Application of hypericum japonicum extract in preparation of medicine for preventing and treating skin itch
By using drugs prepared by the genus dextrose extract, the treatment problems of skin itching and atopic dermatitis caused by various causes were solved, and the effect of significantly improving itching symptoms was achieved, with good application prospects.
Patent Information
- Application Number
- CN202411779993.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-05
- Publication Date
- 2025-02-28
AI Technical Summary
The prior art is difficult to effectively prevent and treat skin itching caused by various reasons, especially itching caused by systemic diseases, skin diseases, immune diseases and infectious diseases. The treatment of atopic dermatitis has problems such as unsatisfactory efficacy, great side effects, and inappropriate long-term application.
Deciduous extract is used as the active ingredient, and the deciduous extract is prepared through ethanol solution extraction, filtration, under-pressure concentration and elution, and is used to prepare drugs for preventing and treating skin itching, including the treatment of skin itching and atopic dermatitis.
The extract of the larvae significantly improves the subjective symptoms of itchy patients, has good therapeutic effects, has certain therapeutic effects on various types of skin itching and atopic dermatitis, and has good application prospects.
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Figure CN119524035A_ABST
Abstract
Description
Technical Field
[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to application of a herba lycopodii extract in preparing a medicine for preventing and treating skin itching. Background Art
[0002] The skin is the outermost organ of the human body and an important part of the body. The skin can protect the body from external mechanical, physical, chemical stimulation and microbial invasion, and can also reflect and participate in the changes in the body's spirit and nutrition.
[0003] Pruritus is a symptom of abnormal skin sensation. It is mainly manifested by itching of the skin, which may be accompanied by burning, tingling or crawling sensations. Pruritus can be systemic or localized, and often presents paroxysmal symptoms, and symptoms may be more severe at night. There are many causes of itching, including dryness, allergies, irritation, temperature changes, friction between clothing and bedding, etc. Survey results among the general population show that about 20% of people often experience itching. It can be seen that itching is a very common clinical symptom.
[0004] Itching caused by kidney disease is more common in patients with late renal failure, and is more common in patients with uremia. 50-70% of patients with uremia have skin itching, and some patients have annoying itching. Among them, 2 / 3 of itching occurs during dialysis or shortly after dialysis. Patients with maintenance hemodialysis often have skin itching, renal osteodystrophy, renal anemia, peripheral neuropathy, pericarditis, immunosuppression, infection, bleeding tendency, etc. The treatment of itching can be oral activated carbon, antihistamines, tranquilizers, sedatives, etc. to relieve uremic itching.
[0005] Diabetes combined with pruritus is one of the common complications of diabetes. It refers to a skin disease in which diabetic patients have no primary skin damage but pruritus as the main clinical manifestation. In severe cases, scratches, blood scabs, skin hypertrophy and lichenification may occur. The incidence rate is about 7% to 43%, especially in the elderly. Western medicine has not yet fully clarified the pathogenesis of diabetic pruritus. It is generally believed that it is closely related to dry skin, high blood sugar or blood sugar fluctuations, microcirculation disorders, nerve dysfunction or nerve damage. The unbearable itching and prolonged and difficult to heal seriously affect the work and life of patients.
[0006] Atopic dermatitis (AD) is a common chronic, inflammatory, recurrent, pruritic and intractable skin disease that usually develops in childhood and may persist into adulthood. It has become a health and economic burden in my country and the world. Atopic dermatitis is characterized by recurrent, itchy, localized eczema, often with seasonal fluctuations. Many patients also suffer from allergic asthma, allergic rhinoconjunctivitis, food allergies and other hypersensitivity reactions. However, drugs for the treatment of moderate to severe atopic dermatitis have problems such as unsatisfactory efficacy, large side effects, and unsuitability for long-term use.
[0007] Hypericum japonicum Thunb., also known as field yellow, is an annual or perennial herb of the genus Hypericum of the family Garcinia. It is bitter and sweet, cool in nature, and has the effects of removing dampness and jaundice, clearing away heat and detoxicating, promoting blood circulation and removing blood stasis, and relieving swelling and relieving pain. It can be used for acute and chronic hepatitis, diarrhea, dysentery, snake bites, sores, carbuncles, injuries from falls, etc. Existing literature reports the effects of Hypericum japonicum in antibacterial, liver protection, antimalarial, antiviral, and antioxidation. There is no report on its application in skin itching drugs or atopic dermatitis drugs. Summary of the invention
[0008] The purpose of the present invention is to provide an application of a herba lycopodii extract in preparing a medicine for preventing and treating skin itching.
