Pharmaceutical composition for reinforcing kidney and producing sperms as well as preparation and application thereof

Abstract

The invention discloses a pharmaceutical composition for reinforcing the kidney and producing sperms as well as a preparation and application of the pharmaceutical composition for reinforcing the kidney and producing sperms. The traditional Chinese medicine composition is prepared from prepared rehmannia root, deer-horn glue, salted flatstem milkvetch seed, radix scrophulariae, radix rehmanniae recen, codonopsis pilosula, astragalus membranaceus, roasted astragalus membranaceus, fructus lycii, salted semen cuscutae, raspberry, wine-processed teasel root, salted eucommia ulmoides, roasted rhizoma polygonati, roasted rhizoma atractylodis macrocephalae, pericarpium citri reticulatae, poria cocos, longan aril, bran-fried Chinese yam, Chinese date, salted semen plantaginis, leonurus, salvia miltiorrhiza, centipede, ligusticum wallichii, caulis spatholobi, radix bupleuri, vinegar-processed schisandra chinensis and calcined dragon bone. The pharmaceutical composition for reinforcing kidney and producing sperm is added with pharmaceutically acceptable auxiliary materials to prepare a preparation. The pharmaceutical composition for reinforcing kidney and producing sperm and the preparation thereof can be used for preparing medicines for invigorating spleen and replenishing qi, promoting qi to activate blood, and tonifying kidney and producing sperm.

Description

Technical Field

[0001] The invention belongs to the field of medicines, and specifically relates to a medicine composition for strengthening the kidney and producing sperm, and a preparation and application thereof. Background Art

[0002] Men's diseases are common and frequent diseases in clinical practice, covering a wide range and with different harmfulness, such as male infertility, asthenospermia, impotence, premature ejaculation, etc., which have a lot of impact on patients' lives. Western medicine usually uses hormones, surgery and other methods for treatment, but the treatment effect is not ideal, the condition often recurs, and surgical treatment usually causes a certain degree of damage to the body, and the side effects of hormone treatment are very large, so some patients are unwilling to choose Western medicine treatment. Traditional Chinese medicine focuses on overall conditioning, treating both the symptoms and the root causes, and has obvious treatment advantages. Many patients are more willing to choose traditional Chinese medicine treatment, but the existing Chinese medicine formula has a slow effect, and it takes a period of accumulation to gradually produce an effect. Patients need to adhere to long-term medication to obtain satisfactory effects. In addition, Chinese medicine decoction is more troublesome and has a poor taste. Therefore, it is necessary to develop a medicine with significant efficacy, convenient taking and suitable taste. Summary of the invention

[0003] In view of the shortcomings of the prior art, the purpose of the present invention is to provide a kidney-strengthening and spermatogenesis-producing pharmaceutical composition and its preparation and application. The pharmaceutical composition of the present invention has the effects of strengthening the spleen and replenishing qi, promoting qi and blood circulation, and nourishing the kidney and producing spermatogenesis, with significant effects, safety and no side effects.

[0004] The objective of the present invention is achieved through the following technical solutions: A medicine composition for strengthening the kidney and producing spermatogenesis, comprising the following components by weight: 9-30 parts of Rehmannia root, 2-10 parts of antler glue, 8-30 parts of salt complanatus seeds, 9-30 parts of Scrophularia ningpoensis, 9-30 parts of raw Rehmannia root, 9-50 parts of Codonopsis pilosula, 9-60 parts of Astragalus, 9-60 parts of roasted Astragalus, 10-30 parts of Lycium barbarum, 6-20 parts of salt Cuscuta seed, 6-20 parts of Rubus idaeus, 9-20 parts of Dipsacus asper, 10-30 parts of salt Eucommia ulmoides, roasted Rhizoma Rhizoma 9-30 parts of celery, 10-30 parts of stir-fried Atractylodes macrocephala, 5-20 parts of dried tangerine peel, 10-30 parts of Poria cocos, 9-30 parts of longan meat, 15-60 parts of stir-fried yam with bran, 10-30 parts of jujube, 9-30 parts of salt plantain seeds, 9-30 parts of motherwort, 10-30 parts of salvia miltiorrhiza, 0.5-2 parts of centipede, 10-20 parts of Chuanxiong, 15-30 parts of Millettia reticulata, 6-30 parts of bupleurum, 3-15 parts of vinegar Schisandra chinensis, and 10-120 parts of calcined dragon bone.

