CN1241586C

CN1241586C - Chinese medicine composition and preparing method thereof

Info

Publication number: CN1241586C
Application number: CN 03138025
Authority: CN
Inventors: 肖伟; 戴翔翎; 凌娅; 李明慧; 毕宇安; 黄广伟; 尚强
Original assignee: Jiangsu Kanion Pharmaceutical Co Ltd
Current assignee: Jiangsu Kanion Pharmaceutical Co Ltd
Priority date: 2003-05-26
Filing date: 2003-05-26
Publication date: 2006-02-15
Anticipated expiration: 2023-05-26
Also published as: CN1552414A

Abstract

The present invention discloses a traditional Chinese medicine composition for curing lumbar intervertebral disk protrusion, a preparation method thereof, and a quality control method of the traditional Chinese medicine composition preparation. The traditional Chinese medicine composition of the present invention comprises the following raw materials of the parts by weight: 100 to 400 parts of radix notoginseng, 200 to 500 parts of corydalis tuber, 200 to 500 parts of radix paeoniae alba, 200 to 500 parts of radix achyranthis bidentatae and 100 to 400 parts of prepared radix et rhizoma rhei. When the traditional Chinese medicine composition is prepared, different components respectively adopt a decoction extracting method and an etanol extracting method to fully exert effective medicine. The medicine preparation of the present invention has obvious curative effect on curing lumbar intervertebral disk protrusion.

Description

A kind of Chinese medicine composition and preparation method, method of quality control and purposes

Invention field

The present invention relates to a kind of Chinese medicine composition and preparation method thereof, particularly relate to a kind of Chinese medicine composition for the treatment of prolapse of lumbar intervertebral disc and preparation method thereof.

Background technology

Prolapse of lumbar intervertebral disc is the clinical the most common disease of orthopedics and traumatology of Chinese medicine, belongs to Chinese medicine " lumbago time " category.This disease is many to be caused by factors such as stagnation of QI and blood, venation impatencies, controls suitable blood circulation promoting and blood stasis dispelling, removing obstruction in the collateral to relieve pain.The object of the invention is to provide a kind of Chinese medicine composition for the treatment of prolapse of lumbar intervertebral disc and preparation method thereof; The object of the invention also is to provide a kind of method of quality control of Chinese medicine composition.

Summary of the invention

The present invention seeks to be achieved through the following technical solutions:

Scheme one Radix Notoginseng 100-400 weight portion Rhizoma Corydalis 200-500 weight portion Radix Paeoniae Alba 200-500 weight portion Radix Achyranthis Bidentatae 200-500 weight portion Radix Et Rhizoma Rhei 100-400 weight portion

The above five tastes are got half Radix Notoginseng powder and are broken into fine powder, and device is preserved in addition, and second half Radix Notoginseng powder is broken into coarse powder; Get Rhizoma Corydalis and be ground into coarse powder, merge, doubly measure the 65-85% ethanol percolation, make fluid extract with 4-8 with the Radix Notoginseng coarse powder; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae, reach and decoct 1-2 time after Radix Et Rhizoma Rhei adds water saturates, each 30-90 minute, it is 50 ℃ of 1.15-1.20 that extracting solution is concentrated into relative density, adding ethanol makes and contains the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol and to be concentrated into relative density be 1.15-1.20 adds ethanol and makes and contain the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol also is concentrated into appropriate volume, adds above-mentioned fluid extract, reclaim ethanol and be concentrated into the thick paste shape, drying adds Radix Notoginseng fine powder mixing, adds conventional adjuvant and makes clinical acceptable forms and comprise granule, oral liquid, capsule and tablet etc.

Scheme two Radix Notoginseng 100-400 weight portion Rhizoma Corydalis 200-500 weight portions

Radix Paeoniae Alba 200-500 weight portion Radix Achyranthis Bidentatae 200-500 weight portion

Radix Et Rhizoma Rhei 100-400 weight portion Rhizoma Drynariae 100-400 weight portion

Flos Carthami 200-500 weight portion Radix Clematidis 100-400 weight portion

More than eight flavors, get half Radix Notoginseng powder and be broken into fine powder, in addition device is preserved, second half Radix Notoginseng powder is broken into coarse powder; Get Rhizoma Corydalis, Flos Carthami, Radix Clematidis pulverizing, merge, doubly measure the 65-85% ethanol percolation, make fluid extract with 4-8 with the Radix Notoginseng coarse powder; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae, Rhizoma Drynariae and Radix Et Rhizoma Rhei decoct 1-2 time after adding water saturates, each 30-90 minute, it is 50 ℃ of 1.15-1.20 that extracting solution is concentrated into relative density, adding ethanol makes and contains the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol and to be concentrated into relative density be 1.15-1.20 adds ethanol and makes and contain the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol also is concentrated into appropriate volume, adds above-mentioned fluid extract, reclaim ethanol and be concentrated into the thick paste shape, drying adds Radix Notoginseng fine powder mixing, adds conventional adjuvant and makes clinical acceptable forms and comprise granule, oral liquid, capsule and tablet etc.

Scheme three Radix Notoginseng 100-400 weight portion Rhizoma Corydalis 200-500 weight portions

Radix Et Rhizoma Rhei 100-400 weight portion Herba Epimedii 100-400 weight portion

Radix Salviae Miltiorrhizae 200-500 weight portion Radix Gentianae Macrophyllae 100-400 weight portion

More than eight flavors, get half Radix Notoginseng powder and be broken into fine powder, in addition device is preserved, second half Radix Notoginseng powder is broken into coarse powder; Get Rhizoma Corydalis, Radix Salviae Miltiorrhizae, Radix Gentianae Macrophyllae pulverizing, merge, doubly measure the 65-85% ethanol percolation, make fluid extract with 4-8 with the Radix Notoginseng coarse powder; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae, Herba Epimedii and Radix Et Rhizoma Rhei decoct 1-2 time after adding water saturates, each 30-90 minute, it is 50 ℃ of 1.15-1.20 that extracting solution is concentrated into relative density, adding ethanol makes and contains the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol and to be concentrated into relative density be 1.15-1.20 adds ethanol and makes and contain the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol also is concentrated into appropriate volume, adds above-mentioned fluid extract, reclaim ethanol and be concentrated into the thick paste shape, drying adds Radix Notoginseng fine powder mixing, adds conventional adjuvant and makes clinical acceptable forms and comprise granule, oral liquid, capsule and tablet etc.

Scheme four Radix Notoginseng 100-400 weight portion Radix Et Rhizoma Rhei 100-400 weight portions

Rhizoma Corydalis 200-500 weight portion Radix Paeoniae Alba 200-500 weight portion

Radix Achyranthis Bidentatae 200-500 weight portion Cortex Eucommiae 100-400 weight portion

Myrrha 200-500 Chong Liang Fen Herba Siegesbeckiae 100-400 weight portion

More than eight flavors, get half Radix Notoginseng powder and be broken into fine powder, in addition device is preserved, second half Radix Notoginseng powder is broken into coarse powder; Get Rhizoma Corydalis, the pulverizing of Myrrha, Herba Siegesbeckiae, merge, doubly measure the 65-85% ethanol percolation, make fluid extract with 4-8 with the Radix Notoginseng coarse powder; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae, the Cortex Eucommiae and Radix Et Rhizoma Rhei decoct 1-2 time after adding water saturates, each 30-90 minute, it is 50 ℃ of 1.15-1.20 that extracting solution is concentrated into relative density, adding ethanol makes and contains the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol and to be concentrated into relative density be 1.15-1.20 adds ethanol and makes and contain the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol also is concentrated into appropriate volume, adds above-mentioned fluid extract, reclaim ethanol and be concentrated into the thick paste shape, drying adds Radix Notoginseng fine powder mixing, adds conventional adjuvant and makes clinical acceptable forms and comprise granule, oral liquid, capsule and tablet etc.

