Pure traditional Chinese medicine eye drops prepared by ancient method and used for treating muscae volitantes and preparation method of pure traditional Chinese medicine eye drops

Abstract

The invention belongs to the technical field of eye drops, and particularly relates to pure traditional Chinese medicine eye drops prepared by an ancient method for treating muscae volitantes and a preparation method. The invention discloses traditional Chinese medicine eye drops for treating muscae volitantes. The traditional Chinese medicine eye drops are characterized by comprising the following raw material medicines in parts by weight: 40-60 parts of American ginseng, 30-40 parts of codonopsis pilosula, 120-140 parts of butterflybush flower, 80-100 parts of selfheal, 60-80 parts of wolfberry fruit, 50-60 parts of dogwood, 30-40 parts of peach kernel, 15-20 parts of safflower, 5-8 parts of nacre mother of pearl, 30-50 parts of pipewort, 20-30 parts of scouring rush and 40-60 parts of kudzuvine root. According to the invention, reasonable compatibility is realized through the principle of monarch, minister, assistant and guide, the components have synergistic effect, the treatment effect is obviously enhanced, meanwhile, degradation loss of active components in the preparation process is reduced by combining ancient processing and magnetic nano-targeting extraction technologies, meanwhile, ocular surface irritation is reduced, and the utilization rate of Chinese herbal medicine components is effectively improved.

Description

Technical Field

[0001] The invention belongs to the technical field of eye drops, and particularly relates to an eye drop prepared by a traditional Chinese medicine method for treating floaters and a preparation method thereof. Background Art

[0002] Floaters are a common eye condition characterized by dark, floating shadows or flocculent objects appearing in the patient's field of vision. These are primarily caused by vitreous liquefaction, collagen fiber aggregation, or an inflammatory response. With the increased use of electronic devices and increased eye strain, the incidence of floaters has increased annually, particularly among middle-aged adults and those with high myopia. Currently, Western medical treatment primarily involves vitrectomy, but this carries risks such as infection and retinal detachment. Conventional eye drops primarily relieve symptoms but cannot cure the condition, and long-term use can cause ocular surface irritation.

[0003] Traditional Chinese medicine has unique advantages in treating floaters. Through the synergistic effect of multiple ingredients, it can not only improve the imbalance of vitreous metabolism, but also regulate the body's qi and blood, achieving the effect of treating both the symptoms and the root cause. However, existing Chinese medicine eye drops currently have some defects: first, the formula and compatibility mostly follow traditional heat-clearing and eyesight-improving drugs, lack targeted ingredients for vitreous collagen repair, and the efficacy is unstable; second, the preparation process mostly uses traditional Chinese medicine extraction to easily destroy heat-sensitive active substances, which can easily lead to the loss of effective ingredients; third, some formulas rely on penetration enhancers such as borneol, which can easily damage the cornea and aggravate eye discomfort with long-term use. Based on this, there is an urgent need to develop a new type of Chinese medicine eye drops to solve the above problems. Summary of the Invention

[0004] The invention provides a traditional Chinese medicine eye drop for treating floaters. The eye drop is composed of the following raw materials in parts by weight: 40-60 parts of American ginseng, 30-40 parts of codonopsis pilosula, 120-140 parts of buddlejac, 80-100 parts of selfheal, 60-80 parts of wolfberry, 50-60 parts of cornus officinalis, 30-40 parts of peach kernel, 15-20 parts of safflower, 5-8 parts of mother-of-pearl, 30-50 parts of coix seed, 20-30 parts of horsetail herb, and 40-60 parts of kudzu root.

[0005] In some embodiments, the nacre is nano-scale fumed nacre with a particle size of 80-120 nm and a calcium carbonate content of ≥90%.

[0006] In some embodiments, the horsetail herb is the dried aerial part of Equisetum equisetum of the Equisetaceae family, and the kaempferol-3-glucoside content is ≥1.2 mg / g.

[0007] In some embodiments, the weight ratio of each component is: 45-48 parts of American ginseng, 32-38 parts of Codonopsis pilosula, 125-135 parts of Buddleja buddleja, 85-95 parts of Prunella vulgaris, 65-75 parts of Lycium barbarum, 52-58 parts of Cornus officinalis, 32-38 parts of peach kernel, 16-18 parts of Carthamus tinctorius, 6-7 parts of mother of pearl, 35-45 parts of Herba Codonopsis pilosulae, 22-28 parts of Equisetum equisetum, and 45-55 parts of Pueraria root.

