Traditional Chinese medicine composition for treating osteoporosis, preparation, preparation method and application

Abstract

The embodiment of the invention discloses a traditional Chinese medicine composition for treating osteoporosis, a traditional Chinese medicine preparation, a preparation method and application. The traditional Chinese medicine composition for treating osteoporosis is prepared from the following raw materials in parts by weight: 10 to 14 parts of radix rehmanniae praeparata, 10 to 14 parts of cortex eucommiae, 10 to 14 parts of radix dipsaci, 7 to 11 parts of fructus psoraleae, 7 to 11 parts of radix angelicae sinensis and 10 to 14 parts of radix paeoniae alba. The traditional Chinese medicine composition provided by the embodiment of the invention has a relatively good curative effect on osteoporosis.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and in particular to a traditional Chinese medicine composition, preparation, preparation method and application for treating osteoporosis. Background Art

[0002] Osteoporosis is the most common bone disease. It is a systemic bone disease characterized by low bone mass, damaged bone tissue microstructure, increased bone brittleness, and easy fractures. Osteoporosis is a bone disease associated with aging. Although modern medicine has proposed many treatment and prevention plans for osteoporosis, a large number of people still choose traditional Chinese medicine for treatment because some drugs are expensive or have disadvantages such as strong side effects. Current basic and clinical studies have shown that traditional Chinese medicine has definite efficacy in treating osteoporosis, has few toxic side effects, and is relatively inexpensive, so people seek treatment strategies from traditional Chinese medicine.

[0003] Therefore, solving the problem of osteoporosis treatment through TCM syndrome differentiation and treatment and using Chinese medicine prescriptions is a good way to accelerate the patient's rehabilitation and functional recovery, and it has great potential for clinical application. Summary of the invention

[0004] Therefore, in order to overcome at least some of the defects and shortcomings in the prior art, the embodiments of the present invention provide a Chinese medicine composition, a Chinese medicine preparation, a preparation method and an application for treating osteoporosis.

[0005] On the one hand, an embodiment of the present invention provides a traditional Chinese medicine composition for treating osteoporosis, comprising the following raw materials in parts by weight: 10-14 parts of Rehmannia glutinosa, 10-14 parts of Eucommia ulmoides, 10-14 parts of Dipsacus asper, 7-11 parts of Psoralea corylifolia, 7-11 parts of Angelica sinensis and 10-14 parts of White Peony Root.

[0006] In one embodiment of the present invention, the Chinese medicine composition comprises the following raw materials in parts by weight: 12 parts of Rehmannia glutinosa, 12 parts of Eucommia ulmoides, 12 parts of Dipsacus asper, 9 parts of Psoralea corylifolia, 9 parts of Angelica sinensis and 12 parts of White Peony Root.

[0007] On the other hand, an embodiment of the present invention provides a Chinese medicine preparation of a Chinese medicine composition for treating osteoporosis, wherein the preparation is prepared by adding a pharmaceutically acceptable excipient to the Chinese medicine composition.

[0008] In one embodiment of the present invention, the preparation is an oral preparation, and the oral preparation is selected from the dosage form of decoction, extract, lyophilized powder, capsule, tablet, powder, granule, wine, pill and micropill.

[0009] In one embodiment of the present invention, the pharmaceutically acceptable excipient is selected from one or more of a diluent, a carrier, a filler, a binder, a wetting agent, a disintegrant, an absorption promoter, a surfactant, an adsorption carrier and a lubricant.

[0010] On the other hand, an embodiment of the present invention provides a method for preparing a traditional Chinese medicine composition for treating osteoporosis, comprising the following steps: weighing raw materials of Rehmannia glutinosa, Eucommia ulmoides, Dipsacus asper, Psoralea corylifolia, Angelica sinensis and Paeonia lactiflora, adding ethanol aqueous solution to soak and decoct, and then filtering out the medicinal liquid to obtain a crude extract of the traditional Chinese medicine; concentrating the crude extract of the traditional Chinese medicine to obtain a concentrated solution of the traditional Chinese medicine; adding a pharmaceutically acceptable excipient to the concentrated solution of the traditional Chinese medicine to prepare an oral dosage form.

[0011] In one embodiment of the present invention, the step of adding ethanol-water solution for soaking and decocting and then filtering out the medicinal liquid to obtain a crude extract of traditional Chinese medicine specifically comprises: adding ethanol-water solution 10 times the weight of the medicinal material for soaking for 30 minutes, boiling and decocting for 2 hours, and filtering out a first medicinal liquid; then adding ethanol-water solution 8 times the weight of the medicinal material, boiling and decocting for 2 hours, and filtering out a second medicinal liquid; and mixing the first medicinal liquid and the second medicinal liquid to obtain the crude extract of traditional Chinese medicine.

