CN1718211A - Traditional Chinese emdicine compounding prepns. for treating fracture - Google Patents

Abstract

A Chinese medicine for treating bone fracture is prepared from 29 Chinese-medicinal materials including acanthopanax bark, safflower, myrrh, red sage root, etc through choosing raw materials, washing baking, pulverizing decocting twice, concentrating, stirring, granulating, vacuum drying, and tabletting.

Description

A kind of compound Chinese medicinal preparation for the treatment of fracture

Technical field

The present invention relates to a kind of compound Chinese medicinal preparation, say so more specifically have invigorate blood circulation, the compound Chinese medicinal preparation of blood stasis dispelling, detumescence, a kind of treatment of arthritis of analgesic, bone injury.

Background technology

The method and the medicine of treatment of arthritis, bone injury are a lot, but how can treat fracture more effective, faster, side effect to human body is little again, this is not only because the composition and the content of each component of medication, the more important thing is pharmaceutical production technology, the composition of same each component of medicine is identical with content, and the different drug effect differences of production technology also are the problems that we study for many years.

Summary of the invention

The purpose of this invention is to provide a kind of compound Chinese medicinal preparation for the treatment of fracture, the medicine therapeutic effect that it is produced is good, and toxic and side effects is little, can effectively improve indexs such as fracture patient serum neutral and alkali phosphatase, bone density, bone biomechanical, osseous tissue morphology.

Technical scheme of the present invention is achieved in that a kind of compound Chinese medicinal preparation for the treatment of fracture of design, it is characterized in that: selected medicine is prepared according to the following steps; Select to decoct medicine → washing → oven dry → thin, coarse powder → decoctions → second time → concentrated → adding extractum stirring → granulation → reduced vacuum drying → granulate → be pressed into tablet;

The described medicine that selects is to get 895 parts medical material by weight, and wherein Rhizoma Bergeniae scopulosae is 50 parts, red 10 parts of strong muscle, 50 parts of Cortex Acanthopanciss, 50 parts of the Cortexs Eucommiae, 5 parts of Rhizoma Panacis Majoris, 5 parts of Rhizoma Iridis Tectori, 25 parts of Cortex Ampelopsis Aconitifoliae Radiciss, 50 parts of Radix Gentianae Macrophyllae, 25 parts of the Radix Aucklandiae, 5 parts of Daphne giraldii Nitsche, 25 parts of Caulis Trachelospermis, 5 parts of Radix Aconitis, 10 parts of Radix chloranthi japonicis, 5 parts of Radix aconiti szechenyiani, 5 parts of Radix Aconiti Kusnezoffii, 10 parts of LAOSHUQI, 25 parts of RHIZOMA POLYGONI SUFFULTI, 25 parts on Flos Carthami, 25 parts of Myrrhas, 25 parts of Rhizoma Tupistrae Chinensis, 50 parts of Rhizoma et radix valerianaes, 10 parts of Herba Lycopodiis, 50 parts of Radix Achyranthis Bidentataes, 75 parts of Radix Salviae Miltiorrhizaes, 25 parts of YANGJIAOQI, 25 parts of Flos Echinopsis latifoliis, 75 parts of Rhizoma Paridis, 25 parts of Olibanums, 125 parts of Radix Angelicae Sinensis;

Described oven dry → thin, coarse powder is with Flos Echinopsis latifolii, the Cortex Eucommiae, Rhizoma Bergeniae scopulosae, strong muscle pellet, Cortex Acanthopancis, Radix Angelicae Sinensis, Rhizoma Panacis Majoris, Rhizoma Iridis Tectori, Radix Gentianae Macrophyllae, the Radix Aucklandiae, Radix Aconiti, Radix aconiti szechenyiani, Radix Aconiti Kusnezoffii, LAOSHUQI, RHIZOMA POLYGONI SUFFULTI, Radix Achyranthis Bidentatae, Rhizoma Paridis, Radix Salviae Miltiorrhizae etc. 18 flavor medical materials are with mobile drinking water washes clean, pull out after washing, with Flos Echinopsis latifolii, Cortex Eucommiae medical material is put reciprocating type medicine cutter, be cut into the segment that is about 2～3cm, send respectively and put the drying chamber drying, bake out temperature is controlled at 58 ℃-62 ℃, dry back is with the Flos Carthami that cleans, Olibanum, Myrrha send clean material chamber, pulverized 80 mesh sieves, get the accurate weighing of fine powder by above-mentioned weight ratio, coarse powder is handed over abstraction process;

