A soft shell pill and a method for preparing the same

Abstract

The present application belongs to the technical field of dermatosis treatment products, and particularly relates to a soft pelleted medicine and a preparation method thereof. The soft pelleted medicine is prepared from the following raw materials in parts by weight: 20-40 parts of Ramulus cinnamomi, 25-35 parts of Radix astragali, 5-15 parts of Semen persicae, 5-15 parts of Ophiopogon, 5-15 parts of Carthamus tinctorius, 15-30 parts of calcined Radix paeoniae alba, 10-20 parts of Radix angelicae sinensis, 15-30 parts of Radix rehmanniae preparata, 20-40 parts of Radix codonopsis, 5-15 parts of Radix paeoniae alba, 5-10 parts of Ephedra, 5-10 parts of Radix rubiae, 5-15 parts of Centella asiatica, 2-5 parts of Radix et Rhizoma aconiti, 5-10 parts of Salvinia natans, and 5-10 parts of Rhizoma zingiberis. The soft pelleted medicine provided by the present application has the main effects of warming yang and benefiting qi, promoting blood circulation to remove meridian obstruction, dispelling cold and dampness, removing blood stasis and promoting tissue regeneration, and is used for treating dermatosis such as scleroderma, frostbite, Raynaud's disease, skin atrophy, and the like, and particularly has remarkable effects on scleroderma, frostbite, Raynaud's disease, and 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. Initially, scleroderma may present with localized or multiple edematous plaques on the skin surface, accompanied by thickening and hardening of the skin. Symptoms of systemic scleroderma may also include joint pain, muscle atrophy, and esophageal and lung lesions.

[0003] Oral medications are convenient to take and can be taken in an environment with access to drinking water, without the need for injections or privacy for changing clothes. Furthermore, oral medications can be combined with topical medications to enhance their 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 scleroderma symptoms. However, 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. There are also Chinese medicine compositions, such as the Chinese medicine for the treatment of scleroderma disclosed in CN102362919A, which is an oral preparation, comprising 19 drug compatibilities such as peach kernel, white moss peel, safflower, prepared rehmannia root, angelica dahurica, radix pubescens, saposhnikovia divaricata, stephania tetrandra, chuanxiong, angelica sinensis, cortex moutan, angelica dahurica, radix notopterygii, radix rehmanniae, radix codonopsis, radix astragali, atractylodes macrocephala, root of poria, longan meat, polygala tenuifolia, cassia twig. However, the Chinese medicine disclosed in this patent is biased towards dispelling rheumatism, and only has a significant effect on the prevention and treatment of scleroderma, and the symptoms of hair loss, anhidrosis, cold hands and feet, and hard skin as stone that occur in scleroderma patients still need new drug solutions. Summary of the Invention

[0005] To address the symptoms of scleroderma patients, such as hair loss, anhidrosis, cold hands and feet, and rock-hard skin, the present invention provides a soft skin pill and its preparation method. The soft skin pill provided by the present invention is an oral medication that addresses the core issues of scleroderma. It is not only effective in treating scleroderma, but also can treat chilblains, Raynaud's disease, and skin atrophy. It has a wide range of indications. Patients suffering from one or more of these skin diseases only need to take the soft skin pill to achieve significant therapeutic effects, reducing the number of medications required by patients and lowering 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 prepared rehmannia, 20 to 40 parts of codonopsis, 5 to 15 parts of prepared 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, induces sweating and relieves muscles, warms the meridians, promotes yang to the limbs, and helps yang transform into qi.

[0009] Astragalus nourishes 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 moistens the intestines, promotes bowel movements, promotes blood circulation and removes 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, activates blood circulation, removes blood stasis and dredges the collaterals.

[0013] Burnt white peony root, softens the liver and nourishes blood, astringes yin and relieves pain.

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

[0015] Rehmannia root 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 the adverse.

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

[0019] Earth element, promotes blood circulation, dredges meridians, and removes blood stasis.

[0020] Centella asiatica has the same function as Liu Ji Nu. It is a warming blood-activating herb. It 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 the meridians and open the orifices.

