CN109925307A - A kind of isoflavones and sodium hyaluronate pharmaceutical composition and its application - Google Patents
A kind of isoflavones and sodium hyaluronate pharmaceutical composition and its application Download PDFInfo
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- CN109925307A CN109925307A CN201811647597.3A CN201811647597A CN109925307A CN 109925307 A CN109925307 A CN 109925307A CN 201811647597 A CN201811647597 A CN 201811647597A CN 109925307 A CN109925307 A CN 109925307A
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- isoflavones
- sodium hyaluronate
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Abstract
The invention discloses pharmaceutical composition, described pharmaceutical composition contains isoflavones and sodium hyaluronate, and the mass ratio of the isoflavones and sodium hyaluronate is 1:3~500.Pharmaceutical composition of the invention can be further prepared into ophthalmically acceptable product, including ophthalmically acceptable injection, eye drops, gel for eye use, spongarion etc.；The pharmaceutical composition has effects that significantly to inhibit to children's ocular tumor such as retinoblastoma, ocular angiogenesis lesion such as fundus flavimaculatus lesion, the use of sodium hyaluronate can further strong isoflavones therapeutic effect, in the case where guarantee effect effect is constant, the usage amount of isoflavones can be reduced, there is biggish application prospect.
Description
Technical field
The invention belongs to eye-drops preparations technical field fields, more particularly, to a kind of isoflavones and sodium hyaluronate drug
Composition and its application.
Background technique
Isoflavones also known as isoflavones are to be extended in plant phenylalanine metabolic process by cinnamoyl coacetylase side chain
Cyclisation forms the phenolic compound based on benzochromone ring afterwards, and 3- phenyl derivatives are isoflavones, platymiscium secondary generation
Thank to product.Isoflavones can prevent menopausal syndrome, and prevention improves osteoporosis, prevents cardiovascular disease, prevent senilism
Property dull-witted, beauty, anti-aging；The study found that isoflavones is to breast cancer, colon cancer, lung cancer, prostate cancer and cutaneum carcinoma
And leukaemia has an apparent therapeutic effect, isoflavones can also preventing ovarian cancer, colon cancer, gastric cancer and prostate cancer hair
It is raw.
Retinoblastoma (Retinoblastoma, Rb) and maculopathy are eye diseases common at present, at present
Primary treatments for both diseases are physical therapy modalities, somewhat expensive and complicated for operation, medication aspect, whole body
Medication is difficult to accurately act on eyeground, since the microvascular diameter at retina is very thin, and blood circulation system in vivo
The more position of end.Therefore, a kind of eye external application is needed, can be done directly on the active drug of eye to treat retina mother
The medicament of cytoma, fundus flavimaculatus lesion.Simultaneously, it yet there are no and eye drops is made in isoflavones is used to treat view
The report of film blastoma and/or maculopathy.
Soda-lime glass acid sodium (Sodium Hyaluronate) also known as Sodium Hyaluronate, be by N- acetyl glucosamine aldehydic acid repeatedly
A kind of macromolecule polysaccharide body biomaterial alternately formed.Sodium hyaluronate is the main component of knuckle synovia, is cartilage matrix
One of ingredient.Lubricating action is played in articular cavity, can cover and protect articular cartilage, improves the contracture of joint, and cartilage is inhibited to become
Property surface variations, improve pathologic joint fluid, increase and drip sliding function.There is sodium hyaluronate significant hydrophilic ability and lubrication to make
With therefore, can obviously relieve the pain of ophthalmoxerosis, itch, burn feeling, the clinical symptoms such as foreign body sensation, hence it is evident that extend tear film rupture
Time.Currently, being had not been reported about the pharmaceutical composition that isoflavones is used with sodium hyaluronate collocation.
Summary of the invention
The technical problem to be solved by the present invention is to be directed to the defect and deficiency of technology, a kind of isoflavones and sodium hyaluronate are provided
Pharmaceutical composition, the pharmaceutical composition is to children's ocular tumor such as retinoblastoma, ocular angiogenesis lesion such as eyeground
Maculopathy has effects that significantly to inhibit, the use of sodium hyaluronate can further strong isoflavones therapeutic effect, protecting
In the case that card function and effect are constant, the usage amount of isoflavones is reduced, there is biggish application prospect.
