Traditional Chinese medicine preparation for treating osteoporosis and preparation method thereof

Abstract

The 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 is prepared from the following raw materials in parts by weight: 25 to 35 parts of herba epimedii, 10 to 20 parts of radix achyranthis bidentatae, 8 to 15 parts of loofah sponge, 10 to 15 parts of black bamboo root, 4 to 10 parts of limonium aureum, 7 to 16 parts of prepared rehmannia root, 12 to 18 parts of rhizoma atractylodis macrocephalae, 5 to 15 parts of fructus lycii, 5 to 10 parts of radix ophiopogonis and 1 to 5 parts of liquorice root. The traditional Chinese medicine preparation can effectively improve the bone mineral density, the bone quality, the hydroxyproline content and the calcium and phosphorus contents in bones of rats after osteoporosis caused by bilateral ovariectomization.

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 mass, damaged bone microstructure, increased bone fragility, and prone to 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 achieves the purpose of treating 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 medicinal effects of traditional Chinese medicine in the treatment of osteoporosis have gradually attracted attention. In the treatment of osteoporosis, traditional Chinese medicine treatment takes tonifying the kidney and replenishing essence, strengthening the spleen and replenishing qi, promoting blood circulation and removing blood stasis as the basic treatment principles 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 of 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 mass, 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 of 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: 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 phyllostachys nigra var. henonis, 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 licorice.

[0008] Further, it includes the following raw materials in parts by weight: 29 parts of Epimedium brevicornu Maxim., 15 parts of Achyranthes bidentata Blume, 12 parts of Luffa cylindrica (L.) Roem., 13 parts of Phyllostachys nigra (Lodd.) Munro var. henonis (Mitf.) Stapf ex Rendle, 7 parts of Limonium aureum (L.) Hill, 14 parts of Rehmannia glutinosa Libosch. f. hueichingensis (Chao et Schih) Hsiao et Keng, 15 parts of Atractylodes macrocephala Koidz., 11 parts of Lycium barbarum L., 8 parts of Ophiopogon japonicus (Thunb.) Ker-Gawl., and 3 parts of Glycyrrhiza uralensis Fisch.

[0009] The preparation method of the above traditional Chinese medicine preparation for treating osteoporosis includes the following steps: (1) Mix all the raw materials evenly according to the above 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 and decoct the first residue with water, and filter to obtain a second filtrate and a second residue; (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 make it into the corresponding dosage form, then it is obtained.

[0010] Further, the amount of water used in steps (1) and (2) is 4 - 10 times the total weight of the raw materials.

[0011] Further, the soaking time in steps (1) and (2) is 0.5 - 1.5 h; the decocting time is 1 - 2 h.

[0012] Further, the concentration temperature in step (3) is 45 - 55 °C.

[0013] Further, the volume of the concentrated solution corresponding to each gram of raw material is 1.5 - 2 mL.

[0014] Further, the dosage form is an oral dosage form.

[0015] Further, the oral dosage form is one of capsules, granules, oral liquids, powders, and tablets.

[0016] The beneficial technical effects of the present invention are as follows: In the formula, Epimedium brevicornu Maxim., Achyranthes bidentata Blume, and Luffa cylindrica (L.) Roem. are the monarch drugs. Epimedium brevicornu Maxim. tonifies the kidney yang and strengthens the muscles and bones. Achyranthes bidentata Blume tonifies the liver and kidney and strengthens the muscles and bones. Luffa cylindrica (L.) Roem. dredges the meridians and harmonizes the blood vessels. Phyllostachys nigra (Lodd.) Munro var. henonis (Mitf.) Stapf ex Rendle, Limonium aureum (L.) Hill, and Rehmannia glutinosa Libosch. f. hueichingensis (Chao et Schih) Hsiao et Keng are the minister drugs. Phyllostachys nigra (Lodd.) Munro var. henonis (Mitf.) Stapf ex Rendle promotes blood circulation, dispels wind, and strengthens the muscles and bones. Limonium aureum (L.) Hill clears heat and detoxifies, and tonifies the blood and regulates menstruation. Rehmannia glutinosa Libosch. f. hueichingensis (Chao et Schih) Hsiao et Keng nourishes yin and blood, and replenishes essence and marrow. Atractylodes macrocephala Koidz., Lycium barbarum L., and Ophiopogon japonicus (Thunb.) Ker-Gawl. are the assistant drugs. Atractylodes macrocephala Koidz. invigorates the spleen and replenishes qi. Lycium barbarum L. benefits essence and improves eyesight. Ophiopogon japonicus (Thunb.) Ker-Gawl. nourishes yin and promotes fluid production. Glycyrrhiza uralensis Fisch. is the envoy drug, which harmonizes all the drugs. The compatibility of monarch, minister, assistant, and envoy in the formula is reasonable, and can effectively improve the symptoms of osteoporosis. Specific embodiments

[0017] The following content is a further detailed description of the present invention in combination with specific preferred embodiments. 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 pertains, without departing from the concept of the present invention, several simple deductions or substitutions can still be made, which should all 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 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.

