CN108434299B - Pharmaceutical composition for treating scapulohumeral periarthritis and preparation method and spray thereof - Google Patents

Pharmaceutical composition for treating scapulohumeral periarthritis and preparation method and spray thereof Download PDF

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CN108434299B
CN108434299B CN201810559957.8A CN201810559957A CN108434299B CN 108434299 B CN108434299 B CN 108434299B CN 201810559957 A CN201810559957 A CN 201810559957A CN 108434299 B CN108434299 B CN 108434299B
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spray
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ethanol
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CN108434299A (en
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曹祺
潘翠萍
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Guangdong Annol Pharmaceutical Co ltd
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Guangdong Annol Pharmaceutical Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/704—Polygonum, e.g. knotweed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/58—Reptiles
    • A61K35/586—Turtles; Tortoises, e.g. terrapins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/11—Pteridophyta or Filicophyta (ferns)
    • A61K36/12—Filicopsida or Pteridopsida
    • A61K36/126—Drynaria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
    • A61K36/296—Epimedium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber tree
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/74—Rubiaceae (Madder family)
    • A61K36/746—Morinda
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • A61K36/804—Rehmannia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/894—Dioscoreaceae (Yam family)
    • A61K36/8945—Dioscorea, e.g. yam, Chinese yam or water yam
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/0012—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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • 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
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a pharmaceutical composition for treating scapulohumeral periarthritis, a preparation method thereof and a spray. The pharmaceutical composition is prepared from the following raw materials in parts by weight: 30-40 parts of radix polygoni multiflori preparata, 20-30 parts of epimedium herb, 25-35 parts of prepared rehmannia root, 15-20 parts of tortoise shell, 20-30 parts of morinda officinalis, 20-30 parts of eucommia bark, 15-20 parts of teasel root, 20-30 parts of rhizoma drynariae, 15-20 parts of angelica and 20-30 parts of Chinese yam. The medicinal composition can be used for treating scapulohumeral periarthritis, has the advantages of quick response, low toxic and side effects and the like, and is simple and convenient in preparation process, stable in medicinal effect, convenient to use and easy to popularize and apply.

Description

Pharmaceutical composition for treating scapulohumeral periarthritis and preparation method and spray thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a pharmaceutical composition for treating scapulohumeral periarthritis, a preparation method thereof and a spray.
Background
The scapulohumeral periarthritis is also called as scapulohumeral periarthritis, commonly called frozen shoulder, congealing cold shoulder and fifty shoulder. The pathological changes are the chronic aseptic inflammation of the soft tissues such as shoulder muscles, tendons, bursa of synovium and joints, and the result is the internal and external adhesion of the joints and the obstruction of the joint movement. The main clinical manifestations are shoulder pain, restricted movement and atrophy of shoulder muscles.
The exact cause of scapulohumeral periarthritis is not clear, and the pain and the reduction of mobility of shoulder caused by various factors are the inducement of scapulohumeral periarthritis. The disease is mostly seen in middle-aged and elderly people over 40 years old, while the female incidence is slightly higher than that of male, and is mostly seen in physical workers. In recent years, scapulohumeral periarthritis is younger and younger, more and more young people begin to suffer from the disease, which is closely related to work and life style changes, physical labor is more and more converted into mental labor, and the common application of computers, mobile phones and netbooks increases local movement of upper limbs than before and is often fixed on a certain position for movement. When the same posture is maintained for a long time, the corresponding muscles, tendons, ligaments and bursa can continuously and repeatedly squeeze and rub, and if proper relief and relaxation is not obtained, chronic strain can be formed and inflammation is generated after a long time.
If the treatment is not carried out or improper, the scapulohumeral periarthritis develops internal and external adhesion of shoulder joints, and common diseases mainly including shoulder pain and joint active or passive movement limitation are mainly caused. At present, the treatment on the scapulohumeral periarthritis is mainly conservative treatment, and comprises oral anti-inflammatory analgesic, physical therapy, traditional Chinese medicine hot compress, local pain point sealing, massage and other therapies. The anti-inflammatory analgesic comprises prednisone acetate (particularly adrenocortical hormone drugs), lidocaine and the like, but western medicines have large toxic and side effects; the traditional Chinese medicine needs to be decocted and washed externally, and the work is complicated. Therefore, it is necessary to research and develop a traditional Chinese medicine external preparation which is convenient to use and can effectively treat scapulohumeral periarthritis.
