CN113082164A

CN113082164A - Traditional Chinese medicine composition for relieving myopia and application thereof

Info

Publication number: CN113082164A
Application number: CN202010017588.7A
Authority: CN
Inventors: 金明
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-01-08
Filing date: 2020-01-08
Publication date: 2021-07-09

Abstract

The invention provides a traditional Chinese medicine composition for relieving myopia, which is prepared from the following raw materials: rhizoma Polygonati, herba Dendrobii, Concha Margaritifera, radix Rhodiolae, Prunellae Spica, semen Cassiae, and herba Menthae. Preferably, as an external preparation, the Chinese medicinal composition also comprises borneol. Clinical test results show that the composition can obviously relieve the increase of myopia degrees of low and medium myopia children, delay the increase of the ocular axis and improve the binocular vision.

Description

Traditional Chinese medicine composition for relieving myopia and application thereof

Technical Field

The invention relates to a traditional Chinese medicine composition and application thereof, in particular to a traditional Chinese medicine composition for relieving juvenile myopia and application thereof, and belongs to the technical field of traditional Chinese medicines.

Background

Epidemiological investigations have shown that myopia affects 18.9 million people worldwide, and by the year 2020 myopia will affect 25.6 million people, as current morbidity remains unchanged. Uncorrected myopia is the leading cause of visual impairment, and ocular fundus lesions with high myopia in the upper sea have been reported to be one of the leading causes of new cases of blindness, with visual impairment due to pathological myopia being the most prominent cause of blindness in young age groups. In recent years, China pays more attention to next-generation education due to high social development speed, learning pressure is increased, and the incidence rate and the myopia growth speed of pupils are obviously higher than those of the western countries.

The causes of myopia are complex, and the risk factors are many, such as ametropia and excessive growth of eyeballs, advancing of onset age, heredity, visual environment, educational activities, and lag in regulation due to asthenopia. Myopia is usually manifested by excessive elongation of the axis of the eye and structural changes, and the incidence of eye diseases such as myopia, especially the retinal detachment of the ocular form of patients with high myopia, myopic maculopathy, glaucoma and cataract is obviously increased. The higher the degree of myopia, the longer the axis of the eye, and the higher the lifetime risk of these orbits. Therefore, it is important to control the progression of myopia and reduce the growth of the axis of the eye.

The method for controlling the growth and development of myopia in modern medicine comprises the following steps:

1. atropine: atropine controls The development of Myopia and is The focus of recent research, and long-term clinical observations of The Atropine in The T-syndrome of Myopia 1(ATOM1), The Atropine in The T-syndrome of Myopia2(ATOM2) and The like show that low (0.01%), medium (0.5%), and high (0.1%) Atropine can reduce The increase of Myopia degrees and simultaneously slow down The increase of The ocular axis. However, the rebound phenomenon of the accelerated increase speed of the myopia degree after stopping the medicine is discovered in different degrees in each study during the observation period after stopping the medicine. And discomfort symptoms such as photophobia, dry eye, blush, abnormal glistening sensation and the like can be generated in the using process of the atropine.

2. A cornea shaping mirror: the orthokeratology lens is also called as OK lens, which is a rigid air permeability contact lens for reducing the myopia degree by reducing the radian of the central area of the cornea by reshaping the shape of the cornea so as to gradually flatten the curvature of the cornea. Research shows that the OK glasses have the effects of controlling the development of myopia of children and delaying the growth of the axis of eyes. However, the increase of the myopia degree and the elongation of the axis of the eye are accelerated after the OK glasses are stopped, and the effect of the OK glasses treatment can be gradually weakened along with the increase of time.

3. Soft contact lenses, multifocal soft contact lenses, and the like: with the progress of science and technology, some new products such as soft contact lenses, multifocal eyes, multifocal soft contact lenses and the like are on the market at a time, and there are also many reports on relevant research on myopia progression control, but the effects of these products on myopia degree control and axis growth retardation are not obvious in general.

4. Oral administration of the medicine: at present, related researches on drugs which can effectively control the myopia development such as adenosine receptor antagonists 7-methylxanthine and crocetin are published in the journal, and researches on ketorolac aminobutanetriamine (a non-steroidal anti-inflammatory drug, NSAID), oral riboflavin, BHVI2 (an experimental drug) and tropicamide are in progress. However, these studies are still in the initial stage, and there is a long distance to market use.

Disclosure of Invention

Aiming at the problems in the prior art, the invention provides a traditional Chinese medicine composition for relieving myopia and application thereof.

As one aspect of the invention, the invention provides a traditional Chinese medicine composition for relieving myopia, which is prepared from the following raw material medicines: rhizoma Polygonati, herba Dendrobii, Concha Margaritifera, radix Rhodiolae, Prunellae Spica, semen Cassiae, and herba Menthae.

Preferably, the dosage of each raw material medicine is as follows: 6-30 parts of rhizoma polygonati, 6-30 parts of dendrobium officinale, 6-30 parts of mother-of-pearl, 6-30 parts of rhodiola rosea, 6-30 parts of selfheal, 6-30 parts of semen cassiae and 3-24 parts of mint.

Further preferably, the dosage of each raw material medicine is as follows: 8-25 parts of rhizoma polygonati, 8-25 parts of dendrobium officinale, 8-25 parts of mother-of-pearl, 8-25 parts of rhodiola rosea, 8-25 parts of selfheal, 8-25 parts of semen cassiae and 5-20 parts of mint.

