Chewing tablet for treating myopia and its preparation method

Abstract

This invention relates to the field of traditional Chinese medicine preparations, specifically a chewable tablet for adjuvant treatment of myopia and its preparation method, comprising the following raw materials and excipients in parts by weight: Codonopsis pilosula 150-220 parts, Angelica sinensis 150-220 parts, Lycium barbarum 300-500 parts, Poria cocos 40-70 parts, Ophiopogon japonicus 50-80 parts, Alisma plantago-aquatica 35-50 parts, Schisandra chinensis 30-40 parts, Acorus tatarinowii 30-40 parts, Paeonia suffruticosa 35-50 parts, and Polygala tenuifolia (processed with licorice water) 30-40 parts; excipients: mannitol 120-160 parts, sucrose 220- 300 parts, 1-3 parts steviol glycosides, 3-5 parts magnesium stearate, 30-35 parts gastric-soluble film-coating premix, and an appropriate amount of 40-60% ethanol; This invention achieves the effects of tonifying qi and blood, nourishing the liver and kidneys through traditional Chinese medicines such as Codonopsis pilosula, Angelica sinensis, and Lycium barbarum, combined with the effects of Acorus tatarinowii and Polygala tenuifolia in opening the orifices and calming the mind. It has a significant effect on improving vision and relieving eye muscle spasms, especially for myopia, particularly pseudomyopia and eye fatigue in adolescents. The formulation of this invention strictly follows the traditional treatment principles of tonifying qi and blood, nourishing the liver and kidneys, and improving vision and calming the mind. The effective ingredient content is clear and the effect is stable.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparations, specifically a chewable tablet for the adjunctive treatment of myopia and its preparation method. Background Technology

[0002] Myopia is a common eye disease, especially prevalent among adolescents. Traditional Chinese medicine often addresses it by tonifying qi and blood, nourishing the liver and kidneys, and improving eyesight and calming the mind. While various drugs and treatments exist for myopia, they often suffer from unstable efficacy, inconvenient administration, or side effects. Therefore, developing a highly effective, convenient, and stable drug for treating myopia is of significant clinical importance. Summary of the Invention

[0003] This invention provides a light-enhancing chewable tablet for treating myopia that is scientifically formulated, has a good taste, disintegrates rapidly, is quickly absorbed, has high compliance, stable and controllable quality, and is suitable for industrial production, as well as its preparation method.

[0004] To achieve the above objectives, the present invention adopts the following technical solution:

[0005] A chewable tablet for the adjunctive treatment of myopia, made from the following parts by weight of active pharmaceutical ingredients and excipients:

[0006] Raw materials: Codonopsis pilosula 150-220 parts, Angelica sinensis 150-220 parts, Lycium barbarum 300-500 parts, Poria cocos 40-70 parts, Ophiopogon japonicus 50-80 parts, Alisma plantago-aquatica 35-50 parts, Schisandra chinensis 30-40 parts, Acorus tatarinowii 30-40 parts, Paeonia suffruticosa 35-50 parts, and Polygala tenuifolia (processed with licorice water) 30-40 parts;

[0007] Excipients: 120-160 parts mannitol, 220-300 parts sucrose, 1-3 parts steviol glycosides, 3-5 parts magnesium stearate, 30-35 parts gastric-soluble film-coating premix, and an appropriate amount of 40-60% ethanol.

[0008] Furthermore, a chewable tablet for the adjunctive treatment of myopia is made from the following parts by weight of active pharmaceutical ingredients and excipients:

[0009] Raw materials: Codonopsis pilosula 190 parts, Angelica sinensis 190 parts, Lycium barbarum 420 parts, Poria cocos 55 parts, Ophiopogon japonicus 70 parts, Alisma plantago-aquatica 45 parts, Schisandra chinensis 40 parts, Acorus tatarinowii 36 parts, Paeonia suffruticosa 48 parts, Polygala tenuifolia (processed with licorice water) 36 parts.

[0010] Excipients: 150 parts mannitol, 250 parts sucrose, 1.6 parts steviol glycosides, 4 parts magnesium stearate, 32 parts gastric-soluble film-coating premix, and an appropriate amount of 40-60% ethanol.

[0011] Furthermore, a chewable tablet for the adjunctive treatment of myopia is made from the following parts by weight of active pharmaceutical ingredients and excipients:

[0012] Raw materials: Codonopsis pilosula 180 parts, Angelica sinensis 210 parts, Lycium barbarum 450 parts, Poria cocos 50 parts, Ophiopogon japonicus 60 parts, Alisma plantago-aquatica 40 parts, Schisandra chinensis 35 parts, Acorus tatarinowii 35 parts, Paeonia suffruticosa 40 parts, and Polygala tenuifolia (processed with licorice water) 38 parts;

[0013] Excipients: 140 parts mannitol, 260 parts sucrose, 1.5 parts steviol glycosides, 3 parts magnesium stearate, 35 parts gastric-soluble film-coating premix, and an appropriate amount of 40-60% ethanol.