[0018] (I) Example Example 1 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 Epimedium brevicornum, 15 parts of Achyranthes bidentata, 12 parts of Luffa cylindrica, 13 parts of Phyllostachys nigra var. henonis, 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.

[0019] Example 1 also provides a preparation method of the above traditional Chinese medicine preparation for treating osteoporosis, which is specifically as follows: (1) Mix the raw materials evenly according to the above-mentioned parts by weight ratio, 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; (2) Add water for soaking for 1 h to the first filter residue 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; (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 raw material is 2 mL, that is, the concentration of 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.

[0020] Example 2 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 brevicornum, 20 parts of Achyranthes bidentata, 15 parts of Luffa cylindrica, 15 parts of Phyllostachys nigra var. henonis, 10 parts of Limonium aureum, 16 parts of Rehmannia glutinosa, 18 parts of Atractylodes macrocephala, 15 parts of Lycium barbarum, 10 parts of Ophiopogon japonicus, and 5 parts of Glycyrrhiza uralensis.

[0021] Example 1 also provides a preparation method of the above traditional Chinese medicine preparation for treating osteoporosis, which is specifically as follows: (1) Mix the raw materials evenly according to the above-mentioned parts by 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; (2) Add water to the first filter residue at a ratio of 10 times the total weight of the raw medicinal materials, soak for 1.5 h, then decoct for 2 h, and filter to obtain the second filtrate and the second filter residue. (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 medicinal materials 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 finished product.

[0022] Example 3 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 brevicornum, 10 parts of Achyranthes bidentata, 8 parts of Luffa cylindrica, 10 parts of Phyllostachys nigra var. henonis, 4 parts of Limonium aureum, 7 parts of Rehmannia glutinosa, 12 parts of Atractylodes macrocephala, 5 parts of Lycium barbarum, 5 parts of Ophiopogon japonicus, and 1 part of Glycyrrhiza uralensis.

[0023] Example 1 also provides a preparation method of the above traditional Chinese medicine preparation for treating osteoporosis, which is specifically as follows: (1) Mix the raw medicinal materials evenly according to the above parts by weight ratio, then add water at a ratio of 4 times the total weight of the raw medicinal materials, soak for 0.5 h to obtain a mixed solution; after the soaking treatment, decoct the mixed solution for 1 h, and filter to obtain the first filtrate and the first filter residue; (2) Add water to the first filter residue at a ratio of 4 times the total weight of the raw medicinal materials, soak for 0.5 h, then decoct for 1 h, and filter to obtain the second filtrate and the second filter residue; (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 raw medicinal materials 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, dry and fill into capsules to obtain the capsule preparation.

[0024] (II) Comparative Examples Comparative Example 1 Comparative Example 1 provides a traditional Chinese medicine preparation, which comprises 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.

[0025] Comparative Example 1 also provides a preparation method of the above traditional Chinese medicine preparation, which is the same as that of Example 1.

[0026] Comparative Example 2 Comparative Example 2 provides a traditional Chinese medicine preparation, which comprises 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 Phyllostachys nigra var. henonis, 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.

[0027] Comparative Example 2 also provides a preparation method of the above traditional Chinese medicine preparation, and this preparation method is the same as that of Example 1.

[0028] (III) Experimental Examples Experimental Example 1 The safety of the traditional Chinese medicine preparations obtained in Examples 1-3 and Comparative Examples 1-2 was detected. The specific detection process is as follows: A total of 60 9-week-old female Wistar rats were selected and adaptively fed for one week. Before the experiment, each group was fasted but allowed to drink water for 12 h. Calculated by the active ingredient, the traditional Chinese medicine preparations of Examples 1-3 and Comparative Examples 1-2 were intragastrically administered at 10 g / kg, and one group was intragastrically administered an equal volume of normal saline (blank control group). They were fed separately in cages and continuously observed for 15 d. The results are shown in Table 1.

[0029] Table 1 As can be seen from Table 1, compared with the blank control group, there were no changes in the body weight, hair color, and behavioral activities of the rats in each experimental group, and no death occurred. As described above, the traditional Chinese medicine preparation obtained in the present invention is safe to use.

[0030] Experimental Example 2 The traditional Chinese medicine preparations obtained in Examples 1-3 and Comparative Examples 1-2 were used to treat osteoporosis and the pharmacodynamic effects of each traditional Chinese medicine preparation were detected. The specific detection process is as follows: . Experimental animals A total of 80 9-week-old female Wistar rats were selected and adaptively fed for one week.

[0031] . Establishing an animal model All the Wistar rats after one week of adaptive feeding were randomly divided into a positive control group, a normal control group, a model group, and low, medium, and high dose groups 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 they were fed separately in cages. Except for the normal control group (the lower fallopian tube was ligated and part of the fat tissue beside the ovary was removed to keep the ovary intact), the other experimental groups were anesthetized by intraperitoneal injection of 3 mL / kg of 10% chloral hydrate solution, and both ovaries were removed and sutured. Three months after the operation, the administration started.

