Traditional Chinese medicine composition for invigorating kidney and strengthening yang and preparation method thereof

Abstract

The invention belongs to the field of pharmaceutical composition preparation, and particularly relates to a traditional Chinese medicine composition for invigorating kidney and strengthening yang and a preparation method thereof, the traditional Chinese medicine composition is composed of the following raw materials by weight: 50 g of epimedium, 50 g of cistanche, 50 g of cordyceps sinensis, 50 g of cynomorium songaricum, and 50 g of eucommia ulmoides. The weight ratio of the herba epimedii to the cistanche to the cordyceps sinensis to the cynomorium songaricum to the eucommia ulmoides is the same and is 1: 1: 1: 1: 1. Therefore, through the raw material combination design that the specific medicinal parts of the raw materials are defined and the weight ratio of the herba epimedii to the herba cistanche to the cordyceps sinensis to the cynomorium songaricum to the eucommia ulmoides is 1: 1, the core effective components of the raw materials are distributed in a balanced proportion, and the effect of synergistically constructing a kidney-tonifying essence-strengthening body-strengthening stable effect system is achieved; therefore, the problems that in the background technology, an existing kidney-tonifying and yang-strengthening traditional Chinese medicine preparation is lack of accuracy in raw material proportioning and fuzzy in medicinal part, so that a preparation effect system is unstable, and the requirements of most people with insufficiency of kidney yang cannot be met are solved.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of preparation of pharmaceutical combinations, and particularly relates to a traditional Chinese medicine composition for tonifying kidney and strengthening yang and a preparation method thereof. BACKGROUND

[0002] At present, there are various tonifying kidney and strengthening yang traditional Chinese medicine preparations on the market for problems of kidney yang deficiency and essence qi deficiency. The traditional Chinese medicine preparations are usually prepared by conventional processes such as crushing, decocting and mixing, with traditional Chinese medicinal materials such as Herba Epimedii, Cistanche deserticola, Cynomorium songaricum and Eucommia ulmoides as raw materials, aiming to improve the discomfort symptoms such as fatigue and aversion to cold caused by kidney yang deficiency through the synergistic effect of traditional Chinese medicine ingredients, and are widely used in the field of traditional Chinese medicine conditioning.

[0003] However, most of the existing tonifying kidney and strengthening yang traditional Chinese medicine preparations lack precision in the design of raw material ratio, and the synergistic mechanism between different medicinal materials is not fully considered, and there is often a situation that the dosage of some medicinal materials is too high or too low, which leads to the inability of the preparation to form a stable efficacy system, or the short-term tonifying kidney effect and the difficulty in continuously improving the essence qi state, or the imbalance of the strengthening yang effect and the inability to adapt to the needs of most people with kidney yang deficiency, and the overall efficacy stability is poor, which is difficult to achieve the ideal conditioning effect. SUMMARY

[0004] The present application aims to solve the problems in the prior art that most of the existing tonifying kidney and strengthening yang traditional Chinese medicine preparations lack precision in the design of raw material ratio, and the synergistic mechanism between different medicinal materials is not fully considered, and there is often a situation that the dosage of some medicinal materials is too high or too low, which leads to the inability of the preparation to form a stable efficacy system, or the short-term tonifying kidney effect and the difficulty in continuously improving the essence qi state, or the imbalance of the strengthening yang effect and the inability to adapt to the needs of most people with kidney yang deficiency, and the overall efficacy stability is poor, which is difficult to achieve the ideal conditioning effect, and provides a traditional Chinese medicine composition for tonifying kidney and strengthening yang and a preparation method thereof.

[0005] To achieve the above-mentioned purpose, the following technical scheme is adopted: a traditional Chinese medicine composition for tonifying kidney and strengthening yang and a preparation method thereof, which is composed of the following raw materials by weight: Herba Epimedii 50g, Cistanche deserticola 50g, Cordyceps sinensis 50g, Cynomorium songaricum 50g, and Eucommia ulmoides 50g; the weight ratio of Herba Epimedii, Cistanche deserticola, Cordyceps sinensis, Cynomorium songaricum and Eucommia ulmoides is 1:1:1:1:1.

