CN114010591B

CN114010591B - External traditional Chinese medicine gel ointment for treating asthenopia and preparation method thereof

Info

Publication number: CN114010591B
Application number: CN202111456395.2A
Authority: CN
Inventors: 许扬; 李标
Original assignee: Institute of Medicinal Plant Development of CAMS and PUMC
Current assignee: Institute of Medicinal Plant Development of CAMS and PUMC
Priority date: 2021-12-01
Filing date: 2021-12-01
Publication date: 2023-08-15
Anticipated expiration: 2041-12-01
Also published as: CN114010591A

Abstract

The invention belongs to the technical field of visual fatigue treatment medicines, and discloses an external traditional Chinese medicine gel paste for visual fatigue treatment and a preparation method thereof, wherein the preparation method of the external traditional Chinese medicine gel paste for visual fatigue treatment comprises the steps of medicinal material preparation, extract powder preparation and gel paste preparation, and the traditional Chinese medicine raw material medicines comprise, by weight, 5-10 parts of folium artemisiae argyi, chrysanthemum, medlar, radix rehmanniae, raw Chinese yam, dogwood, cortex moutan, poria cocos, rhizoma alismatis, radix paeoniae alba, achyranthes bidentata, fructus Broussonetiae, centipeda, mung beans, and 1-5 parts of artificial bezoar, aloe, borneol and peppermint. Extracting to obtain extract powder, and making into gel paste external preparation by gel preparation method. The invention is based on the prescription for clinical treatment of asthenopia in traditional Chinese medicine, and the pure natural traditional Chinese medicine gel paste which is convenient and easy to use and has obvious effect is prepared by a modern preparation method, and has obvious relieving effect on the symptoms of asthenopia such as reading fatigue, dry eyes, blurred vision, eye ache and the like by external application.

Description

External traditional Chinese medicine gel ointment for treating asthenopia and preparation method thereof

Technical Field

The invention belongs to the technical field of asthenopia treatment medicines, and particularly relates to an external traditional Chinese medicine gel ointment for treating asthenopia and a preparation method thereof.

Background

At present, with the development of society and economy in China, the social environment has changed deeply, electronic video terminals such as pad, mobile phones, computers and other electronic products have been deeply integrated into the life and work of people, the work rhythm is continuously accelerated, learning tasks are heavy, visual fatigue caused by visual overload becomes a serious problem which disturbs the life and work of people at all times, and more people have visual fatigue symptoms such as dry eyes, distending pain, blurred vision, eye ache and the like. According to statistics, about one third of school children in China and most computer users have asthenopia symptoms with different degrees. At present, western medicine adopts symptomatic treatment, such as Shi Tulun eyedrops, runner-pamphlet eye drops, only can temporarily relieve symptoms, and long-term curative effect is not obvious. Although effective, the traditional Chinese medicine acupuncture treatment is not easy for patients to adhere because of obvious pain and frequent treatment times. The oral traditional Chinese medicine also has the problems of slow onset of action and incapability of being adhered to by patients for long-term administration. The radical cure purpose cannot be achieved.

Through the above analysis, the problems and defects existing in the prior art are as follows:

(1) At present, symptomatic treatment is adopted by Western medicine, symptoms can be relieved temporarily, and long-term curative effect is not obvious.

(2) At present, the traditional Chinese medicine acupuncture treatment has obvious pain, frequent treatment times and difficult adherence of patients; the oral traditional Chinese medicine also has the problems of slow onset of action and incapability of being adhered to by patients for long-term administration.

The difficulty of solving the problems and the defects is as follows: with the increasing of teenager education, electronic products are popularized, the incidence of asthenopia is increased in an outbreak manner due to the dependence of adults on electronic products such as mobile phones, and no treatment means with obvious curative effects exists at present.

The meaning of solving the problems and the defects is as follows: the external preparation prepared from natural traditional Chinese medicines is safe to use, obvious in curative effect, convenient to carry, easy to use and low in cost. Visual fatigue is also an important factor for developing myopia, and the external preparation of natural traditional Chinese medicine is used for treating myopia, so that the external preparation has important significance for preventing myopia from occurring and developing.