[0009] Furthermore, the skin itching includes itching caused by systemic diseases, itching caused by skin diseases, itching caused by immune diseases, itching caused by infectious diseases, drug-induced itching, senile skin itching, and pregnancy itching.
[0010] Furthermore, the systemic disease is nephropathy, obstructive hepatobiliary disease, thyroid dysfunction, diabetes, anemia, and tumor.
[0011] Furthermore, the skin disease is eczema, allergic dermatitis, urticaria, nodular prurigo, exfoliative dermatitis, neurodermatitis, atopic dermatitis.
[0012] Furthermore, the immune disease is psoriasis, dermatomyositis, or Sjögren's syndrome.
[0013] Furthermore, the infectious disease is scabies infection or fungal infection.
[0014] The present invention also provides the use of the extract of Ligusticum chuanxiong in preparing a medicine for treating atopic dermatitis.
[0015] The present invention also provides the use of the extract of Ligusticum chuanxiong in preparing a medicine for treating skin damage caused by atopic dermatitis.
[0016] Furthermore, the preparation method of the herbaceous earthworm extract is as follows: extracting the herbaceous earthworm material with an ethanol solution, filtering the extract, combining it, concentrating it under reduced pressure, centrifuging it, taking the upper layer liquid and concentrating it again, cooling it, applying it to a treated polyamide column or a macroporous resin column, eluting it, qualitatively identifying it with concentrated sulfuric acid, collecting the alcohol eluate that shows a positive reaction, concentrating it under reduced pressure and vacuum drying it to obtain the herbaceous earthworm extract.
[0017] Preferably, the preparation method of the extract of ground ear grass is as follows: the ground ear grass material is refluxed and extracted with an ethanol solution with a volume concentration of 30% to 90% for 1 to 5 times, each time for 1 to 3 hours, the extract is filtered, combined, concentrated under reduced pressure to a specific gravity of 1.01 to 1.20, centrifuged, the upper layer is taken and concentrated again, cooled, and applied to a treated polyamide column or a macroporous resin column; eluted with a large amount of deionized water, an ethanol solution with a volume concentration of 5 to 30%, and an ethanol with a volume concentration of 50 to 95%, respectively, and qualitatively identified with concentrated sulfuric acid, and the alcohol eluate with a positive reaction is collected, concentrated under reduced pressure and vacuum dried to obtain the ground ear grass extract.
[0018] Furthermore, the drug is an oral preparation prepared by using the extract of Ligusticum chuanxiong as an active ingredient and adding pharmaceutically acceptable excipients.
[0019] The beneficial effects of the present invention are:
[0020] The present invention provides an application of a herba lycopersicum extract in preparing a drug for preventing and treating skin itching. The present invention also provides an application of a herba lycopersicum extract in preparing a drug for treating atopic dermatitis. The present invention also provides an application of a herba lycopersicum extract in preparing a drug for treating skin damage caused by atopic dermatitis.
[0021] The extract of the present invention can improve the pruritus caused by systemic diseases, the pruritus caused by skin diseases, the pruritus caused by immune diseases, the pruritus caused by infectious diseases, the pruritus caused by drugs, the pruritus of the elderly and the pruritus of pregnancy. Clinical trials have shown that the preparation prepared with the extract of the present invention as the active ingredient can significantly improve the subjective symptoms of patients with pruritus, and has a certain therapeutic effect on patients with renal pruritus, diabetic skin pruritus, allergic dermatitis pruritus, eczema pruritus, exfoliative dermatitis pruritus, elderly skin pruritus, scabies pruritus and neurodermatitis. The extract of the present invention has an inhibitory effect on histamine-induced itchy mice; the extract of the present invention can reduce the thickening of the ears and epidermis of mice induced by DNCB, reduce the severity of skin lesions, and has a certain therapeutic effect on atopic dermatitis. The extract of the present invention has a good application prospect in the treatment of pruritus. BRIEF DESCRIPTION OF THE DRAWINGS
[0022] Figure 1 This is a statistical chart of the number of scratching times of mice in Example 7 (Note: compared with the model group, *P<0.05, ***P<0.001).