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

[0024] The compatibility principle of the soft skin pills of the present invention is as follows: cinnamon twig, cooked aconite root, astragalus root, and codonopsis root are used as the main ingredients, and their main functions are to warm yang and dispel cold, replenish qi and nourish blood, and promote the production of body fluids; scorched white peony root, angelica root, and cooked rehmannia root are used as the auxiliary ingredients, and their main functions are to replenish blood, activate blood circulation, and benefit essence; other medicinal materials such as black snake act as auxiliary ingredients, and their main functions are to dredge the meridians and open the orifices, warm yang and dispel cold, activate blood circulation and remove blood stasis, and soften the skin. The main effects of the combination of the ingredients are to warm yang and replenish qi, activate blood circulation and dredge the meridians, dispel cold and dampness, and promote the production of new tissues. The pills are used for skin diseases such as scleroderma, frostbite, Raynaud's disease, and skin atrophy, and are particularly effective in treating 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 soft skin pills of the present invention are taken 2 to 3 times a day, 6 g each time. For children, the dosage can be reduced appropriately according to their weight, for example, halved. Take with warm water after meals.

[0027] Preferably, the soft skin pills are made from 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 scalded 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 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] A second object of the present invention is to provide a method for preparing a soft skin pill, comprising:

[0029] Prepare the raw materials according to weight parts;

[0030] Mix cinnamon twig, astragalus root, peach kernel, safflower, scalded white peony root, angelica root, cooked rehmannia root, codonopsis pilosula, 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 mesh 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% by weight of the medicinal material powder to obtain a concentrated solution. The extraction process comprises: completely immersing the black snake in an extractant, allowing it to stand for 24 to 48 hours, and then filtering out the black snake to obtain the 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 acceptable excipients to form pills, which are called soft skin pills.

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

[0034] In the above preparation method, the concentrated solution is not only the effective component of the soft skin pill, but also serves as a wetting agent to facilitate the formation of the pill, so there is no need to use an additional wetting agent.

[0035] Preferably, the filter used to filter out Trimeresurus jerdoni has a filter hole diameter of 1-2 mm.

[0036] Preferably, the ratio of Trimeresurus jerdoni to the extracting agent 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 is miscible with water. This method of preparing the extracting agent has good dispersion effect and only needs to be stirred and mixed, without the need for homogenization operation.

[0038] It should be noted that after the addition of the excipient, the pill can be prepared by using the existing technology, such as the method described in Example 1 of Chinese patent CN114452328B, which first mixes the medicinal material powder, the concentrated solution and the excipient to form a soft material, then pushes and presses it through a sieve to form granules, and then goes through processes such as pan-coating and surface coating to finally form the pills. Alternatively, the medicinal material powder, the concentrated solution and the excipient are first mixed to form a soft material, which is then transferred to a pill-making machine to form spherical pre-pellets, and then freeze-dried to form the pills.

[0039] Preferably, the excipient is a binder.

[0040] Preferably, the binder is honey, rice paste or flour paste. These are common binders that are 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 meridians, dispelling cold and dampness, and promoting tissue regeneration. They are used for skin diseases such as scleroderma, frostbite, Raynaud's disease, and skin atrophy, and are particularly effective in treating scleroderma, frostbite, Raynaud's disease, and skin atrophy.

[0042] The preparation method of the soft skin pills provided by the present invention comprises the following steps: subjecting a medicinal material of animal origin, namely, black snake, to an extraction process to extract a relatively large amount of active ingredients; the concentrated liquid is mixed with medicinal material powders of cassia twig, astragalus, peach kernel, safflower, scalded white peony root, angelica, prepared rehmannia, codonopsis pilosula, prepared aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger; and the mixture is prepared with auxiliary materials permitted in pharmaceutical science to prepare the 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 pictures of patients before treatment, where A is before treatment and B is after treatment.

[0044] Figure 2 These are the results of the patient's 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 with reference to 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 significant, 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 these drugs is not wide, and there are no corresponding drugs to treat the symptoms of hair loss, no sweating, cold hands and feet, and hard skin like stone in scleroderma patients. Moreover, one drug only targets one symptom. If a patient suffers from two or more skin diseases at the same time, the number of drugs to be taken will increase, resulting in high medical costs.

