Traditional Chinese medicine nasal spray for treating mild cognitive impairment after stroke and preparation method thereof

Through the nasal spray of a combination of Chinese medicines such as Acorus calamus, the rapid absorption of the nasal mucosa and the penetration-promoting effect of borneol and mint are utilized to solve the first-pass effect and gastrointestinal irritation problems of traditional drugs, achieve efficient treatment of mild cognitive impairment after stroke, and improve the targeting and therapeutic effect of drugs in the brain.

CN120695129APending Publication Date: 2025-09-26YUEYANG INTEGRATED TRADITIONAL CHINESE & WESTERN MEDICINE HOSPITAL SHANGHAI UNIV OF CHINESE TRADITIONAL MEDICINE
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Patent Information

Application Number
CN202510789318.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-06-13
Publication Date
2025-09-26

AI Technical Summary

Technical Problem

Existing nasal sprays are mainly used for respiratory diseases, and there is a lack of compound preparations for brain diseases. Traditional oral medications have first-pass effects and gastrointestinal irritation problems, making it difficult to effectively treat mild cognitive impairment after stroke.

Method used

A Chinese herbal medicine composition including Acorus calamus and Cuscuta australis is used, which is rapidly absorbed through the nasal mucosa and combined with the penetration-promoting effects of borneol and mint to prepare a Chinese herbal nasal spray, which targets and improves the brain microenvironment and increases the drug concentration in the brain.

Benefits of technology

Significantly improve the cognitive function of patients with mild cognitive impairment after stroke, provide efficient and safe treatment options, reduce drug irritation to the gastrointestinal tract, and improve drug targeting.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition and a traditional Chinese medicine nasal spray for efficiently and safely treating post-stroke mild cognitive impairment as well as a preparation method and application of the traditional Chinese medicine composition and the traditional Chinese medicine nasal spray. According to the traditional Chinese medicine composition, all the medicines are synergistic to achieve the effects of tonifying the kidney, replenishing essence, reducing phlegm, inducing resuscitation, dredging collaterals and restoring consciousness together, the pathogenesis of'deficiency in root and excess in superficies' after stroke is considered, and the symptoms of cognitive decline, slow response, dysmnesia and the like caused by brain marrow malnutrition and phlegm stasis orifice blocking can be improved. The traditional Chinese medicine nasal spray is rapidly absorbed through nasal mucosa, improves the intracerebral microenvironment in a targeted manner, remarkably improves the intracerebral concentration of the medicine through a nasal cavity-brain targeted delivery technology in combination with the permeation enhancing effect of borneol and mint, is suitable for patients needing to improve the cognitive function, and provides an innovative solution for post-stroke rehabilitation.
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Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine nasal spray for treating mild cognitive impairment after stroke by invigorating the kidney and replenishing essence, resolving phlegm and unblocking meridians, and a preparation method thereof. Background Art

[0002] Stroke is one of the most common cerebrovascular diseases. It is caused by the sudden rupture or blockage of blood vessels in the brain, which leads to impaired blood circulation in the brain. This disease is a major cause of long-term disability in patients. Post-stroke cognitive impairment (PSCI), a common complication of stroke, includes a variety of symptoms caused by stroke, ranging from mild cognitive impairment to dementia. Early identification of PSMCI and appropriate treatment interventions can delay or even reverse cognitive impairment, which is of great practical significance for preventing further progression to dementia and maintaining social independence. Traditional oral medications have first-pass effects and gastrointestinal irritation. Intranasal administration can directly reach the brain through the olfactory nerve pathway, improving targeting.

[0003] However, existing nasal sprays are mostly used for respiratory diseases, and there is still a lack of compound preparations for encephalopathy. Summary of the Invention

[0004] The purpose of the present invention is to provide an efficient and safe traditional Chinese medicine nasal spray for treating mild cognitive impairment after stroke by nourishing the kidney and replenishing essence, resolving phlegm and unblocking the meridians, and a preparation method thereof. The nasal spray is rapidly absorbed through the nasal mucosa and targetedly improves the brain microenvironment.

