CN111686080A - Freeze-dried powder composite preparation for cataract prevention and improvement nursing and preparation method thereof - Google Patents

Freeze-dried powder composite preparation for cataract prevention and improvement nursing and preparation method thereof Download PDF

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CN111686080A
CN111686080A CN202010582600.9A CN202010582600A CN111686080A CN 111686080 A CN111686080 A CN 111686080A CN 202010582600 A CN202010582600 A CN 202010582600A CN 111686080 A CN111686080 A CN 111686080A
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freeze
dried powder
preparation
oligopeptide
lyophilized powder
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唐亚雷
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Shanghai Kuangshi Medical Co ltd
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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
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    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
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    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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    • A61K9/0012—Galenical forms characterised by the site of application
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    • A61P27/12—Ophthalmic agents for cataracts
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    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01017—Lysozyme (3.2.1.17)

Abstract

The invention relates to the field of eye care products, in particular to a freeze-dried powder composite preparation for cataract prevention and improvement care, which consists of freeze-dried powder and solvent liquid; the lyophilized powder contains vitamins, pyrimidine carboxylic acid and active peptide as effective components, wherein the vitamins include at least two of thiamine HCl (vitamin B1), riboflavin (vitamin B2) and ascorbic acid (vitamin C); pyrimidine carboxylic acids are preferably tetrahydromethyl pyrimidine carboxylic acid (Ectoin); active peptides include oligopeptides and tripeptides, preferably oligopeptide-1, oligopeptide-5 and glutathione; the solvent solution comprises hydrogenated lecithin, dipotassium glycyrrhizinate, rubusine, tocopheryl acetate and lysozyme. In addition, the invention also provides a preparation method of the freeze-dried powder composite preparation for preventing and improving and nursing the cataract. The freeze-dried powder composite preparation is non-toxic and non-irritant, can clean and moisturize eyes, resist inflammation, relieve, moisten dryness, clear heat and supplement nutrition when being used for eyes, and has good effects of preventing cataract and improving eyesight.

Description

Freeze-dried powder composite preparation for cataract prevention and improvement nursing and preparation method thereof
Technical Field
The invention relates to the field of eye care products, in particular to a freeze-dried powder composite preparation for cataract prevention and improvement care and a preparation method thereof.
Background
Cataract is the first disease of blindness-causing eye diseases, and is a disease of clouding of the lens of the eye in clinical diagnosis. The pathogenesis of cataract has not been completely scientific yet. Cataracts occur mostly over the age of 40 years and increase in incidence with age. Therefore, the pathogenic cause of cataract can be said to be aging eye disease of the middle-aged and elderly people, and is closely related to health factors such as immunologic function reduction, malnutrition, hypertension, diabetes and the like.
The most effective method for cataract treatment is surgery, and drug therapy is particularly effective. In other words, "prevention in the bud", the World Health Organization (WHO) and the medical community have recognized especially early prevention and health care of cataract, such as physical exercise, nutrition supplementation, eye exercises, etc. This is completely consistent with the eye care of "prevention is the main one and prevention is more important than treatment". How to prevent, according to the discussion of the international classic ophthalmic treatise "THE RETINAL ATLAS" (retinal map), the occurrence of various eye diseases is directly related to ocular dystrophy, such as "retinal inner layer dystrophy", "retinal vascular dystrophy", "macular dystrophy", "cone dystrophy", etc., and ocular infections, such as bacteria, fungi, viruses, etc., and thus, the prevention should be focused on at least two points: daily nutrition and immunity are improved. However, the related products in the two aspects, especially daily health care products, are still not abundant or mainly medicinal eye drops. With the increasing pace of modern work and life, there are more and more internal and external factors affecting the occurrence or recovery of cataract, such as illumination, radiation, pollution, stress, fatigue, etc., and there is a need for a nursing product with non-drug characteristics for preventing and improving cataract, namely: 1. a special prevention health product for people who do not suffer from cataract; 2. the treated cataract personnel can recover and consolidate the nursing product.
Disclosure of Invention
In order to solve the problems of the prevention products, the invention aims to provide a cataract daily care product which is based on modern biotechnology and high-functional active substances and has the functions of cleaning, moisturizing, relieving, nourishing and bacteriostasis, and particularly provides a freeze-dried powder composite preparation for cataract prevention and improvement care, which comprises freeze-dried powder and solvent liquid.
As a preferable technical solution, in the above lyophilized powder composite preparation, the lyophilized powder comprises vitamins, pyrimidine carboxylic acid and active peptide as effective ingredients, wherein the vitamins are selected from at least two of thiamine HCl, riboflavin (vitamin B2) and ascorbic acid (vitamin C); the total weight of the freeze-dried powder is taken as a reference, wherein the content of the vitamins in the freeze-dried powder is 0.15-0.3 wt%.
As a preferable technical scheme, the mass ratio of thiamine HCl, riboflavin (vitamin B2) and ascorbic acid (vitamin C) in the vitamin is (0.05-0.1): (0.05-0.1): (0.05-0.1).
As a preferred embodiment, the pyrimidine carboxylic acidA compound represented by the general formula (I):
Figure BDA0002552931970000021
wherein R1 and R2 are each independently selected from-H, -OH, -CH3、-CH2CH3、-CH2CH (OH) Ra, wherein Ra is selected from the group consisting of-H, C1-C4 alkanes.
As a preferred technical scheme, R1 and R2 are respectively and independently selected from-H, -OH, -CH3、-CH2CH3。
As a preferable technical scheme, the weight ratio of the vitamin to the pyrimidine carboxylic acid is (0.15-0.3): (0.1-0.3).
As a preferred embodiment, the active peptide is selected from one or more of oligopeptides and tripeptides.
As a preferred technical scheme, the oligopeptide is selected from one or more of oligopeptide-1, oligopeptide-3 and oligopeptide-5.
As a preferred technical scheme, the tripeptide is selected from one or more of glutathione, palmitoyl tripeptide-5 and palmitoyl tripeptide-38.
As a preferred technical solution, in the above lyophilized powder preparation, the solvent is used for mixing the lyophilized powder; and the solvent solution comprises hydrogenated lecithin, rubusoside, tocopheryl acetate, dipotassium glycyrrhizinate, lysozyme, sodium chloride and water.
