CN112516250B

CN112516250B - Traditional Chinese medicine composition for treating psoriasis vulgaris and preparation method thereof

Info

Publication number: CN112516250B
Application number: CN202011528901.XA
Authority: CN
Inventors: 安月鹏; 王姗姗
Original assignee: First Affiliated Hospital Heilongjiang University Of Chinese Medicine First Clinical Medical College Of Heilongjiang University Of Chinese Medicine
Current assignee: First Affiliated Hospital Heilongjiang University Of Chinese Medicine First Clinical Medical College Of Heilongjiang University Of Chinese Medicine
Priority date: 2020-12-22
Filing date: 2020-12-22
Publication date: 2022-02-15
Anticipated expiration: 2040-12-22
Also published as: CN112516250A

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine composition for treating psoriasis vulgaris, which comprises the following raw materials in parts by weight: 15-40 parts of dark plum fruit, 15-50 parts of spina gleditsiae, 10-45 parts of indigo naturalis, 15-45 parts of cacumen biotae, 10-40 parts of bletilla striata and 10-35 parts of papermulberry leaf. The traditional Chinese medicine composition for treating psoriasis vulgaris provided by the invention is used for combining objective symptoms and subjective symptoms of pruritus together to play a role in treatment aiming at each skin damage expression link of psoriasis vulgaris from outside to inside and simultaneously showing scales, pimples, erythema, punctate bleeding and no new flesh.

Description

Traditional Chinese medicine composition for treating psoriasis vulgaris and preparation method thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine composition for treating psoriasis vulgaris and a preparation method thereof.

Background

The psoriasis is one of the common clinical skin diseases, the incidence rate of the psoriasis increases year by year along with the changes of environment, diet, life style and the like, the psoriasis can be attacked by people of all ages and both sexes, has certain inheritance, the attack crowd also tends to be expanded to teenagers at present, meanwhile, the north of the psoriasis is more than the south, the disease is heavy in winter and light in summer, the disease course is particularly long, and the psoriasis attacks repeatedly, thereby bringing great psychological and mental pressure to patients.

Psoriasis can be clinically classified into two major types, namely psoriasis vulgaris and psoriasis vulgaris, wherein the psoriasis vulgaris can be classified into pustule type, joint type and erythrodermic type, but psoriasis vulgaris is the most common psoriasis. In the aspect of skin damage, the psoriasis vulgaris can see pimples with the size of a needle head, the pimples are gradually enlarged to be light red or bright red pimples or maculopapules with the size of mung beans or soybeans, the pimples can be fused into maculoderm-shaped, the boundary is clear, a plurality of layers of dry white scales are covered on the surface, a shiny and semitransparent film is exposed when the scales are scraped, the film is in a film phenomenon, a plurality of sieve-shaped bleeding points appear in a scraping mode, the spot bleeding phenomenon appears, severe desquamation can be accompanied by local dryness and chapping, and patients are often accompanied by pruritus feelings with different degrees. Meanwhile, psoriasis vulgaris can be divided into various forms such as drop-shaped, coin-shaped, patch-shaped, map-shaped, oyster shell-shaped, mixed-shaped and the like in the aspect of skin damage. Therefore, the symptoms of psoriasis vulgaris are summarized mainly including two major categories of objective symptoms (5 objective symptoms: scales, papules, erythema, spotting, new flesh growth) and subjective symptoms (1 subjective symptom: pruritus). The skin damage characteristics of each link of psoriasis vulgaris are from outside to inside, from the surface to inside, and sequentially comprise scales (thin film phenomenon), pimples (pimples protruding from the skin), erythema (erythema with the same color and redness as the skin), punctate hemorrhage (hemorrhage point of epidermis), new flesh and pruritus. Therefore, the invention mainly focuses on subjective and objective symptoms of psoriasis vulgaris, and aims at expression links of various skin lesions of the psoriasis vulgaris, and adopts traditional Chinese medicines with corresponding treatment effects to carry out local external washing treatment, thereby achieving the purpose of treating the psoriasis vulgaris.