Disclosure of Invention

Aiming at the problems existing in the prior art, the invention provides an external traditional Chinese medicine gel ointment for treating asthenopia and a preparation method thereof.

The invention discloses an external traditional Chinese medicine gel ointment for treating asthenopia, which comprises, by weight, 5-10 parts of mugwort leaf, 5-10 parts of chrysanthemum, 5-10 parts of medlar, 5-10 parts of dried rehmannia root, 5-10 parts of raw yam, 5-10 parts of dogwood, 5-10 parts of cortex moutan, 5-10 parts of poria cocos, 5-10 parts of rhizoma alismatis, 5-10 parts of white peony root, 5-10 parts of achyranthes root, 5-10 parts of fructus Broussonetiae, 5-10 parts of centipeda, 5-10 parts of mung bean, 1-5 parts of artificial bezoar, 1-5 parts of aloe, 1-5 parts of borneol and 1-5 parts of peppermint.

The efficacy of each component in the traditional Chinese medicine composition is as follows:

the occurrence of asthenopia is caused by the fatigue of the long-term vision, the consumption of qi and blood, or the exhaustion of the fatigue, the deficiency of essence and blood of the liver and kidney, the malnutrition of eyes, and the deficiency of liver and kidney, the weakness of spleen and stomach, qi stagnation and blood stasis, and the main inducing factors are excessive use of eyesight and the fatigue of the heart. Based on the knowledge of traditional Chinese medicine, the traditional Chinese medicine composition provided by the invention is subjected to efficient formula screening on the basis of long-term clinical treatment, so that the traditional Chinese medicine composition with obvious effect is formed.

Mugwort leaf: has effects of dispelling cold, relieving pain, warming channel, promoting blood circulation, and promoting metabolism.

And (3) chrysanthemum: has effects of dispelling pathogenic wind, clearing heat, suppressing hyperactive liver, improving eyesight, and relieving symptoms of acid distention, eye itching, and blurred vision.

Medlar: has effects of nourishing liver and kidney, replenishing essence, and improving eyesight, and can be used for treating asthenopia, hepatic and renal yin deficiency.

Radix rehmanniae: has effects of clearing heat, cooling blood, nourishing yin, and promoting fluid production, and can be used for treating pathogenesis of asthenopia, liver and kidney yin deficiency.

Chinese yam and poria cocos: all have the functions of strengthening spleen and tonifying stomach, and aim at pathogenesis of asthenopia and weakness of spleen and stomach.

Fructus Corni: has effects of invigorating liver and kidney, and can be used for treating asthenopia and yin deficiency of liver and kidney.

Cortex moutan: has effects of clearing heat, cooling blood, promoting blood circulation, and removing blood stasis, and can be used for treating asthenopia, qi stagnation, and blood stasis.

Oriental Waterplantain rhizome: has effects of promoting diuresis and removing dampness, and can be used for treating pathogenesis of water dampness retention caused by asthenopia, spleen and stomach weakness.

White peony root: has effects of suppressing hyperactive liver, relieving pain, nourishing blood, astringing yin, softening liver, and relieving spasm, and is beneficial for relieving asthenopia, eye orbit pain and eye muscle tension.

Achyranthes root: has effects of nourishing liver and kidney, strengthening tendons and bones, dispelling blood stasis, dredging channels, and promoting blood circulation, and can be used for treating asthenopia, liver and kidney yin deficiency, and blood stasis.

Fructus Broussonetiae: has effects in invigorating kidney, removing liver fire, and improving eyesight, and can be used for relieving eye distention, lacrimation, and blurred vision caused by asthenopia.

Centipeda minima: has effects of removing toxic substances, relieving nasal obstruction, improving eyesight, and relieving conjunctival congestion and swelling, and can be used for removing toxin accumulated in eyes under asthenopia state, and relieving blurred vision.

Mung bean, artificial bezoar, aloe: the three traditional Chinese medicines have detoxification efficacy, can help to remove toxin accumulated in eyes under asthenopia state, and can prevent uncomfortable skin reaction of the preparation prepared from the traditional Chinese medicine composition in the use process.