The first purpose of the invention is to provide a kind of isoflavones and sodium hyaluronate pharmaceutical composition.
A second object of the present invention is to provide the applications of the isoflavones and sodium hyaluronate pharmaceutical composition.
Third object of the present invention is to provide the eye-drops preparations comprising the isoflavones Yu sodium hyaluronate pharmaceutical composition.
Above-mentioned purpose of the invention is to give realization by the following technical programs:
A kind of isoflavones and sodium hyaluronate pharmaceutical composition, contain isoflavones and sodium hyaluronate.
Present invention discover that sodium hyaluronate acts not only as a kind of thickener, isoflavones is improved in the effect of eye
Between, intraocular bioavilability is improved, to improve drug effect；Still further aspect, certain density sodium hyaluronate itself can also mention
Therapeutic effect of the high isoflavones to retinoblastoma and fundus flavimaculatus lesion.
Preferably, the mass ratio of the isoflavones and sodium hyaluronate is 1:3~500.
Preferably, the mass ratio of the isoflavones and sodium hyaluronate is 1:20~200.
It is highly preferred that the mass ratio of the isoflavones and sodium hyaluronate is 1:50~100.
The present invention is also claimed any of the above-described described pharmaceutical composition and is preparing the application in ophthalmically acceptable product.
Preferably, the ophthalmically acceptable product is appointing in ophthalmically acceptable injection, eye drops, gel for eye use, spongarion or pharmacy
A kind of what other dosage form suitable for eye local topical.
The present invention also provides a kind of ophthalmically acceptable product, the ophthalmically acceptable product contains isoflavones 0.001%~0.015%
(w/v) and sodium hyaluronate 0.05%~0.5% (w/v).
Preferably, the isoflavone content be 0.005%~0.010%, sodium hyaluronate content be 0.1%~
0.3%.
Preferably, when dosage form is ophthalmically acceptable injection or eye drops, auxiliary material includes, antibacterial agent, osmotic pressure regulator, pH tune
Save agent and water for injection；PH adjusting agent is any one or more of sodium hydroxide, hydrochloric acid, boric acid, borax, is adjusted using pH
The pH value that agent adjusts finished product medicament is 5.0~7.0；Osmotic pressure regulator be sodium chloride, potassium chloride, glucose, boric acid, borax,
One of glycerol, mannitol are a variety of, adjust the infiltration of finished product medicament using osmotic pressure regulator and are depressed into 280~330mOsm/L.
Preferably, when dosage form is ophthalmically acceptable injection or eye drops, auxiliary material further includes cosolvent, and content is 0.1~1%
(w/v)。
Preferably, the content of the antibacterial agent is 0.001%~0.1% (w/v).
It is highly preferred that the antibacterial agent is from ethyl hydroxy benzoate, methyl hydroxybenzoate, Nipasol, phenylmercuric acetate, the tertiary fourth of trichlorine
One of alcohol, thimerosal, benzalkonium chloride and benzalkonium bromide are a variety of.
Preferably, when dosage form is gel for eye use, auxiliary material includes ophthalmic gel base, and the ophthalmic gel base is selected from card
At least one of wave nurse, hydroxypropyl cellulose, xanthan gum, preferably carbomer.Its dosage is 1%~10%.
It is highly preferred that also containing osmotic pressure regulator, pH adjusting agent, antibacterial and agent and water for injection；The pH adjusting agent
For any one or more of sodium hydroxide, hydrochloric acid, boric acid, borax, it is using the pH value that pH adjusting agent adjusts finished product medicament
5.0~7.0；The osmotic pressure regulator is one of sodium chloride, potassium chloride, glucose, boric acid, borax, glycerol, mannitol
Or it is a variety of, the infiltration of finished product medicament, which is adjusted, using osmotic pressure regulator is depressed into 280~330mOsm/L；The antibacterial agent is from oxybenzene
One of ethyl ester, methyl hydroxybenzoate, Nipasol, phenylmercuric acetate, anesin, thimerosal, benzalkonium chloride and benzalkonium bromide
Or it is a variety of, content is 0.001%~0.1% (w/v).
