CN111840505B

CN111840505B - Traditional Chinese medicine preparation and plaster for treating psoriasis and preparation method thereof

Info

Publication number: CN111840505B
Application number: CN202010873499.2A
Authority: CN
Inventors: 黄蜀
Original assignee: Individual
Current assignee: Individual
Priority date: 2020-08-26
Filing date: 2020-08-26
Publication date: 2022-01-04
Anticipated expiration: 2040-08-26
Also published as: CN111840505A

Abstract

The invention discloses a traditional Chinese medicine preparation and plaster for treating psoriasis and a preparation method thereof, and relates to the technical field of medicines. Compared with the prior art, the invention adopts the method of treating both internal and external diseases and treating both principal and secondary aspect of disease, can shorten the treatment period of psoriasis, effectively control the psoriasis and enhance the long-term effect of psoriasis treatment; the oral preparation of the invention takes warming yang to transform qi into water, and attaches importance to yang qi of human body; the external preparation has the effects of dispelling wind, promoting diuresis, cooling blood, moistening dryness and promoting skin repair; the invention is compatible according to the prescription idea of the meridian formula, aims at the basic pathogenesis of psoriasis, is safe and effective, can obviously reduce the recurrence rate of psoriasis and recovers the barrier function of skin.

Description

Traditional Chinese medicine preparation and plaster for treating psoriasis and preparation method thereof

Technical Field

The invention relates to the technical field of medicines, and particularly relates to a traditional Chinese medicine preparation and plaster for treating psoriasis and a preparation method thereof.

Background

Psoriasis is commonly called as psoriasis, is a chronic inflammatory skin disease, has long course of disease and easy recurrence tendency, and some cases are not cured almost for the whole life. The disease is mainly developed in young and old years, and has great influence on the physical health and mental conditions of patients. The clinical manifestations mainly include erythema and scales, all diseases occur in the whole body, the scalp and the limbs are common, and the disease is aggravated in winter. According to incomplete statistics, the number of patients is nearly 20000 thousands worldwide, 300 thousands of patients are still existed in China, and the incidence rate is still on the rising trend in recent years, wherein the incidence rate of the common type accounts for more than 95% of psoriasis, and the progress period is mainly. Because the pathogenesis of the psoriasis is unknown, the pathogenesis is complex, the cure rate is low, the psoriasis is easy to relapse, and the physical and mental health of a patient is seriously influenced.

Many psoriasis treatment methods are available, but most psoriasis treatment methods can only achieve the near-term clinical effect or temporarily relieve symptoms, and no good radical treatment method exists at present. Modern medicine advocates the simple use of topical medications for patients with mild to moderate psoriasis (usually psoriasis vulgaris with skin lesions of <20% of body surface area), in view of the high rate of recurrence of psoriasis and the systemic adverse effects of oral medications. The psoriasis is treated by external drugs, and the western medicine mostly adopts corticosteroid hormone, tretinoin, calcipotriol, tar, anthralin, salicylic acid preparation and the like, and the drugs have large side effect, local stimulation or high price and cannot be used for a long time and a large area. The traditional external treatment prescription for the disease mostly contains heavy metal medicines, and is greatly inhibited on the safety of the external medicines.

At present, the psoriasis is clinically treated by using an anti-tumor drug, glucocorticoid, a retinoic acid drug, an immunotherapy and a biological preparation, and according to years of clinical research, the treatment methods can control skin lesions in a short period and delay the progress of the disease, but the pathogenesis of the psoriasis is not clear, related treatment targets are not clear, the psoriasis is easy to generate drug dependence after long-term use, the disease rebound phenomenon can occur once the psoriasis is reduced or stopped, meanwhile, the skin lesions can have local color deposition, pores and striae atrophy, the barrier function is damaged, and even fungal or bacterial infection is complicated, so that the disease is delayed and difficult to heal, and the life quality of patients is greatly influenced.

Disclosure of Invention

In order to solve the technical problems, the invention firstly aims to provide a traditional Chinese medicine preparation for treating psoriasis, which comprises an oral preparation and an external preparation, adopts a method of simultaneous treatment of internal and external application and treatment of both symptoms and root causes, and can improve the long-term clinical curative effect by comprehensive treatment.

The invention also aims to provide a plaster for treating psoriasis and a preparation method thereof.

In order to achieve the above object, the technical solution of the present invention is as follows.