The external treatment is an important means in the aspect of treating psoriasis vulgaris, and currently, the external medicaments which can be selected mainly comprise tar preparations, glucocorticoid, retinoic acid and vitamin D in the aspect of western medicine treatment₃Steroids, immunosuppressants, etc., but such drugs have disadvantages in that: firstly, the long-term treatment effect is poor, the skin damage is usually rebounded or repeatedly attacks after the medicine is stopped, and particularly, the glucocorticoid can induce psoriasis of pustule type or erythroderma type; secondly, the safety is poor, and the tar preparation has certain carcinogenic tendency; the long-term and large-area application of the glucocorticoid can convert psoriasis vulgaris into psoriasis pustulosa or erythrodermic psoriasis, rather aggravate the disease, and simultaneously can cause the side effects of hirsutism, pigmentation, skin atrophy and the like of the skin; tretinoin can affect blood lipid metabolism of patients and influence development of children; vitamin D₃The quasi-drugs can increase the blood calcium concentration after being absorbed by skin, thereby affecting the heart function; the external percutaneous absorption of the immunosuppressant has a large degree of liver injury, and the long-term external application of the skin immunosuppressant can cause the local barrier function of the skin to be damaged, so as to induce a series of infections; thirdly, the application population and the application part are limited, for example, the tar preparation is not used for pregnant women in gestation period, patients with pustule type and erythrodermic psoriasis, or patients with serious acne and folliculitis; glucocorticoids are not applied to the skin mucosa or patients with severe hypertension, diabetes, low potassium, low calcium; the vitamin A acid is not used for special people such as children and pregnancy; vitamin D₃The medicine is not suitable for patients with serious heart disease and high blood calcium; the immunosuppressant is not used for face, or complicated with severe anemia, or women in childbearing age; fourthly, the cost is high, no matter which kind of medicineThe cost of long-time taking is higher than that of the traditional Chinese medicine preparation.

In the aspect of external treatment of traditional Chinese medicine, there are a plurality of characteristic technologies such as external rubbing, external washing, fumigation, acupuncture and cupping, navel application, package, acupuncture point therapy and the like, but compared with the traditional Chinese medicine, the external washing has the advantages that: firstly, the external washing can ensure that the liquid medicine after the medicine is decocted directly acts on the skin lesions of the whole body, and the range of the liquid medicine is wide; the second step is as follows: the medicine directly reaches the affected part to achieve the purpose of direct treatment; and thirdly: the repeated washing of the liquid medicine acts on the skin damage, so that the liquid medicine amount can be effectively saved, and the liquid medicine is cheaper; fourthly, the method comprises the following steps: the traditional Chinese medicine composition is easy to accept by patients, exerts the advantages and characteristics of small side effect of traditional Chinese medicines, has quick treatment effect after external washing, and is accepted by the psychology of the patients. However, the existing external washing medicine for treating psoriasis vulgaris has the following defects: firstly, the treatment pertinence of the external washing medicine is not strong, only aiming at one or a plurality of skin lesion manifestations of psoriasis, the purpose of breaking one by one cannot be achieved, for example, the external washing medicine only has the functions of clearing away heat and toxic materials, can treat erythema, but cannot moisten skin and promote tissue regeneration and the like; secondly, the external washing medicines cannot give consideration to subjective and objective symptoms, for example, many external washing medicines can only achieve the effect of treating skin lesions but have no efficacy of relieving itching and the like, although the skin lesions of patients are relieved, pruritus at night is intolerable, and the life quality of the patients is seriously affected; thirdly, the external washing medicine has certain irritation, and a patient can generate a series of corresponding manifestations of skin damage, pruritus, burning heat, dryness or irritation caused skin inflammation and the like after application; and fourthly, the external washing medicine can not be applied to places with skin lesions accompanied by superficial lesions, and the formula of the invention can not only be applied to the skin lesions of psoriasis, but also has certain healing effect on bleeding spots of the psoriasis or superficial lesion ulceration.

Therefore, the research on a long-term, safe, effective, wide-application range and cheap external preparation for treating psoriasis is imperative.

Disclosure of Invention

The invention provides a traditional Chinese medicine composition for treating psoriasis vulgaris, which is used for combining objective symptoms and subjective symptoms of pruritus together to play a role in treatment aiming at each skin damage expression link of psoriasis vulgaris from outside to inside and simultaneously visible scales, papules, erythema, punctate bleeding and new flesh.

The invention provides a traditional Chinese medicine composition for treating psoriasis vulgaris, which comprises the following raw materials in parts by weight: 15-40 parts of dark plum fruit, 15-50 parts of spina gleditsiae, 10-45 parts of indigo naturalis, 15-45 parts of cacumen biotae, 10-40 parts of bletilla striata and 10-35 parts of papermulberry leaf.