[0012] In one embodiment of the present invention, the concentration of the ethanol aqueous solution is 70%.

[0013] In one embodiment of the present invention, the concentration of crude drugs in the traditional Chinese medicine concentrate is 0.66 g / mL.

[0014] In another aspect, an embodiment of the present invention provides use of the above-mentioned Chinese medicine composition in preparing a drug for treating osteoporosis.

[0015] In summary, the traditional Chinese medicine composition for treating osteoporosis proposed in the embodiment of the present invention includes Rehmannia glutinosa, Eucommia ulmoides, Dipsacus asper, Psoralea corylifolia, Angelica sinensis and White Peony Root. The traditional Chinese medicine composition for treating osteoporosis provided in this embodiment has obvious therapeutic effect on osteoporosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative work.

[0017] Figure 1 A schematic flow chart of a method for preparing a traditional Chinese medicine composition for treating osteoporosis provided in an embodiment of the present invention.

[0018] Figure 2 for Figure 1 Schematic diagram of the process of step S10.

[0019] Figure 3 It is a line graph of the weight changes of experimental rats in each group.

[0020] Figure 4 This is a comparison of the HE staining results of the fifth lumbar vertebrae of experimental rats in each group.

[0021] Figure 5 This is a comparison of the Masson staining results of the fifth lumbar vertebrae of experimental rats in each group.

[0022] Figure 6 This is a comparison of the two-dimensional structures of the fifth lumbar vertebrae of each group of experimental rats.

[0023] Figure 7 Comparison of the three-dimensional structures of the fifth lumbar vertebrae of each group of experimental rats.

[0024] Figure 8 The figure is a comparison of bone density of bone microscopic parameters in each group of experimental rats.

[0025] Fig. 9 Comparison of bone volume fraction, a microscopic parameter of bones in each group of experimental rats.

[0026] Fig.10 The figure is a comparison of the bone microscopic parameter trabecular number of each group of experimental rats.

[0027] Fig.11 This is a comparison of the bone microscopic parameters of trabecular separation in each group of experimental rats. DETAILED DESCRIPTION

[0028] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0029] The embodiment of the present invention provides a traditional Chinese medicine composition for treating osteoporosis, which comprises the following raw materials in parts by weight: 10-14 parts of Rehmannia root, 10-14 parts of Eucommia bark, 10-14 parts of Dipsacus asper, 7-11 parts of Psoralea corylifolia, 7-11 parts of Angelica sinensis and 10-14 parts of White Peony Root.

[0030] In a specific implementation of this example, the Chinese medicine composition includes the following raw materials in parts by weight: 12 parts of Rehmannia glutinosa, 12 parts of Eucommia ulmoides, 12 parts of Dipsacus asper, 9 parts of Psoralea corylifolia, 9 parts of Angelica sinensis and 12 parts of White Peony Root.

[0031] Chinese medicine composition prescription explanation: Rehmannia root in the prescription is sweet, slightly warm in nature, and belongs to the liver and kidney meridians. "Compendium of Materia Medica" says "fills the bone marrow, grows muscles, produces essence and blood, replenishes the internal injuries of the five internal organs, and dredges the blood vessels", and "Compendium of Materia Medica Seeking Truth" says "Rehmannia root nourishes the liver and kidneys, and enters the essence and marrow of the tendons and bones". In the Chinese medicine composition of this embodiment, Rehmannia root is reused to nourish yin and blood, replenish essence and fill marrow, and is the main medicine. The kidney stores essence and governs bones, and the liver stores blood and governs tendons. If the liver and kidney are deficient, the essence is insufficient and the marrow is dry, resulting in tendon atrophy and bone dryness. Eucommia and Dipsacus are used to replenish the liver and kidney, and Eucommia is good at strengthening tendons and bones, strengthening the waist and spine, and Dipsacus is good at strengthening tendons and bones, and regulating blood vessels; Psoralea corylifolia nourishes the kidney and strengthens yang, warms the water organs, replenishes fire and generates soil, helps the acquired source of biochemistry to benefit the innate, and the three medicines match, helping the main medicine to replenish essence and fill marrow to strengthen tendons and bones, and is the minister medicine. Angelica sinensis nourishes blood and promotes blood circulation, assisting the main medicine in nourishing blood and yin; white peony root nourishes blood, restrains yin, softens the liver and relieves pain, so as to relax muscle spasms. The two medicines are combined to promote blood circulation and nourish blood to nourish muscles and bones, and serve as adjuvant drugs.

