CN102727697A - 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

Chinese medicine composition, its preparation method and quality determining method that a kind of set a broken bone is sick

Technical field

The present invention relates to the sick Chinese medicine composition (" the bone recovering capsule of invigorating blood circulation ") of a kind of set a broken bone, specifically a kind of Chinese medicine composition that is used to treat fracture, soft tissue injury, prolapse of lumbar intervertebral disc, hyperosteogeny and cervical spondylosis.The invention still further relates to this Chinese medicine composition method for preparing 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 bone is the mansion of strange perseverance, and it mainly acts on is 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 doing "." element is asked a flaccidity opinion piece of writing " said: " the kidney being in charge of bone and marrow "; Add: " bone person fu-viscera of marrow, unable to stand for a long time, tottering while walking, bones being about to exhaust." the brief effect of having pointed out bone, not only be the trunk of health, also built-in marrow is relevant with kidney qi.Kidney storing essence, the smart marrow of giving birth to, marrow nourishing bone, the person's kidney that closes the bone also, so kidney qi whether fill the growth that directly affects bone, healthy and strong and regeneration, if deficiency of kidney-QI, then bone marrow need not, the bone injury difficulty heals.Otherwise damaged bone is hindered, and also can involve kidney, causes kidney qi and is cut down, so " element is asked the vital QI of the body connecting with natural QI opinion: " Gu and powerful, kidney qi is to hinder, 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.Internal organs are healthy and strong, and meridians are unobstructed, and the body fluid metabolism is normal, and then QI and blood is vigorous, YIN and YANG balancing, and skin and flesh enjoys excellent health.The internal organs loss, meridians are not smooth, the body fluid metabolism disorder, then QI and blood is inconsiderate, imbalance of YIN and YANG, the skin and flesh cervical carcinoma with cachexia is a little less than muscles and bones is withered.So 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.Say in " roman class will " as Lu Shidao: " limbs decrease in outside, then 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 the integral body of having indicated.Therefore,, must the physiological and pathological relation of various tissues be studied, could be familiar with the sick essence of bone injury and the mutual relation of pathological change from organic conception to the understanding of orthopedics department pathogenesis.

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 just declining evil the victory, disease becomes to worsening and death, if the good and evil struggle is evenly matched, just locked situation can occur.For fracture patients, 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.This moment is if healthy energy is filled Sheng, and is anti-evil strong, gets rid of evils and goes out, and treat properly, and fracture obtains correct reduction and fixes, and knochenbruch is able to continue, and congestion is able to dissipate, and meridians are transferred smooth, and pathogen is difficult to develop.If healthy energy has been defeated pathogen fully, pathogenic factor disappears or termination to the effect of human body, and fracture is healing rapidly, internal organs QI and blood functional rehabilitation, and then disease can be fully recovered.Otherwise then patient's condition worsens day by day and aggravates.

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

At present, still there is not the sick Chinese drugs agentia of ideal set a broken bone.

Summary of the invention

The objective of the invention is for overcoming the deficiency of above-mentioned prior art, provide a kind of set a broken bone sick Chinese medicine composition, its preparation method and quality determining method.

For realizing above-mentioned purpose, the present invention adopts following technical proposals:

The Chinese medicine composition that a kind of set a broken bone is sick, it is the medicament of processing by with following Chinese medicine raw materials by weight proportion:

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

Said medicament is a capsule.

Prescription compatibility of medicines in this Chinese medicine composition by monarch, minister, help, make analysis: Sanguis Draxonis promoting blood circulation to remove blood stasis pain relieving in the side, be most commonly used to traumatic injury, the swelling and pain due to blood stasis of tendon breaking fracture is that orthopedics department uses key medicine always.So 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 go into edema caused by disorder of QI, this then specially goes into blood system." the sweet and tepor of Radix Dipsaci, can liver and kidney tonifying, hardship is let out hot loosing, and the blood vessels that can pass through, activating collaterals to relieve pain have benefit and can declare, and go and the characteristic of not letting out; " herbal classic ": " tonifying for the deficiency ... folding is hindered, reuniting the fractured tendons and bones." hot, the hardship, warm of Cortex Acanthopancis.Go into the Liver and kidney warp.The ability bone and muscle strengthening; " not Lu ": " ... the invigorating middle warmer benefit is smart, 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 is hindered, and falls and pounces on flogging injury." Semen Melo is sweet cold, is longer than blood circulation promoting and blood stasis dispelling, for traumatology fracture article commonly used, takes it in the synthetism folk prescription more.The hot Wen Xiang of Rhizoma Chuanxiong scurries, 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 are the gas medicine in the blood.So 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, goes into the blood promoting the circulation of blood, the blood and relieving pain that can loose, and reunion of bone, " Kaibao Bencao ": " treat folding and hinder, blood and relieving pain looses." above Six-element: Radix Dipsaci, the invigorating the liver and kidney of Cortex Acanthopancis ability principal drug assistance, promoting blood circulation, reuniting the fractured tendons and bones is treated folding and is hindered; 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 is ministerial drug altogether; Lignum Sappan is salty to go into blood, and suffering can be wandered away, the function blood circulation promoting and blood stasis dispelling, and reducing swelling and alleviating pain is the principal agent of traumatology; Pheretima is salty, cold, goes into liver, kidney channel.Can promoting blood circulation to remove obstruction in the collateral.Radix Angelicae Dahuricae wind-expelling pain-stopping, detoxifcation.Compendium of Material Medica: " hot temperature fragrance, wind-expelling pain-stopping removing toxic substances and promoting subsidence of swelling.... ... .. snakebite, cutter arrow incised wound." last three medicines are invigorated blood circulation, collateral dredging, pain relieving.Can treat the disease of holding concurrently by principal drug assistance, be adjuvant drug altogether.The Radix Glycyrrhizae sweet in the mouth is gone into 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, detoxifcation." the Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, priming is returned through being to be messenger drug; Rhizoma Chuanxiong is sensible up and down, penetrating meridians, the usefulness of messenger drug of also holding concurrently; Two medicines share and more can guide all medicines to reach meridians thoroughly, through sick institute.All medicines share the drug effect complementation, play the merit of promoting blood circulation and stopping pain, the kidney invigorating symplectic bone, blood stasis dispersing and deswelling altogether.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 method for preparing of the Chinese medicine composition of set a broken bone disease among the present invention, step is following:

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

(2) extraction of decocting medicine: take by weighing 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; Decocte with water 1-3 time filters merging filtrate; Be evaporated to the thick paste of relative density 1.25-1.30 (50 ℃), subsequent use;

(3) mixing of medicine and drying: Radix Notoginseng, the Radix Angelicae Dahuricae, Pyritum 3 herbal medicine fine powders in the step (1) are added in the extractum that extracts, and mixing is put 65-70 ℃ of vacuum drying, pulverizes, and is subsequent use;

(4) packing of medicine: with incremental method and fine powder of dragons blood mixing, packing promptly gets with above mixed powder.