The method of quality control that each compositions of the invention described above is made medicament comprises discriminating and/or assay.

Discrimination method comprises a kind of and/or several in the following method:

A. get present composition preparation 2g, porphyrize adds methanol 20ml, and supersound process 10 minutes filters, the filtrate evaporate to dryness, residue is dissolved in water, and adds strong ammonia solution and transfers to alkalescence, adds ethanol 20ml, and jolting was extracted 5 minutes, filter, filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets Rhizoma Corydalis control medicinal material 1g, shines medical material solution in pairs with legal system; Get the tetrahydropalmatine reference substance again, add methanol and make solution that every ml contains 1mg product solution in contrast; Test according to thin layer chromatography, draw each 3 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate with the preparation of 1% sodium hydroxide, with 8-12: 3-5: 0.6-1.2 normal hexane-chloroform-methanol is developing solvent, launch, take out, dry, smoked clear with iodine vapor to the speckle colour developing, inspect under the daylight; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the speckle of same color; After in air, waving the iodine that adsorbs on the most plate, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.

B. get present composition preparation 2g, porphyrize adds methanol 10ml, and jolting was extracted 3-6 minute, get supernatant as need testing solution, other gets Radix Paeoniae Alba control medicinal material 0.5g, adds ethanol 10ml jolting and extracts 5 minutes, filters, the filtrate evaporate to dryness adds methanol 1ml and makes dissolving, in contrast medical material solution; Get the paeoniflorin reference substance again, add ethanol and make solution that every ml contains 1mg product solution in contrast; Test according to thin layer chromatography, draw each 5 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, with 30-45: 4-6: 7-11: 0.1-0.3 chloroform-Methane Carboxylic Acid-methanol-formic acid is developing solvent, launch, take out, dry, spray is with 5% vanillin concentrated sulfuric acid solution, it is clear that hot blast blows to the speckle colour developing, in the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show identical bluish violet speckle.

C. get present composition preparation 2g, porphyrize, the 20ml that adds diethyl ether, jolting was extracted 5 minutes, filtered, and filtrate evaporate to dryness, residue add ethyl acetate 2ml makes dissolving, as need testing solution; Get Radix Et Rhizoma Rhei control medicinal material 0.1g, shine medical material solution in pairs with legal system; Get emodin, chrysophanol reference substance again, add methanol and make the reference substance mixed solution that every ml contains 1mg; According to thin layer chromatography test, draw each 4 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, with 12-16: 4-6: the upper solution of 0.5-1 petroleum ether-Ethyl formate-formic acid is developing solvent, launches, and takes out, and dries, and puts under the ultra-violet lamp and inspects; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show five identical orange-yellow fluorescence speckles; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness.

Assay: precision takes by weighing present composition preparation 0.5g, put in the apparatus,Soxhlet's, it is an amount of to add diethyl ether, reflux, extract, 1-3 hours, discard ether solution, filtration paper cylinder takes out, and dries, and puts in the apparatus,Soxhlet's again, it is an amount of to add methanol, reflux, extract, is to colourless, and extracting solution reclaims methanol to doing, and residue is with the 20ml water dissolution; Put in the separatory funnel, with water saturated 10-20ml n-butanol extraction 4-6 time, merge extractive liquid,, with the saturated 20-40ml water washing of n-butyl alcohol 2-4 time; Discard water liquid, the n-butanol extracting liquid reclaim under reduced pressure is to doing; The residue dissolve with methanol is transferred in the measuring bottle of 10ml, adds methanol and is diluted to scale, as need testing solution; Other gets panaxoside Rg ₁Reference substance, the accurate title, decide, and adds methanol and make the solution that every ml contains 1mg, in contrast product solution; Test according to thin layer chromatography, draw need testing solution 2 μ l, reference substance solution 1 μ l, 2 μ l, the cross point is on same silica gel g thin-layer plate respectively, with 13-16: 35-45: 18-24: the subnatant that 8-12 chloroform-ethyl acetate-methanol-water was placed below 10 ℃ after 12-24 hour is developing solvent, launch, take out, dry, spray is with 5% ethanol solution of sulfuric acid, 100-105 ℃ of baking 4-5 minute, clear to the speckle colour developing, take out, cover onesize glass plate, with adhesive tape the edge is sealed, scan wavelength X according to thin layer chromatography _S=535nm, λ _R=650nm, the trap integrated value of measurement test sample and reference substance is calculated with the external standard two-point method, promptly; This composite preparation per unit amount contains panaxoside Rg ₁Should be no less than 7.0-7.6mg.

Above-mentioned unit quantity is meant the finished medicines dosage that contains suitable 3.12g crude drug.

Pharmaceutical preparation of the present invention has blood circulation promoting and blood stasis dispelling, the function of expelling wind and removing dampness, promoting the circulation of QI to relieve pain.Clinical prolapse of lumbar intervertebral disc observation patient 200 examples that are used for the treatment of obtain better curative effect.The inventor also according to its function, cure mainly, from aspects such as lumbar nerve roots inflammation, analgesia, antiinflammatories its main pharmacodynamics is studied.

Be subjected to the reagent thing: to the YBT capsule of scheme four preparation 1-4 number, contain 7.4g crude drug/g granule according to scheme one.

YAOTONGNING, Chengde, Hebei province pharmaceutical factory of traditional Chinese medicine produces, lot number 980108.

Positive control drug YAOTONGNING mice consumption is 0.4g granule/kg, and the rat consumption is 0.2g granule/kg, is equivalent to clinical equivalent dosage. matched group gives the distilled water of equal volume.

Animal: white mice, Switzerland's kind, male, body weight 20 ± 1g; Rat, Wistar system, male, body weight 120 ± 10g provides by Chinese Academy of Medical Sciences's zooscopy, the animal quality certification number is respectively＜cures and moves word〉01-3008,01-3001.

Experimental example 1:The YBT capsule is to the influence of rat lumbar nerve roots inflammation

Reagent: P material radioimmunoassay medicine box is provided by Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences physiology chamber; PGE ₂(prostaglandin), 6-Keto-PGF _1aAnd TXB ₂The radioimmunoassay medicine box provides by pharmacological room of Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences.Instrument: SEM-4101 type stimulator, VC-10 oscillograph, isolator, the equal I:(one of DAT-1100 averager) Japanese photoelectricity electronics justice device company produces; The FJ-2100 liquid scintillation instrument is produced by Xi'an 262 factories.Modelling: rat is used pentobarbital sodium intraperitoneal injection of anesthesia (30mg/kg body weight), conventional preserved skin, sterilization, spread little, with rumpbone top second spinous process is the center, along spinous process longitudinal incision skin and subcutaneous tissue, otch is about 1.5cm, muscle with the sharp property of sharp knife separation spinous process both sides, expose spinous process and both sides vertebral plate, sting out the above vertebral plate of both sides transverse process with rongeur, and upwards dig, expose intraspinal spinal cord, peel off son to the right with nerve with the spinal cord vertebra, manifest left side waist 5 nerve rooies, the oxter of waist 5 nerve rooies on the left of quantitative (2.1mg) filter paper that is soaked with formalin is placed on is restored the vertebral plate that turns over.Careful upward blood, layer-by-layer suture, aseptic wrapping.Rat model is divided into 6 groups at random by body weight, totally 4 groups of YBT capsule 1-4 3.2g crude drug/kg, and one group of YAOTONGNING 0.2g granule/kg, model control group gives cold water.Continuous gastric infusion, twice on the one.Can find that from table 1 result all administration groups all can significantly reduce the scorching rat lymphocyte of lumbar nerve roots number, high, wherein the YBT capsule obviously is better than the YAOTONGNING group No. 2.

