A traditional Chinese medicine composition for treating non-infectious uveitis of heat-toxin invading collaterals syndrome, traditional Chinese medicine preparation and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating non-infectious uveitis of heat-toxin entering collaterals syndrome and a traditional Chinese medicine preparation and application thereof. According to weight parts, raw medicinal materials of the traditional Chinese medicine composition include 6-30 parts of honeysuckle, 9-30 parts of figwort, 6-20 parts of angelica, 2-10 parts of raw licorice, 6-15 parts of red peony root, 3-10 parts of chuanxiong rhizome, 5-15 parts of radix paeoniae alba, 6-20 parts of radix rehmanniae recens and 3-15 parts of dried tangerine or orange peel. Based on the theory of collaterals disease, the traditional Chinese medicine composition provided by the application is used for treating non-infectious uveitis of heat-toxin entering collaterals syndrome with heat-clearing, detoxifying and collaterals-unblocking as a basic rule. When the traditional Chinese medicine composition is combined with basic western medicine for treating non-infectious uveitis, the traditional Chinese medicine composition can not only effectively treat non-infectious uveitis and reduce the recurrence rate of non-infectious uveitis within 6 months, but also accelerate the relief of eye symptoms, accelerate the recovery of eyesight and reduce the toxic side effects of combined hormone medication.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology. More specifically, it relates to a traditional Chinese medicine composition for treating non-infectious uveitis due to heat-toxin invasion of the collaterals, as well as its preparation and application. Background Technology

[0002] Non-infectious uveitis (NIU) is a group of inflammatory eye diseases caused by T-cell-mediated autoimmune inflammatory responses, affecting the uvea, retina, retinal vessels, and vitreous humor. Clinical manifestations include decreased vision, red eyes, eye pain, photophobia, tearing, and floaters. Its etiology is complex, treatment is challenging, and recurrence is common, with the incidence rate increasing annually, making it a public health concern. Western medicine treatments for NIU typically include cycloplegic agents, non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, immunosuppressants, and biologics. Cycloplegic agents and glucocorticoids are the most commonly used in clinical practice. Glucocorticoids are internationally recognized as first-line drugs for treating NIU; however, for patients with poor hormone control and recurrent flare-ups, immunosuppressants are often required in combination. The side effects of both are often intolerable to patients, thus posing a challenge for chronic, recurrent, and complex refractory uveitis, often involving long treatment cycles and significant adverse reactions. Novel biological agents offer a new direction for uveitis that is unresponsive or poorly treated with traditional Western medicine. However, their efficacy still needs to be verified through large-scale clinical trials, and the relatively high price of biological agents increases the financial burden on patients, hindering their widespread use. Currently, the efficacy and adverse reaction control of Western medicine drugs used to treat non-infectious uveitis are not ideal.

[0003] Due to the complex etiology and pathogenesis of uveitis, current clinical and textbook classifications categorize it into four types based on syndrome differentiation: liver and gallbladder wind-heat syndrome, wind-dampness transforming into fire syndrome, yin deficiency with fire excess syndrome, and phlegm-blood stasis syndrome. Different traditional Chinese medicine (TCM) formulas are prescribed for treatment based on these specific syndrome differentiations. Studies have found that combining TCM syndrome differentiation with Western medicine is more effective than Western medicine alone in treating uveitis, playing a positive role in improving ocular symptoms and TCM syndromes. For example, Gao Hui et al. achieved significant efficacy in treating uveitis by combining TCM syndrome differentiation based on the body's defensive qi, nutritive qi, and blood with Western medicine, playing a crucial role in reducing recurrence rates and side effects. However, there are still relatively few TCM formulas available for treating different syndrome differentiations of uveitis. Further improvements are needed in reducing long-term recurrence rates, minimizing Western medicine side effects, and alleviating patient symptoms when used in combination with Western medicine. Summary of the Invention

[0004] To address the aforementioned technical problems, the first objective of this invention is to provide a traditional Chinese medicine composition for treating non-infectious uveitis caused by heat-toxin invading the collaterals. When this traditional Chinese medicine composition is combined with basic Western medicine treatments for non-infectious uveitis, it can effectively treat the condition, showing efficacy against acute, chronic, and late-stage uveitis. It significantly reduces the recurrence rate of non-infectious uveitis, accelerates the relief of ocular symptoms, improves visual prognosis, and reduces the toxic side effects of hormones.