[0023] Figure 2 This is a general picture of the skin in the mouse modeling area in Example 8.
[0024] Figure 3 This is a statistical graph of local skin lesion scores in mice in Example 8.
[0025] Figure 4 This is a statistical graph of the epidermal thickness of the mouse back skin in Example 8.
[0026] Figure 5 This is a statistical graph of the thickness of the right ear of mice in Example 8.
[0027] Figure 6 This is a picture of the skin pathology on the back of mice in Example 8.
[0028] Figure 7 This is a line graph showing the weekly average changes in the itch scores of the 33 itch patients in Example 9.
[0029] Figure 8 This is a line graph of pruritus scores for various diseases in Example 9. DETAILED DESCRIPTION
[0030] The present invention will be further described in detail below through specific examples.
[0031] Example 1 Preparation of Ligusticum chuanxiong Extract
[0032] Cut the herb into 2-3 cm long segments, extract it with 30% ethanol solution by reflux twice, each time for 2 hours, filter the extract, combine it, concentrate it under reduced pressure to a specific gravity of 1.10, centrifuge it, take the upper layer and concentrate it to a small volume (1 mL contains 2 g of the original herb), cool it, and apply it to a treated AB-8 macroporous resin column at a flow rate of 1 mL / min; elute it with a large amount of deionized water, 10% ethanol solution by volume, and 60% ethanol solution by volume, respectively, use concentrated sulfuric acid for qualitative identification, collect the alcohol eluate showing a positive reaction, concentrate it under reduced pressure and dry it in vacuum to obtain the herb extract.
[0033] Example 2 Preparation of Ligusticum chuanxiong Extract
[0034] Cut the herb into 2-3 cm long segments, extract it with 60% ethanol solution by reflux for 3 times, each time for 3 hours, filter the extract, combine it, concentrate it under reduced pressure to a specific gravity of 1.20, centrifuge it, take the upper layer and concentrate it to a small volume (1 mL contains 2 g of the original herb), cool it, and apply it to a treated AB-8 macroporous resin column at a flow rate of 1 mL / min; elute it with a large amount of deionized water, an ethanol solution with a volume concentration of 25%, and an ethanol solution with a volume concentration of 75%, respectively, and identify it qualitatively with concentrated sulfuric acid, collect the alcohol eluate with a positive reaction, concentrate it under reduced pressure and dry it in vacuum to obtain the herb extract.
[0035] Example 3 Preparation of Ligusticum chuanxiong Extract
[0036] Cut the herb into 2-3 cm long segments, extract it with 90% ethanol solution by reflux for 4 times, 3 hours for the first time, 1 hour for the second, third and fourth times respectively, filter the extract, combine, concentrate under reduced pressure to a specific gravity of 1.01, centrifuge, take the upper layer and re-concentrate it to a small volume (1 mL contains 2 g of the original herb), cool it, and apply it to a treated polyamide column at a flow rate of 1 mL / min; elute it with a large amount of deionized water, 30% ethanol solution by volume, and 90% ethanol solution by volume, and identify it qualitatively with concentrated sulfuric acid, collect the alcohol eluate with a positive reaction, concentrate it under reduced pressure and dry it in vacuum to obtain the herb extract.
[0037] Example 4 Preparation of Ligusticum chuanxiong Capsules
[0038] 15 parts of the Herba Lycopodii extract prepared in Example 1, 13.5 parts of colloidal silicon dioxide as a diluent, 20 parts of 85% ethanol as a wetting agent, 1 part of sodium carboxymethyl starch as a disintegrant, 0.3 parts of magnesium stearate as a lubricant, and 0.2 parts of polysorbate 800 as a surfactant.
[0039] Weigh the prescribed amount of polysorbate 80, add 85% ethanol to prepare a polysorbate 80-ethanol suspension; weigh the prescribed amount of ground ear grass extract, silicon dioxide, and sodium carboxymethyl starch, add them to the high-efficiency wet mixing granulator in 2 to 3 times, stir at low speed for 5 minutes, mix evenly, and obtain premixed powder; continue to start low-speed stirring and low-speed shearing, add polysorbate 80-85% ethanol suspension, stir while adding, continue stirring for 2 to 3 minutes after the addition is completed, make a soft material, add it to the swing granulator, granulate twice with a 24-mesh screen, and obtain wet granules; the wet granules are dried with a spray drying granulator to a moisture content of ≤5.0%, sieve through a 24-mesh sieve, add magnesium stearate, mix evenly, and obtain dry granules; the granules are filled with gelatin hollow capsules (0#). The relevant parameters of the capsule are shown in Table 1.
