A cream for warming the kidney and consolidating essence and its preparation method

Abstract

The present invention provides a cream for warming the kidney and consolidating essence, and a preparation method thereof. The cream comprises the following raw materials in parts by weight: 1.5-2.5 parts of ginseng, 1.5-2.5 parts of epimedium, 1.5-2.5 parts of cistanche deserticola, 0.8-1.2 parts of ganoderma lucidum extract, 3.5-4.5 parts of Uncaria rhynchophylla extract, 2.3-3.2 parts of gentiana macrophylla extract, 0.4-0.6 parts of hyaluronic acid, 0.4-0.6 parts of hydrolyzed collagen, 0.4-0.6 parts of glycerin, 1.5-2.0 parts of allantoin, 1.2-1.8 parts of coenzyme Q10, 1-1.5 parts of arginine, and 78-82 parts of water. The present invention uses ginseng, epimedium and cistanche as raw materials to extract effective active ingredients, adds the ganoderma lucidum extract, Uncaria rhynchophylla extract and Gentiana macrophylla extract prepared by the present invention, and adds a certain amount of allantoin, coenzyme Q10 and arginine, and supplements with hyaluronic acid, hydrolyzed collagen, glycerol and the like in preferred dosage ratios. The prepared cream effectively promotes the penetration and absorption of the active ingredients, accelerates the repair of corpus cavernosum cells, has the effects of strengthening kidney yang and replenishing essence, and better and more effectively improves erectile dysfunction.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical preparations, in particular to a cream for warming the kidney and consolidating essence and a preparation method thereof. Background Art

[0002] Erectile dysfunction (ED) is the most common type of male sexual dysfunction. ED has a significant impact on men's physical and mental health and quality of life. First, erectile dysfunction may lead to a decrease in men's self-confidence and affect their quality of life. Second, erectile dysfunction is an early symptom and warning sign of some cardiovascular diseases. For example, cardiovascular diseases such as coronary heart disease, hypertension, and diabetes are all related to vascular lesions, and erectile dysfunction is also caused by vascular lesions. Therefore, improving erectile dysfunction can prevent the occurrence of some cardiovascular diseases. In summary, improving erectile dysfunction is very necessary. It can not only improve men's physical and mental health and quality of life, but also prevent the occurrence of some cardiovascular diseases.

[0003] Treatments for erectile dysfunction (ED) are available in a variety of dosage forms, including oral preparations, topical creams, and injections. Oral preparations are the most common and convenient form of medication, but they place a certain burden on the liver and often have side effects. Injectable preparations, administered via intracavernous injection, have the advantage of rapid onset of action, but require multiple injections and are painful, resulting in low patient acceptance and significant side effects.

[0004] Topical creams are applied topically for treatment. Their advantages include reducing the burden of oral medications on the liver, avoiding the first-pass effect, and being relatively safe. However, commercially available topical creams generally offer suboptimal results. Therefore, there is an urgent need for a new cream to address these issues. Summary of the Invention

[0005] In view of this, the present invention provides a cream for warming the kidney and consolidating semen and a preparation method thereof, which can better improve erectile dysfunction.

[0006] The technical solution of the present invention is achieved as follows:

[0007] A cream for warming the kidney and consolidating essence comprises the following raw materials in parts by weight: 1.5-2.5 parts of ginseng, 1.5-2.5 parts of epimedium, 1.5-2.5 parts of cistanche deserticola, 0.8-1.2 parts of ganoderma lucidum extract, 3.5-4.5 parts of uncaria rhynchophylla extract, 2.3-3.2 parts of gentiana macrophylla extract, 0.4-0.6 parts of hyaluronic acid, 0.4-0.6 parts of hydrolyzed collagen, 0.4-0.6 parts of glycerin, 1.5-2.0 parts of allantoin, 1.2-1.8 parts of coenzyme Q10, 1-1.5 parts of arginine, and 78-82 parts of water.