More preferably, the dosage of each raw material medicine is as follows: 12-22 parts of rhizoma polygonati, 12-22 parts of dendrobium officinale, 12-22 parts of mother-of-pearl, 12-22 parts of rhodiola rosea, 12-22 parts of selfheal, 12-22 parts of cassia seed and 8-18 parts of mint.

Most preferably, the dosage of each raw material medicament is as follows: 20 parts of rhizoma polygonati, 20 parts of dendrobium officinale, 20 parts of mother-of-pearl, 20 parts of rhodiola rosea, 20 parts of selfheal, 20 parts of cassia seed and 15 parts of mint.

In the above technical scheme, the traditional Chinese medicine composition can be in any form composed or prepared from the above raw material medicines, including: the raw materials are respectively crushed and then mixed to form the composition; the raw materials are mixed and crushed to obtain a composition; extracting the above materials respectively by conventional extraction method to obtain extracts (such as rhizoma Polygonati extract, herba Dendrobii extract, and radix Rhodiolae extract), and mixing to obtain composition; mixing the above raw materials, and extracting by conventional extraction method to obtain extract; the effective parts are obtained by further refining and purifying extracts obtained by respectively or mixedly extracting the raw material medicines; the composition, the extract and the effective part are further prepared into conventional formulations according to conventional preparation processes.

The conventional extraction method comprises soaking extraction, decocting extraction, reflux extraction, percolation extraction, ultrasonic extraction, microwave extraction, etc.; the extraction solvent comprises water or conventional organic solvent such as ethanol, methanol, ethyl acetate, petroleum ether, isopropanol, etc.; the refining and purifying process comprises extraction, column chromatography separation, high performance liquid chromatography separation and the like.

The above conventional dosage forms include preparations of various administration routes. Such as by oral (including buccal or sublingual), topical (including buccal, sublingual or transdermal), parenteral (including subcutaneous, intradermal, intramuscular, intraarticular, intrasynovial, intrasternal, intrathecal, intralesional, intravenous or intradermal injection or infusion) or clinically acceptable ophthalmic formulations. These formulations may be prepared by any method known in the art of pharmacy, for example by bringing into association the active ingredient with the carrier or excipient. Such as tablets, capsules, granules, pellets, microspheres, dripping pills, controlled release preparations, sustained release preparations or injections.

Pharmaceutical formulations adapted for oral administration may be presented as discrete units, such as capsules, tablets, powders or granules; a solution, suspension, oil-in-water liquid emulsion or water-in-oil emulsion in an aqueous or non-aqueous liquid. Oral liquids such as solutions, syrups and elixirs may be prepared in unit dosage form. Syrups can be prepared by dissolving the compound in a suitably flavored aqueous solution, while elixirs are prepared through the use of a non-toxic carrier (vehicle). Solubilizers and emulsifiers such as ethoxylated isostearyl alcohol and polyoxyethylene sorbitol ether, preservatives, flavoring additives such as peppermint oil or natural sweeteners, or saccharin or other artificial sweeteners, and the like may also be added. Dosage unit formulations for oral administration may be microencapsulated or formulated for extended or sustained release by coating or embedding the particulate material in a polymer, wax or the like, as appropriate. Administration can also be in the form of liposome delivery systems (such as small unilamellar liposomes, large unilamellar liposomes, and multilamellar liposomes) which can be formed from a wide variety of phospholipids, such as cholesterol, stearylamine, or phosphatidylcholines.

Pharmaceutical formulations adapted for transdermal administration may be presented as discrete patches intended to remain in intimate contact with the epidermis of the recipient for an extended period of time. Pharmaceutical formulations adapted for topical administration may be formulated as ointments, creams, suspensions, lotions, powders, solutions, pastes, gels, sprays, aerosols, liniments or oils.

The clinically acceptable ophthalmic preparation comprises a liquid preparation, an ophthalmic semi-solid preparation and an ophthalmic solid preparation; in particular to eye drops, a preparation convenient for ultrasonic atomization administration, eye film agents, eye gels, eye ointments, eye creams, eye liposomes, eye particle preparations, eye patches and the like. Formulations which facilitate administration by ultrasonic nebulisation may be liquid formulations or solid formulations (granules, powders etc.).

As a second aspect of the present invention, the present invention provides a traditional Chinese medicine composition for external use for relieving myopia, which is prepared from the following raw material medicines: rhizoma Polygonati, herba Dendrobii, Concha Margaritifera, radix Rhodiolae, Prunellae Spica, semen Cassiae, herba Menthae, and Borneolum Syntheticum.

Preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines: 6-30 parts of rhizoma polygonati, 6-30 parts of dendrobium officinale, 6-30 parts of mother-of-pearl, 6-30 parts of rhodiola rosea, 6-30 parts of selfheal, 6-30 parts of cassia seed, 3-24 parts of mint and 0.001-0.1 part of borneol.

Further preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines: 8-25 parts of rhizoma polygonati, 8-25 parts of dendrobium officinale, 8-25 parts of mother-of-pearl, 8-25 parts of rhodiola rosea, 8-25 parts of selfheal, 8-25 parts of cassia seed, 5-20 parts of mint and 0.003-0.05 part of borneol.

More preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines: 12-22 parts of rhizoma polygonati, 12-22 parts of dendrobium officinale, 12-22 parts of mother-of-pearl, 12-22 parts of rhodiola rosea, 12-22 parts of selfheal, 12-22 parts of cassia seed and 0.005-0.02 part of borneol.

