Heating antibacterial traditional Chinese medicine-based hydrogel for treating meibomian gland dysfunction as well as preparation method and application of heating antibacterial traditional Chinese medicine-based hydrogel

Abstract

The invention provides a heating antibacterial traditional Chinese medicine-based hydrogel for treating meibomian gland dysfunction as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine preparations. The preparation method comprises the following steps: adding water into angelica sinensis, ligusticum wallichii, raw salvia miltiorrhiza, selfheal, pawpaw, dandelion, wild chrysanthemum flower, honeycomb, garden balsam stem, honeysuckle, peach kernel, rhizoma pinellinae praeparata, fritillaria, schizonepeta and divaricate saposhnikovia root, decocting and concentrating into a traditional Chinese medicine decoction; adding polyvinyl alcohol, polyvinylpyrrolidone and silver nanowires into the traditional Chinese medicine decoction, heating and stirring to obtain a composite decoction; and freezing the composite decoction, taking out and melting to obtain the traditional Chinese medicine-based hydrogel for treating meibomian gland dysfunction. The copper sheets are respectively clamped at two ends of the traditional Chinese medicine-based hydrogel sheet, and 3-5V voltage is applied, so that hydrogel heating can be realized. The heatable antibacterial traditional Chinese medicine-based hydrogel patch for treating meibomian gland dysfunction has a good treatment and improvement effect on meibomian gland dysfunction of different age groups, and the effective rate reaches up to 93.33%.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine preparations, and in particular relates to a fever-resistant and antibacterial traditional Chinese medicine-based hydrogel for treating meibomian gland dysfunction, and a preparation method and application thereof. Background Art

[0002] Dry eye disease (DED) is a multifactorial ocular surface disease caused by abnormal tear quality or quantity, decreased tear film stability, and accompanied by ocular surface inflammation, tissue damage, and neurosensory abnormalities. Its core characteristic is the imbalance of tear film homeostasis, which may be caused by insufficient tear secretion (such as Symptoms of DED include dry eyes, foreign body sensation, burning sensation, fluctuating vision, and fatigue. Severe cases can lead to corneal damage, blindness, and even psychological disturbances such as anxiety, sleep disturbances, fatigue, and depression. The prevalence of DED is increasing due to lifestyle changes, such as prolonged use of electronic devices, the prevalence of air-conditioned environments, environmental pollution, and climate change.

[0003] Conventional treatments for dry eye caused by meibomian gland dysfunction include meibomian gland massage and intense pulsed light (IPL) therapy. Although these treatments can alleviate symptoms, they still have certain limitations or adverse reactions. Meibomian gland massage requires long-term, regular visits to the hospital for treatment. Similarly, IPL therapy has significant limitations due to the risk of light absorption by pigmented intraocular structures (such as the iris) and its high cost. In addition, traditional Chinese medicine topical applications often use Chinese medicine ointments or cakes applied to the affected area, which are then fixed with gauze, making them inconvenient to use. Therefore, finding a new method for treating dry eye that is safe, easy to use, and has satisfactory efficacy is an urgent problem that needs to be solved. Summary of the Invention

[0004] In view of this, the object of the present invention is to provide a febrile and antibacterial traditional Chinese medicine-based hydrogel for treating meibomian gland dysfunction, as well as a preparation method and application thereof.

[0005] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0006] The present invention provides a traditional Chinese medicine composition for treating meibomian gland dysfunction, comprising angelica sinensis, chuanxiong rhizome, raw salvia miltiorrhiza, selfheal, papaya, dandelion, wild chrysanthemum, honeysuckle, honeysuckle, peach kernel, pinellia ternata, fritillaria, schizonepeta tenuifolia, and siler.

[0007] The mass ratio of the angelica sinensis, chuanxiong, raw salvia miltiorrhiza, selfheal, papaya, dandelion, wild chrysanthemum, honeycomb, radix polygoni lobatae, honeysuckle, peach kernel, pinellia ternata, fritillaria, schizonepeta tenuifolia, and saposhnikovia divaricata is 1:1:1:1:1:1:1:1:1:1:1:1:1:1:1:1.

[0008] The present invention also provides an antibacterial traditional Chinese medicine-based hydrogel for treating meibomian gland dysfunction, comprising the traditional Chinese medicine composition and excipients, wherein the excipients include polyvinyl alcohol, polyvinyl pyrrolidone, and silver nanowires.

