A traditional Chinese medicine preparation for treating osteoporosis and its preparation method

Abstract

The present invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine preparation for treating osteoporosis and a preparation method thereof. The traditional Chinese medicine preparation comprises the following raw materials in parts by weight: 25-35 parts of epimedium, 10-20 parts of achyranthes bidentata, 8-15 parts of luffa cylindrica, 10-15 parts of phyllostachys nigra root, 4-10 parts of limonium aureum, 7-16 parts of prepared rehmannia root, 12-18 parts of atractylodes macrocephala, 5-15 parts of wolfberry, 5-10 parts of ophiopogon japonicus, and 1-5 parts of liquorice. The above traditional Chinese medicine preparation can effectively improve the bone density, bone quality, hydroxyproline content and calcium and phosphorus contents in bone of rats with osteoporosis induced by bilateral ovariectomy.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine preparation for treating osteoporosis and a preparation method thereof. Background Art

[0002] Osteoporosis is a systemic bone disease caused by various reasons, characterized by decreased bone density and bone quality, damaged bone microstructure, increased bone fragility, and easy occurrence of fractures. Its main clinical manifestations are: fatigue, bone pain, spinal deformity, fractures, etc. According to different causes, osteoporosis is divided into the following four types: postmenopausal osteoporosis, senile osteoporosis, idiopathic osteoporosis, and secondary osteoporosis.

[0003] At present, the treatment methods for osteoporosis are divided into two types: drug treatment and non-drug treatment. Among them, drug treatment mainly aims to achieve the treatment of osteoporosis by taking drugs that inhibit osteoclasts, such as alendronate sodium, zoledronic acid, risedronic acid ammonium, etidronate disodium, etc., drugs that inhibit bone resorption, such as calcitonin, sex hormone supplements, such as raloxifene, etc. However, the above drugs have problems such as large side effects, strong dependence, easy recurrence after drug withdrawal, and limited treatment effects.

[0004] In recent years, the efficacy of traditional Chinese medicine in the treatment of osteoporosis has gradually attracted attention. In the treatment of osteoporosis, traditional Chinese medicine treatment is based on the basic principles of tonifying the kidney and replenishing essence, strengthening the spleen and replenishing qi, promoting blood circulation and removing blood stasis, to promote bone metabolism and improve bone microstructure, so as to achieve the purpose of treating osteoporosis. However, the current traditional Chinese medicine preparations for treating osteoporosis have problems with poor treatment effects. Based on the above background, the present invention provides a new traditional Chinese medicine preparation to enhance the treatment effect and relieve the pain of patients. Summary of the Invention

[0005] The first object of the present invention is to provide a traditional Chinese medicine preparation for treating osteoporosis, which can effectively improve the bone density, bone quality, hydroxyproline content, and calcium and phosphorus contents in bone tissue of rats with osteoporosis induced by bilateral ovariectomy.

[0006] The second object of the present invention is to provide a preparation method for a traditional Chinese medicine preparation for treating osteoporosis, and the preparation steps are simple and easy for large-scale production.

[0007] In order to achieve the above objects, the technical solution adopted by the present invention is:

[0008] A traditional Chinese medicine preparation for treating osteoporosis, comprising the following raw materials in parts by weight: 25 - 35 parts of epimedium, 10 - 20 parts of achyranthes bidentata, 8 - 15 parts of luffa cylindrica, 10 - 15 parts of black bamboo root, 4 - 10 parts of limonium aureum, 7 - 16 parts of prepared rehmannia root, 12 - 18 parts of atractylodes macrocephala, 5 - 15 parts of wolfberry fruit, 5 - 10 parts of dwarf lilyturf tuber, 1 - 5 parts of liquorice.

[0009] Further, it comprises the following raw materials in parts by weight: 29 parts of epimedium, 15 parts of achyranthes bidentata, 12 parts of luffa cylindrica, 13 parts of black bamboo root, 7 parts of limonium aureum, 14 parts of prepared rehmannia root, 15 parts of atractylodes macrocephala, 11 parts of wolfberry fruit, 8 parts of dwarf lilyturf tuber, 3 parts of liquorice.

[0010] The preparation method of the above traditional Chinese medicine preparation for treating osteoporosis comprises the following steps:

[0011] (1) Mix the raw materials evenly according to the above parts by weight ratio, then add water for soaking treatment to obtain a mixed solution; after the soaking treatment, decoct the mixed solution, and filter to obtain a first filtrate and a first residue;

[0012] (2) Soak and decoct the first residue with water, and filter to obtain a second filtrate and a second residue;

[0013] (3) Combine the first filtrate and the second filtrate and concentrate to obtain a concentrated solution, add pharmaceutically acceptable excipients to the concentrated solution, and prepare into the corresponding dosage form, then it is obtained.

