A traditional Chinese medicine composition for treating chronic eczema and its preparation method

Abstract

The present invention provides a traditional Chinese medicine composition for treating chronic eczema and a preparation method thereof. The traditional Chinese medicine composition mainly has the functions of strengthening the spleen and regulating the stomach, clearing heat and resolving dampness, and also cooling blood and promoting blood circulation, and finally dispelling the three evils of wind, dampness and heat to restore health. It has a significant effect on relieving the condition of patients with chronic eczema and preventing recurrence, and provides a new choice for the medication and drug usage method in the clinical treatment of chronic eczema. The traditional Chinese medicine composition is composed of 20-25 parts by weight of stir-fried hawthorn, 20-25 parts by weight of medicated leaven, 15-20 parts by weight of purslane, 10-15 parts by weight of forsythia, 10-15 parts by weight of alisma orientale, 15-20 parts by weight of poria cocos, 15-20 parts by weight of coix seed, 10-15 parts by weight of stir-fried semen raphani, 10-15 parts by weight of atractylodes macrocephala, 15-20 parts by weight of raw rehmannia root, 15-20 parts by weight of moutan bark, 10-15 parts by weight of cortex cercidis, 10-15 parts by weight of cortex lycii radicis, 10-15 parts by weight of cortex mori, and 6-10 parts by weight of raw liquorice root. The traditional Chinese medicine composition is prepared into an external preparation.

Description

Technical Field

[0001] The present invention relates to the field of the treatment of chronic eczema, and more particularly, to a traditional Chinese medicine composition for treating chronic eczema and a preparation method thereof. Background Art

[0002] Chronic eczema is clinically characterized by polymorphic skin lesions such as erythema, papules, and blisters. At present, most external hormonal medications are used, but long-term use of external hormonal medications can cause abnormalities in the skin where the medication is applied or some other adverse reactions. Or antihistamine preparations such as chlorpheniramine and astemizole are used, which have toxic side effects such as dry mouth, drowsiness, and dizziness, and even cause myocardial toxicity. Long-term use of glucocorticoids also has reactions such as hormone dependence or rebound hyperfunction of the adrenal cortex. After the treatment is interrupted, itching recurs rapidly.

[0003] "General Treatise on the Causes and Manifestations of Various Diseases · Treatise on Sores on the Head, Face and Body" mentions that "when there is internal heat and external deficiency, and being invaded by wind-dampness, sores will occur... When dampness-heat combines, sores will occur on the head, face and body...", indicating that the internal cause of eczema is disharmony of the five internal organs and spleen deficiency generating dampness and transforming into heat, and externally there are three pathogenic factors of wind, dampness and heat, and dampness-heat combines and attacks the body surface to cause it.

[0004] Through the understanding and summary of eczema by medical experts of past dynasties, modern medical experts have proposed that the pathogenesis of eczema is as follows:

[0005] One is that due to congenital intolerance, deficiency of the spleen and lungs, spleen deficiency generating excessive dampness, which transforms into heat over time, and combined with externally contracted wind-dampness-heat pathogens, it stagnates in the muscle surface and causes the disease;

[0006] Two is that if the course of the disease is lingering and not cured for a long time, then spleen deficiency and blood weakness will occur, and blood deficiency generates wind and causes the disease;

[0007] Three is that the mother eats too much spicy, stimulating and hair-generating foods, leaving heat in the fetus. Traditional Chinese medicine mostly differentiates and treats eczema from the perspectives of zang-fu organs, six channels of exogenous febrile diseases, and wei-qifen-ying-blood of epidemic febrile diseases.

[0008] Traditional Chinese medicine compositions with the effects of clearing heat and drying dampness to relieve itching, cooling blood and detoxifying are often used for treatment. For example, Professor Zhao Bingnan, a famous expert in traditional Chinese medicine dermatology and surgery, proposed that the four pathological development stages of wei, qi, ying, and blood correspond one by one to the severity and depth of the eczema condition. Professor Zhao proposed that the wei-phase syndrome is often accompanied by externally contracted pathogens, so it is advisable to relieve the exterior and clear heat, dispel wind and relieve itching; when the pathogen invades the qi-phase, or transmits from the wei-phase to the qi-phase, and dampness-heat combines in the qi-phase, it is advisable to clear heat and promote diuresis; when the pathogen transmits to the ying-phase, the internal invasion is more serious, and heat-toxin accumulation often manifests as restlessness and insomnia, so it is advisable to clear the ying-phase and detoxify; the blood-phase syndrome is mainly characterized by bleeding and yin injury, often manifested as fever at night, restlessness, so it is advisable to clear heat and cool the blood.

[0009] For another example, a traditional Chinese medicine composition for treating chronic eczema and its preparation method with the patent application number 201210590888.X. Its external medicine includes Artemisia argyi, Sophora flavescens, Mentha haplocalyx, Clematis chinensis, Cynanchum paniculatum, Scutellaria baicalensis, Nidus Vespae, Lemna minor, Gleditsia sinensis spine, Galla chinensis, Bolbostemma paniculatum, Melia toosendan, Panax notoginseng, Rosa chinensis, Viola philippica, and these medicines are also traditional Chinese medicines that mainly have the effects of clearing heat and drying dampness to relieve itching, cooling blood and detoxifying, etc. Summary of the Invention

[0010] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating chronic eczema and its preparation method. It is a traditional Chinese medicine composition that mainly invigorates the spleen and regulates the stomach, clears heat and resolves dampness, and also cools blood and activates blood circulation, ultimately dispelling the three evils of wind, dampness, and heat to restore health. It has a significant effect on relieving the condition of chronic eczema patients and preventing recurrence, providing a new choice for clinical medication and drug usage methods.

