External Chinese medicine composition for preventing and treating myopia and preparation method thereof

Abstract

This invention relates to a topical traditional Chinese medicine composition for the prevention and treatment of myopia and its preparation method. The composition is mainly composed of 1-10 parts of Angelica sinensis, 1-10 parts of Ligusticum chuanxiong, 1-10 parts of Astragalus membranaceus, 1-10 parts of Polygala tenuifolia, 1-10 parts of Pheretima aspergillum, 1-10 parts of Cyperus rotundus, 1-10 parts of Trogopterus xanthipes, 1-10 parts of Citrus aurantium, 1-10 parts of Notopterygium incisum, 1-10 parts of Phellodendron chinense (processed with salt), 1-10 parts of Cinnamomum cassia, 1-10 parts of Anemarrhena asphodeloides, 1-10 parts of Cassia tora, 1-10 parts of Cimicifuga foetida, 1-10 parts of Cicadae periostracum, and 1-10 parts of Ziziphus jujuba var. spinosa. The traditional Chinese medicine composition of this invention has a simple formulation and reasonable compatibility. Through the topical dosage form, the medicine is more concentrated on the eye area for effective action, resulting in rapid onset of action, significant efficacy, and treatment of both the symptoms and root cause. It also has no toxic side effects, is convenient to take, and has high patient compliance.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and particularly relates to an external Chinese medicine composition for preventing and treating myopia and a preparation method thereof. Background Art

[0002] Myopia is a type of refractive error. When the eye is in a relaxed state, parallel light rays enter the eye and focus in front of the retina, which results in the inability to form a clear image on the retina. Myopia seriously affects the quality of life of patients, and the treatment of complications has caused a certain economic burden on the family and society. High myopia can also easily cause retinal detachment, cataracts, glaucoma, posterior scleral staphyloma, myopic maculopathy, etc., and severe cases can cause blindness.

[0003] TCM defines myopia as an eye disease characterized by clear near vision and blurred far vision. In ancient times, it was called "near vision but far vision is not", and it was not until the "Compendium of Eye Sutra" that it was called myopia. From the perspective of TCM, the causes of myopia are mainly manifested in three aspects. First, it is a lack of congenital endowment. Second, excessive use of the eyes damages the qi and blood, and excessive consumption of liver blood causes myopia. In the book of Chinese medicine theory "Suwen. Xuanming Wuqi Chapter", it is mentioned that "long-term viewing hurts blood, long-term lying hurts qi, sitting hurts flesh, long-term standing hurts bones, and long-term walking hurts tendons. These are the five labors referred to by Chinese medicine. It shows that excessive use of the eyes will cause different injuries to the body; it also shows that as long as the liver can store blood and the blood supply is sufficient, the eyes can be nourished by liver blood, and vision will be clear and bright; if the liver blood is deficient, it will lead to decreased vision, because "the liver and kidney have the same origin", so the liver and kidney functions are closely related to the eyes. Third: Chinese medicine also believes that the occurrence of many diseases has a special relationship with the function of human internal organs. For example, if the human internal organs are disordered, yin and yang are out of balance, and yang is too weak, the divine light cannot be emitted to the outside, and myopia occurs. Therefore, when treating myopia, we should focus on regulating the function of internal organs and nourishing the liver and kidneys. In actual treatment, Chinese medicine divides the incidence of myopia into four categories. That is, liver and kidney deficiency type, heart and spleen deficiency type, liver qi stagnation type, liver deficiency and wind-heat type, etc. There are many different treatments for myopia in traditional Chinese medicine. Li Shengyue believes that myopia is located in the liver and kidney, and the pathogenesis is mainly due to liver and kidney essence and blood deficiency and liver yang hyperactivity. The treatment starts with the liver and kidney, and also treats the heart and spleen. The basic formula is: Ligustrum lucidum, Cassia seed, Cnidium monnieri, Tribulus terrestris, Lycium barbarum, Lophatherum gracile, Bombyx batryticatus, Eclipta prostrata, and Chinese yam, hawthorn, Shenqu, Ziziphus jujuba, Polygala tenuifolia, Acorus calamus, etc. can be added according to syndrome differentiation, and emphasis is placed on prevention and conditioning. The fifth edition of the textbook of traditional Chinese medicine recognizes Myopia is mostly caused by the weakness of heart yang, which makes the divine light unable to reach far away, or by the deficiency of liver and kidney, insufficient essence and blood, so that the divine light is weak and the brilliance cannot reach far away. Oral Chinese medicine is mainly used to nourish the heart and replenish qi and nourish the liver and kidney. The seventh edition of the Chinese medicine textbook believes that myopia is mostly caused by overuse of eyesight, long-term vision hurts blood, blood damages qi, so that the divine light cannot reach far away, or by the deficiency of liver and kidney, insufficient endowment, divine light is weak, the brilliance cannot reach far away and can only be nearsighted. Oral Chinese medicine is mainly used to replenish blood and qi and nourish the liver and kidney. It can be seen that oral Chinese medicine in literature reports is mainly used to replenish liver and kidney, replenish qi and nourish blood.

