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`

`

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`Patent Translate
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`
`Notice
`This translation is machine-generated. It cannot be guaranteed thatit is intelligible, accurate, complete, reliable or
`fit for specific purposes. Critical decisions, such as commercially relevant or financial decisions, should not be
`based on machine-translation output.
`
`DESCRIPTION CN101049287
`
`The present invention relates to a low-concentration atropine eye agentthat suppressesthe increase in myopia
`and its manufacturing method. Atpresent, a high-concentration atropine (0.5% or 1%)is used in medicineto
`suppress the increase in myopia,butit is afraid of light The problem is quite troublesomefor the patient, which
`makes the compliance not good andtherate of not returningto theclinic is high, but the effect is not good. The
`present invention uses a low concentration of atropine (<0.1%) as a medicine fortreating myopia, which hasless
`fear Light, less fear of systemicside effects, and better compliance, and can reduce the possible damageto the eyes
`by ultraviolet and harmful blue light, such as cataracts, retinal macular degeneration, etc.
`
`Low-concentration atropine eye agentfor suppressing increase in myopia and its manufacturing method
`
`Technical field
`
`The invention relates to a low-concentration atropine eye medicamentfor suppressing an increase in the degree
`of myopia and a manufacturing method thereof, and mainly relates to a pharmaceutical inventionfortreating the
`deterioration of human myopiain the field of human medicine.
`
`Background technique
`
`Myopia is an importanteye disease, especially high myopia (more thansix degrees of myopia), which can cause
`many complications such as youngcataract, glaucoma,retinal detachment, macular hemorrhage,retinal
`degeneration, and even blindness. In Taiwan, myopia has becomethe second leading causeof blindnessin the
`elderly, so prevention of high myopia is very important. Prevention of high myopia must start with children.
`
`11-03-2020
`
`1
`
`

`

`Children in Asia increase by about 75 to 100 degreesevery year, and children in the West increase by about 50
`Degree, once the child has myopia, the degree will increase until the end of puberty, the child suffers from
`myopia, and the chanceof adult becoming high myopiain the futureis quite high. How to effectively suppress
`the increase in myopiais an importantissue.
`
`It is an important issue for school children to increase myopia and avoid high myopia. Previous studies and
`recent paper reviews have shown that atropineis the only drug that effectively inhibits the increase in myopia.
`
`1999 Thestudy published by Dr. Yongfeng Shi of the National Taiwan University and others (Shih YF, Chen
`CH, Chou AC,et al. Effects of different concentrations of atropine on controlling myopia in myopic children. J.
`Ocul Pharmacol Ther 1999; 15: 85-90.), Showing that 0.5% atropineis most effective, and currently many
`countries use the moreeffective 1% atropine or Taiwan 0.5% atropine Although atropineis effective,it is quite
`difficult to use clinically, mainly because the drug is scared all day after the medicine is administered, and primary
`school children cannot attend physical educationclasses, so the compliance is poorandtherate of giving up
`treatmentis high.
`
`Summary ofthe invention
`
`The technical problem to be solved by the present invention: At present, many countries use atropine (atropine)
`at a high concentration (above 0.5% by weight) to treat myopia, althoughitis effective, but after the drugis
`Clinically used, it will appear all day However, the phenomenonthat primary school children are unable to attend
`physical education classes hasled to a high rate of poor compliance and abandonmentof treatment.
`
`The technicalfeature of the present invention to solve the problem is to propose a low-concentration atropine
`eye drop that suppresses the increase in myopia, wherein the atropine content of the eye dropis effectively
`controlled to a concentration of 0.1% by weightorless.
`
`Advantageously, the atropine contentof the ophthalmic agentis 0.05% by weight.
`
`In addition, the method for manufacturing a low-concentration atropine eye agent for suppressing an increase in
`myopia in the present invention mainly dilutes atropine drug into a liquid that is not harmful to the human body
`to a concentration less than 0.1% by weight ) Pharmacy.
`
`11-03-2020
`
`2
`
`

