Vitreous cavity in-vivo metabolism injection composition and preparation method thereof

Abstract

The invention discloses a vitreous cavity in-vivo metabolism injection composition and a preparation method thereof, and relates to the technical field of biological medicine, the composition comprises the following components: 17%-48% of an active substance, 2%-8% of a buffer agent, 2%-8% of an osmotic pressure regulator, and the balance of water; through the synergistic effect of various active ingredients including verapamil, pinadil, sodium hyaluronate, vitamin C and dexamethasone, the functions of a calcium channel and a potassium channel of eye cells are effectively adjusted, the excitability of nerve cells is optimized, normal metabolism of vitreous bodies is promoted, and the effect of improving the eye quality is achieved. The comprehensive regulation effect remarkably improves the treatment effect on eye diseases, meanwhile, through a reasonable preparation process and sterilization treatment, the purity and safety of the injection are ensured, side effects are reduced, and a safer and more effective treatment scheme is provided for patients.

Description

Technical Field

[0001] The present invention relates to the field of biomedicine technology, and in particular to a vitreous cavity in vivo metabolic injection liquid composition and a preparation method thereof. Background Art

[0002] With the accelerated pace of modern life and the rising incidence of eye diseases, the demand for treatment of eye diseases is increasing. Among them, the vitreous cavity is an important component of the eyeball, and its health status is directly related to the normal function of vision. Therefore, treatment within the vitreous cavity has become one of the hot topics in the biomedical field. By injecting drugs into the vitreous cavity, it can directly act on the lesion site, improve the treatment effect, and reduce the side effects of systemic medication.

[0003] Although a variety of intravitreal injection drugs have been used in clinical practice, these drugs still have many shortcomings. On the one hand, traditional drugs have poor stability and short half-lives in the vitreous cavity, making it difficult to maintain effective concentrations for a long time. On the other hand, the mechanism of action of these drugs is relatively simple and can often only target a specific pathological process. The pathogenesis of eye diseases is complex, and a single drug often cannot achieve an ideal therapeutic effect. In addition, traditional drugs will introduce impurities during the preparation process, affecting the purity and safety of the drugs, and may cause eye discomfort or inflammatory reactions after injection. In particular, existing drugs often ignore the importance of ocular cell calcium channels and potassium channels in the physiological functions of ocular cells and fail to effectively regulate the functions of these channels, thereby affecting the efficacy and safety of the drugs.

[0004] In view of the above problems, it is necessary to optimize the existing vitreous cavity metabolic injection composition, achieve effective regulation of the calcium channels and potassium channels of eye cells through active ingredients, and at the same time improve the stability and safety of the injection and prolong the action time by optimizing the preparation method and sterilization technology. Therefore, it is of great significance to develop a vitreous cavity metabolic injection composition and its preparation method that can comprehensively achieve the above characteristics. Summary of the invention

[0005] The purpose of the present invention is to make up for the deficiencies of the prior art and provide a vitreous cavity metabolic injection composition and a preparation method thereof. It can achieve effective regulation of calcium channels and potassium channels of eye cells, optimize the excitability of nerve cells, and promote normal metabolism of vitreous body by screening active ingredients, including calcium channel regulator verapamil, potassium channel regulator pinacidil, vitreous metabolism promoting substance sodium hyaluronate, antioxidant vitamin C and anti-inflammatory substance dexamethasone. At the same time, by optimizing the preparation method and sterilization technology, the stability and safety of the injection are improved, the action time is prolonged, and the occurrence of side effects is reduced.

[0006] In order to solve the above technical problems, the present invention provides the following technical solutions: On the one hand, a vitreous cavity intravitreal metabolic injection composition is characterized in that the composition comprises the following components: 17%-48% of active substance, 2%-8% of buffer, 2%-8% of osmotic pressure regulator, and the balance is water;

[0007] The active substances include calcium channel regulators, potassium channel regulators, substances that promote vitreous metabolism, antioxidants, and anti-inflammatory substances;

[0008] The buffer is selected from sodium dihydrogen phosphate and disodium hydrogen phosphate, and the ratio thereof is 1:1-1:2;

[0009] The osmotic pressure regulator is selected from sodium chloride or glucose.

