Kidney-tonifying, waist-strengthening and yang-supporting medicine composition and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine biology, and provides a medicine composition for tonifying kidney, strengthening waist and supporting yang, which is prepared from the following raw materials in parts by weight: 5 to 10 parts of cornu cervi pantotrichum, 5 to 10 parts of hippocampus, 10 to 20 parts of fructus lycii, 10 to 20 parts of rhizoma dioscoreae and 10 to 20 parts of semen cuscutae. The invention also provides a preparation method of the medicine composition for tonifying kidney, strengthening waist and supporting yang. The preparation method comprises the following steps: S1, respectively washing the cornu cervi pantotrichum, the sea horse, the Chinese yam, the fructus lycii and the semen cuscutae, drying and crushing; s2, extracting effective components by adopting a water decoction method or an alcohol extraction method to obtain an extracting solution of each traditional Chinese medicinal material; s3, concentrating the extracting solution to obtain a concentrated solution; and S4, adding auxiliary materials into the concentrated solution to prepare freeze-dried powder, and crushing and mixing the freeze-dried powder to obtain the pharmaceutical composition freeze-dried powder for tonifying kidney, strengthening waist and supporting yang. The freeze-dried powder technology is adopted, so that the stability, solubility and absorbability of the medicine are improved, the medicine is convenient to store and transport, side effects are reduced, the treatment effect on impotence is enhanced, and the life quality of a patient is improved.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine biotechnology, in particular to a kidney-tonifying, waist-strengthening and yang-boosting drug combination and a preparation method thereof. Background Art

[0002] Impotence, also known as erectile dysfunction, refers to the inability of the penis to erect or weak erection when a man has sexual desire, or the inability to maintain an erection and a certain degree of hardness but not enough time for sexual intercourse, thus hindering or failing to complete sexual intercourse. Impotence is a common disease in modern society.

[0003] The existing technologies for treating impotence, strengthening the kidney and waist and promoting yang include: 1. PDE5 inhibitors such as sildenafil: the chemical name of sildenafil, whose structure is 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine; by inhibiting phosphodiesterase 5 (PDE5), reducing the degradation of cyclic guanosine monophosphate (cGMP), relaxing the smooth muscle in the corpus cavernosum of the penis, and increasing blood flow, thereby promoting penile erection; however, its mechanism of action is mainly to regulate the local blood flow of the corpus cavernosum of the penis, and has limited improvement on the overall body function. The drug is highly targeted and may interfere with other physiological processes of the body, thereby producing side effects; side effects include headache, facial flushing, indigestion, visual abnormalities, etc. Long-term use may lead to drug dependence, and its therapeutic effect on psychological impotence is limited; it is risky for patients with cardiovascular disease, and combined use with nitrates may cause severe hypotension.

[0004] 2. Chinese medicine compound preparations: mainly composed of black ants, epimedium, wolfberry, cnidium monnieri, etc.; Chinese medicine theory believes that these drug combinations can warm the kidney, strengthen yang, and benefit essence. From the perspective of modern medicine, it may work through multiple mechanisms such as regulating endocrine, improving blood circulation in the reproductive system, and regulating nerve function. However, the mechanism of action of Chinese medicine is relatively complex, and it often works through multiple targets and multiple pathways. Its specific mechanism of action has not yet been fully clarified. The quality of Chinese medicinal materials is affected by factors such as origin, planting method, and harvesting time, resulting in unstable product quality; and the effect is relatively slow, and it takes a long time to take it to see obvious effects. There are large individual differences in efficacy. Some patients may be insensitive to or have adverse reactions to certain Chinese medicine ingredients. At the same time, it is difficult to unify quality standards, and the quality of products produced by different manufacturers may vary.

[0005] 3. Testosterone replacement therapy (for impotence caused by androgen deficiency): Its structure (testosterone preparations) has various forms, such as testosterone gel, testosterone injection, etc.; by supplementing the lack of androgen testosterone in the body, it improves sexual desire and erectile function. Testosterone plays an important role in maintaining the development and function of the male reproductive system, including promoting the growth of penile tissue and maintaining its sensitivity. However, exogenous testosterone supplementation may feedback inhibit the secretion of pituitary gonadotropin, thereby affecting the normal function of the testicles. At the same time, testosterone has a certain stimulating effect on tissues such as the prostate, and long-term use may increase the risk of disease. Long-term use may inhibit the spermatogenic function of the testicles and affect fertility. It may lead to an increased risk of prostate hyperplasia or prostate cancer. It may cause psychological problems such as mood swings and bad temper.