[0011] On the one hand, an embodiment of the present invention provides a traditional Chinese medicine composition for treating chronic eczema. The traditional Chinese medicine composition is composed of 20 - 25 parts by weight of stir-fried Hawthorn Fruit, 20 - 25 parts by weight of Medicated Leaven, 15 - 20 parts by weight of Purslane, 10 - 15 parts by weight of Forsythia suspensa, 10 - 15 parts by weight of Alisma orientale, 15 - 20 parts by weight of Poria cocos, 15 - 20 parts by weight of Coix lacryma-jobi, 10 - 15 parts by weight of stir-fried Raphanus sativus seed, 10 - 15 parts by weight of Atractylodes macrocephala, 15 - 20 parts by weight of Rehmannia glutinosa, 15 - 20 parts by weight of Paeonia suffruticosa, 10 - 15 parts by weight of Cercis chinensis bark, 10 - 15 parts by weight of Lycium chinense Mill., 10 - 15 parts by weight of Morus alba root bark, and 6 - 10 parts by weight of raw liquorice root, and the traditional Chinese medicine composition is prepared into an external preparation.

[0012] Preferably, the traditional Chinese medicine composition is composed of 20 parts by weight of stir-fried Hawthorn Fruit, 20 parts by weight of Medicated Leaven, 15 parts by weight of Poria cocos, 15 parts by weight of Coix lacryma-jobi, 10 parts by weight of Atractylodes macrocephala, 10 parts by weight of stir-fried Raphanus sativus seed, 10 parts by weight of Forsythia suspensa, 10 parts by weight of Alisma orientale, 15 parts by weight of Purslane, 15 parts by weight of Rehmannia glutinosa, 15 parts by weight of Paeonia suffruticosa, 10 parts by weight of Cercis chinensis bark, 10 parts by weight of Lycium chinense Mill., 10 parts by weight of Morus alba root bark, 10 parts by weight of Dictamnus dasycarpus Turcz., and 6 parts by weight of raw liquorice root.

[0013] Preferably, the external preparation includes suppositories, gels or ointments.

[0014] On the second aspect of the embodiment of the present invention, it provides an application of a traditional Chinese medicine composition for treating chronic eczema. Use any of the above external preparations to prepare traditional Chinese medicine rectal suppositories and administer them through anal insertion.

[0015] On the third aspect of the embodiment of the present invention, it provides a preparation method of a traditional Chinese medicine composition for treating chronic eczema. Use any of the above traditional Chinese medicine compositions to prepare an external preparation. The preparation method of the external preparation is as follows:

[0016] Weigh Fructus Crataegi Carbonisatus, Medicated Leaven, Portulaca oleracea L., Forsythia suspensa (Thunb.) Vahl, Alisma orientale (Sam.) Juz., Poria cocos (Schw.) Wolf, Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf, Semen Raphani Praeparatum, Atractylodes macrocephala Koidz., Rehmannia glutinosa Libosch., Cortex Moutan, Cortex Cercidis Chinensis Bunge, Cortex Lycii, Cortex Mori, and Radix Glycyrrhizae Preparata by weight parts, grind them into powder and mix to obtain the powder of the traditional Chinese medicine composition, and soak it in pure water;

[0017] Decoct multiple times and obtain the filtrate of the traditional Chinese medicine composition;

[0018] Concentrate the filtrate of the traditional Chinese medicine composition to a relative density of 1.18 - 1.20, and cool to obtain the concentrated liquid of the traditional Chinese medicine composition;

[0019] Add ethanol to the concentrated liquid of the traditional Chinese medicine composition to ensure that the alcohol content is 70%, stir and let stand for 2 - 3 h, then filter to obtain the concentrated liquid of the traditional Chinese medicine composition containing alcohol;

[0020] Recover the ethanol in the concentrated liquid of the traditional Chinese medicine composition containing alcohol until there is no alcohol smell to obtain the preparative preparation;

[0021] Distill the preparative preparation under reduced pressure, remove ethanol and concentrate it into a thick paste to obtain the external preparation; the water content ratio of the external preparation is 16 - 20%.

[0022] Preferably, during each soaking in pure water, use 6 - 10 times the total weight parts of the traditional Chinese medicine and soak for at least 30 min.

[0023] Preferably, the steps for obtaining the filtrate of the traditional Chinese medicine composition include: decocting the powder of the traditional Chinese medicine composition 3 times, with each decocting time being at least 30 min; taking the filtrates after the three decoctions and combining them to obtain the filtrate of the traditional Chinese medicine composition.

[0024] Preferably, the external preparation is a traditional Chinese medicine rectal suppository, which is prepared by combining the traditional Chinese medicine composition with a pharmaceutically acceptable suppository excipient.

[0025] Preferably, the preparation method of the traditional Chinese medicine rectal suppository is as follows:

[0026] Take 10 - 20 parts of wheat starch, 5 - 20 parts of polyethylene glycol, and 30 - 50 parts of glycerol, heat them until melted to obtain the suppository excipient;

[0027] Add them in batches to 40 - 60 parts of the external preparation, heat and mix, pour the mixture into the suppository mold while it is hot after uniform mixing, cool and take out to obtain the traditional Chinese medicine mixture suppository for treating chronic eczema.

[0028] Preferably, the heating temperature is 30 - 50 °C.