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

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

Said discriminating to Radix Dipsaci is specifically:

Get this medicament content 3g, put in the apparatus,Soxhlet's, add chloroform 100ml, reflux 2 hours is taken out; Dry, put again in the apparatus,Soxhlet's, add methanol 100ml, reflux 3 hours, extracting solution evaporate to dryness; Residue adds water 40ml, and slight fever makes dissolving, and with water saturated n-butanol extraction 2 times, each 30ml merges n-butyl alcohol liquid; With 2% sodium hydroxide solution washing 2 times, each 30ml, alkali liquor discards, the saturated water washing of n-butyl alcohol liquid reuse n-butyl alcohol 3 times, each 30ml; Cleaning mixture discards, and n-butyl alcohol liquid evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution;

Other gets Radix Dipsaci control medicinal material 0.2g, adds methanol 15ml, and reflux, extract, 30 minutes is put coldly, filter, and the filtrating evaporate to dryness, residue adds methanol 2ml makes dissolving, as control medicinal material solution;

According to thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2005 B) test, draw each 3 μ l of above-mentioned 2 kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose; Upper solution with n-butyl alcohol-acetic acid-water (4:1:5) is developing solvent; Launch, take out, dry; Spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the principal spot of same color.

Said discriminating to Radix Notoginseng is specifically:

Get this medicament content 3g, put in the apparatus,Soxhlet's, add chloroform 100ml, reflux 2 hours is taken out; Dry, put again in the apparatus,Soxhlet's, add methanol 100ml, reflux 3 hours, extracting solution evaporate to dryness; Residue adds water 40ml, and slight fever makes dissolving, and with water saturated n-butanol extraction 2 times, each 30ml merges n-butyl alcohol liquid; With 2% sodium hydroxide solution washing 2 times, each 30ml, alkali liquor discards, the saturated water washing of n-butyl alcohol liquid reuse n-butyl alcohol 3 times, each 30ml; Cleaning mixture discards, and n-butyl alcohol liquid evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution;

Get Radix Notoginseng control medicinal material 0.5g, add methanol 15ml, reflux, extract, 30 minutes is put coldly, filter, and the filtrating evaporate to dryness, residue adds methanol 2ml makes dissolving, as control medicinal material solution.

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

Said discriminating to Radix Glycyrrhizae is specifically:

These article of getting content 3g adds water-saturated n-butanol 30ml, soaks 30 minutes, ultrasonic 15 minutes, filters; Filtrating is extracted 2 times with ammonia solution, and each 10ml merges ammonia solution, transfers pH value 1～2 with dilute hydrochloric acid, with ether extraction 2 times; Each 20ml discards ether solution, and water liquid reuse water-saturated n-butanol extracts 2 times, and each 20ml merges n-butyl alcohol liquid; With the saturated water washing of n-butyl alcohol 2 times, each 40ml gets n-butyl alcohol liquid water bath method, and residue adds methanol 2ml makes dissolving, as need testing solution;

Extracting liquorice medicinal powder 0.5g shines medical material solution in pairs with legal system in addition;

According to thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2005 B) test, draw each 3 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the 1%NaOH sodium carboxymethyl cellulose; With ethyl acetate-formic acid-glacial acetic acid-water (15:1:2:2) 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 the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence principal spot of same color.

Said inspection should meet " pertinent regulations under first appendix capsule of Chinese pharmacopoeia version in 2005 item.

The mensuration of said extractum: get this medicament content 4 g, the accurate title, decide, and measures according to the hot dipping under the ethanol-soluble extractives algoscopy item, makes solvent with 85% ethanol, must not be less than 30.0%.

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

The invigorate blood circulation research data and the documents and materials of bone recovering 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, choose the removal of impurity after, take by weighing expense in the prescription ratio, supplying water, it is subsequent use to fry in shallow oil.

(2) Radix Notoginseng, the Radix Angelicae Dahuricae (half amount), Pyritum 3 flavors take by weighing expense in the prescription ratio, and are after mixing is pulverized, subsequent use.

(3) Sanguis Draxonis is a valuable drug, takes by weighing expense in the prescription ratio, and is after pulverizing separately, subsequent use.

Two, preparation technology's research data:

(1) confirming of dosage form:

In view of this medicine is the medicine that is used to treat 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.Through the preparation of test agent in three batches, show that adopting this recipe quantity and preparing process thereof to prepare capsule suits.Its dose is each 4～6, and 3 times on the one, one takes the capsule total amount is 12～18.

The preparation result of test agent in (two) three crowdes: adopt prescription and technology among the embodiment 1 to prepare test agent in 10 batches altogether, wherein quality standard, stability test investigation and censorship are checked each 3 batches in sample and are joined 1 batch in addition.To supply the preparation result of three batches of pilot scale capsule samples that quality standard research uses to converge combines as follows at present.

1, the pulverizing of Sanguis Draxonis: take by weighing 10 times of recipe quantity Sanguis Draxonis in the prescription ratio, be crushed into fine powder by above-mentioned technology, sieve, test agent is pulverized in three batches must measure and yield is seen 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 by weighing 10 times of recipe quantities in the prescription ratio; By above-mentioned technology 3 flavors being pulverized is fine powder; Sieve, test agent is pulverized in three batches must measure and yield is seen 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 by weighing 10 times of recipe quantities in the prescription ratio _{(half amount)}, Radix Glycyrrhizae 8 flavor, add 8 times of water gagings by above-mentioned technology and decocted 2 hours, filter; Medicinal residues add 6 times of water gagings again, and the same decoction 1.5 hours filters; Merge filtrating 2 times, be evaporated to the thick paste of relative density 1.25-1.30 (50 ℃), the three batches of pilot scale sample water soft extracts must be measured and yield is seen table 3.

Herbal decoction must be measured and yield in three batches of pilot scale sample preparations of table 3

4, the mixing of medicine and drying: Radix Notoginseng, Semen Melo, Pyritum 3 herbal medicine fine powders are added in the extractum that extracts, and mixing is put 65-70 ℃ of vacuum drying, pulverizes, and three lot sample article fine drug powders must be measured and see table 4.

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

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

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 bone recovering capsules of above pilot scale preparation; Carry out quality inspection by the character in the quality determining method, discriminating, inspection, extractum etc.; And by " Chinese pharmacopoeia version (an one) in 2005 appendix X III C; " microbial limit test " checked; Each item quality index of the preparation of each batch pilot scale as a result sample all meets the relevant requirements of appended quality standard and medicine sanitary standard, and the quality of the pharmaceutical preparations is qualified, sees table 6.

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

The quality standard of bone recovering capsule of invigorating blood circulation is drafted explanation

One, about the prescription medical material explanation

These article 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 version (an one) in 2005.

Two, the explanation about writing out a prescription

Medical institutions' preparation of this application for registration " the bone recovering capsule of invigorating blood circulation " prescription; Be the high-new honor one Luan Zunyi president of hospital in Weifang on the basis of several generations secret prescription handed down in the family from generation to generation, the effective experience side of from long-term clinical practice, sum up, 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 has 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 these article is on the basis of consulting prescription 11 herbal medicine correlational study documents; Physicochemical property and former prescription tradition medication custom according to contained effective ingredient of each herbal medicine and main component; And the difference and the Sanguis Draxonis of combine respectively to distinguish the flavor of Chinese crude drug quality, hardness are the characteristics of valuable drug; Prescription 11 herbal medicines are divided into the independent pulverizing of Sanguis Draxonis, and the decocting of the mixing pulverizing 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 kept to this technology, thereby guaranteed the quality and the clinical efficacy of medicine.

