Soft-skin pill and preparation method thereof

Abstract

The invention belongs to the technical field of skin disease treatment products, and particularly relates to a soft-skin pill and a preparation method thereof. The soft skin pill is prepared from the following raw materials in parts by weight: 20-40 parts of cassia twig, 25-35 parts of astragalus membranaceus, 5-15 parts of peach kernel, 5-15 parts of garter snake, 5-15 parts of safflower, 15-30 parts of burnt white peony root, 10-20 parts of angelica sinensis, 15-30 parts of prepared rehmannia root, 20-40 parts of codonopsis pilosula, 5-15 parts of prepared radix aconiti lateralis praeparata slice, 5-10 parts of ephedra, 5-10 parts of ground beetle, 5-15 parts of centella asiatica, 2-5 parts of asarum, 5-10 parts of duckweed and 5-10 parts of dried ginger. The skin softening pill provided by the invention has the main effects of warming yang and tonifying qi, promoting blood circulation to remove meridian obstruction, dispelling cold and dampness, removing blood stasis and promoting tissue regeneration, is used for skin diseases such as scleroderma, chilblain, Raynaud's disease and skin atrophy, and particularly has a remarkable curative effect on the scleroderma, the chilblain, the Raynaud's disease and the skin atrophy.

Description

Technical Field

[0001] The invention belongs to the technical field of skin disease treatment products, and particularly relates to a soft skin pill and a preparation method thereof. Background Art

[0002] Scleroderma is a connective tissue disease characterized by skin inflammation, degeneration, thickening and fibrosis, followed by hardening and atrophy. In the early stages of scleroderma, localized or multiple edematous plaques on the skin surface may appear, accompanied by thickening and hardening of the skin. It may also cause joint pain, muscle atrophy, and esophageal and lung lesions, which become systemic scleroderma symptoms.

[0003] Oral medications are easy to take and can be taken in an environment with drinking water. There is no need for injections or privacy for changing clothes. In addition, oral medications can be used in combination with topical medications to improve efficacy.

[0004] In the prior art, oral products for the treatment of scleroderma mainly include immunosuppressants such as glucocorticoids and cyclophosphamide tablets, which can effectively alleviate the symptoms of scleroderma. However, the side effects are large, and for patients who are intolerant to immunosuppressants, such drugs are not suitable. In order to solve the problem of large side effects and intolerance of immunosuppressants, the prior art has also developed some Chinese medicine preparations such as Centella asiatica tablets, which are single-variety drugs with poor effects, and Chinese medicine compositions, such as the Chinese medicine disclosed in CN102362919A for the treatment of scleroderma, which is an oral agent, and is a combination of 19 medicines such as peach kernel, white moss peel, safflower, prepared rehmannia, angelica, moutan bark, notopterygium, raw rehmannia, codonopsis, astragalus, atractylodes, poria, longan meat, polygala, cassia twig. However, the Chinese medicine disclosed in the patent is biased towards rheumatism, and only has a significant effect on the prevention and treatment of scleroderma, and the symptoms of hair loss, no sweat, cold hands and feet, and hard skin as stone in scleroderma patients still need new drugs to solve. Summary of the invention

[0005] In order to solve the symptoms of hair loss, no sweat, cold hands and feet, and hard skin like stone in patients with scleroderma, the present invention provides a soft skin pill and a preparation method thereof. The soft skin pill provided by the present invention is an oral medicine, which solves the core problem of scleroderma, not only has obvious effects in treating scleroderma, but also can treat frostbite, Raynaud's disease and skin atrophy, and has many indications. When a patient suffers from one or more of the above skin diseases, he only needs to take the soft skin pill of the present invention to have obvious curative effect, reduce the types of drugs used by patients, and reduce medical costs.

[0006] The first object of the present invention is to provide a soft skin pill, which is made from the following raw materials in parts by weight: 20 to 40 parts of cassia twig, 25 to 35 parts of astragalus, 5 to 15 parts of peach kernel, 5 to 15 parts of black snake, 5 to 15 parts of safflower, 15 to 30 parts of scalded white peony root, 10 to 20 parts of angelica, 15 to 30 parts of cooked rehmannia, 20 to 40 parts of codonopsis, 5 to 15 parts of cooked aconite root, 5 to 10 parts of ephedra, 5 to 10 parts of earthworm, 5 to 15 parts of Centella asiatica, 2 to 5 parts of asarum, 5 to 10 parts of duckweed, and 5 to 10 parts of dried ginger.

[0007] Among them, the effects of each raw material on scleroderma are as follows

[0008] Cinnamon twig can induce sweating and relieve muscles, warm the meridians, promote yang to reach the limbs, and assist yang in transforming qi.

[0009] Astragalus replenishes Qi and raises Yang, benefits the Wei and strengthens the exterior, promotes diuresis and reduces swelling, promotes fluid production and nourishes blood, and assists Yang and transforms Qi.

[0010] Peach kernel can moisten the intestines, promote bowel movements, promote blood circulation and remove blood stasis.

[0011] Black snake can dispel wind and unclog the meridians, and is specially used to treat stubborn numbness and dead muscles.

