CN105687924A - Traditional Chinese medicine composition for harmonizing stomach and setting fracture and preparation method thereof - Google Patents
Traditional Chinese medicine composition for harmonizing stomach and setting fracture and preparation method thereof Download PDFInfo
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- CN105687924A CN105687924A CN201610112374.1A CN201610112374A CN105687924A CN 105687924 A CN105687924 A CN 105687924A CN 201610112374 A CN201610112374 A CN 201610112374A CN 105687924 A CN105687924 A CN 105687924A
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Abstract
The invention discloses a traditional Chinese medicine composition for harmonizing the stomach and setting a fracture and a preparation method thereof. The traditional Chinese medicine composition for harmonizing the stomach and setting a fracture is prepared from, by weight, 130-180 parts of rhizoma drynariae, 130-180 parts of radix dipsaci, 80-100 parts of ground beeltles, 280-320 parts of native copper, 130-180 parts of radix angelica sinensis, 180-220 parts of rhizoma corydalis, 10-20 parts of diverse wormwood herbs, 130-180 parts of fructus chaenomelis, 5-15 parts of bombyx batryticatus, 5-15 parts of fructus ligustri lucidi, 25-35 parts of radix astragali, 100-150 parts of rhizoma atractylodis macrocephalae, 80-120 parts of fructus citri sarcodactylis, 50-80 parts of radix aucklandiae, 130-180 parts of fructus setariae germinatus, 130-180 parts of fructus hordei germinatus and 1-5 parts of sodium benzoate. The traditional Chinese medicine composition can remarkably promote healing of the facture portion, and the fracture healing process is accelerated; good functions of tonifying the spleen and the stomach, eliminating swelling, relieving pain and continuing bones are achieved, the traditional Chinese medicine combination is suitable for patients in the early period, in the middle period and in the later period, and fracture setting can be conducted without damaging the spleen and the stomach.
Description
Technical field
The present invention relates to a kind of Chinese medicine treating fracture, be specifically related to Chinese medicine composition of a kind of stomach function regulating synthetism and preparation method thereof。
Background technology
Union of fracture is a complex process, although it is believed that there is normal healing to be inclined to, but many experiments and clinical research all prove that its agglutination is implicitly present in various influence factor and the problem of healing speed, therefore occur in that the Chinese and western drugs being relatively used for accelerating union of bone fracture clinically。
For the Western medicine of accelerating union of bone fracture, that commonly uses clinically has calcium preparation and local excitation fracture site healing drug。Wherein calcium preparation such as Gai Tianli, Gaierqi D (vitamin D3 and calcium carbonate) etc., treatment is with supplement calcium, it is provided that skeletal calcium element is principle；Topical remedy have fracture stimulin, Staphyococcin Aureus, transforming growth factor-β (TGF-β), bone morphogenetic protein (BMP), TGF-β and BMP composite (Sun Yupeng, Zhang Wanqing, Ma Fucheng, etc.。The Bone Defect Repari effect of TGF-B and BMP composite。China's wound magazine, 1998,2:10) etc.。Research in recent years finds, transforming growth factor-β (TGF-β) can stimulate periosteum mesenchymal cell propagation, differentiation, promotes osteoblast and chondroblast hypertrophy, stimulates NTx synthesis, induction intramembranous ossification and endochondral ossification process。
Though Western medicine can promote union of fracture, but there is also many defects, as: the absorption problem of (1) calcium；(2) local injection fracture stimulin, Staphyococcin Aureus often cause the side effect such as local redness；(3) the price too expensive such as BMP, many patient families are difficult to bear。
Chinese medicine treatment fracture has long history, and have accumulated rich experience, summarizes many effective side's medicines。Though the Chinese medicine that morning, mid-term are commonly used clinically at present has blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, reunion of bone etc. promotes the effect of union of fracture, but these medicines exist the shortcoming that gastrointestinal reaction is heavier mostly。Clinical observation through the long period, find all fracture patients early, in, rear three phases have weakness of the spleen and stomach performance in various degree, therefore develop patient's digestive system is non-stimulated or that gastrointestinal reaction is lighter Chinese medicine while promoting union of fracture and be significant。
Summary of the invention
The invention provides the Chinese medicine composition of a kind of stomach function regulating synthetism, the problem solving the bone-knitting Chinese medicament gastrointestinal reaction weight of prior art。
The Chinese medicine composition of a kind of stomach function regulating synthetism, is prepared by the composition of following weight portion:
Rhizoma Drynariae 130～180 parts, Radix Dipsaci 130～180 parts, Eupolyphaga Seu Steleophaga 80～100 parts, Pyritum 280～320 parts, Radix Angelicae Sinensis 130～180 parts, Rhizoma Corydalis 180～220 parts, Herba Artemisiae Anomalae 10～20 parts, Fructus Chaenomelis 130～180 parts, Bombyx Batryticatus 5～15 parts, Fructus Ligustri Lucidi 5～15 parts, the Radix Astragali 25～35 parts, the Rhizoma Atractylodis Macrocephalae 100～150 parts, Fructus Citri Sarcodactylis 80～120 parts, the Radix Aucklandiae 50～80 parts, Fructus Setariae Germinatus 130～180 parts, 130～180 parts of Fructus Hordei Germinatus, sodium benzoate 1～5 part。
Containing the Rhizoma Atractylodis Macrocephalae, Fructus Citri Sarcodactylis, the Radix Aucklandiae, Fructus Setariae Germinatus and these several compositions of Fructus Hordei Germinatus in the stomach function regulating bone-knitting Chinese medicament compositions of the present invention, these several compositions act primarily as stomach function regulating effect, test finds, this stomach function regulating bone-knitting Chinese medicament compositions can promote mice Intestinal pushing function, remain without influence on rat stomach, will not injury rats gastric mucosa, and a situation arises to significantly improve the ulcer of the alcohol repellency gastric ulcer model of rat。This shows that this stomach function regulating bone-knitting Chinese medicament compositions will not cause or substantially not cause gastrointestinal reaction, has the effect of good reducing swelling and alleviating pain, blood circulation promoting and blood stasis dispelling and battalion's symplectic bone, invigorating the spleen and stomach, nourishing the liver and kidney, therefore early, in, the bone fracture bone fracture disease of rear three phases can use per capita。
Meanwhile, the Radix Astragali contained in this stomach function regulating bone-knitting Chinese medicament compositions, not only there is filling blood, promote the effect of bone growth, and also have the effect of invigorating the spleen and stomach。In addition, in stomach function regulating bone-knitting Chinese medicament compositions of the present invention, other compositions then primarily serve the effect of synthetism, these compositions can promote that TGF-β was expressed in each stage of union of fracture, remarkably promotes osteoblast and the proliferation of chondrocytes, promotes extracellular matrix synthesis。
Additionally, the stomach function regulating bone-knitting Chinese medicament compositions of the present invention can be obviously promoted osteoblast synthesis and secretion BMP-2, and make the BMP-2 peak expression phase in advance, accelerate mesenchymal cell and convert to chondroblast and osteoblast, thus promoting union of fracture。Synthesis that this Eupolyphaga Seu Steleophaga being possibly due to wherein contain can be accelerated in osteocyte DNA, promotes osteoblastic propagation and enlivens its function；All containing the inorganic elements such as zinc, manganese in the Pyritum, Eupolyphaga Seu Steleophaga and the Endoconcha Sepiae that wherein contain, these elements are the important coenzyme of collagen superoxide dismutase, and osteoblastic active degree plays positive adjustment effect；Rich in a large amount of aminoacid in Eupolyphaga Seu Steleophaga and Radix Angelicae Sinensis, synthesize BMP-2 for osteoblast and provide required raw material；Rhizoma Drynariae also has the effect postponing osteoblast degeneration simultaneously。