[0029] The beneficial effects of the embodiments of the present invention are:

[0030] 1. The traditional Chinese medicine composition of the present invention uses hawthorn and medicated leaven as the monarch drugs. Hawthorn promotes digestion and resolves food stagnation, activates qi and disperses stasis, and is the key medicine for digesting greasy meat; Medicated leaven promotes digestion and strengthens the stomach, harmonizes the middle and stops diarrhea. Both are "sacred drugs for treating the spleen". Forsythia suspensa, purslane, and alisma orientalis are the ministerial drugs to clear heat, remove dampness, and relieve itching. The monarch and ministerial drugs are used together, with both elimination and supplementation, and the emphasis is on strengthening the spleen. Assisting drugs include semen raphani, poria cocos, atractylodes macrocephala, and coix lacryma-jobi to strengthen the spleen and remove dampness; When blood deficiency generates wind, the skin shows itching, and when blood stasis is difficult to nourish, it shows dryness. Therefore, rehmannia glutinosa, cortex cercidis, and cortex moutan are added to achieve the meaning of "eliminating wind by activating blood circulation first, and the wind will disappear naturally when the blood circulates smoothly", dispelling wind and relieving itching, clearing heat and cooling blood; When dampness-heat invades the lungs and spreads to the skin to form eczema, attention should be paid to the coordination of the lungs and spleen. Therefore, cortex lycii radicis, cortex dictamni, and cortex mori are added to enter the lung meridian to achieve the effect of "treating the skin with skin". The combination of these three drugs clears and purges the lung heat and concurrently eliminates dampness and relieves itching. Licorice is used as the guiding drug to harmonize all the drugs. The compatibility in this case is precise, and each drug complements each other. This formula mainly strengthens the spleen and regulates the stomach, clears heat and resolves dampness, and concurrently cools blood and activates blood circulation, and finally eliminates the three evils of wind, dampness, and heat to restore health.

[0031] 2. Using the traditional Chinese medicine composition of the present invention to prepare a traditional Chinese medicine rectal suppository, through anal administration, the medicinal liquid is absorbed into the blood through the rich venous plexus and lymphoid tissue around the intestinal wall, and then through the inferior rectal vein and / or anal vein, avoiding the liver through the internal iliac vein, and thus entering the inferior vena cava. This route avoids the first-pass elimination effect of the liver, can maximize the therapeutic effect of the drug, and achieves the therapeutic purposes of stimulating intestinal peristalsis, diluting the poisons in the intestinal lumen, and promoting toxin excretion, providing a new application method for treating chronic eczema drugs;

[0032] 3. In the production process of the present invention, mainly non-toxic substances such as ethanol and purified water are used, avoiding the use of toxic organic reagents, etc. And after the use of ethanol, it is recycled. Not only is it safe and pollution-free during the production process, without the discharge of "three wastes", but also resources are fully utilized to further reduce production costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following will briefly introduce the drawings required to be used in the embodiments. It should be understood that the following drawings only show some embodiments of the present invention, and therefore should not be regarded as limiting the scope. For those of ordinary skill in the art, without creative efforts, other relevant drawings can also be obtained based on these drawings.

[0034] Figure 1 It is a comparison diagram of the IL-6 (pg / mL) inflammatory states among groups in the embodiments of the present invention;

[0035] Figure 2 It is a comparison diagram of the TNF-α (ng / L) inflammatory state components in the embodiments of the present invention;

[0036] Figure 3 It is a comparison diagram of the IL-6 (pg / mL) inflammatory state before and after enema in the embodiments of the present invention;

[0037] Figure 4 This is a comparison chart of TNF-α (ng / L) inflammatory status before and after enema in the embodiments of the present invention. Detailed implementation manners

[0038] The various exemplary specific implementation manners of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and implementation schemes of the present invention.

[0039] It should be understood that the terms used in the present invention are only for describing specific implementation manners and are not used to limit the present invention. Additionally, for the numerical ranges in the present invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any intermediate value within any stated value or stated range, as well as each smaller range between any other stated value or intermediate value within the stated range, is also included in the present invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0040] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the present invention pertains. Although the present invention only describes preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials related to the documents. In case of conflict with any incorporated document, the content of this specification shall prevail.

[0041] Without departing from the scope or spirit of the present invention, various improvements and changes can be made to the specific implementation manners of the present invention specification, which are obvious to those skilled in the art. Other specific implementation manners obtained from the present invention specification are also obvious to those skilled in the art. The present invention specification and embodiments are only exemplary.

[0042] Regarding the terms "comprising", "including", "having", "containing", etc. used herein, they are all open-ended terms, meaning including but not limited to.

[0043] First embodiment

[0044] This embodiment is based on the understanding and summary of eczema by modern physicians. According to the three types of pathogenesis that cause eczema, a new traditional Chinese medicine composition for treating chronic eczema is provided. The traditional Chinese medicine composition is composed of 20-25 parts by weight of stir-fried hawthorn, 20-25 parts by weight of medicated leaven, 15-20 parts by weight of purslane, 10-15 parts by weight of forsythia, 10-15 parts by weight of oriental waterplantain rhizome, 15-20 parts by weight of poria, 15-20 parts by weight of coix seed, 10-15 parts by weight of stir-fried radish seed, 10-15 parts by weight of atractylodes macrocephala, 15-20 parts by weight of rehmannia glutinosa, 15-20 parts by weight of moutan bark, 10-15 parts by weight of cercis chinensis bark, 10-15 parts by weight of cortex lycii radicis, 10-15 parts by weight of mulberry bark, and 6-10 parts by weight of raw licorice root. The traditional Chinese medicine composition is prepared into an external preparation, and the external preparation includes suppositories, gels or ointments.

[0045] The weight parts of each raw material drug in the traditional Chinese medicine composition are further preferably: 20 parts by weight of stir-fried hawthorn, 20 parts by weight of medicated leaven, 15 parts by weight of poria, 15 parts by weight of coix seed, 10 parts by weight of atractylodes macrocephala, 10 parts by weight of stir-fried radish seed, 10 parts by weight of forsythia, 10 parts by weight of oriental waterplantain rhizome, 15 parts by weight of purslane, 15 parts by weight of rehmannia glutinosa, 15 parts by weight of moutan bark, 10 parts by weight of cercis chinensis bark, 10 parts by weight of cortex lycii radicis, 10 parts by weight of mulberry bark, 10 parts by weight of dictamnus dasycarpus root bark, and 6 parts by weight of raw licorice root.

