Traditional Chinese medicine composition, traditional Chinese medicine patch for eye diseases, preparation method and application

Abstract

This invention belongs to the field of traditional Chinese medicine technology, and particularly relates to a traditional Chinese medicine composition, a traditional Chinese medicine patch, a preparation method, and its application for eye diseases. The traditional Chinese medicine composition comprises the following medicinal materials in parts by weight: 0.5-2 parts of Rehmannia glutinosa, 0.5-2 parts of Ophiopogon japonicus, 1-4 parts of Chrysanthemum morifolium, and 1-4 parts of Prunus armeniaca seed. This invention can effectively prevent and / or treat eye diseases, and the drug components are simple, with low toxicity and side effects, and are safe and reliable.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to a traditional Chinese medicine composition, traditional Chinese medicine patch, preparation method and application for eye diseases. Background Technology

[0002] Currently, Western medicine treatments for eye conditions such as dry eyes, eye strain, and eye fatigue include artificial tears, physical therapy, and lifestyle modifications. Artificial tears involve using eye drops containing sodium hyaluronate or chondroitin sulfate to relieve dryness; physical therapy includes applying warm compresses (40-60℃ hot towels) to promote blood circulation, or alternating hot and cold compresses to relieve fatigue; lifestyle modifications include the 20-20-20 rule (looking at an object 20 feet away for 20 seconds every 20 minutes), supplementing with vitamins A / C (carrots, broccoli) and Omega-3 (deep-sea fish), avoiding prolonged use of electronic devices, and wearing blue light blocking glasses. Traditional Chinese medicine treatments include: treatment based on syndrome differentiation, such as using Qi Ju Di Huang Wan, Shi Hu Ye Guang Wan, and Long Dan Xie Gan Wan; eye massage, massaging acupoints such as Jingming, Sibai, and Taiyang; and acupuncture, stimulating acupoints related to the liver and kidney meridians (such as Taichong and Sanyinjiao) to regulate Qi and blood. However, the efficacy of these treatments for eye conditions is limited.

[0003] In view of this, the present invention is hereby proposed. Summary of the Invention

[0004] In order to overcome the shortcomings of the existing technology, the present invention addresses the technical problem of limited efficacy of existing treatments for eye diseases by proposing a traditional Chinese medicine composition, a traditional Chinese medicine patch, a preparation method, and an application for eye diseases.

[0005] The first aspect of the present invention provides a traditional Chinese medicine composition for eye diseases, the traditional Chinese medicine composition comprising the following traditional Chinese medicinal materials in parts by weight: 0.5-2 parts by weight of Rehmannia glutinosa, 0.5-2 parts by weight of Ophiopogon japonicus, 1-4 parts by weight of Chrysanthemum morifolium and 1-4 parts by weight of Prunus armeniaca seed.

[0006] The detailed pharmacological effects of each of the above components are as follows:

[0007] Rehmannia glutinosa: Sweet and bitter in taste, cold in nature, and enters the heart, liver, and kidney meridians. It clears heat and generates fluids, cools the blood, and stops bleeding. It is used for yin deficiency due to febrile diseases, red tongue with thirst, fever with rashes, hematemesis, epistaxis, and sore throat.

[0008] Ophiopogon japonicus: Sweet, slightly bitter, and slightly cold in nature. It enters the heart, lung, and stomach meridians. It nourishes yin and generates fluids, moistens the lungs and relieves cough: used for thirst and dry cough with hemoptysis due to lung and stomach yin deficiency; palpitations and easy fright due to heart yin deficiency; and heat-induced fluid depletion in the later stages of febrile diseases. Combined with Adenophora stricta and Fritillaria cirrhosa, it can treat dry cough due to lung yin deficiency.

[0009] Chrysanthemum: Bitter and sweet in taste, slightly cold in nature, and enters the lung and liver meridians. It dispels wind and clears heat, calms the liver and improves eyesight, and clears heat and detoxifies. It is used for wind-heat colds, headaches and dizziness, red and swollen eyes, blurred vision, and carbuncles and boils.