Preferably, the traditional Chinese medicine composition comprises 15-20 parts of dark plum fruit, 15-35 parts of spina gleditsiae, 10-25 parts of indigo naturalis, 15-20 parts of cacumen biotae, 10-20 parts of bletilla striata and 10-15 parts of papermulberry leaf.

More preferably, the traditional Chinese medicine composition comprises 30 parts of dark plum fruit, 30 parts of spina gleditsiae, 20 parts of indigo naturalis, 20 parts of cacumen biotae, 15 parts of bletilla striata and 15 parts of papermulberry leaf.

The invention also provides a preparation method of the traditional Chinese medicine composition for treating psoriasis vulgaris, which comprises the following steps:

weighing 30 parts of dark plum fruit, 30 parts of spina gleditsiae, 20 parts of indigo naturalis, 20 parts of cacumen biotae, 15 parts of bletilla striata and 15 parts of papermulberry leaf according to parts by weight, mixing, adding water, decocting, and collecting decoction to obtain the traditional Chinese medicine composition.

Preferably, the decoction is carried out by adding water which is 8 times of the total mass of the dark plum fruit, the spina gleditsiae, the indigo naturalis, the Chinese arborvitae twig, the bletilla striata and the papermulberry leaf.

The traditional Chinese medicine composition can be further prepared into pharmaceutically acceptable external preparations, such as external lotion.

The invention consists of dark plum fruit, spina gleditsiae, natural indigo, Chinese arborvitae twig, bletilla striata and papermulberry leaf. Indigo naturalis, heat-clearing and detoxicating, cooling blood and removing ecchymoses; spina Gleditsiae for promoting blood circulation, dispelling blood stasis, and softening and resolving hard mass; the two are combined to eliminate heat, spot and rash, and are monarch drugs; the cacumen biotae can clear heat and cool blood and can also stop bleeding, on one hand, the cacumen biotae can help the monarch drug of indigo naturalis to strengthen the effects of clearing heat, removing toxicity and cooling blood, on the other hand, the cacumen biotae is combined with the bletilla striata to play a role in stopping bleeding together and improve punctate bleeding of porrigo; bletilla striata is a Chinese herbal medicine for relieving swelling and promoting tissue regeneration, repairing and healing sore, stopping bleeding and regenerating; the dark plum has sour and mild taste, and can promote the production of body fluid, moisten skin, remove dead muscles, nourish skin and eliminate scales and scraps; meanwhile, the dark plum fruit and the bletilla striata, namely, the dark plum fruit and the bletilla striata, remove old muscles and promote regeneration, bring out the best in each other; thus, the Chinese arborvitae twig, the bletilla striata and the dark plum are combined to stop bleeding, promote tissue regeneration and moisten skin, and are used as ministerial drugs; the papermulberry leaf has the effects of clearing heat and removing toxicity, moistening skin and relieving itching, plays a wonderful role in relieving itching on the basis of assisting monarch and minister in clearing heat and moistening skin, and is an adjuvant drug. The medicines are combined to play the roles of clearing away heat and toxic materials, promoting blood circulation to soften hard masses, stopping bleeding, promoting granulation, moistening skin and relieving itching, so that scales, pimples and erythema of porrigo are removed, bleeding is stopped, new flesh is generated, and pruritus is stopped.

Compared with the prior art, the invention has the beneficial effects that:

the traditional Chinese medicine composition for treating psoriasis vulgaris provided by the invention is respectively aimed at 6 different clinical symptoms and physical signs of psoriasis vulgaris, smoked plums can promote the production of body fluid, moisten skin and remove dead muscle and flesh, and is aimed at scales (scales are dead muscles after metabolism) in objective symptoms, namely the phenomenon that the outermost layer of skin is damaged; spina gleditsiae can promote blood circulation and soften hardness, and aims at the pimple in objective symptoms, namely skin lesion protruding from the surface of the skin; indigo naturalis has the effects of clearing away heat and toxic materials, is an essential medicine for treating psoriasis, and aims at erythema in objective symptoms, namely red skin lesions which are equal to skin; the cacumen biotae can cool blood and stop bleeding, one of the common medicinal components of the external washing medicine aims at punctate bleeding in objective symptoms and tiny bleeding points on superficial parts of epidermis to achieve the aim of stopping bleeding; bletilla striata can stop bleeding and promote tissue regeneration and flesh growth, and promotes the growth and healing of normal skin aiming at the phenomenon that new flesh in the deep layer of epidermis is not grown in objective symptoms; the papermulberry leaf is a wonderful medicine for external washing to relieve itching, can well play a role in relieving itching aiming at itching feeling in subjective symptoms, relieves subjective discomfort of patients while relieving the itching feeling, can reduce re-stimulation to skin lesions, prevents and treats new skin lesions caused by scratching on one hand, and can obviously improve the life quality of the patients on the other hand.