[0046] Weakness of the spleen and stomach is the abnormal expression of the immune network, which is the manifestation that the function of "the spleen is the defender" fails, and the defensive qi is insufficient to resist pathogens. It is also the essential internal cause for the repeated attacks and intractable course of eczema. The spleen failing to transport and transform further leads to the retention of water and dampness. Internally, it accumulates heat and generates wind due to long-term stagnation, and externally, it is reinfected by wind pathogens. The three pathogens of wind, dampness, and heat accumulate in the skin and cause eczema. The wind, dampness, and heat pathogens not only trigger the onset of eczema as external factors but also lead to the protracted course of the disease as internal factors.

[0047] Based on the theory in "Inner Canon of Huangdi" that "all dampness, swelling, and fullness pertain to the spleen", the traditional Chinese medicine composition in this scheme follows the treatment principle of "when seeing dampness, do not directly treat dampness, but first strengthen the spleen", and believes that "expelling turbidity and promoting the function of the spleen" is the core link in treating eczema. The lung is related to the skin, so strengthening the spleen to generate metal (the lung) through cultivating the earth (the spleen) and treating both the spleen and the lung simultaneously can achieve immediate effects.

[0048] Patients with chronic eczema often have a deficiency of the spleen and often present symptoms such as chest and abdominal distension and fullness, and a greasy taste in the mouth with poor appetite. In this embodiment, stir-fried hawthorn and medicated leaven are used as the monarch drugs. Hawthorn promotes digestion and removes food stagnation, activates qi and dispels stasis, and is the key drug for digesting greasy and meaty foods; Medicated leaven promotes digestion and strengthens the stomach, and stops diarrhea, and both are "sacred drugs for treating the spleen", strengthening the spleen and nourishing the stomach, and regulating and tonifying the middle energizer.

[0049] In addition, dampness is lingering and liable to be associated with wind and heat, leading to repeated and difficult-to-cure conditions. In this formula, forsythia, purslane, and alisma orientalis are used as ministerial drugs to clear heat, remove dampness, and relieve itching. The monarch and ministerial drugs are used together, with both supplementation and purgation, with emphasis on strengthening the spleen. Forsythia can clear heat and detoxify, disperse swelling and dissipate binds, and reduce inflammation. Firstly, it guides the pathogenic heat in the heart meridian to excrete through urine. Secondly, it utilizes its ascending and dispersing power to expel toxins externally and relieve itching. Purslane can clear heat and detoxify, cool blood and stop bleeding, and arrest dysentery. Alisma orientalis enters the kidney and bladder meridians, promoting urination and clearing damp-heat.

[0050] Assisted by semen raphani, poria cocos, atractylodes macrocephala, and coix lacryma-jobi, they strengthen the spleen and remove dampness. Semen raphani enters the spleen and lung meridians, promoting digestion to relieve distension, descending qi and resolving phlegm. Poria cocos enters the spleen meridian, promoting diuresis to alleviate edema, strengthening the spleen to stop diarrhea, and calming the mind to soothe the nerves. Atractylodes macrocephala enters the spleen meridian, promoting diuresis to reduce swelling, consolidating the exterior to stop sweating, and drying dampness to strengthen the spleen. Coix lacryma-jobi enters the spleen, lung, and kidney meridians, promoting diuresis and percolating dampness, strengthening the spleen to stop diarrhea, and expelling impediment.

[0051] When the spleen fails to transport and transform normally, the nutrient blood will be insufficient. Firstly, it is unable to promote blood circulation, leading to blood stasis. Secondly, it is unable to generate qi and blood, resulting in scanty blood. Wind generated by blood deficiency is manifested as itching on the skin, and dryness due to difficulty in nourishing caused by blood stasis. Therefore, rehmannia glutinosa, cortex cercidis chinensis, and cortex moutan are added, following the principle of "eliminating wind first by activating blood circulation, and the wind will disappear when the blood circulates smoothly", to dispel wind and relieve itching, clear heat and cool blood. Rehmannia glutinosa can clear heat and cool blood, nourish yin and promote the production of body fluid. Cortex cercidis chinensis can activate blood circulation, promote diuresis, and detoxify. Cortex moutan can clear heat and cool blood, promote blood circulation to remove blood stasis, and reduce deficiency heat.

[0052] When damp-heat invades the lung and spreads externally to the skin to form eczema, attention should be paid to the coordination of the lung and spleen. Therefore, cortex lycii radicis, cortex mori, and cortex dictamni are added to enter the lung meridian to achieve the effect of "treating the skin with the skin". Cortex lycii radicis has the effect of clearing heat and relieving steaming, cooling blood and relieving steaming, clearing the lung and reducing fire. Cortex mori can relieve cough and asthma by purging the lung, promoting diuresis to alleviate edema.

[0053] Assisted by semen raphani, poria cocos, atractylodes macrocephala, and coix lacryma-jobi to strengthen the spleen and remove dampness, rehmannia glutinosa, cortex cercidis chinensis, and cortex moutan to clear heat and activate blood circulation, dispel wind and relieve itching, and cortex lycii radicis, cortex mori, and cortex dictamni to treat the skin with the skin. The three drugs are used together to strengthen the spleen, clear and purge lung heat, and concurrently remove dampness and relieve itching.

[0054] Licorice is used as the envoy drug to harmonize all the drugs.

[0055] The drug combination in this embodiment is precisely formulated, and each medicinal flavor complements each other. This formula mainly strengthens the spleen and regulates the stomach, clears heat and resolves dampness, and concurrently cools blood and activates blood circulation. Eventually, it dispels the three pathogenic factors of wind, dampness, and heat to restore health. It has a significant effect on relieving the condition of patients with chronic eczema and preventing recurrence, can more effectively treat patients with chronic eczema, and provides a new choice for clinical medication.

