阅读说明：本技术 一种中药组合物在制备治疗或预防湿疹药物中的应用 (Application of traditional Chinese medicine composition in preparation of medicine for treating or preventing eczema ) 是由 肖伟 王永香 李芳� 吴云 王振中 于 2019-08-14 设计创作，主要内容包括：本发明提供了一种治疗湿疹的组合物。该中药组合物能明显抑制二甲苯引起的小鼠耳肿胀,抑制组胺所致皮肤瘙痒,明显改善过敏接触性皮炎,而且通过临床实验表明,本发明提供的中药组合物对于湿疹具有较好的疗效。(The invention provides a composition for treating eczema. The traditional Chinese medicine composition can obviously inhibit ear swelling of mice caused by xylene, inhibit skin itch caused by histamine and obviously improve allergic contact dermatitis, and clinical experiments show that the traditional Chinese medicine composition provided by the invention has a better curative effect on eczema.)

1. Use of a composition for the manufacture of a medicament for the treatment or prevention of eczema, the composition comprising: 5-30 parts of sweet wormwood, 3-20 parts of honeysuckle and 2-15 parts of gardenia.

2. Use according to claim 1, wherein the composition comprises: 5-25 parts of sweet wormwood, 3-15 parts of honeysuckle and 2-12 parts of gardenia.

3. Use according to claim 1, wherein the composition comprises: 10-25 parts of sweet wormwood, 6-15 parts of honeysuckle and 4-12 parts of gardenia.

4. Use according to claim 1, wherein the composition comprises: 11 parts of sweet wormwood, 8 parts of honeysuckle and 7 parts of gardenia.

5. Use according to claim 1, wherein the composition comprises: 25 parts of sweet wormwood, 15 parts of honeysuckle and 12 parts of cape jasmine.

6. The use according to any one of claims 1 to 5, wherein the medicament for treating or preventing eczema comprises an oral administration form, an injection administration form or an external administration form.

7. The use of claim 6, wherein the medicament for treating or preventing eczema comprises decoction, granules, capsules, tablets, oral liquid, pills, tinctures, syrups, suppositories, gels, sprays and injections.

8. Use according to any one of claims 1 to 5, wherein said composition is prepared by a process comprising the steps of:

Step A, soaking honeysuckle and sweet wormwood in water, heating, decocting and distilling, and collecting volatile oil for later use; concentrating and drying the decoction to obtain dry extract powder of flos Lonicerae and herba Artemisiae Annuae;

Heating and refluxing fructus Gardeniae with ethanol water solution, filtering, recovering ethanol from filtrate, concentrating, adjusting to acidity with hydrochloric acid, heating for 0.5-1.5 hr, refrigerating for 10-14 hr, filtering, concentrating the filtrate, and drying to obtain fructus Gardeniae dry extract powder;

And step C, coating the volatile oil by using auxiliary materials conventionally, and then uniformly mixing the volatile oil with the dry paste powder.

9. Use of a composition for the manufacture of a medicament for the treatment or prevention of allergic contact dermatitis, the composition comprising: 5-30 parts of sweet wormwood, 3-20 parts of honeysuckle and 2-15 parts of gardenia.

10. The use of claim 9, wherein the medicament for treating or preventing allergic contact dermatitis comprises an oral administration form, an injection administration form or an external administration form.

Technical Field

The invention belongs to the field of traditional Chinese medicine application, and particularly relates to application of a traditional Chinese medicine composition in preparation of a medicine for treating or preventing eczema.

Background

Eczema is one of common clinical skin diseases, is mostly caused by repeated attacks and delays of acute eczema and subacute eczema, is considered to be related to I, IV type allergic reaction, bacterial or fungal infection and the like according to modern researches, and is clinically mainly manifested as allergic inflammation, severe itching and the like. Eczema accounts for about 20% of outpatients in dermatology, and the incidence rate of eczema is on the rise in recent years.

Disclosure of Invention

The invention aims to provide a composition or a medicine for treating or preventing eczema, and particularly provides application of the composition in preparing the medicine for treating or preventing eczema, which is characterized by comprising the following components in parts by weight: 5-30 parts of sweet wormwood, 3-20 parts of honeysuckle and 2-15 parts of gardenia. The composition of the present invention may be directly ground into powder, or may be an extract prepared by a conventional method in the art, etc. The traditional Chinese medicine used in the composition of the present invention can also be used by directly grinding into powder, extract or other processing forms.

Further, the composition comprises: 5-25 parts of sweet wormwood, 3-15 parts of honeysuckle and 2-12 parts of gardenia.

Further, the composition comprises: 10-25 parts of sweet wormwood, 6-15 parts of honeysuckle and 4-12 parts of gardenia.

