CN113041264A - Sterile honey gel and preparation method and application thereof - Google Patents
Sterile honey gel and preparation method and application thereof Download PDFInfo
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- CN113041264A CN113041264A CN202110368799.XA CN202110368799A CN113041264A CN 113041264 A CN113041264 A CN 113041264A CN 202110368799 A CN202110368799 A CN 202110368799A CN 113041264 A CN113041264 A CN 113041264A
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- 235000012907 honey Nutrition 0.000 title claims abstract description 95
- 238000002360 preparation method Methods 0.000 title abstract description 11
- 238000001879 gelation Methods 0.000 title description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 28
- 229960002233 benzalkonium bromide Drugs 0.000 claims abstract description 26
- KHSLHYAUZSPBIU-UHFFFAOYSA-M benzododecinium bromide Chemical compound [Br-].CCCCCCCCCCCC[N+](C)(C)CC1=CC=CC=C1 KHSLHYAUZSPBIU-UHFFFAOYSA-M 0.000 claims abstract description 26
- 239000003814 drug Substances 0.000 claims abstract description 16
- 239000002994 raw material Substances 0.000 claims abstract description 4
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- 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
- A61K35/63—Arthropods
- A61K35/64—Insects, e.g. bees, wasps or fleas
- A61K35/644—Beeswax; Propolis; Royal jelly; Honey
-
- 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
- A61K31/13—Amines
- A61K31/14—Quaternary ammonium compounds, e.g. edrophonium, choline
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- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
-
- 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
- A61K9/0048—Eye, e.g. artificial tears
-
- 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
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
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Abstract
The invention provides a sterile honey gel and a preparation method and application thereof, wherein the gel comprises the following raw materials: honey and water; benzalkonium bromide is also included. The honey gel comprises honey, and the honey contains a large amount of glucose and fructose sucrose, can supply energy to corneal epithelial cells and promote proliferation, and can enable the ocular surface of a patient to generate a lipid layer after the gel containing the honey component is used, so that tear evaporation is reduced; it also contains benzalkonium bromide as surfactant, which is easily soluble in water, and can be used for disinfecting skin, mucosa, wound, etc. Experiments show that the sterile honey gel has a good effect on treating xerophthalmia, can be adhered to the surfaces of a cornea and a conjunctiva, enables the action time of a medicament to be more durable, relatively reduces the dripping frequency of the medicament, increases the compliance of people, and is relatively more convenient to use.
Description
Technical Field
The invention relates to the technical field of medicines, and particularly relates to a sterile honey gel and a preparation method and application thereof.
Background
Dry eye is usually due to unstable tear film, hyperosmolality, ocular surface inflammation and even injury caused by the loss of tear film homeostasis, and symptoms of dry eye, such as eye irritation, blurred vision, stabbing pain, etc., may initially appear, and permanent blindness may progress. Triggering the inflammatory cascade and injury of the ocular surface, which, if left untreated, would enter into an undesirable cycle of dry eye.
The medicine for xerophthalmia in China has few choices, mainly comprises artificial tears such as sodium hyaluronate and the like, and is mainly used in 14 domestic clinical medicines for xerophthalmia, wherein 11 medicines belong to the artificial tears, 2 lubricants and 1 cornea repair. Although referred to as "artificial tears," such products do not have the bioactive components found in natural tears, and most often function only as lubricants. There is a clinical need for more effective drugs for the treatment of dry eye, which is also one of the hot areas of current ophthalmic drug development.
Most of the current dry eye-based medicines exert only the efficacy of lubricants and have no actual dry eye treatment effect, and improvement thereof is required.
Disclosure of Invention
In view of the above, the present invention provides a sterile honey gel, a method for preparing the same and applications thereof, which solves or at least partially solves the technical problems of the prior art.
In a first aspect, the invention provides a sterile honey gel comprising the following raw materials: honey and water.
On the basis of the technical scheme, the sterile honey gel preferably further comprises benzalkonium bromide.
On the basis of the technical scheme, the volume ratio of the honey to the water of the sterile honey gel is preferably (120-250): 500.
More preferably, the sterile honey gel has a mass-volume ratio of benzalkonium bromide to honey to water of (0.025-0.05) g to (125-250) ml to 500 ml.