Further, the composition acting primarily as synthetism effect complements each other with the composition acting primarily as stomach function regulating effect, complements one another so that the stomach function regulating bone-knitting Chinese medicament compositions synthetism of the present invention and non-imapirment of the spleen and stomach。
As preferably, the Chinese medicine composition of described stomach function regulating synthetism is prepared by the composition of following weight portion:
Rhizoma Drynariae 150 parts, Radix Dipsaci 150 parts, Eupolyphaga Seu Steleophaga 90 parts, Pyritum 300 parts, Radix Angelicae Sinensis 150 parts, Rhizoma Corydalis 200 parts, Herba Artemisiae Anomalae 15 parts, Fructus Chaenomelis 150 parts, Bombyx Batryticatus 10 parts, Fructus Ligustri Lucidi 10 parts, the Radix Astragali 30 parts, the Rhizoma Atractylodis Macrocephalae 120 parts, Fructus Citri Sarcodactylis 100 parts, the Radix Aucklandiae 60 parts, Fructus Setariae Germinatus 150 parts, 150 parts of Fructus Hordei Germinatus, sodium benzoate 3 parts。
According to different needs, the stomach function regulating bone-knitting Chinese medicament compositions of the present invention can make various difference dosage form well known in the art, such as decoction, mixture, oral liquid, granule, capsule or tablet。
The preparation method that present invention also offers the Chinese medicine composition of described stomach function regulating synthetism, including:
By all compositions by after the mixing of preset weight part, adding 2000～3000 parts of water, decocting to filtrate is 800～1200 parts, filtrate is sealed and preserves, it is thus achieved that stomach function regulating bone-knitting Chinese medicament mixture。
To make stomach function regulating bone-knitting Chinese medicament oral liquid, then the enrichment of filtrate being promoted to big compared with mixture in above-mentioned fried process, concrete enrichment can specifically be arranged according to specific needs。
Or including:
(1) by all compositions by after the mixing of preset weight part, boiling becomes extractum；
(2) in extractum, add adjuvant and make soft material, after granulation, granulate, obtain granule；
Also comprise the steps (3):
(3) by granule tabletting or encapsulated, tablet or colloid are made。
Described adjuvant is the adjuvant for making granule, tablet or capsule commonly used in the art。
The method preparing capsule can also be:
(1) by all compositions by after the mixing of preset weight part, boiling becomes equivalent extract；
(2) by encapsulated after described equivalent extract vacuum drying, it is thus achieved that stomach function regulating bone-knitting Chinese medicament capsule。
The stomach function regulating bone-knitting Chinese medicament compositions of the present invention is more due to component, makes when capsule or tablet patient's dosage relatively big, can increase the sense of discomfort of patient, therefore the preparation such as comparatively preferably made mixture, oral liquid。
Compared with prior art, the invention have the benefit that
(1) the stomach function regulating bone-knitting Chinese medicament compositions of the present invention can promote that TGF-β was expressed in each stage of union of fracture, remarkably promote osteoblast and the proliferation of chondrocytes, promote extracellular matrix synthesis, improve bone density, promote fracture site healing, accelerating bone healing process, after medication, the fracture resistence force of fracture site also significantly improves；
(2) Chinese medicine composition of the stomach function regulating synthetism of the present invention can promote mice Intestinal pushing function, remain without influence on rat stomach, will not injury rats gastric mucosa, and a situation arises to significantly improve the ulcer of the alcohol repellency gastric ulcer model of rat, show that the Chinese medicine composition of the stomach function regulating synthetism of the present invention will not cause or substantially not cause gastrointestinal reaction, there is good invigorating the spleen and stomach, reducing swelling and alleviating pain and battalion's symplectic bone effect, and be suitable for early, in, the patient of rear three phases use, synthetism and non-imapirment of the spleen and stomach。
Accompanying drawing explanation
The X-ray film of fracture site when Fig. 1 a is experimental drug group (A group) rabbit first week after surgery；
The X-ray film of fracture site when Fig. 1 b is positive controls rabbit first week after surgery；
The X-ray film of fracture site when Fig. 1 c is blank group rabbit first week after surgery；
The X-ray film of fracture site when Fig. 1 d is experimental drug group (A group) rabbit second week after surgery；
The X-ray film of fracture site when Fig. 1 e is positive controls rabbit second week after surgery；
The X-ray film of fracture site when Fig. 1 f is blank group rabbit second week after surgery；
The X-ray film of fracture site when Fig. 1 g is experimental drug group (A group) rabbit 4th week after surgery；
The X-ray film of fracture site when Fig. 1 h is positive controls rabbit 4th week after surgery；
The X-ray film of fracture site when Fig. 1 i is blank group rabbit 4th week after surgery；
Wherein, a1 represents " experimental drug group first week ", and b1 represents " positive controls first week ", and c1 represents " blank group first week ", by that analogy；
The histological findings (light microscopic × 4) of the rabbit specimen of experimental drug group (A group) when Fig. 2 a is first week after surgery；
The histological findings (light microscopic × 4) of the rabbit specimen of positive controls when Fig. 2 b is first week after surgery；
The histological findings (light microscopic × 4) of the rabbit specimen of blank matched group when Fig. 2 c is first week after surgery；
Fig. 2 d be after surgery second week time experimental drug group (A group) the histological findings (light microscopic × 10) of rabbit specimen；
Fig. 2 e be after surgery second week time positive controls the histological findings (light microscopic × 10) of rabbit specimen；
Fig. 2 f be after surgery second week time blank matched group the histological findings (light microscopic × 20) of rabbit specimen；
The histological findings (light microscopic × 10) of the rabbit specimen of experimental drug group (A group) when Fig. 2 g is the 3rd week after surgery；
The histological findings (light microscopic × 10) of the rabbit specimen of positive controls when Fig. 2 h is the 3rd week after surgery；
The histological findings (light microscopic × 4) of the rabbit specimen of blank matched group when Fig. 2 i is the 3rd week after surgery；
Fig. 2 j be after surgery 4th week time experimental drug group (A group) the histological findings (light microscopic × 20) of rabbit specimen；
Fig. 2 k be after surgery 4th week time positive controls the histological findings (light microscopic × 4) of rabbit specimen；
Fig. 2 l be after surgery 4th week time blank matched group the histological findings (light microscopic × 40) of rabbit specimen；
The SABC TGF-β 1 coloration result (light microscopic × 20) of the rabbit specimen of experimental drug group (A group) when Fig. 3 a is first week after surgery；
SABC TGF-β 1 coloration result fruit (light microscopic × 20) of the rabbit specimen of positive controls when Fig. 3 b is first week after surgery；
The SABC TGF-β 1 coloration result (light microscopic × 20) of the rabbit specimen of blank matched group when Fig. 3 c is first week after surgery；
