Preparation method and application of ginseng and deer body resistance strengthening tablet for treating impotence and premature ejaculation caused by heart-spleen deficiency

Abstract

The invention provides a preparation method and application of ginseng and deer body resistance strengthening tablets for treating impotence and premature ejaculation caused by heart-spleen deficiency, and belongs to the technical field of medicine processing. The method comprises the following steps: (1) crushing deer-horn glue and ginseng for later use; (2) mixing schisandra chinensis, bighead atractylodes rhizome and water, soaking for 5-7 hours, extracting volatile oil, and collecting medicine residues; (3) mixing the medicine residue, other components and water, decocting, and collecting the decoction; (4) adding ethanol into the decoction, standing, filtering and collecting filtrate; (5) removing ethanol in the filtrate to obtain a liquid medicine; (6) adding crushed deer-horn glue into the liquid medicine, dissolving, concentrating, spray-drying, and crushing into fine powder; and (7) mixing the fine powder obtained in the step (6) with crushed ginseng, granulating, drying, spraying the volatile oil obtained in the step (2), tabletting, and coating to obtain the ginseng-deer body resistance strengthening tablet. The obtained ginseng and deer body resistance strengthening tablet can effectively treat impotence and premature ejaculation caused by heart-spleen deficiency.

Description

Technical Field

[0001] The present invention belongs to the technical field of pharmaceutical processing, and particularly relates to a preparation method and application of Shenlu Fuzheng Tablets for treating impotence and premature ejaculation caused by deficiency of both heart and spleen. Background Art

[0002] Impotence and premature ejaculation are common male sexual dysfunction diseases, and deficiency of both heart and spleen is one of the important traditional Chinese medicine syndromes leading to this disease. The heart governs blood, and the spleen is the source of qi and blood production. When there is deficiency of both heart and spleen, qi and blood are insufficient, and the penis cannot be nourished, thus leading to impotence and premature ejaculation. Currently, there are many drugs for treating impotence and premature ejaculation on the market, including western medicines and traditional Chinese medicines. Western medicines such as sildenafil can take effect quickly, but they have side effects such as headache, facial flushing, and stomach discomfort, and long-term use may have an adverse impact on the body. Traditional Chinese medicine treatment focuses on overall conditioning and has fewer side effects, but existing preparations for treating impotence and premature ejaculation caused by deficiency of both heart and spleen have problems such as complex formula, high cost, and insufficiently significant curative effect.

[0003] Shenlu Fuzheng Tablets is a traditional Chinese medicine preparation produced by Tianyikang (Haicheng) Pharmaceutical Co., Ltd. This medicine is in tablet form and has the effects of strengthening the healthy qi and consolidating the root, nourishing yin and boosting yang, and is used for fatigue, dizziness, tinnitus, forgetfulness, insomnia, soreness and weakness of the waist and knees, and frequent urination at night caused by deficiency of both yin and yang. However, there is no research in the existing technology on the preparation method of this medicine and whether it can be used to treat impotence and premature ejaculation caused by deficiency of both heart and spleen. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide a preparation method and application of Shenlu Fuzheng Tablets for treating impotence and premature ejaculation caused by deficiency of both heart and spleen. Through research on Shenlu Fuzheng Tablets, the present invention finds that it can effectively treat impotence and premature ejaculation caused by deficiency of both heart and spleen, and when used in combination with drugs for treating hypertension, diabetes, and arrhythmia, it can effectively improve the effects of drugs for hypertension, diabetes, and arrhythmia.

[0005] In order to achieve the above-mentioned invention purpose, the present invention provides the following technical solutions:

[0006] The present invention provides a preparation method of Shenlu Fuzheng Tablets for treating impotence and premature ejaculation caused by deficiency of both heart and spleen. The Shenlu Fuzheng Tablets are prepared from the following raw materials in parts by mass: 75 parts of ginseng, 150 parts of prepared rehmannia root, 75 parts of eucommia bark, 150 parts of wolfberry fruit, 115 parts of morinda officinalis, 75 parts of achyranthes root, 150 parts of poria cocos, 75 parts of seabuckthorn, 113 parts of fenugreek, 38 parts of asparagus root, 150 parts of schisandra chinensis, 113 parts of acanthopanax bark, 150 parts of cistanche deserticola, 38 parts of deer horn glue, 75 parts of Chinese yam, 38 parts of wild jujube seed, 113 parts of mulberry, 37 parts of atractylodes macrocephala, 115 parts of scutellaria barbata, 113 parts of cat's claw grass;

[0007] The preparation method includes the following steps:

[0008] (1) Crush antler glue and ginseng;

[0009] (2) Mix schisandra chinensis, atractylodes macrocephala and water, soak for 5 - 7 h, extract volatile oil, and collect the medicinal residues;

[0010] (3) Mix the medicinal residues, other components and water, decoct, and collect the decoction;

[0011] (4) Add ethanol to the decoction, let stand, filter, and collect the filtrate;

[0012] (5) Remove the ethanol from the filtrate to obtain the medicinal liquid;

[0013] (6) Add the crushed antler glue to the medicinal liquid to dissolve it, concentrate, spray dry, and pulverize into fine powder;

[0014] (7) Mix the fine powder obtained in step (6) with the crushed ginseng, granulate, dry, spray in the volatile oil obtained in step (2), tableting, coating, to obtain Shenlu Fuzheng tablets.

