Eye-protecting health-care traditional Chinese medicine composition and preparation method thereof

Abstract

The invention relates to an eye-protecting health-care traditional Chinese medicine composition, which is used for relieving eye fatigue, improving vision and preventing or assisting in treating retinopathy and xerophthalmia, and has the comprehensive effects of clearing liver and improving vision, nourishing blood and liver, promoting blood circulation to remove meridian obstruction, nourishing yin and moistening dryness. All the components have a synergistic effect in efficacy, and the effects of eye protection and health care are achieved by regulating the liver function, enhancing eye blood circulation, improving cell metabolism and enhancing the immune function. According to the traditional Chinese medicine composition disclosed by the invention, various medicinal materials have a good synergistic effect, and the multiple effects of clearing liver and improving vision, nourishing blood and liver, promoting blood circulation to remove meridian obstruction, nourishing yin and moistening dryness are comprehensively exerted by regulating liver and kidney functions, improving eye microcirculation, enhancing cell metabolism capability and improving immune level; therefore, eye fatigue is effectively relieved, eyesight is improved, common eye diseases such as retinopathy and xerophthalmia are prevented or treated in an auxiliary manner, and the eye cream is suitable for sub-health people and daily health care requirements.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of eye-protecting traditional Chinese medicine, and particularly relates to an eye-protecting health-care traditional Chinese medicine combination and a preparation method thereof. BACKGROUND

[0002] In the prior art, eye-protecting traditional Chinese medicine preparations generally have problems of unstable efficacy, insufficient extraction of components, easy loss of active components, single dosage form, inconvenience in taking and non-strict quality control, which seriously restrict the promotion and use of the preparations in clinical application and daily health care. The problems in the prior art are analyzed in detail from multiple aspects below, and the beneficial effects of the present application are compared with the problems. Firstly, in terms of traditional Chinese medicine formula, traditional eye-protecting traditional Chinese medicine is mostly prepared by empirical compounding, and lacks systematic research on the synergistic effect between components, resulting in unbalanced efficacy and difficulty in achieving the synergistic effect of multiple functions of "clearing liver and eyesight, nourishing blood and liver, promoting blood circulation to remove meridian obstruction, and nourishing yin to moisten dryness". Some products only focus on one-sided function, such as only emphasizing "clearing liver", and ignoring the improvement of eye microcirculation or the immunoregulatory effect, thereby affecting the overall efficacy.

[0003] Secondly, in terms of extraction process, the prior art generally adopts single extraction method, such as only one water extraction or alcohol extraction, and the extraction time is short and the extraction times are few, resulting in insufficient extraction of effective components, especially low retention rate of heat-sensitive or fat-soluble components. In addition, the temperature and concentration are not accurately controlled in some extraction processes, and high-temperature treatment can easily damage flavonoids and polysaccharide active components, resulting in decreased efficacy and affecting the stability and clinical effect of the product.

[0004] In the drying link, the traditional method mostly adopts conventional drying or high-temperature drying, which not only causes inactivation of active components, but also causes oxidation and deterioration of traditional Chinese medicine components, thereby affecting the quality and stability of the product. In addition, the differences in physicochemical properties of different components are not fully considered in the drying process, resulting in problems of moisture absorption, caking and discoloration of the finished product during storage, and reducing the practicability and market acceptance of the product. SUMMARY

[0005] In view of the above problems, the present application provides an eye-protecting health-care traditional Chinese medicine combination and a preparation method thereof, to at least partially solve the above technical problems.

[0006] The technical scheme adopted by the present application is as follows: The application provides an eye-care traditional Chinese medicine composition, which is composed of the following traditional Chinese medicine raw materials in proportion by weight: 9-12 g of Flos Genkwa, 2-5 g of Safflower, 10-15 g of Cassia Seed, 10-13 g of Ginseng, 8-12 g of Phellodendri, 6-9 g of Lavender, 10-15 g of Angelica, 11-13 g of Chrysanthemum Indicum, 9-12 g of Tribulus, 0.2-0.5 g of Borneol and 10-13 g of Mint; wherein the traditional Chinese medicine composition is used for relieving eye fatigue, improving eyesight, preventing or assisting in treating retinopathy and dry eye syndrome, and has the comprehensive effects of clearing liver and eyesight, nourishing blood and liver, promoting blood circulation and dredging collaterals, nourishing yin and moistening dryness; the components are synergistically effective in pharmacodynamics, and the eye-care effect is achieved by regulating liver function, enhancing blood circulation of eyes, improving cell metabolism and enhancing immune function.

