Injection composition for treating fundus macular edema and preparation method thereof

Abstract

The invention discloses an injection composition for treating fundus macular edema and a preparation method thereof, and relates to the technical field of injection compositions. The medicament specifically comprises a medicament A, a medicament B, a medicament C, a medicament D, a medicament E and a medicament F. The medicament A, the medicament B, the medicament C, the medicament D, the medicament E and the medicament F are specifically and respectively composed of trifluoromethasone, bevacizumab, vitamin E, warfarin, lirabel and macacin. The mass percent of the medicament A is 2.2 to 12.5 percent, the mass percent of the medicament B is 4.3 to 33.1 percent, the mass percent of the medicament C is 8.5 to 24.7 percent, the mass percent of the medicament D is 5.5 to 13.2 percent, the mass percent of the medicament E is 7.1 to 26.3 percent, and the mass percent of the medicament F is 6.4 to 23.8 percent. The nano filter membrane is adopted for filtration, microorganisms and particles can be effectively filtered out, and the sterility of a medicine solution is ensured; under the action of an electric field and ultrasonic waves, the motion trails of the microorganisms and the particles can be changed.

Description

Technical Field

[0001] The present invention relates to the technical field of injection compositions, and in particular to an injection composition for treating fundus macular edema and a preparation method thereof. Background Art

[0002] Macular edema is an eye disease caused mainly by edema and inflammation of retinal tissue in the macular area. The macula is one of the most important visual centers in the eye, responsible for processing details on the retina and the central visual field. When edema occurs in the macular area, it may affect visual function, leading to symptoms such as decreased vision, blurred central visual field or blindness. The causes of macular edema may include diabetic retinopathy, macular degeneration, retinal vein occlusion, etc. The treatment of macular edema mainly includes medication, laser therapy and surgical treatment. The process of treating macular edema usually requires close monitoring and regular review to evaluate the treatment effect and disease progression. Early detection and timely treatment can help alleviate symptoms, protect vision and increase the chance of successful treatment.

[0003] After searching, the Chinese patent publication number CN102920845B discloses a Chinese medicine composition with the effect of treating fundus macular degeneration. The raw materials of the Chinese medicine composition are: 300-900 parts by weight of Polygonum cuspidatum, 200-600 parts by weight of Veratrum, 300-900 parts by weight of Camellia sinensis, and 200-400 parts by weight of Lycium barbarum. The preparation method of the Chinese medicine composition is: taking Polygonum cuspidatum and Veratrum sinensis, adding 5-7 times of 50-90% ethanol, soaking for 2 hours, refluxing and extracting 1-3 times, each time for 1-3 hours, filtering, combining the filtrate, recovering ethanol from the filtrate, and measuring the relative density at 60'C to be about 1.20 -1.30 thick paste, decompress and dry for standby use: take quezui tea and wolfberry, add 6-10 times of water and boil 1-3 times, each time for 1-3 hours, filter, combine the filtrate, decompress and concentrate to 60"C to determine the relative density of 1.08-1.10, add ethanol to make the alcohol content reach 60-80%, overnight, filter, recover ethanol from the filtrate to 60C to determine the relative density of about 1.20-1.30 thick paste, decompress and dry for standby use; combine the above dried products, crush, add common pharmaceutical excipients, and make the required dosage form. The above patent has the following deficiencies in a Chinese medicine composition with the effect of treating fundus macular degeneration:

[0004] The above-mentioned Chinese medicine composition has good effects in protecting cells, stabilizing vision, preventing recurrence of the disease and absorbing old bleeding and exudation. However, the Chinese medicine composition needs to be used for a long time to treat fundus macular edema, the treatment effect is slow, and patients will have problems of dependence and drug resistance after long-term use. Therefore, there is an urgent need for an injection composition for treating fundus macular edema and a preparation method thereof. Summary of the invention

[0005] The purpose of the present invention is to solve the shortcomings of the prior art and to propose an injection composition for treating fundus macular edema and a preparation method thereof.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions:

[0007] An injection composition for treating fundus macular edema comprises agent A, agent B, agent C, agent D, agent E and agent F, wherein the agent A, agent B, agent C, agent D, agent E and agent F are respectively composed of triflumethasone, bevacizumab, vitamin E, warfarin, lirabel and macain, and the mass percentages thereof are 2.2-12.5% ​​of agent A, 4.3-33.1% of agent B, 8.5-24.7% of agent C, 5.5-13.2% of agent D, 7.1-26.3% of agent E and 6.4-23.8% of agent F.

