CN110960597A

CN110960597A - Traditional Chinese medicine granules for relieving asthenopia and treating amblyopia and preparation method thereof

Info

Publication number: CN110960597A
Application number: CN201911366742.5A
Authority: CN
Inventors: 田景奎; 付红伟; 李守信; 朱玮; 张晓勇; 陈学钊
Original assignee: Zhejiang University ZJU
Current assignee: Zhejiang University ZJU
Priority date: 2019-12-26
Filing date: 2019-12-26
Publication date: 2020-04-07

Abstract

The invention belongs to the field of medicines, and relates to a traditional Chinese medicine granule for relieving asthenopia and treating amblyopia and a preparation method thereof. The Chinese medicinal granule is prepared by extracting radix Angelicae sinensis, fructus Tribuli and semen astragali Complanati with ethanol, decocting the residue with fructus Lycii, radix Paeoniae alba, radix rehmanniae Preparata, flos Chrysanthemi and pericarpium Citri Tangerinae, concentrating into extract, precipitating with ethanol, concentrating, and drying to obtain extract powder; mixing the extract powder with appropriate diluent and sweetener, and granulating to obtain granule. The granules have the functions of tonifying kidney and replenishing vital essence, nourishing liver and improving eyesight, have obvious effects of relieving visual fatigue and treating amblyopia, have high transfer rate of effective components in the preparation method and small administration dosage, and are suitable for industrial production.

Description

Traditional Chinese medicine granules for relieving asthenopia and treating amblyopia and preparation method thereof

Technical Field

The invention belongs to the field of medicines, and relates to a traditional Chinese medicine granule which has the effects of tonifying kidney, replenishing vital essence, nourishing liver and improving eyesight and is used for relieving asthenopia and treating amblyopia and a preparation method thereof.

Background

The asthenopia is a common disease in ophthalmology at present, is a syndrome in which organic factors and mental (psychological) factors of eyes or the whole body are mutually interwoven, and is a group of syndromes which are manifested by visual disturbance, discomfort of eyes and general symptoms after eyes are used so that visual operation cannot be normally carried out, so the asthenopia syndrome is also commonly called as asthenopia syndrome in clinic. The traditional Chinese medicine name of the asthenopia is liver fatigue, the liver fatigue is originally found in the 'essential prescription of thousand gold' of Sun Simiao in Tang dynasty, and the book is written that the eyes are injured due to excessive reading and playing, namely the liver fatigue. Patients usually have symptoms such as pain, soreness, burning sensation, foreign body sensation, lacrimation, photophobia, blurred vision, diplopia, dry eyes, etc. of eyes, and severe patients even have general symptoms such as headache, nausea, vomiting, etc. These symptoms severely interfere with the vision and quality of life of the patient. With the increasing social competition and the increasing pace of life and work, people engaged in characters and other close-distance eye work increase, especially video terminals such as computers and the like are widely popularized, and the incidence of clinical asthenopia increases year by year.

Until now, most of the reports of western medicine treatment on asthenopia syndrome are symptomatic treatment, and most of the reports adopt neurotrophic agents, sedatives or β receptor blockers for local drip, and the weak pertinence, such as the naphthalene sensitive eye drops widely used in clinic, can only relieve temporary local symptoms and can not enhance the fatigue resistance.

The traditional Chinese medicine considers that the people are out of sight, the tendons are not relaxed through relaxation, and the essence and blood of the liver and kidney are consumed; deficiency of essence and blood, failure of the tendons to nourish the muscles and tendons, dysfunction of regulation, and the disease is treated as the primary disease, and the treatment of both the principal and secondary aspects of the disease is as reinforcing kidney, replenishing essence, nourishing liver to improve vision.

The invention designs a traditional Chinese medicine formula for tonifying kidney and replenishing vital essence, nourishing liver and improving eyesight, which has remarkable effects of relieving asthenopia and treating amblyopia.