Table 1 YBT capsule is to the pathological observation I of rat cervical radiculitis (x ± s)

Group	Dosage (g/kg)	Mus number (only)	Lymphocyte quantity (individual)
Group	Dosage (g/kg)	Mus number (only)	Lymphocyte quantity (individual)	The model group YAOTONGNING	0.2	10 10	433.82±57.18 354.86±32.81**
YBT capsule No. 1234	25 groups of dosages are 3.2g crude drug/kg	Every treated animal number average is 10	348.88±32.41 184.26±33.42 ^￥￥￥ 331.21±31.02 341.03±32.47	The model group YAOTONGNING	0.2	10 10	433.82±57.18 354.86±32.81**

Compare * p＜0.05 with model group, * * p＜0.01, * * * p＜0.001 (as follows)

Each group of YBT capsule is compared with the YAOTONGNING group ^$P＜0.05, ^$$＜0.01, ^$$$P＜0.001 (as follows), YBT2 obviously is better than the YAOTONGNING group as a result.Table 2 result can find that the area of 42 days collagen fiber of all administration group modelings is starkly lower than model control group.YBT2 obviously is better than the YAOTONGNING group.

Table 2 YBT capsule is to the pathological observation II of rat lumbar nerve roots inflammation (x ± s)

Group	Dosage (g/kg)	Quantity (only)	Collagen fiber area (pixel)
Group	Dosage (g/kg)	Quantity (only)	Collagen fiber area (pixel)	Model group YAOTONGNING YBT capsule No. 1234	--0.2 25 combination doses are 3.2g crude drug/kg	10 10 every treated animal number averages are 10	81989.9±9816.2 68217.6±6795.5 62539±5495.5 41879±6001.7* ^￥￥￥60759.6±5469.3 60119.4±5517.7**

Experimental example 2:The YBT capsule to the mensuration (radioimmunoassay) of P content of material in the scorching rat nerve root of lumbar nerve roots as can be seen from Table 3, four groups of YBT capsules modeling the 7th day, 14 days, 28 days, the P content of material very significantly be lower than model group, (content of P material raises YBT2 significantly better than the YAOTONGNING group, the threshold of pain descends, the pain sensitivity; Otherwise, pain relief).

Table 3 YBT capsule is to the influence of P content of material in the scorching rat nerve root of lumbar nerve roots (x ± s)

Group	Dosage (g/kg)	Mus number (only)	P content of material (fmol/mg)
			P content of material (fmol/mg)			7 days	14 days	28 days
			Model group YBT1 YBT2 YBT3 YBT4 pain in the back is peaceful	--- 3.2 3.2 3.2 3.2 0.2	10 10 10 10 10 10	7 days	14 days	28 days	747.50±85.08 582.17±74.27* 517.17±60.04* ^￥ 587.90±73.21* 586.26±74.27* 595.54±74.26***	668.43±72.82 518.36±61.98* 461.65±48.21* ^￥ 526.337±61.59* 524.47±63.56* 507.25±54.25***	530.12±88.32 455.86±61.01* 392.48±44.68*** ^￥ 468.22±64.26* 457.99±65.84* 445.47±53.58*

Experiment row 3:The capsular analgesic activity of YBT2 (hot plate method)

By table 4 result as seen, significant analgesia role just occurred in 0.5 hour behind the YBT capsule, it acts on sustainable more than 3 hours.

Table 4 is respectively organized the YBT capsule to the analgesic activity (hot plate method) of mice (n=10)

Group	Dosage (g/kg)	Threshold of pain changing value behind the medicine (x ± s) second
						0.5h	1.0h	2.0h	3.0h
		Matched group YBT1 YBT2 YBT3 YBT4 YAOTONGNING	--- 6.4 6.4 6.4 6.4 0.4	13.6±2.0 14.9±2.1* 16.3±1.7** 15.6±2.5 15.1±2.4 14.9±1.9	14.1±2.3 17.0±2.2* 18.7±2.1*** ^￥ 16.2±2.5 16.2±2.3 17.2±2.5*	0.5h	1.0h	2.0h	3.0h	15.1±2.4 18.2±2.9* 19.9±2.3*** 17.7±2.7* 17.5±2.7* 18.2±2.7*	16.2±3.2 19.1±2.9 20.4±2.1 18.7±2.5 18.6±2.7 19.6±2.8

By table 5 result as seen, each organizes YBT capsule 3.2g/kg all can obviously reduce mice because of acetic acid stimulation the causing occurrence frequency of turning round body, and prompting YBT2 capsule has stronger analgesic effect.

Table 5 YBT capsule is to the analgesic activity (mouse writhing method) of mice

Group	Dosage (g/kg)	Mus number (only)	Turn round body number of times (x ± s)
Group	Dosage (g/kg)	Mus number (only)	Turn round body number of times (x ± s)	Matched group YBT1 YBT2 YBT3 YBT4 YAOTONGNING	--- 6.4 6.4 6.4 6.4 0.2	10 10 10 10 10 10	26.1±4.9 13.5±3.6* 12.3±2.6* ^￥ 15.4±4.7* 13.8±3.2* 14.1±3.3***

Each group is compared * p＜0.05 with model group, * * p＜0.01, * * * p＜0.001 (as follows)

Experimental example 4:The capsular antiinflammatory action of YBT

Table 6 result as seen, three dosage groups of YBT2 capsule all have the obvious suppression effect to the mice ear that Oleum Tiglii causes.

Table 6 YBT2 capsule brings out the inhibitory action of mouse ear edema to Oleum Tiglii

Group	Dosage (g/kg)	Mus number (only)	The ear swelling value (x ± s) that swells
Group	Dosage (g/kg)	Mus number (only)	The ear swelling value (x ± s) that swells	Matched group YBT1 YBT2 YBT3 YBT4 YAOTONGNING	--- 6.4 6.4 6.4 6.4 0.4	10 10 10 10 10 10	20.0±2.7 14.9±2.4* 13.2±2.3* 14.7±3.0* 14.4±2.7* 14.2±2.5***

Above-mentioned experimental example proof medicine of the present invention has: to the therapeutical effect of rat lumbar nerve roots inflammation; The pain that physical property and chemical irritation are caused all has good analgesic effect; Acute and chronic inflammation all there is the obvious suppression effect.

Embodiment 1:

Radix Notoginseng 335g Rhizoma Corydalis 445g

Radix Paeoniae Alba 445g Radix Achyranthis Bidentatae 445g

Radix Et Rhizoma Rhei 335g

The above five tastes are got half Radix Notoginseng powder and are broken into fine powder, and device is preserved in addition, and second half Radix Notoginseng powder is broken into coarse powder; Get Rhizoma Corydalis and be ground into coarse powder, merge,, make fluid extract with 5 times of amount 70% ethanol percolations with the Radix Notoginseng coarse powder; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae and Radix Et Rhizoma Rhei decoct 2 times after adding water saturates, each 50 minutes, it is 50 ℃ of 1.15-1.20 that extracting solution is concentrated into relative density, adds ethanol and makes and contain the alcohol amount and reach 65%, cold preservation 26 hours, filter, filtrate recycling ethanol and to be concentrated into relative density be 1.15-1.20 adds ethanol and makes and contain the alcohol amount and reach 85%, cold preservation 26 hours, filter, filtrate recycling ethanol also is concentrated into appropriate volume, adds above-mentioned fluid extract, reclaims ethanol and is concentrated into the thick paste shape, dry, add Radix Notoginseng fine powder mixing, add appropriate amount of starch, No. 4 resins of the polyacrylic acid with 10% are granulated, encapsulated, make 1000 promptly.