[0015] Preferably, in step (2), the schisandra chinensis, atractylodes macrocephala and water are mixed, and the amount of water used is 6 - 10 times the total mass of schisandra chinensis and atractylodes macrocephala.

[0016] Preferably, the extraction method in step (2) is steam distillation, and the extraction time is 4 - 8 h.

[0017] Preferably, the amount of water used in step (3) is 6 - 12 times the total mass of the medicinal residues and other components.

[0018] Preferably, the number of decoction times in step (3) is 1 - 5 times, and the decoction time is 0.5 - 3 h / time.

[0019] Preferably, the standing time in step (4) is 10 - 14 h.

[0020] Preferably, the concentration method is vacuum concentration, the concentration temperature is 50 - 70 °C, and the density after concentration is 1.0 - 1.2.

[0021] Preferably, the drying method in step (7) is spray drying.

[0022] The present invention provides the application of the Shenlu Fuzheng tablets obtained by the above - mentioned preparation method in the preparation of medicaments for treating impotence and premature ejaculation caused by deficiency of both heart and spleen.

[0023] The present invention also provides the application of the Shenlu Fuzheng tablets obtained by the above - mentioned preparation method in the preparation of medicaments for treating hypertension, diabetes, and arrhythmia, and the Shenlu Fuzheng tablets are used as adjuvant medicaments.

[0024] Compared with the prior art, the present invention has the following beneficial effects: Based on the different physical and chemical properties of the active ingredients in various raw materials, different extraction methods are adopted, and the active ingredients in the raw materials are retained to the greatest extent. Through the research on Shenlu Fuzheng Tablets, it is found that while treating symptoms such as fatigue, dizziness, tinnitus, forgetfulness, insomnia, soreness of the waist and knees, and frequent urination at night, it can also effectively treat impotence and premature ejaculation caused by deficiency of both the heart and spleen. And when used in combination with drugs for treating hypertension, diabetes, and arrhythmia, it can effectively improve the efficacy of drugs for hypertension, diabetes, and arrhythmia. Detailed implementation mode

[0025] The present invention provides a preparation method of Shenlu Fuzheng Tablets for treating impotence and premature ejaculation caused by deficiency of both the heart and spleen. The Shenlu Fuzheng Tablets are prepared from the following raw materials in parts by mass: 75 parts of ginseng, 150 parts of prepared rehmannia root, 75 parts of eucommia bark, 150 parts of wolfberry fruit, 115 parts of morinda officinalis, 75 parts of achyranthes root, 150 parts of poria cocos, 75 parts of seabuckthorn, 113 parts of fenugreek, 38 parts of asparagus root, 150 parts of schizandra fruit, 113 parts of acanthopanax bark, 150 parts of cistanche deserticola, 38 parts of deer horn glue, 75 parts of Chinese yam, 38 parts of wild jujube seed, 113 parts of mulberry fruit, 37 parts of atractylodes macrocephala, 115 parts of scutellaria barbata, 113 parts of cat's claw grass;

[0026] The preparation method includes the following steps:

[0027] (1) Crush deer horn glue and ginseng;

[0028] (2) Mix schizandra fruit, atractylodes macrocephala with water, soak for 5 - 7 h, extract volatile oil, and collect the medicinal residues;

[0029] (3) Mix the medicinal residues with other components and water, decoct, and collect the decoction;

[0030] (4) Add ethanol to the decoction, let it stand, filter, and collect the filtrate;

[0031] (5) Remove the ethanol from the filtrate to obtain the medicinal liquid;

[0032] (6) Add the crushed deer horn glue to the medicinal liquid to dissolve it, concentrate, spray dry, and crush it into fine powder;

[0033] (7) Mix the fine powder obtained in step (6) with the crushed ginseng, granulate, dry, spray in the volatile oil obtained in step (2), press tablets, coat the tablets, and obtain Shenlu Fuzheng Tablets.

[0034] In the present invention, deer horn glue and ginseng are crushed; there is no special limitation on the crushing method in the present invention, and conventional methods can be adopted. Deer horn glue and ginseng are respectively crushed into fine powder with a particle size of 100 - 200 μm. The particle size of the deer horn glue and ginseng fine powder is preferably 120 - 180 μm, and more preferably 150 μm.

