CN102727697B - Traditional Chinese medicine composition for treating bone fracture, preparation method and mass detection method of traditional Chinese medicine composition - Google Patents

Abstract

The invention discloses a traditional Chinese medicine composition for treating bone fracture, which is prepared from the following components: Resina Draconis, dipsacus asperoids, Cortex Acanthopanacis, Panax notoginseng, Muskmelon Seeds, Ligusticum chuanxiong, Pyrite, lignum sappan, lumbricus, Radix Angelicae dahuricae and Radix Glycyrrhizae. A preparation method of the traditional Chinese medicine composition comprises the steps of grinding three components into fine powder for further use, such as Panax notoginseng, Radix Angelicae dahuricae (half dose) and Pyrite; grinding the rest of eight components into fine powder, such as dipsacus asperoids, Cortex Acanthopanacis, Ligusticum chuanxiong, Muskmelon Seeds, lignum sappan, Radix Angelicae dahuricae (half dose) and Radix Glycyrrhizae, adding water to decoct, filtrating, mixing the filtrate, and decompressing and condensing to obtain a thick paste; adding three components into fine powder, such as Panax notoginseng, Radix Angelicae dahuricae (half dose) and Pyrite, drying, grinding, uniformly mixing with Resina Draconis fine powder by an incremental method, feeding into the capsules, and obtaining the traditional Chinese medicine composition. A mass detection method of the traditional Chinese medicine composition comprises an identification item for dipsacus asperoids, Panax notoginseng and Radix Glycyrrhizae, a check item and a detection item for the extracts. The prescription has the effects of promoting blood circulation to arrest pain, tonifying kidney and setting fracture and transforming stasis and dispersing swelling, and also has the definite treating effects for the fracture, soft tissue injury, cervical spondylosis and hernia of intervertebral discs and the like.

Description

A kind of Chinese medicine composition for the treatment of bone injury diseases, its preparation method and quality determining method

Technical field

The present invention relates to a kind of Chinese medicine composition (" Gukang capsule of invigorating blood circulation ") for the treatment of bone injury diseases, specifically a kind of Chinese medicine composition that is used for the treatment of fracture, soft tissue injury, prolapse of lumbar intervertebral disc, hyperosteogeny and cervical spondylosis.The invention still further relates to this Chinese medicine composition preparation method and quality determining method.

Background technology

Orthopedics of Chinese Medicine is medical science applied ingredient, it is a subject of setting forth the control injury of human, be the superfine product precious deposits in motherland's medical treasure-house, it is with a long history, for the Chinese nation multiply and be prosperous and indelible outstanding contribution has been made in the development of world medicine.Motherland's medical science thinks that the mansion that bone is strange perseverance, its Main Function are to support human body, protection internal organs, " a Ling Shu Miraculous Pivot or Divine Axis passages through which vital energy circulates piece of writing ": " bone is for dry "." a Plain Questions flaccidity opinion piece of writing " said: " the kidney being in charge of bone and marrow "; Add: " bone person fu-viscera of marrow, can not standing for a long time, tottering while walking, bones being about to exhaust." the brief effect of having pointed out bone, be not only the trunk of health, also built-in marrow, relevant to kidney qi.Kidney storing essence, essence is given birth to marrow, marrow nourishing bone, the person's kidney that closes the bone also, therefore kidney qi whether fill the growth that directly affects bone, healthy and strong and regeneration, if deficiency of kidney-QI, bone marrow need not, bone injury is difficult to heal.Otherwise the damaged bone wound, also can involve kidney, cause kidney qi and cut down, therefore " Plain Questions vital QI of the body connecting with natural QI opinion: " Gu and, powerful, kidney qi is wound, processus styloideus radii is bad." human body is a unified integral body, skin and flesh muscles and bones, qi-blood-body fluid, internal organs meridians interknit, mutual dependence for existence.The internal organs stalwartness, meridians are unobstructed, the body fluid Metabolism of Normal, QI and blood is vigorous, YIN and YANG balancing, skin and flesh enjoys excellent health.The internal organs loss, meridians are not smooth, the body fluid metabolism disorder, QI and blood is inconsiderate, imbalance of YIN and YANG, the skin and flesh cervical carcinoma with cachexia, a little less than muscles and bones is withered.Therefore the external force damage, more can make skin and flesh muscles and bones impaired, and often cause the disorder of internal organs, meridians, QI and blood, thereby produce a series of inside and outside symptoms.As Lu Shidao, in " roman class will ", say: " limbs damage in outside, QI and blood is hindered in interior, battalion defends does not to some extent pass through, internal organs by discord, can pure maneuver, and the arteries and veins of not asking reason is examined its deficiency and excess, to execute reinforcing and reducing?." clear and definite wound and interior damage, the substantial connection between part and integral body of having indicated.Therefore, to the understanding of orthopedics department pathogenesis, must the physiological and pathological relation of various tissues be studied from organic conception, could be familiar with the essence of bone injury disease and the mutual relation of pathological change.

In the process of disease, healthy energy and pathogen are constantly waged a struggle, its result or just winning heresy and moving back, and disease takes a favorable turn and fully recovers; Or, for evil victory is just declining, disease becomes to worsening and death, if the good and evil struggle is evenly matched, just there will be locked situation.For the patient of fracture, bone does not connect is continuous, and cereal nutrient can't transport, the damage QI and blood, move not smooth, the congestion internal resistance, blockage of main and collateral channels, essence of water and grain is compress normally, skeleton muscles can not get moistening foster, ascending, descending, exiting and entering is out-of-sequence.If now healthy energy is filled Sheng, anti-heresy is strong, gets rid of evils and goes out, and treats properly, and fracture obtains correct reduction and fixes, and knochenbruch is continued, and congestion is dissipated, and meridians are adjusted smooth, and pathogen is difficult to development.If healthy energy has been defeated pathogen fully, pathogenic factor disappears or stops the effect of human body, and fracture is healing rapidly, internal organs QI and blood functional rehabilitation, and disease can be fully recovered.Otherwise patient's condition increasingly worsens and aggravates.

The Therapeutic Principle of orthopedic disease formulates under organic conception and the guidance of determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs essence spirit, and this rule for the treatment of has general directive significance and treatment rule to clinical treatment.

At present, there is no the Chinese drugs agentia of desirable treating bone injury diseases.

Summary of the invention

The objective of the invention is, for overcoming above-mentioned the deficiencies in the prior art, provides a kind of Chinese medicine composition, its preparation method and quality determining method for the treatment of bone injury diseases.

For achieving the above object, the present invention adopts following technical proposals:

A kind of Chinese medicine composition for the treatment of bone injury diseases, it is the medicament of being made by the raw material of Chinese medicine with following weight proportion:

Preferably, wherein the weight proportion of each raw material is:

Said medicament is capsule.

Prescription compatibility of medicines in this Chinese medicine composition by monarch, minister, help, make to analyze: Sanguis Draxonis promoting blood circulation to remove blood stasis pain relieving in side, be most commonly used to traumatic injury, the swelling and pain due to blood stasis of tendon breaking fracture, be that orthopedics department is commonly used key medicine.Therefore can treat main disease, eliminate primary symptom, be we's commander, be to be monarch drug." detailed outline " Yan Qineng: " all pains of dissipating blood stasis blood." meaning again: " though the main disorders of blood of Olibanum Myrrha, and doublely enter edema caused by disorder of QI, this specially enters blood system." the sweet and tepor of Radix Dipsaci, can liver and kidney tonifying, hardship is let out hot loose, the blood vessels that can pass through, activating collaterals to relieve pain has benefit and can declare, and goes and the characteristic of not letting out; " herbal classic ": " tonifying for the deficiency ... folding wound, reuniting the fractured tendons and bones." the Cortex Acanthopancis acrid, bitter, warm.Enter the Liver and kidney warp.The energy bone and muscle strengthening; " not Lu ": " ... invigorating middle warmer benefit essence, hard muscles and bones." Radix Notoginseng sweetness and bitterness and temperature, its function is broadly divided into blood stasis dispelling, detumescence, hemostasis, pain relieving, is usually used in traumatic injury; forefathers have meaning: " Radix Notoginseng simply, can be for the Xiayuxue Tang, Decoction for Dischanging Blood clots of " gold is deficient ", and particularly also safe with Xiayuxue Tang, Decoction for Dischanging Blood clots; " to the merit of its blood stasis dispelling, very have an high regard for." detailed outline ": " hemostasis, loose blood, analgesic therapy.Gold sword arrow wound, fall and flutter flogging injury." Semen Melo is sweet cold, is longer than blood circulation promoting and blood stasis dispelling, for traumatology fracture product commonly used, in the synthetism folk prescription, takes it more.The hot Wen Xiang of Rhizoma Chuanxiong alters, and walks and does not keep, and can go up wardrobe to run, and assigns the sea of blood, outer thorough fur, and bypass four ends, be the gas medicine in blood.Therefore the effects such as blood-activating and qi-promoting pain relieving are arranged.Good medicine for promoting blood circulation and stopping pain.Pyritum acrid in the mouth gas is flat, enters blood blood, the blood and relieving pain that can fall apart, reunion of bone, " Kaibao Bencao ": " treat the folding wound, loose blood and relieving pain." above Six-element: Radix Dipsaci, the invigorating the liver and kidney of Cortex Acanthopancis energy principal drug assistance, promoting blood circulation, reuniting the fractured tendons and bones, treat the folding wound; Radix Notoginseng, Semen Melo, Rhizoma Chuanxiong, Pyritum, principal drug assistance blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, reunion of bone, be ministerial drug altogether; Lignum Sappan is salty can enter blood, and suffering can be wandered away, the function blood circulation promoting and blood stasis dispelling, and reducing swelling and alleviating pain, be the principal agent of traumatology; Pheretima is salty, cold, enters liver, kidney channel.Can promoting blood circulation to remove obstruction in the collateral.Radix Angelicae Dahuricae wind-expelling pain-stopping, removing toxic substances.Compendium of Material Medica: " hot temperature fragrance, wind-expelling pain-stopping removing toxic substances and promoting subsidence of swelling.... ... .. snakebite, cutter arrow incised wound." upper three medicines are invigorated blood circulation, dredging collateral, pain relieving.Can treat the disease of holding concurrently by principal drug assistance, be adjuvant drug altogether.The Radix Glycyrrhizae sweet in the mouth, enter 12 warps, can relieving spasm to stop pain." herbal classic ": " main vital organs of the human body cold and heat pathogen, hard muscles and bones, longue meat, times strength, incised wound is swollen, removing toxic substances." the Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, priming is returned through being for making medicine; Rhizoma Chuanxiong is sensible up and down, penetrating meridians, the also double use that makes medicine; Two medicines share and more can guide all medicines thoroughly to reach meridians, through sick institute.All medicines share the drug effect complementation, play altogether the merit of promoting blood circulation and stopping pain, the kidney invigorating symplectic bone, blood stasis dispersing and deswelling.Blood stasis is dispelled, and fresh blood is given birth to, and internal organs are flat, and QI and blood is multiple, and negative and positive are secret, and channels is unobstructed, and Liver and kidney must be mended, and muscles and bones must continue, and all diseases are from removing.

