CN101773561A - Chinese medicine composition with functions of tonifying kidney, invigorating blood circulation and relieving pain and preparation method thereof - Google Patents
Chinese medicine composition with functions of tonifying kidney, invigorating blood circulation and relieving pain and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Chinese medicine composition with the functions of tonifying the kidney, invigorating the blood circulation and relieving the pain, which is prepared from raw material medicine such as prepared rhizome of rehmannia, fleece-flower root, eucommia bark, gerba pyrolae, rhizoma drynariae (hot), uncaria, radix puerariae, panax pseudo-ginseng and the like. The composition of the invention has the functions of tonifying the kidney, invigorating the blood circulation and relieving the pain, is used for treating diseases such as neck swelling pain and numbness, difficult moving, dizziness and tinnitus caused by kidney deficiency and blood stasis type cervical spondylosis, and has good clinic effect.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition and preparation method thereof, particularly a kind of the kidney invigorating, invigorate blood circulation, analgesic Chinese medicine composition and preparation method thereof.
Background technology
Cervical spondylosis is because the syndrome of degeneration of cervical intervertebral disc, the caused a series of clinical symptoms of hyperosteogeny of cervical vertebra.Cervical spondylosis can be divided into neck type, spondylotic radiculopathy, myeloid form, vertebral artery type, adrenergic type and its alloytype, and clinical often the showing as on neck, shoulder arm, the omoplate of cervical spondylosis carried on the back and anterior pectorial region pain arm numbness of hand wood, amyotrophy, even quadriplegia.Can betide any age, be many with the middle-aged and elderly people more than 40 years old.Cervical spondylosis has the sickness rate height, and treatment time is long, characteristics such as recurrence very easily after the treatment.
The sickness rate of China's cervical spondylosis just is being the trend of continuous rising, and the cervical spondylosis sickness rate is more and more higher, and with the growth of all ages and classes section, its sickness rate also is multiplied.Correlation study shows that also at present, the people of national nearly 7%-10% has suffered from cervical spondylosis.The about 20%-30% of sickness rate of 50～60 years old age bracket cervical spondylosiss; Age bracket reached 50% in 60～70 years old.Meanwhile, cervical spondylosis is broken by reality just gradually for the tradition of person in middle and old age's patent, and morbidity obviously trend becomes younger.
Form the mechanism of cervical spondylosis: the cervical spondylosis major part of suffering from for middle-aged and elderly people is owing to deficiency of the liver and kindey, and QI and blood is gradually empty, weakened defensive QI, rheumatism cold-evil takes advantage of a weak point in opponent's defence and invades, and causes stagnation of QI-blood, fights and ties in neck muscles and bones, passages through which vital energy circulates is obstructed, and muscles and bones muscle loses in the warm of QI and blood and causes with moistening foster.
The traditional Chinese medical science is on differentiation of symptoms and signs for classification of syndrome, and general opinion is divided into deficiency and excess two big classes, and void comprises the hepatic and renal YIN deficiency and weak type of qi and blood, comprises rheumatism it is attacked by the cold and evil, phlegm resistance and qi stagnation and blood stasis type in fact.And the present invention sets about from deficiency syndrome, curing mainly the hepatic and renal YIN deficiency, and dredge the meridian passage, strengthening the tendons and bones is to reach the effect of curing the disease.
Radix Rehmanniae Preparata: be the fresh or dried root of scrophulariaceae rehmannia glutinosa plant Rehmannia glutinosa Libosch..Excavate autumn, removes removing LU, fibrous root and silt, using fresh herb; Or Radix Rehmanniae slowly cured to about eighty per cant do.The former practises title " Radix Rehmanniae ", and the latter practises title " Radix Rehmanniae ".This product is the process of preparing Chinese medicine processed goods of Radix Rehmanniae.
Radix Polygoni Multiflori: be 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.Should meet regulation under 50 pages of Radix Polygoni Multiflori items of " Beijing's prepared slices of Chinese crude drugs standard " version in 2000.
The Cortex Eucommiae: be 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.Should meet regulation under 301 pages of Cortex Eucommiae items of " Beijing's prepared slices of Chinese crude drugs standard " version in 2000.
Herba Pyrolae: be 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.Should meet " regulation under 226 pages of Herba Pyrolae items of Chinese pharmacopoeia version in 2005.
Rhizoma Drynariae: 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.Should meet regulation under 71 pages of Rhizoma Drynariae items of " Beijing's prepared slices of Chinese crude drugs standard " version in 2000
Ramulus Uncariae Cum Uncis: be the dry stem and branch with belt hook of Maguireothamnus speciosus Ramulus Uncariae Cum Uncis Uncaria rhynchOphylla (Miq.) Jacks., Ramulus Uncariae macrophyllae Uncariamacrophylla Wall., Ramulus Uncariae Cum Uncis Uncaria hirsuta Havil., Uncaria sinensis (Oliv.) Havil. Uncaria sinensis (Oliv.) Havil. or stockless fruit Ramulus Uncariae Cum Uncis Uncaria sessilifructus Roxb..Autumn, two seasons of winter gather, defoliation, and cutting is dried.Should meet " regulation under 180 pages of Ramulus Uncariae Cum Uncis items of Chinese pharmacopoeia version in 2005.
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.Should meet " regulation under 233 pages of Radix Puerariae items of Chinese pharmacopoeia version in 2005.
Radix Notoginseng: be 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 ".Should meet the 9th batch of Radix Notoginseng item of " Beijing's Chinese medicine processing standard " revision regulation down
Semen Raphani: be 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.Should meet " regulation under 192 pages of Radix Raphani subitems of Chinese pharmacopoeia version in 2005.
Summary of the invention
The object of the invention is to provide a kind of the kidney invigorating, invigorates blood circulation, the Traditional Chinese medicine used as analgesic compositions; Second purpose of the present invention is to provide a kind of the kidney invigorating, invigorates blood circulation, the preparation method of analgesic Chinese medicine composition; The 3rd purpose of the present invention is to provide the preparation method of this Chinese medicinal composition capsules preparation.
The present invention seeks to be achieved through the following technical solutions:
A kind of the kidney invigorating of the present invention, invigorate blood circulation, the raw material of analgesic Chinese medicinal composition preparation consists of:
Radix Rehmanniae Preparata 150-250 weight portion, Radix Polygoni Multiflori 200-350 weight portion, Cortex Eucommiae 100-200 weight portion, Herba Pyrolae 100-200 weight portion, Rhizoma Drynariae (scalding) 100-200 weight portion, Ramulus Uncariae Cum Uncis 50-150 weight portion, Radix Puerariae 50-150 weight portion, Radix Notoginseng 10-100 weight portion, Semen Raphani (stir-fry) 50-150 weight portion.