[0010] Rui Ren (Rui Ren): Sweet and warm in nature, it mainly enters the liver meridian and secondarily the heart meridian. Its effects include improving eyesight and clearing away corneal opacity. It is used for symptoms such as red and swollen eyes, tearing in the wind, and blurred vision.

[0011] In summary, it can be seen that the traditional Chinese medicine composition of the present invention has sufficient theoretical support at the level of modern pharmacological research, and the traditional Chinese medicine composition of the present invention has good therapeutic and / or preventive effects on eye diseases.

[0012] The formula of the traditional Chinese medicine composition of the present invention is as follows:

[0013] Traditional Chinese medicine's Five Wheels theory divides the eye into five wheels, corresponding to the functions of the five internal organs: Water Wheel (pupil): belongs to the kidneys, reflecting the abundance or deficiency of kidney essence. Insufficient kidney essence leads to blurred vision. Wind Wheel (cornea): belongs to the liver; liver blood nourishes the cornea. Blood Wheel (inner and outer canthal blood vessels): belongs to the heart; insufficient heart blood can cause congestion or stinging at the corners of the eyes, while excessive heart fire causes red eyes and eye discharge. Qi Wheel (sclera): belongs to the lungs; lung heat can cause congestion in the sclera. Flesh Wheel (eyelids): belongs to the spleen; spleen deficiency causes eyelid swelling or drooping, and those with severe spleen dampness experience morning eye swelling. The liver and kidneys are central; "the liver opens into the eyes," meaning liver blood directly nourishes the eyes; "the kidneys store essence, essence generates marrow, and marrow connects to the brain," meaning kidney essence flows to the eyes through the meridians, maintaining visual function. Qi and blood are transported to the eyes through the meridians, such as the Foot Jueyin Liver Meridian and the Hand Shaoyin Heart Meridian, both connected to the eyes. Insufficient or poorly circulated qi and blood can lead to dry eyes and eye fatigue. In summary, Traditional Chinese Medicine (TCM) achieves its effect of improving eyesight by regulating and tonifying liver and kidney functions and promoting the nourishment of qi in the eyes.

[0014] The causes and mechanisms of eye diseases include the following aspects: (1) External factors: invasion of the six evils: wind, cold, summer heat, dampness, dryness, fire and other external evils invade the eyes through the meridians or directly. (2) Internal factors: imbalance of the seven emotions: excessive emotions such as anger, joy, worry, and thought affect the Qi mechanism of the internal organs. For example, liver stagnation and fire can cause red and painful eyes. Long-term worry and thought can damage the spleen, resulting in insufficient Qi and blood production and causing blurred vision. (3) Diet and fatigue: excessive consumption of spicy and greasy foods can generate phlegm and dampness, which can obstruct the eye meridians. Prolonged eye strain and mental fatigue can deplete essence and blood, leading to dry eye syndrome or myopia. (4) Other factors: trauma, which directly damages the meridians or tissues of the eyes, causing blood stasis and edema (such as traumatic retinopathy). Congenital deficiency, deficiency of liver and kidney essence and blood, leading to congenital amblyopia, strabismus and other pathogenic factors. The basic pathogenesis is the dysfunction of the internal organs such as insufficient liver blood, deficiency of kidney essence, and weakness of spleen and stomach.