[0056] In this embodiment, the traditional Chinese medicine composition is prepared into an external preparation. Optional external preparations include suppositories, gels, or ointments. Preferably, the above external preparation is used to prepare a traditional Chinese medicine rectal suppository, and administration is through rectal insertion, providing a new application of the traditional Chinese medicine composition for treating chronic eczema.

[0057] Traditional Chinese medicine enema is an external treatment method with distinct traditional Chinese medicine characteristics. By leveraging the functional feature of the large intestine to conduct and excrete feces for turbidity reduction, it expels pathogenic factors externally, adjusts yin and yang, and delays the progression of diseases. Anatomical and physiological findings show that there are rich arteries, veins, and lymphatic plexuses around the rectum, and the intestinal wall tissue has the characteristics of a semi-permeable membrane, enabling selective absorption and the secretion of cytokines. In view of this, the external preparation in this embodiment is preferably prepared as a traditional Chinese medicine rectal suppository. The traditional Chinese medicine composition in the suppository is absorbed into the blood through the rich venous plexuses and lymphatic tissues around the intestinal wall, and then enters the inferior vena cava through the inferior rectal vein and / or the anal vein, bypassing the liver through the internal iliac vein. This route avoids the first-pass elimination effect of the liver and can maximize the therapeutic effect of the drug in the spleen, lungs, and intestines, achieving the therapeutic purposes of stimulating intestinal peristalsis, diluting toxic substances in the intestinal lumen, and promoting toxin excretion.

[0058] A preparation method of a traditional Chinese medicine composition for treating chronic eczema, using the above traditional Chinese medicine composition to prepare an external preparation. The preparation method of the external preparation is as follows:

[0059] Weigh hawthorn fruit (charred), medicated leaven, purslane, forsythia, oriental waterplantain rhizome, poria, coix seed, stir-fried radish seed, atractylodes macrocephala, rehmannia root, moutan bark, redbud bark, cortex lycii radicis, mulberry bark, and raw licorice root by weight parts, grind them into powder and mix to obtain the traditional Chinese medicine composition powder. The particle size of the finely ground powder is 1 - 50 μm, and soak it in purified water; optionally, during the soaking in purified water, soak it in 6 - 10 times the weight of the total traditional Chinese medicine for at least 30 minutes.

[0060] Decoct multiple times and obtain the filtrate of the traditional Chinese medicine composition; optionally, decoct the traditional Chinese medicine composition powder 3 times, with each decoction time being at least 30 minutes; take the filtrates after the three decoctions and combine them to obtain the filtrate of the traditional Chinese medicine composition.

[0061] Concentrate the filtrate of the traditional Chinese medicine composition to a relative density of 1.18 - 1.20, and cool to obtain the concentrated traditional Chinese medicine composition.

[0062] Add ethanol to the concentrated traditional Chinese medicine composition to ensure an alcohol content of 70%, stir and let stand for 2 - 3 hours, then filter to obtain the alcohol-containing concentrated traditional Chinese medicine composition.

[0063] Recover the ethanol in the alcohol-containing concentrated traditional Chinese medicine composition until there is no ethanol smell to obtain the preliminary preparation; subject the preliminary preparation to vacuum distillation to remove ethanol and concentrate it into a thick paste to obtain the external preparation; the water content ratio of the external preparation is 16 - 20%.

[0064] In this embodiment, a traditional Chinese medicine rectal suppository is prepared from a traditional Chinese medicine composition in combination with a pharmaceutically acceptable suppository excipient. There are various choices for suppository excipients, such as cocoa butter, fructus liquidambaris fat matrix, glycerogelatin, polyethylene glycol composition, and so on.

[0065] Optionally, the preparation method of the traditional Chinese medicine rectal suppository is as follows:

[0066] Take 10 - 20 parts of wheat starch, 5 - 20 parts of polyethylene glycol, and 30 - 50 parts of glycerol, mix them, and heat to melt at 30 - 50 °C to obtain suppository excipients; divide the suppository excipients into 2 equal parts, add them to 40 - 60 parts of topical preparation in batches, continue to heat and mix at the same temperature, pour the evenly mixed mixture into a suppository mold while it is hot, cool and take out to obtain a traditional Chinese medicine mixture suppository for treating chronic eczema.

[0067] The following is specifically illustrated by examples.

[0068] (I) Patient admission criteria / diagnostic criteria

[0069] All the research cases were from the patients with chronic eczema who visited the Dermatology Department of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Sichuan Provincial Hospital of Traditional Chinese Medicine).

[0070] Diagnostic criteria for chronic eczema:

[0071] Western medicine diagnostic criteria: Refer to "Dermatology and Venereology" and "Clinical Dermatology of China" to determine the western medicine diagnostic criteria. The course of disease ≥ 6 months, recurrent attacks, itching ≥ 6 weeks; the skin lesions show symmetrical distribution, often occurring in parts such as hands and feet, flexor sides of the limbs, or around the genitals and anus.

[0072] Traditional Chinese medicine diagnostic criteria: The diagnostic criteria for traditional Chinese medicine syndromes and the quantitative scoring criteria for traditional Chinese medicine symptoms refer to the relevant content in "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial)". It mainly includes 3 syndrome types. Acute onset, accompanied by fever, restlessness, thirst, dry stools and scanty urine, red tongue with yellow and greasy coating, slippery and rapid pulse is the syndrome of damp - heat infiltration; slow onset, skin lesions with flushing color, itching, erosion, scales, accompanied by poor appetite, fatigue, abdominal distension, diarrhea, pale, plump and tender tongue with tooth marks, white and greasy coating, soggy and slow pulse is the syndrome of spleen deficiency and damp accumulation; long course of disease, recurrent attacks, dull - colored skin lesions, lichenification, severe itching, scratch marks or desquamation, accompanied by dizziness, weakness, soreness and weakness of the waist and knees, pale tongue with white coating, string - like and thready pulse is the syndrome of blood deficiency and wind dryness.