A kind of the kidney invigorating of the present invention, invigorate blood circulation, the raw material of analgesic Chinese medicinal composition preparation consists of:
Radix Rehmanniae Preparata 160 weight portions, Radix Polygoni Multiflori 340 weight portions, the Cortex Eucommiae 110 weight portions, Herba Pyrolae 190 weight portions, Rhizoma Drynariae (scalding) 110 weight portions, Ramulus Uncariae Cum Uncis 140 weight portions, Radix Puerariae 60 weight portions, Radix Notoginseng 90 weight portions, Semen Raphani (stir-fry) 60 weight portions.
A kind of the kidney invigorating of the present invention, invigorate blood circulation, the raw material of analgesic Chinese medicinal composition preparation consists of:
Radix Rehmanniae Preparata 240 weight portions, Radix Polygoni Multiflori 210 weight portions, the Cortex Eucommiae 190 weight portions, Herba Pyrolae 110 weight portions, Rhizoma Drynariae (scalding) 190 weight portions, Ramulus Uncariae Cum Uncis 60 weight portions, Radix Puerariae 140 weight portions, Radix Notoginseng 15 weight portions, Semen Raphani (stir-fry) 140 weight portions.
A kind of the kidney invigorating of the present invention, invigorate blood circulation, the raw material of analgesic Chinese medicinal composition preparation forms and is preferably:
Radix Rehmanniae Preparata 204.5 weight portions, Radix Polygoni Multiflori 272.8 weight portions, the Cortex Eucommiae 136.4 weight portions, Herba Pyrolae 136.4 weight portions, Rhizoma Drynariae (scalding) 136.4 weight portions, Ramulus Uncariae Cum Uncis 100 weight portions, Radix Puerariae 100 weight portions, Radix Notoginseng 50 weight portions, Semen Raphani (stir-fry) 86.2 weight portions.
Second technical purpose of the present invention is achieved through the following technical solutions:
A kind of the kidney invigorating, invigorate blood circulation, the preparation method of analgesic Chinese medicinal composition preparation is:
Above-mentioned nine flavor crude drugs, the Radix Notoginseng of getting 1/3-2/3 amount pulverize the Radix Notoginseng fine powder; The Radix Notoginseng of Radix Rehmanniae Preparata, Radix Polygoni Multiflori, the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), Ramulus Uncariae Cum Uncis, Radix Puerariae, Semen Raphani (stir-fry) eight flavors and surplus, decoct with water 1-3 time, each 1-4 hour, collecting decoction, filter, it is 1.30～1.35 thick paste that filtrate is concentrated into 70-90 ℃ of relative density; Thick paste mixes with above-mentioned Radix Notoginseng fine powder, dry, be ground into fine powder again, add conventional adjuvant, according to common process, make clinical or pharmaceutically acceptable dosage form, include but not limited to tablet, capsule, powder, soft capsule, drop pill, honeyed pill, pill, granule, soft extract with bee honey agent, slow releasing preparation, quick releasing formulation, controlled release preparation, oral liquid or external preparation.
Need when these dosage forms of preparation, to add the pharmacy acceptable auxiliary, for example: filler, disintegrating agent, lubricant, suspending agent, binding agent, sweeting agent, correctives, antiseptic, substrate etc.Filler comprises: starch, pregelatinized Starch, lactose, mannitol, chitin, microcrystalline Cellulose, sucrose etc.; Disintegrating agent comprises: starch, pregelatinized Starch, microcrystalline Cellulose, carboxymethyl starch sodium, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose etc.; Lubricant comprises: magnesium stearate, sodium lauryl sulphate, Pulvis Talci, silicon dioxide etc.; Suspending agent comprises: polyvinylpyrrolidone, microcrystalline Cellulose, sucrose, agar, hydroxypropyl emthylcellulose etc.; Binding agent comprises, starch slurry, polyvinylpyrrolidone, hydroxypropyl emthylcellulose etc.; Sweeting agent comprises: saccharin sodium, Aspartane, sucrose, cyclamate, enoxolone etc.; Correctives comprises: sweeting agent and various essence; Antiseptic comprises: parabens, benzoic acid, sodium benzoate, sorbic acid and its esters, benzalkonium bromide, fixed, the Folium eucalypti globueli (Eucalyptus globulus Labill.) wet goods of acetic acid chloroethene; Substrate comprises: PEG6000, PEG4000, insect wax etc.
The preparation method of above-mentioned Chinese medicine composition is preferably:
Get 1/3 the amount Radix Notoginseng pulverize the Radix Notoginseng fine powder; The Radix Notoginseng of Radix Rehmanniae Preparata, Radix Polygoni Multiflori, the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), Ramulus Uncariae Cum Uncis, Radix Puerariae, Semen Raphani (stir-fry) eight flavors and surplus, decoct with water 3 times, each 2 hours, collecting decoction, filter, it is 1.30～1.35 thick paste that filtrate is concentrated into 75 ℃ of relative densities; Thick paste mixes with above-mentioned Radix Notoginseng fine powder, dry, be ground into fine powder again, add conventional adjuvant, according to common process, make clinical or pharmaceutically acceptable dosage form, include but not limited to tablet, capsule, powder, soft capsule, drop pill, honeyed pill, pill, granule, soft extract with bee honey agent, slow releasing preparation, quick releasing formulation, controlled release preparation, oral liquid or external preparation.
The preparation method of above-mentioned Chinese medicine composition is preferably:
Get 2/3 the amount Radix Notoginseng pulverize the Radix Notoginseng fine powder; The Radix Notoginseng of Radix Rehmanniae Preparata, Radix Polygoni Multiflori, the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), Ramulus Uncariae Cum Uncis, Radix Puerariae, Semen Raphani (stir-fry) eight flavors and surplus, decoct secondary, add for the first time 8 times of water, add for the second time 6 times of water, 3 hours for the first time, 2 hours for the second time, collecting decoction, filter, it is 1.30～1.35 thick paste that filtrate is concentrated into 85 ℃ of relative densities; Thick paste mixes with above-mentioned Radix Notoginseng fine powder, dry, be ground into fine powder again, add conventional adjuvant, according to common process, make clinical or pharmaceutically acceptable dosage form, include but not limited to tablet, capsule, powder, soft capsule, drop pill, honeyed pill, pill, granule, soft extract with bee honey agent, slow releasing preparation, quick releasing formulation, controlled release preparation, oral liquid or external preparation.
A kind of the kidney invigorating of the present invention, invigorate blood circulation, the capsule preparations of analgesic Chinese medicine composition, this capsule is made by following crude drug and adjuvant, wherein crude drug consists of:
Radix Rehmanniae Preparata 150-250 weight portion, Radix Polygoni Multiflori 200-350 weight portion, Cortex Eucommiae 100-200 weight portion, Herba Pyrolae 100-200 weight portion, Rhizoma Drynariae (scalding) 100-200 weight portion, Ramulus Uncariae Cum Uncis 50-150 weight portion, Radix Puerariae 50-150 weight portion, Radix Notoginseng 10-100 weight portion, Semen Raphani (stir-fry) 50-150 weight portion;
Wherein adjuvant consists of:
Starch 10-100 weight portion, calcium carbonate 10-40 weight portion, magnesium stearate 1-5 weight portion.