[0004] Although doctors have proposed a variety of treatment methods for myopia, from a clinical treatment perspective, the current diagnostic standards and efficacy standards for the treatment of myopia with traditional Chinese medicine are not unified, so the conclusions cannot withstand repetition and have poor verifiability. Oral Chinese medicine often requires long-term medication. The medicine is not only cumbersome to decoct, but also has a poor taste, which leads to poor patient compliance and greatly affects the treatment effect.

[0005] The inventors of the present application have obtained an external Chinese medicine composition that is effective in preventing and treating myopia by summarizing long-term clinical diagnosis and treatment experience. Summary of the invention

[0006] The object of the present invention is to provide an external Chinese medicine composition for preventing and treating myopia, characterized in that it is made from 1-10 parts of angelica sinensis, 1-10 parts of chuanxiong, 1-10 parts of raw astragalus, 1-10 parts of polygala tenuifolia, 1-10 parts of earthworms, 1-10 parts of cyperus rotundus, 1-10 parts of quinquefolius, 1-10 parts of immature bitter orange, 1-10 parts of notopterygium wilfordii, 1-10 parts of salt phellodendron, 1-10 parts of cinnamon bark, 1-10 parts of anemarrhena asphodeloides, 1-10 parts of cassia seed, 1-10 parts of cicada shell, and 1-10 parts of spiny jujube seed.

[0007] Preferably, the pharmaceutical composition is made of 3-8 parts of angelica sinensis, 3-8 parts of chuanxiong, 3-8 parts of raw astragalus, 3-8 parts of polygala, 3-8 parts of earthworm, 3-8 parts of cyperus rotundus, 3-8 parts of aconiti lobata, 3-8 parts of immature bitter orange, 3-8 parts of notopterygium wilfordii, 3-8 parts of salt phellodendron, 3-8 parts of cinnamon bark, 3-8 parts of anemarrhena asphodeloides, 3-8 parts of cassia seed, 3-8 parts of cicada shell, and 3-8 parts of spiny jujube seed.

[0008] Preferably, the pharmaceutical composition is made of 6-8 parts of angelica sinensis, 6-8 parts of chuanxiong, 6-8 parts of raw astragalus, 6-8 parts of polygala tenuifolia, 3-5 parts of earthworms, 3-5 parts of cyperus rotundus, 3-5 parts of quinquefolius, 3-5 parts of immature bitter orange, 3-5 parts of notopterygium wilfordii, 3-5 parts of salt phellodendron, 3-5 parts of cinnamon bark, 3-5 parts of anemarrhena asphodeloides, 6-8 parts of cassia seed, 6-8 parts of cicada shell, and 6-8 parts of spiny jujube seed.

[0009] More preferably, the pharmaceutical composition is made of 7 parts of Angelica sinensis, 7 parts of Chuanxiong, 7 parts of raw Astragalus, 7 parts of Polygala tenuifolia, 4 parts of Pheretima, 4 parts of Cyperus rotundus, 4 parts of Ophiopogon japonicus, 4 parts of Citrus aurantium, 4 parts of Notopterygium wilfordii, 4 parts of Salt Phellodendron chinense, 4 parts of Cinnamomum cassia, 4 parts of Anemarrhena asphodeloides, 7 parts of Cassia seed, 7 parts of Cimicifuga heracleifolia, 7 parts of Periostracum cicadae, and 7 parts of Semen Ziziphi spinulosus.