[0007] In an embodiment of the application, the traditional Chinese medicine raw materials are in proportion by weight as follows: 10 g of Flos Genkwa, 3 g of Safflower, 12 g of Cassia Seed, 11 g of Ginseng, 10 g of Phellodendri, 7 g of Lavender, 12 g of Angelica, 12 g of Chrysanthemum Indicum, 10 g of Tribulus, 0.3 g of Borneol and 11 g of Mint.

[0008] In an embodiment of the application, the traditional Chinese medicine composition can be prepared into tablets, capsules, oral liquids, granules, ointment dosage forms or eye drops for external use, and is suitable for daily health care, auxiliary treatment of ophthalmic diseases and conditioning use of sub-health people.

[0009] In an embodiment of the application, the traditional Chinese medicine composition further comprises auxiliary materials selected from at least one of sweeteners, lubricants, fillers, disintegrating agents, binders, flavoring agents and coloring agents, which are used for improving the stability, taste and convenience of the preparation, and ensuring the quality stability and bioavailability of the product during storage and use.

[0010] In an embodiment of the application, the preparation method of the eye-care traditional Chinese medicine composition comprises the following steps: Step one, weighing Flos Genkwa, Safflower, Cassia Seed, Ginseng, Phellodendri, Lavender, Angelica, Chrysanthemum Indicum, Tribulus, Borneol and Mint in proportion; Step two, mixing the above raw materials uniformly, and then performing water extraction or alcohol extraction to extract effective components; Step three, concentrating and drying the extraction liquid to obtain a traditional Chinese medicine extract; Step four, mixing the extract with auxiliary materials, and preparing finished products according to different dosage forms.

[0011] In an embodiment of the application, in step two, the water extraction method is used for extraction, the extraction time is 1-2 hours, the extraction times is 2-3 times, and the extraction liquid is filtered, concentrated and combined after each extraction, so that the effective components can be retained to the maximum extent.

[0012] In one embodiment of the present application, in step three, the concentration is carried out under normal pressure or reduced pressure, with temperature controlled at 60-80 DEG C, and the relative density of the medicinal liquid is 1.10-1.25; the drying method is spray drying, vacuum freeze drying or low-temperature drying, so as to maintain the stability and bioactivity of the active ingredients.

[0013] In one embodiment of the present application, in step four, the excipients are microcrystalline cellulose, lactose, magnesium stearate, hypromellose, gum arabic and glycerol, and the corresponding excipients are selected according to the different dosage forms, and granulation, tabletting, filling or packaging are carried out according to the conventional pharmaceutical processes, so as to ensure the appearance quality, taste and convenience for taking of the product.

[0014] In one embodiment of the present application, the preparation method further comprises quality detection of the final product, including effective ingredient content determination, microbial limit test, heavy metal residue detection, pesticide residue detection and stability test, so as to ensure the safety and effectiveness of the product.

[0015] The present application has the following beneficial effects: The present application has the following beneficial effects:

[0016] In the present application, the water extraction method is used for extracting the effective ingredients in the preparation process, and the filtrate is combined and concentrated after multiple extractions, so as to maximize the retention of the water-soluble active ingredients in the medicinal materials, such as flavonoids, polysaccharides and volatile oils, and ensure the effectiveness and purity of the extract. At the same time, through reasonable control of the concentration temperature (60-80 DEG C) and the relative density range (1.10-1.25), the destruction of the heat-sensitive components by high temperature is avoided, and the concentration and stability of the extract are improved, so as to provide a high-quality raw material basis for subsequent processing.

[0017] In the drying stage of the present application, the spray drying, vacuum freeze drying or low-temperature drying method is selected, so as to further ensure the stability and bioactivity of the active ingredients in the traditional Chinese medicine extract, especially for the heat-sensitive medicinal components, so as to ensure the quality and efficacy consistency of the final product during storage. In addition, the selection of excipients is adjusted according to the different dosage forms, such as microcrystalline cellulose, lactose, magnesium stearate and hypromellose, which not only helps to improve the formability, solubility and taste of the preparation, but also enhances the appearance quality and convenience for taking of the product, so as to meet the needs of different consumers.

