CN105687236A - Medical artificial inner ear perilymph fluid, preparation method and application thereof - Google Patents
Medical artificial inner ear perilymph fluid, preparation method and application thereof Download PDFInfo
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- CN105687236A CN105687236A CN201610143431.2A CN201610143431A CN105687236A CN 105687236 A CN105687236 A CN 105687236A CN 201610143431 A CN201610143431 A CN 201610143431A CN 105687236 A CN105687236 A CN 105687236A
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- perilympha
- internal ear
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- 210000003027 ear inner Anatomy 0.000 title claims abstract description 86
- 238000002360 preparation method Methods 0.000 title claims abstract description 15
- 210000004049 perilymph Anatomy 0.000 title abstract description 18
- 239000012530 fluid Substances 0.000 title abstract description 7
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 29
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims abstract description 24
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims abstract description 24
- 239000008227 sterile water for injection Substances 0.000 claims abstract description 17
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 13
- 239000008103 glucose Substances 0.000 claims abstract description 13
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims abstract description 12
- 239000001110 calcium chloride Substances 0.000 claims abstract description 12
- 229910001628 calcium chloride Inorganic materials 0.000 claims abstract description 12
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims abstract description 12
- 229910001629 magnesium chloride Inorganic materials 0.000 claims abstract description 12
- 239000001103 potassium chloride Substances 0.000 claims abstract description 12
- 235000011164 potassium chloride Nutrition 0.000 claims abstract description 12
- 239000011780 sodium chloride Substances 0.000 claims abstract description 12
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims abstract description 4
- 239000007788 liquid Substances 0.000 claims description 31
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 16
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- 230000001954 sterilising effect Effects 0.000 claims description 10
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- 238000009472 formulation Methods 0.000 claims description 7
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- 238000001802 infusion Methods 0.000 claims description 4
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- 241000283984 Rodentia Species 0.000 description 1
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- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
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- ALEXXDVDDISNDU-JZYPGELDSA-N cortisol 21-acetate Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)COC(=O)C)(O)[C@@]1(C)C[C@@H]2O ALEXXDVDDISNDU-JZYPGELDSA-N 0.000 description 1
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- 229910001410 inorganic ion Inorganic materials 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/42—Phosphorus; Compounds thereof
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/08—Solutions
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a medical artificial inner ear perilymph fluid, which comprises the following components in part by weight: 130-140 mmol/L of sodium chloride, 4-5 mmol/L of potassium chloride, 1-3 mmol/L of calcium chloride, 0.5-1.5 mmol/L of magnesium chloride, 8-15 mmol/L of sodium bicarbonate, 0.5-1.5 mmol/L of disodium hydrogen phosphate, 60-75 mg/dL of glucose and the balance of sterile water for injection. The invention also discloses a preparation method and application of the medical artificial inner ear perilymph fluid. The medical artificial inner ear perilymph fluid has simple and reasonable components and safe use, and can be produced in batches; the medical artificial inner ear perilymph fluid can be used for washing operative cavities of middle and inner ear operations, can be used as a solvent or diluent for transround window injection treatment, and can also be used for perilymph cavity perfusion and perilymph fluid replacement.
