CN102058714A - Medicinal composition for treating hemophilia - Google Patents

Abstract

The invention discloses a medicinal composition for treating hemophilia. The medicinal composition for treating the hemophilia is prepared from the following raw materials in part by weight: 15 to 30 parts of rehmannia root, 15 to 25 parts of yerbadetajo herb, 10 to 15 parts of south dodder seed, 10 to 15 parts of Indian buead, 5 to 8 parts of glossy privet fruit, 5 to 8 parts of prepared tuber fleeceflower root, 5 to 10 parts of twotooth achyranthes root, 10 to 15 parts of hairyvein agrimonia herb and bud and 3 to 6 parts of rehmannia root. The medicinal composition for treating the hemophilia can cool the blood and stop bleeding, can also generate and enrich the blood, treats both the symptoms and diseases, has a two-way adjustment function and a good curative effect on the hemophilia and various hemorrhagic diseases caused by blood heat, can stop bleeding quickly, and obviously increases the average value of procoagulant activity.

Description

The haemophiliachemophiliac pharmaceutical composition of a kind of treatment

Technical field

The present invention relates to medical technical field, particularly relate to the haemophiliachemophiliac pharmaceutical composition of a kind of treatment.

Background technology

Hemophilia (hemophilia) is one group of more common hereditary hemorrhagic disease, has the characteristics of X x-linked recessive inheritance.Thrombin difference according to lacking can be divided into hemophilia A (hemophilia A, FVIII deficiency disease) and hemophilia B's (hemophilia B, FIX deficiency disease).Hemophilia A or hemophilia B cause the thromboplastin dyspoiesis because FVIII or FIX procoagulant activity reduce, and cruor time extending has abnormal bleeding tendency after the minor trauma all the life.The sickness rate of China is lower, wherein has 80% to be hemophilia A approximately, is feature with haemophilia, hematoma formation and arthrorrhagia after morbidity childhood, the spontaneous or slight wound.Because lack certain thrombin in patient's blood plasma, behind patient's the angiorrhexis, blood is difficult for condensing than the normal person, thereby can the more blood of diffluence.The wound of body surface is caused hemorrhage also not serious usually, and internal hemorrhage is much then serious.Internal hemorrhage generally occurs in joint, tissue and muscle inside.When visceral hemorrhage or intracranial hemorrhage take place, threat to life usually.

Arthrorrhagia is very common in hemophiliac, the most normal hemorrhage be knee joint, elbow joint and ankle joint.Sludging can make joint motion limited behind patient's articular cavity, and its function is temporarily lost, and for example the hemorrhage back of knee joint patient usually can not the normal stand walking.The blood that deposits in articular cavity usually needs time several weeks to be absorbed gradually, thereby restore funcitons gradually, if can cause synovitis and arthritis but the joint is hemorrhage repeatedly, cause joint deformity, make the function in joint be difficult to recover normal, therefore a lot of hemophiliac have deformity in various degree.

Because the gene of each thrombin all is the sequence of a string complexity, even same type hemophiliac, corresponding gene is also different, thereby the activity level of its thrombin is also different, hemophiliac can be divided into heavy type, medium-sized and light-duty in view of the above.

The level of activity of the thrombin that is lacked in the blood plasma of severe hemophiliac does not reach can be for several times hemorrhage in 3%, month of normal person, hemorrhagely usually takes place under the situation of obvious cause not having, and is called spontaneous hemorrhage.Arthrorrhagia is very general.

The factor active degree of moderate hemophiliac is normal person's 3% to 6%, and their hemorrhage usually caused by little wound, for example athletic injury.Arthrorrhagia generally takes place after wound.The factor active degree of slight hemophiliac is normal person's 6% to 25%, general only haemophilia after surgical operation, exodontia or severe trauma.Arthrorrhagia is less.

Summary of the invention

The object of the present invention is to provide a kind of treatment to treat haemophiliachemophiliac pharmaceutical composition.Technology contents of the present invention is implemented by following scheme:

The haemophiliachemophiliac pharmaceutical composition of a kind of treatment is to be made by following materials of weight proportions:

Radix Rehmanniae 15-30 part, Herba Ecliptae 15-25 part, Semen Cuscutae 10-15 part, Poria 10-15 part,

Fructus Ligustri Lucidi 5-8 part, Radix Polygoni Multiflori Preparata 5-8 part, Radix Achyranthis Bidentatae 5-10 part, Herba Agrimoniae 10-15 part,

Radix Rehmanniae 3-6 part.