Most preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines: 20 parts of rhizoma polygonati, 20 parts of dendrobium officinale, 20 parts of mother-of-pearl, 20 parts of rhodiola rosea, 20 parts of selfheal, 20 parts of cassia seed, 15 parts of mint and 0.01 part of borneol.

In the above technical scheme, the traditional Chinese medicine composition can be in any form composed or prepared from the above raw material medicines, including: the raw materials are respectively crushed and then mixed to form the composition; the raw materials are mixed and crushed to obtain a composition; extracting the above materials respectively by conventional extraction method to obtain extracts (such as rhizoma Polygonati extract, herba Dendrobii extract, and radix Rhodiolae extract), and mixing to obtain composition; mixing the above raw materials, and extracting by conventional extraction method to obtain extract; the effective parts are obtained by further refining and purifying extracts obtained by respectively or mixedly extracting the raw material medicines; the composition, the extract and the effective part are further clinically acceptable ophthalmic preparations according to the conventional preparation process.

The conventional extraction method comprises immersion extraction, decoction extraction, reflux extraction, percolation extraction, ultrasonic extraction, microwave extraction and the like; the extraction solvent comprises water or conventional organic solvent such as ethanol, methanol, ethyl acetate, petroleum ether, isopropanol, etc.; the refining and purifying process comprises extraction, column chromatography separation, high performance liquid chromatography separation and the like.

The composition preparation of the invention is preferably administered by atomization through an ultrasonic atomization device in clinical use. The composition preparation is put into an ultrasonic atomizer, an atomizing pipe is communicated, and the composition preparation forms atomized molecules through ultrasonic vibration to directly act on eyes.

When the composition preparation is clinically used, the medicine is dissolved by hot water at 80-100 ℃, and the eyes are fumigated by gas emitted by dissolution.

As a third aspect of the invention, the invention provides an application of the traditional Chinese medicine composition in preparing a medicine for relieving myopia and/or improving eyesight.

All the raw material medicines are recorded in 2015 edition of Chinese pharmacopoeia, and accord with records in related catalogues of the pharmacopoeia.

In the formula, the sealwort is classified into lung, spleen and kidney, and has sweet taste and mild nature, so that the sealwort has the effects of tonifying qi and yin, tonifying spleen, moistening lung, tonifying kidney and tonifying yin of the lung, spleen and kidney. Kidneys store essence, liver stores blood, essence and blood are homologous, kidney essence and liver blood are mutually combined and nourished, and essence is sufficient to improve eyesight. Dendrobium officinale can enter stomach and kidney meridians, and can treat dim and unclear eyes, yin deficiency with effulgent fire, bone steaming and fatigue heat, myopia which is a long-term near vision and has symptoms of visual fatigue, kidney yin is damaged by long-term work, and dry and astringent eyes are caused by kidney yin deficiency. The rhodiola rosea has the effects of tonifying qi and activating blood, the eyes can see blood, and the spirit can be nourished by true blood and essence, so that everything can be clearly seen; therefore, the blood replenishing and activating can ensure that the eyes are nourished, the myopia lasts for a long time, the qi deficiency can not transport blood, the blood collaterals are stagnated, and the blood is overflowed from the eyes, so the traditional Chinese medicine can tonify qi and replenish blood; the liver opens into the eyes and governs smoothing flow of qi to improve eyesight. Spica Prunellae, semen Cassiae and herba Menthae have effects of clearing liver heat, improving eyesight, and clearing heat of head and eyes. The whole formula takes the sealwort as the monarch, the dendrobium officinale, the rhodiola rosea, the selfheal, the cassia seed and the mint as the ministers, and the nacre and the borneol as the assistants, and the whole formula can nourish yin of liver and kidney, tonify blood of liver and kidney, dissipate heat of head and eyes, and play the roles of improving eyesight and nourishing blood.

Pharmacological experiments show that the traditional Chinese medicine composition can prevent posterior sclera from being kept in good health, reduce scleral matrix damage in the FDM process, strengthen scleral structure and has the effect of relieving the development of FDM myopia. Clinical test results show that the composition can obviously relieve the increase of myopia degrees of low-moderate myopia children, delay the increase of the ocular axis and improve the binocular vision.

Drawings

FIG. 1 Observation of Scleroderma morphology of guinea pigs in FDM model;

wherein, FIG. 1-1 is a blank control group; FIGS. 1-2 are model sets; fig. 1-3 are traditional Chinese medicine groups.

Detailed Description

Example 1

The formula is as follows: 20g of rhizoma polygonati, 20g of dendrobium officinale, 20g of mother-of-pearl, 20g of rhodiola rosea, 20g of selfheal, 20g of cassia seed and 15g of mint;

the preparation method comprises the following steps: the raw material medicines are taken according to a certain proportion, decocted with water for extraction, kept stand at normal temperature, filtered and centrifuged, and supernatant fluid is taken. The concentration of the decoction is as follows: 0.5g/ml, 100 ml/bag, vacuum packaging, and storing in refrigerator at 4 deg.C.

The specific use method comprises the following steps: taking 20ml of liquid medicine, putting into an ultrasonic atomizer container, connecting with an atomizing pipe, and forming atomized molecules in the liquid medicine by ultrasonic vibration to directly act on eyes. The atomization amount is maintained above 2ml/min, 20min each time.