According to the traditional Chinese medicine, the onset of scapulohumeral periarthritis is induced by cold in shoulders, so that the traditional Chinese medicine is also called shoulder-leakage wind, and belongs to the field of arthralgia syndrome in the traditional Chinese medicine. Arthralgia means obstruction of qi and blood circulation, which is caused by strain, old and weak body, deficiency of qi and blood, and invasion of wind-cold-dampness, and is retained between the shoulder blades and bones, obstructing the cold meridians and collaterals without removing them. The "obstruction leading to pain" causes symptoms. The treatment is based on the principles of expelling wind and removing dampness, dispelling cold and removing obstruction in channels, and promoting blood and qi circulation.
Patent document CN 1448176A discloses a medicine for treating osteoporosis, which comprises 243-452 parts by weight of radix polygoni multiflori preparata, 194-361 parts by weight of herba epimedii, 243-452 parts by weight of radix rehmanniae preparata, 146-271 parts by weight of tortoise shell, 194-361 parts by weight of morinda officinalis, 194-361 parts by weight of eucommia ulmoides, 194-361 parts by weight of teasel root, 194-361 parts by weight of rhizoma drynariae, 146-271 parts by weight of angelica sinensis and 194-361 parts by weight of Chinese yam.
Disclosure of Invention
In order to solve the defects in the prior art, the invention firstly provides a pharmaceutical composition for treating scapulohumeral periarthritis, which is prepared from the following raw materials in parts by weight: 30-40 parts of radix polygoni multiflori preparata, 20-30 parts of epimedium herb, 25-35 parts of prepared rehmannia root, 15-20 parts of tortoise shell, 20-30 parts of morinda officinalis, 20-30 parts of eucommia bark, 15-20 parts of teasel root, 20-30 parts of rhizoma drynariae, 15-20 parts of angelica and 20-30 parts of Chinese yam. The medicine composition can be externally used for treating scapulohumeral periarthritis and has a remarkable curative effect.
Further, as a preferred embodiment of the present invention, the pharmaceutical composition for treating scapulohumeral periarthritis is prepared from the following raw materials in parts by weight: 36 parts of radix polygoni multiflori preparata, 24 parts of epimedium, 30 parts of prepared rehmannia root, 16 parts of tortoise shell, 25 parts of morinda officinalis, 25 parts of eucommia bark, 18 parts of teasel root, 24 parts of rhizoma drynariae, 18 parts of angelica and 24 parts of Chinese yam. The treatment effect on the scapulohumeral periarthritis is most obvious in the proportion.
Further, the pharmaceutical composition is an external preparation.
Correspondingly, the invention also provides a preparation method of the pharmaceutical composition for treating scapulohumeral periarthritis, which comprises the following steps: taking prepared fleece flower root, epimedium herb, prepared rehmannia root, tortoise shell, morinda officinalis, eucommia bark, teasel root, drynaria rhizome, Chinese angelica and Chinese yam according to the formula amount, crushing into coarse powder, adding ethanol with the volume percentage concentration of 70-80% which is 10-14 times of the total weight of the medicinal materials, soaking for 12 hours, then percolating by adopting the ethanol with the volume percentage concentration of 70-80%, wherein the percolating speed is 3ml/min (per 1kg of the medicinal materials), and collecting percolate.
In addition, the invention also provides a spray containing the pharmaceutical composition, which further comprises 1-3 parts by weight of borneol and 7-13 parts by weight of penetration enhancer, wherein the penetration enhancer is a composition of eucalyptus oil, decanol and propylene glycol. The spray has good permeability, can directly reach affected parts, and has analgesic and antiinflammatory effects, and obvious therapeutic effect on scapulohumeral periarthritis.
Further, the weight ratio of the eucalyptus oil to the decanol to the propylene glycol is 1 (1-3) to 2-4.
Further, the weight ratio of the eucalyptus oil to the decanol to the propylene glycol is 1:2: 3.
Further, the pH value of the spraying agent is 5.0-6.0.