[0047] Based on the above reasons, the present application provides a soft skin pill, which is made of the following raw materials by weight: 20-40 parts of Ramulus cinnamomi, 25-35 parts of Radix astragali, 5-15 parts of Semen persicae, 5-15 parts of Ophiopogon, 5-15 parts of Carthamus, 15-30 parts of Charred Radix paeoniae, 10-20 parts of Angelica sinensis, 15-30 parts of Radix rehmanniae preparata, 20-40 parts of Codonopsis pilosula, 5-15 parts of Fried Fritillary Bulb, 5-10 parts of Ephedra, 5-10 parts of Radix et rhizoma junci, 5-15 parts of Herba Centellae, 2-5 parts of Herba Asari, 5-10 parts of Salvinia natans, and 5-10 parts of Zingiber officinale. The soft skin pill provided by the present application has the main effects of warming yang and benefiting qi, promoting blood circulation to remove meridian obstruction, dispelling cold and dampness to promote skin regeneration, and is used for treating scleroderma, frostbite, Raynaud's disease, skin atrophy and other skin diseases, especially for treating scleroderma, frostbite, Raynaud's disease and skin atrophy.

[0048] Based on the above soft skin pill formula, in order to further improve the drug efficacy and the content of active ingredients in the drug, the present application further provides a new preparation method of soft skin pill, which comprises the following steps: preparing each raw material according to weight; mixing Ramulus cinnamomi, Radix astragali, Semen persicae, Carthamus, Charred Radix paeoniae, Angelica sinensis, Radix rehmanniae preparata, Codonopsis pilosula, Fried Fritillary Bulb, Ephedra, Radix et rhizoma junci, Herba Centellae, Herba Asari, Salvinia natans and Zingiber officinale, crushing them into powder with a particle size of 100-140 meshes to obtain medicinal material powder; treating Ophiopogon through an extraction process to obtain an extract, and concentrating the extract to 20-25% of the weight of the medicinal material powder to obtain a concentrated solution; wherein the extraction process is that Ophiopogon is completely soaked in an extraction agent, and then Ophiopogon is filtered out after being soaked for 24-48 hours to obtain the extract; the extraction agent is a mixture composed of 1-hexadecanol, ethanol and water according to a volume ratio of 0.5-1.5:10-15:100; and the medicinal material powder is uniformly mixed with the concentrated solution, and then is mixed with pharmaceutically acceptable excipients to prepare a pill.

[0049] Some specific examples and experimental results are provided below to prove the effect of the present application.

[0050] Example 1

[0051] A soft skin pill, which is made of the following raw materials by weight:

[0052] 20 parts of Ramulus cinnamomi, 30 parts of Radix astragali, 10 parts of Semen persicae, 10 parts of Ophiopogon, 10 parts of Carthamus, 20 parts of Charred Radix paeoniae, 15 parts of Angelica sinensis, 20 parts of Radix rehmanniae preparata, 20 parts of Codonopsis pilosula, 10 parts of Fried Fritillary Bulb, 6 parts of Ephedra, 8 parts of Radix et rhizoma junci, 10 parts of Herba Centellae, 3 parts of Herba Asari, 6 parts of Salvinia natans, and 8 parts of Zingiber officinale.

[0053] Example 2

[0054] A soft skin pill, which is made of the following raw materials by weight:

[0055] Cassia twig 40 parts, Astragalus 35 parts, peach kernel 15 parts, black snake 15 parts, safflower 15 parts, burnt white peony 30 parts, angelica 20 parts, prepared rehmannia 30 parts, party 40 parts, cooked appendage 15 parts, ephedra 10 parts, earth Yuan 10 parts, centella asiatica 15 parts, asarum 5 parts, duckweed 10 parts, dried ginger 10 parts.

[0056] Example 3

[0057] A soft skin pill, which is made of the following raw materials by weight:

[0058] Cassia twig 30 parts, Astragalus 25 parts, peach kernel 5 parts, black snake 5 parts, safflower 5 parts, burnt white peony 15 parts, angelica 10 parts, prepared rehmannia 15 parts, party 25 parts, cooked appendage 5 parts, ephedra 5 parts, earth Yuan 5 parts, centella asiatica 5 parts, asarum 2 parts, duckweed 5 parts, dried ginger 5 parts.

[0059] Example 4

[0060] A soft skin pill preparation method, which is suitable for any one of the soft skin pill formulations in examples 1-3. The preparation method comprises the following steps:

[0061] First, prepare each raw material according to the weight parts.

[0062] Second, cassia twig, Astragalus, peach kernel, safflower, burnt white peony, angelica, prepared rehmannia, party, cooked appendage, ephedra, earth Yuan, centella asiatica, asarum, duckweed, dried ginger are mixed and crushed into 100 mesh powder to obtain medicinal powder.