Example 2

The formula is as follows: 13g of rhizoma polygonati, 15g of dendrobium officinale, 9g of mother-of-pearl, 19g of rhodiola rosea, 13g of selfheal, 19g of cassia seed and 9g of mint;

the preparation method and specific application method are the same as those of example 1.

Example 3

The formula is as follows: 19g of rhizoma polygonati, 9g of dendrobium officinale, 15g of mother-of-pearl, 13g of rhodiola rosea, 19g of selfheal, 13g of cassia seed and 15g of mint;

Example 4

The formula is as follows: 15g of rhizoma polygonati, 13g of dendrobium officinale, 11g of mother-of-pearl, 17g of rhodiola rosea, 15g of selfheal, 17g of cassia seed, 11g of mint and 0.014g of borneol;

Example 5

The formula is as follows: 17g of rhizoma polygonati, 11g of dendrobium officinale, 13g of mother-of-pearl, 15g of rhodiola rosea, 17g of selfheal, 15g of cassia seed, 13g of mint and 0.009g of borneol;

Example 6

The formula is as follows: 9g of rhizoma polygonati, 19g of dendrobium officinale, 6g of mother-of-pearl, 24g of rhodiola rosea, 9g of selfheal, 24g of cassia seed, 6g of mint and 0.04g of borneol;

Example 7

The formula is as follows: 24g of rhizoma polygonati, 6g of dendrobium officinale, 19g of mother-of-pearl, 9g of rhodiola rosea, 24g of selfheal, 9g of cassia seed, 19g of mint and 0.003g of borneol;

Example 8

The formula is as follows: 11g of rhizoma polygonati, 17g of dendrobium officinale, 7g of mother-of-pearl, 22g of rhodiola rosea, 11g of selfheal, 22g of cassia seed, 7g of mint and 0.03g of borneol;

Example 9

The formula is as follows: 22g of rhizoma polygonati, 7g of dendrobium officinale, 17g of mother-of-pearl, 11g of rhodiola rosea, 22g of selfheal, 11g of cassia seed, 17g of mint and 0.004g of borneol;

Example 10

The formula is as follows: 7g of rhizoma polygonati, 22g of dendrobium officinale, 4g of mother-of-pearl, 27g of rhodiola rosea, 7g of selfheal, 27g of semen cassiae, 4g of mint and 0.08g of borneol;

Example 11

The formula is as follows: 27g of rhizoma polygonati, 4g of dendrobium officinale, 22g of mother-of-pearl, 7g of rhodiola rosea, 27g of selfheal, 7g of cassia seed, 22g of mint and 0.002g of borneol;

Example 12

The formula is as follows: 6g of rhizoma polygonati, 24g of dendrobium officinale, 3g of mother-of-pearl, 30g of rhodiola rosea, 6g of selfheal, 30g of cassia seed, 3g of mint and 0.1g of borneol;

Example 13

The formula is as follows: 30g of rhizoma polygonati, 3g of dendrobium officinale, 24g of mother-of-pearl, 6g of rhodiola rosea, 30g of selfheal, 6g of cassia seed, 24g of mint and 0.001g of borneol;

Example 14

The formula is as follows: 20g of rhizoma polygonati, 20g of dendrobium officinale, 20g of mother-of-pearl, 20g of rhodiola rosea, 20g of selfheal, 20g of cassia seed, 16g of mint and 0.01g of borneol;

the preparation method comprises the following steps: decocting rhizoma Polygonati, herba Dendrobii, Concha Margaritifera, radix Rhodiolae, Prunellae Spica, semen Cassiae, and herba Menthae with water respectively to obtain water extracts; mixing the water extracts of the above materials, adding Borneolum Syntheticum, and making into 100ml liquid medicine.

The specific application is the same as in example 1.

Example 15

The formula is as follows: 13g of rhizoma polygonati, 15g of dendrobium officinale, 9g of mother-of-pearl, 19g of rhodiola rosea, 13g of selfheal, 19g of cassia seed, 9g of mint and 0.018g of borneol;

the preparation method comprises the following steps: decocting rhizoma Polygonati, herba Dendrobii, Concha Margaritifera, radix Rhodiolae, Prunellae Spica, semen Cassiae, and herba Menthae with water respectively to obtain water extracts; mixing the water extracts of the raw materials, and adding Borneolum Syntheticum to obtain extract.

The formula is as follows: 2g of extract, 5g of carbomer, 1.5g of sodium carboxymethylcellulose, 1.5g of polyvinyl alcohol, 10ml of triethanolamine, 10g of polyacrylic resin pressure-sensitive adhesive, 3g of citric acid, 80g of glycerol and 80g of 1, 2-propylene glycol; respectively adding water to carbomer, sodium carboxymethylcellulose and polyvinyl alcohol for swelling, dissolving in water bath, mixing, and adding triethanolamine, polyacrylic resin pressure sensitive adhesive, citric acid, glycerol and 1, 2-propylene glycol; dispersing the extract in 6ml purified water, mixing with the above matrix under stirring to obtain extract-adhesive solution, and coating the extract-adhesive solution on non-woven fabric to obtain eye patch or eye patch.

The specific use method comprises the following steps: applied topically on eyes, and then closed to rest for 30 min, once a day.

Example 16

The formula is as follows: 19g of rhizoma polygonati, 9g of dendrobium officinale, 15g of mother-of-pearl, 13g of rhodiola rosea, 19g of selfheal, 13g of cassia seed, 15g of mint and 0.007g of borneol;

The specific use method comprises the following steps: soaking the medicinal liquid in non-woven fabric, applying to eye, closing the eye, and resting for 30 min.