A Chinese medicinal preparation for treating psoriasis comprises oral preparation and external preparation;

the oral preparation comprises the following components in parts by weight:

5-10 parts of rhizoma typhonii slice, 5-10 parts of semen coicis, 5-10 parts of rhizoma smilacis glabrae, 5-10 parts of cassia twig, 5-10 parts of ginger, 5-10 parts of peach kernel, 5-10 parts of angelica sinensis, 5-10 parts of cortex phellodendri, 5-10 parts of herba patriniae, 5-10 parts of cortex moutan, 5-10 parts of fructus amomi, 5-10 parts of perilla leaf, 5-10 parts of herba schizonepetae and 5-10 parts of radix paeoniae rubra;

the external preparation comprises the following components in parts by weight:

5-10 parts of indigo naturalis, 5-10 parts of sulfur, 5-10 parts of rheum officinale, 5-10 parts of turmeric, 5-10 parts of golden cypress, 5-10 parts of garden burnet, 5-10 parts of chinaberry fruit, 5-10 parts of prepared kusnezoff monkshood root, 5-10 parts of mint, 1-3 parts of borneol, 5-10 parts of purslane, 5-10 parts of cortex moutan, 5-10 parts of Chinese angelica, 5-10 parts of red paeony root, 5-10 parts of cortex dictamni and 5-10 parts of rhizoma polygonati.

The traditional Chinese medicine preparation provided by the invention has the main effects of dispelling wind and promoting diuresis, warming yang and removing blood stasis, and protecting yang qi in a body. In the invention, the method of treating both internal and external diseases and treating both symptoms and root causes is adopted, and the traditional Chinese medicine is a self-prepared prescription. According to the theory of external treatment, i.e., the theory of internal treatment, and the theory of external treatment, i.e., the theory of internal treatment, in the Congregation, the ear is treated differently. The internal and external concurrent treatment is adopted, so that the psoriasis treatment period can be shortened, the psoriasis recovery can be effectively controlled, and the long-term effect of the psoriasis treatment can be enhanced; the oral preparation of the invention takes warming yang to transform qi into water, and attaches importance to yang qi of human body; the external preparation has the effects of dispelling wind, promoting diuresis, cooling blood, moistening dryness and promoting skin repair; the invention is compatible according to the prescription idea of the meridian formula, aims at the basic pathogenesis of psoriasis, is safe and effective, can obviously reduce the recurrence rate of psoriasis and recovers the barrier function of skin.

In the oral preparation, the rhizoma typhonii slices and the cinnamon branches warm yang and transform qi into water; herba Patriniae and cortex Phellodendri have effects of clearing away heat and toxic materials; the ginger, the perilla leaf and the schizonepeta are used for dispelling wind and relieving exterior syndrome; fructus Amomi is fragrant and turbid; radix Paeoniae Rubra, cortex moutan, semen Persicae, and radix Angelicae sinensis for cooling blood and removing blood stasis; coix seed and rhizoma smilacis glabrae have the effects of removing dampness by means of bland excreting;

in the external preparation, the turmeric, the sulfur and the prepared kusnezoff monkshood root are used for dispelling cold and eliminating dampness; indigo naturalis, rhubarb, phellodendron, chinaberry fruit, purslane and cortex dictamni are capable of clearing away heat and toxic materials, and modern researches prove that the heat-clearing and detoxifying drug has strong effects of inhibiting epidermal cell proliferation and resisting inflammation and inhibiting humoral immunity, and can promote skin lesions of patients with psoriasis to disappear and restore the color to normal. Rhizoma Polygonati, radix Angelicae sinensis, radix Paeoniae Rubra, cortex moutan, and radix Sangusorbae for cooling blood, promoting blood circulation and moistening dryness; herba Menthae and Borneolum Syntheticum has effects of dispelling pathogenic wind, relieving exterior syndrome, and relieving itching; wherein, the angelica enriches the blood and nourishes the yin, the red peony root promotes the blood circulation and removes the obstruction in the channels, and the stagnation in the blood is removed; the two medicines are used together, so that the effects of enriching and nourishing blood, increasing local blood supply, improving skin malnutrition, moistening skin, reducing scales and enhancing itching relieving are achieved.

Further, the oral preparation comprises the following components in parts by weight:

6 parts of rhizoma typhonii slice, 6 parts of semen coicis, 6 parts of rhizoma smilacis glabrae, 6 parts of cassia twig, 6 parts of ginger, 6 parts of peach kernel, 6 parts of angelica, 6 parts of cortex phellodendri, 6 parts of herba patriniae, 6 parts of cortex moutan, 6 parts of fructus amomi, 6 parts of perilla leaf, 6 parts of herba schizonepetae and 6 parts of radix paeoniae rubra.