Borneol: the traditional Chinese medicine composition has the effects of inducing resuscitation, dissipating heat, relieving pain and improving eyesight, can relieve blurred vision symptoms of asthenopia, can promote transdermal absorption of components of the traditional Chinese medicine composition, and can increase comfort level of an external preparation prepared from the traditional Chinese medicine composition.

Peppermint: has effects of dispelling pathogenic wind and heat, and clearing head and eyes, and can relieve symptoms such as discomfort of forehead and eye pain caused by asthenopia. In addition, the cool skin feeling of the mint can also increase the comfort level of the external preparation prepared from the traditional Chinese medicine composition.

The invention also aims to provide a preparation method of the external traditional Chinese medicine gel ointment for treating asthenopia, which comprises the following steps:

the preparation method comprises the following steps of preparing 5-10 parts of folium artemisiae argyi, 5-10 parts of chrysanthemum, 5-10 parts of medlar, 5-10 parts of dried rehmannia root, 5-10 parts of raw yam, 5-10 parts of dogwood, 5-10 parts of cortex moutan, 5-10 parts of poria cocos, 5-10 parts of rhizoma alismatis, 5-10 parts of white paeony root, 5-10 parts of achyranthes root, 5-10 parts of fructus Broussonetiae, 5-10 parts of centipeda, 5-10 parts of mung bean, 1-5 parts of artificial bezoar, 1-5 parts of aloe, 1-5 parts of borneol and 1-5 parts of peppermint;

secondly, cleaning impurities and dust on the surfaces of the mugwort leaf, the chrysanthemum, the medlar, the dried rehmannia root, the raw yam, the dogwood, the cortex moutan, the poria cocos, the rhizoma alismatis, the white peony root, the achyranthes root, the fructus Broussonetiae, the centipeda herb, the mung bean and the peppermint, and not treating the artificial bezoar, the aloe and the borneol;

thirdly, adding pure water into the raw materials except the artificial bezoar, the aloe and the borneol in parts by weight for soaking;

fourth, decocting and extracting, and filtering out liquid medicine; adding purified water into the residues, decocting and extracting, and filtering out the liquid medicine; adding purified water into the residues, decocting and extracting, and filtering out the liquid medicine;

fifthly, combining the liquid medicine filtered out from the three times, adding the calculus bovis, the aloe and the borneol, and stirring while heating to fully dissolve the calculus bovis, the aloe and the borneol;

sixthly, hermetically standing the liquid medicine at room temperature overnight, and taking a supernatant; centrifuging the supernatant to remove sediment and impurities sufficiently to obtain clear filtrate; concentrating the clarified filtrate to obtain concentrated solution;

seventh, adding ethanol into the concentrated solution, fully stirring and uniformly mixing, refrigerating, sealing and standing, filtering to remove sediment, and recovering ethanol to obtain extract; freeze-drying the extract to obtain extract powder;

eighth, placing carbomer 940 and poloxamer 188 in distilled water to disperse carbomer 940 and poloxamer 188 in the distilled water solution; naOH is added to adjust the pH value of the solution;

ninth, adding glycerol into the solution, and uniformly mixing; adding antioxidant EDTA-2Na and surfactant Tween-80 into the solution, and uniformly mixing to obtain a gel paste matrix;

and tenth, adding extract powder of the traditional Chinese medicine into the gel matrix, and homogenizing to obtain the traditional Chinese medicine gel.

Further, the third step is to add 10 times of purified water into the medicinal materials by weight and soak the medicinal materials for 2 hours.

Further, the fourth step of decoction and extraction is carried out for 1 hour, and liquid medicine is filtered out; adding 10 times of purified water into the residues, decocting and extracting for 1 hour, and filtering out liquid medicine; adding 10 times of purified water into the residues, decocting and extracting for 1 hour, and filtering out the liquid medicine.

Further, the sixth step is to concentrate the clarified filtrate to make 1: 2.

And further, adding 95% ethanol into the concentrated solution to reach the final concentration of 50% ethanol, fully stirring and uniformly mixing, refrigerating, sealing and standing for 48 hours.

Further, the final concentration of the eighth step solution contains carbomer 940 at 1% w/v and poloxamer 188 at 2.5% w/v; naOH was added to adjust the pH of the solution to 7.0.