Preferably, when dosage form is spongarion, auxiliary material includes lanolin, yellow petroleum jelly, atoleine, antibacterial agent etc..
Meanwhile aforementioned pharmaceutical compositions are in preparation treatment children's ocular tumor and/or ocular angiogenesis lesion drug
Application, ophthalmically acceptable product preparation treatment children's ocular tumor and/or ocular angiogenesis lesion drug in application also this
In invention protection scope.
Preferably, children's ocular tumor is retinoblastoma.Specifically, the retinoblastoma is behaved
Retinoblastoma Cells system RB44 or Y79 cell.
Preferably, the ocular angiogenesis lesion is fundus flavimaculatus disease.
Compared with prior art, the invention has the following advantages:
The present invention provides the pharmaceutical compositions of a kind of isoflavones and sodium hyaluronate.Described pharmaceutical composition can be into one
Step is prepared into ophthalmically acceptable product, including ophthalmically acceptable injection, eye drops, gel for eye use, spongarion etc.；The pharmaceutical composition is to children with ocular
Tumour such as retinoblastoma, ocular angiogenesis lesion such as fundus flavimaculatus lesion in portion's has effects that significantly to inhibit, glass
The use of sour sodium can further strong isoflavones guarantee the therapeutic effect of retinoblastoma and fundus flavimaculatus lesion
In the case that function and effect are constant, the usage amount of isoflavones can be reduced, there is biggish application prospect.
Specific embodiment
Further illustrate the present invention below in conjunction with specific embodiment, but embodiment the present invention is not done it is any type of
It limits.Unless stated otherwise, the present invention uses reagent, method and apparatus is the art conventional reagents, method and apparatus.
Unless stated otherwise, following embodiment agents useful for same and material are commercially available.
The body outer suppressioning test of 1 isoflavones of embodiment and sodium hyaluronate to retinoblastoma
1, test method
Logarithmic growth phase human retinoblastoma cell line RB44 and Y79 cell respectively, is diluted to 1 × 107/ mL's
Cell suspension is inoculated in 96 orifice plates with every 200 μ L of hole；Following tests group: (1) 40 μ g/mL isoflavones is set；(2)40μg/
ML isoflavones+4mg/mL sodium hyaluronate；(3) 40 μ g/mL isoflavones+4mg/mL carbomers；(4) 40 μ g/mL soybean
Isoflavones+methylcellulose；(5) 4mg/mL sodium hyaluronate；(6) 4mg/mL carbomer；(7) 40 μ g/mL isoflavones+methyl
Cellulose；The carbomer, methylcellulose are common thickener；(8) 80 μ g/mL isoflavones；In addition (9) are set
Control group, is not dosing, and each concentration sets 5 parallel holes, above-mentioned test group is included in corresponding orifice plate, sets in 37 DEG C and cultivate
MTT 20 μ L, the 37 DEG C of incubation 4h that concentration is 5mg/mL are added in 12h, for 24 hours, 36h, 48h, every hole, discard culture solution, and 150 μ are added
L DMSO, slight oscillatory are dissolving crystallized.It is returned to zero with culture medium plus DMSO, surveys absorbance (A) value at 450nm with microplate reader, press
Following formula calculates inhibitory rate of cell growth: inhibitory rate of cell growth (%)=(1- test group absorbance/control group absorbance)
× 100%, 3 repetitions are averaged analysis.
2, result
(1) inhibitory rate of cell growth result such as table 1 of the isoflavones+sodium hyaluronate to Retinoblastoma Cells system RB44
It is shown, it is seen then that under the same terms, isoflavones+sodium hyaluronate combination has Retinoblastoma Cells system RB44 better
Inhibitory effect.
Influence of 1 isoflavones of the table+sodium hyaluronate to Retinoblastoma Cells system RB44 hyperplasia
(2) inhibitory rate of cell growth result such as table 2 of the isoflavones+sodium hyaluronate to Retinoblastoma Cells system Y79
It is shown, it is seen then that under the same terms, isoflavones+sodium hyaluronate combination has preferably suppression to Retinoblastoma Cells system Y79
Effect processed.