[0035] In the present invention, Schisandra chinensis, Atractylodes macrocephala and water are mixed and soaked for 5 - 7 h to extract volatile oil, and the medicinal residues are collected; the amount of water used is 6 - 10 times the total mass of Schisandra chinensis and Atractylodes macrocephala, preferably 7 - 9 times, more preferably 8 times; the soaking time is preferably 5.5 - 6.5 h, more preferably 6 h; the method for extracting volatile oil is distillation extraction, the extraction temperature is 70 - 100 °C, preferably 80 - 90 °C, more preferably 85 °C, and the extraction time is 4 - 8 h, preferably 5 - 7 h, more preferably 6 h.

[0036] In the present invention, the medicinal residues, other components and water are mixed and decocted, and the decoction is collected; the medicinal residues, other components and 6 - 12 times the total mass of the medicinal residues and other components of water are mixed and decocted 1 - 5 times, and the decoction is collected. The other components are: Rehmannia glutinosa, Eucommia ulmoides, Lycium barbarum, Morinda officinalis, Achyranthes bidentata, Poria cocos, Hippohgae rhamnoides, Trigonella foenum-graecum, Asparagus cochinchinensis, Acanthopanax gracilistylus, Cistanche deserticola, Dioscorea opposita, Ziziphus jujuba var. spinosa, Morus alba, Scutellaria barbata, Ranunculus ternatus. The amount of water used is preferably 7 - 11 times the total mass of the medicinal residues and other components, more preferably 8 - 10 times; the number of decoction times is preferably 2 - 4 times, more preferably 3 times; the decoction time is 0.5 - 3 h / time, preferably 0.75 - 2.5 h, more preferably 1 - 2 h.

[0037] In the present invention, ethanol is added to the decoction, allowed to stand, filtered, and the filtrate is collected; 0.5 - 1.5 times the volume of the decoction of ethanol is added to the decoction, allowed to stand for 10 - 14 h, filtered, and the filtrate is collected. The initial concentration of the ethanol is 75% - 100%, preferably 80% - 90%, more preferably 85%; the amount of ethanol used is preferably 0.7 - 1.2 times the volume of the decoction, more preferably 1 time; the standing time is preferably 11 - 13 h, more preferably 12 h.

[0038] In the present invention, the ethanol in the filtrate is removed to obtain the medicinal liquid. The present invention has no special limitation on the method for removing ethanol, and the ethanol in the filtrate can be removed by using a conventional ethanol recovery method.

[0039] In the present invention, powdered deer horn glue is added to the medicinal liquid to dissolve it, concentrated, spray-dried, and pulverized into fine powder; after removing ethanol, powdered deer horn glue is added to the medicinal liquid while it is hot to dissolve it, and concentrated under reduced pressure to an extract with a relative density of 1.0 - 1.2, spray-dried, and pulverized into fine powder. The temperature for concentration under reduced pressure is 50 - 70 °C, preferably 55 - 65 °C, more preferably 60 °C; the relative density after concentration is preferably 1.05 - 1.15, more preferably 1.1. The particle size of the fine powder is 100 - 200 μm, preferably 120 - 180 μm, more preferably 150 μm.

[0040] In the present invention, the fine powder obtained in step (6) is mixed with the pulverized ginseng, granulated, dried, sprayed with the volatile oil obtained in step (2), tabletted, and coated to obtain Shenlu Fuzheng tablets. There are no special limitations on the methods of granulation, tabletting, and coating in the present invention, and conventional methods can be used. The drying method is spray drying.

[0041] In the present invention, there are no special limitations on the raw material sources, and conventional commercially available raw materials can be used. Ginseng is sweet, slightly bitter, and slightly warm in flavor, and belongs to the spleen, lung, heart, and kidney meridians. Ginseng contains more than 30 active ingredients, including ginsenosides, polysaccharides, amino acids, vitamins, etc. These ingredients work together to quickly restore vitality, stabilize symptoms of collapse, and at the same time regulate the function of the spleen and stomach, nourish the lungs, promote hematopoiesis, and soothe the nerves and strengthen the brain.

[0042] Prepared Rehmannia Root is sweet and slightly warm in flavor, and belongs to the liver and kidney meridians. It is mainly used to nourish yin and tonify blood. It can treat symptoms such as yin deficiency and blood deficiency, weakness of the waist and knees, consumptive cough with bone steaming, spermatorrhea, metrorrhagia and metrostaxis, irregular menstruation, polydipsia, frequent urination, deafness, and blurred vision.

[0043] Eucommia Bark is sweet, slightly pungent, and warm in flavor, and belongs to the liver and kidney meridians. It is mainly used to tonify the liver and kidney, strengthen tendons and bones, and prevent miscarriage. It can treat symptoms such as soreness of the lumbar spine, weakness of the feet and knees, residual urine, itching in the perineum, threatened abortion, fetal movement restlessness, and hypertension.