[0006] A preparation method of the traditional Chinese medicine composition for tonifying kidney and strengthening yang according to claim 1, comprising the following steps: S1. Raw material pretreatment, respectively select Epimedium, Cistanche, Cordyceps, Cynomorium, Eucommia, and wash with clean water to remove surface impurities, then place each raw material in a temperature of 60-65℃ air oven for drying until the moisture content of the raw material is ≤8%; after drying, each raw material is put into a pulverizer and pulverized to a powder with a particle size of 80-100 mesh, and then mixed evenly to obtain a raw material mixed powder; S2. Extraction, transfer the raw material mixed powder obtained in step 1 to an extraction tank, add 8-12 times the amount of purified water based on the total weight of the raw material mixed powder, and soak at room temperature for 1-2 hours; after soaking, heat the extraction tank to make the liquid in the tank boil, and keep it in a state of gentle boiling for 2-3 times, each time for 1-1.5 hours; after the end of the decoction, the filtrate obtained by each decoction is collected as the extraction liquid. S3. Concentration and drying, the extraction liquid obtained in step 2 is sent to a reduced pressure concentration tank, the concentration temperature is set to 60-70℃, the vacuum degree is set to -0.08 to -0.09 MPa, and the reduced pressure concentration operation is carried out until the relative density of the extract is 1.20-1.30, which is measured at 60℃; the extract is sent to a spray dryer, the inlet air temperature is set to 180-200℃, and the outlet air temperature is set to 80-90℃, and the spray drying process is carried out to obtain dried extract powder. S4. Preparation of the preparation, add pharmaceutical excipients to the dried extract powder obtained in step 3, mix evenly, then use a wetting agent to make a soft material, pass through an 18-mesh sieve to obtain wet granules; dry the wet granules in an oven at 55-60℃ until the moisture content of the granules is ≤5%, then pass through a 16-mesh sieve to size the granules; fill the sized granules into empty capsule shells to obtain capsule preparations; the weight of each capsule is 0.7 grams, and the total weight of twenty capsule preparations is 14 grams.

[0007] Further, the medicinal parts of the raw materials are as follows: Epimedium is the dried aerial part of Epimedium herb, Cistanche is the dried succulent stem of Cistanche deserticola Y.C.Ma or Cistanche tubulosa (Schenk) R.Wight, Cordyceps is the complex of the stroma of Cordyceps sinensis (Berk.) G.H. Kerr and the larva of Hepialidae, Cynomorium is the dried succulent stem of Cynomorium songaricum, and Eucommia is the dried bark of Eucommia ulmoides.

[0008] Further, in step 2, the amount of purified water added is 10 times the total weight of the raw material mixed powder, the soaking time is 1.5 hours, the number of decoctions is 2, the first decoction time is 1.5 hours, and the second decoction time is 1 hour.

[0009] Further, in step 3, the operating parameters of the reduced pressure concentration are specifically: temperature 65 DEG C, vacuum degree -0.085 MPa, and the relative density of the extract is 1.25, which is measured at 60 DEG C; the operating parameters of the spray drying are specifically: air inlet temperature 190 DEG C, air outlet temperature 85 DEG C.

[0010] Further, in step 4, the medicinal excipient is starch, and the addition amount of the starch is 15% of the weight of the dry extract powder; the wetting agent is an ethanol solution with a volume fraction of 50%, and the addition amount of the ethanol solution is 8%-10% of the total weight of the dry extract powder and the starch.

[0011] Further, the quality standards of each raw material calculated based on the dry product meet the following requirements: the content of icariin in Herba Epimedii is 0.5%-2.0%, the total content of pinostroside and verbascoside in Cistanche is 0.3%-1.0%, the content of chlorogenic acid in Eucommia ulmoides is 0.1%-0.5%, the content of gallic acid in Cynomorium songaricum is 0.1%-0.3%, and the content of adenosine in Cordyceps sinensis is 0.01%-0.05%, and each raw material meets the corresponding medicinal quality standard.

[0012] A tablet preparation of the kidney-tonifying and yang-strengthening traditional Chinese medicine composition of claim 1, wherein the preparation method of the tablet is based on the preparation method of claim 2, and the "preparation forming" step of step 4 is replaced by: adding medicinal excipients to the dry extract powder obtained in step 3, wherein the addition amount of starch is 15% of the weight of the dry extract powder, and the addition amount of magnesium stearate is 0.5% of the total weight of the dry extract powder and the starch, and then uniformly mixing and directly compressing by using a rotary tablet press; the weight of each tablet is 0.7 g, the total weight of twenty tablets is 14 g, and the disintegration time in artificial gastric juice with pH 1.2 is not more than 30 minutes.