Four, about the explanation of character

Character, color, abnormal smells from the patient according to three batches of pilot scale preparation samples are decided.

Five, the explanation (adopting prescription and quality determining method among the embodiment 1) about differentiating

1. [discriminating] (1) is the Radix Dipsaci in the discriminating side.Contain the Radix Dipsaci medical material in the prescription,, carry out thin layer chromatography, to differentiate existing of Radix Dipsaci so be contrast with the Radix Dipsaci medical material.Go back the preparation technology of analog sample and the method for preparing of need testing solution in the experiment, make scarce Radix Dipsaci blank liquid.The result shows, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the principal spot of same color, lacking the Radix Dipsaci blank does not then have this speckle, sees picture 1.

2. [discriminating] (2) are the Radix Notoginseng in the discriminating side.Contain pseudo-ginseng in the prescription,, carry out thin layer chromatography, to differentiate existing of Radix Notoginseng so be contrast with the pseudo-ginseng.Go back the preparation technology of analog sample and the method for preparing of need testing solution in the experiment, make scarce Radix Notoginseng blank liquid.The result shows, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the principal spot of same color, lacking the Radix Notoginseng blank does not then have this speckle, sees picture 2.

3. [discriminating] (3) are the Radix Glycyrrhizae in the discriminating side.Contain licorice medicinal materials in the prescription,, carry out thin layer chromatography, to differentiate existing of Radix Glycyrrhizae so be contrast with the licorice medicinal materials.Go back the preparation technology of analog sample and the method for preparing of need testing solution in the experiment, make scarce Radix Glycyrrhizae blank liquid.The result shows, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence principal spot of same color, lacking the Radix Glycyrrhizae blank does not then have this speckle, sees picture 3.

4. Sanguis Draxonis is differentiated the explanation that excludes the quality standard text: to the monarch drug Sanguis Draxonis in the prescription; With the Sanguis Draxonis control medicinal material is contrast, with reference to the method for distilling that the pharmacopeia Sanguis Draxonis is differentiated, has carried out the preparation and the thin layer of need testing solution by following method and has differentiated; But in the test sample chromatograph; Inspect at daylight and ultra-violet lamp (365nm), all do not see and the corresponding corresponding principal spot of Sanguis Draxonis control medicinal material, so the thin layer discriminating of Sanguis Draxonis is listed in the quality standard text; Its reason maybe because of Sanguis Draxonis with after other drug mixes, it is relevant that composition interferes with each other or produce the compound chemical reaction.It is following that need testing solution, ischemia exhaust the preparation and the concrete discrimination method of blank solution and Sanguis Draxonis control medicinal material solution.

(1) preparation of need testing solution: get these article content 3g, the 20ml that adds diethyl ether, jolting 10 minutes filters, the filtrating evaporate to dryness, residue adds ethyl acetate 2ml makes dissolving, as need testing solution.

(2) ischemia exhausts the preparation of blank solution: get the medical material of respectively distinguishing the flavor of except that Sanguis Draxonis in the prescription, the method for preparing of pressing the preparing process and the need testing solution of sample is processed ischemia and is exhausted 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 method for preparing, make Sanguis Draxonis control medicinal material solution 2ml.

(4) test method and result: the photograph thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2005 B) 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 be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, so that petroleum ether (60 ℃～90 ℃)-ethyl acetate-acetone (5:2:3) is developing solvent, launch; Take out, dry.Put under daylight and the ultra-violet lamp (365nm) and inspect respectively, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on; Do not see all and the corresponding corresponding principal spot of Sanguis Draxonis control medicinal material that (because employing pharmacopeia Sanguis Draxonis is differentiated a developing solvent down, Rf value is less after launching to see Fig. 4 and Fig. 5; And do not see corresponding principal spot with control medicinal material; After change above-mentioned developing solvent into, the principal spot Rf value is moderate, so select above-mentioned developing solvent in this test for use).

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

Six, the explanation about checking

By " the pertinent regulations under an appendix IL of Chinese pharmacopoeia version in 2005 the capsule item; Moisture in three batches of pilot scale preparation capsules, content uniformity, disintegration, extractum, microbial limit etc. are checked; Each item test rating of three lot sample article all complies with relevant regulations as a result; The quality of the pharmaceutical preparations is qualified, sees table 1 for details.

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

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

Because we are made up 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, have both contained animal, plant amedica, contain the mineral drug Pyritum again; And prescription drug is more; Complicated component shows through assay prerun, disturbs bigger between each composition; Be difficult to carry out the assay of composition, so pass through the inherent quality of this preparation of method control of mensuration ethanol-soluble extractives content.According to the physicochemical property of each effective ingredient of prescription and the preparation technology of these article, confirm with 85% ethanol to be solvent, adopt hot dipping this capsule to be carried out the mensuration of extractum.And according to " concrete assay method was below the hot dipping of " ethanol-soluble extractives algoscopy " had been worked out among Chinese pharmacopoeia version (an one) in 2005 the appendix XA " determination of extractives method ":

(1) mensuration of ethanol-soluble extractives: get the about 4g of these article, claim to decide weight, put in the conical flask of 100ml, accurate 85% ethanol 100ml, the jam-pack of adding; Claim decide weight, leave standstill 1 hour after, the connection reflux condensing tube is heated to boiling, and keeps little and boiled 1 hour; Put cold after, take off conical flask, close plug claims to decide weight; Supply the weight that subtracts mistake with 85% ethanol, shake up, filter with dry filter paper, precision is measured filtrating 25ml; Put in the evaporating dish that is dried to constant weight, water bath method is in 105 ℃ of dryings 3 hours, in the dislocation exsiccator; Cooled off 30 minutes, weight decided in accurate rapidly title, calculates the content of ethanol-soluble extractives in each test sample, and the mensuration result of three mass products blood bone recovering capsule ethanol-soluble extractiveses sees table 2.

The mensuration result of table 2 three mass products blood bone recovering capsule ethanol-soluble extractiveses

(2) confirming of ethanol-soluble extractives content limit: on the basis of quality standard three lot sample article determinations of extractives, again stability test and survey report and a collection of 7 lot sample article that supply clinical usefulness to prepare have been carried out the mensuration of ethanol-soluble extractives totally.According to the measured data (seeing table 3) of 10 batches of pilot scales preparation sample ethanol-soluble extractiveses, consider the mass discrepancy of Chinese crude drug between criticizing, tentative these article ethanol-soluble extractives must not be less than 30.0% in dry product.

The mensuration result of ten batches of pilot scale preparations of table 3 sample ethanol-soluble extractives

Eight, function cures mainly: same text.

Nine, usage and dosage: these article can instruct the doctor according to state of an illness weight and take the circumstances into consideration to increase or reduce dose down.

Ten, specification and storage: same text.

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

The bone recovering 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, be guidance with the Chinese medical theory, from long-term clinical practice, sum up the effective experience side and the preparation thereof of coming out.A large amount of clinical observations show that this side has promoting blood circulation and stopping pain, the kidney invigorating symplectic bone, and the effect of blood stasis dispersing and deswelling all has definite therapeutic effect to fracture, soft tissue injury, cervical spondylosis, prolapse of lumbar intervertebral disc etc.For objective evaluation the invigorate blood circulation safety and the effectiveness of bone recovering capsule,, following retrospective clinical efficacy is carried out in clinical treatment situation and safety over nearly 5 years sum up with reference to Ministry of Public Health " new Chinese medicine clinical guidance principle ".