The preparation method of the Chinese medicine composition for the treatment of bone injury diseases in the present invention, step is as follows:

(1) the write out a prescription pulverizing of each medicine: take the Sanguis Draxonis of expense in the prescription ratio, be ground into fine powder, standby; Take Radix Notoginseng, the Pyritum of expense and partly measure the Radix Angelicae Dahuricae 3 flavors in the prescription ratio, pulverize as fine powder, standby;

(2) extraction of decocting medicine: in the prescription ratio, take Radix Dipsaci, Cortex Acanthopancis, Pheretima, Rhizoma Chuanxiong, Semen Melo, Lignum Sappan, the Radix Glycyrrhizae of expense and partly measure the Radix Angelicae Dahuricae 8 flavors, decoct with water 1-3 time, filter merging filtrate, be evaporated to relative density 1.25-1.30(50 ℃) thick paste, standby;

(3) mixing of medicine and drying: Radix Notoginseng, the Radix Angelicae Dahuricae, Pyritum 3 herbal medicine fine powders in step (1) are added in the extractum of extraction, mix, put 65-70 ℃ of vacuum drying, pulverize, standby;

(4) packing of medicine: above mixed powder is mixed with incremental method and fine powder of dragons blood, and packing, obtain.

Preparation method according to claim 4, is characterized in that, in step (2), decocts with water 2 times, wherein for adding 8 times of water gagings, decocts 2 hours for the 1st time, filters, and adds 6 times of water gagings for medicinal residues the 2nd time again, and the same decoction 1.5 hours, filter, and merges filtrate twice.

In the present invention, the quality determining method of the Chinese medicine composition for the treatment of bone injury diseases is, it comprises the mensuration project to discriminating project, inspection item and the extractum of Radix Dipsaci, Radix Notoginseng, Radix Glycyrrhizae, the described discriminating to Radix Dipsaci is to take the Radix Dipsaci control medicinal material to launch take on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is binding agent as contrast, the volume ratio of the take n-butyl alcohol-Acetic Acid-Water that is 4:1:5 as developing solvent, the tlc identification method that 10% ethanol solution of sulfuric acid of take is developer; The described discriminating to Radix Notoginseng is to take the Radix Notoginseng control medicinal material to launch take on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is adhesive as contrast, the volume ratio of the take chloroform-ethyl acetate-methanol-water that is 15:40:22:10 as developing solvent, the tlc identification method that 10% ethanol solution of sulfuric acid of take is developer; The described discriminating to Radix Glycyrrhizae is to take the licorice medicinal materials powder to launch, take 10% ethanol solution of sulfuric acid as at developer the tlc identification method that develops the color as contrast, the volume ratio of the take ethyl acetate-formic acid-glacial acetic acid-water that is 15:1:2:2 as developing solvent take on the silica gel g thin-layer plate that the 1%NaOH sodium carboxymethyl cellulose is adhesive under uviol lamp.

The described discriminating to Radix Dipsaci is specifically:

Get this medicament content 3g, put in apparatus,Soxhlet's, add chloroform 100ml, reflux 2 hours, take out, dry, put again in apparatus,Soxhlet's, add methanol 100ml, reflux 3 hours, the extracting solution evaporate to dryness, residue adds water 40ml, slight fever makes to dissolve, with water saturated n-butanol extraction 2 times, each 30ml, merge n-butyl alcohol liquid, with 2% sodium hydroxide solution washing 2 times, each 30ml, alkali liquor discards, n-butyl alcohol liquid is used the water washing 3 times that n-butyl alcohol is saturated again, each 30ml, cleaning mixture discards, n-butyl alcohol liquid evaporate to dryness, residue adds methanol 2ml to be made to dissolve, as need testing solution,

Separately get Radix Dipsaci control medicinal material 0.2g, add methanol 15ml, reflux, extract, 30 minutes, let cool, filter, and the filtrate evaporate to dryness, residue adds methanol 2ml to be made to dissolve, in contrast medical material solution;

According to thin layer chromatography (" appendix VI B of Chinese Pharmacopoeia 2005 version) test, draw each 3 μ l of above-mentioned 2 kinds of solution, put respectively in same and take on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is binding agent, the upper solution of n-butyl alcohol-Acetic Acid-Water (4:1:5) of take is developing solvent, launch, take out, dry, spray, with 10% ethanol solution of sulfuric acid, is heated to the speckle colour developing clear.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the principal spot of aobvious same color.

The described discriminating to Radix Notoginseng is specifically:

Get this medicament content 3g, put in apparatus,Soxhlet's, add chloroform 100ml, reflux 2 hours, take out, dry, put again in apparatus,Soxhlet's, add methanol 100ml, reflux 3 hours, the extracting solution evaporate to dryness, residue adds water 40ml, slight fever makes to dissolve, with water saturated n-butanol extraction 2 times, each 30ml, merge n-butyl alcohol liquid, with 2% sodium hydroxide solution washing 2 times, each 30ml, alkali liquor discards, n-butyl alcohol liquid is used the water washing 3 times that n-butyl alcohol is saturated again, each 30ml, cleaning mixture discards, n-butyl alcohol liquid evaporate to dryness, residue adds methanol 2ml to be made to dissolve, as need testing solution,

Get Radix Notoginseng control medicinal material 0.5g, add methanol 15ml, reflux, extract, 30 minutes, let cool, filter, and the filtrate evaporate to dryness, residue adds methanol 2ml to be made to dissolve, in contrast medical material solution.

According to thin layer chromatography (" appendix VI B of Chinese Pharmacopoeia 2005 version) test, draw each 3 μ l of above-mentioned need testing solution and above-mentioned control medicinal material solution, put respectively in same and take on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is adhesive, lower floor's solution that the chloroform-ethyl acetate-methanol-water (15:40:22:10) of take is placed below 10 ℃ is developing solvent, launch, take out, dry, spray, with 10% ethanol solution of sulfuric acid, is heated to the speckle colour developing at 105 ℃ clear.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the principal spot of aobvious same color.

The described discriminating to Radix Glycyrrhizae is specifically:

Get this product content 3g, add water-saturated n-butanol 30ml, soak 30 minutes, ultrasonic 15 minutes, filter, filtrate is extracted 2 times with ammonia solution, and each 10ml, merge ammonia solution, adjust pH value 1～2 with dilute hydrochloric acid, use ether extraction 2 times, each 20ml, discard ether solution, water liquid is used the water saturation n-butanol extraction 2 times again, each 20ml, merge n-butyl alcohol liquid, with n-butyl alcohol, saturated water washing is 2 times, each 40ml, get n-butyl alcohol liquid water bath method, residue adds methanol 2ml to be made to dissolve, as need testing solution;

Another extracting liquorice medicinal powder 0.5g, be made in the same way of control medicinal material solution;

According to thin layer chromatography (" appendix VI B of Chinese Pharmacopoeia 2005 version) test, draw each 3 μ l of above-mentioned two kinds of solution, put respectively in same and take on the silica gel g thin-layer plate that the 1%NaOH sodium carboxymethyl cellulose is adhesive, ethyl acetate-formic acid-glacial acetic acid-the water (15:1:2:2) of take is developing solvent, launches, and takes out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ to be heated to the speckle colour developing clear, puts immediately under ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the fluorescence principal spot of aobvious same color.

Described inspection should meet " pertinent regulations under Chinese Pharmacopoeia 2005 version First appendix capsule item.

The mensuration of described extractum: get this medicament content 4 g, accurately weighed, according to the hot dipping under ethanol-soluble extractives algoscopy item, measure, make solvent with 85% ethanol, must not be less than 30.0%.

This quality determining method adopts thin layer chromatography to carry out the thin layer discriminating to the Radix Dipsaci in preparation, Radix Notoginseng and Radix Glycyrrhizae, and result all can significantly identify the existence of above 3 herbal medicines.Adopt the ethanol-soluble extractives algoscopy, take 85% ethanol as solvent, the ethanol-soluble extractives in preparation is measured, and, according to the measured data of 10 batch sample determinations of extractives, worked out the content limit of preparation ethanol-soluble extractives.The quality standard research results such as mensuration of above discriminating and ethanol-soluble extractives show, this preparing process has fully retained effective ingredient and the main component of each medicine of writing out a prescription, through the quality inspection to many batches of pilot scale preparation samples, the quality of the pharmaceutical preparations all meets appended " quality standard " and " pertinent regulations of Chinese pharmacopoeia to medicine sanitary standard, the quality of the pharmaceutical preparations is stable, and this shows that the preparing process of this preparation is scientific and reasonable.

Invigorate blood circulation research data and the documents and materials of Gukang capsule preparing process

One, the pre-treatment of medicine:

(1) Radix Dipsaci, Cortex Acanthopancis, Pheretima, Rhizoma Chuanxiong, Lignum Sappan, Semen Melo, Radix Glycyrrhizae 7 flavors are pharmaceutical decocting piece, after choosing the removal of impurity, in the prescription ratio, take expense, standby for decocting.

(2) Radix Notoginseng, the Radix Angelicae Dahuricae (half amount), Pyritum 3 flavors, take expense in the prescription ratio, after co-grinding, standby.

(3) Sanguis Draxonis is valuable drug, in the prescription ratio, takes expense, after pulverizing separately, standby.