The second aspect of the invention provides a preparation method of the compound preparation, which comprises the preparation methods of freeze-dried powder and solution:
freeze-drying powder preparation: weighing freeze-dried powder raw materials, fully mixing and dissolving the raw materials uniformly, freezing the water in the raw materials in advance by adopting a vacuum freeze-drying method, and then subliming the frozen water in a vacuum sterile environment to obtain freeze-dried solid powder, namely freeze-dried powder;
preparation of a solvent solution: weighing raw materials of the solvent liquid, fully mixing and dissolving the rest raw materials except the lysozyme uniformly, cooling to below 20 ℃, adding the lysozyme, and continuously mixing and dissolving uniformly.
The third aspect of the invention provides a use method of the compound preparation, wherein the freeze-dried powder and the solvent are mutually dissolved to form a uniform transparent solution, and the solution is poured into an eye fluid cup to be used for being attached to eyes, or the solution is added into a sprayer to carry out flexible atomization spraying on the eyes.
Has the advantages that: the invention provides a freeze-dried powder preparation for cataract prevention and improvement nursing, in particular to a compound preparation formed by dissolving freeze-dried powder and solvent liquid, which comprises vitamins, pyrimidine carboxylic acid and active peptide as effective components, has no toxicity or side effect, can achieve the effects of decontamination and cleaning, water replenishing and moisture retaining, dryness moistening and relieving, nutrition replenishing, antibiosis and inflammation diminishing, vein dredging and blood stasis removing, resuscitation and eyesight improving when reaching eyes, and has good effect on preventing cataract or other discomfort of eyes.
Drawings
FIG. 1: an exemplary first method of use of the lyophilized powder formulation of the present invention;
FIG. 2: an exemplary second method of use of the lyophilized powder formulation of the present invention;
FIG. 3: example 1 lyophilized powder formulation test pattern for inhibition of UVA-induced DNA damage to keratinized nuclei;
FIG. 4: example 1 lyophilized powder formulation protects Langerhans Cell (Langerhans Cell/active immune Cell) assay profiles.
Detailed Description
Unless otherwise indicated, implied from the context, or customary in the art, all parts and percentages herein are by weight and the testing and characterization methods used are synchronized with the filing date of the present application. To the extent that a definition of a particular term disclosed in the prior art is inconsistent with any definitions provided herein, the definition of the term provided herein controls.
The technical features of the technical solutions provided by the present invention are further clearly and completely described below with reference to the specific embodiments, and the scope of protection is not limited thereto.
The words "preferred", "preferably", "more preferred", and the like, in the present invention, refer to embodiments of the invention that may provide certain benefits, under certain circumstances. However, other embodiments may be preferred, under the same or other circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, nor is it intended to exclude other embodiments from the scope of the invention. The sources of components not mentioned in the present invention are all commercially available.
In order to solve the technical problems, the invention provides a freeze-dried powder preparation for cataract prevention and improvement nursing, which is composed of freeze-dried powder and solvent liquid.
In a preferred embodiment, the lyophilized powder comprises vitamins selected from at least two of thiamine HCl, riboflavin (vitamin B2), ascorbic acid (vitamin C), pyrimidine carboxylic acid, and active peptide as active ingredients; the content of vitamins in the lyophilized powder is 0.15-0.3 wt%, preferably 0.1-0.25 wt%, and more preferably 0.1-0.2 wt%, based on the total weight of the lyophilized powder.
Vitamin preparation
The thiamine HCl, vitamin B1, is naturally present in rice bran, germ, yeast, eggs, green leaves, and beans and is an important nutritional supplement. Has effects in activating cell metabolism and nervous tissue.
The riboflavin, vitamin B2, is a nutrient essential to the human body and when deficient has an effect on the eye: photophobia, easy lacrimation, easy lassitude, conjunctival congestion, corneal capillary hyperplasia, blurred vision, etc. Can seriously cause eye diseases such as blepharitis, conjunctivitis and the like.
The ascorbic acid, vitamin C, is one of the most needed vitamins for metabolism in human organs. Has strong antioxidant and toxic materials clearing away effects, and can reduce fragility of eye membrane and capillary vessel and prevent capillary vessel dysfunction.
In a preferred embodiment, the mass ratio of thiamine HCl (vitamin B1), riboflavin (vitamin B2), ascorbic acid (vitamin C) in said vitamin is (0.05-0.1): (0.05-0.1): (0.05-0.1), more preferably (0.05-0.07): (0.05-0.08): (0.05-0.06).
Pyrimidine carboxylic acids
In a preferred embodiment, the pyrimidine carboxylic acid is a compound represented by general formula (i):
Figure BDA0002552931970000041
wherein R1 and R2 are each independently selected from-H, -OH, -CH3、-CH2CH3、-CH2CH (OH) Ra, wherein Ra is selected from the group consisting of-H, C1-C4 alkanes.
In a more preferred embodiment, R1 and R2 are each independently selected from-H, -OH, -CH3、-CH2CH3。
In a most preferred embodiment, the pyrimidine carboxylic acid is a tetrahydro-methyl pyrimidine carboxylic acid and/or a hydroxy-tetrahydro-methyl pyrimidine carboxylic acid.
The tetrahydro-methyl pyrimidine carboxylic acid, namely Ectoin, is a micromolecular amino acid derivative prepared by a biological fermentation technology. It can effectively improve the immune protection capability of skin cells, increase the cell repair capability and enable the skin to effectively resist the invasion of microorganisms and allergens. Therefore, the composite material is used for whole cell protection of pollution resistance, allergen resistance, ultraviolet light resistance, blue light resistance and other exogenous damage factors.
In a most preferred embodiment, the content of pyrimidine carboxylic acid in the lyophilized powder is 0.1-2 wt%, preferably 0.1-1 wt%, more preferably 0.1-0.5 wt%, most preferably 0.1-0.3 wt%, based on the total weight of the lyophilized powder.
Surprisingly, when the tetrahydromethyl pyrimidine carboxylic acid is added into the active ingredients, the stimulation feeling during use can be obviously reduced, and the existence of the tetrahydromethyl pyrimidine carboxylic acid in the system can reduce the stimulation of vitamins to eyes, and the probable reason is that the tetrahydromethyl pyrimidine carboxylic acid is easily protonated in the environment, so that the repulsive force between hydrogenated lecithin in a solution is reduced, the active ingredients wrapped in the solution are compact, and can be slowly released and promote the rapid absorption of the active ingredients.