[0005] The first aspect of the present invention provides a traditional Chinese medicine composition for treating mild cognitive impairment after stroke, which is composed of the following raw materials in the following weight ratios:

[0006] 60-120 parts of Acorus calamus, 150-210 parts of Cuscuta seeds, 90-150 parts of Curcuma aromatica, 60-120 parts of Bombyx batryticatus, 60-120 parts of earthworms, 90-150 parts of Pinellia tubers, 150-210 parts of processed Arisaema, 90-150 parts of dried tangerine peel, 120-180 parts of Uncaria rhynchophylla, 60-120 parts of Polygala tenuifolia, 60-120 parts of Styrax storax, 120-180 parts of Poria, 30-90 parts of Menthol, 90-150 parts of Angelica dahurica, 60-120 parts of Ligusticum chuanxiong, and 30-90 parts of Borneolum.

[0007] Furthermore, the traditional Chinese medicine composition for treating cognitive impairment after stroke is composed of the following raw materials in the following weight ratios: 90 parts of Acorus calamus, 180 parts of Cuscuta seeds, 120 parts of Curcuma aromatica, 90 parts of Bombyx batryticatus, 90 parts of earthworms, 120 parts of Pinellia ternata, 180 parts of processed Arisaema, 120 parts of dried tangerine peel, 150 parts of Uncaria rhynchophylla, 90 parts of Polygala tenuifolia, 90 parts of Styrax odorata, 150 parts of Poria, 60 parts of mint, 120 parts of Angelica dahurica, 90 parts of Ligusticum chuanxiong, and 60 parts of borneol.

[0008] The second aspect of the present invention provides a Chinese medicine nasal spray comprising the Chinese medicine composition as an active ingredient.

[0009] The third aspect of the present invention provides a method for preparing the above-mentioned traditional Chinese medicine nasal spray, comprising the following steps:

[0010] a. Weigh the corresponding weight portions of the drug standby, Acorus gramineus, Cuscuta, Curcuma, Bombyx batryticatus, Earthworm, Pinellia, Arisaema, Tangerine peel, Uncaria rhynchophylla, Polygala tenuifolia, Poria were crushed into coarse particles, extracted 2-3 times with 70-80% ethanol under reflux, adding 6-10 times the amount of ethanol each time, extracted for 1-2 hours, the liquid was filtered and combined, the ethanol was recovered and concentrated to a relative density (at 40 ° C) of 1.02-1.05, set aside; mint, Chuanxiong, Angelica dahurica was crushed to 20 mesh, steam distilled for 6 hours, and the volatile oil was collected (condensation temperature ≤ 10 ° C); borneol and storax were dissolved in a small amount of ethanol and filtered through a 0.22 μm filter membrane for later use;

[0011] b. The concentrate of Acorus calamus, Cuscuta chinensis, Curcuma zedoaria, Bombyx batryticatus, earthworm, Pinellia ternata, processed Arisaema, dried tangerine peel, Uncaria rhynchophylla, Polygala tenuifolia, and Poria cocos was adjusted to pH 4-5 with 20% HCl, 5% (v / v) gelatin solution was added until no precipitation was formed, the liquid was concentrated to a concentrate: medicinal material volume ratio of 1:1, ethanol was added to an alcohol precipitation concentration of 60-70%, and the mixture was allowed to stand at 3-10°C for 12-24 hours and filtered; the paloxam was prepared into a 20% (v / v) concentrated solution, and mint, Chuanxiong, angelica dahurica volatile oil and borneol, storax ethanol solution were added while stirring, mixed evenly, and then stirred evenly with the combined liquid;

[0012] c. Adjust the pH to 7-8 with 50% (v / v) sodium hydroxide solution, add purified water to adjust the volume to 1000ml, add propellant (such as hydrofluoroalkane HFA-134a or HFA-227), and mix in a volume ratio of 1:3 to 1:5 between the solution and the propellant.

[0013] d. Use pressure filling equipment to fill the drug solution and propellant into an aerosol container. Sterilize with circulating steam for 30 minutes, and then fill into a sterile metered-dose nasal spray device. Each bottle contains 10 mL, and the single spray volume is 0.05 mL (containing 30 mg of crude drug).

[0014] A fourth aspect of the present invention provides a use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating mild cognitive impairment after stroke.

[0015] A fifth aspect of the present invention provides a use of the above-mentioned traditional Chinese medicine nasal spray in the preparation of a medicament for treating mild cognitive impairment after stroke.