Fig. 3 d be after surgery second week time experimental drug group (A group) the SABC TGF-β 1 coloration result (light microscopic × 20) of rabbit specimen；
Fig. 3 e be after surgery second week time positive controls rabbit specimen SABC TGF-β 1 coloration result fruit (light microscopic × 20)；
Fig. 3 f be after surgery second week time blank matched group the SABC TGF-β 1 coloration result (light microscopic × 20) of rabbit specimen；
Fig. 3 g be after surgery 4th week time experimental drug group (A group) the SABC TGF-β 1 coloration result (light microscopic × 20) of rabbit specimen；
Fig. 3 h be after surgery 4th week time positive controls rabbit specimen SABC TGF-β 1 coloration result fruit (light microscopic × 20)；
Fig. 3 i be after surgery 4th week time blank matched group the SABC TGF-β 1 coloration result (light microscopic × 20) of rabbit specimen；
The SABC BMP-2 coloration result (light microscopic × 10) of the rabbit specimen of experimental drug group (A group) when Fig. 4 a is first week after surgery；
SABC BMP-2 coloration result fruit (light microscopic × 20) of the rabbit specimen of positive controls when Fig. 4 b is first week after surgery；
The SABC BMP-2 coloration result (light microscopic × 40) of the rabbit specimen of blank matched group when Fig. 4 c is first week after surgery；
Fig. 4 d be after surgery second week time experimental drug group (A group) the SABC BMP-2 coloration result (light microscopic × 40) of rabbit specimen；
Fig. 4 e be after surgery second week time positive controls rabbit specimen SABC BMP-2 coloration result fruit (light microscopic × 40)；
Fig. 4 f be after surgery second week time blank matched group the SABC BMP-2 coloration result (light microscopic × 40) of rabbit specimen；
The SABC BMP-2 coloration result (light microscopic × 40) of the rabbit specimen of experimental drug group (A group) when Fig. 4 g is the 3rd week after surgery；
SABC BMP-2 coloration result fruit (light microscopic × 40) of the rabbit specimen of positive controls when Fig. 4 h is the 3rd week after surgery；
The SABC BMP-2 coloration result (light microscopic × 40) of the rabbit specimen of blank matched group when Fig. 4 i is the 3rd week after surgery；
Fig. 4 j be after surgery 4th week time experimental drug group (A group) the SABC BMP-2 coloration result (light microscopic × 40) of rabbit specimen；
Fig. 4 k be after surgery 4th week time positive controls rabbit specimen SABC BMP-2 coloration result fruit (light microscopic × 40)；
Fig. 4 l be after surgery 4th week time blank matched group the SABC BMP-2 coloration result (light microscopic × 40) of rabbit specimen。
Detailed description of the invention
Below in conjunction with the drawings and specific embodiments, technical scheme is described in further detail。
Embodiment 1
The Chinese medicine composition of a kind of stomach function regulating synthetism of the present embodiment, is prepared by the composition of following weight portion:
Rhizoma Drynariae 150g, Radix Dipsaci 150g, Eupolyphaga Seu Steleophaga 90g, Pyritum 300g, Radix Angelicae Sinensis 150g, Rhizoma Corydalis 200g, Herba Artemisiae Anomalae 15g, Fructus Chaenomelis 150g, Bombyx Batryticatus 10g, Fructus Ligustri Lucidi 10g, Radix Astragali 30g, Rhizoma Atractylodis Macrocephalae 120g, Fructus Citri Sarcodactylis 100g, Radix Aucklandiae 60g, Fructus Setariae Germinatus 150g, Fructus Hordei Germinatus 150g, sodium benzoate 3g。
The preparation method of the Chinese medicine composition of this stomach function regulating synthetism includes:
Stomach function regulating synthetism drink (i.e. stomach function regulating bone-knitting Chinese medicament mixture): by all compositions by after the mixing of above-mentioned weight portion, add 2500mL water, decocts to 1000mL, seals and preserve, standby。
Harmonious city: first by all compositions by after the mixing of preset weight part, collecting decoction after boiling at least twice, filtering and concentrating obtains equivalent extract；Decocting 45 minutes, filtering and concentrating obtains equivalent extract (surveying at relative density about 1.20,20 DEG C) every time, will load capsule, it is thus achieved that Harmonious city after equivalent extract vacuum drying。Every Harmonious city is containing medicinal component 9g。
Embodiment 2
The Chinese medicine composition of a kind of stomach function regulating synthetism of the present embodiment, is prepared by the composition of following weight portion:
Rhizoma Drynariae 130g, Radix Dipsaci 180g, Eupolyphaga Seu Steleophaga 80g, Pyritum 320g, Radix Angelicae Sinensis 180g, Rhizoma Corydalis 180g, Herba Artemisiae Anomalae 10g, Fructus Chaenomelis 180g, Bombyx Batryticatus 15g, Fructus Ligustri Lucidi 5g, Radix Astragali 35g, Rhizoma Atractylodis Macrocephalae 100g, Fructus Citri Sarcodactylis 80g, Radix Aucklandiae 80g, Fructus Setariae Germinatus 130g, Fructus Hordei Germinatus 130g, sodium benzoate 5g。
Stomach function regulating synthetism drink and Harmonious city is prepared according to the preparation method identical with embodiment 1。
Embodiment 3
The Chinese medicine composition of a kind of stomach function regulating synthetism of the present embodiment, is prepared by the composition of following weight portion:
Rhizoma Drynariae 180g, Radix Dipsaci 130g, Eupolyphaga Seu Steleophaga 100g, Pyritum 280g, Radix Angelicae Sinensis 130g, Rhizoma Corydalis 220g, Herba Artemisiae Anomalae 20g, Fructus Chaenomelis 130g, Bombyx Batryticatus 5g, Fructus Ligustri Lucidi 15g, Radix Astragali 25g, Rhizoma Atractylodis Macrocephalae 150g, Fructus Citri Sarcodactylis 120g, Radix Aucklandiae 50g, Fructus Setariae Germinatus 180g, Fructus Hordei Germinatus 180g, sodium benzoate 1g。
Stomach function regulating synthetism drink and Harmonious city is prepared according to the preparation method identical with embodiment 1。
Comparative example 1
The Chinese medicine composition of a kind of stomach function regulating synthetism of the present embodiment, is prepared by the composition of following weight portion:
Rhizoma Drynariae 150g, Radix Dipsaci 150g, Eupolyphaga Seu Steleophaga 90g, Pyritum 300g, Radix Angelicae Sinensis 150g, Rhizoma Corydalis 200g, Herba Artemisiae Anomalae 15g, Fructus Chaenomelis 150g, Bombyx Batryticatus 10g, Fructus Ligustri Lucidi 10g, Radix Astragali 30g, sodium benzoate 3g。
Stomach function regulating synthetism drink and Harmonious city is prepared according to the preparation method identical with embodiment 1。
Comparative example 2
The Chinese medicine composition of a kind of stomach function regulating synthetism of the present embodiment, is prepared by the composition of following weight portion:
Rhizoma Drynariae 150g, Radix Dipsaci 150g, Eupolyphaga Seu Steleophaga 90g, Pyritum 300g, Endoconcha Sepiae 150g, Radix Angelicae Sinensis 150g, Rhizoma Corydalis 200g, Herba Artemisiae Anomalae 15g, Fructus Chaenomelis 150g, Rhizoma Atractylodis Macrocephalae 120g, Fructus Citri Sarcodactylis 100g, Radix Aucklandiae 60g, Fructus Setariae Germinatus 150g, Fructus Hordei Germinatus 150g, sodium benzoate 3g。
Stomach function regulating synthetism drink and Harmonious city is prepared according to the preparation method identical with embodiment 1。
The research of the Chinese medicine composition accelerating union of bone fracture of detection example 1 stomach function regulating synthetism
1, animal model is prepared
Aseptically by radius on the left of rabbit, epimere operation cause fracture model, Cranial defect 2～3mm, postoperative rabbit freely walks, without extenal fixation。Postoperative intramuscular injection penicillin G sodium (purchased from Jiangxi east wind Pharmaceutical limited company, the quasi-word (1996) of medicine the 030008th, lot number: 020621-3 are defended in Jiangxi) 200,000 u once a day, totally 3 days。
2, packet and administration