Example 17 clinical trial study

First, research data and method

(one) source of cases

180 myopic children in the eyes of the Zhongri friendly hospital are selected to be diagnosed in 2 months from 2018 to 2 months from 2019, all patients meet the related diagnosis standard of the second degree myopia, and the patients are randomly divided into a treatment group and a control group. Of which 90 had 180 eyes, 43 men (86 eyes), 47 women (94 eyes), mean age 9.33 years; the control group comprises 90 patients with 180 eyes, 44 men (88 eyes), 46 women (92 eyes) and the average age of 9.13 years, and through statistical tests, the two groups of patients have P > 0.05 in terms of general clinical data such as age, sex, living and working environment and the like, the difference is not statistically significant, and the population is comparable.

(II) diagnostic criteria

1. Western diagnostic standards refer to the eighth edition of ophthalmic science (P246)

(1) Poor far vision and normal near vision under normal regulation;

(2) the examination shadow is myopic ametropia, and the far vision can be corrected to be normal by using a negative spherical lens (or a negative cylindrical lens);

(3) the degree of myopia is generally low or moderate;

(4) the near vision and other visual functions are normal.

2. Classification of myopia

(1) Depending on whether the regulation is involved in classification:

the pseudomyopia: upon examination with atropine mydriasis, the disappearance of myopia appears as emmetropia or hyperopia.

② true myopia: myopia was not reduced or was reduced by <0.50D after mydriasis with atropine.

③ mixed myopia: retroflexion with atropine mydriasis was reduced by >0.50D, but no emmetropia was restored.

(2) Classified according to refractive power after refraction:

mild myopia: myopia with diopter less than-3.0D.

Moderate myopia, myopia with diopter between-3.0D to-6.0D.

③ high myopia: diopter > -6.0D of myopia.

3. Diagnostic criteria of traditional Chinese medicine

(1) Refer to the standard of curative effect for diagnosing ophthalmology diseases of traditional Chinese medicine (ZY/T0001.5-94 can be close and distant) issued by the national administration of traditional Chinese medicine in 1994.

The near vision is normal, the far vision is lower than 1.0, but the near vision can be corrected by a concave spherical lens. Mild myopia at-3.00D, -moderate myopia at-3.00D to-6.00D, and high myopia at above-6.00D.

Secondly, the distant vision of the teenagers is reduced in a short time, the vision can be restored as before after eyes are closed and spirit is maintained, and the degree of myopia is checked to be no or less than 0.5D after the atropine is used for eye dropping, so that the pseudomyopia is detected.

(III) inclusion criteria

1. The syndrome accords with the low-medium myopia diagnosis standard; diopter is less than-6.00D, and the children with non-pathological myopia can be corrected to normal LogMAR vision 0;

2. the age is 6-12 years old, and male and female are not limited;

3. the patients without organic lesions are checked by a slit lamp;

4. signing an informed consent and matching with treatment;

(IV) exclusion criteria

1. Before selection, the person who is checked not to meet the inclusion standard;

2. ametropia due to trauma or congenital conditions and a child with > 6.00D high myopia;

3. patients taking drugs for a long time or having other organic lesions or participating in other subject researchers who may have an influence on the treatment results;

4. patients with pathological myopia or combined optic nerve damage or combined intraocular diseases;

(V) shedding criteria

1. In the treatment process, the treatment can not be completed in a matching way, and the final curative effect judgment and statistics can not be carried out;

2. parents and children require to stop the treatment, or patients with complication and no continuous treatment;

3. other reasons have to be terminated.

(VI) standards for suspension test

(1) When serious safety problems occur in the test, all clinical tests should be stopped, and whether the test is recovered or not is considered after reasons are found out;

(2) the test shows that the treatment effect of the test medicament is poor, even aggravated, and the study confirms that the medicament does not have clinical research value;

(3) the clinical test scheme has great errors in the test, and the curative effect of the test is difficult to evaluate.

Second, observation method

(I) mydriatic optometry and retest

All patients in the first visit were subjected to objective examination by a designated technician after dropping atropine sulfate ophthalmic gel 3 times a day, 0.1g each time, 9 times in total, and 3 weeks later, and the refractive power after pupil recovery was examined. All patient optometries are performed by the same optometrist. After the patients are put into the group, the length of the ocular axis is measured for 2 times by using the treatment for half a year, and the change of the ocular axis is observed.

(II) grouping method

Dividing the patients to be diagnosed into two groups at random, wherein the treatment group and the control group do not carry out any treatment except normal mydriasis optometry, and the change of the myopia degrees of the patients is observed; the treatment group patients used the liquid medicine prepared in example 1 after mydriatic examination, and the specific usage method is as follows: ultrasonic atomizing and fumigating eyes 1 time per night for 20min each time. The patients are treated with the test of vision by using a LogMAR visual chart 1 time per month, and a score questionnaire of asthenopia symptoms is filled in.

Third, observe the index

The LogMAR vision change of the eyes is measured 1 time before each double-diagnosis, the mydriatic diopter number of the eyes is measured 1 time respectively before and after the treatment and after the half-year treatment, and the axial length of the eyes is measured 1 time respectively before and after the treatment, and the axial length of the eyes is measured 2 times respectively.