[0016] The Chinese medicine formula of the present invention is explained as follows:

[0017] Main Ingredient: Acorus calamus: Pungent, warm, and aromatic, it ascends to the brain and is a key herb for resolving phlegm and opening the orifices. Chongqing Tang Essays states that it "soothes the mind, relaxes the spirit, brightens the heart, and strengthens the will." It can clear phlegm, refresh the mind, and improve intelligence, specifically opening up obscured orifices. Cuscuta chinensis: Sweet, warm, and moist, it nourishes the liver and kidneys, replenishes essence and marrow. Ben Cao Hui Yan states that it "tonifies the kidneys and liver, warms the spleen, and aids the stomach." It strengthens the lower abdomen and replenishes the brain marrow, treating cognitive decline caused by kidney deficiency and essence deficiency. Auxiliary Medicinal Materials: Curcuma Radix, Bombyx Batryticatus, and Earthworm: Curcuma Radix relieves depression and clears heart heat, Bombyx Batryticatus extinguishes wind and resolves phlegm, and Earthworm unblocks the meridians and stops spasms, collectively relieving qi stagnation and phlegm obstruction. Pinellia Rhizoma, Processed Arisaema Cinnamomi, and Tangerine Peel: Pinellia Rhizoma dries dampness and resolves phlegm, Arisaema Cinnamomi dispels wind and phlegm, and Tangerine Peel regulates qi and resolves phlegm. Together, these three herbs dissolve phlegm stagnation. Uncaria Rhizoma and Polygala Tenuifolia: Uncaria Rhizoma calms the liver and suppresses yang, calms wind and relieves dizziness, while Polygala Tenuifolia connects the heart and kidneys, calms the mind and improves intelligence, collectively relieving dizziness caused by liver-wind disturbance. Styrax and Borneol: Assisting Acorus Gramineus in strengthening its power to open the orifices, Styrax warms and clears turbidity, while Borneol cools and dispels heat, counteracting the cold and warm effects to clear blocked orifices in the brain. Adjuvant Medicinal Materials: Poria Root: Strengthens the spleen and calms the heart, calms the mind and stabilizes spirit, and also prevents expectorant drugs from damaging the spleen. Peppermint: Light and clearing, soothes the liver and relieves depression, assisting Borneol in dispersing stagnant heat in the orifices. Auxiliary drugs: Chuanxiong and Angelica dahurica: Chuanxiong goes up to the head and activates blood circulation and qi, while Angelica dahurica dispels wind and opens the orifices. The two lead all the drugs into the brain meridians; Borneol (also a guiding drug): its fragrance can lead all the drugs directly to the diseased area, awakening the brain and opening and closing it.

[0018] The advantages of the present invention are:

[0019] 1. The present invention provides a traditional Chinese medicine composition for treating mild cognitive impairment after stroke. The various herbs in the prescription work together to nourish the kidney and replenish essence, resolve phlegm and open the orifices, and dredge the meridians and invigorate the brain. This is in line with the pathogenesis of "deficiency of the root and excess of the superficial" after stroke, and can improve symptoms such as cognitive decline, slow reaction, and memory impairment caused by malnutrition of the brain marrow and obstruction of the orifices by phlegm and blood stasis.

[0020] 2. The present invention also provides a highly effective and safe Chinese medicine nasal spray for treating mild cognitive impairment after stroke, which is rapidly absorbed through the nasal mucosa and targeted to improve the brain microenvironment.

[0021] 3. The present invention uses nasal-brain targeted delivery technology combined with the penetration-enhancing effects of borneol and mint to significantly increase the drug concentration in the brain. It is suitable for patients who need to improve cognitive function and provides an innovative solution for post-stroke rehabilitation. DETAILED DESCRIPTION

[0022] The specific implementation methods provided by the present invention are described in detail below with reference to the examples.

[0023] Example 1: Chinese medicine composition of the present invention

[0024] 60 parts of Acorus calamus, 150 parts of Cuscuta seeds, 90 parts of Curcuma aromatica, 60 parts of Bombyx batryticatus, 60 parts of earthworms, 90 parts of Pinellia tubers, 150 parts of Arisaema preparata, 90 parts of dried orange peels, 120 parts of Uncaria rhynchophylla, 60 parts of Polygala tenuifolia, 60 parts of Styrax storax, 120 parts of Poria, 30 parts of Menthol, 90 parts of the Angelica dahurica, 60 parts of Ligusticum chuanxiong, and 30 parts of Borneolum.