[0073] (II) Treatment criteria

[0074] Refer to the relevant content in "Guiding Principles for Clinical Research of New Traditional Chinese Medicines (Trial)" - "Guiding Principles for Clinical Research of New Traditional Chinese Medicines for Treating Chronic Renal Failure" in 2002 edition.

[0075] Table 1. Table of evaluation criteria for traditional Chinese medicine syndrome efficacy

[0076] Therapeutic effect Evaluation criteria Clinical cure Clinical symptoms and signs disappear or basically disappear, and the syndrome score is reduced by ≥ 95% Marked effect Clinical symptoms and signs are significantly improved, and the syndrome score is reduced by ≥ 70% and < 95% Effective Clinical symptoms and signs are improved, and the syndrome score is reduced by ≥ 30% and < 70% Ineffective Clinical symptoms and signs are not significantly improved, or even aggravated, and the syndrome score is reduced by < 30%

[0077] Calculation formula (Nimodipine method): (Score before treatment - Score after treatment) ÷ Score before treatment × 100%; Total effective rate = (Number of cases of clinical cure + marked effect + effective) ÷ Total number of cases × 100%; Effective rate = (Cure + marked effect + effective) / n × 100%.

[0078] (III) Treatment methods

[0079] ① Treatment group: After a definite diagnosis, 58 cases all patients were treated with the following traditional Chinese medicine rectal suppositories:

[0080] The specific method for preparing the traditional Chinese medicine rectal suppositories is as follows:

[0081] Weigh 20 g of stir-fried hawthorn, 20 g of medicated leaven, 15 g of purslane, 10 g of forsythia, 10 g of oriental waterplantain rhizome, 15 g of poria, 15 g of coix seed, 10 g of stir-fried radish seed, 10 g of atractylodes macrocephala, 15 g of rehmannia root, 15 g of moutan bark, 10 g of cercis chinensis bark, 10 g of cortex lycii radicis, 10 g of mulberry bark, 10 g of dictamnus cortex, and 6 g of raw licorice root, grind them into powder and mix; add 1.5 L of water and soak for 30 min, soak twice;

[0082] Decoct the soaked traditional Chinese medicine mixed powder three times, boil for 30 min each time and filter, combine the filtrates to obtain the filtrate of the traditional Chinese medicine composition;

[0083] Then concentrate it to a relative density of 1.18 - 1.20, let it cool to obtain the concentrated solution of the traditional Chinese medicine composition;

[0084] Add ethanol with a concentration of 80% to the concentrated solution of the traditional Chinese medicine composition to make the alcohol content 70%, stir, seal and let stand for 2 - 3 h, filter to obtain the concentrated solution of the alcohol-containing traditional Chinese medicine composition;

[0085] Recover the ethanol from the filtrate until there is no ethanol smell to obtain the preparatory preparation;

[0086] Concentrate by vacuum distillation to remove ethanol until it becomes a thick paste, measure the moisture content and control it at 16 - 20% to obtain the thick paste external preparation;

[0087] Take 10 - 20 parts of wheat starch, 5 - 20 parts of polyethylene glycol and 30 - 50 parts of glycerol, mix them, heat to melt at 30 - 50 °C, add the above-mentioned thick paste product in batches, continue to heat at the same temperature until fully mixed, pour it into the suppository mold while it is hot, let it cool, take it out, and that's it.

[0088] The usage method of the traditional Chinese medicine rectal suppository is as follows: Wear finger cots or gloves; instruct the patient to open the mouth and take a deep breath, and try to relax; insert the traditional Chinese medicine rectal suppository into the anus, and use the index finger to send the suppository along the rectal wall towards the umbilicus for 6 - 7 cm; after inserting the traditional Chinese medicine rectal suppository, maintain the lateral position for 15 min; observe whether the expected medicinal effect is produced. If the suppository slips out of the anus, re-insert it; wipe the perianal skin clean.

[0089] Patients use the traditional Chinese medicine rectal suppository once in the morning and once in the evening every day, 5 days a week, for a total of 4 weeks.

[0090] ② Control group: Given placebo enema.

[0091] Control drug: Enema placebo, containing: 92.2% sodium chloride solution, food additives (5% maltodextrin, 2% caramel pigment, 0.5% lemon yellow pigment, 0.3% sunset yellow pigment). The sodium chloride solution and food additives can be obtained from the manufacturer of any relevant product.

[0092] The enema operation steps include:

[0093] Patient preparation: Understand the purpose and procedure of enema, eliminate nervousness, defecate and urinate completely, and cooperate with the operation.

[0094] Item preparation: Enema drug, syringe, treatment bowl, anal tube (No. 16 - 18), warm water (38 - 40°C) 10 mL, hemostatic forceps, lubricant, thermometer, cotton swab, disposable latex gloves, kidney basin, toilet paper, plastic sheet, treatment towel, small cushion pillow, hand sanitizer, bedpan, domestic waste bin, medical waste bin.

[0095] Posture preparation: Left / right lateral position; elevate the buttocks, place the small cushion pillow, plastic sheet and treatment towel under the buttocks to elevate the buttocks by about 10 cm to prevent the medicine solution from overflowing.

[0096] Nurse's operation steps: Insert the anal tube, wear latex gloves, lubricate the anus and the front section of the anal tube, clamp the anal tube with hemostatic forceps, gently insert the anal tube 15 - 20 cm into the anus after fully exposing the anus. Inject the medicine solution, measure the temperature of the medicine solution, aspirate 75 mL of the medicine solution with a syringe, release the hemostatic forceps and slowly inject the medicine solution. Pull out the anal tube. After injecting the medicine solution, inject 5 - 10 mL of warm water, elevate the tail end of the anal tube to make all the medicine solution in the tube be injected, pull out the anal tube, wipe the anus with toilet paper, remove the gloves, disinfect the hands, instruct the subject to alternately take the left lateral position, supine position and right lateral position to rest, and try to retain the medicine solution for more than 1 hour to make the medicine solution fully absorbed. Clean up the items and fill in the enema record form.