5 parts of rhizoma typhonii slice, 5 parts of semen coicis, 5 parts of rhizoma smilacis glabrae, 5 parts of cassia twig, 5 parts of ginger, 5 parts of peach kernel, 5 parts of angelica, 5 parts of phellodendron, 5 parts of herba patriniae, 5 parts of cortex moutan, 5 parts of fructus amomi, 5 parts of perilla leaf, 5 parts of herba schizonepetae and 5 parts of radix paeoniae rubra.

10 parts of rhizoma typhonii slice, 10 parts of semen coicis, 10 parts of rhizoma smilacis glabrae, 10 parts of cassia twig, 10 parts of ginger, 10 parts of peach kernel, 10 parts of angelica, 10 parts of phellodendron, 10 parts of herba patriniae, 10 parts of cortex moutan, 10 parts of fructus amomi, 10 parts of perilla leaf, 10 parts of schizonepeta and 10 parts of radix paeoniae rubra.

Further, the external preparation also comprises the following components in parts by weight:

5-10 parts of dark plum and 5-10 parts of pearl powder.

Further, the external preparation comprises the following components in parts by weight:

6 parts of indigo naturalis, 6 parts of sulfur, 6 parts of rheum officinale, 6 parts of turmeric, 6 parts of golden cypress, 6 parts of garden burnet, 6 parts of chinaberry fruit, 6 parts of prepared kusnezoff monkshood root, 6 parts of mint, 1 part of borneol, 6 parts of purslane, 6 parts of cortex moutan, 6 parts of Chinese angelica, 6 parts of red paeony root, 6 parts of cortex dictamni, 6 parts of rhizoma polygonati, 6 parts of dark plum fruit and 6 parts of pearl powder.

5 parts of indigo naturalis, 5 parts of sulfur, 5 parts of rheum officinale, 5 parts of turmeric, 5 parts of golden cypress, 5 parts of garden burnet, 5 parts of chinaberry fruit, 5 parts of prepared kusnezoff monkshood root, 5 parts of mint, 1 part of borneol, 5 parts of purslane, 5 parts of cortex moutan, 5 parts of Chinese angelica, 5 parts of red paeony root, 5 parts of cortex dictamni, 5 parts of rhizoma polygonati, 5 parts of dark plum fruit and 5 parts of pearl powder.

10 parts of indigo naturalis, 10 parts of sulfur, 10 parts of rheum officinale, 10 parts of turmeric, 10 parts of golden cypress, 10 parts of garden burnet, 10 parts of chinaberry fruit, 10 parts of prepared kusnezoff monkshood root, 10 parts of mint, 3 parts of borneol, 10 parts of purslane, 10 parts of cortex moutan, 10 parts of Chinese angelica, 10 parts of red paeony root, 10 parts of cortex dictamni, 10 parts of rhizoma polygonati, 10 parts of dark plum fruit and 10 parts of pearl powder.

The invention also provides a plaster for treating psoriasis, which is prepared by adopting the external preparation of the traditional Chinese medicine preparation.

The invention also provides a preparation method of the plaster for treating psoriasis, which comprises the following steps:

processing the raw materials of the external preparation by superfine grinding technology, and sieving with No. 9 sieve to obtain superfine powder (more than 200 meshes); wherein, the viscous medicines such as minerals, peppermint, rhizoma Polygonati, etc. need to be separately pulverized;

weighing the medicinal powder of each raw material according to the formula ratio, and filling the medicinal powder into a container to be uniformly mixed for later use;

40-60 parts by weight of vaseline is put into another container and heated to be melted for standby;

pouring the uniformly mixed medicinal powder into vaseline solution, stirring and heating, stopping heating after stirring uniformly, and cooling to obtain the plaster.

The invention has the beneficial effects that: compared with the prior art:

(1) the invention adopts a method of treating both internal and external diseases and treating both principal and secondary aspect of disease, can shorten the treatment period of psoriasis, effectively control the psoriasis and enhance the long-term effect of psoriasis treatment.

(2) The oral preparation of the invention takes warming yang to transform qi into water, and attaches importance to yang qi of human body; the external preparation has the effects of dispelling wind, promoting diuresis, cooling blood, moistening dryness and promoting skin repair.

(3) The invention is compatible according to the prescription idea of the meridian formula, aims at the basic pathogenesis of psoriasis, is safe and effective, can obviously reduce the recurrence rate of psoriasis and recovers the barrier function of skin.

