A traditional Chinese medicine composition for treating dry eye and its preparation method

Abstract

The present invention discloses a traditional Chinese medicine composition for treating dry eye and a preparation method thereof. The traditional Chinese medicine composition for treating dry eye is made from the following components in parts by weight: 10-12 parts of Chinese wolfberry, 5-10 parts of chrysanthemum, 10-15 parts of cassia seed, 10-12 parts of cortex fraxini, 5-10 parts of safflower, and 10-12 parts of phellodendron amurense. The traditional Chinese medicine composition for treating dry eye prepared by this method has less dosage, is convenient to use, safe and without side effects when treating dry eye, and has a significant therapeutic effect in aspects such as prolonging the breakup of the tear film, increasing the tear flow rate, and improving corneal staining, and can be promoted as a drug for treating dry eye.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine oral liquid, and more particularly to a traditional Chinese medicine composition for treating dry eye and its preparation method. Background Art

[0002] Dry eye, also known as keratoconjunctivitis sicca, refers to a general term for a variety of diseases caused by any reason resulting in abnormal quality or quantity or abnormal dynamics of tears, leading to a decrease in the stability of the tear film, accompanied by eye discomfort and / or characteristics of ocular surface tissue lesions. Common symptoms include dry eyes, easy fatigue, itchy eyes, foreign body sensation, burning pain, viscous secretions, fear of wind, photophobia, and high sensitivity to external stimuli; sometimes the eyes are too dry, the tear fluid is insufficient, and the tear fluid secretion is reflexively stimulated, resulting in frequent tearing; in more severe cases, the eyes will be red, congested, keratinized, and the corneal epithelium will break and there will be filamentous adhesions. Such damage can cause keratoconjunctival lesions over time and affect vision.

[0003] Western medicine mainly uses artificial tears, contact lenses, punctal occlusion, lacrimal duct blockage, and parotid gland transplantation to treat dry eye. Among them, artificial tears are the most commonly used. Artificial tears are a kind of eye health care product that mimics human tears, can protect the normal eyes, eliminate eye discomfort, treat dry eye, and relieve other eye diseases caused by dry eye, but artificial tears do not have a therapeutic effect on dry eye.

[0004] Traditional Chinese medicine believes that dry eye belongs to the categories of "white soreness", "withering of the divine water", "withering of the divine water and withering", "dryness syndrome", etc. in traditional Chinese ophthalmology. This disease is caused by the retention of pathogenic heat, insufficient lung yang, accumulated heat in the spleen and stomach, and deficiency of liver and kidney yin, and insufficient yin and blood, resulting in the eyes losing nourishment. Tears are the fluids of the liver. Disorders of the liver and kidney functions or insufficient liver blood cause the eyes to lose the nourishment of liver blood and body fluids, resulting in dry and astringent eyes. The main treatment methods of traditional Chinese medicine include taking traditional Chinese medicine preparations orally, eye fumigation, acupuncture, etc. Summary of the Invention

[0005] In order to solve the problem of dry and astringent eyes, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating dry eye and its preparation method. The traditional Chinese medicine composition has the effects of nourishing yin and moistening the eyes, benefiting the stomach, nourishing the liver and kidney, and clearing heat and dissipating stasis, so as to solve the problem of dry and astringent eyes.

[0006] To achieve the above object, the present invention provides the following technical solutions:

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating dry eye, which is made from the following components in the following weight ratios: 10-12 parts of wolfberry, 5-10 parts of chrysanthemum, 10-15 parts of cassia seed, 10-12 parts of cortex fraxini, 5-10 parts of safflower, and 10-12 parts of phellodendron amurense.

[0008] As a further aspect of the present invention, the traditional Chinese medicine composition for treating dry eye is prepared from the following components in the following weight ratios: 11 parts of wolfberry fruit, 7 parts of chrysanthemum, 12 parts of cassia seed, 11 parts of cortex fraxini, 7 parts of safflower, and 11 parts of phellodendron bark.