[0014] Further, the amount of water used in steps (1) and (2) is 4 - 10 times the total weight of the raw materials.

[0015] Further, the soaking time in steps (1) and (2) is 0.5 - 1.5 h; the decocting time is 1 - 2 h.

[0016] Further, the concentration temperature in step (3) is 45 - 55 °C.

[0017] Further, the volume of the concentrated solution corresponding to each gram of raw material is 1.5 - 2 mL.

[0018] Further, the dosage form is an oral dosage form.

[0019] Further, the oral dosage form is one of capsules, granules, oral liquids, powders, tablets.

[0020] The beneficial technical effects of the present invention are as follows:

[0021] In the formula, Epimedii Folium, Achyranthis Bidentatae Radix, and Luffae Fructus are the monarch drugs. Epimedii Folium tonifies the kidney yang and strengthens the bones and muscles. Achyranthis Bidentatae Radix tonifies the liver and kidney and strengthens the bones and muscles. Luffae Fructus dredges the meridians and harmonizes the blood vessels. Phyllostachys Nigra Munro var. Henonis (Mitf.) Stapf ex Rendle, Limonium aureum (L.) Hill, and Rehmanniae Radix Praeparata are the minister drugs. Phyllostachys Nigra Munro var. Henonis (Mitf.) Stapf ex Rendle activates blood circulation, dispels wind, and strengthens the tendons and bones. Limonium aureum (L.) Hill clears heat and detoxifies, and tonifies blood and regulates menstruation. Rehmanniae Radix Praeparata nourishes yin and blood, and supplements essence and marrow. Atractylodis Macrocephalae Rhizoma, Lycii Fructus, and Ophiopogonis Radix are the assistant drugs. Atractylodis Macrocephalae Rhizoma invigorates the spleen and benefits qi. Lycii Fructus benefits essence and improves eyesight. Ophiopogonis Radix nourishes yin and promotes the production of body fluid. Glycyrrhizae Radix et Rhizoma is the envoy drug, which harmonizes all the drugs. The compatibility of monarch, minister, assistant, and envoy drugs in the formula is reasonable and can effectively improve the symptoms of osteoporosis. Detailed implementation manners

[0022] The following content is a further detailed description of the present invention in combination with specific preferred implementation manners. It cannot be determined that the specific implementation of the present invention is only limited to these descriptions. For those of ordinary skill in the technical field to which the present invention belongs, without departing from the concept of the present invention, several simple deductions or substitutions can be made, and all should be regarded as belonging to the protection scope of the present invention. The specific conditions not specified in the examples are carried out according to the conventional conditions or the conditions recommended by the manufacturer. The reagents or instruments used, unless otherwise specified, are all conventional products obtained through commercial channels.

[0023] (I) Example

[0024] Example 1

[0025] Example 1 provides a traditional Chinese medicine preparation for treating osteoporosis. The traditional Chinese medicine preparation for treating osteoporosis comprises the following raw materials in parts by weight: 29 parts of Epimedii Folium, 15 parts of Achyranthis Bidentatae Radix, 12 parts of Luffae Fructus, 13 parts of Phyllostachys Nigra Munro var. Henonis (Mitf.) Stapf ex Rendle, 7 parts of Limonium aureum (L.) Hill, 14 parts of Rehmanniae Radix Praeparata, 15 parts of Atractylodis Macrocephalae Rhizoma, 11 parts of Lycii Fructus, 8 parts of Ophiopogonis Radix, and 3 parts of Glycyrrhizae Radix et Rhizoma.

[0026] Example 1 also provides a preparation method of the above traditional Chinese medicine preparation for treating osteoporosis, which is specifically as follows:

[0027] (1) Mix all the raw materials evenly according to the parts by weight ratio, and then add water for soaking for 1 h according to the amount of water being 8 times the total weight of the raw materials to obtain a mixed solution; after the soaking treatment, decoct the mixed solution for 1.5 h, and filter to obtain a first filtrate and a first filter residue;

[0028] (2) Add water to the first filter residue for soaking for 1 h according to the amount of water being 8 times the total weight of the raw materials, then decoct for 1.5 h, and filter to obtain a second filtrate and a second filter residue;

[0029] (3) Combine the first filtrate and the second filtrate, concentrate at 50 °C to obtain a concentrated solution, the volume of the concentrated solution corresponding to each gram of the raw material is 2 mL, that is, the concentration of the crude drug is 0.5 g / mL, add starch to the concentrated solution, and prepare into tablets in a conventional manner to obtain the product.