[0014] Furthermore, the processing method of Polygala tenuifolia is as follows: Take 6 kg of licorice and place it in a jacketed pot, add water and scald it, remove the dregs, add 100 kg of cleaned Polygala tenuifolia, cook until the soup is absorbed, take it out and dry it.

[0015] A method for preparing a chewable tablet for adjunctive treatment of myopia, comprising:

[0016] S1. Weigh out the following ingredients by weight: Schisandra chinensis, Acorus tatarinowii, Poria cocos, Polygala tenuifolia, and 1 / 5 to 1 / 4 of Codonopsis pilosula. Mix and grind them into a fine powder, then pass them through an 80-100 mesh sieve for later use.

[0017] S2, add water to the remaining Codonopsis pilosula, Angelica sinensis, Lycium barbarum, Ophiopogon japonicus, Alisma plantago-aquatica, and Paeonia suffruticosa root bark and decoct 1-3 times, each time adding water 6-10 times the weight of the herbs, extracting for 1-2 hours each time, combine the decoctions, filter, concentrate the filtrate to a clear extract with a relative density of 1.30-1.35 at 50℃, vacuum dry the clear extract to obtain a dry extract, and pulverize it through an 80-mesh sieve;

[0018] S3, mix dry powder, fine powder, mannitol and sucrose, granulate with 60% ethanol containing steviol glycosides as a wetting agent, dry and granulate;

[0019] S4, add magnesium stearate, mix evenly, compress into tablets, and coat with a gastric-soluble film to obtain the finished product.

[0020] Furthermore, in S1, the fine powder material is sent into a sterilizer for heat treatment. The heat treatment parameters are: vacuum degree: -0.08 to -0.1 MPa, heat treatment temperature: 115-125℃, and heat treatment time: 20-30 min.

[0021] Furthermore, in S2, the parameters of the concentrator during concentration are: steam pressure of 0.05-0.20 MPa, concentration temperature of 60-75℃, and vacuum degree of -0.04--0.09 MPa, until a clear paste with a relative density of 1.15-1.20 at 50℃ is obtained. Then, the concentration temperature is adjusted to 40-50℃ until a clear paste with a relative density of 1.30-1.35 at 50℃ is obtained.

[0022] Furthermore, in S2, during drying, the paste is poured into a vacuum dryer, and a vacuum is drawn to maintain a vacuum degree of -0.02 to -0.09 MPa inside the machine. Steam is introduced by opening the steam valve and adjusting the steam pressure to 0.05 to 0.2 MPa to control the temperature at 55-65℃ and the vacuum degree at -0.06 to -0.08 MPa. The dried paste is then pulverized and passed through an 80-mesh sieve.

[0023] Furthermore, in S3, the preparation of 60% ethanol containing steviol glycosides is as follows: steviol glycosides are weighed according to the weight and dissolved in 60% ethanol solution, stirred and mixed to prepare a 60% ethanol steviol glycoside solution.

[0024] Further, in step S3, the dry powder, fine powder, mannitol, and sucrose are added to a mixer according to their weight proportions and premixed for 6-10 minutes. Then, a 60% ethanol solution containing steviol glycosides and an appropriate amount of purified water are added and mixed for 5-8 minutes to form a soft material. The prepared soft material is then granulated using an 18 or 20 mesh sieve and a vibrating granulator. The wet granules are transferred to a fluidized bed dryer granulator with the following parameters set: temperature 70-120℃, heating temperature 40-80℃, outlet air temperature 40-80℃, material temperature 50-70℃, and induced draft fan frequency 20-50Hz. The equipment is started for drying, with the temperature gradually increasing and the stirring and dust removal functions activated. When the outlet air humidity reaches 5-12% and the granule moisture content is 3.0-6.0%, the material is discharged and granulated using a granulator.

[0025] Further, in S4, the prepared granules are transferred to a mixing machine, and a specified amount of magnesium stearate is added. The mixing parameters are controlled as follows: frequency 25 Hz, mixing time 30 min. After mixing, the material is sent to a tableting machine for tableting. The tableting machine parameters are controlled as follows: pressure 40-60 N, filling amount (tablet weight specification 0.8 g, disintegration time: ≤30 min) so that the tablet weight is within the range of (0.764 g-0.836 g). After tableting, a gastrointestinal film coating is applied to obtain the finished product.