[0063] Black snake is treated by extraction process to obtain extract, and the extract is concentrated to 20% of the weight of the medicinal powder to obtain concentrated liquid; wherein the extraction process is: completely immerse the black snake in the extraction agent, stand for 24h, then filter out the black snake to obtain the extract; the extraction agent is a mixture composed of 1-hexadecanol, ethanol and water according to the ratio of 0.5:10:100; the solid-liquid ratio of black snake and extraction agent is 1kg:8L; the preparation method of extraction agent is: first dissolve 1-hexadecanol with ethanol, then add water and mix to obtain the extraction agent. The filter screen with a filter hole diameter of 1mm is used to filter out the black snake.

[0064] Third, mix the medicinal powder and the concentrated liquid evenly, and add the auxiliary materials allowed in pharmacy to make pills. The auxiliary material is honey, which is first mixed with the medicinal powder and the extract to form a soft material, and then shaped and dried to obtain the pills.

[0065] Example 5

[0066] A soft skin pill preparation method, which is suitable for any one of the soft skin pill formulations in examples 1-3. The preparation method comprises the following steps:

[0067] First, prepare each raw material according to the weight parts.

[0068] The second step is to mix the cassia twig, the astragalus root, the persica seed, the safflower, the calcined white peony root, the angelica root, the prepared rehmannia root, the radix codonopsis, the prepared aconite root, the ephedra herb, the radix metaplexi, the centella asiatica, the asarum herb, the lemnor marinus, and the dried ginger, and to crush them into powder with a granularity of 140 meshes to obtain the medicinal material powder.

[0069] The extractive solution is obtained by treating the snake with an extraction process. The extractive solution is concentrated to 20% of the weight of the medicinal material powder to obtain a concentrated solution. The extraction process is that the snake is completely soaked in an extractant and is left for 24 hours, and then the snake is filtered out to obtain the extractive solution. The extractant is a mixture composed of 1-hexadecanol, ethanol, and water in a ratio of 0.5:10:100. The ratio of the snake to the extractant is 1 kg:8 L. The extractant is prepared by dissolving the 1-hexadecanol with ethanol and then adding water to obtain the extractant. The filter screen with a hole diameter of 1 mm is used to filter out the snake.

[0070] The third step is to mix the medicinal material powder and the concentrated solution uniformly, and to add a pharmaceutically acceptable excipient to prepare a pill. The excipient is honey. The medicinal material powder, the extractive solution, and the excipient are first prepared into a soft material, and then the soft material is shaped and dried to obtain the pill.

[0071] Example 6

[0072] A preparation method of a soft shell pill is suitable for any one of the soft shell pills in Examples 1-3. The preparation method comprises the following steps:

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

[0074] The second step is to mix the cassia twig, the astragalus root, the persica seed, the safflower, the calcined white peony root, the angelica root, the prepared rehmannia root, the radix codonopsis, the prepared aconite root, the ephedra herb, the radix metaplexi, the centella asiatica, the asarum herb, the lemnor marinus, and the dried ginger, and to crush them into powder with a granularity of 100 meshes to obtain the medicinal material powder.

[0075] The extractive solution is obtained by treating the snake with an extraction process. The extractive solution is concentrated to 20% of the weight of the medicinal material powder to obtain a concentrated solution. The extraction process is that the snake is completely soaked in an extractant and is left for 24 hours, and then the snake is filtered out to obtain the extractive solution. The extractant is a mixture composed of 1-hexadecanol, ethanol, and water in a ratio of 0.5:10:100. The ratio of the snake to the extractant is 1 kg:8 L. The extractant is prepared by dissolving the 1-hexadecanol with ethanol and then adding water to obtain the extractant. The filter screen with a hole diameter of 1 mm is used to filter out the snake.

[0076] The third step is to mix the medicinal material powder and the concentrated solution uniformly, and to add a pharmaceutically acceptable excipient to prepare a pill. The excipient is honey. The medicinal material powder, the extractive solution, and the excipient are first prepared into a soft material, and then the soft material is shaped and dried to obtain the pill.

[0077] Example 7

[0078] A method for preparing soft pelleted pills, which is suitable for any of the soft pelleted pill formulations in Examples 1-3. The method comprises the following steps:

[0079] First, prepare each raw material according to the weight parts.

[0080] Second, mix the cassia twig, astragalus root, peach kernel, safflower, calcined white peony root, angelica root, prepared rehmannia root, codonopsis root, prepared aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger, and pulverize them into 100-mesh powder to obtain medicinal powder.