Further, the final concentration of the solution in the ninth step contains 10% v/v of glycerol, and the mixture is uniformly mixed; EDTA-2Na with the concentration of 0.25 per mill w/v and Tween-80 with the concentration of 2 percent v/v are uniformly mixed to obtain the gel paste matrix.

And in the tenth step, the extract powder of the traditional Chinese medicine is added into the gel paste matrix, and the concentration is 2.5-10% w/v.

Further, the gel paste is in the form of an external application.

By combining all the technical schemes, the invention has the advantages and positive effects that: the external gel paste has the characteristics of convenient carrying, convenient use and comfort and moisture, the traditional Chinese medicine extract is prepared into the gel paste, and the external effect of the traditional Chinese medicine and the advantages of the external gel paste are exerted by applying upper and lower eyelids for administration, so that the irritation of direct administration of eye drops or eye drops to eyes is avoided, and the external gel paste can be used as an eye fatigue prevention and treatment product for long-term use.

The traditional Chinese medicine composition adopts a traditional Chinese medicine formula which is clinically applied for a long time, comprises 5-10 parts by weight of mugwort leaf, chrysanthemum, medlar, dried rehmannia root, raw Chinese yam, dogwood, cortex moutan, poria cocos, rhizoma alismatis, white paeony root, achyranthes root, fructus broussonetiae, centipeda and mung bean, 1-5 parts by weight of artificial bezoar, aloe, borneol and peppermint, and is prepared into a convenient and easy-to-use traditional Chinese medicine gel paste by extracting and concentrating active ingredients through a modern technical method, and has remarkable treatment effects on symptoms such as dry eyes, distending pain, blurred vision, eye ache and the like caused by asthenopia.

The invention is based on the prescription for clinical treatment of asthenopia in traditional Chinese medicine, and the pure natural traditional Chinese medicine gel paste which is convenient and easy to use and has obvious effect is prepared by a modern preparation method, and the external gel paste prepared by adopting the preferable prescription has obvious relieving effect on dry eyes, distending pain, blurred vision and eye ache symptoms of the asthenopia by external application.

According to the invention, traditional Chinese medicine raw materials are extracted and refined by a modern technology, so that the quality of gel paste is improved, the effect of treating asthenopia is improved, local irritation and allergy are avoided, the moistening effect is good, and the use comfort is high.

Drawings

Fig. 1 is a flowchart of a preparation method of an external traditional Chinese medicine gel paste for treating asthenopia, which is provided by the embodiment of the invention.

Fig. 2 is a schematic diagram of a preparation method of an external traditional Chinese medicine gel paste for treating asthenopia provided by the embodiment of the invention.

Detailed Description

The present invention will be described in further detail with reference to the following examples in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.

Aiming at the problems existing in the prior art, the invention provides an external traditional Chinese medicine gel ointment for treating asthenopia and a preparation method thereof, and the invention is described in detail below with reference to the accompanying drawings.

The external traditional Chinese medicine gel ointment for treating asthenopia consists of, by weight, 5-10 parts of mugwort leaf, 5-10 parts of chrysanthemum, 5-10 parts of medlar, 5-10 parts of dried rehmannia root, 5-10 parts of raw yam, 5-10 parts of dogwood, 5-10 parts of cortex moutan, 5-10 parts of poria cocos, 5-10 parts of rhizoma alismatis, 5-10 parts of white paeony root, 5-10 parts of achyranthes root, 5-10 parts of fructus Broussonetiae, 5-10 parts of centipeda, 5-10 parts of mung bean, 1-5 parts of artificial bezoar, 1-5 parts of aloe, 1-5 parts of borneol and 1-5 parts of peppermint.

