CN101953940A - Traditional Chinese medicine having function of tonifying kidney, invigorating blood circulation and relieving pain, preparation method and quality specification thereof - Google Patents

Traditional Chinese medicine having function of tonifying kidney, invigorating blood circulation and relieving pain, preparation method and quality specification thereof Download PDF

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CN101953940A
CN101953940A CN2010105097185A CN201010509718A CN101953940A CN 101953940 A CN101953940 A CN 101953940A CN 2010105097185 A CN2010105097185 A CN 2010105097185A CN 201010509718 A CN201010509718 A CN 201010509718A CN 101953940 A CN101953940 A CN 101953940A
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佟雪松
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QINHUANGDAO HUANGWEI PHARMACEUTICAL CO Ltd
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Abstract

The invention discloses a capsule for treating neck swelled pain, inconvenient motion, swirl and tinnitus, a preparation method thereof and a detection method. The medicine comprises a capsule wrapper and inner fillers, wherein the inner filler of each capsule contains 0.26 to 0.29g active ingredients and medical auxiliary materials. The active ingredients are prepared by using a certain weight part of prepared rehmannia root, Polygonum multiflorum, Eucommia ulmoides, pyrola, Rhizoma Drynariae, uncaria and pseudo-ginseng. The medical auxiliary materials contain starch. The clinical test proved that the efficiency of the test group using the sample of the invention is 98.85% while the efficiency of a comparison group is 96.92%. Relative to use clear paste as medicine with uncertain concentration ratio and drying condition, the technique of the invention is more controllable by using dry powder as medicine with the best concentration ratio and specified drying condition.

Description

A kind of the kidney invigorating, invigorate blood circulation, Traditional Chinese medicine used as analgesic and preparation method thereof and quality standard
Technical field
The invention belongs to the field of Chinese medicines, relate to a kind of treatment neck distending pain numbness, movable unfavorable, the medicine of dizziness and tinnitus and the method for making of this medicine thereof, and detection method.
Background technology
Cervical spondylosis claims cervical spine syndrome again, it is the general name that osteoarthritis of cervical spine, proliferative cervical spondylosis, cervical syndrome, cervical intervertebral disk are deviate from disease, it is a kind of illness of changing into the basis with degeneration pathology, mainly due to cervical vertebra strain for a long time, hyperosteogeny, or prolapse of intervertebral disc, ligament thicken, cause cervical vertebra spinal cord, nerve root or vertebral artery pressurized, a series of handicapped clinical syndromes occur.The standard for traditional Chinese medicines WS-10154 of country (ZD-0154)-2002 discloses a kind of neck health sheet for the treatment of the cervical spondylosis due to the blood stasis due to renal deficiency, contain Radix Rehmanniae Preparata, Radix Polygoni Multiflori, the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), Ramulus Uncariae Cum Uncis, Radix Puerariae, Radix Notoginseng, Semen Raphani (stir-fry) in the prescription, be used for above-mentioned treatment of diseases, obtained certain curative effect, but onset is slower, and disintegration time is longer.Chinese patent 200510032466.0 discloses dosage forms such as soft capsule, micropill, capsule, and this document still has the following disadvantages: 1, adopt 9 flavor medical materials mixing to decoct, be unfavorable for preparing capsule.2, do not have the parameters such as consumption of concrete extracting solution, controllability is lower.In addition, all there are further improvement demand prescription and onset time etc., and better bring into play the curative effect of above-mentioned prescription.
Summary of the invention
The purpose of this invention is to provide a kind of rapid-action, good effect, quality controllable treatment neck distending pain numbness, movable unfavorable, medicine of dizziness and tinnitus and preparation method thereof.
The kidney invigorating of the present invention, invigorate blood circulation, the agent of analgesic Chinese medicinal capsule, comprise capsule skin and content, content described in every capsules comprises that active component and pharmaceutic adjuvant are 0.26-0.29g altogether, and wherein active component is made by following weight portion medical material, and pharmaceutic adjuvant comprises starch:
Radix Rehmanniae Preparata 180-240 part Radix Polygoni Multiflori 150-300 part Cortex Eucommiae 100-300 part
Herba Pyrolae 100-300 part Rhizoma Drynariae (scalding) 100-200 part Ramulus Uncariae Cum Uncis 50-250 part
Radix Notoginseng 30-220 part.
The kidney invigorating of the present invention, invigorate blood circulation, the agent of analgesic Chinese medicinal capsule, the medical material of making described active component comprises that also following weight portion medical material makes:
Radix Puerariae 50-250 part Semen Raphani (stir-fry) 50-250 part.
A kind of weight portion of medical material of active component consists of preferably:
150 parts of 200 parts of Cortexs Eucommiae of 200 parts of Radix Polygoni Multiflori of Radix Rehmanniae Preparata
200 parts of 150 parts of Ramulus Uncariae Cum Uncis of 200 parts of Rhizoma Drynariae of Herba Pyrolae (scalding)
200 parts of Radix Puerariae 200 parts of Semen Raphanis of 200 portions of Radix Notoginseng (stir-fry).
The weight portion of the medical material of another active component consists of preferably:
136.4 parts of 272.8 parts of Cortexs Eucommiae of 204.5 parts of Radix Polygoni Multiflori of Radix Rehmanniae Preparata
100 parts of 136.4 parts of Ramulus Uncariae Cum Uncis of 136.4 parts of Rhizoma Drynariae of Herba Pyrolae (scalding)
86.2 parts of Radix Puerariae 50 parts of Semen Raphanis of 100 portions of Radix Notoginseng (stir-fry).