(II) visual fatigue questionnaire survey

The children enrolled were subjected to the asthenopia questionnaire, which is shown in table 1. 10 comparative typical asthenopia symptoms were selected for interrogation and the duration of symptoms was asked to classify the symptoms as never occurring in 0, infrequently occurring in 3, frequently occurring in 6 and always present in 9. Inquiring the symptom again in the next double-visit, wherein the symptom is decreased by-1 point and the symptom is increased by +1 point, counting the symptom scoring condition of the patient, and comparing the scoring change.

TABLE 1 asthenopia questionnaire

	0 point (min)	3 points of	6 minutes	9 minutes
					Is the eyes very close to the book when reading and writing?
Is a word skip, line skip or misreading place occurred during reading or writing operation?
					Third, do you jump, skip or see wrong place when copying the blackboard writing of the teacher on the blackboard?
(iv) is there ghosting when seeing things?
					Is it difficult to hit a table tennis ball or catch a flying saucer when playing a table tennis ball or playing a flying saucer?
Sixthly, after a short time of reading, do you feel a feeling of soreness and distension, pain or blurred vision?
					Seventhly, do eyes feel tired, dry and not sensitive to light?
What is experienced is what is experienced with squinting, frequent blinking or askew looking at things?
					Ninthly, when the light is dark at night, the visual objects are blurred?
Do you feel uneven ground when the r is walking in the classroom or home?

Fourth, statistical method

All data were analyzed using statistical software SPSS20.0, and the measured data were statistically expressed using means. + -. standard deviation.

The statistical test method comprises the following steps: and the metering data which are in accordance with normal distribution adopt variance analysis, the metering data which are not in accordance with normal distribution adopt rank sum test in non-parameter test, and the counting data adopt chi-square test. The difference of the test results is statistically significant when P is less than 0.05.

Fifth, test results

Basic conditions of patients

The results are shown in Table 2.

TABLE 2 basic cases of patients in groups

Grouping	Vision (LogMAR)	Degree (unit: -D)	Eye axis (Unit: mm)
				Treatment group	0.45±0.20	1.87±0.94	23.45±0.81
Control group	0.44±0.19	1.94±1.10	23.39±0.73

The difference of indexes such as vision, binocular diopter, ocular axis and the like of two groups of patients has no statistical significance, and the data between the two groups of patients has comparability.

Two groups of observations half a year later

1. And (5) eyesight. The results are shown in Table 3.

TABLE 3 two groups of visual observations half a year later

Grouping	Before treatment	After treatment
			Treatment group	0.45±0.20	0.48±0.23
Control group	0.44±0.19	0.58±0.19

The vision conditions of two groups after half-year treatment are compared, the group of treatment data is obviously superior to that of a control group, the vision of the control group is generally reduced by 0.1-0.2 after half-year, the vision of the treatment group is more stable than that before treatment, no special change exists, and the conjunctiva No. 4 prescription is proved to have the function of delaying the vision reduction of the children with the school age of low-moderate myopia. The two data sets were statistically significant in comparison. And partial children in the treatment group had vision improvement in lines 1-2 of the LogMAR chart (31 people total, 48 eyes total).

2. The degree. The results are shown in Table 4.

TABLE 4 two-group degree observations after half a year

The score P of the fatigue symptoms before treatment of two groups of patients is more than 0.1, and the baseline data of the two groups of patients has no obvious difference. The degree of the treatment group is increased by about-0.2D, the degree of the control group is increased by-0.42D, the treatment group is better than the control group, and the data comparison of the two groups has statistical difference (P is less than 0.01). The composition can relieve the increase of the myopia degree of the children of low and moderate myopia school age.

3. The axis of the eye. The results are shown in Table 5.

TABLE 5 two groups of eye axis observations half a year later

Grouping	Before treatment	After treatment
			Treatment group	23.45±0.81	23.52±0.79
Control group	23.39±0.73	23.61±0.72

The score P of the fatigue symptoms before treatment of two groups of patients is more than 0.1, and the baseline data of the two groups of patients has no obvious difference. Compared with the eye axis conditions of the two groups after half a year of treatment, the eye axis of the treatment group is increased by about 0.07mm, the eye axis of the control group is increased by about 0.22mm, the treatment group is superior to the control group, and the data difference of the two groups has statistical significance (P is less than 0.01). The composition of the invention is proved to be capable of relieving the increase of the ocular axis of the children with the school age of low and medium myopia.

4. Visual fatigue questionnaire. The results are shown in Table 6.

TABLE 6 comparison of two groups of patients before and after asthenopia

	Before treatment	After treatment
			Treatment group	32.70±4.57	26.90±3.92
Control group	33.00±4.47	39.00±5.48

The score P of the fatigue symptoms before treatment of two groups of patients is more than 0.5, and the baseline data of the two groups of patients has no obvious difference. Observing the visual fatigue scoring conditions of the two groups of patients half a year later, wherein the visual fatigue scoring of the treatment group is integrally reduced, and the visual fatigue symptoms are relieved; the control group has an increased asthenopia score, which indicates that asthenopia symptoms are aggravated, and the comparison of the two groups of patients after treatment has statistical significance (P is less than 0.01).

5. Security observation

Patients in all treatment groups of the current time have no adverse reaction during the treatment period. In the group children, 81 people react with ear acupuncture pain, the pain is obvious when the children sleep and press, but the treatment can be normally finished after normal propaganda and the comfort of parents. All abnormal discomfort symptoms of the whole body do not appear in the test process.

