Prepared rehmannia root essence eye moistening formula for treating dry eyes as well as preparation method and application of prepared rehmannia root essence eye moistening formula

Abstract

The invention provides a prepared rehmannia root essence eye moistening formula for treating dry eyes as well as a preparation method and application of the prepared rehmannia root essence eye moistening formula. The prepared rehmannia root essence eye moistening formula comprises the following components in parts by weight: 10-15 parts of prepared rehmannia root, 10-15 parts of angelica sinensis, 10-15 parts of rhizoma polygonati, 10-15 parts of radix polygonati officinalis, 10-20 parts of salvia miltiorrhiza, 10-15 parts of loofah sponge, 5-10 parts of stiff silkworm and 5-10 parts of mint. The provided traditional Chinese medicine composition can nourish yin and blood, dredge collaterals, moisten dryness and promote tear secretion, and the effect of treating dry eyes is achieved.

Description

Technical Field

[0001] The invention relates to the field of traditional Chinese medicine, and in particular to a Rehmannia glutinosa eye-moistening prescription for treating dry eyes, and a preparation method and application thereof. Background Art

[0002] With the aging of the population, the popularization of computers, air pollution, and the abuse of eye drops, dry eyes have become a common ocular surface disease that affects people's lives. Lipid dysregulation dry eyes are one of the most common types, which can cause symptoms such as dry eyes, visual fatigue, burning sensation, conjunctival congestion, etc., which bring inconvenience to patients' study and life. At present, the commonly used treatment methods are local treatment with artificial tears, local tear secretion promoters, antibacterial drugs and glucocorticoid or immunosuppressant eye drops. At present, the treatment for lipid dysregulation dry eyes has shortcomings such as short-lasting effect time and long-term eye drops causing ocular surface damage.

[0003] How to treat dry eyes needs further improvement. Summary of the invention

[0004] The present invention aims to solve one of the technical problems in the related art at least to a certain extent. The present invention provides a Rehmannia glutinosa eye-moistening prescription for treating dry eyes. The Rehmannia glutinosa eye-moistening prescription provided can be used to treat dry eyes with significant effect.

[0005] Specifically, the present invention provides the following technical solutions:

[0006] In a first aspect of the present invention, a Chinese medicine composition for treating dry eyes is provided, comprising, by weight:

[0007] 10-15 parts of Rehmannia glutinosa, 10-15 parts of Chinese Angelica sinensis, 10-15 parts of Polygonatum sibiricum, 10-15 parts of Polygonatum odoratum, 10-20 parts of Salvia miltiorrhiza, 10-15 parts of Luffa sponge, 5-10 parts of Bombyx batryticatus, and 5-10 parts of mint.

[0008] The Chinese medicine composition provided by the present invention has Radix Rehmanniae Preparata and Polygonatum odoratum as the main ingredients, which can nourish yin and blood, promote the production of body fluid and relieve dryness; Radix Angelicae Sinensis and Polygonatum Odorati are the assistant ingredients, which can help the main ingredients nourish yin and increase fluid; Radix Salviae Miltiorrhizae, Bombyx Batryticatus and Luffa Fructus are the auxiliary ingredients, which can dredge the meridians and activate blood circulation, dispel wind and resolve phlegm, and disperse knots; and Mentha arborescens is the auxiliary ingredient, which can soothe the liver and relieve depression, clear the liver and improve eyesight, and guide the medicine upward. The whole formula can achieve the effects of nourishing yin and blood, dredge the meridians and moisten the eyes, and promote the secretion of tears.

[0009] According to an embodiment of the present invention, in parts by weight,

[0010] The prepared rehmannia root is 10 parts, the angelica root is 10 parts, the polygonatum is 10 parts, the polygonatum is 10 parts, the salvia miltiorrhiza is 10 parts, the luffa is 10 parts, the bombyx batryticatus is 6 parts, and the mint is 6 parts.