Two, preparation technology's research data:

(1) determining of dosage form:

In view of this medicine is the medicine that is used for the treatment of the bone diseases such as fracture, soft tissue injury, cervical and lumbar diseases, need the long period to take, observe according to clinical medication experience handed down from one's ancestors and long term clinical results, choose and take, carry, transport all capsule very easily, as the dosage form of this medicine.By the preparation of test agent in three batches, it is suitable showing to adopt this recipe quantity and preparing process thereof to prepare capsule.Its dose is each 4～6, and 3 times on the one, within 1st, taking the capsule total amount is 12～18.

The preparation result of test agent in (two) three batches: adopt formula and technique in embodiment 1 to prepare altogether test agent in 10 batches, wherein quality standard, stability test investigation and censorship are checked each 3 batches, sample and separately join 1 batch.Now will for the preparation result of three batches of pilot scale capsule samples of quality standard research converge combine as follows.

1, the pulverizing of Sanguis Draxonis: take 10 times of recipe quantity Sanguis Draxonis in the prescription ratio, by above-mentioned technique, be crushed into fine powder, sieve, test agent is pulverized in three batches must measure and yield in Table 1.

The pulverizing result of Sanguis Draxonis in three batches of pilot scale sample preparations of table 1

2, the pulverizing of Radix Notoginseng, the Radix Angelicae Dahuricae (half amount), Pyritum 3 herbal medicines: the Radix Notoginseng, the Radix Angelicae Dahuricae (half amount), Pyritum 3 herbal medicines that take 10 times of recipe quantities in the prescription ratio, by above-mentioned technique, 3 flavors are pulverized as fine powder, sieve, test agent is pulverized in three batches must measure and yield in Table 2.

The pulverizing result of 3 herbal medicines in three batches of pilot scale sample preparations of table 2

3, the extraction of decocting medicine: the Radix Dipsaci, Cortex Acanthopancis, Pheretima, Rhizoma Chuanxiong, Semen Melo, Lignum Sappan, the Radix Angelicae Dahuricae that take 10 times of recipe quantities in the prescription ratio _{(half amount)}, Radix Glycyrrhizae 8 flavor, add 8 times of water gagings by above-mentioned technique and decoct 2 hours, filter, medicinal residues add 6 times of water gagings again, and the same decoction 1.5 hours filters, merge 2 times filtrate, be evaporated to relative density 1.25-1.30(50 ℃) thick paste, the three batches of pilot scale sample water soft extracts must measure and yield in Table 3.

In three batches of pilot scale sample preparations of table 3, herbal decoction must be measured and yield

4, the mixing of medicine and drying: Radix Notoginseng, Semen Melo, Pyritum 3 herbal medicine fine powders are added in the extractum of extraction, mix, put 65-70 ℃ of vacuum drying, pulverize, three batch sample fine drug powders must be measured in Table 4.

The preparation of test agent dried cream powder in three batches, table 4

5, mixing and packing of medicated powder and fine powder of dragons blood: mixed powder is mixed with incremental method and fine powder of dragons blood, pack in 1000 capsules by every 0.42g, packing, quality inspection, obtain.

The capsule of three batches of pilot scale sample preparations of table 4 must be measured situation

* this theoretical must measuring for preparing 10 recipe quantities is 10000.

The output of three batches of pilot scale sample preparations of table 5

* this theoretical must measuring for preparing 10 recipe quantities is 208 bottles.

The quality inspection result of (four) three batches of pilot scale preparation powder samples: to three mass products blood Gukang capsules of above pilot scale preparation, carry out quality inspection by the character in quality determining method, discriminating, inspection, extractum etc., and by " Chinese Pharmacopoeia 2005 version (an one) appendix X III C, " microbial limit test " checked, every quality index of each batch of pilot scale preparation sample all meets the relevant requirements of appended quality standard and medicine sanitary standard as a result, the quality of the pharmaceutical preparations is qualified, in Table 6.

The quality inspection result of table 6 three mass products blood Gukang capsules

The quality standard of Gukang capsule of invigorating blood circulation is drafted explanation

One, about the prescription medical material explanation

This product prescription Sanguis Draxonis, Radix Dipsaci, Cortex Acanthopancis, Radix Notoginseng, Pheretima, Rhizoma Chuanxiong, Pyritum, Semen Melo, Lignum Sappan, the Radix Angelicae Dahuricae, Radix Glycyrrhizae 11 flavors, the kind that Semen Melo records for " Shandong Province's Chinese crude drug standard " (version in 2002), its quality should meet the pertinent regulations under the 209th page of Fructus Melo subitem of " Shandong Province's Chinese crude drug standard " (version in 2002), all the other 10 flavors are that " kind that Chinese Pharmacopoeia 2005 version (an one) is recorded, the quality of each tcm and herbal slice all should meet " the pertinent regulations under each medical material kind item of Chinese Pharmacopoeia 2005 version (an one).

Two, the explanation about writing out a prescription

Medical institutions' preparation of this application for registration " Gukang capsule of invigorating blood circulation " prescription, that the high-new honor one Luan Zunyi president of hospital in Weifang is on the basis of several generations secret prescription handed down in the family from generation to generation, sum up effective experience side out from long-term clinical practice, a large amount of clinical observations show, this preparation has promoting blood circulation and stopping pain, the kidney invigorating symplectic bone, the effect of blood stasis dispersing and deswelling, all have good therapeutic effect to miscellaneous fracture, soft tissue injury, prolapse of lumbar intervertebral disc, hyperosteogeny and cervical spondylosis etc.

Three, about the explanation of method for making

The preparation technology of this product is on the basis of consulting prescription 11 herbal medicine correlational study documents, physicochemical property and former prescription tradition medication custom according to the contained effective ingredient of each herbal medicine and main component, and in conjunction with each flavor Chinese crude drug quality, the difference of hardness and the characteristics that Sanguis Draxonis is valuable drug, prescription 11 herbal medicines are divided into to the independent pulverizing of Sanguis Draxonis, the decocting of the co-grinding of Radix Notoginseng, the Radix Angelicae Dahuricae (half amount), Pyritum 3 herbal medicines and Radix Dipsaci, Cortex Acanthopancis, Pheretima, Rhizoma Chuanxiong, Semen Melo, Lignum Sappan, the Radix Angelicae Dahuricae (half amount), Radix Glycyrrhizae 8 herbal medicines extracts three parts.The active component of each medicine of writing out a prescription is fully extracted and retained to this technique, thereby guaranteed quality and the clinical efficacy of medicine.

Four, about the explanation of character

According to character, color, the abnormal smells from the patient of three batches of pilot scale preparation samples, determine.

Five, the explanation (adopting formula and quality determining method in embodiment 1) about differentiating

1.[differentiate] (1) be the Radix Dipsaci in discriminating side.Contain the Radix Dipsaci medical material in prescription, therefore take the Radix Dipsaci medical material as contrast, carry out thin layer chromatography, to differentiate existing of Radix Dipsaci.Go back the preparation technology of analog sample and the preparation method of need testing solution in experiment, make and lack Radix Dipsaci blank liquid.Result shows, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the principal spot of aobvious same color, lack the Radix Dipsaci blank without this speckle, sees picture 1.

2.[differentiate] (2) be the Radix Notoginseng in discriminating side.Contain pseudo-ginseng in prescription, therefore take pseudo-ginseng as contrast, carry out thin layer chromatography, to differentiate existing of Radix Notoginseng.Go back the preparation technology of analog sample and the preparation method of need testing solution in experiment, make and lack Radix Notoginseng blank liquid.Result shows, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the principal spot of aobvious same color, lack the Radix Notoginseng blank without this speckle, sees picture 2.

3.[differentiate] (3) be the Radix Glycyrrhizae in discriminating side.Contain licorice medicinal materials in prescription, therefore take licorice medicinal materials as contrast, carry out thin layer chromatography, to differentiate existing of Radix Glycyrrhizae.Go back the preparation technology of analog sample and the preparation method of need testing solution in experiment, make and lack Radix Glycyrrhizae blank liquid.Result shows, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the fluorescence principal spot of aobvious same color, lack the Radix Glycyrrhizae blank without this speckle, sees picture 3.

4. Sanguis Draxonis is differentiated to the explanation that excludes the quality standard text: to the monarch drug Sanguis Draxonis in prescription, take the Sanguis Draxonis control medicinal material as contrast, the extracting method of differentiating with reference to the pharmacopeia Sanguis Draxonis, carried out preparation and the thin layer of need testing solution differentiates by following method, but in the test sample chromatograph, at daylight and ultra-violet lamp (365nm), inspect, be showed no and the corresponding corresponding principal spot of Sanguis Draxonis control medicinal material, therefore the thin layer of Sanguis Draxonis is not differentiated and is listed in the quality standard text, its reason may be because of Sanguis Draxonis with after other drug mixes, and it is relevant that composition interferes with each other or produce the compound chemical reaction.It is as follows that need testing solution, ischemia exhaust preparation and the concrete discrimination method of blank solution and Sanguis Draxonis control medicinal material solution.

(1) preparation of need testing solution: get this product content 3g, the 20ml that adds diethyl ether, jolting 10 minutes, filter, the filtrate evaporate to dryness, residue adds ethyl acetate 2ml to be made to dissolve, as need testing solution.

(2) ischemia exhausts the preparation of blank solution: get the ingredients except Sanguis Draxonis in prescription, press the preparation method of preparing process and the need testing solution of sample, make ischemia and exhaust blank solution 2ml.

(3) preparation of Sanguis Draxonis control medicinal material solution: get Sanguis Draxonis control medicinal material 0.2g, press the need testing solution preparation method, make Sanguis Draxonis control medicinal material solution 2ml.

(4) test method and result: the photograph thin layer chromatography (" appendix VI B of Chinese Pharmacopoeia 2005 version) test, absorption need testing solution, ischemia exhaust blank solution and each 2 μ l of Sanguis Draxonis control medicinal material solution, put respectively in same and take on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is adhesive, take that petroleum ether (60 ℃～90 ℃)-ethyl acetate-acetone (5:2:3) is developing solvent, launch, take out, dry.Put under daylight and ultra-violet lamp (365nm) and inspect respectively, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, be showed no and the corresponding corresponding principal spot of Sanguis Draxonis control medicinal material, (owing to adopting the pharmacopeia Sanguis Draxonis to differentiate a lower developing solvent, after launching, Rf value is less to see Fig. 4 and Fig. 5, and have no corresponding principal spot with control medicinal material, after change above-mentioned developing solvent into, the principal spot Rf value is moderate, therefore select above-mentioned developing solvent in this test).

