External traditional Chinese medicine composition and preparation for treating demodex blepharitis

Abstract

The invention belongs to the field of traditional Chinese medicine compositions, and relates to an external traditional Chinese medicine composition and preparation for treating demodex blepharitis, the traditional Chinese medicine composition comprises the following raw materials by weight: 3-10 parts of coptis chinensis, 3-10 parts of sophora flavescens, and 7.5-10 parts of saposhnicovia divaricata. According to the formula, coptis chinensis and radix sophorae flavescentis are used as monarch drugs for clearing away heat and drying dampness and killing parasites to relieve itching, and the pathogenesis core of demodex infection and damp-heat interweaving is adopted; divaricate saposhnikovia root is used as a ministerial drug to dispel wind and eliminate dampness, eliminate swelling and relieve itching and help the monarch drug to relieve wind pathogen symptoms such as red, swollen, itching and pain of eyelids. In addition, the radix saposhnikoviae is slightly warm in nature and flavor, has the function of adjuvant drugs in the formula, and moderately restricts the bitter and cold nature of the coptis chinensis and the radix sophorae flavescentis; the traditional Chinese medicine composition is an external preparation, no conductant drug is independently arranged in the whole formula, and the formula is further simplified on the premise that the curative effect is guaranteed. The whole formula directly aims at the pathological core of vermiform mite infection and inflammatory response through triple action mechanisms of clearing away heat and toxic materials, dispelling wind and eliminating dampness and killing parasites to relieve itching. The total effective rate of the traditional Chinese medicine composition for demodex blepharitis reaches 94%, and the traditional Chinese medicine composition has the advantages of stable curative effect, high total effective rate, low recurrence rate, small side effect and the like.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of traditional Chinese medicine compositions, more particularly, to an external traditional Chinese medicine composition and preparation for treating demodex blepharitis. BACKGROUND

[0002] Blepharitis is a chronic inflammatory disease of the eyelid margin, and demodex blepharitis is a common type caused by infection of Demodex folliculorum and / or Demodex brevis. According to the Chinese Demodex Blepharitis Diagnosis and Treatment Expert Consensus (2018), its diagnosis needs to be combined with etiological examination and clinical manifestations. Its typical clinical manifestations include stubborn eyelid itching, sleeve-like secretion at the root of the eyelashes, eyelid hyperemia or erythema, and eyelash loss and breakage, and severe cases can be complicated with keratoconjunctivitis, affecting vision.

[0003] The gold standard for etiological examination is eyelash demodex examination, that is, a total of 8 eyelashes are randomly plucked from the upper and lower eyelids of each eye, and counted under a microscope. If the average number of mites per eyelash is ≥0.5 (or ≥1 / 3 eyelashes), it is determined to be positive.

[0004] Demodex infection can cause eyelid lesions through various mechanisms, including direct blockage of hair follicle and meibomian gland openings by the worm and its metabolites, leading to meibomian gland dysfunction, manifested as abnormal meibum secretion and gland orifice chalazion formation; bacteria carried by the worm (such as Bacillus) can exacerbate local inflammation and induce abnormal immune responses in the host; demodex and its excrement can also induce delayed-type hypersensitivity reactions in the body.

[0005] Epidemiological surveys have shown that the prevalence of demodex blepharitis is high in adults and increases with age. Current Western treatment options mainly include topical application of antiparasitic drugs such as metronidazole and ivermectin, combined with tea tree oil care, antibiotic ointment, and short-term glucocorticoids to control inflammation. However, these options have obvious limitations: long-term use of metronidazole can lead to drug resistance; ivermectin has limited penetration into deep hair follicle worms; tea tree oil is highly irritating and can easily damage the ocular surface; although glucocorticoids can quickly reduce inflammation, they can also increase the risk of underlying infection.

[0006] Traditional Chinese medicine theory classifies this disease as "Chengxian Chilun" and "Meiyou", and the core pathogenesis is "dampness-heat accumulation, transformation of toxins, and wind invasion". Traditional treatment mainly involves oral administration of heat-clearing and dampness-eliminating drugs, but the ocular surface concentration of these drugs is low after systemic metabolism, and long-term oral administration of bitter and cold drugs can easily damage the spleen and stomach. Existing external traditional Chinese medicine prescriptions have some efficacy, but they often have complex compatibility and too many flavors, which not only lack specificity for demodex, but also may increase irritation to the fragile ocular surface.