[0011] According to an embodiment of the present invention, the provided traditional Chinese medicine composition consists of 10-15 parts of Rehmannia glutinosa, 10-15 parts of Angelica sinensis, 10-15 parts of Polygonatum sibiricum, 10-15 parts of Polygonatum odoratum, 10-20 parts of Salvia miltiorrhiza, 10-15 parts of Luffa sponge, 5-10 parts of Bombyx batryticatus and 5-10 parts of mint.

[0012] According to an embodiment of the present invention, the provided Chinese medicine composition further includes a pharmaceutically acceptable excipient.

[0013] According to an embodiment of the present invention, the provided Chinese medicine composition is an oral preparation.

[0014] The second aspect of the present invention provides a traditional Chinese medicine preparation, which is prepared using the traditional Chinese medicine composition described in any one of the first aspects above.

[0015] According to an embodiment of the present invention, the Chinese medicine preparation is at least one of granules, decoctions, pills, tablets, powders, granules, and capsules.

[0016] The third aspect of the present invention provides a use of the Chinese medicine composition described in the first aspect or the Chinese medicine preparation described in the second aspect in the preparation of a drug for treating dry eyes.

[0017] According to an embodiment of the present invention, the dry eye is lipid abnormality dry eye.

[0018] The beneficial effects achieved by the present invention are:

[0019] The Chinese medicine composition provided by the present invention can be used to treat dry eyes with remarkable effects. The Chinese medicine composition provided has Radix Rehmanniae Preparata and Polygonatum odoratum as the main ingredients, which nourish yin, nourish blood and moisten dryness; Angelica sinensis and Polygonatum odoratum as the secondary ingredients, which help the main ingredients nourish yin and increase fluid; Salvia miltiorrhiza, Bombyx batryticatus and Luffa fructus are the auxiliary ingredients, which can dredge meridians and activate blood circulation, dispel wind and resolve phlegm, and disperse knots; and Mentha chinensis soothes the liver and relieves depression, clears the liver and improves eyesight, and guides the medicine upward. The whole formula can achieve the effects of nourishing yin and blood, dredge meridians and moisten eyesight, and promote tear secretion. DETAILED DESCRIPTION

[0020] The embodiments of the present invention are described in detail below. It should be noted that the described embodiments are exemplary and intended to be used to explain the present invention, but should not be construed as limiting the present invention.

[0021] "Tongluo Runmu Recipe" is an empirical prescription of Tang Youzhi, a master of traditional Chinese medicine, and has been used clinically for more than 30 years. The prescription is reasonable in composition, with clear principles, methods and prescriptions, and there are no 18 methods and 19 fears or toxic medicinal materials in the drug composition. Clinical observation and research results show that the prescription has a good effect in treating lipid abnormality dry eyes. Compared with the control group, the treatment group can improve the symptoms of dry eye patients, stabilize the tear film, promote tear secretion, and improve corneal symptoms. The present invention provides a Rehmannia glutinosa and Polygonatum odoratum moistening eye prescription, including: Rehmannia glutinosa, Angelica sinensis, Polygonatum odoratum, Polygonatum odoratum, Salvia miltiorrhiza, Luffa, Bombyx batryticatus and mint. The prescription can significantly improve the symptoms of dry eye patients, prolong BUT time, improve tear film function and promote tear secretion, and the drug efficacy is long-lasting, etc., showing a more excellent dry eye treatment effect.

[0022] The present invention provides a Chinese medicine composition for treating dry eye, comprising: 10-15 parts of Rehmannia glutinosa, 10-15 parts of Angelica sinensis, 10-15 parts of Polygonatum sibiricum, 10-15 parts of Polygonatum odoratum, 10-20 parts of Salvia miltiorrhiza, 10-15 parts of Luffa sponge, 5-10 parts of Bombyx batryticatus, and 5-10 parts of mint. The Chinese medicine composition provided has Rehmannia glutinosa and Polygonatum odoratum as the main ingredients, nourishing yin, nourishing blood and moistening dryness; Angelica sinensis and Polygonatum odoratum as the assistant ingredients, assisting the main ingredients in nourishing yin and increasing fluid; Salvia miltiorrhiza, Bombyx batryticatus, and Luffa sponge as the auxiliary ingredients, promoting blood circulation, dispelling wind and resolving phlegm, and dispersing knots; and Mint soothes the liver and relieves depression, clears the liver and improves eyesight, and guides the medicine upward. The whole formula achieves the effects of nourishing yin and blood, unblocking the meridians and moistening dryness, and promoting tear secretion.