A kind of the kidney invigorating of the present invention, invigorate blood circulation, the capsule preparations of analgesic Chinese medicine composition, this capsule is made by following crude drug and adjuvant, wherein crude drug consists of:
Radix Rehmanniae Preparata 160 weight portions, Radix Polygoni Multiflori 340 weight portions, the Cortex Eucommiae 110 weight portions, Herba Pyrolae 190 weight portions, Rhizoma Drynariae (scalding) 110 weight portions, Ramulus Uncariae Cum Uncis 140 weight portions, Radix Puerariae 60 weight portions, Radix Notoginseng 90 weight portions, Semen Raphani (stir-fry) 60 weight portions;
Wherein adjuvant consists of:
Starch 90 weight portions, calcium carbonate 15 weight portions, magnesium stearate 4.5 weight portions.
A kind of the kidney invigorating of the present invention, invigorate blood circulation, the capsule preparations of analgesic Chinese medicine composition, this capsule is made by following crude drug and adjuvant, wherein crude drug consists of:
Radix Rehmanniae Preparata 240 weight portions, Radix Polygoni Multiflori 210 weight portions, the Cortex Eucommiae 190 weight portions, Herba Pyrolae 110 weight portions, Rhizoma Drynariae (scalding) 190 weight portions, Ramulus Uncariae Cum Uncis 60 weight portions, Radix Puerariae 140 weight portions, Radix Notoginseng 15 weight portions, Semen Raphani (stir-fry) 140 weight portions;
Wherein adjuvant consists of:
Starch 15 weight portions, calcium carbonate 35 weight portions, magnesium stearate 1.5 weight portions.
A kind of the kidney invigorating of the present invention, invigorate blood circulation, the capsule preparations of analgesic Chinese medicine composition, this capsule is made by following crude drug and adjuvant, wherein crude drug consists of:
Radix Rehmanniae Preparata 204.5 weight portions, Radix Polygoni Multiflori 272.8 weight portions, the Cortex Eucommiae 136.4 weight portions, Herba Pyrolae 136.4 weight portions, Rhizoma Drynariae (scalding) 136.4 weight portions, Ramulus Uncariae Cum Uncis 100 weight portions, Radix Puerariae 100 weight portions, Radix Notoginseng 50 weight portions, Semen Raphani (stir-fry) 86.2 weight portions;
Wherein adjuvant consists of:
Starch 57 weight portions, calcium carbonate 22 weight portions, magnesium stearate 3 weight portions.
The preparation method of above-mentioned Chinese medicinal composition capsules agent is preferably:
Get 1/2 the amount Radix Notoginseng pulverize the Radix Notoginseng fine powder; Radix Rehmanniae Preparata, Radix Polygoni Multiflori, the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), Ramulus Uncariae Cum Uncis, Radix Puerariae, Semen Raphani (stir-fry) eight are distinguished the flavor of and remain 1/2 Radix Notoginseng of measuring, decoct with water 2 times, 3 hours for the first time, 2 hours for the second time, collecting decoction, filter, it is 1.30～1.35 thick paste that filtrate is concentrated into 80 ℃ of relative densities; Thick paste mixes with above-mentioned Radix Notoginseng fine powder, and drying is ground into fine powder again, adds calcium carbonate, starch and magnesium stearate, mixing, and filled capsules, promptly.
The influence of principal agent and adjuvant is mutual in the pharmaceutical preparation, briefly, is exactly the selection of the characteristic decision adjuvant of principal agent, the performance of the drug effect of the properties influence principal agent of adjuvant.Though the Chinese medicinal capsule preparation is thought comparatively conventional dosage form by those skilled in the art, is herbal mixture for principal agent,, be difficult to obtain outstanding effect for the selection of adjuvant because it extracts the complexity of back composition.The present invention is in the selection to the capsule adjuvant, by selection, after the adjuvant of finding special ratios and the principal agent combination, on flowability, moisture resistance, obtain beyond thought effect to the ratio of adjuvant, and these adjuvant prices are very cheap, help enterprise and reduce cost.
Present composition preparation can slow down the minimizing that HSP 27 expresses, thus the protection cervical intervertebral disk.The present composition has the kidney invigorating, invigorates blood circulation, the effect of pain relieving.Be used for due to the blood stasis due to renal deficiency myelopathy: neck distending pain numbness, movable unfavorable, the treatment for diseases of dizziness and tinnitus, clinical effectiveness is fine.Capsule treatment vertebral artery type of cervical spondylosis of the present invention and stiff neck have good effect.
Following experimental example and embodiment are used to further specify but are not limited to the present invention.
The selected preparation of following experimental example is the capsule of the present invention that makes according to the embodiment of the invention 1, but experimental result of the present invention is not limited in capsule.
Experimental example 1: pharmacodynamic experiment
1 object and method
1.1 object
In 60 examples, male 35 examples, women 25 examples are divided into 2 groups at random, and 30 examples are organized in treatment, matched group 30 examples.Two groups 20～75 years old, average 52 years old; The course of disease 1 week～8 year, average 8 months.Two groups of difference not statistically significants aspect age, the course of disease.
1.1.1 diagnostic criteria is with reference to " disease of tcm diagnosis criterion of therapeutical effect ".
1.1.2 exclusion standard
(1) is not inconsistent and above-mentioned diagnostic criteria;
(2) age is less than 20 years old or greater than 75 years old;
(3) be associated with severe cardiac, brain, blood vessel, liver, kidney disease;
(4) individual compliance is poor, can not adhere to the treatment person that can't judge the therapeutic effect.
1.2 method
Treatment group: embodiment 1 capsule, oral, one time 4,2 times on the one;
Matched group: each 1 bag of oral QIANLIE KANG TABLETS, every day 3 times.
Check blood vessel parameter and blood flow rate parameter with color Doppler before and after two groups of treatments and compare, carry out general curative effect relatively according to the clinical efficacy evaluation criteria, viewing duration forbidding other drug and Therapeutic Method.
1.3 statistical procedures statistical data Spss 10.0 software processes, measurement data is checked with t, numeration data x
2Check.
2 results
2.1 efficacy assessment standard
(1) cure: dizzy transference cure or basic the disappearance, resume work;
(2) produce effects: dizzy symptom obviously alleviates, and is asymptomatic at ordinary times, when tired mild arranged, and do not influence general work;
(3) effective: dizzy sx;
(4) invalid: symptom does not alleviate or alleviates slightly.