[0007] Therefore, there is an urgent need for an external preparation based on TCM theory, in line with modern pathological mechanisms, with a simple prescription and directly acting on the local eyelid, to achieve the comprehensive treatment goal of killing insects, anti-inflammatory, relieving meibomian gland obstruction and repairing ocular surface barrier. SUMMARY

[0008] In view of the shortcomings and deficiencies of the prior art, the purpose of the present application is to provide an external Chinese medicine composition and preparation for treating Demodex blepharitis, which is based on the TCM theory of "heat and dampness breeding insects" and combines the understanding of the pathogenic mechanism of Demodex in modern pharmacology to address the deficiencies in existing treatment options. The Chinese medicine composition takes Coptis chinensis, Sophora flavescens and Saposhnikovia divaricata as the core, with Coptis chinensis and Sophora flavescens clearing heat and drying dampness, killing insects and relieving itching, directly targeting Demodex infection and inflammatory response; Saposhnikovia divaricata dispels wind and dampness, relieves swelling and itching, and relieves eyelid redness, swelling, itching and pain. The whole prescription has only three kinds of drugs, with simple compatibility, special efficacy, strong specificity, and can be directly used on the affected area in the form of external hot compress, improving the bioavailability of the drug. This prescription has been proven to achieve good therapeutic effect when used alone based on years of clinical experience, with the advantages of fast onset, stable efficacy, high total effective rate, low recurrence rate, small side effects and low cost.

[0009] To achieve the above-mentioned purposes, the technical scheme adopted by the present application is as follows: An external Chinese medicine composition and preparation for treating Demodex blepharitis; wherein the external Chinese medicine composition is composed of the following raw materials by weight: Coptis chinensis 3-10, Sophora flavescens 3-10, Saposhnikovia divaricata 7.5-10.

[0010] As a preferred embodiment of the present application, the mass ratio of Coptis chinensis, Sophora flavescens and Saposhnikovia divaricata in the external Chinese medicine composition is 1:1:(1-2.5).

[0011] As a preferred embodiment of the present application, the external Chinese medicine composition is composed of the following raw materials by weight: Coptis chinensis 10 parts, Sophora flavescens 10 parts, Saposhnikovia divaricata 10 parts; or Coptis chinensis 3 parts, Sophora flavescens 3 parts, Saposhnikovia divaricata 7.5 parts.

[0012] The traditional Chinese medicine composition provided by the present application is based on a deep TCM theory. According to the TCM theory of 'wet heat breeding worms', the essence of Demodex infection is that the wet heat environment in the body provides breeding conditions for the worms. Huanglian in the prescription is very bitter and cold, and has strong heat-clearing and dampness-drying effects, which directly breaks the wet heat; Kuh-seng is bitter and cold, and has the effects of clearing heat and drying dampness, and killing worms, which targets the pathogenesis of 'worm toxin'; Fangfeng disperses wind and penetrates into the body, and dispels wind and stops itching, which solves the symptoms of 'wind evil' such as eyelid itching. The three drugs are used together, which embodies the dialectical thinking of 'clearing heat and drying dampness to eliminate the cause, killing worms and detoxifying to treat the symptoms, dispelling wind and stopping itching to alleviate the symptoms'. From the perspective of modern pharmacology, the prescription has the advantage of multi-target treatment. Berberine in Huanglian and sophoramine in Kuh-seng have been proved to have significant anti-parasitic activity, which can destroy the integrity of Demodex, inhibit its nerve conduction, and cause the worms to be paralyzed and die. In addition, berberine in Huanglian can also inhibit the PI3K-AKt / NF-κB inflammatory pathway, reduce the release of TNF-α, IL-6 and other pro-inflammatory factors; sophoramine can effectively inhibit the formation of bacterial biofilm of Bacillus which coexists with Demodex, and block the bacterial-parasite synergistic pathogenesis; Fangfeng polysaccharide can regulate local immune function, correct Th1 / Th17 immune imbalance, and reduce tissue damage caused by excessive immune response; modern pharmacological studies have confirmed that the components such as epimedium in Fangfeng have the effects of anti-inflammatory, antioxidant and promoting epithelial cell proliferation and migration, which helps to accelerate the repair of damaged skin or mucosal barrier and reduce recurrence.

[0013] Based on the above multi-target mechanism, the traditional Chinese medicine composition provided by the present application has been proved by clinical trials to have a good therapeutic effect on Demodex blepharitis, with a total effective rate of up to 94%. In terms of clinical manifestations, the traditional Chinese medicine composition not only can effectively relieve symptoms, but also shows a significant improvement in eyelid-related signs, such as reducing conjunctival hyperemia and erythema, reducing mucous and purulent secretions, relieving mucosal edema, and improving the obstruction of meibomian gland openings. Therefore, the traditional Chinese medicine composition can be applied in the preparation of drugs for treating Demodex blepharitis.

[0014] The dosage form of the drug for treating Demodex blepharitis provided by the present application is an external preparation, which can be selected from any one of the following: decoction, lotion, gel or patch.