[0015] Therefore, it is evident that the etiology and pathogenesis of eye diseases are closely related. The traditional Chinese medicine composition of this invention comprehensively and dialectically addresses eye diseases, employing a rational combination of principal, assistant, and adjuvant herbs, with the main treatment principle of clearing liver heat, nourishing yin, and improving vision. The formulation strategy is as follows: Chrysanthemum is the principal herb for clearing liver heat and improving vision; Rehmannia glutinosa is the assistant herb, nourishing kidney yin to nourish the liver and orifices. Ophiopogon japonicus, being sweet and cold, is the adjuvant herb, assisting Rehmannia glutinosa in nourishing yin and simultaneously clearing heart fire to remove the heat from the inner and outer canthi of the eyes. Prunus armeniaca is the guiding herb, primarily entering the liver meridian and secondarily the heart meridian, with the effects of improving vision and clearing away corneal opacity, used for symptoms such as red, swollen, and painful eyes, tearing in the wind, and blurred vision. Ancient formulas often combine it with borneol and Coptis chinensis to make eye drops (such as the Chunxue Ointment in the "Formulary of the Bureau of Imperial Physicians"), which can be applied externally to relieve conjunctivitis and night blindness. The combined effects of these herbs are to nourish the kidneys, clear liver heat, nourish yin, improve vision, and relieve eye fatigue.

[0016] Optionally, the traditional Chinese medicine composition consists of the following parts by weight of Chinese medicinal materials: 0.5-2 parts by weight of Rehmannia glutinosa, 0.5-2 parts by weight of Ophiopogon japonicus, 1-4 parts by weight of Chrysanthemum morifolium, and 1-4 parts by weight of Prunus armeniaca seed, wherein the amount of Chrysanthemum morifolium and Prunus armeniaca seed is greater than the amount of Rehmannia glutinosa and Ophiopogon japonicus seed.

[0017] In this formula, chrysanthemum, with its light and volatile nature, clears the liver and improves vision, thus its dosage is relatively large. Rehmannia root, clearing heat and cooling the blood, enters the kidney meridian. Based on the principle of the liver and kidney sharing the same origin and the theory of the five wheels (of the eye), which considers the cornea to belong to the kidney, it nourishes the kidney and improves vision. However, its heavy nature means its dosage should not be too large to prevent the medicine from descending to the kidney; therefore, its dosage is less than that of the principal herb, chrysanthemum. Ophiopogon root, with its moistening and heart-clearing properties, effectively relieves congestion at the inner and outer canthi. Because it is somewhat nourishing, a large dosage would be detrimental to the processing of the powder; clinical experience suggests this ratio is more suitable. Prunus seed, sweet and warm in nature, primarily improves vision and relieves red and painful eyes. Since the principal, assistant, and guiding herbs are all cold in nature, the guiding herb is chosen to be warm in nature and in a larger dosage to prevent the overall medicinal properties from being too cold and harming the constitution. Considering the above principles, clinical powder dosage, and experience, the above ratio is the most reasonable for the herbal composition in this embodiment.

[0018] Optionally, the traditional Chinese medicine composition consists of the following traditional Chinese medicinal materials in parts by weight: 0.5-1 parts by weight of Rehmannia glutinosa, 0.5-1 parts by weight of Ophiopogon japonicus, 1-2 parts by weight of Chrysanthemum morifolium, and 1-2 parts by weight of Prunus armeniaca seed.

[0019] Optionally, the traditional Chinese medicine composition consists of the following traditional Chinese medicinal materials in parts by weight: 1-2 parts of Rehmannia glutinosa, 1-2 parts of Ophiopogon japonicus, 2-4 parts of Chrysanthemum morifolium, and 2-4 parts of Prunus armeniaca seed.

[0020] Optionally, the traditional Chinese medicine composition consists of the following traditional Chinese medicinal materials in parts by weight: 1 part Rehmannia glutinosa, 1 part Ophiopogon japonicus, 2 parts Chrysanthemum morifolium, and 2 parts Prunus armeniaca seed.

[0021] The traditional Chinese medicine composition of this invention can be formulated as powder, ointment, or patch. During use, the ointment can be directly applied to both sides of the Liver Shu acupoint, or the powder can be made into a medicated pack and applied to both sides of the Liver Shu acupoint. Alternatively, the patch can be directly applied to both sides of the Liver Shu acupoint. The traditional Chinese medicine composition of this invention can also be made into a medicated pack and placed inside an eye mask, serving to treat and / or prevent eye diseases while the child wears the eye mask. In practical applications, the dosage form of the traditional Chinese medicine can be flexibly selected based on a comprehensive consideration of the method of administration, application location, and efficacy.