Active peptides
In a preferred embodiment, the active peptide is selected from one or more of oligopeptides, tripeptides.
In a preferred embodiment, the oligopeptide is selected from one or more of oligopeptide-1, oligopeptide-2, oligopeptide-3, oligopeptide-5.
In a preferred embodiment, the tripeptide is selected from one or more of glutathione, palmitoyl tripeptide-5, palmitoyl tripeptide-38.
In a more preferred embodiment, the oligopeptide is oligopeptide-1, oligopeptide-5; based on the total weight of the freeze-dried powder, the content of the oligopeptide-1 in the freeze-dried powder is 0.0001-0.1 wt%, preferably 0.0001-0.05 wt%, more preferably 0.0001-0.01 wt%, and most preferably 0.0001-0.001 wt%; the content of oligopeptide-5 in lyophilized powder is 0.0001-0.1 wt%, preferably 0.0001-0.05 wt%, more preferably 0.0001-0.01 wt%, and most preferably 0.0001-0.001 wt%. More preferably, the content ratio of the oligopeptide-1 and the oligopeptide-5 in the freeze-dried powder is the same.
The Oligopeptide-1 (Oligopeptide-1) is a condensation compound of glycine, histidine and lysine. Has the effects of promoting epidermal cell regeneration, accelerating the renewal of aged cells, synergistically resisting aging and the like, and has the effect of repairing ocular and corneal injuries.
The oligopeptide-5 is a protein consisting of 73 amino acids. The cornea repair liquid can promote the proliferation and the renewal of keratinocytes and stimulate the regeneration, the differentiation and the migration of epithelial cells around wounds, so that the cornea of the eye can be effectively repaired and the health of the retina can be maintained.
In a more preferred embodiment, the tripeptide is glutathione, and wherein the content of glutathione in the lyophilized powder is 0.01-1 wt%, preferably 0.01-0.5 wt%, more preferably 0.05-0.5 wt%, most preferably 0.05-0.3 wt%, based on the total weight of the lyophilized powder.
The glutathione is a tripeptide consisting of glutamic acid, cysteine and glycine, present in almost every cell of the body, acting as an antioxidant, helping to maintain normal immune system function. Has toxic materials clearing away and maintenance effects on cornea and retina of eye.
In a preferred embodiment, the weight ratio of vitamin to pyrimidine carboxylic acid is (0.15-0.3): (0.1-0.3); preferably 0.15: 0.1.
the freeze-dried powder disclosed by the invention comprises the effective components and water, and besides, a proper amount of auxiliary materials can be added, wherein the auxiliary materials can be a humectant, an antioxidant and the like, and can be used as auxiliary materials, for example, when the auxiliary materials are humectants, the content of the moisturizer in the freeze-dried powder is 0.1-10 wt%, preferably 1-10 wt%, and more preferably 2-5 wt%.
Examples of humectants include, but are not limited to: glycerol, mannitol, xylitol, trehalose, hyaluronic acid, hyaluronan, heparin, polyglucuronic acid, chondroitin sulfate, betaine.
The sodium hyaluronate is also called sodium hyaluronate or sodium uronate, and is abbreviated as HA. The eye care product is prepared by fermenting lactococcus lactis, has a molecular weight of 60-130 ten thousand daltons, is a humectant and a repairing agent widely used in cosmetics, and also has a good function in eye care. Water retention: HA HAs strong moistening and lubricating effects on eyes, obviously prolongs the tear film break-up time (BUT), stabilizes the tear film, and can effectively relieve eye diseases such as dry eye surface, congestion and the like; repairing property: HA is combined through a receptor, protein kinase is activated, actin filaments on cytoskeleton are pulled to react and the like, and cell movement and proliferation are promoted, so that cornea and conjunctiva injury healing is promoted, the cornea and the conjunctiva are repaired, and eyes are protected; the synergy is as follows: HA can enable active matters to stay in the conjunctival sac for a long time through physical adhesion and membrane affinity, so that the bioavailability of the active matters is improved, a quasi-slow release effect is exerted, and the effect is improved; comfort: the unique macromolecular reticular structure and the characteristic of the non-Newtonian fluid of the HA can cover the periphery of a pain receptor, reduce discomfort or pain caused by illumination stimulation, pollutant stimulation and mechanical stimulation and increase the comfort of eyes.
The second aspect of the invention provides a solvent solution for fusing the freeze-dried powder; and the solvent solution comprises hydrogenated lecithin, rubusoside, tocopheryl acetate, dipotassium glycyrrhizinate, lysozyme, sodium chloride and water.
In a preferred embodiment, the freeze-dried powder and the solvent liquid are mixed according to the proportion of 1g/100mL, namely when the packaging mass of the freeze-dried powder is 0.05g, the solvent liquid is mixed with the solvent liquid with the volume of 5 mL.
In a preferred embodiment, the hydrogenated lecithin accounts for 0.1-0.3 percent of the total mass of the solvent liquid, 0.5-1.5 percent of the rubusoside, 0.3-0.5 percent of the tocopherol acetate, 0.05-0.15 percent of the dipotassium glycyrrhizinate, 0.01-0.05 percent of the lysozyme, 0.01-0.05 percent of the sodium chloride and the balance of water.
The hydrogenated lecithin is a natural emulsifier prepared by the hydrogenation reaction of lecithin extracted from soybean, and has the functions of emulsification, solubilization and penetration.
The inventor finds that the effective component and the tetrahydromethyl pyrimidine carboxylic acid have good effect when being compounded, and further finds that the stability of the preparation can be improved when the proportion of thiamine HCl is adjusted when being compounded with the hydrogenated lecithin, probably because under the action of proper hydrogenated lecithin, more tetrahydromethyl pyrimidine carboxylic acid can be adsorbed, the viscosity of the system can be increased, the resistance born by thiamine HCl in the decomposition process is increased, and the effective rate is improved. And the mass ratio of thiamine HCl, riboflavin and ascorbic acid contained in the vitamins capable of obtaining the effective components is (0.05-0.1): (0.05-0.1): the most preferable range is (0.05-0.1).