[0008] Preferably, the weight components of the drug A, drug B, drug C, drug D, drug E and drug F include 3-10 parts of triflumetasone, 6-17 parts of bevacizumab, 8-12 parts of vitamin E, 5-7 parts of warfarin, 3-9 parts of lirabel and 4-8 parts of macain.

[0009] Furthermore: the drug A is selected from any one of triflumethasone, methylprednisolone, dexamethasone sodium phosphate and trifluprednisolone; the drug B is selected from any one of acyclovir, bevacizumab, axitomeprazol, ranibizumab and everolimus.

[0010] Based on the above scheme: the agent C is selected from any one of vitamin E, lutein, grape seed extract and coenzyme Q10; the agent D is selected from any one of warfarin, heparin and dabigatran.

[0011] A more preferred embodiment of the aforementioned embodiment is that the drug E is selected from any one of lirabel, nitroglycerin, urapidil and nifedipine; and the drug F is selected from any one of macain, omega-3 fatty acids and choroidergic.

[0012] A method for preparing an injection composition for treating fundus macular edema comprises the following steps:

[0013] S1: Add Agent A, Agent B, Agent C, Agent D, Agent E and Agent F into a sterile glass bottle containing physiological saline in a ratio of 1:2:4:2:3:3, and stir for 6-10 minutes to completely dissolve them;

[0014] S2: sterile filtration of the dissolved drug solution;

[0015] S3: Fill the filtered drug solution into a sterile syringe and seal it;

[0016] S4: Sterilize the syringe and perform quality inspection.

[0017] Meanwhile, in the step S2, the dissolved drug solution is sterile filtered, and the specific steps are as follows:

[0018] S21: preparing a container with an electric field generator and an ultrasonic generator;

[0019] S22: installing a filter membrane composed of a plurality of conical nanofiltration membranes in the container, and filtering the dissolved drug solution through the nanofiltration membrane;

[0020] S23: turning on the electric field generator to make the electric field act on the nanofiltration membrane and the microorganisms and particles in the drug solution, changing the movement trajectories of the microorganisms and particles and increasing the collision frequency between the microorganisms and particles and the filtration membrane;

[0021] S24: Turn on the ultrasonic generator to make the ultrasonic wave generate tiny vibrations and eddies on the surface of the filter membrane, thereby accelerating the filtration speed of the drug solution;

[0022] S25: Transfer the filtered drug solution into a sterile container.

[0023] As a preferred embodiment of the present invention: the step S25, transferring the filtered drug solution into a sterile container, the specific steps are as follows:

[0024] A1: Design microfluidic chip;

[0025] A2: Inject the filtered drug solution into the injection port of the designed microfluidic chip;

[0026] A3: The drug solution passes through the microfluidic chip channel, precisely controlling the flow of the drug solution and transferring it to a sterile container;

[0027] A4: Seal the sterile container filled with the drug container.

[0028] Meanwhile, the channel structure of the microfluidic chip adopts any one of a straight line type, a curved line type and a branch type.

[0029] The beneficial effects of the present invention are:

[0030] 1. An injection composition for treating fundus macular edema and a preparation method thereof. Agents A to F are selected from different types of drugs, respectively. Patients can choose the agent suitable for them according to the specific situation to achieve personalized treatment and improve the pertinence and effectiveness of the treatment. Agents C and F contain vitamin E, lutein, grape seed extract, coenzyme Q10, macain, omega-3 fatty acids and other nutrients, which help maintain eye health and promote the recovery of macular edema. According to the mass percentage and the ratio of mass components, the proportions of various agents in the composition are relatively balanced, avoiding the problem of side effects or insufficient efficacy caused by too much or too little of a certain ingredient.