[0005] Preferably, the medicinal composition for strengthening the kidney and producing spermatogenesis is composed of the following components by weight: 10-15 parts of Rehmannia root, 3-6 parts of antler glue, 10-15 parts of salt complanatus seeds, 15-20 parts of Scrophularia ningpoensis, 10-15 parts of raw Rehmannia root, 15-30 parts of Codonopsis pilosula, 15-30 parts of Astragalus, 15-30 parts of roasted Astragalus, 20-30 parts of Lycium barbarum, 10-15 parts of salt Cuscuta seed, 10-15 parts of Rubus idaeus, 10-15 parts of wine Dipsacus asper, 10-15 parts of salt Eucommia ulmoides 10-15 parts, roasted polygonatum, 10-15 parts, stir-fried atractylodes, 10-15 parts, tangerine peel, 10-15 parts, poria, 10-15 parts, longan meat, 15-30 parts of fried yam with bran, 10-15 parts of jujube, 10-15 parts of salt plantain seeds, 10-15 parts of motherwort, 10-20 parts of salvia miltiorrhiza, 1-1.5 parts of centipede, 10-15 parts of chuanxiong, 15-30 parts of millettia reticulata, 10-15 parts of bupleurum, 5-10 parts of vinegar schisandra chinensis, and 15-30 parts of calcined dragon bone.

[0006] More preferably, the pharmaceutical composition for strengthening the kidney and producing sperm is composed of the following components by weight: 15 parts of Rehmannia glutinosa, 6 parts of antler glue, 30 parts of salt Astragalus, 15 parts of Scrophularia, 15 parts of Rehmannia glutinosa, 30 parts of Codonopsis pilosula, 30 parts of Astragalus, 30 parts of roasted Astragalus, 30 parts of Lycium barbarum, 15 parts of salt Cuscuta chinensis, 15 parts of Rubus idaeus, 15 parts of wine Dipsacus asper, 15 parts of salt Eucommia, 10 parts of roasted Polygonatum, 15 parts of stir-fried Atractylodes macrocephala, 10 parts of dried tangerine peel, 15 parts of Poria, 15 parts of longan meat, 15 parts of stir-fried yam with bran, 10 parts of jujube, 10 parts of salt Plantago, 15 parts of Leonurus japonicus, 20 parts of Salvia miltiorrhiza, 1 part of Scolopendra, 10 parts of Ligusticum chuanxiong, 15 parts of Millettia reticulata, 10 parts of Bupleurum, 6 parts of vinegar Schisandra chinensis, and 30 parts of calcined dragon bones.

[0007] In the pharmaceutical composition described in the present invention, Radix Rehmanniae Preparata, Glutinosa antlers, and Semen Astragali warm the yang, nourish the kidney, and produce essence; Scrophularia ningpoensis and Radix Rehmanniae cool the blood, nourish the blood, and nourish the yin and nourish the kidney; Codonopsis pilosula invigorates the spleen and replenishes qi, Astragalus invigorates the spleen, eliminates dampness, and reduces swelling, and Roasted Radix Astragali replenishes qi and nourishes blood, replenishes qi and blood, and metal and water coexist, and they are all monarch drugs, which play the role of replenishing the spleen and kidney qi and blood, replenishing the innate, and seeking yang in the yin; Raw and roasted Astragalus, raw and cooked Rehmanniae are used together to highlight the replenishment of qi and kidney, while replenishing without being greasy or dry. Lycium barbarum, Semen Cuscutae, and Rubus idaeus assist in nourishing kidney yin; Dipsacus asper, Eucommia ulmoides, and Roasted Polygonatum assist in warming and nourishing kidney yang; Stir-fried Atractylodes macrocephala, dried tangerine peel, Poria, Longan meat, Braised Chinese yam, and jujube assist in strengthening the spleen and replenishing qi, and they are all minister drugs, which assist the monarch drug in further enhancing the function of strengthening the spleen and replenishing qi, and nourishing the kidney and producing essence. Auxiliary drugs: Salt Plantago, Motherwort, Salvia, Scolopendra, Chuanxiong, Millettia reticulata can eliminate dampness and relieve stranguria, promote blood circulation and dredge collaterals, nourish without stagnation, and harmonize qi and blood; Bupleurum can soothe the liver and relieve depression, while Vinegar Schisandrae Chinensis and Calcined Dragon Bone can calm the mind, consolidate essence and stop nocturnal emission, and play the role of water and fire. Auxiliary drugs eliminate the accompanying symptoms of the main diseases such as dampness, depression, and stasis, laying a good foundation for regulating qi and blood and nourishing the liver and kidneys. The above drugs are used together to benefit the acquired constitution and strengthen the innate constitution, regulate qi and blood, and play the role of strengthening the spleen and replenishing qi, promoting qi and activating blood circulation, and nourishing the kidneys and producing essence.