[0015] The present application also provides a traditional Chinese medicine preparation for treating Demodex blepharitis, which is an external decoction. The decocting method of the external decoction comprises the following steps: Step 1: Take Huanglian 3-10 parts by weight, Kuh-seng 3-10 parts by weight, and Fangfeng 7.5-10 parts by weight, soak them in water, then boil them with strong fire, and then change to gentle heat and decoct for 20-40 minutes. After decocting, filter the liquid with sterile gauze, collect the first filtrate, and reserve it for use; Step 2: Add pure water to the filtered residue again, heat to boiling on high heat, then turn to low heat and simmer for 20-40 minutes. After the decoction is completed, filter with sterile gauze and collect the second filtrate; Step 3: Combine the two filtrates, stir well, and let stand. Remove the scum on the liquid surface to obtain the total filtrate.

[0016] The traditional Chinese medicine composition provided by the present application contains Huanglian, which is bitter and cold, and is distributed in the heart, spleen, stomach, gallbladder and large intestine channels, and has the effects of clearing heat and drying dampness, purging fire and detoxifying. Huanglian is bitter and cold, and is good at clearing damp heat and purging fire. It is used to treat eyelid swelling, heat and pain, and increased secretion caused by Demodex infection. Huanglian contains alkaloids such as berberine, coptisine and epigoitrin. Berberine has the effects of broad-spectrum antibacterial, anti-inflammatory and antiparasitic, which can directly inhibit the growth of Demodex and reduce the activity of Demodex, thereby reducing eyelid inflammation.

[0017] Ku Shen is bitter and cold, and is distributed in the heart, liver, stomach, large intestine and bladder channels, and has the effects of clearing heat and drying dampness, killing insects and relieving itching. Ku Shen is bitter and cold, and is good at clearing heat, drying dampness and killing insects. It is used to treat skin parasitic infection and damp-heat sores, and is used to treat eyelid itching, desquamation and secretion caused by Demodex blepharitis. It has a significant effect of killing insects and relieving itching, and can directly kill Demodex and relieve itching. Ku Shen contains alkaloids such as sophoramine, oxysophocarpine and sophocarpine. Sophoramine has the effects of anti-parasite, anti-inflammatory and anti-allergy, and can effectively kill Demodex, reduce eyelid edema, itching and blockage of meibomian glands by insects.

[0018] Fang Feng is pungent and sweet, and is slightly warm, and is distributed in the bladder, liver and spleen channels, and has the effects of dispelling wind and dampness, relieving spasm and relieving pain. Fang Feng is pungent and warm, and is good at dispelling wind and dampness. It is used to treat itching, swelling and pain caused by wind evil, and is used to treat eyelid itching, redness and discomfort caused by Demodex blepharitis. Its effect of relieving spasm and relieving pain can relieve eyelid muscle spasm, improve local blood circulation, enhance skin barrier function, promote eyelid epidermal repair and promote inflammation absorption. Fang Feng contains rhizoma paridesin, 5-O-methylvisamminol glycoside and Fang Feng polysaccharide, which have been confirmed by modern pharmacological research to have the effects of anti-inflammatory, anti-allergic, antioxidant, relieving itching and promoting epithelial cell proliferation and migration. This helps to accelerate the repair of damaged skin or mucosal barrier, reduces eyelid inflammatory reaction and itching, and reduces the recurrence rate.

[0019] This formula uses Coptis chinensis and Sophora flavescens as the principal herbs, which clear heat, dry dampness, kill parasites, and relieve itching, directly targeting the core pathogenesis of Demodex mite infection and the intertwining of damp-heat. Saposhnikovia divaricata is used as the assistant herb, which dispels wind and dampness, reduces swelling and relieves itching, assisting the principal herbs in alleviating the symptoms of wind-evil such as redness, swelling, itching, and pain of the eyelids. Furthermore, Saposhnikovia divaricata, being slightly warm in nature, also serves as an adjuvant in the formula, moderately restraining the bitter and cold nature of Coptis chinensis and Sophora flavescens, reducing potential irritation to the ocular surface. As for the guiding herb, since this formula is a topical preparation, applied directly as a hot compress to the lesions on the eyelids, its administration method itself achieves the effect of "guiding the medicine to its meridian." In addition, all three herbs enter the liver, spleen, and stomach meridians, and their meridian pathways can reach the periorbital area and eyelids, naturally converging on the affected area for synergistic effect. Therefore, no separate guiding herb is used in the entire formula, thus further streamlining the formula while ensuring efficacy, avoiding unnecessary irritation to the ocular surface caused by excessive ineffective drug components, and also helping to reduce the cost of medication for patients. Overall, the formula is well-structured, with simple yet potent ingredients. The three herbs work synergistically to combine the effects of clearing heat and detoxifying, dispelling wind and drying dampness, and killing parasites and relieving itching. It addresses both the symptoms and the root cause, fully embodying the academic ideas of traditional Chinese medicine, namely, "differentiation of syndromes and treatment" and "external treatment directly targeting the disease site."

