CN116211984B

CN116211984B - A Chinese medicinal composition eye ointment for preventing and treating myopia of children and teenagers, and its preparation method

Info

Publication number: CN116211984B
Application number: CN202310245878.0A
Authority: CN
Inventors: 张惠珍; 狄浩浩; 冯思颉
Original assignee: Henan University of Technology
Current assignee: Henan University of Technology
Priority date: 2023-03-14
Filing date: 2023-03-14
Publication date: 2024-02-09
Anticipated expiration: 2043-03-14
Also published as: CN116211984A

Abstract

The invention discloses a traditional Chinese medicine composition eye ointment for preventing and treating myopia of children and teenagers and a preparation method thereof, which belong to the technical field of traditional Chinese medicine preparation, wherein the traditional Chinese medicine composition eye ointment is prepared from a traditional Chinese medicine mixture and auxiliary materials, and the traditional Chinese medicine mixture comprises the following components in parts by weight: 7-11 parts of astragalus membranaceus, 7-11 parts of ginseng, 4-8 parts of angelica sinensis, 4-8 parts of white paeony root, 4-8 parts of medlar, 4-8 parts of turmeric, 4-8 parts of wormwood, 2-4 parts of wild chrysanthemum flower, 2-4 parts of climbing groundsel herb, 2-4 parts of green tangerine peel, 2-4 parts of grassleaf sweelflag rhizome and 2-4 parts of pearl powder. The traditional Chinese medicine composition eye ointment is specific to the specific pathogenesis cause of the myopia of the teenagers of children, has full and specific syndrome differentiation, is low in price, convenient to use, safe and effective.

Description

A Chinese medicinal composition eye ointment for preventing and treating myopia of children and teenagers, and its preparation method

Technical Field

The invention belongs to the technical field of traditional Chinese medicine preparations, and in particular relates to traditional Chinese medicine composition eye ointment for preventing and treating myopia of children and teenagers and a preparation method thereof.

Background

With the rapid development of social information networks, the ocular tension is increased in life, study and work of people, the learning of children and teenagers is heavy, the ocular time and intensity are increased greatly before, and thus the occurrence of myopia of children and teenagers is increased. Light and moderate myopia, poor vision, squinting, wearing glasses, which bring a plurality of inconveniences to the life, study, growth and industry selection of children; the high myopia of more than 600 degrees is accompanied with pathological changes of eyeground, such as retinal detachment and scleral grape swelling, so that the eyesight of children is seriously damaged, the blindness is dangerous, and the life quality of the children and teenagers is seriously affected.

Near vision is good, and far vision is blurred, so that people often squint eyes to see things and eye fatigue is easy. High myopia, prominent eye drops and severely reduced hyperopia. The pathogenesis of the myopia of the teenagers of children mainly comprises excessive use of eyes, consumption of body fluid by the eyes, channel obstruction, liver orifice by the eyes, liver injury caused by eye injury, kidney injury caused by long-term injury, and liver-kidney deficiency.

At present, methods for preventing and treating myopia include wearing glasses, laser surgery and the like. Besides the defect of treating the symptoms without treating the root causes, the laser surgery has potential side effects on eyes. The method for preventing and treating myopia in traditional Chinese medicine comprises acupuncture points, eye plaster, massage, etc. The traditional Chinese medicine of the eye ointment is insufficient in compatibility of medicines, is not specific, has a general formula and is used for all patients with ametropia including myopia. In fact, the myopia of the teenagers and the children has own specific pathogenesis, and the individual treatment based on syndrome differentiation and the individual prescription should be given.

At present, no traditional Chinese medicine prescription eye cream specially aiming at independent diagnosis and treatment of myopia of children and teenagers exists, and the invention can fill the gap. The eye ointment has unique formula, is safe and convenient to use, can effectively relieve the occurrence and development of myopia of children and teenagers, and can help children to have healthy eyesight.

Disclosure of Invention

The invention provides a traditional Chinese medicine composition eye ointment for preventing and treating myopia of children and teenagers and a preparation method thereof.

In order to solve the problems, the invention adopts the following technical scheme.

A traditional Chinese medicine composition eye ointment for preventing and treating myopia of children and teenagers is characterized by being prepared from a traditional Chinese medicine mixture and auxiliary materials in parts by weight:

44-82 parts of a traditional Chinese medicine mixture,

and 441-579 parts of auxiliary materials.