[0005] The second objective of this invention is to provide a traditional Chinese medicine preparation made using the above-mentioned traditional Chinese medicine composition.

[0006] The third objective of this invention is to provide a method for preparing the above-mentioned traditional Chinese medicine preparation.

[0007] The fourth objective of this invention is to provide an application of the above-mentioned traditional Chinese medicine composition and preparation in the preparation of a drug for treating non-infectious uveitis with heat-toxin invasion syndrome.

[0008] To achieve the first objective mentioned above, the present invention adopts the following technical solution:

[0009] This invention provides a traditional Chinese medicine composition for treating non-infectious uveitis due to heat-toxin entering the collaterals. The raw materials of the traditional Chinese medicine composition include, by weight, 6-30 parts of honeysuckle, 9-30 parts of scrophularia, 6-20 parts of angelica, 2-10 parts of raw licorice, 6-15 parts of red peony, 3-10 parts of chuanxiong, 5-15 parts of achyranthes, 6-20 parts of raw rehmannia, and 3-15 parts of tangerine peel.

[0010] Based on the inventor's years of clinical experience and summaries, this invention utilizes the theory of collaterals to treat non-infectious uveitis. It clarifies that the entry of heat toxins into the collaterals and the deep-seated stasis of toxins in the collaterals are the basic pathogenesis of non-infectious uveitis. A new syndrome differentiation is then established, namely, the syndrome of heat toxins entering the collaterals. This syndrome is mainly manifested as heavy and aching headache, tenderness upon pressure, photophobia, tearing, blurred vision, redness around the eyes, cloudy saliva, very small pupils, or yellow fluid rising upwards, accompanied by bitter taste in the mouth, dry mouth, red tongue with a thin yellow coating, and a wiry and rapid pulse. Therefore, the inventor treats the condition by clearing heat, detoxifying, and unblocking the collaterals. Combining the inventor's years of clinical experience and medication rules, the previously disclosed modified Simiao Yong'an Decoction granules were optimized. Considering the insufficient blood-cooling and blood-activating effects in the original prescription, the original prescription was adjusted by adding red peony root, achyranthes root, and rehmannia root to Simiao Yong'an Decoction to enhance the blood-cooling and blood-activating effects, while also cooling the blood and nourishing yin. Tangerine peel was added to protect the stomach qi and prevent stomach damage from prolonged use, ultimately resulting in the traditional Chinese medicine composition of this invention. Studies have found that the traditional Chinese medicine composition of the present invention can be used as an adjunct to the treatment of non-infectious uveitis. When used in conjunction with basic Western medicine treatment for non-infectious uveitis, it can not only effectively treat non-infectious uveitis and reduce the recurrence rate of non-infectious uveitis within 6 months, but also accelerate the relief of eye symptoms, accelerate vision recovery, and reduce the toxic side effects of combined hormone therapy.