Disclosure of Invention

The medlar is used as a monarch drug for nourishing liver and kidney, nourishing liver, improving eyesight, enhancing immunity in vivo, promoting hematopoiesis and increasing the elasticity of crystalline lens. White peony root, radix Angelicae sinensis for nourishing liver yin and liver blood; prepared rehmannia root, flatstem milkvetch seed, kidney tonifying, essence reinforcing and essence consolidating; the tribulus terrestris and the chrysanthemum are used for calming the liver and improving eyesight; the dried orange peel has the effects of tonifying spleen and regulating qi to prevent the stomach from being obstructed by nourishing greasiness, and the combined use of the medicines can tonify the kidney and replenish vital essence, nourish the liver and improve the eyesight, improve the microcirculation of eyes, improve the sensitivity of visual cells and achieve the purposes of eliminating asthenopia and treating amblyopia.

The invention is realized by adopting the following technical scheme:

a traditional Chinese medicine granule for relieving asthenopia and treating amblyopia comprises the following raw material medicines:

1-20 parts of wolfberry, 1-20 parts of white peony root, 1-20 parts of tribulus terrestris

1-20 parts of prepared rehmannia root, 1-20 parts of angelica, 1-20 parts of chrysanthemum flower

1-20 parts of flatstem milkvetch seed and 1-20 parts of dried orange peel.

Preferably, the traditional Chinese medicine granules for relieving asthenopia and treating amblyopia comprise the following raw material medicines:

9-18 parts of wolfberry, 6-12 parts of white peony root, 6-12 parts of tribulus terrestris

6-12 parts of prepared rehmannia root, 6-12 parts of Chinese angelica, 4-10 parts of chrysanthemum flower

6-12 parts of flatstem milkvetch seed, 4-10 parts of dried orange peel.

More preferably, the traditional Chinese medicine granules for relieving asthenopia and treating amblyopia comprise the following raw material medicines:

the invention also provides a preparation method of the traditional Chinese medicine granules for relieving asthenopia and treating amblyopia, which comprises the following steps:

(1) extracting the three medicines of the Chinese angelica, the tribulus terrestris and the flatstem milkvetch seed by using 50-90% ethanol by volume fraction, and recovering a solvent from an ethanol extracting solution to obtain an extract A and dregs;

(2) decocting the medicine residues obtained in the step (1) and the five medicines of medlar, white paeony root, prepared rehmannia root, chrysanthemum and dried orange peel together with 6-12 times of water in volume-mass ratio for two times, and concentrating the decoction to obtain an extract B;

(3) mixing the extract A and the extract B, adding ethanol for ethanol precipitation, filtering, concentrating, and drying to obtain extract powder;

(4) and (4) mixing the extract powder obtained in the step (3) with 14.6-49.6% by weight of diluent and 0.2-1% by weight of sweetener, granulating and packaging to obtain the compound.

Preferably, in the step (3), 95% ethanol is added to make the final ethanol content reach 60% -80% of the volume of the total alcohol precipitation liquid, so that impurities are precipitated.

Preferably, the ethanol with the volume fraction of 60-80% is used for extracting twice in the step (1), and each time lasts for 1-2 hours.

Preferably, the diluent is one or two of dextrin, lactose and starch.

Preferably, the sweetener is one or more of sucralose, AK sugar, aspartame, stevioside and the like.

The invention has the beneficial effects that:

the invention provides a traditional Chinese medicine granule capable of relieving asthenopia and treating amblyopia, which is prepared from medlar, prepared rehmannia root, flatstem milkvetch seed, white paeony root and Chinese angelica, and is used for tonifying kidney essence and nourishing liver blood; the caltrop and the chrysanthemum can calm the liver and improve vision; the dried orange peel can regulate qi, invigorate spleen and prevent nourishing greasy food from obstructing stomach. The combination of the raw materials plays the roles of tonifying kidney, replenishing vital essence, nourishing liver and improving eyesight, treats both principal and secondary aspects of diseases and tonifies without greasiness. The trial experiment shows that the eye drop has obvious improvement effect on symptoms of eye ache, eye swelling, photophobia, blurred vision, dry eye, foreign body sensation, lacrimation and general discomfort, has obvious improvement effect on photopic vision persistence and has no adverse reaction. The traditional Chinese medicine granule has the advantages of easily available raw materials, simple preparation process and convenient administration.

Detailed Description

The present invention is described in more detail below with reference to specific examples, but the scope of the present invention is not limited thereto.