[0009] The present invention also provides a method for preparing the antibacterial traditional Chinese medicine-based hydrogel, comprising the following steps:

[0010] 1) mixing angelica, chuanxiong, raw salvia miltiorrhiza, selfheal, papaya, dandelion, wild chrysanthemum, honeysuckle, honeysuckle, peach kernel, pinellia, fritillaria, schizonepeta, and siler, decocting, and concentrating to obtain a concentrated Chinese medicine decoction;

[0011] 2) mixing the concentrated Chinese medicine decoction, polyvinyl alcohol, polyvinyl pyrrolidone, and silver nanowires, and stirring to obtain a composite decoction;

[0012] 3) freezing the composite decoction and then melting it to obtain the antibacterial traditional Chinese medicine-based hydrogel.

[0013] Preferably, the decoction in step 1) includes a first decoction and a second decoction, the first decoction time is 1 to 3 hours, and the second decoction time is 0.5 to 2 hours.

[0014] Preferably, the density of the concentrated Chinese medicine decoction in step 1) is 1-2 g / mL.

[0015] Preferably, in step 2), the total mass of the PVA and PVP accounts for 6% to 14% of the mass fraction of the composite decoction, and the mass ratio of the PVA to PVP is 8 to 10:1;

[0016] The mass fraction of the silver nanowires in the composite decoction is 3% to 10%.

[0017] Preferably, the stirring temperature in step 2) is 60° C. to 110° C., and the stirring time is 1.5 to 3 hours.

[0018] Preferably, the freezing temperature in step 3) is -5°C to -210°C, and the freezing time is 3 to 300 minutes.

[0019] The present invention also provides the use of the traditional Chinese medicine composition, the antibacterial traditional Chinese medicine-based hydrogel or the antibacterial traditional Chinese medicine-based hydrogel prepared by the preparation method in preparing a drug for treating meibomian gland dysfunction.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] In the Chinese medicine composition of the present invention, siler, schizonepeta, and papaya are monarch drugs, which dispel wind, invigorate the mystical and meridians; pelargonium is an adjuvant drug, which penetrates the drug into the deep subcutaneous tissue; the remaining are ministerial drugs, including angelica, ligusticum, raw salvia miltiorrhiza, and peach kernel, which promote blood circulation and dredge meridians, improve ocular surface or local blood circulation; dandelion, wild chrysanthemum, honeysuckle, selfheal, and honeycomb, which clear away heat and dissipate stagnation, inhibit ocular surface or local inflammatory reactions; and pinellia and fritillaria, which resolve phlegm and dry dampness. The above ingredients cooperate with each other to achieve the effects of clearing heat, promoting blood circulation, dredging meridians, dispersing stagnation, dispelling wind and resolving phlegm, and regulating the mystical and meridians.

[0022] The method for preparing the traditional Chinese medicine-based hydrogel provided by the present invention is simple in process, low in cost, environmentally friendly and clean, antibacterial, easy to operate, and has wide applicability. The obtained hydrogel can be conveniently applied to the meibomian gland for effective treatment, has an increased heating function, can promote the absorption of traditional Chinese medicine, and has a rapid onset of effect. DETAILED DESCRIPTION

[0023] The present invention provides a traditional Chinese medicine composition for treating meibomian gland dysfunction, comprising angelica sinensis, chuanxiong rhizome, raw salvia miltiorrhiza, selfheal, papaya, dandelion, wild chrysanthemum, honeysuckle, honeysuckle, peach kernel, pinellia ternata, fritillaria, schizonepeta tenuifolia, and siler.

[0024] The mass ratio of the angelica sinensis, chuanxiong, raw salvia miltiorrhiza, selfheal, papaya, dandelion, wild chrysanthemum, honeycomb, radix polygoni lobatae, honeysuckle, peach kernel, pinellia ternata, fritillaria, schizonepeta tenuifolia, and saposhnikovia divaricata is 1:1:1:1:1:1:1:1:1:1:1:1:1:1:1:1.