A traditional Chinese medicine composition eye ointment for preventing and treating myopia of children and teenagers is prepared from a traditional Chinese medicine mixture and auxiliary materials in parts by weight:

63 parts of a Chinese medicinal mixture,

500 parts of auxiliary materials.

The traditional Chinese medicine mixture comprises the following components in parts by weight:

wherein, the auxiliary materials comprise the following components in parts by weight:

a preparation method of a traditional Chinese medicine composition eye ointment for preventing and treating myopia of children and teenagers comprises the following steps:

(1) The Chinese medicinal composition is prepared by decocting the filtrate: mixing radix astragali, ginseng radix, radix Angelicae sinensis, radix Paeoniae alba, fructus Lycii, curcuma rhizome, folium Artemisiae Argyi, flos Chrysanthemi Indici, herba Senecionis Scandentis, pericarpium Citri Reticulatae viride, and rhizoma Acori Graminei, decocting in water for 2 times (1 hr each time), mixing decoctions, and filtering with 400 mesh sieve to obtain Chinese medicinal decoction;

(2) Preparing myopia ointment: mixing stearic acid, glyceryl monostearate, liquid paraffin and white vaseline to obtain an oil phase, mixing the Chinese medicinal decoction, triethanolamine, glycerol, tween, methyl benzoate and potassium sorbate to obtain water phase, respectively heating the oil phase and water phase to 85deg.C in water, slowly pouring the oil phase into the water phase, stirring to obtain cream with milky yellow and semisolid, cooling the cream to 55deg.C, adding Margarita powder and Lithargyrum powder, and stirring for 2 hr until the cream is condensed.

The application method of the myopia ointment formula comprises 3 times a day for 5 minutes each time. The eye ointment is applied on the periphery of the eye, and the index finger starts from the Ming acupoint of the eye of the eyebrow and goes from the upper orbit to the Tongziliao acupoint of the eyebrow, then goes to the temple, goes to the lower orbital margin, goes to the four-white acupoint, and finally goes to the inner canthus side of the inner side of the nose, and then is pressed, retracted and stopped by the index finger at the acupoint, and the acid distending pain is felt by itself.

Compared with the prior art, the invention has the beneficial effects that:

the monarch drugs in the invention are astragalus and ginseng, which are good drugs for invigorating qi and blood, and have definite effect and mild effect. Teenagers are pure yang bodies, and the yin fluid is often insufficient, so that excessive eyes are easy to consume qi and consume body fluid, and the qi and blood are deficient, so that the meridians are retarded, and the eyes are unclear and the vision is far from clear. Astragalus mongholicus and ginseng are sweet in taste and slightly warm in nature, can tonify qi and raise yang,

promoting the production of body fluid, nourishing blood, promoting the circulation of qi, and relieving arthralgia. Can be used for treating myopia due to excessive use of eyes of teenagers and children. The two components are monarch drugs, and the dosage is the largest.

The excessive use of eyes causes the discomfort of the distant vision, the deficiency of qi and blood, which inevitably leads to the obstruction of the channels and collaterals around the eyes, which is the orifice of the liver, and the obstruction of the channels and collaterals around the eyes, which inevitably hurts the liver, and the deficiency of both the liver and the kidney. In the formula, the Chinese angelica and the white paeony root enrich the blood,

the medlar nourishes liver and kidney, the turmeric and the wormwood warm channels and unblock collaterals, and the medicines are ministerial medicines, and the dosage is slightly inferior to that of monarch medicines.

Overuse of the eyes causes qi stagnation and fluid impairment in the eyes, and liver and kidney deficiency, which often manifests as up-flaming of liver fire. In the formula, the wild chrysanthemum flower, the groundsel herb, the heat and the toxin are cleared, the fire is discharged, the liver is calmed and the eyesight is improved; pearl powder for suppressing hyperactive liver, subsiding yang, nourishing liver yin, and improving eyesight. Qing Pi, with the actions of activating qi and resolving stagnation, is good at Shu Ganyu. The four are adjuvant drugs with small dosage. The grassleaf sweelflag rhizome has the advantages of pungent and fragrant smell, bitter and dry taste, warmth and general, and mild action, is suitable for children and teenagers to refresh and restore consciousness, and is the drug with the minimum dosage.

