CN114558047B - Traditional Chinese medicine composition for preventing and treating osteoporosis and preparation method thereof - Google Patents
Traditional Chinese medicine composition for preventing and treating osteoporosis and preparation method thereof Download PDFInfo
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- CN114558047B CN114558047B CN202210155649.5A CN202210155649A CN114558047B CN 114558047 B CN114558047 B CN 114558047B CN 202210155649 A CN202210155649 A CN 202210155649A CN 114558047 B CN114558047 B CN 114558047B
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Abstract
The application belongs to the technical field of medicines, and particularly relates to a traditional Chinese medicine composition for preventing and treating osteoporosis and a preparation method thereof. The traditional Chinese medicine composition for preventing and treating osteoporosis comprises the following raw materials in parts by weight: 300-500 parts of epimedium herb, 300-400 parts of drynaria rhizome and 400-600 parts of urolithin A. The traditional Chinese medicine composition for preventing and treating osteoporosis can synergistically regulate bone metabolism, inhibit bone resorption, promote bone formation and further increase bone density through the synergistic compounding effect of the three raw material medicines, and has the effects of preventing and treating osteoporosis of middle-aged and elderly people and promoting bone health of the middle-aged and elderly people.
Description
Technical Field
The application belongs to the technical field of medicines, and particularly relates to a traditional Chinese medicine composition for preventing and treating osteoporosis and a preparation method thereof.
Background
Osteoporosis (OP) is a systemic bone disease characterized by reduced bone mass, damaged bone microstructure, resulting in increased bone fragility and susceptibility to fracture. Osteoporosis is divided into two major categories, primary and secondary, primary including postmenopausal osteoporosis (type i), senile osteoporosis (type ii), and idiopathic osteoporosis (including juvenile). Primary osteoporosis is common in postmenopausal women and older men. In the early stage, no obvious clinical manifestation is usually seen, as the disease progresses, bone mass is continuously lost, pain and spinal deformity can occur to patients, and osteoporosis fracture can occur to serious patients. Some patients have reduced muscle capacity and muscle strength, fall easily, and cause increased fracture risk and reduced quality of life. The harm of the osteoporosis fracture is huge, and the osteoporosis fracture is one of main reasons for disability and death of the old patients. The pathogenesis of senile osteoporosis is multiple, and organ hypofunction caused by aging is a main factor. In addition to endocrine factors, a variety of cytokines also affect bone metabolism, reducing osteogenic activity. For example: insufficient intake of calcium and vitamin D can lead to insufficient conversion of provitamin Xiang Weisheng D, reduced renal function, and insufficient hydroxylation of vitamin D in the skin. Bone marrow mesenchymal stem cells have decreased osteogenic differentiation capacity. Muscle degeneration, stress stimulation to bones is reduced, and bone metabolism regulation is impaired. In all cases, bone metabolism is affected, so that the bone formation is insufficient, the broken bone is excessive, the bone is lost, the bone structure is damaged, and osteoporosis is formed. However, it must be emphasized that osteoporosis is preventable and treatable.
At present, the principle of treating osteoporosis by western medicines has two points: 1. inhibiting osteoclast and reducing bone resorption; 2. promoting osteoblast and increasing bone formation. Western medicines have an effective effect on treating osteoporosis to a certain extent, but with the extension of the treatment course of the medicines, the medicine effect is weakened, the medicine safety and the adverse reaction of the medicines to organisms are gradually brought into the spotlight, for example, the long-term administration of estrogen can increase the risks of female suffering from endometrial cancer, breast cancer and the like.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for preventing and treating osteoporosis and a preparation method thereof, and aims to solve the problems that the traditional medicine for treating osteoporosis is poor in curative effect, poor in medicine safety and easy to cause adverse reaction to organisms to a certain extent.
In order to achieve the purposes of the application, the technical scheme adopted by the application is as follows:
in a first aspect, the application provides a traditional Chinese medicine composition for preventing and treating osteoporosis, which comprises the following raw materials in parts by weight:
300 to 500 parts of epimedium herb,
300 to 400 parts of drynaria rhizome,
400-600 parts of urolithin A.
Further, the traditional Chinese medicine composition for preventing and treating osteoporosis comprises the following raw materials in parts by weight:
350 to 450 parts of epimedium herb,
300 to 350 parts of drynaria rhizome,
450-550 parts of urolithin A.
Further, the traditional Chinese medicine composition for preventing and treating osteoporosis comprises the following raw materials in parts by weight: 400 parts of epimedium herb, 300 parts of drynaria rhizome and 500 parts of urolithin A.
Further, the traditional Chinese medicine composition for preventing and treating osteoporosis comprises the following raw materials in parts by weight: 370 parts of epimedium, 350 parts of rhizoma drynariae and 450 parts of urolithin A.
Further, the traditional Chinese medicine composition for preventing and treating osteoporosis comprises the following raw materials in parts by weight: 420 parts of epimedium, 320 parts of rhizoma drynariae and 530 parts of urolithin A.
Further, the traditional Chinese medicine composition for preventing and treating osteoporosis also comprises pharmaceutically acceptable auxiliary materials. Further, the dosage form of the traditional Chinese medicine composition for preventing and treating osteoporosis comprises at least one of capsules, tablets, granules, electuary and chewable tablets.
Further, the pharmaceutically acceptable excipients include: at least one of silicon dioxide, mannitol, lactose, starch, magnesium stearate, saccharin sodium, talcum powder, cellulose, glucose, gelatin, sucrose and magnesium carbonate.
In a second aspect, the present application provides a method for preparing a traditional Chinese medicine composition for preventing and treating osteoporosis, which is characterized by comprising the following steps:
300-500 parts of epimedium herb and 300-400 parts of drynaria rhizome are obtained, and the epimedium herb and the drynaria rhizome are respectively extracted to obtain an epimedium herb extract and a drynaria rhizome extract;
mixing and granulating the epimedium extract, the drynaria extract and 400-600 parts of urolithin A to obtain the traditional Chinese medicine composition for preventing and treating osteoporosis.
