KR20190115789A - A drug for treating osteoporosis and its preparation method - Google Patents

Abstract

The present invention discloses a medicine for treating osteoporosis and a method for manufacturing the same. The medicine for treating osteoporosis contains: 10 to 20 parts by weight of Salvia miltiorrhiza; 10 to 15 parts by weight of Pyrrosia lingua; 3 to 20 parts by weight of Anemarrhena asphodeloides; 12 to 18 parts by weight of Angelica gigas; and 5 to 10 parts by weight of Paeonia japonica. The medicine for treating osteoporosis according to the present invention has other components compared to medicines of the prior art and can overcome drawbacks of medicines of the prior art.

Description

A drug for the treatment of osteoporosis and a manufacturing method thereof {A DRUG FOR TREATING OSTEOPOROSIS AND ITS PREPARATION METHOD}

FIELD OF THE INVENTION The present invention relates to the field of medicaments, in particular to medicaments for the treatment of osteoporosis and methods of making the same.

Osteoporosis is the most common disease and a worldwide health problem. At present, the incidence of osteoporosis in the world has exceeded 25%; Among the common and frequently-occurring diseases, the incidence of osteoporosis has risen to the top ten. China is one of the oldest countries in the world. Currently, there are 90 million osteoporosis patients, accounting for 7.1% of the total population, and the number of osteoporosis patients is estimated to increase to 221,000,000 by 2050. Therefore, research on the prevention and treatment of osteoporosis is very important for human health and quality of life.

Currently, there are two conventional treatment plans, clinically used to treat osteoporosis, "basic treatment" and "intensive treatment". Basic treatment refers to treatment with "calcium + vitamin D". In general, the "basic treatment" has relatively few side effects and is relatively safe, but the effect of increasing bone density and decreasing the incidence of fracture thereof has not been identified. The intensive treatment includes treatment with bisphosphonate-based agents and calcitonin-based agents. In general, it is believed that these agents can effectively increase bone density, quickly relieve symptoms of osteoporosis, and effectively reduce the likelihood of fracture, but need to be used under the guidance of a physician to avoid side effects. "Triple therapy" is also clinically popular, and the first type of triple therapy applies calcium + vitamin D + periodic bisphosphonate / calcitonin, which is a patient with senile osteoporosis and patients with obvious pain Suitable for the treatment of; The second type of triple therapy applies calcium + vitamin D + selectively estrogen receptor modulators, which can maximize the beneficial effect of estrogen in bone and also effectively avoid side effects in the breast and uterus , Has the potential to replace traditional female hormone replacement therapy.

However, the therapeutic effect of the treatment or therapy is not ideal. In addition, current agents have other toxicity and side effects. Therefore, there is an urgent need for new drugs to treat osteoporosis that overcome the above drawbacks.

In view of the above problems, the present invention provides a medicament for treating osteoporosis that can solve the problems or at least some of the problems, which is used to overcome the shortcomings of the poor therapeutic effect of the medicaments of the prior art.

According to a first aspect, the present invention provides, in parts by weight, Salvia miltiorrhiza 10-20, Pyrrosia lingua 10-15, rhizoma anemarrhenae 3-20, Angelica sinensis 12-18 and Earl (Radix Paeoniae Alba) Provided is a medicament for treating osteoporosis, including 5-10.

A medicament for treating osteoporosis according to the present invention has different ingredients compared to medicaments of the prior art and can overcome the drawbacks of the medicaments of the prior art.

In one embodiment of the present invention, there is provided a medicament for treating osteoporosis, comprising by weight Salvia 10-20, Gracosa 10-15, Jimo 3-20, Angelica 12-18, and Earl 5-10.

In addition, the medicament further comprises Eucommia ulmoides 20-50 by weight.

In addition, the medicament further comprises root of kudzu vine 2-22 by weight.

The larvae and reeds are just some specific examples and are not intended to be limiting, and include other substances such as wolfberry fruit, Gynostemma pentaphyllum, 12 Semen Astragali Complanati, Radix Dipsaci ), Herbal Eclipta (Herba Eclipta), Journey (Fructus Ligustri Lucidi) are also possible. Other possible materials will not be disclosed in detail.

Optionally, in one embodiment of the invention, substances that activate blood circulation, such as Carcuma longa, Ligusticum chuanxiong Hort, Radix Salviae Miltiorrhizae and Evening Primrose, are added Can be.