[0097] The patient is given enema once in the morning and once in the evening every day, 5 days a week, for a total of 4 weeks.

[0098] During the treatment, the diet should be light, avoid fatty, sweet, spicy and seafood foods, avoid smoking and drinking, prohibit or fast certain drugs or foods that are allergenic to the body; instruct the patient to eat more vegetables, avoid contact with allergenic substances, pay attention to temperature changes, adjust cold and warmth, and strengthen exercise. Avoid scratching the rash strongly, avoid scalding with hot water, and at the same time relieve the patient's psychological pressure to gain the patient's trust and cooperation.

[0099] ③ Index detection: After the treatment of both groups is completed, the indexes of intestinal micro - inflammation status and curative effect evaluation are detected respectively.

[0100] (4) Treatment results:

[0101] A total of 134 subjects were planned to be included in this research project, and 116 were actually included. They were divided into a placebo enema group (PEG) and a traditional Chinese medicine suppository group (HEG) with 58 cases in each group by the blocked randomization method. 37 cases were lost due to various reasons, and finally 38 cases and 41 cases were included in the statistics in the two groups respectively. As shown in Table 3-14, for age and BMI between the two groups, independent sample t-tests were performed, and p>0.05; for gender between the two groups, a chi-square test was performed, and p>0.05; all of the above indicated that the baseline data between the PEG and HEG groups were balanced and comparable.

[0102] Table 2. Demographic baseline data

[0103] Item PEG HEG Statistic p Sample size (n, %) 38，48.1％ 41，51.9％ Age (years, M ± SD) 59.50±10.61 57.07±14.49 <![CDATA[0.844 a > 0.401 Male (n, %) 23，60.5％ 23，56.1％ <![CDATA[0.159 b > 0.690 Female (n, %) 15，39.5％ 18，43.9％ BMI (M ± SD) 23.31±3.01 23.42±2.82 <![CDATA[-0.162 a > 0.871 Disease course (years, M (P25, P75)) 2.05(1.00,5.35) 3.10(1.15,6.50) <![CDATA[-1.007 c > 0.314

[0104] Among them, BMI is the body mass index; PEG is the placebo enema group; HEG is the traditional Chinese medicine enema group (the same below); a Indicates an independent sample t-test; b Indicates a chi-square test, c Indicates a Mann-Whitney U test.

[0105] Table 3. Clinical EASI score and pruritus VAS score

[0106]

[0107] The comparison of the clinical EASI score and VAS score between the PEG and HEG groups is shown in Table 3, and combined with Figure 1 - 4 . As shown in the chart: After the rank sum test, there was no statistically significant difference in EASI between the two groups of subjects at baseline (p = 0.883); there was a statistically significant difference in EASI between the two groups of subjects after treatment (p<0.001); there was no statistically significant difference in the VAS score at baseline between the two groups of subjects (p = 0.686); there was a statistically significant difference in the VAS score between the two groups of subjects after treatment (p<0.001).

[0108] The results showed that: compared with placebo enema, traditional Chinese medicine suppositories can reduce the EASI score and pruritus VAS score levels of subjects.

[0109] Table 4. Comparison of microinflammatory state indicators M(P25, P75)

[0110]

[0111] The comparison of the microinflammatory state between the PEG and HEG groups is shown in Table 4 and Figure 1 - 2As shown in the chart: After the rank sum test, there was no significant difference in IL-6 between the two groups of subjects at baseline (p = 0.084); there was a significant difference in IL-6 between the two groups of subjects after treatment (p < 0.001); there was no significant difference in TNF-α between the two groups of subjects at baseline (p = 0.934); there was no significant difference in TNF-α between the two groups of subjects after treatment (p = 0.887).

[0112] Table 5. Comparison of inflammatory status before and after treatment M(P25, P75)

[0113]

[0114]

[0115] The comparison of the micro-inflammatory status before and after PEG and HEG treatment is shown in Table 5 Figure 3 and 4 As shown in the chart: After the rank sum test, there was no significant difference in IL-6 before and after PEG treatment (p = 0.065); there was a significant difference in IL-6 before and after HEG treatment (p = 0.034); there was no significant difference in TNF-α before and after PEG treatment (p = 0.057); there was no significant difference in TNF-α before and after HEG treatment (p = 0.184).

[0116] The results showed that compared with placebo enema, the traditional Chinese medicine rectal suppository could reduce the IL-6 level of the subjects, but had no effect on the TNF-α level of the subjects.

[0117] Table 6. Evaluation of the curative effect of traditional Chinese medicine syndromes

[0118] Therapeutic effect PEG HEG <![CDATA[χ 2 > p Cure 0 0 6.348 0.012 Marked effect 0 0 Effective 9(23.7％) 21(51.2％) Ineffective 29(76.3％) 20(48.8％)

[0119] As shown in the evaluation of the curative effect of treating chronic eczema in Table 6, the total effective rate of PEG was 23.7%, and the total effective rate of HEG was 51.2%; after the chi-square test, there was a significant difference in the total effective rate between the two groups. The results showed that compared with placebo enema, the total effective rate of the traditional Chinese medicine suppository in treating chronic eczema was higher. Among them, the total effective rate = (number of cases of clinical cure + marked effect + effective) ÷ total number of cases × 100%.

[0120] According to the above experimental results, the traditional Chinese medicine rectal suppository prepared from the pharmaceutical composition in the present invention, compared with placebo enema, can reduce the IL-6 level of chronic eczema patients, relieve the micro-inflammatory state, and has a significant curative effect on alleviating the condition of chronic eczema patients.