[0008] The present invention also provides a method for preparing Chinese medicine eye drops, comprising the following steps:

[0009] (a) Flos safflower, peach kernel, mother-of-pearl, and horsetail herb are ground, and surface-modified magnetic nanoparticles are added. The mixture is extracted with shaking at 45-50° C. for 30-40 minutes in a pH 5.5-6.5 buffer solution. The mixture is separated by a magnetic field and eluted to obtain extract phase A.

[0010] (b) soaking American ginseng in rice swill, steaming Buddleja bud with yellow wine, and frying Pueraria root with bran, and extracting them together with Codonopsis pilosula, Prunella vulgaris, Lycium barbarum, Cornus officinalis, and Herba Glechomae glutinosae by a three-decoction-three-filtration method to obtain extract phase B;

[0011] (c) The extracts of phase A and phase B are mixed in a volume ratio of 1:2.5-3.5, an osmotic pressure regulator is added, and the mixture is ultrasonically treated, purified by ion exchange resin, and sterilized.

[0012] In some embodiments, in step (a), the magnetic nanoparticles are Fe3O4@chitosan-β-cyclodextrin composite particles with a particle size of 45-55 nm and a Zeta potential ≥ +30 mV, and the added amount is 6-10% of the total mass of the medicinal material.

[0013] In some embodiments, in step (b), the rice water soaking conditions are: soaking time is 5-7 hours, and drying temperature is 60-70°C.

[0014] In some embodiments, in step (b), the three-decoction-three-filtration method is specifically:

[0015] First decoction: The mass ratio of medicinal materials to cold water is 1:12-15, boil over high heat and then simmer over low heat for 35-45 minutes;

[0016] Second decoction: add 70-75% ethanol, solid-liquid ratio 1:8-10, reflux extraction for 25-35 minutes;

[0017] Third decoction: Steam distillation pressure 0.1-0.15MPa, collect the volatile oil and combine it with the first and second decoctions for concentration.

[0018] In some embodiments, in step (c), the osmotic pressure regulator is trehalose, and the added amount is 1.8-2.2% of the total mass of the mixed solution.

[0019] In some embodiments, in step (c), the ultrasonic treatment conditions are: power 280-320 W, time 4-6 minutes, and the treatment process is carried out under nitrogen protection.

[0020] Compared with the prior art, the present invention has at least the following beneficial effects:

[0021] (1) Through the rational combination of the principles of monarch, minister, assistant and envoy, the components work synergistically and significantly enhance the therapeutic effect.

[0022] (2) Combining the traditional processing method with magnetic nano-targeted extraction technology, the degradation loss of active ingredients during the preparation process is reduced, while reducing ocular surface irritation, effectively improving the utilization rate of Chinese herbal medicine ingredients. DETAILED DESCRIPTION

[0023] The present application will be further described in detail below with reference to specific embodiments. The present application can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to provide a more thorough and comprehensive understanding of the present application's disclosure.

[0024] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application.

[0025] The invention provides a traditional Chinese medicine eye drop for treating floaters. The eye drop is composed of the following raw materials in parts by weight: 40-60 parts of American ginseng, 30-40 parts of codonopsis pilosula, 120-140 parts of buddlejac, 80-100 parts of selfheal, 60-80 parts of wolfberry, 50-60 parts of cornus officinalis, 30-40 parts of peach kernel, 15-20 parts of safflower, 5-8 parts of mother-of-pearl, 30-50 parts of coix seed, 20-30 parts of horsetail herb, and 40-60 parts of kudzu root.

[0026] The prescription of this invention is based on the Traditional Chinese Medicine theory of "liver and kidney homology" and targets the core pathogenesis of floaters, namely "liver and kidney yin deficiency and blood stasis and obstruction of collaterals". The effects of the compatibility of the various Chinese herbs are as follows:

[0027] American ginseng: replenishes qi and nourishes yin, clears away heat and promotes the production of body fluids. According to the Medical Records of Chinese and Western Medicine, it “replenishes the lungs, reduces fire, produces body fluids, and relieves restlessness and fatigue.”