Correspondingly, the invention also provides a preparation method of the spray, which comprises the following steps:
s1, crushing prepared fleece flower root, epimedium herb, prepared rhizome of rehmannia, tortoise shell, morinda officinalis, eucommia ulmoides, teasel root, drynaria rhizome, Chinese angelica and Chinese yam into coarse powder according to the formula amount, adding ethanol which is 10-14 times of the total weight of the medicinal materials, soaking for 12 hours, then percolating by adopting ethanol at the percolating speed of 3ml/min (per 1kg of the medicinal materials), and collecting percolate for later use;
s2, dissolving the penetration enhancer and the borneol in the formula amount by using ethanol to obtain an alcohol solution for later use;
s3, mixing the percolate and the alcoholic solution, adjusting the pH value to 5.0-6.0 by using citric acid, filtering, adding ethanol into the filtrate to a specified amount, uniformly mixing, sealing, standing, filtering, and filling into bottles to obtain the product.
Further, the volume percentage concentration of the ethanol is 70-80%.
The prepared fleece flower root has the effects of nourishing blood, benefiting liver, securing essence and tonifying kidney, has the antibacterial and anti-inflammatory effects, and contains emodin as a main effective active ingredient; herba Epimedii has effects of invigorating kidney, tonifying yang, dispelling pathogenic wind, removing dampness, strengthening tendons and bones, resisting inflammation, and relieving pain, and its main effective active ingredient is icariin; radix rehmanniae Preparata, carapax et Plastrum Testudinis, and Eucommiae cortex have the effects of invigorating kidney yang, and strengthening tendons and bones. Radix Morindae officinalis and radix Dipsaci have effects of dispelling pathogenic wind and removing dampness; rhizoma Drynariae has effects of invigorating kidney, strengthening bone, healing wound and relieving pain; the angelica can promote blood circulation and relieve pain; the Chinese yam has the effects of tonifying spleen and stomach, assisting five internal organs and strengthening bones and muscles; the medicines are combined to play the effects of expelling wind and removing dampness, dispelling cold and dredging collaterals, and promoting blood circulation and qi circulation. The various traditional Chinese medicines of the invention are taken as the medicine at the common medicine application part.
Meanwhile, eucalyptus oil, decanol and propylene glycol are compounded to serve as the penetration enhancer system of the invention, the transdermal penetration capacity of active ingredients of the traditional Chinese medicines is improved, borneol serves as an auxiliary material, the components are mutually coordinated, the purposes of resisting inflammation and easing pain are achieved, the curative effect on scapulohumeral periarthritis is definite, and particularly when the pH value is 5.0-6.0, the system stability is high, the penetration is strong, and the curative effect is obvious.
Therefore, compared with the prior art, the invention has the advantages that:
1) compared with the current western medicine or traditional Chinese medicine, the pharmaceutical composition is an external medicine, the adverse reaction and the toxic and side effect are obviously reduced, the use is convenient, and the medication compliance of patients with scapulohumeral periarthritis is obviously improved; the spraying agent has good permeability, can directly reach the affected part, effectively resists inflammation and relieves pain, greatly relieves the pain of a patient and has obvious treatment effect;
2) the medicinal composition for treating the scapulohumeral periarthritis contains various medicinal components, has numerous action targets, has the effects of dispelling wind and removing dampness, dispelling cold and dredging collaterals, and promoting blood circulation and qi circulation, and has the effect of treating both symptoms and root causes on the treatment effect of the scapulohumeral periarthritis;
3) the pharmaceutical composition for treating scapulohumeral periarthritis has scientific compatibility, has the advantages of quick response, low cost and the like, and has simple and convenient preparation process, stable and safe drug effect, stable preparation system, long-term storage, convenient use and easy popularization and application.
Detailed Description
The invention will be further illustrated by the following specific examples, but it will be understood by those skilled in the art that the present invention is not limited in any way by the specific examples.
Example 1 pharmaceutical composition for treating scapulohumeral periarthritis and preparation thereof according to the present invention
The formula is as follows: 300g of prepared fleece flower root, 200g of epimedium herb, 250g of prepared rehmannia root, 150g of tortoise shell, 200g of morinda officinalis, 200g of eucommia bark, 150g of teasel root, 200g of drynaria rhizome, 150g of angelica and 200g of Chinese yam.