Embodiment 2:

Radix Notoginseng 200g Rhizoma Corydalis 300g

Radix Paeoniae Alba 300g Radix Achyranthis Bidentatae 300g

Radix Et Rhizoma Rhei 200g

The above five tastes are got half Radix Notoginseng powder and are broken into fine powder, and device is preserved in addition, and second half Radix Notoginseng powder is broken into coarse powder; Get Rhizoma Corydalis and be ground into coarse powder, merge,, make fluid extract with 7 times of amount 75% ethanol percolations with the Radix Notoginseng coarse powder; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae and Radix Et Rhizoma Rhei decoct 1 time after adding water saturates, 50 minutes, it is 50 ℃ of 1.15-1.20 that extracting solution is concentrated into relative density, adding ethanol makes and contains the alcohol amount and reach 70%, cold preservation 28 hours, filter, filtrate recycling ethanol and to be concentrated into relative density be 1.15-1.20 adds ethanol and makes and contain the alcohol amount and reach 80%, cold preservation 26 hours, filter, filtrate recycling ethanol also is concentrated into appropriate volume, adds above-mentioned fluid extract, reclaim ethanol and be concentrated into the thick paste shape, drying adds Radix Notoginseng fine powder mixing, makes oral liquid 2000ml through conventional technology.

Embodiment 3:

Radix Notoginseng 335g Flos Carthami 445g Rhizoma Corydalis 445g Radix Paeoniae Alba 445g

Radix Achyranthis Bidentatae 445g Rhizoma Drynariae 335g Radix Et Rhizoma Rhei 335g Radix Clematidis 335g

More than eight flavors, get half Radix Notoginseng powder and be broken into fine powder, in addition device is preserved; Second half Radix Notoginseng powder is broken into coarse powder.Get Rhizoma Corydalis, Flos Carthami, Radix Clematidis and be ground into coarse powder, merge, measure 75% ethanol percolations with 6 times, make fluid extract with the Radix Notoginseng coarse powder; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae, Rhizoma Drynariae and Radix Et Rhizoma Rhei decocted 60 minutes after adding water saturates, it is 1.15-1.20 that extracting solution is concentrated into 50 ℃ of relative densities, adding ethanol makes and contains the alcohol amount and reach 60%, cold preservation 30 hours filters, filtrate recycling ethanol and to be concentrated into 50 ℃ of relative densities be 1.15-1.20, adding ethanol makes and contains the alcohol amount and reach 80%, cold preservation 30 hours filters, and filtrate recycling ethanol also is concentrated into appropriate volume, add above-mentioned fluid extract, reclaim ethanol and be concentrated into the thick paste shape, drying adds Radix Notoginseng fine powder mixing, after the pulverizing, add appropriate amount of starch, No. 4 resins of polyacrylic acid with 10% are granulated, and are encapsulated, make 1000 promptly.

Embodiment 4:

Radix Notoginseng 300g Radix Et Rhizoma Rhei 300g

Rhizoma Corydalis 460g Radix Paeoniae Alba 460g

Radix Achyranthis Bidentatae 460g Rhizoma Drynariae 300g

Flos Carthami 460g Radix Clematidis 300g

More than eight flavors, get half Radix Notoginseng powder and be broken into fine powder, in addition device is preserved; Second half Radix Notoginseng powder is broken into coarse powder; Get Rhizoma Corydalis, Flos Carthami, Radix Clematidis and be ground into coarse powder, merge, measure 70% ethanol percolations with 7 times, make fluid extract with the Radix Notoginseng coarse powder; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae, Rhizoma Drynariae and Radix Et Rhizoma Rhei add decoct after the water saturates 2 times each 40 minutes, extracting solution is concentrated into 50 ℃ of 1.15-1.20, adding ethanol makes and contains the alcohol amount and reach 80%, cold preservation 32 hours filters, filtrate recycling ethanol and to be concentrated into relative density be 1.15-1.20, adding ethanol makes and contains the alcohol amount and reach 70%, cold preservation 30 hours filters, and filtrate recycling ethanol also is concentrated into appropriate volume, add above-mentioned fluid extract, reclaim ethanol and be concentrated into the thick paste shape, drying adds Radix Notoginseng fine powder mixing, after the pulverizing, add appropriate amount of starch, No. 4 resins of polyacrylic acid with 10% are granulated, and are pressed into tablet, make 1000.

Embodiment 5:

Radix Notoginseng 335g Radix Et Rhizoma Rhei 335g

Rhizoma Corydalis 445g Chinese herbaceous peony 445g

Radix Achyranthis Bidentatae 445g Herba Epimedii 335g

Radix Salviae Miltiorrhizae 445g Radix Gentianae Macrophyllae 335g

More than eight flavors, get half Radix Notoginseng powder and be broken into fine powder, in addition device is preserved; Second half Radix Notoginseng powder is broken into coarse powder; Get Rhizoma Corydalis, Radix Salviae Miltiorrhizae, Radix Gentianae Macrophyllae pulverizing, merge,, make fluid extract with 6 times of amount 75% ethanol percolations with the Radix Notoginseng coarse powder; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae, Herba Epimedii and Radix Et Rhizoma Rhei decoct 1 time after adding water saturates, time is 60 minutes, and 1.15-1.20 when extracting solution is concentrated into relative density and is 50 ℃ adds ethanol and makes and contain the alcohol amount and reach 60%, cold preservation 33 hours, filter, filtrate recycling ethanol and 1.15-1.20 when being concentrated into relative density and being 50 ℃ add ethanol and make and contain the alcohol amount and reach 80%, cold preservation 28 hours, filter, filtrate recycling ethanol also is concentrated into appropriate volume, adds above-mentioned fluid extract, reclaim ethanol and be concentrated into the thick paste shape, drying adds Radix Notoginseng fine powder mixing, adds appropriate amount of starch, sucrose, No. 4 resins of polyacrylic acid with 10% are granulated, and make 250 bags of granules, the 2g/ bag.

Embodiment 6:

Radix Notoginseng 200g Radix Et Rhizoma Rhei 200g

Rhizoma Corydalis 300g Radix Paeoniae Alba 300g

Radix Achyranthis Bidentatae 300g Herba Epimedii 200g

Radix Salviae Miltiorrhizae 300g Radix Gentianae Macrophyllae 200g

More than eight flavors, get half Radix Notoginseng powder and be broken into fine powder, in addition device is preserved; Second half Radix Notoginseng powder is broken into coarse powder; Get Rhizoma Corydalis, Radix Salviae Miltiorrhizae, Radix Gentianae Macrophyllae pulverizing, merge,, make fluid extract with 6 times of amount 75% ethanol percolations with the Radix Notoginseng coarse powder; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae, Herba Epimedii and Radix Et Rhizoma Rhei add after the water saturates and decoct 1 time, and the time is 60 minutes, 1.15-1.20 when extracting solution is concentrated into relative density and is 50 ℃, adding ethanol makes and contains the alcohol amount and reach 60%, cold preservation 26 hours filters, filtrate recycling ethanol and 1.15-1.20 when being concentrated into relative density and being 50 ℃, adding ethanol makes and contains the alcohol amount and reach 80%, cold preservation 26 hours filters, filtrate recycling ethanol also is concentrated into appropriate volume, add above-mentioned fluid extract, reclaim ethanol and be concentrated into thick paste shape, drying, add Radix Notoginseng fine powder mixing, add appropriate amount of starch, sucrose, No. 4 resins of the polyacrylic acid with 10% are granulated, make 250 bags of granules, the 2g/ bag.

Embodiment 7:

Radix Notoginseng 335g Radix Et Rhizoma Rhei 335g

Rhizoma Corydalis 445g Radix Paeoniae Alba 445g

Radix Achyranthis Bidentatae 445g Cortex Eucommiae 335g

Myrrha 445g Herba Siegesbeckiae 335g

More than eight flavors, get half Radix Notoginseng powder and be broken into fine powder, in addition device is preserved; Second half Radix Notoginseng powder is broken into coarse powder; Get Rhizoma Corydalis, Myrrha, Herba Siegesbeckiae is ground into coarse powder, with 6 times the amount 75% ethanol percolations, make fluid extract; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae, the Cortex Eucommiae and Radix Et Rhizoma Rhei decoct 1 time after adding water saturates, time is 60 minutes, 1.15-1.20 when extracting solution is concentrated into relative density and is 50 ℃ adds ethanol and makes and contain the alcohol amount and reach 60%, and cold preservation is more than 24 hours, filter, filtrate recycling ethanol and 1.15-1.20 when being concentrated into relative density and being 50 ℃ add ethanol and make and contain the alcohol amount and reach 80%, and cold preservation is more than 24 hours, filter, filtrate recycling ethanol also is concentrated into appropriate volume, adds above-mentioned fluid extract, reclaims ethanol and is concentrated into the thick paste shape, dry, add Radix Notoginseng fine powder mixing, add appropriate amount of starch, No. 4 resins of the polyacrylic acid with 10% are granulated, encapsulated, make 1000.