[0026] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0027] This invention utilizes traditional Chinese medicines such as Codonopsis pilosula, Angelica sinensis, and Lycium barbarum to replenish qi and blood, nourish the liver and kidneys, and combine them with the calming and sedative effects of Acorus tatarinowii and Polygala tenuifolia. It significantly improves vision and relieves eye muscle spasms, particularly for myopia, especially pseudomyopia and eye strain in adolescents. The formulation of this invention strictly adheres to the traditional principles of replenishing qi and blood, nourishing the liver and kidneys, and improving vision and calming the mind. The effective ingredient content is clearly defined, and the effects are stable. All raw materials used are legally approved traditional Chinese medicines, with a mild formula containing no toxic herbs or irritating components. It has high safety in clinical application, no obvious toxic side effects, and good long-term tolerance, making it particularly suitable for long-term conditioning use by adolescents and elderly patients with myopia.

[0028] This invention directly pulverizes Schisandra chinensis and Acorus tatarinowii into medicine, which can maximize the retention of volatile and fat-soluble active ingredients and remove lost active ingredients by high temperature extraction. Codonopsis pilosula, Angelica sinensis and Lycium barbarum are decocted and concentrated to fully extract water-soluble polysaccharides, saponins and other active ingredients. The separate processing according to the characteristics of the medicinal materials can maximize the utilization of the effective ingredients of the medicinal materials.

[0029] By combining fine powder, dry powder, mannitol, sucrose and steviol glycosides, the granule formability and compressibility of tablets are improved, reducing the occurrence of cracked and loose tablets. The combination of mannitol, sucrose and steviol glycosides for flavoring, combined with 60% ethanol granulation, effectively masks the bitter taste of traditional Chinese medicine, resulting in a sweet and sour taste that greatly improves patient medication compliance.

[0030] In terms of the preparation process, precise quantitative parameters are set for the entire process of sterilization, extraction, concentration, drying, granulation and tableting to ensure that the process is stable, controllable and highly reproducible, suitable for large-scale industrial production. At the same time, the moisture content of the particles, the difference in tablet weight and hardness are controlled within the optimal range to reduce the risk of moisture absorption and deterioration and improve the qualification rate of finished products. Detailed Implementation

[0031] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0032] Example 1

[0033] Based on the company's equipment capacity, the standard production capacity of the chewable tablets of this invention is 1 million tablets. The formulation in this embodiment is based on 1 million tablets. All raw materials, auxiliary materials and packaging materials used in this procedure are designed and configured according to the standard production capacity.

[0034] A chewable tablet for the adjunctive treatment of myopia, formulated from the following weights:

[0035] Raw materials: Codonopsis pilosula 190kg, Angelica sinensis 190kg, Lycium barbarum 420kg, Poria cocos 55kg, Ophiopogon japonicus 70kg, Alisma plantago-aquatica 45kg, Schisandra chinensis 40kg, Acorus tatarinowii 36kg, Paeonia suffruticosa 48kg, Polygala tenuifolia 36kg;

[0036] Excipients: 150 kg mannitol, 250 kg sucrose, 1.6 kg steviol glycosides, 4 kg magnesium stearate, 32 kg gastric-soluble film-coating premix, 200 kg 60% ethanol, and 300 kg 40% ethanol.

[0037] A method for preparing a chewable tablet for adjunctive treatment of myopia, comprising the following steps:

[0038] Pre-processing of medicinal materials: Spread the Schisandra chinensis, Poria cocos, Ophiopogon japonicus and Lycium barbarum on the sorting table, pick out the impurities, put them into clean containers, attach material status labels, and transfer them to the clean material warehouse;

[0039] Place Acorus tatarinowii, Codonopsis pilosula, Alisma plantago-aquatica, Paeonia suffruticosa, and Angelica sinensis on a sorting table, spread out the impurities in each herb, and wash them with a washing machine until their surfaces are clean and free of mud, sand, and other contaminants. Drain the water, cut them into slices or segments of 5-20mm, spread the cut herbs on a material cart tray with a thickness of about 2-4cm, put them into the material cart and push them into the drying oven. Turn on the fan and steam, control the temperature at 70±5℃, maintain this temperature for 7-8 hours, and after drying, put them into a clean container, attach a material status label, and transfer them to the clean material warehouse.

[0040] Polygala tenuifolia (processed with licorice): Place an appropriate amount of licorice in a jacketed kettle, add an appropriate amount of water and simmer. Remove the dregs, add cleaned Polygala tenuifolia, and slowly cook until the broth is absorbed. Remove and dry. After drying, pack into a clean container with a material status label and store in a clean material warehouse. The dosage is 6 kg of licorice for every 100 kg of Polygala tenuifolia segments.