The preparation method comprises the following steps: taking prepared fleece flower root, epimedium herb, prepared rehmannia root, tortoise shell, morinda officinalis, eucommia bark, teasel root, drynaria rhizome, Chinese angelica and Chinese yam according to the formula amount, crushing into coarse powder, adding ethanol with the weight 10 times of the total weight of the medicinal materials, soaking for 12 hours, then percolating by adopting ethanol at the percolating speed of 3ml/min (per 1kg of the medicinal materials), and collecting percolate. The volume percentage concentration of the ethanol is 70%. The obtained pharmaceutical composition is an external preparation.
Example 2 pharmaceutical composition for treating scapulohumeral periarthritis and preparation thereof according to the present invention
The formula is as follows: 400g of prepared fleece flower root, 300g of epimedium, 350g of prepared rehmannia root, 200g of tortoise shell, 300g of morinda officinalis, 300g of eucommia bark, 200g of teasel root, 300g of drynaria rhizome, 200g of angelica and 300g of Chinese yam.
The preparation method comprises the following steps: taking prepared fleece flower root, epimedium herb, prepared rehmannia root, tortoise shell, morinda officinalis, eucommia bark, teasel root, drynaria rhizome, Chinese angelica and Chinese yam according to the formula amount, crushing into coarse powder, adding ethanol with the weight 14 times of the total weight of the medicinal materials, soaking for 12 hours, then percolating by adopting ethanol at the percolating speed of 3ml/min (per 1kg of the medicinal materials), and collecting percolate. The volume percentage concentration of the ethanol is 80%. The obtained pharmaceutical composition is an external preparation.
Example 3 pharmaceutical composition for treating scapulohumeral periarthritis and preparation thereof according to the present invention
The formula is as follows: 360g of prepared fleece flower root, 240g of epimedium herb, 300g of prepared rehmannia root, 160g of tortoise shell, 250g of morinda officinalis, 250g of eucommia bark, 180g of teasel root, 240g of rhizoma drynariae, 180g of angelica and 240g of Chinese yam.
The preparation method comprises the following steps: taking prepared fleece flower root, epimedium herb, prepared rehmannia root, tortoise shell, morinda officinalis, eucommia bark, teasel root, drynaria rhizome, Chinese angelica and Chinese yam according to the formula amount, crushing into coarse powder, adding ethanol with the weight being 12 times of the total weight of the medicinal materials, soaking for 12 hours, then percolating by adopting ethanol at the percolating speed of 3ml/min (per 1kg of the medicinal materials), and collecting percolate. The volume percentage concentration of the ethanol is 75%. The obtained pharmaceutical composition is an external preparation.
Example 4 spray for treating scapulohumeral periarthritis according to the present invention
The formula is as follows: 300g of prepared fleece flower root, 200g of epimedium herb, 250g of prepared rehmannia root, 150g of tortoise shell, 200g of morinda officinalis, 200g of eucommia bark, 150g of teasel root, 200g of drynaria rhizome, 150g of angelica, 200g of Chinese yam, 10g of borneol and 70g of penetration enhancer; the eucalyptus oil, the decanol and the propylene glycol are combined into the penetration enhancer according to the weight ratio of 1:1: 2.
The preparation method comprises the following steps: s1, crushing radix Polygoni Multiflori Preparata, herba Epimedii, radix rehmanniae Preparata, carapax et Plastrum Testudinis, radix Morindae officinalis, Eucommiae cortex, radix Dipsaci, rhizoma Drynariae, radix Angelicae sinensis and rhizoma Dioscoreae into coarse powder, adding 10 times of ethanol, soaking for 12 hr, percolating with ethanol at a speed of 3ml/min (per 1 kg), and collecting percolate;
s2, dissolving the penetration enhancer and the borneol in the formula amount by using ethanol to obtain an alcohol solution for later use;
s3, mixing the percolate and the alcoholic solution, adjusting the pH value to 5.0 by using citric acid, filtering, adding ethanol into the filtrate to a specified amount of 30000ml, uniformly mixing, sealing, standing, filtering, and filling into 300 bottles (100 ml/bottle) to obtain the product.
The volume percentage concentration of the ethanol is 70%.
