Traditional Chinese medicine preparation for invigorating kidney and strengthening yang

Abstract

The invention discloses a kidney-tonifying and yang-strengthening traditional Chinese medicine preparation in the technical field of traditional Chinese medicines. Comprising the following components in parts by weight: 12-16 parts of rhizoma polygonati, 6-10 parts of fructus lycii, 13-16 parts of herba cynomorii, 6-12 parts of herba cistanche, 10-15 parts of fructus corni, 8-12 parts of fructus cnidii, 3-7 parts of fructus psoraleae, 2-4 parts of radix morindae officinalis, 12-16 parts of tribulus terrestris, 10-16 parts of leek flowers, 1-3 parts of tortoise shells, 3.5-5 parts of sustained-release gel liquid, 0.4-0.6 part of lecithin and 0.12-0.16 part of cholesterol. The polysaccharide is extracted as a microneedle tip, the nano inclusion is prepared from the alcohol extract and loaded in the sustained-release gel, gastrointestinal absorption is replaced by transdermal absorption, adverse reactions are reduced, and the utilization rate and the effective speed are improved.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a kidney-tonifying and yang-strengthening traditional Chinese medicine preparation. Background Art

[0002] Kidney tonification refers to improving the state of kidney deficiency through various methods. Kidney deficiency can be divided into kidney yin deficiency and kidney yang deficiency. With the continuous improvement of people's quality of life, kidney tonification is becoming increasingly popular among the male population, and the application of kidney tonifying Chinese medicine is becoming more and more extensive. Although the currently commonly used Western medicines such as sildenafil can achieve the purpose of strengthening yang in a short time, they have great side effects and strong dependence, and cannot fundamentally solve the problem of kidney deficiency. Various Chinese medicine formulas, such as ginseng and Huangjing soup, Bushen Yijing, Jianyang capsules, etc., can continuously regulate patient symptoms, but they are slow to take effect and have a long course of treatment. The active ingredients in Chinese medicine, such as flavonoids and steroids, are easily destroyed in gastric juice and difficult to absorb. At the same time, a variety of bitter and irritating ingredients can easily irritate the stomach and intestines and affect appetite.

[0003] The main problems currently exist are as follows: 1. Western aphrodisiac medicines have serious side effects and are highly dependent; 2. Traditional Chinese aphrodisiac medicines are slow to take effect and have low utilization rates of their effective ingredients. Summary of the invention

[0004] In view of the above situation, in order to overcome the defects of the prior art, the present invention provides a kidney-tonifying and aphrodisiac Chinese medicine preparation. In order to solve the problems of slow effect of Chinese medicine and low utilization rate of effective ingredients, the present invention extracts polysaccharides as microneedle tips, prepares nano-inclusions with alcohol extracts and loads them in sustained-release gel, replaces gastrointestinal absorption with transdermal absorption, reduces adverse reactions, and improves utilization rate and speed of effect.

[0005] In order to achieve the above-mentioned purpose, the technical scheme adopted by the present invention is as follows: the present invention proposes a kidney-tonifying and yang-strengthening Chinese medicine preparation, which comprises the following components in parts by weight: 12-16 parts of polygonatum, 6-10 parts of wolfberry, 13-16 parts of cynomorium songaricum, 6-12 parts of cistanche, 10-15 parts of cornus, 8-12 parts of cnidium monnieri, 3-7 parts of psoralea corylifolia, 2-4 parts of morinda officinalis, 12-16 parts of tribulus terrestris, 10-16 parts of leek flower, 1-3 parts of tortoise shell, 3.5-5 parts of sustained-release gel liquid, 0.4-0.6 parts of lecithin, and 0.12-0.16 parts of cholesterol.

[0006] Furthermore, the sustained-release gel solution is prepared from the following components in parts by weight: 10-15 parts of o-vanillin, 30-35 parts of polylysine, 25-30 parts of pullulan, and 28-32 parts of sodium periodate.