[0009] As a further aspect of the present invention, in the traditional Chinese medicine composition for treating dry eye, 10 - 12 parts of wolfberry fruit, 5 - 10 parts of chrysanthemum, 10 - 15 parts of cassia seed, 10 - 12 parts of cortex fraxini, 5 - 10 parts of safflower, and 10 - 12 parts of phellodendron bark form component A, and the synthesis method of component A is as follows:

[0010] Weigh the raw materials required for component A by weight: wolfberry fruit, chrysanthemum, cassia seed, cortex fraxini, safflower, and phellodendron bark; add purified water to a fixed volume of 500 mL. After soaking the raw materials for half an hour, decoct them for the first time with slow fire for one hour, and filter out the medicinal liquid; add purified water to the filtered raw materials again to a fixed volume of 500 mL.

[0011] As a further aspect of the present invention, the raw materials of component A are heated to 100°C - 130°C in a decocting tank and decocted with slow fire for one hour until the medicinal liquid remains 300 mL. Filter out the medicinal residues with a 20 - 25 - mesh filter cloth to obtain the first filtered medicinal liquid; add water to the filtered medicinal residues again and decoct with slow fire for one hour until the medicinal liquid remains 250 mL. Filter out the medicinal residues with a 20 - 25 - mesh filter cloth to obtain the second filtered medicinal liquid. Mix the first filtered medicinal liquid and the second filtered medicinal liquid to obtain the solution of component A.

[0012] As a further aspect of the present invention, the traditional Chinese medicine composition for treating dry eye further includes component B, which is prepared from the following components in the following weight ratios: 5 - 10 parts of anthocyanin, 1 - 3 parts of astragalus membranaceus, 0.2 - 0.5 parts of zinc lactate, 0.5 - 0.8 parts of vitamin B, and 10 - 35 parts of purified water.

[0013] As a further aspect of the present invention, the traditional Chinese medicine composition for treating dry eye is prepared from the following components in the following weight ratios: 7 parts of anthocyanin, 2 parts of astragalus membranaceus, 0.4 parts of zinc lactate, 0.75 parts of vitamin B, and 20 parts of purified water.

[0014] As a further aspect of the present invention, the traditional Chinese medicine composition for treating dry eye is prepared by mixing component A and component B in a volume ratio of 1:1. Mix the medicinal liquids of component A and component B, and divide them into two equal parts for taking once in the morning and once in the evening.

[0015] As a further aspect of the present invention, the synthesis method of component B is as follows:

[0016] After decocting Astragalus membranaceus and the remaining purified water in a decocting pot over a slow fire for 40 minutes until the liquid medicine remains 300 mL, filter and cool to obtain the Astragalus membranaceus decoction; sequentially add anthocyanins, the Astragalus membranaceus decoction, zinc lactate, and vitamin B into a dispersion container, stir at a constant speed for 10 min to 15 min, then stop stirring to obtain the solution of component B.

[0017] As a further aspect of the present invention, the traditional Chinese medicine composition for treating dry eye further comprises 20 to 35 parts of donkey-hide gelatin; the traditional Chinese medicine composition for treating dry eye is also used for heating the filtered decoction obtained by mixing the liquid medicines of component A and component B to 100 °C, adding donkey-hide gelatin and then decocting and concentrating to obtain an extract; after cooling, press it into a mold and cut it into pieces to obtain the donkey-hide gelatin extract.

[0018] In a second aspect, the present invention also provides a preparation method of a traditional Chinese medicine composition for treating dry eye, and the steps are as follows:

[0019] 1) Weigh wolfberries, chrysanthemums, cassia seeds, cortex fraxini, safflower, and phellodendron amurense, add purified water to a fixed volume of 500 mL, soak the raw materials for half an hour, then decoct them over a slow fire for the first time for one hour until 300 mL, filter out the liquid medicine; add purified water to the filtered raw materials again to a fixed volume of 500 mL, decoct them over a slow fire for the first time for one hour until 250 mL, filter out the liquid medicine, and mix the two liquid medicines to obtain the solution of component A;

[0020] 2) After decocting Astragalus membranaceus and the remaining purified water in a decocting pot over a slow fire for 40 minutes until the liquid medicine remains 300 mL, filter and cool to obtain the Astragalus membranaceus decoction; sequentially add anthocyanins, the Astragalus membranaceus decoction, zinc lactate, and vitamin B into a dispersion container, stir at a constant speed for 10 min to 15 min, then stop stirring to obtain the solution of component B;

[0021] 3) Mix component A and component B in a volume ratio of 1:1 to obtain the traditional Chinese medicine composition for treating dry eye.