5. the explanation of other medical material being differentiated: in experiment, the multi-flavor medicines such as the other medicines Semen Melo in prescription, Lignum Sappan have been carried out to discrimination test, but all do not obtained satisfied result, therefore exclude in text.

Six, the explanation about checking

By " the pertinent regulations under appendix IL capsule item of Chinese Pharmacopoeia 2005 version, moisture in three batches of pilot scale preparation capsules, content uniformity, disintegration, extractum, microbial limit etc. are checked, every test rating of three batch samples all complies with relevant regulations as a result, the quality of the pharmaceutical preparations is qualified, refers to table 1.

The check result of three batches of capsule samples of table 1

Seven, the explanation of measuring about ethanol-soluble extractives:

Because we are comprised of Sanguis Draxonis, Radix Dipsaci, Cortex Acanthopancis, Radix Notoginseng, Pheretima, Rhizoma Chuanxiong, Pyritum, Semen Melo, Lignum Sappan, the Radix Angelicae Dahuricae, Radix Glycyrrhizae 11 flavor Chinese medicines, both containing animal, plant amedica, contain again the mineral drug Pyritum, and prescription drug is more, complicated component, show through assay prerun, between each composition, disturbs larger, be difficult to carry out the assay of composition, therefore control the inherent quality of this preparation by the method for measuring ethanol-soluble extractives content.According to the physicochemical property of each effective ingredient of prescription and the preparation technology of this product, determine and take 85% ethanol as solvent, adopt hot dipping this capsule to be carried out to the mensuration of extractum.And according to " in Chinese Pharmacopoeia 2005 version (one one) appendix XA " Extract mensuration ", the hot dipping of " ethanol-soluble extractives algoscopy " has been worked out following concrete assay method and is:

(1) mensuration of ethanol-soluble extractives: get the about 4g of this product, weighed weight, put in the conical flask of 100ml, precision adds 85% ethanol 100ml, jam-pack, weighed weight, after standing 1 hour, connect reflux condensing tube, be heated to boiling, and keep micro-and boil 1 hour, after letting cool, take off conical flask, close plug, weighed weight, supply the weight of less loss with 85% ethanol, shake up, with dry filter paper, filter, precision measures filtrate 25ml, put in the evaporating dish that is dried to constant weight, water bath method, in 105 ℃ of dryings 3 hours, in the dislocation exsiccator, cooling 30 minutes, rapid accurately weighed weight, calculate the content of ethanol-soluble extractives in each test sample, the measurement result of three mass products blood Gukang capsule ethanol-soluble extractiveses is in Table 2.

The measurement result of table 2 three mass products blood Gukang capsule ethanol-soluble extractiveses

(2) determining of ethanol-soluble extractives content limit: on the basis of quality standard three batch sample determinations of extractives, again to stability test and survey report and carried out the mensuration of ethanol-soluble extractives totally for a collection of 7 batch samples of clinical preparation.According to the measured data (in Table 3) of 10 batches of pilot scales preparation sample ethanol-soluble extractiveses, consider the mass discrepancy of Chinese crude drug between criticizing, tentative this product ethanol-soluble extractives, must not be less than 30.0% in dry product.

The measurement result of ten batches of pilot scale preparation sample ethanol-soluble extractiveses of table 3

Eight, function cures mainly: same text.

Nine, usage and dosage: this product can take the circumstances into consideration to increase or reduce according to the state of an illness weight dose under the doctor instructs.

Ten, specification and storage: same text.

The retrospective clinical efficacy of the Gukang capsule of invigorating blood circulation is summed up

The Gukang capsule of invigorating blood circulation be my Luan Zunyi president of institute on the basis of Luan Shi three generations secret prescription handed down in the family from generation to generation, take Chinese medical theory as guidance, sum up effective experience side and preparation thereof out from long-term clinical practice.Clinical observations show in a large number, and the party has promoting blood circulation and stopping pain, the kidney invigorating symplectic bone, and the effect of blood stasis dispersing and deswelling, all have definite therapeutic effect to fracture, soft tissue injury, cervical spondylosis, prolapse of lumbar intervertebral disc etc.For objective evaluation invigorate blood circulation safety and the effectiveness of Gukang capsule, with reference to Ministry of Public Health " new Chinese medicine clinical guidance principle ", clinical treatment situation and safety over nearly 5 years are carried out to following retrospective clinical efficacy and sum up.

One, physical data

(1) case source: all cases all derives from this Out-patient Department and inpatient, from in January, 2006 to 2010 year December adopt the patients such as Gukang capsule treatment fracture, soft tissue injury, cervical and lumbar diseases totally 206 examples of invigorating blood circulation, wherein fracture and soft tissue injury 120 examples, cervical spondylosis 43 examples, prolapse of lumbar intervertebral disc 43 examples, separately establish GUZHE CUOSHANG JIAONANG matched group 138 examples, wherein fracture and soft tissue injury matched group 65 examples, cervical spondylosis matched group 35 examples, prolapse of lumbar intervertebral disc matched group 38 examples.

(2) ordinary circumstance: Epidemiological Analysis treatment group and matched group there are no significant at aspects such as sex, age, state of an illness distributions difference, P by statistics > 0.05, two group there is comparability.In Table 1-3.

The comparison of table 1 liang group sex

Annotate: two groups of comparison P of * 0.05.

The comparison at table 2 liang group age

Annotate: two groups of comparison P of * 0.05.

The comparison of table 3 liang group state of an illness distribution situation

Annotate: two groups of comparison P of * 0.05

Two, diagnostic criteria

(1) diagnostic criteria of fracture and soft tissue injury: draft with reference to relevant fracture bruise diagnostic criteria in " traditional Chinese medical science disease diagnosis curative effect judging standard " of State Administration of Traditional Chinese Medicine's issue:

1. trauma history is arranged, comprise and dampen and sprain;

2. local organization swelling, pain, ecchymosis, dysfunction;

3.X ray examination: the x-ray inspection is defined as fracture or soft tissue injury.

(2) diagnostic criteria of cervical spondylosis

According to " diagnostic criteria of cervical spondylosis "-cervical spondylosis symposium (in May, 1984 is in Guilin), meet cervical spondylotic radiculopathy, vertebral artery type diagnosis:

1. performance has neck, shoulder, the back of the body, upper limb pain and numbness in various degree clinically; Restriction of neck motion, cervical vertigo, headache, feel sick, the symptoms such as tinnitus.

2. cervical spine or vertebra are other tenderness, the intervertebral foramina compression test positive, and the brachial plexus distraction test positive, revolve the neck test positive.

Cervical X-ray just, tiltedly, the side position takes the photograph sheet, prompting cervical vertebral body hyperosteogeny, or narrowing of intervertebral space, the uncovertebral joint hyperosteogeny, intervertebral foramina diminishes, the calcification of cervical vertebra ligament, cervical curvature changes.

4. TCD,transcranial Doppler Doppler TCD checks, prompting vertebra one basilar artery insufficiency.

(3) diagnostic criteria of lumbar intervertebral disc protrusion

1, performance has waist, lower limb, radiated pain and numbness in various degree clinically, paraesthesia, and straight-leg raising test is less than 60 °, the symptoms such as limitation of activity.

2, there are tenderness, the intervertebral foramina compression test positive in spinous process of lumbar vertebra or vertebra side.

3, the lumbar X line just, the side position takes the photograph sheet, or CT prompts for prolapse of lumbar intervertebral disc, lumbar vertebra hyperosteogeny, or interspace of lumbar vertebrae narrows down etc.

(4) symptom, sign score and severity Scaling standard

1 symptom, sign score standard

Local pain

Normally: limbs, without pain and the rear pain disappearance person for the treatment of, are 0 minute.

Slightly: when static, the injury sense is swollen or mild pain, when movable, adds severe one, is 1 minute.

Moderate: sad place distending pain when static, obvious aggravation person when movable, be 2 minutes.

Severe: the obvious pain in injury when static, be reluctant activity suffering limb person, be 3 minutes.

Swelling

Normally: without swelling, identical with strong side limb circumference, be 0 minute.

Slightly: the injury skin texture is smooth-going, flexible, than all path length 1cm of strong side same area, with interior person, is 1 minute.

Moderate: injury skin anxiety, elasticity reduces, and than all path length 1 ~ 2cm persons of strong side same area, is 2 minutes.

Severe: injury skin anxiety is shinny, follows the string, and than the above person of strong side same area week path length 2cm, be 3 minutes.

Tenderness

Normally: local without tenderness person, be 0 minute.

Slightly: local tenderness need the person of exerting oneself, and is 1 minute.

Moderate: the obvious person of local tenderness is 2 minutes.

Severe: the violent or tenderness person of local tenderness is 3 minutes.

Muscle spasm

Normally: of flaccid muscles without spasm, be 0 minute.

Slightly: muscle is spasm slightly, elasticity can, be 1 minute.

Moderate: muscle spasm, poor flexibility, be 2 minutes.

Severe: muscle spasm is as tabular, and elasticity disappears, and is 3 minutes.

Dysfunction

Normally: freely, affected part, without pain, is 0 minute to joint motion.

Slightly: during joint motion, affected part pain is slight, does not affect joint motion, or range of activity reduces (difference) and be less than 10 ° of persons, is 1 minute.

Moderate: during joint motion, affected part pain increases the weight of, and affects joint motion, and range of motion reduces (difference) 10 ° ~ 20 ° persons, is 2 minutes.

Severe: during joint motion, affected part pain is obviously aggravated, and affects joint motion, and range of motion reduces (difference) and is greater than 20 ° of persons, is 3 minutes.

Skin temperature

Normally: skin, normally without rising person, is 0 minute.

Slightly: Pi Wen is rising person slightly, is 1 minute.

Moderate: the more obvious person of skin temperature rise is 2 minutes.

Severe: the scorching hot person of skin is 3 minutes.

2 severity Scaling standards

Slightly: symptom, sign total mark<6 minute.

Moderate: 6≤symptom, sign total mark<12 minute.

Severe: symptom, sign total mark >=12 minute.

Three, case inclusive criteria

Allly meet above-mentioned each sick diagnostic criteria, the age is and includes case in the patient in 16-75 year;

Four, case exclusion standard

1, suffer from severe cardiac, liver, kidney and disease of hematopoietic system, the disease patients such as tuberculosis, tumor;

2, anemia of pregnant woman or women breast-feeding their children and hyperirritability body constitution or to this drug allergy person.

