Traditional Chinese medicine composition for treating spleen deficiency and dampness accumulation type eczema

Abstract

The invention relates to a medicine composition for treating spleen deficiency and dampness accumulation type eczema, the medicine composition is composed of active ingredients and medically acceptable auxiliary materials, and the active ingredients are prepared from the following raw material medicines in percentage by weight: 20-27% of astragalus membranaceus, 12-16% of roasted rhizoma atractylodis macrocephalae, 10-14% of cortex dictamni, 12-16% of cynanchum paniculatum, 20-27% of rhizoma smilacis glabrae and 10-14% of mangnolia officinalis. The pharmaceutical composition disclosed by the invention has a remarkable effect on treating spleen deficiency and dampness accumulation eczema.

Description

Technical Field

[0001] The invention relates to a medical preparation, in particular to a pharmaceutical preparation containing an undetermined structure from traditional Chinese medicine. The pharmaceutical preparation is particularly suitable for treating eczema of spleen deficiency and dampness accumulation type. Background Art

[0002] Eczema is an inflammatory, pruritic skin disease caused by a variety of internal and external factors. Acute and subacute eczema can gradually develop into chronic eczema if it recurs and does not heal. Chronic eczema can also be caused by continuous mild stimulation. The clinical characteristics of chronic eczema are papular erythema, thickening and infiltration of the skin in the affected area, rough surface, covered with scales, or lichenification, accompanied by blood scab scratches, and pigmentation left over over time. Lesions are prone to occur in the elbows, hands, popliteal fossa, calves, feet, vulva, anus, etc., and are often distributed symmetrically. Chronic eczema often recurs, sometimes light and sometimes heavy, accompanied by severe itching symptoms, which can easily affect sleep. The course of the disease is uncertain, and various factors such as weather, work pressure, living environment, diet, etc. can induce aggravation of the disease, which makes patients overwhelmed and seriously affects their quality of life.

[0003] Western medicine believes that the causes of eczema can be summarized into internal and external factors. Internal factors include endocrine disorders or metabolic changes caused by infection, blood circulation disorders, neuropsychiatric factors, and abnormal immune system function, while external factors include changes in living environment and various physical and chemical stimuli. The pathogenesis includes impaired skin barrier function, immune response, oxygen free radical damage, pathogenic microbial infection, etc., which ultimately lead to a series of skin inflammatory reactions.

[0004] Traditional Chinese medicine calls this disease "immersion sore" or "wet sore". It believes that the cause and pathogenesis of the disease are weakened organ function due to congenital deficiency, improper diet, internal injuries caused by the seven emotions, etc., and because of the disharmony between the Ying and Wei systems, the Xuanfu is open and is invaded by external evils. The internal and external evils transform and accumulate in the skin, causing the disease.

[0005] Western medicine treats eczema with antihistamines, glucocorticoids, antibiotics, immunosuppressants, etc., either topically or systemically, combined with physical therapies such as ultraviolet light therapy and freezing. Traditional Chinese medicine mainly guides the internal or external use of Chinese medicine through syndrome differentiation, as well as external treatments such as acupuncture.

[0006] According to the "Eczema" standard (standard number: ZYYXH / T358-2012) issued by the Chinese Association of Traditional Chinese Medicine in 2012, eczema can be divided into four types of TCM syndromes, one of which is spleen deficiency and dampness accumulation syndrome, which is manifested as: skin lesions are mainly papules or papulovesicles, the skin color is dull or scaly, a little exudation, itching. Accompanied by poor appetite, fatigue, abdominal distension, loose stools, clear and long urine or slightly yellow urine. The tongue is pale and fat, the coating is thin and white or greasy, and the pulse is soft or stringy.

[0007] Regarding the treatment of chronic eczema, in modern medicine, the 2011 edition of China's "Guidelines for the Diagnosis and Treatment of Eczema" recommends the use of topical glucocorticoid ointments, plasters, emulsions or tinctures for chronic skin lesions, which can be combined with moisturizers and keratolytics, and oral antihistamines, antibiotics, glucocorticoids, immunosuppressants, etc. as appropriate. In terms of traditional Chinese medicine, the "Eczema" standard recommends the main treatment methods of strengthening the spleen and eliminating dampness, nourishing blood and relieving itching, and the use of Chinese medicine ointments such as Qingdai cream; for eczema of spleen deficiency and dampness accumulation type, the "Eczema" standard recommends oral administration of Chushi Weiling Decoction and Shenling Baizhu Powder. Summary of the invention

[0008] The technical problem to be solved by the present invention is to provide a pharmaceutical composition for treating eczema caused by spleen deficiency and dampness accumulation. The pharmaceutical composition is simple in medicine and has a special effect on treating eczema caused by spleen deficiency and dampness accumulation.