[0010] The external Chinese medicinal composition for preventing and treating myopia of the present invention can be prepared into lotions, fumigants, creams, ointments, patches, powders, eye drops, films, etc. after adding pharmaceutically acceptable excipients. Preferably, the external Chinese medicinal composition for preventing and treating myopia of the present invention is prepared into lotions, fumigants, ointments, creams or patches, etc. after adding pharmaceutically acceptable excipients; more preferably, the external Chinese medicinal composition for preventing and treating myopia of the present invention is prepared into patches after adding pharmaceutically acceptable excipients; most preferably, the patches are selected from: gel patches.

[0011] Preferably, the external Chinese medicine patch for preventing and treating myopia of the present invention comprises a backing layer, a drug-containing layer and a protective layer; more preferably, the drug-containing layer comprises a penetration enhancer, and preferably, the penetration enhancer is selected from: dimethyl sulfoxide, laurocapram Azone, glycerol and the like.

[0012] Another object of the present invention is to provide a method for preparing an external Chinese medicine composition for preventing and treating myopia, which is characterized by comprising the following steps:

[0013] (1) Preparation: Weigh each raw material according to the formula;

[0014] (2) Grinding: Grind each raw material through a 10-30 mesh sieve and mix evenly to obtain a mixed powder for later use;

[0015] (3) Soaking: Add 3-5 times the weight of pure water to the mixed powder, stir and soak for 0.5-3 hours to obtain a soaking solution;

[0016] (4) Decoction: decoct the soaking liquid for 30-60 minutes, filter the filtrate and set it aside, add 2-4 times the weight of the mixed powder into the filter residue and decoct for 15-40 minutes, filter and combine the two filtrates, and optionally concentrate under reduced pressure to obtain an extract with a specific gravity of 1.1-1.2;

[0017] (5) Preparation: The filtrate or optional extract obtained in step (4) is further treated as needed and a pharmaceutically acceptable excipient is added to prepare a Chinese medicine composition for external use for preventing and treating myopia.

[0018] Preferably, in step (2), each raw material drug is crushed and passed through a 20-mesh sieve; in step (3), pure water in an amount of 4 times the weight of the mixed powder is added to the mixed powder, and the mixture is stirred and soaked for 1 hour; in step (4), the soaking liquid is boiled for 50 minutes, the filtrate is filtered and reserved, and pure water in an amount of 2 times the weight of the mixed powder is added to the filter residue and boiled for 30 minutes, and the two filtrates are combined after filtering.

[0019] Another object of the present invention is to provide the use of 1-10 parts of angelica sinensis, 1-10 parts of chuanxiong, 1-10 parts of raw astragalus, 1-10 parts of polygala, 1-10 parts of earthworm, 1-10 parts of cyperus rotundus, 1-10 parts of quinquefolius, 1-10 parts of immature bitter orange, 1-10 parts of notopterygium wilfordii, 1-10 parts of salt phellodendron, 1-10 parts of cinnamon bark, 1-10 parts of anemarrhena, 1-10 parts of cassia seed, 1-10 parts of cicada shell, and 1-10 parts of spiny jujube seed to prepare an external Chinese medicine composition for preventing and treating myopia.

[0020] Preferably, the external Chinese herbal composition for preventing and treating myopia can be prepared into lotions, fumigants, creams, ointments, patches, powders, eye drops, films, etc. after adding pharmaceutically acceptable excipients. Preferably, the external Chinese herbal composition for preventing and treating myopia is prepared into lotions, fumigants, ointments, creams or patches, etc. after adding pharmaceutically acceptable excipients; more preferably, the external Chinese herbal composition for preventing and treating myopia is prepared into patches after adding pharmaceutically acceptable excipients; most preferably, the patches are selected from: gel patches.