[0007] Preferably, the method for preparing the sustained-release gel solution specifically comprises the following steps:

[0008] V1. Add polylysine in an amount of 20-30 g / mL to water to obtain a polylysine solution, add o-vanillin to a 30-40 wt% methanol solution to obtain an o-vanillin solution, add the polylysine solution to the o-vanillin solution, and stir the reaction at 30-60 rpm to obtain a modified polylysine solution;

[0009] V2, adding pullulan in an amount of 15-20 g / mL to water to obtain a polysaccharide solution, adding sodium periodate to the polysaccharide solution, heating in a water bath in the dark for 3-5 hours, adding ethylene glycol to remove the sodium periodate, dialyzing for 5 days, and freeze-drying to obtain modified pullulan;

[0010] V3. Add the modified pullulan obtained in V2 to the modified polylysine solution obtained in V1, stir for 2-3 minutes, and mix well to obtain a sustained-release gel solution.

[0011] The present invention also provides a method for preparing a kidney-tonifying and yang-strengthening Chinese medicine preparation, which specifically comprises the following steps:

[0012] S1, taking polygonatum, wolfberry, cynomorium songaricum, cistanche, cornus officinalis, cnidium monnieri, psoralea corylifolia, morinda officinalis, cynomorium terrestris, leek flower, and tortoise shell, screening, washing, and crushing, and passing through a 60-80 mesh sieve to obtain a Chinese medicine powder;

[0013] S2, adding the Chinese medicine powder obtained in S1 into deionized water, stirring at 5000 rpm for 100-120 min, adding 2-3% of cellulase by weight of the Chinese medicine powder, adjusting the pH to 5-6, performing enzymolysis in a water bath, performing an oil bath at 120° C. for 5 min, and filtering to obtain the Chinese medicine residue and polysaccharide solution;

[0014] S3, adding the Chinese medicine residue obtained in S2 into anhydrous ethanol, extracting with 50w ultrasonic and 800w microwave, repeating the extraction for 3 times, filtering, rotary evaporation, and freeze drying to obtain an alcohol extract;

[0015] S4, adding methanol to chloroform to obtain a solvent, adding lecithin and cholesterol to the solvent, adding the alcohol extract obtained in S3, mixing evenly, evaporating under reduced pressure, and removing the residual solvent in vacuo to obtain a mixture;

[0016] S5, adding 30 wt% ethanol PBS to the mixture obtained in S4, adding citronellol, stirring magnetically at 600-700 rpm for 30 min, and homogenizing with a dynamic high-pressure microfluidizer to obtain nano inclusions;

[0017] S6. Evenly mix the nano inclusions obtained in S5 with the sustained-release gel solution to obtain a drug-loaded gel, add the polysaccharide solution obtained in S2 into the microneedle mold, dry in a vacuum at -0.07 MPa, scrape off excess material, repeat 2-4 times, add the drug-loaded gel, ultrasonically homogenize, dry, and demold to obtain a kidney-tonifying and aphrodisiac Chinese medicine preparation.

[0018] Preferably, in S2, the amount of the Chinese medicine powder added to deionized water is 20-30 mg / mL.

[0019] Preferably, in S2, the water bath enzymolysis temperature is 50-60°C and the time is 70-90 min.

[0020] Preferably, in S3, the ultrasonic microwave extraction is performed for 10-15 min.

[0021] Preferably, in S4, the amount of methanol added to chloroform is 0.5-0.6 g / mL.

[0022] Preferably, in S5, the amount of citronellol added is 0.3-0.5% by mass of the mixture.

[0023] Preferably, in S6, the vacuum drying time is 4-6 minutes.