[0030] Example 2

[0031] Example 2 provides a traditional Chinese medicine preparation for treating osteoporosis. The traditional Chinese medicine preparation for treating osteoporosis comprises the following raw materials in parts by weight: 35 parts of epimedium, 20 parts of achyranthes bidentata root, 15 parts of luffa cylindrica fruit, 15 parts of phyllostachys nigra root, 10 parts of limonium aureum, 16 parts of prepared rehmannia root, 18 parts of atractylodes macrocephala, 15 parts of wolfberry fruit, 10 parts of dwarf lilyturf tuber, and 5 parts of liquorice root.

[0032] Example 1 also provides a preparation method of the above traditional Chinese medicine preparation for treating osteoporosis, which is specifically as follows:

[0033] (1) Mix the raw materials evenly according to the above weight ratio, then add water for soaking for 1.5 h according to the amount of water being 10 times the total weight of the raw materials to obtain a mixed solution; after the soaking treatment, decoct the mixed solution for 2 h, and filter to obtain a first filtrate and a first filter residue;

[0034] (2) Add water for soaking for 1.5 h to the first filter residue according to the amount of water being 10 times the total weight of the raw materials, decoct for 2 h, and filter to obtain a second filtrate and a second filter residue;

[0035] (3) Combine the first filtrate and the second filtrate, concentrate at 55 °C to obtain a concentrated solution. The volume of the concentrated solution corresponding to each gram of the raw material is 2 mL, that is, the concentration of the crude drug is 0.5 g / mL. Add dextrin to the concentrated solution and prepare it into granules in a conventional manner to obtain the product.

[0036] Example 3

[0037] Example 3 provides a traditional Chinese medicine preparation for treating osteoporosis. The traditional Chinese medicine preparation for treating osteoporosis comprises the following raw materials in parts by weight: 25 parts of epimedium, 10 parts of achyranthes bidentata root, 8 parts of luffa cylindrica fruit, 10 parts of phyllostachys nigra root, 4 parts of limonium aureum, 7 parts of prepared rehmannia root, 12 parts of atractylodes macrocephala, 5 parts of wolfberry fruit, 5 parts of dwarf lilyturf tuber, and 1 part of liquorice root.

[0038] Example 1 also provides a preparation method of the above traditional Chinese medicine preparation for treating osteoporosis, which is specifically as follows:

[0039] (1) Mix the raw materials evenly according to the above weight ratio, then add water for soaking for 0.5 h according to the amount of water being 4 times the total weight of the raw materials to obtain a mixed solution; after the soaking treatment, decoct the mixed solution for 1 h, and filter to obtain a first filtrate and a first filter residue;

[0040] (2) Add water for soaking for 0.5 h to the first filter residue according to the amount of water being 4 times the total weight of the raw materials, decoct for 1 h, and filter to obtain a second filtrate and a second filter residue;

[0041] (3) Combine the first filtrate and the second filtrate, concentrate at 45°C to obtain a concentrated solution. The volume of the concentrated solution corresponding to each gram of the crude drug is 1.5 mL, that is, the concentration of the crude drug is 0.67 g / mL. Add starch and dextrin to the concentrated solution, mix evenly, granulate by wet method, and fill into capsules after drying to obtain the capsule preparation.

[0042] (II) Comparative Examples

[0043] Comparative Example 1

[0044] Comparative Example 1 provides a traditional Chinese medicine preparation, which includes the following raw materials in parts by weight: 29 parts of Epimedium brevicornum, 15 parts of Achyranthes bidentata, 12 parts of Luffa cylindrica, 7 parts of Limonium aureum, 14 parts of Rehmannia glutinosa, 15 parts of Atractylodes macrocephala, 11 parts of Lycium barbarum, 8 parts of Ophiopogon japonicus, and 3 parts of Glycyrrhiza uralensis.

[0045] Comparative Example 1 also provides the preparation method of the above traditional Chinese medicine preparation, and this preparation method is consistent with that of Example 1.

