阅读说明：本技术 一种具有促进骨质健康作用的中药复方组合物及其制备方法与应用 (Traditional Chinese medicine compound composition with effect of promoting bone health and preparation method and application thereof ) 是由 张曾亮 宗建成 李文玉 李鑫 李莉 王尚龙 宗磊 邹圣灿 于 2020-06-22 设计创作，主要内容包括：本发明公开了一种具有促进骨质健康作用的中药复方组合物及其制备方法与应用,本发明通过将杜仲、骨碎补与菟丝子单独提取得到的提取物进行复配制备出一种具有促进骨质健康作用的中药复方组合物,该中药复方组合物无副作用、易吸收,可以有效改善中老年人的骨质健康问题,还能有效避免因骨质疏松引起的其他并发疾病,并且本发明公开的中药复方组合物可作为膳食补充剂或保健食品原料,用于预防或者治疗骨质疏松、促进骨质健康,由此可见,本发明公开的中药复方组合物适于推广与应用。(The invention discloses a traditional Chinese medicine compound composition with the effect of promoting bone health and a preparation method and application thereof.)

1. The traditional Chinese medicine compound composition with the effect of promoting bone health is characterized by comprising the following traditional Chinese medicine extracts in percentage by mass:

60-80% of eucommia ulmoides extract;

15-30% of drynaria extract;

5-10% of the dodder seed extract.

2. The compound traditional Chinese medicine composition with the effect of promoting bone health as claimed in claim 1, wherein the compound traditional Chinese medicine composition is composed of the following traditional Chinese medicine extracts in percentage by mass:

60-70% of eucommia ulmoides extract;

20-30% of drynaria extract;

8-10% of the dodder seed extract.

3. The compound traditional Chinese medicine composition with the effect of promoting bone health as claimed in any one of claims 1 to 2, wherein the traditional Chinese medicine extract is prepared by extracting traditional Chinese medicinal materials, and the compound traditional Chinese medicine composition is prepared by separately extracting eucommia ulmoides, rhizoma drynariae and semen cuscutae and then compounding.

4. A preparation method of the traditional Chinese medicine compound composition with the effect of promoting bone health as claimed in any one of claims 1 to 3, characterized by comprising the following steps: extracting Eucommiae cortex, rhizoma Drynariae and semen Cuscutae respectively, purifying, concentrating, spray drying to obtain Chinese medicinal extract, and mixing; the method specifically comprises the following steps:

(1) heating and reflux-extracting the Chinese medicinal materials and ethanol solution according to a ratio, filtering, and mixing the extractive solutions of the residue after multiple extractions;

(2) purifying and concentrating the combined extracting solution obtained in the step (1), spray drying or vacuum drying, and sieving to obtain a traditional Chinese medicine extract;

(3) uniformly mixing the traditional Chinese medicine extracts in the step (2) according to the proportion disclosed in claim 1 to obtain the traditional Chinese medicine compound composition with the effect of promoting bone health.

5. The preparation method of the compound traditional Chinese medicine composition with the effect of promoting bone health according to claim 4, wherein in the step (1), the volume ratio of the added traditional Chinese medicines to the ethanol solution is 1: (5-20), wherein the heating reflux extraction frequency of the traditional Chinese medicinal materials is 1-3 times, the extraction time is 1-3 hours, and the extraction temperature is 80-100 ℃.

6. The preparation method of the traditional Chinese medicine compound composition with the effect of promoting bone health according to claim 4 or 5, wherein the volume ratio of the added solvent to the medicine residue is (6-8): 1, heating reflux extraction of the dregs for 0-3 times, wherein the heating reflux extraction time of the dregs is 1-2 h, and the extraction temperature is 80-100 ℃.

7. The preparation method of the compound traditional Chinese medicine composition with the effect of promoting bone health according to claim 4, wherein in the step (2), the set temperature of spray drying is 180-200 ℃, the set temperature of vacuum drying is 50-100 ℃, and the number of the screened meshes is 60-80 meshes.