2.2 efficacy evaluation result
Effect is as shown in table 1 before and after two groups of treatments, and treatment group total effective rate is 96.7%, and the recovery from illness obvious effective rate is 80%.
The matched group total effective rate is 86.7%, and the recovery from illness obvious effective rate is 63.3%.x
2Assay shows that two groups of curative effect differences have statistical significance (P＜0.05).
The clinical effectiveness of using capsule treatment vertebral artery type of cervical spondylosis of the present invention is better than JINGFUKANG.
2.3 blood vessel parameter relatively before and after two groups of treatments
Two groups of color Doppler check results show: the blood vessel parameter that comprises internal diameter, P I, R I after the treatment of treatment group all has obvious attenuating (P＜0.05) before treating, and matched group above-mentioned blood vessel parameter difference not statistically significant (table 2～3) before and after treatment.
2.4 the interior blood flow rate of vertebral artery relatively before and after two groups of treatments
Color Doppler Detection result shows:
There were significant differences before and after medication for treatment group P S V, and only V M is variant for matched group, sees Table 4～5.
Vertebral artery internal diameter and drag index before and after the treatment of treatment group, all there were significant differences for pulsatility index; And matched group only before and after the blood flow rate contrast variant, analysis-by-synthesis treatment group effect is better than matched group.
Table 1 vertebral artery type of cervical spondylosis treatment group and matched group clinical efficacy are relatively
Annotate: compare * P＜0.05 with matched group
Table 2 vertebral artery type of cervical spondylosis treatment group is treated relatively (x ± s) of forward and backward color Doppler blood vessel parameter
Annotate: with compare * P＜0.05 before the treatment
The forward and backward color Doppler blood vessel parameter comparison of table 3 vertebral artery type of cervical spondylosis treatment of control group (x ± s)
Table 4 vertebral artery type of cervical spondylosis treatment group is treated relatively (cm/s of forward and backward color Doppler blood flow rate parameter; X ± s)
Annotate: with * P＜0.05 of comparing before the treatment
The forward and backward color Doppler blood flow rate of table 5 vertebral artery type of cervical spondylosis treatment of control group parameter is (cm/s relatively; X ± s)
Annotate: with * P＜0.05 of comparing before the treatment
Experimental example 2 pharmacological evaluation
1 material
150 10 monthly age male and female half and half S D cleaning level rats are provided by Shanghai Bi Kai company;
Super quick SP immunohistochemistry reagent closes, and Foochow steps new company and provides;
Ibuprofen, lot number: 07120680, Sino-America Tianjin Shike Pharmaceutical Co., Ltd.;
JINGFUKANG, the method preparation of pressing Chinese Pharmacopoeia;
The embodiment of the invention 1 capsule, biopharmaceutical company provides by Yadong, Beijing;
The rotary paraffin slicing machine of AO, German MICROMHM340E;
Dewaterer, German LEICATP1020; Microscope, Japanese NIKON55i.
2 methods
2.1 modeling and administration
The layering of 150 rat elder generations is divided into 6 groups more at random, and 25 every group, the animal nape is shaved hair, ketamine (0.1g/kg) anesthesia, sterilization, sterile working.A, B, C, D, E5 group are model of intervertebral disc degradation, and F is normal sham operated rats, hits exactly the otch that work one is about 2cm at nape, and the hemostasis back is sewed up.Modeling method: get nape center longitudinal cut (from atlanto-occipital joint to the second dorsal vertebra spinous process) and be about 2cm, cut skin and shallow, deep fascia, successively shallow, the middle level flesh (neck trapezius muscle, musculus rhomboideus capitis, neck rhomboideus, splenius cervicis) of excision Mus nape bilateral from starting point to stop is sewed up after the hemostasis.Modeling is put to death the A treated animal during March, after the checking modeling success, and the beginning administration.B organizes to ibuprofen; C organizes to the embodiment of the invention 1 capsule, and D organizes to JINGFUKANG.
Medicine is evenly sneaked in the feedstuff, and dosage is pressed body surface area and is converted; E is a model blank group, and E, F organize not administration.5 treated animals are freely drunk water, are ingested in same environment.After administration March, the acute bleeding method is put to death rat, gets neck 5～7 intervertebral disc, carries out index and detects.
2.2 sample disposal is got whole section cervical vertebra of C37, muscle around rejecting, and paraformaldehyde is 24h fixedly, the EDTA decalcification, with the dehydration of ethanol gradient, dimethylbenzene is transparent, paraffin mass embedding, middle sagittal plane serial section, bed thickness 4 μ m.Adopt Use immunohistochemistrySP SP to detect the situation that HSP27/72 expresses in the rat disc tissue.
2.2.1 the super quick SP immunohistochemistry test kit of immunohistochemistry reagent provides for Foochow steps new company.
2.2.2 immunohistochemical staining is in strict accordance with the operation of test kit description of step, immunohistochemical assay method (SP method).
The result judges: the person is positive to have the brown particle in the cell.
2.2.3 disc tissue HSP27/72 positive cell is observed and every section of calculating of positive cell percent selected 5 (in the soleplate 2, in the fibrous ring 2, in the vertebral pulp 1) the most tangible high power field of positive staining (* 400), count total cell number, HSP27 positive cell number in vertebral pulp, fibrous ring, the soleplate visual field, and account for the percentage ratio of total cellular score.Compare between group.
2.3 relatively reach between HSP27 positive cell percentage array in each treated animal cervical intervertebral disk of statistical method and relatively adopt F check and LSD check in twos.Data statistic analysis adopts SPSS software to handle.
3 as a result HSP72 and HSP27 stained positive express and be brown yellow granule, be positioned at nucleus and (or) Cytoplasm, be kitchen range shape or diffusivity and distribute.
3.1 disc tissue HSP27 expression HSP27 all has higher expression in each group, and all mainly concentrates on cartilage endplate, fibrous ring is relative with the expression in the nucleus pulposus cell less, sees inset IV Fig. 1.
3.2 every section of positive rate statistics selected 5 (in the soleplate 2, in the fibrous ring 2, in the vertebral pulp 1) the most tangible high power field of positive staining (* 400), total cell number, HSP27/72 positive cell number in counting vertebral pulp, fibrous ring, the soleplate visual field, and account for the percentage ratio of total cellular score.Compare between group.
Each organizes HSP27 in the disc tissue and the detection of HSP72 shows that each organizes the expression that HSP27 and HSP72 are all arranged in the intervertebral disc.