[0011] Honeysuckle and scrophularia are the principal herbs in this formula. Honeysuckle is sweet and cold in nature, and it clears heat and detoxifies, disperses wind-heat, and has the effect of clearing both qi and blood. Scrophularia is bitter and cold in nature, and it enters the liver and kidney meridians. It has the effects of clearing heat and cooling blood, purging fire and detoxifying, and nourishing yin. When used together with honeysuckle, its detoxifying effect is even more pronounced. Scrophularia nourishes the yin of the liver and kidneys. When the liver and kidneys are sufficient, they can nourish the heart fire. When the ministerial fire is normal, water and fire are in balance, and the qi and fire in the meridians are normal. The symptoms of upper burner fire toxicity can then be dissipated. Angelica sinensis, Ligusticum chuanxiong, Paeonia lactiflora, and Achyranthes bidentata are used as assistant herbs. Angelica sinensis is sweet and warm in nature, nourishes blood, promotes blood circulation, disperses blood stasis and promotes blood circulation. It is a qi-regulating herb in the blood. When used with Scrophularia ningpoensis, it can achieve the effect of nourishing blood. Ligusticum chuanxiong is pungent and warm in nature, and its function is to promote blood circulation, promote qi circulation, dispel wind and relieve pain. Paeonia lactiflora is bitter and slightly cold in nature, and enters the liver meridian. It has the effects of nourishing yin, relieving pain, clearing heat and cooling blood, promoting blood circulation and removing blood stasis. Achyranthes bidentata tonifies the liver and kidneys, strengthens tendons and bones, promotes blood circulation and regulates menstruation, guides fire (blood) downward, promotes urination and relieves strangury. It is mainly used to treat soreness and weakness of the waist and knees, weakness of the lower limbs, amenorrhea due to blood stasis, dysmenorrhea, postpartum abdominal pain due to blood stasis, retained placenta, hot strangury, hematuria, traumatic injuries, carbuncles and malignant sores, and sore throat. Rehmannia glutinosa and Citrus reticulata peel are used as adjuvant herbs. Rehmannia glutinosa is sweet and bitter in taste, and cool in nature. It enters the heart, liver, and kidney meridians, and has the effects of clearing heat, generating fluids, nourishing yin, and nourishing blood. Citrus reticulata peel is warm in nature, pungent and bitter in taste, and enters the spleen, stomach, and lung meridians. It has the effects of regulating qi, strengthening the spleen, harmonizing the middle jiao, drying dampness, and resolving phlegm. In this formula, Citrus reticulata peel can protect the stomach qi to prevent damage to the stomach from prolonged use. In this formula, Paeonia lactiflora, Achyranthes bidentata, and Rehmannia glutinosa can enhance the effects of cooling blood and promoting blood circulation, while also cooling blood and nourishing yin. Licorice root is used raw to clear heat and detoxify, and also to harmonize the effects of the other herbs.

[0012] Furthermore, by weight, the raw materials of the traditional Chinese medicine composition include: 15 parts honeysuckle, 15 parts scrophularia, 12 parts angelica, 10 parts raw licorice, 12 parts red peony root, 10 parts chuanxiong rhizome, 10 parts achyranthes root, 15 parts raw rehmannia root, and 15 parts tangerine peel.

[0013] Furthermore, by weight, the raw materials of the traditional Chinese medicine composition include: 30 parts honeysuckle, 30 parts scrophularia, 20 parts angelica, 10 parts raw licorice, 12 parts red peony root, 10 parts chuanxiong rhizome, 10 parts achyranthes root, 15 parts raw rehmannia root, and 10 parts tangerine peel.

[0014] Furthermore, by weight, the raw materials of the traditional Chinese medicine composition include: 9 parts honeysuckle, 9 parts scrophularia, 7 parts angelica, 6 parts raw licorice, 7 parts red peony root, 6 parts chuanxiong rhizome, 6 parts achyranthes root, 9 parts raw rehmannia root, and 9 parts tangerine peel.

[0015] To achieve the second objective mentioned above, the present invention adopts the following technical solution:

[0016] This invention provides a traditional Chinese medicine preparation for treating non-infectious uveitis caused by heat toxin entering the collaterals. The raw materials of the traditional Chinese medicine preparation include the traditional Chinese medicine composition described above.

[0017] Furthermore, the raw materials of the traditional Chinese medicine preparation also include pharmaceutically acceptable excipients.

[0018] Furthermore, the dosage form of the traditional Chinese medicine preparation includes tablets, granules, powders, pills, capsules, or oral liquids, preferably granules.

[0019] To achieve the third objective mentioned above, the present invention adopts the following technical solution:

[0020] This invention provides a method for preparing the traditional Chinese medicine preparation described above, comprising the following steps:

[0021] The honeysuckle, scrophularia, angelica, raw licorice, red peony root, chuanxiong rhizome, achyranthes root, raw rehmannia root, and tangerine peel were weighed in proportion, cleaned and impurities removed, soaked in 10 times the amount of water for 0.5 hours, and then decocted and extracted twice, 1.5 hours each time. The extracts were combined and concentrated under reduced pressure to a clear paste with a relative density of 1.15-1.20 at 50℃.

[0022] The extract was vacuum dried to obtain a dry extract, which was then pulverized and sieved to obtain a fine powder of the dry extract.