3, the treatment compliance is poor, by doctor's advice, does not complete Drug therapy and observes the course for the treatment of, can't judge curative effect, or not congruent the affecting the treatment property of data and safety judgement person, or is participating in the other drug experimenter.

Five, methods of clinical observation

(1) observe case group technology and medicine

1, treatment group: the Gukang capsule of invigorating blood circulation, by the Drug Manufacturing Room of the court preparation (adopting the medicament of embodiment 1).

2, matched group: GUZHE CUOSHANG JIAONANG, by sunflower Pharmaceutical group (Jiamusi) company limited production.

Authentication code: the accurate word Z23021314 of traditional Chinese medicines

(2) administrated method and the course for the treatment of:

1, treatment group: the Gukang capsule of invigorating blood circulation, a 4-6 grain, 3 times on the one, or follow the doctor's advice.Within 4 weeks, be a course for the treatment of, use continuously 1～3 course for the treatment of.

2, matched group: GUZHE CUOSHANG JIAONANG, a 4-6 grain, 3 times on the one, children's is cut down according to the circumstance.Within 4 weeks, be a course for the treatment of, use continuously 1～3 course for the treatment of.

(3) observation item and observation index

1, safety is observed

(1) general physical examination project.

(2) blood, urine, stool routine examination chemical examination (treatment group and matched group respectively select 30 examples).

(3) hepatic and renal function and Electrocardioscopy (treatment group and matched group respectively select 30 examples).

2, health giving quality observation index

(1) clinical symptoms and the sign variations such as fracture and soft tissue injury patient's pain, swelling before and after the observation medication.

(2) observe medication front and back cervical and lumbar diseases patient's clinical symptoms and the sign variations such as pain.

(3) observe the situation of change of the patients' such as medication front and back fracture, cervical and lumbar diseases X sheet.

(4) criterion of therapeutical effect

1, the criterion of therapeutical effect of fracture and soft tissue injury

(1) total effects evaluation criteria: according to the Chinese people in 1989, be total to various countries' Ministry of Public Health officina new drugs (Chinese medicine) guideline of clinical investigations, adopt the method for own control, the relatively symptom before and after patient treatment, the variation of sign Index, as the foundation of judging curative effect.

Cure: feel pain and disappear, the tenderness scope dwindles>and 90%, blood stasis dissipates>90%, swelling disappears>90%, union of fracture (the x-ray photo shows that fracture is fuzzy, has the seriality callus to pass through fracture line), recovery from dysfunction arrive former joint motion more than 90%, doing well,improving rate >=90%.

Produce effects: feel pain and substantially disappear, or slight pain is arranged, or sense of discomfort is arranged after fatigue, the tenderness scope dwindles>and 70%, blood stasis dissipates>70%, and swelling disappears>70%, the union of fracture recovery from dysfunction arrives 50%～80% of former range of motion, doing well,improving rate 70%≤n<90%.

Effectively: pain obviously alleviates, and the tenderness scope dwindles>and 40%, blood stasis dissipates>40%, and swelling disappears>40%,

Can participate in light work, doing well,improving rate 30%≤n<70%.

Invalid: symptom, sign change less or without change, doing well,improving rate<30%.

(2) symptom, sign evaluation criteria: according to integration method, judge symptom, sign curative effect.

2, the criterion of therapeutical effect of cervical spondylosis

With reference to " traditional Chinese medical science disease Standardization of diagnosis and curative effect " and Ministry of Health of the People's Republic of China's " new Chinese medicine guideline of clinical investigations ", and in conjunction with synthetic determinations such as symptom, somatic feature score, TCD and x-ray inspections.

(1) clinical cure: symptom, sign disappear fully, and functional rehabilitation is normal, and TCD normal or x-ray are taken the photograph sheet and obviously improved, and symptom, somatic feature score improvement rate are more than 95%.

(2) produce effects: symptom, sign disappear substantially, and TCD has obvious change or x-ray to take the photograph sheet to make moderate progress, and symptom, somatic feature score improvement rate are 65% ~ 95%.

(3) effective: symptom, sign improvement, TCD and the x-ray inspection person of being improved, symptom, somatic feature score improvement rate are 30% ~ 65%.

(4) invalid: symptom, sign check that without improvement, TCD and x-ray symptom, somatic feature score improvement rate are below 30% without changing.Integration * 100% before integration improvement rate=(integration after integration before treatment-treatment) ÷ treatment.

3, the criterion of therapeutical effect of prolapse of lumbar intervertebral disc

Criterion of therapeutical effect is with reference to the criterion of therapeutical effect of State Administration of Traditional Chinese Medicine's " disease of tcm Standardization of diagnosis and curative effect " prolapse of lumbar intervertebral disc.

(1) recovery from illness: the lumbago and skelalgia symptom is eliminated, and straight lower limb can be engaged in normal activity more than raising 70 degree;

(2) effective: symptom has in various degree and alleviates, and the waist movable function improves;

(3) invalid: after treatment, symptom, sign are without improvement.

Six, clinical curative effect analysis

(1) efficacy analysis of fracture and soft tissue injury

To the patient that fracture is arranged first reset fixing after, then take the Gukang capsule of invigorating blood circulation, the person that only has the soft tissue injury and without the direct oral capsule of fracture patient, a 4-6 grain, 3 times on the one.Employing invigorate blood circulation Gukang capsule medicine treatment fracture and soft tissue injury, the patient is totally 120 examples, fracture patient 50 examples wherein, soft tissue injury 70 examples, separately establish GUZHE CUOSHANG JIAONANG matched group 65 examples.Gukang capsule clinical cure 80 examples of invigorating blood circulation, account for 66.7%, and produce effects 30 examples, account for 25.0%, and effective 6 examples, account for 5.0%, and invalid 4 examples, account for 3.3%, and total effective rate is 96.7%; Matched group clinical cure 29 examples, account for 44.6%, and produce effects 17 examples, account for 26.2%, and effective 12 examples, account for 18.5%, and invalid 7 examples, account for 10.8%, and total effective rate is 89.2%, and treatment group is better than matched group (P<0.05).

1, clinical total effects compares, in Table 4.

Two weeks rear clinical total effectses of table 4 medication relatively

Annotate: * and matched group be P<0.05 relatively.

2, symptom, sign curative effect compare, in Table 5.

Table 5 medication two weeks rear symptoms, sign curative effects compare

Annotate: * compares P<0.05 with matched group.

3, the analysis of severity extent and curative effect, employing Gukang capsule treatment patients with mild 40 examples of invigorating blood circulation, moderate patient's 43 examples, severe 37 examples, clinical cure rate is respectively 87.5%, 60.5%, with 51.4%, total effective rate slight and moderate fracture and soft tissue injury is to 100%, and be 94.6% to severe patient's total effective rate, but this capsule is to slight and moderate patient's clinical cure rate and cure-remarkable-effectiveness rate (healing+produce effects) all apparently higher than the severe patient, and the Gukang capsule that shows to invigorate blood circulation is better to the patients with mild curative effect, in Table 6.

The analysis of table 6 treatment group severity extent and curative effect (number of cases)

Annotate: * and severe group be P<0.05 relatively, ^*p<0.01.

4, the analysis of the course for the treatment of and curative effect: to invigorate blood circulation 120 example fracture and soft tissue injury patients of Gukang capsule treatment of clinical employing, carried out the relative analysis of the course for the treatment of and curative effect, result shows, with the increase of the course for the treatment of, its cure rate obviously improves, in 120 routine patients, treat 36 people of a course for the treatment of, 45 people of two courses for the treatment of, 39 people of three courses for the treatment of, from following table, the cure rate for the treatment of for three courses for the treatment of is 71.8%, apparently higher than the treatment cure rate (52.8%) of one course for the treatment of, P<0.05, in Table 7.

The invigorate blood circulation analysis of the Gukang capsule course for the treatment of and therapeutic effect relationship of table 7

Annotate: with a course for the treatment of, compare ^*p<0.05

(2) to the efficacy analysis of cervical spondylosis clinical observation

1. the curative effect situation of the Gukang capsule of invigorating blood circulation treatment cervical and lumbar diseases: adopt Gukang capsule treatment Patients with Cervical Spondylopathy 43 examples of invigorating blood circulation, cure rate is 41.9%, it is 76.7% that healing adds produce effects, total effective rate is 93.0%, the matched group cure rate is 31.4%, and it is 57.1% that healing adds produce effects, and total effective rate is 85.7%, treatment group is better than matched group, refers to table 8.

The invigorate blood circulation curative effect situation of Gukang capsule treatment cervical spondylosis of table 8

Annotate: * and matched group be P<0.05 relatively.

2. before and after the treatment group treatment, TCD compares: before and after treatment, TCD checks that the relative analysis of average peak flow velocity (VM) shows, there were significant differences (P<0.05) for the vertebral artery for the treatment of Patients Before And After and the variation of basilar artery average peak flow velocity, and the improvement situation of cervical vertebra-basilar artery obviously is better than matched group (P<0.05), in Table 9.

TCD variation comparison before and after table 9 treatment (cm/s * ± s)

Annotate: * and front relatively P<0.05 for the treatment of

(3) to the efficacy analysis of prolapse of lumbar intervertebral disc clinical observation

After first being resetted, the prolapse of lumbar intervertebral disc patient awards again the Gukang capsule treatment of invigorating blood circulation, employing Gukang capsule treatment prolapse of lumbar intervertebral disc 43 examples of invigorating blood circulation, cure rate to prolapse of lumbar intervertebral disc is 39.5%, it is 74.4% that healing adds produce effects, and total effective rate is 90.7%, and the matched group cure rate is 31.6%, it is 63.2% that healing adds produce effects, total effective rate is 84.2%, and treatment group is better than matched group, refers to table 10.

The invigorate blood circulation curative effect situation of Gukang capsule treatment prolapse of lumbar intervertebral disc of table 10

Annotate: * and matched group be P<0.05 relatively.

(4) safety testing result

Before and after treatment group and treatment of control group, respectively select 30 examples to carry out blood, urine, just reach electrocardio, liver, kidney function test, every test rating before and after two groups of treatments of result is showed no extremely, show that two groups of medicines are to human body electrocardio, liver, renal function and blood, urine, just all have no significant effect, and also have no irritated and other untoward reaction generations between the operating period, use safety, in Table 11.