[0020] Advantages and beneficial effects of the present invention: (1) The Chinese medicine composition and preparation provided by the present invention are based on Coptis chinensis, Sophora flavescens and Saposhnikovia divaricata. Coptis chinensis and Sophora flavescens clear heat and dry dampness, kill insects and relieve itching, directly targeting Demodex mite infection and inflammatory reaction; Saposhnikovia divaricata dispels wind and dampness, reduces swelling and relieves itching, relieving symptoms of wind-evil such as redness, swelling and itching of the eyelids; moreover, Saposhnikovia divaricata is slightly warm in nature and plays the role of adjuvant in the formula, moderately restraining the bitter and cold nature of Coptis chinensis and Sophora flavescens, reducing potential stimulation to the ocular surface; in addition, as an external preparation, the present invention does not set up a separate adjuvant, the whole formula is well-matched and concise, abandoning overly complicated compatibility, reducing the stimulation of the eyes by excess drug components, and directly targeting the pathological core of Demodex mite infection through the triple action mechanism of clearing heat and detoxifying, dispelling wind and drying dampness, killing insects and relieving itching, with powerful and effective results.

[0021] (2) The traditional Chinese medicine composition and preparation provided by this invention are administered externally via hot compress. The active ingredients of the medicine can directly penetrate the hair follicle sebaceous gland unit and act on the site of Demodex mite infestation. The bioavailability of the medicine is high, and it can directly stimulate the lesion site. Its warming effect can also inhibit the activity of mites and improve the blockage of meibomian glands. The total effective rate of this formula for Demodex blepharitis is 94%, and it is particularly effective for mild to moderate patients. It has the advantages of rapid onset of action, stable efficacy, high total effective rate, and low cost.

[0022] (3) The traditional Chinese medicine composition and preparation provided by the application has a good improvement effect on the function of the eyelid mucosa and meibomian gland: first, it can repair the damaged eyelid skin barrier by killing insects, anti-inflammatory and promoting epithelial healing; second, it can directly kill Demodex and relieve the physical obstruction of the Demodex to the meibomian gland orifice; the anti-inflammatory effect of the Huanglian and Kushen in the prescription can reduce the inflammation and edema around the gland tube, dredge the gland tube, and the Fangfeng can improve the local blood circulation, and in combination with the physical effect of hot compress, it is helpful to melt and discharge the abnormal lid ester accumulated, so as to restore the normal secretion function of the meibomian gland; third, it can improve the inflammatory state of the palpebral conjunctiva by reducing the hyperemia of the eyelid margin, reducing the sleeve-shaped secretion, relieving the edema and papillary hyperplasia of the mucosa and other inflammatory reactions. These directly correspond to the subsidence of the clinical core signs (eyelid margin hyperemia, sleeve-shaped secretion, obstruction of the meibomian gland orifice), thereby helping the eyelid to restore normal barrier function and reducing the recurrence rate.

[0023] (4) The application provides a TCM external treatment solution for treating Demodex blepharitis, and the Huanglian, Kushen and Fangfeng in the prescription work synergistically to directly target the Demodex infection and secondary inflammatory reaction. Compared with western anti-parasitic drugs, the application is less likely to produce drug resistance, has very small side effects, and has good long-term safety (more suitable for long-term use).

[0024] (5) The traditional Chinese medicine preparation provided by the application is a topical decoction, which has the advantages of simple process, convenient use, high bioavailability and the like.

[0025] (6) The application has good therapeutic effect on patients with damp-heat wind evil syndrome, damp-heat worm accumulation syndrome, wind-heat damp-toxic syndrome and damp-heat wind-toxic syndrome, and has strong clinical practicability. DETAILED DESCRIPTION

[0026] In order to make the purpose, technical scheme and advantages of the application more clear, the application will be further described in detail below, and the description herein is only used to explain the application and not to limit the application.

[0027] The application discloses an external traditional Chinese medicine composition and preparation for treating Demodex blepharitis. Those skilled in the art can refer to the content herein and appropriately improve the component parameters or process parameters to realize. It is particularly pointed out that all similar replacements and changes are obvious to those skilled in the art, and they are regarded as included in the protection scope of the application.

[0028] Embodiment 1

[0029] The embodiment provides an external traditional Chinese medicine composition for treating Demodex blepharitis, which is composed of the following raw materials by weight: Huanglian 3 parts by weight, Kushen 3 parts by weight and Fangfeng 7.5 parts by weight.

