Traditional Chinese medicine composition for treating or preventing osteoporosis

Abstract

The invention relates to a traditional Chinese medicine composition for treating or preventing osteoporosis, and discloses application of the traditional Chinese medicine composition in preparation of a medicine for treating and / or preventing osteoporosis. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials in parts by weight: 22-26 parts of bull penis, 8-12 parts of cinnamon, 10-14 parts of alfalfa seeds, 8-12 parts of galangal, 10-14 parts of onion seeds, 8-12 parts of clove, 10-14 parts of fructus ulmi, 8-12 parts of pepper, 12-16 parts of carrot seeds, 38-46 parts of sesame, 10-14 parts of muskmelon seeds, 56-64 parts of almonds, 10-14 parts of cucumber seeds, 8-12 parts of asarum, 10-14 parts of semen allii tuberosi and 16-20 parts of limonium macrophyllum. The medicine is prepared from the following raw materials in parts by weight: 10-14 parts of dill seeds, 13-17 parts of tribulus terrestris, 36-44 parts of milk peaches, 8-12 parts of mirabilis jalapa roots, 18-22 parts of cotton seeds, 10-14 parts of radix aucklandiae, 10-14 parts of ginger slices, 8-12 parts of nutmeg coats, 46-54 parts of pinus bungeana, 10-14 parts of sesame seeds, 3-7 parts of saffron, 8-12 parts of fern, 8-12 parts of fructus piperis longi and 18-22 parts of nutmeg.

Description

Technical Field

[0001] The present application belongs to the field of pharmaceutical technology, and specifically relates to a Chinese medicine composition for treating or preventing osteoporosis. Background Art

[0002] Menopausal osteoporosis is the main complication of menopausal syndrome in women. With the decline of ovarian function and the decrease of estrogen levels in the body, intestinal calcium absorption decreases, bone calcium release is greater than bone calcium deposition, bone mass is gradually lost, and the possibility of osteoporosis increases. Its pathogenesis is mainly due to the fact that sex hormone deficiency induces changes in the osteoclastogenesis cytokine network system, stimulates the activity of osteoclasts, inhibits the activity of osteoblasts, and the bone absorption rate exceeds the bone formation rate. Hormone replacement therapy (HRT) is the main treatment method, but given that the use of HRT may increase the risk of endometrial cancer, breast cancer and vaginal bleeding, people have now turned their attention to other alternative therapies.

[0003] Luobufu Kebi Pills are mainly composed of 30 kinds of medicinal materials, including bull whip, cinnamon, alfalfa seeds, galangal, onion seeds, cloves, turnip seeds, pepper, carrot seeds, sesame, melon seeds, almonds, cucumber seeds, European asarum (spider incense, asarong), leek seeds, large-leaf limonium, dill seeds, tribulus, milk peach, Mirabilis jalapa root (European cornflower), cotton seeds, costus root, ginger slices, nutmeg, white pine nuts, rocket seeds, saffron, ironwood, longan, and nutmeg. Luobufu Kebi Pills are mainly used for impotence, depression, spermatorrhea, premature ejaculation, physical weakness, weight loss, and neurasthenia. Clinical studies have shown that Luobufu Kebi Pills can improve the semen quality of patients with oligospermia and asthenospermia, increase the level of sex hormones, and reduce erectile dysfunction, with clear clinical effects. However, there are no reports on the effect of Luobufu Kebi Pills in treating or preventing osteoporosis. Summary of the invention

[0004] In order to solve one of the above technical problems, the present application provides the use of the Chinese medicine composition of the present application in the preparation of a drug for treating and / or preventing osteoporosis.

[0005] One or more embodiments of the present application provide the use of a Chinese medicine composition in preparing a medicament for treating and / or preventing osteoporosis, wherein the Chinese medicine composition is prepared from the following Chinese medicinal materials in parts by weight:

[0006]

[0007] In one or more embodiments, the Chinese medicine composition is prepared from the following Chinese medicinal materials in parts by weight:

[0008]

[0009] In one or more embodiments, the traditional Chinese medicine composition is composed of the following parts by weight of powder of traditional Chinese medicine:

[0010]

[0011]

[0012] In one or more embodiments, the traditional Chinese medicine composition is composed of the following parts by weight of powder of traditional Chinese medicine:

[0013]

[0014] In one or more embodiments, the Chinese medicine composition is prepared by the following method: crushing the remaining medicinal materials except saffron into fine powder; grinding saffron and mixing it with the fine powder; adding 550-650 parts by weight of refined honey, stirring well, making small honey pills, and drying to obtain.