[0025] The concept of "Xuanfu" originates from the Yellow Emperor's Classic of Internal Medicine, and the theory of Xuanfu was established by Liu Wansu, a physician during the Jin and Yuan dynasties. In "Suwen: Xuanji Yuanbingshi: Liuqi Weibing," it is stated: "The sweat pores of the skin are the orifices through which qi and fluid are released... Another name, Xuanfu, refers to the Xuanweifu." This theory has been continuously refined and passed down through generations of physicians, evolving and evolving. "Xuan" symbolizes the subtle and hidden, and can be understood as a microscopic network connecting the entire body, connecting the upper and lower parts, the inside and the outside. It serves as the gateway for the rise and fall of qi, blood, body fluids, and spirit. It is widely distributed, minute in form, and numerous in number. Modern medicine suggests that 80% of dry eye cases are caused by meibomian gland dysfunction. Meibomian glands, located on the upper and lower eyelids, number over 20, aligning well with the theory of Xuanfu in Traditional Chinese Medicine. Clinically, it is found that the secretions of the meibomian glands are mainly purulent and toothpaste-like, which are symptoms of excess and heat syndrome, and heat-clearing, blood-activating, and collateral-unblocking analgesic drugs are used; or when the meibomian glands atrophy, the amount is very small or basically disappears, which is a deficiency syndrome. According to the characteristics of wind-clearing drugs such as "ascending, dispersing, penetrating, and running", wind-clearing drugs are used to dispel wind, open the body, and moisten dryness. The Chinese medicine composition of the present invention is composed of angelica, Chuanxiong, raw salvia miltiorrhiza, selfheal, papaya, dandelion, wild chrysanthemum, honeysuckle, peach kernel, pinellia tuber, fritillaria, schizonepeta, and siler. Among them, siler, schizonepeta, and papaya are monarch drugs, which are used to dispel wind, open the mystical meridians and dredge the meridians. The mystical meridian is an adjuvant drug that penetrates the medicine to the deep subcutaneous tissue. The rest are ministerial drugs. Angelica, Chuanxiong, raw salvia miltiorrhiza, and peach kernel promote blood circulation and dredge the meridians, improve ocular surface or local blood circulation, dandelion, wild chrysanthemum, honeysuckle, selfheal, and honeysuckle clear away heat and dissipate stagnation, and inhibit ocular surface or local inflammatory reaction, while pinellia tuber and fritillaria resolve phlegm and dry dampness. The above Chinese medicines play the effect of clearing heat, activating blood circulation, dredge the meridians, dispelling wind and resolving phlegm, and regulating the mystical meridians.

[0026] The present invention also provides an antibacterial traditional Chinese medicine-based hydrogel for treating meibomian gland dysfunction, comprising the traditional Chinese medicine composition and excipients, wherein the excipients include polyvinyl alcohol, polyvinyl pyrrolidone, and silver nanowires.

[0027] The present invention also provides a method for preparing the antibacterial traditional Chinese medicine-based hydrogel, comprising the following steps:

[0028] 1) mixing angelica, chuanxiong, raw salvia miltiorrhiza, selfheal, papaya, dandelion, wild chrysanthemum, honeysuckle, honeysuckle, peach kernel, pinellia, fritillaria, schizonepeta, and siler, decocting, and concentrating to obtain a concentrated Chinese medicine decoction;

[0029] 2) mixing the concentrated Chinese medicine decoction, polyvinyl alcohol, polyvinyl pyrrolidone, and silver nanowires, and stirring to obtain a composite decoction;

[0030] 3) freezing the composite decoction and then melting it to obtain the antibacterial traditional Chinese medicine-based hydrogel.

[0031] In the present invention, angelica, Chuanxiong, raw salvia miltiorrhiza, selfheal, papaya, dandelion, wild chrysanthemum, honeycomb, radix polygoni avicularis, honeysuckle, peach kernel, pinellia tuber, fritillaria, schizonepeta tenuifolia, and saposhnikovia divaricata are mixed, decocted, and concentrated to obtain a concentrated decoction of traditional Chinese medicine. Before decoction, water is added for soaking, and the amount of water added is preferably 2 to 5 cm higher than the medicinal surface, more preferably 3 to 4 cm higher than the medicinal surface; the soaking time is preferably 6 to 18 hours, more preferably 10 to 14 hours, and more preferably 12 hours; the decoction includes a first decoction and a second decoction, and the time of the first decoction is preferably 1 to 3 hours, and more preferably 2.5 hours; the amount of water added for the second decoction is preferably flush with the medicinal surface, and the time of the second decoction is preferably 0.5 to 2 hours, and more preferably 1.5 hours; the density of the concentrated decoction of traditional Chinese medicine is preferably 1 to 2 g / mL, more preferably 1.1 to 1.8 g / mL, and more preferably 1.5 g / mL.