[0008] The kidney-strengthening and sperm-producing medicinal composition can also be added with pharmaceutically acceptable excipients to be made into preparations such as ointments, Chinese medicine mixtures, granules, pills, etc.

[0009] The medicinal composition for strengthening the kidney and producing sperm and its preparation have the effects of strengthening the spleen and replenishing qi, promoting qi and activating blood circulation, and nourishing the kidney and producing sperm, and are used for soreness of waist and knees, impotence, premature ejaculation, fatigue and forgetfulness, oligospermia and weak sperm due to spleen and kidney deficiency.

[0010] Compared with the prior art, the present invention has the following beneficial effects: 1. The kidney-strengthening and spermatogenesis-producing medicinal composition and preparation thereof of the present invention have significant clinical efficacy and are easy to take.

[0011] 2. The kidney-strengthening and sperm-producing medicinal composition and preparation thereof described in the present invention, combined with the diagnosis and treatment of clinical patients and the pathogenesis, pay more attention to the stability of the body's yin and yang, qi and blood, and use both attacking and supplementing methods. It can not only improve sperm motility, but also regulate internal energy balance, thereby improving sexual function.

[0012] 3. The kidney-strengthening and sperm-producing medicinal composition and preparation thereof of the present invention have mild medicinal properties and are nourishing but not greasy or dry. After the course of treatment, the patient has no obvious adverse reactions and will not develop drug dependence.

[0013] 4. The kidney-strengthening and sperm-producing medicinal composition and preparation thereof described in the present invention can be widely used for male infertility and asthenospermia, asthenospermia, fatigue, low back pain, sexual dysfunction, etc., and have good therapeutic effects.

[0014] 5. The preparation of the kidney-strengthening and spermatogenesis-producing medicinal composition of the present invention is easy to use, has a very good taste, and has better compliance with the patients. DETAILED DESCRIPTION

[0015] The present invention will be further described below in conjunction with embodiments, but the present invention is not limited to the embodiments. Example 1

[0016] A medicinal composition for strengthening the kidney and producing sperm, comprising the following components: 15g of Rehmannia root, 6g of antler glue, 30g of salt Astragalus, 15g of Scrophularia, 15g of Raw Rehmannia root, 30g of Codonopsis pilosula, 30g of Astragalus, 30g of roasted Astragalus, 30g of Lycium barbarum, 15g of Salt Cuscuta seed, 15g of Rubus idaeus, 15g of Dipsacus asper, 15g of Salt Eucommia, 10g of roasted Polygonatum, 15g of stir-fried Atractylodes macrocephala, 10g of dried tangerine peel, 15g of Poria, 15g of Longan pulp, 15g of stir-fried Chinese yam with bran, 10g of jujube, 10g of Salt Plantago seed, 15g of Leonurus japonicus, 20g of Salvia miltiorrhiza, 1g of Scolopendra, 10g of Ligusticum chuanxiong, 15g of Millettia reticulata, 10g of Bupleurum yunnanensis, 6g of Vinegar Schisandra chinensis, and 30g of calcined dragon bone. Example 2

[0017] A medicinal composition for strengthening the kidney and producing sperm, comprising the following components: 9g of Rehmannia root, 2g of antler glue, 8g of salt Astragalus, 9g of Scrophularia, 9g of Raw Rehmannia root, 9g of Codonopsis pilosula, 9g of Astragalus, 9g of roasted Astragalus, 10g of Lycium barbarum, 6g of Salt Cuscuta seed, 6g of Rubus idaeus, 9g of Dipsacus asper, 10g of Salt Eucommia, 9g of roasted Polygonatum, 10g of stir-fried Atractylodes macrocephala, 5g of Tangerine peel, 10g of Poria, 9g of Longan meat, 15g of stir-fried Chinese yam with bran, 10g of jujube, 9g of Salt Plantago seed, 9g of Leonurus japonicus, 10g of Salvia miltiorrhiza, 0.5g of Scolopendra, 10g of Chuanxiong, 15g of Millettia reticulata, 6g of Bupleurum yunnanensis, 3g of Vinegar Schisandra chinensis, and 10g of calcined dragon bone. Example 3