One, physical data

(1) case source: all cases all derive from the court's outpatient service and inpatient, from January, 2006 to 2010 year December adopt invigorate blood circulation patients such as bone recovering capsule treatment fracture, soft tissue injury, cervical and lumbar diseases totally 206 examples, wherein fracture and soft tissue injury 120 examples; Cervical spondylosis 43 examples; Prolapse of lumbar intervertebral disc 43 examples, other establishes 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: through statistical analysis treatment group and matched group there are no significant at aspects such as sex, age, state of an illness distributions difference, P>0.05, two group have comparability.See table 1-3.

The comparison of table 1 liang group sex

Annotate: * compares P for two groups>0.05.

The comparison at table 2 liang group age

Annotate: * compares P for two groups>0.05.

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

Annotate: * compares P for two groups>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 examination is confirmed 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 spondylosis 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, symptoms such as tinnitus are felt sick in headache.

2. there is tenderness on cervical spine or vertebra side, and the intervertebral foramina compression test is positive, and the brachial plexus distraction test is positive, revolves the neck test positive.

Cervical vertebra X line 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 inspection, 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 °, symptoms such as limitation of activity.

2, there is tenderness on spinous process of lumbar vertebra or vertebra side, and the intervertebral foramina compression test is positive.

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 the interspace of lumbar vertebrae narrows down etc.

(4) symptom, sign score and state of an illness grade scale

1 symptom, sign score standard

Local pain

Normally: limbs do not have pain and treatment back pain disappearance person, are 0 minute.

Slightly: the injury sense is swollen or mild pain when static, and the person of increasing the weight of when movable is 1 minute.

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

Severe: the obvious pain in injury when static, be reluctant the movable limb person that suffers from, be 3 minutes.

Swelling

Normally: no swelling, directly identical with strong side limbs week, be 0 minute.

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

Moderate: injury skin is nervous, and 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 no tenderness person is 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: no spasm of flaccid muscles is 0 minute.

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

Moderate: muscle spasm, poor flexibility is 2 minutes.

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

Dysfunction

Normally: joint motion freely, the affected part does not have pain, is 0 minute.

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

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

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

Skin temperature

Normally: skin does not normally have rising person, is 0 minute.

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

Moderate: the skin temperature rise is the person obviously, is 2 minutes.

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

2 state of an illness grade scales

Slightly: symptom, sign total mark < 6 minutes.

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

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

Three, case is included standard in

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

Four, case exclusion standard

1, suffers from severe cardiac, liver, kidney and disease of hematopoietic system, 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, does not accomplish Drug therapy by doctor's advice and observes the course of treatment, can't judge curative effect, or not congruent affecting the treatment property of data and safety judgement person, or is participating in the other drug experimenter.

Five, methods of clinical observation

(1) observes case group technology and medicine

1, treatment group: the bone recovering 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 of treatment:

1, treatment group: the bone recovering capsule of invigorating blood circulation, a 4-6 grain, 3 times on the one, or follow the doctor's advice.4 weeks were a course of treatment, used 1～3 course of treatment continuously.

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

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

(2) cervical and lumbar diseases patient's clinical symptoms and sign variations such as pain before and after the observation medication.

(3) situation of change of patients' such as fracture, cervical and lumbar diseases X sheet before and after the observation medication.

(4) criterion of therapeutical effect

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

(1) total effects evaluation criteria: be total to various countries' Ministry of Public Health officina new drugs (Chinese medicine) clinical research guideline according to the Chinese people in 1989; Adopt the method for own control; The relatively symptom before and after the patient treatment, the variation of sign index is 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 skiagram 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 disappear basically, or slight pain is arranged, or sense of discomfort is arranged after the 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 portable work, doing well,improving rate 30%≤n＜70%.

Invalid: symptom, sign change less or do not have change, doing well,improving rate＜30%.

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

2, the criterion of therapeutical effect of cervical spondylosis

With reference to " traditional Chinese medical science disease diagnosis criterion of therapeutical effect " and Ministry of Health of the People's Republic of China's " new Chinese medicine clinical research guideline ", and combine synthetic determinations such as symptom, sign integration, TCD and X ray examination.

(1) clinical cure: symptom, sign complete obiteration, functional rehabilitation is normal, and the basic normal or X line of TCD is taken the photograph sheet and is obviously improved, and symptom, sign integration improvement rate are more than 95%.

(2) produce effects: symptom, sign disappear basically, and TCD has obvious change or X line to take the photograph sheet to make moderate progress, and symptom, sign integration improvement rate are 65% ~ 95%.

(3) effective: symptom, sign improvement, TCD and X ray examination have the improver, and symptom, sign integration improvement rate are 30% ~ 65%.

(4) invalid: symptom, sign do not have improvement, TCD and X ray examination and do not have change, and symptom, sign integration improvement rate are below 30%.Integration * 100% before integration improvement rate=(integration before the treatment-treatment back integration) ÷ 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 diagnosis criterion of therapeutical effect " prolapse of lumbar intervertebral disc.

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

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

(3) invalid: treatment back symptom, sign do not have improvement.

Six, clinical curative effect analysis

(1) efficacy analysis of fracture and soft tissue injury

To the patient that fracture is arranged reset earlier fixing after, take the bone recovering capsule of invigorating blood circulation again, the person that only has the soft tissue injury and do not have directly oral capsule of fracture patient, a 4-6 grain, 3 times on the one.Employing invigorate blood circulation bone recovering capsule medicine treatment fracture and soft tissue injury, the patient is totally 120 examples, fracture patient 50 examples wherein, soft tissue injury 70 examples, other establishes GUZHE CUOSHANG JIAONANG matched group 65 examples.Bone recovering 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 the treatment group is superior to matched group (P < 0.05).

1, clinical total effects is relatively seen table 4.

The clinical total effects in table 4 medication two weeks back relatively

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

2, symptom, sign curative effect are relatively seen table 5.

Symptom, sign curative effect are relatively after two weeks of table 5 medication

Annotate: * compares P < 0.05 with matched group.

3, the analysis of severity extent and curative effect is adopted bone recovering 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%; Slight total effective rate with moderate fracture and soft tissue injury is 100%, and is 94.6% severe patient's total effective rate, but this capsule to slightly and moderate patient's clinical cure rate and cure-remarkable-effectiveness rate (healing+produce effects) all apparently higher than the severe patient; Show that the bone recovering capsule of invigorating blood circulation is better to the patients with mild curative effect, see table 6.

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

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

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

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

Annotate: compare with a course of treatment ^*P<0.05

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

1. the curative effect situation of the bone recovering capsule of invigorating blood circulation treatment cervical and lumbar diseases: adopt bone recovering capsule treatment cervical spondylosis patient 43 examples of invigorating blood circulation, cure rate is 41.9%, and 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%; The treatment group is superior to matched group, sees table 8 for details.