8. The method for preparing the compound Chinese medicinal composition with the effect of promoting bone health according to claim 4, wherein the step (2) further comprises the step of adding maltodextrin to the concentrated extract before spray drying or vacuum drying and uniformly mixing; wherein the addition amount of the maltodextrin is 1-20% of the mass of the traditional Chinese medicinal materials.

9. Use of the compound Chinese medicinal composition with the effect of promoting bone health as claimed in any one of claims 1 to 3 or the compound Chinese medicinal composition prepared by the method as claimed in any one of claims 4 to 8 in preparing health food.

10. The use of the compound Chinese medicinal composition for promoting bone health as claimed in claim 9, wherein the compound Chinese medicinal composition can be used as a dietary supplement or a raw material of health food, and the compound Chinese medicinal composition is in the form of capsule, granule or tablet.

Technical Field

The invention belongs to the technical field of natural medicines, in particular relates to a traditional Chinese medicine compound composition and a preparation method and application thereof, and particularly relates to a traditional Chinese medicine compound composition with the function of promoting bone health and a preparation method and application thereof.

Background

With the change of human dietary structure and the extension of average life span, the population aging of China is increasing day by day, and osteoporosis becomes one of the main diseases threatening the life and health of the middle-aged and elderly people gradually. The middle-aged and the elderly are the main population suffering from osteoporosis, and the pathological characteristics of the middle-aged and the elderly are that the bone mass is reduced and the microstructure of bone tissues is damaged, so that the problems of systemic osteoporosis such as increase of bone fragility, reduction of bone density, easy occurrence of fracture and the like are caused. At present, more than 2 hundred million people all over the world suffer from osteoporosis, the incidence rate of the osteoporosis is leaped up to the sixth of common diseases and frequently encountered diseases, and the number of people suffering from osteoporosis in China exceeds 9000 ten thousand, and the osteoporosis stays at the top of the world. Osteoporosis seriously affects the life and health of middle-aged and elderly people with high morbidity, high disability rate and high mortality, and gradually becomes a public health problem threatening the world.

At present, the medicines for preventing and treating osteoporosis in an auxiliary way are mainly divided into two types, namely, medicines for promoting bone growth, such as growth hormone, estrogen and the like, and medicines for inhibiting bone absorption, such as calcitonin, diphosphate and the like, and because the medicines have large toxic and side effects, the medicines for preventing and treating osteoporosis in the present stage are not suitable for long-term administration, for example, the medicines for preventing and treating osteoporosis in the present stage can increase the risks of women suffering from endometrial cancer, breast cancer and the like after long-term administration of estrogen.

Therefore, the problem that needs to be solved by the technical personnel in the field is how to develop a traditional Chinese medicine compound composition which has no toxic or side effect and is easy to absorb and is used for treating osteoporosis and promoting bone health.

Disclosure of Invention

In view of the above, the present invention aims to provide a Chinese herbal compound composition with an effect of promoting bone health, which has no toxic or side effect and is easy to be absorbed, and can be used as a dietary supplement or a health food raw material for preventing and treating osteoporosis and promoting bone health.

In order to achieve the purpose, the invention adopts the following technical scheme:

because the Chinese medical science thinks that the main pathogenesis of osteoporosis lies in kidney deficiency, the eucommia bark, the drynaria rhizome and the dodder have the efficacies of nourishing liver and kidney and strengthening bones and muscles, and have good treatment effect when being used as medicinal materials for tonifying kidney and strengthening bones clinically. However, the combination of eucommia bark, rhizoma drynariae and semen cuscutae for treating osteoporosis is not reported. The invention follows the compatibility theory of the traditional Chinese medicine, combines and innovates eucommia bark, rhizoma drynariae and semen cuscutae, and designs the composition with excellent proportion for improving osteoporosis and promoting bone health.