[0024] The beneficial effects achieved by the present invention are as follows: a hydrogel is prepared by modifying polylysine with o-vanillin and oxidatively modified pullulan, which has strong adhesion and antibacterial properties, can fit closely to the skin, and reduces the risk of bacterial infection during the use of microneedles; lecithin, cholesterol, ethanol and citronellol are used to encapsulate the alcohol extract of traditional Chinese medicine to prepare nano inclusions, so that the effective ingredients are prevented from being oxidized; the use of citronellol improves the permeability of the stratum corneum and promotes transdermal absorption; at the same time, the traditional Chinese medicine polysaccharide is a soluble needle tip, and the polylysine-pullulan gel-loaded nano inclusions are used as a drug-carrying matrix to form a dual drug-carrying system that promotes absorption; the soluble needle tip destroys the stratum corneum and forms holes, which accelerates the skin's absorption of the nano inclusions released by the gel, and improves the effectiveness speed of the traditional Chinese medicine and the utilization rate of the effective ingredients. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 The figure is the result of the cytotoxicity test of Example 1-3.

[0026] Figure 2 The graph is a result of weight gain of mice in Example 1-3 and Comparative Example 1-3.

[0027] Figure 3 The graph is a result of organ index of mice in Example 1-3 and Comparative Example 1-3.

[0028] Figure 4 The results of the clinical experiments of Examples 1-3 and Comparative Examples 1-3 are shown in FIG.

[0029] The accompanying drawings are used to provide further understanding of the present invention and constitute a part of the specification. They are used to explain the present invention together with the embodiments of the present invention and do not constitute a limitation of the present invention. DETAILED DESCRIPTION

[0030] The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments; based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0031] Unless otherwise defined, all professional and scientific terms used herein have the same meanings as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described herein may be applied to the present invention. The preferred implementation methods and materials described herein are for demonstration purposes only and are not intended to limit the content of this application.

[0032] The experimental methods in the following examples are conventional methods unless otherwise specified; the experimental materials used in the following examples are purchased from commercial channels unless otherwise specified.

[0033] Example 1

[0034] A kidney-tonifying and yang-strengthening Chinese medicine preparation comprises the following components in parts by weight: 12 parts of polygonatum, 6 parts of wolfberry, 13 parts of cynomorium songaricum, 6 parts of cistanche, 10 parts of cornus, 8 parts of cnidium monnieri, 3 parts of psoralea corylifolia, 2 parts of morinda officinalis, 12 parts of tribulus terrestris, 10 parts of leek flower, 1 part of tortoise shell, 3.5 parts of sustained-release gel, 0.4 parts of lecithin and 0.12 parts of cholesterol.

[0035] The sustained-release gel solution is prepared from the following components in parts by weight: 10 parts of o-vanillin, 30 parts of polylysine, 25 parts of pullulan, and 28 parts of sodium periodate.

[0036] The preparation method of the sustained-release gel solution specifically comprises the following steps:

[0037] V1. Add polylysine in an amount of 20 g / mL to water to obtain a polylysine solution, add o-vanillin to a 30 wt% methanol solution to obtain an o-vanillin solution, add the polylysine solution to the o-vanillin solution, and stir the reaction at 30 rpm to obtain a modified polylysine solution;

[0038] V2, adding pullulan in an amount of 15 g / mL to water to obtain a polysaccharide solution, adding sodium periodate to the polysaccharide solution, heating in a water bath in the dark for 3 h, adding ethylene glycol to remove the sodium periodate, dialyzing for 5 days, and freeze-drying to obtain modified pullulan;

[0039] V3. Add the modified pullulan obtained in V2 to the modified polylysine solution obtained in V1, stir for 2 minutes, and mix well to obtain a sustained-release gel solution.

[0040] The present invention also provides a method for preparing a kidney-tonifying and yang-strengthening Chinese medicine preparation, which specifically comprises the following steps:

[0041] S1, taking polygonatum, wolfberry, cynomorium songaricum, cistanche, cornus officinalis, cnidium monnieri, psoralea corylifolia, morinda officinalis, cynomorium terrestris, leek flower, and tortoise shell, screening, washing, crushing, and passing through a 60-mesh sieve to obtain Chinese medicine powder;

[0042] S2, adding the Chinese medicine powder obtained in S1 to deionized water at an addition amount of 20 mg / mL, stirring at a high speed of 5000 rpm for 100 min, adding 2% cellulase by weight of the Chinese medicine powder, adjusting the pH to 5, enzymolyzing in a 50°C water bath for 70 min, and in a 120°C oil bath for 5 min, filtering to obtain the Chinese medicine residue and polysaccharide solution;