[0012] Safflower warms the meridians, promotes blood circulation, removes blood stasis and dredges the collaterals.

[0013] Burnt white peony root can soften the liver, nourish blood, astringe yin and relieve pain.

[0014] Angelica sinensis nourishes blood, promotes blood circulation, moistens the intestines and promotes bowel movements.

[0015] Rehmannia glutinosa, nourishes blood, nourishes yin, replenishes essence and fills marrow.

[0016] Codonopsis pilosula strengthens the spleen and lungs, nourishes blood and produces body fluids.

[0017] Cooked aconite root warms the yang and transforms qi, unblocks the twelve meridians, dispels cold and relieves pain, and restores yang and rescues from adverse conditions.

[0018] Ephedra can induce sweating, dispel cold, dredge meridians and orifices, and soften the skin.

[0019] Earth element can invigorate blood circulation, dredge meridians, and remove blood stasis.

[0020] Centella asiatica, similar to Liu Jinu. A warm blood-activating drug. Can accelerate fracture healing.

[0021] Asarum, relieves exterior symptoms and dispels cold, dispels wind and relieves pain, opens the orifices, warms the lungs and transforms fluid.

[0022] Duckweed is light in texture and can reach the skin, dispel external evil, dredge meridians and open the orifices.

[0023] Dried ginger warms the middle and dispels cold, restores yang and unclogs meridians, warms the lungs and transforms fluid.

[0024] The compatibility principle of the soft skin pill of the present invention is as follows: cinnamon twig, cooked aconite root, astragalus and codonopsis are used as the main ingredients, and the main functions are warming yang and dispelling cold, replenishing qi and nourishing blood, and promoting body fluid; white peony root, angelica and cooked rehmannia are used as the ministers, and the main functions are replenishing blood, promoting blood circulation and benefiting essence; other medicinal materials such as black snakes act as assistants, and the main functions are dredging collaterals and opening the orifices, warming yang and dispelling cold, promoting blood circulation and removing blood stasis, and softening the skin. The main effects of the combination of the raw materials are warming yang and invigorating qi, promoting blood circulation and unblocking collaterals, dispelling cold and dampness, and promoting muscle growth. The pill is used for skin diseases such as scleroderma, frostbite, Raynaud's disease, skin atrophy, etc., and has a significant effect on scleroderma, frostbite, Raynaud's disease and skin atrophy.

[0025] Note: The soft skin pills provided by the present invention are contraindicated for patients with yin deficiency and internal heat.

[0026] The method of taking the soft skin pill of the present invention is: 2 to 3 times a day, 6 g each time. For children, the dosage can be appropriately reduced according to their weight, for example, the dosage can be reduced by half. Take with warm water after meals.

[0027] Preferably, the soft skin pill is made of the following raw materials in parts by weight: 20 parts of cinnamon twig, 30 parts of astragalus, 10 parts of peach kernel, 10 parts of black snake, 10 parts of safflower, 20 parts of white peony root, 15 parts of angelica, 20 parts of cooked rehmannia, 20 parts of codonopsis, 10 parts of cooked aconite, 6 parts of ephedra, 8 parts of earthworm, 10 parts of centella asiatica, 3 parts of asarum, 6 parts of duckweed, and 8 parts of dried ginger. The formula has good therapeutic effect and high drug efficiency.

[0028] The second object of the present invention is to provide a method for preparing a soft skin pill, comprising:

[0029] Prepare each raw material according to weight;

[0030] Mix cinnamon twig, astragalus, peach kernel, safflower, white peony root, angelica, cooked rehmannia, codonopsis, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger, that is, mix all the raw materials except black snake, and grind them into powder of 100-140 meshes to obtain medicinal material powder;

[0031] The black snake is subjected to an extraction process to obtain an extract, and the extract is concentrated to 20% to 25% of the weight of the medicinal material powder to obtain a concentrated solution; wherein the extraction process is: the black snake is completely immersed in an extractant, left to stand for 24 hours to 48 hours, and then the black snake is filtered out to obtain an extract; the extractant is a mixture of 1-hexadecanol, ethanol and water in a volume ratio of 0.5 to 1.5:10 to 15:100;

[0032] The medicinal material powder and the extract are mixed evenly and added with pharmaceutically permitted auxiliary materials to form pills, which are soft-skinned pills.

[0033] In the above preparation method, the medicinal material of the animal source of black snake is subjected to extraction process. Black snake medicinal material is the whole body without internal organs, but it still has some organs or tissues that are not removed, which will produce fishy smell or other side effects. The present invention extracts the effective substances in the black snake, removes the useless components of the internal organs, and can also reduce the fishy smell and side effects of the soft skin pills. 1-hexadecanol is a pharmaceutical excipient, which has the effect of moisturizing and softening the skin. It can be applied externally or taken orally. 1-hexadecanol is also used in pharmacy to stimulate vasoconstriction to treat nasal congestion and reduce mucosal congestion and edema, so 1-hexadecanol has the prospect of relieving swelling and relieving pain. The present invention uses 1-hexadecanol as one of the components of the extractant. In addition to the effect of reducing swelling and relieving pain, it also helps the dissolution of the effective ingredients of amino acids in the black snake, especially the dissolution of lysine and leucine. The other components of the extractant are water and ethanol, which are common reagents for extracting traditional Chinese medicine, safe and without side effects, and can extract most of the active substances in the black snake. In addition, the powder particle size is also very important for the quality of the water pill, so the present invention requires that the powder be crushed into 100-120 mesh powder, so that the water pill is easy to shape and has a smooth surface.