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

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

2. TCD relatively before and after the treatment group treatment: the relative analysis of TCD inspection average peak flow velocity (VM) shows before and after the treatment; There were significant differences for treatment front and back patient's the vertebral artery and the variation of basilar artery average peak flow velocity (P 0.05); And the improvement situation of cervical vertebra-basilar artery obviously is superior to matched group (P < 0.05), sees table 9.

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

Annotate: * and the preceding relatively P < 0.05 of treatment

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

Awarding the bone recovering capsule treatment of invigorating blood circulation after the prolapse of lumbar intervertebral disc patient resetted earlier again, adopt bone recovering capsule treatment prolapse of lumbar intervertebral disc 43 examples of invigorating blood circulation, is 39.5% to the cure rate of prolapse of lumbar intervertebral disc; 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 the treatment group is superior to matched group, sees table 10 for details.

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

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

(4) safety testing result

Respectively select 30 examples to carry out blood, urine, just reach electrocardio, liver, kidney function test before and after treatment group and the treatment of control group; The equal no abnormality seen of each item test rating before and after two groups of treatments of result; Show that two groups of medicines are not to human body electrocardio, liver, renal function and blood, urine, just all have an obviously influence; And also do not meet quick between the operating period and other untoward reaction generations, safe in utilization, see 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 of treatment group, what treatment was the longest was 3 courses of treatment, did not all see obvious adverse reaction and toxic and side effects minimum 1 course of treatment, showed that this preparation takes safety.

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

Model case 1: Qin Lian virtue woman 59 years old, Kuiwen District storehouse South St people is because of right knee joint function obstacle; Increased the weight of 4 years, in my rehabilitation section of the institute treatment of 2010 8 monthly incomes, right knee joint pain is obvious when coming institute; Pain increases the weight of during upper and lower stair, abrasive feel is arranged during the knee joint activity, bend and stretch limitedly, comes institute to have a medical check-up: right knee joint swelling, interior talipes varus; Passive activity can touch bone and wipe sense, 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.Go into the oral bone recovering capsule of invigorating blood circulation after my institute, a 4-6 grain, 3 times on the one; Take that right knee joint pain obviously alleviates after 7 days, the right knee joint pain symptom of being in hospital when leaving hospital in 28 days is alleviated basically, and the joint has not had swelling; Right mild pain is followed up a case by regular visits to the right gonalgia transference cure during upper and lower stair behind the first quarter moon of leaving hospital; Activity is judged as clinical cure freely.

Model case 2: patient Zheng east brightness woman 47 years old Hubei people from Huang gang builder examines over 2 days because of wound causes lumbago, throws from 5 meters eminences during work high above the ground before 2 days, and buttocks lands, and sense waist severe pain dare not be movable; Film making is shown in 89 hospitals of PLA: waist 4 vertebral compression fractures, suggestion row operative treatment, patient's refusal; Come my institute out of admiration for a famous person, come institute to have a medical check-up: lumbar vertebra bends that degree becomes straight, the both sides musculus sacrospinalis is stiff, L4 spinous process place tenderness, percussion pain, is diagnosed as: waist 4 vertebral compression fractures.After going into my institute and giving reduction therapy earlier, the oral bone recovering capsule of invigorating blood circulation, a 4-6 grain, 3 times on the one, take 2 week back lumbago symptoms alleviate basically, the lumbar vertebra activity freely, take January after, the lumbago symptom is alleviated fully; The X line 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 woman, because of wound causes right ankle joint pain and swelling, difficulty 3 days; In my institute of 2010 10 monthly incomes, sprain right ankle accidentally when going downstairs before 3 days, feel right ankle sharp ache immediately, stiff; The rapid swelling in injury, X-ray sheet no abnormality seen, have a medical check-up: right swollen ankles, the sole of the foot is bent, the back of the body is stretched; The obvious limited companion's pain of turning up, internal malleolus place tenderness is diagnosed as right ankle soft tissue injury.The oral bone recovering capsule of invigorating blood circulation after being admitted to hospital, a 4-6 grain, 3 times on the one, pain symptom alleviates slightly after 7 days; Swelling is still obvious, and activity is still limited, takes the back pain symptom disappearance of 2 weeks; Slight swelling is only arranged, activity freely, continued was taken medicine for 2 weeks; Pain and swelling disappears when following up a case by regular visits to, and activity is judged as clinical cure freely.

Model case 4:2006 October, Yao town peasant Liu Anji of Anqiu City Liu family is because of " lumbago companion right lower extremity pain 5 years increases the weight of half a year " moves in my rehabilitation section of institute.Left lower extremity sharp ache when being admitted to hospital need be leant on the crutch walking, and night, pain had difficulty in going to sleep.Have a medical check-up: lumbar curvature becomes straight, L4/5, the other tenderness companion of 1.5cm place lower limb radiating pain, the left buttocks piriformis traveling place tenderness surveyed in a left side, L5/S1 spinous process gap; The slight atrophy of left lower extremity muscle, left lower extremity are looked into lower limb and are raised test 40 ° of (+), reinforcement tests (+), and the side skin superficial sensibility of left leg place is gone down; The left side big toe back of the body is stretched power; The sole of the foot is bent power and is weakened, and left knee jerk is normal, and left Achilles tendon reflex weakens.Babinski sign (-), lumbar vertebra CT; L4/5, L5/S1 intervertebral disk hernia are diagnosed as " intervertebral disc prolapse ", the Duo Jia clinic row traditional Chinese massage in Anqiu before the patient is admitted to hospital, and the Dressed plaster treatment does not all have positive effect.After going into my institute and giving reduction therapy earlier, the oral bone recovering capsule of invigorating blood circulation, a 4-6 grain, 3 times on the one, serve on for 2 weeks after, waist sour jujube lower limb pain obviously alleviates, be in hospital when leaving hospital in 30 days lumbago and left lower extremity pain symptom are alleviated basically, walking does not have the pain outbreak night freely.The continued of leaving hospital is taken medicine and 2 weeks was consolidated curative effect.After repeatedly phone follow up a case by regular visits to, 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 is because of " lumbago companion right lower extremity sharp ache, numb 2 years "; Move in my rehabilitation section of institute in May, 2007, the right lower extremity sharp ache had intermittent claudication at that time; Have a medical check-up: lumbar vertebra left lateral bend, the right side 1.5cm in L4/5 spinous process gap place tenderness, no lower limb radiating pain; Buttocks does not have tenderness, and the lower limb muscles atrophy is arranged, and right lower extremity is looked into lower limb and raised test 50 ° (+) and strengthen the outside skin superficial sensibility of test (+) right leg and go down; The right big toe back of the body power of stretching weakens, and sole of the foot power in the wrong is normal, and knee jerk is normal; Right Achilles tendon reflex weakens, and lumbar vertebra CT shows: L4/5 intervertebral disk hernia and spinal canal stenosis are diagnosed as " prolapse of lumbar intervertebral disc and spinal stenosis "; After going into my institute and giving reduction therapy earlier, the oral bone recovering capsule of invigorating blood circulation, a 4-6 grain; 3 times on the one, serve on for 2 weeks after, lumbago and right lower extremity pain symptom are alleviated basically; Walk freely, only right lower extremity has slight feeling of numbness, the back oral drugs after treatment 20 days of leaving hospital; All symptoms all had alleviation when phone was followed up a case by regular visits to, and not recurrence again is judged as clinical cure so far.