[0043] S3, adding the Chinese medicine residue obtained in S2 into anhydrous ethanol, extracting with 50w ultrasonic and 800w microwave for 10min, repeating the extraction for 3 times, filtering, rotary evaporation, and freeze drying to obtain an ethanol extract;

[0044] S4, adding methanol in an amount of 0.5 g / mL to chloroform to obtain a solvent, adding lecithin and cholesterol to the solvent, adding the alcohol extract obtained in S3, mixing evenly, evaporating under reduced pressure, and removing the residual solvent in vacuo to obtain a mixture;

[0045] S5, adding 30wt% ethanol PBS to the mixture obtained in S4, adding 0.3% citronellol by weight of the mixture, stirring magnetically at 600rpm for 30min, and homogenizing with a dynamic high-pressure microfluidizer to obtain nano inclusions;

[0046] S6. Evenly mix the nano inclusions obtained in S5 with the sustained-release gel solution to obtain a drug-loaded gel, add the polysaccharide solution obtained in S2 into the microneedle mold, vacuum dry at -0.07 MPa for 4 min, scrape off excess material, repeat twice, add the drug-loaded gel, ultrasonically homogenize, dry, and demold to obtain a kidney-tonifying and aphrodisiac Chinese medicine preparation.

[0047] Example 2

[0048] A kidney-tonifying and yang-strengthening Chinese medicine preparation comprises the following components in parts by weight: 16 parts of polygonatum, 10 parts of wolfberry, 16 parts of cynomorium songaricum, 12 parts of cistanche, 15 parts of cornus, 12 parts of cnidium monnieri, 7 parts of psoralea corylifolia, 4 parts of morinda officinalis, 16 parts of tribulus terrestris, 16 parts of leek flower, 3 parts of tortoise shell, 5 parts of sustained-release gel, 0.6 parts of lecithin and 0.16 parts of cholesterol.

[0049] The sustained-release gel solution is prepared from the following components in parts by weight: 15 parts of o-vanillin, 35 parts of polylysine, 30 parts of pullulan, and 32 parts of sodium periodate.

[0050] The preparation method of the sustained-release gel solution specifically comprises the following steps:

[0051] V1. Add polylysine in an amount of 30 g / mL to water to obtain a polylysine solution, add o-vanillin to a 30-40 wt% methanol solution to obtain an o-vanillin solution, add the polylysine solution to the o-vanillin solution, and stir the reaction at 30-60 rpm to obtain a modified polylysine solution;

[0052] V2, adding pullulan in an amount of 20 g / mL to water to obtain a polysaccharide solution, adding sodium periodate to the polysaccharide solution, heating in a water bath in the dark for 5 h, adding ethylene glycol to remove the sodium periodate, dialyzing for 5 days, and freeze-drying to obtain modified pullulan;

[0053] V3. Add the modified pullulan obtained in V2 to the modified polylysine solution obtained in V1, stir for 3 minutes, and mix well to obtain a sustained-release gel solution.

[0054] The present invention also provides a method for preparing a kidney-tonifying and yang-strengthening Chinese medicine preparation, which specifically comprises the following steps:

[0055] S1, taking polygonatum, wolfberry, cynomorium songaricum, cistanche, cornus officinalis, cnidium monnieri, psoralea corylifolia, morinda officinalis, cynomorium terrestris, leek flower, and tortoise shell, screening, washing, crushing, and passing through an 80-mesh sieve to obtain Chinese medicine powder;

[0056] S2, adding the Chinese medicine powder obtained in S1 to deionized water at an addition amount of 30 mg / mL, stirring at a high speed of 5000 rpm for 120 min, adding 3% cellulase by weight of the Chinese medicine powder, adjusting the pH to 6, enzymolysis in a water bath at 60°C for 90 min, and an oil bath at 120°C for 5 min, filtering to obtain the Chinese medicine residue and polysaccharide solution;