Each group of the expression of HSP27 is compared, and has statistically-significant difference (P＜0.05).Wherein the expression of sham operated rats is the highest, and relatively there were significant differences (P＜0.01) with all the other each model group.The expression of capsule group of the present invention is higher in the model group, with other 3 group models statistically-significant difference (P＜0.05) arranged more all.Compare no difference of science of statistics between other 3 group model groups.Each group of the expression of HSP72 is compared, and does not have statistically-significant difference (P＞0.05).Above result shows: each organizes the expression that HSPs is all arranged in the disc tissue, the expression decreased of HSP27 in the heavier intervertebral disc of cervical vertebra tissue of regression, and the expression of HSP72 does not have the bright difference that now shows.We infer thus, and the expression of HSP27 can suppress the regression of cervical intervertebral disk, and HSP72 does not then have obvious effect.Capsule of the present invention can slow down the minimizing that HSP27 expresses, thus the protection cervical intervertebral disk.
The clinical experiment of experimental example 3 treatment stiff necks
1, physical data:
Male's 54 examples in the treatment group, women's 46 examples; 18～58 years old age; The course of disease 1～27 day.
Male's 44 examples in the matched group, women's 32 examples; 19～57 years old age; The course of disease 1～26 day.
Two groups of clinical data there was no significant differences have comparability.The patient all has and plays a side neck pain morning, and is movable unfavorable, arrests tight numbly, and very person's pain increases the weight of when movable to Ipsilateral upper limb or back radiation, checks the Ipsilateral trachelism, and sternocleidomastoid, trapezius muscle, levator scapulae etc. have been located tenderness.X-ray c spine ap ﹠ lat sheet all shows normally.
2, Therapeutic Method
The embodiment of the invention 1 capsule is oral, one time 4,2 times on the one.The heavier person of pain every day 4 times.
Matched group clothes ibuprofen tablet 0.2g, vitamin B12 0mg, vitamin B12 500 μ g, 3 of Radix Notoginseng Tabellae, equal every day 3 times, one after each meal.
Two groups of patients all follow the muscle and tendon injury Therapeutic Principle that is association of activity and inertia, and adjust medicated pillow and just make its appropriateness, avoid cervical region undue tired and suffer from cold.Therapeutic effect curative effect determinate standard: cure: symptom and sign disappear, and recover operate as normal, do not recur more than 1 year; Produce effects: symptom and sign obviously alleviate, and still can adhere to work; Invalid: symptom and sign do not have change.
The result:
The treatment group is treated through 2～12 days (average 6 days), all cures, and follows up a case by regular visits to not recurrence in 1 year.
Matched group is treated through 3～15 days (average 8 days), cures 44 examples, produce effects 24 examples, invalid 8 examples.Treatment group curative effect obviously is better than matched group.The treatment group is not found untoward reaction, and matched group 3 examples have slight gastrointestinal reaction, transference cure behind symptomatic treatment.
Experimental example 4 Study on extraction
Experimental technique: get each medicine in the prescription by recipe quantity 1/10th, about altogether 120g puts in the round-bottomed flask, add the water of ormal weight, decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filters, and filtrate is concentrated into the thick paste that relative density is 1.30～1.35 (80 ℃), put the baking oven drying under reduced pressure, calculate the dry extract yield.Experimental design and the results are shown in Table 6.
Table 6 group liquid medicine extraction process is investigated
The result shows: when amount of water for 8 times for the first time, for the second time 6 times with 10 times for the first time, 8 times for the second time, the gained dry extract must be measured approaching, for producing actual consideration, less solvent load can be saved extractions, consume and energy consumption when spissated, therefore determine that extraction process by water is: get each medicine decoction pieces, add for the first time 8 times of water, add 6 times of water for the second time, decoct secondary, 3 hours for the first time, 2 hours for the second time.
Experimental example 5: prescription screening experiment
1: appearance character:
Get the embodiment of the invention 1 capsule 's content, put on the clean blank sheet of paper, the flowability of observed content thing is surveyed angle of repose.
Adopt the fixed funnel method, with the series connection of 3 funnels and be fixed in the height place of 1cm on the graph paper of horizontal positioned, carefully powder is poured into along hopper walls in the funnel of going up most till the cone tip that forms on the graph paper touches bell mouth, measure the diameter (2R) of conical base by graph paper, calculate angle of repose tga=H/R. and do calculating mean value 5 times.
2 hygroscopicity:
The foregoing thing is put observation characters powder variation under the room temperature condition.
Wettability test: get the glass exsiccator that the bottom fills the sodium chloride supersaturated solution, put into 25 ℃ of constant incubator constant temperature 24h, the interior relative humidity of drying baker this moment is 75%.In the weighing botle bottom of constant weight, put into about 2g sample respectively, in the exsiccator that is placed on the sodium chloride supersaturated solution of accurately weighing (the weighing bottle cap is opened), preserve weighing behind the 48h, calculating moisture absorption percentage rate in 25 ℃ of constant incubators.
Table 7 capsule prescription screening of the present invention
Table 8 capsule prescription screening----hygroscopicity is investigated
The examination of 3 critical relative humiditys
Because it is very big that ambient humidity is loaded influence to capsule, measured the critical relative humidity of content powder for this reason.Adopt dried medicated powder method to carry out wettability test, i.e. the moisture equilibrium at dry side curve.The about 2g of sample thief puts in the weighing botle respectively, and accurate the title decided totally 7 parts, open the weighing bottle cap, putting into relative humidity respectively is 20%, 30%, 40%, 50%, 60%, in 70% the environment, in 25 ℃ of incubators, placed 7 days, take out weighing botle, it is fixed to add a cover the accurate title in back, the accurate devise a stratagem that claims is calculated hydroscopicity, measures critical relative humidity (CRH), the results are shown in Table 9.With the moisture absorption percentage rate % in the table 9 is vertical coordinate, and relative humidity RH% is the abscissa mapping.The tangent line at curve two ends in the mapping, the abscissa of two point of intersection of tangents correspondences is critical relative humidity.
The hygroscopic capacity of neck recovering capsule content under the various relative humidity conditions of table 9
Result of the test shows: the critical relative humidity CRH of this product content is 40%, so it sieves, always mixes, loads and storage should be in temperature below 25 ℃, under the environment of relative humidity below 40%, to reduce the influence of moisture to pharmaceutical properties and stability.
Experimental example 6 pilot scale process studies
We are according to the determined technology of above-mentioned test, have carried out altogether that 10 batches of pilot-scales are above to be produced, and wherein feed intake by 10,30,50 times of recipe quantity again and have carried out the trial-production of 3 batch samples, to investigate the stability of technology.Creation data sees Table 10.
Table 10 pilot scale production technology data
The result shows: ten batches of production technologies all reach designing requirement.Illustrate that big production technology is stable.
Following embodiment all can realize the effect of above-mentioned experimental example.