[0032] The embodiment of the present invention provides a Chinese medicine preparation of a Chinese medicine composition for treating osteoporosis, wherein the Chinese medicine preparation is prepared by adding a pharmaceutically acceptable excipient to the Chinese medicine composition. The Chinese medicine preparation is an oral preparation, and the oral preparation is selected from the dosage form of a decoction, an extract, a lyophilized powder, a capsule, a tablet, a powder, a granule, a wine, a pill, and a micropill. Among them, the pharmaceutically acceptable excipient is selected from one or more of a diluent, a carrier, a filler, a binder, a wetting agent, a disintegrant, an absorption promoter, a surfactant, an adsorption carrier, and a lubricant.

[0033] See also Figure 1 The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0034] S10, weighing raw materials of Radix Rehmanniae Preparata, Eucommia ulmoides, Dipsacus asper, Psoralea corylifolia, Angelica sinensis and Paeonia lactiflora, adding ethanol aqueous solution to soak and decoct, and filtering out the medicinal liquid to obtain a crude extract of traditional Chinese medicine;

[0035] S20, concentrating the crude extract of traditional Chinese medicine to obtain a concentrated solution of traditional Chinese medicine;

[0036] S30, adding a pharmaceutically acceptable excipient to the Chinese medicine concentrate to prepare an oral dosage form. Wherein, the ethanol aqueous solution is added to soak and decoct, and then the medicinal liquid is filtered out to obtain a crude Chinese medicine extract, which specifically includes:

[0037] S11, adding 10 times the weight of the medicinal material in ethanol aqueous solution to soak for 30 minutes, boiling and then decocting for 2 hours, and filtering out the first medicinal liquid;

[0038] S12, adding 8 times the weight of the medicinal material ethanol aqueous solution, boiling and decocting for 2 hours, and filtering out the second medicinal liquid;

[0039] S13, mixing the first medicinal liquid and the second medicinal liquid to obtain the crude Chinese medicine extract.

[0040] Preferably, the concentration of the ethanol aqueous solution is 70%. The concentration of crude drugs in the traditional Chinese medicine concentrate is 0.66 g / mL.

[0041] In order to facilitate a better understanding of the embodiments of the present invention, the following is an example of preparing a Chinese medicine composition for treating osteoporosis into a concentrated liquid Chinese medicine, and an experimental description is performed.

[0042] [Example 1]

[0043] 10 parts of Rehmannia glutinosa, 10 parts of Eucommia ulmoides, 10 parts of Dipsacus asper, 7 parts of Psoralea corylifolia, 7 parts of Angelica sinensis and 10 parts of White Peony Root.

[0044] [Example 2]

[0045] 14 parts of Rehmannia glutinosa, 14 parts of Eucommia ulmoides, 14 parts of Dipsacus asper, 11 parts of Psoralea corylifolia, 11 parts of Angelica sinensis and 14 parts of White Peony Root.

[0046] [Example 3]

[0047] 12 parts of Radix Rehmanniae Preparata, 12 parts of Eucommia ulmoides, 12 parts of Radix Dipsaci, 9 parts of Psoralea corylifoliae, 9 parts of Angelica sinensis and 12 parts of White Peony Root.

[0048] Preparation process of concentrated liquid Chinese medicine composition for treating osteoporosis:

[0049] (1) Weigh the Chinese medicinal materials required for each dose of the Chinese medicinal compound composition, add 10 times the weight of the raw materials to a 70% ethanol aqueous solution, soak for 30 minutes, set the electric heating jacket to a voltage of 200V and boil, reduce the voltage to 50-70V after boiling, and filter out the first medicinal liquid after boiling for 2 hours; then add 8 times the weight of the 70% ethanol aqueous solution, boil at a voltage of 200V, reduce the voltage to 50-70V after boiling, and filter out the second medicinal liquid after boiling for 2 hours; mix the first medicinal liquid and the second medicinal liquid to obtain a crude extract.

[0050] (2) The crude extract obtained in step (1) is concentrated by rotary evaporation until it becomes thick, thereby obtaining a concentrated solution, wherein the concentration of the crude drug in the concentrated solution is 0.66 g / mL.