[0041] Pulverization and heat treatment of some medicinal materials: Weigh out Schisandra chinensis, Acorus tatarinowii, Poria cocos, Polygala tenuifolia, and 1 / 5 of the weight of Codonopsis pilosula according to the above weight, mix and add to the feeding hopper, and feed into the pulverizer chamber at a uniform speed through the feeder for pulverization into fine powder. Pass through a 100-mesh sieve, load the fine powder into drying trays, control the thickness of each tray to be 2-4 cm, and place the trays containing the materials on the sterilization material cart rails in sequence. After filling, push into the sterilization cabinet guide rail and insert screws to lock. Enter the heat treatment control program interface of the sterilization cabinet and set and confirm the heat treatment parameters: vacuum degree control: -0.08~-0.1MPa, heat treatment temperature: 121℃, heat treatment time: 30 minutes, drying time: 20 minutes. After drying, obtain fine powder, collect and seal the material, and attach material labels for later use.

[0042] Extraction and concentration of some medicinal materials: The remaining 4 / 5 of the Codonopsis pilosula, Angelica sinensis, Lycium barbarum, Ophiopogon japonicus, Alisma plantago-aquatica, and Paeonia suffruticosa were added to a multi-functional extraction tank. Water was added and the mixture was decocted twice, each time with 8 times the amount of drinking water for 1.5 hours. The combined decoctions were filtered through a pipeline filter and then sent to a concentrator. The concentrator parameters were: steam pressure 0.10 MPa, concentration temperature 65℃, vacuum degree -0.04 to -0.09 MPa, until the relative density at 50℃ was 1.15. The concentration temperature was then adjusted to 45℃ until a clear extract with a relative density of 1.35 at 50℃ was obtained. The clear extract was then... Pour the contents into a stainless steel tray of the vacuum dryer, about 1-2 cm thick. Then place the tray on the drying rack inside the dryer, close the sealing door, tighten the handwheel, open the vacuum valve, and evacuate the machine to maintain a vacuum of -0.02 to -0.09 MPa. Open the steam valve of the vacuum dryer to introduce steam, and adjust the steam pressure to 0.05 to 0.2 MPa to control the temperature at 60±5℃ and the vacuum at -0.06 to -0.08 MPa. After drying for 2-3 hours, a dry paste is obtained. Remove it and let it stand at room temperature, then pulverize it into a fine powder using a pulverizer. Pass the powder through an 80-mesh sieve to obtain the dry paste powder. Collect the material, seal it, and attach a material label for later use.

[0043] Mixing and granulation: Add the dry extract powder, fine powder, mannitol, and sucrose to a mixer and premix for 8 minutes. Then add 200 kg of 60% ethanol solution containing steviol glycosides and an appropriate amount of purified water, and mix for 6 minutes to form a soft mass. Granulate the prepared soft mass using a 20-mesh sieve and a vibrating granulator. Transfer the wet granules to a fluidized bed dryer and set the parameters as follows: heating temperature 75℃, outlet air temperature 55℃, material temperature controlled between 55 and 65℃, and induced draft fan frequency 35 Hz. Start the equipment for drying. During the drying process, the temperature gradually increases, and the stirring and dust removal functions are activated to ensure that the granules are dried evenly and do not clump together. When the equipment displays that the air humidity is stable at around 8%, and the granule moisture content is within the range of 3.0% to 6.0%, stop drying and discharge the material. Granulate the dried granules using a granulator to obtain uniform, free-flowing formulation granules for later use.

[0044] Tableting and Coating: Transfer the prepared granules to a mixing machine, add magnesium stearate, and control the mixing parameters as follows: frequency 25 Hz, mixing time 30 min. After mixing, send the material to a tableting machine for tableting. Control the tableting machine parameters as follows: pressure 50 N, filling amount (tablet weight specification 0.8 g, disintegration time: ≤30 min) to ensure the tablet weight is within the range of (0.764 g-0.836 g). Obtain uncoated tablets for later use. Weigh 32 kg of gastric-soluble film coating premix (orange-yellow) and add it to 300 kg of 40% ethanol. Place it in a heated mixing tank and stir for 45 minutes until completely dissolved. Filter through a 70-mesh sieve to obtain the coating solution. Place the uncoated tablets in a high-efficiency coating machine, preheat to an outlet air temperature of about 65°C, spray in the coating solution, and control the coating weight gain to be 2.5% to 4%. After spraying, dry for 5 to 10 minutes to obtain the present invention.

[0045] Example 2

[0046] The chewable tablets prepared in Example 1 were identified as follows:

[0047] Microscopic identification

[0048] Take this product and observe it under a microscope: Irregularly branched, colorless clumps dissolve in chloral hydrate solution; hyphae are colorless or pale brown, 4–5 μm in diameter (Poria cocos). Connecting latex ducts are 12–15 μm in diameter and contain fine granular material (Codonopsis pilosula). Seed coat epidermal stone cells are pale yellowish-brown, polygonal in surface view, with thick walls, fine pits, and dark brown material in the cell lumen (Schisandra chinensis). Oil cells are round and contain yellow or yellowish-brown oily material (Acorus tatarinowii).