[0032] In the present invention, a concentrated decoction of traditional Chinese medicine, polyvinyl alcohol, polyvinyl pyrrolidone, and silver nanowires are mixed and stirred to obtain a composite decoction. The total mass of PVA and PVP in the composite decoction is preferably 6% to 14%, more preferably 7% to 13%, and more preferably 12%; the mass ratio of PVA to PVP is preferably 8 to 10:1, more preferably 9:1; the mass fraction of silver nanowires in the composite decoction is preferably 3% to 10%, more preferably 5% to 9%, and more preferably 8%; the stirring temperature is preferably 60°C to 110°C, more preferably 65°C to 90°C, and more preferably 70°C; and the stirring time is preferably 1.5 to 3 hours, and more preferably 2 hours.

[0033] In the present invention, the composite decoction is frozen and then thawed to obtain the antibacterial traditional Chinese medicine-based hydrogel. The freezing temperature is preferably -5°C to -210°C, more preferably -10°C to -200°C, and even more preferably -190°C; the freezing time is preferably 3 to 300 minutes, more preferably 4 to 240 minutes, and even more preferably 5 minutes.

[0034] The present invention also provides the use of the traditional Chinese medicine composition, the antibacterial traditional Chinese medicine-based hydrogel or the antibacterial traditional Chinese medicine-based hydrogel prepared by the preparation method in preparing a drug for treating meibomian gland dysfunction.

[0035] The technical solutions provided by the present invention are described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0036] Example 1

[0037] (1) Weigh 30g each of angelica, Chuanxiong, raw salvia miltiorrhiza, Prunella vulgaris, papaya, dandelion, wild chrysanthemum, honeysuckle, honeysuckle, peach kernel, pinellia, Fritillaria, schizonepeta, and saposhnikovia divaricata, add 30g each of ... which is 2cm above the surface of the medicinal material, and soak for 6h.

[0038] (2) Heat the soaked herbs to a boil, then reduce the heat to low and boil twice. Boil for 2 hours the first time, squeeze out the medicinal liquid, then add water to the medicinal surface and boil for 1 hour. Each time, squeeze out the medicinal liquid and pass it through a 100-mesh sieve. Combine the two medicinal liquids and refrigerate them. Let them settle for 6 hours. Take the supernatant and pass it through a 200-mesh sieve to extract the medicinal liquid.

[0039] (3) After the drug solution is extracted, impurities are filtered and the drug is concentrated using a steam pressure cooker to a density of 1 g / mL;

[0040] (4) Take 50 mL of the 1 g / mL concentrated decoction in (3), add 4 g of polyvinyl alcohol (PVA) and 0.5 g of polyvinyl pyrrolidone (PVP) (PVA and PVP account for 7.8% of the total mass fraction of the composite decoction, and the mass ratio of PVA to PVP is 8:1), and 2.87 g of silver nanowires (accounting for 5.0% of the total mass fraction of the composite decoction) to the aforementioned concentrated decoction, heat to 70°C and stir for 3 h until PVA and PVP are completely dissolved to obtain a composite decoction;

[0041] (5) Pour the above-mentioned composite decoction into a flat-bottomed container, place it in a freezing environment at -5°C for 5 hours, and then freeze it. Then, take it out and melt it to obtain a traditional Chinese medicine-based hydrogel for treating meibomian gland dysfunction.

[0042] By clamping copper sheets at both ends of the hydrogel and applying a 3V voltage, the hydrogel can generate heat and maintain it at 30°C.

[0043] Example 2

[0044] (1) Weigh 30g each of angelica, Chuanxiong, raw salvia miltiorrhiza, Prunella vulgaris, papaya, dandelion, wild chrysanthemum, honeysuckle, honeysuckle, peach kernel, pinellia, fritillaria, schizonepeta, and saposhnikovia divaricata, add 30g each of each of each of each of each of each of each of each of each of each of each of each of each of each of each of each of each of which is 3cm above the surface of the medicinal material, and soak for 10h.