Description
Technical field
The invention belongs to medicine and hygiene fields, particularly relate to medical artificial internal ear perilympha, its preparation method and application。
Background technology
Internal ear perilympha is colourless transparent liquid, is filled between internal ear bony labyrinth and membranous labyrinth, and maintenance audition and static sense is most important: the fluid wave vibration of inside and outside lymph fluid, stimulates the hair cell of basement membrane to produce electrical activity, thus producing audition。Membranous labyrinth is played protective effect by perilympha, also participates in the metabolic process of inner ear tissue cell, to the nutritious effect of spiral organ of Corti。
It is now recognized that perilympha has three kinds of sources: 1, derive from cerebrospinal fluid, because observing anatomical structure, perilymph chamber borrows aquaeductus cochleae to communicate with subarachnoid space, and the similar cerebrospinal fluid of composition；2, deriving from the ultrafiltrate of blood, because observing from histology, the connective tissue in perilymph chamber contains abundant capillary network, and perilymph is probably derived from this；3, dual origin, it is believed that perilymph generates and produced by capillary blood ultrafiltrate in perilymph chamber, and around the blood vessel in gap, modiolus, gap is supplemented from cerebrospinal fluid around aqueduct of cochlea, acoustic nerve。To be perilympha the be result that two kinds of liquid slowly exchanges comparatively accepted, so that having eventually formed perilymphatic intrinsic physicochemical property, the generation of internal ear perilympha and absorb and keep dynamic equilibrium。
The internal ear perilympha of normal adult is about 75-85 μ L, and osmotic pressure is about 285-320mOsm/kg, and pH value is about 7.2-7.4, and containing inorganic ions, glucose, protein, a small amount of cholesterol and trace element, cell is little, is mainly mononuclear cell and lymphocyte。The dynamic equilibrium of perilympha is by the impact of many factors, and research finds the change that all there is perilympha composition and physicochemical property in the disease of inner ear such as noise deaf, acoustic neuroma, hydrolabyrinth, Meniere, drug induced deafness。Visible, the dynamic equilibrium of internal ear perilympha is one of essential condition playing internal ear physiological function。
In, operation on the inner ear be otorhinolaryngologic common surgical。During Irrigation is, the important step of operation on the inner ear, it can wash away the bone meal under electric drill mill on the one hand, ensure that patient obtains the visual field clearly, residual lesions can be removed on the one hand, extensive use normal saline is as Irrigation agent clinically, and the ion component of normal saline, concentration, osmotic pressure, pH value is widely different with perilympha, in the operation on the middle ear of operation on the inner ear and merging perilymphatic fistula, as merged the otitis media of lateral semicircular canal fistula, stapes surgery, artificial cochlear implant etc., opening due to internal ear, normal saline can affect stablizing of perilympha unavoidably as Irrigation agent, improve postoperative auditory function, the risk of vestibular function damage。It is therefore believed that medical artificial internal ear perilympha as in, the Irrigation agent of operation on the inner ear safer compared with normal saline。
In recent years, the exploration of internal ear injection for curing is got more and more by otology, and this method can make medicine stride across blood labyrinth barrier, is directly entered internal ear, improves local drug concentration, reduces therapeutic dose, alleviates the impact on systemic organs。Based on the anatomic characteristic of oeil de boeuf, become internal ear injection for curing path the most easily through oeil de boeuf injection。In medical research field, through oeil de boeuf drug administration by injection, through oeil de boeuf gene injection, through the treatment phonosensitive nerve deafness such as oeil de boeuf stem cell implantation be current study hotspot。And part Therapeutic Method has been applied to clinic, as injected hormone to protect the residual hearing of patient through oeil de boeuf to internal ear in stapes surgery, artificial cochlea's operation。In these local treatments, medical artificial internal ear perilympha can carry effective ingredient as a kind of comparatively safe solvent or diluent and arrive internal ear, reduces the direct injection interference to internal ear perilympha dynamic equilibrium。Additionally, medical artificial perilymph also can be directly used in the perfusion in perilymph chamber and the displacement of perilympha as a kind of physiological fluid。
Summary of the invention
It is an object of the invention to provide a kind of medical artificial internal ear perilympha, the medical artificial internal ear perilympha composition advantages of simple of the present invention, safe and convenient to use。