[0030] Based on the above prescription, the embodiment also provides a traditional Chinese medicine preparation for treating demodex blepharitis, which is an external use decoction. The preparation method of the external use decoction comprises the following steps: Step 1: Take 3 parts by weight of Coptis chinensis, 3 parts by weight of Sophora flavescens and 7.5 parts by weight of Saposhnikovia divaricata, soak in water for 30 minutes, and the water amount is preferably 5-8 cm above the surface of the medicinal materials; then boil with strong fire, and then change to weak fire for 30 minutes of decoction. After the decoction is completed, filter the medicinal liquid with 80-mesh sterile gauze, collect the first filtrate, and reserve it for use; Step 2: Add pure water to the filtered residue again, and the water amount is preferably 3-4 cm above the surface of the residue. After heating to boiling with strong fire, change to small fire for 30 minutes of micro-boiling decoction. After the decoction is completed, filter with 80-mesh sterile gauze, and collect the second filtrate; Step 3: Combine the two filtrates, stir uniformly, and then stand for 15 minutes. Remove the scum on the liquid surface to obtain the total filtrate (about 200-300 ml).

[0031] In this embodiment, the combined filtrate is cooled to room temperature (20-25℃), and the medicinal liquid is aseptically divided into sealed bags (food-grade PE material, high-temperature resistant) at 100 ml per bottle / bag, and immediately sealed (to prevent contamination of the medicinal liquid or volatilization of the active ingredients). After the division is completed, mark the preparation date and the formula type (basic formula / preferred formula). The unused medicinal liquid is stored in a 4℃ refrigerator, and the storage period is not more than 7 days (cold storage can inhibit the growth of microorganisms, avoid deterioration of the medicinal liquid, and discard it if the storage period exceeds 7 days to prevent use risks). If long-term storage is required, the medicinal liquid can be sealed after pasteurization at 80℃ for 30 minutes and stored at -20℃. The storage period is not more than 3 months. Before use, thaw and heat to the specified temperature.

[0032] Example 2

[0033] The embodiment provides an external traditional Chinese medicine composition for treating demodex blepharitis, which is composed of the following raw materials by weight: 10 parts of Coptis chinensis, 10 parts of Sophora flavescens and 10 parts of Saposhnikovia divaricata.

[0034] Based on the above prescription, the embodiment also provides a traditional Chinese medicine preparation for treating demodex blepharitis, which is an external use decoction. The preparation method of the external use decoction comprises the following steps:

[0035] Comparative Example 1 (blank hot compress): The difference between the embodiment 1 and 2 and the comparative example 1 is that the eye lid is simply hot compressed with warm water soaked gauze.

[0036] The application provides a method for treating demodex blepharitis by using the traditional Chinese medicine preparation, which comprises the following steps: taking the stored medicinal liquid from the refrigerator, if the medicinal liquid is refrigerated, the medicinal liquid is heated in a 50-60 DEG C warm water bath for 5-8 minutes, and then the temperature of the medicinal liquid is measured by using a medical thermometer to ensure that the temperature is stable at 38-40 DEG C (the temperature is close to the skin temperature around the eyes of human body, which can promote the blood circulation around the eyes, help the lipid of meibomian glands melt, and avoid the high temperature from burning the skin around the eyes or the low temperature from affecting the drug effect); if the medicinal liquid is frozen, the medicinal liquid is first thawed at room temperature until the medicinal liquid is completely melted, and then the above method is used to heat the medicinal liquid to the specified temperature. The sterile medical gauze, the clean cotton swab and the normal saline are prepared, the patient is in a supine position (or a leaning position, the head is tilted backward), the cotton swab is soaked in the normal saline, and then the skin around the eyes is gently wiped (from the medial canthus to the lateral canthus, the eyelashes are avoided to be stimulated) to remove the impurities such as oil and dust around the eyes, and ensure that the skin around the eyes is clean and dry. The sterile gauze is put into the heated medicinal liquid, the gauze is taken out by using the tweezers after being completely soaked, the gauze is gently squeezed (it is appropriate that no water drops, and the excessive medicinal liquid is avoided to flow into the eyes to cause irritation), and then the gauze is quickly applied to the closed eyelids, and the gauze edge is gently pressed by using the fingers to make the gauze closely adhere to the skin around the eyes and reduce the heat loss. During the hot compress process, the gauze is taken out by using the tweezers every 3-5 minutes, the gauze is soaked in the medicinal liquid again, squeezed and then applied again (the temperature is ensured to be maintained at 38-40 DEG C during the whole hot compress process, and the temperature is avoided to be reduced to affect the treatment effect), the total time of each hot compress is 10-15 minutes, the hot compress is performed twice a day, and one treatment course is 7 days; if the patient feels uncomfortable, such as burning and stinging pain around the eyes during the hot compress, the gauze is immediately taken out, the skin around the eyes is wiped by using the normal saline, the use is stopped and the symptoms are observed.