[0025] Example 2: Chinese medicine composition of the present invention

[0026] 70 parts of Acorus calamus, 160 parts of Cuscuta seeds, 100 parts of Curcuma aromatica, 70 parts of Bombyx batryticatus, 70 parts of earthworms, 100 parts of Pinellia tubers, 160 parts of Arisaema processed, 100 parts of dried tangerine peels, 130 parts of Uncaria rhynchophylla, 70 parts of Polygala tenuifolia, 70 parts of Styrax storax, 130 parts of Poria, 40 parts of Menthol, 100 parts of the Angelica dahurica, 70 parts of Ligusticum chuanxiong, and 40 parts of Borneolum.

[0027] Example 3: Chinese medicine composition of the present invention

[0028] 80 parts of Rhizoma Acorus, 170 parts of Semen Cuscutae, 110 parts of Radix Curcumae, 80 parts of Bombyx Batryticatus, 80 parts of Pheretima, 110 parts of Rhizoma Pinelliae, 170 parts of Arisaema Preparata, 110 parts of Pericarpium Citri Reticulatae, 140 parts of Rhizoma Uncariae, 80 parts of Polygala Tenuifolia, 80 parts of Styrax, 140 parts of Poria, 50 parts of Menthol, 110 parts of Radix Angelicae Dahuricae, 80 parts of Rhizoma Chuanxiong, 50 parts of Borneolum Syntheticum.

[0029] Example 4: Chinese medicine composition of the present invention

[0030] 90 parts of Rhizoma Acorus, 180 parts of Semen Cuscutae, 120 parts of Radix Curcumae, 90 parts of Bombyx Batryticatus, 90 parts of Pheretima, 120 parts of Rhizoma Pinelliae, 180 parts of Arisaema Preparata, 120 parts of Pericarpium Citri Reticulatae, 150 parts of Rhizoma Uncariae, 90 parts of Polygala Tenuifolia, 90 parts of Styrax Ophiopogonis, 150 parts of Poria, 60 parts of Menthol, 120 parts of Radix Angelicae Dahuricae, 90 parts of Rhizoma Chuanxiong, and 60 parts of Borneolum Syntheticum.

[0031] Example 5: Chinese medicine composition of the present invention

[0032] 100 parts of Acorus calamus, 190 parts of Cuscuta seeds, 130 parts of Curcuma aromatica, 100 parts of Bombyx batryticatus, 100 parts of earthworms, 130 parts of Pinellia tubers, 190 parts of processed Arisaema, 130 parts of dried tangerine peel, 160 parts of Uncaria rhynchophylla, 100 parts of Polygala tenuifolia, 100 parts of Styrax odorata, 160 parts of Poria, 70 parts of Menthol, 130 parts of the Angelica dahurica, 100 parts of Ligusticum chuanxiong, and 70 parts of Borneolum.

[0033] Example 6: Chinese medicine composition of the present invention

[0034] 110 parts of Acorus calamus, 200 parts of Cuscuta seeds, 140 parts of Curcuma aromatica, 110 parts of Bombyx batryticatus, 110 parts of earthworms, 140 parts of Pinellia tubers, 200 parts of Arisaema preparata, 140 parts of dried tangerine peels, 170 parts of Uncaria rhynchophylla, 110 parts of Polygala tenuifolia, 110 parts of Styrax odorata, 170 parts of Poria, 80 parts of Menthol, 140 parts of the Angelica dahurica, 110 parts of Ligusticum chuanxiong, and 80 parts of Borneolum.

[0035] Example 7: Chinese medicine composition of the present invention

[0036] 120 parts of Acorus calamus, 210 parts of Cuscuta seeds, 150 parts of Curcuma aromatica, 120 parts of Bombyx batryticatus, 120 parts of earthworms, 150 parts of Pinellia tubers, 210 parts of processed Arisaema, 150 parts of dried tangerine peels, 180 parts of Uncaria rhynchophylla, 120 parts of Polygala tenuifolia, 120 parts of Styrax odorata, 180 parts of Poria, 90 parts of Menthol, 150 parts of the Angelica dahurica, 120 parts of Ligusticum chuanxiong, and 90 parts of Borneolum.