[0009] The technical solution of the present invention to solve the above problems is as follows:

[0010] A pharmaceutical composition for treating eczema due to spleen deficiency and dampness accumulation, the pharmaceutical composition is composed of an effective ingredient and medically acceptable excipients, wherein the effective ingredient is made of the following raw materials in percentage by weight:

[0011] Astragalus 20-27%, stir-fried Atractylodes 12-16%, Dictamni Cortex 10-14%, Cynanchum 12-16%, Smilax glabra 20-27%, Magnolia officinalis 10-14%.

[0012] The pharmaceutical composition of the present invention, wherein the optimal ratio of the raw materials is:

[0013] Astragalus 24%, stir-fried Atractylodes 14%, Dictamni 12%, Cynanchum 14%, Smilax glabra 24%, Magnolia officinalis 12%.

[0014] The pharmaceutical composition of the present invention, wherein the active ingredient is prepared by the following method:

[0015] (1) Add 12 times the amount of water to the drug and boil for 2 hours, filter, add 10 times the amount of water to the residue and boil for 2 hours, filter, combine the decoctions, and concentrate under reduced pressure to a thick paste with a relative density of 1.30 at 25°C;

[0016] (2) taking the thick paste obtained in step (1), vacuum drying it to obtain a dry paste powder, that is, the active ingredient.

[0017] The pharmaceutical composition of the present invention is a conventional granule, tablet or capsule.

[0018] Based on long-term clinical research, the inventor believes that the skin lesions of eczema are stubborn and difficult to heal, which is due to the spleen deficiency and inability to transport and distribute. The spleen is responsible for transportation and transformation, and is the center for transporting and conducting body fluids, and controls the movement of water. If the spleen is deficient, the transportation and distribution are weak, and water and dampness are retained locally, accumulated in the skin and not dispersed, and become stubborn skin lesions and lingering and difficult to heal. Therefore, chronic eczema is often caused by spleen deficiency and dampness accumulation. For this type of patients, treatment should start with replenishing qi, strengthening the spleen and consolidating the lungs, with the restoration of the lung and spleen transportation and distribution functions as the priority, while not forgetting to start with dispelling wind and dampness and relieving itching, giving dampness a way out and achieving the effect of relieving itching. Only by treating both the symptoms and the root causes can the lingering disease be resolved.

[0019] In the pharmaceutical composition of the present invention, astragalus and stir-fried atractylodes are used as the main ingredients. Astragalus has the effect of invigorating qi and raising yang, while atractylodes can invigorate the spleen and dry dampness, and they are one above and one below astragalus, invigorating the spleen and replenishing qi and can eliminate water and dampness; Dictamni can dry dampness, dispel wind and relieve itching, so as to help the main ingredient relieve itching, while Cynanchum chinense can dispel wind and eliminate dampness to help the main ingredient eliminate dampness, and the two ingredients are used together as the minister; Smilax glabra is used as the auxiliary ingredient, which can remove dampness and detoxify, and is especially good at guiding water and dampness to penetrate and transform it, and can infiltrate the exudate in the skin lesions and reduce the degree of swelling and hypertrophy; Magnolia officinalis is used as the messenger, so as to lead the whole prescription to concentrate the power on the skin and muscle surface, and can help the main ingredient and minister ingredient to promote qi and eliminate dampness. The whole prescription plays the effect of invigorating qi and invigorating spleen, promoting qi and eliminating dampness.