[0008] Furthermore, the cream for warming the kidney and consolidating essence includes the following raw materials in parts by weight: 2 parts of ginseng, 2 parts of epimedium, 2 parts of Cistanche deserticola, 1 part of Ganoderma lucidum extract, 4 parts of Uncaria rhynchophylla extract, 3 parts of Gentiana macrophylla extract, 0.5 parts of hyaluronic acid, 0.5 parts of hydrolyzed collagen, 0.5 parts of glycerin, 1.8 parts of allantoin, 1.5 parts of coenzyme Q10, 1.2 parts of arginine, and 80 parts of water.

[0009] Furthermore, the preparation method of the Ganoderma lucidum extract includes the following steps: taking the fruiting body of Ganoderma lucidum (Leyss. Ex Fr.) Karst., crushing it, adding purified water according to a solid-liquid ratio of 1:50-100 g / ml, and then adding a complex enzyme of 1%-2% by weight of the Ganoderma lucidum, wherein the complex enzyme is composed of cellulase and snailase in a mass ratio of 1:2-3, and ultrasonicating at a power of 350-400W and 38-42°C for 20-30 minutes to obtain the Ganoderma lucidum extract.

[0010] Furthermore, the preparation method of the Uncaria rhynchophylla extract includes the following steps: taking the hooked stems and branches of Uncaria rhynchophylla (Miq.) Jacks., crushing them, adding 45%-55% v / v ethanol solution according to a solid-liquid ratio of mg / ml 1:7-8, soaking for 0.8-1.2 hours, heating and refluxing at 80-85°C for 2-3 times, each time for 0.8-1.2 hours, combining the extracts, filtering, concentrating the filtrate under reduced pressure, and freeze-drying to obtain the Uncaria rhynchophylla extract.

[0011] Furthermore, the preparation method of the gentiana macrophylla extract includes the following steps: taking the root of gentiana macrophylla (Gentianamacrophylla Pall.), crushing it, adding 65%-70% v / v ethanol solution according to the solid-liquid ratio mg / ml 1:9-11, soaking it for 0.8-1.2 hours, heating and refluxing it at 80-85°C for 2-3 times, each time for 0.8-1.2 hours, combining the extracts, filtering, concentrating the filtrate under reduced pressure, and freeze-drying it to obtain the gentiana macrophylla extract.

[0012] The preparation method of the cream for warming the kidney and consolidating essence of the present invention comprises the following steps: firstly taking Chinese medicinal materials of ginseng, epimedium and cistanche deserticola, washing them, decocting them in water for 1-2 hours, letting them stand, filtering them to obtain a medicinal liquid, and concentrating them into an extract to obtain a Chinese medicinal extract; mixing the Chinese medicinal extract and a ganoderma lucidum extract, an Uncaria rhynchophylla extract and a gentiana macrophylla extract with 40%-60% of water by weight, stirring them at 200-300 rpm and 30-40° C. for 20-40 minutes, then adding hyaluronic acid, hydrolyzed collagen, glycerin and the balance of water, performing a first homogenization, and finally adding allantoin, coenzyme Q10 and arginine, and performing a second homogenization to obtain the cream.

[0013] Furthermore, the first homogenization conditions are: homogenization pressure 0.5-1MPa, homogenization temperature 40-50°C, and homogenization time 3-8min; the second homogenization conditions are: homogenization pressure 1.5-2MPa, homogenization temperature 25-35°C, and homogenization time 10-15min.

[0014] Compared with the prior art, the present invention has the following beneficial effects:

[0015] (1) The present invention uses ginseng, epimedium, and Cistanche deserticola as raw materials to extract effective active ingredients, adds Ganoderma lucidum extract, Uncaria rhynchophylla extract, and Gentiana macrophylla extract prepared by the present invention, and adds a certain amount of allantoin, coenzyme Q10, and arginine, supplemented by hyaluronic acid, hydrolyzed collagen, glycerol, etc., with preferred dosage ratios. The prepared cream effectively promotes the penetration and absorption of active ingredients, accelerates the repair of corpus cavernosum cells, plays the role of strengthening kidney yang and replenishing essence, and better and more effectively improves erectile dysfunction. The cream prepared by the present invention has high biological safety and effectively improves drug utilization.