The test proves that the combined treatment scheme of the composition can obviously relieve the myopia degree increase of the children with low and moderate myopia, delay the increase of the ocular axis and improve the binocular vision by comparing the degree, the ocular axis and the vision conditions of the treatment group and the control group in the treatment period and the observation period.

Example 18 Effect of the Chinese medicinal composition of the present invention on myopia progression in Low to moderate myopia deprived Guinea pigs

1. Laboratory animal

Guinea pigs were used in this experimental study with approval from the ethical committee (regent No. 180103), and the procedure was in accordance with the ophthalmic and visual study section of the ARVO treatment principles for animals purchased from the animal breeding center of kyoto (license No.: SCXK (Jing) 2017.0002] totaling 30 2-week-old guinea pigs; the experimental animals were obtained from the animal laboratory of the institute of traditional Chinese medicine of the academy of science of traditional Chinese medicine [ license number: SYXK (Kyoto) 2016-. The laboratory environment: the illumination is carried out for 12h every day (500lux), the room temperature is kept at 25 ℃, and the relative humidity is controlled to be 45-50%. In the group, the guinea pigs were examined for both eyes in the 1 week examination experiment and the patients with eye diseases were removed.

2. Equipment and reagent for experiment

An a-type ophthalmic ultrasonic measuring instrument (ODM-1000, tianjin mada medical science and technology ltd.), a point-like optical inspection mirror (suzhou sixa vision science and technology ltd.), and a lens box (danyang medical instrument factory).

The traditional Chinese medicine composition comprises the following components: 20g of rhizoma polygonati, 20g of dendrobium officinale, 20g of mother-of-pearl, 20g of rhodiola rosea, 20g of selfheal, 20g of cassia seed and 15g of mint; the raw material medicines are taken according to a certain proportion, decocted with water for extraction, kept stand at normal temperature, filtered and centrifuged, and supernatant fluid is taken.

Second, Experimental methods

1. The molding method comprises the following steps: after the guinea pigs are adapted to be raised for 1 week, the experimental guinea pigs are subjected to image examination and optometry, the length of the axis of the eyes of both eyes is measured, 20 guinea pigs are randomly selected, levofloxacin eye drops are used for 5 min/time, the upper and lower eyelid margins of the guinea pigs are cut by an ophthalmologic operation scissors for about 3mm after the guinea pigs are spotted on the right eyes for 9 times, and the guinea pigs are sutured along the incision by an operation suture line. After the operation, the ofloxacin eye ointment is used for smearing and is covered by gauze, and a form-deprivation myopia (FDM) model is established. The left eye was self-control and left untreated. The healing condition of the operated eye is observed regularly, and if abnormal, the eye is treated in time. The 10 guinea pigs used as a blank control group were subjected to normal saline intragastric administration every day, the FDM guinea pigs were randomly divided into a traditional Chinese medicine group and a model group, the traditional Chinese medicine group was subjected to traditional Chinese medicine decoction administration of 10g/kg every day, and the model group was subjected to normal saline administration of the same dose.

2. Refractive and axis examination method: compound tropicamide (batch number: M356711, manufactured by Shentian pharmaceutical Co., Ltd., China) was used to sufficiently disperse a large pupil, and the image was examined with a point-like light microscope, and the examination was repeated 3 times per eye, and the average value was taken, and the cylinder power was counted as half of the sphere power. The oxybuprocaine hydrochloride eye drops (batch number B1008, China limited of Shentian pharmaceutical Co., Ltd.) are subjected to surface anesthesia, then the axis of the eye is measured, the probe of an ultrasonic instrument A is perpendicular to the plane of the cornea, the center of the pupil is aligned, the pressure of the probe on the cornea is reduced, a determined image is obtained, the image is stable and clear, the two peaks of the lens posterior capsule and the retina are both higher than the base line, the measurement is repeated for 8 times in each eye, and the average value is obtained.

3. Histomorphological observations of the sclera of three groups of guinea pigs:

after 6 weeks from the start of molding, 3 groups of guinea pigs were subjected to optometry and eye axis measurement (same method as above), and then, according to the 15mL · kg-1 body mass standard, 100g · L concentration sodium pentobarbital anesthetic was injected into the abdominal cavity, all guinea pigs were sacrificed after 1min, the bilateral eyeballs were removed, placed in ice cubes, the limbus was ring-cut, and the anterior segment of the eye and the vitreous were removed. Selecting posterior segment sclera tissue, fixing in 40 g.L-1 paraformaldehyde solution, dehydrating, embedding in paraffin, slicing, HE staining, and observing the staining condition of the sclera tissue under 40 times of an optical microscope.

Thirdly, a statistical method: SPSS 19.0 statistical software is adopted for data processing, the measurement data is expressed in a mean plus or minus standard deviation (x plus or minus s) mode, normal distribution test is carried out, and the experimental data result has statistical significance when P is less than 0.05.

Fourth, experimental results

1. Refractive and axial changes in guinea pigs for each group

The results are shown in Table 7. The results of the contrast of the dilated pupil examination optometry and the A-ultrasonic eye axis length after the model making with the blank control group show that the FDM model making of the right eyes of the two groups of guinea pigs in the traditional Chinese medicine group and the blank control group is successful. Comparing the refractive power changes of the traditional Chinese medicine and the model group, the traditional Chinese medicine group is obviously lower than the model group (the difference is approximately equal to-0.87D, and P is less than 0.05), and the traditional Chinese medicine in the length of the ocular axis is less than the model group (the difference is approximately equal to 0.42mm, and P is less than 0.05). The traditional Chinese medicine composition disclosed by the invention is proved to be capable of relieving the increase of the ocular axis and the increase of the refractive power of FDM guinea pigs.