[0023] It is prepared into tablets, granules, powders, pills, capsules or oral liquids according to conventional formulation processes.

[0024] To achieve the fourth objective mentioned above, the present invention adopts the following technical solution:

[0025] This invention provides an application of the traditional Chinese medicine composition and preparation described above in the preparation of any of the following drugs;

[0026] 1) Treatment of non-infectious uveitis due to heat toxin entering the collaterals;

[0027] 2) Reduce the recurrence rate of non-infectious uveitis caused by heat toxin entering the collaterals;

[0028] 3) Accelerates visual recovery during combined hormone therapy;

[0029] 4) Reduces intraocular pressure elevation during combined hormone therapy;

[0030] 5) Improves symptoms such as headache, heaviness, pain in the eyes, photophobia, tearing, blurred vision, redness of the eyes, cloudy saliva, and bitter taste in the mouth.

[0031] In addition, unless otherwise specified, all raw materials of the traditional Chinese medicine composition of the present invention can be obtained commercially available. Any traditional Chinese medicine composition of any range described in the present invention, including any value between the endpoints and any sub-ranges formed by the endpoints or any value between the endpoints, can achieve the purpose of treating non-infectious uveitis with heat toxin entering the collaterals syndrome.

[0032] The beneficial effects of this invention are as follows:

[0033] Based on the theory of collaterals, the traditional Chinese medicine composition provided by this invention treats non-infectious uveitis by using the basic principle of clearing heat, detoxifying, and unblocking collaterals. When used in conjunction with basic Western medicine treatment for non-infectious uveitis, it can not only effectively treat non-infectious uveitis, but also be effective for acute uveitis, persistent uveitis, and late uveitis, reducing the recurrence rate of non-infectious uveitis within 6 months, accelerating the relief of eye symptoms, accelerating vision recovery, and reducing the toxic side effects of combined hormone therapy. Detailed Implementation

[0034] To more clearly illustrate the present invention, the following description, in conjunction with preferred embodiments, further clarifies the invention. Those skilled in the art should understand that the specific descriptions below are illustrative rather than restrictive, and should not be construed as limiting the scope of protection of the present invention.

[0035] Example 1

[0036] This embodiment provides a traditional Chinese medicine composition and preparation for treating non-infectious uveitis caused by heat-toxin invading the collaterals:

[0037] Honeysuckle 15g, Scrophularia ningpoensis 15g, Angelica sinensis 12g, raw licorice root 10g, red peony root 12g, Ligusticum chuanxiong 10g, Achyranthes bidentata 10g, Rehmannia glutinosa 15g, tangerine peel 15g.

[0038] The honeysuckle, scrophularia, angelica, raw licorice, red peony root, chuanxiong rhizome, achyranthes root, raw rehmannia root, and tangerine peel were weighed in proportion, cleaned and impurities removed, soaked in 10 times the amount of water for 0.5 hours, and then decocted and extracted twice, 1.5 hours each time. The extracts were combined and concentrated under reduced pressure to a clear paste with a relative density of 1.15-1.20 at 50℃.

[0039] The extract was vacuum dried to obtain a dry extract, which was then pulverized and sieved to obtain a fine powder of the dry extract.

[0040] It is made into granules according to conventional formulation processes.

[0041] Example 2

[0042] This embodiment provides a traditional Chinese medicine composition and preparation for treating non-infectious uveitis caused by heat-toxin invading the collaterals:

[0043] Honeysuckle 30g, Scrophularia ningpoensis 30g, Angelica sinensis 20g, raw licorice root 10g, red peony root 12g, Ligusticum chuanxiong 10g, Achyranthes bidentata 10g, Rehmannia glutinosa 15g, tangerine peel 10g.

[0044] The honeysuckle, scrophularia, angelica, raw licorice, red peony root, chuanxiong rhizome, achyranthes root, raw rehmannia root, and tangerine peel were weighed in proportion, cleaned and impurities removed, soaked in 10 times the amount of water for 0.5 hours, and then decocted and extracted twice, 1.5 hours each time. The extracts were combined and concentrated under reduced pressure to a clear paste with a relative density of 1.15-1.20 at 50℃.