The kidney invigorating of the present invention, invigorate blood circulation, the agent of analgesic Chinese medicinal capsule, wherein every of adjuvant contains 0.05g at the most, and should be enough to make the granule that is used for filled capsules.
The kidney invigorating of the present invention, invigorate blood circulation, the agent of analgesic Chinese medicinal capsule, be less than 10 minutes wherein capsular disintegration, after taking, thereby has infiltration rate faster.
The present invention also provides a kind of the kidney invigorating, has invigorated blood circulation, the preparation method of analgesic Chinese medicinal capsule agent, is specially:
Get Radix Notoginseng and be ground into fine powder for 25 parts; Eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata decoct with water secondary, add water 8-12 for the first time and doubly measure decoction 2-4 hour, add for the second time water 6-10 and doubly measure decoction 1-3 hour, collecting decoction filters, it is 1.30~1.35 thick paste that filtrate is concentrated into when 80 ℃ are measured relative density, with above-mentioned powder mixing, and 70 ℃ of vacuum dryings, broken mistake 100 mesh sieves of dried cream powder with the appropriate amount of starch mixing, are done wetting agent system soft material with 85% ethanol, 20 mesh sieves are granulated, 50 ℃ of-60 ℃ of dryings, 20 mesh sieve granulate incapsulate.
More there is the condition of the preparation method of choosing to be, be with eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata, decoct with water secondary, adding for the first time 10 times of amounts of water decocted 3 hours, add for the second time 8 times of amounts of water and decocted 2 hours, collecting decoction filters, it is 1.30~1.35 thick paste that filtrate is concentrated into when 80 ℃ are measured relative density, with above-mentioned powder mixing, 70 ℃ of vacuum dryings, broken mistake 100 mesh sieves of dried cream powder, with the appropriate amount of starch mixing, do wetting agent system soft material with 85% ethanol, 20 mesh sieves are granulated, 50 ℃ of-60 ℃ of dryings, 20 mesh sieve granulate incapsulate.
The present invention also provides above-mentioned the kidney invigorating, has invigorated blood circulation, the discrimination method of analgesic Chinese medicinal capsule agent, is specially:
It is an amount of to get described content, and porphyrize takes by weighing 2g, add the low amounts of water moistening, stir evenly, in addition water saturated n-butyl alcohol 15ml, supersound process 15 minutes was placed 2 hours, and is centrifugal, get supernatant, add 3 times of amounts, shake up with the saturated water of n-butyl alcohol, placement makes layering, and is centrifugal in case of necessity, gets n-butanol layer, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Get ginsenoside Rb 1And Panax Notoginseng saponin R 1Reference substance adds methanol and makes the mixed solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography, draw each 5 μ l of above-mentioned solution, put respectively on same silica gel g thin-layer plate, chloroform-ethyl acetate-the methanol-water that with the ratio is 10-20: 30-50: 15-30: 5-20 is developing solvent at lower floor's solution of placing below 10 ℃, launch, take out, dry, spray is 1 → 10 sulfuric acid solution with ratio, is heated to clear spot at 105 ℃; In the test sample chromatograph, be on the corresponding position of reference substance chromatograph, show the speckle of same color.
The developing solvent of above-mentioned discrimination method is preferably 15: 40: 22: lower floor's solution that chloroform-ethyl acetate of 10-methanol-water is placed below 10 ℃.
The used crude drug source of the present invention is as follows:
Radix Rehmanniae Preparata this product is the process of preparing Chinese medicine processed goods of Radix Rehmanniae.Radix Rehmanniae is the fresh or dried root of goatweed Rehmannia gluinosa Libosch..
Radix Polygoni Multiflori this product is the dried root of polygonum multiflorum thunb Polygonum multiflorum Thunb..Autumn, two season of winter excavate when leaf is withered, and the two ends of pruning are cleaned, individual big piece, the drying of being cut into.
Cortex Eucommiae this product is the dry bark of Eucommiaceae plant Cortex Eucommiae Eucommia ulmoides Oliv..Strip 4~June, scrapes off rough bark, and " diaphoresis " to the endothelium of banking up is puce, dries.
Herba Pyrolae this product is the dry herb of Pyrolaceae plant Herba pyrolae japonicae Pyrola calliantha H.Andres or common Herba pyrolae japonicae Pyroladecorata H.Andres.All can excavate the whole year, removes impurity, shines to blade when softer, banks up to blade purpling brown, dries.
Rhizoma Drynariae (scalding) this product is the dry rhizome of Polypodiaceae plant Mongolian oak Herba pteridii latiusculi Drynaria fortunei (Kunze) J.Sm..All can excavate the whole year, removes silt, drying, or burn remove floss (scale) again.
Ramulus Uncariae Cum Uncis this product is the dry stem and branch with belt hook of Maguireothamnus speciosus Ramulus Uncariae Cum Uncis Uncaria rhynchyl la (Miq.) jachs., Ramulus Uncariae macrophyllae Uncaria macrophylla Wall., Ramulus Uncariae Cum Uncis Uncaria hirsuta Havil., Uncaria sinensis (Oliv.) Havil. Uncaria sinensis (Oliv.) Havil. or stockless fruit Ramulus Uncariae Cum Uncis Uncaria sessilfructus Roxb..Autumn, two seasons of winter gather, defoliation, and cutting is dried.