The traditional Chinese medicine composition eye ointment provided by the invention aims at the specific pathogenesis cause of the myopia of the teenagers of children, has full and specific syndrome differentiation, is low in price, convenient to use, safe and effective.

Detailed Description

The technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention, and it is apparent that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

The invention is further described below in connection with specific embodiments.

Preparing articles:

1 stage of electronic balance;

1 stove;

1 pan;

2 beakers;

1 stage of stirrer;

2 thermometer at 100deg.C.

When the following examples are used to prepare the eye ointments of the Chinese medicinal composition, the following requirements are set:

1. ultraviolet lamp sterilization is needed for 2 hours in the manufacturing environment;

2. the container is manufactured by high-pressure sterilization;

3. the paste is stirred in the same direction so as to avoid whipping.

Example 1

The embodiment provides a traditional Chinese medicine composition eye ointment for preventing and treating myopia of children and teenagers, which is prepared from a traditional Chinese medicine mixture and auxiliary materials, wherein the traditional Chinese medicine mixture comprises the following components in parts by weight:

wherein the auxiliary materials comprise the following components:

the preparation method of the traditional Chinese medicine composition eye ointment for preventing and treating the myopia of the teenagers and the children comprises the following steps:

(1) The Chinese medicinal composition is prepared by decocting the filtrate: mixing radix astragali, radix Ginseng, radix Angelicae sinensis, radix Paeoniae alba, fructus Lycii, rhizoma Curcumae Longae, folium Artemisiae Argyi, flos Chrysanthemi Indici, herba Senecionis Scandentis, pericarpium Citri Reticulatae viride, and rhizoma Acori Tatarinowii, decocting in 10 times of water for 2 times (1 hr each time), mixing decoctions, and filtering with 400 mesh sieve to obtain 1000ml decoction;

Example 2

wherein the auxiliary materials comprise the following components:

Example 3

wherein the auxiliary materials comprise the following components:

Example 4

wherein the auxiliary materials comprise the following components:

Example 5

wherein the auxiliary materials comprise the following components:

Comparative example 1

in this example, compared with the traditional Chinese medicine composition of example 1, turmeric is replaced by ginger, and other components and formula amounts are the same.

Wherein the auxiliary materials comprise the following components:

(1) The Chinese medicinal composition is prepared by decocting the filtrate: mixing radix astragali, radix Ginseng, radix Angelicae sinensis, radix Paeoniae alba, fructus Lycii, rhizoma Zingiberis recens, folium Artemisiae Argyi, flos Chrysanthemi Indici, herba Senecionis Scandentis, pericarpium Citri Reticulatae viride, and rhizoma Acori Tatarinowii, decocting in 10 times of water for 2 times (1 hr each time), mixing decoctions, and filtering with 400 mesh sieve to obtain 1000ml decoction;

Comparative example 2

compared with the traditional Chinese medicine mixture in the embodiment 1, the traditional Chinese medicine mixture does not contain green tangerine peel, and other components and the formula amount are the same.

Wherein the auxiliary materials comprise the following components:

(1) The Chinese medicinal composition is prepared by decocting the filtrate: mixing radix astragali, radix Ginseng, radix Angelicae sinensis, radix Paeoniae alba, fructus Lycii, rhizoma Curcumae Longae, folium Artemisiae Argyi, flos Chrysanthemi Indici, herba Senecionis Scandentis, margarita powder, and rhizoma Acori Tatarinowii, decocting in 10 times of water for 2 times (1 hr each time), mixing decoctions, and filtering with 400 mesh sieve to obtain 1000ml decoction;

Animal toxicity test

1. Acute periocular skin allergy test:

10 healthy guinea pigs with the age of 3 months are selected, the weight is 450-700 g, and the male and female are half. The upper part of the guinea pig in the eyes was dehaired at about 1cm by 1cm in area 24 hours before administration. The myopia ointment of the example 1 is uniformly smeared on a dehairing area, the medical non-irritant adhesive tape is used for fixing and sealing for 24 hours, the adhesive tape and the eye ointment are removed after 24 hours, the skin and systemic poisoning signs of animals are observed, the observation period is 7 days, and the animals are sacrificed by a neck pulling method after the test is finished, so that the general pathology observation is carried out.

Test results: the test animals did not die during the test period, the activities were fed normally, and no abnormalities were seen in the whole body skin. Cadavers were generally necropsied, and no obvious abnormalities were seen in heart, liver, spleen, lung, kidney.