[0028] Buddleja buddhistata: clears the liver and brightens the eyes, removes cataracts. Kaibao Materia Medica says it "treats amblyopia, skin cataracts, red and astringent skin, and excessive mucus and tears."

[0029] Prunella Vulgaris: Clears the liver and purges fire, dissipates stagnation and reduces swelling. "Compendium of Materia Medica" records that it "relieves the heat accumulated in the yin."

[0030] Peach kernel: promotes blood circulation and removes blood stasis, moistens the intestines and promotes bowel movements. "Pharmaceutical Chemistry" says that it "breaks blood and removes blood stasis, moistens dryness and lubricates the intestines."

[0031] Safflower: It can promote blood circulation and menstruation, dissipate blood stasis and relieve pain. According to the "Compendium of Materia Medica", "more use can break up blood, less use can nourish blood".

[0032] Codonopsis: Strengthens the spleen and lungs, nourishes blood and produces body fluids. The "Compendium of Materia Medica" says it "tonifies the middle and replenishes qi, harmonizes the spleen and stomach."

[0033] Wolfberry: nourishes the liver and kidneys, improves essence and improves eyesight. "Compendium of Materia Medica" praises it for "nourishing the kidneys and moistening the lungs, and improving eyesight."

[0034] Cornus officinalis: nourishes the liver and kidneys, astringes and strengthens the body. Shennong's Herbal Classic lists it as a "top-grade product" for treating "cold and heat in the lower part of the heart due to pathogenic qi."

[0035] Mother of Pearl: soothes the liver and suppresses yang, calms the mind and calms nerves. The Chinese Pharmacopoeia states that it can improve eyesight and dispel cataracts.

[0036] Equisetum arvense: Dispels wind-heat, brightens eyesight and removes cataracts. Bencao Qiuzhen says it "has similar properties to ephedra, and its ascending and dispersing properties are also quite similar."

[0037] Pueraria root: It relieves muscle tension, reduces fever, promotes the production of body fluids and quenches thirst. According to the "Yongyao Faxiang" (Medicine Use Method), it "disperses external pathogens and raises the clear qi."

[0038] Herba Glehniae: dispels wind-heat, brightens eyesight and removes cataracts. Compendium of Materia Medica records that it “treats headaches, blindness and cataracts”.

[0039] In some embodiments, the nacre is nano-scale fumed nacre with a particle size of 80-120 nm and a calcium carbonate content of ≥90%.

[0040] In some embodiments, the horsetail herb is the dried aerial part of Equisetum equisetum of the Equisetaceae family, and the kaempferol-3-glucoside content is ≥1.2 mg / g.

[0041] In some embodiments, the weight ratio of each component is: 45-48 parts of American ginseng, 32-38 parts of Codonopsis pilosula, 125-135 parts of Buddleja buddleja, 85-95 parts of Prunella vulgaris, 65-75 parts of Lycium barbarum, 52-58 parts of Cornus officinalis, 32-38 parts of peach kernel, 16-18 parts of Carthamus tinctorius, 6-7 parts of mother of pearl, 35-45 parts of Herba Codonopsis pilosulae, 22-28 parts of Equisetum equisetum, and 45-55 parts of Pueraria root.

[0042] The present invention also provides a method for preparing Chinese medicine eye drops, comprising the following steps:

[0043] (a) Flos safflower, peach kernel, mother-of-pearl, and horsetail herb are ground, and surface-modified magnetic nanoparticles are added. The mixture is extracted with shaking at 45-50° C. for 30-40 minutes in a pH 5.5-6.5 buffer solution. The mixture is separated by a magnetic field and eluted to obtain extract phase A.

[0044] (b) soaking American ginseng in rice swill, steaming Buddleja bud with yellow wine, and frying Pueraria root with bran, and extracting them together with Codonopsis pilosula, Prunella vulgaris, Lycium barbarum, Cornus officinalis, and Herba Glechomae glutinosae by a three-decoction-three-filtration method to obtain extract phase B;

[0045] (c) The extracts of phase A and phase B are mixed in a volume ratio of 1:2.5-3.5, an osmotic pressure regulator is added, and the mixture is ultrasonically treated, purified by ion exchange resin, and sterilized.