Preferably, the composition comprises: 11 parts of sweet wormwood, 8 parts of honeysuckle and 7 parts of gardenia.

Preferably, the composition comprises: 25 parts of sweet wormwood, 15 parts of honeysuckle and 12 parts of cape jasmine.

Further, the medicine for treating or preventing eczema comprises an oral administration dosage form, an injection administration dosage form or an external administration preparation.

Specifically, the medicine for treating or preventing eczema comprises decoction, granules, capsules, tablets, oral liquid, pills, tinctures, syrups, suppositories, gels, sprays and injections.

The eczema is a common inflammatory skin disease of epidermis and dermis superficial layer caused by various internal and external factors, and is generally considered to have a certain relation with allergy. Its clinical manifestations are symmetrical, exudative, pruritic, polymorphic and recurrent.

Further, the composition preparation method may comprise the steps of:

Step A, soaking honeysuckle and sweet wormwood in water, heating, decocting and distilling, and collecting volatile oil for later use; concentrating and drying the decoction to obtain dry extract powder of flos Lonicerae and herba Artemisiae Annuae;

Heating and refluxing fructus Gardeniae with ethanol water solution, filtering, recovering ethanol from filtrate, concentrating, adjusting to acidity with hydrochloric acid, heating for 0.5-1.5 hr, refrigerating for 10-14 hr, filtering, concentrating the filtrate, and drying to obtain fructus Gardeniae dry extract powder;

and step C, coating the volatile oil by using auxiliary materials conventionally, and then uniformly mixing the volatile oil with the dry paste powder.

preferably, the composition preparation method comprises: soaking 15 parts by weight of honeysuckle and 25 parts by weight of sweet wormwood in 13-18 times of water for 3 hours, heating, decocting and distilling for 2 times, 2 hours each time, and collecting volatile oil for later use; mixing the decoctions, concentrating under reduced pressure to relative density of 1.03-1.08, centrifuging at high speed (20000 rpm) to obtain supernatant, performing fractional ultrafiltration, and concentrating the ultrafiltrate under reduced pressure to obtain extract of 1.23-1.27 (70 + -5 deg.C); pulverizing 12 parts by weight of gardenia into coarse powder, heating and refluxing for 1-3 times by using 80% ethanol in an amount which is 6 times that of the coarse powder for 1 hour each time, combining liquid medicines, filtering, recovering ethanol from filtrate, concentrating to 1: 1, adjusting the pH to 4.0 by using hydrochloric acid, heating for 1 hour at 100 ℃, refrigerating for 12 hours, filtering, and concentrating the filtrate into an extract at 1.23-1.27 (70 +/-5 ℃) for later use; mixing the above extracts and volatile oil. Further, the preparation method of the medicine for treating or preventing eczema comprises the steps of coating the volatile oil with auxiliary materials through a conventional method, and then uniformly mixing the volatile oil with the dry paste powder. The composition can be prepared into clinically acceptable formulations directly through conventional processes or by adding pharmaceutically acceptable excipients.

The invention also provides application of the composition in preparing a medicament for treating or preventing allergic contact dermatitis, which is characterized by comprising the following components in part by weight: 5-30 parts of sweet wormwood, 3-20 parts of honeysuckle and 2-15 parts of gardenia.

Further, the composition comprises: 10-25 parts of sweet wormwood, 6-15 parts of honeysuckle and 4-12 parts of gardenia.

Preferably, the composition comprises: 25 parts of sweet wormwood, 15 parts of honeysuckle and 12 parts of cape jasmine.

Specifically, the medicament for treating or preventing allergic contact dermatitis comprises an oral administration dosage form, an injection administration dosage form or an external administration preparation.

The traditional Chinese medicine composition disclosed by the invention has good curative effects on an animal model of mouse auricle swelling caused by xylene, an animal model of guinea pig skin itch caused by histamine and an animal model of allergic contact dermatitis caused by DNCB. In addition, clinical experiment results also show that the traditional Chinese medicine composition provided by the invention has a better curative effect on eczema.

Detailed Description

As described above, the present invention is directed to a composition or a medicament for treating or preventing eczema. The following will specifically describe the contents of the experimental examples.

The sweet wormwood (Artemisia annua Herba) in the medicine is the dry overground part of Artemisia annua L of Compositae, and is mainly produced in Jiangsu, Jiangxi, Zhejiang and Hunan places. Flos Lonicerae (Lonicera Japonica Flos) is dried bud or flower with initial bloom of Lonicera Japonica (Lonicera Japonica Thunb.) belonging to Caprifoliaceae, and is mainly produced in Shandong, Henan, and Jiangsu; gardenia jasminoides Ellis (Gardenia Fructus) is dried mature fruit of Gardenia jasminoides Ellis (Gardenia jasminoides Ellis) belonging to Gardenia of Rubiaceae, and is mainly produced in Zhejiang, Jiangxi, Hubei and Hunan provinces.