As shown in fig. 1, the preparation method of the external traditional Chinese medicine gel paste for treating asthenopia provided by the invention comprises the following steps:

s101: preparing the following medicinal materials, by weight, 5-10 parts of mugwort leaf, 5-10 parts of chrysanthemum, 5-10 parts of medlar, 5-10 parts of dried rehmannia root, 5-10 parts of raw yam, 5-10 parts of dogwood, 5-10 parts of cortex moutan, 5-10 parts of poria cocos, 5-10 parts of rhizoma alismatis, 5-10 parts of white paeony root, 5-10 parts of achyranthes root, 5-10 parts of fructus Broussonetiae, 5-10 parts of centipeda, 5-10 parts of mung bean, 1-5 parts of artificial bezoar, 1-5 parts of aloe, 1-5 parts of borneol and 1-5 parts of peppermint;

s102: cleaning impurities and dust on the surfaces of mugwort leaf, chrysanthemum, medlar, dried rehmannia root, raw yam, dogwood, cortex moutan, poria cocos, rhizoma alismatis, white paeony root, achyranthes root, fructus Broussonetiae, centipeda, mung bean and peppermint, and not treating the artificial bezoar, aloe and borneol;

s103: adding 10 times of purified water into the raw materials except artificial bezoar, aloe and borneol, and soaking for 2 hours;

s104: decocting for 1 hr, and filtering to obtain medicinal liquid; adding 10 times of purified water into the residues, decocting and extracting for 1 hour, and filtering out liquid medicine; adding 10 times of purified water into the residues, decocting and extracting for 1 hour, and filtering out liquid medicine;

s105: mixing the three filtrates, adding calculus bovis, aloe and Borneolum Syntheticum, heating under stirring to dissolve calculus bovis, aloe and Borneolum Syntheticum;

s106: standing the liquid medicine at room temperature under sealed condition overnight, and collecting supernatant; centrifuging the supernatant to remove sediment and impurities sufficiently to obtain clear filtrate; concentrating the clear filtrate to obtain a filtrate 1: 2;

s107: adding 95% ethanol to final concentration of 50%, stirring, refrigerating, sealing, standing for 48 hr, filtering to remove precipitate, and recovering ethanol to obtain extract; freeze-drying the extract to obtain extract powder;

s108: placing carbomer 940 and poloxamer 188 in distilled water to disperse carbomer 940 and poloxamer 188 in distilled water solution, wherein the final concentration of the solution contains carbomer 940 1% (w/v) and poloxamer 188 2.5% (w/v); naOH is added to adjust the pH value of the solution to 7.0;

s109: adding glycerol into the solution, wherein the final concentration of the solution contains 10% (v/v) of glycerol, and uniformly mixing; adding antioxidant EDTA-2Na and surfactant Tween-80 into the solution, wherein the concentration of EDTA-2Na is 0.25 per mill (w/v), the concentration of Tween-80 is 2% (v/v), and uniformly mixing to obtain gel paste matrix;

s110: adding the extract powder of the traditional Chinese medicine into the gel matrix, adding the extract powder with the concentration of 2.5-10% (w/v), and homogenizing to obtain the traditional Chinese medicine gel.

In an embodiment of the invention: the gel paste is in the form of external application.

The preparation method of the external traditional Chinese medicine gel paste for treating asthenopia provided by the invention can be implemented by other steps by a person skilled in the art, and the preparation method of the external traditional Chinese medicine gel paste for treating asthenopia provided by the invention in fig. 1 is only one specific embodiment.

The technical scheme of the invention is further described below with reference to specific embodiments.

Example 1

The preparation method of the traditional Chinese medicine composite extract powder comprises the following steps:

step one: accurately weighing 5 g each of mugwort leaf, chrysanthemum, medlar, dried rehmannia root, raw yam, dogwood, cortex moutan, tuckahoe, rhizoma alismatis, white paeony root, achyranthes root, fructus Broussonetiae, centipeda minima and mung bean, and 1 g each of artificial bezoar, aloe, borneol and mint.

Step two: except for artificial bezoar, aloe and borneol, 71 g of the medicinal materials are removed with impurities and dust by weight, 701ml of purified water with the quantity of 10 times is added, and the mixture is soaked for 2 hours.

Step three: decocting for 1 hr, and filtering to obtain medicinal liquid; adding 701ml of purified water with the amount of 10 times of the residues, decocting and extracting for 1 hour, and filtering out liquid medicine; adding 701ml of purified water with the amount of 10 times of the residue, decocting and extracting for 1 hour, and filtering out the liquid medicine.