Decoct described decoction → second time → concentrate, be with Daphne giraldii Nitsche, Rhizoma Tupistrae Chinensis, Radix chloranthi japonici, Cortex Ampelopsis Aconitifoliae Radicis, YANGJIAOQI, Caulis Trachelospermi, Rhizoma et radix valerianae is after Herba Lycopodii is rinsed well, getting above-mentioned weight ratio cuts into 3～4cm and puts in the multi-function extractor with the coarse powder of pulverizing medical material, decoct for the first time amount of water and be 9 times of medical material, soaks and begin decoction after 30 minutes, when being heated to 100 ℃, pick up counting, after little the boiling 2 hours, emit medicinal liquid, put in the fluid reservoir from the feed opening filtration; Decoct for the second time, amount of water is 9 times of amounts of medical material, is heated to 100 ℃, after little the boiling 2 hours, extracts medicinal liquid out, merges with the medicinal liquid that decocts for the first time; In the decompression of the decoction liquor suction after merging triple effect concentration tank, be decompressed to 0.03-0.08MPa, temperature remains on 60-80 ℃, and being concentrated into relative density is 1.20, the extractum that temperature to 60 is ℃-70 ℃;

Described adding extractum stirring → granulation → reduced vacuum drying → granulate → compacting is in blocks, is the medicated powder of recipe quantity to be put slowly add the extractum stirring in the trough type mixing machine, after stirring, granulate, evenly be laid in the rustless steel charging tray, lay thickness is no more than 2cm and sends into reduced vacuum exsiccator drying with dish, temperature 60-80 ℃, 2～3 hours time, turned over once in 30 minutes, moisture content is controlled in the 4-7% scope, after cooling, granulate, compacting is in flakes, every 0.3 gram of specification, promptly.

The present invention compared with the prior art, its outstanding characteristics are: the strict control of its production technology temperature, pressure, concentrate density and time, so reduce toxic and side effects, patient is easy to accept, and production cost is low; Promote that union of fracture is effective; Rheumatic arthritis there is good therapeutical effect.

The specific embodiment

Embodiment 1 produces according to the following steps:

1, get it filled 895kg, wherein content: Rhizoma Bergeniae scopulosae 50kg; The red 10kg of strong muscle; Cortex Acanthopancis 50kg; Cortex Eucommiae 50kg; Rhizoma Panacis Majoris 5kg; Rhizoma Iridis Tectori 5kg; Cortex Ampelopsis Aconitifoliae Radicis 25kg; Radix Gentianae Macrophyllae 50kg; Radix Aucklandiae 25kg; Daphne giraldii Nitsche 5kg; Caulis Trachelospermi 25kg; Radix Aconiti 5kg; Radix chloranthi japonici 10kg; Radix aconiti szechenyiani 5kg; Radix Aconiti Kusnezoffii 5kg; LAOSHUQI 10kg; RHIZOMA POLYGONI SUFFULTI 25kg; Flos Carthami 25kg; Myrrha 25kg; Rhizoma Tupistrae Chinensis 25kg; Rhizoma et radix valerianae 50kg; Herba Lycopodii 10kg; Radix Achyranthis Bidentatae 50kg; Radix Salviae Miltiorrhizae 75kg; YANGJIAOQI 25kg; Flos Echinopsis latifolii 25kg; Rhizoma Paridis 75kg; Olibanum 25kg; Radix Angelicae Sinensis 125kg.

The above-mentioned medicine of getting needs conformance with standard, (meet 2000 editions " Chinese pharmacopoeia one ministerial standard regulation) Cortex Acanthopancis, the Cortex Eucommiae, the Radix Aucklandiae, Radix Aconiti Kusnezoffii, Radix Aconiti, Flos Carthami, Radix Salviae Miltiorrhizae, Rhizoma Paridis, Radix Angelicae Sinensis, Herba Lycopodii, Rhizoma Panacis Majoris, trachelospermum jasminoide are risen, Radix Gentianae Macrophyllae, Radix Achyranthis Bidentatae 14 flavor crude drugs, meet " Daphne giraldii Nitsche, RHIZOMA POLYGONI SUFFULTI, Olibanum, the Myrrha of in 1977 version one ministerial standard of Chinese pharmacopoeia; Wherein Rhizoma et radix valerianae, strong muscle Pan Dan, Cortex Ampelopsis Aconitifoliae Radicis, Radix chloranthi japonici, LAOSHUQI, ferrum give that hammer, bamboo limit seven, Flos Echinopsis latifolii, Rhizoma Iridis Tectori, Rhizoma Bergeniae scopulosae be to name by provincial standard.