The specific embodiment
Embodiment 1 capsule
Prescription:
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
Starch 57g calcium carbonate 22g magnesium stearate 3g
Preparation method:
More than nine the flavor medical materials, get Radix Notoginseng 25g and be ground into fine powder; Eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata decoct with water secondary, add 8 times of water for the first time, add for the second time 6 times of water, 3 hours for the first time, 2 hours for the second time 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, filtrate is concentrated into the thick paste that relative density is 1.30～1.35 (80 ℃), with above-mentioned powder mixes, drying, be ground into fine powder, add an amount of calcium carbonate, starch and magnesium stearate, mixing, filled capsules, promptly.Make 1000 of capsules.
Method of quality control:
Differentiate:
(1) gets 15 of this product, get content, add methanol 100ml, ultrasonic place 30 minutes filters the filtrate evaporate to dryness, residue adds in the dislocation separatory funnel of 0.3% sodium hydroxide solution 30ml dissolving back, behind dilute hydrochloric acid adjusting pH value to 5～6, extracts with ethyl acetate 30ml jolting, divide and get the ethyl acetate layer, use anhydrous sodium sulfate dehydration, filter, the filtrate evaporate to dryness, residue adds ethyl acetate 2ml makes dissolving, filters, and filtrate is as need testing solution.Other gets the puerarin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with chloroform-methanol-water (7: 2.5: 0.25) is developing solvent, launches, and takes out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
(2) get 10 of this product, get content, add methanol 50ml, supersound process 30 minutes filters the filtrate evaporate to dryness, residue adds water 10ml makes dissolving, adds hydrochloric acid 1ml again, puts in the water-bath and heats 30 minutes, cooling divides 2 extractions with ether immediately, each 20ml, merge ether solution, evaporate to dryness, residue add chloroform 1ml makes dissolving, as need testing solution.Get Radix Polygoni Multiflori control medicinal material powder 2g, add methanol 50ml, prepare control medicinal material solution by the test sample preparation method.Other gets the emodin reference substance, adds methanol and makes the solution that every 1ml contains lmg, in contrast product solution.Test according to thin layer chromatography, draw each 5 μ l of need testing solution 10 μ l, control medicinal material and reference substance solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, upper solution with petroleum ether (30～60 ℃)-Ethyl formate-formic acid (15: 5: 1) is developing solvent, launch, take out, dry.In the test sample chromatograph, with the corresponding position of emodin reference substance chromatograph on, show the yellow spotting of same color; Put under the ultra-violet lamp (365nm) and inspect, show the fluorescence speckle of same color respectively with emodin reference substance and Radix Polygoni Multiflori control medicinal material.
(3) get 10 of this product, get content, add water saturated n-butyl alcohol 50ml, supersound process 1 hour 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, get n-butanol layer, put in the evaporating dish evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution.Other gets ginsenoside Rb
1, ginsenoside Rg1 and arasaponin R1 reference substance, add methanol and make the mixed solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography, draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, (15: 40: 22: 10) upper solution of placing below 10 ℃ was developing solvent with chloroform-ethyl acetate-methanol-water, launch, take out airing, spray is with sulfuric acid solution (1 → 10), and it is clear to be heated to the speckle colour developing in 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color; Put under the ultra-violet lamp (365nm) and inspect, show identical fluorescence speckle.
Assay:
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile-0.05% phosphoric acid solution (99: 400) is a mobile phase; The detection wavelength is 203nm.Number of theoretical plate is by the ginsenoside Rg
1The peak calculates should be not less than 2500;
The preparation of reference substance solution: precision takes by weighing the ginsenoside Rg
1Reference substance is an amount of, adds methanol and makes the solution that every 1ml contains 0.1mg, shakes up, promptly;
The preparation of need testing solution: get 20 of this product, take out content, grind well, get 1g, the accurate title, decide, add water saturated n-butyl alcohol 50ml, close plug claims to decide weight, and placement is spent the night, supersound process 1 hour, put coldly, claim again decide weight, supply the weight that subtracts mistake with water saturated n-butyl alcohol, filtration.Precision is measured subsequent filtrate 25ml, the ammonia solution saturated with n-butyl alcohol washs 2 times, each 25ml, and the water saturated n-butyl alcohol jolting of cleaning mixture reuse is extracted 2 times, each 20ml, merge n-butyl alcohol liquid, steam in, residue adds dissolve with methanol and is transferred in the 10ml measuring bottle, add methanol to scale, shake up, cross the leaching subsequent filtrate, promptly;
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly; Every of this product contains Radix Notoginseng with the ginsenoside Rg
1(C
42H
72O
14) meter, must not be less than 0.30mg.
Embodiment 2 capsules
Prescription:
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
Starch 57g calcium carbonate 22g magnesium stearate 3g
Preparation method:
More than nine the flavor medical materials, get Radix Notoginseng 25g and be ground into fine powder; Eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata decoct with water secondary, add 8 times of water for the first time, add for the second time 6 times of water, 3 hours for the first time, 2 hours for the second time 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, filtrate is concentrated into the thick paste that relative density is 1.30～1.35 (80 ℃), with above-mentioned powder mixes, drying, be ground into fine powder, add an amount of calcium carbonate, starch and magnesium stearate, mixing, filled capsules, promptly.Make 1000 of capsules.
Method of quality control:
Differentiate:
(1) gets 15 of this product, get content, add methanol 100ml, ultrasonic place 30 minutes filters the filtrate evaporate to dryness, residue adds in the dislocation separatory funnel of 0.3% sodium hydroxide solution 30ml dissolving back, behind dilute hydrochloric acid adjusting pH value to 5～6, extracts with ethyl acetate 30ml jolting, divide and get the ethyl acetate layer, use anhydrous sodium sulfate dehydration, filter, the filtrate evaporate to dryness, residue adds ethyl acetate 2ml makes dissolving, filters, and filtrate is as need testing solution.Other gets the puerarin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with chloroform-methanol-water (7: 2.5: 0.25) is developing solvent, launches, and takes out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
(2) get 10 of this product, get content, add methanol 50ml, supersound process 30 minutes filters the filtrate evaporate to dryness, residue adds water 10ml makes dissolving, adds hydrochloric acid 1ml again, puts in the water-bath and heats 30 minutes, cooling divides 2 extractions with ether immediately, each 20ml, merge ether solution, evaporate to dryness, residue add chloroform 1ml makes dissolving, as need testing solution.Get Radix Polygoni Multiflori control medicinal material powder 2g, add methanol 50ml, prepare control medicinal material solution by the test sample preparation method.Other gets the emodin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5 μ l of need testing solution 10 μ l, control medicinal material and reference substance solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, upper solution with petroleum ether (30～60 ℃)-Ethyl formate-formic acid (15: 5: 1) is developing solvent, launch, take out, dry.In the test sample chromatograph, with the corresponding position of emodin reference substance chromatograph on, show the yellow spotting of same color; Put under the ultra-violet lamp (365nm) and inspect, show the fluorescence speckle of same color respectively with emodin reference substance and Radix Polygoni Multiflori control medicinal material.