[0046] The present invention adopts Fe3O4@chitosan-β-cyclodextrin composite magnetic particles, which utilize magnetic adsorption and the formation of hydrogen bonds with the amino / carboxyl groups of medicinal materials to enhance adsorption force, thereby improving the targeted adsorption of active molecules and enhancing the separation effect. Combined with the ancient processing technology, the two can realize the extraction and separation of different active ingredients, and the ingredients complement each other to jointly enhance the efficacy of the drug.

[0047] In some embodiments, in step (a), the magnetic nanoparticles are Fe3O4@chitosan-β-cyclodextrin composite particles with a particle size of 45-55 nm and a Zeta potential ≥ +30 mV, and the added amount is 6-10% of the total mass of the medicinal material.

[0048] In some embodiments, in step (b), the rice water soaking conditions are: soaking time is 5-7 hours, and the drying temperature is 60-70°C.

[0049] In some embodiments, in step (b), the three-decoction-three-filtration method is specifically:

[0050] First decoction: The mass ratio of medicinal materials to cold water is 1:12-15, boil over high heat and then simmer over low heat for 35-45 minutes;

[0051] Second decoction: add 70-75% ethanol, solid-liquid ratio 1:8-10, reflux extraction for 25-35 minutes;

[0052] Third decoction: Steam distillation pressure 0.1-0.15MPa, collect the volatile oil and combine it with the first and second decoctions for concentration.

[0053] In some embodiments, in step (c), the osmotic pressure regulator is trehalose, and the added amount is 1.8-2.2% of the total mass of the mixed solution.

[0054] In some embodiments, in step (c), the ultrasonic treatment conditions are: power 280-320 W, time 4-6 minutes, and the treatment process is carried out under nitrogen protection.

[0055] Example 1

[0056] A traditional Chinese medicine eye drop for treating floaters is composed of the following raw materials in parts by weight: 45g of American ginseng, 35g of Codonopsis pilosula, 130g of Buddlejac, 90g of Prunella vulgaris, 70g of Lycium barbarum, 55g of Cornus officinalis, 35g of peach kernel, 18g of Carthamus tinctorius, 6g of Mother of Pearl, 40g of Herba Codonopsis pilosulae, 25g of Herba Equisetum, and 50g of Radix Puerariae.

[0057] The preparation method is as follows:

[0058] (a) Carthamus tinctorius, peach kernel, mother-of-pearl, and horsetail herb were ground to 40 mesh size. Fe3O4@chitosan-β-cyclodextrin magnetic particles (50 nm in diameter, 8% by weight of the medicinal materials) were then extracted in pH 6 buffer at 45°C for 30 min with shaking. After magnetic separation, the extract was eluted with 70% ethanol to obtain extract phase A.

[0059] (b) American ginseng was soaked in rice water for 6 h and then dried at 65°C. Buddleja budsii was steamed with rice wine for 2 h. Pueraria root was stir-fried with bran at 180°C and extracted with Codonopsis pilosula, Prunella vulgaris, Lycium barbarum, Cornus officinalis, and Herba Glechomae serrata using the three-decoction-three-filtration method to obtain extract B.

[0060] The three-decoction and three-filtration method is as follows:

[0061] First decoction: The mass ratio of medicinal materials to cold water is 1:13, boil over high heat and then simmer over low heat for 40 minutes;

[0062] Second decoction: add 73% ethanol, solid-liquid ratio 1:9, reflux extraction for 30 minutes;

[0063] Third decoction: Steam distillation pressure is 0.8MPa. The volatile oil is collected and then combined with the first and second decoctions for concentration.

[0064] (c) The extracts of phase A and phase B were mixed in a volume ratio of 1:3, 2% trehalose was added, and the mixture was sonicated at 300 W for 5 minutes, purified by ion exchange resin, and sterilized.

[0065] Example 2

[0066] A traditional Chinese medicine eye drop for treating floaters is composed of the following raw materials in parts by weight: 40g of American ginseng, 30g of Codonopsis pilosula, 120g of Buddlejac, 80g of Prunella vulgaris, 60g of Lycium barbarum, 50g of Cornus officinalis, 30g of Peach Kernel, 15g of Carthamus tinctorius, 5g of Mother of Pearl, 30g of Herba Corydalis, 20g of Herba Equisetum, and 40g of Radix Puerariae.