2, method for making: above 29 flavors, remove Daphne giraldii Nitsche, Rhizoma Tupistrae Chinensis, Radix chloranthi japonici, Cortex Ampelopsis Aconitifoliae Radicis, YANGJIAOQI, Caulis Trachelospermi, Rhizoma et radix valerianae, outside the Herba Lycopodii, all the other 20 are ground into fine powder to 80 mesh sieve simply, and mixing, coarse powder (must not be less than 160kg) decoct with water twice together with eight flavor medicines such as Daphne giraldii Nitsche, add the water, each 2 hours of 9 times of amounts of medical material at every turn, filter, filtrate merges, and being condensed into relative density is the extractum of 1.20 (60 ℃), with above-mentioned fine powder 539kg mixing, drying is made tablet promptly.

3,18 flavor medical materials such as the Flos Echinopsis latifolii that need pulverize, the Cortex Eucommiae, Rhizoma Bergeniae scopulosae, strong muscle pellet, Cortex Acanthopancis, Radix Angelicae Sinensis, Rhizoma Panacis Majoris, Rhizoma Iridis Tectori, Radix Gentianae Macrophyllae, the Radix Aucklandiae, Radix Aconiti, Radix aconiti szechenyiani, Radix Aconiti Kusnezoffii, LAOSHUQI, RHIZOMA POLYGONI SUFFULTI, Radix Achyranthis Bidentatae, Rhizoma Paridis, Radix Salviae Miltiorrhizae are pulled out after washing with mobile drinking water washes clean.Flos Echinopsis latifolii, Cortex Eucommiae medical material are put reciprocating type medicine cutter, be cut into the segment that is about 3cm, send respectively and put the drying chamber drying, bake out temperature is controlled at 60 ℃ of the bests, and temperature is too high, and the drug effect that has will lose, cross the low purpose of oven dry that do not reach, therefore will be controlled at 60 ℃, upper and lower temperature difference is at ± 2 ℃, and clean material chamber is sent with the Flos Carthami, Olibanum, the Myrrha that clean in dry back, press the accurate weighing of recipe quantity, crushing screening takes by weighing the fine powder of recipe quantity, and coarse powder is handed over abstraction process.

4, press Daphne giraldii Nitsche, Rhizoma Tupistrae Chinensis, Radix chloranthi japonici, Cortex Ampelopsis Aconitifoliae Radicis, YANGJIAOQI, Caulis Trachelospermi, Rhizoma et radix valerianae, after Herba Lycopodii is rinsed well, cutting into 3cm puts in the multi-function extractor with the coarse powder of pulverizing medical material, decoct for the first time amount of water and be 9 times of medical material, soaks and begin decoction after 30 minutes, when being heated to 100 ℃, pick up counting, after little the boiling 2 hours.Emit medicinal liquid from the feed opening filtration, put in the fluid reservoir; Decoct for the second time, amount of water is 9 times of amounts of medical material, is heated to 100 ℃, after little the boiling 2 hours, extracts medicinal liquid out, merges with the medicinal liquid that decocts for the first time.In the decoction liquor suction decompression triple effect concentration tank after merging, decompression 0.05MPa, 70 ℃, being concentrated into relative density is the extractum of 1.20 (65 ℃).

5, the medicated powder of above-mentioned amount is put slowly added extractum in the trough type mixing machine and stir, after stirring, granulate, evenly be laid in the rustless steel charging tray, lay thickness is no more than 2cm and sends into reduced vacuum exsiccator drying, 70 ℃ of temperature, 2～3 hours time (turning over once in 30 minutes) with dish, moisture content is controlled in the 4-7% scope, after cooling, granulate is pressed into tablet, every 0.3 gram of specification, promptly.