[0015] In one or more embodiments, the traditional Chinese medicine composition is prepared as an oral preparation.

[0016] In one or more embodiments, the oral formulation is a pill.

[0017] In one or more embodiments, the pill is a small honey pill.

[0018] In one or more embodiments, the formulation specifications of the small honey pills are 0.3g, 1.5g or 3g per pill.

[0019] In one or more embodiments, the osteoporosis is menopausal osteoporosis.

[0020] In one or more embodiments, the osteoporosis is menopausal osteoporosis.

[0021] The bullwhip is the dried penis of the bovine cattle Bos taurus domesticus Gmelin or the yak Bos grunnienslinnaeusa.

[0022] Cinnamon is the dried bark of Cinnamomum cassia Presl, a plant of the Lauraceae family.

[0023] Alfalfa seeds are the dried mature seeds of Medicago sativa L., a plant of the leguminous family.

[0024] Galangal is the dried rhizome of Alpinia officinarum Hance, a plant of the ginger family.

[0025] Onion seeds are the dried mature seeds of the onion Allium cepa L. of the Liliaceae family.

[0026] Clove is the dried flower buds of Eugenia caryophyllata Thunb., a plant of the Myrtaceae family.

[0027] Turnip seeds are the dried mature seeds of Brassica rapa L., a plant of the cruciferous family.

[0028] Zanthoxylum schinifolium Sieb.et Zucc. or Zanthoxylum bungeanum Maxim., a plant of the Rutaceae family, is the dried mature peel of the green pepper.

[0029] Carrot seed is the dried mature fruit of the Umbelliferae plant Daucus carota L. VarSativa DC.

[0030] Sesame is the dried mature seed of Sesamum indicum L. of the Sesamaceae family.

[0031] Muskmelon seeds are the dried mature seeds of Cucumis melo L., a plant of the Cucurbitaceae family.

[0032] Almonds are the dried mature seeds of Amygdalus communis L., a plant of the Rosaceae family.

[0033] Cucumber seeds are the dried mature seeds of the Cucurbitaceae plant Cucumis sativus L.

[0034] Asarum, also known as spider incense and Asaron, is the dried rhizome and root of the spider incense Valerianajatamansi Jones of the Valerianaceae family.

[0035] Leek seeds are the dried mature seeds of Allium tuberosum Rottl ex Spreng., a plant of the Liliaceae family.

[0036] Big leaf blood-replenishing grass is the rhizome of big leaf blood-replenishing grass Limonium gmelinii (willd.) O.ktze of the family Pleurotus eryngii.

[0037] Dill seeds are the dried mature fruits of the Umbelliferae plant Anethum graveolens L.

[0038] Tribulus terrestris is the dried mature fruit of Tribulus terrestris L., a plant of the Tribulaceae family.

[0039] Milk peach is the endosperm of the mature seeds of Cocos nucifera L., a plant of the palm family.

[0040] Mirabilis jalapa root, also known as cornflower, is the dried root and rhizome of Centaurea behen L. of the Asteraceae family.

[0041] Cotton seeds are the seeds of Gossypium herbaceum L., Gossypium hirsutum L., Gossypium barbadense L. and Gossypium arboreum L. of the Malvaceae family.

[0042] Costus root is the dried root of Aucklandia lappa Decne. of the Asteraceae family.

[0043] Ginger slices are the dried rhizomes of Zingiber officinale Rosc., a plant of the ginger family.

[0044] Nutmeg is the dried aril of Myristica fragrans Houtt., a plant of the Myristicaceae family.

[0045] White pine nuts are the seeds of the Tibetan white pine Pinus gerardiana Wall., a plant of the Pinaceae family.

[0046] Arugula seeds are the dried mature seeds of the cruciferous plant arugula Eurca sativa Mill.

[0047] Saffron is the dried stigma of Crocus sativus L., a plant of the Iridaceae family.

[0048] Ironwood is the dried flower buds of Mesua ferrea L., a plant of the family Gustaceae.

[0049] Piper longum is the dried nearly mature or mature fruit cluster of Piper longum L., a plant of the Piperaceae family.

[0050] Nutmeg is the dried seed kernel of Myristica fragrans Houtt., a plant of the Myristicaceae family. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Figure 1 It showed that compared with the model group, the OPG and PINP concentrations in the serum of rats in the low, medium and high dose groups of Luobufu Kebi Pills, as well as the Gengnian An Tablets group and the estradiol valerate group were significantly increased, while OC and β-CTx were inhibited.