[0034] In the above preparation method, the concentrated liquid is the effective ingredient of the soft skin pills on the one hand, and also serves as a wetting agent on the other hand, so as to facilitate the preparation of the pills, and no additional wetting agent is needed.

[0035] Preferably, a filter with a pore diameter of 1 mm to 2 mm is used to filter out the black snake.

[0036] Preferably, the solid-liquid ratio of black snake to extractant is 1:8-10.

[0037] Preferably, since 1-hexadecanol is insoluble in water, 1-hexadecanol is first dissolved in ethanol, and then the mixture of ethanol and 1-hexadecanol is mixed using the principle that ethanol and water are mutually soluble. The extractant prepared by this method has a good dispersion effect, and only stirring and mixing are required, without homogenization operation.

[0038] It should be noted that after adding the auxiliary materials, the preparation of the pills can be carried out by any existing technical method, such as referring to the method described in Example 1 of Chinese patent CN114452328B, firstly, the medicinal material powder, the concentrated solution and the auxiliary materials are made into a soft material, then pushed and sieved to form particles, and then through processes such as panning and covering, finally forming pills. Alternatively, the medicinal material powder, the concentrated solution and the auxiliary materials are first made into a soft material, then transferred to a pill making machine to form spherical pre-pellets, and then freeze-dried to form pills.

[0039] Preferably, the auxiliary material is an adhesive.

[0040] Preferably, the adhesive is honey, rice paste or flour paste, which are common, safe and have no side effects.

[0041] Compared with the prior art, the present invention has at least the following beneficial effects: the main effects of the soft skin pills provided by the present invention are warming yang and invigorating qi, promoting blood circulation and unblocking collaterals, dispelling cold, removing dampness and promoting tissue regeneration, and are used for skin diseases such as scleroderma, frostbite, Raynaud's disease, and skin atrophy, especially for scleroderma, frostbite, Raynaud's disease, and skin atrophy.

[0042] The preparation method of the soft skin pill provided by the invention comprises the following steps: subjecting the animal-source medicinal material, black snake, to an extraction process to extract more active ingredients; the concentrated solution is mixed with medicinal material powders of cassia twig, astragalus, peach kernel, safflower, scalded white peony root, angelica, prepared rehmannia root, codonopsis pilosula, prepared aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed and dried ginger, and the mixture is prepared with auxiliary materials permitted in pharmacy to prepare pills; the preparation method is simple and the prepared pills have good therapeutic effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 These are the effect diagrams of patients before treatment, where A is before treatment and B is after treatment.

[0044] Figure 2 These are the pictures of the patients after treatment, where A is before treatment and B is after treatment. DETAILED DESCRIPTION

[0045] In order to enable those skilled in the art to better understand and implement the technical solution of the present invention, the present invention is further described below in conjunction with specific embodiments and drawings.

[0046] In the prior art, oral products for the treatment of scleroderma mainly include immunosuppressants such as glucocorticoids and cyclophosphamide tablets, which can effectively relieve the symptoms of scleroderma. However, the side effects are large, and such drugs are not suitable for patients who are intolerant to immunosuppressants. Although there are also traditional Chinese medicines for the treatment of scleroderma in the prior art, the scope of treatment of the drugs is not wide, and there is no corresponding drug for the symptoms of hair loss, no sweat, cold hands and feet, and hard skin like stone in patients with scleroderma. Moreover, one drug only targets one symptom. If a patient suffers from two or more skin diseases at the same time, the types of drugs taken must be increased, and the medical cost is high.

[0047] Based on the above reasons, the present invention provides a soft skin pill, which is made of the following raw materials in parts by weight: 20 to 40 parts of cinnamon twig, 25 to 35 parts of astragalus, 5 to 15 parts of peach kernel, 5 to 15 parts of black snake, 5 to 15 parts of safflower, 15 to 30 parts of white peony root, 10 to 20 parts of angelica, 15 to 30 parts of cooked rehmannia, 20 to 40 parts of codonopsis, 5 to 15 parts of cooked aconite, 5 to 10 parts of ephedra, 5 to 10 parts of earthworm, 5 to 15 parts of centella asiatica, 2 to 5 parts of asarum, 5 to 10 parts of duckweed, and 5 to 10 parts of dried ginger. The main effects of the soft skin pill provided by the present invention are warming yang and invigorating qi, promoting blood circulation and unblocking collaterals, dispelling cold, removing dampness and promoting muscle regeneration, and it is used for skin diseases such as scleroderma, frostbite, Raynaud's disease, skin atrophy, etc., especially for scleroderma, frostbite, Raynaud's disease, and skin atrophy.