TABLE 7 refractive and axial changes in guinea pigs

2. Changes in the form of the sclera of guinea pigs in each group under the light mirror

The results are shown in FIG. 1. The blank group ragus eye sclera thickness is normal, the traditional Chinese medicine group and the model group sclera thickness are obviously thinner than the blank group, and the model group is thinner than the traditional Chinese medicine group. Each of the fiber nuclei of the components is stained bluish purple, fusiform or oblong, the extracellular matrix is pink, and the blank group is as follows: the collagen fibers are arranged neatly, and the running is normal, and the diameters are uniform; the traditional Chinese medicine comprises: sclera collagen is sparsely distributed and obviously thinned, obvious fibrous gaps can be seen, the arrangement is irregular, obvious distortion and separation phenomena are caused, and extracellular matrix is increased compared with a blank group; model group: the sclera collagen fibers are similar to the traditional Chinese medicine group in condition and are irregularly arranged, but the fiber separation degree and the extracellular matrix are obviously larger than those of the traditional Chinese medicine group, and the fiber separation degree and the extracellular matrix have more obvious fracture phenomena, and compared with the blank group, the sclera thickness and the shape of the self-control group have no special difference. The traditional Chinese medicine composition can obviously improve the form of the scleral tissue of the guinea pig form-sensation deprivation myopia.

The experiment observes the influence of the traditional Chinese medicine composition on the sclera shape, sclera collagen fiber arrangement and sclera thickness of the FDM guinea pig with moderate myopia. After the model is successfully made, the myopia degree and the length of the ocular axis of the traditional Chinese medicine group are obviously lower than those of the blank group, which shows that the traditional Chinese medicine composition of the invention delays the development of the myopia of the FDM guinea pigs and slows down the growth of the ocular axis. Compared with the blank group, the traditional Chinese medicine has obvious difference in sclera thickness and collagen fiber arrangement, and the overall shape of the traditional Chinese medicine is better than that of the blank group, so that the traditional Chinese medicine composition can prevent the health maintenance of the posterior sclera, reduce the scleral matrix damage in the FDM process, strengthen the scleral structure and has the effect of relieving the development of FDM myopia.

Claims

1. The traditional Chinese medicine composition for relieving myopia is characterized by being prepared from the following raw materials: 6-30 parts of rhizoma polygonati, 6-30 parts of dendrobium officinale, 6-30 parts of mother-of-pearl, 6-30 parts of rhodiola rosea, 6-30 parts of selfheal, 6-30 parts of semen cassiae and 3-24 parts of mint.

2. The traditional Chinese medicine composition of claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines: 8-25 parts of rhizoma polygonati, 8-25 parts of dendrobium officinale, 8-25 parts of mother-of-pearl, 8-25 parts of rhodiola rosea, 8-25 parts of selfheal, 8-25 parts of semen cassiae and 5-20 parts of mint.

3. The traditional Chinese medicine composition of claim 2, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines: 12-22 parts of rhizoma polygonati, 12-22 parts of dendrobium officinale, 12-22 parts of mother-of-pearl, 12-22 parts of rhodiola rosea, 12-22 parts of selfheal, 12-22 parts of cassia seed and 8-18 parts of mint.

4. The traditional Chinese medicine composition of claim 3, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines: 20 parts of rhizoma polygonati, 20 parts of dendrobium officinale, 20 parts of mother-of-pearl, 20 parts of rhodiola rosea, 20 parts of selfheal, 20 parts of cassia seed and 15 parts of mint.

5. The traditional Chinese medicine composition for relieving myopia is characterized by being prepared from the following raw materials: 6-30 parts of rhizoma polygonati, 6-30 parts of dendrobium officinale, 6-30 parts of mother-of-pearl, 6-30 parts of rhodiola rosea, 6-30 parts of selfheal, 6-30 parts of cassia seed, 3-24 parts of mint and 0.001-0.1 part of borneol.

6. The traditional Chinese medicine composition of claim 5, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines: 12-22 parts of rhizoma polygonati, 12-22 parts of dendrobium officinale, 12-22 parts of mother-of-pearl, 12-22 parts of rhodiola rosea, 12-22 parts of selfheal, 12-22 parts of cassia seed and 0.005-0.02 part of borneol.

7. The traditional Chinese medicine composition of claim 6, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines: 20 parts of rhizoma polygonati, 20 parts of dendrobium officinale, 20 parts of mother-of-pearl, 20 parts of rhodiola rosea, 20 parts of selfheal, 20 parts of cassia seed, 15 parts of mint and 0.01 part of borneol.

8. The Chinese medicinal composition according to any one of claims 1 to 7, wherein the Chinese medicinal composition is prepared into tablets, capsules, granules, pellets, microspheres, dripping pills, controlled-release preparations, sustained-release preparations, injections or ophthalmic preparations.

9. The traditional Chinese medicine composition of any one of claims 1-7, wherein the traditional Chinese medicine composition is formulated for ophthalmic nebulization or as an ophthalmic patch.

10. Use of a Chinese medicinal composition as claimed in any one of claims 1 to 7 in the manufacture of a medicament for the relief of myopia and/or improvement of vision.