[0031] 2. The injection composition for treating fundus macular edema and its preparation method adopt nanofiltration membrane for filtration, which can effectively filter out microorganisms and particles and ensure the sterility of drug solution; and through the action of electric field and ultrasonic wave, the movement trajectory of microorganisms and particles can be changed, and the collision frequency with the filter membrane can be increased, thereby improving the filtration efficiency; at the same time, the tiny vibration and eddy current of ultrasonic wave can accelerate the speed of drug solution passing through the filter membrane, saving time and improving production efficiency; through aseptic filtration, impurities and microorganisms can be effectively removed, and the purity and quality stability of drug solution can be ensured; the whole filtration process is assisted by equipment, and the operation is relatively simple, which can improve production efficiency and reduce the difficulty of operation for operators.

[0032] 3. The injection composition for treating fundus macular edema and the preparation method thereof can achieve precise control of the flow of drug solution by designing a microfluidic chip and controlling parameters such as flow rate, pressure, and temperature, thereby ensuring accurate transfer and stability of the drug. The design and optimization of the microfluidic chip can improve the transfer efficiency of the drug solution, speed up the transfer speed, save time and improve production efficiency. The entire transfer process is carried out under sterile conditions, avoiding the possibility of external contamination and ensuring the sterility and purity of the drug solution. At the same time, due to precise control and efficient transfer, drug waste can be reduced and drug utilization rate can be improved. Sealing the sterile container filled with the drug can effectively protect the drug from external environmental contamination and extend the shelf life of the drug. DETAILED DESCRIPTION

[0033] The technical solution of the present invention is further described in detail below in conjunction with specific implementation methods.

[0034] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] An injection composition for treating fundus macular edema, comprising agent A, agent B, agent C, agent D, agent E and agent F, wherein the agent A, agent B, agent C, agent D, agent E and agent F are respectively composed of triflumethasone, bevacizumab, vitamin E, warfarin, lirabel and macain, and the mass percentages thereof are 2.2-12.5% ​​of agent A, 4.3-33.1% of agent B, 8.5-24.7% of agent C, 5.5-13.2% of agent D, 7.1-26.3% of agent E and 6.4-23.8% of agent F;

[0036] The composition by weight includes 3-10 parts of triflumetasone, 6-17 parts of bevacizumab, 8-12 parts of vitamin E, 5-7 parts of warfarin, 3-9 parts of lirabel and 4-8 parts of macain.

[0037] The drug A is selected from any one of triflumethasone, methylprednisolone, dexamethasone sodium phosphate and trifluprednisolone; the drug B is selected from any one of acyclovir, bevacizumab, axitomeprazol, ranibizumab and everolimus;

[0038] Agent C is selected from any one of vitamin E, lutein, grape seed extract and coenzyme Q10; Agent D is selected from any one of warfarin, heparin and dabigatran;

[0039] Drug E is selected from any one of lirabel, nitroglycerin, urapidil and nifedipine; Drug F is selected from any one of macain, omega-3 fatty acids and choroidergic acid;

[0040] A method for preparing an injection composition for treating fundus macular edema comprises the following steps:

[0041] S1: Add Agent A, Agent B, Agent C, Agent D, Agent E and Agent F into a sterile glass bottle containing 20-40 ml of normal saline in a ratio of 1:2:4:2:3:3, and stir for 6-10 minutes to completely dissolve them;

[0042] S2: sterile filtration of the dissolved drug solution;

[0043] S3: Fill the filtered drug solution into a 5-8 ml sterile syringe and seal it;

[0044] S4: Sterilize the syringe and perform quality inspection.