[0013] Compared with the prior art, the kidney-tonifying and yang-strengthening traditional Chinese medicine composition and the preparation method thereof have the following advantages: 1. The raw material combination design of "defining specific medicinal parts of each raw material (such as the dry aboveground part of Epimedium sagittatum Maxim. of the Berberidaceae family, the dry succulent stem of Cistanche tubulosa, etc.) + 1:1 weight ratio of Epimedium sagittatum Maxim., Cistanche tubulosa, Cordyceps sinensis, Cynomorium songaricum, Eucommia ulmoides" realizes the balanced distribution of the core effective components (icariin, pinostroside, adenosine, etc.) of each raw material in a balanced proportion, and cooperatively constructs a stable efficacy system of "tonifying kidney, nourishing essence and strengthening body", thereby solving the problems of the background art, such as the lack of precision in the raw material ratio of the existing kidney-tonifying and yang-strengthening traditional Chinese medicine preparation, the ambiguity of medicinal parts, and the instability of the efficacy system of the preparation, which cannot adapt to the needs of most people with insufficient kidney yang.

[0014] 2、The application realizes that the effective components in the raw materials are fully dissolved, the heat-sensitive components (such as adenosine and icariin) are stably reserved without being destroyed by high temperature, and the preparation particles are uniform and the dose of each particle (tablet) is accurate, thereby solving the problems of the loose preparation process steps, the insufficient extraction of effective components, the low retention rate due to high temperature destruction and the large dose fluctuation in the background art.

[0015] 3、The application realizes that the capsule particles are good in forming, the disintegration time of the tablets in artificial gastric juice pH1.2 is less than or equal to 30 minutes (the effective components are quickly dissolved and absorbed), and the effective components of each batch of raw materials meet the standard, thereby solving the problems of the poor particle forming, the slow disintegration of the tablets / effective component absorption delay and the large fluctuation of the effective component content due to the improper selection of the preparation auxiliary materials in the background art. BRIEF DESCRIPTION OF DRAWINGS

[0016] Figure 1 is a structural schematic diagram of a kidney-tonifying and yang-strengthening traditional Chinese medicine composition and a preparation method process thereof provided by the application. DETAILED DESCRIPTION

[0017] The following examples are for illustrative purposes only and are not intended to limit the scope of the application.

[0018] As shown in Figure 1 , the application provides a kidney-tonifying and yang-strengthening traditional Chinese medicine composition and a preparation method thereof, which are composed of the following raw materials by weight: 50 grams of Epimedium, 50 grams of Cistanche, 50 grams of Cordyceps, 50 grams of Cynomorium, and 50 grams of Eucommia.

[0019] It should be noted that the traditional Chinese medicine composition described in this embodiment is combined by matching Epimedium, Cistanche, Cordyceps, Cynomorium songaricum and Eucommia ulmoides by equal weight, fully taking into account the core effect of each raw material - Epimedium can be targeted to warm kidney yang, Cistanche can assist in nourishing essence and blood, moistening the intestines and dryness, Cordyceps can nourish the lungs and kidneys, fill essence and marrow, Cynomorium songaricum can nourish kidney yang and essence and blood, and Eucommia ulmoides can nourish the liver and kidney and strengthen bones and muscles. The effects of the five raw materials are complementary and have no conflict, and a stable "nourishing kidney-essence-strengthening body" efficacy system can be formed, avoiding the overuse of a single raw material leading to biased efficacy or the lack of a single raw material leading to the loss of efficacy, and ensuring that the composition can achieve multi-dimensional regulation when improving symptoms related to kidney yang deficiency and essence deficiency.

[0020] Specifically, by matching the five raw materials by equal weight, the effective components in each raw material (such as icariin in Epimedium, trichosanthin in Cistanche, etc.) exist in a balanced proportion, and after taking, each effective component can act on the human kidney and related functional systems, synergistically playing the role of warming and tonifying kidney yang and filling essence and marrow, without relying on the excessive addition of a certain raw material to make up for the deficiency of other raw materials. This matching method precisely solves the problem of "lack of precision in raw material matching and instability of efficacy system in existing kidney-nourishing and yang-strengthening traditional Chinese medicine preparations" in the background art, making the conditioning effect of the composition more balanced and more easily adaptable to the needs of most people with kidney yang deficiency.