Step four: mixing the three decoctions, adding artificial bezoar, aloe and Borneolum Syntheticum, heating under stirring, and dissolving in the mixed filtrate.

Step five: standing under sealed condition at room temperature overnight, and collecting supernatant.

Step six: centrifuging the supernatant to remove precipitate and impurities completely to obtain clear filtrate.

Step seven: concentrating the clear filtrate to obtain a filtrate 1:2, 148ml.

Step eight: adding 164ml of 95% ethanol into the concentrated solution until the final concentration of ethanol is 50%, stirring, mixing, refrigerating, sealing, standing for 48 hr, filtering to remove precipitate, recovering ethanol, and concentrating into extract.

Step nine: freeze drying the extract to obtain extract powder.

Example 2

The preparation method of the traditional Chinese medicine composite extract powder provided by the embodiment of the invention comprises the following steps:

step one: 7.5 g of each of mugwort leaf, chrysanthemum, medlar, dried rehmannia root, raw yam, dogwood, cortex moutan, tuckahoe, rhizoma alismatis, white paeony root, achyranthes root, papermulberry fruit, centipeda minima and mung bean, and 2.5 g of each of artificial bezoar, aloe, borneol and mint are accurately weighed.

Step two: except for artificial bezoar, aloe and borneol, 107.5 g of the medicinal materials in parts by weight are removed of impurities and dust, 1075ml of 10 times of purified water is added, and the mixture is soaked for 2 hours.

Step three: decocting for 1 hr, and filtering to obtain medicinal liquid; adding 1075ml of 10 times of purified water into the residues, decocting and extracting for 1 hour, and filtering out the liquid medicine; adding 10 times of purified water 1075ml into the residue, decocting and extracting for 1 hr, and filtering to obtain medicinal liquid.

Step seven: concentrating the clear filtrate to obtain a filtrate 1:2, and 230ml.

Step eight: 256ml of 95% ethanol is added into the concentrated solution until the final concentration of the ethanol is 50%, and after the concentrated solution is fully stirred and uniformly mixed, the concentrated solution is refrigerated, sealed and kept stand for 48 hours, the sediment is removed by filtration, the ethanol is recovered, and the concentrated solution is concentrated into extractum.

Step nine: freeze drying the extract to obtain extract powder.

Example 3

step one: accurately weighing 10 g of each of mugwort leaf, chrysanthemum, medlar, dried rehmannia root, raw yam, dogwood, cortex moutan, tuckahoe, rhizoma alismatis, white paeony root, achyranthes root, fructus Broussonetiae, centipeda minima and mung bean, and 5 g of each of artificial bezoar, aloe, borneol and mint.

Step two: except for artificial bezoar, aloe and borneol, 145 g of the medicinal materials in parts by weight are removed of impurities and dust, 1450ml of 10 times of purified water is added, and the mixture is soaked for 2 hours.

Step three: decocting for 1 hr, and filtering to obtain medicinal liquid; 1450ml of 10 times of purified water is added into the residues, the decoction is extracted for 1 hour, and the liquid medicine is filtered; adding 1450ml of 10 times of purified water into the residues, decocting and extracting for 1 hour, and filtering to obtain medicinal liquid.

Step seven: concentrating the clear filtrate to obtain a filtrate 1:2, 320ml.

Step eight: adding 242ml of 95% ethanol into the concentrated solution until the final concentration of ethanol is 50%, stirring, mixing, refrigerating, sealing, standing for 48 hr, filtering to remove precipitate, recovering ethanol, and concentrating into extract.

Step nine: freeze drying the extract to obtain extract powder.

Example 4

The preparation method of the gel matrix provided by the embodiment of the invention comprises the following steps:

step one: carbomer 940 (1 gram) and poloxamer 188 (2.5 grams) were placed in distilled water 100ml to disperse carbomer 940 and poloxamer 188 in the distilled water solution.

Step two: naOH was added to adjust the pH of the above solution to 7.0.

Step three: 10 ml of glycerol is added into the solution and stirred and mixed uniformly.

