Application of ginseng antler kidney-tonifying tablet in preparation of medicine for preventing and / or treating prostatic hyperplasia

Abstract

The invention discloses application of ginseng and antler kidney tonifying tablets in preparation of drugs for preventing and / or treating prostatic hyperplasia. The ginseng antler kidney-tonifying tablet has a good treatment effect on prostatic hyperplasia, the treatment effect is remarkable, no operation is needed, the ginseng antler kidney-tonifying tablet belongs to new use of an old medicine, the safety is high, the side effect is small, and the production cost is greatly reduced. The problems that current western medicines for treating benign prostatic hyperplasia are long in medication cycle, large in toxic and side effects and limited in clinical application are solved. Experimental results show that the ginseng and antler kidney-tonifying tablet can reduce the prostate gland coefficient; the androgen level of a prostatic hyperplasia patient is reduced; the gland and glandular cavity expansion and hyperplasia degree of a prostatic hyperplasia patient is improved.

Description

Technical Field

[0001] This invention belongs to the field of medicine, specifically relating to the application of Shenrong Bushen tablets in the preparation of drugs for the prevention and / or treatment of benign prostatic hyperplasia. Background Technology

[0002] Ginseng and Deer Antler Kidney-Nourishing Tablets are a marketed traditional Chinese medicine preparation made from 48 kinds of Chinese herbs. Its functions and indications include tonifying the kidneys and strengthening yang, replenishing qi and nourishing blood. It is used for deficiency of both yin and yang, manifested as impotence, cold genitals, nocturnal emission, and fatigue. Ginseng and Deer Antler Kidney-Nourishing Tablets can improve the body's immunity, protect the liver, promote diuresis, protect the kidneys, anti-aging, anti-stress response, lower blood pressure, lower blood lipids, and effectively control inflammation, among other health benefits. Ginseng and Deer Antler Kidney-Nourishing Tablets can benefit liver qi, strengthen muscles and bones, and replenish the middle qi. It can be used as an adjunct treatment for related symptoms, such as impotence, premature ejaculation, nocturnal emission, and spermatorrhea caused by kidney deficiency in men; it can also treat cold uterus and decreased libido in women. In fact, Ginseng and Deer Antler Kidney-Nourishing Tablets are also suitable for people with neurasthenia, high mental stress, and sub-health conditions, as they have a strong tonic effect.

[0003] Benign prostatic hyperplasia (BPH), also known as enlarged prostate or prostatic hypertrophy, falls under the categories of urinary retention and urinary tract infection in traditional Chinese medicine. This disease is common among middle-aged and elderly men, with the incidence gradually increasing with age. Currently, it is believed that its onset may be related to hormonal imbalances or cholesterol buildup in the elderly, or that inflammation of the urinary system and pelvic congestion can worsen symptoms. The main symptoms are frequent urination, difficulty urinating, acute urinary retention, or urinary incontinence. In the early stages, it often only presents as increased frequency of urination at night. In mild cases, BPH does not cause urinary tract obstruction; in severe cases, it initially increases the frequency of urination, especially at night, followed by difficulty urinating, a feeling of incomplete bladder emptying, and in severe cases, straining to urinate, sometimes leading to acute urinary retention.

[0004] Drug therapy is the most common clinical treatment for benign prostatic hyperplasia (BPH). Western medicine is advantageous for BPH with a clear cause (e.g., a known pathogen infection), but relapse is common after discontinuation; furthermore, Western medicine has significant side effects. Traditional Chinese medicine (TCM), on the other hand, is more advantageous for chronic BPH, BPH with unclear causes, and BPH complicated by other bodily dysfunctions. BPH presents differently due to varying causes, forming a complex syndrome requiring a long treatment period. Traditional Chinese herbal decoctions significantly impact patient compliance and absorption rates. Therefore, while preserving the characteristics of TCM's syndrome differentiation and treatment, modifying traditional dosage forms and administration routes is crucial for improving drug absorption, efficacy, expanding indications, and reducing side effects.