Detailed Description

The present invention will be described in further detail in order to make the objects, technical solutions and advantageous effects of the present invention more apparent. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

Example 1

the oral preparation comprises the following components in parts by weight:

6 parts of rhizoma typhonii, 6 parts of semen coicis, 6 parts of rhizoma smilacis glabrae, 6 parts of cassia twig, 6 parts of ginger, 6 parts of peach kernel, 6 parts of angelica, 6 parts of phellodendron, 6 parts of herba patriniae, 6 parts of cortex moutan, 6 parts of fructus amomi, 6 parts of perilla leaf, 6 parts of herba schizonepetae and 6 parts of radix paeoniae rubra;

the external preparation comprises the following components in parts by weight:

Decocting the oral preparation in water for 2 hr, filtering, and collecting filtrate for oral administration;

weighing the raw materials of the external preparation according to the formula, separately crushing by an ultrafine crusher, sieving to obtain 1000-mesh medicinal powder, respectively filling into a sealed tank, and irradiating all the filled medicinal powder with cobalt 60 for sterilization;

putting the medicinal powder according to the formula amount into a 1000 ml container, and uniformly mixing the medicinal powder by using a stirring rod for later use;

50 parts by weight of vaseline is put into a 2000 ml stainless steel container and heated to be melted for 20 minutes at 300 ℃;

pouring the uniformly mixed medicinal powder into vaseline solution, stirring and heating, stirring for 10 min till uniformity, stopping heating, pouring into a split charging box while the mixture is hot, and cooling to obtain the plaster.

The using method comprises the following steps: the cooled plaster is directly applied to the skin lesion three times a day.

Example 2

the oral preparation comprises the following components in parts by weight:

5 parts of rhizoma typhonii slices, 5 parts of semen coicis, 5 parts of rhizoma smilacis glabrae, 5 parts of cassia twig, 5 parts of ginger, 5 parts of peach kernel, 5 parts of angelica, 5 parts of phellodendron, 5 parts of herba patriniae, 5 parts of cortex moutan, 5 parts of fructus amomi, 5 parts of perilla leaf, 5 parts of herba schizonepetae and 5 parts of radix paeoniae rubra;

the external preparation comprises the following components in parts by weight:

40 parts by weight of vaseline is put into a 2000 ml stainless steel container and heated to be melted for 20 minutes at 300 ℃;

Example 3

the oral preparation comprises the following components in parts by weight:

10 parts of rhizoma typhonii slices, 10 parts of semen coicis, 10 parts of rhizoma smilacis glabrae, 10 parts of cassia twig, 10 parts of ginger, 10 parts of peach kernel, 10 parts of angelica, 10 parts of phellodendron, 10 parts of herba patriniae, 10 parts of cortex moutan, 10 parts of fructus amomi, 10 parts of perilla leaf, 10 parts of schizonepeta and 10 parts of radix paeoniae rubra;

the external preparation comprises the following components in parts by weight:

60 parts by weight of vaseline is put into a 2000 ml stainless steel container and heated to be melted for 20 minutes at 300 ℃;

Example 4

the oral preparation comprises the following components in parts by weight:

the external preparation comprises the following components in parts by weight:

6 parts of indigo naturalis, 6 parts of sulfur, 6 parts of rheum officinale, 6 parts of turmeric, 6 parts of golden cypress, 6 parts of garden burnet, 6 parts of chinaberry fruit, 6 parts of prepared kusnezoff monkshood root, 6 parts of mint, 1 part of borneol, 6 parts of purslane, 6 parts of cortex moutan, 6 parts of Chinese angelica, 6 parts of red paeony root, 6 parts of cortex dictamni and 6 parts of rhizoma polygonati.

Example 5

the oral preparation comprises the following components in parts by weight:

8 parts of rhizoma typhonii slices, 8 parts of semen coicis, 8 parts of rhizoma smilacis glabrae, 8 parts of cassia twig, 8 parts of ginger, 8 parts of peach kernel, 8 parts of angelica, 8 parts of phellodendron, 8 parts of herba patriniae, 8 parts of cortex moutan, 8 parts of fructus amomi, 8 parts of perilla leaf, 8 parts of schizonepeta and 8 parts of radix paeoniae rubra;

the external preparation comprises the following components in parts by weight:

8 parts of indigo naturalis, 8 parts of sulfur, 8 parts of rheum officinale, 8 parts of turmeric, 8 parts of golden cypress, 8 parts of garden burnet, 8 parts of chinaberry fruit, 8 parts of prepared kusnezoff monkshood root, 8 parts of mint, 2 parts of borneol, 8 parts of purslane, 8 parts of cortex moutan, 8 parts of Chinese angelica, 8 parts of red paeony root, 8 parts of cortex dictamni, 8 parts of rhizoma polygonati, 8 parts of dark plum fruit and 8 parts of pearl powder.