[0044] Wolfberry Fruit is sweet and flat in flavor, and belongs to the liver and kidney meridians. It is mainly used to nourish the kidney, moisten the lungs, tonify the liver, and improve eyesight. It can treat symptoms such as kidney and liver yin deficiency, weakness of the waist and knees, dizziness, vertigo, excessive tears in the eyes, consumptive cough, polydipsia, and spermatorrhea.

[0045] Morinda Root is sweet, pungent, and slightly warm in flavor, and belongs to the kidney and liver meridians. Morinda Root can not only gently supplement the yang qi of the kidney, increase essence and blood, but also expel wind-dampness in the body and strengthen bones and muscles. It is an important medicinal material for treating kidney yang deficiency or accompanied by wind-dampness problems. Morinda Root contains anthraquinones (helping to regulate body functions), iridoid components (having anti-inflammatory effects), oligosaccharides (helping to enhance immunity) and other active ingredients, mainly playing the roles of enhancing kidney function, strengthening bones and muscles, and expelling wind-dampness.

[0046] Achyranthes Root is bitter, sweet, and sour in flavor, with a mild nature, and belongs to the liver and kidney meridians. Achyranthes Root mainly contains sterone, triterpenoid saponins, flavonoid compounds, polysaccharides, and amino acids, etc., and has the effects of promoting blood circulation and regulating menstruation, improving urination, guiding blood downward, tonifying the liver and kidney, and strengthening bones and muscles.

[0047] Poria is sweet, light, and flat in nature, and belongs to the heart, lung, spleen, and kidney meridians. Poria can not only eliminate edema by promoting urination, but also enhance the transportation and transformation ability of the spleen and stomach, and help soothe the nerves and promote sleep. It is especially suitable for treating problems such as palpitation and edema caused by abnormal water metabolism in the body, and has a better effect on edema caused by spleen deficiency.

[0048] Hippohgae rhamnoides L. tastes sour, astringent, and warm, and pertains to the spleen, stomach, lung, and heart meridians. It is mainly used for insufficient appetite due to spleen deficiency, abdominal pain due to food retention, profuse phlegm in cough, chest impediment pain, amenorrhea due to stasis of blood, and swelling and pain due to falls and bruises.

[0049] Trigonella foenum-graecum L. tastes bitter and warm, and pertains to the kidney meridian. It is mainly used for yang deficiency of the kidney, deficiency and coldness of the lower energizer, cold pain in the lower abdomen, pain of cold-induced hernia, and damp-cold beriberi.

[0050] Asparagus cochinchinensis (Lour.) Merr. tastes sweet and bitter, is slightly cold in nature, and pertains to the lung, kidney, stomach, and large intestine meridians. Asparagus mainly contains steroid saponins (natural active substances), polysaccharides, amino acids and other components, which together play a role in nourishing yin and moistening dryness, clearing lung heat, and promoting the production of body fluids.

[0051] Schisandra chinensis (Turcz.) Baill. tastes sour and sweet, is warm in nature, and pertains to the lung, heart, and kidney meridians. Schisandra mainly contains lignans, volatile oils, as well as polysaccharides and amino acids and other components, and has the effects of astringing and consolidating, replenishing physical strength, and calming the mind.

[0052] Acanthopanax gracilistylus W. W. Smith tastes pungent, bitter, and warm, and pertains to the liver and kidney meridians. Acanthopanax gracilistylus W. W. Smith mainly contains phenylpropanoid glycosides, terpenoid components, and also contains polysaccharides, fatty acids and volatile oils, etc. It has the effects of expelling wind and dampness, tonifying the liver and kidney, strengthening tendons and bones, and promoting diuresis and reducing swelling. It is used for rheumatic arthralgia, flaccidity of tendons and bones, delayed walking in children, physical weakness, edema, and beriberi.

[0053] Cistanche deserticola Ma tastes sweet, salty, and warm, and pertains to the kidney and large intestine meridians. Cistanche deserticola Ma nourishes the kidney through its salty taste, tonifies the body through its sweet and warm properties, and its action is relatively mild without causing dryness and heat. It can enhance yang qi and replenish essence qi for the kidney, and relieve dryness and gently promote defecation for the intestine.

[0054] Colla Cornus Cervi is a kind of traditional Chinese medicine for warming and tonifying, belonging to the yang-tonifying drugs, and has the effects of nourishing the liver and kidney and replenishing essence and blood. Its medicinal property is mild and suitable for people with asthenia-cold constitution and insufficient energy.

[0055] Dioscorea opposita Thunb. tastes sweet and neutral, and pertains to the lung, spleen, and kidney meridians. Dioscorea opposita Thunb. can help improve problems such as loss of appetite and chronic diarrhea caused by weakness of the spleen and stomach. It also has a regulatory effect on abnormal increase in vaginal discharge in women and frequent spermatorrhea in men. It can enhance lung function, relieve symptoms of chronic cough and asthma, and improve frequent urination caused by kidney deficiency. At the same time, it can also assist in relieving common symptoms of diabetes such as thirst and polyuria.