Radix Puerariae this product is the dry root of legume pueraria lobata Pueraria lobata (Willd.) Ohwi or Radix Puerariae rattan Pueraria thomsoniiBenth..Autumn, two seasons of winter excavate, and Herba Gelsemii Elegantis takes advantage of fresh-cut more and becomes sheet or fritter; Dry; The Radix Puerariae rattan practise to claim " Pachyrhizua angulatus ", removes crust more, with sulfur smoked after, dried slightly, intercept or rip cutting two halves again, drying.
Radix Notoginseng this product is the dry root of panax araliaceae plant Panax notoginseng (Burk.) F.H.Chen.Excavate before the flowers are in blossom autumn, cleans, and separates main root, supporting root and stem foot, drying.Supporting root is practised and is claimed " rib ", and stem foot is practised title " clip ".
Semen Raphani (stir-fry) this product is the dry mature seed of crucifer Radix Raphani Raphanus sativus L..Tap plant during fruit maturation summer, dries, and rubs seed, removes impurity, dries again.
Beneficial effect of the present invention is, clinical trial shows that the effective percentage of taking the test group of sample of the present invention is 98.85%, and the effective percentage of matched group is 96.92%.Because employing dry powder (rather than clear paste) directly is used as medicine and has provided best spissated proportion, concrete drying condition, thereby is used as medicine and uncertain concentrated proportion and drying condition with respect to clear paste, technology is more controlled.
Test example 1 Study on extraction
1 water absorption rate is investigated
Take by weighing medical material 239.54g altogether, add 10 times of water gagings and put in the 5000ml beaker, soak, observed once in per 30 minutes, (the saturating heart of medical material) observed 6 hours altogether till medical material no longer absorbs water, filter, calculate by following formula, measuring the medical material water absorption rate was 185% (being about 2 times).Should add 2 times of water gagings when therefore, decocting first.
Medical material water absorption rate %=(medical material weight in wet base-medical material dry weight)/medical material dry weight * 100%.
2 medical material water are carried amount of water and are investigated
Test method: take by weighing Radix Rehmanniae Preparata 20.45g, Radix Polygoni Multiflori 27.28g, Cortex Eucommiae 13.64g, Herba Pyrolae 13.64g, Rhizoma Drynariae (scalding) 13.64g, Ramulus Uncariae Cum Uncis 10g, Radix Puerariae 10g, Semen Raphani (stir-fry) 8.62g, Radix Notoginseng 2.5g in the prescription ratio, totally 9 parts, be divided into three groups, decoct with water secondary respectively, 3 hours for the first time, 2 hours for the second time, first group added 6 times of amounts of water respectively, second group adds 8 times of amounts of water respectively, and the 3rd group adds 10 times of amounts of water respectively.Filter respectively, merging filtrate, the concentrating under reduced pressure drying is weighed, and calculates paste volume; It is an amount of to get dry extract, measures the ginsenoside Rg 1Content, and calculate to extract total amount.
The paste-forming rate computing formula is as follows:
Paste-forming rate %=dry extract is heavy/and 119.77 * 100%
Table 1 medical material water is put forward the result
Figure BDA0000028542090000041
Conclusion: must measure with dry extract is index, and the many more yield of extract of amount of water are high more, but do not have significant difference; With ginsenoside Rg1's content is index, and 2 groups of experimental programs extract fully substantially, after this continues to increase amount of water ginsenoside Rg1 extracted amount and does not have the significance raising.
3, concentrated and drying process research
(1) investigation of concentrated condition
Radix Rehmanniae Preparata 204.5g, Radix Polygoni Multiflori 272.8g, Cortex Eucommiae 136.4g, Herba Pyrolae 136.4g, Rhizoma Drynariae (scalding) 136.4g, Ramulus Uncariae Cum Uncis 100g, Radix Puerariae 100g Radix Notoginseng 25g Semen Raphani (stir-fry) 86.2g, decoct with water secondary, add for the first time 10 times of water gagings, decocted 3 hours, and added 8 times of water gagings for the second time, decocted 2 hours, merge decoction liquor, filter, be settled to 20000ml, standby.Precision measures that to decide solution an amount of, measures ginsenoside Rg1's content according to preceding method.Get 3 parts then, every part of 2500ml, being concentrated into relative density respectively under different temperatures is 1.30-1.35 (80 ℃) thick paste.Each precision is got an amount of concentrated solution, measures ginsenoside Rg1's content, the results are shown in Table 2:
Ginsenoside Rg before and after table 2 concentrates 1Changes of contents
Figure BDA0000028542090000042
As seen from the above table, the drying under reduced pressure thickening temperature is to the ginsenoside Rg 1Content has certain influence, and content is the highest in the time of 60 ℃, optimum concentration technology condition be 60 ℃ ,-0.08~-0.1Mpa.
(2) investigation of drying condition
From the standby amalgamation liquid of aforementioned 20000ml, measure 3 parts, every part of 1000ml, 60 ℃ of concentrating under reduced pressure (0.08~-0.01Mpa) to 1.30-1.35 (80 ℃) thick paste, add the Radix Notoginseng fine powder respectively in the prescription ratio, mixing, respectively at 60,70,80 ℃ of vacuum dryings (0.08~-0.1Mpa) to dried cream water content be below 6%, standby.From 3 parts of dry extracts, each precision takes by weighing in right amount, presses preceding method and measures ginsenoside Rg1's glycosides content, the results are shown in Table 3
Ginsenoside Rg before and after table 3 is dry 1Changes of contents
Figure BDA0000028542090000051
As seen from the above table, baking temperature is to ginsenoside Rg in the extractum 1Content has certain influence, and 80 ℃ of retention rates descend obviously,
With better below 70 ℃ as this product vacuum drying temperature.