The present invention tests as follows:

The long term toxicity test report

The compound Chinese medicinal preparation of this treatment fracture that the present invention is produced, do long term toxicity test, administration time is more than 2 times of clinical course of treatment, by clinical consumption per day 3.0g/kg (50 times), (1.8g/kg 30 times), 0.9g/kg (15 times) three months dosage has carried out 60 days gastric infusions of rat, establishes negative control group (water) simultaneously.Irritate stomach every day once, continuous 6 times, intermittently one day, observe administration group and control rats diet, general situation such as hair color and activity, per two weeks claim a body weight, to adjust dosage.Yu Weici gives respectively to organize on an empty stomach after 24 hours and puts to death 12 rats, gets blood and carries out 5 of hematologys and coagulation time test; Separation of serum carries out 10 biochemical indicators mensuration and 13 internal organs are weighed, and calculates dirty body ratio, and 18 internal organs are made histopathological examination.All the other every group 8 rats stop administration, observe 2 all backs and handle with the same manner, check above-mentioned every index.Learn by statistics and handle, each dosage of administration group and negative control group compare, difference that there are no significant substantially.The result of above-mentioned every index confirms that tablet of the present invention is not seen tangible toxic reaction through rat continuous irrigation stomach two months and the observation after 2 weeks of drug withdrawal.

The acute toxicity testing report

Observe the toxic reaction of a gastric infusion of medicine of the present invention, select ICR strain white mice, be born 45-60 days, body weight 18-22g, male and female half and half, provide by Xian Medical Univ's animal center, the animal quality certification number: No. 05, the moving word in Shaanxi; porphyrize is put into the band graduated vessels after getting 24 of medicines of the present invention and removing sugar-coat; add water to 15ml, stir, and is standby.Only get hungry 12 hours ICR white mice 18-22g8, be divided into two groups, 4 every group, irritate stomach for first group and give gastric infusion of 48% solution, 0.4% solution 0.4ml/10g, under experiment condition, normally raise; Observed 7 days continuously, during drinking water normal, hair luster, the behavioral activity no abnormality seen, none is only dead in the experiment operation.Experiment mice dislocation place row carry out gross necropsy after 7 days, do not see that main organs has color, form and pathological change.Tablet of the present invention as a result greater than 19.2g/kg, is equivalent to more than 320 times of the clinical consumption per day of people through gastric infusion maximum tolerated dose of mice.

Main pharmacodynamics test of the present invention

Test objective: medicine of the present invention, have invigorate blood circulation, effects such as blood stasis dispelling, detumescence, pain relieving, clinical treatment rheumatic arthritis, the fracture of being mainly used in.In order to study the pharmacological experiment foundation that the present invention treats bone injury and inflammation, carried out the rat experiment fracture model, inflammatory model, to rat assist agent arthritis, the rat granuloma forms, rat paw edema degree, rabbit abdominal cavity blood stasis model and analgesic experiment.

Select animal: ICR strain white mice, the certification of fitness are 08-004; The SD strain rat quality certification is 08-005; New Zealand's strain rabbit certification of fitness is 08-018 respectively, and animal and feedstuff are provided by Xi'an Communications University's Experimental Animal Center.

Selected the weight of animals and sex: white mice 18-22g; Rat 150-200g; Rabbit 1.8-2.2kg. male and female dual-purpose.

Every group of 10-12 of the big white mice of each treated animal number, 6 every group of rabbit.

Experimental temperature, humidity: room temperature 20-23 ℃, relative humidity 45%-65%.

Medicine:

Above-mentioned every result of the test is found, tablet jar stomach of the present invention administration can improve indexs such as the clear neutral and alkali phosphatase of rat fracture bleeding from anus, bone density, bone biomechanical, osseous tissue morphology, the present invention is described to the rat assist agent arthritis model, granulomatous formation of rat and rat paw edema degree have certain inhibitory action; Can promote the absorption of rabbit blood stasis piece; The mice pain that chemical stimulation is caused has analgesic activity.Main pharmacodynamics studies show that medicine of the present invention has the union of fracture of promotion effect to experimental fracture, acute and chronic inflammation is had certain antiinflammatory and detumescence effect, and have blood stasis dispelling and analgesic activity.Medicament main pharmacodynamics test of the present invention treats acute and chronic trauma for clinical practice and inflammation provides the pharmacological evaluation foundation.