[0051] [Experimental example]

[0052] Twenty-four SPF 3-month-old female SD rats with a body weight of 300±20g were randomly divided into a sham operation group of 8 and a modeling group of 16 after 1 week of adaptive feeding. An osteoporosis model was constructed by ovariectomy. Finally, penicillin (200,000 units / rat, qd) was given intramuscularly for 3 consecutive days to prevent infection. The sham operation group did not remove the bilateral ovaries, only a small amount of fat tissue around the ovaries was removed, and the rest of the operations were the same as the modeling group. The modeling group was randomly divided into a model group of 8 and a Chinese medicine combination group of 8. One week after modeling, oral gavage intervention was given for a total of 12 weeks. The intervention methods of each group are as follows:

[0053] Sham operation group: 0.9% saline was administered intragastrically at 0.5 mL / 100 g once a day.

[0054] Model group: 0.9% saline was administered by intragastric administration at 0.5 mL / 100 g, once a day.

[0055] Chinese medicine combination group: The rat equivalent dose was calculated according to the human-rat body surface area conversion factor of 6, and the adult body weight was converted to 60 kg. The oral gavage dose for rats was 6.6 g of crude drug / kg / d, once a day.

[0056] Sampling and sample processing:

[0057] After 12 weeks of intragastric administration, rats in each group were fasted for 12 hours before sampling, but not water deprivation, and were sampled after isoflurane anesthesia. The fifth lumbar vertebra was bluntly separated and fixed with 4% paraformaldehyde fixative for microcomputed tomography (Micro-CT) detection, hematoxylin-eosin (HE) staining, and Masson staining.

[0058] Micro-CT detection:

[0059] The experiment used a small animal in vivo micro-CT imaging system (Quantum GX2) for scanning. The experimental samples of the fifth lumbar vertebra of each group of mice were fixed in the fixator along the long axis. The parameters were set as follows: voltage 90KV, current 88μA, scanning field of view (FOV) 36mm, voxel size 72μm, scanning time 14 minutes, and the scan was completed in one rotation.

[0060] HE staining and Masson staining:

[0061] (1) Fixation: Fix the sections with 4% paraformaldehyde neutral solution at room temperature for 48 h. After fixation, rinse the sections with running water three times.

[0062] (2) Decalcification: decalcify with 10% ethylenediaminetetraacetic acid solution until the texture is like soft tissue.

[0063] (3) Preparation of tissue paraffin-embedded blocks: Dehydration with gradient alcohol, clearing with xylene, wax immersion, and embedding are performed in this order.

[0064] (4) Tissue sectioning: The slice thickness was 4 μm. The slices were spread on 38°C distilled water and baked at 60°C for 3 hours.

[0065] (5) Dewaxing and hydration of paraffin sections: After dewaxing, use gradient alcohol, finally to pure water, and then perform HE staining and Masson staining.

[0066] (6) HE staining: After the paraffin sections were dewaxed and hydrated, they were stained with hematoxylin for 30 seconds and rinsed with running water for 10 minutes. The sections were differentiated with differentiation solution for 1-3 seconds and soaked in distilled water for 5 minutes. The sections were stained with eosin for 1-3 seconds and rinsed with running water for 10 minutes. The sections were dried and sealed with neutral gum. The morphological structure of the bone tissue of the fifth lumbar vertebra was observed under an inverted microscope.

[0067] (7) Masson staining: The dewaxed and hydrated sections were placed in Bouin solution and mordanted in a 60°C incubator for 2 hours, then rinsed with running water until the yellow color on the sections disappeared; stained with lapis lazuli blue solution for 3 to 5 minutes and rinsed with water; stained with Mayer's hematoxylin solution for 30 seconds and running water for 5 minutes; differentiated with differentiation solution for 1 second and distilled water for 5 minutes; stained with Ponceau fuchsin solution for 1 to 2 minutes and running water for 5 minutes; treated with phosphomolybdic acid solution for about 30 to 40 minutes until the red collagen fibers were differentiated into colorless or light red; stained with aniline blue solution for 2 to 3 minutes and running water for 5 minutes; dried, sealed with neutral gum, and the morphological changes of the fifth lumbar vertebrae of each group of rats were observed under an inverted microscope.

[0068] Experimental results:

[0069] 1. See Figure 3 During the intervention of the Chinese medicine composition, the weight change trend of rats in the Chinese medicine composition group and the model group was the same, with no statistical difference.

[0070] 2. HE staining and Masson staining

[0071] See also Figure 4 and Figure 5 Under light microscopy, the sham operation group had relatively complete trabeculae, abundant bone marrow cells, fewer and smaller fat vacuoles; the model group had broken and thinned trabeculae, reduced bone marrow cells, and increased and larger bone marrow fat vacuoles; compared with the model group, the continuity and integrity of trabeculae in the Chinese medicine combination group were improved, with more bone marrow cells, fewer and smaller fat vacuoles.