[0020] Animal experiments

[0021] 1. Drugs and reagents:

[0022] Experimental group: the granules of Example 1 were dissolved in pure water to prepare a solution containing 0.78 g of the drug substance per ml;

[0023] Cetirizine hydrochloride tablets were purchased from Chongqing Huabang Pharmaceutical Co., Ltd.;

[0024] DNCB was purchased from Shanghai Aladdin Biochemical Technology Co., Ltd.;

[0025] Acetone was purchased from Sigma-Aldrich (Shanghai) Trading Co., Ltd.;

[0026] Experimental animals: 36 Balb / C mice, weighing 18-22 g, were purchased from Guangdong Medical Animal Experiment Center;

[0027] Experimental instruments: AUY120 SHIMADZU analytical balance, Guangzhou Xiangyi Electromechanical Equipment Co., Ltd.; MEGAFUGE2.0R low-temperature high-speed centrifuge, German HERMLE; vortex mixer, Shanghai Qingpu Huxi Instrument Factory;

[0028] 2 Experimental methods

[0029] 2.1 Modeling method of eczema with spleen deficiency and dampness obstruction syndrome

[0030] Acetone was used to prepare the matrix solution, and DNCB powder was added to make a DNCB solution with a concentration of 1% or 0.5%. 200 μL of DNCB solution was dripped on the back of mice in the disease model group and the disease-syndrome combination group with a syringe, and 20 μL of DNCB solution was dripped on the right ear to model eczema. 1% DNCB solution was dripped once on the 1st and 5th day, 0.5% DNCB solution was dripped on the 7th day, and 200 μL and 20 μL of DNCB solution were dripped on the back and right ear of mice every other day, respectively. The normal control group was dripped on the back and right ear, respectively, with 200 μL and 20 μL of matrix solution as a control treatment. 200 μL of senna leaf decoction was gavaged every other day.

[0031] 2.2 Animal grouping and drug administration

[0032] 36 mice were randomly divided into 6 groups: blank control group, model group, cetirizine hydrochloride group and experimental group, with 6 mice in each group. According to the equivalent dose conversion of experimental animals, the cetirizine hydrochloride group was given 1 mg / kg by gavage, the experimental groups were given 15.6 g / kg (raw drug amount) by gavage, and the blank control group and model group were treated with equal doses of normal saline for 28 consecutive days.

[0033] 2.3 Skin lesion severity and skin lesion score

[0034] Before sampling on the 28th day, the skin damage on the ears and backs of mice in each group was observed according to the SCORAD scoring standard, including erythema, edema, desquamation, and scabs, and was scored as none (0 point), mild (1 point), moderate (2 points), severe (3 points), and extremely severe (4 points).

[0035] 2.4 Evaluation of spleen deficiency and dampness obstruction syndrome in mice

[0036] Diagnostic criteria for the physical signs of the mouse spleen deficiency and dampness obstruction model: (1) mucus, pus and blood, mostly white and less red; feces are sometimes soft and sometimes loose. (2) Loose stools with undigested food. (3) Poor appetite, emaciation, and weight loss. (4) Dejected demeanor, skin is not firm, and fur is withered. (5) Abdominal distension, dull pain, and curled and gathered. (6) Easy fatigue.

[0037] 2.5 HE staining of mouse back skin and measurement of epidermal thickness

[0038] The skin lesions of 2 cm × 2 cm in size were cut from the back and fixed in 4% paraformaldehyde solution. After dehydration and embedding, the paraffin tissue was sliced ​​with a thickness of 4 μm. The slices were dewaxed, hydrated, and then stained with hematoxylin-eosin. After sealing, the pathological changes of skin tissue were observed under a microscope, and the epidermal thickness was measured using Image J software.

[0039] 2.6 Statistical methods

[0040] The results were expressed as mean ± SD. One-way ANOVA was used to compare the significant differences among the groups, with P < 0.05 as the standard for statistically significant differences.

[0041] 3 Results:

[0042] 2.1 Results of weight changes of mice in each group

[0043] Compared with the control group, the weight of mice in the model group decreased significantly, which is consistent with the characteristics of decreased appetite and weight loss in mice with spleen deficiency and dampness. As the modeling time of spleen deficiency and dampness increased, the mice showed mental depression, slow reaction, curled up and did not like to move, and also showed symptoms of unstable gait, dirty fur, dirty anus, soft and wet stool or even loose stool. After treatment with cetirizine tablets and the experimental group, the weight was significantly adjusted (Table 1), indicating that the experimental group can effectively improve the symptoms of weight loss in mice with spleen deficiency and dampness syndrome of eczema, and the mental state has improved significantly, and the stool has gradually formed.