[0121] This specification describes examples of embodiments of the present invention and does not imply that these embodiments illustrate and describe all possible forms of the present invention. It should be understood that the embodiments in the specification can be implemented in various alternative forms. The accompanying drawings are not necessarily drawn to scale; some features may be enlarged or reduced to show details of particular components. The specific structural and functional details disclosed should not be construed as limiting, but merely as a representative basis for teaching those skilled in the art to implement the present invention in multiple forms. Those skilled in the art should understand that the multiple features described and illustrated with reference to any one of the accompanying drawings can be combined with features illustrated in one or more other drawings to form embodiments not explicitly illustrated or described. The described combinations of features provide representative embodiments for typical applications. However, various combinations and variations of features consistent with the teachings of the present invention can be used for specific applications or implementations as needed.

[0122] The foregoing are only preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, the present invention can have various changes and modifications. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating chronic eczema, characterized in that, The traditional Chinese medicine composition is composed of 20-25 parts by weight of stir-fried hawthorn, 20-25 parts by weight of medicated leaven, 15-20 parts by weight of purslane, 10-15 parts by weight of forsythia, 10-15 parts by weight of alisma orientale, 15-20 parts by weight of poria cocos, 15-20 parts by weight of coix seed, 10-15 parts by weight of stir-fried radish seed, 10-15 parts by weight of atractylodes macrocephala, 15-20 parts by weight of raw rehmannia root, 15-20 parts by weight of moutan bark, 10-15 parts by weight of cercis chinensis bark, 10-15 parts by weight of cortex lycii radicis, 10-15 parts by weight of mulberry bark, and 6-10 parts by weight of raw licorice root, and the traditional Chinese medicine composition is prepared into an external preparation.

2. The traditional Chinese medicine composition for treating chronic eczema according to claim 1, characterized in that, The traditional Chinese medicine composition is composed of 20 parts by weight of stir-fried hawthorn, 20 parts by weight of medicated leaven, 15 parts by weight of purslane, 10 parts by weight of forsythia, 10 parts by weight of alisma orientale, 15 parts by weight of poria cocos, 15 parts by weight of coix seed, 10 parts by weight of stir-fried radish seed, 10 parts by weight of atractylodes macrocephala, 15 parts by weight of raw rehmannia root, 15 parts by weight of moutan bark, 10 parts by weight of cercis chinensis bark, 10 parts by weight of cortex lycii radicis, 10 parts by weight of mulberry bark, and 6 parts by weight of raw licorice root.

3. The traditional Chinese medicine composition for treating chronic eczema according to claim 1, characterized in that, The external preparation includes suppositories, gels or ointments.

4. A preparation method of a traditional Chinese medicine composition for treating chronic eczema, characterized in that, Using the traditional Chinese medicine composition described in any one of claims 1 or 3 to prepare an external preparation, the preparation method of the external preparation is as follows: Weigh stir-fried hawthorn, medicated leaven, purslane, forsythia, alisma orientale, poria cocos, coix seed, stir-fried radish seed, atractylodes macrocephala, raw rehmannia root, moutan bark, cercis chinensis bark, cortex lycii radicis, mulberry bark, and raw licorice root according to parts by weight, grind them into powder and mix to obtain the traditional Chinese medicine composition powder, and soak it with purified water for multiple times; Decoct for multiple times and obtain the filtrate of the traditional Chinese medicine composition; Concentrate the filtrate of the traditional Chinese medicine composition to a relative density of 1.18-1.20, and cool to obtain the concentrated liquid of the traditional Chinese medicine composition; Add ethanol to the concentrated liquid of the traditional Chinese medicine composition to ensure that the alcohol content is 70%, stir and let stand for 2-3 h, then filter to obtain the concentrated liquid of the traditional Chinese medicine composition containing alcohol; Recover the ethanol in the concentrated liquid of the traditional Chinese medicine composition containing alcohol until there is no alcohol smell to obtain a preliminary preparation; Perform vacuum distillation on the preliminary preparation, remove ethanol and concentrate it into a thick paste to obtain the external preparation; the water content ratio of the external preparation is 16-20%.

5. The preparation method of the traditional Chinese medicine composition for treating chronic eczema according to claim 4, characterized in that, During the process of soaking with purified water, use 6-10 times the total weight of the traditional Chinese medicine each time and soak for at least 30 min.

6. The preparation method of the traditional Chinese medicine composition for treating chronic eczema according to claim 4, characterized in that, The step of obtaining the filtrate of the traditional Chinese medicine composition includes: decocting the traditional Chinese medicine composition powder 3 times, with each decocting time being at least 30 min; taking the filtrates after the three decoctions and combining them to obtain the filtrate of the traditional Chinese medicine composition.

7. The preparation method of the traditional Chinese medicine composition for treating chronic eczema according to claim 4, characterized in that, The external preparation is a traditional Chinese medicine rectal suppository, which is prepared by combining the traditional Chinese medicine composition with pharmaceutically acceptable suppository excipients.

8. The preparation method of the traditional Chinese medicine composition for treating chronic eczema according to claim 7, characterized in that, The preparation method of the traditional Chinese medicine rectal suppository is as follows: Take 10-20 parts of wheat starch, 5-20 parts of polyethylene glycol, and 30-50 parts of glycerol, heat until melted to obtain suppository excipients; Add the suppository excipients to 40-60 parts of the external preparation in batches, heat and mix, pour the uniformly mixed mixture into a suppository mold while it is hot, cool and take out to obtain the traditional Chinese medicine mixture suppository for treating chronic eczema.

9. The preparation method of the traditional Chinese medicine composition for treating chronic eczema according to claim 8, characterized in that, The heating temperature is 30-50 °C.

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