[0072] 3. Micro-CT

[0073] See also Figure 6 and Figure 7 In the two-dimensional scanning and three-dimensional structural reconstruction of the fifth lumbar sagittal plane, the trabeculae of the rats in the sham operation group were coarser and thicker, more closely arranged, regular in shape, uniform in thickness, and in a consistent direction; compared with the sham operation group, the number of trabeculae in the rats in the model group decreased, became thinner and thinner, the continuity decreased, the arrangement was more irregular, the spacing was wider, and some cavities were formed; compared with the model group, the trabeculae in the Chinese medicine combination group became coarser and denser, more evenly arranged, the bone continuity was better, and the bone microstructure was significantly improved. Figures 8 to 11It can be seen that compared with the sham operation group, the bone mineral density (BMD), bone volume fraction (BV / TV) and trabecular number (Tb.N) of the rats in the model group were decreased (P<0.01 or P<0.05), and the trabecular separation (Tb.Sp) was increased (P<0.05); compared with the model group, the BMD, BV / TV and Tb.N of the rats in the Chinese medicine combination group were increased (P<0.05), and Tb.Sp was decreased (P<0.05).

[0074] It can be seen from the above experimental results that the traditional Chinese medicine composition for treating osteoporosis provided by the embodiment of the present invention has a good therapeutic effect on osteoporosis.

[0075] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A Chinese medicine composition for treating osteoporosis, characterized in that: The Chinese medicine composition comprises the following raw materials in parts by weight: 10-14 parts of Rehmannia root, 10-14 parts of Eucommia bark, 10-14 parts of Dipsacus asper, 7-11 parts of Psoralea corylifolia, 7-11 parts of Angelica sinensis and 10-14 parts of White Peony Root.

2. The Chinese medicine composition for treating osteoporosis according to claim 1, characterized in that: The Chinese medicine composition comprises the following raw materials in parts by weight: 12 parts of Rehmannia root, 12 parts of Eucommia bark, 12 parts of Dipsacus asper, 9 parts of Psoralea corylifolia, 9 parts of Angelica sinensis and 12 parts of White Peony Root.

3. A preparation of a Chinese medicine composition for treating osteoporosis according to claim 1 or 2, characterized in that: The preparation is prepared by adding a pharmaceutically acceptable excipient into the traditional Chinese medicine composition.

4. The preparation according to claim 3, characterized in that The preparation is an oral preparation, and the oral preparation is selected from the dosage form of decoction, extract, lyophilized powder, capsule, tablet, powder, granule, wine, pill and micropill.

5. The preparation according to claim 3, characterized in that The pharmaceutically acceptable excipient is selected from one or more of a diluent, a carrier, a filler, a binder, a wetting agent, a disintegrant, an absorption promoter, a surfactant, an adsorption carrier and a lubricant.

6. A method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that: The following steps are involved: Weigh the raw materials of Radix Rehmanniae Preparata, Eucommia ulmoides, Radix Dipsaci, Fructus Psoraleae, Radix Angelicae Sinensis and Paeoniae Alba, add ethanol aqueous solution to soak and decoct, filter out the medicinal liquid, and obtain a crude extract of traditional Chinese medicine; Concentrating the crude extract of traditional Chinese medicine to obtain a concentrated solution of traditional Chinese medicine; A pharmaceutically acceptable excipient is added to the traditional Chinese medicine concentrated solution to prepare an oral dosage form.

7. The preparation method according to claim 6, characterized in that: The ethanol aqueous solution is added for soaking and boiling, and then the medicinal liquid is filtered out to obtain a crude extract of the traditional Chinese medicine, which specifically comprises: Add 10 times the weight of the medicinal material in ethanol aqueous solution and soak for 30 minutes, boil and decoct for 2 hours, and filter out the first medicinal liquid; Then add ethanol water solution 8 times the weight of the medicinal material, boil it for 2 hours, and filter out the second medicinal liquid; The first medicinal liquid and the second medicinal liquid are mixed to obtain the crude Chinese medicine extract.

8. The preparation method according to claim 7, characterized in that: The concentration of the ethanol aqueous solution is 70%.

9. The preparation method according to claim 7, characterized in that: The Chinese medicine concentrate contains crude drug concentration of 0.66 g / mL.

10. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for treating osteoporosis.

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