The haemophiliachemophiliac pharmaceutical composition of treatment of the present invention is preferably composed as follows:

Radix Rehmanniae 10-20 part, Herba Ecliptae 20-25 part, Poria 12-15 part, Radix Rehmanniae 4-6 part

Fructus Ligustri Lucidi 6-8 part, Radix Polygoni Multiflori Preparata 6-8 part, Radix Achyranthis Bidentatae 6-10 part, Herba Agrimoniae 12-15 part,

Semen Cuscutae 12-15 part.

The haemophiliachemophiliac pharmaceutical composition of treatment of the present invention, what be more preferably is composed as follows:

20 parts of Radix Rehmanniae, 25 parts of Herba Ecliptaes, 12 parts of Semen Cuscutae, 12 parts in Poria,

8 parts of Fructus Ligustri Lucidi, 6 parts of Radix Polygoni Multiflori Preparata, 6 parts of Radix Achyranthis Bidentataes, 15 parts of Herba Agrimoniaes,

4 parts of Radix Rehmanniae.

The present invention can be mixed and made into various preparations with pharmaceutical composition and excipient substance.The preparation concrete operations of various pharmaceutical preparatioies are as follows:

(1) takes by weighing each Chinese medicine ingredients by the configuration total amount, the filler of adding 40-90%, binding agent, disintegrating agent, lubricant, correctives etc., fully mix and make granule, compacting in 60-70 ℃ of dry 2-4 hour in flakes, maybe with the wet granular made directly at 60-70 ℃ of dry 2-4 hour, be filled into then in the hungry area shell.

(2) composition material adds solvent, the antiseptic of 70-99.5%, fully mixes, and adds activated carbon decolorizing, filters, and uses less than 0.45 μ m microvoid membrane filtration, and embedding after ultrafiltration was sterilized 30-60 minute, and made every ml contain compositions 5-300mg for 100 ℃; Or with gained filtrate by after the standard packing, lyophilized injectable powder is made in lyophilization under vacuum condition.

(3) filler of composition material adding 40%-90%, disintegrating agent, correctives etc. fully mix with the 12-14 mesh sieve and make granule.At 60-70 ℃ of dry 2-4 hour, make every gram granule contain compositions 100-600mg.

Can adopt water, ethanol 30-90% in the preparation method of the present invention is that solvent extracts each Chinese medicine ingredients, and extracting solution separates again, organic solvent extraction, enrichment, effective ingredient.

The present invention can be mixed and made into various preparations with compositions and the excipient substance of making.Pharmaceutic adjuvant of the present invention comprises following excipient: filler: lactose, sucrose, starch, microcrystalline Cellulose, sorbitol, cellulose.Binding agent: gelatin, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, starch, dextrin.Disintegrating agent: microcrystalline Cellulose, carboxymethyl starch sodium, sodium carboxymethyl cellulose, polyvinylpyrrolidone.Lubricant: magnesium stearate; High-molecular bone frame material, for example hydroxypropyl emthylcellulose, hydroxypropyl cellulose, ethyl cellulose, Brazil wax, hydrogenated vegetable oil, acrylic resin.Preparation of pharmaceutical compositions is as follows: use standard and conventional technology; acceptable solid or liquid-carrier are combined, and make it at random to combine and be prepared into microgranule or microsphere with acceptable adjuvant and excipient on the galenic pharmacy.Solid dosage forms comprises tablet, discrete particles, capsule, slow releasing tablet, slow-release micro-pill or the like.Solid carrier can be at least a material, and it can serve as diluent, flavouring agent, solubilizing agent, lubricant, suspending agent, binding agent, disintegrating agent and coating agent.Inert solid carrier comprises magnesium phosphate, magnesium stearate, smoothers sugar, lactose, pectin, propylene glycol, polyoxyethylene sorbitan monoleate, dextrin, starch, gelatin, cellulose substances for example methylcellulose, microcrystalline Cellulose, low melt point paraffin, Polyethylene Glycol, mannitol, cocoa butter etc.Liquid dosage form comprises solvent, suspension for example injection, powder or the like.