[0022] The pharmacological effects of each raw material medicine in the formula of the present invention are as follows:

[0023] Wolfberries: Tonify the kidney and benefit essence, nourish the liver and improve eyesight, promote the production of body fluid.

[0024] Chrysanthemums: Slightly cold in nature, belonging to the lung and liver meridians. Disperse wind and clear heat, soothe the liver and improve eyesight; used for wind-heat colds, headache and dizziness, red and swollen eyes, and dim eyesight.

[0025] Cassia seeds: Sweet, bitter, cold in nature, slightly salty; belonging to the liver and large intestine meridians; clear the liver and improve eyesight, moisten the intestines and relieve constipation; used for red and painful eyes, photophobia with excessive tearing, headache and dizziness, dim eyesight, and constipation.

[0026] Cortex fraxini: Bitter, astringent, cold in nature; belonging to the liver, gallbladder, and large intestine meridians; clear heat and dry dampness, astringe to stop diarrhea, arrest vaginal discharge, improve eyesight; mainly treat damp-heat diarrhea, red and white vaginal discharge, red and swollen eyes, and corneal nebula.

[0027] Safflower: pungent and warm in nature, attributing to the heart and liver meridians; functions and indications: promoting blood circulation to dredge the meridians, dispelling stasis and relieving pain. It is used for amenorrhea, dysmenorrhea, retention of lochia, mass in the abdomen, chest impediment pain, stasis abdominal pain, stabbing pain in the chest and hypochondrium, traumatic injury, swelling and pain of sores and ulcers.

[0028] Phellodendron amurense: bitter in taste and cold in nature; attributing to the kidney and bladder meridians; having the effects of clearing away heat and dampness, purging fire and removing steaming, detoxifying and treating sores; used for damp-heat diarrhea and dysentery, jaundice with red urine, leukorrhea with genital itching, stranguria with pain, beriberi with flaccidity, consumptive fever due to yin deficiency, night sweats, spermatorrhea, swelling and toxicity of sores and ulcers, eczema and damp sores. Phellodendron amurense processed with salt nourishes yin and purges fire, and is used for yin deficiency with exuberant fire, night sweats and consumptive fever due to yin deficiency.

[0029] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0030] The preparation method of a traditional Chinese medicine composition for treating dry eye of the present invention, and the prepared traditional Chinese medicine composition for treating dry eye have less dosage, simple administration, safety and no side effects during the treatment of dry eye, and have significant therapeutic effects in aspects such as prolonging the breakup time of the tear film, increasing the tear flow rate, and improving corneal staining, and can be promoted as a drug for treating dry eye. Detailed implementation manners

[0031] The technical solution of the present invention will be further described in detail below in combination with the specific implementation manners.

[0032] In order to solve the problem of dry eyes, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating dry eye and its preparation method. The traditional Chinese medicine composition has the effects of nourishing yin and moistening the eyes, benefiting the stomach, nourishing the liver and kidney, clearing heat and dissipating stasis, so as to solve the problem of dry eyes.

[0033] Example 1

[0034] The present invention provides a traditional Chinese medicine composition for treating dry eye. The preparation method is as follows: take 12 parts of Chinese wolfberry, 10 parts of chrysanthemum, 15 parts of cassia seed, 12 parts of ash bark, 10 parts of safflower, and 12 parts of phellodendron amurense.

[0035] Preparation method: take the above raw materials, add an appropriate amount of water, soak for half an hour, and then decoct with slow fire for about one hour until the medicinal liquid remains about 300 mL, filter out the medicinal liquid; add an appropriate amount of water again, decoct with slow fire for about one hour until the medicinal liquid remains 250 mL, filter out the medicinal liquid, mix the two medicinal liquids, divide them into two equal parts on average, and take one part in the morning and one part in the evening. One month is a course of treatment, which can effectively treat dry eye.