Model case 6: Lu builds 55 years old Shuan Tai people from town of retired Changyi City of flourish woman, moves in my rehabilitation section of institute because of " lumbago companion right lower extremity pain 3 years " in April, 2009, and the patient was main with lumbago at that time; Sitting and when bending over activity pain obvious, have a medical check-up: lumbar vertebra is bent degree and is become straight, L5 spinous process place tenderness, percussion pain; The tenderness companion of 1cm place, right side, L5/S1 spinous process gap lower limb radiating pain; Look into lower limb and raise test (-), the skin numbness is unusual, and two big toe back forces are normal; The sole of the foot bend 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 °) is diagnosed as " lumbar spondylolisthesis, prolapse of lumbar intervertebral disc "; After going into my institute and giving reduction therapy earlier, the oral bone recovering capsule of invigorating blood circulation, a 4-6 grain, 3 times on the one; Took 7 days, waist and right lower extremity pain symptom alleviate slightly, take 2 all backs symptoms and obviously alleviate, and symptom is alleviated fully when leaving hospital in 4 weeks in hospital; Do not occur untoward reaction in the 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.With headache, dizzy symptom is outstanding, and symptom is obvious during rotation, and the how tame inside the province large hospital of going to a doctor before this adopts multiple way to treat, and does not all have positive effect, after come my institute out of admiration for a famous person.Human health screening: cervical vertebra is bent degree and is become straight, muscle rigidity, and tenderness is obvious between neck 4-7 spinous process; Right upper extremity is radiated pain, anteflexion neck test (+) pressure head test (+), the neural distraction test (+) of left arm clump of revolving; 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 become straight; Be diagnosed as: cervical spondylosis (mixed type).After the patient is admitted to hospital, the orally give bone recovering capsule of invigorating blood circulation, a 4-6 grain, 3 times on the one, the cervical pain malaise symptoms is alleviated basically after 10 days, and headache, dizziness, left upper extremity pain and numbness obviously alleviate; The cervical region pain symptom is alleviated fully after 20 days, and idol has headache, dizzy sense, and left upper extremity has slight numbness; The continued of leaving hospital is taken medicine 2 weeks of after treatment, follows 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 all symptoms all disappear when following up a case by regular visits to after half a year, and not recurrence is judged as clinical cure so far.

Model case 8: 52 years old people from Luohu District of civil servant Shenzhen of the precious living man of grandson, come my institute out of admiration for a famous person in June, 2009, move in rehabilitation section.The patient suffers from multiple diseases such as " intervertebral disk hernia are levied, cervical spondylosis, rheumatoid arthritis ".Physical examination: cervical vertebra is bent degree and is become tenderness, pressure head test (+) between straight, L4-L7 sour jujube, the neural distraction test (+) of left arm clump, and the both hands grip descends; Left side 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, cervical vertebra is bent degree and is become straight, L4/5,1.5cm place, right side, L5/S1 spinous process gap tenderness; Right lower extremity is looked into lower limb and is raised 50 ° (+) of test, and it is unusual to strengthen test (+) skin numbness, 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 orally give bone recovering 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 begin to alleviate, take 2 week all symptoms of back obviously alleviate, take 4 week all symptoms of back alleviate basically; Both hands interphalangeal joint pain also obviously alleviates, and leaves hospital after the January of being in 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 bone recovering capsule of invigorating blood circulation to treat various patient's 206 examples such as fracture, soft tissue injury altogether; Wherein, fracture and soft tissue injury 120 examples, cervical spondylosis 43 examples, lumbar intervertebral disc synapse 43 examples; Other establishes 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.The treatment group is 66.7% to the fracture and the cure rate of soft tissue injury, and total effective rate is 96.7%, is superior to 44.6% (P < 0.01) and 89.2% of matched group respectively; Cure rate to cervical spondylosis is 41.9%, and total effective rate is 93.0%, is superior to 31.4% (P < 0.01) and 85.7% of matched group respectively; Cure rate to prolapse of lumbar intervertebral disc is 39.5%, and total effective rate is 90.7%, is superior to 31.6% (P < 0.05) and 84.2% of matched group respectively; Do not see obvious adverse reaction in the clinical practice, safe in utilization, above result shows; These article all have significant curative effect to above-mentioned disease, are a kind of medicines of ideal treatment safely and effectively.

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

The legislation of this capsule is with promoting blood circulation and stopping pain, and the kidney invigorating symplectic bone, blood stasis dispersing and deswelling are the rule of treatment, and Sanguis Draxonis promoting blood circulation to remove blood stasis pain relieving in the side is 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.So 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 go into edema caused by disorder of QI, this then specially goes into blood system." the sweet and tepor of Radix Dipsaci, can liver and kidney tonifying, hardship is let out hot loosing, and the blood vessels that can pass through, activating collaterals to relieve pain have benefit and can declare, and go and the characteristic of not letting out; " herbal classic ": " tonifying for the deficiency ... folding is hindered, reuniting the fractured tendons and bones." hot, the hardship, warm of Cortex Acanthopancis.Go into the Liver and kidney warp.The ability bone and muscle strengthening; " not Lu ": " ... the invigorating middle warmer benefit is smart, 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 is hindered, and falls and pounces on flogging injury." Semen Melo is sweet cold, is longer than blood circulation promoting and blood stasis dispelling, for traumatology fracture article commonly used, takes it in the synthetism folk prescription more.The hot Wen Xiang of Rhizoma Chuanxiong scurries, 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 are the gas medicine in the blood.So 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, goes into the blood promoting the circulation of blood, the blood and relieving pain that can loose, and reunion of bone, " Kaibao Bencao ": " treat folding and hinder, blood and relieving pain looses." above Six-element: Radix Dipsaci, the invigorating the liver and kidney of Cortex Acanthopancis ability principal drug assistance, promoting blood circulation, reuniting the fractured tendons and bones is treated folding and is hindered; 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 is ministerial drug altogether; Lignum Sappan is salty to go into blood, and suffering can be wandered away, the function blood circulation promoting and blood stasis dispelling, and reducing swelling and alleviating pain is the principal agent of traumatology; Pheretima is salty, cold, goes into liver, kidney channel.Can promoting blood circulation to remove obstruction in the collateral.Radix Angelicae Dahuricae wind-expelling pain-stopping, detoxifcation.Compendium of Material Medica: " hot temperature fragrance, wind-expelling pain-stopping removing toxic substances and promoting subsidence of swelling.... ... .. snakebite, cutter arrow incised wound." last three medicines are invigorated blood circulation, collateral dredging, pain relieving.Can treat the disease of holding concurrently by principal drug assistance, be adjuvant drug altogether.The Radix Glycyrrhizae sweet in the mouth is gone into 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, detoxifcation." the Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, priming is returned through being to be messenger drug; Rhizoma Chuanxiong is sensible up and down, penetrating meridians, the usefulness of messenger drug of also holding concurrently; Two medicines share and more can guide all medicines to reach meridians thoroughly, through sick institute.All medicines share the drug effect complementation, play the merit of promoting blood circulation and stopping pain, the kidney invigorating symplectic bone, blood stasis dispersing and deswelling altogether.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.

Description of drawings

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 materials 5. feminine genders);

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

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

The specific embodiment

Through instantiation the present invention is further set forth below, should be noted that following explanation only is in order to explain the present invention, its content not to be limited.

