CN104107272A

CN104107272A - Medicine composition for treating fracture

Info

Publication number: CN104107272A
Application number: CN201410337241.5A
Authority: CN
Inventors: 逄海东
Original assignee: Individual
Current assignee: Individual
Priority date: 2014-07-09
Filing date: 2014-07-09
Publication date: 2014-10-22
Anticipated expiration: 2034-07-09
Also published as: CN104107272B

Abstract

The invention relates to a medicine composition for treating fracture and a preparation method of the medicine composition. The medicine composition is prepared from rhizoma drynariae, garden balsam stem, angelica sinensis, cortex acanthopanacis, eucommia ulmoides, morinda officinalis, donkey-hide gelatin and the fruit of Chinese wolfberry. The dosage form comprises hard capsules, tablets and granules. The invention aims to provide a medicine which is used for treating fracture with exact curative effect.

Description

A kind of pharmaceutical composition for the treatment of fracture

Technical field

The invention belongs to field of medicaments, be specifically related to a kind of pharmaceutical composition for the treatment of fracture and preparation method thereof.

Background technology

Fracture refers to health bone because direct or indirect external force causes cracked or distortion.When skeleton has just formed, be soft flexible and plastic originally, along with the growth at age, the composition of cartilage is gradually few, and it is many that the composition of os osseum becomes gradually, and fracture starts easily to occur.Itself does not have nerve bone, but the periosteum of bone outside has intensive nerve, has serious pain while therefore fracturing.And can concurrent internal hemorrhage, swelling and large nerve, arteriovenous compressing and damage around.

Summary of the invention

Goal of the invention of the present invention is to provide a kind of Traditional Chinese medicine composition for the treatment of fracture and preparation method thereof, and aspect curative effect, detumescence, pain relieving, effect is remarkable, has reduced patient's misery, has reduced treatment time, creates good society and economic benefit.

Drug regimen raw material of the present invention is by weight ratio: Rhizoma Drynariae 130-170 part, Herba speranskiae tuberculatae 130-170 part, Radix Angelicae Sinensis part 160-200, Cortex Acanthopancis 130-170 part, Cortex Eucommiae 180-220 part, Radix Morindae Officinalis 160-200 part, Colla Corii Asini 100-140 part, Fructus Lycii 100-140 part.

Preferably: 150 parts of Rhizoma Drynariae, 150 parts of Herba speranskiae tuberculataes, 180 parts of Radix Angelicae Sinensis, 150 parts of Cortex Acanthopanciss, 200 parts of the Cortexs Eucommiae, 180 parts of Radix Morindae Officinaliss, 120 parts, Colla Corii Asini, 120 parts of Fructus Lycii.Above-mentioned raw materials is made hard capsule, tablet, granule etc. by the method for accepting on pharmaceutics, is wherein preferably granule.

The preparation method of above pharmaceutical composition is: get above pharmaceutical composition crude drug and mix, be ground into 10～20 order coarse granules, add 6 times, water, with the continuous 60 ℃ of extractions of microwave assisted extraction methods three times, extract carries out centrifugalize, and it is 1.30～1.35 thick paste that clean immersion is concentrated into relative density, vacuum drying, dried cream powder is broken, adds proper auxiliary materials, makes corresponding dosage form.

Adjuvant in the present invention can be acceptable any excipient or carrier on pharmaceutics.

The present invention is on Chinese medical theory basis, through a large amount of clinical practice screening gained.Its formula is simple, onset is rapid, evident in efficacy, short treating period, be difficult for recurrence.

Rhizoma Drynariae: the kidney invigorating bone strengthening, continuous hinder pain relieving.Modern pharmacy studies have shown that, to experimental rat bone injury, healing has facilitation to Rhizoma Drynariae water decoction gavage, rat experiment arthritis is had to the effect of the bone articular cartilage of stimulation cell compensatory hypertrophy, and can partly improve because mechanical stress line changes the degeneration that causes articular cartilage, thereby reduce osteoarthritis variability.

Herba speranskiae tuberculatae: expelling wind and removing dampness, relaxing muscles and tendons and activating QI and blood in the collateral.Modern pharmacy studies have shown that, Herba speranskiae tuberculatae analgesia anti rheumatism action is similar to Salicylates.

Radix Angelicae Sinensis: enrich blood invigorate blood circulation, menstruction regulating and pain relieving.Modern pharmacy studies have shown that, Radix Angelicae Sinensis can significantly promote hemoglobin and erythrocytic generation.

Cortex Acanthopancis: expelling wind and removing dampness, strong muscles and bones, liver and kidney tonifying, promoting blood circulation to remove obstruction in the collateral.Modern pharmacy studies have shown that, Cortex Acanthopancis decocting alcohol extract can obviously suppress the allergic inflammation reaction of rat adjuvant arthroncus and immune complex mediation, separately has sedation and analgesia effect.

The Cortex Eucommiae: liver and kidney tonifying, bone and muscle strengthening.Modern pharmacy studies have shown that, Cortex Eucommiae extract can obviously improve castrated rats bone biomechanical level, effectively prevents the generation of fracturing due to osteoporosis.