In a second aspect, the invention also provides a preparation method of the sterile honey gel, which comprises the following steps:
dissolving Mel in water to obtain sterile Mel gel;
or comprises the following steps:
dissolving honey in water to obtain honey solution for use;
the benzalkonium bromide is dissolved in water to obtain a benzalkonium bromide solution for later use;
mixing the Mel solution with benzalkonium bromide solution to obtain sterile Mel gel.
On the basis of the above technical solution, preferably, the preparation method of the sterile honey gel further comprises, before mixing the honey solution with the benzalkonium bromide solution: putting the honey solution under the pressure of 0.4-0.8 kg/cm2And sterilizing the mixture for 25 to 35min under steam at the temperature of 105 to 115 ℃.
On the basis of the technical scheme, preferably, the preparation method of the sterile honey gel comprises the steps of dissolving honey in water and placing the honey under the pressure of 0.4-0.8 kg/cm2And sterilizing the mixture for 25 to 35min under steam at the temperature of 105 to 115 ℃ to obtain the sterile honey gel.
In a third aspect, the invention also provides application of the sterile honey gel in preparing a medicine for treating dry eye.
Compared with the prior art, the sterile honey gel disclosed by the invention has the following beneficial effects:
(1) the sterile honey gel comprises honey, wherein the honey contains a large amount of glucose and fructose sucrose, can supply energy to corneal epithelial cells and promote proliferation, and can enable the ocular surface of a patient to generate a lipid layer after the gel containing the honey component is used, so that tear evaporation is reduced; benzalkonium bromide is also included, is used as a surfactant, is easy to dissolve in water, has stable property, and can be used for disinfecting skin, mucosa, wound and the like; experiments show that the sterile honey gel has a good effect on treating xerophthalmia, can play an adhesive role, can be adhered to the surfaces of a cornea and a conjunctiva, enables the action time of a medicament to be more durable, relatively reduces the dripping frequency of the medicament, increases the compliance of people, and is relatively more convenient to use.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below. It is obvious that the drawings in the following description are only some embodiments of the invention, and that for a person skilled in the art, other drawings can be derived from them without inventive effort.
FIG. 1 is a histogram of the mean SIT values of 8 mice in A, B, C three groups in tables 1-3;
FIG. 2 is a histogram of the mean FL values of 8 mice in A, B, C three groups in tables 1-3;
FIG. 3 is a histogram of mean nerve fiber density values of 8 mice in A, B, C three groups in tables 1-3;
FIG. 4 is a histogram of the mean fiber branch values of 8 mice in A, B, C three groups in tables 1-3;
FIG. 5 is a bar graph of the mean curvature scores of 8 mice in A, B, C groups in tables 1-3;
FIG. 6 is a bar graph of the mean inflammatory cell counts of 8 mice in A, B, C three groups in tables 1-3;
FIG. 7 is a histogram of the mean basal cell counts of 8 mice in A, B, C three groups in tables 1-3.
Detailed Description
In the following, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention.
The embodiment of the application provides a sterile honey gel, which comprises the following raw materials: honey and water.
The sterile honey gel of the present application contains a large amount of glucose and fructose and sucrose in honey, can supply energy to corneal epithelial cells to promote proliferation, and can produce a lipid layer on the ocular surface of a patient to reduce tear evaporation after the gel containing the honey component is used, thereby being used for treating xerophthalmia.
In some embodiments, the composition further comprises benzalkonium bromide as a surfactant, is easily soluble in water, has stable properties, can be used for disinfecting skin, mucous membrane, wound and the like, and can also play a role in preservation, however, the benzalkonium bromide content in the composition is low, and the oxidative stress on the surface of eyes cannot be increased when the composition is used; the sterile honey gel can play a role in adhesion, can be adhered to the surfaces of a cornea and a conjunctiva, enables the action time of a medicament to be more lasting, relatively reduces the dripping times of the medicament, and increases the compliance of a person.
In some embodiments, the volume ratio of honey to water is (120-250): 500.
In some embodiments, the mass-to-volume ratio of benzalkonium bromide, said honey and water is (0.025-0.05) g (125-250) ml:500 ml.