[0044] Table 1 Comparison of the weight of each mouse

[0045]

[0046] Note: Compared with the model group, ##P<0.01; compared with the cetirizine hydrochloride group and the blank control group, *P<0.05.

[0047] 2.2 Differences in ear mass and pathological ear changes in each group of mice

[0048] Compared with the control group, the weight of the right ear of the mice in the model group was significantly increased (Table 2), and the pathological results showed that the epidermis of the right ear of the mice in the model group was hyperkeratotic, the epidermis was thickened, and a large number of inflammatory cells infiltrated the dermis, the number of mast cells increased, and the blood vessels were significantly dilated, indicating that the level of inflammation in the right ear was high, which was consistent with the disease characteristics of eczema mice. After treatment with cetirizine tablets and the experimental group, the inflammation level of the right ear was significantly reduced, and the thickness of the epidermis decreased ( Figure 1 ), indicating that the experimental group can effectively improve the ear inflammation level of mice with eczema and spleen deficiency and dampness obstruction syndrome.

[0049] Table 2 Comparison of ear weights of mice in each group

[0050]

[0051] Note: Compared with the model group, ##P<0.01; compared with the blank control group, *P<0.05; compared with the cetirizine hydrochloride group, **P<0.01.

[0052] 2.3 Results of back dermatitis scores of mice in each group

[0053] The degree of dermatitis on the back of each group of mice was evaluated according to the dermatitis scoring standard. Figure 2 As shown, the results showed that the model group mice had obvious skin lesions on the back skin, edema was significantly higher than the skin surface, dark red erythema, diffuse superficial epidermal exfoliation, and thick scaling. After treatment with cetirizine tablets and the experimental group, the erythema and scaling were alleviated. The experimental group was able to effectively improve the back skin lesions of eczema with spleen deficiency and dampness obstruction syndrome.

[0054] Table 3 Skin lesion scores on the back of mice in each group on day 28

[0055]

[0056] Note: Compared with the model group, ##P<0.01; compared with the cetirizine hydrochloride group and the blank control group, **P<0.01.

[0057] 2.4 HE staining of skin tissue morphology of mice in each group

[0058] Compared with the control group, the skin pathology of the mice in the model group showed thickening of the spinous layer, elongation of the epidermal protuberances, hyperkeratosis, infiltration of inflammatory cells, and dilation and congestion of the superficial dermal capillaries. After treatment with cetirizine tablets and the experimental group, the mice in each group showed thinning of the epidermis, shortening of the epidermal protuberances, reduced infiltration of inflammatory cells, and reduced dilation of the superficial dermal capillaries.

[0059] Table 4 HE staining skin thickness of mice in each group

[0060]

[0061] Note: Compared with the model group, ##P<0.01; compared with the blank control group, *P<0.05; compared with the cetirizine hydrochloride group, **P<0.01.

[0062] 4 Conclusion

[0063] In this study, a mouse model of spleen deficiency and dampness accumulation eczema was constructed, and the therapeutic effect of experimental drugs on spleen deficiency and dampness accumulation eczema was investigated. The results showed that after modeling, the weight of mice decreased significantly, and they showed mental depression, slow reaction, curled up and did not like to move. They also showed symptoms of unstable gait, dirty fur, dirty anus, soft and wet stools or even loose stools, which were consistent with the symptoms of spleen deficiency and dampness accumulation. The experimental group was able to improve the above symptoms. After modeling, the ear epidermis of the model group was hyperkeratotic, the epidermis thickened, and a large number of inflammatory cells infiltrated the dermis, mast cells increased, blood vessels were significantly dilated, and obvious skin lesions appeared on the back skin. The edema was significantly higher than the skin surface, and dark red erythema appeared. There was diffuse superficial epidermal exfoliation and thick scales, which were consistent with the disease characteristics of eczema mice. After treatment in the experimental group, there was a significant improvement effect. The above results show that the experimental group has an improvement effect on spleen deficiency and dampness accumulation eczema. BRIEF DESCRIPTION OF THE DRAWINGS

[0064] Figure 1 The following are microscopic photos of pathological ear tissues of mice in each group.

[0065] Figure 2 Photos of skin lesions on the back of mice in each group on day 28.