[0037] Example 8: Preparation method of the Chinese medicine nasal spray of the present invention

[0038] The following steps are involved:

[0039] a. Weigh the corresponding weight portions of the drug standby, Acorus gramineus, Cuscuta, Curcuma, Bombyx batryticatus, Earthworm, Pinellia, Arisaema, Tangerine peel, Uncaria rhynchophylla, Polygala tenuifolia, Poria were crushed into coarse particles, extracted 2-3 times with 70-80% ethanol under reflux, adding 6-10 times the amount of ethanol each time, extracted for 1-2 hours, the liquid was filtered and combined, the ethanol was recovered and concentrated to a relative density (at 40 ° C) of 1.02-1.05, set aside; mint, Chuanxiong, Angelica dahurica was crushed to 20 mesh, steam distilled for 6 hours, and the volatile oil was collected (condensation temperature ≤ 10 ° C); borneol and storax were dissolved in a small amount of ethanol and filtered through a 0.22 μm filter membrane for later use;

[0040] b. The concentrate of Acorus calamus, Cuscuta chinensis, Curcuma zedoaria, Bombyx batryticatus, earthworm, Pinellia ternata, processed Arisaema, dried tangerine peel, Uncaria rhynchophylla, Polygala tenuifolia, and Poria cocos was adjusted to pH 4-5 with 20% HCl, 5% (v / v) gelatin solution was added until no precipitation formed, the liquid was concentrated to a volume ratio of 1:1 (concentrate: medicinal material), ethanol was added to an alcohol precipitation concentration of 60-70%, the solution was allowed to stand at 3-10°C for 12-24 hours, and filtered; a 20% (v / v) concentrated solution of Poloxamer was prepared, and the peppermint, Chuanxiong, Angelica dahurica volatile oil, borneol, and styrax ethanol solution were added while stirring, mixed evenly, and then stirred evenly with the combined liquid;

[0041] c. Adjust the pH to 7-8 with 50% (v / v) sodium hydroxide solution, add purified water to adjust the volume to 1000ml, add propellant (such as hydrofluoroalkane HFA-134a or HFA-227), and mix in a volume ratio of 1:3 to 1:5 between the solution and the propellant.

[0042] d. Use pressure filling equipment to fill the drug solution and propellant into an aerosol container. Sterilize with circulating steam for 30 minutes, and then fill into a sterile metered-dose nasal spray device. Each bottle contains 10 mL, and the single spray volume is 0.05 mL (containing 30 mg of crude drug).

[0043] Example 9: Clinical Trial

[0044] 1. Clinical Data

[0045] A total of 100 patients with mild cognitive impairment after stroke (52 males and 48 females) were enrolled from our hospital. The patients had a mean age of (72.31±9.10) years and a mean disease duration of 1.06 years. They were randomly divided into a nasal spray group (50 patients) or a placebo group (50 patients) for an 8-week treatment course. There were no significant differences in gender, age, or disease duration between the groups (P>0.05), indicating comparability.

[0046] 2. Diagnostic criteria

[0047] All cases were diagnosed according to the TCM diagnostic criteria for stroke in the national TCM higher education textbook "Chinese Medicine Internal Medicine" and met the diagnostic criteria for dementia. The Western medicine diagnostic criteria for "stroke" cover both ischemic and hemorrhagic strokes. The diagnostic criteria for "ischemic stroke" refer to the diagnostic criteria for ischemic stroke in the "Key Points for Diagnosis of Various Cerebrovascular Diseases in China 2019":

[0048] ① Acute onset of focal neurological deficits, sometimes global neurological deficits;

[0049] ② The corresponding brain infarction focus is confirmed by cranial CT / MRI, or the symptoms and signs persist for more than 24 hours, or death occurs within 24 hours;

[0050] ③Exclude non-ischemic causes.

[0051] The diagnostic criteria for "hemorrhagic stroke" refer to the diagnostic criteria for hemorrhagic stroke in the "Key Points for Diagnosis of Various Cerebrovascular Diseases in China 2019":

[0052] ①Sudden focal neurological deficit or headache, vomiting, or varying degrees of impaired consciousness;

[0053] ② Head CT / MRI showing intracerebral hemorrhage lesions;

[0054] ③Exclude secondary or traumatic cerebral hemorrhage caused by other causes.