[0010] Furthermore, among the active substances, the calcium channel regulator is verapamil, with a content of 5%-15%, the potassium channel regulator is pinacidil, with a content of 5%-12%, the substance promoting vitreous metabolism is sodium hyaluronate, with a content of 4%-10%, the antioxidant is vitamin C, with a content of 2%-6%, and the anti-inflammatory substance is dexamethasone, with a content of 1%-5%.

[0011] In another aspect, a method for preparing a vitreous cavity metabolic injection composition comprises the following specific steps:

[0012] Raw material pretreatment: Verapamil and pinacidil are micronized using micronizing equipment, verapamil and pinacidil are ground into fine particles, sodium hyaluronate is preactivated using hyaluronidase, and vitamin C and dexamethasone are stabilized;

[0013] Weighing and dissolving: weigh the pretreated verapamil, pinacidil, sodium hyaluronate, vitamin C, dexamethasone, buffer and osmotic pressure regulator according to the formula ratio, add the weighed substances into water for injection, and stir to dissolve;

[0014] pH adjustment and volume setting: Use a buffer to adjust the pH of the solution, add the remaining water for injection to the predetermined volume, and stir evenly;

[0015] Filtration and sterilization: The solution is coarsely filtered by sand filtration to remove large particles of impurities in the solution, and then finely filtered by microporous membrane filtration to further remove impurities and particles. The filtered solution is sterilized by combining radiation sterilization technology with traditional high-temperature sterilization;

[0016] Finished product preparation: After filtering and sterilizing, the product is packaged to obtain a vitreous cavity metabolic injection liquid composition.

[0017] Furthermore, in the raw material pretreatment step, verapamil and pinacidil are micronized using a micronizing device, the rotation speed of the micronizing device is between 1000rpm-5000rpm, the processing time is 10 minutes-60 minutes, and the particle size range of verapamil and pinacidil after micronization is between 1μm-10μm.

[0018] Furthermore, in the raw material pretreatment step, hyaluronidase accounting for 0.1%-5% of the mass of sodium hyaluronate is used to pre-activate sodium hyaluronate at a temperature of 20° C.-40° C. for 30 minutes-180 minutes.

[0019] Furthermore, in the raw material pretreatment step, vitamin C and dexamethasone are subjected to stability treatment. Specifically, vitamin E is selected as an antioxidant, and the amount used is 0.1%-3% of the mass of vitamin C and dexamethasone. The antioxidant is slowly added to the container where vitamin C and dexamethasone are located, and stirred for 10-30 minutes.

[0020] Furthermore, in the weighing and dissolving step, the weighed substance is added to water for injection and stirred to dissolve. The stirring speed during dissolution is between 100rpm-500rpm, the dissolution temperature is between 20°C-35°C, and the dissolution time is 10 minutes-60 minutes.

[0021] Furthermore, in the pH adjustment and volume fixing steps, a buffer is used to adjust the pH value of the solution to 7.0-7.4.

[0022] Furthermore, in the filtering and sterilizing steps, the solution is coarsely filtered by sand filtration to remove larger particle impurities in the solution, and the filter pore size is between 10μm-50μm, and then fine filtration is performed using a microporous filter membrane to further remove fine impurities and particles. The filter pore size can be between 0.22μm-0.45μm.

[0023] Furthermore, in the filtering and sterilization steps, the filtered solution is sterilized by combining radiation sterilization technology with traditional high-temperature sterilization. Specifically, the container containing the injection solution is placed in a gamma ray sterilization device, the gamma ray sterilization dose is set between 5kGy-25kGy, and the sterilization time is 30 minutes-60 minutes. The injection solution container that has been sterilized by gamma ray is taken out from the gamma ray sterilization device, placed in a high-temperature sterilization device, the high-temperature sterilization temperature is set between 100°C-121°C, the sterilization time is 10 minutes-30 minutes, and the high-temperature sterilization device is started to perform high-temperature sterilization.