Influence of 2 isoflavones of the table+sodium hyaluronate to Retinoblastoma Cells system Y79 hyperplasia
Work as sodium hyaluronate, carbomer, methylcellulose independent role retinoblastoma it can be seen from the above results
When cell, inhibiting effect is not present, illustrates sodium hyaluronate, carbomer, methylcellulose itself to Retinoblastoma Cells
Object unrestraint effect, mainly improves the inhibiting rate to tumour cell by increasing the drug effect of isoflavones, wherein especially
It is that sodium hyaluronate synergy is most obvious, guess may be because sodium hyaluronate is in the also other effects except thickener that can be used as
Approach improves the bioavilability of isoflavones drug.40 μ g/mL isoflavones+4mg/mL sodium hyaluronate test groups exist
Suitable with 80 μ g/mL isoflavones to the inhibiting rate of retinoblastoma when 48h, this is also indicated that, can be led to a certain degree
Isoflavones+sodium hyaluronate combination is crossed to reduce the usage amount of isoflavones.
Embodiment 2~4
Isoflavones+sodium hyaluronate eye drops of different component content are prepared, as shown in table 3:
3 embodiment of table, 2~4 eye drip formula of liquid
By technical solution of the present invention, prepares the available auxiliary material kind of isoflavones eye drops and is not limited to kind listed by table,
There can also be following multiple choices:
The antibacterial agent be from ethyl hydroxy benzoate, methyl hydroxybenzoate, Nipasol, phenylmercuric acetate, anesin, thimerosal,
One of benzalkonium chloride and benzalkonium bromide are a variety of.
It the use of the osmotic pressure molar density that osmotic pressure regulator adjusts finished product eye drops is 280~330mOsmol/kg；It seeps
Pressure regulator is one of sodium chloride, potassium chloride, glucose, boric acid, borax, glycerol, mannitol or a variety of thoroughly.
It the use of the pH value that pH adjusting agent adjusts finished product eye drops is 5.0~7.0；The pH adjusting agent is disodium hydrogen phosphate-
Phosphate sodium dihydrogen buffer solution, potassium dihydrogen phosphate-dipotassium hydrogen phosphate buffer, boric acid-borate buffer solution, sodium hydroxide, bicarbonate
One of sodium, citric acid, sodium citrate and acetic acid are a variety of.
Preparation method is to take appropriate water for injection that cosolvent is added, and is redissolved isoflavones and sodium hyaluronate obtains liquid
A；Then other eye drops auxiliary materials are dissolved with appropriate water for injection again, obtains solution B；Then solution A and solution B are mixed, is added
Enter remaining injection water, using osmotic pressure regulator adjust finished product eye drops osmotic pressure molar density be 260~
340mOsmol/kg；Using pH adjusting agent adjust finished product eye drops pH value be 5.0~7.0, filtering, packing to get.System used
Standby utensil and packing container must sterilize.
Embodiment 5~7
The ophthalmically acceptable gel of isoflavones+sodium hyaluronate of different component content is prepared, as shown in table 4:
4 embodiment of table, 5~7 gel for eye use formula
The antibacterial agent, osmotic pressure regulator, pH adjusting agent, gel-type vehicle formula be not limited to the above embodiments；
The antibacterial agent be from ethyl hydroxy benzoate, methyl hydroxybenzoate, Nipasol, phenylmercuric acetate, anesin, thimerosal,
One of benzalkonium chloride and benzalkonium bromide are a variety of.
It the use of the osmotic pressure molar density that osmotic pressure regulator adjusts finished product eye drops is 280~330mOsmol/kg；It seeps
Pressure regulator is one of sodium chloride, potassium chloride, glucose, boric acid, borax, glycerol, mannitol or a variety of thoroughly.
It the use of the pH value that pH adjusting agent adjusts finished product eye drops is 5.0~7.0；The pH adjusting agent is disodium hydrogen phosphate-
Phosphate sodium dihydrogen buffer solution, potassium dihydrogen phosphate-dipotassium hydrogen phosphate buffer, boric acid-borate buffer solution, sodium hydroxide, bicarbonate
One of sodium, citric acid, sodium citrate and acetic acid are a variety of.