[0023] The provided Chinese medicine composition can be prepared into different dosage forms as needed to meet the needs of different groups of people.

[0024] The technical solution of the present invention is described below through specific embodiments. It should be noted that these embodiments are only used to facilitate the understanding of those skilled in the art and should not be regarded as limiting the protection scope of the present invention.

[0025] Example 1

[0026] Example 1 provides a prescription for moistening eyes with cooked rehmannia and polygonatum, which comprises: 15g cooked rehmannia, 10g angelica, 10g polygonatum, 10g polygonatum, 15g salvia miltiorrhiza, 9g luffa, 6g bombyx batryticatus, and 6g mint.

[0027] Weigh each Chinese medicine in the prescribed amount, decoct in water and prepare a water decoction.

[0028] A clinical control study was conducted to observe 156 patients (156 eyes) with lipid dysregulation dry eye. The diagnostic criteria for lipid dysregulation dry eye were formulated in accordance with the "Chinese Dry Eye Expert Consensus: Examination and Diagnosis (2020)". (1) The patient complained of one of the subjective symptoms such as dry eyes, foreign body sensation, burning sensation, fatigue, discomfort, red eyes, and visual fluctuations. The Chinese Dry Eye Questionnaire ≥ 7 points or the ocular surface disease index (OSDI) ≥ 13 points. At the same time, the patient's tear film break-up time (BUT) stability was significantly decreased (≤ 5s), but the tear secretion volume of the schirmerⅠtest (SⅠtest) was slightly abnormal (5-10mm / 5min), and the corneal fluorescein sodium staining method (Fluorescent test, FL) was positive (≥ 5 points). The TCM diagnostic standards refer to the relevant TCM diagnostic standards in "Traditional Chinese Medicine Ophthalmology" (Li Chuan Ke. Beijing: People's Medical Publishing House, 1999: 432-439). The syndrome is liver-kidney yin deficiency. The main symptoms are dry and uncomfortable eyes, photophobia, pale red sclera, etc. The secondary symptoms are dizziness, tinnitus, soreness of waist and knees, etc. The tongue is red with little coating and the pulse is thin and rapid.

[0029] Inclusion criteria: (1) patients met the diagnostic criteria for lipid dyslipidemia-type dry eye; (2) patients met the TCM white astringency syndrome and liver-kidney yin deficiency type; (3) patients aged 18 to 80 years; (4) patients who had not used other medications, or had used other medications but had stopped taking them for more than 2 weeks; (5) if the patient had bilateral disease, the eye with the more serious disease was used as the observation eye.

[0030] Exclusion criteria: (1) Patients with dry eyes caused by factors other than lipid abnormalities, such as other ocular surface diseases, trachoma, pemphigus, and ocular trauma; (2) Patients with a history of ophthalmic surgery or contact lens wear within the past 3 months; (3) Patients with tear pore closure surgery; (4) Pregnant or lactating women; (5) Patients with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system diseases, as well as patients with mental or legal disabilities; (6) Patients who are allergic to the ingredients in traditional Chinese medicine prescriptions.

[0031] There were 83 cases (83 eyes) in the treatment group and 73 cases (73 eyes) in the control group. There was no statistical difference in age and gender between the two groups (p>0.05). The treatment group was treated with "Shudihuangjing Runmu Fang" (oral, 1 dose per day, morning and evening) combined with sodium hyaluronate eye drops 4 times a day, while the control group was treated with simple sodium hyaluronate eye drops (0.1%).

[0032] The patients were treated for one month and followed up for one month. The ocular surface disease index (OSDI) questionnaire, TCM symptom quantitative score, tear secretion test (Schirmer I test, SIT), tear film breakup time (BUT), corneal fluorescein test (FL) score and other indicators were observed in the two groups.