[0021] Preferably, the external Chinese medicine patch for preventing and treating myopia comprises a backing layer, a drug-containing layer and a protective layer; more preferably, the drug-containing layer comprises a penetration enhancer, and preferably, the penetration enhancer is selected from: dimethyl sulfoxide, laurocapram Azone, glycerol and the like.

[0022] The effects of each raw material in the pharmaceutical composition of the present invention are as follows:

[0023] Angelica sinensis tastes sweet and spicy, and is warm in nature. It enters the liver, heart, and spleen meridians. It has the effects of nourishing blood and activating blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. It is mainly used to treat blood deficiency and sallow complexion, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic arthralgia, injuries from falls, carbuncles, ulcers, and dry intestines and constipation.

[0024] Chuanxiong is pungent in taste and warm in nature. It enters the liver and gallbladder meridians. It has the effects of promoting qi and relieving depression, eliminating wind, dryness and dampness, promoting blood circulation and relieving pain. It is mainly used to treat irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain, chest and flank pain, swelling and pain due to falls, headache, rheumatic pain and other symptoms.

[0025] Raw Astragalus is sweet and warm in nature. It enters the spleen and lung meridians. It has the effects of consolidating the exterior and stopping sweating, expelling toxins and promoting tissue regeneration, replenishing qi and raising yang. It is mainly used to treat qi deficiency and fatigue, poor appetite and loose stools, sinking of the middle qi, long-term diarrhea and prolapse of the anus, bloody stool and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, carbuncles that are difficult to heal, long-term ulcers that do not heal, blood deficiency and jaundice, internal heat and thirst, etc.

[0026] Polygala tenuifolia is bitter in taste, pungent and warm in nature, and enters the heart, kidney and lung meridians. It has the effects of calming the mind, improving intelligence, removing phlegm and opening the orifices, and dissipating carbuncles and swellings. It is mainly used to treat insomnia, forgetfulness, palpitations, trance, coughing and sputum, sores, swelling and pain in the breasts caused by disharmony between the heart and kidneys.

[0027] Earthworms are salty in taste and cold in nature. They enter the liver, spleen, and bladder meridians. They have the effects of clearing away heat and calming the nerves, unblocking meridians, relieving asthma, and promoting diuresis. After frying, they are mainly used to treat high fever, coma, epilepsy, convulsions, joint pain, lung heat, asthma, and cough, oliguria, edema, and hypertension.

[0028] Cyperus rotundus tastes pungent, slightly sweet and slightly bitter, and is neutral in nature. It enters the liver, spleen, and triple burner meridians. It has the effects of soothing the liver and relieving depression, regulating menstruation and relieving pain. It is mainly used to treat liver depression and qi stagnation syndrome, irregular menstruation, dysmenorrhea, breast pain, etc.

[0029] Wulingzhi, bitter and sweet in taste, warm in nature, enters the liver and spleen meridians, and can be used raw to promote blood circulation and relieve pain, and treat various pains caused by blood and qi in the heart and abdomen, amenorrhea in women, and pain caused by blood stasis after childbirth; it can also be used externally to treat bites by snakes, scorpions, and centipedes. It can be fried to stop bleeding, and treat metrorrhagia, excessive menstruation, and continuous red discharge in women.

[0030] Zhishi tastes bitter, pungent and sour, is slightly cold in nature, and enters the spleen and stomach meridians. It has the effects of breaking up qi and eliminating accumulation, resolving phlegm and dispersing abdominal distension. It is mainly used to treat internal stagnation, fullness and pain, heaviness after diarrhea, constipation, phlegm stagnation and qi obstruction, chest pain, chest congestion, and prolapse of internal organs.

[0031] Qianghuo tastes pungent and bitter, is warm in nature, and belongs to the bladder and kidney meridians. It has the effects of dispelling cold, expelling wind and dampness, and relieving pain. It is mainly used to treat colds, wind-cold and dampness, stiff neck and tendons, sore joints, edema, carbuncles and sores.