[0036] Example 2

[0037] The present invention provides a traditional Chinese medicine composition for treating dry eye. The preparation method is as follows: take 10 parts of Chinese wolfberry, 6 parts of chrysanthemum, 12 parts of cassia seed, 12 parts of ash bark, 6 parts of safflower, and 10 parts of phellodendron amurense.

[0038] Preparation method: Take the above raw materials, add an appropriate amount of water, soak for half an hour, then decoct over a slow fire for about one hour until the medicinal liquid remains about 300 mL, filter out the medicinal liquid; add an appropriate amount of water again, decoct over a slow fire for about one hour until the medicinal liquid remains 250 mL, filter out the medicinal liquid, mix the two portions of medicinal liquid, divide them into two equal parts, and take one part in the morning and one part in the evening. One month is a treatment course, which can effectively treat dry eye disease.

[0039] Example 3

[0040] The embodiment of the present invention provides a traditional Chinese medicine composition for treating dry eye disease, and the preparation method is as follows: Take 10 parts of wolfberry fruit, 6 parts of chrysanthemum, 10 parts of cassia seed, 10 parts of cortex fraxini, 6 parts of safflower, and 10 parts of phellodendron bark.

[0041] Preparation method: Take the above raw materials, add an appropriate amount of water, soak for half an hour, then decoct over a slow fire for about one hour until the medicinal liquid remains about 300 mL, filter out the medicinal liquid; add an appropriate amount of water again, decoct over a slow fire for about one hour until the medicinal liquid remains 250 mL, filter out the medicinal liquid, mix the two portions of medicinal liquid, divide them into two equal parts, and take one part in the morning and one part in the evening. One month is a treatment course, which can effectively treat dry eye disease.

[0042] Example 4

[0043] The embodiment of the present invention provides a traditional Chinese medicine composition for treating dry eye disease, and the preparation method is as follows:

[0044] (1) Take 12 parts of wolfberry fruit, 10 parts of chrysanthemum, 15 parts of cassia seed, 12 parts of cortex fraxini, 10 parts of safflower, and 12 parts of phellodendron bark.

[0045] Heat 12 parts of wolfberry fruit, 10 parts of chrysanthemum, 15 parts of cassia seed, 12 parts of cortex fraxini, 10 parts of safflower, and 12 parts of phellodendron bark in a decocting tank to 100 °C and decoct over a slow fire for one hour until the medicinal liquid remains 300 mL, filter out the medicinal residues with a 20-mesh filter cloth to obtain the first filtered medicinal liquid; add water to the medicinal residues again and decoct over a slow fire for one hour until the medicinal liquid remains 250 mL, filter out the medicinal residues with a 20-mesh filter cloth to obtain the second filtered medicinal liquid, and mix the first filtered medicinal liquid and the second filtered medicinal liquid to obtain the solution of component A.

[0046] (2) Take 10 parts of anthocyanin, 3 parts of astragalus membranaceus, 0.5 part of zinc lactate, 0.8 part of vitamin B, and 35 parts of purified water.

[0047] Decoct astragalus membranaceus and the remaining purified water in a decocting tank over a slow fire for 40 minutes until the medicinal liquid remains 300 mL, filter and cool to obtain the astragalus membranaceus decoction; add anthocyanin, astragalus membranaceus decoction, zinc lactate, and vitamin B to a dispersion container in sequence, stir at a constant speed for 115 min, then stop stirring to obtain the solution of component B.

[0048] (3) Mix the medicinal liquids of component A and component B, divide them into two equal parts on average, and take one part in the morning and one part in the evening.

[0049] Example 5

[0050] The embodiment of the present invention provides a traditional Chinese medicine composition for treating dry eye, and the preparation method is as follows:

[0051] (1) Take 10 parts of wolfberry fruits, 5 parts of chrysanthemums, 10 parts of cassia seeds, 10 parts of fraxinus rhynchophylla, 5 parts of safflowers, and 10 parts of phellodendron amurense.