[0045] (2) Heat the soaked herbs to a boil, then reduce the heat to low and boil twice. Boil for 3 hours the first time, squeeze out the medicinal liquid, then add water to the medicinal surface and boil for 2 hours. Each time, squeeze out the medicinal liquid and pass it through a 100-mesh sieve. Combine the two medicinal liquids and refrigerate them. Let them settle for 7 hours. Take the supernatant and pass it through a 200-mesh sieve to extract the medicinal liquid.

[0046] (3) After the extraction of the drug solution, impurities were filtered and the drug was concentrated using a steam pressure cooker to a density of 1.2 g / mL;

[0047] (4) Take 50 mL of the 1.2 g / mL concentrated decoction in (3), add 6.34 g of polyvinyl alcohol (PVA), 0.71 g of polyvinyl pyrrolidone (PVP) (PVA and PVP account for 10% of the total mass fraction of the composite decoction, and the mass ratio of PVA to PVP is 9:1), and 3.43 g of silver nanowires (accounting for 4.9% of the total mass fraction of the composite decoction) to the above-mentioned concentrated decoction, heat to 90°C and stir for 2 h until PVA and PVP are completely dissolved to obtain a composite decoction;

[0048] (5) Pour the above-mentioned composite decoction into a flat-bottomed container, place it at -50°C in a freezing environment for 1 hour, and then freeze it. Then, take it out and melt it to obtain a traditional Chinese medicine-based hydrogel for treating meibomian gland dysfunction.

[0049] By clamping copper sheets at both ends of the hydrogel and applying a 4V voltage, the hydrogel can generate heat and maintain it at 35-37°C.

[0050] Example 3

[0051] (1) Weigh 30g each of angelica, Chuanxiong, raw salvia miltiorrhiza, Prunella vulgaris, papaya, dandelion, wild chrysanthemum, honeysuckle, honeysuckle, peach kernel, pinellia, fritillaria, schizonepeta, and saposhnikovia divaricata, add 4cm of water above the surface of the medicine, and soak for 12h;

[0052] (2) Heat the soaked herbs to a boil, then reduce the heat to low and boil twice. Boil for 2.5 hours the first time, squeeze out the medicinal liquid, then add water to the medicinal surface and boil for 1.5 hours. Each time, squeeze out the medicinal liquid and pass it through a 100-mesh sieve. Combine the two medicinal liquids and refrigerate them. Let them settle for 8 hours. Take the supernatant and pass it through a 200-mesh sieve to extract the medicinal liquid.

[0053] (3) After the drug solution is extracted, impurities are filtered and the drug is concentrated using a steam pressure cooker to a density of 1.5 g / mL;

[0054] (4) Take 50 mL of the 1.5 g / mL concentrated decoction in (3), add 10.23 g of polyvinyl alcohol (PVA), 1.02 g of polyvinyl pyrrolidone (PVP) (PVA and PVP account for 12% of the total mass fraction of the composite decoction, and the mass ratio of PVA to PVP is 10:1), and 7.5 g of silver nanowires (accounting for 8% of the total mass fraction of the composite decoction) to the aforementioned concentrated decoction, heat to 70°C and stir for 2 h until PVA and PVP are completely dissolved to obtain a composite decoction;

[0055] (5) Pour the above-mentioned composite decoction into a flat-bottomed container, place it at -190°C in a freezing environment for 5 minutes, and then freeze it. Then, take it out and melt it to obtain a traditional Chinese medicine-based hydrogel for treating meibomian gland dysfunction.

[0056] By clamping copper sheets at both ends of the hydrogel and applying a 5V voltage, the hydrogel can generate heat and maintain it at 38-42°C.

[0057] Experimental Example 1

[0058] Determination of antibacterial activity of the traditional Chinese medicine-based hydrogels of Examples 1 to 3

[0059] The bacteria were cultured in phosphate buffered saline (PBS) to obtain a colony forming unit (CFU) of 10 8 coli solution. The prepared hydrogel sample was immersed in the E. coli solution and cultured in a constant temperature environment at 37°C for 12 hours. After culture, a sample was taken and 1 ml of the solution was diluted. The live bacteria agglutinated in the previous solution were completely separated after dilution. Subsequently, 1 ml of the diluted bacterial solution was sampled and dropped onto LuriaBertani (LB) agar, and then the agar was transferred to an incubator and cultured again at 37°C for 18 hours. This culture will allow each isolated bacterium to develop into a colony, so by counting the number of colonies on the LB agar, the live bacterial concentration C in the second sampling droplet can be known. 处 The same treatment was performed except that the prepared hydrogel was not added. The other steps were the same and the untreated bacterial concentration C was obtained. 未 The antibacterial rate can then be calculated using the following formula:

[0060] Antibacterial rate = [(C 未 -C 处 ) / C 未 ]×100%

[0061] Experimental results: as shown in Table 1.