[0032] Salt-coated Phellodendron chinense is bitter in taste and cold in nature. It enters the kidney, bladder and large intestine meridians. It has the effects of drying dampness, clearing heat, purging fire and detoxifying. It is mainly used to treat damp-heat dysentery, diarrhea, jaundice, nocturnal emission, stranguria, leucorrhea, bone steaming and fatigue fever, night sweats, mouth and tongue ulcers, red and swollen eyes, carbuncles, skin eczema and other symptoms.

[0033] Cinnamon bark tastes pungent and sweet, and is very hot in nature. It enters the kidney, spleen, heart, and liver meridians. It has the effects of replenishing fire and assisting yang, guiding fire back to the origin, dispersing cold and relieving pain, and warming and unblocking the meridians. It is mainly used to treat impotence, cold uterus, cold pain in the waist and knees, asthma due to kidney deficiency, floating of false yang, dizziness and red eyes, cold pain in the heart and abdomen, vomiting and diarrhea due to deficiency and cold, abdominal pain due to cold hernia, dysmenorrhea, and amenorrhea.

[0034] Anemarrhena asphodeloides is bitter in taste and cold in nature. It enters the lung, stomach and kidney meridians. It has the effects of clearing away heat and purging fire, nourishing yin and moistening dryness. It is mainly used to treat fever, thirst, lung heat and dry cough, bone steaming and hot flashes, internal heat and thirst, intestinal dryness and constipation.

[0035] Cassia seed tastes bitter, sweet and salty, and is slightly cold in nature. It enters the liver, kidney and large intestine meridians. It has the effects of moistening the intestines and promoting bowel movements, lowering blood lipids and improving eyesight. It is mainly used to treat symptoms such as red and painful eyes, photophobia and excessive tears, headaches and dizziness, blurred vision, and constipation.

[0036] Cimicifuga heracleifolia tastes pungent and sweet, and is slightly cold in nature. It enters the lung, spleen, large intestine, and stomach meridians. It has the effects of dispelling wind and relieving rashes, clearing away heat and detoxifying, and raising yang and lifting the sunken. It is mainly used to treat epidemics, headaches, chills and fever, sore throats, mouth ulcers, and rashes that do not clear up; sinking of the middle qi, long-term diarrhea and dysentery, prolapse of the anus, metrorrhagia, leucorrhea, and uterine prolapse in women; carbuncles, swellings, and sores.

[0037] Cicada shell is sweet and salty in taste and cool in nature. It enters the lung and liver meridians. It has the effects of dispersing wind-heat, relieving sore throat and opening voice, clearing rash, improving eyesight and removing cataracts, calming wind and stopping convulsions. It is mainly used to treat wind-heat colds, the initial stage of febrile disease, sore throat and hoarseness, measles that does not break out, itchy rubella, red eyes and cataracts, acute and chronic convulsions, tetanus, and children's night crying and restlessness.

[0038] Ziziphus jujuba seeds are sweet and sour in taste, and neutral in nature. They enter the liver, gallbladder, and heart meridians. They have the effects of nourishing the heart and liver, calming the mind and tranquilizing the nerves, astringing sweat, and promoting body fluid production. They are mainly used to treat insomnia, palpitations, frequent dreams, physical weakness, sweating, and thirst due to loss of body fluids.

[0039] Beneficial effects of the present invention

[0040] 1. The external Chinese medicine composition for preventing and treating myopia of the present invention has a simple formula and reasonable compatibility. In addition, the external Chinese medicine dosage form allows the drug to be more concentrated on the eye to take effect, with rapid onset and significant efficacy, treating both the symptoms and the root cause, without any toxic side effects, and also has the advantages of being easy to take and having high patient compliance.

[0041] 2. The preparation method of the formula of the present invention is simple, does not require complicated extraction technology, is convenient for large-scale production, and has low cost, and is suitable for wide application in the prevention and treatment of myopia.

[0042] 3. The effect of the external Chinese medicine composition of the present invention on preventing and treating myopia has been repeatedly verified by animal models, and the efficacy is definite and the repeatability is good. DETAILED DESCRIPTION

[0043] The present invention is described in more detail hereinafter to facilitate understanding of the present invention.

