KR20190134182A - 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 Scrophularia nodosa; 10 to 15 parts by weight of Achyranthes bidentata; 3 to 20 parts by weight of Lindera aggregata; 12 to 18 parts by weight of Angelica sinensis; and 5 to 10 parts by weight of Paeonia japonica The medicine for treating osteoporosis according to the present invention has different components compared to medicines in the prior art, and can overcome the deficiencies of medicines in the prior art.

Description

A drug for treating osteoporosis and its preparation method

The present invention relates to the field of drugs, in particular drugs for the treatment of osteoporosis and methods of making the same.

Osteoporosis is the most common disease and a worldwide health problem. Currently, the global incidence of osteoporosis has exceeded 25%, and osteoporosis has risen to the top ten among common and frequent diseases. China is one of the oldest countries in the world. The number of existing osteoporosis patients is 90 million, accounting for 7.1% of the total population, and it is estimated that the number of osteoporosis patients will increase to 220 million by 2050. Therefore, research on the prevention and treatment of osteoporosis is very important for human health and quality of life.

At present, there are two general methods of treatment, "basic treatment" and "intensive treatment," which are clinically used to treat osteoporosis. Basic treatment refers to treatment with "calcium + vitamin D". In general, “basic treatment” is relatively safe with little side effects, but the effect of increasing bone density and reducing fracture incidence has not been identified. Intensive therapy includes bisphosphonate-based drugs and calcitonin-based drug therapy. It is generally believed that these drugs can effectively improve bone density, relieve osteoporosis symptoms quickly, and reduce the likelihood of fracture, but should be used under the guidance of a specialist to avoid side effects. “Triple treatment” is also clinically popular, the first type of triple treatment applies calcium + vitamin D + periodic bisphosphonate / calcitonin, and is suitable for the treatment of patients with senile osteoporosis and patients with apparent pain; The second type of triple therapy applies calcium + vitamin D + selective estrogen receptor modulators, maximizes the beneficial effects of estrogen on bones, and effectively avoids adverse side effects on the breast and uterus, leading to traditional female hormone replacement therapy. Has the potential to replace

However, the therapeutic effect of the treatment or therapy is not ideal. In addition, current drugs have other toxicity and side effects. Therefore, in order to overcome the above drawbacks, it is urgent to develop a new drug for treating osteoporosis.

In view of the above problems, the present invention provides a drug for treating osteoporosis which can solve the above problem or at least a part of the above problem, which can be used to overcome the drawback that the therapeutic effect of the drug in the prior art is insignificant.

According to the first aspect, the present invention is 10-20 parts by weight of Radix scrophulariae , 10-15 parts by weight of Achyranthes bidentata , 3-20 parts by weight of Lindera aggregate It provides a drug for the treatment of osteoporosis, which comprises 12-18 parts by weight of Chinese Angelica sinensis and 5-10 parts by weight of Radix Paeoniae Alba .

The drug for treating osteoporosis according to the present invention is different in composition compared to the drug of the prior art and can overcome the drawbacks of the drug of the prior art.

In one embodiment of the present invention, the drug for treating osteoporosis comprising 10-20 parts by weight of Hyunsam, 10-15 parts by weight of knee, 3-20 parts by weight of oak, 12-18 parts by weight of Chinese Angelica and 5-10 parts by count to provide.

In addition, the drug further comprises 20-50 parts by weight of worms ( Eucommia ulmoides ).

In addition, the drug may further comprise 2-22 parts by weight of the root of the root of kudzu vine.

The larvae and reeds are only a few specific examples and are not intended to be limiting, but are not intended to be limiting, including wolfberry fruit, Gynostemma pentaphyllum , Semen Astragali Complanati , Radix Dipsaci ), Other substances such as Herba Eclipta and Fructus Ligustri Lucidi are also possible. Other possible materials will not be described in detail.

Optionally, in one embodiment of the present invention, blood, such as Curcuma longa , Ligusticum chuanxiong Hort , Chinese Radix Salviae Miltiorrhizae , Evening Primrose Materials that activate the circulation can be added.