Embodiment 8:

Radix Notoginseng 360g Radix Et Rhizoma Rhei 360g

Rhizoma Corydalis 460g Radix Paeoniae Alba 460g

Radix Achyranthis Bidentatae 460g Cortex Eucommiae 360g

Myrrha 460g Herba Siegesbeckiae 360g

More than eight flavors, get half Radix Notoginseng powder and be broken into fine powder, in addition device is preserved; Second half Radix Notoginseng powder is broken into coarse powder; Get Rhizoma Corydalis, Myrrha, Herba Siegesbeckiae is ground into coarse powder, merges with the Radix Notoginseng coarse powder, measures 75% ethanol percolations with 6 times, makes fluid extract; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae, the Cortex Eucommiae and Radix Et Rhizoma Rhei decoct 1 time after adding water saturates, time is 60 minutes, and 1.15-1.20 when extracting solution is concentrated into relative density and is 50 ℃ adds ethanol and makes and contain the alcohol amount and reach 60%, cold preservation is more than 24 hours, filter, filtrate recycling ethanol and 1.15-1.20 when being concentrated into relative density and being 50 ℃ add ethanol and make and contain the alcohol amount and reach 80%, cold preservation is more than 24 hours, filter,, filtrate recycling ethanol also is concentrated into appropriate volume, add above-mentioned fluid extract, reclaim ethanol and be concentrated into the thick paste shape, drying adds Radix Notoginseng fine powder mixing, add appropriate amount of starch, No. 4 resins of polyacrylic acid with 10% are granulated, and are encapsulated, make 1000.

Embodiment 9: the invention described above compositions is made the method for quality control of capsule

Differentiate: get capsule 's content 2g, porphyrize adds methanol 20ml, and ultrasonic place 10 minutes filters, the filtrate evaporate to dryness, residue is dissolved in water, and adds strong ammonia solution and transfers to alkalescence, adds ethanol 20ml, and jolting was extracted 5 minutes, filter, filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets Rhizoma Corydalis control medicinal material 1g, shines medical material solution in pairs with legal system; Get the tetrahydropalmatine reference substance again, add methanol and make solution that every ml contains 1mg product solution in contrast; According to the thin layer chromatography test, draw each 3 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate with the preparation of 1% sodium hydroxide, with 10: 4: 1 normal hexane-chloroform-methanol was developing solvent, launched, and took out, dry, smoked clear with iodine vapor to the speckle colour developing, inspect under the daylight; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the speckle of same color; After in air, waving the iodine that adsorbs on the most plate, put under the ultra-violet lamp 365nm and inspect; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.

Get capsule 's content 2g, porphyrize adds methanol 10ml, and jolting was extracted 5 minutes, got supernatant as need testing solution; Other gets Radix Paeoniae Alba control medicinal material 0.5g, adds ethanol 10ml jolting and extracts 5 minutes, filters, and the filtrate evaporate to dryness adds methanol 1ml and makes dissolving, in contrast medical material solution; Get the paeoniflorin reference substance again, add ethanol and make solution that every ml contains 1mg product solution in contrast; According to the thin layer chromatography test, draw each 5 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, with 40: 5: 10: 0.2 chloroform-ethyl acetate-methanol-formic acid was developing solvent, launched, and took out, dry, spray is with 5% vanillin concentrated sulfuric acid solution, and it is clear that hot blast blows to the speckle colour developing; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show identical bluish violet speckle;

Get capsule 's content 2g, porphyrize, the 20ml that adds diethyl ether, jolting was extracted 5 minutes, filtered, and filtrate evaporate to dryness, residue add ethyl acetate 2ml makes dissolving, as need testing solution; Get Radix Et Rhizoma Rhei control medicinal material 0.1g, shine medical material solution in pairs with legal system; Get emodin, chrysophanol reference substance again, add methanol and make the reference substance mixed solution that every ml contains 1mg; According to thin layer chromatography test, draw each 4 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, be developing solvent with the upper solution of 15: 5: 1 petroleum ether-Ethyl formate-formic acid, launch, take out, dry; Put under the ultra-violet lamp 365nm and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show five identical orange-yellow fluorescence speckles; With the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness.

Assay: precision takes by weighing capsule 's content 0.5g, puts in the apparatus,Soxhlet's, and it is an amount of to add diethyl ether, and reflux, extract, 2 hours discards ether solution, and filtration paper cylinder takes out, and dries, and puts in the apparatus,Soxhlet's again, and it is an amount of to add methanol, and reflux, extract, is to colourless; Extracting solution reclaims methanol to doing, and residue is with the 20ml water dissolution; Put in the separatory funnel, with water saturated 20ml, 20ml, 15ml, 15ml, 10ml n-butanol extraction 5 times, merge extractive liquid,, with the saturated water 30ml of n-butyl alcohol, 30ml, 30ml washing 3 times discards water liquid, and the n-butanol extracting liquid reclaim under reduced pressure is to doing; The residue dissolve with methanol is transferred in the measuring bottle of 10ml, adds methanol and is diluted to scale, as need testing solution; Other gets panaxoside Rg ₁Reference substance, the accurate title, decide, and adds methanol and make the solution that every ml contains 1mg, in contrast product solution; Test according to thin layer chromatography, draw need testing solution 2 μ l, reference substance solution 1 μ l, 2 μ l, the cross point is on same silica gel g thin-layer plate respectively, with 15: 40: 22: the subnatant that 10 chloroforms-ethyl acetate-methanol-water was placed below 10 ℃ after 12 hours was developing solvent, launch, take out, dry, spray is with 5% ethanol solution of sulfuric acid, 100-105 ℃ of baking 4-5 minute, clear to the speckle colour developing, take out, cover onesize glass plate, with adhesive tape the edge is sealed, scan wavelength X according to thin layer chromatography _S=535nm, λ _R=650nm, the trap integrated value of measurement test sample and reference substance is calculated with the external standard two-point method, that is and, every capsules content contains panaxoside Rg ₁Should be no less than 7.2mg.

Claims

1, a kind of Chinese medicine composition for the treatment of prolapse of lumbar intervertebral disc is characterized in that this Chinese medicine compositions made by following raw material medicaments:

Radix Notoginseng 100-400 weight portion Rhizoma Corydalis 200-500 weight portion

Radix Et Rhizoma Rhei 100-400 weight portion.

2, Chinese medicine composition as claimed in claim 1 is characterized in that this Chinese medicine composition made by following raw materials according:

Radix Notoginseng 335 weight portion Rhizoma Corydalis 445 weight portions

The Radix Paeoniae Alba 445 weight portion Radix Achyranthis Bidentataes 445 weight portions

Radix Et Rhizoma Rhei 335 weight portions.

3, Chinese medicine composition as claimed in claim 1 is characterized in that this Chinese medicine composition made by following raw materials according:

Flos Carthami 200-500 weight portion Radix Clematidis 100-400 weight portion.

4, Chinese medicine composition as claimed in claim 3 is characterized in that this Chinese medicine composition made by following raw materials according:

Radix Notoginseng 335 weight portion Radix Et Rhizoma Rhei 335 weight portions

The Rhizoma Corydalis 445 weight portion Radix Paeoniae Albas 445 weight portions

Radix Achyranthis Bidentatae 445 weight portion Rhizoma Drynariae 335 weight portions

Flos Carthami 445 weight portion Radix Clematidis 335 weight portions.