Embodiment 1

The sick Chinese medicine composition (the bone recovering capsule of promptly invigorating blood circulation) of a kind of set a broken bone is made up 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 contained effective ingredient of each medicine and main component; Carried out the master-plan of preparation production technique; And the quality of product analyzed, worked out the quality standard of these article, the testing data and the documents and materials brief introduction of the bone recovering capsule quality research work of at present will invigorating blood circulation are following.

Invigorate blood circulation the bone recovering capsule quality standard (draft) and draft explanation

The bone recovering capsule of invigorating blood circulation

Huoxüe?Gukang?Jiaonang

[method for making] above 11 flavors, Sanguis Draxonis is pulverized to fine powder, and is subsequent use.Radix Notoginseng, the Radix Angelicae Dahuricae (half amount), Pyritum 3 are distinguished the flavor of, and pulverize to be fine powder, and be subsequent use.All the other Radix Dipsacis, Cortex Acanthopancis, Pheretima, Rhizoma Chuanxiong, Semen Melo, Lignum Sappan, the Radix Angelicae Dahuricae (half amount), Radix Glycyrrhizae 8 flavors add 8 times of water gagings and decocted 2 hours, filter; Medicinal residues add 6 times of water gagings again, and the same decoction 1.5 hours filters; Merge filtrating twice, be evaporated to the thick paste of relative density 1.25-1.30 (50 ℃), add Radix Notoginseng, the Radix Angelicae Dahuricae (half amount), Pyritum 3 herbal medicine fine powders; Put 65-70 ℃ of vacuum drying, pulverize, with incremental method and fine powder of dragons blood mixing; Pack in 1000 capsules by every 0.42g, promptly get.

[character] these article are capsule, and content is that light brown is to chocolate brown powder; Feeble QI is fragrant, mildly bitter flavor.

These article content 3g is got in [discriminating] (1), puts in the apparatus,Soxhlet's, adds chloroform 100ml, and reflux 2 hours is taken out; Dry, put again in the apparatus,Soxhlet's, add methanol 100ml, reflux 3 hours, extracting solution evaporate to dryness; Residue adds water 40ml, and slight fever makes dissolving, and with water saturated n-butanol extraction 2 times, each 30ml merges n-butyl alcohol liquid; With 2% sodium hydroxide solution washing 2 times, each 30ml, alkali liquor discards, the saturated water washing of n-butyl alcohol liquid reuse n-butyl alcohol 3 times, each 30ml; Cleaning mixture discards, and n-butyl alcohol liquid evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution.Other gets Radix Dipsaci control medicinal material 0.2g, adds methanol 15ml, and reflux, extract, 30 minutes is put coldly, filter, and the filtrating evaporate to dryness, residue adds methanol 2ml makes dissolving, as control medicinal material solution.According to thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2005 B) test, draw each 3 μ l of above-mentioned 2 kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose; Upper solution with n-butyl alcohol-acetic acid-water (4:1:5) is developing solvent; Launch, take out, dry; Spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the principal spot of same color.

(2) get Radix Notoginseng control medicinal material 0.5g, add methanol 15ml, reflux, extract, 30 minutes is put coldly, filter, and the filtrating evaporate to dryness, residue adds methanol 2ml makes dissolving, as control medicinal material solution.According to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B) test, draw above-mentioned discriminating (1) down need testing solution and each 3 μ l of above-mentioned control medicinal material solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose; With 10 ℃ of lower floor's solution with held of chloroform-ethyl acetate-methanol-water (15:40:22:10) is developing solvent; Launch, take out, dry; Spray is with 10% ethanol solution of sulfuric acid, and it is clear to be heated to the speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the principal spot of same color.

(3) get these article content 3g, add water-saturated n-butanol 30ml, soaked 30 minutes, ultrasonic 15 minutes, filter; Filtrating is extracted 2 times with ammonia solution, and each 10ml merges ammonia solution, transfers pH value 1～2 with dilute hydrochloric acid, with ether extraction 2 times; Each 20ml discards ether solution, and water liquid reuse water-saturated n-butanol extracts 2 times, and each 20ml merges n-butyl alcohol liquid; With the saturated water washing of n-butyl alcohol 2 times, each 40ml gets n-butyl alcohol liquid water bath method, and residue adds methanol 2ml makes dissolving, as need testing solution.Extracting liquorice medicinal powder 0.5g shines medical material solution in pairs with legal system in addition.According to thin layer chromatography (" an appendix VI of Chinese pharmacopoeia version in 2005 B) test, draw each 3 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the 1%NaOH sodium carboxymethyl cellulose; With ethyl acetate-formic acid-glacial acetic acid-water (15:1:2:2) 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 the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence principal spot of same color.

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

[mensuration of extractum] is got the about 4g of these article content, and accurate the title decides, and measures according to the hot dipping (appendix XA) under the ethanol-soluble extractives algoscopy item, makes solvent with 85% ethanol, 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.Be used 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.

Shady and cool dry place is put in [storage] sealing.

Present embodiment " the bone recovering capsule of invigorating blood circulation " is a Luan Shi family through " Luan Tongcheng ", " Luan Zhang it ", the sick secret prescription handed down in the family from generation to generation preparation of " Luan Zunyi " three generations human therapy bone injury; Having experienced the individual practises medicine; In a plurality of stages such as cooperative medical service, the cooperation of town hospital, nineteen ninety-five, Hanting District health bureau ratified to have set up " clinic of Luan Zhang " through the Weifang City.Calendar year 2001 is carried out cooperative with medical treatment with Hanting District Shuan Yangdian town hospital on the basis of clinic, health bureau ratifies formally to have set up Weifang high-new honor one hospital in December, 2004 through the high and new technology industrial development zone, Weifang City." the bone recovering capsule medicine of invigorating blood circulation " all is applied to clinical with the form of the personal preparation of autogamy in each stage of above-mentioned each medical and health organization; Use in the clinic of Luan Zhang from nineteen ninety-five and to count, so far the time in existing 12 years, annual set a broken bone patient reaches up to ten thousand person-times; And obtained good curative effect; And do not see toxic and side effects, safe in utilization, obtain the high evaluation of extensive patients and relevant government department.For improving the health preparation condition of said preparation; Formally declared the hospital preparation chamber in 2006; And obtained approval, issue medical institutions' Chinese medicine preparation licence, and introduced 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 sick clinical practice of long-term treatment bone injury, said preparation has obtained local and the peripheral masses' height trusts, and receives the welcome of extensive patients deeply.Increase along with out-patient's therapeutic dose; The demand of " the bone recovering capsule medicine of invigorating blood circulation " also strengthens day by day; For the preparing process of further standard said preparation, set up the strong quality standard of controllability, guarantee the quality and the clinical efficacy of formulated; So will " the bone recovering capsule medicine of invigorating blood circulation " application for registration medical institutions preparation, to satisfy the needs of the clinical application of increase day by day.