Fracture model rabbit is randomly divided into experimental drug group, and (rabbit of the Harmonious city taking embodiment 1 preparation is A group, the rabbit of the Harmonious city taking embodiment 2 preparation is B group, the rabbit of the Harmonious city taking embodiment 3 preparation is C group, the rabbit of the Harmonious city taking comparative example 1 preparation is D group, the rabbit of Harmonious city taking comparative example 1 preparation is E group), positive controls and blank group, often group 16。Postoperative 1 day of rabbit modeling, in experimental drug group, every animal takes corresponding Harmonious city one；Positive controls takes musk bone knitting pill (purchased from Jilin Dongfeng pharmacy one factory, lot number: 990106)；Blank group takes placebo one, takes 14 continuously。
3, the process of the execution of animal and specimen
Often group every time respectively at postoperative 7 days, 14 days, 21 days, 28 days with air tap inserting method dead 4 everywhere。Often group execution animal is cut from upper arm lower end, both sides, puts into 20 DEG C of Refrigerator stores。Draw materials after carrying out x-ray inspection, bone density inspection, biomechanics inspection respectively and do histopathology and SABC inspection。The specimen of postoperative 28 days is only done in wherein bone density inspection, biomechanics inspection；The specimen of postoperative 7 days, 14 days, 28 days is only done in x-ray inspection, SABC inspection。
4, observation index
(1) general data: Continuous Observation three treated animal hair luster degree, appetite, mobility, degree of reaction, otch situation。
(2) X-ray film is taken the photograph: observe on the left of postoperative 7 days, 14 days, 21 days, 28 days rabbit in radius, epimere fracture defect situation, periosteal reaction, yield of callus, bone trabecula。
(3) bone density inspection: the volume measuring rabbit fracture with UBIS3000 ultrasonic bone density analyzer (DMS company of France) weakens value (BUA), to react bone amount, sclerotin change。
(4) fracture resistence force test: carrying out rabbit radius three-point bending maximum load dynamics measurement with Shimadzu universl tester, centered by fracture, span is 2 centimetres, and loading speed is 5mm/min, measures the bending load of every rabbit radius。In order to overcome individual variation, the percentage ratio that fracture side radius three-point bending load value obtains divided by strong side three-point bending load value should be taked to add up, with the error that minimizing brings because of individual variation。
(5) histological observation: take include fracture site and about cartilage crust about 1 centimetre as observe specimen, specimen is inserted after 4% paraformaldehyde soaks 48h, the fritter of 5mm × 5mm × 5mm it is cut into osteotome, insert 10%EDTA liquid (pH7.2) decalcification, 4 DEG C, change weekly decalcifying Fluid 1 time。When pin can thrust cortical bone, stop decalcification, subsequently paraffin embedding (60 DEG C), prepare 4 μ m thick sections；Cut into slices after dewaxing to water, HE dyeing, carry out histological observation。
(6) immunohistochemical staining: cut into slices after dewaxing to water, close endogenous enzymes through 0.3% hydrogen peroxide respectively；ABC method carries out SABC TGF-β 1 dyeing and SABC BMP-2 dyeing routinely。
Wherein, SABC TGF-β 1 coloration result is observed: occur in cell dyeing that brown yellow granule is positive reaction mark, each dyeing all compares, by the microscope being connected with computer, the SABC sectioning image collected is stored in microcomputer, is analyzed by PAS-9000 Pathologic image analysis system。Stained is amplified through microscope, and every example random uptake callus organization charts is as 5 width。Every batch and batch between input image incident intensity be all strict controlled in same level。By Color Segmentation method, in segmentation callus image, the pigmented section of TGF-β 1 positive products, obtains the stained area of positive products and the dyeing gray scale of positive products。
Cell inner dyeing: mesenchymal cell, in the endochylema such as osteoblast, mononuclear cell, the brown yellow granule of distribution is TGF-B1 stained positive。Extracellular contaminates: the pale brown pin granule of lamellar of distribution in the intercellular substance in periosteum, substrate, hematoma, for TGFB-1 stained positive。
SABC BMP-2 coloration result is observed: occur brown for positive reaction in cell dyeing, each dyeing all compares, by the microscope being connected with computer, the SABC sectioning image collected is stored in microcomputer, is analyzed by PAS-9000 Pathologic image analysis system。Stained amplifies 400 times through microscope, and every example random uptake callus organization charts is as 5 width。Every batch and batch between input image incident intensity be all strict controlled in same level。By Color Segmentation method, BMP-2 positive products region in segmentation callus image, obtain positive products average optical (representing the average coloring degree of BMP-2) and positive products average integral optical density (representing BMP-2 content), substitute primary antibodie as negative control with 0.01mol/LPBS。
Each Sets of Measurement Data mean ± standard deviationRepresent, and with SPSS13.0 software statistics bag, each group of data carried out statistical analysis that data one factor analysis of variance between group adopts t inspection, with P < 0.05 for there being significant difference。
5, observed result
(1) general data: three treated animals are postoperative all without infecting, the action in postoperative 2 days of experimental drug group and diet recover as before, blank group and positive controls are tired sleeping few dynamic, and postoperative 3～4 Japanese sides recover；Postoperative 3 day by day experimental drug group and positive controls limb swelling substantially disappear, and blank group local ecchymosis is obvious, just disappearance after 1 week。
(2) X-ray film is taken the photograph:
Art one week after: the fracture line of experimental drug group, positive controls and blank group is all high-visible, but experimental drug group (A group, the absorption of hematoma of Fig. 1 a) and positive controls (Fig. 1 b) local is better, and visible more hematoma shade around the broken ends of fractured bone of blank group (Fig. 1 c)。
Art two weeks after: (A group, the fracture site impact of Fig. 1 d) and positive controls (Fig. 1 e) all tends to fuzzy to experimental drug group, and has slight periosteal reaction, and indivedual specimen have a large amount of callus formation；The specimen of blank group (Fig. 1 f) also shows as that fracture end is fuzzy, slight periosteal reaction, but callus formation is less。
Postoperative surrounding: experimental drug group (the visible obvious external callus of A group, Fig. 1 g) and positive controls (Fig. 1 h), increase, and cortical bone seriality is good, and the major part specimen broken ends of fractured bone has been reinvented close to normal sclerotin by fracture local density；And blank group (Fig. 1 i) broken ends of fractured bone also has a large amount of callus formation, the broken ends of fractured bone is continuous, and callus bulge is relatively big, but pulp cavity does not lead to。
At the 1st, 2 weeks x-ray plain films, experimental drug group checked that result is without significant difference with positive controls, but when the 4th week, in experimental drug group Cranial defect, bone trabecula is substantially closely knit than positive controls。
Result above shows, the fracture repair of experimental drug group and positive controls is faster than blank group, and the fracture repair of experimental drug group is faster than positive controls。
(3) bone density inspection: see table 1 below:
The bone density respectively organized during table 1 surrounding compare (n=4,)
Note:*Represent to compare with blank group that there is significant difference (P < 0.05), represent do not possess significant difference (P > 0.05) compared with positive controls。
From table 1, when postoperative 28 days, the bone density value of experimental drug group and positive controls is without significant difference, significant difference is then there is between experimental drug group and blank group, average differs nearly 2 times, it was shown that Harmonious city can increase bone amount, promotes union of fracture。
