CN110354069B - Ointment and preparation method thereof - Google Patents

Ointment and preparation method thereof Download PDF

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CN110354069B
CN110354069B CN201910596901.4A CN201910596901A CN110354069B CN 110354069 B CN110354069 B CN 110354069B CN 201910596901 A CN201910596901 A CN 201910596901A CN 110354069 B CN110354069 B CN 110354069B
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ointment
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CN110354069A (en
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沈进
邓伟健
林锦雄
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Guangzhou Aibei Biological Technology Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • A61K31/125—Camphor; Nuclear substituted derivatives thereof
    • A—HUMAN NECESSITIES
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    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/286—Carthamus (distaff thistle)
    • 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)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/534—Mentha (mint)
    • 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)
    • A61K36/61—Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • 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
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • 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
    • A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
    • 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]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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Abstract

The invention provides ointment and a preparation method thereof. The ointment comprises a gel and a softening agent, wherein the gel comprises hydroxystearic acid and petrolatum which respectively account for 0.3-2% and 5-60% of the weight of the ointment, the softening agent comprises caprylic acid/capric acid triglyceride which accounts for 0.01-20% of the weight of the ointment, and the hydroxystearic acid, the petrolatum and the caprylic acid/capric acid triglyceride are reasonably compounded; and the menthol crystal, the eucalyptus globulus leaf oil, the camphor, the safflower seed oil and the clove oil which are reasonably compatible are added, so that the ointment has the effects of preventing mosquito bites, clearing heat, eliminating dampness, dredging collaterals, removing blood stasis and treating red swelling and slight sprain, also has natural fragrance and good bacteriostatic ability, does not need to add essence and preservative, is natural and safe, and is simple in preparation process and easy for industrialized production.