In addition, in one embodiment of the invention, in order to enhance the pharmacological effect, the medicament is a substance that removes heat, for example, Gardenia (Fructus Gardeniae), Chrysanthemum (Flos Chrysanthemi), Semen Cassiae, Cortex fraxini), red ginseng (Radix Sophorae Flavescentis), wild chrysanthemum (Flos Chrysanthemi Indici), Andrographis paniculata and the like may further include.

In addition, the medicament may further include substances that remove moisture and promote diuresis, such as Herba Sedi, Abrus Herb, and the like.

In addition, the medicament may further include a substance for warming the inside, for example, pepper.

In one embodiment of the invention, the dosage form of the medicament is a film-coated tablet, dragee, enteric coated tablet, dispersible tablet, capsule, granule, decoction, mixture, syrup At least one of vinum, injection, oral solution, and oral turbid liquid.

In one embodiment of the invention, optionally, the medicament has an oral-dosage formulation.

In one embodiment of the invention, optionally, the oral-dose formulation comprises a tablet, capsule, pill, injection, sustained release preparation and controlled release formulation.

The medicaments of the embodiments provided herein or pharmaceutical compositions comprising the same may be administered in unit dosage form via intestinal tract, nasal, oral mucosa, eye, lung, respiratory tract, skin, rectum, or the like, oral administration, It can be administered by intravenous injection, intramuscular injection and subcutaneous injection.

The dosage form can be a liquid dosage form, a solid dosage form, or a semi-solid dosage form. The liquid dosage form may be a solution, emulsion, suspension, injection (including water injection, powder injection and transfusion), eye drop, nasal drop, lotion and liniment. There is; The solid dosage forms can be tablets (uncoated tablets, enteric-coated tablets, buccal tablets, dispersible tablets, chewable tablets, effervescent tablets, orally disintegrating tablets). ), Capsules (including hard capsules, soft capsules, enteric capsules), granules, powders, pellets, dropping pills, suppositories, films, pastes, aerosols, sprays, and the like; And the semi-solid dosage form can be an ointment, gel, paste, or the like. Dosage forms of the medicament are preferably tablets, capsules, pills and injections.

Pharmaceuticals according to one embodiment of the present invention can be prepared from existing preparations, sustained release formulations, controlled release formulations, targeting formulations, and various granule dosage formulations.

In one embodiment of the present invention, various excipients, such as diluents, binders, wetting agents, disintegrants, lubricants and glidants, may be used to prepare the medicaments of the present invention into tablets. The diluent may be starch, dextrin, sucrose, glucose, lactose, mannitol, sorbitol, xylitol, microcrystalline cellulose, calcium sulfate, calcium hydrogen phosphate, calcium carbonate and the like; The wetting agent may be water, ethanol, isopropanol and the like; The binder may be starch pulp, dextrin, syrup, honey, glucose solution, microcrystalline cellulose, gum arabic pulp, gelatin pulp, sodium carboxymethyl cellulose and methyl cellulose; The disintegrant may be dry starch, microcrystalline cellulose, low-substituted hydroxypropylcellulose; In addition, the lubricant and lubricant may be talc, silica, stearate, liquid paraffin and the like.

Additionally, the medicament may also be coated tablets, such as dragees, film coated tablets, enteric coated tablets, and the like.

When the medicament is prepared in capsules, the active ingredient can be prepared in granules or pellets with the addition of diluents, binders and disintegrants, which are then placed in hard capsules or soft capsules.

When the medicament is prepared as an injection, the solvent may consist of water, ethanol, isopropanol, propylene glycol, or mixtures thereof. In addition, an appropriate amount of solubilizer, cosolvent, pH adjuster, osmotic pressure adjuster may be added.

In addition, colorants, preservatives, perfumes, corrigents or other additives may be added to the agent.

In one embodiment of the invention, there is provided a method of preparing the medicament, comprising the following steps:

First step: weighing 10-20 g of Salviae, 10-15, Geum 3-20, Angelica 12-18 and Earl of 5-10 by weight;

Second step: grinding the salvia, granules and hairs into a powder, sifting the powder into a sieve of 200 mesh and uniformly mixing to obtain fine powder;

Third step: decocting the Angelica vulgaris and Earl of Peanuts twice with water for 30-60 minutes each, and filtering to obtain two filtrates;

Fourth step: mixing the two filtrates, standing to obtain a supernatant, and concentrating the supernatant in vacuo to obtain a thick paste; And

Step 5: uniformly mixing the thick paste with the fine powder and the adjuvant material in a suitable ratio to obtain a desired medicament.