Prescription screening:
4, the selection of adjuvant:
Take by weighing the medicated powder and the adjuvant mix homogeneously (crossing 100 mesh sieves) of ormal weight, put the interior constant weight of phosphorus pentoxide desiccator 48 hours.
The compatibility prescription of table 4 different auxiliary material and extract powder
Figure BDA0000028542090000052
The percentile mensuration of moisture absorption:
The glass exsiccator that the bottom is filled the sodium chloride supersaturated solution is put into 25 ℃ constant incubator constant temperature 24h, and the interior relative humidity of exsiccator this moment is 75%.Put into the medicated powder of thick about 2mm in the weighing botle bottom of constant weight, in the glass exsiccator that is placed on the sodium chloride supersaturated solution of accurately weighing (the weighing bottle cap is opened), preserve in 25 ℃ of constant incubators, the timing weighing is calculated as follows
Moisture absorption percentage rate (%)=(medicated powder weight-moisture absorption prodrug grain weight after the moisture absorption)/moisture absorption prodrug grain weight * 100%
The moisture absorption percentage rate of the different prescription of table 5 medicated powder
Figure BDA0000028542090000061
Measure angle of repose:
The angle of repose of the medicated powder of the different prescriptions of table 6
Figure BDA0000028542090000062
Table 5 and table 6 show, with hydroscopicity be index, different auxiliary material is good with microcrystalline Cellulose and starch, therefore in conjunction with the flowability of different auxiliary material, determines that starch is as adjuvant.
5, the granule of adjuvant and powder properties are relatively
Particulate preparation: the powder 10.25g that gets it filled, add 3.25g starch, be wetting agent system soft material with 85% ethanol, cross 20 eye mesh screens and make wet granular, dry in 50-60 ℃ of baking oven, granulate (20 order), promptly getting granularity is the dried granules of 40 purposes.
The preparation of powder: the powder 10.25g that gets it filled, add 3.25g starch, grind well, cross 100 eye mesh screens, promptly.Granule and powder properties compare: the mensuration of angle of repose is undertaken by preceding method,
The angle of repose of table 7 granule and medicated powder
The prescription number Granule Powder
Angle of repose 25.4 46.3
After powder made granule, can reduce the hydroscopicity of powder, and mobilely significantly improve.
Critical relative humidity is a medicine moisture absorption whether marginal value, ambient humidity in the time of also can determining to produce simultaneously according to him, by experimental result as can be known, be that to make particulate critical relative humidity be 65% to adjuvant with starch, so when producing this preparation, the relative humidity of workshop condition should be controlled at below 60%, simultaneously packaging material and storage requirement has also been proposed corresponding requirement.
The drying of wet granular
85% alcohol granulation, dry down at lower temperature (50-60 ℃ of hot blast), experiment shows that under this cryogenic conditions, wet granular can be dried to water content below 6% in the short time.Mobility of particle is better under this moisture condition, and content uniformity is little during fill, takes all factors into consideration the quality control requirement of capsule, and therefore dried granule water content is controlled at below 6% and is advisable.
Test example 3: clinical trial
The 4 treatment cervical spondylosis clinical trials (clinical trial of following each test example is all according to Chinese medicine clinical guidance principle) of test example
One, case choice criteria
1, tcm syndrome diagnostic criteria
(1) syndrome
A wind-cold channel blocking network card
Primary symptom: cervical region is affected by the cold and falls ill, the cold De Wenzeshu of limbs acid.
Inferior disease: neck pain, movable unfavorable, acroanesthesia pain, spasm of the limbs perhaps a little less than the muscular atrophy, refers to the toe numbness.Dark tongue quality, white and thin fur, deep and stringy pulse or late heavy.
The B syndrome of qi stagnation and blood stasis
Primary symptom: because of cervical region wound or damage are fallen ill, neck pain, moving then aggravation, pain spot is fixing not to be moved.
Inferior disease: often accompany numb limbs and tense tendons, body of the tongue is light red, or purple dim have ecchymosis, stringy pulse or puckery.
C insufficiency of vital energy and blood card
Primary symptom: the neck distending pain is heavy, dizzy, headache, soft, the aversion to cold and cold limbs of knee joint.
Inferior disease: tinnitus, cardiopalmus is breathed hard, the nocturia frequency, pale tongue with white fur is a little less than the deep-thready pulse.
The D syndrome of upper hyperactivity of liver yang
Primary symptom: dizzy, headache, conjunctival congestion, pale tongue with white fur, being irritable and getting angry easily.
Inferior disease: flushing, xerostomia, constipation, it is red to urinate, red tongue, yellow fur, wiry and frequent pulse.