Example 5 spray for treating scapulohumeral periarthritis according to the present invention
The formula is as follows: 400g of prepared fleece flower root, 300g of epimedium, 350g of prepared rehmannia root, 200g of tortoise shell, 300g of morinda officinalis, 300g of eucommia bark, 200g of teasel root, 300g of drynaria rhizome, 200g of angelica, 300g of Chinese yam, 30g of borneol and 130g of penetration enhancer; the eucalyptus oil, the decanol and the propylene glycol are combined into the penetration enhancer according to the weight ratio of 1:3: 4.
The preparation method comprises the following steps: s1, crushing radix Polygoni Multiflori Preparata, herba Epimedii, radix rehmanniae Preparata, carapax et Plastrum Testudinis, radix Morindae officinalis, Eucommiae cortex, radix Dipsaci, rhizoma Drynariae, radix Angelicae sinensis and rhizoma Dioscoreae into coarse powder, adding 14 times of ethanol, soaking for 12 hr, percolating with ethanol at a speed of 3ml/min (per 1 kg), and collecting percolate;
s2, dissolving the penetration enhancer and the borneol in the formula amount by using ethanol to obtain an alcohol solution for later use;
s3, mixing the percolate and the alcoholic solution, adjusting the pH value to 6.0 by using citric acid, filtering, adding ethanol into the filtrate to a specified amount of 30000ml, uniformly mixing, sealing, standing, filtering, and filling into 300 bottles (100 ml/bottle) to obtain the product.
The volume percentage concentration of the ethanol is 80%.
Example 6 spray for treating scapulohumeral periarthritis according to the present invention
The formula is as follows: 360g of prepared fleece flower root, 240g of epimedium herb, 300g of prepared rehmannia root, 160g of tortoise shell, 250g of morinda officinalis, 250g of eucommia bark, 180g of teasel root, 240g of drynaria rhizome, 180g of angelica, 240g of Chinese yam, 20g of borneol and 100g of penetration enhancer; the eucalyptus oil, the decanol and the propylene glycol are combined into the penetration enhancer according to the weight ratio of 1:2: 3.
The preparation method comprises the following steps: s1, crushing radix Polygoni Multiflori Preparata, herba Epimedii, radix rehmanniae Preparata, carapax et Plastrum Testudinis, radix Morindae officinalis, Eucommiae cortex, radix Dipsaci, rhizoma Drynariae, radix Angelicae sinensis and rhizoma Dioscoreae into coarse powder, adding 12 times of ethanol, soaking for 12 hr, percolating with ethanol at a speed of 3ml/min (per 1 kg), and collecting percolate;
s2, dissolving the penetration enhancer and the borneol in the formula amount by using ethanol to obtain an alcohol solution for later use;
s3, mixing the percolate and the alcoholic solution, adjusting the pH value to 5.6 by using citric acid, filtering, adding ethanol into the filtrate to a specified amount of 30000ml, uniformly mixing, sealing, standing, filtering, and filling into 300 bottles (100 ml/bottle) to obtain the product.
The volume percentage concentration of the ethanol is 75%.
Comparative example 1
The comparative example differs from example 6 only in that: in step S3, the pH value is adjusted to 4.5.
Comparative example 2
The comparative example differs from example 6 only in that: in step S3, the pH value is adjusted to 6.5.
Test example one, stability test of spray for treating scapulohumeral periarthritis according to the present invention
Room temperature stability test:
the filled sprays of examples 4-6 and comparative examples 1-2 are sealed and placed in a room for experiment under natural conditions, and the content, pH value, appearance, sterility and centrifugation test (500r/min) of emodin and icariin in the sprays are detected in 0, 1, 2 and 3 months respectively. The results are given in table 1 below:
TABLE 1 results of stability test at room temperature
Figure BDA0001683071820000061
From table 1 above, it can be seen that: the quality of the spray of the embodiment 4-6 is stable in a room temperature test, the spray is stored for 3 months under indoor natural conditions, the contents, pH values, appearances and the like of emodin and icariin are not obviously changed, and the spray of the embodiment 6 is particularly stable; while the pH values of comparative examples 1 and 2 were reduced, the contents of the active substances emodin and icariin were also reduced, and delamination occurred after centrifugation.