Radix Morindae Officinalis: reinforcing the kidney and supporting YANG, bone and muscle strengthening, expelling wind and removing dampness.Modern pharmacy studies have shown that, Radix Morindae Officinalis can improve osteoblast activity.

Colla Corii Asini: tonifying blood and arresting bleeding, nourshing Yin and drynsessmoistening prescription.

Fructus Lycii: the liver and the kidney tonifying, replenishing vital essence to improve eyesight.The effect of the aspects such as modern pharmacology studies confirm that Fructus Lycii scalable body's immunity, can effectively suppress tumor growth and cell mutation, has slow down aging, anti-fatty liver, adjusting blood fat and blood glucose.

In order to show that medicine of the present invention has therapeutic effect, the present invention to carry out following clinical experiment to fracture.

1. object and method

1.1 object choice are through clarify a diagnosis as patient's 80 examples of fracture totally, and all patients carry out random packet, are divided into 40 routine matched group patients, 40 routine treatment group patients.In matched group, 22 routine patients are women, and 18 routine patients are male, and the age, the median age was 42.3 years old from 25～62 years old.In treatment group, 23 routine patients are women, and 17 routine patients are male, and the age, the median age was 40.1 years old from 23～63 years old.The every situation contrast of matched group and treatment group no significant difference, can carry out comparative study.Matched group chi is scratched bone shaft fracture 6 examples, fracture of scaphoid bone 3 examples, fracture of metacarpal bone and phalanges of fingers 2 examples, humerus shaft fracture 7 examples, fracture of shafts of tibia and fibula 8 examples, calcaneus, fracture of phalanges 3 examples, femur backbone fracture 5 examples, fracture of pelvis 6 examples; Treatment group chi is scratched bone shaft fracture 5 examples, fracture of scaphoid bone 4 examples, fracture of metacarpal bone and phalanges of fingers 3 examples, humerus shaft fracture 6 examples, fracture of shafts of tibia and fibula 6 examples, calcaneus, fracture of phalanges 5 examples, femur backbone fracture 5 examples, fracture of pelvis 6 examples.Matched group and treatment group disease situation contrast no significant difference.

After 1.2 methods are clarified a diagnosis, give after maneuver and the operation reduction of the fracture, fixing processing, the oral embodiment of the present invention 1 granule for the treatment of group, once two bags, one day three bags; The oral bone setting tablet of matched group, one time four, three times on the one.The time of all patient's drug application treatments is that 4-8 is about week.

1.3 evaluation indexes are assessed all patients according to following standard.Pain: 1. painless (0 minute); 2. endurable pain, does not need to take analgesic intervention, have a rest (2 minutes); 3. pain is obvious, moving increase the weight of to be impatient at, and need take a small amount of analgesic, sleep influenced (4 minutes); 4. sharp ache, endurable, need take analgesic, sleep adversely effected (6 minutes).Swelling: 1. fracture is without swelling (0 minute); 2. surrounding soft tissue's mild swelling, skin texture is slightly shallow, and Peripheral blood circulation is influenced (2 minutes) slightly; 3. swelling is obvious, and Peripheral blood circulation is influenced obviously, skin texture obviously shoal (4 minutes); 4. serious swelling, epidermis is shinny, and texture disappears, and there are (6 minutes) in Tension Vesicle.

1.4 curative effect index clinical cures: clinical practice administration time shortens more than 1/4 than similar healing time, reaches clinical healing standard person.Clinical effective: clinical practice administration time reaches clinical healing standard person more than shifting to an earlier date 1/4-1/6 than similar healing time.Clinical effective: clinical practice administration time shifts to an earlier date 1/5-1/6 than similar healing time, reaches clinical healing standard person.Clinical invalid: clinical practice administration time, equal to or greater than similar healing time, reaches clinical healing standard person.Healing time is standard by clinical healing time reference value, is compared.

The all data of 1.5 statistical procedures are all applied ssps16.0 software and are processed, and apply t check, x ²check is processed data.

2. result

All patients are matched group and observation group's therapeutic effect contrast after treatment, and detailed results, in Table 1.All patients integration contrast situation of subsiding a swelling after treatment, detailed results, in Table 2.Treatment group and the contrast of matched group pain relieving integration, detailed results, in Table 3.

Table 1 matched group and observation group's therapeutic effect contrast

Note: * and matched group be P < 0.05 relatively

Table 2 liang group detumescence integration situation comparison

Note: * and matched group be P < 0.05 relatively

Table 3 liang group pain relieving integration situation comparison

Note: * and matched group be P < 0.05 relatively

As can be seen from the above results, treatment group and matched group comparison, aspect curative effect, detumescence, pain relieving, medicine of the present invention is all better than control drug bone setting tablet.The advantages such as hence one can see that, and the pharmaceutical composition for the treatment of in the present invention fracture, has treatment time short to the treatment of fracture clinically, and detumescence is fast, and analgesic effect onset time is fast.