Embodiment 2

The Chinese medicine composition that a kind of set a broken bone is sick, it is the medicament of processing by with following Chinese medicine raw materials by weight proportion:

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

Embodiment 3

The Chinese medicine composition that a kind of set a broken bone is sick, it is the medicament of processing by with following Chinese medicine raw materials by weight proportion:

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

Claims (10)

1. the sick Chinese medicine composition of a set a broken bone is characterized in that it is the medicament of processing by with following Chinese medicine raw materials by weight proportion:

2. the Chinese medicine composition that set a broken bone according to claim 1 is sick is characterized in that wherein the weight proportion of each raw material is:

3. the Chinese medicine composition that set a broken bone according to claim 1 and 2 is sick is characterized in that said medicament is a capsule.

4. the method for preparing of the sick Chinese medicine composition of the described set a broken bone of claim 3 is characterized in that step is following:

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

(2) extraction of decocting medicine: take by weighing 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; Decocte with water 1-3 time filters merging filtrate; Be evaporated to the thick paste of relative density 1.25-1.30 (50 ℃), subsequent use;

(3) mixing of medicine and drying: Radix Notoginseng, the Radix Angelicae Dahuricae, Pyritum 3 herbal medicine fine powders in the step (1) are added in the extractum that extracts, and mixing is put 65-70 ℃ of vacuum drying, pulverizes, and is subsequent use;

(4) packing of medicine: with incremental method and fine powder of dragons blood mixing, packing promptly gets with above mixed powder.

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

6. the quality determining method of the sick Chinese medicine composition of the described set a broken bone of claim 3; It is characterized in that; It comprises the mensuration project to discriminating project, inspection item and the extractum of Radix Dipsaci, Radix Notoginseng, Radix Glycyrrhizae; Said discriminating to Radix Dipsaci is to be contrast, to be that n-butyl alcohol-acetic acid-water of 4:1:5 is that developing solvent launches on the silica gel g thin-layer plate that is binding agent with the sodium carboxymethyl cellulose with the volume ratio with the Radix Dipsaci control medicinal material, is the tlc identification method of developer with 10% ethanol solution of sulfuric acid; Said discriminating to Radix Notoginseng is to be contrast, to be that chloroform-ethyl acetate-methanol-water of 15:40:22:10 is that developing solvent launches on the silica gel g thin-layer plate that is adhesive with the sodium carboxymethyl cellulose with the volume ratio with the Radix Notoginseng control medicinal material, is the tlc identification method of developer with 10% ethanol solution of sulfuric acid; Said discriminating to Radix Glycyrrhizae be with the licorice medicinal materials powder be contrast, with the volume ratio be ethyl acetate-formic acid-glacial acetic acid-water of 15:1:2:2 be developing solvent on the silica gel g thin-layer plate that with the 1%NaOH sodium carboxymethyl cellulose is adhesive, launch, with 10% ethanol solution of sulfuric acid at developer and the tlc identification method that under uviol lamp, develops the color.

7. quality determining method according to claim 5 is characterized in that, said discriminating to Radix Dipsaci specifically:

Get this medicament content 3g, put in the apparatus,Soxhlet's, add chloroform 100ml, reflux 2 hours is taken out; Dry, put again in the apparatus,Soxhlet's, add methanol 100ml, reflux 3 hours, extracting solution evaporate to dryness; Residue adds water 40ml, and slight fever makes dissolving, and with water saturated n-butanol extraction 2 times, each 30ml merges n-butyl alcohol liquid; Use unit to be 2% sodium hydroxide solution of mg/ml washing 2 times, each 30ml, alkali liquor discards, the saturated water washing of n-butyl alcohol liquid reuse n-butyl alcohol 3 times, each 30ml; Cleaning mixture discards, and n-butyl alcohol liquid evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution;

Other gets Radix Dipsaci control medicinal material 0.2g, adds methanol 15ml, and reflux, extract, 30 minutes is put coldly, filter, and the filtrating evaporate to dryness, residue adds methanol 2ml makes dissolving, as control medicinal material solution;

According to thin layer chromatography test, draw each 3 μ l of above-mentioned 2 kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose; The upper solution that with the volume ratio is n-butyl alcohol-acetic acid-water of 4:1:5 is developing solvent; Launch, take out, dry; Spray is 10% ethanol solution of sulfuric acid of g/ml with the unit, and it is clear to be heated to speckle colour developing.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the principal spot of same color.

8. quality determining method according to claim 5 is characterized in that, said discriminating to Radix Notoginseng specifically:

Get this medicament content 3g, put in the apparatus,Soxhlet's, add chloroform 100ml, reflux 2 hours is taken out; Dry, put again in the apparatus,Soxhlet's, add methanol 100ml, reflux 3 hours, extracting solution evaporate to dryness; Residue adds water 40ml, and slight fever makes dissolving, and with water saturated n-butanol extraction 2 times, each 30ml merges n-butyl alcohol liquid; Use unit to be 2% sodium hydroxide solution of mg/ml washing 2 times, each 30ml, alkali liquor discards, the saturated water washing of n-butyl alcohol liquid reuse n-butyl alcohol 3 times, each 30ml; Cleaning mixture discards, and n-butyl alcohol liquid evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution;

Get Radix Notoginseng control medicinal material 0.5g, add methanol 15ml, reflux, extract, 30 minutes is put coldly, filter, and the filtrating evaporate to dryness, residue adds methanol 2ml makes dissolving, as control medicinal material solution;

According to thin layer chromatography test, draw each 3 μ l of above-mentioned need testing solution and above-mentioned control medicinal material solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose; Chloroform-ethyl acetate-the methanol-water that with the volume ratio is 15:40:22:10 is developing solvent at 10 ℃ of lower floor's solution with held; Launch, take out, dry; Spray is 10% ethanol solution of sulfuric acid of g/ml with the unit, and it is clear to be heated to speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the principal spot of same color.

9. quality determining method according to claim 5 is characterized in that, said discriminating to Radix Glycyrrhizae specifically:

These article of getting content 3g adds water-saturated n-butanol 30ml, soaks 30 minutes, ultrasonic 15 minutes, filters; Filtrating is extracted 2 times with ammonia solution, and each 10ml merges ammonia solution, transfers pH value 1～2 with dilute hydrochloric acid, with ether extraction 2 times; Each 20ml discards ether solution, and water liquid reuse water-saturated n-butanol extracts 2 times, and each 20ml merges n-butyl alcohol liquid; With the saturated water washing of n-butyl alcohol 2 times, each 40ml gets n-butyl alcohol liquid water bath method, and residue adds methanol 2ml makes dissolving, as need testing solution;

Extracting liquorice medicinal powder 0.5g shines medical material solution in pairs with legal system in addition;

According to thin layer chromatography test, draw each 3 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the 1%NaOH sodium carboxymethyl cellulose; Ethyl acetate-formic acid-glacial acetic acid-the water that with the volume ratio is 15:1:2:2 is developing solvent, launches, and takes out; Dry; Spray is 10% ethanol solution of sulfuric acid of g/ml with the unit, and 105 ℃ to be heated to speckle colour developing clear, puts immediately under the ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence principal spot of same color.

10. quality determining method according to claim 5 is characterized in that, said inspection should meet " pertinent regulations under first appendix capsule of Chinese pharmacopoeia version in 2005 item;

The mensuration of said extractum: get this medicament content 4g, the accurate title, decide, and makes solvent with 85% ethanol, measures according to the hot dipping under the ethanol-soluble extractives algoscopy item.

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