The preparation method of the isoflavones gel for eye use is to take appropriate water for injection that gel-type vehicle is added, and it is different to be redissolved soybean
Flavones and sodium hyaluronate obtain liquid A；Then other eye drops auxiliary materials are dissolved with appropriate water for injection again, obtains solution B；Then
Solution A and solution B are mixed, remaining injection water is added, the osmol of finished product eye drops is adjusted using osmotic pressure regulator
Your concentration is 260~340mOsmol/kg；The use of the pH value that pH adjusting agent adjusts finished product eye drops is 5.0~7.0, filters, point
Dress to get.The utensil and packing container used of preparing must sterilize.
Embodiment 8~10
Isoflavones+sodium hyaluronate spongarion of different component content is prepared, as shown in table 5:
5 embodiment of table, 8~10 gel for eye use formula
The antibacterial agent be from ethyl hydroxy benzoate, methyl hydroxybenzoate, Nipasol, phenylmercuric acetate, anesin, thimerosal,
One of benzalkonium chloride and benzalkonium bromide are a variety of.
The preparation method of the isoflavones spongarion: taking in isoflavones and sodium hyaluronate and sterile mortar, is added few
Amount sterilizing liquid paraffin, after being fully ground；It will；It is added and is made by lanolin, remaining liq paraffin, yellow petroleum jelly mixing by several times
Spongarion matrix, with add with grind well to get.
Comparative example 1
A kind of isoflavones eye drops, formula is substantially the same manner as Example 3, the difference is that, do not contain sodium hyaluronate.System
Preparation Method is identical with embodiment 3.
Comparative example 2
A kind of isoflavones eye drops, formula is substantially the same manner as Example 3, the difference is that, sodium hyaluronate is substituted for
Carbomer；Preparation method is identical with embodiment 3.
Comparative example 3
A kind of isoflavones eye drops, formula is substantially the same manner as Example 3, the difference is that, sodium hyaluronate is substituted for
Methylcellulose；Preparation method is identical with embodiment 3.
Growth inhibition test of 1 isoflavones of the test case+sodium hyaluronate eye drops to retinoblastoma
0.005%, 0.008%, 0.01% isoflavones being prepared using the embodiment of the present invention 2~4, comparative example 1~3
Eye drops does the pharmacodynamic study test of ophthalmic applications, while doing negative control with 0.9% sodium chloride injection；
RB mouse 96 are taken, is randomly divided into 8 groups, every group 12, respectively normal group, model control group, embodiment 2~4
Group, 1~3 group of comparative example；Model control group, embodiment group and comparative example group modeling: RB44 cell is only injected with 4 μ L/ respectively
Eye vitreous to mouse is intracavitary, concentration 1 × 107/mL；After modeling success, normal group and 0.9% chlorination of model control group
Sodium injection, three times a day, 2 drip every time；Three times a day, 2 drip each ophthalmically acceptable eye drops eye drip of Examples 1 to 3 every time.
Mouse is normally raised, and mice tumors grew situation is observed after 10 days, 20 days, 30 days, 60 days.And by outer
Tumour is won in section's operation, and the calculating of gross tumor volume: the diameter of the second largest tumour of diameter 2x of maximum tumour is carried out according to formula
X0.5, in triplicate, the results are shown in Table 6:
The gross tumor volume of 6 retinoblastoma RB44 cell of table compares
Meanwhile Y79 cell is selected, take above-mentioned identical method to carry out isoflavones eye drops to retinoblastoma
Growth inhibition test, the results are shown in Table 7:
The gross tumor volume of 7 retinoblastoma Y79 cell of table compares
The above result shows that isoflavones+sodium hyaluronate eye drops prepared by the present invention are to human retinoblastoma RB44
Cell and Y79 cell have significant growth inhibition effect, compared to the isoflavones drop without using sodium hyaluronate or other thickeners
Ocular fluid has better retinoblastoma growth inhibitory effect.