[0021] A preparation method of the kidney-nourishing and yang-strengthening traditional Chinese medicine composition according to claim 1, comprising the following steps: S1. Raw material pretreatment, respectively select Epimedium, Cistanche, Cordyceps, Cynomorium songaricum and Eucommia ulmoides, wash with clean water to remove surface impurities, then dry each raw material in a forced air oven at a temperature of 60-65°C until the water content of the raw material is ≤8%; after drying, each raw material is respectively put into a pulverizer and pulverized to a powder with a particle size of 80-100 mesh, and the single powders of each raw material are mixed uniformly to obtain a raw material mixed powder; S2. Extraction, transfer the raw material mixed powder obtained in step 1 to an extraction tank, add 8-12 times the amount of purified water based on the total weight of the raw material mixed powder, soak at room temperature for 1-2 hours; after soaking, heat the extraction tank to make the liquid in the tank boil, keep it in a state of micro-boiling and decoct for 2-3 times, each time for 1-1.5 hours; after decoction, combine the medicinal liquid obtained from each decoction, filter with 100-120 mesh filter cloth to remove the dregs, and collect the filtrate as the extraction liquid; S3. Concentration and drying, transfer the extraction liquid obtained in step 2 to a vacuum concentration tank, set the concentration temperature to 60-70°C and the vacuum degree to -0.08 to -0.09 MPa, and perform vacuum concentration operation until the relative density of the obtained extract is 1.20-1.30, which is measured at 60°C; send the extract into a spray dryer, set the inlet air temperature to 180-200°C and the outlet air temperature to 80-90°C, and perform spray drying to obtain dried extract powder; S4. Formulation molding, adding pharmaceutical excipients to the dry extract powder obtained in step 3, uniformly mixing, then using a wetting agent to make a soft material, passing through an 18-mesh sieve to obtain wet granules; placing the wet granules in an oven at 55-60°C for drying until the moisture content of the granules is ≤5%, then passing through a 16-mesh sieve to size the granules; filling the sized granules into empty gelatin capsule shells to make capsule tablets; each capsule tablet weighs 0.7 grams, and the total weight of twenty capsule tablets is 14 grams.

[0022] It should be noted that the preparation method described in this embodiment forms a close logical connection between each step: the pretreatment of the raw materials ensures the purity of the raw materials by washing to remove impurities, drying controls the moisture content to avoid mold growth or affect the subsequent crushing effect, and crushing to a specific particle size provides sufficient contact area for the dissolution of the active ingredients in the extraction step; the combination of soaking and decoction in the extraction step can first allow the raw materials to fully absorb water and swell, break the cell wall, and then gradually dissolve the active ingredients with different solubilities through multiple gentle boiling decoctions, and filtration removes the dregs to avoid impurities mixing in; the low-temperature and reduced-pressure method used in the concentration and drying step can avoid the destruction of heat-sensitive active ingredients at high temperatures while concentrating the extract to an appropriate consistency, and spray drying can quickly convert the extract into a dry extract powder with good flowability, facilitating subsequent preparation; the formulation molding step ensures the uniformity of the granules through granulation, drying, and sizing, thereby ensuring the accuracy of each dose when filling the capsules, and ultimately achieving the preparation goal of "sufficient extraction of active ingredients, stable retention of ingredients, and precise control of dosage".

[0023] Specifically, the working principle of the preparation method is: taking "pretreatment as the basis for extraction, extraction as the raw material for concentration, concentration and drying as the retention of active ingredients in the preparation, and formulation molding as the guarantee of convenience and dosage accuracy" as the core logic, through the cooperation of each step, the active ingredients in the raw materials are first maximized, then the activity of the ingredients is retained through a mild concentration and drying method, and finally the active ingredient content of each capsule is ensured to be consistent through a standardized preparation process; This method solves the problems of "loose connection between steps of existing preparation processes, insufficient extraction or low retention rate of active ingredients, and large fluctuations in the dosage of the preparation" in the background art, significantly improving the efficacy stability and reliability of the final product.

[0024] Further, the medicinal parts of the raw materials are as follows: Epimedium is the dry aboveground part of Epimedium brevicornum, Cistanche is the dry succulent stem of Cistanche tubulosa or Cistanche deserticola, Cordyceps is the complex of the stroma of Ophiocordyceps sinensis parasitizing on the larva of the Hepialidae family and the larva's body, Cynomorium is the dry succulent stem of Cynomorium songaricum, and Eucommia is the dry bark of Eucommia ulmoides.

[0025] It should be noted that the raw material parts described in this embodiment are determined based on the distribution of each raw material active ingredient: the kidney-warming and yang-strengthening active ingredients (such as icariin) of Epimedium are mainly concentrated in the dry aboveground parts, and the underground parts have low content and are easily mixed with impurities; the essence and blood-nourishing active ingredients (such as echinacoside and verbascoside) of Cistanche are mainly stored in the dry stem, which is thick and has sufficient ingredient accumulation; the lung and kidney-tonifying active ingredients (such as adenosine) of Cordyceps are mainly present in the complex of stroma and larva corpse, and the content of single stroma or larva corpse is not complete; the kidney-yang tonifying active ingredients (such as gallic acid) of Cynomorium are mainly enriched in the dry stem, and the content of other parts is very low; the liver and kidney tonifying active ingredients (such as chlorogenic acid) of Eucommia are mainly distributed in the dry bark, and the xylem hardly contains active ingredients; specifying specific medicinal parts can ensure that the active ingredient basis of each batch of raw materials is consistent, and avoid fluctuations in ingredient content caused by mixed medicinal parts.