[0006] There is currently a lack of safe and effective treatments for impotence, a common male sexual dysfunction. Some existing treatments may have serious side effects and short-lasting effects; traditional kidney-tonifying and aphrodisiac drugs often only focus on the single kidney-tonifying effect, while ignoring the strengthening of the waist and the regulation of overall body functions; the preparation method of the drug is complicated and costly, which is not conducive to large-scale production and promotion and application.

[0007] To this end, technicians in this field have proposed a kidney-tonifying, waist-strengthening and yang-boosting drug combination and a preparation method thereof, aiming to improve drug stability, solubility and absorbability, facilitate storage and transportation, while reducing side effects, enhancing the therapeutic effect on impotence, and improving the quality of life of patients. Summary of the invention

[0008] In order to solve the above technical problems, the present invention provides a kidney-tonifying, waist-strengthening and yang-boosting drug combination and a preparation method thereof to solve the problems raised in the background technology.

[0009] According to the first aspect of the present disclosure, a kidney-tonifying, waist-strengthening and yang-boosting drug combination is proposed, which is composed of the following raw materials in parts by weight: 5-10 parts of deer antler, 5-10 parts of hippocampus, 10-20 parts of wolfberry, 10-20 parts of yam, and 10-20 parts of dodder seed.

[0010] According to the second aspect of the present disclosure, a method for preparing a kidney-tonifying, waist-strengthening and yang-boosting drug combination is proposed, comprising the following steps:

[0011] S1. Wash pilose antler, seahorse, yam, wolfberry and dodder respectively, then dry and crush;

[0012] S2, extracting effective ingredients by water decoction or alcohol extraction to obtain extracts of various Chinese medicinal materials;

[0013] S3, concentrating the extracts of each Chinese medicinal material to obtain concentrated solutions of each Chinese medicinal material;

[0014] S4. Add auxiliary materials to various concentrated solutions to prepare freeze-dried powders respectively; grind and mix the freeze-dried powder of deer antler, freeze-dried powder of hippocampus, freeze-dried powder of yam, freeze-dried powder of wolfberry and freeze-dried powder of dodder seed to obtain freeze-dried powder of kidney-tonifying, waist-strengthening and yang-boosting drug combination.

[0015] Preferably, after the pilose antler, seahorse, yam, wolfberry and dodder seeds are washed, the drying temperature is controlled at 50-80° C. and the pulverized particle size is 50-100 meshes.

[0016] Preferably, when the water decoction method is used to extract the effective ingredients, the amount of water added is 5-10 times the total amount of the medicinal materials, the soaking time is 1-2 hours, the decoction temperature is 90-100°C, the decoction time is 1-2 hours each time, and the decoction is repeated 2-3 times.

[0017] Preferably, when the alcohol extraction method is used to extract the effective ingredients, the ethanol concentration is 50% to 70%, and the soaking time is 2 to 3 days.

[0018] Preferably, the auxiliary material includes one or more of starch and dextrin.

[0019] Preferably, the freeze-dried powder of the Chinese medicine composition is mixed and packaged using sealed packaging materials; and when used, the freeze-dried powder of the Chinese medicine composition is made into dosage forms including capsules, tablets or granules.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] 1. The present invention provides a safe and effective drug combination, which can nourish the kidney and strengthen the waist, boost yang, and effectively improve the symptoms of impotence. By selecting natural Chinese medicinal materials such as velvet antler, seahorse, yam, wolfberry, and dodder, the effects of nourishing kidney yang, strengthening muscles and bones, and benefiting essence and blood are exerted, and the male reproductive system function is fundamentally regulated.

[0022] 2. The present invention realizes the strengthening effect of the drug on the waist, which not only improves sexual function, but also relieves the discomfort symptoms such as soreness and pain in the waist caused by kidney deficiency, thereby enhancing the physical fitness of men and improving the quality of life.

[0023] 3. The present invention provides a simple and easy preparation method, thereby reducing the production cost of the drug, so that the drug combination can be widely used in family health care. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 The present invention is a flow chart of the preparation method of the kidney-tonifying, waist-strengthening and yang-boosting drug combination. DETAILED DESCRIPTION

[0025] The following embodiments of the present invention are described in further detail in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0026] Embodiment 1: The present invention provides a kidney-tonifying, waist-strengthening and yang-boosting drug combination, which is composed of the following raw materials in parts by weight: 5-10 parts of pilose antler, 5-10 parts of hippocampus, 10-20 parts of wolfberry, 10-20 parts of yam, and 10-20 parts of dodder seed.

[0027] Deer antler: It has the effects of strengthening kidney yang, improving blood and essence, and strengthening tendons and bones;

[0028] Seahorse: warms the kidney and strengthens yang, dispels stagnation and reduces swelling;

[0029] Wolfberry: nourishes the liver and kidneys, improves sperm quality and improves eyesight;

[0030] Cuscuta: nourishes the kidney and improves essence, nourishes the liver and improves eyesight;

[0031] Yam: strengthens the spleen and lungs, nourishes the kidneys and strengthens the essence.