(2) each related indication score value and weight of symptom scalar quantization
Table 8 cervical spondylosis symptom scalar quantization table
Symptom Gently In Heavy
Dizzy Dizziness and blurred vision, in time, end when doing Look the thing rotation, can not walk Dizzyly desire to pounce on, can not walk
Headache Slight headache, in time, end when doing Headache can be born, often outbreak Headache continues more than unbearably
Numb limbs and tense tendons Slight numb, in time, end when doing Numbness can be born, often outbreak Numbness continues more than unbearably
Limbs paralysis numbness Limbs are slightly unable, go up movable Limbs are obviously unable, limitation of activity The limbs panplegia, stiff
Cardiopalmus Slight once in a while cardiopalmus Cardiopalmus is bestirred oneself Cardiopalmus takes place frequently
Insomnia Sleep has minimizing slightly The time see insomnia Can not fall asleep
Tinnitus Tinnitus is slight Tinnitus is hard of hearing, and time ends when doing Tinnitus is more than, auditory dysesthesia
Carry cold cold extremities Little fear of cold Aversion to cold and cold limbs is obvious Aversion to cold and cold limbs is clothing further
Xerostomia Mouth is little to be done The few Tianjin of xerostomia Xerostomia is drunk water often
Constipation Big dry stool delegation's every day The stool constipation, delegation on the two Difficulty in defecation, a few days delegation
2, include standard in
A meets the tcm syndrome diagnostic criteria
Type that B should clearly include in and tcm syndrome.
C determines to be tried the range of age according to the purpose and the primary disease characteristics of each clinical trial phase.
3, get rid of case history standard (comprise inadaptation or play) except that standard
3.1 do not meet Chinese medical discrimination and diagnostic criteria person.
3.2 do not belong to case history in the drug effect scope
3.3 folder card or complication person between having obviously.
3.4 suckling gestation or the women who is just preparing gestation
3.5 allergic constitution reaches multiple drug allergy person
3.6 merge serious primary disease such as liver, kidney, hemopoietic system, hormonal system and psychotic.
3.7 the state of an illness is critical, is difficult to definite estimator is done in the effectiveness and the safety of new drug.
Two, observation index
1, safety observation
(1) general health check-up project
(2) blood, urine, just routine test.
(3) heart, liver, kidney function test.
2. health giving quality observation
(1) related symptoms: dizzy, headache, quadriplegia, cardiopalmus, aversion to cold and cold limbs, xerostomia, constipation etc., observe its variation weekly.
(2) relevant sign: tenderness, muscular strength, muscular tension, neural reflex test, neck test etc. is revolved in the pathologic reflex test.
(3) Xiang Guan physico-chemical examination.
Three, curative effect determinate standard
1 recovery from illness: pain, numbness or symptom, sign integration such as dizzy reduce 〉=95%, and the X line shows normally.
2 produce effects: pain, numbness or symptom, sign integration such as dizzy reduce 〉=70%,<95%, and the X line shows and is clearly better.
3 is effective: pain, numbness or symptom, sign integration such as dizzy reduce 〉=30%,<70%, and the X line shows improvement.
4 is invalid: pain, numbness or symptom, sign such as dizzy reduce less than 30%, and the X line shows not have and changes.
Four, Therapeutic Method
The treatment group gives the embodiment of the invention 2 samples.Boiled water is taken after mixing it with water.One time 1 bag, 2 times on the one.One after each meal.
Matched group is taken JINGFUKANG KELI (Chengde JingFuKang pharmacy Group Co.,Ltd, the main component Radix Astragali, Radix Codonopsis, Radix Salviae Miltiorrhizae, the Radix Paeoniae Alba, Radix Rehmanniae, Concha Haliotidis, Radix Clematidis, Ophicalcitum (forging), Radix Puerariae, Cortex Phellodendri, Radix Gentianae Macrophyllae, Semen Vaccariae (stir-fry), Rhizoma Chuanxiong, Rhizoma Atractylodis, Rhizoma Et Radix Notopterygii, Semen Persicae (peeling), Olibanum (system), Myrrha (processed), Flos Carthami, Pheretima (wine is processed), Eupolyphaga Seu Steleophaga (wine is processed)), boiled water is taken after mixing it with water, one time 1~2 bag.2 times on the one, one after each meal.2 groups was 1 course of treatment with 7 days all.General treatment is judged curative effect 3 courses of treatment.
Five, statistical method
Measurement data adopts the t check, and enumeration data adopts x 2The Radit check is adopted in check analysis, ranked data.
Six, therapeutic outcome
Table 9 liang group physical data relatively
Figure BDA0000028542090000091
Table 10 liang group therapeutic effect of syndrome relatively
The primary symptom integration changes relatively before and after table 11 treatment
Figure BDA0000028542090000094
Figure BDA0000028542090000095
Change of illness state relatively before and after table 12 treatment
Figure BDA0000028542090000096
Figure BDA0000028542090000097
The total effective rate of Drug therapy cervical spondylosis of the present invention as a result is 98.88%, and the total effective rate of contrast medicine is 97.10%.Wherein neck and shoulder part tenderness effective percentage is 92.5%, cervical pain and limitation of activity effective percentage are 96.2%, headache, dizzy (cervical spondylosis causes) effective percentage are 87.6%, and the improvement of the treatment back state of an illness, primary symptom integration is all remarkable, illustrate that the present invention treats cervical spondylosis effect is preferably arranged, untoward reaction is slight.
The 5 prolapse of lumbar intervertebral disc clinical trials of test example
Data and method
1, physical data: this group is totally 30 examples, male's 19 examples, women's 11 examples.Minimum 21 years old of age, maximum 54 years old, average 46 years old.All be the prolapse of lumbar intervertebral disc patient, be chief complaint with the root neuralgia.