`

`Wherein,the diluted liquid system is a distilling agent.
`
`Thediluted liquid system is a physiological salt.
`
`Thepresent invention mainly discloses a low-concentration atropine eye agent that suppresses the increasein
`myopia. The atropine contentof the atropine eye agent has been almost determined to be 0.5% after a study
`published by Dr. Shi Yongfeng. The contentis the most effective, and it is not expected that atropineless than
`0.1% will actually be effective.
`
`Therefore, the present invention proposes a low-concentration atropine eye agent that suppresses the increasein
`myopia, wherein the atropine content of the eye agent proposed bythe presentinventionis effectively controlled
`below 0.1% by weight concentration; and Furthermore,it is necessary to prove by experimental data that 0.05%
`is even moreeffective than 0.1% and 0.25%, and has better compliance, which makesit possible for a wide range
`of people to treat myopia deterioration.
`
`First ofall, in our clinical patient response, we found that 0.1% atropinecanstill cause symptoms of photophobia
`and poor compliance, but 0.05% atropineis significantly better than 0.1%. The improvementof pupil dilation
`and photophobia,and the effect of suppressing the increase in myopia powerwill not be worse than 0.1% and
`0.25%, please refer to the following Tables 1 and 2 for cooperation:
`
`Table 1. Dr. Shi’s research in 1999
`
`Table 2.Our research in 2006
`
`[image]
`
`[image]
`
`According to the experimental data in Tables 1 and 2,the effect of 0.05% atropine on the suppression of myopia
`is not different from that of 0.1% and 0.25% atropine, and somepatients have a good effect.
`
`11-03-2020
`
`3
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`

`

`In addition, the following Table 3 showsthe status of myopia year by year in patients receiving 0.05% atropine:
`
`Table 3. Yearly deterioration data table for the treatment of myopia with 0.05%
`
`atropine
`
`[image]
`
`It can be seen from the data in Table 3 that Table 3 showsthe status of myopia year by yearin patients receiving
`0.05% atropine by year, andit showsthat the long-term effect is also good.
`
`In addition, the deterioration of myopiais related to the work at close range, and the workof close rangeis
`related to the excessive continuoususe of high adjustment power. Therefore,if the adjustment powercan be
`suppressed, the myopia powerwill not be easily deteriorated, as shown in Table 4 below, where:
`
`Table 4.Indicates the effect of the application of different concentrationsof atropine on
`the body’s regulation
`
`[image]
`
`From the experimental data in Table 4 above,it can be seen that the inhibition of atropine by a concentration of
`0.05% by weightof atropineis less than that of atropine by a concentration of 0.1% by weight. The differenceis
`very obvious, but compared to the control group, whether the experimental group is at 0.1% or 0.05% by weight
`of atropine, compared with the control group (0%), P = 0.001 (P valueis less than 0.05), In statistical
`significance,it meansthatit has a significant inhibitory effect on regulating power, so it can be proved that
`atropine (0.05%) has a good effect on suppressing regulating power. Another exampleis Table 5.
`
`Table 5.Efficacy of atropine administeredin different concentrations on human dilated
`
`pupils
`
`[image]
`
`11-03-2020
`
`4
`
`