[0046] Comparative Example 2

[0047] Comparative Example 2 provides a traditional Chinese medicine preparation, which includes the following raw materials in parts by weight: 29 parts of Epimedium brevicornum, 15 parts of Achyranthes bidentata, 12 parts of Luffa cylindrica, 13 parts of Phragmites communis root, 14 parts of Rehmannia glutinosa, 15 parts of Atractylodes macrocephala, 11 parts of Lycium barbarum, 8 parts of Ophiopogon japonicus, and 3 parts of Glycyrrhiza uralensis.

[0048] Comparative Example 2 also provides the preparation method of the above traditional Chinese medicine preparation, and this preparation method is consistent with that of Example 1.

[0049] (III) Experimental Examples

[0050] Experimental Example 1

[0051] Detect the safety of the traditional Chinese medicine preparations obtained in Examples 1-3 and Comparative Examples 1-2. The specific detection process is as follows:

[0052] Select 60 female Wistar rats at 9 weeks old and adaptively raise them for one week. Before the experiment, each group was fasted for 12 h without water restriction. Calculated by the active ingredient, intragastrically administer the traditional Chinese medicine preparations of Examples 1-3 and Comparative Examples 1-2 at 10 g / kg, and one group was intragastrically administered an equal volume of normal saline (blank control group). Raise them in separate cages and continuously observe for 15 d. The results are shown in Table 1.

[0053] Table 1

[0054]

[0055] As can be seen from Table 1, compared with the blank control group, the body weight, hair color, and behavioral activities of the rats in each experimental group did not change, and no death occurred. From the above, it can be seen that the traditional Chinese medicine preparation obtained in the present invention is safe to use.

[0056] Experimental Example 2

[0057] The traditional Chinese medicine preparations obtained in Examples 1 - 3 and Comparative Examples 1 - 2 were used to treat osteoporosis, and the efficacy of each traditional Chinese medicine preparation was detected. The specific detection process is as follows:

[0058] . Experimental animals

[0059] A total of 80 9 - week - old female Wister rats were selected and adaptively fed for one week.

[0060] . Establishment of animal models

[0061] All Wister rats after one - week adaptive feeding were randomly divided into a positive control group, a normal control group, a model group, a low - medium - high dose group of Example 1, a low - dose group of Comparative Example 1, and a low - dose group of Comparative Example 2, with 10 rats in each group, and fed separately in cages. Except for the normal control group (after ligating the lower fallopian tubes and removing part of the adipose tissue beside the ovaries to keep the ovaries intact), the other experimental groups were anesthetized by intraperitoneal injection of 3 mL / kg of 10% chloral hydrate solution, and both ovaries were excised and sutured. Administration started 3 months after the operation.

[0062] . Administration method

[0063] Positive control group: gavaged with 0.2 mg / kg of estradiol valerate once a day for 12 consecutive weeks;

[0064] Normal control group and model group: gavaged with 10 mL / kg of normal saline once a day for 12 consecutive weeks;

[0065] Low - dose group of Example 1: gavaged with 0.5 g / kg of the traditional Chinese medicine preparation of Example 1 based on the active ingredient once a day for 12 consecutive weeks;

[0066] Medium - dose group of Example 1: gavaged with 1.0 g / kg of the traditional Chinese medicine preparation of Example 1 based on the active ingredient once a day for 12 consecutive weeks;

[0067] High - dose group of Example 1: gavaged with 2.0 g / kg of the traditional Chinese medicine preparation of Example 1 based on the active ingredient once a day for 12 consecutive weeks;

[0068] Low - dose group of Comparative Example 1: gavaged with 0.5 g / kg of the traditional Chinese medicine preparation of Comparative Example 1 based on the active ingredient once a day for 12 consecutive weeks;

[0069] Low - dose group of Comparative Example 2: gavaged with 0.5 g / kg of the traditional Chinese medicine preparation of Comparative Example 2 based on the active ingredient once a day for 12 consecutive weeks.

[0070] . Detection indicators

[0071] 24 h after the last intragastric administration, the experimental animals in each group were sacrificed, and the femurs and tibias on both sides were quickly dissected, and the attached soft tissues were removed.

[0072] Bone mineral density: The bone mineral density of the right femur was measured using a dual-energy X-ray absorptiometer, and the results are shown in Table 2.

[0073] Bone quality: After weighing the wet weight of the left femur, it was defatted with a chloroform-methanol (v / v = 2:1) mixture for 72 h, and then dried at 120 °C to constant weight. After cooling, the dry weight of the left femur was obtained. Then, it was heated and digested, ashed in a crucible, and after cooling, the ash mass was weighed, and the results are shown in Table 2.