In four test medication groups, the bone density of A group is maximum, though the bone density of B group, C group, D group and E group is more slightly lower than A group, but remains above positive controls。Show that the Harmonious city of embodiment 1 is best to the facilitation of union of fracture。By the detection data of A group and E group it can be seen that the combination relatively Endoconcha Sepiae of Bombyx Batryticatus, Fructus Ligustri Lucidi and the Radix Astragali is more beneficial for increasing bone amount, promote union of fracture。
(4) fracture resistence force test: see table 2 below:
Respectively organize during table 2 surrounding 3 bending maximal destruction bending moment average ratio relatively (n=4,)
Note:*Represent to compare with blank group that there is significant difference (P < 0.05), represent do not possess significant difference (P > 0.05) compared with positive controls。
From table 2, when postoperative 28 days, all there is significant difference with blank group in experimental drug group and positive controls, and average differs nearly 2 times, it was shown that the radius specimen of test medication group mechanical property in union of fracture is better than blank group。
(5) histological observation:
Postoperative 7th day: experimental drug group (A group, the all visible mesenchymal cell propagation of Fig. 2 a), positive controls (Fig. 2 b) and blank group (Fig. 2 c) is active, it can be seen that the trend of the oriented cartilage osteocyte of mesenchymal cell, Chondrocyte Differentiation from structure and form；All visible blood capillary proliferation and inflammatory cell infiltration in intercellular substance, and visible a large amount of collagenocyte formation。But blank group mesenchymal cell differentiation degree is low, and fibroblast is less, the collagen fiber in substrate are rare；Positive controls mesenchymal cell differentiation degree is higher, and fibroblast distribution is dense, and in substrate, collagen fiber generate more；Experimental drug group (A group) fibroblast quantity and collagen fiber are more, break up more ripe, and cell distribution rule is dense。
Postoperative 14th day: experimental drug group (A group, in Fig. 2 d), positive controls (Fig. 2 e) and blank group (Fig. 2 f) callus, collagen fiber are replaced by bone trabecula gradually, but blank group bone trabecula is less, the collagen fiber cell of visible more immaturity differentiation, osteoblast in callus, cell arrangement is sparse, negligible amounts；Positive controls address cell is more, and osteocyte is less, and bone trabecula generates more；Experimental drug group (A group) bone trabecula quantity is more, and the osteoclast number at bone trabecula edge is also more, and cell arrangement is fine and close neat, the visible calcareous infarct of Medium Culture, accidental osteoclast。
Postoperative 21st day: experimental drug group (A group, the newborn callus of Fig. 2 g) joins together with fracture end normal bone tissues, and have the trend forming continuous slab layer bone, callus is heavily located at mature osteocytes in bone lacuna as seen formed, visible a large amount of calcareous infarcts in cell peripheral substrate, around osteocyte, pleasure is shown in more osteoclast；Positive controls (Fig. 2 h) also has lamellar bone to be formed, but negligible amounts, and osteocyte in substrate, osteoblast are more；Blank group (Fig. 2 i) bone trabecula increases gradually, osteocyte negligible amounts ripe in callus, the visible more osteoblast in bone trabecula edge。
Postoperative 28th day: (A group, Fig. 2 j) callus tissue cellularity and form, substrate ossification intensity are close to ripe osseous tissue for experimental drug group；And positive controls (Fig. 2 k) is heavily located at mature osteocytes in bone lacuna as seen, and formed lamellar bone ripe continuously, substrate calcification is obvious；Osteocyte ripe in blank group (Fig. 2 l) callus is more, it is seen that flaggy bone formation, the osteoblast of the visible marshalling in lamellar bone edge continuously。
As can be seen here, compared with experimental drug group and positive controls, the union of fracture process of blank group substantially slows down, and tests the union of fracture process of medication group faster than positive controls。
(6) immunohistochemical staining:
1. SABC TGF-β 1 dyes
Postoperative 7th day: under each group periosteum and in the hematoma of surrounding soft tissue's formation, have substantial amounts of neutrophilic granulocyte, lymphocyte, mononuclear cell, erythrocyte to infiltrate, TGF-β 1 slabbing distribution in these intercellular substancies, dye in strong positive；Around monokaryon inflammatory cell, the dyeing of TGF-β 1 becomes apparent from；The positive staining of TGF-β 1 is had in the periosteum cell of hypertrophy；A large amount of fibroblasts are arranged in loose fibrin rack brokenly, also the extracellular dyeing of visible TGF-β 1；Wherein, experimental drug group (A group) substrate positive cells is more, dyeing relatively deep (Fig. 3 a)；Positive controls substrate positive cells is also more, but dyeing is compared with experimental drug group shallow (Fig. 3 b)；Blank group substrate positive cells is then less, and dye thin (Fig. 3 c)。
The dyeing of experimental drug group and positive controls relatively blank group is strong, and the average gray between experimental drug group and positive controls and blank group there is also significant differences。
Postoperative 14th day: experimental drug group (A group, Fig. 3 d) and in positive controls (Fig. 3 e) in mesenchymal cell around all visible new vessels wall and extracellular be positive staining, form a TGF-β 1 ring dyeing band clearly；And the propagation that is also shown between periosteum deep layer cell mobilization in experimental drug group (Fig. 3 d), and oriented fibroblast, chondrocyte, osteoblast differentiation trend；Between positive controls (Fig. 3 e) periosteum deep layer, cell mobilization degree is also higher, also the trend of oriented functioning cell differentiation。And the cell mobilization of blank group (Fig. 3 f) and differentiation degree are all relatively low。When second week, in the endochylema of three groups of cells, all see TGF-β 1 positive staining, interstitial has no TGF-β 1 dyeing location。
Postoperative 28th day: experimental drug group (all starts dyeing location TGF-β 1 occur in the intercellular substance of A group, Fig. 3 g) and positive controls (Fig. 3 h)；At intramembranous ossification position, in the osteoblast that area of new bone girder surface lining is attached, the dyeing of visible TGF-β 1, also has extracellular to dye simultaneously, and imbeds TGF-β 1 dyeing inside and outside the osteoblast of bone matrix and be feminine gender；The strong positive still having TGF-β 1 in chondrocyte dyes；Still TGF-β 1 positive staining is had in the mesenchymal cell continuing differentiation more than intramembranous ossification；In endochondral ossification region, having no the dyeing of TGF-β 1 in the chondrocyte slurry in calcification forward position, surrounding substrate then dyes for strong positive；The position that bridge callus periosteum thickens remains unchanged the differentiation of visible mesenchymal cell, and has cell inner dyeing positive。And area of new bone girder is less in blank group (Fig. 3 i), in the osteoblast that bone trabecula surface lining is attached, the dyeing of TGF-β 1 positive products is shallower, and osteoblast, chondroblast negligible amounts in bone matrix, TGF-β 1 positive expression is more weak。
Can be found by immunohistochemical staining, in test medication group, the TGF-β 1 expression in cell is higher, the high expressed of TGF-β 1 can stimulate periosteum mesenchymal cell proliferation and differentiation, promote osteoblast and the proliferation of chondrocytes, induction intramembranous ossification and endochondral ossification process, promote extracellular matrix synthesis。Show that Harmonious city improves the effect of healing of fracture relevant with promoting the TGF-β 1 expression in each stage of union of fracture, promotion osteoblastic proliferation and substrate synthesis。