[0048] On the basis of the above-mentioned formula of soft skin pills, in order to further improve the efficacy and increase the content of active ingredients in the medicine, the present invention also provides a new method for preparing soft skin pills, comprising: preparing various raw materials according to weight; mixing cinnamon twig, astragalus, peach kernel, safflower, scalded white peony root, angelica, cooked rehmannia, codonopsis, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger, and crushing them into powders of 100 mesh to 140 mesh to obtain medicinal material powder; subjecting black snake to extraction process to obtain extract, and concentrating the extract to 20% to 25% of the weight of the medicinal material powder to obtain concentrated solution; wherein the extraction process is: completely immersing the black snake in the extractant, standing for 24h to 48h, and then filtering out the black snake to obtain the extract; the extractant is a mixture composed of 1-hexadecanol, ethanol and water in a volume ratio of 0.5 to 1.5:10 to 15:100; the medicinal material powder and the concentrated solution are evenly mixed, and are prepared with auxiliary materials permitted in pharmacy to form pills.

[0049] Some specific embodiments and experimental results are provided below to demonstrate the effects of the present invention.

[0050] Example 1

[0051] A soft skin pill, which is prepared from the following raw materials in parts by weight:

[0052] 20 parts of cinnamon twigs, 30 parts of astragalus, 10 parts of peach kernels, 10 parts of black snakes, 10 parts of safflower, 20 parts of white peony root, 15 parts of angelica, 20 parts of prepared rehmannia, 20 parts of codonopsis, 10 parts of prepared aconite root, 6 parts of ephedra, 8 parts of earthworms, 10 parts of centella asiatica, 3 parts of asarum, 6 parts of duckweed, and 8 parts of dried ginger.

[0053] Example 2

[0054] A soft skin pill, which is prepared from the following raw materials in parts by weight:

[0055] 40 parts of cinnamon twigs, 35 parts of astragalus, 15 parts of peach kernels, 15 parts of black snakes, 15 parts of safflower, 30 parts of white peony root, 20 parts of angelica, 30 parts of prepared rehmannia, 40 parts of codonopsis, 15 parts of prepared aconite root, 10 parts of ephedra, 10 parts of earthworms, 15 parts of centella asiatica, 5 parts of asarum, 10 parts of duckweed, and 10 parts of dried ginger.

[0056] Example 3

[0057] A soft skin pill, which is prepared from the following raw materials in parts by weight:

[0058] 30 parts of cinnamon twigs, 25 parts of astragalus, 5 parts of peach kernels, 5 parts of black snakes, 5 parts of safflower, 15 parts of scalded white peony root, 10 parts of angelica, 15 parts of prepared rehmannia, 25 parts of codonopsis, 5 parts of prepared aconite root, 5 parts of ephedra, 5 parts of earthworms, 5 parts of centella asiatica, 2 parts of asarum, 5 parts of duckweed, and 5 parts of dried ginger.

[0059] Example 4

[0060] A method for preparing a soft skin pill is applicable to any one of the soft skin pill formulas in Examples 1 to 3. The preparation method comprises the following steps:

[0061] The first step is to prepare the raw materials according to weight.

[0062] In the second step, cinnamon twig, astragalus, peach kernel, safflower, boiled white peony root, angelica, cooked rehmannia, codonopsis, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger are mixed and crushed into 100-mesh powder to obtain medicinal material powder.

[0063] The black snake is processed by an extraction process to obtain an extract, and the extract is concentrated to 20% of the weight of the medicinal material powder to obtain a concentrated solution; wherein the extraction process is: completely immerse the black snake in an extractant, let it stand for 24 hours, and then filter out the black snake to obtain an extract; the extractant is a mixture of 1-hexadecanol, ethanol and water in a ratio of 0.5:10:100; the solid-liquid ratio of the black snake to the extractant is 1kg:8L; the preparation method of the extractant is: first dissolve 1-hexadecanol with ethanol, then add water, mix, and obtain the extractant. A filter with a pore diameter of 1mm is used to filter out the black snake.

[0064] The third step is to mix the medicinal powder and the concentrated solution evenly, and add auxiliary materials permitted in pharmacy to make pills. The auxiliary material is honey. The medicinal powder, the extract and the auxiliary materials are first made into a soft material, and then formed and dried to obtain pills.

[0065] Example 5

[0066] A method for preparing a soft skin pill is applicable to any one of the soft skin pill formulas in Examples 1 to 3. The preparation method comprises the following steps:

[0067] The first step is to prepare the raw materials according to weight.

[0068] In the second step, cinnamon twig, astragalus, peach kernel, safflower, boiled white peony root, angelica, cooked rehmannia, codonopsis, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger are mixed and crushed into a powder of 140 mesh to obtain medicinal material powder.

[0069] The black snake is processed by an extraction process to obtain an extract, and the extract is concentrated to 20% of the weight of the medicinal material powder to obtain a concentrated solution; wherein the extraction process is: completely immerse the black snake in an extractant, let it stand for 24 hours, and then filter out the black snake to obtain an extract; the extractant is a mixture of 1-hexadecanol, ethanol and water in a ratio of 0.5:10:100; the solid-liquid ratio of the black snake to the extractant is 1kg:8L; the preparation method of the extractant is: first dissolve 1-hexadecanol with ethanol, then add water, mix, and obtain the extractant. A filter with a pore diameter of 1mm is used to filter out the black snake.