[0045] Embodiment 1:

[0046] An injection composition for treating fundus macular edema, comprising agent A, agent B, agent C, agent D, agent E and agent F, wherein the agent A, agent B, agent C, agent D, agent E and agent F are respectively composed of triflumethasone, bevacizumab, vitamin E, warfarin, lirabel and macain, and the mass percentages thereof are 2.2% of agent A, 4.3% of agent B, 8.5% of agent C, 5.5% of agent D, 7.1% of agent E and 6.4% of agent F;

[0047] The mass components include 3 parts of triflumethasone, 6 parts of bevacizumab, 12 parts of vitamin E, 5 parts of warfarin, 8 parts of lirabel and 8 parts of macain.

[0048] The drug A is selected from any one of triflumethasone, methylprednisolone, dexamethasone sodium phosphate and trifluprednisolone; the drug B is selected from any one of acyclovir, bevacizumab, axitomeprazol, ranibizumab and everolimus;

[0049] Agent C is selected from any one of vitamin E, lutein, grape seed extract and coenzyme Q10; Agent D is selected from any one of warfarin, heparin and dabigatran;

[0050] Drug E is selected from any one of lirabel, nitroglycerin, urapidil and nifedipine; Drug F is selected from any one of macain, omega-3 fatty acids and choroidergic acid;

[0051] Medicines A to F are selected from different types of drugs. Patients can choose the medicine suitable for them according to their specific circumstances to achieve personalized treatment and improve the targetedness and effectiveness of the treatment. Medicines C and F contain vitamin E, lutein, grape seed extract, coenzyme Q10, macain, omega-3 fatty acids and other nutrients, which help maintain eye health and promote the recovery of macular edema. According to the mass percentage and the ratio of mass components, the proportion of various medicines in the composition is relatively balanced, avoiding the problem of side effects or insufficient efficacy caused by too much or too little of a certain ingredient.

[0052] A method for preparing an injection composition for treating fundus macular edema comprises the following steps:

[0053] S1: Add Agent A, Agent B, Agent C, Agent D, Agent E and Agent F into a sterile glass bottle containing 20 ml of normal saline in a ratio of 1:2:4:2:3:3, and stir for 6 minutes to completely dissolve them;

[0054] S2: sterile filtration of the dissolved drug solution;

[0055] S3: Fill the filtered drug solution into a 5 ml sterile syringe and seal it;

[0056] S4: Sterilize the syringe and perform quality inspection.

[0057] Wherein, in step S2, the dissolved drug solution is sterile filtered, and the specific steps are as follows:

[0058] S21: prepare a container with an electric field generator and an ultrasonic generator, and set the parameters of the electric field generator to be 100 V / cm in electric field strength and 50 Hz in frequency, and the parameters of the ultrasonic generator to be 10 W in power and 20 kHz in frequency;

[0059] S22: a filter membrane composed of a plurality of 1 nm conical nanofilter membranes is installed in the container, and the dissolved drug solution is filtered through the nanofilter membrane;

[0060] S23: turning on the electric field generator to make the electric field act on the nanofiltration membrane and the microorganisms and particles in the drug solution, changing the movement trajectories of the microorganisms and particles and increasing the collision frequency between the microorganisms and particles and the filtration membrane;

[0061] S24: Turn on the ultrasonic generator to make the ultrasonic wave generate tiny vibrations and eddies on the surface of the filter membrane, thereby accelerating the filtration speed of the drug solution;

[0062] S25: Transfer the filtered drug solution into a sterile container.

[0063] Filtration using nanofiltration membranes can effectively filter out microorganisms and particles, ensuring the sterility of the drug solution; and through the action of electric fields and ultrasonic waves, the movement trajectory of microorganisms and particles can be changed, increasing the frequency of their collision with the filter membrane, thereby improving the filtration efficiency. At the same time, the tiny vibrations and eddy currents of ultrasonic waves can accelerate the speed at which the drug solution passes through the filter membrane, saving time and improving production efficiency. Through aseptic filtration, impurities and microorganisms can be effectively removed to ensure the purity and quality stability of the drug solution. The entire filtration process is assisted by equipment and is relatively simple to operate, which can improve production efficiency and reduce the difficulty of operation for operators.