Further, the epimedium herb is subjected to alcohol extraction to obtain the epimedium herb extract.
Further, the drynaria rhizome is subjected to alcohol extraction to obtain the drynaria rhizome extract.
Further, in the epimedium extract, the mass percent of total flavonoids is not less than 30 percent calculated by icariin.
Further, in the drynaria extract, the mass percentage of total flavonoids is not less than 30%.
Further, the step of the mixed granulating treatment comprises the following steps: preparing the epimedium extract, the drynaria extract, the urolithin A and pharmaceutically acceptable auxiliary materials into an oral preparation by adopting wet granulation or dry granulation.
Further, the oral preparation comprises at least one of capsules, tablets, granules, electuaries and chewable tablets.
Further, the pharmaceutically acceptable excipients include: at least one of silicon dioxide, mannitol, lactose, starch, magnesium stearate, saccharin sodium, talcum powder, cellulose, glucose, gelatin, sucrose and magnesium carbonate.
In the traditional Chinese medicine composition for preventing and treating osteoporosis provided by the first aspect, on one hand, urolithin A can obviously inhibit the activation of osteoclasts, obviously reduce the number and the size of osteoclasts, has obvious inhibition effect on bone resorption function and the expression of osteoclast related genes, can obviously inhibit the proliferation and the activity of osteoclasts, slows down cartilage degradation, and plays a role in promoting bone health. On the other hand, the urolithin A can regulate the expression of skeletal muscle mitochondria, improve the cellular respiration intensity of skeletal muscle, further improve the intensity of skeletal muscle and indirectly promote the normal regulation of bone metabolism. Both epimedium and drynaria have the effect of promoting the osteogenic differentiation of bone marrow mesenchymal stem cells. Through the synergistic combination effect of the three raw materials, the bone metabolism can be regulated in a synergistic way, the bone absorption can be inhibited, the bone formation can be promoted, the bone density can be further increased, and the effects of preventing and treating osteoporosis of middle-aged and elderly people and promoting bone health of the middle-aged and elderly people can be achieved. If the urolithin A proportion is too low, the Chinese medicinal composition has poor effect of inhibiting the activation of osteoclast; if the ratio of epimedium to drynaria is too low, the effect of promoting osteogenic differentiation of mesenchymal stem cells is poor.
According to the preparation method of the traditional Chinese medicine composition for preventing and treating osteoporosis, provided by the second aspect, the epimedium extract and the drynaria extract are respectively extracted in the formula amount, and then mixed and granulated with the urolithin A in the formula amount to obtain the traditional Chinese medicine composition for preventing and treating osteoporosis. The preparation process is simple and is suitable for industrial mass production and application. The prepared traditional Chinese medicine composition for preventing and treating osteoporosis can synergistically regulate bone metabolism, inhibit bone resorption, promote bone formation and further increase bone density through the synergistic compounding effect of the three raw materials, and has the effects of preventing and treating osteoporosis of middle-aged and elderly people and promoting bone health of the middle-aged and elderly people.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following description will briefly introduce the drawings that are needed in the embodiments or the description of the prior art, it is obvious that the drawings in the following description are only some embodiments of the present application, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
Fig. 1 is a schematic flow chart of a preparation method of a traditional Chinese medicine composition for preventing and treating osteoporosis according to an embodiment of the present application.
Detailed Description
In order to make the technical problems, technical schemes and beneficial effects to be solved by the present application more clear, the present application is further described in detail below with reference to the embodiments. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the present application.
In this application, the term "and/or" describes an association relationship of an association object, which means that there may be three relationships, for example, a and/or B may mean: a alone, a and B together, and B alone. Wherein A, B may be singular or plural. The character "/" generally indicates that the context-dependent object is an "or" relationship.
In the present application, "at least one" means one or more, and "a plurality" means two or more. "at least one of" or the like means any combination of these items, including any combination of single item(s) or plural items(s). For example, "at least one (individual) of a, b, or c," or "at least one (individual) of a, b, and c" may each represent: a, b, c, a-b (i.e., a and b), a-c, b-c, or a-b-c, wherein a, b, c may be single or multiple, respectively.
It should be understood that, in various embodiments of the present application, the sequence number of each process does not mean that the sequence of execution is sequential, and some or all of the steps may be executed in parallel or sequentially, where the execution sequence of each process should be determined by its functions and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present application.
The terminology used in the embodiments of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used in this application in the examples and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.
The weights of the relevant components mentioned in the embodiments of the present application may refer not only to specific contents of the components, but also to the proportional relationship between the weights of the components, and thus, any ratio of the contents of the relevant components according to the embodiments of the present application may be enlarged or reduced within the scope disclosed in the embodiments of the present application. Specifically, the mass in the specification of the embodiment of the present application may be a mass unit well known in the chemical industry field such as μ g, mg, g, kg.
The terms "first" and "second" are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated for distinguishing between objects such as substances from each other. For example, a first XX may also be referred to as a second XX, and similarly, a second XX may also be referred to as a first XX, without departing from the scope of embodiments of the present application. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature.
The first aspect of the embodiment of the application provides a traditional Chinese medicine composition for preventing and treating osteoporosis, which comprises the following raw material medicines in parts by weight:
300 to 500 parts of epimedium herb,
300 to 400 parts of drynaria rhizome,
400-600 parts of urolithin A.