Detailed Description

The present invention is further described below by way of examples, but the present invention is not limited by these examples. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

The preparation method of the traditional Chinese medicine composition for treating psoriasis vulgaris comprises the following steps:

weighing 15-40 parts of dark plum, 15-50 parts of spina gleditsiae, 10-45 parts of indigo naturalis, 15-45 parts of cacumen biotae, 10-40 parts of bletilla striata and 10-35 parts of papermulberry leaf according to parts by weight, mixing, adding water, decocting, and collecting decoction to obtain the traditional Chinese medicine composition.

The traditional Chinese medicine composition can be further prepared into a pharmaceutically acceptable external preparation.

The following description will be given with reference to specific examples

Example 1

A traditional Chinese medicine composition for treating psoriasis vulgaris is composed of the following raw materials: 30g of dark plum fruit, 30g of spina gleditsiae, 20g of indigo naturalis, 20g of cacumen biotae, 15g of bletilla striata and 15g of papermulberry leaf;

the preparation method of the traditional Chinese medicine composition comprises the following steps:

weighing dark plum 30g, spina gleditsiae 30g, natural indigo 20g, Chinese arborvitae twig 20g, bletilla striata 15g and papermulberry leaf 15g, mixing, adding water which is 8 times of the total mass of the dark plum, the spina gleditsiae, the natural indigo, the Chinese arborvitae twig, the bletilla striata and the papermulberry leaf, decocting, and collecting decoction.

The Chinese medicinal composition is administered by directly using external lotion method 1 time per day.

Example 2

The traditional Chinese medicine composition for treating psoriasis vulgaris is different from the traditional Chinese medicine composition in the embodiment 1 in the mixture ratio, and the traditional Chinese medicine composition provided by the embodiment is composed of the following raw materials: 40g of dark plum fruit, 50g of spina gleditsiae, 45g of indigo naturalis, 45g of cacumen biotae, 40g of bletilla striata and 35g of papermulberry leaf.

The preparation method of the traditional Chinese medicine composition is the same as that of the embodiment 1.

Example 3

The traditional Chinese medicine composition for treating psoriasis vulgaris is different from the traditional Chinese medicine composition in the embodiment 1 in the mixture ratio, and the traditional Chinese medicine composition provided by the embodiment is composed of the following raw materials: 15g of dark plum fruit, 15g of spina gleditsiae, 10g of natural indigo, 15g of cacumen biotae, 10g of bletilla striata and 10g of papermulberry leaf.

The effect of the Chinese medicinal composition for treating psoriasis vulgaris provided by the invention is explained below.

1. General data

90 patients with psoriasis vulgaris are selected, the patients are randomly divided into 43 cases in a treatment group and 47 cases in a control group by adopting a random number table method, 4 cases (1 case in the treatment group and 3 cases in the control group) are dropped in the clinical research process due to various reasons, and finally the number of actually finished cases is 42 cases in the treatment group and 44 cases in the control group, and the total number is 86.

2. Diagnostic criteria

(1) The diagnosis standard of western medicine diseases: the discussion about psoriasis vulgaris in the general diagnosis and treatment consensus of combined traditional and western medicine (discussed in 2009) is summarized as follows: skin lesion form: the red spots, pimples and patches can be from mung beans to coins or fused with each other with silvery white scales. ② the affected parts: skin lesions occur on the sides of the limbs, scalp, back or may develop the whole body. Third, good hair season: generally, the weight is increased in winter and is relieved in summer. (iv) family inheritance: some patients have a family history. Special physical signs: the nail can be accompanied with the nail pit or the nail ridge of the finger (toe), the thin film phenomenon (+), the punctate bleeding phenomenon (+), and the isomorphic reaction (+).