[0081] The snake is subjected to 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. The extraction process is as follows: the snake is completely immersed in an extraction agent and left to stand for 48 hours, then the snake is filtered out to obtain the extract. The extraction agent is a mixture composed of 1-hexadecanol, ethanol, and water in a ratio of 0.5:10:100. The ratio of snake to extraction agent is 1 kg:8 L. The extraction agent is prepared by first dissolving 1-hexadecanol in ethanol, then adding water and mixing to obtain the extraction agent. The filter mesh used to filter out the snake has a pore diameter of 1 mm.

[0082] Third, mix the medicinal powder with the concentrated solution and add pharmaceutically acceptable excipients to form pills. The excipient is honey. First, the medicinal powder, extract, and excipient are mixed to form a soft material, then the soft material is shaped and dried to obtain the pills.

[0083] Example 8

[0084] A method for preparing soft pelleted pills, which is suitable for any of the soft pelleted pill formulations in Examples 1-3. The method comprises the following steps:

[0085] First, prepare each raw material according to the weight parts.

[0086] Second, mix the cassia twig, astragalus root, peach kernel, safflower, calcined white peony root, angelica root, prepared rehmannia root, codonopsis root, prepared aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger, and pulverize them into 100-mesh powder to obtain medicinal powder.

[0087] The snake is subjected to 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. The extraction process is as follows: the snake is completely immersed in an extraction agent and left to stand for 48 hours, then the snake is filtered out to obtain the extract. The extraction agent is a mixture composed of 1-hexadecanol, ethanol, and water in a ratio of 0.5:10:100. The ratio of snake to extraction agent is 1 kg:8 L. The extraction agent is prepared by first dissolving 1-hexadecanol in ethanol, then adding water and mixing to obtain the extraction agent. The filter mesh used to filter out the snake has a pore diameter of 1 mm.

[0088] In the third step, the medicinal powder and the concentrated solution are evenly mixed and then added with pharmaceutically acceptable excipients to form pills, wherein the excipient is honey. The medicinal powder, the extract and the excipients are first formed into a soft material, which is then formed and dried to obtain the pills.

[0089] Example 9

[0090] A method for preparing soft skin pills, applicable to the formulation of any one of the soft skin pills 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, scalded 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 subjected to an extraction process to obtain an extract, which is then concentrated to 20% of the weight of the medicinal material powder to obtain a concentrated solution. The extraction process involves completely immersing the black snake in an extractant, allowing it to stand for 24 hours, and then filtering out the snake to obtain the extract. The extractant is a mixture of 1-hexadecanol, ethanol, and water in a ratio of 0.5:15:100. The material-to-liquid ratio of the black snake to the extractant is 1kg:8L. The extractant is prepared by first dissolving 1-hexadecanol in ethanol, then adding water and mixing to obtain the extractant. A filter with a pore diameter of 1mm is used to filter out the black snake.

[0094] In the third step, the medicinal powder and the concentrated solution are evenly mixed and then added with pharmaceutically acceptable excipients to form pills, wherein the excipient is honey. The medicinal powder, the extract and the excipients are first formed into a soft material, which is then formed and dried to obtain the pills.

[0095] Example 10

[0096] A method for preparing soft skin pills, applicable to the formulation of any one of the soft skin pills 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, scalded 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 extract of black snakes is concentrated to 20% of the weight of the medicinal powder to obtain an extract. The extraction process involves completely immersing the black snakes in an extractant, allowing them to stand for 24 hours, and then filtering out the snakes to obtain the extract. The extractant is a mixture of 1-hexadecanol, ethanol, and water in a ratio of 0.5:10:100. The material-to-liquid ratio of the black snakes to the extractant is 1kg:8L. The extractant is prepared by first dissolving 1-hexadecanol in ethanol, then adding water and mixing to obtain the extractant. A filter with a 2mm pore diameter is used to filter out the black snakes.

[0100] In the third step, the medicinal powder and the concentrated solution are evenly mixed and then added with pharmaceutically acceptable excipients to form pills, wherein the excipient is honey. The medicinal powder, the extract and the excipients are first formed into a soft material, which is then formed and dried to obtain the pills.