[0016] (2) The present invention adds a certain proportion of ginseng, epimedium, Cistanche deserticola, and Ganoderma lucidum extract, Uncaria rhynchophylla extract, and Gentiana macrophylla extract to synergistically enhance the efficacy of improving erectile function; the present invention adds a certain amount of allantoin, coenzyme Q10, and arginine to better promote the repair and proliferation of cavernous cells.

[0017] (3) The cream prepared by the present invention can increase the ratio of intracavernous pressure to mean arterial pressure (ICP / MAP) in male rats, has a significant regulatory effect on sexual dysfunction, and can effectively improve erectile function. DETAILED DESCRIPTION

[0018] In order to better understand the technical content of the present invention, specific examples are provided below to further illustrate the present invention.

[0019] Unless otherwise specified, the experimental methods used in the examples of the present invention are all conventional methods.

[0020] Unless otherwise specified, the materials, reagents, etc. used in the examples of the present invention can be obtained from commercial sources.

[0021] The commercially available Ganoderma lucidum extract, Uncaria rhynchophylla extract, and Gentiana macrophylla extract used in the examples of the present invention were purchased from Shaanxi Kangjun Biotechnology Co., Ltd.

[0022] Example 1 - Preparation of a cream for warming the kidney and consolidating essence

[0023] (1) Formula

[0024] Table 1

[0025]

[0026]

[0027] (2) Process

[0028] (1) Preparation of extract

[0029] The preparation method of Ganoderma lucidum extract comprises the following steps: taking Ganoderma lucidum fruiting bodies, crushing them, adding purified water at a material-liquid ratio of 1:80 (g / ml), then adding a complex enzyme (1.5% by weight of the Ganoderma lucidum fruiting bodies), wherein the complex enzyme is composed of cellulase and snailase at a mass ratio of 1:2.3, and ultrasonicating at a power of 380W and 40°C for 30 minutes to obtain the Ganoderma lucidum extract.

[0030] The preparation method of the Uncaria rhynchophylla extract comprises the following steps: taking the hooked stems and branches of the Uncaria rhynchophylla, crushing them, adding 50% v / v ethanol solution at a material-liquid ratio of mg / ml 1:8, soaking for 1.0 hour, heating and refluxing at 85°C for 1.0 hour each time, combining the extracts, filtering, concentrating the filtrate under reduced pressure, and freeze-drying to obtain the Uncaria rhynchophylla extract.

[0031] The preparation method of gentiana macrophylla extract comprises the following steps: taking the root of gentiana macrophylla, crushing it, adding 70% v / v ethanol solution according to the material-liquid ratio of mg / ml 1:10, soaking it for 1.0 hour, heating and refluxing at 80°C for 1.0 hour twice, each time for 1.0 hour, combining the extracts, filtering, concentrating the filtrate under reduced pressure, and freeze-drying to obtain the gentiana macrophylla extract.

[0032] (2) Preparation of cream

[0033] First, Chinese medicinal materials including ginseng, epimedium, and cistanche deserticola were washed, decocted in water for 90 minutes, allowed to stand, filtered, and a medicinal solution was obtained, which was concentrated to an extract to obtain a Chinese medicinal extract; the Chinese medicinal extract, as well as a Ganoderma lucidum extract, an Uncaria rhynchophylla extract, and a Gentiana macrophylla extract were mixed with 50% water by weight of the formula, stirred at 250 rpm and 40° C. for 30 minutes, and then hyaluronic acid, hydrolyzed collagen, glycerin, and the remainder of water were added, and the first homogenization was performed at a homogenization pressure of 0.8 MPa, a homogenization temperature of 45° C., and a homogenization time of 5 minutes; finally, allantoin, coenzyme Q10, and arginine were added, and the second homogenization was performed at a homogenization pressure of 1.8 MPa, a homogenization temperature of 30° C., and a homogenization time of 10 minutes to obtain the target cream.