A traditional Chinese medicine compound composition with the effect of promoting bone health is composed of the following traditional Chinese medicine extracts in percentage by mass:

60-80% of eucommia ulmoides extract;

15-30% of drynaria extract;

5-10% of semen cuscutae extract.

Preferably, the traditional Chinese medicine compound composition is composed of the following traditional Chinese medicine extracts in percentage by mass:

60-70% of eucommia ulmoides extract;

20-30% of drynaria extract;

8-10% of semen cuscutae extract.

Further preferably, the traditional Chinese medicine compound composition is composed of the following traditional Chinese medicine extracts in percentage by mass:

60% of eucommia ulmoides extract;

30% of drynaria extract;

semen Cuscutae extract 10%.

Preferably, the traditional Chinese medicine extract is obtained by extracting traditional Chinese medicinal materials, and the traditional Chinese medicine compound composition is prepared by separately extracting eucommia bark, rhizoma drynariae and semen cuscutae and compounding.

It is worth saying that the dosage of the traditional Chinese medicine compound composition extracted by the process disclosed by the invention is 0.5-2.0 g according to the crude drug dosage recommended by the pharmacopoeia literature, and the effective dosage of the traditional Chinese medicine compound composition is obtained by screening according to the later animal efficacy test.

In addition, the traditional Chinese medicinal materials used in the traditional Chinese medicine extract disclosed by the invention are screened according to scientific basis (prescription related to bone health), organically combined and combined according to the theory of traditional Chinese medicine, rather than simply superposed according to the efficacy of a single traditional Chinese medicine, and the specific efficacies of various traditional Chinese medicinal materials are as follows:

eucommia ulmoides: sweet in flavor and warm in nature. [ FUNCTIONS AND INDICATIONS ] can tonify liver and kidney, strengthen tendons and bones, and prevent miscarriage. It is indicated for soreness and pain of lumbar and knees, atrophy and weakness of feet and knees, dribbling urination, itching of vulva, vaginal bleeding, threatened abortion, and hypertension.

Rhizoma drynariae: [ FUNCTIONS AND INDICATIONS ] can treat wound, relieve pain, tonify kidney, and strengthen bone; dispel wind and remove spots for external use. Can be used for treating traumatic injury, sprain, fracture, lumbago due to kidney deficiency, flaccidity of bones and muscles, tinnitus, deafness, and odontoseisis; it is used externally to treat alopecia areata and vitiligo.

Dodder seed: [ FUNCTIONS AND INDICATIONS ] can tonify liver and kidney, secure essence, reduce urination, prevent miscarriage, improve eyesight, and stop diarrhea; dispel wind and remove spots for external use. Can be used for treating deficiency of liver and kidney, soreness of waist and knees, sexual impotence, spermatorrhea, enuresis, frequent micturition, vaginal bleeding due to kidney deficiency, fetal irritability, blurred vision, tinnitus, and diarrhea due to deficiency of spleen and kidney; externally treat vitiligo.

Through the efficacy analysis of the plant traditional Chinese medicinal materials, although the eucommia ulmoides and the rhizoma drynariae have the efficacies of strengthening the muscles and bones, the eucommia ulmoides are respectively emphasized, the eucommia ulmoides is emphasized to tonify the liver and the kidney and strengthen the muscles and the bones, the traditional Chinese medicine theory considers that the kidney stores essence, the kidney governs bones and produces marrow, the kidney essence is full, the marrow is generated and is active, and the bones are broken firmly and strong; if kidney essence is deficient, bone marrow is deficient, oxygen is eliminated from bones, and the bones are weak and powerless, so that the important factor for bone health is kidney health. Rhizoma drynariae emphasizes on healing wounds and relieving pain, is used for tonifying kidney and replenishing essence, strengthening waist and strengthening bone, is a common traditional Chinese medicine for treating bone diseases, has abundant clinical application, and has the effects of tonifying liver and kidney and dispelling wind-damp.