[0062] Table 1 Antibacterial activity of the traditional Chinese medicine-based hydrogels of Examples 1 to 3

[0063] deal with Antibacterial rate% Example 1 93.5 Example 2 94 Example 3 96

[0064] As shown in Table 1, the antibacterial rates of the prepared traditional Chinese medicine-based hydrogels against Escherichia coli are all above 90%.

[0065] Experimental Example 2

[0066] Clinical Research

[0067] 1 Research subjects

[0068] 1.1 Source of research subjects

[0069] This study selected 30 patients (60 eyes) aged 18-60 years with meibomian gland dysfunction who visited the Department of Ophthalmology of the Hospital of Integrated Traditional Chinese and Western Medicine in Minhang District, Shanghai from January to March 2025 as research subjects.

[0070] This study adhered to the Declaration of Helsinki and was approved by the Medical Ethics Committee of the Shanghai Minhang District Hospital of Integrated Traditional Chinese and Western Medicine. The subjects carefully read and signed the informed consent form before enrollment.

[0071] 1.2 Selection criteria for research subjects

[0072] 1.2.1 Diagnostic criteria

[0073] 1.2.1.1 Western Medical Diagnostic Criteria for Meibomian Gland Dysfunction

[0074] Refer to the "Expert Consensus on Diagnosis and Treatment of Meibomian Gland Dysfunction in my country" formulated in 2017.

[0075] Diagnostic criteria for meibomian gland dysfunction: ① Abnormalities of the eyelid margin and meibomian gland opening; ② Abnormal meibomian secretion; ③ Ocular symptoms; ④ Meibomian gland absence; ⑤ Abnormal lipid layer thickness.

[0076] Items ①, ②, and ③ are diagnostic indicators for MGD. Items ④ and ⑤ are enhanced diagnostic indicators.

[0077] 1.2.1.2 Traditional Chinese Medicine Diagnostic Criteria

[0078] It is formulated based on clinical practice and with reference to the diagnostic basis of "white and astringent disease" in "Traditional Chinese Medicine Ophthalmology".

[0079] Eye redness and swelling are not noticeable, but dryness and discomfort are present, with frequent blinking, slight photophobia, burning and itching, or even blurred vision. Inability to stare for extended periods, fluctuating vision, increased eye discharge, noticeable stickiness in the morning eyelids, difficulty opening the eyes, and redness of the eyelid margins are all symptoms of meibomian gland dysfunction. A diagnosis is made if both dryness and meibomian gland obstruction are present.

[0080] 1.2.2 Inclusion criteria

[0081] ①Meet the above diagnostic criteria for meibomian gland dysfunction;

[0082] ②Age 18 to 60 years old;

[0083] ③All patients received diagnosis and treatment for the first time;

[0084] ④ Informed consent and voluntary participation in the experiment.

[0085] 1.2.3 Exclusion criteria

[0086] ① Wearing a pacemaker or cardiac defibrillator;

[0087] ② Those with systemic diseases such as severe diabetes, hypertension, cardiovascular and cerebrovascular diseases, liver and kidney diseases, rheumatic diseases, history of photosensitivity, severe blood diseases, severe skin diseases, etc.;

[0088] ③ Mental abnormalities and psychological disorders (anxiety disorders and depression tendencies);

[0089] ④ Long-term oral anticoagulants, hormones, antipsychotics, antihistamines, etc.;

[0090] ⑤ History of eye surgery (including in situ keratectomy) or eye trauma, eye disease or developmental deformity;

[0091] ⑥Has received other dry eye treatments;

[0092] ⑦Change the treatment plan during follow-up.