[0024] Compared with the prior art, the vitreous cavity in vivo metabolic injection composition and the preparation method thereof have the following beneficial effects:

[0025] 1. The present invention effectively regulates the calcium channel and potassium channel functions of eye cells, optimizes the excitability of nerve cells, and promotes the normal metabolism of vitreous body through the synergistic effect of multiple active ingredients, including verapamil, pinacidil, sodium hyaluronate, vitamin C and dexamethasone. This comprehensive regulatory effect significantly improves the therapeutic effect on eye diseases. At the same time, through reasonable preparation technology and sterilization treatment, the purity and safety of the injection are ensured, the occurrence of side effects is reduced, and a safer and more effective treatment plan is provided for patients.

[0026] 2. The present invention improves the stability and solubility of the drug by adopting a specific pretreatment method and preparation process, so that it can maintain its activity in the vitreous cavity for a long time, which not only prolongs the action time of the drug and reduces the injection frequency of the patient, thereby alleviating the patient's pain and economic burden, but also improves the convenience of treatment and the patient's compliance, providing strong support for long-term treatment.

[0027] Other advantages, objectives and features of the present invention will be set forth in part in the following description and, in part, will be apparent to those skilled in the art based on an examination of the following or may be taught from the practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the prior art descriptions are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention, and for ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0029] Figure 1 The present invention is a flow chart of a method for preparing a vitreous cavity in vivo metabolic injection liquid composition. DETAILED DESCRIPTION

[0030] 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 them. 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.

[0031] Comparative Example

[0032] Configuration of the vitreous cavity intravitreal metabolic injection composition: active substances account for 45%, of which: verapamil accounts for 12% for calcium channel regulation, pinacidil accounts for 10% as a potassium channel regulator, sodium hyaluronate accounts for 8% to promote vitreous metabolism, vitamin C accounts for 7% to play an antioxidant role, dexamethasone accounts for 8% to have an anti-inflammatory effect, the buffer accounts for 4%, sodium dihydrogen phosphate and disodium hydrogen phosphate are selected in a ratio of 1:1.2 to ensure that the pH value of the solution is stable at 7.1, the osmotic pressure regulator accounts for 4%, sodium chloride is selected to make the osmotic pressure of the injection solution compatible with the osmotic pressure in the vitreous cavity, and water for injection accounts for 47%.

[0033] First, verapamil and pinacidil were micronized by using micronizing equipment, the equipment speed was set to 2500rpm, and the processing time was 40 minutes. After the treatment, the particle size of verapamil and pinacidil was controlled between 3μm and 8μm, which was conducive to better play a role after injection and improve the bioavailability of the drug. Secondly, sodium hyaluronate was pre-activated by using hyaluronidase accounting for 2.5% of the mass of sodium hyaluronate and treating it at 35°C for 120 minutes. The activity of sodium hyaluronate was activated by enzyme treatment, so that it can better play a role in promoting vitreous metabolism. Vitamin C and dexamethasone were stabilized, and vitamin E was selected as an antioxidant. The dosage is 1.5% of the mass of vitamin C and dexamethasone. Vitamin E is slowly added to the container where vitamin C and dexamethasone are located, and stirred with a stirrer for 25 minutes to ensure that the antioxidant is fully mixed with vitamin C and dexamethasone to improve its stability and prevent oxidation and degradation during preparation and storage. Then, according to the above precise formula ratio, each component is weighed using a high-precision weighing device with a weighing accuracy controlled at ±0.3mg. The weighed substance is added to an appropriate amount of water for injection, and dissolved at a temperature of 28°C and a stirring speed of 250rpm for 45 minutes. By controlling the dissolution temperature and stirring speed, the uniform dissolution of each component is promoted to form a stable solution system, and then the Use pre-prepared sodium dihydrogen phosphate and disodium hydrogen phosphate buffers to adjust the pH value of the solution to 7.1. During the adjustment process, closely monitor the changes in pH value to ensure that it is stable within the required range, and add the remaining water for injection to the predetermined volume while continuously stirring to ensure the uniformity of the solution. The precision of constant volume is controlled within ±0.2ml to ensure that the volume of the injection is accurate. Then, use sand filtration with a filtration pore size of 25μm to remove larger particle impurities in the solution through coarse filtration, providing a good foundation for subsequent fine filtration. Then use microporous membrane filtration with a filtration pore size of 0.25μm to further remove fine impurities and particles to ensure the purity and transparency of the injection. The filtered solution The liquid is first sterilized by gamma rays, and the container containing the injection is placed in the gamma ray sterilization equipment. The sterilization dose is set to 18kGy and the sterilization time is 50 minutes. Gamma rays can penetrate the container and the solution, kill various microorganisms, and ensure the sterility of the injection. Then, the treated injection container is taken out from the gamma ray sterilization equipment, and placed in the high-temperature sterilization equipment. The high-temperature sterilization temperature is set to 115℃ and the sterilization time is 25 minutes. Through high-temperature sterilization, possible residual microorganisms are further killed to improve the reliability of the sterilization effect. Finally, the injection is packaged, and packaging materials that meet medical standards are selected to ensure the sealing and stability of the package to prevent the injection from being contaminated by the external environment.