2. SABC BMP-2 dyeing
Postoperative first week: experimental drug group (A group, all there is BMP-2 positive stained cells (BMP-2 positive staining is brown color, is distributed mainly in bone trabecula and positive cell endochylema) in Fig. 4 a), positive controls (Fig. 4 b) and blank group (Fig. 4 c) granulation tissue and fibrous callus tissue。Wherein, in blank group, BMP-2 positive stained cells is less, and positive staining is more weak；And positive controls BMP-2 positive stained cells is more, positive staining is stronger；Visible a large amount of positive stained cells in brown color in the mirror downward view of experimental drug group (A group), positive staining is strong。
Postoperative second week: (A group, all visible BMP-2 positive stained cells of the mirror downward view of Fig. 4 d), positive controls (Fig. 4 e) and blank group (Fig. 4 f) increases experimental drug group。Wherein the positive staining intensity of blank group is still relatively low；The positive staining intensity enhancing of positive controls, and the bone trabecula generation of visible arrangement disorder；And there is substantial amounts of cartilage islands and area of new bone girder in experimental drug group (A group), it is seen that a large amount of positive stained cells in brown color, positive staining further enhances。
Postoperative 3rd week: blank group (Fig. 4 i) BMP-2 positive stained cells increases, and positive staining intensity strengthens gradually；Positive controls (Fig. 4 h) also shows more positive stained cells, and positive staining intensity is stronger；And experimental drug group (A group, during Fig. 4 g) BMP-2 positive stained cells relatively second week decline, during positive staining intensity relatively second week decline weaken。
Postoperative 4th week: the BMP-2 positive stained cells quantity of positive controls (Fig. 4 k) and blank group (Fig. 4 l) is all greatly reduced, weak when positive staining intensity is all substantially compared with the 3rd week。And experimental drug group (, based on osteocyte in substrate, in cellular matrix, BMP-2 positive products is expressed and is substantially disappeared for A group, Fig. 4 j) hone lamella edge a small amount of BMP-2 positive stained cells as seen。
The cell type of BMP-2 positive expression mainly has mesenchymal cell, chondroblast, osteoblast etc., has no obvious positive expression in the osteocyte of the chondrocyte of regression and maturation。
(7) TGF-β 1 immunohistochemical staining analysis
1. TGF-β 1 positive products areal analysis result, asks for an interview table 3。
Table 3TGF-β 1 stained area (um2, n=8)
Note: represent, in the same time, there is compared with blank group significant difference (P < 0.05)；ΔRepresent, in the same time, there is compared with positive controls significant difference (P < 0.05)。
From table 3, first week after surgery, second week, in test medication group, TGF-β 1 positive products area is all higher than positive controls and blank group, and has significant difference；4th week after surgery, in test medication group, TGF-β 1 positive products area has significant difference compared with blank group, but without significant difference compared with positive controls。
Although showing that positive controls all can reach similar healing effect to test medication group in longer healing stage, but the healing process of test medication group being faster than positive controls。Further, it is absent from significant difference between the TGF-β 1 positive products area of four test medication groups。
2. TGF-β 1 positive products dyeing gray analysis result, referring to table 4:
Table 4TGF-β 1 dye gray scale (um2, n=8)
Note: represent, in the same time, there is compared with blank group significant difference (P < 0.05)；Δ represents have significant difference (P < 0.05) compared with positive controls in the same time。
From table 4, postoperative first week, in each test medication group, TGF-β 1 positive products dyeing gray scale all had significant difference compared with blank group；Postoperative second week, in each test medication group, TGF-β 1 positive products dyeing gray scale all has significant difference compared with blank group, and A group also has significant difference compared with positive controls；Postoperative 4th week, A group all has significant difference with TGF-β 1 positive products dyeing gray scale in B group compared with blank group。
It can be seen that first week after surgery in from the above, TGF-β 1 expression is relatively low, and dyeing gray scale is higher；Postoperative second week, TGF-β 1 expression raises, and dye gray scale step-down；Postoperative 4th week, union of fracture process draws to an end, and TGF-β 1 expression is lowered, and dyeing gray scale uprises。This is consistent with the observed result of Fig. 2 a～Fig. 2 i。
(8) BMP-2 immunohistochemical staining is analyzed
1. BMP-2 positive products mean optical density is analyzed, and analyzes result in Table 5:
Table 5BMP-2 positive products mean optical density (n=10,)
Note: represent, in the same time, there is compared with blank group pole significant difference (P < 0.01)；Represent, in the same time, there is compared with blank group significant difference (P < 0.05)；Δ represents have significant difference (P < 0.05) compared with positive controls in the same time；Represent, in the same time, not there is compared with positive controls significant difference (P > 0.05)。
From table 5, postoperative first week and second week, each BMP-2 positive products mean optical density testing medication group is respectively provided with pole significant difference compared with blank group, is respectively provided with significant difference compared with positive controls。Postoperative 3rd week, 4th week time, each BMP-2 positive products mean optical density testing medication group decreases, and this is consistent with the result of BMP-2 immunohistochemical staining。
2. BMP-2 average integral optical density value is analyzed, and analyzes result in Table 6:
Table 6BMP-2 positive products average integral optical density value (n=10,)
Note: represent, in the same time, there is compared with blank group pole significant difference (P < 0.01)；?Represent, in the same time, there is compared with blank group significant difference (P < 0.05)；Δ represents have significant difference (P < 0.05) compared with positive controls in the same time；Represent, in the same time, not there is compared with positive controls significant difference (P > 0.05)。
From table 6, postoperative first week and second week, each BMP-2 positive products average integral optical density value testing medication group is respectively provided with pole significant difference compared with blank group, is respectively provided with significant difference compared with positive controls。Postoperative 3rd week, 4th week time, each BMP-2 positive products average integral optical density value testing medication group decreases, and this is consistent with the result of BMP-2 immunohistochemical staining。
Result above shows, the stomach function regulating bone-knitting Chinese medicament compositions of the present invention can be obviously promoted osteoblast synthesis and secretion BMP-2, and make BMP-2 peak expression phase (the BMP-2 peak expression phase second week after surgery of test medication group in advance, positive controls and blank group then the 3rd week after surgery), accelerate mesenchymal cell to convert to chondroblast and osteoblast, thus promoting union of fracture。
The impact on digestive system of the Chinese medicine composition of detection example 2 stomach function regulating synthetism
Select stomach function regulating synthetism drink (containing crude drug 0.3g in every milliliter) of embodiment 1 preparation, the musk bone knitting pill distilled water identical with detection example 1 is configured to 0.3g/ml, stand-by。