[0026] Specifically, by locking the specific parts where each raw material active ingredient is concentrated, the "active ingredient basis purity" of the raw material is ensured from the source, so that when the subsequent 1:1 combination is made, the active ingredients of each raw material can synergistically act in the expected proportion, rather than breaking the ratio balance due to improper medicinal parts leading to insufficient actual active ingredients of a certain raw material; this selection method solves the problem in the background art that "the medicinal parts of existing preparation raw materials are not clear, the content of active ingredients fluctuates greatly, and then leads to unstable preparation efficacy", and provides a source guarantee for the stability of the efficacy of the composition.

[0027] Further, in step 2, the amount of purified water added is 10 times the total weight of the raw material mixed powder, the soaking time is 1.5 hours, and the decoction time is 2 times, the first decoction time is 1.5 hours, and the second decoction time is 1 hour.

[0028] It should be noted that the extraction step parameters described in this embodiment are verified through multiple optimizations: the addition of 10 times the amount of purified water can completely immerse the raw material mixed powder, ensure that the active ingredients are fully dissolved, and also avoid excessive water leading to longer time and increased energy consumption in the subsequent concentration step; the soaking time of 1.5 hours can make the raw material mixed powder fully absorb water and swell, making the cell wall structure loose, creating conditions for the rapid dissolution of active ingredients in the subsequent decoction, avoiding slow dissolution due to too short soaking time, or deterioration of the raw material due to too long soaking time; the time allocation of two decoctions (1.5 hours + 1 hour) can fully extract the easily dissolved active ingredients in the raw material in the first decoction, and can specifically extract the residual difficult-to-dissolve ingredients in the second decoction, which can improve the extraction efficiency in the same total time compared to single long-time decoction, while reducing the damage to some heat-sensitive ingredients caused by long-time high temperature.

[0029] Specifically, by precisely controlling the water amount, soaking time, and decoction times and time, a balance is found between "sufficient extraction of effective components" and "energy saving and protection of components" - sufficient water amount and appropriate soaking time lay the foundation for dissolution, and gradient extraction of effective components is realized by multiple decoctions, avoiding insufficient extraction or component loss caused by improper single parameter; the parameter setting solves the problem of "existing extraction process parameter ambiguity, low extraction efficiency or large effective component loss" in the background art, so that the extraction steps can not only ensure the yield of effective components, but also take into account the economy and stability of the subsequent process.

[0030] Further, in step 3, the operating parameters of the reduced pressure concentration are: temperature 65℃, vacuum degree -0.085MPa, and the relative density of the extract is 1.25, which is measured at 60℃.

[0031] It should be noted that the concentration and drying parameters described in this embodiment are designed according to the characteristics of the effective components: the reduced pressure concentration temperature of 65℃ and the vacuum degree of -0.085MPa can reduce the boiling point of the extract while achieving low-temperature concentration, avoiding the decomposition of heat-sensitive effective components such as icariin and adenosine in high-temperature environment; the relative density of the extract of 1.25 can ensure that the extract has appropriate viscosity, avoiding excessive energy consumption during spray drying due to excessive thinning, or pipe blockage due to excessive thickening, and also provides a good foundation for forming uniform powder during subsequent spray drying; the inlet air temperature of 190℃ for spray drying can quickly atomize the extract into small droplets, and the outlet air temperature of 85℃ can quickly dry the droplets into powder while avoiding the deterioration of the finished powder due to excessive temperature, ultimately obtaining dry extract powder with uniform particle size and good flowability.

[0032] Specifically, with "low-temperature protection of components, appropriate consistency to ensure smooth process, and precise air temperature to ensure drying effect" as the core, the operating temperature is reduced by reduced pressure concentration to protect heat-sensitive effective components from being destroyed, the relative density of the extract is controlled to ensure smooth subsequent spray drying, and the inlet and outlet air temperatures are matched to achieve rapid drying of the extract and stable quality of the finished product; the parameter setting solves the problem of "existing concentration and drying temperature being too high to cause damage to effective components, or improper parameters causing process failure" in the background art, effectively improving the retention rate of effective components in the dry extract powder and the quality of the finished product.

[0033] Further, in step 4, the pharmaceutical excipient is starch, and the addition amount of starch is 15% of the weight of the dry extract powder; the wetting agent is an ethanol solution with a volume fraction of 50%, and the addition amount of the ethanol solution is 8%-10% of the total weight of the dry extract powder and starch.