[0040] Table 1 Relevant parameters of the prepared capsules
[0041] Test items Measurement results Characteristics It is a hard capsule with brown to brown granules as the contents; slight odor and slightly bitter taste Dissolution 93.7％ Difference in filling volume 4.3％ Moisture 6.3％ Total flavonoids content <![CDATA[Each capsule contains 90.2 mg of total flavonoids calculated as quercitrin (C 21 H 20 O 11 )]]> Microbial Limits Comply with regulations
[0042] Example 5 Preparation of Ligusticum wallichii tablets
[0043] 15 parts of the Herba Lycopodii extract prepared in Example 1, 11.5 parts of starch as a diluent, 1 part of povidone K30 as a binder, 15 parts of 80% ethanol as a wetting agent, 2 parts of sodium carboxymethyl starch as a disintegrant, and 0.5 parts of magnesium stearate as a lubricant.
[0044] Weigh the prescribed amount of the extract of the ground ear grass, starch, povidone K30, and sodium carboxymethyl starch, respectively, and pass through a 100-mesh sieve, and mix them evenly using a high-efficiency wet mixing granulator for use; add 80% ethanol and mix to make a soft material, granulate twice with a 20-mesh sieve to obtain wet granules; dry the wet granules with a spray dryer granulator at 60°C, pass through an 18-mesh sieve to granulate, add magnesium stearate, mix evenly, and obtain dry granules; use a tablet press to compress the tablets to obtain plain tablets, and coat them with a gastric-soluble film coating premix of 2-4% by weight to obtain tablets. Tablet-related parameters are shown in Table 2.
[0045] Table 2 Relevant parameters of the prepared tablets
[0046] Test items Measurement results Characteristics Yellow-brown tablets, smooth surface Disintegration time 18min Difference in filling volume 3.9％ Moisture 5.8％ hardness 9.64kg friability 0.3％ Total flavonoids content <![CDATA[Each tablet contains 89.6 mg of total flavonoids calculated as quercitrin (C 21 H 20 O 11 )]]> Microbial Limits Comply with regulations
[0047] Example 6 Preparation of granules
[0048] 15 parts of the extract of the herb prepared in Example 1, 30 parts of diluents dextrin and mannitol, 5 parts of a binder hydroxymethyl cellulose, 15 parts of a wetting agent 20% ethanol, 2 parts of a disintegrant low-substituted hydroxypropyl cellulose, 0.5 parts of a lubricant magnesium stearate, and 0.1 parts of a flavoring agent sucralose.
[0049] Weigh sucralose, stir and dissolve it with 20% ethanol to prepare sucralose-20% ethanol solution; weigh the prescribed amount of ground ear extract, dextrin, mannitol, hydroxymethyl cellulose, and low-substituted hydroxypropyl cellulose, pass through a 100-mesh sieve, and mix them evenly using a high-efficiency wet mixing granulator for standby use; add the prepared sucralose-20% ethanol solution to wet-process soft material, granulate with a 12-mesh sieve to prepare wet granules; dry the wet granules at 60°C until the moisture content is less than 7% to obtain dry granules, sieve the dry granules with a 12-mesh sieve, and then pass through a 65-mesh sieve. Take the granules that can pass through the 12-mesh sieve and cannot pass through the 65-mesh sieve as qualified granules for standby use. The coarse granules that cannot pass through the 12-mesh sieve and the unqualified granules that can pass through the 65-mesh sieve are crushed and re-granulated; add magnesium stearate to each granule in a mixer and mix for 10 minutes, and pack into bags to obtain the granules. The relevant parameters of the granules are shown in Table 3.