The betaine is extracted from beetroot and mainly contains trimethylglycine. Has long-acting moisturizing and anti-allergy repairing effects, provides sufficient water and nutrients for the horny layer, activates cells, and enhances moisturizing and barrier functions.
The dipotassium glycyrrhizinate is extracted from liquorice and is an anti-inflammatory, allergy-relieving and repairing agent with excellent performance.
The lysozyme is a natural antibacterial agent, has the characteristics of antivirus, repair, safety, no toxicity, good stability and the like, and also can be used as a preservative.
The vehicle of the present invention may contain, in addition to the above-mentioned components, an appropriate amount of an antioxidant, an emulsifier, a preservative, and the like.
Examples of antioxidants include, but are not limited to: sulfites such as sodium hydrogen sulfite, sodium pyrosulfite and the like; edetic acids such as edetate calcium disodium, edetate sodium, and edetate tetrasodium; ascorbic acids such as ascorbic acid, sodium L-ascorbate, calcium ascorbate, L-ascorbyl stearate, and ascorbyl palmitate; erythorbic acids such as erythorbic acid and sodium erythorbate; tocopherols such as natural vitamin E, d 1-alpha-tocopherol, d 1-alpha-tocopherol acetate, d 1-alpha-tocopherol succinate, and d-alpha-tocopherol calcium succinate; dibutylhydroxytoluene; butyl hydroxyanisole; propyl gallate or a mixture thereof, preferably natural vitamin E, d 1-alpha-tocopherol, d 1-alpha-tocopherol acetate, d 1-alpha-tocopherol succinate, d-alpha-tocopherol calcium succinate or a mixture thereof. The antioxidant may be a mixture of any 1 or 2 or more antioxidants. Generally, the antioxidant is present in the vehicle liquid in an amount of 0.01 to 1% by weight.
The second aspect of the invention provides a preparation method of the compound preparation, which comprises the preparation of the freeze-dried powder and the solution.
The freeze-dried powder is generally solid powder obtained by freezing the water in the liquid medicine in advance by adopting a vacuum freeze-drying method of a freeze dryer, and then sublimating the frozen water in the liquid medicine in a vacuum sterile environment.
When the freeze-dried powder is used, the freeze-dried powder is generally matched with the solvent solution for use, so that the compound preparation is a combined package of the freeze-dried powder and the solvent solution. After the solvent liquid and the freeze-dried powder are fused, the biological activity of the freeze-dried powder can be quickly recovered, the active ingredients can be quickly released, and the high-efficiency nursing effect is generated.
More specifically, the preparation method of the more preferable freeze-dried powder preparation for cataract prevention and improvement nursing comprises the preparation of freeze-dried powder and solution, and the specific steps are as follows:
preparing freeze-dried powder:
(1) weighing the components in respective containers according to the formula ratio at room temperature, marking and placing on a feeding vehicle according to the feeding sequence;
(2) adding deionized water into a vacuum homogenizing emulsifying pot at room temperature, heating to 85-90 ℃, preserving heat for 30min for sterilization, then cooling to 80 ℃, adding mannitol, slowly stirring at 25-30 rpm for 5-10 min, and uniformly dissolving;
(3) cooling to 40 ℃ while stirring, vacuumizing, adding sodium hyaluronate, stirring at medium speed of 35-40 rpm for 15-20 minutes, fully dissolving uniformly, sequentially adding thiamine HCl, riboflavin, tetrahydromethylpyrimidine carboxylic acid (Ectoin), ascorbic acid and glutathione, stirring for 10 minutes after adding, and fully mixing and dissolving uniformly;
(4) cooling to below 20 ℃, keeping the vacuum in the pot, sequentially adding oligopeptide-1 and oligopeptide-5, stirring at the slow speed of 25-30 r/min for 10-15 min, and uniformly mixing and dissolving;
(5) sampling to detect appearance, smell, color and pH value, and filtering and discharging to obtain lyophilized liquid; 2ml of the solution is quantitatively filled into a cleaned and sterilized 10ml penicillin bottle, and is filled into a tray and is half plugged;
(6) putting the tray into a freeze dryer, starting the freeze dryer, freezing the freeze-dried liquid in the bottle from room temperature to-50 ℃, and maintaining for 4 hours to fully freeze the freeze-dried liquid;
(7) gradually heating the frozen and compacted freeze-dried liquid from-50 ℃ to-25 ℃, wherein the heating rate is about 0.17-1 ℃/min, maintaining for 15h, and the vacuum degree is 0.05 mbar;
(8) heating from-25 ℃ to 0 ℃, wherein the heating rate is about 0.5-1 ℃/min, maintaining for 10h, and the vacuum degree is 0.1 mbar;
(9) finally, heating from 0 ℃ to 25 ℃, wherein the heating rate is about 0.5-1 ℃/min, the temperature is maintained for 8 hours, and the vacuum degree is 0.15 mbar;
(10) and (3) after freeze-drying is finished, keeping the vacuum degree in a freeze-dryer bin, pressing a plug, removing the vacuum, opening the bin, and then pricking an aluminum cover to obtain a finished freeze-dried powder product with the net content of 0.15 g/bottle.
Preparation of a solvent solution:
(1) weighing the components in respective containers according to the formula amount at room temperature, marking and placing on a feeding vehicle according to the feeding sequence.
(2) Adding deionized water into a vacuum homogenizing emulsifying pot at room temperature, heating to 85-90 ℃, preserving heat for 30min for sterilization, cooling to below 40 ℃, adding hydrogenated lecithin, fully stirring at medium speed of 35-40 revolutions per minute for 10-15 min to dissolve uniformly, then sequentially adding dipotassium glycyrrhizinate, theophylline, tocopheryl acetate and sodium chloride, stirring at slow speed of 25-30 revolutions per minute for 10-15 min to dissolve uniformly, and homogenizing for 4-5 min at 2200-2500 revolutions per minute to completely dissolve uniformly.
(3) And cooling to below 20 ℃, adding lysozyme, stirring at a slow speed of 25-30 r/min for 10-15 min, and fully mixing and dissolving uniformly to obtain a finished product of the solvent liquid.
(4) Sampling to detect appearance, smell, color and pH value, and filtering and discharging to obtain a solution medium, wherein the appearance, smell, color and pH value meet the requirement of an internal control quality control standard; quantitatively filling 5ml of the solution into a cleaned and sterilized 5ml penicillin bottle, plugging and pricking an aluminum cap to obtain a finished product of the solvent solution, wherein the net content is 5 ml/bottle.