[0018] A medicinal composition for strengthening the kidney and producing sperm, comprising the following components: 30g of Rehmannia root, 10g of antler glue, 30g of salt Astragalus, 30g of Scrophularia, 30g of Rehmannia root, 50g of Codonopsis, 60g of Astragalus, 60g of roasted Astragalus, 30g of Lycium barbarum, 20g of Salt Cuscuta seed, 20g of Rubus idaeus, 20g of Dipsacus asper, 30g of salt Eucommia, 30g of roasted Polygonatum, 30g of stir-fried Atractylodes, 20g of Tangerine peel, 30g of Poria, 30g of Longan meat, 60g of stir-fried Chinese yam with bran, 30g of jujube, 30g of salt Plantago seed, 30g of Leonurus, 30g of Salvia miltiorrhiza, 2g of Scolopendra, 20g of Chuanxiong, 30g of Millettia reticulata, 30g of Bupleurum, 15g of Vinegar Schisandra chinensis, and 120g of calcined dragon bone. Example 4

[0019] A medicinal composition for strengthening the kidney and producing sperm, comprising the following components: 9g of Rehmannia root, 2g of antler glue, 30g of salt Astragalus, 15g of Scrophularia, 10g of Rehmannia root, 9g of Codonopsis pilosula, 45g of Astragalus, 30g of roasted Astragalus, 30g of Lycium barbarum, 10g of salt Cuscuta seed, 6g of Rubus idaeus, 18g of wine Dipsacus asper, 30g of salt Eucommia, 25g of roasted Polygonatum, 20g of stir-fried Atractylodes macrocephala, 15g of dried tangerine peel, 20g of Poria, 10g of longan pulp, 40g of stir-fried yam with bran, 30g of jujube, 9g of salt Plantago seed, 15g of Leonurus japonicus, 15g of Salvia miltiorrhiza, 1.2g of Scolopendra, 10g of Chuanxiong, 30g of Millettia reticulata, 10g of Bupleurum, 10g of vinegar Schisandra chinensis, and 90g of calcined dragon bone. Example 5

[0020] A medicinal composition for strengthening the kidney and producing sperm, comprising the following components: 10g of Rehmannia root, 3g of antler glue, 8g of salt Astragalus, 20g of Scrophularia, 15g of Rehmannia root, 15g of Codonopsis pilosula, 60g of Astragalus, 45g of roasted Astragalus, 10g of Lycium barbarum, 13g of Salt Cuscuta seed, 10g of Rubus idaeus, 20g of Dipsacus asper, 10g of Salt Eucommia, 30g of roasted Polygonatum, 25g of stir-fried Atractylodes macrocephala, 20g of Tangerine peel, 25g of Poria, 15g of Longan pulp, 50g of stir-fried Chinese yam with bran, 10g of jujube, 10g of Salt Plantago seed, 25g of Leonurus japonicus, 20g of Salvia miltiorrhiza, 1.5g of Scolopendra, 12g of Chuanxiong, 15g of Millettia reticulata, 15g of Bupleurum yunnanensis, 15g of Vinegar Schisandra chinensis, and 120g of calcined dragon bone. Example 6

[0021] A medicinal composition for strengthening the kidney and producing sperm, comprising the following components: 15g of Rehmannia root, 6g of antler glue, 10g of salt Astragalus, 25g of Scrophularia, 25g of Rehmannia root, 30g of Codonopsis, 9g of Astragalus, 60g of roasted Astragalus, 15g of Lycium barbarum, 15g of salt Cuscuta seed, 12g of Rubus idaeus, 9g of wine Dipsacus asper, 15g of salt Eucommia, 9g of roasted Polygonatum, 30g of stir-fried Atractylodes, 5g of dried orange peel, 30g of Poria, 25g of Longan pulp, 60g of stir-fried Chinese yam with bran, 15g of jujube, 15g of salt Plantago seed, 30g of Leonurus japonicus, 25g of Salvia miltiorrhiza, 2g of Scolopendra, 15g of Ligusticum chuanxiong, 20g of Millettia reticulata, 25g of Bupleurum yunnanensis, 3g of vinegar Schisandra chinensis, and 10g of calcined dragon bone. Example 7