[0034] Example 2 - Preparation of a cream for warming the kidney and consolidating essence

[0035] (1) Formula

[0036] Table 2

[0037] Components Dosage / g Ginseng 1.5 Epimedium 2.5 Cistanche deserticola 2.0 Ganoderma lucidum extract 0.8 Uncaria rhynchophylla extract 3.8 Gentiana macrophylla extract 3.2 Hyaluronic acid 0.4 hydrolyzed collagen 0.6 glycerin 0.4 Allantoin 2.0 Coenzyme Q10 1.8 Arginine 1.0 purified water 80.0 total 100.00

[0038] (2) The process is consistent with that of Example 1.

[0039] Example 3 - Preparation of a cream for warming the kidney and consolidating essence (I) Formula

[0040] Table 3

[0041] Component / g Dosage / g Ginseng 4.0 Epimedium 5.0 Cistanche deserticola 5.0 Ganoderma lucidum extract 0.0 Uncaria rhynchophylla extract 0.0 Gentiana macrophylla extract 0.0 Hyaluronic acid 0.5 hydrolyzed collagen 0.5 glycerin 0.5 Allantoin 1.8 Coenzyme Q10 1.5 Arginine 1.2 purified water 80.0 total 100.00

[0042] (2) The process is consistent with that of Example 1.

[0043] Example 4 - Preparation of a cream for warming the kidney and consolidating essence

[0044] (1) The formula is consistent with that of Example 1.

[0045] (2) The process is mainly different from Example 1 in that the Ganoderma lucidum extract, Uncaria rhynchophylla extract, and Gentiana macrophylla extract used are commercially available plant extracts (purchased from Shaanxi Kangjun Biotechnology Co., Ltd.), the extraction solvent is water, and the extraction method is heating reflux extraction.

[0046] Comparative Example 1

[0047] The main difference from Example 1 is that the Ganoderma lucidum extract, Uncaria rhynchophylla extract and Gentiana macrophylla extract are not added, and the added amounts of ginseng, epimedium and Cistanche deserticola are increased.

[0048] (1) Formula

[0049] Table 4

[0050] Component / g Dosage / g Ginseng 4.0 Epimedium 5.0 Cistanche deserticola 5.0 Ganoderma lucidum extract 0.0 Uncaria rhynchophylla extract 0.0 Gentiana macrophylla extract 0.0 Hyaluronic acid 0.5 hydrolyzed collagen 0.5 glycerin 0.5 Allantoin 1.8 Coenzyme Q10 1.5 Arginine 1.2 purified water 80.0 total 100.00

[0051] (2) The process is consistent with that of Example 1.

[0052] Comparative Example 2

[0053] The main difference from Example 1 is that allantoin, coenzyme Q10 and arginine are not added, and the amounts of hyaluronic acid, hydrolyzed collagen and glycerol added are increased.

[0054] (1) Formula

[0055] Table 5

[0056] Component / g Dosage / g Ginseng 2.0 Epimedium 2.0 Cistanche deserticola 2.0 Ganoderma lucidum extract 1.0 Uncaria rhynchophylla extract 4.0 Gentiana macrophylla extract 3.0 Hyaluronic acid 2.0 hydrolyzed collagen 2.0 glycerin 2.0 Allantoin 0.0 Coenzyme Q10 0.0 Arginine 0.0 purified water 80.0 total 100.00

[0057] (2) The process is consistent with that of Example 1.

[0058] Test Example 1

[0059] The purpose of this study was to investigate the effect of the cream prepared by the present invention on the intracavernous pressure (ICP) of the male rat penis.

[0060] Healthy male SD rats were selected and the experiment was started after 3 days of adaptive feeding. After fasting for 12 hours, 10 rats were randomly taken out as the normal group and intraperitoneally injected with citric acid-sodium citrate buffer. The remaining rats were given a one-time intraperitoneal injection of 65mg / kg of streptozotocin (using citric acid buffer as a solvent, pH 4.5) to create a diabetic model. After 7 days, blood sugar was measured, and a value higher than 16.7mM indicated that a diabetic model had been formed. If the blood sugar value was lower than this value, the same dose of streptozotocin was injected again. The rats were allowed to remain in a hyperglycemic state for 8 weeks to form a sexual dysfunction model, i.e., the model was successfully established.