[0101] Example 11

[0102] A method for preparing soft skin pills, applicable to the formulation of any one of the soft skin pills 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, scalded 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 subjected to an extraction process to obtain an extract, which is then concentrated to 20% of the weight of the medicinal material powder. The extraction process involves completely immersing the black snake in an extractant, allowing it to stand for 24 hours, and then filtering out the snake to obtain a concentrate. The extractant is a mixture of 1-hexadecanol, ethanol, and water in a ratio of 0.5:10:100. The material-to-liquid ratio of the black snake to the extractant is 1kg:10L. The extractant is prepared by first dissolving 1-hexadecanol in ethanol, then adding water and mixing to obtain the extractant. A filter with a 1mm pore diameter is used to filter out the black snake.

[0106] In the third step, the medicinal powder and the concentrated solution are evenly mixed and then added with pharmaceutically acceptable excipients to form pills, wherein the excipient is honey. The medicinal powder, the extract and the excipients are first formed into a soft material, which is then formed and dried to obtain the pills.

[0107] Example 12

[0108] A method for preparing soft skin pills, applicable to the formulation of any one of the soft skin pills 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, scalded 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 subjected to an extraction process to obtain an extract, which is then concentrated to 20% of the weight of the medicinal material powder to obtain a concentrated solution. The extraction process involves completely immersing the black snake in an extractant, allowing it to stand for 24 hours, and then filtering out the snake to obtain the extract. The extractant is a mixture of 1-hexadecanol, ethanol, and water in a ratio of 0.5:10:100. The material-to-liquid ratio of the black snake to the extractant is 1kg:8L. The extractant is prepared by first dissolving 1-hexadecanol in ethanol, then adding water and mixing to obtain the extractant. A filter with a 1mm pore diameter is used to filter out the black snake.

[0112] In the third step, the medicinal powder and the concentrated solution are evenly mixed and then added with pharmaceutically acceptable excipients to form pills. The excipients are batter, which is first made into a soft paste by mixing the medicinal powder, the extract, and the excipients, and then forming and drying the paste to obtain the pills.

[0113] The 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) Main criteria: Sclerotic changes proximal to the metacarpophalangeal joints, which may involve the entire limbs, face, body, and trunk.

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

[0118] (3) Other manifestations that are helpful for diagnosis: Raynaud's phenomenon, polyarthritis or joint pain, esophageal motility abnormalities, skin pathology 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] 2. Patient inclusion

[0121] Scleroderma patients, 100 cases in each group, half male and half female, aged 20 to 55 years old.

[0122] III. Criteria for determining efficacy

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

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

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

[0126] Ineffective: Treatment lasts for more than 4 months without any signs of improvement, or even worsening of the condition.

[0127] IV. Treatment Plan

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

[0129] V. Experimental Design: The soft skin pills prepared in each example and the soft skin pills prepared in Example 1 of the existing patent CN102362919A. Compared with the existing technology, the present invention has made changes after decades of clinical practice and drug compatibility.

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

[0131] A method for preparing soft skin pills 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, scalded 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 subjected to an extraction process to obtain an extract, which is then concentrated to 20% of the weight of the medicinal material powder. The extraction process involves completely immersing the black snake in an extractant, allowing it to stand for 24 hours, and then filtering out the snake to obtain a concentrate. The extractant is a mixture of ethanol and water in a ratio of 10:100. The material-to-liquid ratio of the black snake to the extractant is 1kg:8L. The extractant is prepared by first dissolving 1-hexadecanol in ethanol, then adding water and mixing to obtain the extractant. A filter with a 1mm pore diameter is used to filter out the snake.

[0135] In the third step, the medicinal powder and the concentrated solution are evenly mixed and then added with pharmaceutically acceptable excipients to form pills, wherein the excipient is honey. The medicinal powder, the extract and the excipients are first formed into a soft material, which is then formed and dried to obtain the pills.

[0136] 6. Active ingredient statistics

[0137] To analyze the effects of different extraction processes on the extraction of active ingredients from black snakes, the present invention employed a primary extraction process comprising completely immersing the black snakes in an extractant, allowing the mixture to stand, and then filtering out the snakes to obtain an extract. The extractant was a mixture of 1-hexadecanol, ethanol, and water. The extractant was prepared by first dissolving 1-hexadecanol in ethanol, then adding water and mixing to obtain the extractant. For more specific extraction process parameters, refer to Examples 4, 7-11, and a control group.