[0022] A second aspect of the present invention provides a traditional Chinese medicine patch for eye diseases, the traditional Chinese medicine preparation comprising a carrier and the traditional Chinese medicine composition for eye diseases proposed in the first aspect of the present invention.

[0023] Optionally, the herbal patch may further include rice vinegar, and the ratio of the herbal composition to the rice vinegar is 1:1 to 2.

[0024] Optionally, the carrier may include nonwoven fabric, gauze, adhesive tape, adhesive plaster, or medical rubber.

[0025] The third aspect of this invention provides a method for preparing a traditional Chinese medicine patch for eye diseases, wherein the preparation method is applied to the traditional Chinese medicine patch for eye diseases proposed in the second aspect of this application, and the preparation method includes:

[0026] Weigh out each Chinese medicinal herb according to its weight and mix them together;

[0027] The mixed Chinese medicinal materials are pulverized and passed through a 40-100 mesh sieve, preferably through an 80 mesh sieve, to obtain a powdered Chinese medicinal mixture;

[0028] Add excipients to a mixture of powdered Chinese medicine to prepare a dressing.

[0029] The dressing is placed on a carrier to obtain a traditional Chinese medicine patch. In practical applications, the dressing can be prepared into a medicinal ball, then pressed into a cake shape, and then the cake-shaped dressing is placed on a carrier to obtain the traditional Chinese medicine patch.

[0030] An optional method of using the herbal patch of the present invention is as follows:

[0031] Treatment course: Apply the patch continuously for two weeks, one patch per day, for two hours each time;

[0032] Administration method: External acupoint application, applied to both sides of the Liver Shu acupoint.

[0033] The fourth aspect of the present invention provides the application of the traditional Chinese medicine composition for eye diseases proposed in the first aspect of the present invention or the traditional Chinese medicine patch for eye diseases proposed in the second aspect of the present invention in the preparation of a medicine, the medicine being used to prevent and / or treat pediatric eye diseases, the diseases including visual fluctuations, eye discomfort and accommodation abnormalities.

[0034] The aforementioned visual fluctuations manifest as temporary visual loss or blurred vision, which can partially recover after rest; the aforementioned eye discomfort manifests as dry eyes, soreness, photophobia, foreign body sensation, or even pain or headache around the eye socket; the aforementioned accommodation abnormalities manifest as slow focusing and double vision after close-range use of the eyes.

[0035] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0036] The traditional Chinese medicine composition and herbal patch of the present invention have good therapeutic effects on eye diseases. The formula is simple and reasonable, with few toxic side effects and is safe and reliable. Moreover, the herbal composition is convenient to use after being made into a herbal patch, which is easy for children to accept, and is especially suitable for children's eye diseases. Detailed Implementation

[0037] The present invention will be further described below through specific embodiments, but this is not a limitation of the present invention. Those skilled in the art can make various modifications or improvements based on the basic idea of ​​the present invention, but as long as they do not depart from the basic idea of ​​the present invention, they are all within the scope of the present invention.

[0038] Example 1

[0039] Step 1: Weigh out 1 part by weight of Rehmannia glutinosa, 1 part by weight of Ophiopogon japonicus, 2 parts by weight of chrysanthemum and 2 parts by weight of Prunus armeniaca seed and mix them together.

[0040] Step 2: Grind the mixed Chinese medicinal materials into powder and pass them through an 80-mesh sieve to obtain a powdered Chinese medicinal mixture;

[0041] Step 3: Add rice vinegar to the powdered Chinese medicine mixture to make a dressing, wherein the ratio of the Chinese medicine composition to rice vinegar is 1:1.