[0034] In the above comparative example, the calcium channel regulator verapamil accounts for 12%. Verapamil can effectively inhibit the over-activation of calcium channels, reduce the intracellular calcium concentration by 30%, greatly reduce the risk of cell damage caused by intracellular calcium overload, and protect the normal physiological function of eye cells. At the same time, the potassium channel regulator pinacidil accounts for 10% of the comparative example. Pinacidil mainly adjusts the excitability of nerve cells to the normal range by 28% by regulating potassium channels, reduces nerve damage, and optimizes the function of eye nerve cells. In addition, pinacidil regulates the potassium channels of vascular smooth muscle cells, dilates ocular blood vessels, increases ocular blood flow by 20%, and brings more sufficient nutrition and oxygen to eye tissues.

[0035] Embodiment 1

[0036] Configuration of the vitreous cavity intravitreal metabolic injection composition: active substances account for 43%, of which: verapamil accounts for 10%, which is used for calcium channel regulation, pinacidil accounts for 10%, which is used as a potassium channel regulator, sodium hyaluronate accounts for 8%, which promotes vitreous metabolism, vitamin C accounts for 7%, which plays an antioxidant role, dexamethasone accounts for 8%, which has an anti-inflammatory effect, the buffer accounts for 4%, and sodium dihydrogen phosphate and disodium hydrogen phosphate are selected in a ratio of 1:1.2 to ensure that the pH value of the solution is stable at 7.2, the osmotic pressure regulator accounts for 4%, and sodium chloride is selected to make the osmotic pressure of the injection solution compatible with the osmotic pressure in the vitreous cavity, and water for injection accounts for 49%.

[0037] Same as the comparative example.

[0038] In the above comparative example, the calcium channel regulator verapamil accounts for 10%. Verapamil can effectively inhibit the excessive activation of calcium channels and reduce the intracellular calcium concentration by 25%. Compared with the comparative example, the reduction in intracellular calcium concentration was reduced by 5%. At the same time, the potassium channel regulator pinacidil accounts for 10% of the comparative example, which has not changed compared with the comparative example.

[0039] Embodiment 2

[0040] Configuration of the vitreous cavity intravitreal metabolic injection composition: active substances account for 48%, of which: verapamil accounts for 15% for calcium channel regulation, pinacidil accounts for 10% as a potassium channel regulator, sodium hyaluronate accounts for 8% to promote vitreous metabolism, vitamin C accounts for 7% to play an antioxidant role, dexamethasone accounts for 8% for anti-inflammatory effect, buffer accounts for 4%, sodium dihydrogen phosphate and disodium hydrogen phosphate are selected in a ratio of 1:1.2 to ensure that the pH value of the solution is stable at 7.2, osmotic pressure regulator accounts for 4%, sodium chloride is selected to make the osmotic pressure of the injection solution compatible with the osmotic pressure in the vitreous cavity, and water for injection accounts for 44%.

[0041] Same as the comparative example.

[0042] In the above comparative example, the calcium channel regulator verapamil accounts for 15%. Verapamil can effectively inhibit the excessive activation of calcium channels and reduce the intracellular calcium concentration by 35%. Compared with the comparative example, the reduction in intracellular calcium concentration increased by 5%. At the same time, the potassium channel regulator pinacidil accounts for 10% of the comparative example, which has not changed compared with the comparative example.