The traditional Chinese medicine composition for preventing and treating osteoporosis provided by the first aspect of the embodiment of the application comprises the following raw materials of 300-500 parts of epimedium herb, 300-400 parts of drynaria rhizome and 400-600 parts of Urolithin A (Urolithin-A). On one hand, the urolithin A can obviously inhibit the activation of osteoclasts, obviously reduce the number and the size of osteoclasts, has obvious inhibition effect on bone resorption function and the expression of related genes of the osteoclasts, can obviously inhibit the proliferation and the activity of the osteoclasts, slows down cartilage degradation, and has the effect of promoting bone health. On the other hand, the urolithin A can regulate the expression of skeletal muscle mitochondria, improve the cellular respiration intensity of skeletal muscle, further improve the intensity of skeletal muscle and indirectly promote the normal regulation of bone metabolism. Both epimedium and drynaria have the effect of promoting the osteogenic differentiation of bone marrow mesenchymal stem cells. According to the traditional Chinese medicine composition for preventing and treating osteoporosis, through the synergistic combination effect of the three raw material medicines, bone metabolism can be regulated in a synergistic manner, bone absorption can be inhibited, bone formation can be promoted, bone density can be increased, and the effects of preventing and treating osteoporosis of middle-aged and elderly people and promoting bone health of the middle-aged and elderly people can be achieved together. If the urolithin A proportion is too low, the Chinese medicinal composition has poor effect of inhibiting the activation of osteoclast; if the ratio of epimedium to drynaria is too low, the effect of promoting osteogenic differentiation of mesenchymal stem cells is poor.
In the traditional Chinese medicine composition for preventing and treating osteoporosis, the main effective components of epimedium herb and anti-osteoporosis are flavonoid compounds represented by icariin, and besides the icariin, the traditional Chinese medicine composition also contains epimedin A, epimedin B, epimedin C, baohuoside-I and the like, and the active groups of the epimedin A, the epimedin B, the epimedin C, baohuoside-I and the like are more, and the action targets are also more abundant, so that the traditional Chinese medicine composition has stronger anti-osteoporosis activity than an icariin monomer. The mechanism of action of epimedium in resisting osteoporosis is to promote osteogenic differentiation of bone marrow mesenchymal stem cells and has dual activities of promoting bone formation and inhibiting bone resorption. The epimedium total flavone can effectively prevent the oophorectomy rat from generating osteoporosis, and the action mechanism of the epimedium total flavone is different from that of estrogen, so that the epimedium total flavone has the function of preventing postmenopausal osteoporosis, and can not cause potential adverse reactions such as reproductive system tumors and the like. Rhizoma Drynariae has effects of relieving pain, invigorating kidney and strengthening bones, and its core compound is flavonoid such as naringin, eriodictyol, kaempferol, etc., has biological effects of estrogen-like compounds, and has anti-osteoporosis action mechanism from antiinflammatory and endocrine system. Drynaria rhizome acts on various targets through various paths, and the biological effect of resisting osteoporosis is exerted. The application field of the complex formulation of the epimedium and the drynaria rhizome for promoting the bone health of the old people still has great research and promotion space. In this way, in the traditional Chinese medicine composition for preventing and treating osteoporosis, the urolithin A is added for compounding, and the urolithin A aims to exert the effects of enhancing cell functions, inhibiting osteoclasts and increasing muscle strength, so that the purpose of resisting the osteoporosis of middle-aged and elderly people is achieved. Urolithin A has main efficacy substances with anti-inflammatory, antioxidant and other biological activities, and the effects of reducing harmful inflammation and enhancing cell health are achieved by promoting autophagy of mitochondria and improving mitochondrial function. Urolithin A has the effects of relieving muscle and joint degeneration caused by aging, enhancing muscle strength, enhancing organism cell activity, delaying muscle aging of the aged people, relieving cartilage degeneration and gonarthritis, relieving systemic organ function decline caused by aging, including kidney and skeleton, further improving bone metabolism of the aged people, promoting bone formation and relieving bone fracture. In addition, the activity of the osteoclast can be inhibited, the number and the size of the osteoclast generation can be reduced, and the expression of the osteoclast related gene can be inhibited. Thereby maintaining stress stimulation to bones and normal bone metabolism regulation mechanisms. Therefore, the effect of the urolithin A is superior to that of the epimedium or the drynaria fortunei for increasing the bone mineral density.
In some embodiments, the traditional Chinese medicine composition for preventing and treating osteoporosis comprises the following raw materials in parts by weight:
350 to 450 parts of epimedium herb,
300 to 350 parts of drynaria rhizome,
450-550 parts of urolithin A.
In the traditional Chinese medicine composition for preventing and treating osteoporosis, when the proportion of the three raw materials is 350-450 parts of epimedium herb, 300-350 parts of drynaria rhizome and 450-550 parts of urolithin A, the three raw materials have better compound effect, so that the traditional Chinese medicine composition has better inhibition effect on the activation of osteoclasts; meanwhile, the osteogenic differentiation of the mesenchymal stem cells can be better promoted.
In some specific embodiments, the traditional Chinese medicine composition for preventing and treating osteoporosis comprises the following raw materials in parts by weight: 400 parts of epimedium herb, 300 parts of drynaria rhizome and 500 parts of urolithin A. In some specific embodiments, the traditional Chinese medicine composition for preventing and treating osteoporosis comprises the following raw materials in parts by weight: 370 parts of epimedium, 350 parts of rhizoma drynariae and 450 parts of urolithin A. In some specific embodiments, the traditional Chinese medicine composition for preventing and treating osteoporosis comprises the following raw materials in parts by weight: 420 parts of epimedium, 320 parts of rhizoma drynariae and 530 parts of urolithin A. The traditional Chinese medicine composition for preventing and treating osteoporosis, disclosed by the embodiment of the application, has the advantages that the traditional Chinese medicine composition can effectively prevent, improve and treat osteoporosis of middle-aged and elderly people, improve bone density of patients with osteoporosis, obviously inhibit bone resorption and reduce loss of bone mass, so that the traditional Chinese medicine composition for preventing and treating osteoporosis is used for treating osteoporosis and promoting bone health of middle-aged and elderly people.