[0018] Additional aspects and advantages of the application will be set forth in part in the description which follows, and in part will become apparent to those skilled in the art upon examination of the following or can be learned by practice of the application. BRIEF DESCRIPTION OF DRAWINGS

[0019] The above mentioned and / or additional aspects and advantages of the application will become apparent and the application will be understood from a description of embodiments which follows with reference to the drawings, wherein: Figure 1 A schematic diagram of an eye-care traditional Chinese medicine combination according to an embodiment of the application. DETAILED DESCRIPTION

[0020] Embodiments of the application are described in detail below with reference to the accompanying drawings, in which like reference numerals designate identical or similar elements or elements having the same or similar functions throughout the several views. The embodiments described below are exemplary, and are intended to be illustrative of the application rather than to limit the application as construed in accordance with the appended claims.

[0021] An eye-care traditional Chinese medicine combination and a manufacturing method according to an embodiment of the application are described below with reference to the accompanying drawings.

[0022] As shown in Figure 1 An eye-care traditional Chinese medicine combination according to an embodiment of the application is provided, and the composition is composed of the following traditional Chinese medicine raw materials in a weight ratio: 9-12 g of Mimi flower, 2-5 g of saffron, 10-15 g of Cassia seed, 10-13 g of ginseng, 8-12 g of Huangbai, 6-9 g of lavender, 10-15 g of Angelica, 11-13 g of wild chrysanthemum, 9-12 g of Tribulus terrestris, 0.2-0.5 g of borneol, and 10-13 g of mint. The traditional Chinese medicine combination is used for relieving eye fatigue, improving eyesight, preventing or assisting in treating retinopathy and dry eye syndrome, and has the comprehensive effects of clearing liver and eyesight, nourishing blood and liver, promoting blood circulation to remove meridian obstruction, and nourishing yin to moisten dryness. The components are synergistically effective in terms of pharmacodynamics, and the eye-care effect is achieved by regulating liver function, enhancing blood circulation in the eyes, improving cell metabolism, and enhancing immune function.

[0023] The weight ratio of the traditional Chinese medicine raw materials is 10 g of Mimi flower, 3 g of saffron, 12 g of Cassia seed, 11 g of ginseng, 10 g of Huangbai, 7 g of lavender, 12 g of Angelica, 12 g of wild chrysanthemum, 10 g of Tribulus terrestris, 0.3 g of borneol, and 11 g of mint. The traditional Chinese medicine combination can be prepared into tablets, capsules, oral liquids, granules, paste dosage forms, or eye drops for external use, and is suitable for daily health care, auxiliary treatment of ophthalmic diseases, and conditioning use for sub-health people. The traditional Chinese medicine combination also contains auxiliary materials selected from at least one of sweeteners, lubricants, fillers, disintegrants, binders, flavoring agents, and colorants, for improving the stability, taste, and convenience of the preparation, and ensuring the quality stability and bioavailability of the product during storage and use.

[0024] In a specific application, the traditional Chinese medicine combination is composed of twelve kinds of traditional Chinese medicines, i.e., Jiaonanhuaba, safflower, Semen Cassiae, ginseng, golden cypress, lavender, angelica, wild chrysanthemum, tribulus terrestris, borneol and peppermint, and the specific weight ratio is as follows: Jiaonanhuaba 10g, safflower 3g, Semen Cassiae 12g, ginseng 11g, golden cypress 10g, lavender 7g, angelica 12g, wild chrysanthemum 12g, tribulus terrestris 10g, borneol 0.3g and peppermint 11g. Among them, Jiaonanhuaba and Semen Cassiae have the effect of clearing liver and brightening eyes, which can improve the blood circulation of retina; safflower and angelica have the effect of activating blood and resolving stasis, nourishing blood and softening liver, which can help to relieve eye fatigue and improve microcirculation; ginseng and golden cypress can enhance the body's immunity and regulate liver function; lavender and peppermint have the effect of cooling and relieving, calming and soothing, which can relieve eye discomfort; wild chrysanthemum and tribulus terrestris can clear heat and detoxify and calm the liver and brighten the eyes; borneol, as a central nervous stimulant, can enhance drug absorption and promote local blood circulation of the eye. The components cooperate with each other to form a multi-level, multi-path and multi-target synergistic system, which can regulate liver function, improve eye metabolism and enhance immune defense ability as a whole, so as to achieve the purpose of eye care, prevention and auxiliary treatment of common ophthalmic diseases such as vision loss, dry eye syndrome and retinal disease.