In the following, some specific embodiments of a method of preparing a medicament for treating osteoporosis are provided.

Example 1

First step: weighing 10-20 g of Salviae, 10-15, Geum 3-20, Angelica 12-18 and Earl of 5-10 by weight;

Second step: grinding the salvia, granules and hairs into a powder, sieving the powder into a sieve of 200 mesh, and uniformly mixing to obtain fine powder;

Third step: adding the Angelica and Baekjak, each with 10 ml of water at 30 minute intervals, decoction with water twice at 4O < 0 > C for 4 hours and filtering to obtain two filtrates;

Fourth step: mixing the two filtrates, standing at room temperature for 30 minutes to obtain a supernatant, and concentrating the supernatant in vacuo to obtain a thick paste; And

Step 5: Drying the thick paste, grinding it, and uniformly mixing the ground thick paste with the fine powder and adjuvant material in a suitable ratio to obtain a desired medicament.

Example 2

First step: mixing the roots, salvia, stone and hair;

Second step: grinding the root, salvia, stone and hair into powder, sieving the powder into a sieve of 200 mesh, and uniformly mixing to obtain fine powder;

Third step: immersing the Angelica vulgaris and Earl of Water for at least 8 hours to completely immerse them;

Fourth step: adding the Angelica and Baekjak to each of 30 ml at 30 minute intervals, decoction with water twice at 4O < 0 > C for 4 hours, and filtering to obtain two filtrates;

Step 5: mixing the two filtrates, standing at room temperature for 30 minutes to obtain a supernatant, and concentrating the supernatant in vacuo to obtain a thick paste; And

Step 6: Drying the thick paste, grinding it, and uniformly mixing the ground thick paste with the fine powder and the adjuvant material in a suitable ratio to obtain a desired medicament.

Example 3 (Preparation of Granules)

First step: mixing the roots, salvia, stone and hair;

Second step: grinding the roots, salvia, granules, and hairs into powder, sifting the powder into a sieve of 200 mesh, and uniformly mixing to obtain fine powder;

Third step: immersing the Angelica vulgaris and Earl of Water for at least 8 hours to completely immerse them;

Fourth step: adding the Angelica and Baekjak to each of 30 ml at 30 minute intervals, decoction with water twice at 4O < 0 > C for 4 hours, and filtering to obtain two filtrates;

Step 5: The two filtrates were mixed and the filtrate was concentrated in vacuo to give an extract having a relative density of 1.25 (60 ° C.), and the extract was mixed with 3-fold of dextrin to yield a soft material. Preparing granules using an oscillating granulator; And

Step 6: Drying the granules at 65 ° C. for 30 minutes, finishing the granules, sieving to remove small granules, and packaging.

Claims (5)

By weight, including Salvia miltiorrhiza 10-20, Pyrrosia lingua 10-15, Gizo (rhizoma anemarrhenae) 3-20, Angelica sinensis 12-18, and Radix Paeoniae Alba 5-10 , Medicine for treating osteoporosis. The agent for treating osteoporosis of claim 1, further comprising Eucommia ulmoides 20-50 by weight. The agent for treating osteoporosis according to claim 1, further comprising root of kudzu vine 2-22 by weight. The dosage form of claim 1, wherein the dosage form of the medicament is a film-coated tablet, dragee, enteric coated tablet, dispersible tablet, capsule, granule, decoction, mixture, syrup, medicinal wine A drug for treating osteoporosis, which is at least one of vinum, injection, oral solution, and oral turbid liquid. A method of preparing a medicament according to any one of claims 1 to 4, comprising:
First step: weighing by weight part Salviae 10-20, Soybean 10-15, Jimo 3-20, Angelica 12-18 and Earl 5-10;
Second step: grinding the salvia, granules and hairs into powder, sifting the powder into a sieve of 200 mesh, and uniformly mixing to obtain fine powder;
Third step: decocting the Angelica vulgaris and Earl Twice with water twice and filtering to obtain two filtrates;
Fourth step: mixing the two filtrates, standing to obtain a supernatant, and concentrating the supernatant in vacuo to obtain a thick paste; And
Fifth step: uniformly mixing the thick paste with the fine powder and an adjuvant material in a suitable ratio to obtain a desired medicament.