Example 6

the oral preparation comprises the following components in parts by weight:

9 parts of rhizoma typhonii, 9 parts of semen coicis, 9 parts of rhizoma smilacis glabrae, 9 parts of cassia twig, 9 parts of ginger, 9 parts of peach kernel, 9 parts of angelica, 9 parts of phellodendron, 9 parts of herba patriniae, 9 parts of cortex moutan, 9 parts of fructus amomi, 9 parts of perilla leaf, 9 parts of herba schizonepetae and 9 parts of radix paeoniae rubra;

the external preparation comprises the following components in parts by weight:

9 parts of indigo naturalis, 9 parts of sulfur, 9 parts of rheum officinale, 9 parts of turmeric, 9 parts of golden cypress, 9 parts of garden burnet, 9 parts of chinaberry fruit, 9 parts of prepared kusnezoff monkshood root, 9 parts of mint, 2 parts of borneol, 9 parts of purslane, 9 parts of cortex moutan, 9 parts of Chinese angelica, 9 parts of red paeony root, 9 parts of cortex dictamni, 9 parts of rhizoma polygonati, 9 parts of dark plum fruit and 9 parts of pearl powder.

In order to verify the treatment effect of the traditional Chinese medicine preparation for treating psoriasis, a single-center random control research method is adopted.

1. 100 subjects were divided into two groups (50 in each of the treatment and control groups) using a completely randomized protocol, all patients enrolled were numbered in the order of treatment, and a randomized assignment was generated using the existing SPSS software. The random dispensing protocol was hidden (enclosed in a sequence-coded, sealed, light-tight envelope) for dispensing therapy and registered.

2 case selection

2.1 Western diagnostic standards

Reference is made to clinical dermatology (edited by Zhao dialectic sciences, 3 rd edition of Jiangsu science and technology Press, 4 months 2001).

Diagnostic criteria for psoriasis vulgaris

i. The skin damage of the disease is gradually enlarged from red inflammatory papules and maculopapules, and the red maculopapules are fused into red spot sheets with different sizes, and are covered with a plurality of layers of silvery white scales, and a layer of bright film can be seen after the scales are scraped off, and spot bleeding can occur under the film.

The rash form can be of a plurality of types such as a little drop, a coin, a map, a mixture and the like, but the boundary is obvious.

Rashes can occur everywhere on the body surface. When the scalp occurs, the hair is in the shape of a bundle; the nail plate (finger, toe) may have a point-shaped concave part in the shape of a thimble or the nail plate may be uneven, yellow and thick.

Different degrees of itching may accompany it.

v. slow course of disease, easy recurrence.

(II) clinical staging criteria

i. The implementation period is as follows: acute onset, continuous appearance of new rash, continuous expansion of old rash, thick and accumulated scales, obvious inflammation and remarkable itching feeling, and homomorphic reaction can be seen.

Stationary phase (stationary phase): stable disease condition, temporary stop of development, reduced inflammation, no new eruption and no regression of old rash.

Recovery period (regression period): the skin lesion becomes thin and small, the color turns to be light, the inflammation basically disappears, the scale is obviously reduced until the skin lesion is faded, and the temporary pigmentation spots or depigmentation spots are left.

2.2 Chinese medicine syndrome diagnostic criteria

It is formulated according to the "standard of curative effect for diagnosing Chinese medicine diseases" (national institute of Chinese medicine and drug administration, Nanjing university Press, 1994).

Wind-heat and blood-dryness type

The main symptoms are: the skin lesions are bright red, the rash appears continuously, the erythema is increased, the scales are scraped off, a bright film can be seen, the blood is in a punctate state, and the isomorphic reaction can be seen.

The secondary symptoms include pruritus of different degrees, vexation, thirst, dry stool, yellow urine, red tongue, yellow or greasy tongue coating, and wiry, slippery or rapid pulse.

② blood deficiency and wind dryness type

The main symptoms are that the skin is light in color, part of the skin is faded and scales are more.

The secondary symptoms are dry mouth, dry stool, pale red tongue with thin and white coating and thready and slow pulse.

Skin type of stasis

The main symptoms are that the skin is damaged, fat and wet, the color is dark red, and the skin can not be withdrawn for a long time.

The secondary symptoms are purple dark tongue or ecchymosis, petechia, and unsmooth or thready and slow pulse.

Those with more than 2 items of the above major and minor symptoms can be diagnosed as the syndrome.

2.3 test case criteria

2.3.1 case inclusion criteria

The medicine meets the traditional Chinese medicine diagnosis standard of wind-heat and blood dryness type psoriasis and the Western medicine diagnosis standard for ordinary psoriasis patients.

② the area of skin damage is less than 20 percent.