5, Chinese medicine composition as claimed in claim 1 is characterized in that this Chinese medicine composition made by following raw materials according:

Radix Salviae Miltiorrhizae 200-500 weight portion Radix Gentianae Macrophyllae 100-400 weight portion.

6, Chinese medicine composition as claimed in claim 5 is characterized in that this Chinese medicine composition made by following raw materials according:

Radix Notoginseng 335 weight portion Radix Et Rhizoma Rhei 335 weight portions

Radix Achyranthis Bidentatae 445 weight portion Herba Epimedii 335 weight portions

Radix Salviae Miltiorrhizae 445 weight portion Radix Gentianae Macrophyllae 335 weight portions.

7, Chinese medicine composition as claimed in claim 1 is characterized in that this Chinese medicine composition made by following raw materials according:

Radix Notoginseng 100-400 weight portion Radix Et Rhizoma Rhei 100-400 weight portion

Myrrha 200-500 Chong Liang Fen Herba Siegesbeckiae 100-400 weight portion.

8, Chinese medicine composition as claimed in claim 7 is characterized in that this Chinese medicine composition made by following raw materials according:

Radix Notoginseng 335 weight portion Radix Et Rhizoma Rhei 335 weight portions

The Radix Achyranthis Bidentatae 445 weight portion Cortexs Eucommiae 335 weight portions

Myrrha 445 Chong Liang Fen Herba Siegesbeckiaes 335 weight portions.

9, the preparation method of Chinese medicine composition as claimed in claim 1 or 2 is characterized in that this method is:

Get half Radix Notoginseng powder and be broken into fine powder, device is preserved in addition, and second half Radix Notoginseng powder is broken into coarse powder; Get the Rhizoma Corydalis flour, merge, doubly measure the 65-85% ethanol percolation, make fluid extract with 4-8 with the Radix Notoginseng coarse powder; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae, Radix Et Rhizoma Rhei decocts 1-2 time after adding water saturates, each 30-90 minute, it is 50 ℃ of 1.15-1.20 that extracting solution is concentrated into relative density, adding ethanol makes and contains the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol and to be concentrated into relative density be 1.15-1.20 adds ethanol and makes and contain the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol also is concentrated into appropriate volume, adds above-mentioned fluid extract, reclaim ethanol and be concentrated into the thick paste shape, drying adds Radix Notoginseng fine powder mixing, adds the granule that conventional adjuvant is made clinical acceptance, oral liquid, capsule and tablet.

10,, it is characterized in that this method is as the preparation method of claim 3 or 4 described Chinese medicine compositions:

Get half Radix Notoginseng powder and be broken into fine powder, device is preserved in addition; Second half Radix Notoginseng powder is broken into coarse powder; Get Rhizoma Corydalis, Flos Carthami, Radix Clematidis pulverizing, merge, doubly measure the 65-85% ethanol percolation, make fluid extract with 4-8 with the Radix Notoginseng coarse powder; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae, Rhizoma Drynariae and Radix Et Rhizoma Rhei decoct 1-2 time after adding water saturates, each 30-90 minute, it is 50 ℃ of 1.15-1.20 that extracting solution is concentrated into relative density, adding ethanol makes and contains the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol and to be concentrated into relative density be 1.15-1.20 adds ethanol and makes and contain the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol also is concentrated into appropriate volume, adds above-mentioned fluid extract, reclaim ethanol and be concentrated into the thick paste shape, drying adds Radix Notoginseng fine powder mixing, adds the granule that conventional adjuvant is made clinical acceptance, oral liquid, capsule and tablet.

11,, it is characterized in that this method is as the preparation method of claim 5 or 6 described Chinese medicine compositions:

Get half Radix Notoginseng powder and be broken into fine powder, device is preserved in addition; Second half Radix Notoginseng powder is broken into coarse powder; Get Rhizoma Corydalis, Radix Salviae Miltiorrhizae, Radix Gentianae Macrophyllae pulverizing, merge, doubly measure the 65-85% ethanol percolation, make fluid extract with 4-8 with the Radix Notoginseng coarse powder; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae, Herba Epimedii and Radix Et Rhizoma Rhei decoct 1-2 time after adding water saturates, each 30-90 minute, it is 50 ℃ of 1.15-1.20 that extracting solution is concentrated into relative density, adding ethanol makes and contains the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol and to be concentrated into relative density be 1.15-1.20 adds ethanol and makes and contain the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol also is concentrated into appropriate volume, adds above-mentioned fluid extract, reclaim ethanol and be concentrated into the thick paste shape, drying adds Radix Notoginseng fine powder mixing, adds the granule that conventional adjuvant is made clinical acceptance, capsule, oral liquid, and tablet.

12,, it is characterized in that this method is as the preparation method of claim 7 or 8 described Chinese medicine compositions:

Get half Radix Notoginseng powder and be broken into fine powder, device is preserved in addition; Second half Radix Notoginseng powder is broken into coarse powder; Get Rhizoma Corydalis, the pulverizing of Myrrha, Herba Siegesbeckiae, merge, doubly measure the 65-85% ethanol percolation, make fluid extract with 4-8 with the Radix Notoginseng coarse powder; The Radix Paeoniae Alba, Radix Achyranthis Bidentatae, the Cortex Eucommiae and Radix Et Rhizoma Rhei decoct 1-2 time after adding water saturates, each 30-90 minute, it is 50 ℃ of 1.15-1.20 that extracting solution is concentrated into relative density, adding ethanol makes and contains the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol and to be concentrated into relative density be 1.15-1.20 adds ethanol and makes and contain the alcohol amount and reach 60-90%, cold preservation 24-48 hour, filter, filtrate recycling ethanol also is concentrated into appropriate volume, adds above-mentioned fluid extract, reclaim ethanol and be concentrated into the thick paste shape, drying adds Radix Notoginseng fine powder mixing, adds the granule that conventional adjuvant is made clinical acceptance, oral liquid, capsule and tablet.

13, as the method for quality control of Chinese medicinal composition preparation as described in one of claim 1-8, it is characterized in that discrimination method in this method comprises one or more in the following discriminating: a. gets composite preparation 2g, porphyrize, add methanol 20ml, supersound process 10 minutes filters, the filtrate evaporate to dryness, residue is dissolved in water, and adds strong ammonia solution and transfers to alkalescence, add ethanol 20ml, jolting was extracted 5 minutes, filtered the filtrate evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution; Other gets Rhizoma Corydalis control medicinal material 1g, shines medical material solution in pairs with legal system; Get the tetrahydropalmatine reference substance again, add methanol and make solution that every ml contains 1mg product solution in contrast; Test according to thin layer chromatography, draw each 3 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate with the preparation of 1% sodium hydroxide, with 8-12: 3-5: 0.6-1.2 normal hexane one chloroform one methanol is developing solvent, launch, take out, dry, smoked clear with iodine vapor to the speckle colour developing, inspect under the daylight; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the speckle of same color; After in air, waving the iodine that adsorbs on the most plate, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color;

B. get composite preparation 2g, porphyrize adds methanol 10ml, and jolting was extracted 3-6 minute, get supernatant as need testing solution, other gets Radix Paeoniae Alba control medicinal material 0.5g, adds ethanol 10ml jolting and extracts 5 minutes, filters, the filtrate evaporate to dryness adds methanol 1ml and makes dissolving, in contrast medical material solution; Get the paeoniflorin reference substance again, add ethanol and make solution that every ml contains 1mg product solution in contrast; Test according to thin layer chromatography, draw each 5 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, with 30-45: 4-6: 7-11: 0.1-0.3 chloroform-Methane Carboxylic Acid-methanol-formic acid is developing solvent, launch, take out, dry, spray is with 5% vanillin concentrated sulfuric acid solution, it is clear that hot blast blows to the speckle colour developing, in the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show identical bluish violet speckle;

C. get composite preparation 2g, porphyrize, the 20ml that adds diethyl ether, jolting was extracted 5 minutes, filtered, and filtrate evaporate to dryness, residue add ethyl acetate 2ml makes dissolving, as need testing solution; Get Radix Et Rhizoma Rhei control medicinal material 0.1g, shine medical material solution in pairs with legal system; Get emodin, chrysophanol reference substance again, add methanol and make the reference substance mixed solution that every ml contains 1mg; According to thin layer chromatography test, draw each 4 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, with 12-16: 4-6: the upper solution of 0.5-1 petroleum ether one Ethyl formate one formic acid is developing solvent, launches, and takes out, and dries, and puts under the ultra-violet lamp and inspects; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show five identical orange-yellow fluorescence speckles; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness.