[0057] S3, adding the Chinese medicine residue obtained in S2 into anhydrous ethanol, extracting with 50w ultrasonic and 800w microwave for 15min, repeating the extraction for 3 times, filtering, rotary evaporation and freeze drying to obtain an ethanol extract;

[0058] S4, adding methanol in an amount of 0.6 g / mL to chloroform to obtain a solvent, adding lecithin and cholesterol to the solvent, adding the alcohol extract obtained in S3, mixing evenly, evaporating under reduced pressure, and removing the residual solvent in vacuo to obtain a mixture;

[0059] S5, adding 30wt% ethanol PBS to the mixture obtained in S4, adding 0.5% citronellol by weight of the mixture, stirring magnetically at 700rpm for 30min, and homogenizing with a dynamic high-pressure microfluidizer to obtain nano inclusions;

[0060] S6. Evenly mix the nano inclusions obtained in S5 with the sustained-release gel solution to obtain a drug-loaded gel, add the polysaccharide solution obtained in S2 into the microneedle mold, vacuum dry at -0.07 MPa for 6 min, scrape off excess material, repeat 4 times, add the drug-loaded gel, ultrasonically homogenize, dry, and demold to obtain a kidney-tonifying and aphrodisiac Chinese medicine preparation.

[0061] Example 3

[0062] A kidney-tonifying and yang-strengthening Chinese medicine preparation comprises the following components in parts by weight: 14 parts of polygonatum, 8 parts of wolfberry, 15 parts of cynomorium songaricum, 10 parts of cistanche, 12 parts of cornus, 9 parts of cnidium monnieri, 4 parts of psoralea corylifolia, 3 parts of morinda officinalis, 15 parts of tribulus terrestris, 14 parts of leek flower, 2 parts of tortoise shell, 4.5 parts of sustained-release gel, 0.5 parts of lecithin and 0.14 parts of cholesterol.

[0063] The sustained-release gel solution is prepared from the following components in parts by weight: 13 parts of o-vanillin, 33 parts of polylysine, 27 parts of pullulan, and 30 parts of sodium periodate.

[0064] The preparation method of the sustained-release gel solution specifically comprises the following steps:

[0065] V1. Add polylysine in an amount of 25 g / mL to water to obtain a polylysine solution, add o-vanillin to a 35 wt% methanol solution to obtain an o-vanillin solution, add the polylysine solution to the o-vanillin solution, and stir the reaction at 40 rpm to obtain a modified polylysine solution;

[0066] V2, adding pullulan in an amount of 17 g / mL to water to obtain a polysaccharide solution, adding sodium periodate to the polysaccharide solution, heating in a water bath in the dark for 4 h, adding ethylene glycol to remove the sodium periodate, dialyzing for 5 days, and freeze-drying to obtain modified pullulan;

[0067] V3. Add the modified pullulan obtained in V2 to the modified polylysine solution obtained in V1, stir for 2.5 min, and mix well to obtain a sustained-release gel solution.

[0068] The present invention also provides a method for preparing a kidney-tonifying and yang-strengthening Chinese medicine preparation, which specifically comprises the following steps:

[0069] S1, taking polygonatum, wolfberry, cynomorium songaricum, cistanche, cornus officinalis, cnidium monnieri, psoralea corylifolia, morinda officinalis, cynomorium terrestris, leek flower, and tortoise shell, screening, washing, crushing, and passing through a 70-mesh sieve to obtain Chinese medicine powder;

[0070] S2, adding the Chinese medicine powder obtained in S1 to deionized water at an addition amount of 25 mg / mL, stirring at a high speed of 5000 rpm for 110 min, adding 2.5% cellulase by weight of the Chinese medicine powder, adjusting the pH to 5.5, enzymolyzing in a water bath at 55°C for 80 min, and in an oil bath at 120°C for 5 min, filtering to obtain the Chinese medicine residue and polysaccharide solution;

[0071] S3, adding the Chinese medicine residue obtained in S2 into anhydrous ethanol, extracting with 50w ultrasonic and 800w microwave for 12min, repeating the extraction 3 times, filtering, rotary evaporation, and freeze drying to obtain an ethanol extract;