[0044] Example 1: A topical patch for preventing and treating myopia

[0045] 7 parts of Chinese Angelicae Sinensis, 7 parts of Chuanxiong, 7 parts of Raw Astragalus, 7 parts of Polygala Tenuifolia, 4 parts of Pheretima, 4 parts of Cyperus Rhizoma, 4 parts of Ophiopogon japonicus, 4 parts of Citrus aurantium, 4 parts of Notopterygium wilfordii, 4 parts of Phellodendron chinense, 4 parts of Cinnamomum cassia, 4 parts of Anemarrhena asphodeloides, 7 parts of Cassia seed, 7 parts of Cimicifuga heracleifolia, 7 parts of Periostracum Cicadae, and 7 parts of Semen Ziziphi Spinosae were prepared according to the following method:

[0046] Preparation: weigh each raw material according to the formula;

[0047] Grinding: Grind each raw material through a 20-mesh sieve and mix evenly to obtain a mixed powder for later use;

[0048] Soaking: Add 4 times the weight of pure water to the mixed powder, stir and soak for 1 hour to obtain the soaking solution;

[0049] Decoction: decoct the soaking liquid for 50 minutes, filter the filtrate for later use, add purified water twice the weight of the mixed powder to the residue and decoct for 30 minutes, filter and combine the two filtrates, and concentrate under reduced pressure to an extract with a specific gravity of 1.1-1.2;

[0050] Preparation: Add a penetration enhancer to the extract obtained in step (4) and, as required, add other pharmaceutically acceptable excipients to prepare an external patch for preventing and treating myopia.

[0051] Effect Example 1: The preventive and therapeutic effect of the external Chinese medicine composition of the present invention on myopia in visual deprivation model guinea pigs

[0052] 1.1 Experimental drugs

[0053] The Chinese medicine extract of the present invention: 7 parts of angelica, 7 parts of chuanxiong, 7 parts of raw astragalus, 7 parts of polygala, 4 parts of earthworm, 4 parts of cyperus, 4 parts of quinquefolius, 4 parts of immature bitter orange, 4 parts of notopterygium, 4 parts of salt phellodendron, 4 parts of cinnamon bark, 4 parts of anemarrhena, 7 parts of cassia seed, 7 parts of cicada shell, 7 parts of spiny jujube seed, prepared into a Chinese medicine extract according to the method of Example 1;

[0054] Comparative Example 1 Chinese medicine extract: 7 parts of angelica, 7 parts of chuanxiong, 7 parts of raw astragalus, 7 parts of polygala, 4 parts of earthworm, 4 parts of cyperus, 4 parts of pentastract, 4 parts of immature bitter orange, 4 parts of notopterygium, 4 parts of salt phellodendron, 4 parts of cinnamon bark, 4 parts of anemarrhena, 7 parts of cassia seed, 7 parts of cicada shell, 7 parts of spiny jujube seed, 10 parts of wolfberry, prepared into a Chinese medicine extract according to the method of Example 1;

[0055] Comparative Example 2 Chinese medicine extract: 7 parts of Polygala, 4 parts of Pheretima, 4 parts of Cyperus, 4 parts of Atractylodes, 4 parts of Citrus aurantium, 4 parts of Notopterygium, 4 parts of Rhizoma Angelicae Pubescentis, 4 parts of Phellodendron, 4 parts of Cinnamon, 4 parts of Rhizoma Anemarrhenae, 7 parts of Cassia Seed, 7 parts of Cimicifuga, 7 parts of Periostracum Cicadae, and 7 parts of Semen Ziziphi Spinosae were prepared into Chinese medicine extract according to the method of Example 1.

[0056] When using the above Chinese medicine extracts, 100 mg of the Chinese medicine extracts were coated on a circular non-woven fabric backing layer and then applied around the eyes of experimental animals, or physiological saline was added to prepare a suspension for gavage.