Based on the same inventive concept, the embodiment of the application also provides a preparation method of the sterile honey gel, which comprises the following steps:
dissolving Mel in water to obtain sterile Mel gel;
or comprises the following steps:
dissolving honey in water to obtain honey solution for use;
the benzalkonium bromide is dissolved in water to obtain a benzalkonium bromide solution for later use;
mixing the Mel solution with benzalkonium bromide solution to obtain sterile Mel gel.
In some embodiments, mixing the honey solution with the benzalkonium bromide solution further comprises, prior to: putting the honey solution under the pressure of 0.4-0.8 kg/cm2And sterilizing the mixture for 25 to 35min under steam at the temperature of 105 to 115 ℃.
In some embodiments, the honey is dissolved in water and then placed under a pressure of 0.4-0.8 kg/cm2And sterilizing the mixture for 25 to 35min under steam at the temperature of 105 to 115 ℃ to obtain the sterile honey gel.
Based on the same inventive concept, the application also provides the application of the prepared sterile honey gel in preparing the medicine for treating xerophthalmia.
The following further illustrates the preparation of the sterile honey gel of the present application in specific examples.
Example 1
The embodiment of the application provides a preparation method of sterile honey gel, which comprises the following steps:
s1, adding 250ml of honey into 250ml of sterilized distilled water to obtain a honey solution; then placing the honey solution at 0.6kg/cm2Sterilizing under 110 deg.C steam for 30min, and cooling to obtain sterilized Mel solution;
s2, dissolving 0.025g of benzalkonium bromide in 250ml of sterilized distilled water to obtain a benzalkonium bromide solution for later use;
s3, mixing the sterilized honey solution and benzalkonium bromide solution, and stirring to obtain sterile honey gel.
Example 2
The embodiment of the application provides a preparation method of sterile honey gel, which comprises the following steps:
s1, adding 250ml of honey into 250ml of sterilized distilled water to obtain a honey solution; sterilizing the Mel solution under 0.6kg/cm2 pressure and 110 deg.C steam for 30min, and cooling to obtain sterile Mel gel.
Application case
Xiejieyi, male, 24 years old, south Chang people in Jiangxi province, the diagnosis is 5 months in 2020, the patients are complained of dry eyes, foreign body sensation is caused and photophobia lacrimation symptom is accompanied, basic lacrimation secretion SIT examination, tear protein examination and confocal microscope examination are carried out to diagnose the dry eye, the patients are ordered for 6 times a day, 2-3 drops are continuously used for 1 month, follow-up is carried out again, the dry eye symptom is obviously relieved, meanwhile, basic lacrimation secretion SIT examination, tear protein examination and confocal microscope examination are carried out again, and the comparison result shows that the inflammatory cell infiltration of the cornea is obviously reduced, the corneal epithelial basal cell atrophy, the tear protein and the SIT are improved, and the product is proved to be effective in treatment.
Xuping Yun, female, 57 years old, Shangxi province people, the diagnosis of 8 months in 2020, chief complaints of eye pain, discomfort, blurred vision, basic lacrimal secretion SIT examination, tear protein examination, confocal microscopy diagnosis of dry eye, advocates the patient for 6 times a day, each time 2-3 drops, continuously uses the sterile honey gel prepared in the application example 1 for 1 month, follow-up again, obviously relieves the dry eye symptom, and simultaneously carries out the basic lacrimal secretion SIT examination, tear protein examination, confocal microscopy again, the comparison result shows that the inflammatory cell infiltration of cornea is obviously reduced, the corneal epithelial basal cell atrophy, the tear protein and the SIT are improved, and the product is proved to be effective in treatment.