The technical solution used in the present invention is: a kind of medical artificial internal ear perilympha, the formula of described medical artificial internal ear perilympha is: sodium chloride 130～140mmol/L, potassium chloride 4～5mmol/L, calcium chloride 1～3mmol/L, magnesium chloride 0.5～1.5mmol/L, sodium bicarbonate 8～15mmol/L, disodium hydrogen phosphate 0.5～1.5mmol/L, glucose 60～75mg/dL, remaining for sterilized water for injection。
As the further improvement to technique scheme, the formula of described artificial internal ear perilympha is: sodium chloride 135mmol/L, potassium chloride 4.5mmol/L, calcium chloride 2mmol/L, magnesium chloride 1mmol/L, sodium bicarbonate 12mmol/L, disodium hydrogen phosphate 1mmol/L, glucose 68mg/dL, remaining for sterilized water for injection。The result of use of the artificial internal ear perilympha of this formula is more preferably。
The preparation method that present invention also offers described medical artificial internal ear perilympha, comprises the following steps:
1) by sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium bicarbonate, glucose and disodium hydrogen phosphate and sterilized water for injection mixed dissolution, concentrated wiring liquid is obtained；
2) filtration step 1) concentrated wiring liquid that obtains, filtrate adds sterilized water for injection constant volume, obtains constant volume liquid；
3) to step 2) the constant volume liquid that obtains passes into O2And CO2Mixing gas to saturated, regulating constant volume liquid PH is 7.2-7.4, and sterilizing obtains described artificial internal ear perilympha。
As the further improvement to technique scheme, described step 2) particularly as follows: by step 1) concentrated wiring liquid that obtains is after needle-use activated carbon filters, then through 0.45 μm and 0.22 μm of microporous membrane filtration, filtrate adds sterilized water for injection constant volume, obtains constant volume liquid。
What mix gas passes into the oxygen content that can improve perilympha, improves ear cells anaerobic condition, reduces the permeability of internal ear capillary endothelium, and minimizing is oozed out。As the further improvement to technique scheme, described step 3) in mixing gas contain the O that concentration of volume percent is 90%～95%2And concentration of volume percent is the CO of 5%～10%2。
As the further improvement to technique scheme, described step 3) implemented by following steps:
31) to step 2) to pass into containing concentration of volume percent in the constant volume liquid that obtains be the O of 95%2And 5%CO2Mixing gas to saturated, regulating constant volume liquid PH is after 7.2-7.4, adds fill operation by constant volume liquid embedding in infusion bottle or transfusion bag；
32) embedding liquid sterilizing, packs warehouse-in after the assay was approved, obtains medical artificial internal ear perilympha。
As the further improvement to technique scheme, described step 3) in, sterilizing refers to sterilizing 15min at 121 DEG C。
Present invention also offers the application in compound formulation of the described medical artificial internal ear perilympha。
Present invention also offers a kind of compound formulation, comprise described medical artificial internal ear perilympha。
As the further improvement to technique scheme, described compound formulation also comprises at least one in following components: aminoacid, albumin, antioxidant, PH regulator。
Relative to prior art, the invention have the benefit that
The medical artificial internal ear perilympha composition advantages of simple of the present invention, use safety, can manufacture；During the medical artificial internal ear perilympha of the present invention can be used for, the Irrigation of operation on the inner ear, be used as the solvent through oeil de boeuf injection for curing or diluent, it may also be used for the perfusion of perilymph chamber and perilympha displacement；
The medical artificial internal ear perilymph stock solution of the present invention stores, easy to use, only need to be placed in the place of cool place, dry, lucifuge during storage；Can using after the environment preheating of 37 DEG C during use, preheating time was less than 2 hours；
The preparation method of the medical artificial internal ear perilympha of the present invention only needs dissolving, filtration, fill and sterilizing, simple to operate, convenient, time saving and energy saving, it is not necessary to special installation, can be mass。
Accompanying drawing explanation
Fig. 1 is the use state diagram of artificial internal ear perilympha in application examples 1。
Detailed description of the invention
For better illustrating the object, technical solutions and advantages of the present invention, below in conjunction with specific embodiment, the invention will be further described。
Embodiment 1