The third aspect of the invention provides a use method of the compound preparation, wherein the freeze-dried powder and the solvent are mutually fused to form a uniform and transparent solution, and the solution is poured into an eye fluid cup to be used for being attached to eyes, or the solution is added into a sprayer to carry out flexible atomization and spraying on the eyes.
For example, in using the complex formulation of the present invention, any one of the methods as illustrated in the drawings may be generally employed.
As shown in fig. 1, when the first method is used, more specifically, the operation steps are that the prepared freeze-dried powder finished product and the solvent liquid finished product are respectively opened, the solvent liquid is completely poured into the freeze-dried powder bottle, the bottle stopper is covered and the bottle stopper is gently shaken to completely dissolve the freeze-dried powder to form a uniform transparent solution, then the solution is poured into a special silica gel eye liquid making cup, the cup is tightly attached to the eye orbit, the head is tilted backwards, the solution is fully contacted with the eyeball and blinks and rotates for a plurality of times, and the solution is poured out after keeping for about 1-2 minutes.
As shown in figure 2, when the second method is adopted, more specifically, the operation steps are that the prepared freeze-dried powder finished product and the solvent liquid finished product are respectively opened, the solvent liquid is completely poured into the freeze-dried powder bottle, the bottle stopper is covered and the bottle stopper is gently shaken to completely dissolve the freeze-dried powder to form a uniform transparent solution, then the uniform transparent solution is poured into a specialized atomizing spray gun cup of the eye beautifying instrument, and then the eyes are sprayed.
The water of the invention is ultrapure water prepared by three-level deionization treatment of tap water through two-level Reverse Osmosis (RO) and Electrodeionization (EDI) and distillation. Sterilizing at 90 deg.C for 30min before use. The raw materials are all purchased from the market.
The present invention is described in detail below with reference to examples, which are provided for the purpose of further illustration only and are not to be construed as limiting the scope of the present invention, and the insubstantial modifications and adaptations thereof by those skilled in the art based on the teachings of the present invention will still fall within the scope of the present invention.
Example 1
Embodiment 1 provides a compound preparation, which is composed of two parts, namely freeze-dried powder and solvent liquid, and the components in percentage by mass are as follows:
freeze-drying powder: based on the total weight of the freeze-dried powder before freeze-drying, the freeze-dried powder comprises 2.0% of mannitol, 0.03% of sodium hyaluronate, 0.05% of thiamine HCl, 0.05% of riboflavin, 0.05% of ascorbic acid, 0.1% of tetrahydro-methylpyrimidine carboxylic acid, 0.05% of glutathione, 10.0005% of oligopeptide-50.0005% of oligopeptide and the balance of deionized water.
Solution of a medium: based on the total weight of the solution, the solution comprises 0.1 percent of hydrogenated lecithin, 0.05 percent of dipotassium glycyrrhizinate, 0.5 percent of rubusoside, 0.3 percent of tocopheryl acetate, 0.01 percent of lysozyme, 0.01 percent of sodium chloride and the balance of water.
The preparation method of the compound preparation comprises the following steps:
freeze-drying powder preparation:
(1) weighing the components in respective containers according to the formula ratio at room temperature, marking and placing on a feeding vehicle according to the feeding sequence;
(2) adding deionized water into a vacuum homogenizing emulsifying pot at room temperature, heating to 85-90 ℃, preserving heat for 30min for sterilization, then cooling to 80 ℃, adding mannitol, slowly stirring at 25-30 rpm for 5-10 min, and uniformly dissolving;
(3) cooling to 40 ℃ while stirring, vacuumizing, adding sodium hyaluronate, stirring at medium speed of 35-40 rpm for 15-20 minutes, fully and uniformly dissolving, sequentially adding thiamine HCl, riboflavin, tetrahydromethylpyrimidine carboxylic acid, ascorbic acid and glutathione, stirring for 10 minutes after the addition is finished, and fully mixing and uniformly dissolving;
(4) cooling to below 20 ℃, keeping the vacuum in the pot, sequentially adding oligopeptide-1 and oligopeptide-5, stirring at the slow speed of 25-30 r/min for 10-15 min, and uniformly mixing and dissolving;
(5) sampling to detect appearance, smell, color and pH value, and filtering and discharging with 400-mesh sterilizing filter cloth to obtain lyophilized liquid; quantitatively filling 1.5ml of the solution into a cleaned and sterilized 5ml penicillin bottle, and filling a tray and a half plug;
(6) putting the tray into a freeze dryer, starting the freeze dryer, freezing the freeze-dried liquid in the bottle from room temperature to-50 ℃, and maintaining for 4 hours to fully freeze the freeze-dried liquid;
(7) gradually heating the frozen and compacted freeze-dried liquid from-50 ℃ to-25 ℃, wherein the heating rate is about 0.17-1 ℃/min, maintaining for 15h, and the vacuum degree is 0.05 mbar;
(8) heating from-25 ℃ to 0 ℃, wherein the heating rate is about 0.5-1 ℃/min, maintaining for 10h, and the vacuum degree is 0.1 mbar;
(9) finally, heating from 0 ℃ to 25 ℃, wherein the heating rate is about 0.5-1 ℃/min, the temperature is maintained for 8 hours, and the vacuum degree is 0.15 mbar;
(10) and (3) after freeze-drying is finished, keeping the vacuum degree in a freeze-dryer bin, removing the vacuum after a plug is pressed, opening the bin, taking out, and pricking an aluminum cover to obtain a finished freeze-dried powder product with the net content of 0.15 g/bottle.
Preparation of a solvent solution:
(1) weighing the components in respective containers according to the formula amount at room temperature, marking and placing on a feeding vehicle according to the feeding sequence.
(2) Adding deionized water into a vacuum homogenizing emulsifying pot at room temperature, heating to 85-90 ℃, preserving heat for 30min for sterilization, cooling to below 40 ℃, adding hydrogenated lecithin, fully stirring at medium speed of 35-40 revolutions per minute for 10-15 min to dissolve uniformly, then sequentially adding dipotassium glycyrrhizinate, theophylline, tocopheryl acetate and sodium chloride, stirring at slow speed of 25-30 revolutions per minute for 10-15 min to dissolve uniformly, and beating to homogenize for 4-5 min at 2200-2500 revolutions per minute to completely dissolve and mix uniformly.