[0045] The extract was vacuum dried to obtain a dry extract, which was then pulverized and sieved to obtain a fine powder of the dry extract.

[0046] It is made into granules according to conventional formulation processes.

[0047] Example 3

[0048] This embodiment provides a traditional Chinese medicine composition and preparation for treating non-infectious uveitis caused by heat-toxin invading the collaterals:

[0049] Honeysuckle 9g, Scrophularia ningpoensis 9g, Angelica sinensis 7g, raw licorice root 6g, red peony root 7g, Ligusticum chuanxiong 6g, Achyranthes bidentata 6g, raw Rehmannia glutinosa 9g, dried tangerine peel 9g.

[0050] The honeysuckle, scrophularia, angelica, raw licorice, red peony root, chuanxiong rhizome, achyranthes root, raw rehmannia root, and tangerine peel were weighed in proportion, cleaned and impurities removed, soaked in 10 times the amount of water for 0.5 hours, and then decocted and extracted twice, 1.5 hours each time. The extracts were combined and concentrated under reduced pressure to a clear paste with a relative density of 1.15-1.20 at 50℃.

[0051] The extract was vacuum dried to obtain a dry extract, which was then pulverized and sieved to obtain a fine powder of the dry extract.

[0052] It is made into granules according to conventional formulation processes.

[0053] Clinical Trial 1

[0054] Study subjects: 100 patients with non-infectious uveitis who visited the ophthalmology outpatient clinic of Xiyuan Hospital of China Academy of Chinese Medical Sciences between October 2022 and November 2023 and met the TCM syndrome differentiation of "heat toxin entering the collaterals". The syndrome differentiation manifestations were heavy headache and eye pain, pain in the eye that was tender to pressure, photophobia and tearing, blurred vision, red eyes, cloudy iris, very small pupils, or yellow fluid rushing upwards, accompanied by bitter taste in the mouth, dry mouth, red tongue with thin yellow coating and wiry and rapid pulse.

[0055] Inclusion criteria for study participants:

[0056] ① Age between 18 and 65 years old.

[0057] ② Anyone who meets the diagnostic criteria for non-infectious uveitis and whose TCM syndrome differentiation is heat-toxin entering the collaterals can be included in the trial.

[0058] ③ Sign the informed consent form.

[0059] Exclusion criteria for study subjects:

[0060] ① Abnormal blood routine test results within 2 weeks are clinically significant, that is, all blood routine indicators are higher than the upper limit or lower than the lower limit by 20% (for patients taking oral glucocorticoids, white blood cells and platelets are allowed to be higher than the upper limit of normal by 40%).

[0061] ② He has systemic diseases such as diabetes, hypertension, coronary heart disease, and rheumatism, and his current condition is unstable.

[0062] ③ Patients with concurrent infectious eye diseases, corneal dystrophy or other corneal lesions, eye trauma, or who have undergone eye surgery within the past 2 weeks.

[0063] ④ Those with weak spleen and stomach who are not suitable for long-term use of cold and cooling medicines.

[0064] ⑤ Accompanied by liver and kidney dysfunction, specifically referring to liver and kidney function (AST, ALT, BUN, Cr) exceeding the high limit by 1.5 times within 2 weeks; and patients with mental illness (considering that they cannot express themselves accurately).

[0065] ⑥ Pregnant or breastfeeding women.

[0066] Experimental grouping: Third-party statisticians used SPSS statistical software to generate randomization schemes using the random number table method, and sealed them in envelopes. After enrollment, the envelopes were opened and patients were randomly divided into a control group (50 cases) and an experimental group (50 cases).

[0067] Medication method: The control group received conventional treatment, namely, topical corticosteroids (1% cyclophosphamide or 0.1% fluorometholone) and mydriatics (atropine sulfate ophthalmic gel or compound tropicamide eye drops) based on the type, course, condition, and individual patient condition of non-infectious uveitis. The type and frequency of the initial ophthalmic medication were determined according to the severity of the patient's inflammation and the dosage was gradually reduced. One course of treatment lasted for 3 consecutive months. After 3 months of medication, topical corticosteroids were discontinued and the patient was followed up for another 3 months. The experimental group received conventional treatment (same dosage and administration as the control group) plus Jiawei Simiao Yong'an Decoction granules (granules from Example 1), one sachet of Chinese herbal medicine granules was taken orally twice a day for 3 months. After discontinuation of the medication, the patient was followed up for another 3 months.