In some embodiments, the traditional Chinese medicine composition for preventing and treating osteoporosis further comprises pharmaceutically acceptable auxiliary materials. The traditional Chinese medicine composition for preventing and treating osteoporosis can also contain pharmaceutically acceptable auxiliary materials, for example, the taste of the traditional Chinese medicine composition for preventing and treating osteoporosis is improved through the auxiliary materials, and the patient compliance is improved; the shaping effect of the traditional Chinese medicine composition for preventing and treating osteoporosis can be improved through auxiliary materials, so that the traditional Chinese medicine composition for preventing and treating osteoporosis can be conveniently prepared into different dosage forms, and the use flexibility of the traditional Chinese medicine composition for preventing and treating osteoporosis is improved.
In some embodiments, the pharmaceutically acceptable excipients include: at least one of silicon dioxide, mannitol, lactose, starch, magnesium stearate, saccharin sodium, talcum powder, cellulose, glucose, gelatin, sucrose and magnesium carbonate, and the auxiliary materials can improve the shaping effect of the traditional Chinese medicine composition for preventing and treating osteoporosis, improve the taste of the traditional Chinese medicine composition for preventing and treating osteoporosis and improve the compliance of patients.
In some embodiments, the dosage form of the traditional Chinese medicine composition for preventing and treating osteoporosis comprises at least one solid oral preparation of capsules, tablets, granules, electuaries and chewable tablets. In practical application, the traditional Chinese medicine composition for preventing and treating osteoporosis can be prepared into different dosage forms, wherein the capsule has the characteristics of stable quality, high bioavailability, convenient administration and the like, and is a preferred dosage form.
In some embodiments, in the traditional Chinese medicine composition for preventing and treating osteoporosis, the daily effective dose of epimedium is 150-450 mg calculated by the total flavone content and 15-45 mg calculated by the icariin content; the effective daily dose of the drynaria rhizome is 250-300 mg calculated by the total flavone intake and 80-120 mg calculated by the naringin intake; the daily effective dose of urolithin A is 500-1000 mg. The raw materials can obviously regulate the expression of the mitochondrial gene of skeletal muscle and increase the intensity of skeletal muscle within the dosage range. In some embodiments, the amount of the traditional Chinese medicine composition for preventing and treating osteoporosis is preferably 2-3 months.
The traditional Chinese medicine composition for preventing and treating osteoporosis can be prepared by the method in the following examples.
As shown in fig. 1, a second aspect of the embodiments of the present application provides a method for preparing a traditional Chinese medicine composition for preventing and treating osteoporosis, which includes the following steps:
s10, 300-500 parts of epimedium herb and 300-400 parts of drynaria rhizome are obtained, and the epimedium herb extract and the drynaria rhizome extract are respectively extracted;
s20, mixing and granulating the epimedium extract, the drynaria extract and 400-600 parts of urolithin A to obtain the traditional Chinese medicine composition for preventing and treating osteoporosis.
According to the preparation method of the traditional Chinese medicine composition for preventing and treating osteoporosis, provided by the second aspect of the embodiment, the epimedium and the drynaria rhizome are respectively extracted according to the formula amount, and after the epimedium extract and the drynaria rhizome extract are obtained, the traditional Chinese medicine composition for preventing and treating osteoporosis is obtained through mixing granulation treatment with the urolithin A according to the formula amount. The preparation process is simple and is suitable for industrial mass production and application. The prepared traditional Chinese medicine composition for preventing and treating osteoporosis can synergistically regulate bone metabolism, inhibit bone resorption, promote bone formation and further increase bone density through the synergistic compounding effect of the three raw materials, and has the effects of preventing and treating osteoporosis of middle-aged and elderly people and promoting bone health of the middle-aged and elderly people.
In some embodiments, in step S10, the drynaria rhizome is subjected to alcohol extraction to obtain an drynaria rhizome extract. In some embodiments, the step of extracting the drynaria rhizome with alcohol comprises:
s11, mixing the drynaria rhizome medicinal material with an ethanol solution (the concentration is about 70%) according to the ratio of 1 (6-10), heating and refluxing the extract for 1-3 hours, and filtering to obtain filtrate extract and dregs;
s12, adding ethanol solution (the concentration is about 70%) which is 5-7 times of the residues in sequence, and extracting for 2-3 times by heating and reflux for 1-3 hours each time; filtering and collecting the extracting solution;
s13, concentrating all the extracting solutions into small volume, adding auxiliary materials such as maltodextrin and the like with the raw material quantity of about 0-10%, and continuously concentrating until the density is 1.25-1.5 g/ml.
S14, placing the concentrate into a vacuum drying oven, vacuum drying at about 70 ℃, crushing the dried concentrate, and sieving with a sieve with more than 80 meshes to obtain the drynaria rhizome extract.
In some embodiments, in step S10, the epimedium is subjected to alcohol extraction to obtain an epimedium extract. In some embodiments, the step of alcohol extracting the epimedium herb comprises:
s15, mixing the epimedium herb with ethanol solution (the concentration is about 60%) according to 1 (8-12) times, heating and refluxing the extract for 1-3 hours, and filtering to obtain filtrate extract and dregs;
s16, sequentially adding 8-12 times of ethanol solution (the concentration is about 60%), heating and refluxing for 2-3 times, each time for 1-3 hours, and filtering and collecting an extracting solution;
s17, concentrating all the extracting solutions into small volume, adding auxiliary materials such as maltodextrin and the like with the raw material amount of about 0-10%, and continuously concentrating until the density is 1.25-1.5 g/ml;
s18, placing the concentrate into a vacuum drying oven, vacuum drying at about 60 ℃, crushing the dried concentrate, and sieving with a sieve with more than 80 meshes to obtain the epimedium extract.
In some embodiments, the total flavonoids are not less than 30% by mass of icariin in the epimedium extract. The main active ingredients of the epimedium anti-osteoporosis composition are flavonoid compounds represented by icariine, and the content of the active ingredients of the epimedium extract is not lower than 30wt% based on the total flavone content, so that the content of the active ingredients such as the icariine in the epimedium extract can be effectively ensured, the epimedium extract has rich active groups and action targets, and the effect of the epimedium extract and the traditional Chinese medicine composition on the osteoporosis is ensured.