[0067] The preparation method is as follows:

[0068] (a) Carthamus tinctorius, peach kernel, mother-of-pearl, and horsetail herb were ground to 40 mesh size. Fe3O4@chitosan-β-cyclodextrin magnetic particles (50 nm in diameter, 6% by weight of the medicinal materials) were then extracted in pH 6 buffer at 45°C for 30 min with shaking. After magnetic separation, the extract was eluted with 70% ethanol to obtain extract phase A.

[0069] (b) American ginseng was soaked in rice water for 5 h and then dried at 60°C. Buddleja buddha was steamed with rice wine for 2 h. Pueraria root was stir-fried with bran at 180°C and extracted with Codonopsis pilosula, Prunella vulgaris, Lycium barbarum, Cornus officinalis, and Herba Glechomae serrata using the three-decoction-three-filtration method to obtain extract B.

[0070] The three-decoction and three-filtration method is as follows:

[0071] First decoction: The mass ratio of medicinal materials to cold water is 1:12, boil over high heat and then simmer over low heat for 35 minutes;

[0072] Second decoction: add 70% ethanol, solid-liquid ratio 1:8, reflux extraction for 25 minutes;

[0073] Third decoction: Steam distillation pressure is 0.1MPa. The volatile oil is collected and then combined with the first and second decoctions for concentration.

[0074] (c) The extracts of phase A and phase B were mixed at a volume ratio of 1:2.5, 1.8% trehalose was added, and the mixture was sonicated at 280 W for 4 minutes, purified by ion exchange resin, and sterilized.

[0075] Example 3

[0076] A traditional Chinese medicine eye drop for treating floaters is composed of the following raw materials in parts by weight: 60g of American ginseng, 40g of Codonopsis pilosula, 140g of Buddlejac bud, 100g of Prunella vulgaris, 80g of Lycium barbarum, 60g of Cornus officinalis, 40g of Peach Kernel, 20g of Carthamus tinctorius, 8g of Mother of Pearl, 50g of Herba Corydalis, 30g of Herba Equisetum, and 60g of Radix Puerariae.

[0077] The preparation method is as follows:

[0078] (a) Carthamus tinctorius, peach kernel, mother-of-pearl, and horsetail herb were ground to 40 mesh size. Fe3O4@chitosan-β-cyclodextrin magnetic particles (50 nm in diameter, 10% by weight of the medicinal materials) were then extracted in pH 6 buffer at 45°C for 30 min with shaking. After magnetic separation, the extract was eluted with 70% ethanol to obtain extract phase A.

[0079] (b) American ginseng was soaked in rice water for 7 h and then dried at 70°C. Buddleja budsii was steamed with rice wine for 2 h. Pueraria root was stir-fried with bran at 180°C and extracted with Codonopsis pilosula, Prunella vulgaris, Lycium barbarum, Cornus officinalis, and Herba Glechomae serrata using the three-decoction-three-filtration method to obtain extract B.

[0080] The three-decoction and three-filtration method is as follows:

[0081] First decoction: The mass ratio of medicinal materials to cold water is 1:15, boil over high heat and then simmer over low heat for 45 minutes;

[0082] Second decoction: add 75% ethanol, solid-liquid ratio 1:10, reflux extraction for 35 minutes;

[0083] Third decoction: Steam distillation pressure is 0.15MPa. The volatile oil is collected and then combined with the first and second decoctions for concentration.

[0084] (c) The extracts of phase A and phase B were mixed at a volume ratio of 1:2.5, 2.2% trehalose was added, and the mixture was sonicated at 320 W for 6 minutes, purified by ion exchange resin, and sterilized.

[0085] Comparative Example 1

[0086] Phase B medicinal materials were directly crushed to 40 mesh without processing, and Fe3O4@chitosan-β-cyclodextrin magnetic particles with a particle size of 50 nm and a dosage of 8% of the medicinal materials were used. The extraction was carried out in pH 6 buffer at 45°C for 30 minutes under shaking. After magnetic field separation, the extract was eluted with 70% ethanol to obtain phase B. The rest of the process was the same as in Example 1.

[0087] Comparative Example 2

[0088] Phase A medicinal materials were extracted by three-decoction and three-boil method, and the rest was the same as in Example 1.