A kind of artificial internal ear perilympha, the formula of described artificial internal ear perilympha is: sodium chloride 135mmol/L, potassium chloride 4.5mmol/L, calcium chloride 2mmol/L, magnesium chloride 1mmol/L, sodium bicarbonate 12mmol/L, disodium hydrogen phosphate 1mmol/L, glucose 68mg/dL, remaining for sterilized water for injection。
The preparation method of the medical artificial internal ear perilympha in the present embodiment, comprises the following steps:
1) in sterilized water for injection, add sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium bicarbonate, glucose and disodium hydrogen phosphate, stirring and dissolving, obtain concentrated wiring liquid；
2) by step 1) concentrated wiring liquid that obtains is after needle-use activated carbon filters, and then through 0.45 μm and 0.22 μm of microporous membrane filtration, filtrate adds sterilized water for injection constant volume, obtains constant volume liquid；
3) to step 2) the constant volume liquid that obtains passes into containing 95% (v/v) O2, 5% (v/v) CO2Mixing gas to saturated, regulating constant volume liquid PH is after 7.2-7.4, adds fill operation by constant volume liquid embedding in infusion bottle or transfusion bag；
Embedding liquid is sterilizing 15min at 121 DEG C, packs warehouse-in after the assay was approved, obtains medical artificial internal ear perilympha。
Embodiment 2
A kind of artificial internal ear perilympha, the formula of described artificial internal ear perilympha is: sodium chloride 130mmol/L, potassium chloride 5mmol/L, calcium chloride 1.5mmol/L, magnesium chloride 1.5mmol/L, sodium bicarbonate 8mmol/L, disodium hydrogen phosphate 1.5mmol/L, glucose 60mg/dL, remaining for sterilized water for injection。
The preparation method of the medical artificial internal ear perilympha in the present embodiment is with embodiment 1。
Embodiment 3
A kind of artificial internal ear perilympha, the formula of described artificial internal ear perilympha is: sodium chloride 140mmol/L, potassium chloride 4mmol/L, calcium chloride 1mmol/L, magnesium chloride 1.2mmol/L, sodium bicarbonate 15mmol/L, disodium hydrogen phosphate 0.5mmol/L, glucose 75mg/dL, remaining for sterilized water for injection。
The preparation method of the medical artificial internal ear perilympha in the present embodiment is with embodiment 1。
Embodiment 4
A kind of artificial internal ear perilympha, the formula of described artificial internal ear perilympha is: sodium chloride 132mmol/L, potassium chloride 4.2mmol/L, calcium chloride 3mmol/L, magnesium chloride 0.5mmol/L, sodium bicarbonate 10mmol/L, disodium hydrogen phosphate 1.2mmol/L, glucose 65mg/dL, remaining for sterilized water for injection。
The preparation method of the medical artificial internal ear perilympha in the present embodiment is with embodiment 1。
Application examples 1
The Irrigation of chronic suppurative otitis media concurrent lateral semicircular canal fistula: the medical artificial internal ear perilympha of the present invention is connect disposable infusion set and is hung on drip stand, intravenous needle and flow regulator are placed in art district, in mastoid process, in tympanic antrum and the open process of tympanum, needs according to patient control to rinse droplet speed and a flush position, while rinsing, suction pipe is absorbed and is rinsed thing, granulation around thoroughly removing, the pathological changes afterflush art chambeies such as cholesteatoma substrate, finally process the pathological changes on lateral semicircular canal fistula surface, the Temporal fascia dried in advance is cut into the lamellar more than fistula mouth according to fistula mouth size, carefully cover fistula discharge surface, external receive suction cover。More conventional normal saline flushing effectiveness comparison, the application of medical artificial internal ear perilymph Irrigation is convenient, and the impact of vestibular function is little。The use state diagram of artificial internal ear perilympha is as shown in Figure 1。
Application examples 2
Perilymph chamber perfusion in rupture of round window membrane kposthesis: the medical artificial internal ear perilympha taking the present invention is placed in the environment of 37 DEG C and preheats 30min, expose the oeil de boeuf broken through mastoid process-face crypts pathway under microscope, as round window membrane is excessively deep, REN is opened fully to expose round window membrane with 1mm electric drill mill, film fistula mouth can be expanded if desired with sharp knife, the 50 medical artificial internal ear perilymphas of μ L are extracted with microsyringe, with the speed of 5 μ L/s, artificial internal ear perilympha is injected tympanic canal, see and have perilympha stop perfusion after flowing out and absorb the perilympha overflowed with suction pipe, last stringing film, external method repairs round window membrane, external is received suction and is fixed。Artificial internal ear perilympha can well maintain the normal level of endocochlear potential, is conducive to basement membrane and the recovery of hair cell function。