Modern researches show that the eucommia total flavonoids contained in eucommia can promote osteoblasts to synthesize type I collagen; the rhizoma drynariae can improve bone strength and inhibit bone absorption, and bone formation is faster; semen Cuscutae flavone has effects of promoting intestinal calcium absorption and increasing osteoporosis bone density. The three functions complement each other, and are not simply superposed.

In addition, in the prior art, although the common usage amount of each traditional Chinese medicine is known, the prescription is an organic whole prepared by combining a plurality of medicines according to diseases, the drug effect of the prescription is not equal to the simple superposition of the medicines on the basis of the common usage amount, the dosage of each traditional Chinese medicine in the prescription can not be determined according to the common usage amount of each traditional Chinese medicine, the dosage and the proportion of the medicines are determined by various considerations such as the characteristics of the medicines and monarch, minister, assistant and guide compatibility, and the like, and the prescription can not be obtained by experimental means such as a comparison method, an orthogonal method and the like simply and preferably.

The invention also aims to provide a preparation method of the traditional Chinese medicine compound composition with the function of promoting bone health, which comprises the following steps: extracting Eucommiae cortex, rhizoma Drynariae and semen Cuscutae respectively, purifying, concentrating, spray drying to obtain Chinese medicinal extract, and mixing; the method specifically comprises the following steps:

(1) heating and reflux-extracting the Chinese medicinal materials and ethanol solution according to a ratio, filtering, and mixing the extractive solutions of the residue after multiple extractions;

(2) purifying and concentrating the combined extracting solution obtained in the step (1), spray drying or vacuum drying, and sieving to obtain a traditional Chinese medicine extract;

(3) and (3) uniformly mixing the traditional Chinese medicine extracts in the step (2) according to the disclosed proportion to obtain the traditional Chinese medicine compound composition with the function of promoting bone health.

Preferably, in the step (1), the volume ratio of the added Chinese medicinal materials to the ethanol solution is 1: (5-20), wherein the heating reflux extraction frequency of the traditional Chinese medicinal materials is 1-3 times, the extraction time is 1-3 hours, and the extraction temperature is 80-100 ℃.

Further, the volume ratio of the added solvent to the medicine residue is (6-8): 1, heating reflux extraction of the dregs for 0-3 times, wherein the heating reflux extraction time of the dregs is 1-2 h, and the extraction temperature is 80-100 ℃.

In addition, the solvent used for further extraction of the dregs is deionized water or ethanol solution.

Preferably, in the step (2), the set temperature of spray drying is 180-200 ℃, the temperature of vacuum drying is 50-100 ℃, and the number of sieving meshes is 60-80 meshes.

Exemplarily, the step (2) further comprises the step of adding dextrin into the concentrated extracting solution before spray drying or vacuum drying and uniformly mixing; wherein the addition amount of the dextrin is 1-20% of the mass of the traditional Chinese medicinal materials.

Specifically, the preparation method of the traditional Chinese medicine compound composition comprises the following steps:

(1) adding 1 to the eucommia ulmoides medicinal materials: (5-20) heating and refluxing 60-80% ethanol solution, extracting for 1-3 h, filtering, adding 6-8 times deionized water into the residue, heating and refluxing for 2-3 times, each time for 1-2 h, combining the extracting solutions, concentrating to a small volume, adding 5% of maltodextrin, continuously concentrating to a density of 1.15-1.2, putting into a vacuum oven, vacuum-drying at 50-100 ℃, crushing the dried product, sieving with an 80-mesh sieve, and mixing to obtain an extract A;

further, adding 75-80% ethanol in an amount which is 6 times that of the eucommia ulmoides medicinal materials, extracting for 1 time, refluxing for 2 hours each time, filtering, adding deionized water in an amount which is 6 times that of the eucommia ulmoides medicinal materials, extracting for two times, refluxing for 1.5 hours each time, combining the extracting solutions, concentrating to a small volume, adding maltodextrin with the amount which is 5% of the raw material amount, continuously concentrating to the density of 1.15-1.2, putting the mixture into a vacuum oven at 75 ℃, performing vacuum drying, crushing the dried product, sieving the dried product by a sieve with 80 meshes, and;