[0052] Heat 10 parts of wolfberry fruits, 5 parts of chrysanthemums, 10 parts of cassia seeds, 10 parts of fraxinus rhynchophylla, 5 parts of safflowers, and 10 parts of phellodendron amurense in a decocting tank to 100 °C and decoct them over a slow fire for one hour until the medicinal liquid remains 300 mL. Filter out the medicinal residues with a 25-mesh filter cloth to obtain the first filtered medicinal liquid; add water to the filtered medicinal residues again and decoct them over a slow fire for one hour until the medicinal liquid remains 250 mL. Filter out the medicinal residues with a 25-mesh filter cloth to obtain the second filtered medicinal liquid, and mix the first filtered medicinal liquid and the second filtered medicinal liquid to obtain the solution of component A.

[0053] (2) Take 5 parts of anthocyanins, 1 part of astragalus membranaceus, 0.2 part of zinc lactate, 0.5 part of vitamin B, and 10 parts of purified water.

[0054] After decocting astragalus membranaceus and the remaining purified water in a decocting tank over a slow fire for 40 minutes until the medicinal liquid remains 300 mL, filter and cool it to obtain the astragalus membranaceus decoction; add anthocyanins, the astragalus membranaceus decoction, zinc lactate, and vitamin B to a dispersion container in sequence, keep stirring at a certain speed for 115 min, and then stop stirring to obtain the solution of component B.

[0055] (3) Mix the medicinal liquids of component A and component B, divide them into two equal parts on average, and take one part in the morning and one part in the evening.

[0056] Example 6

[0057] The embodiment of the present invention provides a traditional Chinese medicine composition for treating dry eye. The preparation method is the same as that of the above-mentioned fact 5. After mixing the medicinal liquids of component A and component B, add 35 parts of donkey-hide gelatin to the filtered decoction and heat it to 100 °C. After adding donkey-hide gelatin, decoct and concentrate to obtain an extract; cool it and press it into a mold to cut into pieces to obtain the donkey-hide gelatin extract. Just chew the obtained donkey-hide gelatin extract.

[0058] Clinical trial data:

[0059] To verify the therapeutic effects of Examples 1 to 6 of the present invention, the following clinical trials were carried out on the present invention in the ophthalmology outpatient department of Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine from 2018 to 2021:

[0060] 1. Data and methods

[0061] 1.1 Diagnostic criteria

[0062] 1.1.1 Western medicine diagnostic criteria

[0063] Referring to the "Ophthalmology" by Li Fengming, Professor Zhang Hancheng in China proposed a standard for diagnosing dry eye based on the results of fluorescein staining (rb staining), BUT, and Schirmer I in 1987. This standard stipulates that in these three examinations, if two items are positive (rb++, BUT ≤ 10 seconds, Schirmer I ≤ 10 mm) or one item is strongly positive (rb++, BUT ≤ 5 seconds, Schirmer I ≤ 5 mm), dry eye can be diagnosed.

[0064] 1.2.3 Traditional Chinese medicine diagnostic criteria

[0065] Subjective symptoms: dryness sensation, foreign body sensation, visual fatigue, photophobia, burning sensation, eye pain, tearing, red eyes.

[0066] Tongue manifestation and pulse condition: red or yellow tongue, thready and weak or soggy and rapid pulse.

[0067] Among them, the inclusion criteria:

[0068] (1) Meeting the diagnostic criteria:

[0069] (2) Patients aged 18 - 62 should be included in the study subjects, regardless of gender;

[0070] (3) Having been treated with other drugs, but having stopped taking them for more than 2 weeks;

[0071] (4) Informed consent: Only those who meet the above conditions can be selected.

[0072] Case exclusion criteria:

[0073] (1) Those with obvious combined lesions of other conjunctiva, cornea, and iris;

[0074] (2) Pregnant or lactating women;

[0075] (3) Those who are allergic to or intolerant of the drugs used, and those who do not take the drugs as prescribed;

[0076] (4) Those with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, liver, kidney, and hematopoietic systems, and psychiatric patients, as well as patients participating in other drug clinical trials.