[0034] It should be noted that the selection and amount of the adjuvant and wetting agent described in this embodiment fully adapt to the characteristics of the dry paste powder: starch as a pharmaceutical adjuvant has good fluidity and formability, and the addition of 15% can just improve the problem of strong moisture absorption and poor fluidity of the dry paste powder, so that the mixed material is easy to be made into soft material, and the excessive amount of starch will not cause the effective ingredient content to be diluted too much; the 50% ethanol solution as a wetting agent can provide appropriate viscosity to form uniform soft material, and due to the volatility of ethanol, it can quickly evaporate in the subsequent drying step to avoid mold growth caused by excessive residual moisture, and the addition of 8%-10% can adapt to the humidity difference of different batches of dry paste powder to ensure that whether the humidity of the dry paste powder is slightly high or slightly low, the soft material meeting the requirements can be prepared.

[0035] Specifically, the physical properties of the dry paste powder are improved by starch to solve the problems of poor fluidity and poor formability, and 50% ethanol solution is used to provide appropriate viscosity and facilitate subsequent drying, and the combination of the two ensures smooth preparation of soft material and uniform particle formation; this selection method solves the problem of "inappropriate selection of existing preparation adjuvants leading to poor particle formation or residual wetting agent affecting product quality" in the background art, ensuring the uniformity and stability of the capsule particles, and further ensuring the accurate dosage of each capsule.

[0036] Further, the quality standards of each raw material calculated based on dry products meet the following requirements: the content of icariin in Herba Epimedii is 0.5%-2.0%, the total content of echinacoside and verbascoside in Herba Cistanche is 0.3%-1.0%, the content of chlorogenic acid in Eucommia ulmoides is 0.1%-0.5%, the content of gallic acid in Herba Cynomorii is 0.1%-0.3%, and the content of adenosine in Cordyceps sinensis is 0.01%-0.05%, and each raw material meets the corresponding pharmaceutical quality standard of medicinal materials.

[0037] It should be noted that the quality standards of the raw materials described in this embodiment are determined based on the efficacy threshold of the core effective ingredients of each raw material: the content range of icariin in Herba Epimedii can ensure that its warming kidney yang effect meets the basic requirements, while avoiding the discomfort caused by excessive content; the total content range of echinacoside and verbascoside in Herba Cistanche can ensure that its effect of benefiting essence and blood and moistening the intestines and dryness is stable; the content range of chlorogenic acid in Eucommia ulmoides can ensure that its effect of tonifying liver and kidney and strengthening bones meets the standard; the content range of gallic acid in Herba Cynomorii can ensure its basic effect of tonifying kidney yang and benefiting essence and blood; the content range of adenosine in Cordyceps sinensis can ensure that its effect of tonifying lung and kidney and filling essence and marrow meets the expectation; by specifying these content ranges, inferior raw materials with low effective ingredient content can be excluded at the raw material level to avoid affecting the efficacy of the final preparation.

[0038] Specifically, the working principle of setting the raw material quality standard is: by specifying the content range of each raw material core active ingredient, establishing the raw material access threshold, ensuring that each batch of raw material used has a stable active ingredient basis, and then making the overall active ingredient content of the composition prepared according to 1:1 ratio always within the range that can exert stable efficacy; the standard setting solves the problem in the background art that "there is no clear quality standard for existing preparation raw materials, the active ingredient content fluctuates greatly, leading to unstable preparation efficacy", and provides a key guarantee for the consistency of the efficacy of the composition.

[0039] A tablet preparation of the kidney-tonifying and yang-strengthening traditional Chinese medicine composition of claim 1, wherein the tablet is prepared by replacing the "preparation molding" step of step 4 with the following step: adding pharmaceutical excipients to the dry paste powder obtained in step 3, wherein the amount of starch added is 15% of the weight of the dry paste powder, and the amount of magnesium stearate added is 0.5% of the total weight of the dry paste powder and starch, and then uniformly mixing and directly compressing the mixture using a rotary tablet press; the weight of each tablet is 0.7 grams, the total weight of twenty tablets is 14 grams, and the disintegration time in artificial gastric juice with pH 1.2 is not more than 30 minutes.

[0040] It should be noted that the tablet preparation and preparation described in this embodiment optimize the excipients and process according to the characteristics of the tablet: starch as a filler, an addition amount of 15% can make the dry paste powder form a material with suitable hardness and brittleness, facilitating direct compression; magnesium stearate as a lubricant, an addition amount of 0.5% can reduce the friction between the material and the mold of the tablet press, avoiding problems such as sticking, cracking, etc. during compression, while not affecting the disintegration and active ingredient dissolution of the tablet; the direct compression process does not require a granulation step, simplifying the operation process and reducing the impact of the process on the active ingredient; the disintegration time control ensures that the tablet can quickly disintegrate after entering the human body, so that the active ingredient is dissolved and absorbed in time, avoiding delayed drug efficacy due to slow disintegration.