(2) adding 1 part of rhizoma drynariae medicinal materials: (5-20) heating and refluxing 60-80% ethanol solution, extracting for 1-3 h, filtering, adding 6-8 times of 60-80% ethanol solution into the medicine residues, heating and refluxing for 2-3 times, extracting for 1-2 h each time, filtering the extracting solution, concentrating to a small volume, adding 10% maltodextrin, continuing to concentrate to a density of 1.2, putting into a vacuum oven, vacuum-drying at 50-100 ℃, crushing the dried product, sieving with an 80-mesh sieve, and mixing to obtain an extract B;

further, after coarsely crushing the rhizoma drynariae raw material, respectively adding 75% ethanol 6 times, 5 times and 5 times of the rhizoma drynariae raw material, extracting for 3 times, refluxing for 2 hours each time, filtering the extracting solution, concentrating to a small volume, adding maltodextrin 10% of the raw material, continuously concentrating to a density of 1.2, drying at 75 ℃ in vacuum, crushing the dried product, sieving with a 80-mesh sieve, and mixing to obtain the rhizoma drynariae extract;

(3) adding 1 part of semen cuscutae medicinal materials: (5-20) soaking in 60-80% ethanol solution for 10 min-60 min, heating and refluxing for 1-3 h, filtering, adding 6-8 times of 60-80% ethanol solution into the medicine residues, heating and refluxing for 2-3 times, 1-2 h each time, concentrating the filtered extract to density of 1.12-1.15, spray-drying at 180-200 ℃, crushing the dried product, sieving with 80-mesh sieve, and mixing to obtain an extract C;

further, respectively adding 6 times, 5 times and 5 times of 75% ethanol into the raw materials of the dodder, extracting for 3 times, refluxing for 2 hours each time, filtering the extracting solution, concentrating until the density is 1.12-1.15, carrying out spray drying at 180 ℃, crushing the dried product, sieving with a 80-mesh sieve, and mixing to obtain the dodder extract;

(4) and (3) uniformly mixing the extracts A, B, C obtained in the steps (1) to (3) according to the mixture ratio to obtain the traditional Chinese medicine compound composition.

In addition, the invention also aims to provide application of the traditional Chinese medicine compound composition with the effect of promoting bone health in preparation of health-care products.

Furthermore, the traditional Chinese medicine compound composition can be used as a dietary supplement or a raw material of health food for preventing or treating osteoporosis and promoting bone health, and the dosage form of the traditional Chinese medicine compound composition is capsules, granules or tablets.

According to the technical scheme, compared with the prior art, the traditional Chinese medicine compound composition with the effect of promoting bone health, and the preparation method and the application thereof provided by the invention have the following excellent effects:

1. the Chinese medical science doctors think that the main pathogenesis of osteoporosis lies in kidney deficiency, and the eucommia bark, the drynaria rhizome and the dodder have the effects of nourishing liver and kidney and strengthening bones and muscles, are clinically used as medicinal materials for tonifying kidney and strengthening bones, and have good treatment effect. However, the combination of eucommia bark, rhizoma drynariae and semen cuscutae for treating osteoporosis is not reported. The invention follows the compatibility theory of the traditional Chinese medicine, combines and innovates eucommia bark, rhizoma drynariae and semen cuscutae, and designs the composition with excellent proportion for improving osteoporosis and promoting bone health.

2. The invention adopts a composite preparation process after the medicinal materials are extracted separately, determines that the main active substances of the separate extract are all the total flavonoids, and has more stable extract quality and higher controllability compared with the traditional Chinese medicine extraction method.

3. The Chinese medicinal compound composition disclosed and protected by the invention is determined to have good effects of improving osteoporosis and promoting bone health through pharmacodynamic experiments.