[0068] Outcome indicators: statistical analysis of recurrence rate, visual acuity, and changes in TCM syndrome scores (based on the TCM syndrome grading and quantification table).

[0069] Statistical analysis methods: All data were analyzed using SPSS 21.0 statistical software. Test statistics and corresponding p-values ​​were provided, and two-tailed tests were used, with p < 0.05 considered statistically significant. All continuous data were expressed as mean ± standard deviation (X ± S). t-tests were used for comparisons between groups, and χ² tests were used for categorical data. 2 For the validation, the ordinal data were analyzed using Ridit.

[0070] Results Analysis

[0071] 1. Shedding status

[0072] After 3 months of treatment, a total of 87 patients completed the 3-month follow-up (see Table 1). The specific conditions of these patients at the initial consultation were as follows: 37 patients with anterior uveitis, 10 patients with posterior uveitis, 3 patients with intermediate uveitis, 20 patients with B27-related uveitis, 3 patients with Fuchs syndrome, 8 patients with VKH syndrome, 3 patients with Behçet's disease uveitis, and 3 patients with blue eyelid syndrome.

[0073] Table 1

[0074]

[0075] 2. Recurrence rate

[0076] The recurrence rate during the 6-month follow-up is shown in Table 2. As can be seen from Table 2, P<0.05, the difference in recurrence rate between the two groups was statistically significant, and the recurrence rate of the experimental group was significantly lower than that of the control group. This indicates that when the traditional Chinese medicine preparation of the present invention is used in combination with basic Western medicine treatment to treat non-infectious uveitis, the combined use of drugs can significantly reduce the recurrence rate of non-infectious uveitis within 6 months.

[0077] Table 2

[0078]

[0079]

[0080] 3. Vision

[0081] The visual acuity results at the 6-month follow-up are shown in Table 3. Compared with before treatment, the visual acuity of the experimental group improved significantly after 1 month of treatment, while the visual acuity of the control group improved significantly after 2 months of treatment. This indicates that, compared with the control group, the combined use of the traditional Chinese medicine preparation of this invention and basic Western medicine to treat non-infectious uveitis can accelerate the visual recovery of patients.

[0082] Table 3

[0083]

[0084] 4. Intraocular pressure

[0085] The intraocular pressure (IOP) data at the 6-month follow-up are shown in Table 4. Compared with before treatment, the IOP in the control group was significantly higher 2 months after treatment, which may be due to the toxic side effect of the increased IOP caused by Western medicine hormones. In contrast, the IOP in the experimental group remained stable within 6 months after treatment, and the IOP in the experimental group was lower than that in the control group 2 months after treatment. When the traditional Chinese medicine preparation of this invention is used in combination with basic Western medicine treatment to treat non-infectious uveitis, the combined use of drugs can reduce the toxic side effects of Western medicine hormones.

[0086] Table 4

[0087]

[0088] 5. Traditional Chinese Medicine Syndrome Scoring

[0089] Table 5 provides a quantitative table for the TCM syndrome grading of uveitis for non-infectious uveitis patients with heat-toxin entering the collaterals, as described in this invention.

[0090] Table 5

[0091]

[0092]

[0093] The efficacy was assessed based on the reduction in syndrome scores before and after treatment. The efficacy index (n) was calculated as (score before treatment minus score after treatment) divided by the score before treatment × 100%. (1) Significantly effective: Significant improvement in ocular symptoms, signs, or TCM syndromes, n ≥ 70%; (2) Effective: Improvement in ocular symptoms, signs, and TCM syndromes, n ≥ 40%; (3) Ineffective: Slight changes or worsening in ocular symptoms, signs, and TCM syndromes, n < 40%.

[0094] The TCM syndrome scores of patients were assessed 3 months after treatment. Statistical analysis showed that the Ridit test showed P>0.05 at 3 months after treatment, indicating that there was no difference in TCM syndrome scores between the two groups at 3 months after treatment.