Embodiment 3 capsules
Prescription:
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
Starch 57g calcium carbonate 22g magnesium stearate 3g
Preparation method:
More than nine the flavor medical materials, get Radix Notoginseng 25g and be ground into fine powder; Eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata decoct with water secondary, add 8 times of water for the first time, add for the second time 6 times of water, 3 hours for the first time, 2 hours for the second time 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, filtrate is concentrated into the thick paste that relative density is 1.30～1.35 (80 ℃), with above-mentioned powder mixes, drying, be ground into fine powder, add an amount of calcium carbonate, starch and magnesium stearate, mixing, filled capsules, promptly.Make 1000 of capsules.
Method of quality control:
Differentiate:
(1) gets 15 of this product, get content, add methanol 100ml, ultrasonic place 30 minutes filters the filtrate evaporate to dryness, residue adds in the dislocation separatory funnel of 0.3% sodium hydroxide solution 30ml dissolving back, behind dilute hydrochloric acid adjusting pH value to 5～6, extracts with ethyl acetate 30ml jolting, divide and get the ethyl acetate layer, use anhydrous sodium sulfate dehydration, filter, the filtrate evaporate to dryness, residue adds ethyl acetate 2ml makes dissolving, filters, and filtrate is as need testing solution.Other gets the puerarin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with chloroform-methanol-water (7: 2.5: 0.25) is developing solvent, launches, and takes out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
(2) get 10 of this product, get content, add water saturated n-butyl alcohol 50ml, supersound process 1 hour 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, get n-butanol layer, put in the evaporating dish evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution.Other gets ginsenoside Rb
1, ginsenoside Rg1 and arasaponin R1 reference substance, add methanol and make the mixed solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (appendix VI B), draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, (15: 40: 22: 10) upper solution of placing below 10 ℃ was developing solvent with chloroform-ethyl acetate-methanol-water, launch, take out airing, spray is with sulfuric acid solution (1 → 10), and it is clear to be heated to the speckle colour developing in 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color; Put under the ultra-violet lamp (365nm) and inspect, show identical fluorescence speckle.
Assay:
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile-0.05% phosphoric acid solution (99: 400) is a mobile phase; The detection wavelength is 203nm.Number of theoretical plate is by the ginsenoside Rg
1The peak calculates should be not less than 2500;
The preparation of reference substance solution: precision takes by weighing the ginsenoside Rg
1Reference substance is an amount of, adds methanol and makes the solution that every 1ml contains 0.1mg, shakes up, promptly;
The preparation of need testing solution: get 20 of this product, take out content, grind well, get 1g, the accurate title, decide, add water saturated n-butyl alcohol 50ml, close plug claims to decide weight, and placement is spent the night, supersound process 1 hour, put coldly, claim again decide weight, supply the weight that subtracts mistake with water saturated n-butyl alcohol, filtration.Precision is measured subsequent filtrate 25ml, the ammonia solution saturated with n-butyl alcohol washs 2 times, each 25ml, and the water saturated n-butyl alcohol jolting of cleaning mixture reuse is extracted 2 times, each 20ml, merge n-butyl alcohol liquid, evaporate to dryness, residue add dissolve with methanol and are transferred in the 10ml measuring bottle, add methanol to scale, shake up, cross the leaching subsequent filtrate, promptly;
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly; Every of this product contains Radix Notoginseng with the ginsenoside Rg
1(C
42H
72O
14) meter, must not be less than 0.30mg.
Embodiment 4 capsules
Prescription:
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
Starch 57g calcium carbonate 22g magnesium stearate 3g
Preparation method:
More than nine the flavor medical materials, get Radix Notoginseng 25g and be ground into fine powder; Eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata decoct with water secondary, add 8 times of water for the first time, add for the second time 6 times of water, 3 hours for the first time, 2 hours for the second time 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, filtrate is concentrated into the thick paste that relative density is 1.30～1.35 (80 ℃), with above-mentioned powder mixes, drying, be ground into fine powder, add an amount of calcium carbonate, starch and magnesium stearate, mixing, filled capsules, promptly.Make 1000 of capsules.
Method of quality control:
Differentiate:
(1) gets 10 of this product, get content, add methanol 50ml, supersound process 30 minutes filters the filtrate evaporate to dryness, residue adds water 10ml makes dissolving, adds hydrochloric acid 1ml again, puts in the water-bath and heats 30 minutes, cooling divides 2 extractions with ether immediately, each 20ml, merge ether solution, evaporate to dryness, residue add chloroform lml makes dissolving, as need testing solution.Get Radix Polygoni Multiflori control medicinal material powder 2g, add methanol 50ml, prepare control medicinal material solution by the test sample preparation method.Other gets the emodin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography, draw each 5 μ l of need testing solution 10 μ l, control medicinal material and reference substance solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, upper solution with petroleum ether (30～60 ℃)-Ethyl formate-formic acid (15: 5: 1) is developing solvent, launch, take out, dry.In the test sample chromatograph, with the corresponding position of emodin reference substance chromatograph on, show the yellow spotting of same color; Put under the ultra-violet lamp (365nm) and inspect, show the fluorescence speckle of same color respectively with emodin reference substance and Radix Polygoni Multiflori control medicinal material.
(2) get 10 of this product, get content, add water saturated n-butyl alcohol 50ml, supersound process 1 hour 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), get n-butanol layer, put in the evaporating dish evaporate to dryness, residue adds methanol 1ml makes dissolving, as need testing solution.Other gets ginsenoside Rb
1, ginsenoside Rg1 and arasaponin R1 reference substance, add methanol and make the mixed solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (appendix VI B), draw each 2 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, (15: 40: 22: 10) upper solution of placing below 10 ℃ was developing solvent with chloroform-ethyl acetate-methanol-water, launch, take out airing, spray is with sulfuric acid solution (1 → 10), and it is clear to be heated to the speckle colour developing in 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color; Put under the ultra-violet lamp (365nm) and inspect, show identical fluorescence speckle.
Assay:
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile-0.05% phosphoric acid solution, (99: 400) are mobile phase; The detection wavelength is 203nm.Number of theoretical plate is by the ginsenoside Rg
1The peak calculates should be not less than 2500;
The preparation of reference substance solution: precision takes by weighing the ginsenoside Rg
1Reference substance is an amount of, adds methanol and makes the solution that every 1ml contains 0.1mg, shakes up, promptly;
The preparation of need testing solution: get 20 of this product, take out content, grind well, get 1g, the accurate title, decide, add water saturated n-butyl alcohol 50ml, close plug claims to decide weight, and placement is spent the night, supersound process 1 hour, put coldly, claim again decide weight, supply the weight that subtracts mistake with water saturated n-butyl alcohol, filtration.Precision is measured subsequent filtrate 25ml, the ammonia solution saturated with n-butyl alcohol washs 2 times, each 25ml, and the water saturated n-butyl alcohol jolting of cleaning mixture reuse is extracted 2 times, each 20ml, merge n-butyl alcohol liquid, evaporate to dryness, residue add dissolve with methanol and are transferred in the 10ml measuring bottle, add methanol to scale, shake up, cross the leaching subsequent filtrate, promptly;
Algoscopy: accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing, inject chromatograph of liquid, measure, promptly; Every of this product contains Radix Notoginseng with the ginsenoside Rg
1(C
42H
72O
14) meter, must not be less than 0.30mg.