[0037] The traditional Chinese medicine composition provided by the embodiment takes Coptis chinensis and Sophora flavescens as monarch drugs, clears heat and dries dampness, and kills insects and relieves itching; and Radix Saposhnikoviae as ministerial and auxiliary drugs, expels wind and dampness, and relieves swelling and itching. The whole prescription achieves the effect of treating the symptoms and the root cause by clearing heat and resolving toxins, expelling wind and drying dampness, and killing insects and relieving itching, is simple in prescription, strong in pertinence, and embodies the thoughts of "treatment according to syndrome" and "external treatment directly reaching the disease site" in traditional Chinese medicine. The prescription has been applied in the Affiliated Hospital of Changchun University of Chinese Medicine and Liaoyuan Ophthalmic Hospital for many years, and has good treatment effect on patients with demodex blepharitis. The treatment effect of the traditional Chinese medicine preparation of the application is illustrated by clinical data as follows: the traditional Chinese medicine preparations prepared by using the traditional Chinese medicine preparation of Example 1 and the traditional Chinese medicine preparation of Example 2 are used to treat patients with demodex blepharitis, and are recorded as the traditional Chinese medicine preparation of Example 1 and the traditional Chinese medicine preparation of Example 2 respectively, and the specific conditions are as follows: 1. Case selection: As a topical Chinese medicine composition and preparation for treating Demodex blepharitis, 200 cases of patients with confirmed Demodex blepharitis, aged 18-70 years, gender unrestricted, and positive etiology examination were selected. According to the Expert Consensus on Diagnosis and Treatment of Demodex Blepharitis (2018), 2 eyelashes were randomly taken from each upper and lower eyelid of each eye, a total of 8 eyelashes, and examined under an optical microscope. The Demodex count was ≥1 per 3 eyelashes; 2. At least 2 of the following clinical symptoms or signs were accompanied: stubborn eye lid itching, sleeve-like secretion or cylindrical dregs at the root of eyelashes, eyelid hyperemia / redness, eyelash loss / breakage / thinning, or complications such as conjunctivitis, keratitis, and meibomian gland dysfunction; the disease course was ≥1 month, and no drugs affecting the efficacy such as anti-parasitic drugs, antibiotics, and glucocorticoids were used in the past 2 weeks. Patients with severe eye diseases, pregnant or lactating women, and those allergic to the ingredients of Chinese medicine were excluded. The patients were randomly divided into 4 groups, 50 cases in each group, and clinical observation was conducted.

[0038] 2. Treatment method: In the 4 groups of patients with Demodex blepharitis, 3 groups were selected to use the Chinese medicine preparations of Example 1 and Example 2, respectively. The use method was as follows: 1 bag of 100 ml of Chinese medicine preparation was heated to 38℃, and the gauze was soaked and hot compress was applied to the eyelids, 2 times a day, 10-15 minutes each time, 7 days as a course of treatment, and 3 courses were used. In Comparative Example 1, only gauze soaked in 38℃ warm water was used for hot compress, 2 times a day, 10-15 minutes each time, 7 days as a course of treatment, and 3 courses were used. The remaining control group used metronidazole gel (0.75%, manufacturer: Shandong Fangming Pharmaceutical Group Co., Ltd.), which was applied to the eyelids 2 times a day, and 3 courses were used.

[0039] 3. Efficacy determination: This study used a combination of comprehensive efficacy and special evaluation of signs to comprehensively evaluate the therapeutic effect of the drug. The comprehensive efficacy aimed to evaluate the recovery of the overall condition of the patients, and the symptoms, signs, and Demodex count were considered. The improvement of eyelid signs was evaluated to investigate the repair effect of the product on the local tissues of the eyelid. The body sign score in the "comprehensive efficacy evaluation" was independently analyzed. This evaluation focused on the improvement of core signs such as eyelid hyperemia, sleeve-like secretion, and meibomian gland obstruction. The syndrome efficacy evaluation was in accordance with the Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine (Trial), and the nimodipine method was used for calculation: The comprehensive efficacy index = [(pre-treatment score - post-treatment score) / pre-treatment score] x 100%, which was divided into 4 levels: clinical recovery, significant effect, effectiveness, and no effect.

[0040] Clinical recovery: symptoms and signs disappeared or basically disappeared, efficacy index ≥95%, and Demodex examination turned negative; Significant effect: symptoms and signs improved significantly, 70%≤efficacy index<95%, and the number of Demodex reduced by ≥70%; Effective: the symptoms and signs are obviously improved, the therapeutic effect index is 30%≤therapeutic effect index<70%, and the number of Demodex is reduced by ≥30%; Invalid: the symptoms and signs are not obviously improved, the therapeutic effect index is <30%, and the number of Demodex is reduced by <30%.