[0050] Table 3 Relevant parameters of the prepared granules
[0051] Test items Measurement results Characteristics The particles are yellow-brown, with little fine powder and slightly sweet Difference in filling volume 4.7％ Moisture 5.9％ Solubility qualified Total flavonoids content <![CDATA[Each bag contains 150.4 mg of total flavonoids calculated as quercitrin (C 21 H 20 O 11 )]]> Microbial Limits Comply with regulations
[0052] Example 7 Evaluation of the efficacy of Ligusticum chuanxiong extract on histamine-induced pruritus mouse model
[0053] 46 10-week-old ICR mice were randomly divided into 3 groups: normal control group, model group, and lycopodiella group, including 6 normal control group, 22 model group, and 18 lycopodiella group. After the mice were adapted to feeding, the normal control group and the model group were given 0.5% CMC-Na, 10 mL / kg, by oral gavage every day; the lycopodiella group was given the lycopodiella extract prepared in Example 1, 240 mg / kg, by oral gavage every day. Once a day, for a total of 4 days.
[0054] One hour after the last administration, except for the normal control group, the pruritus mouse model was established by a single intradermal injection of histamine 30μg / 50μL at the back of the neck in all other groups, and the normal control group was injected with an equal amount of saline at the same site. After intradermal injection of histamine / saline, the number of scratching of the mice within 30 minutes was counted to evaluate the inhibitory effect of the drug on histamine-induced pruritus.
[0055] The experimental results are shown in Figure 1 Compared with the model group, the number of scratching times of mice in the lycopodiella group was significantly reduced (*p<0.05). The experimental results showed that the lycopodiella extract had an inhibitory effect on histamine-induced pruritus, indicating that the lycopodiella extract had a certain preventive and therapeutic effect on skin pruritus.
[0056] Example 8 Evaluation of the efficacy of Ligusticum wallichii extract on atopic dermatitis (AD) mouse model
[0057] Thirty-five 8-week-old BALB / C mice were randomly divided into four groups: normal control group, model group, dexamethasone group, and lycopodiella ciliata group. There were 5 mice in the normal control group and 10 mice in each of the other groups.
[0058] The back skin and ears of all mice were depilated and hair removed to expose the skin. On the first day of the experiment, all mice except the normal control group were evenly smeared with 100 μL and 50 μL of 1% DNCB solution on the back and right ear for the first sensitization. No treatment was given on the second day, and on the third day, the same dose and concentration of DNCB were applied to the back and left ear of the mice to strengthen sensitization. On the 7th, 9th, 11th, 13th, 15th, 17th, and 19th days of the experiment, 0.5% DNCB solution was used to apply the same dose to the back and left ear of the mice for stimulation. The normal control group mice were smeared with an equal volume of matrix solution (acetone and olive oil 3:1) at the same time point and the same part.
[0059] Each group of mice was given the corresponding intervention drugs at the sensitized site 8 hours after modeling on the first day of the experiment. The normal control group and the model group were given 0.5% CMC-Na, 10 mL / kg, by gavage. The herba lycopersicum group was given the herba lycopersicum extract prepared in Example 1 by gavage, with a dose of 240 mg / kg. A thin layer of dexamethasone ointment was applied to the modeling site in the dexamethasone group, once a day, for 20 days.
[0060] Scoring of local skin lesions in mice: On the 4th day of the experiment and at intervals of 1 day thereafter, the skin of the mice was photographed and the skin lesions were recorded before administration. The observation indicators included erythema (rash or bleeding), edema (papule), epidermal exfoliation (scratches or ulcers) and scaling (dryness). The score was comprehensively evaluated based on the symptoms. The scoring criteria for each symptom are shown in Table 4. The final score was the sum of the scores of the four symptoms, with a total score of 0 to 12 points.
[0061] Statistics of epidermal thickness of mouse back skin: After HE staining of the back skin, 15 sites were randomly selected to measure the epidermal thickness.
[0062] Table 4 Skin lesion scoring criteria
[0063]
[0064] The experimental results are shown in Figures 2 to 6 .
[0065] Mouse local skin lesion scoring: see Figure 2 to Figure 4 , (Note: Compared with the model group, *P<0.05, **P<0.01, ***P<0.001, result = mean±SEM) Compared with the normal control group, the model group mice had obvious symptoms of right ear dermatitis from the 6th day, and the ear thickness increased significantly (p<0.001), and the back dermatitis symptoms were obvious from the 4th day, and the total score increased significantly (p<0.001). The thickness of the right ear of the dexamethasone group was lower than that of the model group from the 8th day to the 14th day, which was statistically different (p<0.001, p<0.05), and the back dermatitis score was not significantly different from the model group. The thickness of the right ear of the mice in the lycopodiella group was significantly lower than that of the model group from the 8th day, and the total score of the back dermatitis was significantly lower than that of the model group from the 6th day, which was statistically different (p<0.05 or p<0.01 or p<0.001).