[0064] Among them, step S25, transferring the filtered drug solution into a sterile container, the specific steps are as follows:

[0065] A1: Design a microfluidic chip, set the channel size of the microfluidic chip to 10 μm, the channel structure to be linear, and the microfluidic chip material to be glass;

[0066] A2: Inject the filtered drug solution into the injection port of the designed microfluidic chip;

[0067] A3: The drug solution passes through the microfluidic chip channel, precisely controlling the flow of the drug solution and transferring it to a sterile container at a flow rate of 3 ml / min, a pressure of 4 Pa, and a temperature of 25 °C;

[0068] A4: Seal the sterile container filled with the drug container.

[0069] By designing microfluidic chips and controlling parameters such as flow rate, pressure, and temperature, precise control of the flow of drug solutions can be achieved to ensure accurate transfer and stability of drugs. The design and optimization of microfluidic chips can improve the transfer efficiency of drug solutions, speed up transfer speed, save time and improve production efficiency. The entire transfer process is carried out under sterile conditions, avoiding the possibility of external contamination and ensuring the sterility and purity of the drug solution. At the same time, due to precise control and efficient transfer, drug waste can be reduced and drug utilization can be improved. Sealing the sterile container filled with drugs can effectively protect the drugs from external environmental contamination and extend the shelf life of the drugs.

[0070] The channel structure of the microfluidic chip adopts any one of a straight line type, a curved line type and a branch type;

[0071] The linear channel structure is simple and intuitive, easy to design and prepare, with a clear fluid flow path, and can achieve relatively stable fluid transmission and mixing. In addition, the linear channel structure is conducive to reducing the resistance and mixing of the fluid, improving the flow rate and transmission efficiency, and the curved channel structure can increase the mixing and contact area of ​​the fluid, which is conducive to improving the reaction efficiency and mass transfer efficiency. In addition, the curved channel structure can also slow down the fluid speed, which is conducive to mixing and stable transmission. At the same time, the branched channel structure can realize multi-channel parallel operation, improve experimental efficiency and diversity. At the same time, the branched channel structure can also realize the mixing and reaction of different reagents, increasing the flexibility and versatility of the experiment.

[0072] Embodiment 2:

[0073] An injection composition for treating fundus macular edema, comprising agent A, agent B, agent C, agent D, agent E and agent F, wherein the agent A, agent B, agent C, agent D, agent E and agent F are respectively composed of triflumethasone, bevacizumab, vitamin E, warfarin, lirabel and macain, and the mass percentages thereof are 4.1% of agent A, 8.2% of agent B, 16.5% of agent C, 7.2% of agent D, 10.3% of agent E and 15.4% of agent F;

[0074] The mass components include 5 parts of triflumethasone, 10 parts of bevacizumab, 9 parts of vitamin E, 5 parts of warfarin, 7 parts of lirabel and 7 parts of macain.

[0075] The drug A is selected from any one of triflumethasone, methylprednisolone, dexamethasone sodium phosphate and trifluprednisolone; the drug B is selected from any one of acyclovir, bevacizumab, axitomeprazol, ranibizumab and everolimus;

[0076] Agent C is selected from any one of vitamin E, lutein, grape seed extract and coenzyme Q10; Agent D is selected from any one of warfarin, heparin and dabigatran;

[0077] Drug E is selected from any one of lirabel, nitroglycerin, urapidil and nifedipine; Drug F is selected from any one of macain, omega-3 fatty acids and choroidergic acid;

[0078] A method for preparing an injection composition for treating fundus macular edema comprises the following steps:

[0079] S1: Add Agent A, Agent B, Agent C, Agent D, Agent E and Agent F in a ratio of 1:2:4:2:3:3 into a sterile glass bottle containing 15 ml of normal saline and stir for 6 minutes to completely dissolve;

[0080] S2: sterile filtration of the dissolved drug solution;

[0081] S3: Fill the filtered drug solution into a 5 ml sterile syringe and seal it;

[0082] S4: Sterilize the syringe and perform quality inspection.