Furthermore, in one embodiment of the invention, in order to improve the pharmacological effect, gardenia (梔子, Fructus Gardeniae), chrysanthemum (菊花, Flos Chrysanthemi), Cassia tora (決明子, Semen Cassiae), dermis (秦皮, cortex fraxini) It may further include heat-removing substances such as Radix Sophorae Flavescentis , Ginseng Flos Chrysanthemi Indici, Andrographis paniculata , etc.

In addition, the drug may further include a substance that removes moisture and promotes diuresis, such as Medicinal herbs , Herba Sedi , Abrus Herb, and the like.

In addition, the drug may further comprise a material that warms the interior, such as pepper (pepper).

In one embodiment of the invention, the formulation of the drug is a film-coated tablet (sugar-coated tablet), sugar coated tablet (sugar coated tablet), enteric coated tablet (enteric coated tablet), dispersible tablet, capsule (capsule) ), Granules, decoctions, mixtures, syrups, sirups, medicinal wines, injections, oral solutions and oral turbid liquids It can be one.

In one embodiment of the invention, optionally, the drug has an oral-administration dosage form.

In one embodiment of the invention, optionally, the oral dosage form comprises a tablet, capsule, pill, injectable, sustained release preparation and controlled release preparation.

Drugs or drug compositions according to embodiments provided in the present invention may be used in the intestinal tract, nasal cavity, oral mucosa, eyes, lungs, respiratory tract, skin. Can be administered in unit dosage form via rectal, rectal, oral administration, oral administration, intravenous injection, intramuscular injection and subcutaneous injection. May be administered.

Dosage forms may be liquid dosage forms, solid dosage forms, or semisolid dosage forms. Liquid dosage forms include solutions, emulsions, suspensions, injections (including water injections, powder injections and transfusions), eye drops, May be nasal drops, lotions, and liniments; Solid dosage forms are 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 ), Suppository, film agent, paste, aerosol, spray, and the like; Semi-solid dosage forms can be ointments, gels, pastes and the like. The formulation of the drug is preferably tablets, capsules, pills and injections.

Drugs according to one embodiment of the invention can be prepared in conventional formulations, sustained release formulations, controlled release formulations, targeting preparations and various granule dosage formulations.

In one embodiment of the invention, diluents, binders, humectants, disintegrating agents, lubricants and glidants are used to prepare the drugs of the invention into tablets. Various excipients such as The diluent may be starch, dextrin, sucrose, glucose, lactose, mannitol, sorbitol, xylitol, microcrystalline cellulose, calcium sulfate, calcium hydrogen phosphate, calcium carbonate and the like; Wetting agents can be water, ethanol, isopropanol, and the like; The binder is starch pulp, dextrin, syrup, honey, glucose solution, microcrystalline cellulose, gum arabic pulp, gelatin pulp, sodium carboxymethyl cellulose ), And methyl cellulose; Disintegrants can be dry starch, microcrystalline cellulose, low-substituted hydroxypropylcellulose; Lubricants and lubricants can be talc, silica, stearate, liquid paraffin, and the like.

In addition, the drug may be a coated tablet, for example, sugar coated tablets, film coated tablets, enteric coated tablets and the like.

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

When the drug is prepared as an injection, the solvent may be prepared from water, ethanol, isopropanol, propylene glycol or mixtures thereof. In addition, an appropriate amount of solubilizing agent, cosolvent, pH adjusting agent, osmotic pressure adjusting agent may be added.

In addition, the drug may be added a colorant, preservative, perfume, corrigent or other additives.

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

The first step: measuring the weight of 10-20 parts by weight of ginseng, 10-15 parts by weight of the knee, 3-20 parts by weight of koja, 12-18 parts by weight of Chinese Angelica, and 5-10 parts by weight of earluff;

Second step: grinding the ginseng, knees and oak into powder, sieving the powder into a 200 mesh sieve, and uniformly mixing to obtain fine powder;

Third step: weighing the Chinese Angelica and Earl of Peony twice with water for 30-60 minutes each, filtration to obtain two filtrates;

Fourth step: mixing the two filtrates, standing to obtain a supernate, 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 an appropriate ratio to obtain a target drug.