[0066] Statistics of mouse back skin epidermal thickness: see Figure 5-6 , (Note: compared with the model group, *P<0.05, **P<0.01, ***P<0.001, result = mean±SEM), compared with the normal control group, the epidermal thickness of the model group was significantly increased (p<0.001); the epidermal thickness of the mice in the Ligustrum lucidum group was significantly lower than that in the model group (***P<0.001).
[0067] The results showed that the extract of Ligusticum chuanxiong could reduce DNCB-induced ear and epidermal thickening in mice, reduce the severity of skin lesions, and have a certain therapeutic effect on atopic dermatitis.
[0068] Example 9 Effectiveness Test
[0069] The present invention included 34 patients with pruritus, and one patient withdrew from the drug after taking it once and developed diarrhea, and finally 33 cases of clinical effectiveness observation data were obtained. The research methods and test results adopted are as follows:
[0070] 9.1 General Information:
[0071] Age was over 18 years old, regardless of gender. Patients were classified according to pruritus diseases, including 16 cases of renal pruritus, 2 cases of diabetic skin pruritus, 8 cases of atopic dermatitis, 3 cases of eczema, 1 case of exfoliative dermatitis, 1 case of senile skin pruritus, 1 case of scabies, and 1 case of neurodermatitis.
[0072] 9.2 Inclusion criteria:
[0073] (1) Those with skin itching symptoms who had received treatment before enrollment and had no significant improvement. (2) Aged 18 years or older, regardless of gender. (3) Willing to take the Diercao capsule preparation of the present invention as required and able to cooperate in completing the questionnaire survey.
[0074] 9.3 Treatment methods:
[0075] The Diercao capsule preparation prepared by Example 4 of the present invention was taken orally, 3 capsules each time, 3 times a day, for 4 consecutive weeks.
[0076] 9.4 Observation indicators:
[0077] Itch score: change in itch symptom score after 4 weeks of medication. Each patient scored pruritus 5 times (before medication and 1, 2, 3, and 4 weeks after medication), and completed the score once a week, according to the degree of itching. The effectiveness index is the pruritus score value of 0 to 10 points.
[0078] 9.5 Efficacy determination
[0079] The treatment was divided into three levels: markedly effective, effective, and ineffective, based on the percentage reduction of the clinical pruritus severity score.
[0080] [(score before treatment - score after treatment) ÷ score before treatment] x 100%.
[0081] (1) Significantly effective: The total score of pruritus intensity decreased by ≥50%.
[0082] (2) Effective: The total score of pruritus intensity decreased by ≥30% but less than 50%.
[0083] (3) Ineffective: Failure to meet the effective criteria or worsening of symptoms.
[0084] Total effective rate = [(number of markedly effective cases + number of effective cases) ÷ total number of cases] x 100%.
[0085] Efficacy evaluation: The evaluation is based on the score of the Worst Itch Intensity Numerical Rating Scale (WI-NRS) before and after treatment. The score range of this scale is from 0 to 10, where 0 represents no itching and 10 represents extremely severe itching. Patients need to select a number that best describes their itching level in the past 24 hours.
[0086] The specific standards are as follows:
[0087] 0 points: no itching sensation;
[0088] 1-3 points: mild itching, but tolerable, not affecting daily life and sleep;
[0089] 4-6 points: moderate itching, requiring scratching or massage, somewhat affecting daily life and sleep;
[0090] 7-9 points: severe itching, requiring constant scratching or massage, seriously affecting daily life and sleep;
[0091] 10 points: Extreme itching, unbearable, requiring immediate scratching or massage, seriously affecting daily life and sleep.
[0092] 9.6 Results of effectiveness studies
[0093] After 33 pruritus patients took Di Er Cao capsule for 4 weeks, the pruritus score was reduced by an average of 6.5 points compared with before medication, of which 31 patients had a reduction of ≥ 5 points (94%), and 2 patients had a reduction of 3 points (6%). Figure 7 .