In some embodiments, the total flavonoids are not less than 30% by mass of the drynaria extract. The core compounds of the drynaria rhizome are flavonoid compounds such as naringin, eriodictyol, kaempferol and the like, mainly include naringin, have biological effects of estrogen-like compounds, and have an action mechanism for playing an anti-osteoporosis role from anti-inflammatory and endocrine system and other ways. The naringin and total flavone content in the drynaria extract are limited, so that the active ingredients of the drynaria are effectively ensured, and the action of the traditional Chinese medicine composition on resisting bone litigation is ensured. In other embodiments, the naringin comprises greater than 30% by mass of the total flavonoids in the drynaria extract.
In some embodiments, in the step S20, the step of the mixing granulation process includes: wet granulating or dry granulating, and making into oral preparation with herba Epimedii extract, rhizoma Drynariae extract, urolithin A and pharmaceutically acceptable adjuvants. The taste of the traditional Chinese medicine composition for preventing and treating osteoporosis is improved through pharmaceutically acceptable auxiliary materials, and the patient compliance is improved; improving the shaping effect of the traditional Chinese medicine composition for preventing and treating osteoporosis.
In some embodiments, the pharmaceutically acceptable excipients include: at least one of silicon dioxide, mannitol, lactose, starch, magnesium stearate, saccharin sodium, talcum powder, cellulose, glucose, gelatin, sucrose and magnesium carbonate, and the auxiliary materials can improve the shaping effect of the traditional Chinese medicine composition for preventing and treating osteoporosis, improve the taste of the traditional Chinese medicine composition for preventing and treating osteoporosis and improve the compliance of patients.
In some embodiments, the oral formulation comprises at least one of a capsule, a tablet, a granule, a chewable tablet; the Chinese medicinal composition for preventing and treating osteoporosis can be prepared into different dosage forms, wherein the capsule has the characteristics of stable quality, high bioavailability, convenient administration and the like, and is a preferred dosage form.
In some embodiments, the step of wet granulating comprises: adding binder into medicinal powder, and agglomerating the powder together by bridge or bonding action of the binder to obtain solid oral preparation. Including but not limited to extrusion granulation, rotary granulation, fluid granulation, stirred granulation, and the like. The particles prepared by the wet method have the advantages of good particle quality, attractive appearance, strong wear resistance, good compression formability and the like after being wetted on the surface.
In some embodiments, the step of dry granulating comprises: the loose powder is compressed and agglomerated, and then the compacted powder is crushed and granulated to improve the fluidity of the powder, so that the powder is suitable for process production such as tabletting and capsule filling. Compared with wet granulation, dry granulation has the advantage that no water or other organic solvents are needed in the whole process, and the dry granulation is particularly suitable for drugs sensitive to humidity and heat. Including but not limited to, roll dry granulation, easy to implement automated control, efficient, simple in process and more environment-friendly. The powder compression mode is a rolling and non-rolling mode, rolling is the main stream of the pharmaceutical industry, and the main advantages are that the process has larger production capacity continuously, the dependence of powder on lubricant is small, and the like. The main variables of the general dry granulation rolling process are three: pressure, rotational speed of feed screw and rotational speed of roller. The auxiliary materials with larger influence on rolling in the mixed powder mainly comprise two kinds of materials: a binder and a lubricant.
In order to make the implementation details and operations of the present application clearly understood by those skilled in the art, and to significantly embody the advanced performance of the traditional Chinese medicine composition for preventing and treating osteoporosis and the preparation method thereof according to the embodiments of the present application, the above technical solutions are exemplified by a plurality of embodiments below.
Example 1
A traditional Chinese medicine hard capsule preparation for preventing and treating osteoporosis comprises the following raw materials:
400g of epimedium herb, 300g of drynaria rhizome, 500g of urolithin A and the auxiliary materials of microcrystalline cellulose, silicon dioxide and magnesium stearate.
The preparation method comprises the following steps:
(1) extracting herba Epimedii: mixing herba Epimedii with ethanol solution (concentration 60%) at a ratio of 1:10, heating and refluxing the extract for 2 hr, and filtering to obtain filtrate extract and residue; adding 10 times of ethanol solution (concentration 60%) into the residue, refluxing for 2 times each for 2 hr, and filtering to collect extractive solution; concentrating all the extractive solutions into small volume, adding adjuvants such as maltodextrin with a raw material content of about 10%, and concentrating to a density of 1.25g/ml; placing the concentrate into a vacuum drying oven, vacuum drying at 60deg.C, pulverizing, and sieving with 80 mesh sieve to obtain herba Epimedii extract.
(2) Extracting the drynaria rhizome: mixing rhizoma Drynariae with ethanol solution (concentration 70%) at a ratio of 1:8, heating and refluxing the extract for 2 hr, and filtering to obtain filtrate extract and residue; adding 6 times of ethanol solution (concentration 70%) into the residue, and extracting under reflux for 2 times each for 2 hr; filtering and collecting the extracting solution; concentrating all the extractive solutions into small volume, adding adjuvants such as maltodextrin with a raw material content of about 10%, and concentrating until the density is 1.25g/ml; placing the concentrate into a vacuum drying oven, vacuum drying at 70deg.C, pulverizing, and sieving with 80 mesh sieve to obtain rhizoma Drynariae extract.
(3) Sieving herba Epimedii extract, rhizoma Drynariae extract, and urolithin A with 60 mesh sieve; taking the mixed powder, taking 80% ethanol solution as an adhesive, manually mixing to prepare a soft material, granulating by a 20-mesh sieve, drying, and finishing by a 30-mesh sieve.
(4) Taking dry particles, adding a proper amount of microcrystalline cellulose, silicon dioxide and magnesium stearate, manually sieving with a 30-mesh sieve, uniformly mixing, filling with a No. 0 capsule, and obtaining the traditional Chinese medicine hard capsule preparation for preventing and treating osteoporosis, wherein the filling amount is 0.50 g/granule. The capsule prepared by the method contains 160mg of epimedium extract, 120mg of drynaria extract and 200mg of urolithin A in each capsule.