[0055] The diagnostic criteria for "mild cognitive impairment" refer to the diagnostic criteria for MCI in the "2018 China Dementia and Cognitive Impairment Diagnosis and Treatment Guidelines (V): Diagnosis and Treatment of Mild Cognitive Impairment" compiled by the Cognitive Impairment Disease Professional Committee of the Neurology Branch of the Chinese Medical Association:

[0056] ① Cognitive impairment reported by patients or informed parties, or discovered by experienced clinicians;

[0057] ② Objective evidence of impairment in one or more domains of cognitive function (from cognitive tests).

[0058] 3. Inclusion criteria

[0059] ①Meet all the above diagnostic criteria;

[0060] ② For cognitive impairment that occurs after a stroke, other possible causes need to be excluded;

[0061] ③ Cognitive dysfunction occurs within 6 months after stroke, and the stroke duration is between 90 and 180 days;

[0062] ④ Individuals experiencing symptoms for the first time and excluding cognitive impairment caused by other diseases;

[0063] ⑤Age range: 45 to 75 years old;

[0064] ⑥MoCA scores range from 19 to 25 points;

[0065] 7. The MMSE score should be higher than the corresponding educational level limit: if no education, the score should be more than 17 points; if the years of education are ≤ 6 years, the score should be more than 20 points; if the years of education are > 6 years, the score should be more than 24 points;

[0066] ⑧ The daily living ability scale (ADL) is greater than 60 points;

[0067] ⑨The patient and his / her family accepted the treatment plan and signed the informed consent form.

[0068] 4. Exclusion criteria

[0069] ① History of stroke;

[0070] ②Any neuropsychiatric comorbidities and affective disorders that may affect the test results;

[0071] ③ Patients with new bilateral brain lesions;

[0072] ④Current skull defect;

[0073] ⑤ Currently taking antidepressants or stimulants;

[0074] ⑥ Those who have metal implants or pacemakers installed near the treatment site;

[0075] ⑦Previous history of other brain diseases, such as brain tumors, brain trauma, epileptic seizures, etc.;

[0076] ⑧ History of malignant tumor;

[0077] ⑨Unstable vital signs or failure of important organs.

[0078] 5. Treatment Methods

[0079] Two groups of 50 cases each were used. The nasal spray group received clinical treatment with the Chinese medicine nasal spray of the present invention (prepared by the methods of Examples 4 and 8). The patients were instructed to apply pressure directly to the nasal cavity while inhaling, three times a day, 2-3 times each time, for a course of treatment of 8 weeks. The placebo group received a normal saline nasal spray of the same appearance, and the use method was the same as that of the nasal spray group.

[0080] 6. Efficacy Evaluation

[0081] The efficacy criteria established in the 2003 "Criteria for the Diagnosis, Syndrome Differentiation, and Therapeutic Evaluation of Vascular Dementia" were used, with the MMSE score as the primary indicator. The change in MMSE score before and after treatment was used as the evaluation indicator. The efficacy index = (score after 4 weeks of treatment - MMSE score before treatment) / MMSE score before treatment × 100%. The total effective rate = (number of markedly effective + effective cases) / total number of cases × 100%. Markedly effective: score improvement ≥ 20%; effective: score improvement ≥ 12% but less than 20%; ineffective: score improvement < 12%. Secondary indicators included the MoCA score and the ADL scale.

[0082] Table 1 Evaluation of therapeutic efficacy

[0083]

[0084] Table 2 MoCA scores and ADL daily living ability scale scores before and after treatment in the two groups

[0085]

[0086] The total effective rate of the nasal spray group was significantly better than that of the control group (P<0.05). Before treatment, there was no statistical difference in the MoCA scale scores and ADL daily living ability scale scores of the two groups of patients, and the baselines were comparable. After treatment, the MoCA scale scores and ADL daily living ability scale scores of the experimental group were better than those of the control group, and the differences were statistically significant (P<0.05). Only 2 cases (4%) experienced transient nasal dryness, and no allergy or burning pain was reported.