[0032] . Administration method Positive control group: Intragastric administration of 0.2 mg / kg estradiol valerate once a day for 12 consecutive weeks; Normal control group and model group: Intragastric administration of 10 mL / kg normal saline once a day for 12 consecutive weeks; Low-dose group of Example 1: Intragastric administration of 0.5 g / kg of the traditional Chinese medicine preparation of Example 1 calculated by the active ingredient once a day for 12 consecutive weeks; Medium-dose group of Example 1: Intragastric administration of 1.0 g / kg of the traditional Chinese medicine preparation of Example 1 calculated by the active ingredient once a day for 12 consecutive weeks; High-dose group of Example 1: Intragastric administration of 2.0 g / kg of the traditional Chinese medicine preparation of Example 1 calculated by the active ingredient once a day for 12 consecutive weeks; Low-dose group of Comparative Example 1: Intragastric administration of 0.5 g / kg of the traditional Chinese medicine preparation of Comparative Example 1 calculated by the active ingredient once a day for 12 consecutive weeks; Low-dose group of Comparative Example 2: Intragastric administration of 0.5 g / kg of the traditional Chinese medicine preparation of Comparative Example 2 calculated by the active ingredient once a day for 12 consecutive weeks.

[0033] . Detection indexes 24 hours after the last intragastric administration, the experimental animals in each group were sacrificed and the bilateral femurs and tibias were quickly dissected, and the attached soft tissues were removed.

[0034] 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.

[0035] Bone mass: After weighing the wet weight of the left femur, it was degreased in a chloroform-methanol (v / v = 2:1) mixture for 72 hours, and then dried at 120 °C to constant weight. After cooling, the dry weight of the left femur was obtained. Then, it was heated, digested, and ashed in a crucible, and after cooling, the ash mass was weighed. The results are shown in Table 2.

[0036] 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.

[0037] 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.

[0038] Calcium content in bone: The calcium content in the ash of the left femur was determined using the EDTA titration method, and the results are shown in Table 3.

[0039] Table 2 Table 3 As can be seen from Table 2-3, compared with the model group, after using the traditional Chinese medicine preparation of the present invention, the bone density, bone mass, hydroxyproline content, and calcium and phosphorus contents in the bones of rats increased significantly. The above results indicate that the traditional Chinese medicine preparation obtained in the present invention can effectively improve the bone density, bone mass, hydroxyproline content, and calcium and phosphorus contents in the 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.

[0040] Compared with the low-dose group of Example 1, the traditional Chinese medicine preparations obtained by omitting Phyllostachys nigra var. henonis roots in Comparative Example 1 and Limonium aureum in Comparative Example 2 can relieve osteoporosis, but the effects are not good.

[0041] 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 with specific implementation schemes above. 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 Chinese medicine preparation for treating osteoporosis, characterized in that: The invention 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, 10-15 parts of purple bamboo roots, 4-10 parts of yellow flower limonene, 7-16 parts of 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.

2. The Chinese medicine preparation for treating osteoporosis according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 29 parts of epimedium, 15 parts of cyathula, 12 parts of luffa, 13 parts of purslane root, 7 parts of yellow flower limonene, 14 parts of rehmannia root, 15 parts of atractylodes, 11 parts of wolfberry, 8 parts of ophiopogon and 3 parts of liquorice.

3. The method for preparing the Chinese medicine preparation for treating osteoporosis according to claim 1 or 2, characterized in that: The following steps are involved: (1) mixing the raw materials uniformly according to the weight ratio, and then adding water for soaking to obtain a mixed solution; after the soaking treatment, decocting the mixed solution, filtering to obtain a first filtrate and a first filter residue; (2) soaking and boiling the first filter residue in water, and filtering to obtain a second filtrate and a second filter residue; (3) The first filtrate and the second filtrate are combined and concentrated to obtain a concentrated solution, and a pharmaceutically acceptable excipient is added to the concentrated solution to prepare a corresponding dosage form.

4. The method for preparing the Chinese medicine preparation for treating osteoporosis according to claim 3, characterized in that: The amount of water used in steps (1) and (2) is 4-10 times the total weight of the raw material.

5. The method for preparing the Chinese medicine preparation for treating osteoporosis according to claim 3, characterized in that: The soaking time in steps (1) and (2) is 0.5-1.5 hours; the decoction time is 1-2 hours.

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

7. The method for preparing the traditional Chinese medicine preparation for treating osteoporosis according to claim 3, characterized in that: The volume of the concentrate corresponding to each gram of raw material is 1.5-2mL.

8. The method for preparing the traditional Chinese medicine preparation for treating osteoporosis according to claim 3, characterized in that: The dosage form is an oral dosage form.

9. The method for preparing the traditional Chinese medicine preparation for treating osteoporosis according to claim 8, characterized in that: The oral dosage form is one of capsules, granules, oral liquid, powder and tablets.

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