Example 2
A Chinese medicinal tablet for preventing and treating osteoporosis comprises the following raw materials:
370g of epimedium, 350g of drynaria rhizome, 450g of urolithin A and the auxiliary materials of microcrystalline cellulose, silicon dioxide and magnesium stearate.
The preparation method comprises the following steps:
(1) extracting herba Epimedii: mixing herba Epimedii with ethanol solution (concentration 60%) at a ratio of 1:10, heating and refluxing the extract for 2 hr, and filtering to obtain filtrate extract and residue; adding 10 times of ethanol solution (concentration 60%) into the residue, refluxing for 2 times each for 2 hr, and filtering to collect extractive solution; concentrating all the extractive solutions into small volume, adding adjuvants such as maltodextrin with a raw material content of about 10%, and concentrating to a density of 1.25g/ml; placing the concentrate into a vacuum drying oven, vacuum drying at 60deg.C, pulverizing, and sieving with 80 mesh sieve to obtain herba Epimedii extract.
(2) Extracting the drynaria rhizome: mixing rhizoma Drynariae with ethanol solution (concentration 70%) at a ratio of 1:8, heating and refluxing the extract for 2 hr, and filtering to obtain filtrate extract and residue; adding 6 times of ethanol solution (concentration 70%) into the residue, and extracting under reflux for 2 times each for 2 hr; filtering and collecting the extracting solution; concentrating all the extractive solutions into small volume, adding adjuvants such as maltodextrin with a raw material content of about 10%, and concentrating until the density is 1.25g/ml; placing the concentrate into a vacuum drying oven, vacuum drying at 70deg.C, pulverizing, and sieving with 80 mesh sieve to obtain rhizoma Drynariae extract.
(3) Sieving herba Epimedii extract, rhizoma Drynariae extract, and urolithin A with 60 mesh sieve; taking the mixed powder, taking 50% ethanol solution as an adhesive, manually mixing to prepare a soft material, granulating by a 20-mesh sieve, drying, and finishing by a 30-mesh sieve.
(4) Taking dry particles, adding a proper amount of microcrystalline cellulose, silicon dioxide and magnesium stearate, manually sieving with a 20-mesh sieve, and uniformly mixing. Tabletting by a tablet press according to the operation rules, adjusting the loading amount to 0.75 g/tablet, and coating by a coating machine according to the operation rules until the weight is increased by 3-5%, thus obtaining the traditional Chinese medicine tablet for preventing and treating osteoporosis. The tablet prepared by the method contains 185mg of epimedium extract, 175mg of drynaria extract and 225mg of urolithin A.
Example 3
A Chinese medicinal tablet for preventing and treating osteoporosis comprises the following raw materials:
420 parts of epimedium herb, 320 parts of drynaria rhizome, 530 parts of urolithin A and the auxiliary materials of microcrystalline cellulose, silicon dioxide and magnesium stearate.
The preparation method comprises the following steps:
(1) extracting herba Epimedii: mixing herba Epimedii with ethanol solution (concentration 60%) at a ratio of 1:10, heating and refluxing the extract for 2 hr, and filtering to obtain filtrate extract and residue; adding 10 times of ethanol solution (concentration 60%) into the residue, refluxing for 2 times each for 2 hr, and filtering to collect extractive solution; concentrating all the extractive solutions into small volume, adding adjuvants such as maltodextrin with a raw material content of about 10%, and concentrating to a density of 1.25g/ml; placing the concentrate into a vacuum drying oven, vacuum drying at 60deg.C, pulverizing, and sieving with 80 mesh sieve to obtain herba Epimedii extract.
(2) Extracting the drynaria rhizome: mixing rhizoma Drynariae with ethanol solution (concentration 70%) at a ratio of 1:8, heating and refluxing the extract for 2 hr, and filtering to obtain filtrate extract and residue; adding 6 times of ethanol solution (concentration 70%) into the residue, and extracting under reflux for 2 times each for 2 hr; filtering and collecting the extracting solution; concentrating all the extractive solutions into small volume, adding adjuvants such as maltodextrin with a raw material content of about 10%, and concentrating until the density is 1.25g/ml; placing the concentrate into a vacuum drying oven, vacuum drying at 70deg.C, pulverizing, and sieving with 80 mesh sieve to obtain rhizoma Drynariae extract.
(3) Sieving herba Epimedii extract, rhizoma Drynariae extract, and urolithin A with 60 mesh sieve; taking the mixed powder, taking 50% ethanol solution as an adhesive, manually mixing to prepare a soft material, granulating by a 20-mesh sieve, drying, and finishing by a 30-mesh sieve.
(4) Taking dry particles, adding a proper amount of microcrystalline cellulose, silicon dioxide and magnesium stearate, manually sieving with a 20-mesh sieve, and uniformly mixing. Tabletting by a tablet press according to the operation rules, adjusting the loading amount to 0.75 g/tablet, and coating by a coating machine according to the operation rules until the weight is increased by 3-5%, thus obtaining the traditional Chinese medicine tablet for preventing and treating osteoporosis. The tablet prepared by the method contains 210mg of epimedium extract, 160mg of drynaria extract and 265mg of urolithin A.
Furthermore, in order to verify the progress of the embodiment of the application, the effect of the traditional Chinese medicine composition for preventing and treating osteoporosis, which is prepared by the embodiment, on the aspects of regulating bone metabolism, increasing bone density function, bone calcium content and the like is observed by establishing a rat osteoporosis model, so that the effect of the test product on improving the osteoporosis resistance is evaluated.
1. And (3) testing the reagent:
the traditional Chinese medicine hard capsule preparation for preventing and treating osteoporosis prepared in the embodiment 1 is taken as an experimental object, and a high-dose group, a low-dose group, a drynaria extract group, an epimedium extract group and an estrogen group are respectively arranged.
2. 70 animals are adopted, female with the age of 3 months are large in Wistar, and an osteoporosis animal model is constructed through castration operation. Animals were free to drink water and feed to feed, the feed formulation is shown in table 1.