[0138] The present invention compares the methods of Examples 4, 7-11, and a control group. The resulting concentrated solution is freeze-dried to obtain a lyophilized product, which is then tested for amino acid content and the typical amino acids lysine and leucine. This evaluation evaluates the effects of different extraction processes on the extraction of active ingredients from snake snakes. Examples 4 and 7 compare preparation methods with different resting times. Examples 4 and 8 compare preparation methods with different 1-hexadecanol dosages. Examples 4 and 9 compare preparation methods with different ethanol dosages. Examples 4 and 10 compare preparation methods with different filter screens with different pore diameters. Examples 4 and 11 compare preparation methods with different material-to-liquid ratios. The results are shown in Table 1. The results show that compared to the control group without 1-hexadecanol, the active ingredients extracted from the other examples have higher total amino acid content, lysine content, and leucine content. This suggests that 1-hexadecanol facilitates the dissolution of amino acid components.

[0139] Table 1 Active ingredient test results

[0140]

[0141] 7. Treatment Results Statistics

[0142] Based on the above results, the extraction process using the method in Example 8 produced the highest active ingredient content. Therefore, using this method as a basis, pills were prepared according to the soft skin pill formulations described in Examples 1 to 3. Additionally, based on the formulation in Example 1, pills were prepared using the methods in Examples 4, 5, 6, and 12. Examples 4 and 5 compare the preparation methods for different medicinal powder particle sizes. Examples 4 and 6 compare the preparation methods for different concentration percentages. Examples 4 and 12 compare the preparation methods for different binders. The treatment results were statistically analyzed. See Table 2 for the results. The results show that the pills prepared by the present invention are superior to those prepared by the prior art.

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

[0144] Table 2 statistics of scleroderma treatment results

[0145]

[0146] VIII. Verification of other diseases

[0147] The pellets prepared in Example 8 and Example 1 were respectively used to treat patients with chilblain, Raynaud's disease and skin atrophy, and compared with the drugs of the prior art. The results are shown in Table 3. The results show that the pellets prepared in the present application are superior to the prior art. 100 cases were taken from each group, half male and half female, aged 20-55 years old. The treatment scheme: 6g each time, 3 times a day. 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 numerical ranges are involved in the present application, it is understood that each numerical range is a continuum between the two endpoints and that any number within the range is also encompassed. The preferred embodiments are described to enable others skilled in the art to readily utilize the application. Although modifications and changes to this application are suggested by the preferred embodiments, it is intended that the application be limited only by the scope of the appended claims.

[0151] Obviously, various modifications and changes can be made to the present application without departing from the spirit and scope thereof. It is intended that the present application encompass any and all such modifications and changes and, accordingly, the claims are to be interpreted as including all such modifications and changes.

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 scalded white peony root, 10-20 parts of angelica, 15-30 parts of prepared rehmannia, 20-40 parts of codonopsis, 5-15 parts of prepared 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, 5-10 parts of dried ginger; The preparation method of the soft skin pill comprises: Prepare the raw materials according to weight parts; Mix cinnamon twig, astragalus root, peach kernel, safflower, scalded white peony root, angelica root, cooked rehmannia root, codonopsis pilosula, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger, and grind them into a powder of 100-140 mesh 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% by weight of the medicinal material powder to obtain a concentrated solution. The extraction process comprises: completely immersing the black snake in an extractant, allowing it to stand for 24 hours to 48 hours, and then filtering out the black snake to obtain the 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 liquid are mixed evenly and added with pharmaceutically permitted auxiliary materials to prepare pills.

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 kernel, 10 parts of black snakes, 10 parts of safflower, 20 parts of scalded white peony root, 15 parts of angelica, 20 parts of prepared rehmannia, 20 parts of codonopsis pilosula, 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 the raw materials according to weight parts; Mix cinnamon twig, astragalus root, peach kernel, safflower, scalded white peony root, angelica root, cooked rehmannia root, codonopsis pilosula, cooked aconite root, ephedra, earthworm, centella asiatica, asarum, duckweed, and dried ginger, and grind them into a powder of 100-140 mesh 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% by weight of the medicinal material powder to obtain a concentrated solution. The extraction process comprises: completely immersing the black snake in an extractant, allowing it to stand for 24 hours to 48 hours, and then filtering out the black snake to obtain the 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 liquid are mixed evenly and added with pharmaceutically permitted auxiliary materials to prepare pills.

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

5. The method for preparing the soft skin pill according to claim 3, characterized in that: The material-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 as follows: firstly dissolving 1-hexadecanol with ethanol, then adding water, and mixing to obtain 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: First, the medicinal material powder, concentrated liquid and auxiliary materials are made into a soft material, and then formed 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 an adhesive.

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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