[0056] Semen Ziziphi Spinosae tastes sweet, sour, and neutral, and pertains to the liver, gallbladder, and heart meridians. It is suitable for regulating symptoms such as restlessness of mind, insomnia and dreaminess, and being easily frightened caused by insufficiency of yin and blood. At the same time, Semen Ziziphi Spinosae can also astringe sweating and is suitable for people with weak bodies who are prone to sweating. Semen Ziziphi Spinosae contains triterpenoid saponins, alkaloids, flavonoids, as well as volatile oils, sugars, proteins and organic acids and other components, which together play a role in nourishing the viscera, calming the nerves, stopping sweating and promoting the production of body fluids.

[0057] Mulberries are sweet, sour, and cold in nature, and enter the heart, liver, and kidney meridians. Mulberries are good at nourishing yin and blood, treating various symptoms of yin and blood deficiency; they can nourish yin and clear heat to promote fluid production, treating thirst due to fluid impairment and diabetes; and they can moisten the intestines and relieve constipation, treating constipation due to intestinal dryness.

[0058] Atractylodes macrocephala is bitter, sweet, and warm in nature, and enters the spleen and stomach meridians. It dispels dampness in the body by strengthening the spleen and stomach functions, and can both nourish the body and eliminate edema. Its main effects include: enhancing digestive function, eliminating edema, stopping abnormal sweating, and preventing miscarriage. It is applicable to cases of weak spleen and stomach, edema, excessive phlegm retention, easy sweating, and fetal restlessness.

[0059] Scutellaria barbata is pungent, bitter, and cold in nature, and enters the lung, liver, and kidney meridians. The pungent property of Scutellaria barbata helps promote the circulation of qi and blood, and the bitter and cold properties can clear heat toxins in the body. At the same time, it can disperse stasis, improve bleeding, and eliminate edema. It has an improving effect on various symptoms of heat toxins, stasis problems, and dysuria caused by damp-heat, and is particularly good at treating snake bites, skin abscesses, and tumors.

[0060] Ranunculus ternatus is sweet, pungent, and warm in nature, and enters the liver and lung meridians. It is mainly used for scrofula, phlegm nodules, furuncles and carbuncles, and snake and insect bites.

[0061] The present invention provides the use of the Shenlu Fuzheng tablets obtained by the described preparation method in the preparation of medicaments for treating impotence and premature ejaculation caused by deficiency of both the heart and spleen.

[0062] The present invention also provides the use of the Shenlu Fuzheng tablets obtained by the described preparation method in the preparation of medicaments for treating hypertension, diabetes, and arrhythmia, with the Shenlu Fuzheng tablets being used as adjuvant medicaments.

[0063] The technical solutions provided by the present invention will be described in detail below in conjunction with embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0064] Example 1

[0065] Shenlu Fuzheng tablets in the preparation:

[0066] (1) Weigh 75 g of ginseng, 150 g of cooked rehmannia root, 75 g of eucommia bark, 150 g of wolfberry fruit, 115 g of morinda officinalis, 75 g of achyranthes bidentata, 150 g of poria cocos, 75 g of seabuckthorn, 113 g of trigonella foenum-graecum, 38 g of asparagus root, 150 g of schisandra chinensis, 113 g of acanthopanax gracilistylus, 150 g of cistanche deserticola, 38 g of deer horn glue, 75 g of Chinese yam, 38 g of wild jujube seed, 113 g of mulberries, 37 g of atractylodes macrocephala, 115 g of scutellaria barbata, and 113 g of ranunculus ternatus, and set aside.

[0067] (2) Crush the deer horn glue and ginseng into fine powder with a particle size of 150 μm respectively, and set aside;

[0068] (3) Add Schisandra chinensis and Atractylodes macrocephala to 1486 g of water, soak for 6 h, and perform distillation extraction at 85 °C for 6 h to collect the volatile oil. Filter the aqueous solution after distillation and collect the medicinal residues;

[0069] (4) Decoct the medicinal residues together with 16 raw materials such as Rehmannia glutinosa for 3 times. For the first time, place them in 18.45 kg of water and decoct for 2 h before filtering. For the second and third times, place them in 14.76 kg of water respectively and decoct for 1 h each time, then filter. Combine the filtrates from the 3 times, add 85% ethanol of equal volume, let it stand for 12 h, filter, remove the ethanol, and obtain the medicinal liquid;

[0070] (5) While the medicinal liquid is hot, add the fine powder of Cornu Cervi Colla. After the Cornu Cervi Colla melts, concentrate the medicinal liquid under reduced pressure at 60 °C to a clear paste with a relative density of 1.1, perform spray drying, and then pulverize it into fine powder of 150 μm;

[0071] (6) Mix the obtained fine powder with the fine powder of Ginseng, granulate, and perform spray drying. Then spray the volatile oil obtained in step (3) into it, press tablets, and coat them to obtain Shenlu Fuzheng Tablets.