[0042] Step 4: Place the dressing on the carrier to obtain the traditional Chinese medicine patch;

[0043] Examples 2-10 prepared traditional Chinese medicine patches according to the formulation, sieving process and preparation ratio in Table 1, following the preparation method in Example 1.

[0044] Table 1: Components, sieving conditions, and blending ratios of each Chinese medicinal material in Examples 2-10

[0045]

[0046] Test case

[0047] This experimental example is a clinical study of the application of a traditional Chinese medicine patch made from the herbal composition of Example 1 in the treatment of eye diseases.

[0048] Case selection: Sixty children with eye diseases were randomly selected from Beijing Huimin Traditional Chinese Medicine Children's Hospital. The average age of the children was 6 years and 8 months, and the male-to-female ratio was 1:1.

[0049] 1. Patient grouping:

[0050] The control group and the experimental group were mainly grouped based on the following criteria: an equal number of men and women, equal average age, similar main symptoms, and similar severity.

[0051] 2. The diagnostic criteria are as follows:

[0052] (1) Symptom assessment

[0053] Vision fluctuations: manifested as temporary vision loss or blurred vision, which can partially recover after rest;

[0054] Eye discomfort: including dryness, soreness, photophobia, foreign body sensation, and even pain or headache around the eyes;

[0055] Accommodation disorder: slow focusing and double vision after close-range use of the eyes.

[0056] (2) Analysis of medical history and eye habits

[0057] Eye strain intensity: History of prolonged use of electronic products, reading, or detailed tasks (more than 40 minutes without a break).

[0058] Environmental factors: insufficient / excessive light, exposure to blue light from the screen, or dry environment in an air-conditioned room.

[0059] Overall condition: Insufficient sleep, high stress, or systemic diseases (such as diabetes or thyroid disease) may worsen symptoms.

[0060] (3) Medical examination items

[0061] Basic checks:

[0062] Vision test: Assess uncorrected and corrected visual acuity.

[0063] Slit-lamp examination: Observe whether there are any abnormalities in structures such as the cornea and conjunctiva.

[0064] Functional checks:

[0065] Refraction and accommodation function test: Myopia / hyperopia / astigmatism is confirmed by cycloplegic refraction, and the ciliary muscle accommodation ability is assessed.

[0066] 3. Medication process: Apply the herbal patch of this embodiment to the bilateral liver shu acupoints for 2 consecutive weeks, one patch per day, for 2 hours each time.

[0067] 4. Scoring criteria: The commonly used EyeStrain Symptom Score (ESS) is used to subjectively assess the severity of eye fatigue and the effectiveness of treatment. The EyeStrain Symptom Score is shown in Table 2.

[0068] Table 2: Eye Fatigue Symptom Scoring Table

[0069]

[0070] 5. Total Score Calculation and Grading:

[0071] 5.1 Total score range: 0~27 points (sum of 9 symptoms).

[0072] 5.2 Severity Grading:

[0073] 0-5 points: Normal / mild (no intervention required).

[0074] 6-12 points: Mild eye strain (adjusting eye habits is recommended).

[0075] 13-18 points: Moderate eye strain (medical intervention required).

[0076] ≥19 points: Severe eye strain (detailed ophthalmological examination required).

[0077] 6. Reference for Efficacy Assessment

[0078] Significant effect: Total score decreased by ≥50%;

[0079] Effective: Total score decreases by 20% to 50%;

[0080] Invalid: Total score decreases by less than 20% or worsens.

[0081] 7. Experimental results: The statistical data of symptom scores before and after medication for the same child are shown in Table 3.

[0082] Table 3. Statistical analysis of symptom scores before and after medication in the same child.

[0083]

[0084] The results above show that after using the herbal patch in this embodiment, the eye symptoms of most children were effectively relieved, with an effectiveness rate of over 75%, and no obvious adverse reactions were found during the treatment.