14, the method for quality control of drug combination preparation as claimed in claim 13, the discrimination method that it is characterized in that capsule comprises one or more in the following discriminating:

Get capsule 's content 2g, porphyrize adds methanol 20ml, and supersound process 10 minutes filters, the filtrate evaporate to dryness, residue is dissolved in water, and adds strong ammonia solution and transfers to alkalescence, adds ethanol 20ml, and jolting was extracted 5 minutes, filter, filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets Rhizoma Corydalis control medicinal material 1g, shines medical material solution in pairs with legal system; Get the tetrahydropalmatine reference substance again, add methanol and make solution that every ml contains 1mg product solution in contrast; According to the thin layer chromatography test, draw each 3 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate with the preparation of 1% sodium hydroxide, with 10: 4: 1 normal hexane one chloroform one methanol was developing solvent, launched, and took out, dry, smoked clear with iodine vapor to the speckle colour developing, inspect under the daylight; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the speckle of same color; After in air, waving the iodine that adsorbs on the most plate, put under the ultra-violet lamp 365nm and inspect; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color;

Get capsule 's content 2g, porphyrize adds methanol 10ml, and jolting was extracted 5 minutes, got supernatant as need testing solution; Other gets Radix Paeoniae Alba control medicinal material 0.5g, adds ethanol 10ml jolting and extracts 5 minutes, filters, and the filtrate evaporate to dryness adds methanol 1ml and makes dissolving, in contrast medical material solution; Get the paeoniflorin reference substance again, add ethanol and make solution that every ml contains 1mg product solution in contrast; According to the thin layer chromatography test, draw each 5 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, with 40: 5: 10: 0.2 chloroform-ethyl acetate one methanol one formic acid was developing solvent, launched, and took out, dry, spray is with 5% vanillin concentrated sulfuric acid solution, and it is clear that hot blast blows to the speckle colour developing; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show identical bluish violet speckle;

Get capsule 's content 2g, porphyrize, the 20ml that adds diethyl ether, jolting was extracted 5 minutes, filtered, and filtrate evaporate to dryness, residue add ethyl acetate 2ml makes dissolving, as need testing solution; Get Radix Et Rhizoma Rhei control medicinal material 0.1g, shine medical material solution in pairs with legal system; Get emodin, chrysophanol reference substance again, add methanol and make the reference substance mixed solution that every ml contains 1mg; According to thin layer chromatography test, draw each 4 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, be developing solvent with the upper solution of 15: 5: 1 petroleum ether one Ethyl formate one formic acid, launch, take out, dry; Put under the ultra-violet lamp 365nm and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show five identical orange-yellow fluorescence speckles; With the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness.

15, as the method for quality control of Chinese medicinal composition preparation as described in one of claim 1-8, it is characterized in that content assaying method is:

Precision takes by weighing composite preparation 0.5g, puts in the apparatus,Soxhlet's, and it is an amount of to add diethyl ether, reflux, extract, 1-3 hour, discard ether solution, filtration paper cylinder takes out, and dries, and puts in the apparatus,Soxhlet's again, it is an amount of to add methanol, and reflux, extract, is to colourless, and extracting solution reclaims methanol to doing, and residue is with the 20ml water dissolution; Put in the separatory funnel, with water saturated 10-20ml n-butanol extraction 4-6 time, merge extractive liquid,, with the saturated 20-40ml water washing of n-butyl alcohol 2-4 time; Discard water liquid, the n-butanol extracting liquid reclaim under reduced pressure is to doing; The residue dissolve with methanol is transferred in the measuring bottle of 10ml, adds methanol and is diluted to scale, as need testing solution; Other gets panaxoside Rg ₁Reference substance, the accurate title, decide, and adds methanol and make the solution that every ml contains 1mg, in contrast product solution; Test according to thin layer chromatography, draw need testing solution 2 μ l, reference substance solution 1 μ l, 2 μ l, the cross point is on same silica gel g thin-layer plate respectively, with 13-16: 35-45: 18-24: the subnatant that 8-12 chloroform-ethyl acetate one methanol one water was placed below 10 ℃ after 12-24 hour is developing solvent, launch, take out, dry, spray is with 5% ethanol solution of sulfuric acid, 100-105 ℃ of baking 4-5 minute, clear to the speckle colour developing, take out, cover onesize glass plate, with adhesive tape the edge is sealed, scan wavelength X according to thin layer chromatography _S=535nm, λ _R=650nm, the trap integrated value of measurement test sample and reference substance is calculated with the external standard two-point method, promptly; Composite preparation per unit amount contains panaxoside Rg ₁Should be no less than 7.0-7.6mg.

16, method of quality control as claimed in claim 15 is characterized in that the content assaying method of capsule:

Precision takes by weighing capsule 's content 0.5g, puts in the apparatus,Soxhlet's, and it is an amount of to add diethyl ether, and reflux, extract, 2 hours discards ether solution, and filtration paper cylinder takes out, and dries, and puts in the apparatus,Soxhlet's again, and it is an amount of to add methanol, and reflux, extract, is to colourless; Extracting solution reclaims methanol to doing, and residue is with the 20ml water dissolution; Put in the separatory funnel, with water saturated 20ml, 20ml, 15ml, 15ml, 10ml n-butanol extraction 5 times, merge extractive liquid,, with the saturated water 30ml of n-butyl alcohol, 30ml, 30ml washing 3 times discards water liquid, and the n-butanol extracting liquid reclaim under reduced pressure is to doing; The residue dissolve with methanol is transferred in the measuring bottle of 10ml, adds methanol and is diluted to scale, as need testing solution; Other gets panaxoside Rg ₁Reference substance, the accurate title, decide, and adds methanol and make the solution that every ml contains 1mg, in contrast product solution; Test according to thin layer chromatography, draw need testing solution 2 μ l, reference substance solution 1 μ l, 2 μ l, the cross point is on same silica gel g thin-layer plate respectively, with 15: 40: 22: the subnatant that 10 chloroforms-ethyl acetate one methanol one water was placed below 10 ℃ after 12 hours was developing solvent, launch, take out, dry, spray is with 5% ethanol solution of sulfuric acid, 100-105 ℃ of baking 4-5 minute, clear to the speckle colour developing, take out, cover onesize glass plate, with adhesive tape the edge is sealed, scan wavelength X according to thin layer chromatography _S=535nm, λ _R=650nm, the trap integrated value of measurement test sample and reference substance is calculated with the external standard two-point method, that is and, every capsules content contains panaxoside Rg ₁Should be no less than 7.2mg.