[0072] S4, adding methanol in an amount of 0.5.5 g / mL to chloroform to obtain a solvent, adding lecithin and cholesterol to the solvent, adding the alcohol extract obtained in S3, mixing evenly, evaporating under reduced pressure, and removing the residual solvent in vacuo to obtain a mixture;

[0073] S5, adding 30wt% ethanol PBS to the mixture obtained in S4, adding 0.4% citronellol by weight of the mixture, stirring magnetically at 650rpm for 30min, and homogenizing with a dynamic high-pressure microfluidizer to obtain nano inclusions;

[0074] S6. Evenly mix the nano inclusions obtained in S5 with the sustained-release gel solution to obtain a drug-loaded gel; add the polysaccharide solution obtained in S2 into the microneedle mold, vacuum dry at -0.07 MPa for 5 min, scrape off excess material, repeat 3 times, add the drug-loaded gel, ultrasonically homogenize, dry, and demold to obtain a kidney-tonifying and aphrodisiac Chinese medicine preparation.

[0075] Comparative Example 1

[0076] This comparative example provides a kidney-tonifying and yang-strengthening Chinese medicine preparation, which differs from Example 1 only in that nano-inclusions are not prepared in the components, but are simply mixed, and the remaining components and component contents are the same as those in Example 1.

[0077] Comparative Example 2

[0078] This comparative example provides a kidney-tonifying and yang-strengthening Chinese medicine preparation, which differs from Example 1 only in that no drug-loaded gel is prepared among the components, and only simple mixing is performed, and the remaining components and component contents are the same as those in Example 1.

[0079] Comparative Example 3

[0080] This comparative example provides a kidney-tonifying and yang-strengthening Chinese medicine preparation, which differs from Example 1 only in that no microneedles are prepared from the components, but only simple mixing is performed, and the remaining components and component contents are the same as those in Example 1.

[0081] Experimental example

[0082] 1. Toxicity test

[0083] The toxicity test was carried out on mouse Leydig cells, which were inoculated on a 96-well plate with 3000 cells per well. 10uL of culture medium was added to each well, and the culture medium was removed after 24 hours. The experimental group was added with 10ug of the kidney-tonifying and aphrodisiac Chinese medicine preparation obtained in Example 1-3 and 90uL of a culture medium containing 1wt% dimethyl sulfoxide, the control group was added with 100uL of a culture medium containing 1wt% dimethyl sulfoxide, and the blank group was 100uL of a culture medium containing 1% dimethyl sulfoxide. The absorbance of each group was detected at 570nm using an ELISA reader, and the survival rate was calculated using the following formula:

[0084] Survival rate = (absorbance of experimental group - absorbance of blank group) / (absorbance of control group - absorbance of blank group) × 100%.

[0085] Figure 1 The result diagram of the cytotoxicity test of Examples 1-3 is shown in the figure. As shown in the figure, the survival rates of Examples 1-3 are 103.2%, 102.9%, and 101.6%, respectively; the survival rates of Examples 1-3 are all 100% and above, which shows that the kidney-tonifying and aphrodisiac Chinese medicine preparations obtained in Examples 1-3 are non-toxic to cells and have no inhibitory effect on cell division, differentiation and growth.

[0086] 2. Mouse Experiment

[0087] SD rats of similar weight were randomly divided into blank group, model group, Example 1-3, and Comparative Example 1-3, with 10 rats in each group. The blank group was subcutaneously injected with an equal volume of normal saline, and the rats in the other groups were subcutaneously injected with 10 mg / kg hydrocortisone injection for 15 consecutive days to prepare a kidney-yang deficiency erectile dysfunction model.

[0088] Example 1-3, Comparative Example 1-3 The backs of the rats were shaved and administered for 10 days, and the weight of the rats was recorded. The weight gain of the rats was calculated by the following formula: weight gain = weight before the last administration - initial weight;

[0089] After blood sampling, the prostate and seminal vesicles of the rats were dissected and weighed as the total wet weight. The organ index was calculated using the following formula: organ index = total wet weight (g) / rat body weight (100 g).