[0061] After successful modeling, the rats were randomly divided into a model group and test groups 1-6, with 10 rats in each group. The model group was given normal saline, and the test groups 1-6 were given 5 g / kg of the cream daily for 2 consecutive weeks. Among them, the test groups 1-6 were given the creams of Examples 1-4 and Comparative Examples 1-2, respectively.

[0062] After 2 weeks of using the cream, the test was performed using the electrical stimulation cavernous body pressure measurement method. The test method was:

[0063] a. Anesthesia and Preparation: Rats were anesthetized with an intraperitoneal injection of sodium pentobarbital and placed in the supine position with their limbs restrained for surgery. Hair in the surgical area was clipped to reduce the risk of infection.

[0064] b. Laparotomy and nerve exposure: After successful anesthesia, the rat is fixed in the dorsal position and a midline incision is made into the abdomen to locate and free the posterior lobes of the prostate and thus expose the pelvic stellate ganglion.

[0065] c. Nerve Identification and Electrode Placement: Starting from the pelvic stellate ganglion, carefully dissect the nerves in the surrounding area. Identify the pelvic nerve, hypogastric nerve, and the cavernous nerve, its largest output branch, which runs along the lateral side of the urethra. Place a bipolar electrode on the cavernous nerve 1-2 mm from the pelvic stellate ganglion, ensuring that the positive electrode is located proximal to the nerve. Maintain a 1 mm distance between the two electrodes, and the electrode diameter is approximately 0.2 mm.

[0066] d. Treatment of the corpus cavernosum: Cut open the foreskin of the penis and peel it off to fully expose the corpus cavernosum of the penis. Then, puncture the scalp with a needle into the corpus cavernosum on one side.

[0067] e. Connection and preparation: Connect the cavernous nerve to the signal acquisition processor (MedLab-U / 4C501H) through a catheter. Perfuse heparin solution (250 U / ml) into the catheter to prevent blood clotting and ensure that there are no bubbles in the catheter.

[0068] f. Electrical stimulation parameter setting: Electrically stimulate the cavernous nerves and adjust the signal acquisition processor to a continuous square wave stimulation with a width of 5 ms, a frequency of 15 Hz, and a voltage of 7.5 V. Each stimulation lasts for 60 s.

[0069] g.ICP change recording: Record the ICP changes during the entire electrical stimulation process.

[0070] h. Mean arterial pressure monitoring: A midline incision was made in the neck, the left common carotid artery was exposed and cut, and a PE10 tube was inserted. A 40 kPa pressure transducer (YP100 model) was connected via a PE50 tube to continuously monitor the mean arterial pressure of the rats.

[0071] The results are shown in Table 6 below:

[0072] Table 6

[0073] ICP MAP ICP / MAP ratio Normal group 84.23±4.41 126.27±6.20 0.67 Model Group 50.95±5.23 120.50±6.19 0.42 Example 1 82.59±4.48 125.52±6.70 0.66 Example 2 77.74±4.12 123.49±6.57 0.63 Example 3 80.52±4.37 124.45±6.18 0.65 Example 4 74.12±4.93 121.59±6.45 0.61 Comparative Example 1 61.23±5.39 118.74±6.80 0.52 Comparative Example 2 68.95±4.55 119.30±6.48 0.58

[0074] As shown in Table 6 above, the changes in ICP, MAP, and ICP / MAP ratio between the normal and model groups were statistically significant (P < 0.05). Compared with the model group, the ICP and ICP / MAP ratio of experimental groups 1-6 (Examples 1-4 and Comparative Examples 1-2) were all improved, with Examples 1-4 showing a more significant improvement. Compared with Example 1, the improvement in Comparative Examples 1-2 was less than that in Example 1.

[0075] In summary, the cream prepared by the present invention can increase the ratio of intracavernous pressure to mean arterial pressure (ICP / MAP) in male rats, has a significant regulatory effect on sexual dysfunction, and can effectively improve the erectile function of rats.