Claims (1)

1, a kind of compound Chinese medicinal preparation for the treatment of fracture is characterized in that: selected medicine is prepared according to the following steps; Select to decoct medicine → washing → oven dry → thin, coarse powder → decoctions → second time → concentrated → adding extractum stirring → granulation → reduced vacuum drying → granulate → be pressed into tablet;

The described medicine that selects is to get 895 parts medical material by weight, and wherein Rhizoma Bergeniae scopulosae is 50 parts, red 10 parts of strong muscle, 50 parts of Cortex Acanthopanciss, 50 parts of the Cortexs Eucommiae, 5 parts of Rhizoma Panacis Majoris, 5 parts of Rhizoma Iridis Tectori, 25 parts of Cortex Ampelopsis Aconitifoliae Radiciss, 50 parts of Radix Gentianae Macrophyllae, 25 parts of the Radix Aucklandiae, 5 parts of Daphne giraldii Nitsche, 25 parts of Caulis Trachelospermis, 5 parts of Radix Aconitis, 10 parts of Radix chloranthi japonicis, 5 parts of Radix aconiti szechenyiani, 5 parts of Radix Aconiti Kusnezoffii, 10 parts of LAOSHUQI, 25 parts of RHIZOMA POLYGONI SUFFULTI, 25 parts on Flos Carthami, 25 parts of Myrrhas, 25 parts of Rhizoma Tupistrae Chinensis, 50 parts of Rhizoma et radix valerianaes, 10 parts of Herba Lycopodiis, 50 parts of Radix Achyranthis Bidentataes, 75 parts of Radix Salviae Miltiorrhizaes, 25 parts of YANGJIAOQI, 25 parts of Flos Echinopsis latifoliis, 75 parts of Rhizoma Paridis, 25 parts of Olibanums, 125 parts of Radix Angelicae Sinensis;

Described oven dry → thin, coarse powder is with Flos Echinopsis latifolii, the Cortex Eucommiae, Rhizoma Bergeniae scopulosae, strong muscle pellet, Cortex Acanthopancis, Radix Angelicae Sinensis, Rhizoma Panacis Majoris, Rhizoma Iridis Tectori, Radix Gentianae Macrophyllae, the Radix Aucklandiae, Radix Aconiti, Radix aconiti szechenyiani, Radix Aconiti Kusnezoffii, LAOSHUQI, RHIZOMA POLYGONI SUFFULTI, Radix Achyranthis Bidentatae, Rhizoma Paridis, Radix Salviae Miltiorrhizae etc. 18 flavor medical materials are with mobile drinking water washes clean, pull out after washing, with Flos Echinopsis latifolii, Cortex Eucommiae medical material is put reciprocating type medicine cutter, be cut into the segment that is about 2～3cm, send respectively and put the drying chamber drying, bake out temperature is controlled at 58 ℃-62 ℃, dry back is with the Flos Carthami that cleans, Olibanum, Myrrha send clean material chamber, pulverized 80 mesh sieves, get the accurate weighing of fine powder by above-mentioned weight ratio, coarse powder is handed over abstraction process;

Decoct described decoction → second time → concentrate, be with Daphne giraldii Nitsche, Rhizoma Tupistrae Chinensis, Radix chloranthi japonici, Cortex Ampelopsis Aconitifoliae Radicis, YANGJIAOQI, Caulis Trachelospermi, Rhizoma et radix valerianae is after Herba Lycopodii is rinsed well, getting above-mentioned weight ratio cuts into 3～4cm and puts in the multi-function extractor with the coarse powder of pulverizing medical material, decoct for the first time amount of water and be 9 times of medical material, soaks and begin decoction after 30 minutes, when being heated to 100 ℃, pick up counting, after little the boiling 2 hours, emit medicinal liquid, put in the fluid reservoir from the feed opening filtration; Decoct for the second time, amount of water is 9 times of amounts of medical material, is heated to 100 ℃, after little the boiling 2 hours, extracts medicinal liquid out, merges with the medicinal liquid that decocts for the first time; In the decompression of the decoction liquor suction after merging triple effect concentration tank, be decompressed to 0.03-0.08MPa, temperature remains on 60-80 ℃, and being concentrated into relative density is 1.20, the extractum that temperature to 60 is ℃-70 ℃;

Described adding extractum stirring → granulation → reduced vacuum drying → granulate → compacting is in blocks, is the medicated powder of recipe quantity to be put slowly add the extractum stirring in the trough type mixing machine, after stirring, granulate, evenly be laid in the rustless steel charging tray, lay thickness is no more than 2cm and sends into reduced vacuum exsiccator drying with dish, temperature 60-80 ℃, 2～3 hours time, turned over once in 30 minutes, moisture content is controlled in the 4-7% scope, after cooling, granulate, compacting is in flakes, every 0.3 gram of specification, promptly.