[0043] Embodiment 3

[0044] Configuration of the vitreous cavity intravitreal metabolic injection composition: active substances account for 46%, of which: verapamil accounts for 13% for calcium channel regulation, pinacidil accounts for 10% as a potassium channel regulator, sodium hyaluronate accounts for 8% to promote vitreous metabolism, vitamin C accounts for 7% to play an antioxidant role, dexamethasone accounts for 8% to have an anti-inflammatory effect, buffer accounts for 4%, sodium dihydrogen phosphate and disodium hydrogen phosphate are selected in a ratio of 1:1.2 to ensure that the pH value of the solution is stable at 7.2, osmotic pressure regulator accounts for 4%, sodium chloride is selected to make the osmotic pressure of the injection solution compatible with the osmotic pressure in the vitreous cavity, and water for injection accounts for 47%.

[0045] Same as the comparative example.

[0046] In the above comparative example, the calcium channel regulator verapamil accounts for 13%. Verapamil can effectively inhibit the excessive activation of calcium channels and reduce the intracellular calcium concentration by 32%. Compared with the comparative example, the reduction in intracellular calcium concentration increased by 2%. At the same time, the potassium channel regulator pinacidil accounts for 10% of the comparative example, which has not changed compared with the comparative example.

[0047] Embodiment 3

[0048] Configuration of the vitreous cavity intravitreal metabolic injection composition: active substances account for 46%, of which: verapamil accounts for 13% for calcium channel regulation, pinacidil accounts for 10% as a potassium channel regulator, sodium hyaluronate accounts for 8% to promote vitreous metabolism, vitamin C accounts for 7% to play an antioxidant role, dexamethasone accounts for 8% for anti-inflammatory effect, buffer accounts for 4%, sodium dihydrogen phosphate and disodium hydrogen phosphate are selected in a ratio of 1:1.2 to ensure that the pH value of the solution is stable at 7.2, osmotic pressure regulator accounts for 4%, sodium chloride is selected to make the osmotic pressure of the injection solution compatible with the osmotic pressure in the vitreous cavity, and water for injection accounts for 46%.

[0049] Same as the comparative example.

[0050] In the above comparative example, the calcium channel regulator verapamil accounts for 13%. Verapamil can effectively inhibit the excessive activation of calcium channels and reduce the intracellular calcium concentration by 32%. Compared with the comparative example, the reduction in intracellular calcium concentration increased by 2%. At the same time, the potassium channel regulator pinacidil accounts for 10% of the comparative example, which has not changed compared with the comparative example.

[0051]

[0052]

[0053] Table 1

[0054] As shown in Table 1, through the analysis of comparative examples and multiple embodiments, it is concluded that in the vitreous cavity intravitreal metabolic injection composition, changing the content of the calcium channel regulator verapamil will affect the degree of reduction in intracellular calcium concentration. In the development process of the injection composition, the degree of reduction in intracellular calcium concentration can be regulated by adjusting the content of verapamil to meet different clinical needs.

[0055] Embodiment 4

[0056] Configuration of the vitreous cavity intravitreal metabolic injection composition: active substances account for 43%, of which: verapamil accounts for 12% for calcium channel regulation, pinacidil accounts for 8% as a potassium channel regulator, sodium hyaluronate accounts for 8% to promote vitreous metabolism, vitamin C accounts for 7% to play an antioxidant role, dexamethasone accounts for 8% to have an anti-inflammatory effect, buffer accounts for 4%, sodium dihydrogen phosphate and disodium hydrogen phosphate are selected in a ratio of 1:1.2 to ensure that the pH value of the solution is stable at 7.1, osmotic pressure regulator accounts for 4%, sodium chloride is selected to make the osmotic pressure of the injection solution compatible with the osmotic pressure in the vitreous cavity, and water for injection accounts for 49%.

[0057] Same as the comparative example.

[0058] In the above comparison examples, the calcium channel regulator verapamil accounted for 12%, which was unchanged compared with the comparison example. Meanwhile, the potassium channel regulator pinacidil accounted for 8% of the comparison example. The proportion of nerve cell excitability adjusted to the normal range increased by about 25%, which was 3% lower than the comparison example. The ocular blood flow increased by 18%, which was 2% lower than the comparison example.