Embodiment 5 powders
Prescription:
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
Starch 57g calcium carbonate 22g magnesium stearate 3g
Preparation method:
More than nine the flavor medical materials, get Radix Notoginseng 25g and be ground into fine powder; Eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata decoct with water secondary, add 8 times of water for the first time, add for the second time 6 times of water, 3 hours for the first time, 2 hours for the second time 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, filtrate is concentrated into the thick paste that relative density is 1.30～1.35 (80 ℃), with above-mentioned powder mixes, drying is ground into fine powder, add conventional adjuvant, make powder.
Embodiment 6 granules
Prescription:
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
Starch 57g calcium carbonate 22g magnesium stearate 3g
Preparation method:
More than nine the flavor medical materials, get Radix Notoginseng 25g and be ground into fine powder; Eight flavors such as remaining Radix Notoginseng and Radix Rehmanniae Preparata decoct with water secondary, add 8 times of water for the first time, add for the second time 6 times of water, 3 hours for the first time, 2 hours for the second time 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, filtrate is concentrated into the thick paste that relative density is 1.30～1.35 (80 ℃), with above-mentioned powder mixes, drying is ground into fine powder, add conventional adjuvant, make granule through conventional technology.
Claims (10)
1. a kidney invigorating, invigorate blood circulation, the analgesic Chinese medicine composition, it is characterized in that the crude drug of this pharmaceutical composition consists of:
Radix Rehmanniae Preparata 150-250 weight portion, Radix Polygoni Multiflori 200-350 weight portion, Cortex Eucommiae 100-200 weight portion, Herba Pyrolae 100-200 weight portion, Rhizoma Drynariae (scalding) 100-200 weight portion, Ramulus Uncariae Cum Uncis 50-150 weight portion, Radix Puerariae 50-150 weight portion, Radix Notoginseng 10-100 weight portion, Semen Raphani (stir-fry) 50-150 weight portion.
2. pharmaceutical composition as claimed in claim 1 is characterized in that the crude drug of this pharmaceutical composition consists of:
Radix Rehmanniae Preparata 160 weight portions, Radix Polygoni Multiflori 340 weight portions, the Cortex Eucommiae 110 weight portions, Herba Pyrolae 190 weight portions, Rhizoma Drynariae (scalding) 110 weight portions, Ramulus Uncariae Cum Uncis 140 weight portions, Radix Puerariae 60 weight portions, Radix Notoginseng 90 weight portions, Semen Raphani (stir-fry) 60 weight portions.
3. pharmaceutical composition as claimed in claim 1 is characterized in that the crude drug of this pharmaceutical composition consists of:
Radix Rehmanniae Preparata 204.5 weight portions, Radix Polygoni Multiflori 272.8 weight portions, the Cortex Eucommiae 136.4 weight portions, Herba Pyrolae 136.4 weight portions, Rhizoma Drynariae (scalding) 136.4 weight portions, Ramulus Uncariae Cum Uncis 100 weight portions, Radix Puerariae 100 weight portions, Radix Notoginseng 50 weight portions, Semen Raphani (stir-fry) 86.2 weight portions.
4. as described any one preparation of drug combination method of claim 1-3, it is characterized in that this method is:
The Radix Notoginseng of getting 1/3-2/3 amount pulverize the Radix Notoginseng fine powder; The Radix Notoginseng of Radix Rehmanniae Preparata, Radix Polygoni Multiflori, the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), Ramulus Uncariae Cum Uncis, Radix Puerariae, Semen Raphani (stir-fry) eight flavors and surplus, decoct with water 1-3 time, each 1-4 hour, collecting decoction, filter, it is 1.30～1.35 thick paste that filtrate is concentrated into 70-90 ℃ of relative density; Thick paste mixes with above-mentioned Radix Notoginseng fine powder, dry, be ground into fine powder again, add conventional adjuvant, according to common process, make tablet, capsule, powder, soft capsule, drop pill, honeyed pill, pill, granule, soft extract with bee honey agent, slow releasing preparation, quick releasing formulation, controlled release preparation, oral liquid or external preparation.
5. as described any one medicament composition capsule agent of claim 1-3, it is characterized in that the adjuvant of this pharmaceutical composition consists of:
Starch 10-100 weight portion, calcium carbonate 10-40 weight portion, magnesium stearate 1-5 weight portion.
6. medicament composition capsule agent as claimed in claim 5 is characterized in that the adjuvant of this pharmaceutical composition consists of:
Starch 90 weight portions, calcium carbonate 15 weight portions, magnesium stearate 4.5 weight portions.
7. medicament composition capsule agent as claimed in claim 5 is characterized in that the adjuvant of this pharmaceutical composition consists of:
Starch 57 weight portions, calcium carbonate 22 weight portions, magnesium stearate 3 weight portions.
8. the preparation method of medicament composition capsule agent as claimed in claim 5 is characterized in that this method is:
Get 1/2 the amount Radix Notoginseng pulverize the Radix Notoginseng fine powder; Radix Rehmanniae Preparata, Radix Polygoni Multiflori, the Cortex Eucommiae, Herba Pyrolae, Rhizoma Drynariae (scalding), Ramulus Uncariae Cum Uncis, Radix Puerariae, Semen Raphani (stir-fry) eight are distinguished the flavor of and remain 1/2 Radix Notoginseng of measuring, decoct with water 2 times, 3 hours for the first time, 2 hours for the second time, collecting decoction, filter, it is 1.30～1.35 thick paste that filtrate is concentrated into 80 ℃ of relative densities; Thick paste mixes with above-mentioned Radix Notoginseng fine powder, and drying is ground into fine powder again, adds calcium carbonate, starch and magnesium stearate, mixing, and filled capsules, promptly.
9. as the application of described any one pharmaceutical composition of claim 1-3 in preparation treatment blood stasis due to renal deficiency myelopathy medicine.
10. as the application of described any one pharmaceutical composition of claim 1-3 in preparation treatment stiff neck medicine.
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| CN101953940A (en) * | 2010-10-16 | 2011-01-26 | 秦皇岛皇威制药有限公司 | Traditional Chinese medicine having function of tonifying kidney, invigorating blood circulation and relieving pain, preparation method and quality specification thereof |
| 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 |
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