[0049] This product contains some fine powder of the original medicinal materials. Through microscopic characteristics, it can quickly identify the four medicinal materials in the prescription: Poria cocos, Codonopsis pilosula, Schisandra chinensis, and Acorus tatarinowii.

[0050] Physicochemical identification

[0051] Take 5 tablets of this product, grind them into a fine powder, add 50 ml of ethanol, reflux in a water bath for 30 minutes, filter while hot, add 1 g of activated carbon to the filtrate to decolorize, filter again, and test the filtrate as follows: Take 1 ml of the filtrate, evaporate to dryness in a water bath, dissolve the residue in 1 ml of glacial acetic acid, add 1 ml of acetic anhydride-concentrated sulfuric acid (19:1), a yellow color gradually turns to a dirty green. Take 1 ml of the filtrate, add 1-2 drops of ferric chloride test solution, a blue, light purple, or green color appears.

[0052] Physicochemical identification is used to examine the characteristic components of triterpenoid saponins and phenolic acids in this product. It can quickly reflect the effective component groups of medicinal materials such as Codonopsis pilosula, Ophiopogon japonicus, Lycium barbarum, Angelica sinensis, and Paeonia suffruticosa in the prescription, ensuring the presence of effective components in the preparation.

[0053] Thin-layer chromatography identification of Acorus tatarinowii

[0054] Take 8 tablets of this product, grind them into a fine powder, add 80 ml of ethyl acetate, sonicate for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 2 ml of ethyl acetate, and use this as the test solution. Separately, take 2 g of Acorus tatarinowii reference material and prepare a reference material solution using the same method. Perform thin-layer chromatography (General Rule 0502). Apply 10 μl of each of the above two solutions to the same silica gel G thin-layer plate. Develop using petroleum ether (60–90℃)-ethyl acetate (8:2) as the developing solvent. Remove the plate, air dry, and let it stand for about 1 hour. Examine under ultraviolet light (365 nm). In the chromatogram of the test sample, fluorescent spots of the same color appear at the corresponding positions as in the chromatogram of the reference material.

[0055] Thin-layer chromatography identification of wolfberry

[0056] Take 5 tablets of this product, grind them into a fine powder, add 50 ml of water, sonicate for 15 minutes, cool, filter, and extract the filtrate with 30 ml of ethyl acetate by shaking. Evaporate the extract to dryness, and dissolve the residue in 1 ml of ethyl acetate to obtain the test solution. Separately, take 0.5 g of wolfberry reference material, add 30 ml of water, heat to boiling for 15 minutes, cool, filter, and extract the filtrate with 15 ml of ethyl acetate by shaking. Evaporate the extract to dryness, and dissolve the residue in 1 ml of ethyl acetate to obtain the reference material solution. Perform thin-layer chromatography (General Rule 0502), applying 10 μl of each of the above two solutions separately to the same silica gel G thin-layer plate. Develop using chloroform-formic acid (15:1) as the developing solvent, remove, air dry, and examine under ultraviolet light (365 nm). In the chromatogram of the test sample, fluorescent spots of the same color appear at the corresponding positions as in the chromatogram of the reference material.

[0057] Comparative Example 1

[0058] Comparative Example 1 has the same prescription as Example 1, but is reduced in weight by a factor of one thousand. Specifically, it is a chewable tablet for the adjunctive treatment of myopia, made from the following prescription by weight:

[0059] Raw materials: Codonopsis pilosula 0.19kg, Angelica sinensis 0.19kg, Lycium barbarum 0.42kg, Poria cocos 0.055kg, Ophiopogon japonicus 0.07kg, Alisma plantago-aquatica 0.045kg, Schisandra chinensis 0.036kg, Acorus tatarinowii 0.036kg, Paeonia suffruticosa 0.048kg, Polygala tenuifolia 0.036kg;

[0060] Excipients: Mannitol 0.15kg, sucrose 0.25kg, steviol glycosides 0.0016kg, magnesium stearate 0.004kg, gastric-soluble film-coating premix 0.032kg, 60% ethanol 0.2kg, 40% ethanol 0.3kg.