[0077] Criteria for cases withdrawing from the trial

[0078] For those who experience allergic reactions or serious adverse events and should immediately stop the clinical trial as judged by the doctor, that is, the clinical trial of this case is aborted. If the condition does not deteriorate during the course of the disease and should immediately stop the clinical trial as judged by the doctor, that is, the clinical trial of this case is aborted and treated as an invalid case. During the clinical trial, if the patient is unwilling to continue the clinical trial and requests to withdraw from the clinical trial from the attending doctor.

[0079] Withdrawal and management of cases

[0080] When the subject drops out, contact the subject by means of door-to-door appointment, telephone, letter, etc., ask for reasons, record the time of the last medication, and complete the assessment items that can be completed. For cases that drop out of the trial due to allergic reactions, adverse reactions, or ineffective treatment, take corresponding treatment measures according to the actual situation of the subject. For all patients who are selected and have used the numbered drugs, whether they drop out or not, record and retain the case observation form. Summarize and statistically analyze the data such as the case observation form for all dropout cases.

[0081] Among them, from August 2018 to December 2021, a total of 77 cases (105 eyes) of dry eye patients who met the diagnostic criteria were admitted to the Ophthalmology Outpatient Department of Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine. They were divided into a treatment group of 38 cases (53 eyes) and a control group of 39 cases (54 eyes) by simple randomization method. Among the 77 cases, 3 cases were lost to follow-up, including 2 cases in the treatment group and 1 case in the control group, which were excluded. A total of 74 patients completed this study. There were 36 cases (51 eyes) in the treatment group, including 14 males and 22 females, with an average age of 50.00±8.62 years and an average disease course of 2.46±1.53 years. There were 38 cases (53 eyes) in the control group, including 15 males and 23 females, with an average age of 47.87±8.93 years and an average disease course of 2.80±1.24 years. After statistical analysis, there were no significant differences in the composition ratio, gender, age, disease course, and disease symptom scores between the two groups of patients (P>0.05), and they were comparable.

[0082] Treatment method

[0083] 2.1 Treatment method

[0084] The treatment group used the traditional Chinese medicine composition prepared in Example 1 of the present invention,

[0085] Formula: 12 parts of wolfberry, 10 parts of chrysanthemum, 15 parts of cassia seed, 12 parts of fraxinus rhynchophylla, 10 parts of safflower, 12 parts of phellodendron amurense. Decoct in water for oral administration, 1 dose each time, taken twice in the morning and evening, and the course of treatment is 8 weeks.

[0086] Decoct in water for oral administration, 1 dose each time, taken twice in the morning and evening, and the course of treatment is 8 weeks.

[0087] The control group was treated with sodium hyaluronate eye drops (0.1%) produced by Santen Pharmaceutical Co., Ltd., one drop at a time, 3 times / day, for 8 consecutive weeks.

[0088] Symptom scores, tear secretion, tear breakup time, corneal staining and adverse reactions were observed and evaluated at the time of enrollment (day 0) and every 2 weeks after the start of treatment.

[0089] Observation indicators:

[0090] Subjective symptoms: dryness, foreign body sensation, visual fatigue, photophobia, burning sensation, eye pain, tearing, and red eyes.

[0091] Objective indicators: BUT, fluorescein staining, Schirmer I test.

[0092] 2.3 Observation Method

[0093] (1) BUT measurement: Use a glass rod to dip 20 parts / L of sodium fluorescein into the conjunctival sac of the lower eyelid. After closing the eyelids, the fluorescein is evenly distributed on the corneal surface. Then fix the upper and lower eyelids to expose the cornea and observe it under a slit lamp using cobalt blue light. Start timing from the last blink and record the time when the first rupture point on the tear film appears.

[0094] (2) Fluorescein staining: A glass rod dipped in fluorescein is applied to the conjunctival sac of the lower eyelid. The cornea is divided into four quadrants under slit lamp observation and all scores are added together to obtain the final score.

[0095] Scoring Criteria

[0096] Scoring Phenomenon 0 points No staining 1 point Less than 30 dot-like stainings 2 points More than 30 dot-like stainings but not diffuse 3 points Severely diffuse staining but no plaque-like staining 4 points With plaque-like staining

[0097] (3) Schirmer I test: Use a 2.5 mm x 35 mm tear test filter paper strip, bend one end by 5 mm, place it in the inner 1 / 3 conjunctival sac of the lower eyelid, and let the rest hang on the skin surface. Close the eyes and measure the wet length of the filter paper after 5 minutes.