TABLE 1
| Composition of the components | Mass fraction% |
| Casein protein | 23 |
| DL-methionine | 0.3 |
| Corn starch | 32 |
| Sucrose | 30 |
| Fiber | 5 |
| Corn oil | 5 |
| Mixed mineral salt | 3.5 |
| Mixed vitamins | 1 |
| Choline ditartrate | 0.2 |
Note that: (1) the mixed mineral salt contains the following components in parts by weight per kilogram of feed: mnSO 4 110mg，CuSO 4 0.8mg，FeSO 4 1.2mg，KI 18mg，ZnSO 4 2960mg，CaHPO 4 2890mg，MgSO 4 1.25*10 4 mg; (2) the mixed vitamins, each kilogram of feed contains the following components: vitamin a 1.4 x 10 4 IU, 1500IU of vitamin D, 120mg of vitamin E, 3mg of vitamin K, 12mg of vitamin B, 20mg of vitamin B, 12mg of vitamin B, 0.03mg of vitamin B, 60mg of nicotinic acid, 24mg of pantothenic acid, 6mg of folic acid and 0.54mg of biotin.
3. Reagent and instrument:
instrument: atomic absorption spectrophotometers, single photon bone densitometers or dual energy X-ray bone densitometers or other related instruments, precision calipers, animal dissecting instruments, animal balances, 105 ℃ ovens.
Reagent: nitric acid (superior purity), perchloric acid (superior purity), lanthanum oxide, and calcium standard solution.
4. Experimental grouping and experimental dose:
the rats after surgery were adaptively fed for 3-5 days and then grouped into 7 groups of 10 animals each according to body weight. Gastric administration was given 1 time daily, beginning at week 5 post-surgery, following the schedule of table 1.
And setting the dose according to the recommended crowd amount of the instruction. The instruction prescribes that the dosage of the crowd is 1.5 g/d/person. The experiment sets that the bioequivalence dosage of the rat is 10 times of the clinical dosage of the human, and the equivalent dosage of the rat is 1.5 g/50 kg by 10=0.30 g/kg/d according to 50kg of human standard weight. The feeding time was 12 weeks, the body weight was measured weekly during the experiment, and the dose was adjusted according to the body weight. The details are shown in table 2 below:
TABLE 2
5. Detection index
After the experiment is finished, the animals are sacrificed, the abdominal aorta is subjected to blood sampling and standing for 1h, and serum is taken after centrifugation, so that the biochemical indexes of serum bone metabolism are detected:
(1) serum Osteocalcin (OC): higher levels of bone formation markers indicate stronger bone formation activity.
(2) Bone alkaline phosphatase (Alkaline phosphatase, ALP): higher levels of bone formation markers indicate stronger bone formation activity.
(3) Type I collagen amino-terminal cross-linking peptide (N-terminal cross-linked telopeptide of type I collagen, NTx): higher levels of bone resorption markers indicate greater bone resorption activity.
(4) Tartrate-resistant acid phosphatase (TRACP-5 b): higher levels of bone resorption markers indicate stronger bone resorption activity.
Taking bilateral complete femur (or humerus) and lumbar vertebra of a rat, separating the muscle tissues above, and detecting bone calcium and bone density:
(1) bone calcium content: the right femur was taken for measurement.
(2) Bone density (Bone mineral density, BMD): the left femur and the 2 nd to 4 th lumbar vertebrae were measured. The efficacy evaluation of the inventive compositions was obtained based on the above experimental data.
6. Data analysis
Experimental data are indicated as "mean ± standard deviation (x ± SD)". The data adopts analysis of variance and advanced variance alignment test. The variance is uniform, the F value is calculated<F 0.05 There is no significant difference between the averages of the groups; f value>F 0.05 And p is less than or equal to 0.05, using two of the averages between multiple test groups and one control groupThe two comparison methods are used for statistics.
7. Experimental results:
(1) The change of the bone metabolism biochemical index of each group of rats is shown in table 3:
TABLE 3 Table 3
As shown by the experimental results in the table 3, serum osteocalcin and bone alkaline phosphatase levels in the model group were significantly reduced, and there was a significant difference (p < 0.01) from the sham operation group. The serum osteocalcin and bone alkaline phosphatase levels of the traditional Chinese medicine composition group for preventing and treating osteoporosis in the embodiment 1 of the application are obviously higher than those of the model group, which shows that the traditional Chinese medicine composition for preventing and treating osteoporosis in the embodiment of the application has the effect of promoting bone formation. In addition, model group NTx and TRACP-5b levels were significantly higher than in sham surgery group (p < 0.01). The levels of NTx and TRACP-5b in the traditional Chinese medicine composition group for preventing and treating osteoporosis in the embodiment of the application are obviously lower than those in a model group (p is less than 0.01), which indicates that the traditional Chinese medicine composition for preventing and treating osteoporosis in the embodiment of the application has the effect of inhibiting bone resorption.
(2) The changes in femur and lumbar bone density of rats in each group are shown in Table 4
TABLE 4 Table 4
From the experimental results in table 4 above, the bone density of the rats in the model construction group was significantly lower than that in the sham operation group (p < 0.01). Both the capsule high dose and low dose groups of example 1 of the present application significantly increased bone density (p < 0.01) in model rats compared to model groups. The traditional Chinese medicine composition for preventing and treating osteoporosis can effectively improve bone density of castrated rats. In addition, the bone density of the high-dose group rats is obviously higher than that of the drynaria extract rat group and the epimedium extract rat group (p is less than 0.01), which indicates that the efficacy of the traditional Chinese medicine composition for preventing and treating osteoporosis in the application is superior to that of the drynaria single prescription or the epimedium single prescription.