The amount of the active ingredient that contains in pharmaceutical composition and the unit dosage form (The compounds of this invention) can be according to patient's the state of an illness, specific being applied of situation of diagnosis, the amount of used chemical compound or concentration are regulated in the scope of a broad, usually, the weight range of reactive compound is 0.5%～90% (weight) of compositions, and another preferred range is 0.5%-70%.

Below in conjunction with two model cases of example:

Xiao Xie, the man, 2 years old, to be born after 8 months, that collision back skin occurs repeatedly is livid purple, speckle, epistaxis, oral mucosa haemophilia, prolong (68.5 seconds) at local examination in hospital partial thromboplastin time (KPTT), can be corrected by normal serum, correct the prompting hemophilia B but can not be adsorbed blood plasma, using prothrombin complex repeatedly could stop blooding, and the family circle is anxious for it.Admission examination: the large stretch of ecchymosis in skin many places, epistaxis, VIII factor active 40%, IX factor active 1.2%, XI factor active 102%, diagnosis: hemophilia B, skin soft tissue and epistaxis.Adopt oral haemophiliachemophiliac pharmaceutical composition after being in hospital, non-blood products therapies of combining Chinese and Western medicine such as blood friend mixture, mixture for hemostasis.Epistaxis stopped the same day, and the skin ecchymosis disappears after 1 week, and two weeks of after treatment leave hospital, and followed up a case by regular visits to and did not have repeatedly in four months, and baby's body constitution is clearly better.Self coagulation factor activity of patient is improved, thereby reduces patient's sickness rate, perhaps do not fall ill, tackle the problem at its root.

Xiao Feng, man, 8 years old; The Anhui nationality.

Just stepped into primary school soon, two ankle joint swelled and ache unbearably 2 years repeatedly, influence study.One disease does not heal, and presents hematuria again, and the family circle is very much worried, asks that everywhere the doctor asks medicine.Human health screening: two ankle swelling, the tenderness positive.Gross hematuria.FVIII:C2.2%, ultrasound diagnosis: left renal pelvis calculus.Diagnosis: hemophilia A, two ankle joint inflammation, left renal pelvis calculus hematuria.

Adopt non-blood products therapies of combining Chinese and Western medicine such as oral haemophiliachemophiliac pharmaceutical composition, beneficial blood are peaceful, clofenamic acid joint cavity injection 3 days in hospital, arthralgia disappears, and hematuria stops, and leaves hospital in 3 weeks, and it is steady to follow up a case by regular visits to 4 months state of an illness, does not have repeatedly.The family circle has saved child from the grateful new therapy of heart.

The specific embodiment:

The present invention is described further below in conjunction with embodiment.Embodiment only is to explanation of the present invention, can not be used for limiting the present invention with this.

Embodiment 1

20 parts of Radix Rehmanniae, 25 parts of Herba Ecliptaes, 12 parts of Semen Cuscutae, 12 parts in Poria,

8 parts of Fructus Ligustri Lucidi, 6 parts of Radix Polygoni Multiflori Preparata, 6 parts of Radix Achyranthis Bidentataes, 15 parts of Herba Agrimoniaes,

4 parts of Radix Rehmanniae.

Above-mentioned each Chinese crude drug is mixed, and heating or percolation 2 times merge 2 times extracting solution, and decompression recycling ethanol gets crude extract, and medicinal residues discard.Crude extract is regulated pH to 7-8 with 5%NaOH liquid, gets alkaline medicinal liquid, with chloroform (or petroleum ether) extraction.Tell the solvent layer, discard, water layer reuse 5% sulphuric acid is transferred pH to 2-4, place, centrifugal, acidic precipitation is standby, get 30g (C) after the drying, solution extracts with chloroform (or petroleum ether), layering, water layer, concentrate 86g, the solvent layer concentrate extract, after the drying 40g and acidic precipitation mix homogeneously, must mixture 70g.Extract is added 5% sodium chloride brine 250ml iv drip.

Embodiment 2

10 parts of Radix Rehmanniae, Herba Ecliptae 20-part, 12 parts in Poria, Radix Rehmanniae-6 part

6 parts of Fructus Ligustri Lucidi, 6 parts of Radix Polygoni Multiflori Preparata, 10 parts of Radix Achyranthis Bidentataes, 12 parts of Herba Agrimoniaes, 15 parts of Semen Cuscutae.