[0072] Example 2

[0073] Preparation of Shenlu Fuzheng Tablets:

[0074] (1) Weigh 75 g of Ginseng, 150 g of Rehmannia glutinosa, 75 g of Eucommia ulmoides, 150 g of Lycium barbarum, 115 g of Morinda officinalis, 75 g of Achyranthes bidentata, 150 g of Poria cocos, 75 g of Hippohgae rhamnoides, 113 g of Trigonella foenum-graecum, 38 g of Asparagus cochinchinensis, 150 g of Schisandra chinensis, 113 g of Acanthopanax gracilistylus, 150 g of Cistanche deserticola, 38 g of Cornu Cervi Colla, 75 g of Dioscorea opposita, 38 g of Ziziphus jujuba var. spinosa, 113 g of Morus alba, 37 g of Atractylodes macrocephala, 115 g of Scutellaria barbata, 113 g of Ranunculus ternatus, and set aside.

[0075] (2) Pulverize Cornu Cervi Colla and Ginseng respectively into fine powder with a particle size of 100 μm and set aside;

[0076] (3) Add Schisandra chinensis and Atractylodes macrocephala to 1486 g of water, soak for 7 h, and perform distillation extraction at 70 °C for 8 h to collect the volatile oil. Filter the aqueous solution after distillation and collect the medicinal residues;

[0077] (4) Decoct the medicinal residues together with 16 raw materials such as Rehmannia glutinosa for 3 times. For the first time, place them in 18.45 kg of water and decoct for 2 h before filtering. For the second and third times, place them in 14.76 kg of water respectively and decoct for 1 h each time, then filter. Combine the filtrates from the 3 times, add 75% ethanol of equal volume, let it stand for 14 h, filter, remove the ethanol, and obtain the medicinal liquid;

[0078] (5) While the medicinal liquid is hot, add the fine powder of Cornu Cervi Colla. After the Cornu Cervi Colla melts, concentrate the medicinal liquid under reduced pressure at 50 °C to a clear paste with a relative density of 1.0, perform spray drying, and then pulverize it into fine powder of 100 μm;

[0079] (6) Mix the obtained fine powder with the fine powder of ginseng, granulate, and after spray drying, spray the volatile oil obtained in step (3), press tablets, and coat them to obtain Shenlu Fuzheng Tablets.

[0080] Example 3

[0081] Shenlu Fuzheng Tablets are prepared as follows:

[0082] (1) Weigh 75 g of ginseng, 150 g of Rehmannia glutinosa, 75 g of Eucommia ulmoides, 150 g of Lycium barbarum, 115 g of Morinda officinalis, 75 g of Achyranthes bidentata, 150 g of Poria cocos, 75 g of Hippohgae rhamnoides, 113 g of Trigonella foenum-graecum, 38 g of Asparagus cochinchinensis, 150 g of Schisandra chinensis, 113 g of Acanthopanax gracilistylus, 150 g of Cistanche deserticola, 38 g of Cornu Cervi Colla, 75 g of Dioscorea opposita, 38 g of Ziziphus jujuba var. spinosa, 113 g of Morus alba, 37 g of Atractylodes macrocephala, 115 g of Scutellaria barbata, and 113 g of Ranunculus ternatus, and set aside.

[0083] (2) Crush Cornu Cervi Colla and ginseng into fine powders with a particle size of 200 μm respectively, and set aside;

[0084] (3) Add Schisandra chinensis and Atractylodes macrocephala to 1486 g of water, soak for 5 h, distill and extract at 100 °C for 4 h, collect the volatile oil, filter the aqueous solution after distillation, and collect the medicinal residues;

[0085] (4) Decoct the medicinal residues and the other 16 raw materials such as Rehmannia glutinosa in water 3 times. The first time, place them in 18.45 kg of water, decoct for 2 h and then filter. The second and third times, place them in 14.76 kg of water respectively, decoct for 1 h each time, filter, combine the 3 filtrates, add an equal volume of 100% ethanol, let stand for 10 h, filter, remove the ethanol, and obtain the medicinal liquid;

[0086] (5) While the medicinal liquid is hot, add the fine powder of Cornu Cervi Colla. After the Cornu Cervi Colla melts, concentrate the medicinal liquid under reduced pressure at 70 °C to a clear paste with a relative density of 1.2, spray dry, and crush it into a fine powder of 200 μm;

[0087] (6) Mix the obtained fine powder with the fine powder of ginseng, granulate, and after spray drying, spray the volatile oil obtained in step (3), press tablets, and coat them to obtain Shenlu Fuzheng Tablets.