[0093] 1.2.4.1 Case Exclusion

[0094] ① Those who do not return for follow-up on time or are lost to follow-up, whose efficacy cannot be judged or whose data are incomplete and affect the judgment;

[0095] ② The subjects have poor compliance and fail to follow the doctor's instructions for treatment; do not comply with the provisions of the design plan;

[0096] ③ Patients who use other treatment methods during the treatment process.

[0097] Research Methods

[0098] Thirty patients aged 18-60 years diagnosed with meibomian gland dysfunction were randomly divided into two groups using a random number table: a group receiving a concentrated decoction prepared in Example 3 for Chinese medicine atomization plus meibomian gland massage (Group A) and a group receiving a heatable antibacterial Chinese medicine-based hydrogel patch prepared in Example 3 combined with meibomian gland massage (Group B). Changes in tear film breakup time, meibomian gland secretion shape, meibomian gland excretion capacity, and lipid layer thickness were recorded before treatment, at a 2-week follow-up, and at a 4-week follow-up in both groups. All examinations and assessments were performed and evaluated by the same physician.

[0099] 2.1 Observation index collection

[0100] (1) Meibomian gland secretion characteristics examination method: Assessment is performed during meibomian gland massage, 0 points: clear, transparent liquid; 1 point: turbid liquid; 2 points: turbid granular secretion; 3 points: thick secretion like toothpaste.

[0101] (2) Meibomian gland discharge ability test method: Use meibomian gland forceps to observe the ease of discharge of secretions from the five glands in the middle of the lower eyelid. 0 points: When squeezing the eyelid, all five glands can discharge secretions; 1 point: When squeezing the eyelid, 3 or 4 glands can discharge secretions; 2 points: When squeezing the eyelid, 1 or 2 glands can discharge secretions; 3 points: When squeezing the eyelid, the meibomian glands have no discharge ability.

[0102] (3) Tear film breakup time and lipid layer thickness: These are checked using an ocular surface analyzer. Tear film breakup time of <5s is abnormal, 5-10s is unstable, and 10-15s is normal. Lipid layer thickness >80nm is normal.

[0103] 2.2 Treatment methods

[0104] (1) Chinese medicine atomization + meibomian gland massage group (Group A)

[0105] The above-mentioned traditional Chinese medicine atomization combined with meibomian gland massage was used for conventional treatment, with the traditional Chinese medicine atomization lasting 20 minutes.

[0106] (2) Heatable antibacterial Chinese medicine-based hydrogel patch combined with meibomian gland massage group (Group B)

[0107] Use a heatable antibacterial Chinese medicine-based hydrogel patch and perform meibomian gland massage after 20 minutes of use.

[0108] Both groups received treatment once a week for a total of 4 times, with no interval between treatment courses. The observation period was 4 weeks.

[0109] 2.3 Efficacy evaluation criteria

[0110] Ocular signs efficacy evaluation criteria

[0111] Formulated with reference to the State Administration of Traditional Chinese Medicine's "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes" and "TCM Diagnosis and Treatment Plan for Ophthalmology":

[0112] (1) Degree of ocular signs: 0 points for normal, 1 point for mild, 2 points for moderate, and 3 points for severe.

[0113] (2) Main indicators: tear film breakup time, meibomian gland discharge capacity, meibomian gland secretion characteristics, and lipid layer status.

[0114] (3) Evaluation criteria:

[0115] ①Cure: Clinical symptoms completely disappear after treatment;

[0116] ② Markedly effective: After the treatment, the patient's condition changes from severe to mild and the clinical symptoms decrease by 2 levels, which is considered markedly effective;

[0117] ③ Effective: After the treatment, the patient's condition changes from severe to moderate or from moderate to mild and the clinical symptoms decrease by one level, which is considered effective;

[0118] ④ Ineffective: If there is no significant improvement in clinical symptoms after the end of treatment, it is considered ineffective.

[0119] 2.4 Statistical analysis

[0120] Data were statistically analyzed using SPSS 26.0 software. Measurement data were presented as mean ± standard deviation. For count data with a minimum expected value greater than 5 and a total sample size greater than 40, the chi-square test was used; for data not meeting these criteria, the Fisher exact test was used. For measurement data from two related samples that conformed to a normal distribution, the paired t-test was used; for measurement data that did not conform to a normal distribution, the Kruskal-Wallis H test was used. A P value less than 0.05 was considered significant.

[0121] Experimental results: as shown in Table 2.