17,, it is characterized in that this method may further comprise the steps as the method for quality control of one of claim 1-8 described Chinese medicinal composition preparation:

Differentiate: a. gets composite preparation 2g, and porphyrize adds methanol 20ml, and supersound process 10 minutes filters, the filtrate evaporate to dryness, residue is dissolved in water, and adds strong ammonia solution and transfers to alkalescence, adds ethanol 20ml, and jolting was extracted 5 minutes, filter, filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets Rhizoma Corydalis control medicinal material 1g, shines medical material solution in pairs with legal system; Get the tetrahydropalmatine reference substance again, add methanol and make solution that every ml contains 1mg product solution in contrast; Test according to thin layer chromatography, draw each 3 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate with the preparation of 1% sodium hydroxide, with 8-12: 3-5: 0.6-1.2 normal hexane one chloroform one methanol is developing solvent, launch, take out, dry, smoked clear with iodine vapor to the speckle colour developing, inspect under the daylight; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the speckle of same color; After in air, waving the iodine that adsorbs on the most plate, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color;

C. get composite preparation 2g, porphyrize, the 20ml that adds diethyl ether, jolting was extracted 5 minutes, filtered, and filtrate evaporate to dryness, residue add ethyl acetate 2ml makes dissolving, as need testing solution; Get Radix Et Rhizoma Rhei control medicinal material 0.1g, shine medical material solution in pairs with legal system; Get emodin, chrysophanol reference substance again, add methanol and make the reference substance mixed solution that every ml contains 1mg; According to thin layer chromatography test, draw each 4 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, with 12-16: 46: the upper solution of 0.5-1 petroleum ether one Ethyl formate one formic acid is developing solvent, launches, and takes out, and dries, and puts under the ultra-violet lamp and inspects; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show five identical orange-yellow fluorescence speckles; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness;

Assay: precision takes by weighing composite preparation 0.5g, put in the apparatus,Soxhlet's, it is an amount of to add diethyl ether, reflux, extract, 1-3 hour, discard ether solution, filtration paper cylinder takes out, and dries, and puts in the apparatus,Soxhlet's again, it is an amount of to add methanol, reflux, extract, is to colourless, and extracting solution reclaims methanol to doing, and residue is with the 20ml water dissolution; Put in the separatory funnel, with water saturated 10-20ml n-butanol extraction 4-6 time, merge extractive liquid,, with the saturated 20-40ml water washing of n-butyl alcohol 2-4 time; Discard water liquid, the n-butanol extracting liquid reclaim under reduced pressure is to doing; The residue dissolve with methanol is transferred in the measuring bottle of 10ml, adds methanol and is diluted to scale, as need testing solution; Other gets panaxoside Rg ₁Reference substance, the accurate title, decide, and adds methanol and make the solution that every ml contains 1mg, in contrast product solution; Test according to thin layer chromatography, draw need testing solution 2 μ l, reference substance solution 1 μ l, 2 μ l, the cross point is on same silica gel g thin-layer plate respectively, with 13-16: 35-45: 18-24: the subnatant that 8-12 chloroform-ethyl acetate one methanol one water was placed below 10 ℃ after 12-24 hour is developing solvent, launch, take out, dry, spray is with 5% ethanol solution of sulfuric acid, 100-105 ℃ of baking 4-5 minute, clear to the speckle colour developing, take out, cover onesize glass plate, with adhesive tape the edge is sealed, scan wavelength X according to thin layer chromatography _S=535nm, λ _R=650nm, the trap integrated value of measurement test sample and reference substance is calculated with the external standard two-point method, promptly; Composite preparation per unit amount contains panaxoside Rg ₁Should be no less than 7.0-7.6mg.

18, the method for quality control of Chinese medicinal composition preparation as claimed in claim 17 is characterized in that the capsule method of quality control may further comprise the steps:

Differentiate: get capsule 's content 2g, porphyrize adds methanol 20ml, and supersound process 10 minutes filters, the filtrate evaporate to dryness, residue is dissolved in water, and adds strong ammonia solution and transfers to alkalescence, adds ethanol 20ml, and jolting was extracted 5 minutes, filter, filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other gets Rhizoma Corydalis control medicinal material 1g, shines medical material solution in pairs with legal system; Get the tetrahydropalmatine reference substance again, add methanol and make solution that every ml contains 1mg product solution in contrast; According to the thin layer chromatography test, draw each 3 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate with the preparation of 1% sodium hydroxide, with 10: 4: 1 normal hexane one chloroform one methanol was developing solvent, launched, and took out, dry, smoked clear with iodine vapor to the speckle colour developing, inspect under the daylight; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the speckle of same color; After in air, waving the iodine that adsorbs on the most plate, put under the ultra-violet lamp 365nm and inspect; In the test sample chromatograph, with control medicinal material and the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color;

Get capsule 's content 2g, porphyrize, the 20ml that adds diethyl ether, jolting was extracted 5 minutes, filtered, and filtrate evaporate to dryness, residue add ethyl acetate 2ml makes dissolving, as need testing solution; Other gets Rhizoma Chuanxiong control medicinal material fine powder 0.5g, the 10ml that adds diethyl ether, and jolting 5 minutes filters, and filtrate volatilizes, and residue adds ethyl acetate 2ml makes dissolving, in contrast medical material solution; Test according to thin layer chromatography, draw each 2 μ l of above-mentioned two kinds of solution, putting respectively on same silica gel g thin-layer plate, is developing solvent with 9: 1 normal hexane-ethyl acetates, launches, take out, dry, put 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 speckle of same color;

Get capsule 's content 2g, porphyrize, the 20ml that adds diethyl ether, jolting was extracted 5 minutes, filtered, and filtrate evaporate to dryness, residue add ethyl acetate 2ml makes dissolving, as need testing solution; Get Radix Et Rhizoma Rhei control medicinal material 0.1g, shine medical material solution in pairs with legal system; Get emodin, chrysophanol reference substance again, add methanol and make the reference substance mixed solution that every ml contains 1mg; According to thin layer chromatography test, draw each 4 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, be developing solvent with the upper solution of 15: 5: 1 petroleum ether one Ethyl formate one formic acid, launch, take out, dry; Put under the ultra-violet lamp 365nm and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show five identical orange-yellow fluorescence speckles; With the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle; Put in the ammonia smoked after, inspect under the daylight, speckle becomes redness;

Assay: precision takes by weighing capsule 's content 0.5g, puts in the apparatus,Soxhlet's, and it is an amount of to add diethyl ether, and reflux, extract, 2 hours discards ether solution, and filtration paper cylinder takes out, and dries, and puts in the apparatus,Soxhlet's again, and it is an amount of to add methanol, and reflux, extract, is to colourless; Extracting solution reclaims methanol to doing, and residue is with the 20ml water dissolution; Put in the separatory funnel, with water saturated 20ml, 20ml, 15ml, 15ml, 10ml n-butanol extraction 5 times, merge extractive liquid,, with the saturated water 30ml of n-butyl alcohol, 30ml, 30ml washing 3 times discards water liquid, and the n-butanol extracting liquid reclaim under reduced pressure is to doing; The residue dissolve with methanol is transferred in the measuring bottle of 10ml, adds methanol and is diluted to scale, as need testing solution; Other gets panaxoside Rg ₁Reference substance, the accurate title, decide, and adds methanol and make the solution that every ml contains 1mg, in contrast product solution; Test according to thin layer chromatography, draw need testing solution 2 μ l, reference substance solution 1 μ l, 2 μ l, the cross point is on same silica gel g thin-layer plate respectively, with 15: 40: 22: the subnatant that 10 chloroforms-ethyl acetate one methanol one water was placed below 10 ℃ after 12 hours was developing solvent, launch, take out, dry, spray is with 5% ethanol solution of sulfuric acid, 100-105 ℃ of baking 4-5 minute, clear to the speckle colour developing, take out, cover onesize glass plate, with adhesive tape the edge is sealed, scan wavelength X according to thin layer chromatography _S=535nm, λ _R=650nm, the trap integrated value of measurement test sample and reference substance is calculated with the external standard two-point method, that is and, every capsules content contains panaxoside Rg ₁Should be no less than 7.2mg.

19, as the application of the described Chinese medicine composition of one of claim 1-8 in preparation treatment prolapse of lumbar intervertebral disc medicine.