[0022] A medicinal composition for strengthening the kidney and producing sperm, comprising the following components: 25g of Rehmannia root, 8g of antler glue, 15g of salt Astragalus, 30g of Scrophularia, 30g of Raw Rehmannia root, 40g of Codonopsis pilosula, 15g of Astragalus, 9g of roasted Astragalus, 20g of Lycium barbarum, 20g of Salt Cuscuta seed, 15g of Rubus idaeus, 10g of Dipsacus asper, 20g of Salt Eucommia, 10g of roasted Polygonatum, 10g of stir-fried Atractylodes macrocephala, 10g of Tangerine peel, 10g of Poria, 30g of Longan pulp, 15g of stir-fried Chinese yam with bran, 20g of jujube, 25g of Salt Plantago seed, 9g of Leonurus japonicus, 30g of Salvia miltiorrhiza, 0.5g of Scolopendra, 18g of Chuanxiong, 23g of Millettia reticulata, 30g of Bupleurum yunnanensis, 5g of Vinegar Schisandra chinensis, and 15g of calcined dragon bone. Example 8

[0023] A medicinal composition for strengthening the kidney and producing sperm, comprising the following components: 30g of Rehmannia root, 10g of antler glue, 20g of salt Astragalus, 9g of Scrophularia, 9g of Rehmannia root, 50g of Codonopsis pilosula, 30g of Astragalus, 15g of roasted Astragalus, 25g of Lycium barbarum, 6g of Salt Cuscuta seed, 20g of Rubus idaeus, 15g of Dipsacus asper, 25g of Salt Eucommia, 20g of roasted Polygonatum, 15g of stir-fried Atractylodes macrocephala, 12g of dried tangerine peel, 15g of Poria, 9g of Longan pulp, 30g of stir-fried Chinese yam with bran, 25g of jujube, 30g of Salt Plantago seed, 10g of Leonurus japonicus, 10g of Salvia miltiorrhiza, 1g of Scolopendra subspinipes, 20g of Chuanxiong, 25g of Millettia reticulata, 6g of Bupleurum, 6g of Vinegar Schisandra chinensis, and 30g of calcined dragon bone. Example 9

[0024] A medicinal composition for strengthening the kidney and producing sperm, comprising the following components: 15g of Rehmannia root, 6g of antler glue, 15g of salt Astragalus, 20g of Scrophularia, 15g of Raw Rehmannia root, 30g of Codonopsis pilosula, 30g of Astragalus, 30g of roasted Astragalus, 20g of Lycium barbarum, 13g of Salt Cuscuta seed, 12g of Rubus idaeus, 15g of Wine Dipsacus, 20g of Salt Eucommia, 20g of roasted Polygonatum, 20g of Stir-fried Atractylodes macrocephala, 12g of Tangerine peel, 20g of Poria, 15g of Longan pulp, 40g of stir-fried Chinese yam with bran, 20g of jujube, 15g of Salt Plantago seed, 15g of Leonurus japonicus, 20g of Salvia miltiorrhiza, 1.2g of Scolopendra, 15g of Chuanxiong, 23g of Millettia reticulata, 15g of Bupleurum, 6g of Vinegar Schisandra chinensis, and 30g of calcined dragon bone. Example 10

[0025] An ointment of a medicine composition for strengthening the kidney and producing sperm is prepared by weighing medicinal materials according to the weight of the medicine composition described in any one of Examples 1 to 9 and following the steps below: (1) Soaking: Place all medicines except deer antler glue into a container, add water to soak them, and allow them to fully absorb and swell. Then add more water to a height of about 10 cm above the surface of the medicine and soak for 24 hours.

[0026] (2) Decoction: Decoction the soaked herbs. First boil over high heat, then simmer over low heat for about 1 hour, then turn to low heat and boil for about 3 hours. At this time, the medicinal juice becomes thicker and can be filtered out with gauze. Soak the residue in water and then decoct. The decoction method is the same as before. This is the second decoction. When the third decoction is reached, filter out the medicinal juice and discard the residue (if the medicinal juice is still thick, it can be decocted once more). Mix the medicinal juices obtained from the three decoctions, let it stand, and then filter it out after settling.