(II) accelerated test:
taking the filled spray of example 4-6, sealing and placing at 40 ℃ and 75% of relative humidity for accelerated test, and detecting the content, pH value, appearance, sterility and centrifugation test (500r/min) of emodin and icariin in the spray at 0, 1 and 3 months respectively. The results are given in table 2 below:
TABLE 2 accelerated test results
Figure BDA0001683071820000071
From table 2 above, it can be seen that: the sprays of the embodiments 4 to 6 of the invention have stable quality in an accelerated test, are stored for 3 months at 40 ℃ and 75% of relative humidity, have no obvious changes in the contents, pH values, appearances and the like of emodin and icariin, and are particularly stable as the spray of the embodiment 6. The spray system of the present invention is suggested to be stable and have a long shelf life, whereas example 6 is the best example.
Test example two, skin permeation study test of spray for treating scapulohumeral periarthritis of the present invention
1. Preparation of ex vivo mouse skin: 18 Kunming mice with weight of 20 +/-2 g and unlimited sexes are divided into 6 groups, namely experimental groups 1-6. Killing the mice, peeling off the ventral skin, carefully depilating with a razor (care not to injure the horny layer), peeling off the subcutaneous mucosa and adipose tissue, repeatedly washing with distilled water until no white turbidity exists, repeatedly washing with normal saline, sealing in an aluminum plastic bag, and storing in a refrigerator at-20 deg.C for use. Before the experiment, the mixture is naturally thawed and soaked in normal saline for 0.5 h.
2. In vitro permeability test methods: the volume of the Franz diffusion chamber is 15ml, and the diffusion area is 3.14cm2The skin is fixed between the sample chamber and the receiving tank, and the stratum corneum faces upward to the supply tank.
Experimental group 1: the reservoir was filled with 2ml of the percolate of example 3 and the receiving chamber with 75% ethanol.
Experimental group 2: 2ml of the spray of example 4 is added into a supply pool, and 70% ethanol is added into a receiving chamber;
experimental group 3: 2ml of the spray of example 5 is added into a supply pool, and 80% ethanol is added into a receiving chamber;
experimental group 4: 2ml of the spray of example 6 is added into a supply pool, and 75% ethanol is added into a receiving chamber;
experimental group 5: 2ml of the spray of comparative example 1 is added into a supply pool, and 75% ethanol is added into a receiving chamber;
experimental group 6: 2ml of the spray of comparative example 2 is added into a supply pool, and 75% ethanol is added into a receiving chamber;
the magnetic stirring speed is about 100 r.min-1And keeping the temperature in a water bath at 37 ℃. Taking out all ethanol solution from the receiving pool at 24h, evaporating to dry in water bath, diluting to 5ml with methanol, and measuring emodin and icariin content in the sample by high performance liquid chromatography.
Emodin permeability (emodin amount in the receiving pool/emodin amount added) x 100%
Icariin permeability (amount of icariin in receiving tank/amount of icariin added) x 100%
3. The experimental results are as follows: see table 3 below.
TABLE 3 results of the transdermal penetration study of the spray of the present invention
Figure BDA0001683071820000081
From table 3 above, it can be seen that:
(1) the transdermal permeability of the spray is good, which shows that the transdermal permeability of the spray can be remarkably improved by using the compound of eucalyptus oil, decanol and propylene glycol as the permeation promoter system, particularly, the emodin and icariin of an experimental group 4 have the highest permeability of 41.9 percent and 39.4 percent respectively, which shows that the skin permeability of the compound system of eucalyptus oil, decanol and propylene glycol in a weight ratio of 1:2:3 is the best; meanwhile, compared with the experimental group 1, the permeation rates of the emodin and the icariin are respectively improved by 33.6 percent and 32.2 percent.
(2) Compared with the experimental group 4, the emodin and icariin permeability of the experimental group 5 and the experimental group 6 is reduced, which indicates that the change of the pH value can influence the transdermal permeability of the spraying agent of the invention, thereby influencing the treatment effect of the spraying agent.
Test example three, permeability test of different combinations of penetration enhancers
1. Preparation of ex vivo mouse skin: 24 Kunming mice with weight of 20 +/-2 g and unlimited sexes are divided into 8 groups, namely experimental groups 1-8. Killing the mice, peeling off the ventral skin, carefully depilating with a razor (care not to injure the horny layer), peeling off the subcutaneous mucosa and adipose tissue, repeatedly washing with distilled water until no white turbidity exists, repeatedly washing with normal saline, sealing in an aluminum plastic bag, and storing in a refrigerator at-20 deg.C for use. Before the experiment, the mixture is naturally thawed and soaked in normal saline for 0.5 h.