[0005] Traditional Chinese medicine (TCM) treatments for benign prostatic hyperplasia (BPH) involve the lungs, kidneys, and spleen, and may also be related to qi deficiency and blood stasis. In TCM, the lungs are considered the "canopy" of the body; when the spleen qi fails to function properly, it becomes difficult to regulate the downward flow of qi, leading to blockage of the upper and lower orifices. The spleen, considered the foundation of postnatal health, is also affected; if its function of transformation and transportation is impaired, water retention occurs, resulting in urinary retention. Clinically, dampness and damp-heat are considered prevalent, and treatment focuses on clearing heat and promoting diuresis, using modified Bazheng San (Eight-Ingredient Decoction for Clearing Heat). Treatment options include Plantago seed, talc, gardenia, rush pith, and licorice root. For severe toxicity, treatment focuses on clearing heat, removing toxins, and purging liver fire, using Longdan Xiegan Tang (Gentiana Decoction for Draining Liver Fire), but the effects are not always satisfactory.

[0006] There are currently no reports on the use of "Shenrong Bushen Pian" in the treatment of benign prostatic hyperplasia. Summary of the Invention

[0007] The purpose of this invention is to provide a new pharmaceutical use for Shenrong Bushen tablets.

[0008] The novel pharmaceutical use of the ginseng and deer antler kidney-tonifying tablets provided by this invention is their application in the preparation of drugs for the prevention and / or treatment of benign prostatic hyperplasia.

[0009] Furthermore, the benign prostatic hyperplasia described belongs to the lung heat and qi stagnation type.

[0010] Furthermore, the prevention and / or treatment of benign prostatic hyperplasia is manifested in at least one of the following aspects:

[0011] a) Reduce the number of prostate glandular systems;

[0012] b) Reduce androgen levels in patients with benign prostatic hyperplasia;

[0013] c) Improves the degree of glandular and cavitary dilation and hyperplasia in patients with benign prostatic hyperplasia.

[0014] The kidney-tonifying tablets of this invention are made from the following ingredients: Astragalus membranaceus 50g, stir-fried Ziziphus jujuba var. spinosa 7.5g, Schisandra chinensis 12.5g, Acorus tatarinowii 5g, deer antler (hair removed) 12.5g, Amomum villosum 7.5g, Alisma plantago-aquatica (salted) 10g, Angelica sinensis 10g, red ginseng (root removed) 3.75g, Amomum cardamomum 6.25g, medicated leaven (charred) 7.5g, Magnolia officinalis 7.5g, Paeonia suffruticosa 6.5g, Atractylodes macrocephala (stir-fried) 18.75g, fennel seeds (salted) 5g, coarse salt 8.75g, Polygala tenuifolia (honey) 5g, charred hawthorn 7.5g, dried ginger 6.25g, Citrus aurantium (stir-fried) 7.5g, calcined Yangqi stone 7.5g, Cistanche deserticola 7.5g, and black aconite. 6.25g of sliced ​​herbs, 18.75g of Poria cocos, 6.25g of Cornus officinalis, 10g of Eucommia ulmoides (charred), 2.5g of seahorse (scalded), 7.5g of roasted malt, 6.25g of stir-fried radish seeds, 6.25g of roasted areca nut, 6.25g of raspberry, 3.125g of Asparagus cochinchinensis, 0.125g of dog kidney (scalded), 6.25g of leek seeds, 7.5g of salt-processed Psoralea corylifolia, 3.125g of Ophiopogon japonicus, 7.5g of Citrus reticulata peel, 2.5g of donkey kidney (scalded), 5g of Achyranthes bidentata, 6.25g of licorice root, 6.25g of cinnamon, 10g of Dioscorea opposita, 25g of Codonopsis pilosula, 6.25g of Cynomorium songaricum, 5g of Paeonia lactiflora, 6.25g of Curculigo orchioides, 12.5g of Lycium barbarum, 5g of Ligusticum chuanxiong.

[0015] The preparation method is as follows:

[0016] The above forty-eight ingredients, including seahorse, dog kidney, donkey kidney, poria cocos, calamus, red ginseng, yam, angelica sinensis, medicated leaven, malt, white peony root, yangqi stone, dried ginger, peony bark, amomum villosum, aconite, coarse salt, cardamom, cynomorium songaricum, chuanxiong rhizome, deer antler, and fennel, are ground into a fine powder. Hawthorn, wolfberry, alisma plantago-aquatica, astragalus membranaceus, jujube seed, areca nut, codonopsis pilosula, schisandra chinensis, leek seed, achyranthes bidentata, radix laurentii, cistanche deserticola, asparagus cochinchinensis, ophiopogon japonicus, licorice root, and raspberry, are decocted three times with water: 3 hours for the first time, 2 hours for the second, and 1 hour for the third. The decoction is then filtered. The filtrates were combined and concentrated to a thick paste with a relative density of 1.30 (50℃). The remaining ten herbs, including Polygala tenuifolia, were extracted three times by reflux with 60% ethanol, for 2 hours the first time and 1 hour each the second and third times. The ethanol extracts were combined, filtered, and the ethanol was recovered from the filtrate and concentrated under reduced pressure to a thick paste with a relative density of 1.30 (50℃). The above fine powder and thick paste were mixed evenly, dried, pulverized, sieved, and an appropriate amount of starch and dextrin were added, mixed evenly, granulated, dried, magnesium stearate was added, mixed evenly, pressed into 1000 tablets, and coated with sugar to obtain the final product.

[0017] Explanation of the formula for Ginseng and Deer Antler Kidney Tonifying Tablets:

[0018] This formula uses ginseng and deer antler as the principal ingredients. Ginseng, being sweet and warm in nature, greatly replenishes vital energy and strengthens the spleen, opening the source of qi and blood production, nourishing the innate essence, and also invigorating kidney yang, replenishing kidney qi, and replenishing innate essence. Deer antler replenishes kidney yang, benefits essence and blood, strengthens tendons and bones, governs the yang qi of the whole body, generates essence and replenishes marrow, and greatly replenishes innate essence. The combined use of ginseng and deer antler regulates both innate and acquired essence and qi, replenishes qi, blood, yin, and yang, making it an essential medicine for treating various deficiencies and injuries, the five weaknesses and seven injuries, insufficient vital energy, deficiency of essence and blood, decline of the fire of the gate of life, impotence, coldness of the genitals, seminal emission, premature ejaculation, cold limbs and fatigue; therefore, it is the principal ingredient in this formula.

[0019] This formula uses seahorse, dog kidney, and donkey kidney as assistant ingredients. Seahorse, dog kidney, and donkey kidney are all fleshy and nourishing ingredients, which, together with ginseng and deer antler, enhance the effects of replenishing essence and blood, warming kidney yang, strengthening yang, and nourishing the tendons and ligaments.

[0020] The formula includes aconite, cinnamon, cistanche, cynomorium, yangqi stone, curculigo, psoralea, leek seed, raspberry, schisandra, eucommia, and achyranthes as assistant herbs. Aconite and cinnamon are pungent, warm, and very hot, tonifying fire and assisting yang, dispelling cold and relieving pain, thus becoming the source of fire to dispel yin stagnation; cistanche, cynomorium, and yangqi stone tonify the kidneys and assist yang, strengthening yang and relieving atrophy; curculigo and psoralea strengthen kidney yang, warm the water organs, and have the functions of tonifying fire and benefiting earth, warming the kidneys and strengthening yang, and invigorating the spleen and stopping diarrhea; leek seed, raspberry, and schisandra tonify the kidneys and strengthen yang, consolidate essence and stop seminal emission, combining tonifying the kidneys and replenishing essence with consolidating essence and stopping seminal emission, playing the role of opening up new sources and reducing waste; eucommia and achyranthes tonify the liver and kidneys, strengthen tendons and bones, and strengthen the waist and knees, thus relieving weakness of tendons and bones and cold pain in the waist and knees. When used together, these herbs replenish essence, nourish blood, and fill marrow, drastically tonify the vital fire, warm the lower abdomen, strengthen yang and cure impotence, consolidate essence and stop seminal emission, strengthen tendons and bones, dispel cold and relieve pain, thus eliminating symptoms such as impotence, coldness in the genitals, seminal emission, spermatorrhea, and soreness and cold pain in the lower back and knees.