[0033] The evaluation criteria for each observation index are as follows:

[0034] OSDI: A dedicated person will complete the OSDI questionnaire based on the symptoms described by the patient and calculate the dry eye score.

[0035] SIT: Use Schirmer test paper, fold the tip inward and place it in the conjunctival sac at the junction of the outer and middle 1 / 3 of the lower eyelid, and let the rest of the paper hang on the skin surface. Measure the length of the filter paper wetted by tears within 5 minutes.

[0036] BUT: After instilling 1% sodium fluorescein eye drops into the conjunctival sac of the affected eye, timing was performed with a stopwatch and observation was performed with cobalt blue light. The tear film showed the first black spot, indicating tear film rupture, and the average value was taken for three consecutive times.

[0037] FL: corneal fluorescein display corneal lesion classification method, use commercially available sodium fluorescein test paper soaked with normal saline, apply to the conjunctival sac of the lower eyelid, blink several times to make it diffuse and evenly distributed, ask the patient to open his eyes, observe under the cobalt blue diffuse light of the slit lamp microscope, divide the corneal area into 5 equal parts, each equal part is divided into four levels of 0-3 points, 0 point for no staining, 1 point for a little staining, 2 points for more staining, 3 points for block staining, finally add up the scores of each equal part, the full score is 15 points.

[0038] The efficacy evaluation criteria are:

[0039] The formula was developed with reference to the Diagnosis and Treatment Program for Ophthalmology in Traditional Chinese Medicine (Diagnosis and Treatment Program for Vitiligo (Dry Eyes)) edited by the Medical Administration Department of the State Administration of Traditional Chinese Medicine in 2010 and Modern Chinese Ophthalmology.

[0040] Among them, marked effect: symptoms were eliminated, SIT>10mm / 5min, BUT>10s, and FL disappeared;

[0041] Effective: Symptoms are alleviated, SIT and BUT increase compared with before treatment, and FL staining decreases compared with before treatment;

[0042] Ineffective: Symptoms and signs did not improve or worsened, and SIT, BUT, and FL did not improve.

[0043] Total effective rate = (number of markedly effective + effective) cases / total number of treated cases × 100%.

[0044] The results are as follows:

[0045] Baseline comparison:

[0046] Before treatment, there was no statistical difference in age, visual acuity, intraocular pressure, OSDI score, etc. between the two groups of patients (P>0.05), and the baseline levels were consistent and comparable.

[0047] Comparison of efficacy between the two groups of patients:

[0048] In the treatment group, 22 patients showed marked effect, 49 patients showed effective effect, 12 patients showed ineffective effect, and the total effective rate was 85.54%. In the control group, 9 patients showed marked effect, 44 patients showed effective effect, 20 patients showed ineffective effect, and the total effective rate was 72.60%. There was a statistically significant difference in the efficacy between the two groups. (χ 2 =7.109, P=0.029), indicating that the treatment group had better therapeutic effect than the control group.

[0049] OSDI score:

[0050] Before and after treatment, the OSDI scores were: 43.09±24.07, 23.06±12.91 in the treatment group and 38.12±24.92, 28.59±19.67 in the control group. There was a statistically significant difference between the two groups (t=-2.048, P=0.042), indicating that the treatment group was superior to the control group in improving dry eye symptoms.

[0051] Comparison of BUT between the two groups of patients:

[0052] The BUT before and after treatment were: 4.84±2.32 seconds, 7.61±3.19 seconds in the treatment group, and 4.68±2.29 seconds, 5.89±2.57 seconds in the control group. There was a statistically significant difference between the two groups (t=2.610, P=0.011), indicating that the treatment group was superior to the control group in terms of tear film stability.

[0053] Comparison of SIT between the two groups of patients:

[0054] Before and after treatment, the values ​​were: 7.57±6.71 (mm / 5min), 10.13±5.75 (mm / 5min) in the treatment group and 7.51±4.92 (mm / 5min), 6.59±3.65 (mm / 5min) in the control group.