[0059] Embodiment 5

[0060] Configuration of the vitreous cavity intravitreal metabolic injection composition: active substances account for 47%, of which: verapamil accounts for 12% for calcium channel regulation, pinacidil accounts for 12% as a potassium channel regulator, sodium hyaluronate accounts for 8% to promote vitreous metabolism, vitamin C accounts for 7% to play an antioxidant role, dexamethasone accounts for 8% to have an anti-inflammatory effect, the buffer accounts for 4%, sodium dihydrogen phosphate and disodium hydrogen phosphate are selected in a ratio of 1:1.2 to ensure that the pH value of the solution is stable at 7.1, the osmotic pressure regulator accounts for 4%, sodium chloride is selected to make the osmotic pressure of the injection solution compatible with the osmotic pressure in the vitreous cavity, and water for injection accounts for 45%.

[0061] Same as the comparative example.

[0062] In the above comparison examples, the calcium channel regulator verapamil accounted for 12%, which was unchanged compared with the comparison example. Meanwhile, the potassium channel regulator pinacidil accounted for 12% of the comparison example. The proportion of nerve cell excitability adjusted to the normal range increased by 32%, which was 4% higher than the comparison example. The ocular blood flow increased by 23%, which was 3% higher than the comparison example.

[0063] Embodiment 6

[0064] Configuration of the vitreous cavity intravitreal metabolic injection composition: active substances account for 46%, of which: verapamil accounts for 12% for calcium channel regulation, pinacidil accounts for 11% as a potassium channel regulator, sodium hyaluronate accounts for 8% to promote vitreous metabolism, vitamin C accounts for 7% to play an antioxidant role, dexamethasone accounts for 8% to have an anti-inflammatory effect, buffer accounts for 4%, sodium dihydrogen phosphate and disodium hydrogen phosphate are selected in a ratio of 1:1.2 to ensure that the pH value of the solution is stable at 7.1, osmotic pressure regulator accounts for 4%, sodium chloride is selected to make the osmotic pressure of the injection solution compatible with the osmotic pressure in the vitreous cavity, and water for injection accounts for 46%.

[0065] Same as the comparative example.

[0066] In the above comparison examples, the calcium channel regulator verapamil accounted for 12%, which was unchanged compared with the comparison example. Meanwhile, the potassium channel regulator pinacidil accounted for 11% of the comparison example. The proportion of nerve cell excitability adjusted to the normal range increased by 30%, which was 2% higher than the comparison example. The ocular blood flow increased by 21%, which was 1% higher than the comparison example.

[0067]

[0068]

[0069] Table 2

[0070] As shown in Table 2, in the vitreous cavity intravitreal metabolic injection composition, when the content of the calcium channel regulator verapamil remains unchanged, changing the content of the potassium channel regulator pinacidil will have different degrees of influence on the proportion of nerve cell excitability adjusted to the normal range and the ocular blood flow, that is, in the research and development process of the injection composition, the effects such as nerve cell excitability and ocular blood flow are regulated by adjusting the content of pinacidil, thereby providing a variety of formulation options to meet different clinical needs.

[0071] It will be apparent to those skilled in the art that the invention is not limited to the details of the exemplary embodiments described above and that the invention can be implemented in other specific forms without departing from the spirit or essential features of the invention. Therefore, the embodiments should be considered exemplary and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description, and it is intended that all variations falling within the meaning and scope of the equivalent elements of the claims be included in the invention. Any reference numeral in a claim should not be considered as limiting the claim to which it relates.

Claims

1. A vitreous cavity metabolic injection composition, characterized in that: The composition comprises the following components: 17%-48% of active substance, 2%-8% of buffer, 2%-8% of osmotic pressure regulator, and the balance is water; The active substances include calcium channel regulators, potassium channel regulators, substances that promote vitreous metabolism, antioxidants, and anti-inflammatory substances; The buffer is selected from sodium dihydrogen phosphate and disodium hydrogen phosphate, and the ratio thereof is 1:1-1:2; The osmotic pressure regulator is selected from sodium chloride or glucose.

2. The vitreous body intravitreal metabolic injection composition according to claim 1, characterized in that: Among the active substances, the calcium channel regulator is verapamil, with a content of 5%-15%, the potassium channel regulator is pinacidil, with a content of 5%-12%, the substance promoting vitreous metabolism is sodium hyaluronate, with a content of 4%-10%, the antioxidant is vitamin C, with a content of 2%-6%, and the anti-inflammatory substance is dexamethasone, with a content of 1%-5%.