[0027] (3) Concentration: To concentrate the filtered medicinal juice, you can first boil it over high heat to accelerate the evaporation of water, and skim off the foam at any time to allow the medicinal juice to slowly become thick. Then use low heat to further concentrate it. At this time, you should stir it constantly, because the medicinal juice will easily stick to the bottom and burn when it becomes thick. Continue stirring until the medicinal juice drops on paper without dispersing. This is the concentrated clear paste.

[0028] (4) Collecting the paste: Pour the melted deer antler glue and sugar (preferably rock sugar and honey) into the clear paste in a weight ratio of 1 to 5:3. Slowly simmer over low heat, stirring constantly with a spatula, until it can be pulled into flags or drop into beads (drop the paste into clear water to condense into beads without dispersing).

[0029] (5) Storage: After the paste has cooled, put it into a clean porcelain container. Cover the container with clean gauze without covering it. Leave it overnight. After it has completely cooled, cover it and place it in a cool place.

[0030] Application Example 1 - Observation on the therapeutic effect of the preparation of the kidney-strengthening and sperm-producing pharmaceutical composition of the present invention on male erectile dysfunction (ED) 1. Observation object In order to explore the clinical effectiveness and safety of the pharmaceutical composition of the present invention in treating ED, a comparative study on its safety and effectiveness was conducted using a control trial.

[0031] The subjects were 130 ED patients treated in the men's department of our hospital, aged 20-60 years, with a disease course of 3 months to 6 years. The patients gave their informed consent to this study. To ensure sample balance, IIEF-5 scores were performed before the study, and the patients were randomly assigned to the treatment group and the control group in a 1:1 ratio according to the random number table method. There was no statistical difference between the two groups in terms of age, disease course, and condition score ( P >0.05), which are comparable, see Table 1.

[0032]

[0033] Inclusion criteria: ①IIEF-5 score between 5 and 21 points; ②age range 20-60 years old; ③normal genitalia and secondary sexual characteristics; ④having a stable sexual partner for more than 6 months; ⑤having good compliance and being able to complete follow-up observations.

[0034] Exclusion criteria: ① patients with anatomical deformity of the penis; ② patients taking other clinical drugs, such as hypoglycemic drugs and psychotropic drugs; ③ patients with severe hypertension, hyperlipidemia, atherosclerosis, diabetes and other diseases that can cause ED; ④ patients with traumatic damage or nerve damage to the penis; ⑤ patients with drug allergies; ⑥ patients who fail to take medication according to the course of treatment.

[0035] 2. Methods 2.1 Treatment methods Treatment group: Take the ointment prepared by the method described in Example 10 and the pharmaceutical composition described in Example 1 orally, 20 g each time, three times a day, for a course of 6 weeks, and observe the efficacy of one course of treatment.

[0036] Control group: Orally take Compound Xuanju Capsule, 3 capsules each time, three times a day, for a course of 6 weeks, and observe the efficacy of one course of treatment.

[0037] Observation indicators: The IIEF-5 score results were used as indicators for ED grouping and efficacy evaluation. The IIEF-5 score standard classification: 22-25 points for normal penile erection, 12-21 points for mild erectile dysfunction, 8-11 points for moderate erectile dysfunction, and 5-7 points for severe erectile dysfunction.

[0038] Efficacy = (score after treatment - score before treatment) / score before treatment × 100%.

[0039] Recovery after treatment: IIEF-5 score>22 points; marked effect: increase of more than 50%; effective: increase of 25-50%; ineffective: increase of <25%.

[0040] Total effective rate (%) = (cured + markedly effective + effective) / total number of cases × 100%.

[0041] At the same time, changes in liver and kidney function and adverse reactions were monitored before and after treatment.

[0042] 2.2 Observations Since 3 patients in the treatment group did not take the medicine according to the course of treatment and 2 patients took other drugs, after exclusion according to the exclusion criteria, 60 cases were effectively evaluated. In the control group, 2 patients stopped taking the medicine on their own and 4 patients took other drugs on their own at the same time. After exclusion according to the exclusion criteria, 59 cases were effectively evaluated. No adverse reactions were observed during the medication period, and there was no significant change in liver and kidney function monitoring before and after medication.