[0055] There was a statistically significant difference between the two groups (t=3.039, P=0.003), indicating that the treatment group was superior to the control group in promoting tear secretion.

[0056] Comparison of FL scores between the two groups of patients:

[0057] Before treatment and after 1 month of treatment, the FL scores in the treatment group were 1.46±2.12 and 0.52±1.16, respectively, while the FL scores in the control group were 1.54±2.13 and 0.97±1.79, respectively.

[0058] There was no statistical difference between the two groups (t=1.407, P=0.163), indicating that both groups could quickly promote the repair of corneal damage.

[0059] Follow-up results:

[0060] During the one-month follow-up, 34 cases (44.32%) of the patients in the treatment group and 19 cases (26.03%) of the patients in the control group had continuous improvement of symptoms and stopped taking the medication. 2 =3.863, P=0.049, there was statistical significance between the two groups, indicating that the long-term effect of the treatment group was better than that of the control group.

[0061] The above results indicate that the "Rehmannia glutinosa eye moistening prescription" provided by the present invention is more effective in treating lipid dyslipidemia dry eye than simple artificial tears, can improve the symptoms of patients with lipid dyslipidemia dry eye, prolong BUT time, improve tear film function and promote tear secretion, and the drug efficacy is long-lasting.

[0062] In the description of this specification, the description with reference to the terms "embodiment", "specific implementation", etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example.

[0063] Although the embodiments of the present invention have been shown and described above, it is to be understood that the above embodiments are exemplary and are not to be construed as limitations of the present invention. A person skilled in the art may change, modify, replace and vary the above embodiments within the scope of the present invention.

Claims

1. A Chinese medicine composition for treating dry eyes, characterized in that: In parts by weight, it includes: 10-15 parts of Rehmannia glutinosa, 10-15 parts of Chinese angelica, 10-15 parts of Polygonatum sibiricum, 10-15 parts of Polygonatum odoratum, 10-20 parts of Salvia miltiorrhiza, 10-15 parts of Luffa sponge, 5-10 parts of Bombyx batryticatus and 5-10 parts of mint.

2. The Chinese medicine composition according to claim 1, characterized in that: In parts by weight, The prepared rehmannia root is 10 parts, the angelica root is 10 parts, the polygonatum is 10 parts, the polygonatum is 10 parts, the radix polygonati odoratis is 10 parts, the salvia miltiorrhiza is 10 parts, the luffa is 10 parts, the bombyx batryticatus is 6 parts, and the mint is 6 parts.

3. The Chinese medicine composition according to claim 1, characterized in that The composition comprises 10-15 parts of Rehmannia glutinosa, 10-15 parts of Chinese angelica, 10-15 parts of Polygonatum sibiricum, 10-15 parts of Polygonatum odoratum, 10-20 parts of Salvia miltiorrhiza, 10-15 parts of Luffa sponge, 5-10 parts of Bombyx batryticatus and 5-10 parts of mint.

4. The Chinese medicine composition according to claim 1, characterized in that: Includes pharmaceutically acceptable excipients.

5. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is an oral preparation.

6. A Chinese medicine preparation, characterized in that: The Chinese medicine preparation is prepared using the Chinese medicine composition according to any one of claims 1 to 5.

7. The Chinese medicine preparation according to claim 6, characterized in that: The Chinese medicine preparation is at least one of granules, decoctions, pills, tablets, powders, granules and capsules.

8. The method for preparing the Chinese medicine composition according to any one of claims 1 to 5, characterized in that: include: Mix the prescribed amount of 10-15 parts of Rehmannia glutinosa, 10-15 parts of Angelica sinensis, 10-15 parts of Polygonatum sibiricum, 10-15 parts of Polygonatum odoratum, 10-20 parts of Salvia miltiorrhiza, 10-15 parts of Luffa sponge, 5-10 parts of Bombyx batryticatus and 5-10 parts of mint.

9. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the Chinese medicine preparation according to claim 6 or 7 in the preparation of a medicament for treating dry eyes.

10. The use according to claim 9, characterized in that The dry eye type is lipid abnormality dry eye.