Step four: antioxidant EDTA-2Na (27.5 mg) and surfactant Tween-80 (2.2 ml) were added to the above solution, and the mixture was mixed to obtain a gel matrix.

Example 5

The traditional Chinese medicine extract freeze-dried extract powder obtained in the example 1 is added into the gel matrix of the example 4, and the traditional Chinese medicine gel paste sample 1 is obtained after homogenization.

Example 6

The traditional Chinese medicine extract freeze-dried extract powder obtained in the example 2 is added into the gel matrix of the example 4, and the traditional Chinese medicine gel paste sample 2 is obtained after homogenization.

Example 7

The traditional Chinese medicine extract freeze-dried extract powder obtained in the example 3 is added into the gel matrix of the example 4, and the traditional Chinese medicine gel paste sample 3 is obtained after homogenization.

The technical effects of the present invention will be described in detail with reference to experiments.

1. Observing an object: the test cases are 200 cases, the ages of which are 18-45 years, wherein men, 120 cases and women are 80 cases. The consistency in gender and age of each group was maintained according to gender and age random groupings. The gel paste matrix of example 4 was applied to the first three groups of samples 1 to 3 prepared in examples 5, 6 and 7, respectively, and the first three groups of 50 examples each were divided into 4 groups of examples 5, 6 and 7, respectively.

2. Diagnostic criteria: the following criteria are formulated according to the visual fatigue diagnosis and treatment expert consensus 2014.

(1) The eye-use with long short distance cannot be tolerated, the object is ghost or blurred, and the eye-use can be relieved after stopping.

(2) Eye discomfort symptoms such as dry eyes, itching eyes, eye pain, photophobia, lacrimation, foreign body sensation and burning sensation which last for more than 3 months.

(3) With or without general symptoms such as dizziness, headache, hypodynamia, memory decline, nausea, vomiting, anxiety, dysphoria, etc.

(4) The ophthalmic examination is free of strabismus, amblyopia, diopter spread and eye infection and organic diseases.

(5) The distance vision or corrected vision of eyes reaches 1.0 or more.

3. Medicament: examples 5 to 7 and example 4 (comparative example).

4. The treatment method comprises the following steps: the medical gauze and the preservative film are cut into 5 multiplied by 6 cm for standby, a patient lies on a treatment bed, the eyes are closed, a layer of gauze is covered on both eyes, then the gauze is uniformly coated on the traditional Chinese medicine gel paste, the coating range comprises the whole eyes, after the application, the preservative film is covered on the whole eyes, and then two layers of gauze are covered, and the patient is kept for 20 minutes.

5. Standard of efficacy:

5.1 symptom improvement effectiveness: 3 of 8 symptoms of eye ache, eye distention, photophobia, blurred vision, dry eyes, foreign body sensation, lacrimation, general discomfort are improved, and the improvement of the symptoms is judged without deterioration of other symptoms.

Symptom improvement effective rate (%) =symptom improvement number/total number×100.

5.2 symptom score assessment:

TABLE 1 method for determining asthenopia symptoms (semi-quantitative integration method)

Note that: "even feel" means 1-2 times/2 days; "sometimes" means 1 to 3 times/day; "frequent" means > 3 times/day.

5.3 photopic persistence detection: drawing a three-dimensional block diagram of a figure shape on a check list, wherein each side of the block is 1cm long, and the local illumination is 100-150 LX (a specially-manufactured lamp box can be used). The distance between the check list and eyes should be kept at a proper distance according to the habit of the object to be seen by the subject, the object is regulated to see the image of the 'article' as bright vision, the object is not bright vision when the 'article' is inverted, and the measuring time is 3 minutes.

Photopic persistence = (photopic time/total fixation time) ×100%.

6. And (3) judging curative effect:

(1) The test group itself or the control group showed significant improvement in symptom efficiency or total integral difference (P < 0.05).

(2) The difference of the photopic persistence is significant (P < 0.05) in the test group or the comparison between the test group and the control group, and the average photopic persistence is improved by more than or equal to 10 percent.

7. Test results:

7.1 total integral of symptoms and improvement of effective rate of the invention; statistics of total effective rate of symptom improvement before and after the test of four groups of subjects respectively show that the total effective rate of the external application treatment of the examples 5 to 7 reaches more than 88%, and the effect of the example 7 is optimal, as shown in table 2.