Specific embodiment

Embodiment 1 Rhizoma Drynariae 150g, Herba speranskiae tuberculatae 150g, Radix Angelicae Sinensis 180g, Cortex Acanthopancis 150g, Cortex Eucommiae 200g, Radix Morindae Officinalis 180g, Colla Corii Asini 120g, Fructus Lycii 120g.

The preparation method of granule of the present invention: get above pharmaceutical composition crude drug and mix, be ground into 10～20 order coarse granules, add 6 times, water, with the continuous 60 ℃ of extractions of microwave assisted extraction methods three times, extract carries out centrifugalize, and it is 1.30～1.35 thick paste that clean immersion is concentrated into relative density, vacuum drying, dried cream powder is broken, then adds amylum pregelatinisatum, sodium carboxymethyl cellulose, mixed 80 mesh sieves, adds suitable quantity of water and granulates, 60 ℃ of drying under reduced pressure, granulate, is distributed into 100 bags, obtains.

Embodiment 2 Rhizoma Drynariae 145g, Herba speranskiae tuberculatae 160g, Radix Angelicae Sinensis 160g, Cortex Acanthopancis 175g, Cortex Eucommiae 205g, Radix Morindae Officinalis 190g, Colla Corii Asini 110g, Fructus Lycii 135g.

The preparation method of capsule of the present invention: get above pharmaceutical composition crude drug and mix, be ground into 10～20 order coarse granules, add 6 times, water, with the continuous 60 ℃ of extractions of microwave assisted extraction methods three times, extract carries out centrifugalize, and it is 1.30～1.35 thick paste that clean immersion is concentrated into relative density, vacuum drying, dried cream powder is broken, incapsulates, and obtains.

Embodiment 3 Rhizoma Drynariae 160g, Herba speranskiae tuberculatae 145g, Radix Angelicae Sinensis 190g, Cortex Acanthopancis 145g, Cortex Eucommiae 185g, Radix Morindae Officinalis 175g, Colla Corii Asini 125g, Fructus Lycii 113g.

The preparation method of tablet of the present invention: get above pharmaceutical composition crude drug and mix, be ground into 10～20 order coarse granules, add 6 times, water, with the continuous 60 ℃ of extractions of microwave assisted extraction methods three times, extract carries out centrifugalize, and it is 1.30～1.35 thick paste that clean immersion is concentrated into relative density, vacuum drying, dried cream powder is broken, add starch, Pulvis Talci and magnesium stearate appropriate, granulate, compacting in flakes, coating, obtains.

Claims

1. a pharmaceutical composition for the treatment of fracture, it is characterized in that according to weight portion meter, the raw material of making this pharmaceutical composition active component is: Rhizoma Drynariae 130-170 part, Herba speranskiae tuberculatae 130-170 part, Radix Angelicae Sinensis part 160-200, Cortex Acanthopancis 130-170 part, Cortex Eucommiae 180-220 part, Radix Morindae Officinalis 160-200 part, Colla Corii Asini 100-140 part, Fructus Lycii 100-140 part.

2. a kind of pharmaceutical composition for the treatment of fracture as claimed in claim 1, it is characterized in that according to weight portion meter, the raw material of making this pharmaceutical composition active component is: 150 parts of Rhizoma Drynariae, 150 parts of Herba speranskiae tuberculataes, 180 parts of Radix Angelicae Sinensis, 150 parts of Cortex Acanthopanciss, 200 parts of the Cortexs Eucommiae, 180 parts of Radix Morindae Officinaliss, 120 parts, Colla Corii Asini, 120 parts of Fructus Lycii.

3. a kind of pharmaceutical composition for the treatment of fracture as claimed in claim 1 or 2, is characterized in that described medicine composition dosage form is hard capsule, tablet, granule.

4. a kind of preparation method for the treatment of the pharmaceutical composition of fracture as claimed in claim 1 or 2, it is characterized in that the method is: get above pharmaceutical composition crude drug and mix, be ground into 10～20 order coarse granules, add 6 times, water, with the continuous 60 ℃ of extractions of microwave assisted extraction methods three times, extract carries out centrifugalize, it is 1.30～1.35 thick paste that clean immersion is concentrated into relative density, vacuum drying, and dried cream powder is broken, add proper auxiliary materials, make corresponding dosage form.

5. a kind of preparation method for the treatment of the pharmaceutical composition of fracture as claimed in claim 2, it is characterized in that the method is: get Rhizoma Drynariae 150g, Herba speranskiae tuberculatae 150g, Radix Angelicae Sinensis 180g, Cortex Acanthopancis 150g, Cortex Eucommiae 200g, Radix Morindae Officinalis 180g, Colla Corii Asini 120g, Fructus Lycii 120g, above crude drug is mixed, be ground into 10～20 order coarse granules, add 6 times, water, with the continuous 60 ℃ of extractions of microwave assisted extraction methods three times, extract carries out centrifugalize, it is 1.30～1.35 thick paste that clean immersion is concentrated into relative density, vacuum drying, dried cream powder is broken, add again amylum pregelatinisatum, sodium carboxymethyl cellulose, mixed 80 mesh sieves, adding suitable quantity of water granulates, 60 ℃ of drying under reduced pressure, granulate, be distributed into 100 bags.