[0061] The preparation method of Comparative Example 1 is the same as that of Example 1, except that some of the pulverizing and heat treatment steps of the medicinal materials are removed. Specifically, Schisandra chinensis, Acorus tatarinowii, Poria cocos, Polygala tenuifolia, Codonopsis pilosula, Angelica sinensis, Lycium barbarum, Ophiopogon japonicus, Alisma plantago-aquatica, and Paeonia suffruticosa are added to a multi-functional extraction tank and decocted twice with water. Each time, 8 times the amount of drinking water is added and the decoction is decocted for 1.5 hours. The combined decoction is filtered through a pipeline filter and then sent to a concentrator. The parameters of the concentrator are: steam pressure of 0.10 MPa, concentration temperature of 65℃, and vacuum degree of -0.04 to -0.09 MPa. Concentration continues until the relative density at 50℃ is 1.15. Then, the concentration temperature is adjusted to 45℃ until the concentration reaches 5... The paste, with a relative density of 1.35 at 0℃, is poured into a stainless steel tray of a vacuum dryer to a thickness of about 1-2 cm. The tray is then placed on the drying rack inside the dryer. The sealing door is closed, the handwheel is tightened, and the vacuum valve is opened to create a vacuum, maintaining a vacuum degree of -0.02 to -0.09 MPa. Steam is introduced into the vacuum dryer by opening the steam valve and adjusting the steam pressure to 0.05 to 0.2 MPa to control the temperature at 60±5℃ and the vacuum degree at -0.06 to -0.08 MPa. After drying for 2-3 hours, a dry paste is obtained. It is then removed and allowed to stand at room temperature before being pulverized into a fine powder using a pulverizer. The powder is then passed through an 80-mesh sieve to obtain the dry paste powder. The collected material is sealed and labeled for future use.

[0062] Comparative Example 2

[0063] Comparative Example 2 uses the same prescription as Comparative Example 1, and the preparation method is the same as Example 1. The difference is that the extraction and concentration steps of some medicinal materials are removed. Specifically, Schisandra chinensis, Acorus tatarinowii, Poria cocos, Polygala tenuifolia, Codonopsis pilosula, Angelica sinensis, Lycium barbarum, Ophiopogon japonicus, Alisma plantago-aquatica, and Paeonia suffruticosa are weighed, mixed, and added to the feeding hopper. The mixture is fed into the pulverizer chamber at a uniform speed through the feeder and pulverized into fine powder. The powder is then passed through a 100-mesh sieve and placed into drying trays. The thickness of each tray is controlled to be 2-4 cm. The trays containing the materials are placed on the sterilization material cart rails. After filling the trays, they are pushed into the sterilization cabinet guide rails and locked with screws. The heat treatment control program interface of the sterilization cabinet is entered, and the heat treatment parameters are set and confirmed: vacuum control: -0.08 to -0.1 MPa, heat treatment temperature: 121℃, heat treatment time: 30 minutes, drying time: 20 minutes. After drying, the fine powder is obtained. The material is collected, sealed, and labeled for later use.

[0064] Comparative Example 3

[0065] In Comparative Example 3, Codonopsis pilosula, Angelica sinensis, and Schisandra chinensis were removed from the prescription, while the other prescription amounts were the same as in Comparative Example 1. Specifically, a chewable tablet for the adjunctive treatment of myopia was prepared from the following prescription by weight:

[0066] Raw materials: 0.42 kg of wolfberry, 0.055 kg of poria cocos, 0.07 kg of ophiopogon japonicus, 0.045 kg of alisma plantago-aquatica, 0.036 kg of acorus tatarinowii, 0.048 kg of peony bark, and 0.036 kg of polygala tenuifolia;

[0067] Excipients: Mannitol 0.15kg, sucrose 0.25kg, steviol glycosides 0.0016kg, magnesium stearate 0.004kg, gastric-soluble film-coating premix 0.032kg, 60% ethanol 0.2kg, 40% ethanol 0.3kg.

[0068] The preparation method of Comparative Example 3 is the same as that of Example 1, except that the process involves three raw materials: Codonopsis pilosula, Angelica sinensis and Schisandra chinensis, which can be removed.

[0069] Comparative Example 4

[0070] In Comparative Example 4, the prescription was modified by removing Acorus tatarinowii and Polygala tenuifolia, while the other prescription amounts were the same as in Comparative Example 1. Specifically, it was a chewable tablet for the adjunctive treatment of myopia, prepared from the following prescription by weight:

[0071] Raw materials: Codonopsis pilosula 0.19kg, Angelica sinensis 0.19kg, Lycium barbarum 0.42kg, Poria cocos 0.055kg, Ophiopogon japonicus 0.07kg, Alisma plantago-aquatica 0.045kg, Schisandra chinensis 0.04kg, Paeonia suffruticosa 0.048kg;

[0072] Excipients: Mannitol 0.15kg, sucrose 0.25kg, steviol glycosides 0.0016kg, magnesium stearate 0.004kg, gastric-soluble film-coating premix 0.032kg, 60% ethanol 0.2kg, 40% ethanol 0.3kg.