[0025] Secondly, in order to ensure that the traditional Chinese medicine combination has good stability, bioavailability and convenient use in practical application, the application also specially introduces auxiliary ingredients, such as sweeteners, lubricants, fillers, disintegrants, binders, flavoring agents and colorants. The auxiliary ingredients can not only improve the physical stability of the preparation and prolong the shelf life, but also improve the taste and patient compliance, so that the medicine is more acceptable and easier to take. For example, adding an appropriate amount of sweeteners and flavoring agents in oral liquid or granules can mask the bitter taste of some traditional Chinese medicines and improve the willingness of patients to take medicine; adding lubricants and disintegrants in tablets or capsules can help to improve the dissolution rate and absorption efficiency of the medicine; adding binders and fillers in paste dosage forms can help to improve the formability and uniformity of the finished product, ensuring accurate dosage and convenient use.

[0026] In terms of production method, first, all raw materials are weighed according to the specific ratio, mixed uniformly and then subjected to water extraction or alcohol extraction treatment to extract the effective components to the greatest extent. The water extraction method is suitable for the extraction of most traditional Chinese medicines and is simple and low in cost, while the alcohol extraction method can better extract fat-soluble components and improve the biological activity of the medicine. In the extraction process, a multi-stage extraction process is adopted, the first-stage extraction time is 1 hour and the second-stage extraction time is 0.5 hour, and after each extraction, the filtrate is combined and subjected to concentration treatment. This process can not only ensure the sufficient extraction of effective components, but also avoid the damage of active components caused by excessive heating.

[0027] Next, the extract is concentrated under reduced pressure, with the temperature controlled at 60-80 DEG C, and concentrated to a relative density of 1.10-1.25 to remove excess water and increase the concentration. Subsequently, spray drying or vacuum freeze drying is used for drying treatment to maintain the stability and bioactivity of the active ingredients and prevent degradation of the ingredients caused by high temperature. Finally, the dried traditional Chinese medicine extract is mixed with excipients in proportion, and granulation, tabletting, filling or packaging are performed according to the requirements of different dosage forms, so as to finally form products in the forms of tablets, capsules, oral liquids, granules, paste dosage forms or eye drops for external use.

[0028] In one possible implementation, a method for preparing an eye-care healthcare traditional Chinese medicine combination includes the following steps: Step one, weigh the Flos Genkwa, saffron, Cassia Seed, ginseng, Huangbai, lavender, angelica, wild chrysanthemum, Tribulus terrestris, borneol and mint in proportion; Step two, after the above raw materials are uniformly mixed, water extraction or alcohol extraction treatment is performed to extract effective components; Step three, the extract is concentrated and dried to obtain a traditional Chinese medicine extract; Step four, the extract is mixed with excipients and prepared into finished products according to the requirements of different dosage forms.

[0029] In step two, the water extraction method is used for extraction, the extraction time is 1-2 hours, the extraction times are 2-3 times, the filtrate is filtered after each extraction, and the filtrate is combined and concentrated to maximize the retention of effective components. In step three, the concentration is performed under normal pressure or reduced pressure, the temperature is controlled at 60-80 DEG C, and the relative density of the medicinal liquid is 1.10-1.25. The drying method is spray drying, vacuum freeze drying or low-temperature drying to maintain the stability and bioactivity of the active ingredients. In step four, the excipients are microcrystalline cellulose, lactose, magnesium stearate, hydroxypropyl methyl cellulose, gum arabic and glycerol. According to the different dosage forms, the corresponding excipients are selected, and granulation, tabletting, filling or packaging are performed according to the conventional pharmaceutical process to ensure the appearance quality, taste and convenience of the product. The preparation method further includes quality detection of the finished product, including effective component content determination, microbial limit test, heavy metal residue detection, pesticide residue detection and stability test to ensure the safety and effectiveness of the product.