[0122] Table 2 Therapeutic effects of different treatment groups on meibomian gland dysfunction

[0123]

[0124]

[0125] In treatment group A, 19 patients were cured, 6 were effective, and 5 were ineffective, for a total effective rate of 83.3%. In treatment group B, 21 patients were cured, 7 were effective, and 2 were ineffective, for a total effective rate of 93.3%. The total effective rate in group B was significantly higher than that in group A. The heatable antibacterial Chinese medicine-based hydrogel patch significantly improved dry eye by increasing tear film breakup time, lipid layer thickness, and improving the characteristics of meibomian gland secretions.

[0126] As shown in the above examples and experimental examples, the heatable, antibacterial, traditional Chinese medicine-based hydrogel patch for treating meibomian gland dysfunction of the present invention has a significant therapeutic improvement effect on meibomian gland dysfunction in patients of different age groups, with an efficacy rate of up to 93.33%. Furthermore, the traditional Chinese medicine composition of the present invention, prepared as a traditional Chinese medicine-based hydrogel patch, is convenient for patients to use and acts directly on the eyelids, improving clinical efficacy, patient compliance, and patient satisfaction, thus having promising application prospects. This invention provides a novel therapeutic approach and method for the treatment of meibomian gland dysfunction, effectively guiding clinical medication use and improving patients' quality of life.

[0127] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating meibomian gland dysfunction, characterized in that: Including angelica, Chuanxiong, raw salvia miltiorrhiza, selfheal, papaya, dandelion, wild chrysanthemum, beehive, radix polygoni avicularis, honeysuckle, peach kernel, French pinellia, fritillaria, schizonepeta, and siler; The mass ratio of the angelica sinensis, chuanxiong, raw salvia miltiorrhiza, selfheal, papaya, dandelion, wild chrysanthemum, honeycomb, radix polygoni lobatae, honeysuckle, peach kernel, pinellia ternata, fritillaria, schizonepeta tenuifolia, and saposhnikovia divaricata is 1:1:1:1:1:1:1:1:1:1:1:1:1:1:1:

1.

2. An antibacterial Chinese medicine-based hydrogel for treating meibomian gland dysfunction, characterized in that: The invention comprises the traditional Chinese medicine composition according to claim 1 and excipients, wherein the excipients comprise polyvinyl alcohol, polyvinyl pyrrolidone and silver nanowires.

3. The method for preparing the antibacterial Chinese medicine-based hydrogel according to claim 2, characterized in that: The following steps are involved: 1) mixing angelica, chuanxiong, raw salvia miltiorrhiza, selfheal, papaya, dandelion, wild chrysanthemum, honeysuckle, honeysuckle, peach kernel, pinellia, fritillaria, schizonepeta, and siler, decocting, and concentrating to obtain a concentrated Chinese medicine decoction; 2) mixing the concentrated Chinese medicine decoction, polyvinyl alcohol, polyvinyl pyrrolidone, and silver nanowires, and stirring to obtain a composite decoction; 3) freezing the composite decoction and then melting it to obtain the antibacterial traditional Chinese medicine-based hydrogel.

4. The preparation method according to claim 3, characterized in that Step 1) The decoction includes a first decoction and a second decoction, the first decoction time is 1 to 3 hours, and the second decoction time is 0.5 to 2 hours.

5. The preparation method according to claim 3, characterized in that The density of the concentrated Chinese medicine decoction in step 1) is 1-2 g / mL.

6. The preparation method according to claim 3, characterized in that Step 2) the total mass of the PVA and PVP accounts for 6% to 14% of the composite decoction, and the mass ratio of the PVA to PVP is 8 to 10:1; The mass fraction of the silver nanowires in the composite decoction is 3% to 10%.

7. The preparation method according to claim 3, characterized in that Step 2) The stirring temperature is 60° C. to 110° C., and the stirring time is 1.5 to 3 hours.

8. The preparation method according to claim 3, characterized in that Step 3) The freezing temperature is -5°C to -210°C, and the freezing time is 3 to 300 minutes.

9. Use of the traditional Chinese medicine composition according to claim 1, the antibacterial traditional Chinese medicine-based hydrogel according to claim 2, or the antibacterial traditional Chinese medicine-based hydrogel prepared by the preparation method according to any one of claims 3 to 8 in the preparation of a drug for treating meibomian gland dysfunction.

Images