[0090] Figure 2 The results of the experimental weight gain of mice in Examples 1-3 and Comparative Examples 1-3 are shown in the figure. As shown in the figure, the blank group is 163.2g, the model group is 122.7g, the weight gains of Examples 1-3 are 166.9g, 166.5g, and 166.3g, respectively, and the weight gains of Comparative Examples 1-3 are 143.5g, 143.8g, and 146.9g, respectively; the weight gain of Examples 1-3 is significantly higher than that of Comparative Examples 1-3 and the model group, and slightly higher than that of the blank group, indicating that the preparation of nano-inclusions, drug-loaded gels and microneedles in Examples 1-3 is beneficial for mice to get rid of the symptoms of renal deficiency caused by hydrocortisone.

[0091] Figure 3 The result graph of the organ index of the mouse experiment of Examples 1-3 and Comparative Examples 1-3 is as shown in the figure. The blank group is 0.71, the model group is 0.62, the organ indexes of Examples 1-3 are 0.73, 0.73, and 0.72, respectively, and the organ indexes of Comparative Examples 1-3 are 0.66, 0.67, and 0.66, respectively; the organ index of Examples 1-3 is significantly higher than that of Comparative Examples 1-3 and the model group, and slightly higher than that of the blank group, indicating that the preparation of the nano-inclusions, drug-loaded gels, and microneedles in Examples 1-3 is beneficial for mice to get rid of the symptoms of kidney deficiency caused by hydrocortisone.

[0092] 3. Clinical trials

[0093] 60 male patients were clinically treated, with an age distribution of 20 to 40 years old; they were randomly divided into 6 groups, with 10 people in each group, and used the kidney-tonifying and aphrodisiac Chinese medicine preparations obtained in Examples 1-3 and Comparative Examples 1-3 for 1 week, once in the morning and once in the evening, to understand the improvement of the patients' physical health. The recovery of erectile function within 1 week was considered effective, and the effective rate was calculated by the following formula:

[0094] Effectiveness (%) = number of effective people / 10×100%.

[0095] Figure 4 The results of the clinical experiments of Examples 1-3 and Comparative Examples 1-3 are shown in the figure. As shown in the figure, the effective rates of Examples 1-3 are 90%, 90%, and 90%, respectively, and the organ indexes of Comparative Examples 1-3 are 60%, 70%, and 60%, respectively; the effective rate of Examples 1-3 is significantly higher than that of Comparative Examples 1-3 and the model group, and slightly higher than that of the blank group, indicating that the preparation of nano-inclusions, drug-loaded gels and microneedles in Examples 1-3 is beneficial to the treatment of symptoms of impotence due to kidney deficiency.

[0096] 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 can be modified or replaced by equivalents without departing from the purpose and scope of the technical solutions of the present invention, which should be included in the scope of the claims of the present invention.

Claims

1. A Chinese medicine preparation for invigorating the kidney and strengthening yang, characterized in that: The invention comprises the following components in parts by weight: 12-16 parts of polygonatum, 6-10 parts of wolfberry, 13-16 parts of cynomorium songaricum, 6-12 parts of cistanche, 10-15 parts of cornus, 8-12 parts of cnidium monnieri, 3-7 parts of psoralea corylifolia, 2-4 parts of morinda officinalis, 12-16 parts of tribulus terrestris, 10-16 parts of leek flower, 1-3 parts of tortoise shell, 3.5-5 parts of sustained-release gel, 0.4-0.6 parts of lecithin and 0.12-0.16 parts of cholesterol.

2. The kidney-tonifying and yang-strengthening Chinese medicine preparation according to claim 1, characterized in that: The sustained-release gel solution is prepared from the following components in parts by weight: 10-15 parts of o-vanillin, 30-35 parts of polylysine, 25-30 parts of pullulan, and 28-32 parts of sodium periodate.