[0032] For medicinal materials with hard texture, effective processing methods are adopted. For example, Cuscuta australis can be roasted with salt to enhance its kidney-tonifying effect.

[0033] The Chinese medicine composition is used for strengthening the kidney and waist and boosting yang for impotence, and adopts freeze-dried powder technology, which has the following advantages:

[0034] 1. Drug stability

[0035] 1. Preservation of active ingredients: Many Chinese herbal medicine ingredients that nourish the kidneys and waist and boost yang contain bioactive substances, such as polysaccharides, peptides, etc., as well as some ingredients that are easily oxidized and decomposed. Freeze-dried powder technology dries at low temperatures, which can minimize the denaturation and inactivation of these active ingredients. For example, the active peptides in deer antlers may gradually degrade at room temperature, but freeze-dried powder technology can preserve them in a nearly original state.

[0036] 2. Prevent deterioration: This technology removes moisture, making it impossible for microorganisms to grow and reproduce in a moisture-deficient environment, thereby greatly extending the shelf life of the drug. For compound preparations containing multiple Chinese medicinal materials, the risk of deterioration due to microbial growth is reduced.

[0037] 2. Drug Solubility and Absorption

[0038] 1. Improve solubility: The lyophilized powder has a loose and porous structure, which allows the drug to dissolve quickly when reconstituted. When the patient takes it, the drug can be dispersed more quickly and contact the liquid in the gastrointestinal tract, which is conducive to improving the absorption speed and degree of the drug.

[0039] 2. Enhanced absorption effect: Since freeze-dried powder can better preserve the active ingredients of the drug, these ingredients may be more easily absorbed by the gastrointestinal mucosa after entering the human body in a state closer to nature, thereby improving the bioavailability of the drug.

[0040] 3. Production, storage and transportation

[0041] 1. Production flexibility: Freeze-dried powder technology can freeze-dry different dosage forms (such as solutions, suspensions, etc.), and is suitable for making traditional Chinese medicine extracts into freeze-dried powder. During the production process, the proportion of various ingredients in the formula can be adjusted as needed, and then freeze-dried, which has high production flexibility.

[0042] 2. Easy to store and transport: Lyophilized powder is relatively stable at room temperature and does not require special refrigeration equipment (before reconstitution), which greatly reduces storage and transportation costs. For remote areas or situations with limited transportation conditions, drugs in the form of lyophilized powder are easier to distribute and use.

[0043] Embodiment 2: The present invention also provides a method for preparing a kidney-tonifying, waist-strengthening and yang-boosting drug combination, comprising the following steps:

[0044] S1. Wash antler, seahorse, Chinese yam, wolfberry and dodder respectively, then dry and crush them; after washing the antler, seahorse, Chinese yam, wolfberry and dodder, the drying temperature is controlled at 50-80° C. and the crushing particle size is 50-100 mesh.

[0045] S2. Extract the effective ingredients by water decoction or alcohol extraction to obtain the extract of each Chinese medicinal material; when the water decoction is used for extracting the effective ingredients, the amount of water added is 5-10 times the total amount of the medicinal materials, the soaking time is 1-2 hours, the decoction temperature is 90-100°C, the decoction time is 1-2 hours each time, and the decoction is repeated 2-3 times.

[0046] When the alcohol extraction method is used to extract the effective ingredients, the ethanol concentration is 50% to 70%, and the soaking time is 2 to 3 days.

[0047] S3, concentrating each Chinese medicinal material extract to obtain its concentrated solution;

[0048] S4. Add auxiliary materials to the concentrated solutions of various Chinese medicinal materials, including one or more of starch and dextrin, to make freeze-dried powders. Grind and mix freeze-dried powders of deer antler, freeze-dried powder of hippocampus, freeze-dried powder of yam, freeze-dried powder of wolfberry and freeze-dried powder of dodder seed to obtain freeze-dried powder of kidney-tonifying, waist-strengthening and yang-boosting drug combination.

[0049] The Chinese medicine composition freeze-dried powder is mixed and packaged using sealed packaging materials; and when used, the Chinese medicine composition freeze-dried powder is made into dosage forms including capsules, tablets or granules.

[0050] Process conditions: The entire production process should be carried out in a clean environment, and the temperature, humidity and other conditions should be strictly controlled to ensure stable product quality. During the extraction process, pay attention to the control of heat and time to fully extract the active ingredients. During the preparation molding process, ensure the quality of the excipients and the addition ratio are accurate.