[0095] Table 6

[0096]

[0097] Note: Relapse is recorded as ineffective, and dropout is recorded according to the last follow-up data; Effective rate = (effective + significant effect) / total number of cases; Compared with before treatment, a TCM syndrome score improvement of ≥70% is considered significant effect, ≥40% is considered effective, and <40% is considered ineffective.

[0098] Statistical analysis of the TCM syndrome grading scale for patients revealed a significant difference (P<0.05) between the two groups after treatment and before treatment (t-test). One month after treatment, the TCM syndrome scores between the two groups showed a significant difference (P<0.05), with the experimental group showing a lower score. This indicates that combining the TCM preparation of this invention with basic Western medicine treatment for non-infectious uveitis can reduce the TCM syndrome score to a lower level more quickly, and the experimental group showed a faster rate of inflammation resolution than the control group.

[0099] Table 7

[0100]

[0101] Clinical Trial 2

[0102] To better compare the formulation of this invention with the previously disclosed modified Simiao Yong'an Decoction granules, a clinical study based on the original formulation is provided.

[0103] Study subjects: 84 patients with non-infectious uveitis who visited the ophthalmology outpatient clinic of Xiyuan Hospital of China Academy of Chinese Medical Sciences between October 2022 and November 2023 and met the TCM syndrome differentiation of heat toxin entering the collaterals were included. Among them, 34 patients had acute anterior uveitis, 25 patients had panuveitis, and 25 patients had B27-related uveitis.

[0104] Inclusion and exclusion criteria are the same as in clinical trial 1.

[0105] Experimental grouping: Third-party statisticians used SPSS statistical software to generate randomization schemes using the random number table method, and sealed them in envelopes. After enrollment, the envelopes were opened and patients were randomly divided into a control group (39 cases) and an experimental group (45 cases).

[0106] Medication method: The control group received conventional treatment, namely, topical corticosteroids (1% cyclophosphamide or 0.1% fluorometholone) and mydriatics (atropine sulfate ophthalmic gel or compound tropicamide eye drops) based on the type, course, condition, and individual patient condition of non-infectious uveitis. The type and frequency of initial ophthalmic medication were determined according to the severity of the patient's inflammation and gradually reduced. One course of treatment lasted for 3 consecutive months. After 3 months of medication, topical corticosteroids were discontinued and the patient was followed up for another 3 months. The experimental group received conventional treatment (same dosage and administration as the control group) plus Jiawei Simiao Yong'an Decoction granules (prescription ingredients: honeysuckle 30g, scrophularia ningpoensis 20g, angelica sinensis 20g, licorice 10g, atractylodes macrocephala 15g, poria cocos 15g, astragalus membranaceus 15g, lily bulb 15g, cynanchum paniculatum 10g, chuanxiong rhizome 10g, prepared into granules using the preparation method in Example 1). The patient took one packet of the Chinese herbal medicine granules orally twice a day for 3 months.

[0107] Outcome indicators: statistical analysis of recurrence, inflammatory markers, visual acuity, and changes in TCM syndrome scores (TCM syndrome grading and quantification table).

[0108] Statistical analysis methods: All data were analyzed using SPSS 21.0 statistical software. Test statistics and corresponding p-values ​​were provided, and two-tailed tests were used, with p < 0.05 considered statistically significant. All continuous data were expressed as mean ± standard deviation (X ± S). t-tests were used for comparisons between groups, and χ² tests were used for categorical data. 2 For the validation, the ordinal data were analyzed using Ridit.

[0109] Results Analysis

[0110] 1. Vision

[0111] The visual acuity data at the 3-month follow-up are shown in Table 8. Compared with before treatment, the visual acuity of the experimental group improved significantly one week after treatment (P = 0.031), while the visual acuity of the control group improved significantly two weeks after treatment (P = 0.021). This indicates that the experimental group can significantly accelerate the visual recovery of patients compared with the control group.

[0112] Table 8

[0113]

[0114] 2. Intraocular pressure

[0115] The intraocular pressure data at the 3-month follow-up are shown in Table 9. There was no statistically significant difference between the experimental group and the control group, and the combined use of medication could not reduce the toxic side effects of Western medicine hormones.