[0052] Figure 2 It indicated that compared with the model group, the femoral sections of rats in the low, medium and high dose groups of Luobufu Kebi Niwan, as well as the Gengnian An tablets group and the estradiol valerate group were changed. DETAILED DESCRIPTION

[0053] The following examples are used to illustrate the technical solution of the present application in detail, but are not used to limit the scope of the present application.

[0054] Example 1

[0055] 1 Materials

[0056] 1.1 Drugs and reagents: Estradiol valerate tablets (Bayer, Germany, J20171038, batch number 654A); Gengnian'an tablets (Jiangxi Sanghai Pharmaceutical, national medicine standard Z20073293, batch number 220715); Luobufu Kebiri Pills (Hotan Uygur Pharmaceutical Co., Ltd., national medicine standard Z65020142, batch number 20211013); Rat estradiol (E2) ELISA kit (Wuhan Elerite Biotechnology Co., Ltd., product number E-OSEL-R0001); Sodium penicillin for injection: North China Pharmaceutical Co., Ltd., specification: 800,000 units / bottle.

[0057] 1.2 Experimental instruments: multifunctional microplate reader (TECAN, Switzerland); microcentrifuge (Mio, Hangzhou); DM3000 microscope (Leica).

[0058] 2. Preparation technology of Luobufu Kebiri pills

[0059]

[0060]

[0061] Take the above-mentioned weight of bull whip, cinnamon, alfalfa seeds, galangal, onion seeds, cloves, turnip seeds, pepper, carrot seeds, sesame, melon seeds, almonds, cucumber seeds, European asarone (spider incense, asarong), leek seeds, large-leaf limonium, dill seeds, tribulus, milk peach, Mirabilis jalapa root (European cornflower), cotton seeds, costus root, ginger slices, nutmeg skin, white pine nuts, arugula seeds, saffron, ironwood, longan, nutmeg and 30 kinds of medicinal materials, except saffron, the remaining 29 kinds of bull whip and other 29 kinds of ingredients are crushed into fine powder; grind the saffron, mix it with the above-mentioned fine powder, add 550-650g of refined honey, stir well, make small honey pills, and dry to obtain the traditional Chinese medicine composition of the present application.

[0062] Example 2

[0063] 1. Materials

[0064] 1.1 Experimental animals

[0065] 50 SPF female SD rats, 12 months old, weighing 300-320g, were provided by the Experimental Animal Center of Xinjiang Medical University. The temperature was (22±1)℃, the relative humidity was 50%-60%, and they were allowed to eat and drink freely, with a 12h / 12h day and night natural rhythm. The entire experimental process followed the relevant regulations of the Experimental Animal Ethics Committee of this unit.

[0066] 1.2 Reagents and drugs

[0067] Estradiol valerate tablets (Bayer, Germany, J20171038, batch number 654A); Gengnian'an tablets (Jiangxi Sanghai Pharmaceutical, national medicine standard Z20073293, batch number 220715); Luobufu Kebiri pills (Hotan Uygur Pharmaceutical, national medicine standard Z65020142, batch number 20211013; its preparation method refers to Example 1); (OC, OPG, β-CTX, PINP) ELISA kit (Wuhan Elerite Biotechnology Co., Ltd., item number E-EL-0243c, E-EL-R3005, E-EL-R1405c, E-EL-R1414c); Sodium penicillin for injection: North China Pharmaceutical Co., Ltd., specification: 800,000 units / bottle.

[0068] 1.3 Instruments

[0069] Multifunctional microplate reader (TECAN, Switzerland); microcentrifuge (Mio, Hangzhou); DM3000 microscope (Leica)

[0070] 1. Methods

[0071] 2.1 Modeling and drug administration

[0072] After 1 week of adaptive feeding, the animals were divided into 6 groups according to the random number table method, with 6 animals in each group (model group, low-, medium- and high-dose groups of Luobufu Kebi pills, positive Chinese medicine group, and positive Western medicine group). The model establishment method was based on the literature. Vaginal smears were performed on rats one by one, once a day for 5 consecutive days. If no estrus reaction occurred, the model was successful. The dosage design was converted according to the equivalent dose conversion coefficient between humans and animals. The dose of estradiol group was prepared into a suspension of 14.17 mg / kg with distilled water; Gengnian An tablets were prepared into a suspension of 0.49 g / kg with distilled water; the low, medium and high doses of Luobufu Kebi pills were 0.63 g / kg, 0.78 g / kg, and 0.94 g / kg suspensions, respectively; the model group was given an equal amount of distilled water. The drug was administered once a day for 45 days.