[0021] The formula uses wolfberry, cornus officinalis, yam, asparagus root, ophiopogon japonicus, alisma plantago-aquatica, and peony bark as assistant herbs. Wolfberry nourishes the liver and kidneys and replenishes essence and blood; cornus officinalis nourishes the liver and kidneys and astringes and consolidates; yam gently replenishes qi and yin; asparagus root nourishes kidney yin and reduces deficiency fire; ophiopogon japonicus nourishes stomach yin, replenishes heart yin, and clears heart fire; alisma plantago-aquatica drains kidney fire; and peony bark clears liver fire. When these herbs are used together, they greatly replenish yin fluids, nourish yin and reduce fire. They can be used in conjunction with ginseng, deer antler, cinnamon, aconite, and other herbs that tonify fire, assist yang, and replenish essence and marrow. This is based on the principle that those who are good at tonifying yang seek yang within yin, and that isolated yin cannot generate, and isolated yang cannot grow. Moreover, they can clear and reduce deficiency fire. When used with other yang-tonifying herbs, they tonify yang without being warm and dry, and nourish yin without being cold and stagnant, so that yin and yang are mutually rooted and mutually generating.

[0022] This formula uses Astragalus membranaceus, Atractylodes macrocephala, Codonopsis pilosula, Poria cocos, Glycyrrhiza uralensis, Angelica sinensis, Paeonia lactiflora, and Ligusticum chuanxiong as adjuvant herbs. Astragalus membranaceus is used in large quantities, combined with ginseng, and paired with Atractylodes macrocephala, Codonopsis pilosula, Poria cocos, and Glycyrrhiza uralensis to strengthen the spleen and replenish qi, nourish qi and generate blood. Combined with Angelica sinensis, Paeonia lactiflora, and Ligusticum chuanxiong, it nourishes blood and regulates the blood, astringes yin and unblocks the meridians, thus opening the source of qi and blood production to nourish the innate essence, embodying the principle of nourishing the innate with the acquired, and harmonizing the innate and acquired.

[0023] The formula also uses dried ginger and fennel as adjuvants. Dried ginger warms the middle and dispels cold, and warms and unblocks the meridians. Fennel warms the liver and dispels cold. The Compendium of Materia Medica states that it "treats coldness in the scrotum". Combined with aconite, cinnamon, psoralea, and curculigo, it can not only replenish fire and assist yang, warm the lower jiao, warm the liver and dispel cold, thus removing dampness and coldness in the scrotum, but also warm the spleen and kidneys to treat spleen and kidney yang deficiency and cold-damp diarrhea.

[0024] The formula also uses Amomum villosum, Amomum cardamomum, Magnolia officinalis, Citrus aurantium, Citrus reticulata peel, and the four roasted herbs (roasted hawthorn, roasted medicated leaven, roasted malt, roasted areca nut) and radish seed as adjuvants. Amomum villosum, Amomum cardamomum, Magnolia officinalis, Citrus aurantium, and Citrus reticulata peel regulate qi and strengthen the spleen; roasted hawthorn, medicated leaven, roasted malt, roasted areca nut, and radish seed eliminate stagnation and promote digestion. Combined with other herbs that regulate yin and yang and replenish qi and blood, the formula ensures that tonification is not stagnant, and that elimination is achieved through tonification, thus invigorating the spleen and pleasing the stomach.

[0025] The formula also includes Acorus tatarinowii, Polygala tenuifolia, Poria cocos, and Ziziphus jujuba var. spinosa as adjuvant herbs. Acorus tatarinowii clears phlegm, opens the orifices, refreshes the mind and invigorates the brain; Polygala tenuifolia harmonizes the heart and kidneys, calms the mind and stabilizes the will. When combined with ginseng, which calms the mind and enhances intelligence; Poria cocos, which nourishes the heart and calms the mind; and Ziziphus jujuba var. spinosa, which nourishes blood and calms the mind, it can relieve fright, disordered qi, and restlessness, as well as dizziness, vertigo, confusion, and forgetfulness caused by insufficient kidney essence and empty marrow sea, thus having a calming and stabilizing effect.

[0026] Salt is salty and enters the kidneys, nourishing the liver and kidneys; licorice strengthens the spleen and replenishes qi, harmonizes the properties of the medicine. When the two medicines are used together, they assist the principal medicine in tonifying the kidneys and strengthening the spleen, harmonize the properties of the medicine, and guide the medicine into the meridians, thus serving as an adjuvant medicine.