2 isoflavones of test case+sodium hyaluronate eye drops form the inhibiting effect of (CNV) to choroidal neovascular
0.005%, 0.008%, 0.01% isoflavones being prepared using the embodiment of the present invention 2~4, comparative example 1~3
Eye drops does the pharmacodynamic study test of ophthalmic applications, while doing negative control with 0.9% sodium chloride injection；With new vessels
The western general ophthalmically acceptable injection of typical therapeutic agent-Compaq of prevention or the treatment of related all kinds of eye illnesses is positive control.
The coloured rabbit of health is chosen, male and female are unlimited, weight 2~3kg, 40, it is randomly divided into 8 groups, every group 5, respectively
Normal group, model control group, 2~4 groups of embodiment, 1~3 group of comparative example；Model control group, embodiment group and comparative example group are made
Mould: with the argon green laser (50 μm of spot diameter, power 0.7W, time 0.1s) of wavelength 514.5nm, in 2~3 away from optic disk optic disks
20 points are intensively irradiated at retina above and below the white side medullary ray of diameter.After modeling success, normal group and model control group are with 0.9%
Sodium chloride injection, three times a day, 2 drip every time；Three times a day, 2 drip each ophthalmically acceptable eye drops eye drip of Examples 1 to 3 every time.It is positive right
According to group, injection 0.05mL, i.e. 0.5mg Compaq are western general daily；Mouse modeling success after the 7th day, 14 days, 21 days it is glimmering with blood vessel
The case where light radiography (FFA) and optical coherence tomography method (OCT) measurement choroidal artery.FFA result combination OCT method result
T inspection is carried out after quantization to compare.The results are shown in Table 7 for it:
Choroidal neovascular forms area and compares after the processing of 7 flavones eye drops of table
The above result shows that isoflavones+sodium hyaluronate eye drops prepared by the present invention have choroidal neovascular formation
Significant growth inhibition effect is new to choroid compared to the isoflavones eye drops without using sodium hyaluronate or other thickeners
Vascularization has better growth inhibitory effect.
It will be apparent to those skilled in the art that can make various other according to the above description of the technical scheme and ideas
Corresponding change and deformation, and all these changes and deformation all should belong to the protection scope of the claims in the present invention
Within.
Claims (10)
1. a kind of isoflavones and sodium hyaluronate pharmaceutical composition, which is characterized in that contain isoflavones and sodium hyaluronate.
2. pharmaceutical composition described in claim 1, which is characterized in that the mass ratio of the isoflavones and sodium hyaluronate
For 1:3~500.
3. pharmaceutical composition of any of claims 1 or 2 is preparing the application in ophthalmically acceptable product.
4. application according to claim 3, which is characterized in that the ophthalmically acceptable product is ophthalmically acceptable injection, eye drops, ophthalmically acceptable
Any one in gel, spongarion or pharmacy is suitable for other dosage forms of eye local topical.
5. a kind of ophthalmically acceptable product, which is characterized in that contain 0.001%~0.015%(w/v of isoflavones) and sodium hyaluronate
0.05%~0.5%(w/v).
6. ophthalmically acceptable product according to claim 5, which is characterized in that when dosage form is eye drops or gel for eye use, auxiliary material
Including bacteriostatic agent, osmotic pressure regulator, pH adjusting agent and water for injection.
7. pharmaceutical composition of any of claims 1 or 2 is in preparation treatment children's ocular tumor and/or ocular angiogenesis lesion
Application in drug.
8. ophthalmically acceptable product described in claim 5 or 6 is in preparation treatment children's ocular tumor and/or ocular angiogenesis lesion medicine
Application in object.
9. application according to claim 7 or 8, which is characterized in that children's ocular tumor is retinoblastoma.
10. application according to claim 7 or 8, which is characterized in that the ocular angiogenesis lesion is fundus flavimaculatus
Disease.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN112546044A (en) * | 2020-12-23 | 2021-03-26 | 广东宏盈科技有限公司 | Tilofenac and isoflavone pharmaceutical composition and application thereof |
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| CN112546044A (en) * | 2020-12-23 | 2021-03-26 | 广东宏盈科技有限公司 | Tilofenac and isoflavone pharmaceutical composition and application thereof |
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