[0041] The sign therapeutic effect index = [(sign integral before treatment-sign integral after treatment) / sign integral before treatment] x 100%, and is divided into clinical recovery, obvious effect, effective, and invalid in total four levels.

[0042] Clinical recovery: the signs disappear or basically disappear, and the therapeutic effect index is ≥95%; Obvious effect: the signs are obviously improved, and the therapeutic effect index is 70%≤therapeutic effect index<95%; Effective: the signs are obviously improved, and the therapeutic effect index is 30%≤therapeutic effect index<70%; Invalid: the signs are not obviously improved, and the therapeutic effect index is <30%.

[0043] 4. Treatment results Table 1: treatment of Demodex blepharitis patients using the traditional Chinese medicine preparation and the control sample (metronidazole gel) Total number of patients / cases Cured / cases Markedly effective / cases Effective / cases Ineffective / cases Total effective rate Control sample (metronidazole gel) 50 12 10 11 17 66.00% Chinese medicine preparation in Example 1 50 18 15 13 4 92.00% Chinese medicine preparation in Example 2 50 20 15 12 3 94.00% Comparative Example 1 (blank hot compress) 50 0 5 13 32 36.00% It can be seen from the above results that the total effective rate of the traditional Chinese medicine preparation of the present application is obviously higher than that of the control sample group and the blank hot compress group, which fully proves that the traditional Chinese medicine preparations of embodiments 1 and 2 of the present application have a good treatment effect on Demodex blepharitis patients.

[0044] Table 2: improvement of core signs of Demodex blepharitis patients using the traditional Chinese medicine preparation and the control sample (metronidazole gel) Total number of patients / cases Cured / cases Markedly effective / cases Effective / cases Ineffective / cases Total effective rate Control sample (metronidazole gel) 50 8 8 11 23 54.0% Chinese medicine preparation in Example 1 50 15 12 16 7 86.0% Chinese medicine preparation in Example 2 50 13 14 17 6 88.0% Comparative Example 1 (blank hot compress) 50 0 0 8 42 16.0% The core signs of the eyelid of the patient (including the hyperemia of the eyelid margin, the sleeve-shaped secretion and the obstruction of the meibomian gland orifice) are subjected to special efficacy evaluation, and the results are shown in Table 2. It can be seen from the above results that the traditional Chinese medicine preparations of embodiments 1 and 2 of the present application show significant and similar effects in promoting the regression of the signs of the eyelid and the repair of the tissue, and the total effective rates are 88% and 86% respectively, which are significantly better than the control sample (metronidazole gel, 54%) and the comparative example 1 (blank hot compress, 16%).

[0045] It is worth noting that the effective rate of special sign evaluation is lower than the total effective rate based on the comprehensive score of symptoms and signs (94% and 92% in Examples 1 and 2 in Table 1, respectively). This phenomenon is consistent with the clinical recovery rule of Demodex blepharitis, that is, the subjective symptoms such as "itching and pain" improve faster, while the complete repair of objective signs such as "hyperemia and secretion" requires a longer physiological cycle. This result not only confirms the advantage of the traditional Chinese medicine preparation in quickly relieving the subjective pain of patients (high comprehensive efficacy), but also objectively reflects the exact treatment effect of the traditional Chinese medicine preparation in deep repair of the local tissues of the eyelid.

[0046] The traditional Chinese medicine composition and preparation provided by the present application determine the medication course according to the patient's condition, and usually 1-4 courses are used. The traditional Chinese medicine composition and preparation have good therapeutic effect on patients with different severity of Demodex blepharitis, and are not easy to relapse after treatment. The following will be illustrated by typical cases: (1) Ms. Wang, born in 1985, from Changchun City, Jilin Province, office clerk, visited the outpatient department of ophthalmology of Changchun University of Chinese Medicine in March 2023. The patient has had eyelid itching, redness for 1 year, especially in the morning and evening, accompanied by white secretion at the root of the eyelashes, and partial obstruction of the meibomian gland opening. She usually uses her eyes too much and has an average hygiene habit. Demodex was positive at the root of the eyelashes under optical microscopy. The TCM diagnosis is damp-heat wind evil. The traditional Chinese medicine preparation of Example 1 in the present application is used, 1 bag (100 ml) is heated each time, and the eyelid is hot compress for 15 minutes, 2 times a day; after 1 week of treatment, the eyelid itching, redness, secretion and meibomian gland opening obstruction are improved; after 3 weeks of continuous treatment, the symptoms are basically disappeared, and the Demodex is negative under the microscope. Follow-up to June 2024, the disease is stable and has not recurred.