(2) The traditional Chinese medicine syndrome diagnosis standard is as follows: refer to the discussions of the porrigo blood heat syndrome, blood dryness syndrome and blood stasis syndrome in the consensus of experts in traditional Chinese medicine for treating psoriasis in dermatological departments (2017), which are summarized as follows: blood-heat syndrome: the occurrence and development of the rash are rapid, the rash is continuously increased, flushing occurs, the sifting bleeding points are obvious, and the scales are large; it is often accompanied by dry mouth, dry tongue, restlessness, irritability, dry stool, and yellow or red urine; a red or deep-red tongue with a thin and yellow coating and a wiry and rapid or slippery and rapid pulse. ② blood dryness syndrome: the rash stops developing or gradually subsides, the flushing is reduced, and the scales are less and the attachment is tighter; dizziness, a pale complexion, constipation; the tongue is pale red, with little coating, and the pulse is wiry, thready or soft-superficial. ③ syndrome of blood stasis: the rash does not decline for a long time, the color is dark red, and the skin is rough and thick; dark and red tongue, ecchymosis at the tip of tongue, wiry or unsmooth pulse.

3. Inclusion criteria

(1) Meets the Western medicine disease diagnosis standard of psoriasis vulgaris.

(2) According with the traditional Chinese medicine syndrome diagnosis standard of the blood-heat syndrome, the blood-dryness syndrome and the blood stasis syndrome caused by the porrigo.

(3) Adult patients over the age of 18 years.

(4) The patient compliance is good, can cooperate clinical research, and sign informed consent.

4. Exclusion criteria

(1) Patients with psoriasis of joint type, pustule type, and erythrodermic type.

(2) Those allergic to the relevant test drug ingredients in this study are known.

(3) The chronic consumptive diseases such as serious cardiovascular and cerebrovascular diseases, liver and kidney insufficiency, hematopoietic system diseases, mental diseases, malignant tumors and the like are not suitable for observers.

(4) Pregnant or lactating women.

(5) The oral administration or external application of glucocorticoid, immunosuppressant, photochemotherapy, etc. for about 1 month.

(6) Patients who are participating in other clinical trials.

5. Treatment methods and therapies

(1) Treatment groups: the lotion to which the Chinese medicinal composition provided in example 1 of the present invention was administered (the effect of the Chinese medicinal composition provided in example 1 was only explained by taking the Chinese medicinal composition provided in example 1 as an example because the therapeutic effects of the Chinese medicinal compositions prepared in examples 1 to 3 were substantially the same), was applied 1 time per day for 4 weeks as a treatment course.

(2) Control group: tacalcitol ointment for external use, trade name: lovely glover. The components: each 1g of tacalcitol contained 2. mu.g. Specification: 2 μ g 10 g. Production enterprises: TEIJIN PHARMALIMITED IWAKUNI PHARMACEUTICAL family (japan). Approval document No.: H20160628. the usage and dosage are as follows: applying the composition on affected part 2 times daily in the morning and evening. The course of treatment is as follows: 4 weeks.

(3) Note that: during the treatment period, the occurrence of exogenous infection, pharyngitis, tonsillitis or trauma is avoided. ② stabilizing the emotion and the life rule without tiredness. ③ pungent and fishy foods are prohibited.

6. Observation index

(1) Evaluation of skin Damage index

The method comprises the steps of evaluating psoriasis patients before and 4 weeks after treatment by adopting a psoriasis skin damage area and severity index (PASI) grading method respectively, wherein the skin damage severity is measured by a five-grade grading method of 0-4 grades according to 3 indexes such as erythema, infiltration and scale, the skin damage area is calculated by a seven-grade grading method of 0-6 grades according to the proportion of skin damage in different parts of a human body, and finally obtaining the PASI value of each psoriasis patient according to a formula. The conditions of erythema, infiltration, scaling, skin lesion area and PASI value of patients in different groups are expressed in the form of mean +/-standard deviation, and the intra-group or inter-group evaluation is carried out by t test of matched or independent samples.

(2) Evaluation of clinical efficacy

The discussion of the evaluation criteria for psoriasis efficacy in the guidelines for diagnosis and treatment of common diseases in dermatology of traditional Chinese medicine (2012 edition) is summarized as follows:

the clinical recovery: the skin loss change index is more than or equal to 90 percent;

secondly, effect is displayed: 90 percent more than the skin damage change index is more than or equal to 60 percent;

③ effective: 60 percent more than the skin damage change index is more than or equal to 20 percent;

fourthly, invalidation: the index of change in skin damage is < 20% or negative.