[0070] The third step is to mix the medicinal powder and the concentrated solution evenly, and add auxiliary materials permitted in pharmacy to make pills. The auxiliary material is honey. The medicinal powder, the extract and the auxiliary materials are first made into a soft material, and then formed and dried to obtain pills.

[0071] Example 6

[0072] A method for preparing a soft skin pill is applicable to any one of the soft skin pill formulas in Examples 1 to 3. The preparation method comprises the following steps:

[0073] The first step is to prepare the raw materials according to weight.

[0074] In the second step, cinnamon twig, astragalus, peach kernel, safflower, boiled white peony root, angelica, cooked rehmannia, codonopsis, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger are mixed and crushed into 100-mesh powder to obtain medicinal material powder.

[0075] The black snake is processed by an extraction process to obtain an extract, and the extract is concentrated to 25% of the weight of the medicinal powder to obtain a concentrated solution; wherein the extraction process is: completely immerse the black snake in an extractant, let it stand for 24 hours, and then filter out the black snake to obtain an extract; the extractant is a mixture of 1-hexadecanol, ethanol and water in a ratio of 0.5:10:100; the solid-liquid ratio of the black snake to the extractant is 1kg:8L; the preparation method of the extractant is: first dissolve 1-hexadecanol with ethanol, then add water, mix, and obtain the extractant. A filter with a pore diameter of 1mm is used to filter out the black snake.

[0076] The third step is to mix the medicinal powder and the concentrated solution evenly, and add auxiliary materials permitted in pharmacy to make pills. The auxiliary material is honey. The medicinal powder, the extract and the auxiliary materials are first made into a soft material, and then formed and dried to obtain pills.

[0077] Example 7

[0078] A method for preparing a soft skin pill is applicable to any one of the soft skin pill formulas in Examples 1 to 3. The preparation method comprises the following steps:

[0079] The first step is to prepare the raw materials according to weight.

[0080] In the second step, cinnamon twig, astragalus, peach kernel, safflower, boiled white peony root, angelica, cooked rehmannia, codonopsis, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger are mixed and crushed into 100-mesh powder to obtain medicinal material powder.

[0081] The black snake is processed by an extraction process to obtain an extract, and the extract is concentrated to 20% of the weight of the medicinal material powder to obtain a concentrated solution; wherein the extraction process is: completely immerse the black snake in an extractant, let it stand for 48 hours, and then filter out the black snake to obtain an extract; the extractant is a mixture of 1-hexadecanol, ethanol and water in a ratio of 0.5:10:100; the solid-liquid ratio of the black snake to the extractant is 1kg:8L; the preparation method of the extractant is: first dissolve 1-hexadecanol with ethanol, then add water, mix, and obtain the extractant. A filter with a pore diameter of 1mm is used to filter out the black snake.

[0082] The third step is to mix the medicinal powder and the concentrated solution evenly, and add auxiliary materials permitted in pharmacy to make pills. The auxiliary material is honey. The medicinal powder, the extract and the auxiliary materials are first made into a soft material, and then formed and dried to obtain pills.

[0083] Example 8

[0084] A method for preparing a soft skin pill is applicable to any one of the soft skin pill formulas in Examples 1 to 3. The preparation method comprises the following steps:

[0085] The first step is to prepare the raw materials according to weight.

[0086] In the second step, cinnamon twig, astragalus, peach kernel, safflower, boiled white peony root, angelica, cooked rehmannia, codonopsis, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger are mixed and crushed into 100-mesh powder to obtain medicinal material powder.

[0087] The black snake is processed by an extraction process to obtain an extract, and the extract is concentrated to 20% of the weight of the medicinal material powder to obtain a concentrated solution; wherein the extraction process is: completely immerse the black snake in an extractant, let it stand for 24 hours, and then filter out the black snake to obtain an extract; the extractant is a mixture of 1-hexadecanol, ethanol and water in a ratio of 1.5:10:100; the solid-liquid ratio of the black snake to the extractant is 1kg:8L; the preparation method of the extractant is: first dissolve 1-hexadecanol with ethanol, then add water, mix, and obtain the extractant. A filter with a pore diameter of 1mm is used to filter out the black snake.

[0088] The third step is to mix the medicinal powder and the concentrated solution evenly, and add auxiliary materials permitted in pharmacy to make pills. The auxiliary material is honey. The medicinal powder, the extract and the auxiliary materials are first made into a soft material, and then formed and dried to obtain pills.

[0089] Example 9

[0090] A method for preparing a soft skin pill is applicable to any one of the soft skin pill formulas in Examples 1 to 3. The preparation method comprises the following steps:

[0091] The first step is to prepare the raw materials according to weight.

[0092] In the second step, cinnamon twig, astragalus, peach kernel, safflower, boiled white peony root, angelica, cooked rehmannia, codonopsis, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger are mixed and crushed into 100-mesh powder to obtain medicinal material powder.