2. In vitro permeability test methods: the volume of the Franz diffusion chamber is 15ml, and the diffusion area is 3.14cm2The skin is fixed between the sample chamber and the receiving tank, and the stratum corneum faces upward to the supply tank. 2ml of the percolate of example 3 containing 100g of the different penetration enhancer combinations of Table 4 below were added to the feed reservoir and 75% ethanol was added to the receiving chamber;
the magnetic stirring speed is about 100 r.min-1And keeping the temperature in a water bath at 37 ℃. Taking out all ethanol solution from the receiving pool at 24h, evaporating to dry in water bath, diluting to 5ml with methanol, and measuring emodin and icariin content in the sample by high performance liquid chromatography.
Emodin permeability (emodin amount in the receiving pool/emodin amount added) x 100%
Icariin permeability (amount of icariin in receiving tank/amount of icariin added) x 100%
TABLE 4 results of transdermal penetration study of different combinations of penetration enhancers
Figure BDA0001683071820000091
3. The experimental results are as follows: as can be seen from the above table 4, the penetration of the penetration enhancer of the invention prepared by compounding eucalyptus oil, decanol and propylene glycol according to a certain proportion in the experimental group 2 is the best, compared with the blank group, the penetration rates of emodin and icariin are respectively improved by 33.2% and 31.7%, so the invention selects the compound of eucalyptus oil, decanol and propylene glycol as the penetration enhancer of the spray of the invention.
Test example four, ear swelling test of mouse using the pharmaceutical composition for treating scapulohumeral periarthritis of the present invention
1. Grouping: taking 32 male Kunming mice with the weight of 20-24 g, randomly dividing the mice into 4 groups, 8 mice in each group, and randomly dividing the mice into the following groups:
matrix group: administering a 75% ethanol solution;
example 4 group: the spray prepared in the embodiment 4 of the invention;
example 5 group: the spray prepared in the embodiment 5 of the invention;
example 6 group: the spray prepared in the embodiment 6 of the invention.
2. The method comprises the following steps: 15ul of each drug was applied to the front and back of the right ear of the mouse three times at 1h intervals. Coating xylene on front and back surfaces of right ear 10ul before 2 times of administration, wiping off medicine with warm water after last administration for 1h, removing cervical vertebra of mouse after 1h, killing, cutting off ears, punching down round ear pieces at the same position with a 9mm diameter puncher, and weighing with analytical balance. The results are shown in Table 5.
Swelling degree WRight ear piece－WLeft ear
The swelling inhibition rate is [ (swelling degree in stroma group-swelling degree in drug group)/swelling degree in stroma group ] × 100%
3. As a result: see table 5 below.
TABLE 5 Effect of the pharmaceutical compositions of the present invention on the resistance of ear swelling in mice
Group of Animal number (only) Swelling inhibition ratio (%)
SubstrateGroup of 8 0
EXAMPLE 4 group 8 17.0
EXAMPLE 5 group 8 18.5
EXAMPLE 6 group 8 23.7
From table 5 above, it can be seen that: the local administration of the pharmaceutical composition for treating scapulohumeral periarthritis disclosed by the invention has an obvious inhibition effect on mouse ear swelling, and the pharmaceutical composition disclosed by the invention has an anti-inflammatory effect, and particularly has the highest inhibition rate and the best anti-inflammatory effect compared with the pharmaceutical composition in the example 6.
Fifth test example, analgesic test of the pharmaceutical composition for treating scapulohumeral periarthritis of the present invention
1. Grouping: taking mice with the weight of 20-24 g, wherein the male and female parts are half of each other, each group comprises 8 mice, and the mice are randomly divided into the following groups:
matrix group: administering a 75% ethanol solution;
example 4 group: the spray prepared in the embodiment 4 of the invention;
example 5 group: the spray prepared in the embodiment 5 of the invention;
example 6 group: the spray prepared in the embodiment 6 of the invention.