Skin loss change index ═ (pre-treatment PASI score-post-treatment 4 weeks PASI score)/pre-treatment PASI score 100%;

total effective rate (clinical recovery number + number of significant effects + number of effective effects)/total number of patients in the group 100%.

(3) Evaluation of degree of itching

Adopting a visual analogue evaluation method (VAS) for pruritus, using a moving scale with the length of 10cm and 10 scales, wherein 0 represents no pruritus and 10 represents intolerable pruritus, carrying out positioning between 0 and 10 by the patient when evaluating the side with scales back to the patient, selecting a position capable of representing the degree of pruritus, recording the score by the doctor, repeating the above process for 3 times, and taking the average value as the final visual analogue evaluation for pruritus. The degree of itching of patients in different groups is expressed in the form of mean ± standard deviation, and the evaluation within or between groups is performed by t-test of paired or independent samples.

(4) Th1/Th2 related drift factor detection

Before treatment and 4 weeks after treatment, under the condition of fasting in the early morning of a patient, extracting 4ml of peripheral venous blood into a vacuum blood collection tube, placing for 2h at 4 ℃, centrifuging for 20min at 3000r/min by adopting a high-speed centrifuge, extracting serum, and respectively measuring the serum content values before and after treatment of Th1 type cell secretion factors IL-2, IFN-gamma, TNF-alpha, Th2 type cell secretion factors IL-4 and IL-10 by applying an enzyme-linked immunosorbent assay (ELISA). The measured values of each index in different groups are expressed as mean ± standard deviation, and intra-or inter-group evaluation is performed by t-test of paired or independent samples.

7. Results

7.1 distribution of STDs in two groups

See table 1 for details.

TABLE 1 two groups of patient sex distribution table (n)

Note: the sex constitution ratio of two groups of patients is proved by chi-square test, P is more than 0.05, and the sex ratio is comparable.

As can be seen from Table 1, the number of actual cases in the group was 86, 50 in men and 36 in women. Wherein the treatment group comprises 23 male patients and 19 female patients; control group 27 male patients and 17 female patients. The sex constitution ratio of two groups of patients is proved by chi-square test, P is more than 0.05, and the sex ratio is comparable.

7.2 age distribution of two groups of patients

See table 2 for details.

TABLE 2 two groups of patients' age distribution table (years)

Note: the age of two groups of patients is tested by independent samples t, P is more than 0.05, and the patients have comparability.

As can be seen from Table 2, the mean age of the patients in the treatment group (32.47. + -. 5.68) was old; the mean age of the control patients (31.52. + -. 6.20) years. The age of two groups of patients is tested by independent samples t, P is more than 0.05, and the patients have comparability.

7.3 distribution of disease courses of two groups of patients

See table 3 for details.

TABLE 3 two groups of patient disease distribution chart (moon)

Note: the disease course of two groups of patients is tested by independent samples t, P is more than 0.05, and the disease course is comparable.

As can be seen from Table 3, the mean course of disease (13.20. + -. 4.41) is months for the patients in the treatment group; the mean course of disease (12.65. + -. 3.89) months in the control group of patients. The disease course of two groups of patients is tested by independent samples t, P is more than 0.05, and the disease course is comparable.

7.4 evaluation results of skin lesion status and area of two groups of patients

See table 4 for details.

TABLE 4 comparison of skin lesion status and area of psoriasis patients before and after treatment: (

Minute)

Note: compared with the control group with the same index before treatment,^ap is more than 0.05 and is comparable; compared with the same group of pre-treatment with the same index,^bP＜0.05，^cp is less than 0.01; compared with a control group with the same index after treatment,^dP＜0.05，^eP＜0.01。

as shown in Table 4, after 4 weeks of treatment, the skin lesion status (erythema, infiltration, and scaling) and the skin lesion area of the psoriasis patients in the treatment group were significantly decreased (P < 0.01), and were superior to the indexes (P < 0.05 or P < 0.01) of the control group compared with the control group after the treatment.

7.5 evaluation results of psoriasis lesion index (PASI) of two groups of patients

See table 5 for details.

TABLE 5 comparison of psoriasis patient skin damage index (PASI) before and after treatment TABLE: (

Minute)

Note: in comparison with the control group,^aP＞0.05，^bp is less than 0.05; compared with the treatment before the same group of treatment,^cP＜0.05。

as can be seen from Table 5, the PASI score was significantly lower in the treated group than in the control group (P < 0.05) after 4 weeks of treatment.