1, the stomach function regulating synthetism drink impact on mice charcoal end Intestinal pushing
ICR mice 50, female, body weight 25.5 ± 2.31g, is divided into 4 groups by body weight collocation, wherein, blank group gavage gives distilled water (gavage volume 0.2ml/10g, lower same), positive controls gavage gives musk bone knitting pill aqueous solution (0.045g/ml is converted to crude drug content), test medication group gavage respectively gives stomach function regulating synthetism drink heavy dose of (0.21g/ml) and low dose of (0.105g/ml)
ICR mice 96, female, body weight 25.5 ± 2.31g, it is divided into 8 groups by body weight collocation, wherein, blank group gavage gives distilled water (gavage volume 0.2ml/10g, lower same), positive controls gavage gives musk bone knitting pill aqueous solution (0.045g/ml), test medication group (A-1 group) gavage gives the stomach function regulating synthetism drink heavy dose of (0.21g/ml) of embodiment 1, test medication group (A-2 group) gavage gives the stomach function regulating synthetism drink low dose of (0.105g/ml) of embodiment 1, test medication group (B group, C group, D group, E group) respectively gavage give embodiment 2, embodiment 3, comparative example 1, the stomach function regulating synthetism drink low dose of (0.105g/ml) of comparative example 2；Every day 1 time, continuous 7 days；Last administration plays fasting 20min gavage de-neck mortar execution after giving 5% Actidose 0.2ml/10g, 20min after last is administered for first 1 day, measures charcoal end forward position length and small intestinal total length, calculates charcoal end ink propulsive rate, and result is in Table 7。
The impact (X ± SD) on mice charcoal end Intestinal pushing of the table 7 each experimental group
Note: * represents and blank group comparing difference notable (P < 0.05)。
From table 7, each test medication group is respectively provided with higher charcoal end Intestinal pushing percentage rate, has significant difference (p < 0.05) compared with blank group；And the charcoal end Intestinal pushing percentage rate of positive controls mice is lower than blank group, and there is significant difference (p < 0.05)；Showing that stomach function regulating synthetism drink can promote mice Intestinal pushing function, and musk bone knitting pill makes mice charcoal end Intestinal pushing slow down, after namely taking musk bone knitting pill, mice Intestinal pushing function dies down。
By test medication group (D group) and A-1 group, A-2 group, B group, C group, E group data can be seen that the testing result of example 1 (combine detect), although the stomach function regulating bone-knitting Chinese medicament of D group has close bone-connecting functions with other test medication groups, but owing to not containing the Rhizoma Atractylodis Macrocephalae, Fructus Citri Sarcodactylis, the Radix Aucklandiae, Fructus Setariae Germinatus and Fructus Hordei Germinatus in the stomach function regulating synthetism of D group drink, its Intestinal pushing miopragia degree is relatively big, but not completely loses。Though showing that Fructus Citri Sarcodactylis and Endothelium Corneum Gigeriae Galli primarily serve stomach function regulating effect, but still suffering from synergism, Fructus Citri Sarcodactylis and Endothelium Corneum Gigeriae Galli between the two composition and other composition and also can play part bone-connecting functions, and other compositions also have certain stomach function regulating function, two aspects complement each other。
Further, though the charcoal end Intestinal pushing percentage rate of E group is higher than D group, but still lower than other test medication groups, it was shown that Endoconcha Sepiae is weak compared with the combination of Bombyx Batryticatus, Fructus Ligustri Lucidi and the Radix Astragali to the facilitation of mice Intestinal pushing function。
2, the stomach function regulating synthetism drink impact on the phenol red stomach residual of rat
SD rat 80, male and female dual-purpose, body weight 232 ± 60g, it is divided into 8 groups by body weight collocation, often group 10, wherein, blank group gavage gives distilled water (gavage volume 1ml/100g, lower same), positive controls gavage gives musk bone knitting pill aqueous solution (0.063g/ml), test medication group (A-1 group) gavage gives the stomach function regulating synthetism drink heavy dose of (0.3g/ml) of embodiment 1, test medication group (A-2 group) gavage gives the stomach function regulating synthetism drink low dose of (0.15g/ml) of embodiment 1, test medication group (B group, C group, D group, E group) respectively gavage give embodiment 2, embodiment 3, comparative example 1, the stomach function regulating synthetism drink low dose of (0.15g/ml) of comparative example 2；Every day 1 time, continuous 21 days, weigh weekly 1 time, last administration plays fasting for first 1 day, and 1h is with the phenol red paste gavage (1ml/100g) of 20mg% after last is administered, and after 20min, de-neck mortar is put to death, take stomach, two ends ligation, washes out content to scale test tube with distilled water, processes according to a conventional method, with 721 visible spectrophotometers at 560nm place mensuration absorbance, with the phenol red amount of initial gavage for radix, calculating the phenol red retained percentage of stomach, result is in Table 8。
The impact (X ± SD) on the phenol red retained percentage of rat stomach of the table 8 stomach function regulating synthetism drink
Note: * represents and blank group comparing difference notable (P < 0.05)。
From table 8, test medication group (A-1 group, A-2 group, B group, C group, D group, E group) is organized rat and is respectively provided with the phenol red retained percentage of relatively low stomach, without significant difference compared with blank group, wherein the phenol red retained percentage of the stomach of D group rat is more slightly higher than other test medication groups；And the phenol red retained percentage of stomach of positive controls mice apparently higher than blank group and has significant difference。
The above results shows that stomach function regulating synthetism drink does not affect rat stomach residual, and rat stomach residual is had considerable influence by musk bone knitting pill。
Simultaneously, by test medication group (D group) and A-1 group, A-2 group, B group, C group, E group data can be seen that the testing result of example 1 (combine detect), although the stomach function regulating bone-knitting Chinese medicament of D group has close bone-connecting functions with other test medication groups, but owing to not containing the Rhizoma Atractylodis Macrocephalae, Fructus Citri Sarcodactylis, the Radix Aucklandiae, Fructus Setariae Germinatus and Fructus Hordei Germinatus in the stomach function regulating synthetism of D group drink, the phenol red retained percentage of its stomach raises relatively to some extent, but still with blank group without significant difference。Though showing that these five kinds of compositions primarily serve stomach function regulating effect, but and still suffer from synergism between other composition, these five kinds of compositions also can play part bone-connecting functions, and other compositions also have certain stomach function regulating function, and two aspects complement each other。
Further, though the phenol red retained percentage of the stomach of E group is lower than D group, but still higher than other test medication groups, it was shown that the combination of Bombyx Batryticatus, Fructus Ligustri Lucidi and the Radix Astragali is more beneficial for reducing the phenol red retained percentage of stomach compared with Endoconcha Sepiae。
3, the stomach function regulating synthetism drink impact on normal gastric mucosa of rat