[0085] 8. Case Analysis:

[0086] The patient, a 6-year-old boy, recently experienced dry and painful eyes due to prolonged reading and studying, along with an irritable temperament. Artificial tears provided slight relief, but were subsequently replaced by red and painful eyes, a bitter taste in the mouth, and a dry throat. Physical examination revealed conjunctival hyperemia in both eyes, a red tongue tip and sides with prominent lingual papillae, and a thready, wiry pulse. The diagnosis was excessive liver fire, and the treatment principle was to clear liver heat, nourish yin, and improve vision. An external treatment method, a vision-improving patch, was selected. After one week, the eye pain subsided, the dryness was relieved, the conjunctival hyperemia slightly improved, and the irritability disappeared. The treatment was satisfactory, and the patch was continued for another week for consolidation.

[0087] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine patch for the prevention and / or treatment of pediatric eye diseases, said patch comprising a traditional Chinese medicine composition, characterized in that, The traditional Chinese medicine composition consists of the following parts by weight of Chinese medicinal materials: 0.5-2 parts by weight of Rehmannia glutinosa, 0.5-2 parts by weight of Ophiopogon japonicus, 1-4 parts by weight of Chrysanthemum morifolium and 1-4 parts by weight of Prunus armeniaca seed, wherein the amount of Chrysanthemum morifolium and Prunus armeniaca seed is greater than the amount of Rehmannia glutinosa and Ophiopogon japonicus seed. The symptoms described include fluctuating vision, eye discomfort, and accommodative abnormalities.

2. The traditional Chinese medicine patch for preventing and / or treating pediatric eye diseases according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following parts by weight of Chinese medicinal materials: 0.5-1 parts by weight of Rehmannia glutinosa, 0.5-1 parts by weight of Ophiopogon japonicus, 1-2 parts by weight of Chrysanthemum morifolium, and 1-2 parts by weight of Prunus armeniaca seed.

3. The traditional Chinese medicine patch for preventing and / or treating pediatric eye diseases according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicinal materials in parts by weight: 1-2 parts of Rehmannia glutinosa, 1-2 parts of Ophiopogon japonicus, 2-4 parts of Chrysanthemum morifolium, and 2-4 parts of Prunus armeniaca seed.

4. The traditional Chinese medicine patch for preventing and / or treating pediatric eye diseases according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following traditional Chinese medicinal materials in parts by weight: 1 part of Rehmannia glutinosa, 1 part of Ophiopogon japonicus, 2 parts of Chrysanthemum morifolium, and 2 parts of Prunus armeniaca seed.

5. The traditional Chinese medicine patch for preventing and / or treating pediatric eye diseases according to claim 1, characterized in that, The herbal patch includes a carrier.

6. The traditional Chinese medicine patch for preventing and / or treating pediatric eye diseases according to claim 1, characterized in that, The herbal patch also includes rice vinegar, and the ratio of the herbal composition to the rice vinegar is 1:1 to 2.

7. The traditional Chinese medicine patch for preventing and / or treating pediatric eye diseases according to claim 5, characterized in that, The carrier may include non-woven fabric, gauze, or medical rubber.

8. A method for preparing a traditional Chinese medicine patch for the prevention and / or treatment of pediatric eye diseases, characterized in that, The preparation method is applied to the traditional Chinese medicine patch according to any one of claims 1-7, and the preparation method includes: Weigh out each Chinese medicinal herb according to its weight and mix them together; The mixed Chinese medicinal materials are pulverized and passed through a 40-100 mesh sieve to obtain a powdered Chinese medicinal mixture; Add excipients to a mixture of powdered Chinese medicine to prepare a dressing. The dressing is placed on a carrier to produce a traditional Chinese medicine patch.

9. The use of the traditional Chinese medicine patch according to any one of claims 1-7 in the preparation of a drug, characterized in that, The medication is used to prevent and / or treat pediatric eye conditions, including visual fluctuations, eye discomfort, and accommodation abnormalities.

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