7.6 evaluation results of psoriasis clinical efficacy of two groups of patients

See table 6 for details.

TABLE 6 comparative clinical efficacy of psoriasis patients after treatment (example,%)

Note: in comparison with the control group,^aP＜0.05。

as can be seen from Table 6, the overall efficacy was evaluated by comprehensive analysis of the PASI scores for erythema, infiltration, scaling and lesion area after treatment, with the clinical efficacy of the treatment group being higher than that of the control group (P < 0.05).

7.7 evaluation results of degree of itching in two groups of patients

See table 7 for details.

TABLE 7 comparison of degree of itching in psoriasis patients before and after treatment: (

Minute)

as can be seen from Table 7, the itch score of the treated group was significantly lower than that of the control group (P < 0.05) after 4 weeks of treatment.

7.8, the detection result of the relevant drift factors Th1/Th2 of psoriasis patients

See table 8 for details.

TABLE 8 comparison of serum Th1/Th2 wandering factor in psoriasis before and after treatment: (

pg/mL)

as can be seen from Table 8, by comparing the serum levels of Th1 cell secretion factors (IL-2, IFN-gamma, TNF-alpha) and Th2 cell secretion factors (IL-4, IL-10) before and after treatment, the treatment groups can significantly reduce the levels of IL-2, IFN-gamma and TNF-alpha (P < 0.01), and up-regulate the levels of IL-4 and IL-10 (P < 0.01), so as to improve the shift state of Th1/Th2 toward Th 1.

In conclusion, the traditional Chinese medicine composition provided by the invention can effectively relieve the skin damage states of erythema, infiltration and scale of psoriasis vulgaris patients, reduce the skin damage area, reduce the PASI score of psoriasis, and has obvious clinical curative effect; can also effectively improve the subjective itching symptom of the patient; meanwhile, the content of Th1 cell-related secretion factors IL-2, IFN-gamma and TNF-alpha in serum can be inhibited, the content of Th2 cell-related secretion factors IL-4 and IL-10 in serum can be improved, the drifting state of Th1/Th2 in the direction of Th1 under the psoriasis condition is corrected, and Th1/Th2 cells tend to be balanced, so that the aim of treating psoriasis is fulfilled.

Case 1

For men, 12 years old, the main symptoms are tonsil inflammation caused by exogenous pathogenic factors, erythema punctate and papule are scattered on the whole body, silvery white scale is covered on the part of the body, the subjective pruritus is obvious, the phenomenon of thin film (+), the phenomenon of punctate hemorrhage (+), the swelling of tonsil II degrees, and the course of the disease is more than 1 week. And (3) diagnosis: psoriasis vulgaris. Treatment: the medicine is applied for external washing for 1 time every day, scales disappear and pruritus basically disappear after 10 days, most of pimples disappear after 15 days, most of erythema basically disappear after 20 days, and the color is similar to the skin color.

Case 2

The main symptoms of a female, 37 years old, are no obvious inducement, flaky erythema on the whole body, papule-like protrusion, thick scale covering, obvious subjective itching, obvious local dryness and chapping, a thin film phenomenon (+), a punctate bleeding phenomenon (+), and repeated attack in the course of several years. And (3) diagnosis: psoriasis vulgaris. Treatment: the external washing of the medicine of the invention is carried out 1 time a day, most of skin lesions disappear after 4 weeks, and the medicine has no recurrence and no irritation.

Case 3

The main symptoms of the male, age 32, are erythema, pimple and maculopapule of mung bean size, silvery white scale on the whole body, similar skin damage on the scalp, and subjective pruritus, after the pharyngitis, the course of the disease is 2 months. And (3) diagnosis: psoriasis vulgaris. Treatment: the external washing with the medicine of the invention is carried out 1 time a day, the skin damage of scalp basically fades after 2 weeks, the skin is not itchy, most of the skin damage of the scalp flattens after 3 weeks, the skin color recovers, and the skin damage heals and fades after 6 weeks.