[0030] In the specific application of the embodiment, in step one, the Flos Genkwa, saffron, Cassia Seed, ginseng, Huangbai, lavender, angelica, wild chrysanthemum, Tribulus terrestris, borneol and mint are weighed in strict accordance with the specific weight ratio, and the amount of each medicinal material is accurately controlled. This not only helps to maintain the balance of the overall efficacy of the formula, but also avoids the imbalance of drug efficacy or the increase of side effects caused by improper dosage. Meanwhile, all the medicinal materials need to be screened and cleaned before mixing to remove impurities, ensure the purity of the medicinal materials and provide high-quality basic raw materials for subsequent extraction.

[0031] After entering step two, the active ingredients are extracted using water extraction, which is one of the most commonly used and cost-effective methods in traditional Chinese medicine extraction. By setting the extraction time to 1-2 hours and performing 2-3 consecutive extractions, the water-soluble active ingredients in traditional Chinese medicinal materials, such as flavonoids, polysaccharides, and volatile oils, can be maximally released, thereby increasing the concentration and activity of the extract. After each extraction, filtration is performed to ensure the purity of the filtrate and reduce impurities. Subsequently, the filtrates from multiple extractions are combined and subjected to preliminary concentration, which can increase the concentration of the medicinal solution, lay the foundation for the next step of refining and drying, and also help reduce the cost and energy consumption of subsequent processing.

[0032] In step three, concentration and drying are key steps that determine the quality of the final product. During the concentration process, normal or reduced pressure conditions are used, with the temperature controlled between 60-80°C, which can avoid damage to heat-sensitive components and maintain the flowability and stability of the extract. The extract is concentrated to a relative density of 1.10-1.25, which allows the active ingredients to be concentrated and facilitates subsequent drying. The drying method is selected based on actual needs, such as spray drying, vacuum freeze-drying, or low-temperature drying. Spray drying is suitable for large-scale production and can quickly obtain powdered products; vacuum freeze-drying is more conducive to preserving the active ingredients in the medicinal extract, especially for heat-sensitive traditional Chinese medicines; low-temperature drying is a relatively low-cost option suitable for products with low stability requirements. Regardless of the drying method used, the dried product must have good flowability, solubility, and storage stability to provide high-quality raw materials for subsequent dosage form processing.

[0033] Step four involves mixing the dried traditional Chinese medicine extract with excipients and performing appropriate formulation processing according to the requirements of different dosage forms, such as tablets, capsules, oral solutions, granules, paste formulations, or eye drops for external use. For example, in tablets or capsules, microcrystalline cellulose is usually added as a filler, lactose as a sweetener, magnesium stearate as a lubricant, hydroxypropyl methylcellulose as a binder, and glycerol as a humectant to improve the formability, taste, and convenience of the preparation. In oral solutions or granules, flavorings and colorants are added to enhance the sensory experience of the product. In paste formulations, a certain amount of gum material, such as gum arabic or gelatin, is added to enhance the viscosity and stability of the paste. Throughout the formulation process, conventional pharmaceutical processing standards, such as granulation, tablet pressing, filling, and packaging, must be followed to ensure that the product has an attractive appearance, accurate dosage, and easy use.

[0034] The detection content includes active ingredient content determination to ensure the consistency of the efficacy of each batch of products; microbial limit test to prevent bacterial and mold contamination; heavy metal residue detection to avoid harmful element overproof; pesticide residue detection to ensure the safety of raw material source; and stability test to evaluate the quality change of the product under different storage conditions.

[0035] It is to be noted that the relational terms herein such as first and second and the like are used solely to distinguish one entity or action from another, without necessarily requiring or implying any such actual relationship or order between such entities or actions. Moreover, the terms "comprises", "comprising", or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but can also include other elements not expressly listed or inherent to such process, method, article, or apparatus.

[0036] The above description of the present application and its embodiments is not restrictive, and the embodiments shown in the drawings are only one of the embodiments of the present application, and the actual structure is not limited thereto. In general, if a person skilled in the art is inspired by it, without departing from the purpose of the present application, similar structural modes and embodiments can be designed without creativity, which should belong to the protection scope of the present application.