[0087] The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the described embodiments. Those skilled in the art may make various equivalent modifications or substitutions without departing from the spirit of the present invention. These equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims

1. A Chinese medicine composition for treating mild cognitive impairment after stroke, characterized in that: It is composed of the following raw materials in the following weight proportions: 60-120 parts of Acorus calamus, 150-210 parts of Cuscuta seeds, 90-150 parts of Curcuma aromatica, 60-120 parts of Bombyx batryticatus, 60-120 parts of earthworms, 90-150 parts of Pinellia tubers, 150-210 parts of processed Arisaema, 90-150 parts of dried tangerine peel, 120-180 parts of Uncaria rhynchophylla, 60-120 parts of Polygala tenuifolia, 60-120 parts of Styrax storax, 120-180 parts of Poria, 30-90 parts of Menthol, 90-150 parts of Angelica dahurica, 60-120 parts of Ligusticum chuanxiong, and 30-90 parts of Borneolum.

2. The Chinese medicine composition for treating mild cognitive impairment after stroke according to claim 1, characterized in that: The medicine is composed of the following raw materials in parts by weight: 90 parts of Acorus calamus, 180 parts of Cuscuta seeds, 120 parts of Curcuma aromatica, 90 parts of Bombyx batryticatus, 90 parts of earthworms, 120 parts of Pinellia ternata, 180 parts of processed Arisaema, 120 parts of dried tangerine peel, 150 parts of Uncaria rhynchophylla, 90 parts of Polygala tenuifolia, 90 parts of Styrax odorata, 150 parts of Poria, 60 parts of mint, 120 parts of Angelica dahurica, 90 parts of Ligusticum chuanxiong and 60 parts of borneol.

3. A Chinese medicine nasal spray comprising the Chinese medicine composition according to claim 1 or 2 as an active ingredient.

4. A method for preparing the Chinese medicine nasal spray according to claim 3, characterized in that: The following steps are involved: a. Weigh the corresponding parts by weight of the drug standby, Acorus gramineus, Cuscuta, Curcuma, Bombyx batryticatus, earthworm, Pinellia, Arisaema, Tangerine peel, Uncaria rhynchophylla, Polygala tenuifolia, Poria were crushed into coarse particles, extracted with 70-80% ethanol reflux 2-3 times, each time adding 6-10 times the amount of ethanol, extracted for 1-2 hours, the liquid was filtered and combined, the ethanol was recovered and concentrated to a relative density of 1.02-1.05 at 40 ℃, set aside; mint, Chuanxiong, Angelica dahurica powder to 20 mesh, steam distilled for 6 hours, the volatile oil was collected, the condensation temperature ≤10 ℃; borneol, storax dissolved in a small amount of ethanol 0.22μm membrane filter standby; b. The concentrate of Acorus calamus, Cuscuta chinensis, Curcuma zedoaria, Bombyx batryticatus, earthworm, Pinellia ternata, processed Arisaema, dried tangerine peel, Uncaria rhynchophylla, Polygala tenuifolia, and Poria cocos was adjusted to pH 4-5 with 20% HCl, 5% (v / v) gelatin solution was added until no precipitation was formed, the liquid was concentrated to a concentrate: medicinal material volume ratio of 1:1, ethanol was added to an alcohol precipitation concentration of 60-70%, and the mixture was allowed to stand at 3-10°C for 12-24 hours and filtered; the paloxam was prepared into a 20% (v / v) concentrated solution, and mint, Chuanxiong, angelica dahurica volatile oil and borneol, storax ethanol solution were added while stirring, mixed evenly, and then stirred evenly with the combined liquid; c. Adjust the pH to 7-8 with 50% (v / v) sodium hydroxide solution, add purified water to adjust the volume to 1000ml, add the propellant, and mix in a volume ratio of 1:3 to 1:5 between the drug solution and the propellant; d. Use pressure filling equipment to fill the drug solution and propellant into an aerosol container. Sterilize with circulating steam for 30 minutes, and then fill into a sterile metered-dose nasal spray device. Each bottle contains 10 mL, a single spray volume of 0.05 mL, and 30 mg of crude drug.

5. Use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating mild cognitive impairment after stroke.

6. Use of the traditional Chinese medicine nasal spray according to claim 3 in the preparation of a medicament for treating mild cognitive impairment after stroke.