Example 1:

(1) 0.8kg of angelica, 0.8kg of tribulus terrestris and 0.6kg of flatstem milkvetch seed are extracted twice by 60 percent ethanol under reflux, the dosage of 60 percent ethanol is 13.2kg each time, the reflux is carried out for 2 hours each time, and the reflux liquid is concentrated to obtain extract A;

(2) decocting the reflux residues of radix Angelicae sinensis, fructus Tribuli and semen astragali Complanati with fructus Lycii 1.5kg, radix Paeoniae alba 1.0kg, radix rehmanniae Preparata 1.0kg, flos Chrysanthemi 0.6kg and pericarpium Citri Tangerinae 0.6kg twice with water for 1.5 hr each time, adding water 69kg each time, filtering, and concentrating the decoction to obtain extract B;

(3) mixing extract A and extract B, adding 95% ethanol until the ethanol content reaches 60%, precipitating, filtering, concentrating to obtain extract, and spray drying to obtain extract powder;

(4) mixing the extract powder with 35% lactose, 0.3% sucralose, 0.2% aspartame and 0.3% magnesium stearate, granulating by dry method, and packaging.

Example 2:

(1) 0.8kg of angelica, 0.8kg of tribulus terrestris and 0.6kg of flatstem milkvetch seed are extracted twice by refluxing with 70 percent ethanol, the dosage of 70 percent ethanol is 22kg each time, the reflux is carried out for 1.5 hours each time, and the reflux liquid is concentrated to obtain extract A;

(2) decocting the reflux residues of radix Angelicae sinensis, fructus Tribuli and semen astragali Complanati with fructus Lycii 1.5kg, radix Paeoniae alba 1.0kg, radix rehmanniae Preparata 1.0kg, flos Chrysanthemi 0.6kg and pericarpium Citri Tangerinae 0.6kg twice with water, wherein the water addition amount is 55.2kg each time and 2 hours each time, filtering, and concentrating the decoction to obtain extract B;

(3) mixing extract A and extract B, adding 95% ethanol until the ethanol content reaches 70%, precipitating, filtering, concentrating to obtain extract, and vacuum drying to obtain extract powder;

(4) mixing the extract powder with 25% dextrin, 0.5% AK sugar, and 0.5% steviosin, granulating, and packaging.

Example 3:

(1) 0.8kg of angelica, 0.8kg of tribulus terrestris and 0.6kg of flatstem milkvetch seed are extracted twice by refluxing with 80 percent ethanol, the dosage of 80 percent ethanol is 26.4kg each time, the reflux is carried out for 1 hour each time, and the reflux liquid is concentrated to obtain extract A;

(2) decocting the reflux residues of radix Angelicae sinensis, fructus Tribuli and semen astragali Complanati with fructus Lycii 1.5kg, radix Paeoniae alba 1.0kg, radix rehmanniae Preparata 1.0kg, flos Chrysanthemi 0.6kg and pericarpium Citri Tangerinae 0.6kg twice with water for 1 hr each time, adding water 82.8kg each time, filtering, and concentrating the decoction to obtain extract B;

(3) mixing extract A and extract B, adding 95% ethanol until the ethanol content reaches 80%, precipitating, filtering, concentrating to obtain extract, and spray drying to obtain extract powder;

(4) mixing the extract powder with 15% lactose, 5% starch, and 0.6% sucralose, granulating, and packaging.

Example 4 application of a Chinese medicinal granule for relieving asthenopia and treating amblyopia

Human body test

The function of improving the asthenopia of the invention is functionally evaluated by investigating the influence on the asthenopia of the testee before and after taking the test sample of the invention.

1 subject inclusion criteria

1.118 adult aged-65 years old.

1.2 it is easy to fatigue the vision for long-term use.

Subject exclusion criteria

2.1 patients with infectious, traumatic eye diseases. Eye surgery is performed for less than 3 months.

2.2 patients with internal and external eye diseases such as cornea, lens, vitreous body, eyeground pathological changes and the like.

2.3 patients with cardiovascular, cerebrovascular, hepatic, renal, hematopoietic diseases.

2.4 pregnant or lactating women, allergic constitution patients.

2.5 taking the article related to the tested function in a short period of time affects the judger of the result.

2.6 taking medicine, health product or other treatment method for treating vision for a long time.