[0027] When used together, the above-mentioned herbs replenish both innate and acquired constitutions, harmonize Qi, blood, Yin, and Yang, and nourish the kidneys to replenish essence, invigorate Yang, and treat impotence. The combination of tonifying and astringent herbs helps to astringe essence and stop seminal emission, thus opening up new sources of energy and reducing waste. The combination of eliminating and tonifying herbs integrates elimination into tonification, ensuring that tonification does not cause stagnation. In addition, herbs nourish the heart and brain, harmonize the heart and kidneys, and calm the mind and stabilize the will, so as to achieve unity of body and spirit. Together, they can tonify the kidneys and invigorate Yang, and replenish Qi and blood. This combination is an effective treatment for deficiency of both Yin and Yang, insufficiency of Qi and blood, impotence, coldness, seminal emission, fatigue, and weakness.

[0028] This invention utilizes the excellent therapeutic effect of Shenrong Bushen tablets on benign prostatic hyperplasia (BPH), achieving significant therapeutic results without surgery. Furthermore, this Shenrong Bushen tablet is a repurposed old drug, boasting high safety and minimal side effects, significantly reducing research and development costs. It solves the problems of long treatment cycles, significant toxic side effects, and limited clinical application associated with current Western medicine treatments for BPH. Detailed Implementation

[0029] The present invention will now be described in further detail with reference to specific embodiments. The given embodiments are merely illustrative of the invention and not intended to limit its scope. The embodiments provided below can serve as a guide for further improvements by those skilled in the art and do not constitute a limitation on the invention in any way.

[0030] Unless otherwise specified, the experimental methods used in the following examples are conventional methods, performed according to the techniques or conditions described in the literature in this field or according to the product instructions. Unless otherwise specified, the materials and reagents used in the following examples are commercially available.

[0031] The ginseng and deer antler kidney-tonifying tablets used in this invention can be obtained commercially or prepared according to the method of Example 1. Commercially available tablets include those produced by Jilin Yizheng Pharmaceutical Group Co., Ltd. (Yizheng).

[0032] Example 1: Preparation of Ginseng and Deer Antler Kidney-Tonifying Tablets

[0033] The Ginseng and Deer Antler Kidney-Nourishing Tablets are made from the following ingredients: Astragalus membranaceus 50g, stir-fried Ziziphus jujuba var. spinosa 7.5g, Schisandra chinensis 12.5g, Acorus tatarinowii 5g, deer antler (hair removed) 12.5g, Amomum villosum 7.5g, Alisma plantago-aquatica (salted) 10g, Angelica sinensis 10g, red ginseng (root removed) 3.75g, Amomum cardamomum 6.25g, medicated leaven (charred) 7.5g, Magnolia officinalis (ginger) 7.5g, Paeonia suffruticosa 6.5g, Atractylodes macrocephala (stir-fried) 18.75g, fennel seeds (salted) 5g, coarse salt 8.75g, Polygala tenuifolia (honey) 5g, charred hawthorn 7.5g, dried ginger 6.25g, Citrus aurantium (stir-fried) 7.5g, Yangqishi (calcined) 7.5g, Cistanche deserticola 7.5g, and Aconitum carmichaelii (black) slices 6g. 25g, Poria cocos 18.75g, Cornus officinalis 6.25g, Eucommia ulmoides (charred) 10g, Hippocampus (scalded) 2.5g, Roasted malt 7.5g, Fried radish seed 6.25g, Roasted areca nut 6.25g, Rubus idaeus 6.25g, Asparagus cochinchinensis 3.125g, Dog kidney (scalded) 0.125 pieces, Allium tuberosum seed 6.25g, Salt-processed Psoralea corylifolia 7.5g, Ophiopogon japonicus 3.125g, Citrus reticulata peel 7.5g, Donkey kidney (scalded) 2.5g, Achyranthes bidentata 5g, Licorice root 6.25g, Cinnamon bark 6.25g, Dioscorea opposita 10g, Codonopsis pilosula 25g, Cynomorium songaricum 6.25g, Paeonia lactiflora 5g, Curculigo orchioides 6.25g, Lycium barbarum 12.5g, Ligusticum chuanxiong 5g,

[0034] The preparation method is as follows:

[0035] The above forty-eight ingredients, including seahorse, dog kidney, donkey kidney, poria cocos, calamus, red ginseng, yam, angelica sinensis, medicated leaven, malt, white peony root, yangqi stone, dried ginger, peony bark, amomum villosum, aconite, coarse salt, cardamom, cynomorium songaricum, chuanxiong rhizome, deer antler, and fennel, are ground into a fine powder. Hawthorn, wolfberry, alisma plantago-aquatica, astragalus membranaceus, jujube seed, areca nut, codonopsis pilosula, schisandra chinensis, leek seed, achyranthes bidentata, radix laurentii, cistanche deserticola, asparagus cochinchinensis, ophiopogon japonicus, licorice root, and raspberry, are decocted three times with water: 3 hours for the first time, 2 hours for the second, and 1 hour for the third. The decoction is then filtered. The filtrates were combined and concentrated to a thick paste with a relative density of 1.30 (50℃). The remaining ten herbs, including Polygala tenuifolia, were extracted three times by reflux with 60% ethanol, the first time for 2 hours, and the second and third times for 1 hour each. The ethanol extracts were combined, filtered, and the ethanol was recovered from the filtrate and concentrated under reduced pressure to a thick paste with a relative density of 1.30 (50℃). The above fine powder and thick paste were mixed evenly, dried, pulverized, sieved, and then an appropriate amount of starch and dextrin were added, mixed evenly, granulated, dried, and then magnesium stearate was added, mixed evenly, and pressed into 1000 tablets, which were then sugar-coated. Each tablet core weighed 0.3g.

[0036] Characteristics: This product is a sugar-coated tablet. After removing the sugar coating, it is brown to brownish-brown in color; it tastes sour, bitter, and slightly salty.

[0037] Example 2: Effects of Shenrong Bushen Tablets on Experimental Benign Prostatic Hyperplasia in Mice

[0038] Sixty male mice (weighing 18-22g) were randomly divided into a model group, a blank control group, a positive drug group [Pulean tablets (Qianliekang), production license number: National Drug Approval Number Z33020303, Zhejiang Kang Enbei Pharmaceutical Co., Ltd., specification 0.57g*60 tablets) 0.57g / kg group, and a Shenrong Bushen tablets 3g / kg group prepared in Example 1 of this invention. Except for the blank control group, the other mice were subcutaneously injected (Sc) once a day with testosterone propionate (5mg / kg), and 1 hour later, they were administered the drug by gavage (ig). The blank group and the model group were given the same volume of distilled water. The drug administration was continued for 60 days. Mice were sacrificed on day 61. The prostates of each mouse were carefully dissected and weighed (mg). The number of glandular tissues was calculated (number of glandular tissues = gland weight / mouse body weight × 100%). After weighing, the prostate tissues from each group were mixed with physiological saline to form a 10% prostate tissue homogenate. The androgen and estrogen levels in the prostate tissue homogenate were measured by ELISA, and the ratio between the two was calculated. Prostate tissues from each group were fixed with 10% formaldehyde phosphate buffer, embedded in paraffin, sectioned, stained with hematoxylin and eosin (HE) (hematoxylin-eosin staining method), and examined under a microscope to observe the degree of prostate tissue hyperplasia.

[0039] Compared with the normal group, the prostate coefficient of rats in the model group was significantly increased (P<0.05). Compared with the model group, both the positive control group and the Shenrong Bushen tablet group of this invention significantly reduced the prostate coefficient of mice with benign prostatic hyperplasia (P<0.05), and the effect of this invention was better than that of the positive control group.

[0040] Compared with the normal group, the androgen level in the prostate tissue homogenate of the model group mice was significantly increased; the estrogen level was not significantly different from that of the normal group. Compared with the model group, both the positive control group and the Shenrong Bushen tablet group of this invention significantly reduced the androgen level in the prostate tissue homogenate of mice with benign prostatic hyperplasia.

[0041] To further demonstrate the therapeutic effect of Shenrong Bushen tablets on benign prostatic hyperplasia (BPH), the degree of prostatic tissue hyperplasia was observed by microscopic examination. In the control group (normal group), the prostatic glandular tissue structure in the ventral and dorsal lobes was basically normal, with some tissues showing inflammatory cell infiltration. In the model group, the glands were enlarged, the lumens were dilated, and some lumens showed increased and hyperplastic papillae. The glandular epithelium was stratified, and some lumens showed vacuolated epithelial cell damage. Inflammatory cell infiltration was also observed in some stroma and lumens. Shenrong Bushen tablets significantly reduced the size of the prostatic glands, and the degree of glandular and lumen dilation and hyperplasia was significantly reduced compared to the model group, indicating a significant improvement in the BPH condition.