[0093] The black snake is processed by an extraction process to obtain an extract, and the extract is concentrated to 20% of the weight of the medicinal powder to obtain a concentrated solution; wherein the extraction process is: completely immerse the black snake in an extractant, let it stand for 24 hours, and then filter out the black snake to obtain an extract; the extractant is a mixture of 1-hexadecanol, ethanol and water in a ratio of 0.5:15:100; the solid-liquid ratio of the black snake to the extractant is 1kg:8L; the preparation method of the extractant is: first dissolve 1-hexadecanol with ethanol, then add water, mix, and obtain the extractant. A filter with a pore diameter of 1mm is used to filter out the black snake.

[0094] The third step is to mix the medicinal powder and the concentrated solution evenly, and add auxiliary materials permitted in pharmacy to make pills. The auxiliary material is honey. The medicinal powder, the extract and the auxiliary materials are first made into a soft material, and then formed and dried to obtain pills.

[0095] Example 10

[0096] A method for preparing a soft skin pill is applicable to any one of the soft skin pill formulas in Examples 1 to 3. The preparation method comprises the following steps:

[0097] The first step is to prepare the raw materials according to weight.

[0098] In the second step, cinnamon twig, astragalus, peach kernel, safflower, boiled white peony root, angelica, cooked rehmannia, codonopsis, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger are mixed and crushed into 100-mesh powder to obtain medicinal material powder.

[0099] The black snake is subjected to an extraction process, and the extract is concentrated to 20% of the weight of the medicinal material powder to obtain an extract; wherein the extraction process is: completely immerse the black snake in the extractant, let it stand for 24 hours, and then filter out the black snake to obtain an extract; the extractant is a mixture of 1-hexadecanol, ethanol and water in a ratio of 0.5:10:100; the solid-liquid ratio of the black snake to the extractant is 1kg:8L; the preparation method of the extractant is: first dissolve 1-hexadecanol with ethanol, then add water, mix, and obtain the extractant. A filter with a pore diameter of 2mm is used to filter out the black snake.

[0100] The third step is to mix the medicinal powder and the concentrated solution evenly, and add auxiliary materials permitted in pharmacy to make pills. The auxiliary material is honey. The medicinal powder, the extract and the auxiliary materials are first made into a soft material, and then formed and dried to obtain pills.

[0101] Embodiment 11

[0102] A method for preparing a soft skin pill is applicable to any one of the soft skin pill formulas in Examples 1 to 3. The preparation method comprises the following steps:

[0103] The first step is to prepare the raw materials according to weight.

[0104] In the second step, cinnamon twig, astragalus, peach kernel, safflower, boiled white peony root, angelica, cooked rehmannia, codonopsis, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger are mixed and crushed into 100-mesh powder to obtain medicinal material powder.

[0105] The black snake is processed by an extraction process to obtain an extract, and the extract is concentrated to 20% of the weight of the medicinal material powder to obtain an extract; wherein the extraction process is: completely immerse the black snake in the extractant, let it stand for 24 hours, and then filter out the black snake to obtain a concentrated solution; the extractant is a mixture of 1-hexadecanol, ethanol and water in a ratio of 0.5:10:100; the solid-liquid ratio of the black snake to the extractant is 1kg:10L; the preparation method of the extractant is: first dissolve 1-hexadecanol with ethanol, then add water, mix, and obtain the extractant. A filter with a pore diameter of 1mm is used to filter out the black snake.

[0106] The third step is to mix the medicinal powder and the concentrated solution evenly, and add auxiliary materials permitted in pharmacy to make pills. The auxiliary material is honey. The medicinal powder, the extract and the auxiliary materials are first made into a soft material, and then formed and dried to obtain pills.

[0107] Example 12

[0108] A method for preparing a soft skin pill is applicable to any one of the soft skin pill formulas in Examples 1 to 3. The preparation method comprises the following steps:

[0109] The first step is to prepare the raw materials according to weight.

[0110] In the second step, cinnamon twig, astragalus, peach kernel, safflower, boiled white peony root, angelica, cooked rehmannia, codonopsis, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger are mixed and crushed into 100-mesh powder to obtain medicinal material powder.

[0111] The black snake is processed by an extraction process to obtain an extract, and the extract is concentrated to 20% of the weight of the medicinal material powder to obtain a concentrated solution; wherein the extraction process is: completely immerse the black snake in an extractant, let it stand for 24 hours, and then filter out the black snake to obtain an extract; the extractant is a mixture of 1-hexadecanol, ethanol and water in a ratio of 0.5:10:100; the solid-liquid ratio of the black snake to the extractant is 1kg:8L; the preparation method of the extractant is: first dissolve 1-hexadecanol with ethanol, then add water, mix, and obtain the extractant. A filter with a pore diameter of 1mm is used to filter out the black snake.

[0112] The third step is to mix the medicinal powder and the concentrated solution evenly, and add the auxiliary materials permitted in pharmacy to make pills. The auxiliary materials are batter, and the medicinal powder, the extract and the auxiliary materials are first made into a soft material, and then formed and dried to obtain pills.