Conclusion: guinea pig has no acute skin anaphylaxis to tested eye ointment

2. Acute conjunctival irritation test

6 healthy guinea pigs with the age of 3 months are selected, the weight is 450-700 g, and the male and female are half. In the test, the water decoction of the traditional Chinese medicine composition obtained in the application is placed to normal temperature, and 1 drop of the water decoction is dripped into the left eye of each guinea pig after being sucked by a sterile dropper, and the right eye is used for comparison observation. 30min,1h,24h,48h,72h after dripping the test substance, and observing the conjunctival congestion of the eyes of the guinea pigs.

Test results: no ocular abnormalities were observed at each time point after instillation of the test article, and during the observation period, animals were fed normally with activity and no death.

Conclusion: the Chinese medicinal composition water decoction used in the application has no obvious irritation to guinea pig conjunctiva

Clinical data of myopia ointment

1. Case sources

Collecting 240 myopic teenager patients from a certain ophthalmic hospital in Zhengzhou city from 11 months 2021 to 4 months 2022.

2. Diagnostic criteria and classification

Diagnostic criteria are formulated with reference to diagnosis and classification criteria for myopia in Chinese ophthalmology. The diagnosis standard of myopia is a refractive error in which the eye forms a focus in front of the retina after parallel rays pass through the refractive system of the eye in a state of regulating relaxation, the far point moves closer, and the axial length of the eyeball is larger than the refractive power of the eyeball.

Classification of myopia extent:

1) Mild myopia: myopia of < -3.0D

2) Moderate myopia: myopia of-3.0D-6.0D

3) High myopia: myopia of > -6.0D

3. Exclusion criteria

1) Is not in compliance with the above diagnostic and inclusion criteria

2) Patients with other eye diseases and have influence on curative effect determination

3) Patients with other systemic diseases and mental diseases

4) Those undergoing other treatment methods

4. Grouping and treatment method

240 patients which are taken into observation are randomly divided into four groups according to the order of clinic visits, and all cases are completed in the whole process without falling cases. Before treatment, the comparison between the two groups of examination results has no statistical difference, and the data has comparability. Wherein, 60 cases of treatment group 1 are treated, the myopia ointment of the embodiment 1 of the invention is applied for 3 times per day in the observation period; treatment of 60 cases in treatment group 2, treatment with the myopia ointment of comparative example 1 of the present invention was applied 3 times daily over the observation period; treatment of 3 groups of 60 cases, treatment with the inventive comparative example 2 myopic eye ointment was applied 3 times daily over the observation period; treatment of 4 groups 60 cases, administration of cool compress gel with bosom and eye moistening effects, and application of cool compress gel with eye moistening effect was performed 3 times daily during observation period. After 2 months, the two groups of cases are subjected to index detection, and the curative effect is observed.

5. Effect determination

The use effect is divided into effective and ineffective.

The method is effective: the original subjective visual discomfort, such as blurred vision, eye soreness, eye distension, eye pain, headache and the like, disappears; or the wearing mirror power is reduced by more than 50 degrees; or the naked eyes are far away, and the near vision is improved by more than 0.1 compared with the prior art. Any one of the above steps is effective.

Invalidation: subjective visual discomfort such as blurred vision, eye soreness, eye distension, eye pain, headache, etc. still exists; or the lens wearing degree is unchanged; or the wearing power is deepened more forward; or the naked eyes are far away, and the near vision is not improved; or the naked eyes are far away, and the near vision is reduced by more than 0.1 compared with the front.

6. Statistical method

SPSS17.0 software was used for data processing. The pre-and post-treatment metering data of each group adopts paired t test, the comparison among groups adopts variance analysis, the test level a=0.05, and the difference is statistically significant when p is less than 0.05.

7. Observation result

Group of	Eye ointment name	Case (personal)	Effective and effective	Invalidation of	Effective rate of
						Treatment group 1	Myopia ointment	60	57	3	95.0％
Treatment group 2	Myopia ointment	60	54	6	90.0％
						Treatment 3 groups	Myopia ointment	60	51	9	85.0％
Treatment 4 groups	Eye-moistening cold compress gel	60	52	8	86.7％

8. Conclusion(s)

The observation results show that the treatment of the group 1 and the treatment of the group 2 can improve the clinical symptoms of teenager myopia patients, and compared with the eye-moistening cold compress gel, the myopia ointment has more remarkable curative effect. And the eye pastes of comparative example 1 and comparative example 2 were significantly lower in efficacy than the eye paste of example 1.