`

`From the experimental data in Table 5, it can be seen that the effect of 0.05% atropine on mydriasisis significantly
`smaller than that of 0.1% atropine (P <0.05).
`
`From the data in Table 6 below,it can be provedthat patients treated with 0.05% atropine are obviously lowerin
`photophobia than patients treated with 0.1% atropine, andit is indeedless likely to make the applicator The
`phenomenonof photophobia.
`
`Table 6 Patients with photophobia after treatment with atropine
`
`Therefore, according to ourclinical statistics, it can be knownthat 0.1% atropine ophthalmic agent can cause
`symptomsof photophobia and poor compliance. However, in contrast, the 0.05% atropine of the present
`invention significantly improves pupil dilation and photophobia (see Table 5 and Table 6 above) compared with
`0.1% atropine, and its Compared with 0.1% atropine and 0.25% atropine,the effect of suppressingthe increasein
`myopia is not muchdifferent (as shown in Tables 1 and 2), and patients are less worried. Eye and systemic side
`effects, so drug complianceis also improved, reducing resistance to treatment.
`
`In the following table, you can see the results of the test. The period of ditropia of atropine at a concentration of
`1% by weight takes about seven to fourteen days; Cyclopentolate and hydrochloride Two days; while
`Tropicamide (topicamide) is about six hours, and the above three drugs have beentried as a treatment for
`myopia, only atropineis effective. As shownin the followingtable, the atropineof the present invention at a
`concentration of 0.05% by weight has a mydriasis period of about 12 to 18 hours. It can be provedthat the
`effectiveness of atropineis 1% and 0.5% atropine. Atropine has a significantly smallereffect.
`
`Finally, in the manufacture of the medicamentof the present invention, the atropine drug can be diluted with a
`distilling agent or a physiological salt to a drug having a concentrationof atropine ofless than 0.1% by weight.
`
`In summary, the present invention utilizes the content of atropine in pharmaceuticals, whichis reduced from the
`current 1%, 0.5%, 0.25%, or 0.1% to less than 0.1% atropine content (preferably (0.05%). With this adjustment,
`the sideeffects such as dilated pupils and photophobia can be improved after treatment, and the patient’s
`compliance and return rate can be strengthened,so that the treatment can be continued to achievethe effect,
`making the widespread and popular Worsening treatment becomespossible.
`
`The medicamentof the present invention can achievethe following effects:
`
`11-03-2020
`
`5
`
`

`

`1,
`Reducepupil dilation, avoid photophobia, improve doctor’s order compliance, and reduce runawayrate.
`
`2,
`
`Atropine at a low concentration can effectively suppress the regulating powerand effectively suppress the
`increase in myopia.
`
`3.
`
`Low concentrationsof atropine avoid systemic side effects.
`
`4,
`
`Decreasing atropine caused by high concentrationwill increase the myopia more quickly after stopping the drug.
`
`5s
`
`Provide physicians with treatment options and adjust medicationsto individual patient differences.
`
`detailed description
`
`However, the above description is only an overviewof the present invention. In order for professionals reading
`this specification to understand the present invention and implementit according to the contents ofthis
`description,the description with the iconsis as follows, but it does not limit the present invention in any form.
`Therefore, any modification or change made underthe samespirit of the invention should be includedin the
`protection scopeof the present invention.
`
`Example 1
`
`The preparation of the medicamentofthe presentinvention is a medicament which can dilute atropine medicine
`with a distilling agent to a concentration of less than 0.1% by weight of atropine.
`
`Example 2
`
`11-03-2020
`
`6
`
`

`

`The preparation of the medicamentof the present invention is a medicamentin which atropineis diluted with
`physiologicalsalt to a concentration of 0.1% by weight ofatropine.
`
`Example 3
`
`The preparation of the medicamentofthe present invention is a medicament which can dilute atropine medicine
`with a distilling agent to a concentration of 0.05% by weightof atropine.
`
`Example 4
`
`The preparation of the medicamentof the present invention is a medicament which candilute atropine medicine
`with physiological salt to a concentration of 0.05% by weight of atropine.
`
`11-03-2020
`
`7
`
`

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`CLAIMS CN101049287
`
`1,
`
`A low-concentration atropine eye agent that suppresses an increase in the degree of myopia, wherein the atropine
`content of the eye agentis effectively controlled to a concentration of 0.1% by weightorless.
`
`2.
`
`The low-concentration atropine eye agent for inhibiting an increase in the degree of myopia according to claim
`1, wherein the atropine contentof the eye agentis 0.05% by weight.
`
`3,
`
`A method for manufacturing a low-concentration atropine eye agentthat suppressesthe increase in myopia,
`mainly diluting the atropine drug into a liquid that is harmless to the human bodyto a concentrationofless than
`0.1% by weight of atropine.
`
`4,
`
`The method for producing a low-concentration atropine ophthalmic agent for suppressing an increase in the
`degree of myopia accordingto claim 3, wherein the diluted liquid is distilled water.
`
`Ds
`
`The method for producing a low-concentration atropine eye agentfor suppressing an increase in the myopia
`degree according to claim 3, wherein the dilutedliquid is physiological saline.
`
`11-03-2020
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`1
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`11-03-2020
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`2
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