[0043] After one course of observation, in the control group, 2 cases were cured, 9 cases were significantly effective, 33 cases were effective, 15 cases were ineffective, and the total effective rate was 74.57%; in the treatment group, 3 cases were clinically cured, 14 cases were significantly effective, 35 cases were effective, 8 cases were ineffective, and the total effective rate was 86.67%. The total effective rate of the treatment group was significantly higher than that of the control group, as shown in Table 2.

[0044]

[0045] The scores of both groups of patients improved after treatment, and the improvement in the treatment group was more significant than that in the control group, and the difference was statistically significant ( P <0.05), see Table 3.

[0046]

[0047] The results show that the pharmaceutical composition of the present invention can effectively treat male erectile dysfunction (ED), significantly improve symptoms, and has no adverse reactions.

[0048] Application Example 2 - Case 1. Liu, male, 33 years old, has not taken any contraceptive measures for 2 years and has not conceived. He came to our hospital for treatment in the Department of Andrology on June 4, 2023. He had no obvious discomfort in the whole body and no special physical examination. The semen analysis showed normal density and morphology, PR: 12.3%, and activity rate: 31%. He took the ointment prepared by the method described in Example 10 of the pharmaceutical composition described in Example 5 orally, 20 g each time, three times a day. After 3 months, the semen analysis was reviewed: PR: 46.2%, and activity rate: 63.1%.

[0049] 2. Guo, male, 38 years old, has not taken any contraceptive measures for 1 year and has not conceived. He went to our hospital for treatment in the Department of Andrology on May 28, 2024. He had no obvious discomfort in the whole body and no special physical examination. The semen analysis showed normal density and morphology, PR: 24.8%, and activity rate: 33.1%. He took the ointment prepared by the method described in Example 10 of the pharmaceutical composition described in Example 2 orally, 20 g each time, three times a day. On July 4, 2024, the semen analysis was reviewed: PR: 37.5%, and activity rate: 50.4%.

[0050] 3. Lv, male, 40 years old, has not used contraceptives for 1 year and has not conceived. He came to our hospital for treatment in the Department of Andrology on March 10, 2024. He had no obvious discomfort and no special physical examination. Semen analysis: density 19.61×10 6 / mL, PR: 10.69%, activity rate: 12.96%. Oral administration of the ointment prepared by the method described in Example 10 of the pharmaceutical composition described in Example 9, 20 g each time, three times a day. Semen analysis was reviewed on July 7, 2024: density 48×10 6 / mL, PR: 35.6%, activity rate: 45.7%.

Claims

1. A medicinal composition for strengthening the kidney and producing sperm, characterized in that: The composition is composed of the following components by weight: 9-30 parts of Rehmannia glutinosa, 2-10 parts of antler glue, 8-30 parts of salted Astragalus, 9-30 parts of Scrophularia, 9-30 parts of Raw Rehmannia, 9-50 parts of Codonopsis, 9-60 parts of Astragalus, 9-60 parts of roasted Astragalus, 10-30 parts of Lycium barbarum, 6-20 parts of salted Cuscuta, 6-20 parts of Rubus idaeus, 9-20 parts of Dipsacus asper, 10-30 parts of salted Eucommia, 9-30 parts of roasted Polygonatum. , fried Atractylodes macrocephala 10-30 parts, tangerine peel 5-20 parts, Poria cocos 10-30 parts, longan meat 9-30 parts, fried yam with bran 15-60 parts, jujube 10-30 parts, salt plantain seeds 9-30 parts, motherwort 9-30 parts, Salvia miltiorrhiza 10-30 parts, centipede 0.5-2 parts, Chuanxiong 10-20 parts, Millettia reticulata 15-30 parts, Bupleurum 6-30 parts, vinegar Schisandra chinensis 3-15 parts, calcined dragon bone 10-120 parts.