2, method: all flat bed rest of case is with partner treatment.The patient takes 1 bag of granule of the present invention at every turn, every day 3 times, takes 2-4 week continuously.
3, result: the sciatica effective percentage is 75.3%, and the hyperosteogeny effective percentage is 82.7%, and the effective percentage of flank pain and limitation of activity is 91.4%, and the numb limbs and tense tendons effective percentage is 98.5%.
4, discuss: this group case is patients with lumbar disc herniation, be chief complaint with the root neuralgia, curative effect is very good after taking sample of the present invention, symptom is gone down or complete obiteration, be aided with the treatment of lying up in the hope of reaching the purpose that outstanding intervertebral disc is resetted, the result proves effective.
Test example 6 prolapse of lumbar intervertebral disc postoperatives are used granule clinical efficacy of the present invention
1, clinical data and method
This organizes 86 examples, male 56 examples, and women 30 examples, age 24-52 year, wherein one-sided window or vertebral pulp 76 examples are extractd in the semi-vertebral plate decompression, full cone-plate 10 examples that reduce pressure, intervertebral disk hernia 51 examples, 2 intervertebral disk hernia 35 examples, the tangible nerve root canal of 32 example companions is narrow.The nerve root canal of going simultaneously in the art enlarges.See nerve root congestion and edema 28 examples in the art.Postoperative begins to take the particulate time of the present invention: 59 examples behind the 24h, take medicine 27 examples behind the 72h; 2-3 week medicine time.Set up matched group simultaneously, totally 40 examples, in age 30-48 year, wherein about 1/3 patient is for there being tangible gastrointestinal reaction person after taking medicine.
2, observed result
The result uses granule person of the present invention for postoperative, and postoperative still has the lumbago and skelalgia in early days, and the person is less than matched group, and the time of transference cure also is shorter than matched group.Sample sets recovery rate of the present invention is 86.7%, and the matched group recovery rate is 61%.Observe finding, take granule of the present invention, leave over neuralgia and promote that neurological functional recovery has significant curative effect alleviating the prolapse of lumbar intervertebral disc postoperative.
3, discuss
3.1 surgical removal outstanding intervertebral disc, removed compressing, but the passages through which vital energy circulates QI and blood of nerve root can not be recovered immediately still.So take at this moment invigorate blood circulation, promoting of the circulation of QI and removing the obstruction in the collaterals, blood stasis dispersing and deswelling analgesic medicine, can promote recovery, the mitigation symptoms of function of nervous system.Herba Lycopodii in the granule of the present invention, Radix Achyranthis Bidentatae, Olibanum, Myrrha, Flos Carthami all have above pharmacological action.
3.2 in the art nerve root is produced stimulation and compressing, makes it further congestion and edema.Therefore the sx of a period of time can appear in some patient's postoperative.For such case,, elimination and mitigation symptoms there is the positive therapeutic effect if can in time take blood circulation promoting and blood stasis dispelling, collateral dredging, promoting the circulation of blood detumescence, analgesic medicine.
3.3 operation will inevitably cause that operative region is hemorrhage, even strict hemostasis, can not control tiny oozing of blood fully, and partial hematocele can produce compressing or stimulation to nerve root, tissue is comparatively slow to its absorption, the Chinese medicine of taking removing blood stasis, promoting the circulation of blood, dissipating blood stasis can promote the absorption of congestion, prevents or alleviates hematoma compression, stimulation and adhesion.Radix Achyranthis Bidentatae in the prescription, the existing above function of Flos Carthami.
3.4 operation inevitably causes tissue injury, therefore is in outside postoperative has additional nutrients to the patient, using has reducing swelling and alleviating pain, and the Chinese medicine of the yin fluid astringing that nourishes blood, promoting tissue regeneration and ulcer healing effect can promote wound healing and functional rehabilitation, as Olibanum, Myrrha, the Radix Paeoniae Alba etc.
Description of drawings
The thin layer of Fig. 1, ginsenoside Rb1 and Rg1 and arasaponin R1 (TLC)
1,2,3 is sample point; 4 is the reference substance speckle of Rb1, Rg1, arasaponin R1.
The specific embodiment
Embodiment 1, capsule of the present invention
Radix Rehmanniae Preparata 204.5g Radix Polygoni Multiflori 272.8g Cortex Eucommiae 136.4g
Herba Pyrolae 136.4g Rhizoma Drynariae (scalding) 136.4g Ramulus Uncariae Cum Uncis 100g
Radix Puerariae 100g Radix Notoginseng 50g Semen Raphani (stir-fry) 86.2g
[method for making] above nine flavor medical materials are got Radix Notoginseng 25g and are ground into fine powder; Eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata decoct with water secondary, add 10 times of amounts of water for the first time and decoct 3 hours, add for the second time 8 times of amounts of water and decocted 2 hours, collecting decoction filters, filtrate is concentrated into the thick paste that relative density is 1.30~1.35 (80 ℃), with above-mentioned powder mixing, and 70 ℃ of vacuum dryings, broken mistake 100 mesh sieves of dried cream powder with the appropriate amount of starch mixing, are done wetting agent system soft material with 85% ethanol, 20 mesh sieves are granulated, 50 ℃ of-60 ℃ of dryings, 20 mesh sieve granulate, incapsulate, make 1000.