[0066] Figure 3 These are microphotographs of skin tissue morphology stained with HE in each group of mice. DETAILED DESCRIPTION

[0067] Example 1 (granules)

[0068] 1. Prescription:

[0069] 200g of Astragalus, 120g of stir-fried Atractylodes, 100g of Dictamni, 120g of Cynanchum wilfordii, 200g of Smilax glabra, and 100g of Magnolia officinalis.

[0070] 2. Preparation method:

[0071] (1) Add 12 times the amount of water to the above drugs and boil for 2 hours, filter, add 10 times the amount of water to the residue and boil for 2 hours, filter, combine the decoctions, and concentrate under reduced pressure to a thick paste with a relative density of 1.30 at 25°C;

[0072] (2) The thick paste obtained in step (1) is combined and vacuum dried to obtain dry paste powder, which is granulated with auxiliary materials, and then dried and granulated, and packaged into 10g / bag.

[0073] Example 2 (granules)

[0074] 1. Prescription:

[0075] 230g of Astragalus, 128g of stir-fried Atractylodes macrocephala, 103g of Dictamni cortex, 112g of Cynanchum wilfordii, 173g of Smilax glabra, and 94g of Magnolia officinalis.

[0076] 2. Preparation method:

[0077] Same as Example 1.

[0078] Example 3 (granules)

[0079] 1. Prescription:

[0080] 187g of Astragalus, 102g of stir-fried Atractylodes macrocephala, 93g of Dictamni cortex, 136g of Cynanchum wilfordii, 220g of Smilax glabra, and 102g of Magnolia officinalis.

[0081] 2. Preparation method:

[0082] Same as Example 1.

[0083] Example 4 (granules)

[0084] 1. Prescription:

[0085] 215g of Astragalus, 133g of stir-fried Atractylodes macrocephala, 108g of Dictamni cortex, 116g of Cynanchum wilfordii, 183g of Smilax glabra, and 85g of Magnolia officinalis.

[0086] 2. Preparation method:

[0087] Same as Example 1.

[0088] Example 5 (granules)

[0089] 1. Prescription:

[0090] 170g of Astragalus, 109g of stir-fried Atractylodes macrocephala, 101g of Dictamni cortex, 126g of Cynanchum wilfordii, 225g of Smilax glabra, and 109g of Magnolia officinalis.

[0091] 2. Preparation method:

[0092] Same as Example 1.

[0093] Example 6 (capsules)

[0094] The drug particles prepared according to the method of Example 1 were loaded into gelatin capsules to prepare capsules.

[0095] Example 7 (Tablet)

[0096] Take the drug granules prepared according to the method of Example 1, add sugar powder, use 95% ethanol as a wetting agent to make a soft material, sieve through a 16-mesh sieve to granulate, dry, and press into tablets using a conventional method to make tablets.

Claims

1. A pharmaceutical composition for treating eczema of spleen deficiency and dampness accumulation type, the pharmaceutical composition is composed of an effective ingredient and a medically acceptable excipient, wherein the effective ingredient is made of the following raw materials in percentage by weight: Astragalus 20-27%, stir-fried Atractylodes 12-16%, Dictamni Cortex 10-14%, Cynanchum 12-16%, Smilax glabra 20-27%, Magnolia officinalis 10-14%.

2. A pharmaceutical composition for treating spleen deficiency and dampness accumulation type eczema according to claim 1, characterized in that: The active ingredients are made from the following raw materials in percentage by weight: Astragalus 24%, stir-fried Atractylodes 14%, Dictamni 12%, Cynanchum 14%, Smilax glabra 24%, Magnolia officinalis 12%.

3. A pharmaceutical composition for treating eczema due to spleen deficiency and dampness accumulation according to claim 1 or 2, characterized in that: The active ingredient is prepared by the following method: (1) Add 12 times the amount of water to the drug and boil for 2 hours, filter, add 10 times the amount of water to the residue and boil for 2 hours, filter, combine the decoctions, and concentrate under reduced pressure to a thick paste with a relative density of 1.30 at 25°C; (2) taking the thick paste obtained in step (1), vacuum drying it to obtain a dry paste powder, that is, the active ingredient.

4. A pharmaceutical composition for treating eczema due to spleen deficiency and dampness accumulation according to claim 3, characterized in that: The traditional Chinese medicine composition is a conventional granule, tablet or capsule.

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