Zhang Si Ying, female, 53 years old, Jiangxi province, Jiangxi Jiangzhou, visit in 11 months of 2020, mainly complain of dry eyes and foreign body sensation, and other symptoms comprise burning sensation, itching sensation, photophobia, congestion, pain, blurred vision, fatigue, sticky silk secretion and the like. The basic lacrimal eye secretion SIT examination, the tear protein examination and the confocal microscope examination are carried out to diagnose the dry eye syndrome, a patient is ordered to carry out the dry eye syndrome 6 times a day, 2-3 drops of the sterile honey gel are continuously used for 1 month, follow-up is carried out again, the dry eye symptom is obviously relieved, the basic lacrimal eye secretion SIT examination, the tear protein examination and the confocal microscope examination are carried out again, and the contrast result shows that the inflammatory cell infiltration of the cornea is obviously reduced, the corneal epithelium basal cell atrophy is realized, the tear protein and the SIT are improved, and the product is proved to be effective in treatment.
The germen and the 56-year-old are diagnosed in 2020 within 5 months, the patients mainly complain about burning pain and stabbing pain of eyes with acid swelling of eyes and local hyperemia of bulbar conjunctiva, basic lacrimal secretion SIT examination, tear protein examination and confocal microscope examination are diagnosed as xerophthalmia, the patients are ordered to use the sterile honey gel prepared in the application example 2 continuously for 1 month with 2-3 drops each time, follow-up is carried out again, xerophthalmia is obviously relieved, and meanwhile basic lacrimal secretion SIT examination, tear protein examination and confocal microscope examination are carried out again, and the comparison result shows that the inflammatory cell infiltration of the cornea is obviously reduced, the corneal epithelial basal cell atrophy is reduced, the tear protein and SIT are improved, no damage to the ocular surface is found, and the product is proved to be effective in treatment.
The diagnosis is carried out 8 months after 40 years old and 2020, the patient is advised to continuously use the sterile honey gel prepared in the application example 2 for 1 month for 6 times each day and 2-3 drops each time, follow-up is carried out again, the dry eye symptom is obviously relieved, meanwhile, the basic lacrimal secretion SIT examination, the tear protein examination and the confocal microscope examination are carried out again, and the comparison result shows that the inflammatory cell infiltration of the cornea is obviously reduced, the corneal epithelial basal cell atrophy, the tear protein and the SIT are improved, the ocular surface damage is not found, and the treatment effect of the product is verified.
The patient is advised to continuously use the sterile honey gel prepared in the embodiment 2 for 1 month, follow-up visit again, the dry eye symptom is obviously relieved, meanwhile, the basic lacrimal secretion SIT examination, the tear protein examination and the confocal microscope examination are carried out again, the comparison result shows that the inflammatory cell infiltration of the cornea is obviously reduced, the corneal epithelial basal cell atrophy, the tear protein and the SIT are improved, and the product is proved to be effective in treatment.
Dry eye mouse assay: randomly selecting 32 mice with xerophthalmia symptoms, and randomly dividing the mice into A, B, C, D four groups, wherein each group comprises eight mice; wherein group A used the sterile honey gel prepared in example 1, group B used sodium hyaluronate eye drops, group C used a blank control group (without any drug), and group D used the sterile honey gel prepared in example 2; respectively counting SIT (tear secretion test), FL (corneal fluorescence staining), nerve fiber density, fiber branching, curvature score, basal cell count and inflammatory cell count before using the honey gel or sodium hyaluronate eye drops (namely before intervention), and after using the honey gel or sodium hyaluronate eye drops for 1 week (namely 1 week after intervention), 2 weeks (namely 2 weeks after intervention) in the A group, the B group and the D group; correspondingly, the data of the group A, the group B and the group D before intervention, at 1 week and at 2 weeks are counted, the same data of the group C are counted and are respectively marked as the data before experiment, at 1 week and at 2 weeks, and the results are shown in tables 1-4.
The specific method of the tear secretion experiment comprises the following steps: gently inserting the phenol red cotton thread into the conjunctival sac at the inner canthus of the mouse by using a needle holder of the ophthalmology department, and taking off the phenol red cotton thread after 25 seconds to measure the color change length.
The specific method for corneal fluorescence staining comprises the following steps: 0.5 mu L of fluorescein sodium staining solution is dripped into the conjunctival sac of the mouse by using a pipette, the eye is performed manually, 1mL of physiological saline is used for washing the conjunctival sac after 1 minute, and the corneal epithelium fluorescence staining condition is observed and photographed under a living body fluorescence microscope.