Description

Ointment and preparation method thereof
Technical Field
The invention relates to the field of ointment products, in particular to an ointment and a preparation method thereof.
Background
The ointment products currently on the market have the following problems:
(1) the formula contains menthol, vaseline and/or paraffin, the thermal stability is poor, and oil is easy to separate out when the temperature is over 40 ℃, so that the efficacy of the active ingredients is weakened;
(2) most ointments have single effect, and do not have multiple effects of preventing mosquito bites, red swelling and slight sprain, detoxifying and diminishing inflammation, clearing heat and eliminating dampness, dredging collaterals and dredging blood stasis and the like.
Therefore, there is a need to develop a stable, multifunctional ointment.
Disclosure of Invention
The invention aims to overcome the defects in the prior art and provides ointment and a preparation method thereof.
In order to achieve the purpose, the invention adopts the technical scheme that:
in a first aspect, the present invention provides an ointment comprising a gel comprising hydroxystearic acid and petrolatum in amounts of 0.3 to 2% and 5 to 60%, respectively, by weight of the ointment, and an emollient comprising caprylic/capric triglyceride in amounts of 0.01 to 20% by weight of the ointment. The applicant finds that the gel formed by compounding the hydroxystearic acid, the petrolatum and the caprylic/capric triglyceride can form a gel, is soft to touch and easy to apply, and has good cold resistance and heat resistance stability when the factice comprises 0.3-2% of the hydroxystearic acid, 5-60% of the petrolatum and 0.01-20% of the caprylic/capric triglyceride, and the functional components contained in the formula can be effectively prevented from being separated out in high-temperature and low-temperature environments, so that the function of the functional components is guaranteed.
Preferably, hydroxystearic acid is present in an amount of 0.6%, petrolatum is present in an amount of 33.35%, and caprylic/capric triglyceride is present in an amount of 6%, based on the total weight of the ointment. Under the condition, the ointment has better cold resistance and heat resistance stability.
Preferably, the ointment further comprises efficacy ingredients, wherein the efficacy ingredients comprise menthol, eucalyptus globulus labill leaf oil, camphor, safflower seed oil and clove oil which respectively account for 1-40% of the weight of the ointment; further preferably, the menthol accounts for 15%, the eucalyptus globulus leaf oil accounts for 5%, the camphor accounts for 10%, the safflower seed oil accounts for 10%, and the clove oil accounts for 5% of the total weight of the ointment. Menthol is a saturated cyclic alcohol obtained from peppermint oil and has the effects of dispelling wind, clearing heat and detoxifying; the Eucalyptus globulus Labill leaf oil has effects of improving respiratory function, resisting parasite, promoting skin absorption, dispelling pathogenic wind, relieving pain, relieving itching, relieving summer-heat, and treating burn; the camphor has the effects of opening orifices, killing parasites, relieving itching, reducing swelling and relieving pain; safflower seed oil is a kind of carminative drug, and can be used for treating rheumatalgia, traumatic injury, sprain, and skin pruritus; clove oil has analgesic effect; the ointment contains menthol, eucalyptus globulus leaf oil, camphor, safflower seed oil and clove oil, has the effects of preventing mosquito bites, clearing heat, eliminating dampness, dredging collaterals, removing blood stasis, treating red swelling, slight sprain and the like, has natural fragrance, does not need to be added with other essence, and particularly does not need to be added with synthetic essence; when the menthol, the eucalyptus globulus leaf oil, the camphor, the safflower seed oil and the clove oil respectively account for 1-40% by taking the total weight of the ointment as a reference, the ointment has better efficacy than that of the ointment only containing one of the five components due to the synergistic effect of the five components, and especially, the efficacy is better when the menthol accounts for 15%, the eucalyptus globulus leaf oil accounts for 5%, the camphor accounts for 10%, the safflower seed oil accounts for 10% and the clove oil accounts for 5% by taking the total weight of the ointment as a reference. In addition, the eucalyptus globulus leaf oil has an antibacterial effect and can replace a preservative to play a role in antisepsis.
Preferably, the gel further comprises a mixture of microcrystalline wax and paraffin wax in an amount of 1-20% by weight of the ointment, and beeswax in an amount of 0.1-20% by weight of the ointment, wherein the weight ratio of microcrystalline wax to paraffin wax is 3: 7; further preferably, the gel further comprises a mixture of microcrystalline wax and paraffin wax at 14% by weight of the ointment and beeswax at 1%. By adding microcrystalline wax, paraffin and beeswax, the ointment is easy to form and convenient to pick up and use, and the ointment has better use feeling and stability.
Preferably, the ointment further comprises an oil-soluble colorant, the oil-soluble colorant comprising 0.002-2% by weight of the ointment; further preferably, said oil soluble colorant comprises 0.02% by weight of said ointment; still further preferably, the oil-soluble colorant is a green chromium oxide, namely CI 77288.
In a second aspect, the invention provides a method for preparing an ointment, comprising the steps of:
(1) mixing petrolatum, microcrystalline wax, paraffin, hydroxystearic acid, beeswax, caprylic/capric triglyceride and oil-soluble colorant, heating to 90-95 ℃, stirring until the mixture is completely dissolved uniformly, cooling to 60-80 ℃, and keeping the temperature for later use to obtain an A-phase material;
(2) and sequentially adding the phase B material into the phase A material, keeping the temperature at 60-80 ℃, stirring until the phase B material is completely dissolved, defoaming, and filling to obtain the ointment.
Preferably, the oil-soluble colorant is a chromium oxide green, i.e., CI 77288.
Compared with the prior art, the invention has the following advantages and beneficial effects:
(1) the ointment disclosed by the invention is soft in touch, easy to smear, excellent in cold resistance and heat resistance stability, and capable of effectively preventing functional components contained in the formula from being separated out in high-temperature and low-temperature environments, so that the functions of the functional components are ensured.
(2) The ointment has the effects of better preventing mosquito bites, clearing heat and eliminating dampness, dredging collaterals and removing stasis, treating red swelling, slight sprain and the like by reasonably compounding the menthol, the eucalyptus globulus leaf oil, the camphor, the safflower seed oil and the clove oil, has natural fragrance and good bacteriostatic ability, does not need extra essence and preservative, and is natural and safe.
(3) The preparation method of the ointment has simple process and controllable conditions, and is easy for industrial production.
Drawings
Fig. 1 is a photograph of the ointment of example 2.
Detailed Description
To better illustrate the objects, aspects and advantages of the present invention, the present invention will be further described with reference to specific examples.
Examples 1 to 9
Examples 1-9 are examples of ointments according to the invention and the compositions of these compositions are shown in table 1, wherein the mixture of microcrystalline wax and paraffin wax consists of microcrystalline wax and paraffin wax in a weight ratio of 3: 7.
TABLE 1 composition of ointments in examples 1-9/%)
Figure BDA0002116117620000041
The ointments of examples 1-9 were prepared by the following steps:
(1) mixing petrolatum, microcrystalline wax, paraffin wax, hydroxystearic acid, beeswax, caprylic/capric triglyceride and oil-soluble colorant, heating to 90-95 ℃, stirring until the mixture is completely dissolved uniformly, cooling to 60-80 ℃, and keeping the temperature for later use to obtain a phase A material;
(2) sequentially adding the phase B material into the phase A material, keeping the temperature at 60-80 deg.C, stirring to dissolve completely, defoaming, and packaging to obtain the ointment;
wherein the B phase material comprises menthol, eucalyptus globulus leaf oil, camphor, safflower seed oil and clove oil.
Comparative example 1
Comparative example 1 is an ointment having the same ingredients and proportions as in example 2 except that it does not contain microcrystalline wax, paraffin wax and beeswax.
Comparative example 2
Comparative example 2 is an ointment having the same ingredients and proportions as in example 2 except that it does not contain hydroxystearate.
Comparative example 3
Comparative example 3 is an ointment having the same composition and proportions as in example 2 except that it does not contain menthol.
Comparative example 4
Comparative example 4 is an ointment having the same ingredients and proportions as in example 2 except that eucalyptus globulus oil is not included.
Comparative example 5
Comparative example 5 is an ointment having the same ingredients and proportions as in example 2 except that it does not contain camphor.
Comparative example 6
Comparative example 6 is an ointment having the same composition and ratio as in example 2 except that safflower seed oil is not contained.
Comparative example 7
Comparative example 7 is an ointment having the same ingredients and proportions as in example 2, except that it does not contain clove oil.
The applicant has studied the effects of the present invention using the following tests, in particular:
(1) stability test
Test object(s): ointments in examples 1 to 9 and comparative examples 1 to 2.
The test method comprises the following steps: the test sample was left at 50 ℃, room temperature and-20 ℃ for 3 months, respectively, after which whether the sample was stable or not was observed, and the sample was tested for hardness.
And (3) testing results: see table 2 for details.
Table 2 stability and hardness test results for samples
Test sample 50℃ At room temperature -20℃
Example 1 Stable and soft Stable and moderate hardness Stabilization
Example 2 Stable and moderate hardness Stable and moderate hardness Stabilization
Example 3 Stable and moderate hardness Stable and moderate hardness Having cracks on the surface
Example 4 Unstable, slight oil out Stable and moderate hardness Stabilization of
Example 5 Stabilization of Stable and hard Stabilization
Example 6 Stabilization Stable and hard Stabilization of
Example 7 Stabilization of Stable and hard Stabilization
Example 8 Stabilization Stable and hard Stabilization
Example 9 Stabilization Stable and hard Stabilization of
Comparative example 1 Unstable and obvious oil production Stable and soft Stabilization of
Comparative example 2 Melting of the oil Stabilization of Stabilization
The ointment of comparative example 1, although having good stability at room temperature, was soft, had an uneven surface, had an unsightly appearance, and was not easily picked up for use.
(2) Efficacy testing
Test objects: ointments according to example 2 and comparative examples 3 to 7.
The test method comprises the following steps: the test samples were distributed to 30 subjects, and then the mosquito repellent effect, vein relaxing and stasis removing, pain relieving effects of the statistical samples were investigated.
And (3) testing results: investigation shows that the comparative example 3 and the comparative example 5 have poor mosquito bite prevention effect compared with the example 2, namely the menthol or camphor is absent, and the mosquito bite prevention effect is weakened; compared with example 2, comparative examples 4 and 6 have poor effects of dredging collaterals and removing stasis, namely the eucalyptus globulus oil or the safflower oil is lacked, and the effects of dredging collaterals and removing stasis are weakened; comparative example 5 had a poorer analgesic effect than example 2, i.e. the analgesic effect was reduced in the absence of clove oil.
Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention and not for limiting the protection scope of the present invention, and although the present invention is described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions can be made on the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.