Age 18-60 years old, male and female are unlimited, women with fertility are not prepared for pregnancy during the test period and within one year after the test is finished.

Subjects had to voluntarily attend the study and comply with the study regulations, understand and comply with the follow-up schedule, and sign informed consent.

Within about one month, glucocorticoid, immunosuppressant and tretinoin preparation are not applied systematically; photochemotherapy and other topical treatments were not used for 2 weeks.

2.3.2 exclusion criteria

Those not meeting the inclusion standard.

② the case with exudation, erosion or ulcer of skin.

③ psoriasis of joint type, pustule type and erythroderma type.

Fourthly, other medicines which can influence the state of the psoriasis are used at the same time.

Fifth, for allergic patients.

Sixthly, the patient with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system and the like and the patient with mental disease are combined.

Seventhly, pregnant women and women in lactation.

2.3.3 cases of rejection and shedding

The patients who are wrongly taken in the case that the standard is not met or the cases which are not treated as required after the standard is met are eliminated.

② the patients with incomplete data will influence the curative effect or safety judgment.

And thirdly, the patient who can not insist on treatment due to the occurrence of accidents in the treatment process.

Patients who are not matched with the therapy in the treatment process.

Fifthly, the rejection rate and the falling rate are less than 20 percent.

3 methods of treatment

3.1 treatment group

A plaster prepared from the external preparation of example 1 of the present invention.

The method comprises the following steps: cleaning skin, and applying the plaster to affected part half an hour before sleep every night with an average application of 0.1g/cm 2.

The course of treatment is as follows: the medicine is continuously taken for 4 weeks, and the treatment is repeated for 1, 2, 3 and 4 weeks.

3.2 control group

Tazarotene (trade name: Leshi, manufactured by Chongqing Huabang pharmaceutical Co., Ltd.)

The method comprises the following steps: cleaning skin, and applying tamalodine to affected part twice a night before sleep with an average application of 0.1g/cm 2.

The course of treatment is as follows: the same treatment groups are used.

4 index Observation

4.1 Security Observation

4.1.1 demographic data: including age (range), sex, race, height, weight, health history, medication history, allergy history, medical history, etc.

4.1.2 general physical examination: such as respiration, heart rate, blood pressure, pulse, etc.

4.1.3 adverse reaction indexes: refer to the guidelines for research on new Chinese drugs (pharmacy, pharmacology, toxicology), observe skin irritation around skin lesions, and observe whether the affected area has pigmentation, bleeding spots, rough skin or thin skin.

4.1.4 Effect index

And (3) integral observation of skin damage: referring to' clinical guidelines (trial) for new Chinese medicine.

(1) Form of rash

Degree of scale: 0 minute: no scale is left; and 2, dividing: scales are visible; and 4, dividing: the scale is thick; 6 min: scale accumulation;

erythema: 0 point is no erythema; 2, the erythema is light or dark; 4, red skin damage; 6, fresh red skin lesions;

the infiltration thickening is 0 min, no infiltration thickening; 2, slightly higher than the surface of the skin, and unobvious appearance; 4, obviously higher than the surface, and moderately soaks the hardness when touching; medium hypertrophic or lichenified in 6 points.

(2) The degree of pruritus is 0, namely no pruritus exists; 2 points of occasional pruritus without affecting, working, learning and living; 4, paroxysmal pruritus, which is mild, heavy and affects sleep, work, study and life; 6 points of severe pruritus which seriously affects sleep, work, study and life

(3) Area of rash: (the area of a single palm occupies 1% of the body surface area when the five fingers of the patient are closed, estimated by the burned palm scoring method).

0 minute: no skin damage; and 5, dividing: the skin damage range accounts for less than or equal to 1 percent of the total surface area of the body; 10 min: the skin damage range accounts for more than 1% and less than or equal to 5% of the total surface area; 15 min: the skin damage range accounts for more than 5% of the total body surface area.

4.2 Observation time

Before treatment, 1, 2, 3, 4 weeks after treatment.

5 follow-up visit

Follow-up visits were made 1 time each at 1 and 3 months after the treatment was completed, and follow-up visits were made by means of a follow-up visit or telephone. And (5) observing the cure rate and the recurrence rate of the cases with obvious effects.

6 clinical evaluation

6.1 Effect evaluation

6.1.1 Observation of skin lesion score

6.1.2 evaluation of comprehensive therapeutic Effect

The comprehensive curative effect is judged according to the change of the skin damage score, and a 4-grade curative effect judgment standard is specially formulated according to the clinical guidelines (trial) for new traditional Chinese medicines in 2002 edition. The calculation formula (nimodipine method) is: [ (pre-treatment integral-post-treatment integral) ÷ pre-treatment integral ] × 100%, detailed below.