[0051] Testing methods: Quality testing of raw materials, including authenticity identification of medicinal materials, determination of active ingredient content, etc. Quality testing of finished products, such as hardness and disintegration testing of tablets, and filling volume difference testing of capsules, etc. Quantitative analysis of the main active ingredients in the product can also be performed using methods such as high performance liquid chromatography.

[0052] Experimental results: The efficacy and safety of the product are observed through animal experiments and clinical trials. Male animal models can be used for animal experiments to observe the sexual behavior, reproductive organ tissue morphology and other changes of the animals after medication. Clinical trials can recruit patients with impotence and conduct randomized controlled trials to observe the improvement of patients' erectile function, sexual life satisfaction and other indicators. The experimental results show that the product has a good effect of tonifying the kidney and waist, and boosting yang, and has fewer side effects.

[0053] Importantly, it should be noted that the construction and arrangement of the present application shown in a plurality of different exemplary embodiments are only exemplary. Although only a few embodiments are described in detail in this disclosure, it should be readily understood by those who refer to this disclosure that many modifications are possible without substantially departing from the novel teachings and advantages of the subject matter described in the application. Without departing from the scope of the present invention, other replacements, modifications, changes and omissions may be made in the design, operating conditions and arrangement of the exemplary embodiments. Therefore, the present invention is not limited to specific embodiments, but extends to a variety of modifications still falling within the scope of the appended claims.

[0054] Additionally, in order to provide a concise description of exemplary embodiments, all features of an actual embodiment (ie, those features that are not relevant to the best mode presently contemplated for carrying out the invention or those that are not relevant to implementing the invention) may not be described.

[0055] It will be appreciated that in the development of any actual implementation, as in any engineering or design project, numerous implementation-specific decisions may be made. Such a development effort may be complex and time-consuming, but will be a routine task of design, fabrication, and production for those of ordinary skill having the benefit of this disclosure without undue experimentation.

[0056] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present invention may be modified or replaced by equivalents without departing from the spirit and scope of the technical solutions of the present invention, which should all be included in the scope of the claims of the present invention.

Claims

1. A kidney-tonifying, waist-strengthening and yang-boosting drug combination, characterized in that: The invention is composed of the following raw materials in parts by weight: 5-10 parts of pilose antler, 5-10 parts of seahorse, 10-20 parts of wolfberry, 10-20 parts of yam and 10-20 parts of dodder seed.

2. A method for preparing a kidney-tonifying, waist-strengthening and yang-boosting drug combination, comprising preparing a kidney-tonifying, waist-strengthening and yang-boosting drug combination as claimed in claim 1, characterized in that: The following steps are involved: S1. Wash pilose antler, seahorse, yam, wolfberry and dodder respectively, then dry and crush; S2, extracting effective ingredients by water decoction or alcohol extraction to obtain extracts of various Chinese medicinal materials; S3, concentrating the extracts of each Chinese medicinal material to obtain concentrated solutions of each Chinese medicinal material; S4. Add auxiliary materials to various concentrated solutions to prepare freeze-dried powders respectively; grind and mix the freeze-dried powder of deer antler, freeze-dried powder of hippocampus, freeze-dried powder of yam, freeze-dried powder of wolfberry and freeze-dried powder of dodder seed to obtain freeze-dried powder of kidney-tonifying, waist-strengthening and yang-boosting drug combination.

3. A method for preparing a kidney-tonifying, waist-strengthening and yang-boosting drug combination as claimed in claim 2, characterized in that: After the Chinese medicinal materials of pilose antler, seahorse, yam, wolfberry and dodder are washed, the drying temperature is controlled at 50-80° C. and the pulverized particle size is 50-100 meshes.

4. A method for preparing a kidney-tonifying, waist-strengthening and yang-boosting drug combination as claimed in claim 2, characterized in that: When the water decoction method is used to extract the effective ingredients, the amount of water added is 5-10 times the total amount of the medicinal materials, the soaking time is 1-2 hours, the decoction temperature is 90-100° C., the decoction time is 1-2 hours each time, and the decoction is repeated 2-3 times.

5. A method for preparing a kidney-tonifying, waist-strengthening and yang-boosting drug combination as claimed in claim 2, characterized in that: When the effective components are extracted by the alcohol extraction method, the ethanol concentration is 50% to 70%, and the soaking time is 2 to 3 days.

6. A method for preparing a kidney-tonifying, waist-strengthening and yang-boosting drug combination as claimed in claim 2, characterized in that: The auxiliary materials include one or more of starch and dextrin.

7. A method for preparing a kidney-tonifying, waist-strengthening and yang-boosting drug combination as claimed in claim 2, characterized in that: The Chinese medicine composition freeze-dried powder is mixed and packaged using sealed packaging materials; and when used, the Chinese medicine composition freeze-dried powder is made into dosage forms including capsules, tablets or granules.

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