Table 11 safety indexes observed result (n=30)

(5) untoward reaction of clinical practice and toxic and side effects

In 206 routine patients for the treatment of group, treating the longest was 3 courses for the treatment of, minimum 1 course for the treatment of, was showed no obvious adverse reaction and toxic and side effects, showed that this preparation takes safety.

Seven, model case (all taking the medicament of embodiment 1 preparation)

Model case 1: Qin Lian virtue female 59 years old, Kuiwen District storehouse people from South Street, because of right knee joint disorders, increase the weight of 4 years, in my institute's rehabilitation department of 8 monthly incomes in 2010, treat, while coming institute, right knee joint pain is obvious, and during upper and lower stair, pain increases the weight of, and during the knee joint activity, has friction to feel, bend and stretch limited, come institute to have a medical check-up: right knee joint swelling, Varus deformity, passive activity can touch the bone rubbing feeling, stretches 110 ° of 10 ° of flexings, stretches in the wrong obviously limited; Xiyan place, both sides tenderness, floating hip test (-), grinding test (-), X-ray film shows: right knee joint degeneration is diagnosed as: right kneecap arthrosis.Enter the oral Gukang capsule of invigorating blood circulation after my institute, a 4-6 grain, 3 times on the one, to take 7 days rear right knee joint pain and obviously alleviate, while within 28 days, leaving hospital in hospital, right knee joint pain symptom is alleviated substantially, joint is without swelling, right mild pain during upper and lower stair, follow up a case by regular visits to after the first quarter moon of leaving hospital, right gonalgia transference cure, activity freely, is judged as clinical cure.

Model case 2: patient Zheng east 47 years old Huanggang people builder of brightness female examines over 2 days because wound causes lumbago, before 2 days, from 5 meters eminences, throws during work high above the ground, and buttocks lands, and sense waist severe pain, dare not be movable; In 89 hospitals of PLA, film making is shown: waist 4 vertebral compression fractures, suggestion row operative treatment, patient's refusal; Come out of admiration for a famous person my institute, come institute to have a medical check-up: lumbar vertebra bends that degree straightens, the both sides musculus sacrospinalis is stiff, L4 spinous process place tenderness, percussion pain, is diagnosed as: waist 4 vertebral compression fractures.After entering my institute and first giving reduction therapy, the oral Gukang capsule of invigorating blood circulation, a 4-6 grain, 3 times on the one, to take lumbago symptom after 2 weeks and substantially alleviate, freely, after taking January, the lumbago symptom is alleviated fully in the lumbar vertebra activity; X-ray shows: callus generates good, and the lumbar vertebra form has become normally, is judged as clinical cure, and stomach discomfort and other untoward reaction do not appear in patient's period in a medicine.

Model case 3: 31 years old Weicheng District Fructus Pruni people from port of Liu Xiuli female, because wound causes right ankle joint pain and swelling, movable difficulty 3 days; In my institute of 10 monthly incomes in 2010, accidentally sprain right ankle while going downstairs before 3 days, feel immediately right ankle sharp ache, stiff, the rapid swelling in injury, the X-ray no abnormality seen, have a medical check-up: right swollen ankles, plantar flexion, the back of the body are stretched, the obvious limited companion's pain of turning up, internal malleolus place tenderness, be diagnosed as right ankle soft tissue injury.The rear oral Gukang capsule of invigorating blood circulation of being admitted to hospital, a 4-6 grain, 3 times on the one, after 7 days, pain symptom slightly alleviates, swelling is still obvious, and activity is still limited, takes pain symptom after 2 weeks and disappears, slight swelling is only arranged, activity freely, continues to take medicine 2 weeks afterwards, and while following up a case by regular visits to, pain and swelling disappears, activity freely, is judged as clinical cure.

Model case 4:2006 October, Liu Jiayao town, Anqiu City peasant Liu Anji, because " lumbago companion right lower extremity pain 5 years, increase the weight of half a year " moves in my institute's rehabilitation department.Left lower extremity sharp ache while being admitted to hospital, need lean on the crutch walking, and night, pain had difficulty in going to sleep.Have a medical check-up: lumbar curvature straightens, L4/5, the left other tenderness companion of the 1.5cm place lower limb radiating pain of surveying of L5/S1 interspinal interstice, left buttocks piriformis traveling place tenderness, the slight atrophy of left lower extremity muscle, left lower extremity is looked into lower limb and is raised test 40 ° of (+), reinforcement tests (+), and the side skin superficial sensibility of left leg place is gone down, the left big toe back of the body is stretched power, plantar flexion power weakens, and left knee jerk is normal, and left Achilles tendon reflex weakens.Babinski sign (-), lumbar vertebra CT; L4/5, L5/S1 intervertebral disk hernia, be diagnosed as " intervertebral disc prolapse ", and before the patient is admitted to hospital, at Duo Jia clinic, Anqiu row traditional Chinese massage, the Dressed plaster treatment, all without positive effect.After entering my institute and first giving reduction therapy, the oral Gukang capsule of invigorating blood circulation, a 4-6 grain, 3 times on the one, after serveing on 2 weeks, waist sour jujube lower limb pain obviously alleviates, and while within 30 days, leaving hospital in hospital, lumbago and left lower extremity pain symptom are alleviated substantially, and freely, show effect night without pain in walking.Continue after leaving hospital to take medicine and within 2 weeks, consolidate curative effect.After Effect of follow-up visit by telephone repeatedly, symptom does not recur, and is judged as clinical cure.

Model case 5: Zheng Tiantang: 58 years old peasant of man, Yang Zi people from town, littoral area, Weifang City, because of " lumbago companion right lower extremity sharp ache, numb 2 years ", move in my institute's rehabilitation department in May, 2007, right lower extremity sharp ache at that time, intermittent claudication is arranged, have a medical check-up: the lumbar vertebra left side is curved, the right side 1.5cm of L4/5 interspinal interstice place tenderness, without the lower limb radiating pain, buttocks is without tenderness, the lower limb muscles atrophy is arranged, right lower extremity is looked into lower limb and is raised test 50 ° (+) and strengthen the outside skin superficial sensibility of test (+) right legs and go down, the right big toe back of the body power of stretching weakens, plantar flexion power is normal, knee jerk is normal, right Achilles tendon reflex weakens, lumbar vertebra CT shows: L4/5 intervertebral disk hernia spinal canal stenosis, be diagnosed as " prolapse of lumbar intervertebral disc spinal stenosis ", after entering my institute and first giving reduction therapy, the oral Gukang capsule of invigorating blood circulation, a 4-6 grain, 3 times on the one, after serveing on 2 weeks, lumbago and right lower extremity pain symptom are alleviated substantially, and freely, only right lower extremity has slight feeling of numbness in walking, the rear oral drugs after treatment 20 days of leaving hospital, during Effect of follow-up visit by telephone, all symptoms all have alleviation, do not recur so far again, are judged as clinical cure.

Model case 6: Lu builds 55 years old Shuan Tai people from town of retired Changyi City of flourish female, because " lumbago companion right lower extremity pain 3 years " moves in my institute's rehabilitation department in April, 2009, the patient be take lumbago at that time as main, sitting and while bending over activity pain obvious, have a medical check-up: lumbar vertebra is bent degree and is straightened, L5 spinous process place tenderness, percussion pain, the tenderness companion of 1cm place, L5/S1 interspinal interstice right side lower limb radiating pain, look into lower limb and raise test (-), the skin numbness is abnormal, two big toe back forces are normal, plantar flexion power slightly a little less than, two patellar tendon Achilles tendon reflexs are normal.Lumbar vertebra CT:L5/S1 intervertebral disk hernia, L5 centrum olisthe (I °), be diagnosed as " lumbar spondylolisthesis; prolapse of lumbar intervertebral disc ", after entering my institute and first giving reduction therapy, the oral Gukang capsule of invigorating blood circulation, a 4-6 grain, 3 times on the one, take 7 days, waist and right lower extremity pain symptom slightly alleviate, take symptom after 2 weeks and obviously alleviate, while within 4 weeks, leaving hospital in hospital, symptom is alleviated fully, does not occur untoward reaction in drug administration process, follow up a case by regular visits to nearly 2 years symptoms and do not recur, be judged as clinical cure.

Model case 7: 53 years old individual Changyue County of Liu Yu beauty does the people in the area just outside a city gate street, and move in my institute because of " numb 2 years of cervical pain discomfort, headache, dizziness, left upper extremity " in May, 2009.Take headache, dizzy symptom as outstanding, and during rotation, symptom is obvious, and medical many large hospitals inside the province, adopt multiple way treatment before this, all without positive effect, after come out of admiration for a famous person my institute.Human health screening: Cervical curve straightens, muscle rigidity, between neck 4-7 spinous process, tenderness is obvious, and right upper extremity is radiated pain, and anteflexion neck test (+) pressure head that revolves is tested (+), left arm clump neutral stretch test (+), the left hand grip than the right hand a little less than, left biceps brachii m., triceps reflex weaken, left side Hoffmann sign (+), cervical vertebra CT:L4/5, L5/6, L6/7 intervertebral disk hernia, cervical vertebra straightens; Be diagnosed as: cervical spondylosis (mixed type).After the patient is admitted to hospital, the oral Gukang capsule of invigorating blood circulation, a 4-6 grain, 3 times on the one, after 10 days, the cervical pain malaise symptoms is alleviated substantially, and headache, dizziness, left upper extremity pain and numbness obviously alleviate; After 20 days, the cervical region pain symptom is alleviated fully, and headache, dizzy sense are occasionally arranged, and left upper extremity has slight numbness; The after treatment 2 weeks that continues after leaving hospital to take medicine, follow up a case by regular visits to the only right slight feeling of numbness of left upper extremity after January, all the other transference cures, and while following up a case by regular visits to after half a year, all symptoms all disappear, and recurrence, be judged as clinical cure so far.