The clinical recovery: the skin lesions are completely removed, the symptoms disappear, and the integral value is reduced by more than or equal to 95 percent.

Secondly, effect is displayed: the skin lesions mostly disappear, the symptoms are obviously relieved, and the integral value is reduced by more than or equal to 70 percent by 95 percent.

③ effective: the lesions partially resolved and symptoms improved, with a 70% score reduction of > 50%.

Fourthly, invalidation: the regression of the skin lesions was not evident, and the symptoms were not reduced or worsened adversely: the integral value decreases by less than 50%.

Eligible subjects were randomized into treatment (50) and control (50) groups, and the gender distribution of the patients in both groups is shown in table 1:

TABLE 1 gender profiles of two groups of patients

Group of	N	For male	Woman
				Treatment group	50	29	21
Control group	50	28	22

The chi-square test shows that the P value is greater than 0.05, which indicates that the two groups of samples have no significant difference.

The age and disease course of the two groups are shown in table 2:

TABLE 2 comparison of age and course of disease (X. + -. S) between the treatment and control groups

Group of	N	Age (age)	Course of disease
				Treatment group	50	38.62±12.11	49.57±23.09
Control group	50	41.10±11.52	48.90±19.78

After statistical treatment and non-parameter (M-W) test of two independent samples, the comparison P value between each index group is more than 0.05, which indicates that two groups of samples have no significant difference.

Comparison of the values of the PASI scores of the two groups before treatment is shown in Table 3

TABLE 3 comparison of the pre-treatment PASI scores (X. + -. S) for the treatment and control groups

Group of	N	Before treatment
			Treatment group	50	9.58±1.40
Control group	50	9.88±1.41

After statistical treatment and nonparametric (M-W) test of two independent samples, the P value is greater than 0.05, which indicates that the two groups of samples have no significant difference.

The traditional Chinese medicine preparation for treating psoriasis and the tazarotene (produced by Chongqing Huabang pharmaceutical Co., Ltd.) are respectively administered for treatment. The treatment effect is observed by repeated diagnosis at weeks 1, 2, 3 and 4 after 4 weeks of continuous administration. The treatment group specifically used the plaster prepared from the external preparation of example 1 of the present invention, and the external plaster was directly applied to the skin lesion.

The results are shown in Table 4:

TABLE 4 comparison of the overall efficacy of the treatment groups and the control groups after treatment (50 cases) (%)

Group of	N	Show effect	Is effective	Invalidation	High efficiency
						Treatment group	50	37	6	7	86
Control group	50	16	18	16	68

Comparative analysis of clinical efficacy after treatment in two groups of patients: the effective rate of the treatment group is 86.00%, the effective rate of the control group is 68.00%, and P is less than 0.05, which shows that the traditional Chinese medicine preparation is superior to 0.1% tazarotene cream for external use in treating common plaque psoriasis, and the curative effects of the two groups are statistically different.

Therefore, the experiments prove that the plaster prepared by adopting the formula of the external preparation has better curative effect compared with the existing external application product.

Furthermore, the curative effect of the traditional Chinese medicine prescription for treating psoriasis is compared with that of the traditional Chinese medicine preparation of the invention, and long-term clinical observation shows that the psoriasis is easy to recur in the later period when the traditional Chinese medicine prescription is used for treating psoriasis; by adopting the traditional Chinese medicine preparation of the embodiment 1 of the invention, the oral preparation and the external preparation are used together, the curative effect is definite, the safety is good, and no adverse reaction and side effect are found when the traditional Chinese medicine preparation is used in clinic for about 13 years.

This is because the existing prescription treatment focuses on cooling blood, and scutellaria baicalensis and dried rehmannia root are generally selected to clear heat and cool blood, but in most patients with psoriasis, due to changes of diet and living style, such as overeating, uncooked, sleeping late and staying up all night, yang qi of spleen and kidney of human body can be injured, cold-dampness can be generated in the spleen and kidney, and cold-dampness can be generated in the body. The facial heat manifestations of some patients are due to the transformation of internal cold-dampness into heat, and the appearance of true cold with false heat syndrome due to external wind-evil. At the moment, the idea of clearing heat and cooling blood is taken as a prescription, so that yang qi of a patient is easy to further hurt, in addition, the defect of cold and cool retention of blood stasis is easy to cause, and the skin of the face is dark red in the later period.