Hereinafter, some specific examples of a method for preparing a drug for treating osteoporosis are provided.

Example 1

The first step: measuring the weight of 10-20 parts by weight of ginseng, 10-15 parts by weight of the knee, 3-20 parts by weight of koja, 12-18 parts by weight of Chinese Angelica, and 5-10 parts by weight of earluff;

Second step: grinding chopped ginseng, knees and oak into powder, sifting the powder into a 200 mesh sieve and mixing uniformly to obtain fine powder;

Third step: adding 10 ml of water at 30 minutes intervals to each of Chinese Angelica and Earl of Peony, which was then doubled with water at 30 ° C. for 4 hours and filtered to obtain two filtrates;

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

Step 5: After drying and pulverizing the thick paste, uniformly mixing the pulverized thick paste with the fine powder and the adjuvant material in an appropriate ratio to obtain a target drug.

Example 2

First step: mixing the reeds, string ginseng, knees and oak;

Second step: grinding the roots, hyeonsam, knees and oak into powder, sifting the powder into a 200 mesh sieve, and mixing them uniformly to obtain fine powder;

Step 3: soaking in water for at least 8 hours until the Chinese Angelica and Earl are completely soaked;

Fourth step: adding 10 ml of water at 30 minutes intervals to each of Chinese Angelica and Baekjak, twice with water at 30 ° C. for 4 hours, and filtering to obtain two filtrates;

Fifth 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 6: After drying and pulverizing the thick paste, uniformly mixing the pulverized thick paste with the fine powder and adjuvant material in an appropriate ratio to obtain a target drug.

Example 3 (Preparation of Granules)

First step: mixing the reeds, string ginseng, knees and oak;

Second step: grinding the roots, hyeonsam, knees and oak into powder, sifting the powder into a 200 mesh sieve, and mixing them uniformly to obtain fine powder;

Third step: immersing in water for at least 8 hours until Chinese Angelica and Earl Cough completely submerged;

Fourth step: adding 10 ml of water at 30 minutes intervals to each of Chinese Angelica and Baekjak, twice with water at 30 ° 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 of relative density 1.25 (60 ° C.), and the extract was mixed with three times the amount of dextrin to obtain a soft material and vibrating granules Preparing granules with an oscillating granulator;

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

Claims (5)

10-20 parts by weight of Radix scrophulariae , 10-15 parts by weight of knee, Achyranthes bidentata , 3-20 parts by Lindera aggregate , 12-18 parts by weight of Angelica sinensis , and Radix Paeoniae Alba ) A drug for treating osteoporosis comprising 5-10 parts by weight. The method of claim 1,
Eucommia ulmoides A drug for treating osteoporosis further comprising 20-50 parts by weight. The method of claim 1,
The root of kudzu vine The drug for treating osteoporosis further comprises 2-22 parts by weight. The method of claim 1,
The formulation of the drug is at least one of film coated tablets, sugar coated tablets, enteric coated tablets, dispersion tablets, capsules, granules, decoctions, mixtures, syrups, medicinal wines, injections, oral solutions and oral suspensions. A drug for treating osteoporosis, characterized in that. A method of making a drug according to any one of claims 1 to 4, comprising the following steps:
The first step: measuring the weight of 10-20 parts by weight of ginseng, 10-15 parts by weight of the knee, 3-20 parts by weight of koja, 12-18 parts by weight of Chinese Angelica, and 5-10 parts by weight of earluff;
Second step: grinding chopped ginseng, knees and oak into powder, sifting the powder into a 200 mesh sieve and mixing uniformly to obtain fine powder;
Third step: decoction of Chinese Angelica and Earl Twice with water twice and filtered to obtain two filtrates;
Fourth step: mixing the two filtrates, standing to obtain a supernate, 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 an appropriate ratio to obtain a target drug.