(3) The femoral calcium content of each group of rats is shown in table 5 below:
TABLE 5
| Group of | Number of examples | Bone calcium content (mg/g) |
| False operation group | 10 | 322.32±15.70 |
| Model group | 10 | 220.50±40.46 |
| Example 1 high dose group | 10 | 295.12±22.51 |
| Example 1 Low dose group | 10 | 276.76±18.91 |
| Rhizoma drynariae extract group | 10 | 245.93±14.34 |
| Epimedium extract group | 10 | 250.73±24.13 |
| Positive control group (estradiol valerate) | 10 | 307.28±18.10 |
The test results in table 5 above show that the model group femoral calcium content is significantly reduced (p < 0.001). The high and low dose groups of example 1 of this application can significantly increase the femoral bone calcium content of model rats, with significant differences (p < 0.01) from the model group. And the high dose group of example 1 of this application was significantly higher than the drynaria group and the epimedium group (p < 0.01).
The test results show that compared with a sham operation group, the femur and lumbar BMD and bone calcium content of a rat in a model group are obviously reduced, the serum OC and ALP levels are obviously reduced, the NTx and TRACP-5b levels are obviously increased, and the differences are statistically significant (P < 0.05). Compared with the model group, the capsule of the example 1 has the advantages that the femur and lumbar BMD, bone calcium content, serum OC and ALP levels are all increased, the serum NTx and TRACP-5b levels are obviously reduced, and the differences are all statistically significant (P < 0.05). Compared with the single group of rhizoma drynariae or epimedium, the high-dose group of the capsule of the application example 1 has higher femur and lumbar vertebra BMD, bone calcium content, serum OC and ALP levels, lower serum NTx and TRACP-5b levels and statistically significant difference (P < 0.05).
Conclusion that the traditional Chinese medicine composition for preventing and treating osteoporosis can treat an osteoporosis rat caused by ovariectomy, and can improve bone metabolism and BMD by regulating the level of serum OC, ALP, NTx, TRACP-5 b. The traditional Chinese medicine composition for preventing and treating osteoporosis can improve bone density of patients with osteoporosis, can obviously inhibit bone resorption, and can reduce loss of bone mass, thereby treating osteoporosis.
The foregoing description of the preferred embodiments of the present application is not intended to be limiting, but is intended to cover any and all modifications, equivalents, and alternatives falling within the spirit and principles of the present application.
Claims (7)
1. The traditional Chinese medicine composition for preventing and treating osteoporosis is characterized by being prepared from the following raw materials in parts by weight:
300 to 500 parts of epimedium herb,
300 to 400 parts of drynaria rhizome,
400-600 parts of urolithin A;
the preparation method of the traditional Chinese medicine composition for preventing and treating osteoporosis comprises the following steps:
300-500 parts of epimedium herb and 300-400 parts of drynaria rhizome are obtained, and the epimedium herb and the drynaria rhizome are respectively extracted to obtain an epimedium herb extract and a drynaria rhizome extract;
mixing and granulating the epimedium extract, the drynaria extract and 400-600 parts of urolithin A to obtain the traditional Chinese medicine composition for preventing and treating osteoporosis;
in the epimedium extract, the mass percent of total flavone is not less than 30 percent calculated by icariin; in the drynaria extract, the mass percentage of total flavone is not less than 30%.
2. The traditional Chinese medicine composition for preventing and treating osteoporosis according to claim 1, wherein the traditional Chinese medicine composition for preventing and treating osteoporosis is prepared from the following raw materials in parts by weight:
350 to 450 parts of epimedium herb,
300 to 350 parts of drynaria rhizome,
450-550 parts of urolithin A.
3. The traditional Chinese medicine composition for preventing and treating osteoporosis according to claim 2, wherein the traditional Chinese medicine composition for preventing and treating osteoporosis is prepared from the following raw materials in parts by weight: 400 parts of epimedium herb, 300 parts of drynaria rhizome and 500 parts of urolithin A;
or, the traditional Chinese medicine composition for preventing and treating osteoporosis is prepared from the following raw materials in parts by weight: 370 parts of epimedium herb, 350 parts of rhizoma drynariae and 450 parts of urolithin A;
or, the traditional Chinese medicine composition for preventing and treating osteoporosis is prepared from the following raw materials in parts by weight: 420 parts of epimedium, 320 parts of rhizoma drynariae and 530 parts of urolithin A.
4. The traditional Chinese medicine composition for preventing and treating osteoporosis according to any one of claims 1 to 3, wherein the traditional Chinese medicine composition for preventing and treating osteoporosis further comprises pharmaceutically acceptable auxiliary materials;
and/or the dosage form of the traditional Chinese medicine composition for preventing and treating osteoporosis is at least one selected from capsules, tablets and granules.
5. The traditional Chinese medicine composition for preventing and treating osteoporosis according to claim 4, wherein the pharmaceutically acceptable auxiliary materials comprise: at least one of silicon dioxide, mannitol, lactose, starch, magnesium stearate, saccharin sodium, talcum powder, cellulose, glucose, gelatin, sucrose and magnesium carbonate.
6. The Chinese medicinal composition for preventing and treating osteoporosis of claim 1, wherein said epimedium is subjected to alcohol extraction to obtain said epimedium extract;
and/or extracting the rhizoma drynariae with alcohol to obtain the rhizoma drynariae extract.
7. The method for preparing a Chinese medicinal composition for preventing and treating osteoporosis according to claim 1, wherein the step of mixing granulation treatment comprises: preparing the epimedium extract, the drynaria extract, the urolithin A and pharmaceutically acceptable auxiliary materials into an oral preparation by adopting wet granulation or dry granulation.
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Effective date of registration: 20241012 Address after: No. 2, Yaogu 1st Road, Yaogu Industrial Park, Haikou National Hi tech Industrial Development Zone, Hainan 570100 Patentee after: Aomei Pharmaceutical (Hainan) Co.,Ltd. Country or region after: China Address before: 215000 186 Xinzhen Road, Tong'an Town, high tech Zone, Suzhou City, Jiangsu Province Patentee before: Aomei Pharmaceutical (Suzhou) Co.,Ltd. Country or region before: China |