Model case 8: 52 years old civil servant's In Luohu District of Shenzhen Municipal people of the precious living man of grandson, come out of admiration for a famous person my institute in June, 2009, move in rehabilitation department.The patient suffers from various diseases such as " intervertebral disk hernia are levied, cervical spondylosis, rheumatoid arthritis ".Physical examination: Cervical curve straightens, tenderness, pressure head test (+) between the L4-L7 sour jujube, left arm clump neutral stretch test (+), the both hands grip descends, and left biceps brachii m., triceps reflex weaken, left side Hoffmann sign (+), the fusiformis enlargement of a plurality of joint of both hands, tenderness, bend and stretch limitedly, and Cervical curve straightens, L4/5,1.5cm place, L5/S1 interspinal interstice right side tenderness, right lower extremity is looked into lower limb and is raised 50 ° (+) of test, strengthens test (+) skin numbness abnormal, has patellar tendon, Achilles tendon reflex to weaken.Blood ESP shows: 58mm/h, cervical vertebra CT:L4/5, L5/6, L6/7 intervertebral disk hernia, regression, cervical vertebra CT:L3/4, L5/S1 intervertebral disk hernia.After the patient is admitted to hospital, the oral Gukang capsule of invigorating blood circulation, a 4-6 grain, 3 times on the one, take 7 days collare waists and lower limb pain symptom and start to alleviate, take all symptoms after 2 weeks and obviously alleviate, take 4 weeks afterwards all symptoms substantially alleviate, both hands interphalangeal joint pain also obviously alleviates, and after the January of being in hospital, leaves hospital and continues the after treatment of taking medicine.Follow up a case by regular visits to neck waist lower limb symptom after half a year and alleviate fully, only the both hands articulations digitorum manus has mild pain, and period in a medicine does not go out untoward reaction, is judged as clinical cure.

Eight, conclusion and discussion

(1) conclusion: adopt the Gukang capsule of invigorating blood circulation to treat altogether various patient's 206 examples such as fracture, soft tissue injury, wherein, fracture and soft tissue injury 120 examples, cervical spondylosis 43 examples, lumbar intervertebral disc synapse 43 examples, separately establish GUZHE CUOSHANG JIAONANG matched group 138 examples, wherein fracture and soft tissue injury 65 examples, cervical spondylosis 35 examples, prolapse of lumbar intervertebral disc 38 examples.Treatment group is 66.7% to the cure rate of fracture and soft tissue injury, total effective rate is 96.7%, be better than respectively the 44.6%(P of matched group<0.01) and 89.2%, cure rate to cervical spondylosis is 41.9%, total effective rate is 93.0%, be better than respectively the 31.4%(P of matched group<0.01) and 85.7%, cure rate to prolapse of lumbar intervertebral disc is 39.5%, total effective rate is 90.7%, be better than respectively the 31.6%(P of matched group<0.05) and 84.2%, have no obvious adverse reaction in clinical practice, use safety, above result shows, this product all has significant curative effect to above-mentioned disease, it is a kind of medicine of ideal treatment safely and effectively.

(2) discuss: fracture, soft tissue injury, cervical and lumbar diseases etc. are many because of direct violence, indirect violence or accumulation property external force, cause muscles and bones and muscle acute injury, lumbago and skelalgia or chronic functional obstacle in various degree, such disease is clinical common frdquently encountered disease, the traditional Chinese medical science is thought above-mentioned each disease, belong to the categories such as the traditional Chinese medical science " arthromyodynia " " lumbago and skelalgia ", due to the Liver and kidney insufficiency of vital energy and blood, external force injures muscles and bones, cause the rear qi depression to blood stasis of wound, blood-stasis internal-depression, blockage of main and collateral channels, the muscle arteries and veins loses supports, the QI-blood circulation imbalance, or invade outward because of wind-cold damp pathogen, evil stagnant meridians, cause the body imbalance between YIN and YANG and cause primary disease.

This capsule is made laws with promoting blood circulation and stopping pain, the kidney invigorating symplectic bone, and blood stasis dispersing and deswelling is the rule for the treatment of, and Sanguis Draxonis promoting blood circulation to remove blood stasis pain relieving in side, be most commonly used to traumatic injury, and the swelling and pain due to blood stasis of tendon breaking fracture is orthopedics department key medicine commonly used.Therefore can treat main disease, eliminate primary symptom, be we's commander, be to be monarch drug." detailed outline " Yan Qineng: " all pains of dissipating blood stasis blood." meaning again: " though the main disorders of blood of Olibanum Myrrha, and doublely enter edema caused by disorder of QI, this specially enters blood system." the sweet and tepor of Radix Dipsaci, can liver and kidney tonifying, hardship is let out hot loose, the blood vessels that can pass through, activating collaterals to relieve pain has benefit and can declare, and goes and the characteristic of not letting out; " herbal classic ": " tonifying for the deficiency ... folding wound, reuniting the fractured tendons and bones." the Cortex Acanthopancis acrid, bitter, warm.Enter the Liver and kidney warp.The energy bone and muscle strengthening; " not Lu ": " ... invigorating middle warmer benefit essence, hard muscles and bones." Radix Notoginseng sweetness and bitterness and temperature, its function is broadly divided into blood stasis dispelling, detumescence, hemostasis, pain relieving, is usually used in traumatic injury; forefathers have meaning: " Radix Notoginseng simply, can be for the Xiayuxue Tang, Decoction for Dischanging Blood clots of " gold is deficient ", and particularly also safe with Xiayuxue Tang, Decoction for Dischanging Blood clots; " to the merit of its blood stasis dispelling, very have an high regard for." detailed outline ": " hemostasis, loose blood, analgesic therapy.Gold sword arrow wound, fall and flutter flogging injury." Semen Melo is sweet cold, is longer than blood circulation promoting and blood stasis dispelling, for traumatology fracture product commonly used, in the synthetism folk prescription, takes it more.The hot Wen Xiang of Rhizoma Chuanxiong alters, and walks and does not keep, and can go up wardrobe to run, and assigns the sea of blood, outer thorough fur, and bypass four ends, be the gas medicine in blood.Therefore the effects such as blood-activating and qi-promoting pain relieving are arranged.Good medicine for promoting blood circulation and stopping pain.Pyritum acrid in the mouth gas is flat, enters blood blood, the blood and relieving pain that can fall apart, reunion of bone, " Kaibao Bencao ": " treat the folding wound, loose blood and relieving pain." above Six-element: Radix Dipsaci, the invigorating the liver and kidney of Cortex Acanthopancis energy principal drug assistance, promoting blood circulation, reuniting the fractured tendons and bones, treat the folding wound; Radix Notoginseng, Semen Melo, Rhizoma Chuanxiong, Pyritum, principal drug assistance blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, reunion of bone, be ministerial drug altogether; Lignum Sappan is salty can enter blood, and suffering can be wandered away, the function blood circulation promoting and blood stasis dispelling, and reducing swelling and alleviating pain, be the principal agent of traumatology; Pheretima is salty, cold, enters liver, kidney channel.Can promoting blood circulation to remove obstruction in the collateral.Radix Angelicae Dahuricae wind-expelling pain-stopping, removing toxic substances.Compendium of Material Medica: " hot temperature fragrance, wind-expelling pain-stopping removing toxic substances and promoting subsidence of swelling.... ... .. snakebite, cutter arrow incised wound." upper three medicines are invigorated blood circulation, dredging collateral, pain relieving.Can treat the disease of holding concurrently by principal drug assistance, be adjuvant drug altogether.The Radix Glycyrrhizae sweet in the mouth, enter 12 warps, can relieving spasm to stop pain." herbal classic ": " main vital organs of the human body cold and heat pathogen, hard muscles and bones, longue meat, times strength, incised wound is swollen, removing toxic substances." the Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, priming is returned through being for making medicine; Rhizoma Chuanxiong is sensible up and down, penetrating meridians, the also double use that makes medicine; Two medicines share and more can guide all medicines thoroughly to reach meridians, through sick institute.All medicines share the drug effect complementation, play altogether the merit of promoting blood circulation and stopping pain, the kidney invigorating symplectic bone, blood stasis dispersing and deswelling.Blood stasis is dispelled, and fresh blood is given birth to, and internal organs are flat, and QI and blood is multiple, and negative and positive are secret, and channels is unobstructed, and Liver and kidney must be mended, and muscles and bones must continue, and all diseases are from removing.

The accompanying drawing explanation

Fig. 1 is preparation technology's flow chart of preparation;

Fig. 2 is Radix Dipsaci discriminating figure (1.2.3 test sample 4. Radix Dipsaci medical material 5. feminine genders);

Fig. 3 is Radix Notoginseng discriminating figure (1.2.3 test sample 4. pseudo-ginseng 5. feminine genders);

Fig. 4 is Radix Glycyrrhizae discriminating figure (1.2.3 test sample 4. licorice medicinal materials 5. feminine genders);

Fig. 5 is Sanguis Draxonis discriminating figure (daylight) (1.2.3 test sample 4. Sanguis Draxonis medical material 5. feminine genders);

Fig. 6 is Sanguis Draxonis discriminating figure (365nm) (1.2.3 test sample 4. Sanguis Draxonis medical material 5. feminine genders).

The specific embodiment

Below by instantiation, the present invention will be further elaborated, should be noted that following explanation is only in order to explain the present invention, is not limited its content.

Embodiment 1

A kind of Chinese medicine composition for the treatment of bone injury diseases (Gukang capsule of invigorating blood circulation) is comprised of Sanguis Draxonis, Radix Dipsaci, Cortex Acanthopancis, Radix Notoginseng, Semen Melo, Rhizoma Chuanxiong, Pyritum, Lignum Sappan, Pheretima, the Radix Angelicae Dahuricae, Radix Glycyrrhizae 11 flavor Chinese medicines, on the basis of consulting each Drugdoc of prescription, physicochemical property according to the contained effective ingredient of each medicine and main component, carried out the master-plan of preparation production technique, and the quality of product is analyzed, worked out the quality standard of this product, testing data and the documents and materials brief introduction of the Gukang capsule quality research work of now invigorating blood circulation are as follows.

Invigorate blood circulation Gukang capsule quality standard (draft) and draft explanation

The Gukang capsule of invigorating blood circulation

Huoxüe?Gukang?Jiaonang

[method for making] above 11 flavors, Sanguis Draxonis is pulverized as fine powder, standby.Radix Notoginseng, the Radix Angelicae Dahuricae (half amount), Pyritum 3 flavors, pulverize as fine powder, standby.All the other Radix Dipsacis, Cortex Acanthopancis, Pheretima, Rhizoma Chuanxiong, Semen Melo, Lignum Sappan, the Radix Angelicae Dahuricae (half amount), Radix Glycyrrhizae 8 flavors, adding 8 times of water gagings decocts 2 hours, filter, medicinal residues add 6 times of water gagings again, the same decoction 1.5 hours, filter, merge filtrate twice, be evaporated to relative density 1.25-1.30(50 ℃) thick paste, add Radix Notoginseng, the Radix Angelicae Dahuricae (half amount), Pyritum 3 herbal medicine fine powders, put 65-70 ℃ of vacuum drying, pulverize, mix with incremental method and fine powder of dragons blood, pack in 1000 capsules by every 0.42g, obtain.