2. The medicinal composition for strengthening the kidney and producing sperm according to claim 1, characterized in that: The invention is composed of the following components by weight: 10-15 parts of Rehmannia root, 3-6 parts of antler glue, 10-15 parts of salted Complanatus chinensis, 15-20 parts of Scrophularia ningpoensis, 10-15 parts of raw Rehmannia root, 15-30 parts of Codonopsis pilosula, 15-30 parts of Astragalus, 15-30 parts of roasted Astragalus, 20-30 parts of Lycium barbarum, 10-15 parts of salted Cuscuta seed, 10-15 parts of Rubus idaeus, 10-15 parts of wine Dipsacus asper, 10-15 parts of salted Eucommia ulmoides, 10-15 parts of roasted Polygonatum sibiricum. 15 parts, stir-fried Atractylodes macrocephala 10-15 parts, dried tangerine peel 10-15 parts, Poria cocos 10-15 parts, longan meat 10-15 parts, fried yam with bran 15-30 parts, jujube 10-15 parts, salt plantain seeds 10-15 parts, motherwort 10-15 parts, salvia miltiorrhiza 10-20 parts, centipede 1-1.5 parts, chuanxiong 10-15 parts, Millettia reticulata 15-30 parts, bupleurum 10-15 parts, vinegar Schisandra chinensis 5-10 parts, calcined dragon bone 15-30 parts.

3. The medicinal composition for strengthening the kidney and producing sperm according to claim 2, characterized in that: The invention is composed of the following components by weight: 15 parts of Rehmannia root, 6 parts of antler glue, 30 parts of salt Astragalus, 15 parts of Scrophularia, 15 parts of Rehmannia root, 30 parts of Codonopsis, 30 parts of Astragalus, 30 parts of roasted Astragalus, 30 parts of Lycium barbarum, 15 parts of salt Cuscuta, 15 parts of Rubus idaeus, 15 parts of wine Dipsacus asper, 15 parts of salt Eucommia, 10 parts of roasted Polygonatum, 15 parts of stir-fried Atractylodes, 10 parts of dried orange peel, 15 parts of Poria, 15 parts of longan meat, 15 parts of stir-fried yam with bran, 10 parts of jujube, 10 parts of salt Plantago, 15 parts of Leonurus, 20 parts of Salvia miltiorrhiza, 1 part of Scolopendra, 10 parts of Ligusticum chuanxiong, 15 parts of Millettia reticulata, 10 parts of Bupleurum, 6 parts of vinegar Schisandra chinensis, and 30 parts of calcined dragon bones.

4. The preparation of the medicinal composition for strengthening the kidney and producing spermatogenesis according to any one of claims 1 to 3, characterized in that: The preparation is prepared by adding pharmaceutically acceptable excipients to the kidney-strengthening and sperm-producing medicinal composition.

5. The preparation of the medicinal composition for strengthening the kidney and producing sperm according to claim 4, characterized in that: The preparation is a paste.

6. The method for preparing the ointment of the medicinal composition for strengthening the kidney and producing spermatogenesis according to claim 5, characterized in that: The following steps are involved: (1) Soaking: Except for deer antler glue, soak other drugs in water to allow them to fully absorb and swell, then soak in water again; (2) Decoction: Boil the soaked herbs over high heat, then simmer over low heat for 1 hour, then simmer over low heat for 3 hours, filter, soak the residue in water and decoct again. Repeat the decocting method 2-3 times, combine the juice, let it stand, and then filter. (3) Concentration: Concentrate the filtered medicinal juice by first boiling it over high heat, skimming off the foam at any time, and letting the medicinal juice slowly become thick. Then, use low heat to further concentrate it until the medicinal juice does not disperse when dropped on paper. This is the clear paste. (4) Make the paste: Pour the melted deer antler glue and sugar into the clear paste, and simmer over low heat, stirring constantly, until it can be pulled into flags or dripped into beads. (5) Storage: After the paste has cooled, put it into a container without covering it. Cover the mouth of the container with clean gauze. After it has completely cooled, cover it and store it in a cool place.

7. The method for preparing the ointment of the medicinal composition for strengthening the kidney and producing sperm according to claim 6, characterized in that: The weight ratio of deer antler glue to sugar is 1~5:

3.

8. Use of the kidney-strengthening and spermatogenesis-producing pharmaceutical composition according to any one of claims 1 to 3, characterized in that: The medicinal composition for strengthening the kidney and producing sperm is used in preparing medicines for strengthening the spleen and replenishing qi, promoting qi and activating blood circulation, and nourishing the kidney and producing sperm.

9. The use of the preparation of the kidney-strengthening and spermatogenesis-producing pharmaceutical composition according to claim 4, characterized in that: The preparation of the medicinal composition for strengthening the kidney and producing sperm is used in the preparation of medicines for strengthening the spleen and replenishing qi, promoting qi and activating blood circulation, and nourishing the kidney and producing sperm.

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