xiaojin pill group and little Jin aerosol group are apparently higher than blank 15min without writhing response number of animals Interior writhing response number is significantly lower than blank group, illustrates that xiaojin pill and little Jin aerosol of the present invention lead to Mouse Acetic Acid stimulation Pain reaction has inhibiting effect;Little Jin aerosol group is apparently higher than xiaojin pill group without writhing response number of animals, and writhing is anti-in 15min It answers number significantly lower than xiaojin pill group, illustrates that little Jin aerosol of the present invention can faster inhibit Mouse Acetic Acid stimulation to cause pain anti- It answers, it may be assumed that little Jin aerosol of the invention, percutaneous dosing is rapid-action, can be in lesion part fast onset analgesic activity.
Above-mentioned description of test, little Jin aerosol provided by the invention, percutaneous dosing is rapid-action, can quickly send out in lesion part Wave anti-inflammatory and analgesic effect.
To sum up, little Jin extract aerosol of the invention can effectively treat shingles zoster, it may also be used for thyroid nodule and The adjuvant treatment of the proliferation of mammary gland, and auxiliaring effect is obvious.Little Jin extract aerosol of the invention, percutaneous dosing is rapid-action, can In lesion part fast onset anti-inflammatory and analgesic effect.

Claims (10)

1. a kind of little Jin aerosol, it is characterised in that: it is made of the supplementary material that following weight matches:
60~70 parts of little Jin extract, 30~70 parts of propellant, 5~20 parts of cosolvent, 0.2~0.6 part of solubilizer, film forming agent 1 ~3 parts, 0.5~2 part of penetrating agent;
Wherein, the little Jin extract is prepared by following weight proportion bulk pharmaceutical chemicals:
20~40 parts of Moschus, 130~170 parts of wild aconite root, 130~170 parts of semen momordicae, 130~170 parts of resina liquidamberis, pheretima 130~ 170 parts, 130~170 parts of excrementum pteropi, 65~85 parts of olibanum, 65~85 parts of myrrh, 65~85 parts of Radix Angelicae Sinensis, 8~16 parts of capital ink.
2. aerosol according to claim 1, it is characterised in that: it by following weight match supplementary material at:
62~68 parts of little Jin extract, 40~60 parts of propellant, 6~18 parts of cosolvent, 0.3~0.5 part of solubilizer, film forming agent 1.5~2.5 parts, 1~1.5 part of penetrating agent.
3. aerosol according to claim 1, it is characterised in that: it is made of the supplementary material that following weight matches:
65 parts of little Jin extract, 50 parts of propellant, 9 parts of cosolvent, 0.4 part of solubilizer, 2 parts of film forming agent, 1 part of penetrating agent.
4. described in any item aerosols according to claim 1~3, it is characterised in that: the little Jin extract is by following heavy The raw material of amount proportion is prepared:
30 parts of Moschus, 150 parts of wild aconite root, 150 parts of semen momordicae, 150 parts of resina liquidamberis, 150 parts of pheretima, 150 parts of excrementum pteropi, olibanum 75 Part, 75 parts of myrrh, 75 parts of Radix Angelicae Sinensis, 12 parts of capital ink.
5. aerosol according to claim 4, it is characterised in that: the extract is ethanol extract.
6. aerosol according to claim 5, it is characterised in that: the extract is the second that bulk pharmaceutical chemicals are used to 40% Alcoholic solution is extracted as solvent, solid-liquid ratio 1:12, extraction time 3h.
7. described in any item aerosols according to claim 1~6, it is characterised in that: the propellant be tetrafluoroethane, 1,1, One of 1,2,3,3,3- heptafluoro-propane, dimethyl ether are a variety of;Preferably, the propellant is tetrafluoroethane;
The cosolvent is one of ethyl alcohol, isopropanol, propylene glycol and polyethylene glycol or a variety of;Preferably, the cosolvent For propylene glycol;
The solubilizer is one of Tween 80, polysorbate40, poloxamer and paregal O or a variety of;Preferably, the solubilising Agent is Tween 80;
The film forming agent is one of PVP K30 and povidone S630 or a variety of;Preferably, the film forming agent is povidone K30。
The penetrating agent is one of azone and borneol or a variety of;Preferably, the penetrating agent is azone.
8. the preparation method of the described in any item aerosols of claim 1~7, it is characterised in that: it includes the following steps:
1) configuration of medical fluid: taking the little Jin extract of formula ratio, and formula ratio is added after being concentrated to the medicinal extract that relative density is 1.1 Cosolvent, solubilizer, film forming agent, penetrating agent, shake up, static, and filtering adds 40% ethanol solution constant volume;
2) dispense: the liquid medicine quantitative that step 1) is configured is packed into aerosol bottle, gland;
3) filling of propellant: be filled with propellant in above-mentioned aerosol bottle to get.
9. purposes of the described in any item aerosols of claim 1~7 in the drug of preparation treatment shingles zoster.
10. aerosol according to any one of claims 1 to 8 is in preparation adjuvant treatment thyroid nodule and the drug of the proliferation of mammary gland In purposes.
CN201810948866.3A 2018-08-20 2018-08-20 A kind of little Jin aerosol and its preparation method and application Pending CN109010451A (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106377519A (en) * 2016-08-31 2017-02-08 广东同德药业有限公司 Inflammation preventing, disinfecting, heat rash eliminating and itch relieving aerosol and preparation method thereof
CN108354981A (en) * 2018-05-21 2018-08-03 成都中医药大学 A kind of little Jin rubber emplastrum and preparation method thereof and purposes

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106377519A (en) * 2016-08-31 2017-02-08 广东同德药业有限公司 Inflammation preventing, disinfecting, heat rash eliminating and itch relieving aerosol and preparation method thereof
CN108354981A (en) * 2018-05-21 2018-08-03 成都中医药大学 A kind of little Jin rubber emplastrum and preparation method thereof and purposes

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
徐瑞军;等: "小金丹临床应用研究进展", 《长春中医学院学报》 *

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