3. The kidney-tonifying and yang-strengthening Chinese medicine preparation according to claim 2, characterized in that: The method for preparing the sustained-release gel solution specifically comprises the following steps: V1. Add polylysine in an amount of 20-30 g / mL to water to obtain a polylysine solution, add o-vanillin to a 30-40 wt% methanol solution to obtain an o-vanillin solution, add the polylysine solution to the o-vanillin solution, and stir the reaction at 30-60 rpm to obtain a modified polylysine solution; V2, adding pullulan in an amount of 15-20 g / mL to water to obtain a polysaccharide solution, adding sodium periodate to the polysaccharide solution, heating in a water bath in the dark for 3-5 hours, adding ethylene glycol to remove the sodium periodate, dialyzing for 5 days, and freeze-drying to obtain modified pullulan; V3. Add the modified pullulan obtained in V2 to the modified polylysine solution obtained in V1, stir for 2-3 minutes, and mix well to obtain a sustained-release gel solution.

4. The kidney-tonifying and yang-strengthening Chinese medicine preparation according to claim 3, characterized in that: The preparation method specifically comprises the following steps: S1, taking polygonatum, wolfberry, cynomorium songaricum, cistanche, cornus officinalis, cnidium monnieri, psoralea corylifolia, morinda officinalis, cynomorium terrestris, leek flower, and tortoise shell, screening, washing, and crushing, and passing through a 60-80 mesh sieve to obtain a Chinese medicine powder; S2, adding the Chinese medicine powder obtained in S1 into deionized water, stirring at 5000 rpm for 100-120 min, adding 2-3% of cellulase by weight of the Chinese medicine powder, adjusting the pH to 5-6, performing enzymolysis in a water bath, performing an oil bath at 120° C. for 5 min, and filtering to obtain the Chinese medicine residue and polysaccharide solution; S3, adding the Chinese medicine residue obtained in S2 into anhydrous ethanol, extracting with 50w ultrasonic and 800w microwave, repeating the extraction for 3 times, filtering, rotary evaporation, and freeze drying to obtain an alcohol extract; S4, adding methanol to chloroform to obtain a solvent, adding lecithin and cholesterol to the solvent, adding the alcohol extract obtained in S3, mixing evenly, evaporating under reduced pressure, and removing the residual solvent in vacuo to obtain a mixture; S5, adding 30 wt% ethanol PBS to the mixture obtained in S4, adding citronellol, stirring magnetically at 600-700 rpm for 30 min, and homogenizing with a dynamic high-pressure microfluidizer to obtain nano inclusions; S6. Evenly mix the nano inclusions obtained in S5 with the sustained-release gel solution to obtain a drug-loaded gel, add the polysaccharide solution obtained in S2 into the microneedle mold, dry in a vacuum at -0.07 MPa, scrape off excess material, repeat 2-4 times, add the drug-loaded gel, ultrasonically homogenize, dry, and demold to obtain a kidney-tonifying and aphrodisiac Chinese medicine preparation.

5. The kidney-tonifying and yang-strengthening Chinese medicine preparation according to claim 4, characterized in that: In S2, the amount of the Chinese medicine powder added to deionized water is 20-30 mg / mL.

6. The kidney-tonifying and yang-strengthening Chinese medicine preparation according to claim 5, characterized in that: In S2, the water bath enzymolysis temperature is 50-60°C and the time is 70-90 min.

7. The kidney-tonifying and yang-strengthening Chinese medicine preparation according to claim 6, characterized in that: In S3, the ultrasonic microwave extraction is performed for 10-15 minutes.

8. The kidney-tonifying and yang-strengthening Chinese medicine preparation according to claim 7, characterized in that: In S4, the amount of methanol added to chloroform is 0.5-0.6 g / mL.

9. The kidney-tonifying and yang-strengthening Chinese medicine preparation according to claim 8, characterized in that: In S5, the amount of citronellol added is 0.3-0.5% by mass of the mixture.

10. The kidney-tonifying and yang-strengthening Chinese medicine preparation according to claim 9, characterized in that: In S6, the vacuum drying time is 4-6 minutes.

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