[0076] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A cream for warming the kidney and consolidating essence, characterized in that: The product is prepared from the following raw materials in parts by weight: 1.5-2.5 parts of ginseng, 1.5-2.5 parts of epimedium, 1.5-2.5 parts of cistanche deserticola, 0.8-1.2 parts of ganoderma lucidum extract, 3.5-4.5 parts of uncaria rhynchophylla extract, 2.3-3.2 parts of gentiana macrophylla extract, 0.4-0.6 parts of hyaluronic acid, 0.4-0.6 parts of hydrolyzed collagen, 0.4-0.6 parts of glycerin, 1.5-2.0 parts of allantoin, 1.2-1.8 parts of coenzyme Q10, 1-1.5 parts of arginine, and 78-82 parts of water; The preparation method of the ganoderma lucidum extract comprises the following steps: taking ganoderma lucidum, crushing it, adding purified water at a material-liquid ratio of 1:50-100 g / ml, then adding a complex enzyme of 1%-2% by weight of the ganoderma lucidum, wherein the complex enzyme is composed of cellulase and snailase in a mass ratio of 1:2-3, and ultrasonicating at a power of 350-400W and 38-42°C for 20-30 minutes to obtain the ganoderma lucidum extract; The preparation method of the Uncaria rhynchophylla extract comprises the following steps: taking Uncaria rhynchophylla, crushing it, adding 45%-55% v / v ethanol solution at a material-liquid ratio of 1:7-8 mg / ml, soaking it for 0.8-1.2 hours, heating and refluxing at 80-85° C. for 2-3 times, each time for 0.8-1.2 hours, combining the extracts, filtering, concentrating the filtrate under reduced pressure, and freeze-drying it to obtain the Uncaria rhynchophylla extract; The preparation method of the gentiana macrophylla extract comprises the following steps: taking gentiana macrophylla, crushing it, adding 65%-70% v / v ethanol solution according to a material-liquid ratio of mg / ml of 1:9-11, soaking it for 0.8-1.2 hours, heating and refluxing it at 80-85°C for 2-3 times, each time for 0.8-1.2 hours, combining the extracts, filtering, concentrating the filtrate under reduced pressure, and freeze-drying it to obtain the gentiana macrophylla extract.

2. A cream for warming the kidney and consolidating essence according to claim 1, characterized in that The invention comprises the following raw materials in parts by weight: 2 parts of ginseng, 2 parts of epimedium, 2 parts of cistanche, 1 part of ganoderma lucidum extract, 4 parts of uncaria rhynchophylla extract, 3 parts of gentiana macrophylla extract, 0.5 parts of hyaluronic acid, 0.5 parts of hydrolyzed collagen, 0.5 parts of glycerin, 1.8 parts of allantoin, 1.5 parts of coenzyme Q10, 1.2 parts of arginine and 80 parts of water.

3. The method for preparing the cream for warming the kidney and consolidating essence according to claim 1, characterized in that: The following steps are involved: First, take Chinese medicinal materials such as ginseng, epimedium, and cistanche, wash them, place them in water and boil them for 1-2 hours, let them stand, filter them to obtain a medicinal solution, and concentrate them into an extract to obtain a Chinese medicinal extract; mix the Chinese medicinal extract and Ganoderma lucidum extract, Uncaria rhynchophylla extract, and Gentiana macrophylla extract with 40%-60% of the formula weight of water, stir them at 200-300 rpm and 30-40°C for 20-40 minutes, then add hyaluronic acid, hydrolyzed collagen, glycerin and the remaining water, perform the first homogenization, and finally add allantoin, coenzyme Q10, and arginine, and perform the second homogenization to obtain the Chinese medicinal extract.

4. The method for preparing a cream for warming the kidney and consolidating essence according to claim 3, wherein: The first homogenization conditions are: homogenization pressure 0.5-1MPa, homogenization temperature 40-50°C, and homogenization time 3-8min; the second homogenization conditions are: homogenization pressure 1.5-2MPa, homogenization temperature 25-35°C, and homogenization time 10-15min.

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