[0073] The preparation method of Comparative Example 4 is the same as that of Example 1, except that the two raw materials involved in the process, Acorus tatarinowii and Polygala tenuifolia, can be removed.

[0074] Experimental Example

[0075] One hundred adolescents with mild to moderate myopia, aged 10 to 16 years, with myopia ranging from 100 to 400 degrees, were selected and randomly divided into 5 groups of 20 patients each.

[0076] The chewable tablets prepared in Example 1 and Comparative Examples 1-4 were administered twice daily, two tablets each time, chewed and swallowed, for 90 consecutive days. Visual acuity improvement was assessed after 90 days, and the results are shown in Table 1.

[0077] Group Overall efficiency Effective efficient invalid Example 1 70.0% 6 cases 8 cases 6 cases Comparative Example 1 55.0% 4 cases 7 cases 9 cases Comparative Example 2 45.0% 4 cases 5 cases 11 cases Comparative Example 3 35.0% 3 cases 4 cases 13 cases Comparative Example 4 40.0% 4 cases 4 cases 12 cases

[0078] Table 1

[0079] The evaluation criteria are:

[0080] Significant effect: Improvement in uncorrected visual acuity ≥ 1 line

[0081] Effective: No improvement in vision

[0082] Ineffective: Decreased vision

[0083] Overall effectiveness rate = (Significantly effective + Effective) / Total number of cases × 100%

[0084] The data above shows that the overall effective rate of Example 1 of this invention is 70.0%, significantly higher than that of the four comparative examples. This indicates that the formula and process of this invention have the best effect on the adjunctive treatment of myopia. Comparative example 1, by removing the pulverization and heat treatment steps, and comparative example 2, by removing the extraction and concentration steps, did not process the raw materials separately according to their characteristics, resulting in the loss of effective ingredients and a significant decrease in efficacy. Comparative example 3, by removing Codonopsis pilosula, Angelica sinensis, and Schisandra chinensis, suffered from insufficient Qi and blood, weakened vision-improving ability, and the worst improvement in vision. Comparative example 4, by removing Acorus tatarinowii and Polygala tenuifolia, had reduced effects on opening the orifices, improving vision, calming the mind, and stabilizing the spirit, and weakened the effect on relieving eye fatigue. Using the prescription and process of this invention, the effects of replenishing Qi and blood, nourishing the liver and kidneys, improving vision, and calming the mind are significantly enhanced, and the effect on the adjunctive treatment of myopia is significantly better than any simplified process or prescription lacking ingredients.

[0085] The above are merely embodiments of the present invention and do not limit the patent scope of the present invention. Any equivalent structural or procedural transformations made based on the content of the present invention specification, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of the present invention.

Claims

1. A chewable tablet for adjunctive treatment of myopia, characterized in that, Made from the following parts by weight of active pharmaceutical ingredient and excipients: Raw materials: Codonopsis pilosula 150-220 parts, Angelica sinensis 150-220 parts, Lycium barbarum 300-500 parts, Poria cocos 40-70 parts, Ophiopogon japonicus 50-80 parts, Alisma plantago-aquatica 35-50 parts, Schisandra chinensis 30-40 parts, Acorus tatarinowii 30-40 parts, Paeonia suffruticosa 35-50 parts, and Polygala tenuifolia (processed with licorice water) 30-40 parts; Excipients: 120-160 parts mannitol, 220-300 parts sucrose, 1-3 parts steviol glycosides, 3-5 parts magnesium stearate, 30-35 parts gastric-soluble film-coating premix, and an appropriate amount of 40-60% ethanol.

2. The chewable tablet for adjuvant treatment of myopia according to claim 1, characterized in that, Made from the following parts by weight of active pharmaceutical ingredient and excipients: Raw materials: Codonopsis pilosula 190 parts, Angelica sinensis 190 parts, Lycium barbarum 420 parts, Poria cocos 55 parts, Ophiopogon japonicus 70 parts, Alisma plantago-aquatica 45 parts, Schisandra chinensis 40 parts, Acorus tatarinowii 36 parts, Paeonia suffruticosa 48 parts, Polygala tenuifolia (processed with licorice water) 36 parts. Excipients: 150 parts mannitol, 250 parts sucrose, 1.6 parts steviol glycosides, 4 parts magnesium stearate, 32 parts gastric-soluble film-coating premix, and an appropriate amount of 40-60% ethanol.