(3) And cooling to below 20 ℃, adding lysozyme, and stirring at a slow speed of 25-30 r/min for 10-15 min to be fully mixed and dissolved uniformly.
(4) Sampling to detect appearance, smell, color and pH value, and filtering and discharging with 400-mesh filter cloth to obtain a solution; quantitatively filling 5ml of the solution into a cleaned and sterilized 5ml penicillin bottle, plugging and pricking an aluminum cap to obtain a finished product of the solvent solution, wherein the net content is 5 ml/bottle.
Preparing a compound preparation:
and opening the bottle caps of the freeze-dried powder finished product and the solvent liquid finished product at room temperature, adding 5mL of solvent liquid into 0.15g of freeze-dried powder, and slightly shaking to dissolve uniformly to obtain the compound preparation.
(evaluation of Properties)
1. Sensory, physicochemical and hygienic indexes: the test results are shown in tables 1 and 2.
TABLE 1 sensory, physicochemical indices
Figure BDA0002552931970000111
Figure BDA0002552931970000121
TABLE 2 hygiene index
Figure BDA0002552931970000122
Remarking: the detection method comprises the following steps: inspection method for microbial limit in appendix XI J of second part of Chinese pharmacopoeia 2010 edition
2. Toxic substance index: the test results are shown in Table 3.
TABLE 3 toxic substance index
Figure BDA0002552931970000123
Remarking: the detection method comprises the following steps: cosmetic safety specifications (2015 edition).
3. Irritation (eye irritation test): the test results are shown in Table 4.
Table 4 eye irritation test
Figure BDA0002552931970000124
Figure BDA0002552931970000131
The test method comprises the following steps: the test substance is dripped into the conjunctival sac of eyes at one side of the rabbit, the eyes are closed for one second, and the eyes at the other side are not treated to be used as self control. Observation and rating were required after dropping the test substance according to the cosmetic safety specifications (2015 edition).
4. Inhibition of UVA-induced keratinized nuclear DNA damage test: the test results are shown in FIG. 3.
The test method comprises the following steps: keratinocytes (HaCaT) were irradiated with UVA (5J/cm2) and the DNA migration value (. mu.m) of the keratinocytes was determined.
The results show that: the DNA migration value of keratinocytes after 12 hours pretreatment with the test sample was less than 29(μm) after UVA irradiation compared to the control sample without pretreatment, indicating that the test sample was able to significantly reduce UVA damage to cellular DNA.
5. Protection of Langerhans cells (Langerhans cells/active immune cells) was tested and the results are shown in FIG. 4.
The test method comprises the following steps: 5 volunteers were selected to irradiate the forearm medial skin smear test sample with UVA (1.5 times the minimum erythema dose MDA) and the ratio (%) of Langerhans cell change before and after irradiation was measured.
The results show that: langerhans cells were well protected in skin subjected to sample treatment and UV damage to Langerhans cells was significantly reduced compared to the control group. The test sample is proved to have the effect of protecting the cell immunity.
6. Inhibition of bacterial Lipopolysaccharide (LPS) -induced inflammatory responses test: the test results are shown in Table 5.
TABLE 5 inhibition of inflammatory response test results
Figure BDA0002552931970000141
The test method comprises the following steps: keratinocytes (HaCaT) were pretreated with a test sample and LPS (10. mu.g/ml, Pseudomonas aeruginosa-derived), and the expression of IL-1. alpha. (interleukin IL-1. alpha.), IL-6 (interleukin-6), IL-8 (interleukin-8), TNF-. alpha (tumor necrosis factor-alpha), and IkB-alpha (arrestin-alpha) which are each inflammatory factor involved in degradation was examined in comparison with the untreated sample.
The results show that: the test sample can effectively inhibit the degradation of I kappa B-alpha and the expression of related inflammatory factors, thereby inhibiting inflammatory response induced by LPS.
7. And (3) effect verification test: the test results are shown in Table 6.
After the combined preparation of this example was used for the test of 62 volunteers, the effect and irritation verification test was performed before and after the use, and the results are shown in table 6.
TABLE 6 volunteer effects
Figure BDA0002552931970000142
Figure BDA0002552931970000151
Remarking: 1) the using method comprises the following steps: following application method one, the effect is reported after administration in a bottle (5ml) each time after morning and a month (not less than 22 days). Using effect evaluation criteria: obvious effect-the user feels self-describing according to the user, such as an option of 'obviously improving' or 'really good effect' for original uncomfortable symptoms; effective-the user feels self-describing, such as "improving" or "having effect, but not significant" for the original discomfort symptoms; ineffectiveness-the user feels self-describing, such as "no improvement" or "no effect" for the original discomfort. 2) Warning for initial diagnosis: volunteers visit the hospital by self, and doctors diagnose and notice the prevention of cataract risk. Mild first-aid: the doctor at the time of the visit informs that cataract is early symptom. Rehabilitation after old age surgery: the test subjects were in the recovery stage after cataract surgery, and were self-reported without any history of heritable disease. And (3) hereditary postoperative rehabilitation: the test subjects were in the recovery stage after cataract surgery and had a history of inherited diseases. The effective rate is as follows: (the number of effective people + the number of effective people)/the total number of used people is multiplied by 100 percent.
8. Typical use cases are:
a typical use case one:
chai chi, male, 50 years old. The eyes were blurred for 3 weeks, and the eyes were sore and swollen. The primary early stage of cataract is warned by the first diagnosis with 0.5 left and 0.4 right vision. After a certain amount of eye drop is opened, the eye drop is used for 1 month without obvious improvement. The product of the embodiment is used for 26 times in a month, the feedback of self-description blur is obviously improved, the vision examination is performed for 0.6 on the left and 0.5 on the right, the vision is recovered to be in a normal state before hospitalization, and the product has stable comfort such as continuous non-swelling, non-acid, non-dry and the like.