Case 4

The main symptoms of a female, 52 years old, are that after eating seafood hair, the skin has large red spots, the color is dark red, scales are obvious, the local part is rough and thick, particularly, double elbows are heavy, dozens of sieve-shaped bleeding points, scratch marks and blood scabs are visible in flaky erythema on the whole body, patients feel severe pruritus at night, particularly, the phenomenon of a thin film (+), the phenomenon of punctate bleeding (+), and the course of disease is 3 months. And (3) diagnosis: psoriasis vulgaris. Treatment: the medicine is applied for external washing, 1 time per day, after 1 week, the screenful bleeding completely disappears, after 10 days, the pruritus is obviously relieved, the itching is basically not itchy at night, the sleep is not influenced, and most of erythema and pimple subside after 4 weeks.

Case 5

For a female aged 67 years, the main symptoms are more than 15 years of psoriasis history, skin damage is mild, severe and recurrent, winter is severe, summer is mild, the disease is not obvious, the skin damage of the whole body is heavy at the hip and waist, thick-layer silvery white scales can be seen, the scales are like cow leather, dry and chap, coarse and thick, the subjective pruritus is difficult to endure, and the psoriasis is accompanied with the change of a psoriasis. And (3) diagnosis: psoriasis vulgaris. Treatment: after the medicine is applied for external washing, 1 time per day, scales at skin lesions disappear after 2 weeks, dead skin basically disappears, the skin lesions obviously disappear after 3 weeks, dry skin at buttocks is obviously relieved, local chap symptoms basically disappear, pruritus is relieved, most of skin lesions disappear after 8 weeks, and new skin lesions do not exist.

Case 6

For men, 60 years old, the main symptoms are flaky erythema visible on skin lesions of the whole body after drinking all year round, dark color, large scale, skin lesions with heavy weight on both lower limbs, self scratching after pruritus, obvious scratch and blood scab of local skin lesions, superficial skin ulcer, small amount of blood and liquid seepage at sores, pain feeling during self walking, thin film phenomenon (+), punctate bleeding phenomenon (+), and relapse of the disease course for decades. And (3) diagnosis: psoriasis vulgaris. Treatment: after the medicine is applied for external washing, 1 time per day, most scales disappear after 2 weeks, the red spot turns light, the wound seepage basically disappears, most of the sore openings heal after 4 weeks without itching, the superficial wound surfaces of the lower limbs heal completely after 10 weeks, the skin damage of the whole body disappears, the walking is free, and the self-perception is free from abnormality.

The above disclosure is only for the specific embodiment of the present invention, but the embodiment of the present invention is not limited thereto, and any variations that can be made by those skilled in the art should fall within the scope of the present invention.

Claims

1. The traditional Chinese medicine composition for treating psoriasis vulgaris is characterized by comprising the following raw materials in parts by weight: 15-40 parts of dark plum fruit, 15-50 parts of spina gleditsiae, 10-45 parts of indigo naturalis, 15-45 parts of cacumen biotae, 10-40 parts of bletilla striata and 10-35 parts of papermulberry leaf.

2. The traditional Chinese medicine composition for treating psoriasis vulgaris according to claim 1, which is characterized by comprising the following raw materials in parts by weight: 15-20 parts of dark plum fruit, 15-35 parts of spina gleditsiae, 10-25 parts of indigo naturalis, 15-20 parts of cacumen biotae, 10-20 parts of bletilla striata and 10-15 parts of papermulberry leaf.

3. The traditional Chinese medicine composition for treating psoriasis vulgaris according to claim 1, which is characterized by comprising the following raw materials in parts by weight: 30 parts of dark plum fruit, 30 parts of spina gleditsiae, 20 parts of indigo naturalis, 20 parts of cacumen biotae, 15 parts of bletilla striata and 15 parts of papermulberry leaf.

4. The preparation method of the traditional Chinese medicine composition for treating psoriasis vulgaris according to claim 1, characterized by comprising the following steps:

5. The method for preparing a Chinese medicinal composition for treating psoriasis vulgaris as claimed in claim 4, wherein said decocting is carried out by adding water in an amount of 8 times of the total mass of mume fructus, spina Gleditsiae, indigo naturalis, cacumen Platycladi, rhizoma Bletillae and folium Broussonetiae.

6. The method for preparing a Chinese medicinal composition for treating psoriasis vulgaris according to claim 4 or 5, wherein the Chinese medicinal composition can be further prepared into a pharmaceutically acceptable external preparation.

7. The method for preparing a Chinese medicinal composition for treating psoriasis vulgaris as claimed in claim 6, wherein the external preparation is an external lotion.