[0098] The quantification standard of clinical symptom classification in traditional Chinese medicine (referring to the Guiding Principles for Clinical Research of New Chinese Medicines), divides symptoms into 0 points (no symptoms), 1 point (mild), 2 points (moderate), and 3 points (severe).

[0099] Dryness

[0100]

[0101] Visual fatigue

[0102]

[0103] Foreign body sensation

[0104]

[0105] Burning sensation

[0106]

[0107] Photophobia

[0108]

[0109] 2.4 Basis for evaluating clinical efficacy

[0110] (1) Efficacy is determined according to the scoring method: Efficacy index (n) = (total symptom score before treatment - total symptom score after treatment) / total symptom score before treatment × 100%.

[0111] (2) Measurement of tear secretion: Evaluate the change in tear volume before and after treatment.

[0112] (3) Evaluation of tear film break-up time: Evaluate the change in tear film stability before and after treatment.

[0113] (4) Corneal staining detection: Evaluate the change before and after treatment.

[0114] The clinical efficacy evaluation criteria (refer to the Diagnostic and Therapeutic Efficacy Criteria for Traditional Chinese Medicine Diseases and Syndromes issued by the State Administration of Traditional Chinese Medicine) are based on clinical symptoms, tear secretion volume, tear film break-up time, and corneal staining.

[0115] Clinical cure: After one course of treatment, the symptoms and signs basically disappear (efficacy index > 90%).

[0116] Marked effect: After one course of treatment, the symptoms and signs are significantly improved (90 > efficacy index > 60%).

[0117] Effective: After one course of treatment, the symptoms and signs are improved (60 > efficacy index > 30%).

[0118] Ineffective: After one course of treatment, the symptoms and signs are not significantly improved (efficacy index < 30%).

[0119] Time point for efficacy evaluation: Evaluate after 4 weeks of treatment. Clinical efficacy evaluation method: Adopt the method of separating treatment and evaluation, and clinical physicians make treatment according to the regulations in the random table.

[0120] Allocate cases into groups, and appoint a physician with a professional title of deputy chief physician or above to be specifically responsible for efficacy evaluation.

[0121] Safety evaluation

[0122] All cases are subjected to general physical examination items, three major routine tests, liver and kidney function, and electrocardiogram examinations before and after treatment. Record any adverse reactions, the measures taken, and the outcome if there are any adverse reactions.

[0123] Grouping method

[0124] For subjects who met the above criteria, a single-blind randomized controlled research method was adopted. They were numbered in the order of medical treatment, and the random number table was checked. Those with an even last digit of the random number were assigned to the treatment group, and those with an odd last digit of the random number were assigned to the control group.

[0125] Statistical method

[0126] The clinical trial data were input into the computer, and a database was established through the SPSS 13.0 software package for data processing. For categorical data, the X2 test was used; for measurement data, if they conformed to normality and homogeneity of variance, the two-sample comparison t-test or one-way analysis of variance was used, and the paired t-test was used for comparison before and after treatment. A P < 0.05 indicated a statistically significant difference.

[0127] Research results (see the following tables for details)

[0128] Table 1 Comparison of the total subjective symptom scores before and after treatment in the two groups ( ±SD)

[0129] Group Number of eyes Before treatment After treatment P Comparison between the two groups Treatment group 51 9.35±2.84 6.13±2.46 0 P＝0.035 Control group 53 9.62±2.86 7.13±2.27 0.02 P〈0.05

[0130] For the treatment group, P = 0.000 < 0.05 before and after treatment, indicating a statistically significant difference; for the control group, P = 0.02 < 0.05 after treatment, indicating a statistically significant difference; for the two groups after treatment, P = 0.035 < 0.05, indicating a statistically significant difference between the two groups after treatment, and the improvement of subjective symptoms in the treatment group was better than that in the control group.