[0073] 2.2 Sample preparation

[0074] After the last administration, rats in each group were fasted for 12 hours, anesthetized with 10% chloral hydrate (0.3 ml / 100 g) by intraperitoneal injection, and 5 mL of blood was collected from the abdominal aorta. The blood was kept at room temperature for 2 hours, centrifuged at 4°C, 3000 r / min for 15 minutes, and the serum was separated and stored in a -20°C refrigerator. The femurs of the rat hind legs were removed, rinsed with saline, and the surface moisture of the tissue was absorbed with filter paper. The femurs were fixed in 4% paraformaldehyde. After 48 hours, the fixed ipsilateral femurs were placed in EDTA for 3 days of decalcification. The femurs were cut without resistance when cut with a knife.

[0075] 3. Observation indicators and measurement methods

[0076] 3.1ELISA detection of serum bone metabolism index levels in rats

[0077] The bone formation index osteoprotegerin (OPG) and type I procollagen amino-terminal peptide (PINP) were measured. The serum content of bone resorption index osteocalcin (OC) and β-collagen cross-linking enzyme (β-CTx) was measured. The specific steps were as follows: according to the reagent manufacturer's instructions, the centrifuged rat serum was diluted in a certain proportion, and biotin antibody working solution, enzyme conjugate working solution, substrate solution (TMB), and stop solution were added successively. Then the OD value was measured on the microplate reader and finally converted to the corresponding concentration.

[0078] 3.2 HE staining to observe tissue pathological changes

[0079] The femurs of the rats in each group that had been decalcified were excised and embedded in paraffin to make wax blocks, which were then sliced ​​with a microtome to a thickness of about 5 μm. The sections were stained with hematoxylin-eosin and sealed, and the pathological changes of the tissue sections were observed under a microscope.

[0080] 4. Results

[0081] 4.1 Effects of Luobufu Kebiri Pills on Bone Metabolism Indexes in Rats with Perimenopausal Syndrome

[0082] Compared with the model group, the OPG and PINP concentrations in the serum of the rats in the low, medium and high dose groups of Luobufu Kebi Pills, as well as the Gengnian An Tablets group and the estradiol valerate group were significantly increased, while OC and β-CTx were inhibited. This indicates that Luobufu Kebi Pills promote bone formation and inhibit bone resorption, and can improve osteoporosis caused by menopause. Figure 1 shown.

[0083] 4.2 Effect of Luobufu Kebiri Pills on Femoral Pathology in Rats

[0084] Compared with the model group, the femoral sections of rats in the low, medium and high dose groups of Luobu Fu Ke Bi Ni Wan, as well as the Geng Nian An Tablets group and the estradiol valerate group showed changes. The rats in the Luobu Fu Ke Bi Ni Wan group showed a significant increase in the number of trabeculae in the epiphyseal region and a decrease in the area of ​​the bone marrow cavity. The results showed that Luobu Fu Ke Bi Ni Wan had a preventive effect on osteoporosis in menopausal rats. Figure 2 shown.

Claims

1. Use of a Chinese medicine composition in the preparation of a medicament for treating and / or preventing osteoporosis, wherein the Chinese medicine composition is prepared from the following Chinese medicinal materials in parts by weight:

2. The use according to claim 1, wherein the Chinese medicine composition is prepared from the following Chinese medicinal materials in parts by weight:

3. The use according to claim 1, wherein the Chinese medicine composition is composed of the following parts by weight of powder of Chinese medicinal materials:

4. The use according to claim 3, wherein the Chinese medicine composition is composed of the following parts by weight of Chinese medicinal material powder:

5. The use according to any one of claims 1 to 4, wherein the Chinese medicine composition is prepared by the following method: crushing the remaining medicinal materials except saffron into fine powder; grinding the saffron and mixing it with the fine powder; adding 550-650 parts by weight of refined honey, stirring evenly, making small honey pills, and drying to obtain the product.

6. The use according to any one of claims 1 to 4, wherein the Chinese medicine composition is prepared into an oral preparation; preferably, the oral preparation is a pill; preferably, the pill is a small honey pill; preferably, the preparation specification of the small honey pill is 0.3g, 1.5g or 3g per pill.

7. The use according to claim 1, wherein the osteoporosis is menopausal osteoporosis.

8. The use according to claim 1, wherein the osteoporosis is menopausal osteoporosis.

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