3. The chewable tablet for adjuvant treatment of myopia according to claim 1, characterized in that, Made from the following parts by weight of active pharmaceutical ingredient and excipients: Raw materials: Codonopsis pilosula 180 parts, Angelica sinensis 210 parts, Lycium barbarum 450 parts, Poria cocos 50 parts, Ophiopogon japonicus 60 parts, Alisma plantago-aquatica 40 parts, Schisandra chinensis 35 parts, Acorus tatarinowii 35 parts, Paeonia suffruticosa 40 parts, and Polygala tenuifolia (processed with licorice water) 38 parts; Excipients: 140 parts mannitol, 260 parts sucrose, 1.5 parts steviol glycosides, 3 parts magnesium stearate, 35 parts gastric-soluble film-coating premix, and an appropriate amount of 40-60% ethanol.

4. A method for preparing a chewable tablet for adjuvant treatment of myopia, characterized in that, It includes: S1. Weigh out the following ingredients by weight: Schisandra chinensis, Acorus tatarinowii, Poria cocos, Polygala tenuifolia, and 1 / 5 to 1 / 4 of Codonopsis pilosula. Mix and grind them into a fine powder, then pass them through an 80-100 mesh sieve for later use. S2, add water to the remaining Codonopsis pilosula, Angelica sinensis, Lycium barbarum, Ophiopogon japonicus, Alisma plantago-aquatica, and Paeonia suffruticosa root bark and decoct 1-3 times, each time adding water 6-10 times the weight of the herbs, extracting for 1-2 hours each time, combine the decoctions, filter, concentrate the filtrate to a clear extract with a relative density of 1.30-1.35 at 50℃, vacuum dry the clear extract to obtain a dry extract, and pulverize it through an 80-mesh sieve; S3, mix dry powder, fine powder, mannitol and sucrose, granulate with 60% ethanol containing steviol glycosides as a wetting agent, dry and granulate; S4, add magnesium stearate, mix evenly, compress into tablets, and coat with a gastric-soluble film to obtain the finished product.

5. The method for preparing a chewable tablet for adjuvant treatment of myopia according to claim 4, characterized in that, In S1, the fine powder material is sent into the sterilization cabinet for heat treatment. The heat treatment parameters are: vacuum degree: -0.08 to -0.1 MPa, heat treatment temperature: 115-125℃, and heat treatment time: 20-30 min.

6. The method for preparing a chewable tablet for adjuvant treatment of myopia according to claim 4, characterized in that, In S2, the parameters of the concentrator during concentration are: steam pressure of 0.05-0.20 MPa, concentration temperature of 60-75℃, and vacuum degree of -0.04--0.09 MPa, until a clear paste with a relative density of 1.15-1.20 at 50℃ is obtained. Then, the concentration temperature is adjusted to 40-50℃ until a clear paste with a relative density of 1.30-1.35 at 50℃ is obtained.

7. The method for preparing a chewable tablet for adjuvant treatment of myopia according to claim 4, characterized in that, In S2, during drying, the paste is poured into a vacuum dryer, and a vacuum is drawn to maintain a vacuum degree of -0.02 to -0.09 MPa inside the machine. Steam is introduced by opening the steam valve and adjusting the steam pressure to 0.05 to 0.2 MPa to control the temperature at 55-65℃ and the vacuum degree at -0.06 to -0.08 MPa. The dried paste is then pulverized and passed through an 80-mesh sieve.

8. The method for preparing a chewable tablet for adjuvant treatment of myopia according to claim 4, characterized in that, In S3, dry powder, fine powder, mannitol, and sucrose are added to a mixer according to their weight proportions and premixed for 6-10 minutes. Then, a 60% ethanol solution containing steviol glycosides and an appropriate amount of purified water are added and mixed for 5-8 minutes to form a soft material. The prepared soft material is then granulated using a vibrating granulator with an 18 or 20 mesh screen. The wet granules are then transferred to a fluidized bed dryer granulator. The parameters are set as follows: temperature 70-120℃, heating temperature 40-80℃, outlet air temperature 40-80℃, material temperature 50-70℃, and induced draft fan frequency 20-50Hz. The equipment is started for drying. During drying, the temperature should be gradually increased, and the stirring and dust removal functions should be turned on. When the outlet air humidity reaches 5-12% and the granule moisture content is 3.0-6.0%, the material is discharged and granulated using a granulator.

9. A method for preparing a chewable tablet for adjuvant treatment of myopia according to claim 4, characterized in that, In step S4, the prepared granules are transferred to a mixer, and a specified amount of magnesium stearate is added. The mixing parameters are controlled as follows: frequency 25 Hz, mixing time 30 min. After mixing, the material is fed into a tableting machine for tableting. The tableting machine parameters are controlled as follows: pressure 40-60 N, filling amount (tablet weight specification: 0.8 g, disintegration time: ≤30 min) to ensure the tablet weight is within the range of (0.764 g-0.836 g). After tableting, a gastrointestinal film coating is applied to obtain the finished product.