4. The traditional Chinese medicine compound composition disclosed and protected by the invention has no toxic or side effect and is easy to absorb, is used for treating osteoporosis and promoting bone health, can improve the bone health problem of middle-aged and elderly people, and can effectively avoid other complications caused by osteoporosis.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the provided drawings without creative efforts.

FIG. 1 is a graph showing the results of measurement of estrogen levels in various groups of rats.

FIG. 2 is a graph showing the results of biochemical blood index measurements in various groups of rats.

FIG. 3 is a diagram of biochemical indicators of bone metabolism in various groups of rats.

FIG. 4 is a graph showing the results of measurement of bone density index in each rat group.

FIG. 5 is a graph showing the results of measurements of various mechanical testing indexes of rats.

Detailed Description

The technical solutions disclosed in the present invention will be clearly and completely described below with reference to the specification and the corresponding embodiments, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

The embodiment of the invention discloses a Chinese medicinal compound composition which has no toxic or side effect and is easy to absorb, has the effect of promoting bone health, can be used as a dietary supplement or a health-care food raw material for preventing or treating osteoporosis, and is suitable for market popularization.

The present invention will be further specifically illustrated by the following examples for better understanding, but the present invention is not to be construed as being limited thereto, and certain insubstantial modifications and adaptations of the invention by those skilled in the art based on the foregoing disclosure are intended to be included within the scope of the invention.

The invention discloses a traditional Chinese medicine compound composition with the effect of promoting bone health, which consists of the following traditional Chinese medicine extracts in percentage by mass:

60-80% of eucommia ulmoides extract;

15-30% of drynaria extract;

5-10% of semen cuscutae extract.

In order to further optimize the technical scheme, the traditional Chinese medicine extract is prepared by extracting traditional Chinese medicinal materials, and the traditional Chinese medicine compound composition is prepared by separately extracting eucommia bark, rhizoma drynariae and semen cuscutae and compounding.

The invention also discloses a preparation method of the traditional Chinese medicine compound composition with the function of promoting bone health, which comprises the following steps: extracting Eucommiae cortex, rhizoma Drynariae and semen Cuscutae respectively, purifying, concentrating, spray drying to obtain Chinese medicinal extract, and mixing; the method specifically comprises the following steps:

(1) heating and reflux-extracting the Chinese medicinal materials and ethanol solution according to a ratio, filtering, and mixing the extractive solutions of the residue after multiple extractions;

(2) purifying and concentrating the combined extracting solution obtained in the step (1), spray drying or vacuum drying, and sieving to obtain a traditional Chinese medicine extract;

(3) uniformly mixing the traditional Chinese medicine extracts in the step (2) according to the proportion disclosed in claim 1 to obtain the traditional Chinese medicine compound composition with the effect of promoting bone health.

Further, in the step (1), the volume ratio of the traditional Chinese medicinal materials to the ethanol solution is 1: (5-20), wherein the heating reflux extraction frequency of the traditional Chinese medicinal materials is 1-3 times, the extraction time is 1-3 hours, and the extraction temperature is 80-100 ℃.

Furthermore, the volume ratio of the added solvent to the medicine residue is (6-8): 1, heating reflux extraction of the dregs for 0-3 times, and heating reflux extraction of the dregs for 1-2 h at 80-100 ℃.

And in the step (2), the set temperature of spray drying is 180-200 ℃, the temperature of vacuum drying is 50-100 ℃, and the number of sieving meshes is 60-80 meshes.

And the step (2) also comprises the step of adding dextrin into the concentrated extracting solution before spray drying or vacuum drying and uniformly mixing; wherein the addition amount of dextrin is 1-20% of the mass of the traditional Chinese medicinal materials.

In addition, the invention also discloses application of the traditional Chinese medicine compound composition with the effect of promoting bone health in preparing health-care food.

Furthermore, the Chinese herbal compound composition can be used as a dietary supplement or a raw material of health food, and the dosage form of the Chinese herbal compound composition is capsules, granules or tablets.

The technical solution disclosed in the present invention will be further described with reference to the following specific examples.