[0057] 1.2 Establishment of experimental model

[0058] 3-week-old healthy tricolor guinea pigs (Institute of Medical Experimental Animals, Chinese Academy of Medical Sciences (license number SYXK (Beijing) 2022-0016)), weighing 140-160g, 50, half male and half female, were adaptively raised for 3 days and randomly divided into a model group, an external use group of the present invention, an oral group of the present invention, and a comparative example 1-2 group, each group was half male and half female. All guinea pigs were instilled with compound tropicamide eye drops in both eyes, 1 drop per eye every 5 minutes, a total of 4 drops, and the refractive power of the left and right eyes of the guinea pigs was detected and recorded 1 hour after the last instillation, and each was detected 3 times, and the average value was calculated and recorded as the refractive power before the start of the experiment.

[0059] Except for the guinea pigs in the oral group of the present invention, the hair on the right side of the midline of the nose of the guinea pig head is shaved, and the annular non-woven fabric coated with the Chinese medicine extract is applied around the eyes of the experimental animals. Note that the size of the inner ring of the annular non-woven fabric is appropriately adjusted according to the experimental animals. When the Chinese medicine extract is applied, the extract is avoided to be applied within 5mm from the inner ring, and the extract is avoided to enter the guinea pig eyes due to the movement of the guinea pigs, and the guinea pigs with the extract entering the eyes during the experiment are eliminated, wherein the model group is pasted with a blank annular non-woven fabric backing layer. According to the guinea pig weight, a milky latex balloon with a thickness of 0.02mm of the appropriate size is selected, and the balloon is used to cover the guinea pig head, minus the left eye, ears and nose, so that the above parts leak out, and the annular non-woven fabric backing layer needs to be avoided from moving during the period. The annular non-woven fabric backing layer is removed under the condition of shading after applying for 1h, and the gauze soaked in physiological saline is used to wipe around the right eye of the guinea pig, and a paper towel is used to blot, and then the balloon is re-set to ensure that the left eye, ears and nose leak out. Apply once a day for 6 weeks.

[0060] Rats in the oral group were also given a milky white latex balloon of appropriate size with a thickness of 0.02 mm. The balloon was used to cover the guinea pig's head, minus the left eye, ears, and nose and mouth, so that the above parts were leaking out. The rats were gavaged once a day with a gavage volume of 2 ml / 100 g body weight. The gavage volume of Chinese medicine extract was 150 mg / 100 g body weight, and the gavage was performed once a day for 6 consecutive weeks.

[0061] 4 h after the last application or intragastric administration, the refractive power of the left and right eyes of rats in each group was measured again and recorded as the refractive power after the end of the experiment.

[0062] 1.3 Experimental Results

[0063] SPSS statistical software was used to perform paired t-test analysis of the data, and P < 0.05 indicated a statistically significant difference.

[0064] Table 1 Effect of the external Chinese medicine composition of the present invention on the diopter of visual deprivation model guinea pigs

[0065]

[0066] Compared with the ipsilateral eye before the experiment: ## P<0.005, # P<0.05; compared with the ipsilateral eye: * P<0.05, **P<0.01.

[0067] The experimental results in Table 1 show that there was no statistical difference in the refractive power of the left and right eyes of the guinea pigs in each group before the experiment. However, after the experiment, the right eye of the model group rats showed obvious myopia, which was statistically different from the refractive power of the left eye and the right eye before the experiment, indicating that myopia in the right eye of the guinea pig was successfully induced by covering the right eye.

[0068] After oral administration of the Chinese medicine composition of the present invention, the degree of myopia in the right eye of the rats in the oral group of the present invention after the experiment was significantly better than that in the model group, but after the experiment, the right eye still had a statistical difference in refraction relative to the left eye and the right eye before the experiment, indicating that although the oral Chinese medicine composition of the present invention has a certain myopia prevention and treatment effect, it still cannot be effectively reversed. However, after the experiment of the guinea pigs in the external group of the present invention, which applied the Chinese medicine composition of the present invention to the periorbital area, the right eye had no statistical difference in refraction compared with the left eye and the right eye before the experiment, which fully proved that the external application of the Chinese medicine composition of the present invention has an excellent myopia prevention and treatment effect, and the effect is significantly better than oral administration. The possible mechanism is that after external application, the active ingredients of the medicine are concentrated in the eye to play a role, avoiding the influence of oral drug absorption, metabolism, and distribution on the active ingredients of the medicine.