[0083] Wherein, in step S2, the dissolved drug solution is sterile filtered, and the specific steps are as follows:

[0084] S21: prepare a container with an electric field generator and an ultrasonic generator, and set the parameters of the electric field generator to be 110 V / cm in electric field strength and 65 Hz in frequency, and the parameters of the ultrasonic generator to be 12 W in power and 25 kHz in frequency;

[0085] S22: a filter membrane composed of a plurality of 1.5 nm conical nanofilter membranes is installed in the container, and the dissolved drug solution is filtered through the nanofilter membrane;

[0086] S23: turning on the electric field generator to make the electric field act on the nanofiltration membrane and the microorganisms and particles in the drug solution, changing the movement trajectories of the microorganisms and particles and increasing the collision frequency between the microorganisms and particles and the filtration membrane;

[0087] S24: Turn on the ultrasonic generator to make the ultrasonic wave generate tiny vibrations and eddies on the surface of the filter membrane, thereby accelerating the filtration speed of the drug solution;

[0088] S25: Transfer the filtered drug solution into a sterile container.

[0089] Among them, step S25, transferring the filtered drug solution into a sterile container, the specific steps are as follows:

[0090] A1: Design a microfluidic chip, set the channel size of the microfluidic chip to 9.5 μm, the channel structure to be linear, and the microfluidic chip material to be glass;

[0091] A2: Inject the filtered drug solution into the injection port of the designed microfluidic chip;

[0092] A3: The drug solution passes through the microfluidic chip channel, precisely controlling the flow of the drug solution and transferring it to a sterile container at a flow rate of 2.4 ml / min, a pressure of 5 Pa, and a temperature of 28 °C;

[0093] A4: Seal the sterile container filled with the drug container.

[0094] Embodiment 3:

[0095] An injection composition for treating fundus macular edema, comprising agent A, agent B, agent C, agent D, agent E and agent F, wherein the agent A, agent B, agent C, agent D, agent E and agent F are respectively composed of triflumethasone, bevacizumab, vitamin E, warfarin, lirabel and macain, and the mass percentages thereof are 3.3% of agent A, 6.4% of agent B, 9.7% of agent C, 6.3% of agent D, 12.1% of agent E and 10.8% of agent F;

[0096] The mass components include 4 parts of triflumethasone, 11 parts of bevacizumab, 8 parts of vitamin E, 6 parts of warfarin, 4 parts of lirabel and 7 parts of macain.

[0097] The drug A is selected from any one of triflumethasone, methylprednisolone, dexamethasone sodium phosphate and trifluprednisolone; the drug B is selected from any one of acyclovir, bevacizumab, axitomeprazol, ranibizumab and everolimus;

[0098] Agent C is selected from any one of vitamin E, lutein, grape seed extract and coenzyme Q10; Agent D is selected from any one of warfarin, heparin and dabigatran;

[0099] Drug E is selected from any one of lirabel, nitroglycerin, urapidil and nifedipine; Drug F is selected from any one of macain, omega-3 fatty acids and choroidergic acid;

[0100] A method for preparing an injection composition for treating fundus macular edema comprises the following steps:

[0101] S1: Add Agent A, Agent B, Agent C, Agent D, Agent E and Agent F in a ratio of 1:2:4:2:3:3 into a sterile glass bottle containing 15 ml of normal saline and stir for 6 minutes to completely dissolve;

[0102] S2: sterile filtration of the dissolved drug solution;

[0103] S3: Fill the filtered drug solution into a 5 ml sterile syringe and seal it;

[0104] S4: Sterilize the syringe and perform quality inspection.