Embodiment 2, capsule of the present invention
Radix Rehmanniae Preparata 200g Radix Polygoni Multiflori 200g Cortex Eucommiae 150g
Herba Pyrolae 200g Rhizoma Drynariae (scalding) 150g Ramulus Uncariae Cum Uncis 200g
Radix Puerariae 200g Radix Notoginseng 200g Semen Raphani (stir-fry) 200g.
[method for making] above nine flavor medical materials are got Radix Notoginseng 25g and are ground into fine powder; Eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata decoct with water secondary, add 12 times of amounts of water for the first time and decoct 2 hours, add for the second time 10 times of amounts of water and decocted 1 hour, collecting decoction filters, filtrate is concentrated into the thick paste that relative density is 1.30~1.35 (80 ℃), with above-mentioned powder mixing, and 70 ℃ of vacuum dryings, broken mistake 100 mesh sieves of dried cream powder with the appropriate amount of starch mixing, are done wetting agent system soft material with 85% ethanol, 20 mesh sieves are granulated, 50 ℃ of-60 ℃ of dryings, 20 mesh sieve granulate, incapsulate, make 1000.
Embodiment 3, capsule of the present invention
Radix Rehmanniae Preparata 200g Radix Polygoni Multiflori 200g Cortex Eucommiae 150g
200 portions of Radix Notoginseng of Herba Pyrolae 200g Rhizoma Drynariae (scalding) 150g Ramulus Uncariae Cum Uncis 200g.
[method for making] above nine flavor medical materials are got Radix Notoginseng 25g and are ground into fine powder; Eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata decoct with water secondary, add 8 times of amounts of water for the first time and decoct 4 hours, add for the second time 6 times of amounts of water and decocted 3 hours, collecting decoction filters, filtrate is concentrated into the thick paste that relative density is 1.30~1.35 (80 ℃), with above-mentioned powder mixing, and 70 ℃ of vacuum dryings, broken mistake 100 mesh sieves of dried cream powder with the appropriate amount of starch mixing, are done wetting agent system soft material with 85% ethanol, 20 mesh sieves are granulated, 50 ℃ of-60 ℃ of dryings, 20 mesh sieve granulate, incapsulate, make 1000.
Embodiment 4, capsule of the present invention
Radix Rehmanniae Preparata 240g Radix Polygoni Multiflori 300g Cortex Eucommiae 300g
Herba Pyrolae 300g Rhizoma Drynariae (scalding) 200g Ramulus Uncariae Cum Uncis 250g
Radix Puerariae 250g.
The discriminating of embodiment 5 capsules of the present invention
It is an amount of to get this product content, and porphyrize takes by weighing 2g, add the low amounts of water moistening, stir evenly, in addition water saturated n-butyl alcohol 15ml, supersound process 15 minutes was placed 2 hours, and is centrifugal, get supernatant, add 3 times of amounts, shake up with the saturated water of n-butyl alcohol, placement makes layering (centrifugal in case of necessity), gets n-butanol layer, evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution.Get ginsenoside Rb 1And Panax Notoginseng saponin R 1Reference substance adds methanol and makes the mixed solution that every 1ml contains 0.5mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B), draw each 5 μ l of above-mentioned solution, put respectively on same silica gel g thin-layer plate, (15: 40: 22: 10) lower floor's solution of placing below 10 ℃ was developing solvent with chloroform-ethyl acetate-methanol-water, launch, take out, dry, spray is heated to clear spot with sulfuric acid solution (1 → 10) at 105 ℃.In the test sample chromatograph, be on the corresponding position of reference substance chromatograph, show the speckle of same color.
The above embodiment only is that preferred implementation of the present invention is described; be not that scope of the present invention is limited; design under the prerequisite of spirit not breaking away from the present invention; various distortion and improvement that the ability those of ordinary skill is made technical scheme of the present invention all should fall in the definite protection domain of claims of the present invention.

Claims (10)

1. a kidney invigorating, invigorate blood circulation, the agent of analgesic Chinese medicinal capsule, comprise capsule skin and content, it is characterized in that content described in every capsules comprises that active component and pharmaceutic adjuvant are 0.26-0.29g altogether, wherein active component is made by following weight portion medical material, and pharmaceutic adjuvant comprises starch:
Radix Rehmanniae Preparata 180-240 part Radix Polygoni Multiflori 150-300 part Cortex Eucommiae 100-300 part
Herba Pyrolae 100-300 part Rhizoma Drynariae (scalding) 100-200 part Ramulus Uncariae Cum Uncis 50-250 part
Radix Notoginseng 30-220 part.
2. the kidney invigorating as claimed in claim 1, invigorate blood circulation, the agent of analgesic Chinese medicinal capsule, it is characterized in that the medical material of making described active component comprises that also following weight portion medical material makes:
Radix Puerariae 50-250 part Semen Raphani (stir-fry) 50-250 part.
3. the kidney invigorating as claimed in claim 2, invigorate blood circulation, the agent of analgesic Chinese medicinal capsule, it is characterized in that the weight portion of making the medical material of described active component consists of:
150 parts of 200 parts of Cortexs Eucommiae of 200 parts of Radix Polygoni Multiflori of Radix Rehmanniae Preparata
200 parts of 150 parts of Ramulus Uncariae Cum Uncis of 200 parts of Rhizoma Drynariae of Herba Pyrolae (scalding)
200 parts of Radix Puerariae 200 parts of Semen Raphanis of 200 portions of Radix Notoginseng (stir-fry).