Table 2 Total effective rate (%)

Meanwhile, total integral of symptoms before and after the test of four groups of subjects were analyzed, respectively, which shows that total integral of symptoms before and after the external application treatment of examples 5 to 7 was significantly improved (P < 0.01), as shown in table 3. Meanwhile, the total integral of symptoms is also significantly improved (P < 0.01) in examples 5 to 7 compared with example 4 (comparative example), as shown in Table 3.

Exterior-applied Chinese-medicinal gel ointment for treating general integral variation of symptom

Comparison before and after application P <0.01; compared to the control, #p <0.01.

(2) Photopic persistence change: examples 5 to 7 each show a significant improvement in photopic persistence (P < 0.01) compared with example 4 (comparative example), as shown in table 4. And the average photopic persistence of examples 5 to 7 is improved by not less than 10.1%.

Exterior-applied Chinese-medicinal gel ointment for treating durable change of front and back photopic vision

The test results also show that the skin allergy and skin irritation reaction do not occur in all the examples and the comparative examples in the treatment process, and the traditional Chinese medicine gel paste provided by the invention has higher use safety.

The foregoing is merely illustrative of specific embodiments of the present invention, and the scope of the invention is not limited thereto, but any modifications, equivalents, improvements and alternatives falling within the spirit and principles of the present invention will be apparent to those skilled in the art within the scope of the present invention.

Claims

1. The external traditional Chinese medicine gel ointment for treating asthenopia is characterized by being prepared from, by weight, 5-10 parts of mugwort leaf, 5-10 parts of chrysanthemum, 5-10 parts of medlar, 5-10 parts of dried rehmannia root, 5-10 parts of raw yam, 5-10 parts of dogwood, 5-10 parts of cortex moutan, 5-10 parts of poria cocos, 5-10 parts of rhizoma alismatis, 5-10 parts of white paeony root, 5-10 parts of achyranthes root, 5-10 parts of papermulberry fruit, 5-10 parts of centipeda minima, 5-10 parts of mung bean, 1-5 parts of artificial bezoar, 1-5 parts of aloe, 1-5 parts of borneol and 1-5 parts of peppermint;

the preparation method comprises the following steps:

seventh, adding 95% ethanol to the concentrated solution to reach ethanol final concentration of 50%, fully stirring, mixing, refrigerating, sealing, standing for 48 hours, filtering to remove precipitate, and recovering ethanol to obtain extract; freeze-drying the extract to obtain extract powder;

eighth, placing carbomer 940 and poloxamer 188 in distilled water to make the final concentration of the distilled water solution contain carbomer 940 1% w/v and poloxamer 188 2.5% w/v; naOH is added to adjust the pH value of the solution to 7.0;

and tenth, adding the extract powder of the traditional Chinese medicine into the gel matrix, adding the extract powder with the concentration of 2.5-10% w/v, and homogenizing to obtain the traditional Chinese medicine gel.

2. The topical Chinese medicinal gel ointment for treating asthenopia according to claim 1, wherein the third step comprises adding 10 times of purified water into the medicinal materials, and soaking for 2 hours.

3. The topical Chinese medicinal gel paste for treating asthenopia according to claim 1, wherein the fourth step of decoction is carried out for 1 hour, and the medicinal liquid is filtered; adding 10 times of purified water into the residues, decocting and extracting for 1 hour, and filtering out liquid medicine; adding 10 times of purified water into the residues, decocting and extracting for 1 hour, and filtering out the liquid medicine.

4. The topical traditional Chinese medicine gel ointment for treating asthenopia according to claim 1, wherein the sixth step is to concentrate the clarified filtrate to prepare 1: 2.

5. The topical Chinese medicinal gel paste for treating asthenopia according to claim 1, wherein the final concentration of the solution in the ninth step comprises 10% v/v of glycerin, and the mixture is uniformly mixed; EDTA-2Na with the concentration of 0.25 per mill w/v and Tween-80 with the concentration of 2 percent v/v are uniformly mixed to obtain the gel paste matrix.