The foregoing is a further elaboration of the present invention in connection with the detailed description, and it is not intended that the invention be limited to the specific embodiments shown, but rather that a number of simple deductions or substitutions be made by one of ordinary skill in the art without departing from the spirit of the invention, should be considered as falling within the scope of the invention as defined in the appended claims.

Claims

1. A traditional Chinese medicine composition eye ointment for preventing and treating myopia of children and teenagers is characterized by being prepared from a traditional Chinese medicine mixture and auxiliary materials in parts by weight:

44-82 parts of a traditional Chinese medicine mixture,

441-579 parts of auxiliary materials;

the traditional Chinese medicine mixture comprises the following raw materials in parts by weight:

7-11 parts of astragalus root,

7-11 parts of ginseng and the like,

4-8 parts of Chinese angelica,

4-8 parts of white peony root,

4-8 parts of medlar, which are mixed together,

4-8 parts of turmeric, namely,

4-8 parts of wormwood,

2-4 parts of wild chrysanthemum flower,

2-4 parts of groundsel herb,

2-4 parts of green tangerine peel,

2-4 parts of grassleaf sweelflag rhizome,

2-4 parts of pearl powder;

the auxiliary materials comprise the following components in parts by weight:

90-110 parts of stearic acid,

40-60 parts of glycerin monostearate,

40-60 parts of liquid paraffin,

90-110 parts of white vaseline,

40-60 parts of triethanolamine, wherein the triethanolamine comprises the following components,

90-110 parts of glycerin, and the balance of glycerin,

5-15 parts of tween-A,

3-7 parts of methyl benzoate,

3-7 parts of potassium sorbate,

20-40 parts of litharge powder.

2. The traditional Chinese medicine composition eye ointment for preventing and treating the myopia of the teenagers and the children, which is characterized by being prepared from a traditional Chinese medicine mixture and auxiliary materials in parts by weight:

63 parts of a Chinese medicinal mixture,

500 parts of auxiliary materials.

3. The traditional Chinese medicine composition eye ointment for preventing and treating the myopia of the teenagers and the children according to claim 1, wherein the traditional Chinese medicine mixture comprises the following raw materials in parts by weight:

9 parts of astragalus root,

9 parts of ginseng and the like,

6 parts of Chinese angelica root, the root of Chinese angelica,

6 parts of white paeony root,

6 parts of medlar, which is prepared from the following components,

6 parts of turmeric, namely, 6 parts of turmeric,

6 parts of wormwood herb,

3 parts of wild chrysanthemum flower,

3 parts of groundsel herb,

3 parts of green tangerine peel and the like,

3 parts of grassleaf sweelflag rhizome,

and 3 parts of pearl powder.

4. The traditional Chinese medicine composition eye ointment for preventing and treating the myopia of the teenagers of the children, which is characterized by comprising the following components in parts by weight:

100 parts of stearic acid, wherein the components are mixed,

50 parts of glycerin monostearate,

50 parts of liquid paraffin, and the like,

100 parts of white vaseline and the balance of the white vaseline,

50 parts of triethanolamine, and the components are mixed together,

100 parts of glycerin, and the total weight of the glycerin,

10 parts of tween-10, which is used for preparing the medicine,

5 parts of methyl benzoate and the total weight of the methyl benzoate,

5 parts of potassium sorbate, which are mixed together,

30 parts of litharge powder.

5. A method for preparing the traditional Chinese medicine composition eye ointment for preventing and treating the myopia of children and teenagers according to any one of claims 1-4, which is characterized by comprising the following steps:

(1) Preparing a traditional Chinese medicine composition water decoction filtrate: mixing radix astragali, ginseng radix, radix Angelicae sinensis, radix Paeoniae alba, fructus Lycii, curcuma rhizome, folium Artemisiae Argyi, flos Chrysanthemi Indici, herba Senecionis Scandentis, pericarpium Citri Reticulatae viride, and rhizoma Acori Graminei, decocting in water for 2 times (1 hr each time), mixing decoctions, and filtering with 400 mesh sieve to obtain Chinese medicinal decoction;