[0131] Table 2 Comparison of BUT before and after treatment between the treatment group and the control group

[0132]

[0133]

[0134] When comparing BUT after treatment between the treatment group and the control group, P = 0.00 < 0.05, indicating a statistically significant difference between the two groups after treatment, and the curative effect of the treatment group was better than that of the control group.

[0135] Table 3 Comparison of fluorescein staining before and after treatment between the two groups

[0136]

[0137] When comparing the staining conditions after treatment between the two groups, P = 0.00 < 0.05, indicating a statistically

[0138] significant difference, indicating that the curative effect of the treatment group was better than that of the control group.

[0139] Table 4 Comparison of visual acuity before and after treatment between the treatment group and the control group

[0140]

[0141] There was no significant difference in vision between the two groups before and after treatment.

[0142] Table 5 Comparison of symptom scores of patients between the two groups before and after treatment

[0143]

[0144] After comparing the symptom scores of the two groups after treatment, P = 0.035 < 0.05. The improvement of symptoms in the treatment group was significantly better than that in the control group after treatment, and the difference was statistically significant.

[0145] The improvement of symptoms in the treatment group was significantly better than that in the control group after treatment, and the difference was statistically significant.

[0146] Table 6 Comparison of curative effects obtained from symptom scores

[0147]

[0148] 5. Drug adverse reactions:

[0149] During the medication period, no abnormal phenomena such as nausea, vomiting, and allergic reactions occurred in the patients. There was no abnormality in liver function, and no adverse reactions occurred for all patients to stop taking the medicine. 3 cases were lost to follow-up during the treatment process. No local or systemic adverse reactions occurred during the treatment period, and no patient had a decrease in vision.

[0150] Discussion

[0151] 6.1 Dry eye with astringency is mostly caused by heat pathogens injuring yin, resulting in insufficient lung yin and the eyes losing nourishment, and the eyes lacking the moistening of body fluids; or accumulation of heat in the spleen and stomach, dampness stagnation and heat steaming, qi mechanism disorder, and the eye orifices losing nourishment; or insufficient kidney yin, the eyes losing nourishment, resulting in discomfort and dryness of the eyeballs. This formula comprehensively addresses the above etiologies and gives nourishing yin to moisten the eyes, benefiting the stomach, nourishing the liver and kidney, clearing heat and dissipating nodules, and the curative effect is definite.

[0152] This study was based on a large number of previous clinical observations and research projects. Sodium hyaluronate eye drops (0.1%) were selected as the control group for double-blind simulation to exclude the deviation caused by subjective factors and objectively determine the absolute effectiveness of the traditional Chinese medicine composition for nourishing yin and moistening the eyes in the treatment of dry eye.

[0153] Summary of curative effects

[0154] This study shows that after 8 weeks of treatment, the cure rate of the treatment group is 54.90%, the marked effective rate is 21.57%, the effective rate is 19.61%, and the ineffective rate is 3.92%. The cure rate of the control group is 20.75%, the marked effective rate is 35.85%, the effective rate is 33.96%, and the ineffective rate is 9.43%; the cure rate, marked effective rate and total effective rate of the treatment group are higher than those of the control group, and the difference between the two groups is statistically significant (P < 0.05). It shows that the traditional Chinese medicine composition of the present invention has a good curative effect on treating dry eye disease.

[0155] The above has described the preferred embodiments of the present invention in detail, but the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those of ordinary skill in the art, various changes can also be made without departing from the purpose of the present invention.

Claims

1. A traditional Chinese medicine composition for treating dry eye syndrome, characterized in that, it is made from the following components in the following weight ratios: 10 - 12 parts of Chinese wolfberry, 5 - 10 parts of chrysanthemum, 10 - 15 parts of cassia seed, 10 - 12 parts of cortex fraxini, 5 - 10 parts of safflower, 10 - 12 parts of phellodendron amurense.

2. The traditional Chinese medicine composition for treating dry eye syndrome according to claim 1, characterized in that, the traditional Chinese medicine composition for treating dry eye syndrome is made from the following components in the following weight ratios: 11 parts of Chinese wolfberry, 7 parts of chrysanthemum, 12 parts of cassia seed, 11 parts of cortex fraxini, 7 parts of safflower, 11 parts of phellodendron amurense.

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