[0113] Clinical treatment methods and effect statistics are as follows:

[0114] 1. Clinical diagnostic criteria

[0115] Localized scleroderma can be diagnosed based on typical skin changes. Systemic sclerosis: American College of Rheumatology (ARA) 1998 criteria:

[0116] (1) Major criteria: Sclerotic changes proximal to the metacarpophalangeal joints, which may affect the entire limbs, face, body, and trunk.

[0117] (2) Minor criteria: digital scleroderma, the above skin changes are limited to the fingers; depressed scars on the fingertips and disappearance of the finger pads; fibrosis of the basilar parts of both lungs.

[0118] (3) Other manifestations that are helpful for diagnosis: Raynaud's phenomenon, polyarthritis or joint pain, esophageal motility abnormalities, skin pathology of collagen fiber swelling and fibrosis, etc.

[0119] Please note that the above clinical diagnostic criteria are based on the indicators currently used in actual clinical diagnostic activities, including but not limited to the above-mentioned major criteria, minor criteria or other manifestations that are helpful for diagnosis.

[0120] II. Patient inclusion

[0121] There were 100 patients with scleroderma in each group, half of them were male and half were female, aged 20 to 55 years old.

[0122] III. Criteria for determining efficacy

[0123] Recovery: The damaged part returns to normal, the skin becomes soft, and only mild pigmentation or atrophy remains.

[0124] Markedly effective: More than 50% of the lesions returned to normal, the skin gradually softened, and the clinical symptoms were significantly alleviated.

[0125] Effective: The skin lesions improved, the skin sclerosis phenomenon improved, and the clinical symptoms improved.

[0126] Ineffective: Treatment lasts for more than 4 months with no signs of improvement or even worsening of the condition.

[0127] IV. Treatment Plan

[0128] Take 6g 3 times a day with warm water after meals. Continue treatment for 5 months.

[0129] V. Experimental Design: Soft skin pills prepared in each embodiment and soft skin pills prepared in Example 1 of the existing patent CN102362919A. Compared with the prior art, the present invention has been changed after decades of clinical practice and drug compatibility.

[0130] In addition, a control group in which the extractant does not contain 1-hexadecanol is also set up, as follows:

[0131] A method for preparing a soft skin pill comprises the following steps:

[0132] The first step is to prepare the raw materials according to weight.

[0133] In the second step, cinnamon twig, astragalus, peach kernel, safflower, boiled white peony root, angelica, cooked rehmannia, codonopsis, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger are mixed and crushed into 100-mesh powder to obtain medicinal material powder.

[0134] The black snake is processed by an extraction process to obtain an extract, and the extract is concentrated to 20% of the weight of the medicinal material powder to obtain an extract; wherein the extraction process is: completely immerse the black snake in the extractant, let it stand for 24 hours, and then filter out the black snake to obtain a concentrated solution; the extractant is a mixture of ethanol and water in a ratio of 10:100; the solid-liquid ratio of the black snake to the extractant is 1kg:8L; the preparation method of the extractant is: first dissolve 1-hexadecanol with ethanol, then add water, mix, and obtain the extractant. A filter with a pore diameter of 1mm is used to filter out the black snake.

[0135] The third step is to mix the medicinal powder and the concentrated solution evenly, and add auxiliary materials permitted in pharmacy to make pills. The auxiliary material is honey. The medicinal powder, the extract and the auxiliary materials are first made into a soft material, and then formed and dried to obtain pills.

[0136] 6. Active ingredient statistics

[0137] In order to analyze the effects of different extraction processes on the extraction of active ingredients from black snakes, the main extraction process provided by the present invention is: completely immersing the black snake in an extractant, standing, and then filtering out the black snake to obtain an extract; the extractant is a mixture of 1-hexadecanol, ethanol and water; the preparation method of the extractant is: first dissolving 1-hexadecanol with ethanol, then adding water, mixing, and obtaining an extractant. For more specific extraction process parameters, refer to Example 4, Example 7 to Example 11 and the control group.

[0138] The present invention compares the methods of Example 4, Example 7 to Example 11 and the control group, and the concentrated solution is freeze-dried to obtain a lyophilized product, and then the amino acid content and the content of typical amino acids lysine and leucine in the lyophilized product are tested to evaluate the effect of different extraction processes on the extraction of active ingredients from black snakes. Among them, Example 4 and Example 7 are comparisons of preparation methods with different standing times. Example 4 and Example 8 are comparisons of preparation methods with different 1-hexadecanol dosages. Example 4 and Example 9 are comparisons of preparation methods with different ethanol dosages. Example 4 and Example 10 are comparisons of preparation methods for filter screens with different filter pore diameters. Example 4 and Example 11 are comparisons of preparation methods with different solid-liquid ratios. The results are shown in Table 1. The results show that compared with the control group without adding 1-hexadecanol, the total amino acid content, lysine content and leucine content in the active ingredients extracted in other embodiments are all higher. It shows that 1-hexadecanol helps the dissolution of amino acid components.