SD rat 80, body weight 200 ± 20g, male and female dual-purpose, it is divided into 8 groups, often group 5, former method rat dosage gastric infusion by body weight collocation, every day 1 time, continuous 21 days, the 21st day and fasting, next day, de-neck mortar was put to death, and took stomach, two ends ligation, every stomach fills and fixes with 1% formaldehyde 8ml, inspecting gastric mucosa damage situations after 1h, result is respectively organized gastric mucosa of rat and is not all found ulcer and petechia, it was shown that stomach function regulating synthetism drink and musk bone knitting pill all will not injury rats normal gastric mucosas。
4, the stomach function regulating synthetism drink impact on alcohol repellency rat gastric ulcer model
SD rat 28, body weight 336 ± 60g, male and female dual-purpose, it is divided into 3 groups by body weight collocation, wherein, blank group gavage gives distilled water (gavage volume 1ml/100g, lower same), positive controls gavage gives musk bone knitting pill aqueous solution (0.063g/ml), test medication group (A group, B group, C group, D group, E group) respectively gavage give embodiment 1, embodiment 2, embodiment 3, comparative example 1, the stomach function regulating synthetism drink low dose of (0.15g/ml) of comparative example 2, on, each 1 time of afternoon, rise morning next day and fasting, the 3rd day morning, last was administered latter 1 hour, each group rat oral gavage gives dehydrated alcohol every 1ml, after 1 hour, de-neck mortar is put to death, take stomach, two ends ligation, every stomach fills and fixes with 1% formaldehyde 8ml, gastric mucosa damage situations is inspected after 1 hour, record strip ulcer length and hemorrhage count, a situation arises respectively to organize ulcer using accumulative ulcer length (mm) as ulcer index, result is in Table 9。
The impact (X ± SD) that the alcohol repellency gastric ulcer of rat is occurred by table 9 stomach function regulating synthetism drink
Note: * represents and blank group comparing difference notable (P < 0.05)。
From table 9, compared with blank group, each stomach function regulating synthetism drink testing medication group all can substantially reduce the ulcer index (P < 0.05) of the alcohol repellency gastric ulcer model of rat, and musk bone knitting pill to the alcohol repellency gastric ulcer model of rat without any repair。Show that stomach function regulating synthetism kitchenware has good invigorating the spleen and stomach, reducing swelling and alleviating pain effect, synthetism and non-imapirment of the spleen and stomach。
D group is owing to having lacked the Rhizoma Atractylodis Macrocephalae, Fructus Citri Sarcodactylis, the Radix Aucklandiae, Fructus Setariae Germinatus and Fructus Hordei Germinatus, and therefore ulcer index relatively other test medication groups want height, but still have significant difference compared with blank group, it was shown that other components acting primarily as synthetism effect also possess certain stomach function regulating function。
Further, though the ulcer index of E group is lower than D group, but still more slightly higher than other test medication groups, it was shown that the combination of Bombyx Batryticatus, Fructus Ligustri Lucidi and the Radix Astragali is more beneficial for repairing the ulcer index of the alcohol repellency gastric ulcer model of rat compared with Endoconcha Sepiae。
Claims (7)
1. the Chinese medicine composition of a stomach function regulating synthetism, it is characterised in that prepared by the composition of following weight portion:
Rhizoma Drynariae 130～180 parts, Radix Dipsaci 130～180 parts, Eupolyphaga Seu Steleophaga 80～100 parts, Pyritum 280～320 parts, Radix Angelicae Sinensis 130～180 parts, Rhizoma Corydalis 180～220 parts, Herba Artemisiae Anomalae 10～20 parts, Fructus Chaenomelis 130～180 parts, Bombyx Batryticatus 5～15 parts, Fructus Ligustri Lucidi 5～15 parts, the Radix Astragali 25～35 parts, the Rhizoma Atractylodis Macrocephalae 100～150 parts, Fructus Citri Sarcodactylis 80～120 parts, the Radix Aucklandiae 50～80 parts, Fructus Setariae Germinatus 130～180 parts, 130～180 parts of Fructus Hordei Germinatus, sodium benzoate 1～5 part。
2. the Chinese medicine composition of stomach function regulating synthetism as claimed in claim 1, it is characterised in that prepared by the composition of following weight portion:
Rhizoma Drynariae 150 parts, Radix Dipsaci 150 parts, Eupolyphaga Seu Steleophaga 90 parts, Pyritum 300 parts, Radix Angelicae Sinensis 150 parts, Rhizoma Corydalis 200 parts, Herba Artemisiae Anomalae 15 parts, Fructus Chaenomelis 150 parts, Bombyx Batryticatus 10 parts, Fructus Ligustri Lucidi 10 parts, the Radix Astragali 30 parts, the Rhizoma Atractylodis Macrocephalae 120 parts, Fructus Citri Sarcodactylis 100 parts, the Radix Aucklandiae 60 parts, Fructus Setariae Germinatus 150 parts, 150 parts of Fructus Hordei Germinatus, sodium benzoate 3 parts。
3. the Chinese medicine composition of stomach function regulating synthetism as claimed in claim 1, it is characterised in that for mixture, oral liquid, granule, capsule or tablet。
4. the Chinese medicine composition of stomach function regulating synthetism as claimed in claim 3, it is characterised in that for mixture or oral liquid。
5. the preparation method of the Chinese medicine composition of stomach function regulating synthetism as claimed in claim 1 or 2, it is characterised in that including: after all compositions are mixed by preset weight part, add 2000～3000 parts of water, decocting to filtrate is 800～1200 parts, filtrate is sealed and preserves, it is thus achieved that stomach function regulating bone-knitting Chinese medicament mixture。
6. the preparation method of the Chinese medicine composition of stomach function regulating synthetism as claimed in claim 1 or 2, it is characterised in that including:
(1) by all compositions by after the mixing of preset weight part, boiling becomes extractum；
(2) in extractum, add adjuvant and make soft material, after granulation, granulate, obtain granule；
Or, also comprise the steps (3):
(3) by granule tabletting or encapsulated, tablet or capsule are made。
7. the preparation method of stomach function regulating bone-knitting Chinese medicament as claimed in claim 1 or 2, it is characterised in that including:
(1) by all compositions by after the mixing of preset weight part, boiling becomes equivalent extract；
(2) by encapsulated after described equivalent extract vacuum drying, it is thus achieved that stomach function regulating bone-knitting Chinese medicament capsule。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610112374.1A CN105687924A (en) | 2016-02-29 | 2016-02-29 | Traditional Chinese medicine composition for harmonizing stomach and setting fracture and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610112374.1A CN105687924A (en) | 2016-02-29 | 2016-02-29 | Traditional Chinese medicine composition for harmonizing stomach and setting fracture and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105687924A true CN105687924A (en) | 2016-06-22 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610112374.1A Pending CN105687924A (en) | 2016-02-29 | 2016-02-29 | Traditional Chinese medicine composition for harmonizing stomach and setting fracture and preparation method thereof |
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| CN (1) | CN105687924A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108815511A (en) * | 2018-08-06 | 2018-11-16 | 广州加原医药科技有限公司 | A kind of composition promoting bone uptake |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1435191A (en) * | 2002-01-29 | 2003-08-13 | 罗福田 | Chinese medicine for bone-knitting and method for preparing same |
-
2016
- 2016-02-29 CN CN201610112374.1A patent/CN105687924A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1435191A (en) * | 2002-01-29 | 2003-08-13 | 罗福田 | Chinese medicine for bone-knitting and method for preparing same |
Non-Patent Citations (3)
| Title |
|---|
| 周辉等: "和胃接骨饮对消化系统影响的实验研究", 《中医正骨》 * |
| 张志敬等: "和胃接骨胶囊促进实验性骨折愈合的超微结构观察", 《中国中医骨伤科杂志》 * |
| 盛鲁文等: "和胃接骨饮对老年股骨转子间骨折内固定术后疗效影响的病例对照研究", 《中国骨伤》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108815511A (en) * | 2018-08-06 | 2018-11-16 | 广州加原医药科技有限公司 | A kind of composition promoting bone uptake |
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