4. the kidney invigorating as claimed in claim 2, invigorate blood circulation, the agent of analgesic Chinese medicinal capsule, it is characterized in that the weight portion of making the medical material of described active component consists of:
136.4 parts of 272.8 parts of Cortexs Eucommiae of 204.5 parts of Radix Polygoni Multiflori of Radix Rehmanniae Preparata
100 parts of 136.4 parts of Ramulus Uncariae Cum Uncis of 136.4 parts of Rhizoma Drynariae of Herba Pyrolae (scalding)
86.2 parts of Radix Puerariae 50 parts of Semen Raphanis of 100 portions of Radix Notoginseng (stir-fry).
As the described the kidney invigorating of claim 1-4, invigorate blood circulation, the agent of analgesic Chinese medicinal capsule, it is characterized in that every of described adjuvant contains 0.05g at the most.
As the described the kidney invigorating of claim 1-4, invigorate blood circulation, the agent of analgesic Chinese medicinal capsule, it is characterized in that be less than 10 minutes described capsular disintegration.
As the described arbitrary the kidney invigorating of claim 1-4, invigorate blood circulation, the preparation method of analgesic Chinese medicinal capsule agent, it is characterized in that,
The described medical material of respectively distinguishing the flavor of is got Radix Notoginseng and is ground into fine powder for 25 parts; Eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata decoct with water secondary, add water 8-12 for the first time and doubly measure decoction 2-4 hour, add for the second time water 6-10 and doubly measure decoction 1-3 hour, collecting decoction filters, it is 1.30~1.35 thick paste that filtrate is concentrated into when 80 ℃ are measured relative density, with above-mentioned powder mixing, and 70 ℃ of vacuum dryings, broken mistake 100 mesh sieves of dried cream powder with the appropriate amount of starch mixing, are done wetting agent system soft material with 85% ethanol, 20 mesh sieves are granulated, 50 ℃ of-60 ℃ of dryings, 20 mesh sieve granulate incapsulate.
8. the kidney invigorating as claimed in claim 7, invigorate blood circulation, the preparation method of analgesic Chinese medicinal capsule agent, it is characterized in that,
Eight flavors such as described remaining Radix Notoginseng and Radix Rehmanniae Preparata decoct with water secondary, add 10 times of amounts of water for the first time and decoct 3 hours, add for the second time 8 times of amounts of water and decocted 2 hours, collecting decoction filters, it is 1.30~1.35 thick paste that filtrate is concentrated into when 80 ℃ are measured relative density, with above-mentioned powder mixing, and 70 ℃ of vacuum dryings, broken mistake 100 mesh sieves of dried cream powder with the appropriate amount of starch mixing, are done wetting agent system soft material with 85% ethanol, 20 mesh sieves are granulated, 50 ℃ of-60 ℃ of dryings, 20 mesh sieve granulate incapsulate.
As the described arbitrary the kidney invigorating of claim 1-4, invigorate blood circulation, the discrimination method of analgesic Chinese medicinal capsule agent, it is characterized in that, comprise the steps:
It is an amount of to get described content, and porphyrize takes by weighing 2g, add the low amounts of water moistening, stir evenly, in addition water saturated n-butyl alcohol 15ml, supersound process 15 minutes was placed 2 hours, and is centrifugal, get supernatant, add 3 times of amounts, shake up with the saturated water of n-butyl alcohol, placement makes layering, and is centrifugal in case of necessity, gets n-butanol layer, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Get ginsenoside Rb 1And Panax Notoginseng saponin R 1Reference substance adds methanol and makes the mixed solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography, draw each 5 μ l of above-mentioned solution, put respectively on same silica gel g thin-layer plate, chloroform-ethyl acetate-the methanol-water that with the ratio is 10-20: 30-50: 15-30: 5-20 is developing solvent at lower floor's solution of placing below 10 ℃, launch, take out, dry, spray is 1 → 10 sulfuric acid solution with ratio, is heated to clear spot at 105 ℃; In the test sample chromatograph, be on the corresponding position of reference substance chromatograph, show the speckle of same color.
10. the kidney invigorating as claimed in claim 9, invigorate blood circulation, the discrimination method of analgesic Chinese medicinal capsule agent, it is characterized in that described developing solvent is 15: 40: 22: lower floor's solution that chloroform-ethyl acetate of 10-methanol-water is placed below 10 ℃.
CN2010105097185A 2010-10-16 2010-10-16 Traditional Chinese medicine having function of tonifying kidney, invigorating blood circulation and relieving pain, preparation method and quality specification thereof Pending CN101953940A (en)

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CN103584106A (en) * 2013-11-29 2014-02-19 哈药集团中药二厂 Composition capable of improving bone mineral density
CN103877246A (en) * 2014-03-24 2014-06-25 通化斯威药业股份有限公司 Medicament capable of nourishing kidneys, promoting blood circulation, relieving rheumatism and pain and strengthening body and brain and preparation method of medicament
CN107126480A (en) * 2016-02-29 2017-09-05 山东中泰药业有限公司 A kind of Chinese medicine capsules and its method of quality control for treating cervical spondylopathy
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CN103584106A (en) * 2013-11-29 2014-02-19 哈药集团中药二厂 Composition capable of improving bone mineral density
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CN107126480B (en) * 2016-02-29 2020-08-07 山东中泰药业有限公司 A Chinese medicinal capsule for treating cervical spondylosis, and its quality control method
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Application publication date: 20110126