Corneal confocal microscope observation: after the mice are anesthetized, eyes are anesthetized and dripped with ocular surface anesthesia, carbomer gel is coated on the ocular surface, the ocular surface is observed under a corneal confocal microscope, and the corneal nerve fiber density, nerve fiber branches, corneal curvature score, corneal epithelial basal cell number and inflammatory cell number of each group of mice are analyzed and counted.
Table 1-A mice in group statistical results using the sterile Honey gel prepared in example 1
Table 2-B statistics of the results of mice in group using sodium hyaluronate eye drops
TABLE 3 statistics of results for mice in the blank control group of group C
Table 4-D mice in group statistical results using the sterile Honey gel prepared in example 2
As can be known from the upper table 1-4, the prepared sterile honey gel can effectively reduce inflammatory cells and basal cells, promote the lacrimal gland secretion function, repair corneal epithelium abrasion and abnormal distribution of nerve fibers and branches, and obviously improve the stability of the tear film, so that the dry eye symptom is relieved, and a certain treatment effect is achieved.
Experiments show that the shelf life of the sterile honey gel prepared in the above example 1 can reach 24 months, and the shelf life of the sterile honey gel prepared in the example 2 can reach 20 months; therefore, the shelf life of the sterile honey gel can be further prolonged after adding benzalkonium bromide.
The SIT values of 8 mice in each of the A, B, C three groups were averaged, and the results are shown in fig. 1; the FL values of 8 mice in each of the A, B, C three groups were averaged, and the results are shown in fig. 2; the nerve fiber density values of 8 mice in each of the A, B, C three groups were averaged, and the results are shown in fig. 3; fiber branching values of 8 mice in each of the A, B, C three groups were averaged, and the results are shown in FIG. 4; the curvature scores of 8 mice in each of the A, B, C three groups were averaged, and the results are shown in FIG. 5; the inflammatory cell counts of 8 mice in each of the A, B, C three groups were averaged, and the results are shown in FIG. 6; the basal cell counts of 8 mice in each of the A, B, C three groups were averaged, and the results are shown in FIG. 7.
As can be seen from the graphs 1-7, on the basis of a blank control group, the existing sodium hyaluronate eye drops for treating xerophthalmia in the market and the sterile honey gel prepared by the method are compared, and through statistical analysis, the sterile honey gel can effectively reduce inflammatory cells and basal cells, promote lacrimal gland secretion function, repair corneal epithelium abrasion and abnormal distribution of nerve fibers and branches, and simultaneously remarkably improve the stability of the tear film.
The invention is not to be considered as limited to the particular embodiments shown and described, but is to be accorded the widest scope consistent with the principles and novel features herein disclosed.
Claims (8)
1. A sterile honey gel, characterized by comprising the following raw materials: honey and water.
2. A sterile honey gel according to claim 1, further comprising benzalkonium bromide.
3. A sterile honey gel according to claim 1 wherein the volume ratio of honey to water is (120-250): 500.
4. A sterile honey gel according to claim 2 wherein the mass to volume ratio of benzalkonium bromide, honey and water is (0.025-0.05) g (125-250) ml:500 ml.
5. A method of preparing a sterile honey gel according to any one of claims 1 to 4, comprising the steps of:
dissolving Mel in water to obtain sterile Mel gel;
or comprises the following steps:
dissolving honey in water to obtain honey solution for use;
the benzalkonium bromide is dissolved in water to obtain a benzalkonium bromide solution for later use;
mixing the Mel solution with benzalkonium bromide solution to obtain sterile Mel gel.
6. A method of preparing a sterile honey gel according to claim 5, further comprising, prior to mixing the honey solution with the benzalkonium bromide solution: putting the honey solution under the pressure of 0.4-0.8 kg/cm2And sterilizing the mixture for 25 to 35min under steam at the temperature of 105 to 115 ℃.
7. A method of preparing a sterile honey gel according to claim 5 wherein the honey is dissolved in water and placed under a pressure of 0.4 to 0.8kg/cm2And sterilizing the mixture for 25 to 35min under steam at the temperature of 105 to 115 ℃ to obtain the sterile honey gel.
8. Use of a sterile honey gel according to any one of claims 1 to 4 in the manufacture of a medicament for the treatment of dry eye.
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