[character] this product is capsule, and content is that light brown is to chocolate brown powder; Feeble QI perfume (or spice), mildly bitter flavor.

This product content 3g is got in [discriminating] (1), put in apparatus,Soxhlet's, add chloroform 100ml, reflux 2 hours, take out, dry, put again in apparatus,Soxhlet's, add methanol 100ml, reflux 3 hours, the extracting solution evaporate to dryness, residue adds water 40ml, slight fever makes to dissolve, with water saturated n-butanol extraction 2 times, each 30ml, merge n-butyl alcohol liquid, with 2% sodium hydroxide solution washing 2 times, each 30ml, alkali liquor discards, n-butyl alcohol liquid is used the water washing 3 times that n-butyl alcohol is saturated again, each 30ml, cleaning mixture discards, n-butyl alcohol liquid evaporate to dryness, residue adds methanol 2ml to be made to dissolve, as need testing solution.Separately get Radix Dipsaci control medicinal material 0.2g, add methanol 15ml, reflux, extract, 30 minutes, let cool, filter, and the filtrate evaporate to dryness, residue adds methanol 2ml to be made to dissolve, in contrast medical material solution.According to thin layer chromatography (" appendix VI B of Chinese Pharmacopoeia 2005 version) test, draw each 3 μ l of above-mentioned 2 kinds of solution, put respectively in same and take on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is binding agent, the upper solution of n-butyl alcohol-Acetic Acid-Water (4:1:5) of take is developing solvent, launch, take out, dry, spray, with 10% ethanol solution of sulfuric acid, is heated to the speckle colour developing clear.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the principal spot of aobvious same color.

(2) get Radix Notoginseng control medicinal material 0.5g, add methanol 15ml, reflux, extract, 30 minutes, let cool, filter, and the filtrate evaporate to dryness, residue adds methanol 2ml to be made to dissolve, in contrast medical material solution.According to thin layer chromatography (appendix VI B of Chinese Pharmacopoeia version in 2005), test, draw above-mentioned discriminating (a 1) lower need testing solution and each 3 μ l of above-mentioned control medicinal material solution, put respectively in same and take on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is adhesive, lower floor's solution that the chloroform-ethyl acetate-methanol-water (15:40:22:10) of take is placed below 10 ℃ is developing solvent, launch, take out, dry, spray, with 10% ethanol solution of sulfuric acid, is heated to the speckle colour developing at 105 ℃ clear.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the principal spot of aobvious same color.

(3) get this product content 3g, add water-saturated n-butanol 30ml, soak 30 minutes, ultrasonic 15 minutes, filter, filtrate is extracted 2 times with ammonia solution, and each 10ml, merge ammonia solution, adjust pH value 1～2 with dilute hydrochloric acid, use ether extraction 2 times, each 20ml, discard ether solution, water liquid is used the water saturation n-butanol extraction 2 times again, each 20ml, merge n-butyl alcohol liquid, with n-butyl alcohol, saturated water washing is 2 times, each 40ml, get n-butyl alcohol liquid water bath method, residue adds methanol 2ml to be made to dissolve, as need testing solution.Another extracting liquorice medicinal powder 0.5g, be made in the same way of control medicinal material solution.According to thin layer chromatography (" appendix VI B of Chinese Pharmacopoeia 2005 version) test, draw each 3 μ l of above-mentioned two kinds of solution, put respectively in same and take on the silica gel g thin-layer plate that the 1%NaOH sodium carboxymethyl cellulose is adhesive, ethyl acetate-formic acid-glacial acetic acid-the water (15:1:2:2) of take is developing solvent, launches, and takes out, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ to be heated to the speckle colour developing clear, puts immediately under ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, the fluorescence principal spot of aobvious same color.

[inspection] should meet pertinent regulations under the capsule item (" Chinese Pharmacopoeia 2005 version (an one) appendix IL).

[mensuration of extractum] gets the about 4g of this product content, accurately weighed, according to the hot dipping (appendix XA) under ethanol-soluble extractives algoscopy item, measures, and with 85% ethanol, makes solvent, must not be less than 30.0%.

[function cures mainly] promoting blood circulation and stopping pain, the kidney invigorating symplectic bone, blood stasis dispersing and deswelling.For fracture, soft tissue injury, prolapse of lumbar intervertebral disc, hyperosteogeny and cervical spondylosis etc.

[usage and dosage] is oral, one time 4～6,3 times on the one, or follow the doctor's advice.

[specification] every dress 0.42g

[taboo] anemia of pregnant woman forbidding.

[storage] sealing, put shady and cool dry place.

The present embodiment " Gukang capsule of invigorating blood circulation " is Luan Shi family through the secret prescription handed down in the family from generation to generation preparation of " Luan Tongcheng ", " Luan Zhang it ", " Luan Zunyi " three generations human therapy bone injury disease, having experienced the individual practises medicine, in a plurality of stages such as cooperative medical service, the cooperation of town hospital, nineteen ninety-five has been set up " clinic of Luan Zhang " through the approval of Weifang City Hanting District health bureau.Calendar year 2001 on the basis of clinic with Hanting District Shuan Yangdian town hospital cooperative with medical treatment, in December, 2004 has formally been set up Weifang high-new honor one hospital through the approval of high and new technology industrial development zone, Weifang City health bureau." the Gukang capsule medicine of invigorating blood circulation " all is applied to clinical with the form of the personal preparation of autogamy at the stages of above-mentioned each medical and health organization, use and count in the clinic of Luan Zhang from nineteen ninety-five, so far have the time of 12 years, annual set a broken bone patient reaches up to ten thousand person-times, and obtained good curative effect, and have no toxic and side effects, use safety, obtain the high evaluation of extensive patients and relevant government department.For improving the health preparation condition of said preparation, within 2006, formally declared Preparation Room in Hospital, and obtained approval, issued medical institutions' Chinese medicine preparation licence, and introduce and trained the Chinese medicine preparation professional and technical personnel, the preparation condition of said preparation is greatly improved, thereby has guaranteed drug quality and clinical efficacy.

In the clinical practice of long-term treatment bone injury disease, said preparation has obtained local and the peripheral masses' height trusts, and deeply is subject to the welcome of extensive patients.Increase along with out-patient's therapeutic dose, the demand of " the Gukang capsule medicine of invigorating blood circulation " also strengthens day by day, preparing process for further standard said preparation, set up the quality standard that controllability is strong, guarantee quality and the clinical efficacy of formulated, therefore will " the Gukang capsule medicine of invigorating blood circulation " application for registration medical institutions preparation, to meet the needs of the clinical application day by day increased.

Embodiment 2

A kind of Chinese medicine composition for the treatment of bone injury diseases, it is the medicament of being made by the raw material of Chinese medicine with following weight proportion:

Its preparation method and quality determining method are with embodiment 1.

Embodiment 3

A kind of Chinese medicine composition for the treatment of bone injury diseases, it is the medicament of being made by the raw material of Chinese medicine with following weight proportion:

Its preparation method and quality determining method are with embodiment 1.

Claims (3)

1. the preparation method of the Chinese medicine composition of a treating bone injury diseases, the Chinese medicine composition of described treating bone injury diseases is the medicament of being made by the raw material of Chinese medicine with following weight proportion:

25～35 parts of Sanguis Draxonis, 200～300 parts of Radix Dipsacis, 150～250 parts of Cortex Acanthopanciss, 50～100 parts of Radix Notoginseng, 80～120 parts of Semen Melos, 120～180 parts of Rhizoma Chuanxiongs, 15～25 parts of Pyritums, 120～180 parts of Lignum Sappans, 80～120 parts of Pheretimas, 120～180 parts of the Radixs Angelicae Dahuricae, 80～120 parts, Radix Glycyrrhizae;

Dosage form is capsule;

It is characterized in that, step is as follows:

(1) the write out a prescription pulverizing of each medicine: take the Sanguis Draxonis of expense in the prescription ratio, be ground into fine powder, standby; Take Radix Notoginseng, the Pyritum of expense and partly measure the Radix Angelicae Dahuricae 3 flavors in the prescription ratio, pulverize as fine powder, standby;

(2) extraction of decocting medicine: take Radix Dipsaci, Cortex Acanthopancis, Pheretima, Rhizoma Chuanxiong, Semen Melo, Lignum Sappan, the Radix Glycyrrhizae of expense and partly measure the Radix Angelicae Dahuricae 8 flavors in the prescription ratio, decoct with water 1～3 time, filter, merging filtrate, be evaporated to the thick paste of relative density 1.25～1.30,50 ℃ of surveys, standby;

(3) mixing of medicine and drying: Radix Notoginseng, the Radix Angelicae Dahuricae, Pyritum 3 herbal medicine fine powders in step (1) are added in the extractum of extraction, mix, put 65～70 ℃ of vacuum dryings, pulverize, standby;

(4) packing of medicine: above mixed powder is mixed with incremental method and fine powder of dragons blood, and packing, obtain.

2. the preparation method of the Chinese medicine composition for the treatment of bone injury diseases according to claim 1, it is characterized in that: the weight proportion of described each raw material of Chinese medicine is:

30 parts of Sanguis Draxonis, 250 parts of Radix Dipsacis, 200 parts of Cortex Acanthopanciss, 80 parts of Radix Notoginseng, 100 parts of Semen Melos, 150 parts of Rhizoma Chuanxiongs, 20 parts of Pyritums, 150 parts of Lignum Sappans, 100 parts of Pheretimas, 150 parts of the Radixs Angelicae Dahuricae, 100 parts, Radix Glycyrrhizae.

3. the preparation method of the Chinese medicine composition for the treatment of bone injury diseases according to claim 1 and 2, it is characterized in that: in described step (2), decoct with water 2 times, wherein for adding 8 times of water gagings, decoct 2 hours for the 1st time, filter, add again 6 times of water gagings for medicinal residues the 2nd time, the same decoction 1.5 hours, filter, and merges filtrate twice.

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