[0116] Table 9

[0117]

[0118] 3. Traditional Chinese Medicine Symptom Scoring

[0119] Three months after treatment, patients were assessed using traditional Chinese medicine symptom scores (see Table 10). Statistical analysis revealed no significant difference between the experimental group and the control group.

[0120] Table 10

[0121]

[0122]

[0123] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. For those skilled in the art, other variations or modifications can be made based on the above description. It is impossible to exhaustively list all the implementation methods here. All obvious variations or modifications derived from the technical solutions of the present invention are still within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating non-infectious uveitis due to heat-toxin invading the collaterals, characterized in that, The raw materials of the traditional Chinese medicine composition, by weight, are: 15 parts honeysuckle, 15 parts scrophularia, 12 parts angelica, 10 parts raw licorice, 12 parts red peony root, 10 parts chuanxiong rhizome, 10 parts achyranthes root, 15 parts raw rehmannia root, and 15 parts tangerine peel.

2. A traditional Chinese medicine composition for treating non-infectious uveitis due to heat-toxin invading the collaterals, characterized in that, The raw materials of the traditional Chinese medicine composition, by weight, are: 30 parts honeysuckle, 30 parts scrophularia, 20 parts angelica, 10 parts raw licorice, 12 parts red peony root, 10 parts chuanxiong rhizome, 10 parts achyranthes root, 15 parts raw rehmannia root, and 10 parts tangerine peel.

3. A traditional Chinese medicine composition for treating non-infectious uveitis due to heat-toxin invading the collaterals, characterized in that, The raw materials of the traditional Chinese medicine composition, by weight, are: honeysuckle 9 parts, scrophularia ningpoensis 9 parts, angelica sinensis 7 parts, raw licorice 6 parts, red peony root 7 parts, chuanxiong rhizome 6 parts, achyranthes bidentata root 6 parts, raw rehmannia root 9 parts, and tangerine peel 9 parts.

4. A traditional Chinese medicine preparation for treating non-infectious uveitis due to heat-toxin invading the collaterals, characterized in that, The raw materials for the traditional Chinese medicine preparation include the traditional Chinese medicine composition as described in any one of claims 1-3.

5. The traditional Chinese medicine preparation according to claim 4, characterized in that, The raw materials for the traditional Chinese medicine preparations also include pharmaceutically acceptable excipients.

6. The traditional Chinese medicine preparation according to claim 4, characterized in that, The dosage forms of the traditional Chinese medicine preparations include tablets, granules, powders, pills, capsules, or oral liquids.

7. The traditional Chinese medicine preparation according to claim 4, characterized in that, The dosage form of the traditional Chinese medicine preparation is granules.

8. The method for preparing a traditional Chinese medicine preparation according to any one of claims 4-7, characterized in that, Includes the following steps: The honeysuckle, scrophularia, angelica, raw licorice, red peony root, chuanxiong rhizome, achyranthes root, raw rehmannia root, and tangerine peel were weighed in proportion, cleaned and impurities removed, soaked in 10 times the amount of water for 0.5 hours, and then decocted and extracted twice, 1.5 hours each time. The extracts were combined and concentrated under reduced pressure to a clear paste with a relative density of 1.15-1.20 at 50℃. The extract was vacuum dried to obtain a dry extract, which was then pulverized and sieved to obtain a fine powder of the dry extract. It is prepared into tablets, granules, powders, pills, capsules or oral liquids according to conventional formulation processes.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-3 or the traditional Chinese medicine preparation according to any one of claims 4-7 in the preparation of any of the following drugs; 1) Treatment of non-infectious uveitis due to heat toxin entering the collaterals; 2) Reduce the recurrence rate of non-infectious uveitis caused by heat-toxin entering the collaterals; 3) To accelerate visual recovery during combined hormone therapy for non-infectious uveitis; 4) Reduce intraocular pressure elevation during combined hormone therapy for non-infectious uveitis; 5) Improves symptoms of non-infectious uveitis such as headache, heaviness, pain and tenderness, photophobia, tearing, blurred vision, redness of the iris, cloudy saliva, and bitter taste in the mouth.

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