[0069] Compared with the Chinese medicine extract of the external application group of the present invention, only 10 portions of wolfberry were added to the comparative example 1 group. However, under the same external application condition, its myopia prevention and treatment effect was significantly weaker than that of the external application group of the present invention. The possible mechanisms include: (1) after the addition of wolfberry, the dosage of other medicinal ingredients was reduced to a certain extent when the dosage of the extract was the same; (2) nourishing the liver and kidney is one of the main treatment methods of oral Chinese medicine, and the liver and kidney nourishing effect of wolfberry was significantly affected when applied externally, resulting in the weakening of the myopia prevention and treatment effect of the Chinese medicine composition after adding wolfberry with kidney nourishing effect.

[0070] Compared with the Chinese medicine extract of the external group of the present invention, the comparison example 2 group only removed Angelica sinensis, Chuanxiong and raw Astragalus membranaceus while keeping the ratio of other medicinal ingredients unchanged. When the amount of extract remained unchanged, although the extract of the comparison example 2 group still showed a certain myopia prevention and treatment effect compared with the model group, the corresponding effect was significantly weaker than that of the external group of the present invention, which proved that the compatibility of the corresponding medicinal ingredients of the external Chinese medicine composition of the present invention is an important basis for exerting its myopia prevention and treatment effect.

[0071] The above describes the preferred embodiments of the present invention, but it is not intended to limit the present invention. Those skilled in the art may make improvements and changes to the embodiments disclosed herein without departing from the scope and spirit of the present invention.

Claims

1. A Chinese medicine composition for external use for preventing and treating myopia, characterized in that: The invention is prepared from 7 parts of angelica sinensis, 7 parts of chuanxiong rhizome, 7 parts of raw astragalus, 7 parts of polygala tenuifolia, 4 parts of earthworm, 4 parts of cyperus rotundus, 4 parts of olivine root, 4 parts of immature bitter orange, 4 parts of notopterygium wilfordii, 4 parts of salt phellodendron, 4 parts of cinnamon bark, 4 parts of anemarrhena asphodeloides, 7 parts of cassia seed, 7 parts of cicada shell, 7 parts of spiny jujube seed.

2. The external Chinese medicine composition for preventing and treating myopia according to claim 1, characterized in that: After adding pharmaceutically acceptable excipients, the mixture is prepared into a cream, ointment or patch.

3. A method for preparing the external Chinese medicine composition for preventing and treating myopia according to claim 1 or claim 2, characterized in that: The following steps are involved: (1) Preparation: Weigh each raw material according to the formula; (2) Grinding: Grind each raw material through a 10-30 mesh sieve and mix evenly to obtain a mixed powder for later use; (3) Soaking: Add 3-5 times the weight of pure water to the mixed powder, stir and soak for 0.5-3 hours to obtain a soaking solution; (4) Decoction: decoct the soaking liquid for 30-60 minutes, filter the filtrate and set it aside, add 2-4 times the weight of the mixed powder into the filter residue and decoct for 15-40 minutes, filter and combine the two filtrates, and concentrate under reduced pressure to obtain an extract with a specific gravity of 1.1-1.2; (5) Preparation: The extract obtained in step (4) is further processed and a pharmaceutically acceptable excipient is added to prepare a Chinese medicine composition for external use for preventing and treating myopia.

4. The preparation method according to claim 3, characterized in that: In the step (2), each raw material drug is crushed and passed through a 20-mesh sieve.

5. The preparation method according to claim 3, characterized in that: In the step (3), pure water in an amount of 4 times the weight of the mixed powder is added to the mixed powder, and the mixture is stirred and then soaked for 1 hour.

6. The preparation method according to claim 3, characterized in that: In the step (4), the soaking liquid is boiled for 50 minutes, the filtrate is filtered and set aside, purified water twice the weight of the mixed powder is added to the filter residue and boiled for 30 minutes, and the two filtrates are combined after filtering.

7. Use of the external Chinese medicine composition according to claim 1 or claim 2 in the preparation of an external Chinese medicine composition for preventing and treating myopia.

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