If the specific conditions are not indicated, the method is carried out according to the conventional conditions or the conditions suggested by manufacturers, and the used raw material medicines or auxiliary materials and the used reagents or instruments are the conventional products which can be obtained commercially.

It is particularly pointed out that the present invention is described in more detail below by means of specific embodiments in order to be able to better understand the solution of the invention and the advantages of its various aspects. The present invention is not limited by the following examples, and specific embodiments may be determined according to the technical solutions and practical situations of the present invention.

Influence of traditional Chinese medicine composition on mouse auricle swelling caused by xylene

1. Experimental Material

1.1 drugs and reagents

the Chinese medicinal composition prepared according to example 1, Jiangsu Kangyuan pharmaceutical industry GmbH, specification 5.2g crude drug/g gel; hydrocortisone cream, manufactured by Hainan pharmaceutical factory Co., Ltd, with specification of 10 g/count of 100 mg; xylene, national chemical group, chemical reagents, Inc., specification 500 mL/bottle.

1.2 animals

ICR mouse, SPF grade, male, weight 18 ~ 22g, offered by the university of Nantong experimental animals center, license number: SCXK (Su) 2014-.

1.3 instruments

Electronic balance, Sidorist scientific instruments (Beijing) Inc.

2. Experimental methods

50 ICR male mice with the weight of 18-22 g are randomly divided into 5 groups, and each group comprises 10 mice, namely a model group, a hydrocortisone ointment group (65mg/kg), a traditional Chinese medicine composition high-dose group (13.52g crude drugs/kg), a traditional Chinese medicine composition medium-dose group (6.76g crude drugs/kg) and a traditional Chinese medicine composition low-dose group (3.38g crude drugs/kg). Each group of mice was given the corresponding drug for external application, and the model group was given the vehicle 1 time/day for 3 days. After lh administration, 25ul xylene was coated on the front and back surfaces of the right auricle of the mouse, the mouse was sacrificed by dislocation of the cervical vertebra after lh administration, the left and right ears were cut off along the baseline of the auricle, the round ear pieces were taken off at the same positions with a punch (diameter 8mm), the round ear pieces were weighed with an electronic balance, the difference between the weights of the left and right ear pieces was used as an index of the degree of swelling, and the significance was determined and compared with the model group by the interclass t test method.

3. results

TABLE 1 Effect of Chinese medicinal composition on mouse ear swelling caused by xylene

P <0.05, p <0.01, compared to model group

The right ear of the mice in the model group is obviously swollen, the swelling degree of auricles of the mice in each group is lower than that of the mice in the model group, and the high and medium dosage groups of the traditional Chinese medicine composition have statistical difference (p is less than 0.05) compared with the mice in the model group. The result shows that the traditional Chinese medicine composition can obviously inhibit the mouse ear swelling caused by the dimethylbenzene.

Influence of traditional Chinese medicine composition on skin itch of guinea pigs caused by histamine

1. Experimental Material

1.1 drugs and reagents

The composition prepared according to example 1, Jiangsu Kangyuan pharmaceutical industry Co., Ltd, specification 5.2g crude drug/g gel; hydrocortisone cream, manufactured by Hainan pharmaceutical factory Co., Ltd, with specification of 10 g/count of 100 mg; histamine diphosphate monohydrate, Sigma, size 25 g/bottle.

1.2 animals

Guinea pig, common grade, male, weight 250-350 g, provided by Lefu farm in Pukou area of Nanjing, license number: SCXK (Su) 2014-.

1.3 instruments

An electronic balance: sidoris scientific instruments (Beijing) Inc.

2. Experimental methods

The guinea pigs were randomly divided into 5 groups by weight, each group consisting of 8 animals, namely a model group, a hydrocortisone ointment group (36mg/kg), a high dose group of Chinese medicinal composition (7.6g crude drug/kg), a medium dose group of Chinese medicinal composition (3.8g crude drug/kg), and a low dose group of Chinese medicinal composition (1.9g crude drug/kg). Each guinea pig group was administered with the corresponding drug for external application, and the model group was administered with vehicle 1 time/day for 3 days. Before the first application, the back of the left hind foot of each guinea pig is unhaired, and the area is about 0.8cm²Scratching the hair-removed part of the left and the back of the foot with fine sand paper before the last administration to make the foot red but not bleed, applying 0.01 percent of histamine phosphate 0.05 mL/per body on the wound surface 1h after the last administration, observing for 3min, if no itching reaction occurs in the guinea pig within 3min, then sequentially applying increasing concentrations of 0.02 percent, 0.03 percent, 0.04 percent and the like every 3min until the guinea pig licks the left and the back of the foot again, accumulatingThe total amount of histamine given is the itching threshold value which is used as an observation index of the itching relieving effect intensity, the itching threshold value of each group of animals is recorded and compared, and the significance determination and comparison are carried out by adopting an inter-group t test method and a model group.