[0074] Hydroxyproline content: The content of hydroxyproline in the left tibia was detected using the chloramine-T method, and the results are shown in Table 2.

[0075] Phosphorus content in bone: The phosphorus content in the right femur was measured using the extraction-phosphomolybdenum blue colorimetric method, and the results are shown in Table 3.

[0076] Calcium content in bone: The calcium content in the ash of the left femur was measured using the EDTA titration method, and the results are shown in Table 3.

[0077] Table 2

[0078]

[0079] Table 3

[0080]

[0081] As can be seen from Tables 2-3, compared with the model group, after using the traditional Chinese medicine preparation of the present invention, the bone mineral density, bone quality, hydroxyproline content, and calcium and phosphorus contents in bone of rats increased significantly. The above results indicate that the traditional Chinese medicine preparation obtained in the present invention can effectively improve the bone mineral density, bone quality, hydroxyproline content, and calcium and phosphorus contents in bone tissue after osteoporosis induced by bilateral ovariectomy in rats. That is, the traditional Chinese medicine preparation obtained in the present invention can be used to treat osteoporosis.

[0082] Compared with the low-dose group of Example 1, the traditional Chinese medicine preparations obtained in Comparative Example 1 by omitting Phyllostachys nigra var. henonis roots and in Comparative Example 2 by omitting Limonium aureum can relieve osteoporosis, but the effect is poor.

[0083] 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 them. The basic principles and main features of the present invention have been described in the above with specific implementation schemes. On the basis of the present invention, some modifications or replacements can be made, but these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of protection required by the present invention.

Claims

1. A traditional Chinese medicine preparation for treating osteoporosis, characterized in that, It is composed of the following raw materials in parts by weight: 25 - 35 parts of epimedium, 10 - 20 parts of achyranthes bidentata, 8 - 15 parts of luffa cylindrica, 10 - 15 parts of black bamboo root, 4 - 10 parts of limonium aureum, 7 - 16 parts of prepared rehmannia root, 12 - 18 parts of atractylodes macrocephala, 5 - 15 parts of wolfberry fruit, 5 - 10 parts of dwarf lilyturf tuber, 1 - 5 parts of liquorice.

2. The traditional Chinese medicine preparation for treating osteoporosis according to claim 1, wherein It is composed of the following raw materials in parts by weight: 29 parts of epimedium, 15 parts of achyranthes bidentata, 12 parts of luffa cylindrica, 13 parts of black bamboo root, 7 parts of limonium aureum, 14 parts of prepared rehmannia root, 15 parts of atractylodes macrocephala, 11 parts of wolfberry fruit, 8 parts of dwarf lilyturf tuber, 3 parts of liquorice.

3. The preparation method of the traditional Chinese medicine preparation for treating osteoporosis according to claim 1 or 2, characterized in that, It includes the following steps: (1) Mix all the raw medicinal materials evenly according to the above-mentioned parts by weight ratio, then add water for soaking treatment to obtain a mixed solution; after the soaking treatment, decoct the mixed solution, and filter to obtain a first filtrate and a first residue; (2) Soak the first residue in water and conduct decocting treatment, and filter to obtain a second filtrate and a second residue; (3) Combine the first filtrate and the second filtrate and concentrate them to obtain a concentrated solution, add pharmaceutically acceptable excipients to the concentrated solution, and prepare the corresponding dosage form, thus obtaining the product; The volume of the concentrated solution corresponding to each gram of the raw medicinal material is 1.5 - 2 mL.

4. The preparation method of the traditional Chinese medicine preparation for treating osteoporosis according to claim 3, wherein, In steps (1) and (2), the dosage of the water is 4 - 10 times the total weight of the raw medicinal materials.

5. The preparation method of the traditional Chinese medicine preparation for treating osteoporosis according to claim 3, characterized in that, In steps (1) and (2), the soaking time is 0.5 - 1.5 h; the decocting time is 1 - 2 h.

6. The preparation method of the traditional Chinese medicine preparation for treating osteoporosis according to claim 3, characterized in that, In step (3), the concentration temperature is 45 - 55 °C.

7. The preparation method of the traditional Chinese medicine preparation for treating osteoporosis according to claim 3, wherein, The dosage form is an oral dosage form.

8. The preparation method of the traditional Chinese medicine preparation for treating osteoporosis according to claim 7, wherein, The oral dosage form is one of capsule, granule, oral liquid, and tablet.

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