2.7 the patient does not meet the inclusion standard, does not eat the tested object according to the regulation, or has incomplete data to influence the efficacy or the safety judgment.

3 design of experiments and grouping

Two control designs, self and group, were used. Grouping according to random and double-blind requirements, and balancing the symptoms and vision level of the trial group and the control group according to the symptoms and vision examination conditions during grouping. Meanwhile, factors such as age, sex and the like are considered, so that the two groups have comparability. Each group had 55 persons.

4 dose of test substance and method of use

Experimental groups: the granules prepared in examples 1 to 3 were administered orally twice a day, 10 g each time, for 60 consecutive days.

Control group: equal placebo was taken.

5. Observation index

5.1 safety index

5.1.1 routine examination of blood and urine, physical examination.

5.1.2 liver and kidney function examination.

5.1.3 chest X-ray or X-ray film, electrocardiogram, B-ultrasonic examination of abdomen (one examination before eating trial).

5.2 efficacy index, check at the beginning and end of the test meal.

5.2.1 questionnaire-symptom query, eye condition.

5.2.2 ophthalmologic examinations including fundus examination, vision examination (myopia, hyperopia, astigmatism, etc.).

5.2.3 the method for measuring the photopic vision persistence is disclosed in appendix of evaluation method for asthenopia-relieving function.

6 criteria for efficacy determination

6.1 effective rate for improving symptoms

The symptoms of the eye are 3 improved symptoms of ache of the eye, eye swelling, photophobia, blurred vision, dry eyes, foreign body sensation, lacrimation and general discomfort, and the symptoms are judged to be improved if other symptoms are not worsened. Two groups of symptom improvement cases and two groups of symptom improvement effective rates are calculated. The effective rate (%) for symptom improvement was calculated as the number of symptom improvement cases/number of test food cases × 100. The two groups of symptoms are tested for improving the effective rate statistically.

6.2 mean integral of symptoms

The symptom scores before and after the test eating of each test taker are calculated, see table 1, and the average score values of the two groups are calculated respectively and are subjected to statistical test.

TABLE 1 asthenopia symptom determination method (semi-quantitative integration method)

The 'accidental feeling' means 1-2 times per 2 days; "occasionally" means 1-3 times per day; "often" means >3 times per day

6.3 improvement rate of eyesight

After the test food is eaten, the two behaviors are improved compared with the pre-eating condition, and the vision improvement rate of two groups of patients is counted as a reference index. The reference index does not serve as a criterion for determining whether the asthenopia-relieving function is effective.

6.4 photopic Vision persistence

Compared with the test group or the test group and the control group, the photopic vision persistence difference is significant (p is less than 0.05), and the improvement of the average photopic vision persistence is more than or equal to 10 percent, which is effective.

7 data processing and statistical analysis

The metrology data can be analyzed using a t-test. Paired t-tests were used for self-control and grouped t-tests were used for two-panel mean comparisons. Carrying out appropriate variable conversion on the data with non-normal distribution or uneven variance, and carrying out t test on the converted data after the data meets the condition of uniform normal variance; if the converted data can not meet the requirement of normal variance, the t' test or the rank sum test is used. On the premise that the comparison difference between groups before test feeding is not significant, comparison between groups after test can be carried out.

X for counting data²And (6) checking. And when the total case number of the four-table is less than 40 or the total case number is equal to or more than 40 but the theoretical frequency is equal to or less than 1, the exact probability method is applied.

8 determination of results

8.1 compared with the test group or the test group and the control group, the effective rate of improving symptoms or the difference of total score of symptoms is significant (p is less than 0.05).

8.2 compared with the test group or the test group and the control group, the photopic vision persistence difference is significant (p is less than 0.05), and the average photopic vision persistence is improved by more than or equal to 10%.

The test article has 8.1 and 8.2, and the rate of improvement of vision is not significantly reduced, and it can be judged that the test article has the function of alleviating asthenopia.

9 test results

9.1 safety index observations

During the test period, the subjects in the test group and the control group have no abnormal conditions of spirit, diet, sleep and defecation. The subjects have no abnormality in blood routine, urine routine, liver function, kidney function, chest X-ray or X-ray film, electrocardiogram, abdominal B-ultrasonic examination and physical examination before and after the test.