[0047] (2) Mr. Zhang, born in 1978, from Changchun City, Jilin Province, a teacher, visited the outpatient department of ophthalmology of Changchun University of Chinese Medicine in September 2022. The patient has had eyelid scaling, itching and pain for half a year, eyelashes are easy to fall off, and the meibomian gland opening is partially blocked. He has used metronidazole gel, which is effective in the early stage, but relapses after stopping the drug. Demodex is positive under optical microscopy. The TCM diagnosis is damp-heat worm accumulation. The traditional Chinese medicine preparation of Example 1 in the present application is used, and the method is the same as above; after 2 weeks of treatment, the eyelid scaling, itching and pain, and meibomian gland opening obstruction are significantly improved, and the eyelash shedding is reduced; after 4 courses of treatment, the symptoms are completely disappeared, and the Demodex is negative under the optical microscopy. Follow-up to May 2024, no recurrence.

[0048] (3) Ms. Li, born in 1990, from Jilin City, Jilin Province, programmer, visited the outpatient department of Ophthalmology of the Affiliated Hospital of Changchun University of Chinese Medicine in November 2023. The patient has felt eyelid discomfort and obvious itching for half a year, accompanied by mild swelling, partial obstruction of meibomian gland openings, and positive optical microscopy examination of Demodex. TCM diagnosis: wind-heat and damp-toxic syndrome. Use the traditional Chinese medicine preparation of Example 1 in the present application, the method is the same as above; after 1 week of treatment, the itching is reduced, the swelling subsides, and the obstruction of the meibomian gland openings is significantly improved; after 2 courses of treatment, the symptoms are completely controlled, and the optical microscopy examination of Demodex turns negative. Follow-up to August 2024, stable condition.

[0049] (4) Mr. Zhao, born in 1965, from Liaoyuan City, Jilin Province, retired worker, visited the outpatient department of Ophthalmology of the Affiliated Hospital of Changchun University of Chinese Medicine in January 2024. The patient has had recurrent eyelid swelling, itching, and pain for 3 years, accompanied by increased secretion, partial obstruction of meibomian gland openings, and positive optical microscopy examination of Demodex. TCM diagnosis: damp-heat and wind-toxic syndrome. Use the traditional Chinese medicine preparation of Example 1 in the present application, the method is the same as above; after 3 weeks of treatment, the swelling, itching, and pain are significantly reduced, the secretion is reduced, and the obstruction of the meibomian gland openings is significantly improved; after 4 courses of treatment, the clinical symptoms disappear, and the optical microscopy examination of Demodex turns negative. Follow-up to February 2025, no recurrence.

[0050] The above describes the preferred embodiments of the present application and is not intended to limit the present application. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A topical traditional Chinese medicine composition for treating Demodex blepharitis, characterized in that, The external application Chinese medicine composition is composed of the following raw materials in parts by weight: Coptis chinensis 3-10, Sophora flavescens 3-10, and Saposhnikovia divaricata 7.5-10.

2. The topical traditional Chinese medicine composition for treating Demodex blepharitis according to claim 1, characterized in that, The mass ratio of Coptis chinensis, Sophora flavescens, and Saposhnikovia divaricata in the topical Chinese medicine composition is 1:1:(1-2.5).

3. The topical traditional Chinese medicine composition for treating Demodex blepharitis according to claim 2, characterized in that, The external Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts Coptis chinensis, 10 parts Sophora flavescens, and 10 parts Saposhnikovia divaricata; or 3 parts Coptis chinensis, 3 parts Sophora flavescens, and 7.5 parts Saposhnikovia divaricata.

4. The topical traditional Chinese medicine composition for treating Demodex blepharitis according to any one of claims 1 to 3 is used in the preparation of a medicament for treating Demodex blepharitis.

5. The application according to claim 4, characterized in that, The dosage form of the external Chinese medicine composition is an external preparation, which is selected from any one of decoction, lotion, gel or patch.

6. A traditional Chinese medicine preparation for treating Demodex blepharitis, characterized in that, The traditional Chinese medicine preparation is a decoction for external use, and the decoction preparation method includes the following steps: Step 1: Take 3-10 parts by weight of Coptis chinensis, 3-10 parts by weight of Sophora flavescens, and 7.5-10 parts by weight of Saposhnikovia divaricata, soak them in water, then bring to a boil over high heat, and then simmer over low heat for 20-40 minutes. After simmering, filter the liquid with sterile gauze and collect the first filtrate for later use. Step 2: Add purified water to the filtered dregs again, heat over high heat until boiling, then reduce to low heat and simmer for 20-40 minutes. After simmering, filter with sterile gauze and collect the second filtrate. Step 3: Combine the two filtrates, stir well, let stand, remove the scum on the surface, and obtain the total filtrate.