Claims

1. An eye-protecting health-care traditional Chinese medicine combination, characterized in that, The composition is composed of the following proportion by weight of traditional Chinese medicine raw materials: 9-12g of Jiumenghua, 2-5g of saffron, 10-15g of Semen Cassiae, 10-13g of ginseng, 8-12g of Phellodendri, 6-9g of lavender, 10-15g of Angelica, 11-13g of wild chrysanthemum, 9-12g of Tribulus terrestris, 0.2-0.5g of borneol, and 10-13g of mint; wherein the traditional Chinese medicine combination is used for relieving eye fatigue, improving eyesight, preventing or assisting in treating retinopathy and dry eye, and has the comprehensive effects of clearing liver and eyesight, nourishing blood and liver, promoting blood circulation and unblocking collaterals, and nourishing yin and moistening dryness; the components are synergistically effective in terms of pharmacodynamics, and can regulate liver function, enhance ocular blood circulation, improve cell metabolism, and enhance immune function, thereby achieving the effect of eye care.

2. The eye-protecting traditional Chinese medicine combination of claim 1, characterized in that, The weight proportion of the traditional Chinese medicine raw materials is: 10g of Jiumenghua, 3g of saffron, 12g of Semen Cassiae, 11g of ginseng, 10g of Phellodendri, 7g of lavender, 12g of Angelica, 12g of wild chrysanthemum, 10g of Tribulus terrestris, 0.3g of borneol, and 11g of mint.

3. The eye-protecting traditional Chinese medicine combination of claim 1, characterized in that, The traditional Chinese medicine combination can be prepared into tablets, capsules, oral liquids, granules, ointment dosage forms, or eye drops for external use, and is suitable for daily health care, auxiliary treatment of ophthalmic diseases, and conditioning use for sub-health people.

4. The eye-protecting traditional Chinese medicine combination of claim 1, characterized in that, The traditional Chinese medicine combination further comprises excipients selected from at least one of sweeteners, lubricants, fillers, disintegrants, binders, flavoring agents, and colorants, which are used to improve the stability, taste, and convenience of the preparation, and to ensure the quality stability and bioavailability of the product during storage and use.

5. A method for preparing the eye-protecting health-care traditional Chinese medicine combination according to claims 1-4, characterized in that, The method comprises the following steps: Step one, proportionally weigh Jiumenghua, saffron, Semen Cassiae, ginseng, Phellodendri, lavender, Angelica, wild chrysanthemum, Tribulus terrestris, borneol, and mint; Step two, mix the above raw materials uniformly, and then perform water extraction or alcohol extraction to extract effective components; Step three, concentrate and dry the extract to obtain a traditional Chinese medicine extract; Step four, mix the extract with excipients, and prepare finished products according to different dosage forms.

6. The method for preparing the eye-protecting and health-preserving traditional Chinese medicine combination according to claim 5, characterized in that, In step two, the extraction is performed by water extraction, and the extraction time is 1-2 hours, the extraction is performed for 2-3 times, and the filtrate is combined and concentrated after each extraction to maximize the retention of effective components.

7. The method for preparing the eye-protecting and health-preserving traditional Chinese medicine combination according to claim 5, characterized in that, In step three, the concentration is performed under normal pressure or reduced pressure, and the temperature is controlled at 60-80℃, and the relative density of the medicinal liquid is concentrated to 1.10-1.25; the drying method is spray drying, vacuum freeze drying, or low-temperature drying to maintain the stability and bioactivity of active ingredients.

8. The method for preparing the eye-protecting and health-preserving traditional Chinese medicine combination according to claim 5, characterized in that, In step four, the excipients are microcrystalline cellulose, lactose, magnesium stearate, hydroxypropyl methyl cellulose, gum arabic, and glycerol, and the corresponding excipients are selected according to the dosage form, and the products are prepared by granulation, tablet pressing, filling, or packaging according to the conventional pharmaceutical process, to ensure the appearance quality, taste, and convenience of the products.

9. The method for preparing the eye-protecting and health-preserving traditional Chinese medicine combination according to claim 5, characterized in that, The preparation method further comprises quality detection of the final product, including effective component content determination, microbial limit test, heavy metal residue detection, pesticide residue detection, and stability test, to ensure the safety and effectiveness of the product.

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