Application examples 3
Experimentation through round window membrane gene injection: the plasmid that 10 μ L contain target gene adds in the medical artificial internal ear perilympha of the 90 μ L present invention, gently after mixing, room temperature stands 20min, anaesthetize after successfully, otic capsule is opened through otic capsule ventral approach, rongeur chisels about 1cm aperture in otic capsule sclerotin weak spot place, under operating microscope, electricity consumption is drilled in all nearly oeil de boeuf places brill at the bottom of cochlea and opens 1mm aperture, 10 μ L injection are extracted with microsyringe, it is slowly injected in cochlea tympanic canal, gelfoam filling oeil de boeuf, sews up the incision。Effectively avoiding blood labyrinth barrier through round window membrane gene injection, success rate is high, internal ear gene therapy is studied further and lays a good foundation。
Finally be should be noted that; above example is only in order to illustrate technical scheme but not limiting the scope of the invention; although the present invention being explained in detail with reference to preferred embodiment; it will be understood by those within the art that; technical scheme can be modified or equivalent replacement, without deviating from the spirit and scope of technical solution of the present invention。
Claims (10)
1. a medical artificial internal ear perilympha, it is characterized in that: the formula of described medical artificial internal ear perilympha is: sodium chloride 130～140mmol/L, potassium chloride 4～5mmol/L, calcium chloride 1～3mmol/L, magnesium chloride 0.5～1.5mmol/L, sodium bicarbonate 8～15mmol/L, disodium hydrogen phosphate 0.5～1.5mmol/L, glucose 60～75mg/dL, remaining for sterilized water for injection。
2. medical artificial internal ear perilympha according to claim 1, it is characterized in that: the formula of described medical artificial internal ear perilympha is: sodium chloride 135mmol/L, potassium chloride 4.5mmol/L, calcium chloride 2mmol/L, magnesium chloride 1mmol/L, sodium bicarbonate 12mmol/L, disodium hydrogen phosphate 1mmol/L, glucose 68mg/dL, remaining for sterilized water for injection。
3. the preparation method of medical artificial internal ear perilympha according to claim 1 and 2, it is characterised in that: comprise the following steps:
1) by sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium bicarbonate, glucose and disodium hydrogen phosphate and sterilized water for injection mixed dissolution, concentrated wiring liquid is obtained；
2) filtration step 1) concentrated wiring liquid that obtains, filtrate adds sterilized water for injection constant volume, obtains constant volume liquid；
3) to step 2) the constant volume liquid that obtains passes into O2And CO2Mixing gas to saturated, regulating constant volume liquid PH is 7.2-7.4, and sterilizing obtains described artificial internal ear perilympha。
4. the preparation method of medical artificial internal ear perilympha according to claim 3, it is characterized in that: described step 2) particularly as follows: by step 1) concentrated wiring liquid that obtains is after needle-use activated carbon filters, then through 0.45 μm and 0.22 μm of microporous membrane filtration, filtrate adds sterilized water for injection constant volume, obtains constant volume liquid。
5. the preparation method of medical artificial internal ear perilympha according to claim 3, it is characterised in that: described step 3) in mixing gas contain the O that concentration of volume percent is 90%～95%2And concentration of volume percent is the CO of 5%～10%2。
6. the preparation method of medical artificial internal ear perilympha according to claim 3, it is characterised in that: described step 3) implemented by following steps:
31) to step 2) to pass into containing concentration of volume percent in the constant volume liquid that obtains be the O of 95%2And 5%CO2Mixing gas to saturated, regulating constant volume liquid PH is after 7.2-7.4, adds fill operation by constant volume liquid embedding in infusion bottle or transfusion bag；
32) embedding liquid sterilizing, packs warehouse-in after the assay was approved, obtains medical artificial internal ear perilympha。
7. the preparation method of medical artificial internal ear perilympha according to claim 3, it is characterised in that: described step 3) in, sterilizing refers to sterilizing 15min at 121 DEG C。
8. the medical artificial internal ear perilympha according to claim 1 and 2 application in compound formulation。
9. a compound formulation, it is characterised in that: comprise the medical artificial internal ear perilympha described in claim 1 or 2。
10. compound formulation according to claim 9, it is characterised in that: described compound formulation also comprises at least one in following components: aminoacid, albumin, antioxidant, PH regulator。
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