[0088] Experimental Example 1

[0089] Test method: Male SD rats, weighing 275±25 g, were selected. Forty rats were randomly and evenly divided into 4 groups, specifically the blank control group, the experimental group (Shenlu Fuzheng Tablets obtained in Example 1), the medicament control group 1 (Renshen Guipi Pills, purchased from Liaoning Baidaotang Pharmaceutical Co., Ltd.), and the medicament control group 2 (Sildenafil, purchased from Pfizer Pharmaceuticals (Dalian) Co., Ltd.). The rats in the experimental group were given medicine by gavage, with the dosage of 3 g / kg / d. The blank control group was given the same volume of distilled water by gavage. The medicine was administered continuously for 7 days. Thirty minutes after the last administration, a penile erection reflex experiment was conducted on the rats. The rats were placed in a glass experimental device, and the environment was kept quiet and the light was dim. The rats were filmed with a camera for 50 minutes, and the number of erections (the total number of erections of the rats within 50 minutes) and the erection time (the average erection time of each rat) were recorded. The test results are shown in Table 1.

[0090] Table 1 Erection times and erection times of SD rats in different groups

[0091] Test sample Number of erections / times Erection duration / min Blank control group 1.51±0.32 16.7±3.03 Experimental group 5.47±0.74 20.4±2.62 Drug control group 1 4.86±1.01 18.9±3.11 Drug control group 2 5.82±0.97 20.9±2.54

[0092] As can be seen from Table 1, compared with the blank control group, the efficacy of Shenlu Fuzheng Tablets is similar to that of sildenafil, and it is better than that of Renshen Guipi Pills. Moreover, since the Shenlu Fuzheng Tablets of the present invention are Chinese patent medicines, there is no risk of side effects such as headache, facial flushing, and stomach discomfort caused by the use of sildenafil. It shows that the use of Shenlu Fuzheng Tablets can effectively treat impotence and premature ejaculation caused by deficiency of both the heart and spleen.

[0093] Experimental Example 2

[0094] Thirty patients diagnosed with impotence and premature ejaculation caused by deficiency of both the heart and spleen were selected, with an average age of 32.4 years. The patients took the Shenlu Fuzheng Tablets described in Example 1, 3 times a day, 3 tablets each time, and each tablet was 0.35 g. One course of treatment was 10 days. After continuous use for 3 courses, the erectile function status of the patients was evaluated with the International Index of Erectile Function (IIEF-5), and the premature ejaculation status of the patients was evaluated with the intravaginal ejaculation latency time (IELT). The treatment conditions of the patients with impotence and premature ejaculation were statistically analyzed. The results are shown in Table 2 and Table 3.

[0095] Table 2 Treatment results of impotence and premature ejaculation cases

[0096] Grouping Judgment criteria Patient Cured (cases) With IIEF-5 ≥ 22 points and IELT ≥ 2 min 5 Markedly effective (cases) With IIEF-5 < 22 points but increased by 5 points or more compared with before and IELT significantly prolonged 18 Improved (cases) With IIEF-5 < 22 points but increased by 2 - 4 points compared with before and IELT slightly prolonged 5 Ineffective (cases) With IIEF-5 < 22 points but increased by ≤ 1 point or no increase or decrease compared with before and IELT not prolonged or shortened 2 Total effective (cases) Cured + Markedly effective + Improved 28

[0097] Table 3 Comparison of IIEF-5 and IELT evaluations before and after patients' medication

[0098] Time IIEF-5 / points IELT / min Before use 10.08±1.83 1.03±0.17 After use 19.97±1.94 5.82±0.21

[0099] The results showed that after 3 courses of taking Shenlu Fuzheng Tablets, the cure rate of patients with impotence and premature ejaculation caused by deficiency of both heart and spleen was 16.67%, the marked effective rate was 60%, the improvement rate was 16.67%, and the total effective rate was 93.33%. It shows that the Shenlu Fuzheng Tablets of the present invention can effectively treat impotence and premature ejaculation caused by deficiency of both heart and spleen, and no adverse reactions such as dry mouth and facial flushing occurred in the treated patients.

[0100] Experimental Example 3

[0101] Twenty patients with both hypertension and impotence and premature ejaculation were selected. Among them, 10 patients took Shenlu Fuzheng Tablets 30 minutes after taking antihypertensive drugs (benazepril), and the other 10 patients only took antihypertensive drugs. The results showed that no adverse reactions occurred in the 10 subjects who took antihypertensive drugs and Shenlu Fuzheng Tablets at the same time. Compared with the subjects who only took benazepril, the antihypertensive effect of the subjects who took Shenlu Fuzheng Tablets was better.