Claims (7)

1. An ointment is characterized in that: the ointment consists of an oil-soluble coloring agent, a gel, an efficacy component and a softening agent, wherein the gel consists of hydroxystearic acid accounting for 0.3-0.6% of the weight of the ointment, a mixture of microcrystalline wax and paraffin wax accounting for 1-20%, beeswax accounting for 0.1-20% and petrolatum accounting for 5-34.298%, and the softening agent is caprylic/capric triglyceride accounting for 0.01-6% of the weight of the ointment; wherein the weight ratio of the microcrystalline wax to the paraffin wax is 3: 7; the oil-soluble colorant accounts for 0.002-2% of the ointment, and the effective components are menthol, eucalyptus globulus leaf oil, camphor, safflower seed oil and clove oil which respectively account for 1-40% of the ointment.
2. The ointment of claim 1, wherein: calculated by taking the total weight of the ointment as a reference, the hydroxystearic acid accounts for 0.6 percent, the petrolatum accounts for 33.35 percent, and the caprylic/capric triglyceride accounts for 6 percent.
3. The ointment of claim 1, wherein: calculated by taking the total weight of the ointment as a reference, the menthol accounts for 15 percent, the eucalyptus globulus leaf oil accounts for 5 percent, the camphor accounts for 10 percent, the safflower seed oil accounts for 10 percent, and the clove oil accounts for 5 percent.
4. The ointment of claim 1, wherein: based on the total weight of the ointment, the mixture of microcrystalline wax and paraffin wax accounts for 14%, and the beeswax accounts for 1%.
5. The ointment of claim 1, wherein: the oil-soluble colorant comprises 0.02% by weight of the ointment.
6. The ointment of claim 5, wherein: the oil-soluble colorant is chromium oxide green.
7. A process for the preparation of an ointment according to any one of claims 1 to 6, characterized in that: the preparation method comprises the following steps:
(1) mixing petrolatum, microcrystalline wax, paraffin wax, hydroxystearic acid, beeswax, caprylic/capric triglyceride and oil-soluble colorant, heating to 90-95 ℃, stirring until the mixture is completely dissolved uniformly, cooling to 60-80 ℃, and keeping the temperature for later use to obtain a phase A material;
(2) sequentially adding the phase B material into the phase A material, keeping the temperature, cooling to 60-80 deg.C, stirring to dissolve completely, defoaming, and packaging to obtain the ointment;
wherein the B phase material comprises Mentholum, Eucalyptus globulus Labill leaf oil, Camphora, safflower seed oil and oleum Caryophylli.
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