Above-mentioned each Chinese crude drug is mixed, and heating or percolation 2 times merge 2 times extracting solution, and decompression recycling ethanol gets crude extract, and medicinal residues discard.Crude extract is regulated pH to 7-8 with 5%NaOH liquid, gets alkaline medicinal liquid, filters, discard precipitate, supernatant is transferred pH to 2-4 with 5% sulphuric acid, places, centrifugal, acidic precipitation is standby, gets 34g after the drying, solution extracts with ethyl acetate (or n-butyl alcohol), layering, water layer discarded, the solvent layer concentrate extract, after the drying 45g, with the acidic precipitation mix homogeneously, get mixture 79g, add 20 parts of starch, 5 parts of mixed pressuring plates of magnesium stearate.

Embodiment 3

30 parts of Radix Rehmanniae, 25 parts of Herba Ecliptaes, 15 parts of Semen Cuscutae, 15 parts in Poria, 5 parts of Radix Achyranthis Bidentataes

8 parts of Fructus Ligustri Lucidi, 5 parts of Radix Polygoni Multiflori Preparata, 10 parts of Herba Agrimoniaes, 6 parts of Radix Rehmanniae.

Above-mentioned each Chinese crude drug is mixed, extract 2 times with 18 times of amount 1% sodium hydroxide (or sodium carbonate) solution, merge 2 times extracting solution, concentrating under reduced pressure gets crude extract, and medicinal residues discard.Silicagel column on the crude extract with chloroform (or ethyl acetate, methanol) eluting, is collected each several part, carries out qualitative identification with magnesium powder-hydrochloric acid, merges positive part, and concentrating under reduced pressure must mixture 30g, adds No. 2 capsule, makes capsule.

Embodiment 4

18 parts of Radix Rehmanniae, 20 parts of Herba Ecliptaes, 13 parts of Semen Cuscutae, 12 parts in Poria,

5 parts of Fructus Ligustri Lucidi, 7 parts of Radix Polygoni Multiflori Preparata, 9 parts of Radix Achyranthis Bidentataes, 15 parts of Herba Agrimoniaes,

5 parts of Radix Rehmanniae.

Above-mentioned each Chinese crude drug is mixed, extract with 18 times of amount 30% ethanol (heating or percolation), get crude extract, be dissolved in water solution organic solvent petroleum ether extraction, petroleum ether layer discards, water layer adds ethanol, makes the alcohol amount of containing reach 75% ethanol precipitate with ethanol, filters, discard precipitate, supernatant concentrates and receives alcohol, gets extractum, be dissolved in water, with counter-current distribution method continuous extraction 6 hours, aqueous solvent-n-butyl alcohol, extract concentrate mixture 55g, with the extract evaporate to dryness, add 5% glucose saline and make injection for 100 parts.

Claims (4)

1. treating haemophiliachemophiliac pharmaceutical composition for one kind, is to be made by following materials of weight proportions:

Radix Rehmanniae 15-30 part, Herba Ecliptae 15-25 part, Semen Cuscutae 10-15 part, Poria 10-15 part,

Fructus Ligustri Lucidi 5-8 part, Radix Polygoni Multiflori Preparata 5-8 part, Radix Achyranthis Bidentatae 5-10 part, Herba Agrimoniae 10-15 part,

Radix Rehmanniae 3-6 part.

2. treat haemophiliachemophiliac pharmaceutical composition according to claim 1, it is characterized in that it being to make by following materials of weight proportions:

Radix Rehmanniae 10-20 part, Herba Ecliptae 20-25 part, Poria 12-15 part, Radix Rehmanniae 4-6 part

Fructus Ligustri Lucidi 6-8 part, Radix Polygoni Multiflori Preparata 6-8 part, Radix Achyranthis Bidentatae 6-10 part, Herba Agrimoniae 12-15 part,

Semen Cuscutae 12-15 part.

3. treat haemophiliachemophiliac pharmaceutical composition according to claim 1, it is characterized in that it being to make by following materials of weight proportions:

20 parts of Radix Rehmanniae, 25 parts of Herba Ecliptaes, 12 parts of Semen Cuscutae, 12 parts in Poria,

8 parts of Fructus Ligustri Lucidi, 6 parts of Radix Polygoni Multiflori Preparata, 6 parts of Radix Achyranthis Bidentataes, 15 parts of Herba Agrimoniaes,

4 parts in Poria.

4. haemophiliachemophiliac pharmaceutical composition of the described treatment of claim 1-3 and excipient substance are mixed and made into various preparations.