[0139] Table 1 Active ingredient test results

[0140]

[0141] VII. Treatment Results Statistics

[0142] According to the above results, the active ingredient content of the extraction process of the method in Example 8 is the highest, so its method is used as a basis, and pills are prepared according to the soft skin pill formula described in Examples 1 to 3. In addition, based on the formula of Example 1, pills are prepared using the methods of Examples 4, 5, 6 and 12. Examples 4 and 5 are comparisons of preparation methods at different medicinal powder particle sizes. Example 4 and Example 6 are comparisons of preparation methods at different concentration percentages. Example 4 and Example 12 are comparisons of preparation methods of different adhesives. Statistical treatment results. See Table 2 for the results. The results show that the pills prepared by the present invention are better than the prior art.

[0143] Figure 1 and Figure 2 The pills are prepared by the method of Example 4 using the formula of the soft skin pills described in Example 1. The comparison chart of the effects before and after the treatment of scleroderma is shown. The circled area is the location where the scleroderma symptoms change significantly before and after.

[0144] Table 2 Statistics of scleroderma treatment results

[0145]

[0146] 8. Verification of other symptoms

[0147] The present invention uses the pills prepared in Example 8+Example 1 to treat patients with frostbite, Raynaud's disease, and skin atrophy, and compares them with the existing drugs. The results are shown in Table 3. The results show that the pills prepared in the present invention are better than the existing drugs. Each group has 100 cases, half of which are male and half are female, aged 20 to 55 years old. Treatment plan: 3 times a day, 6g each time. Take with warm water after meals. Continuous treatment for 5 months.

[0148] Table 3 Statistics of treatment results of other skin diseases

[0149]

[0150] It should be noted that when the present invention involves a numerical range, it should be understood that the two endpoints of each numerical range and any value between the two endpoints can be selected. Since the steps and methods used are the same as those in the embodiments, in order to avoid redundancy, the present invention describes a preferred embodiment. Although the preferred embodiments of the present invention have been described, once those skilled in the art know the basic inventive concept, they can make other changes and modifications to these embodiments, and these changes and modifications all fall within the scope of the present invention.

[0151] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. If these modifications and variations of the present invention fall within the scope of the equivalent technology of the present invention, the present invention is also intended to include these modifications and variations.

Claims

1. A soft skin pill, characterized in that: Made from the following raw materials in parts by weight: 20-40 parts of cinnamon twig, 25-35 parts of astragalus, 5-15 parts of peach kernel, 5-15 parts of black snake, 5-15 parts of safflower, 15-30 parts of blanched white peony root, 10-20 parts of angelica, 15-30 parts of cooked rehmannia, 20-40 parts of codonopsis, 5-15 parts of cooked aconite root, 5-10 parts of ephedra, 5-10 parts of earthworm, 5-15 parts of Centella asiatica, 2-5 parts of asarum, 5-10 parts of duckweed, and 5-10 parts of dried ginger.

2. The soft skin pill according to claim 1, characterized in that: Made from the following raw materials in parts by weight: 20 parts of cinnamon twigs, 30 parts of astragalus, 10 parts of peach kernels, 10 parts of black snakes, 10 parts of safflower, 20 parts of white peony root, 15 parts of angelica, 20 parts of prepared rehmannia, 20 parts of codonopsis, 10 parts of prepared aconite root, 6 parts of ephedra, 8 parts of earthworms, 10 parts of centella asiatica, 3 parts of asarum, 6 parts of duckweed, and 8 parts of dried ginger.

3. The method for preparing the soft skin pill according to claim 1, characterized in that: include: Prepare each raw material according to weight; Mix cinnamon twig, astragalus, peach kernel, safflower, white peony root, angelica, cooked rehmannia root, codonopsis, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger, and grind into powder of 100-140 meshes to obtain medicinal material powder; The black snake is subjected to an extraction process to obtain an extract, and the extract is concentrated to 20% to 25% of the weight of the medicinal material powder to obtain a concentrated solution; wherein the extraction process is: the black snake is completely immersed in an extractant, left to stand for 24 hours to 48 hours, and then the black snake is filtered out to obtain an extract; the extractant is a mixture of 1-hexadecanol, ethanol and water in a volume ratio of 0.5 to 1.5:10 to 15:100; The medicinal material powder and the concentrated solution are mixed evenly and added with auxiliary materials permitted in pharmaceutical science to prepare pills.

4. The method for preparing the soft skin pill according to claim 3, characterized in that: The filter with a pore diameter of 1mm to 2mm is used to filter out the black snake.

5. The method for preparing the soft skin pill according to claim 3, characterized in that: The solid-liquid ratio of black snake to extractant is 1kg:8L~10L.

6. The method for preparing the soft skin pill according to claim 3, characterized in that: The preparation method of the extractant is: firstly dissolving 1-hexadecanol with ethanol, then adding water, mixing, and obtaining the extractant.

7. The method for preparing the soft skin pill according to claim 3, characterized in that: The active ingredients in the extract include amino acids.

8. The method for preparing the soft skin pill according to claim 3, characterized in that: The medicinal powder, concentrated liquid and auxiliary materials are first made into a soft material, which is then molded and dried to obtain pills.

9. The method for preparing the soft skin pill according to claim 3, characterized in that: The auxiliary material is a binder.

10. The method for preparing soft skin pills according to claim 9, characterized in that: The adhesive is honey, rice paste or flour paste.

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