Claims

1. Application of Ginseng and Deer Antler Kidney-Nourishing Tablets in the preparation of drugs for the prevention and / or treatment of benign prostatic hyperplasia.

2. The application according to claim 1, characterized in that: The aforementioned ginseng and deer antler kidney-tonifying tablets are made from the following ingredients: Astragalus membranaceus 50g, stir-fried jujube seed 7.5g, Schisandra chinensis 12.5g, Acorus tatarinowii 5g, deer antler (hair removed) 12.5g, Amomum villosum 7.5g, salt-processed Alisma plantago-aquatica 10g, Angelica sinensis 10g, red ginseng (root removed) 3.75g, cardamom 6.25g, styrax glutinosa (charred) 7.5g, Magnolia officinalis 7.5g, Paeonia suffruticosa 6.5g, Atractylodes macrocephala (stir-fried) 18.75g, salt-processed fennel 5g, coarse salt 8.75g, Polygala tenuifolia (honey-processed) 5g, charred hawthorn 7.5g, dried ginger 6.25g, Citrus aurantium (stir-fried) 7.5g, calcined yangqi stone 7.5g, Cistanche deserticola 7.5g, and black aconite slices 6g. 0.25g, Poria cocos 18.75g, Cornus officinalis 6.25g, Eucommia ulmoides (charred) 10g, Hippocampus (scalded) 2.5g, Roasted malt 7.5g, Fried radish seed 6.25g, Roasted areca nut 6.25g, Rubus idaeus 6.25g, Asparagus cochinchinensis 3.125g, Dog kidney (scalded) 0.125 pieces, Allium tuberosum seed 6.25g, Salt-processed Psoralea corylifolia 7.5g, Ophiopogon japonicus 3.125g, Citrus reticulata peel 7.5g, Donkey kidney (scalded) 2.5g, Achyranthes bidentata 5g, Licorice root 6.25g, Cinnamon 6.25g, Dioscorea opposita 10g, Codonopsis pilosula 25g, Cynomorium songaricum 6.25g, Paeonia lactiflora 5g, Curculigo orchioides 6.25g, Lycium barbarum 12.5g, Ligusticum chuanxiong 5g.

3. The application according to claim 2, characterized in that: The preparation method of the aforementioned Ginseng and Deer Antler Kidney-Nourishing Tablets is as follows: The above forty-eight ingredients, including seahorse, dog kidney, donkey kidney, Poria cocos, Acorus tatarinowii, red ginseng, yam, angelica sinensis, Shenqu (medicated leaven), malt, white peony root, Yangqishi (a type of mineral), dried ginger, peony bark, amomum villosum, aconite, coarse salt, cardamom, Cynomorium songaricum, Ligusticum chuanxiong, deer antler, and fennel, are ground into a fine powder; hawthorn, wolfberry, Alisma plantago-aquatica, Astragalus membranaceus, jujube seed, areca nut, Codonopsis pilosula, Schisandra chinensis, leek seed, Achyranthes bidentata, Raphanus sativus seed, Cistanche deserticola, Asparagus cochinchinensis, Ophiopogon japonicus, licorice root, and raspberry, are decocted three times with water: the first time for 3 hours, the second time for 2 hours, and the third time for 1 hour. After 2 hours, the decoction was filtered, the filtrates were combined, and concentrated to a thick paste with a relative density of 1.30 (50℃). The remaining ten herbs, including Polygala tenuifolia, were extracted three times by reflux with 60% ethanol. The first extraction was for 2 hours, and the second and third extractions were for 1 hour each. The ethanol solutions were combined, filtered, and the ethanol was recovered from the filtrates and concentrated under reduced pressure to a thick paste with a relative density of 1.30 (50℃). The above fine powder and thick paste were mixed evenly, dried, pulverized, sieved, and an appropriate amount of starch and dextrin were added. The mixture was mixed evenly, granulated, dried, and magnesium stearate was added. The mixture was pressed into 1000 tablets, coated with sugar, and the final product was obtained.

4. The application according to any one of claims 1-3, characterized in that: The prevention and / or treatment of benign prostatic hyperplasia is manifested in at least one of the following aspects: a) Reduce the number of prostate glandular systems; b) Reduce androgen levels in patients with benign prostatic hyperplasia; c) Improves the degree of glandular and cavitary dilation and hyperplasia in patients with benign prostatic hyperplasia.