[0089] Comparative Example 3

[0090] 60g of American ginseng, 150g of Buddleja buddleja, 10g of mother-of-pearl, and the rest are the same as in Example 1.

[0091] Comparative Example 4

[0092] The formula is the same as Example 1 except that horsetail herb and mother-of-pearl are removed.

[0093] Comparative Example 5

[0094] Add 30g of chrysanthemum and 3g of borneol, and the rest is the same as Example 1.

[0095] Efficacy experiments

[0096] Experimental modeling of rabbit vitreous opacity clearance: Fifty-four healthy New Zealand rabbits were injected intravitreally with 0.1 mL of hyaluronidase (100 U / mL) to induce opacity. After 48 hours, the rabbits were randomly divided into groups: Examples 1-3, Comparative Examples 1-5, and a blank control group, with six rabbits in each group. Administration: Each group received the corresponding sample eye drops, while the blank control group received one drop of normal saline four times daily for 28 consecutive days.

[0097] Evaluation: OCT was used to measure the vitreous opacity area (mm 2 ), clearance rate = (initial area - 28-day area) / initial area × 100%.

[0098] Results and Discussion:

[0099] Table 1 Rabbit eye vitreous opacity clearance test results

[0100]

[0101]

[0102] According to the results in Table 1, the cleaning effect of the embodiments is significantly higher than that of the control examples, among which the effects of control examples 1-2 are better than those of control examples 3-4, indicating that the prescription of the present invention is reasonable in composition and compatibility, the dosage is scientific, and the combination of the ancient processing technology and the magnetic nanoparticle extraction technology achieves a better active enrichment efficiency, and its effect is better than that of using the ancient processing technology or the magnetic nanoparticle extraction technology alone, and the combined process has a synergistic effect.

[0103] Patient population clinical test experimental grouping: 60 patients diagnosed with floaters were recruited and randomly divided into an embodiment group (Example 1) and a commercially available control group (containing borneol / chrysanthemum eye drops), with 30 cases in each group.

[0104] Dosage: Eye drops 3 times a day for 4 consecutive weeks.

[0105] Evaluation: Markedly effective: vitreous opacities are significantly absorbed, primary lesions are controlled, symptoms disappear, visual acuity improves by more than 5 lines, vitreous opacities recover from grade IV to grade II, from grade III to grade I, and from grade II to fundus clearly visible; Effective: vitreous opacities are partially absorbed, symptoms are alleviated, visual acuity improves by 2 to 5 lines, vitreous opacities recover from grade IV to grade III, and from grade III to grade II; Ineffective: vitreous opacities remain unchanged or worsen, symptoms do not improve, and visual acuity does not improve.

[0106] Results and Discussion:

[0107] Table 2 Clinical test results of patients

[0108] Group Significantly effective efficient invalid Total effective rate% Example Group 17 11 2 93.33％ control group 12 12 6 80.00％

[0109] According to the results in Table 2, the effective rate of the embodiment group was significantly improved compared with the control group, indicating that the eye drops provided by the present invention have good therapeutic effects.

[0110] Rabbit ocular surface irritation test: Healthy adult New Zealand White rabbits, weighing 2.5-3.0 kg, half male and half female, were divided into four groups: Groups 1-3 and a commercially available control group (containing borneol / chrysanthemum eye drops), with six animals per group. Each rabbit's left / right eye was randomly assigned: one side was administered the test substance, and the other side was administered a normal saline control.

[0111] Administration: Use a micropipette to drop into the conjunctival sac, gently close the eyelids for 5 seconds, and administer a single dose of 40 μL to each eye. Evaluation should be performed 72 hours after administration.

[0112] evaluate:

[0113] Eye injury evaluation form

[0114]

[0115] Calculation formula: Total score = (corneal score × 5) + (iris score × 2) + [(conjunctival hyperemia score + conjunctival edema score) × 2]

[0116] Irritation Rating Scale

[0117] Total score range Irritation rating Clinical significance 0～1 Non-irritating No visible damage, safe to use 2～5 Slightly irritating Transient congestion / edema, which resolves spontaneously within 24 hours 6～9 Moderate irritation Medical intervention required (eg, flushing, drug discontinuation) 10～16 Severe irritant May cause permanent damage (such as corneal scarring)

[0118] Results and Discussion:

[0119] Table 3 Rabbit ocular surface irritation test results

[0120]

[0121]

[0122] According to the results in Table 3, the scores of Examples 1-3 were lower than those of the commercially available control group, indicating that the eye drops of the present invention are less irritating and safer than those of the commercially available control group.