[0041] Specifically, by optimizing the excipient combination (starch + magnesium stearate), the process difficulty of directly compressing the dry paste powder is solved, the tablet molding quality is ensured, and the rapid release of the active ingredient is ensured by controlling the disintegration time; this preparation form and preparation method, while retaining the core efficacy of the composition, provides a different choice for taking capsules, and solves the problems in the background art that "existing tablet preparations disintegrate slowly, active ingredient absorption is delayed, or the compression process is complex, leading to ingredient loss", further improving the adaptability of the composition to taking and the efficiency of efficacy exertion.

[0042] In summary, the purity of the raw material base effective component is ensured; then Epimedium, Cistanche, Cordyceps sinensis, Cynomorium songaricum and Eucommia ulmoides are combined in equal weight to make the core effective components (such as icariin, trilobatin, adenosine, etc.) of each raw material exist in a balanced proportion, forming a synergistic efficacy system of "tonifying kidney, nourishing essence and strengthening body"; and then through the closely linked preparation steps, the effective components are fully extracted and stably retained. In the raw material pretreatment stage, impurities are removed by water, the moisture is controlled by drying at 60-65℃, and the raw material is crushed to 80-100 mesh to provide pure and sufficient contact area for the dissolution of effective components; in the extraction stage, 10 times the amount of purified water is used, soaked for 1.5 hours, and decocted twice (1.5 hours + 1 hour) to realize the gradient dissolution of effective components, and the residue is removed by filtration to avoid the mixing of impurities; in the concentration and drying stage, 65℃, -0.085MPa reduced pressure concentration (extract relative density 1.25) and 190℃ inlet air / 85℃ outlet air spray drying are adopted to protect the heat-sensitive effective components and form a dry extract powder with good fluidity; in the preparation stage, the appropriate excipients are selected according to the dosage form requirements (starch is used as an excipient for capsules, 50% ethanol is used as a wetting agent, and starch + 0.5% magnesium stearate is used for tablets), the amount of excipients is controlled (starch is 15% of the dry extract powder), and the capsule particles are uniform, the dosage of each capsule is 0.7g, and the tablet is directly compressed into a tablet and the disintegration time in artificial gastric juice pH 1.2 is ≤30 minutes; at the same time, the content range of each raw material core effective component (such as icariin 0.5%-2.0%, total amount of Cistanche trilobatin and verbascoside 0.3%-1.0%, etc.) is determined to establish the raw material access standard, and to ensure that the effective components of each batch of raw materials meet the standards. The overall working principle accurately solves the series of problems raised in the background technology: the equal weight ratio of raw materials combined with the clear medicinal parts solves the problem of unstable efficacy system caused by the lack of precision in the existing kidney tonifying and yang invigorating traditional Chinese medicine preparation raw material ratio and the ambiguity of medicinal parts; the closely linked preparation steps and the optimization of each link parameters (such as extraction water volume, decoction time, concentration temperature, spray air temperature) solve the problem of loose existing process steps, insufficient extraction of effective components or low retention rate caused by high temperature damage; the selection and amount control of the appropriate excipients (such as starch to improve fluidity and magnesium stearate to reduce tablet friction) solve the problem of poor particle formation and large dosage fluctuation of the existing preparation caused by improper excipients; the tablet disintegration time control and the direct compression process solve the problem of slow disintegration of the existing tablet preparation, delayed absorption of effective components or complex process leading to component loss; the determination of the content range of the core effective component of the raw material solves the problem of no clear quality standard of the existing preparation raw material and large fluctuation of the content of effective components, and finally realizes the goals of balanced and stable composition efficacy, efficient and controllable preparation process, convenient and accurate dosage of the preparation.

[0043] The above is only a preferred embodiment of the present application, and is not intended to limit the present application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition for tonifying kidney and strengthening yang, characterized in that it is composed of the following raw materials by weight: Herba Epimedii 50 g, Cistanche 50 g, Cordyceps 50 g, Cynomorium 50 g, Eucommia 50 g; the weight proportions of Herba Epimedii, Cistanche, Cordyceps, Cynomorium and Eucommia are the same, and the weight ratio is 1:1:1:1:

1. It comprises the following steps:

2. The method for preparing the kidney-tonifying and yang-strengthening traditional Chinese medicine composition according to claim 1, characterized in that, S1. Pretreatment of raw materials, Herba Epimedii, Cistanche, Cordyceps, Cynomorium and Eucommia are selected respectively, and then washed with clean water to remove surface impurities, and then dried in a blast drying oven at a temperature of 60-65℃ until the moisture content of the raw materials is ≤8%; after drying, each raw material is put into a pulverizer and pulverized to a powder with a particle size of 80-100 mesh, and then mixed evenly to obtain a raw material mixture powder; S2. Extraction, the raw material mixture powder obtained in step 1 is transferred to an extraction tank, 8-12 times the weight of the raw material mixture powder of purified water is added, and soaked at room temperature for 1-2 hours; after soaking, the extraction tank is heated to make the liquid in the tank boil, and the state of micro-boiling is maintained for 2-3 times of decoction, each time for 1-1.5 hours; after decoction, the liquid obtained by each decoction is combined, filtered with 100-120 mesh filter cloth to remove the dregs, and the filtrate is collected as the extract; S3. Concentration and drying, the extract obtained in step 2 is sent to a vacuum concentration tank, the concentration temperature is set to 60-70℃, the vacuum degree is set to -0.08 to -0.09 MPa, and vacuum concentration is performed until the relative density of the extract is 1.20-1.30, which is measured at 60℃; the extract is sent to a spray dryer, the inlet air temperature is set to 180-200℃, and the outlet air temperature is set to 80-90℃, and spray drying is performed to obtain dried extract powder; S4. Preparation of the preparation, medicinal adjuvants are added to the dried extract powder obtained in step 3, mixed evenly, and then made into a soft material with a wetting agent, and then sieved through an 18-mesh sieve to obtain wet granules; the wet granules are dried in an oven at 55-60℃ until the moisture content of the granules is ≤5%, and then sieved through a 16-mesh sieve to size the granules; the sized granules are filled into empty capsule shells to prepare capsules; the weight of each capsule is 0.7 g, and the total weight of twenty capsules is 14 g. The medicinal parts of the raw materials are as follows: Herba Epimedii is the dry aboveground part of Epimedium sagittatum, Cistanche is the dry succulent stem of Cistanche deserticola or Cistanche tubulosa, Cordyceps is the complex of the stroma of Cordyceps sinensis parasitizing on the larva of Hepialidae and the larva, Cynomorium is the dry succulent stem of Cynomorium songaricum, and Eucommia is the dry bark of Eucommia ulmoides.

3. The kidney-tonifying and yang-strengthening traditional Chinese medicine composition according to claim 1, characterized in that, In step 2, the amount of purified water added is 10 times the weight of the raw material mixture powder, the soaking time is 1.5 hours, the number of decoctions is 2, the first decoction time is 1.5 hours, and the second decoction time is 1 hour.

4. The kidney-tonifying and yang-strengthening traditional Chinese medicine composition according to claim 2, characterized in that, In step 3, the operation parameters of vacuum concentration are as follows: temperature 65℃, vacuum degree -0.085 MPa, and the relative density of the extract is 1.25, which is measured at 60℃; the operation parameters of spray drying are as follows: inlet air temperature 190℃, and outlet air temperature 85℃.

5. The method for preparing the kidney-tonifying and aphrodisiac traditional Chinese medicine composition according to claim 2, characterized in that, ​ 6. The method for preparing the kidney-tonifying and aphrodisiac traditional Chinese medicine composition according to claim 2, characterized in that, In step 4, the pharmaceutical excipient is starch, and the added amount of starch is 15% of the weight of the dry extract powder; the wetting agent is 50% ethanol solution by volume, and the added amount of ethanol solution is 8%-10% of the total weight of the dry extract powder and starch.

7. The kidney-tonifying and yang-strengthening traditional Chinese medicine composition according to claim 1, characterized in that, The quality standards of each raw material, calculated based on the dry product, meet the following requirements: the Epimedium contains icariin at 0.5%-2.0%, the Cistanche contains the total amount of trichosanthin and verbascoside at 0.3%-1.0%, the Eucommia contains chlorogenic acid at 0.1%-0.5%, the Cynomorium contains gallic acid at 0.1%-0.3%, and the Cordyceps contains adenosine at 0.01%-0.05%. Each raw material meets the corresponding pharmaceutical quality standard of medicinal materials.

8. A tablet formulation of the kidney-tonifying and yang-strengthening traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the tablets is based on the preparation method of claim 2, and the "formulation molding" step of step 4 is replaced by: adding pharmaceutical excipients to the dry extract powder obtained in step 3, wherein the added amount of starch is 15% of the weight of the dry extract powder, and the added amount of magnesium stearate is 0.5% of the total weight of the dry extract powder and starch, mixing uniformly, and then directly compressing the tablets using a rotary tablet press; the weight of each tablet is 0.7 grams, the total weight of twenty tablets is 14 grams, and the disintegration time in artificial gastric juice pH 1.2 is not more than 30 minutes.

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