Example two is typically used:
zhu lady, 63 years old. The self-diagnosis of cataract in two eyes is mild, the eyes are blurred for about 1 year, the operation treatment is not wanted for the time, and no obvious effect is seen when eye liquid medicine and other methods are used for treatment. The product of the embodiment is used for 30 times in a month, the feedback eyes are very relaxed, the discomfort of foreign body feeling, tightness, clear vision and time blurring in the past is greatly improved, and the television subtitles of 2-3 meters can be seen clearly and cannot be seen clearly before use. Ask what eye medicine is available there. The effect on the tested sample is very satisfactory.
Example three is typically used:
young women, 71 years old. Cataract surgery has been performed as described. However, the eyes are often swollen and blurred, and the eyeballs have foreign bodies, so that the patients suspect that the cataract recurs. After hospitalization, doctors diagnose infection and open eyes for treatment, but the improvement is not great. The product of the embodiment is tried for 36 times, the foreign body sensation disappears in the feedback eyes, the fuzzy sensation is reduced, the vision is relatively stable compared with the prior art, and the discomfort is greatly improved. The irritation is reflected just before the use for several times, and the irritation disappears after the guide and the permanent use. The overall effect on the test specimen was very satisfactory.
The total effect verification test shows that: the compound preparation of the invention has obvious effect on users, the effective rate is 100 percent, and all users hardly see irritation and any other adverse reaction, which is consistent with the result of animal irritation test.
Example 2
Embodiment 2 provides a compound preparation, which is composed of two parts, namely freeze-dried powder and solvent liquid, and the components in percentage by mass are as follows:
freeze-drying powder: the freeze-dried powder comprises, by total weight of freeze-dried powder before freeze-drying, 3.0% of mannitol, 0.07% of sodium hyaluronate, 0.07% of thiamine HCl, 0.08% of riboflavin, 0.06% of ascorbic acid, 0.2% of tetrahydro-methylpyrimidine carboxylic acid, 0.02% of glutathione, oligopeptide-10.0008%, oligopeptide-50.0006% and the balance of deionized water.
Solution of a medium: based on the total weight of the solution, the solution comprises 0.3 percent of hydrogenated lecithin, 0.1 percent of dipotassium glycyrrhizinate, 1.0 percent of rubusoside, 0.4 percent of tocopheryl acetate, 0.03 percent of lysozyme, 0.03 percent of sodium chloride and the balance of deionized water.
The preparation method of the composite preparation is the same as that of example 1.
(evaluation of Properties)
The composite formulations were sampled for testing as follows 1-5:
1. appearance, color, odor (sensory index);
2. viscosity, pH value, heat resistance, cold resistance (physicochemical index);
3. total bacteria, staphylococcus aureus, pseudomonas aeruginosa, mold and yeast (hygiene indicators);
4. lead, arsenic, mercury, methanol (toxic indicators);
the test method and indexes of 1-4 are the same as those of example 1, and the test results are all qualified;
5. irritation (eye irritation test): the test method adopts a feedback method tried by volunteers, and the conclusion is that no stimulation exists.
Example 3
Embodiment 3 provides a compound preparation, which is composed of two parts, namely freeze-dried powder and solvent liquid, and the components in percentage by mass are as follows:
freeze-drying powder: the freeze-dried powder comprises, by total weight of freeze-dried powder before freeze-drying, 4.0% of mannitol, 0.1% of sodium hyaluronate, 0.1% of thiamine HCl, 0.1% of riboflavin, 0.1% of ascorbic acid, 0.3% of tetrahydro-methylpyrimidine carboxylic acid, 0.3% of glutathione, oligopeptide-10.001%, oligopeptide-50.001% and the balance of deionized water.
Solution of a medium: based on the total weight of the solution, the solution comprises 0.5 percent of hydrogenated lecithin, 0.15 percent of dipotassium glycyrrhizinate, 1.5 percent of rubusoside, 0.5 percent of tocopheryl acetate, 0.05 percent of lysozyme, 0.05 percent of sodium chloride and the balance of deionized water.
The preparation method of the composite preparation is the same as that of example 1.
(evaluation of Properties)
The composite formulations were sampled for testing as follows 1-5:
1. appearance, color, odor (sensory index);
2. viscosity, pH value, heat resistance, cold resistance (physicochemical index);
3. total bacteria, staphylococcus aureus, pseudomonas aeruginosa, mold and yeast (hygiene indicators);
4. lead, arsenic, mercury, methanol (toxic indicators);
the test method and indexes of 1-4 are the same as those of example 1, and the test results are all qualified;
5. irritation (eye irritation test): the test method adopts a feedback method tried by volunteers, and the conclusion is that no stimulation exists.
Comparative example 1
Comparative example 1 provides a composite preparation, which is composed of two parts, namely freeze-dried powder and solvent liquid, and the components in percentage by mass are as follows:
freeze-drying powder: based on the total weight of the freeze-dried powder before freeze-drying, the freeze-dried powder comprises 2.0% of mannitol, 0.03% of sodium hyaluronate, 0.05% of thiamine HClH, 0.05% of riboflavin, 0.05% of ascorbic acid, 0.05% of glutathione, oligopeptide-10.0005%, oligopeptide-50.0005% and the balance of deionized water.
Solution of a medium: based on the total weight of the solution, the solution comprises 0.1 percent of hydrogenated lecithin, 0.05 percent of dipotassium glycyrrhizinate, 0.5 percent of rubusoside, 0.3 percent of tocopheryl acetate, 0.01 percent of lysozyme, 0.01 percent of sodium chloride and the balance of deionized water.
The preparation method of the composite preparation is the same as that of example 1.
(evaluation of Properties)
The composite formulations were sampled for testing as follows 1-5:
1. appearance, color, odor (sensory index);
2. viscosity, pH value, heat resistance, cold resistance (physicochemical index);
3. total bacteria, staphylococcus aureus, pseudomonas aeruginosa, mold and yeast (hygiene indicators);
4. lead, arsenic, mercury, methanol (toxic indicators);
the test method and indexes of 1-4 are the same as those of example 1, and the test results are all qualified;
5. irritation (eye irritation test): the test method adopts a feedback method tried by a volunteer, and the conclusion is slight stimulation.
Comparative example 2
Comparative example 2 provides a composite preparation, which is composed of two parts, namely freeze-dried powder and solvent liquid, and the components in percentage by mass are as follows:
freeze-drying powder: based on the total weight of the freeze-dried powder before freeze-drying, the freeze-dried powder comprises 2.0% of mannitol, 0.03% of sodium hyaluronate, 0.3% of thiamine HCl, 0.05% of riboflavin, 0.05% of ascorbic acid, 0.1% of tetrahydro-methylpyrimidine carboxylic acid, 0.05% of glutathione, 10.0005% of oligopeptide-50.0005% of oligopeptide and the balance of deionized water.