[0123] The above is a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A Chinese medicine eye drop for treating floaters, characterized in that The invention is composed of the following raw materials in parts by weight: 40-60 parts of American ginseng, 30-40 parts of Codonopsis pilosula, 120-140 parts of Buddleja buddleja, 80-100 parts of Prunella vulgaris, 60-80 parts of Lycium barbarum, 50-60 parts of Cornus officinalis, 30-40 parts of peach kernel, 15-20 parts of Carthamus tinctorius, 5-8 parts of mother of pearl, 30-50 parts of Herba Codonopsis pilosulae, 20-30 parts of Equisetum equisetum and 40-60 parts of Pueraria root.

2. The Chinese medicine eye drops according to claim 1, characterized in that: The nacre is nano-scale calcined nacre with a particle size of 80-120 nm and a calcium carbonate content of ≥90%.

3. The Chinese medicine eye drops according to claim 1, characterized in that: The horsetail grass is the dried aerial part of the horsetail grass of the Equisetaceae family, and the kaempferol-3-glucoside content is ≥1.2 mg / g.

4. The Chinese medicine eye drops according to claim 1, characterized in that: The weight proportions of each component are: 45-48 parts of American ginseng, 32-38 parts of Codonopsis pilosula, 125-135 parts of Buddleja buddleja, 85-95 parts of Prunella vulgaris, 65-75 parts of Lycium barbarum, 52-58 parts of Cornus officinalis, 32-38 parts of peach kernel, 16-18 parts of Carthamus tinctorius, 6-7 parts of mother of pearl, 35-45 parts of Herba Codonopsis pilosulae, 22-28 parts of Equisetum equisetum, and 45-55 parts of Pueraria root.

5. A method for preparing the Chinese medicine eye drops according to any one of claims 1 to 4, characterized in that The following steps are involved: (a) Flos safflower, peach kernel, mother-of-pearl, and horsetail herb are ground, and surface-modified magnetic nanoparticles are added. The mixture is extracted with shaking at 45-50° C. for 30-40 minutes in a pH 5.5-6.5 buffer solution. The mixture is separated by a magnetic field and eluted to obtain extract phase A. (b) soaking American ginseng in rice swill, steaming Buddleja bud with yellow wine, and frying Pueraria root with bran, and extracting them together with Codonopsis pilosula, Prunella vulgaris, Lycium barbarum, Cornus officinalis, and Herba Glechomae glutinosae by a three-decoction-three-filtration method to obtain extract phase B; (c) The extracts of phase A and phase B are mixed in a volume ratio of 1:2.5-3.5, an osmotic pressure regulator is added, and the mixture is ultrasonically treated, purified by ion exchange resin, and sterilized.

6. The preparation method according to claim 5, characterized in that In step (a): the magnetic nanoparticles are Fe3O4@chitosan-β-cyclodextrin composite particles with a particle size of 45-55 nm and a Zeta potential of ≥+30 mV, and the added amount is 6-10% of the total mass of the medicinal material.

7. The preparation method according to claim 5, characterized in that In step (b), the rice water soaking conditions are: soaking time is 5-7 hours, and drying temperature is 60-70°C.

8. The preparation method according to claim 5, characterized in that In step (b): the three-decoction-three-filtration method is specifically: First decoction: The mass ratio of medicinal materials to cold water is 1:12-15, boil over high heat and then simmer over low heat for 35-45 minutes; Second decoction: add 70-75% ethanol, solid-liquid ratio 1:8-10, reflux extraction for 25-35 minutes; Third decoction: Steam distillation pressure 0.1-0.15MPa, collect the volatile oil and combine it with the first and second decoctions for concentration.

9. The preparation method according to claim 5, characterized in that In step (c): the osmotic pressure regulator is trehalose, and the added amount is 1.8-2.2% of the total mass of the mixed solution.

10. The preparation method according to claim 5, characterized in that In step (c), the ultrasonic treatment conditions are: power 280-320W, time 4-6 minutes, and the treatment process is carried out under nitrogen protection.

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