[0105] Wherein, in step S2, the dissolved drug solution is sterile filtered, and the specific steps are as follows:

[0106] S21: prepare a container with an electric field generator and an ultrasonic generator, and set the parameters of the electric field generator to have an electric field strength of 120 V / cm and a frequency of 43 Hz, and the parameters of the ultrasonic generator to have a power of 16 W and a frequency of 31 kHz;

[0107] S22: a filter membrane composed of a plurality of 2 nm conical nanofilter membranes is installed in the container, and the dissolved drug solution is filtered through the nanofilter membrane;

[0108] S23: turning on the electric field generator to make the electric field act on the nanofiltration membrane and the microorganisms and particles in the drug solution, changing the movement trajectories of the microorganisms and particles and increasing the collision frequency between the microorganisms and particles and the filtration membrane;

[0109] S24: Turn on the ultrasonic generator to make the ultrasonic wave generate tiny vibrations and eddies on the surface of the filter membrane, thereby accelerating the filtration speed of the drug solution;

[0110] S25: Transfer the filtered drug solution into a sterile container.

[0111] Among them, step S25, transferring the filtered drug solution into a sterile container, the specific steps are as follows:

[0112] A1: Design a microfluidic chip, set the channel size of the microfluidic chip to 11 μm, the channel structure to be linear, and the microfluidic chip material to be glass;

[0113] A2: Inject the filtered drug solution into the injection port of the designed microfluidic chip;

[0114] A3: The drug solution passes through the microfluidic chip channel, precisely controlling the flow of the drug solution and transferring it to a sterile container at a flow rate of 3.1 ml / min, a pressure of 3.4 Pa, and a temperature of 26 °C;

[0115] A4: Seal the sterile container filled with the drug container.

[0116] Experimental example:

[0117] 1. The injection composition prepared by the preparation method of this case and the traditional drugs for treating fundus macular edema (axitinib, lepril, docetaxel) were analyzed and compared, and the efficacy of the drug solutions of Examples 1-3 was verified as follows:

[0118] 1. Experimental subjects: 36 experimental rats of both sexes, aged 3 months, were selected and all were induced to have macular edema;

[0119] 2. Experimental method: 36 experimental rats were randomly divided into 6 groups. The first 3 groups were injected with the injection compositions of Examples 1-3 and observed for 5 days. The last 3 groups were injected with traditional drugs (axitinib, lepril, docetaxel) and observed for 5 days. The retinal thickness, vascular permeability, retinal cell morphology and arrangement density, inflammatory factor content (TNF-α) and light sensitivity were measured to evaluate the efficacy of the drug solution.

[0120] Among them, retinal thickness is measured by fundus OCT (optical coherence tomography) technology, blood penetration is measured by fluorescent angiography imaging technology to obtain fluorescence intensity value, retinal cell morphology and arrangement density are measured by quantitative analysis of retinal cell morphological characteristics using a high-resolution digital fundus camera, inflammatory factor content (TNF-α) is measured by ELISA, and light sensitivity is measured by VEP (visual evoked potential) to obtain VEP waveform amplitude. The experimental results are shown in the table below:

[0121]

[0122] According to the above table, the retinal thickness, vascular permeability, retinal cell morphology arrangement density, inflammatory factor content (TNF-α) and light sensitivity of the traditional drugs for treating fundus macular edema (Axitinib, Lepril, Docetaxel) measured in rats three days after taking them are slightly inferior to the above data obtained by injecting the injection composition prepared by the preparation method of this case. It can be seen that the injection composition used in this case for treating fundus macular edema has better efficacy, faster effect, and faster recovery of experimental subjects. The above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field within the technical scope disclosed by the present invention, according to the technical solution and its inventive concept of the present invention, is equivalently replaced or changed, which should be covered within the protection scope of the present invention.