[0102] Twenty patients with both diabetes and impotence and premature ejaculation were selected. Among them, 10 patients took antidiabetic drugs (glibenclamide) before meals and Shenlu Fuzheng Tablets after meals, and the other 10 patients only took antidiabetic drugs (glibenclamide). The results showed that no adverse reactions occurred in the 10 subjects who took antidiabetic drugs and Shenlu Fuzheng Tablets at the same time. Compared with the subjects who only took glibenclamide, the hypoglycemic effect of the subjects who took Shenlu Fuzheng Tablets was slightly better.

[0103] Twenty patients with both arrhythmia and impotence and premature ejaculation were selected. Among them, 10 patients took Shenlu Fuzheng Tablets 30 minutes after taking antiarrhythmic drugs (metoprolol), and the other 10 patients only took antiarrhythmic drugs. The results showed that no adverse reactions occurred in the 10 subjects who took antiarrhythmic drugs and Shenlu Fuzheng Tablets at the same time. Compared with the subjects who only took metoprolol, there was no significant difference in the effect of treating arrhythmia in the subjects who took Shenlu Fuzheng Tablets, but the subjects who took Shenlu Fuzheng Tablets said that their sleep quality improved significantly and the symptoms of physical weakness were significantly reduced.

[0104] It can be seen from this that while effectively treating impotence and premature ejaculation caused by deficiency of both heart and spleen with Shenlu Fuzheng Tablets, it does not affect the therapeutic effect of other drugs, and when used in combination with drugs for treating hypertension, diabetes, and arrhythmia, it can effectively improve the effects of drugs for hypertension, diabetes, and arrhythmia.

[0105] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A preparation method of Shenlu Fuzheng tablets for treating impotence and premature ejaculation caused by deficiency of both heart and spleen, characterized in that, The Shenlu Fuzheng tablet is prepared from the following raw materials in parts by weight: 75 parts of ginseng, 150 parts of Rehmannia root, 75 parts of Eucommia bark, 150 parts of Lycium barbarum, 115 parts of Morinda officinalis, 75 parts of Achyranthes bidentata, 150 parts of Poria cocos, 75 parts of Hippophae rhamnoides, 113 parts of Fenugreek, 38 parts of Asparagus cochinchinensis, 150 parts of Schisandra chinensis, 113 parts of Acanthopanax acanthopanax, 150 parts of Cistanche deserticola, 38 parts of Deer Horn Glue, 75 parts of Dioscorea opposita, 38 parts of Ziziphus jujuba seeds, 113 parts of Morus alba, 37 parts of Atractylodes macrocephala, 115 parts of Scutellaria barbata, and 113 parts of Cat's Claw; The preparation method comprises the following steps: (1) Crush antler glue and ginseng; (2) Mix Schisandra chinensis and Atractylodes macrocephala with water and soak for 5 to 7 hours to extract the volatile oil and collect the residue; (3) mixing the medicinal residues and other components with water, boiling them, and collecting the decoction; (4) adding ethanol to the decoction, allowing it to stand, filtering, and collecting the filtrate; (5) removing ethanol from the filtrate to obtain a drug solution; (6) adding the crushed antler glue to the liquid medicine to dissolve, concentrate, spray dry, and crush into fine powder; (7) The fine powder obtained in step (6) is mixed with the crushed ginseng, granulated, dried, sprayed with the volatile oil obtained in step (2), tableted, coated, and obtained Shenlu Fuzheng Tablets.

2. The preparation method according to claim 1, characterized in that, In step (2), the Schisandra chinensis and Atractylodes macrocephala are mixed with water, and the amount of water used is 6 to 10 times the total mass of the Schisandra chinensis and Atractylodes macrocephala.

3. The preparation method according to claim 1, characterized in that, The extraction method in step (2) is distillation extraction, and the extraction time is 4 to 8 hours.

4. The preparation method according to claim 1, characterized in that, The amount of water used in step (3) is 6 to 12 times the total mass of the medicinal residue and other components.

5. The preparation method according to claim 1, wherein The number of decoctions in step (3) is 1 to 5 times, and the decoction time is 0.5 to 3 hours per time.

6. The preparation method according to claim 1, characterized in that, The standing time in step (4) is 10 to 14 hours.

7. The preparation method according to claim 1, characterized in that, The concentration method is reduced pressure concentration, the concentration temperature is 50-70° C., and the density after concentration is 1.0-1.

2.

8. The preparation method according to claim 1, wherein The drying method in step (7) is spray drying.

9. Use of Shenlu Fuzheng Tablets obtained by the preparation method according to any one of claims 1 to 8 in the preparation of a medicament for treating impotence and premature ejaculation caused by deficiency of both heart and spleen.

10. Use of the Shenlu Fuzheng tablets obtained by the preparation method according to any one of claims 1 to 8 in the preparation of medicaments for treating hypertension, diabetes, and arrhythmia, characterized in that, The Shenlu Fuzheng tablets are used as an auxiliary medicine.