Although the existing prescription is compatible with blood-activating medicines, under the condition of yang qi deficiency in vivo, the blood-activating efficacy of the traditional prescription is necessarily greatly reduced by the application of cold medicines, and the fundamental contradiction of low in-vivo warming and dredging functions is not solved, which is one of the important factors for easy relapse in the later stage of psoriasis. In addition, some patients with spleen deficiency, and wind, cold, dampness and heat can block qi movement of the body and affect the metabolism of body fluids, so edema, red swelling, even blisters, erosion of fluid and the like can appear on the face. The basic pathogenesis of the disease is that yin is blocked inside, yang is marked on the exterior or upper, and wind evil is attacked outside. Therefore, the existing prescription lacks the thought of warming yang, has insufficient efficacy of excreting dampness and invigorating spleen, and has the disadvantages of cooling blood and retaining stasis.

The traditional Chinese medicine preparation of the invention mainly has the functions of dispelling wind and promoting diuresis, warming yang and removing blood stasis, and protecting yang qi in the body. In the oral preparation, the rhizoma Typhonii and the ramulus Cinnamomi have the effects of warming yang, resolving qi and promoting diuresis; herba Patriniae and cortex Phellodendri have effects of clearing away heat and toxic materials; the ginger, the perilla leaf and the schizonepeta are used for dispelling wind and relieving exterior syndrome; fructus Amomi is fragrant and turbid; radix Paeoniae Rubra, cortex moutan, semen Persicae, and radix Angelicae sinensis for cooling blood and removing blood stasis; coix seed, semen Coicis and rhizoma Smilacis Glabrae have the effects of inducing diuresis.

In the external preparation, the turmeric, the sulfur and the prepared kusnezoff monkshood root are used for dispelling cold and eliminating dampness; indigo naturalis, rhubarb, phellodendron, chinaberry fruit, purslane and cortex dictamni are capable of clearing away heat and toxic materials, and modern researches prove that the heat-clearing and detoxifying drug has strong effects of inhibiting epidermal cell proliferation and resisting inflammation and inhibiting humoral immunity, and can promote skin lesions of patients with psoriasis to disappear and restore the color to normal.

In addition, rhizoma Polygonati, radix Angelicae sinensis, radix Paeoniae Rubra, cortex moutan, and radix Sangusorbae have effects of cooling blood, promoting blood circulation and moistening dryness; herba Menthae and Borneolum Syntheticum has effects of dispelling pathogenic wind, relieving exterior syndrome, and relieving itching; wherein, the angelica enriches the blood and nourishes the yin, the red peony root promotes the blood circulation and removes the obstruction in the channels, and the stagnation in the blood is removed; the combination of the two medicines can enrich and nourish blood, increase local blood supply, improve skin malnutrition, moisten skin, reduce scales and strengthen the efficacy of relieving itching, and is obviously superior to the prior prescription in the aspects of relieving local red swelling and hot pain, pruritus, subcutaneous edema and the like of psoriasis of a patient.

In addition, considering that the skin diseases can easily cause emotional anxiety of patients, in order to realize better treatment effect, the invention selects the dark plum and the angelica to nourish the liver and soften the liver, calm the liver and relieve depression. The pearl powder is selected to remove freckles, whiten skin and promote skin damage repair.

The present invention is not limited to the above preferred embodiments, and any modifications, equivalent replacements, and improvements made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. The traditional Chinese medicine external preparation for treating psoriasis is characterized by comprising the following components in parts by weight:

5-10 parts of indigo naturalis, 5-10 parts of sulfur, 5-10 parts of rheum officinale, 5-10 parts of turmeric, 5-10 parts of golden cypress, 5-10 parts of garden burnet, 5-10 parts of chinaberry fruit, 5-10 parts of prepared kusnezoff monkshood root, 5-10 parts of mint, 1-3 parts of borneol, 5-10 parts of purslane, 5-10 parts of cortex moutan, 5-10 parts of Chinese angelica, 5-10 parts of red paeony root, 5-10 parts of cortex dictamni, 5-10 parts of rhizoma polygonati, 5-10 parts of dark plum fruit and 5-10 parts of pearl powder.

2. The external traditional Chinese medicine preparation for treating psoriasis according to claim 1, which is prepared from the following components in parts by weight:

3. The external traditional Chinese medicine preparation for treating psoriasis according to claim 1, which is prepared from the following components in parts by weight:

4. The external traditional Chinese medicine preparation for treating psoriasis according to claim 1, which is prepared from the following components in parts by weight:

5. A plaster for treating psoriasis, which is prepared by using the external preparation of a Chinese medicine according to any one of claims 1 to 4.

6. A process for preparing a plaster for the treatment of psoriasis according to claim 5 wherein the raw materials of the external preparation of any one of claims 1 to 4 are separately crushed and sieved to powder for use;