Claims

1. An injection composition for treating fundus macular edema, comprising agent A, agent B, agent C, agent D, agent E and agent F, characterized in that: The medicine A, medicine B, medicine C, medicine D, medicine E and medicine F are respectively composed of triflumetasone, bevacizumab, vitamin E, warfarin, lirabel and macain, and their mass percentages are 2.2-12.5% ​​of medicine A, 4.3-33.1% of medicine B, 8.5-24.7% of medicine C, 5.5-13.2% of medicine D, 7.1-26.3% of medicine E and 6.4-23.8% of medicine F.

2. An injection composition for treating fundus macular edema according to claim 1, characterized in that: The mass components of the medicine A, medicine B, medicine C, medicine D, medicine E and medicine F include 3-10 parts of triflumethasone, 6-17 parts of bevacizumab, 8-12 parts of vitamin E, 5-7 parts of warfarin, 3-9 parts of lirabel and 4-8 parts of macain.

3. The injection composition for treating fundus macular edema according to claim 1, characterized in that: The drug A is selected from any one of triflumethasone, methylprednisolone, dexamethasone sodium phosphate and trifluprednisolone; and the drug B is selected from any one of acyclovir, bevacizumab, axitomeprazol, ranibizumab and everolimus.

4. The injection composition for treating fundus macular edema according to claim 1, characterized in that: The drug C is selected from any one of vitamin E, lutein, grape seed extract and coenzyme Q10; and the drug D is selected from any one of warfarin, heparin and dabigatran.

5. The injection composition for treating fundus macular edema according to claim 1, characterized in that: The drug E is selected from any one of lirabel, nitroglycerin, urapidil and nifedipine; the drug F is selected from any one of macain, omega-3 fatty acids and choroidergic.

6. A method for preparing an injection composition for treating fundus macular edema according to any one of claims 1 to 5, characterized in that: The following steps are involved: S1: Add Agent A, Agent B, Agent C, Agent D, Agent E and Agent F into a sterile glass bottle containing physiological saline in a ratio of 1:2:4:2:3:3, and stir for 6-10 minutes to completely dissolve them; S2: sterile filtration of the dissolved drug solution; S3: Fill the filtered drug solution into a sterile syringe and seal it; S4: Sterilize the syringe and perform quality inspection.

7. The method for preparing an injection composition for treating fundus macular edema according to claim 6, characterized in that: In the step S2, the dissolved drug solution is sterile filtered, and the specific steps are as follows: S21: prepare a container with an electric field generator and an ultrasonic generator, and set the parameters of the electric field generator to be 100 V / cm in electric field strength and 50 Hz in frequency, and the parameters of the ultrasonic generator to be 10 W in power and 20 kHz in frequency; S22: a filter membrane composed of a plurality of 1 nm conical nanofilter membranes is installed in the container, and the dissolved drug solution is filtered through the nanofilter membrane; S23: turning on the electric field generator to make the electric field act on the nanofiltration membrane and the microorganisms and particles in the drug solution, changing the movement trajectories of the microorganisms and particles and increasing the collision frequency between the microorganisms and particles and the filtration membrane; S24: Turn on the ultrasonic generator to make the ultrasonic wave generate tiny vibrations and eddies on the surface of the filter membrane, thereby accelerating the filtration speed of the drug solution; S25: Transfer the filtered drug solution into a sterile container.

8. The method for preparing an injection composition for treating fundus macular edema according to claim 7, characterized in that: The step S25, transferring the filtered drug solution into a sterile container, has the following specific steps: A1: Design a microfluidic chip, set the channel size of the microfluidic chip to 10 μm, the channel structure to be linear, and the microfluidic chip material to be glass; A2: Inject the filtered drug solution into the injection port of the designed microfluidic chip; A3: The drug solution passes through the microfluidic chip channel, precisely controlling the flow of the drug solution and transferring it to a sterile container at a flow rate of 3 ml / min, a pressure of 4 Pa, and a temperature of 25 °C; A4: Seal the sterile container filled with the drug container.

9. The method for preparing an injection composition for treating fundus macular edema according to claim 8, characterized in that: The channel structure of the microfluidic chip adopts any one of a straight line type, a curved line type and a branch type.

Images