2. The method comprises the following steps: the method comprises unhairing abdomen of each group of mice by acetic acid writhing method, exposing 2cm × 2cm skin as administration region, smearing 0.1mL medicinal liquid, and administering twice at 15min interval. After administration for 30min, 0.06g/L glacial acetic acid 0.2mL was injected into the abdominal cavity of each mouse. The number of writhing of the mice within 15min after injection was recorded and the pain inhibition rate was calculated: the pain inhibition rate p is ═ p [ (n matrix group writhing reaction times-n administration group writhing reaction times)/n matrix group writhing reaction times ] × 100%.
3. As a result: the results are shown in Table 6.
TABLE 6 Effect of the pharmaceutical compositions of the present invention on acetic acid-induced pain in mice
Figure BDA0001683071820000111
Group of Animal number (only) number of twisted bodies/times p inhibition rate/%)
Substrate group 8 1.672±0.96 —
EXAMPLE 4 group 8 0.320±0.34 80.86
EXAMPLE 5 group 8 0.240±0.33 85.65
EXAMPLE 6 group 8 0.160±0.30 90.43
From table 6 above, it can be seen that: the pharmaceutical composition for treating scapulohumeral periarthritis disclosed by the invention can inhibit pain reaction caused by acetic acid stimulation to a certain extent, so that the number of times of writhing of mice is reduced, and the pharmaceutical composition disclosed by the invention has an analgesic effect, wherein the pharmaceutical composition in example 6 has the highest inhibition rate and the most obvious analgesic effect.
The above is only a preferred embodiment of the present invention, and it should be noted that the above preferred embodiment should not be considered as limiting the present invention, and the protection scope of the present invention should be subject to the scope defined by the claims. It will be apparent to those skilled in the art that various modifications and adaptations can be made without departing from the spirit and scope of the invention, and these modifications and adaptations should be considered within the scope of the invention.

Claims (3)

1. The spray for treating scapulohumeral periarthritis is characterized by being prepared from the following raw materials in parts by weight: 30-40 parts of radix polygoni multiflori preparata, 20-30 parts of epimedium herb, 25-35 parts of prepared rehmannia root, 15-20 parts of tortoise shell, 20-30 parts of morinda officinalis, 20-30 parts of eucommia bark, 15-20 parts of teasel root, 20-30 parts of rhizoma drynariae, 15-20 parts of angelica, 20-30 parts of Chinese yam, 1-3 parts of borneol and 7-13 parts of penetration enhancer;
the penetration enhancer is a composition of eucalyptus oil, decanol and propylene glycol, and the weight ratio of the eucalyptus oil to the decanol to the propylene glycol is 1 (1-3) to 2-4;
the pH value of the spray is 5.0-6.0;
the preparation method of the spray comprises the following steps:
s1, taking prepared fleece flower root, epimedium herb, prepared rhizome of rehmannia, tortoise shell, morinda officinalis, eucommia ulmoides, teasel root, drynaria rhizome, Chinese angelica and Chinese yam according to the formula amount, crushing into coarse powder, adding ethanol with the volume percentage concentration of 70-80% of 10-14 times of the total weight of the medicinal materials, soaking for 12 hours, then percolating by adopting ethanol at the percolation speed of 3ml/min, and collecting percolate for later use;
s2, dissolving the penetration enhancer and the borneol in the formula amount by using ethanol to obtain an alcohol solution for later use;
s3, mixing the percolate and the alcoholic solution, adjusting the pH value to 5.0-6.0 by using citric acid, filtering, adding ethanol into the filtrate to a specified amount, uniformly mixing, sealing, standing, filtering, and filling into bottles to obtain the product.
2. The spray according to claim 1, which is prepared from the following raw materials in parts by weight: 36 parts of radix polygoni multiflori preparata, 24 parts of epimedium, 30 parts of prepared rehmannia root, 16 parts of tortoise shell, 25 parts of morinda officinalis, 25 parts of eucommia bark, 18 parts of teasel root, 24 parts of rhizoma drynariae, 18 parts of angelica, 24 parts of Chinese yam, 1-3 parts of borneol and 7-13 parts of penetration enhancer.
3. The spray according to claim 1 or 2, wherein the weight ratio of eucalyptus oil, decanol and propylene glycol is 1:2: 3.
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