Solution of a medium: based on the total weight of the solution, the solution comprises 0.1 percent of hydrogenated lecithin, 0.05 percent of dipotassium glycyrrhizinate, 0.5 percent of rubusoside, 0.3 percent of tocopheryl acetate, 0.01 percent of lysozyme, 0.01 percent of sodium chloride and the balance of deionized water.
The preparation method of the composite preparation is the same as that of example 1.
(evaluation of Properties)
The composite formulations were sampled for testing as follows 1-5:
1. appearance, color, odor (sensory index);
2. viscosity, pH value, heat resistance, cold resistance (physicochemical index);
3. total bacteria, staphylococcus aureus, pseudomonas aeruginosa, mold and yeast (hygiene indicators);
4. lead, arsenic, mercury, methanol (toxic indicators);
the test method and indexes of 1-4 are the same as those of example 1, the physical and chemical indexes of the test result are unqualified, and the rest are qualified;
5. irritation (eye irritation test): the test method adopts a feedback method tried by volunteers, and the conclusion is moderate stimulation.
Comparative example 3
Comparative example 3 provides a composite preparation, which is composed of two parts, namely freeze-dried powder and solvent liquid, and the components in percentage by mass are as follows:
freeze-drying powder: based on the total weight of the freeze-dried powder before freeze-drying, the freeze-dried powder comprises 2.0% of mannitol, 0.03% of sodium hyaluronate, 0.05% of thiamine HCl, 0.05% of riboflavin, 0.05% of ascorbic acid, 0.1% of tetrahydro-methylpyrimidine carboxylic acid, 0.05% of glutathione, 10.0005% of oligopeptide-50.0005% of oligopeptide and the balance of deionized water.
Solution of a medium: based on the total weight of the solvent, the solvent comprises 0.05 percent of dipotassium glycyrrhizinate, 0.5 percent of rubusoside, 0.3 percent of tocopheryl acetate, 0.01 percent of lysozyme, 0.01 percent of sodium chloride and the balance of deionized water.
The preparation method of the composite preparation is the same as that of example 1.
(evaluation of Properties)
The composite formulations were sampled for testing as follows 1-5:
1. appearance, color, odor (sensory index);
2. viscosity, pH value, heat resistance, cold resistance (physicochemical index);
3. total bacteria, staphylococcus aureus, pseudomonas aeruginosa, mold and yeast (hygiene indicators);
4. lead, arsenic, mercury, methanol (toxic indicators);
the test method and indexes of 1-4 are the same as those of example 1, the physical and chemical indexes of the test result are unqualified, and the rest are qualified;
5. irritation (eye irritation test): the test method adopts a feedback method tried by a volunteer, and the conclusion is slight stimulation.

Claims (10)

1. A freeze-dried powder composite preparation for cataract prevention and improvement nursing is characterized in that the freeze-dried powder composite preparation is composed of freeze-dried powder and solvent liquid; wherein the lyophilized powder comprises vitamins, pyrimidine carboxylic acid and active peptide as effective components, wherein the vitamins are selected from at least two of thiamine HCl, riboflavin and ascorbic acid; the content of the vitamins in the freeze-dried powder is 0.15-0.3 wt% based on the total weight of the freeze-dried powder.
2. The lyophilized powder of claim 1, wherein the ratio of thiamine HCl, riboflavin, ascorbic acid in said vitamins is (0.05-0.1): (0.05-0.1): (0.05-0.1).
3. The lyophilized powder formulation of claim 1, wherein the pyrimidine carboxylic acid is a compound represented by general formula (i):
Figure FDA0002552931960000011
wherein R1 and R2 are each independently selected from-H, -OH, -CH3、-CH2CH3、-CH2CH (OH) Ra, wherein Ra is selected from the group consisting of-H, C1-C4 alkanes.
4. The lyophilized powder formulation of claim 3, wherein R1 and R2 are each independently selected from the group consisting of-H, -OH, -CH3、-CH2CH3。
5. Lyophilized powder formulation according to any of claims 1-4, wherein the weight ratio of vitamin to pyrimidine carboxylic acid is (0.15-0.3): (0.1-0.3).
6. Lyophilized powder formulation according to claim 1, wherein the active peptide is selected from one or more of oligopeptides and tripeptides.
7. Lyophilized powder formulation according to claim 6, wherein the oligopeptide is selected from one or more of oligopeptide-1, oligopeptide-3, oligopeptide-5; the tripeptide is selected from one or more of glutathione, palmitoyl tripeptide-5 and palmitoyl tripeptide-38.
8. Lyophilized powder formulation according to any of claims 1-7, wherein the vehicle is used for the solubilization of the lyophilized powder; preferably, the solvent solution comprises hydrogenated lecithin, rubusine, tocopheryl acetate, dipotassium glycyrrhizinate, lysozyme, sodium chloride and water.
9. A method for preparing the composite preparation of any one of claims 1 to 8, comprising preparing a lyophilized powder and a solution;
wherein, the preparation steps of the freeze-dried powder comprise: weighing freeze-dried powder raw materials, fully mixing and dissolving the raw materials uniformly, freezing the water in the raw materials in advance by adopting a vacuum freeze-drying method, and then subliming the frozen water in a vacuum sterile environment to obtain freeze-dried solid powder, namely freeze-dried powder;
the preparation method of the solution comprises the following steps: weighing raw materials of the solvent liquid, fully mixing and dissolving the rest raw materials except the lysozyme uniformly, cooling to below 20 ℃, adding the lysozyme, and continuously mixing and dissolving uniformly.
10. A method for using the composite preparation of claim 9, wherein the lyophilized powder and the solvent are fused with each other to form a uniform transparent solution, and the solution is poured into an eye fluid cup to be attached to the eyes, or the solution is added into a sprayer to be sprayed on the eyes by flexible atomization.
CN202010582600.9A 2020-06-23 2020-06-23 Freeze-dried powder composite preparation for cataract prevention and improvement nursing and preparation method thereof Withdrawn CN111686080A (en)

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