[0094] Among them, 31 cases (accounting for 94%) were markedly effective, 2 cases (accounting for 6%) were effective, and 0 cases (accounting for 0%) were ineffective, with an overall effective rate of 100%.
[0095] The average itch scores by disease category, all 8 itch types had a decrease in itch scores. See Table 5 and Figure 8 .
[0096] Table 5 Itch scores of patients with pruritus
[0097]
[0098] The medication took effect on patients with pruritus in as little as 1 day and as late as 20 days, with an average of 5.8 days (see Table 6).
[0099] Table 6 Onset time of medication in patients with pruritus
[0100] Effective days Number of cases percentage Remark 20 days 1 3.0％ 14 days 3 9.1％ 9 days 1 3.0％ 8 days 1 3.0％ 7 days 13 39.4％ Mainly chronic kidney disease pruritus 6 days 1 3.0％ 3 days 1 3.0％ 2 days 3 9.1％ 1 day 9 27.3％ Mainly allergic dermatitis
[0101] 9.7 Safety Study Results
[0102] One patient (renal pruritus) experienced short-term stomach distension and discomfort after taking the medicine, which then improved. Another patient (renal pruritus) developed diarrhea after taking the medicine once and then stopped taking the medicine. No other adverse reactions were found. No serious adverse events occurred.
[0103] In summary, the preparation prepared by the extract of the present invention can significantly improve the subjective symptoms of patients with itching, and has a certain therapeutic effect on patients with renal itching, diabetic skin itching, allergic dermatitis itching, eczema itching, exfoliative dermatitis itching, senile skin itching, scabies itching, and neurodermatitis. The extract of the present invention has an inhibitory effect on histamine-induced itchy mice; the extract of the present invention can reduce DNCB-induced mouse ear and epidermal thickening, reduce the severity of skin lesions, and has a certain therapeutic effect on atopic dermatitis. The extract of the present invention has a good application prospect in the treatment of pruritus.
Claims
1. Application of extract of Ligusticum chuanxiong in the preparation of medicines for preventing and treating skin itching.
2. The use according to claim 1, characterized in that: The skin itching includes itching caused by systemic diseases, itching caused by skin diseases, itching caused by immune diseases, itching caused by infectious diseases, drug-induced itching, senile skin itching, and pregnancy itching.
3. The use according to claim 2, characterized in that: The systemic diseases are kidney disease, obstructive hepatobiliary disease, thyroid dysfunction, diabetes, anemia, and tumor.
4. The use according to claim 2, characterized in that: The skin diseases are eczema, allergic dermatitis, urticaria, nodular prurigo, exfoliative dermatitis, neurodermatitis, and atopic dermatitis.
5. The use according to claim 2, characterized in that: The infectious diseases are scabies infection and fungal infection.
6. Use of the extract of Ligusticum chuanxiong in the preparation of medicines for treating atopic dermatitis.
7. Use of extract from Ligusticum chuanxiong in the preparation of drugs for treating skin damage caused by atopic dermatitis.
8. The use according to claim 1, characterized in that: The preparation method of the extract of ground ear grass comprises the following steps: extracting the ground ear grass material with an ethanol solution, filtering the extract, combining the extract, concentrating under reduced pressure, centrifuging, taking the upper layer liquid and concentrating it again, cooling it, applying it to a treated polyamide column or a macroporous resin column, eluting it, qualitatively identifying it with concentrated sulfuric acid, collecting the alcohol eluate showing a positive reaction, concentrating it under reduced pressure, and vacuum drying it to obtain the ground ear grass extract.
9. The use according to claim 8, characterized in that: At least one of the following is met: The volume concentration of the ethanol solution is 30% to 90%; The extraction is performed by reflux extraction, the number of extractions is 1 to 5 times, each time for 1 to 3 hours; The extracts were filtered, combined, concentrated under reduced pressure to a specific gravity of 1.01 to 1.20, and centrifuged; The elution is performed by using a large amount of deionized water, an ethanol solution with a volume concentration of 5 to 30%, and an ethanol solution with a volume concentration of 50 to 95%.
10. The use according to claim 1 or 6 or 7, characterized in that: The medicine is an oral preparation prepared by taking the extract of Ligusticum chuanxiong as the active ingredient and adding pharmaceutically acceptable auxiliary materials.