3. A method for preparing a vitreous cavity metabolic injection composition according to any one of claims 1 to 2, characterized in that: The method comprises the following specific steps: Raw material pretreatment: Verapamil and pinacidil are micronized using micronizing equipment, verapamil and pinacidil are ground into fine particles, sodium hyaluronate is preactivated using hyaluronidase, and vitamin C and dexamethasone are stabilized; Weighing and dissolving: weigh the pretreated verapamil, pinacidil, sodium hyaluronate, vitamin C, dexamethasone, buffer and osmotic pressure regulator according to the formula ratio, add the weighed substances into water for injection, and stir to dissolve; pH adjustment and volume setting: Use a buffer to adjust the pH of the solution, add the remaining water for injection to the predetermined volume, and stir evenly; Filtration and sterilization: The solution is coarsely filtered by sand filtration to remove large particles of impurities in the solution, and then finely filtered by microporous membrane filtration to further remove impurities and particles. The filtered solution is sterilized by combining radiation sterilization technology with traditional high-temperature sterilization; Finished product preparation: After filtering and sterilizing, the product is packaged to obtain a vitreous cavity metabolic injection liquid composition.

4. The method for preparing a vitreous cavity metabolic injection composition according to claim 3, characterized in that: In the raw material pretreatment step, verapamil and pinacidil are micronized using a micronizing device, the rotation speed of the micronizing device is between 1000rpm and 5000rpm, the treatment time is 10 minutes to 60 minutes, and the particle size range of verapamil and pinacidil after micronization is between 1μm and 10μm.

5. The method for preparing a vitreous cavity metabolic injection composition according to claim 3, characterized in that: In the raw material pretreatment step, 0.1%-5% of the mass of sodium hyaluronate is used to pre-activate sodium hyaluronate at a temperature of 20° C.-40° C. for 30 minutes-180 minutes.

6. The method for preparing a vitreous cavity metabolic injection composition according to claim 3, characterized in that: In the raw material pretreatment step, vitamin C and dexamethasone are subjected to stability treatment. Specifically, vitamin E is selected as an antioxidant, and the amount used is 0.1%-3% of the mass of vitamin C and dexamethasone. The antioxidant is slowly added to the container where vitamin C and dexamethasone are located, and stirred for 10-30 minutes.

7. The method for preparing a vitreous body metabolic injection composition according to claim 3, characterized in that: In the weighing and dissolving step, the weighed substance is added to water for injection and stirred to dissolve. The stirring speed during dissolution is between 100 rpm and 500 rpm, the dissolution temperature is between 20° C. and 35° C., and the dissolution time is between 10 minutes and 60 minutes.

8. The method for preparing a vitreous cavity metabolic injection composition according to claim 3, characterized in that: In the pH adjustment and volume fixing steps, a buffer is used to adjust the pH value of the solution to 7.0-7.

4.

9. The method for preparing a vitreous body metabolic injection composition according to claim 3, characterized in that: In the filtering and sterilizing step, the solution is coarsely filtered by sand filtration to remove larger particle impurities in the solution, and the filter pore size is between 10μm-50μm. Then, fine filtration is performed using a microporous filter membrane to further remove fine impurities and particles. The coarse filtration can be between 0.22μm-0.45μm.

10. The method for preparing a vitreous body metabolic injection composition according to claim 3, characterized in that: In the filtering and sterilizing step, the filtered solution is sterilized by combining radiation sterilization technology with traditional high-temperature sterilization. Specifically, the container containing the injection solution is placed in a gamma ray sterilization device, the gamma ray sterilization dose is set between 5kGy-25kGy, and the sterilization time is 30 minutes-60 minutes. The injection solution container that has been sterilized by gamma ray is taken out from the gamma ray sterilization device, and placed in a high-temperature sterilization device. The high-temperature sterilization temperature is set between 100°C and 121°C, and the sterilization time is 10 minutes-30 minutes. The high-temperature sterilization device is started to perform high-temperature sterilization.

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