3. Results

TABLE 2 threshold of itch of skin itch of groups of guinea pigs caused by histamine with the Chinese medicinal composition

P <0.05, p <0.01, compared to model group

Compared with a model group, the scratchiness threshold value of the guinea pigs in each administration group is obviously improved, wherein the statistical difference (p <0.05) exists between the high and medium dosage group and the model group of the traditional Chinese medicine composition. The result shows that the traditional Chinese medicine composition has the effect of inhibiting skin itch caused by histamine.

Effect of Chinese medicinal composition on allergic contact dermatitis

1. Experimental Material

1.1 drugs and reagents

The composition prepared according to example 1, Jiangsu Kangyuan pharmaceutical industry Co., Ltd, specification 5.2g crude drug/g gel; hydrocortisone cream, manufactured by Hainan pharmaceutical factory Co., Ltd, with specification of 10 g/count of 100 mg; 1-chloro-2, 4-Dinitrobenzene (DNCB), Sigma, scale 50 g/bottle.

1.2 animals

ICR mouse, SPF grade, male, weight 18 ~ 22g, offered by the university of Nantong experimental animals center, license number: SCXK (Su) 2014-.

1.3 instruments

An electronic balance: sidoris scientific instruments (Beijing) Inc.

2. Experimental methods

Randomly dividing 60 mice into 6 groups, each group containing 10 mice, namely blank control group, model group, hydrocortisone ointment group (65mg/kg), and high-dosage group containing Chinese medicinal composition (13.5)2g crude drug/kg), medium dosage group (6.76g crude drug/kg) and low dosage group (3.38g crude drug/kg) of Chinese medicinal composition. The abdomen of each group of mice was shaved and the area was about 3x3cm²The blank control group is coated with excipient, the model group is not coated with drug, and the rest groups are respectively administered once a day for 7 days. After sensitization for 6 days, 1% DNCB is applied to right auricles of mice of each group for attacking, the mice are dislocated 1h after the last administration, equal-area ear sheets are punched at the same positions of two ears of the mice by a puncher (with the diameter of 8mm), the mice are placed on an electronic analytical balance for weighing, and the swelling degree of allergic inflammatory tissues is evaluated according to the weight difference value of the left ear and the right ear.

3. Results

TABLE 3 Effect of Chinese medicinal composition on ear swelling of allergic contact dermatitis model mice

P <0.05, p <0.01, compared to model group

Compared with the blank group, the model group has obviously increased ear weight difference and has obvious statistical significance (P is less than 0.01). Compared with a model group, the guinea pigs of each administration group can reduce the weight difference of the ears of the mice, wherein the statistical difference (p <0.05) exists between the high and medium dosage group and the model group of the traditional Chinese medicine composition. The result shows that the traditional Chinese medicine composition has a better effect of treating allergic contact dermatitis.

Clinical therapeutic effect of the Chinese medicinal composition

1. General data

30 observed cases are observed in 1 month to 8 months in 2018, and are all outpatients, the age is 12 to 56 years, and the course of disease is 1 to 14 days.

2. Method of treatment

Diagnostic criteria: eczema refers to eczema diagnosis standard of traditional Chinese medicine science: acute patients have exudation, chronic patients have infiltrative hypertrophy, irregular course of disease, and recurrent and severe pruritus.

Inclusion criteria were: the eczema diagnosis standard is met; those who have not used glucocorticoids and immunosuppressants within about 2 weeks; the disease condition is acute, and the course of disease does not exceed 2 weeks.

The Chinese medicinal composition is used for treating patients with confirmed diagnosis, the patients are respectively smeared once in the morning, at noon and at night every day, 14 days is a treatment course, and the curative effect is observed after 14 days of treatment.

3. Judgment of therapeutic effect

3.1 therapeutic criteria

Observation index

The method has the following advantages: after treatment, clinical examination shows that the traditional Chinese medicine composition has no clinical symptoms of eczema and no pruritus.

Secondly, the method is effective: after treatment, clinical examination was performed to find that the clinical symptoms were improved, and that itching occasionally occurred.

③ invalid: after treatment, clinical examination revealed that the symptoms did not resolve, and even tended to worsen. 3.2 therapeutic results

After 14 days of treatment, 20 cases of treatment, 7 cases of treatment and 3 cases of treatment are effective, and the total effective rate is 90.0%.

Practice proves that the traditional Chinese medicine composition has a good effect on treating eczema, and is safe and effective.