9.2 efficacy test results

9.2.1 symptom improvement effective rate before and after test

The effective rate of symptom improvement before and after the test is shown in table 2, and after the test, the effective rate of symptom improvement of the groups of example 1, example 2 and example 3 is obviously higher than that of the control group (P < 0.01).

TABLE 2 symptom improvement in response rate

Item	Effective number of cases	Number of invalid cases	Effective rate (%)
				EXAMPLE 1 group (n ═ 55)	30	25	54.55**
EXAMPLE 2 group (n ═ 56)	30	26	53.57**
				EXAMPLE 3 group (n ═ 55)	29	26	52.73**
Control group (n ═ 55)	9	46	16.36

Note: denotes P <0.01 compared to control group

9.2.2 mean integral Change in symptoms before and after the test

The mean integral change of symptoms before and after the test is shown in Table 3. After the test feeding, the mean integral of symptoms of the groups of example 1, example 2 and example 3 is obviously reduced compared with the control group (P < 0.01); after the test feeding, the mean integral of symptoms of the groups of example 1, example 2 and example 3 is remarkably reduced compared with that before the experiment (P <0.01)

TABLE 3 mean integral of symptoms

Note: denotes P <0.01 compared to control group; #; denotes a self-context comparison P <0.01

9.2.3 distant vision change before and after experiment

The change conditions of the far vision before and after the test are shown in the table 4, and the far vision of the right eye is obviously improved (P is less than 0.05) by self-contrast before and after the test of the group in the example 1; in the example 2, the binocular distance vision is obviously improved (P <0.05) by self control before and after the test; example 3 group controls were self-administered before and after the test, with a significant improvement in far-vision in the left eye (P < 0.05).

TABLE 4 Change in distance vision before and after the test

Note: denotes comparison P <0.05 before and after self

9.2.4 photopic Vision persistence Change before and after test

The change of the photopic vision persistence before and after the test is shown in Table 5. After the test feeding, the photopic vision persistence of the group of example 1, the group of example 2 and the group of example 3 is obviously improved compared with that of the control group (P < 0.01); after the test feeding, the photopic vision persistence of the example 1 group, the example 2 group and the example 3 group is obviously improved compared with that before the experiment (P < 0.01).

TABLE 5 Sunstrual photopic vision persistence before and after the test

It should be noted that the above-mentioned embodiments are only for illustrating the technical solutions of the present invention and not for limiting, and although the present invention has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions may be made on the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, which should be covered by the claims of the present invention.

Claims

1. A traditional Chinese medicine granule for relieving asthenopia and treating amblyopia is characterized by comprising the following raw material medicines:

2. the traditional Chinese medicine granule for relieving asthenopia and treating amblyopia as claimed in claim 1, which comprises the following raw material medicines:

3. the traditional Chinese medicine granule for relieving asthenopia and treating amblyopia as claimed in claim 2, which comprises the following raw material medicines:

4. the preparation method of the traditional Chinese medicine granules for relieving asthenopia and treating amblyopia as claimed in any one of claims 1 to 3, which comprises the following steps:

(2) decocting the residue obtained in the step (1) and the five medicines of medlar, white paeony root, prepared rehmannia root, chrysanthemum and tangerine peel together with water with the volume and mass ratio of 6-12 times for two times, and concentrating the decoction to obtain an extract B;

5. The method for preparing traditional Chinese medicine granules for alleviating asthenopia and treating amblyopia as claimed in claim 4, wherein the ethanol added in step (3) is 95% ethanol, so that the final volume fraction of ethanol is 60% -80% of the total ethanol precipitation solution.

6. The method for preparing a Chinese medicinal granule for alleviating asthenopia and treating amblyopia as claimed in claim 4, wherein the step (1) comprises extracting twice with ethanol with a volume fraction of 60-80% for 1-2 hours each time.

7. The method for preparing traditional Chinese medicine granules for relieving asthenopia and treating amblyopia as claimed in claim 4, wherein the diluent is one or two of dextrin, lactose and starch.

8. The method for preparing traditional Chinese medicine granules for relieving asthenopia and treating amblyopia as claimed in claim 4, wherein the sweetener is one or more of sucralose, AK sugar, aspartame and stevioside.