CN104523940B - A kind of preparation method of sweet extra large stomach health preparation - Google Patents
A kind of preparation method of sweet extra large stomach health preparation Download PDFInfo
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Abstract
The invention discloses a kind of preparation method of sweet extra large stomach health preparation, this method extracts the Six-elements such as radix glycyrrhizae, sea-buckthorn after selection, net system, thick paste after extraction is using vacuum drying, fine powder is ground into, the fine powder and appropriate starch of cuttlebone and Gypenosides is added, particle is made, less than 60 DEG C dryings, mix, capsule filling is made 1000, it is aluminum-plastic packaged, produce.Through principle active component assay and evaluating drug effect, it was demonstrated that the sweet extra large Weikang capsule for curing gastric disease prepared by the above method, active constituent content can be improved, product dose is reduced, while lifting product curative effect.
Description
Technical field
The invention belongs to the preparation of Chinese patent drug, it is related to a kind of preparation technology of Chinese patent drug, more particularly to one kind is to existing
The sweet extra large Weikang capsule for curing gastric disease (Chinese medicines quasi-word Z20025708) of medicine extracts the method prepared using organic solvent.
Background technology
The quickening of modern life rhythm, people's dietary it cannot be guaranteed that, stomach trouble incidence more and more higher, everyone one
Can nearly all occur acute or chronic stomach trouble in life to some extent.It is clinically common disease that enterogastric diseases, which are also, is also
One of chief complaint of disease of digestive system.The survey data of China some areas shows that its incidence of disease is 15.6%, has at present
Nearly 30,000,000 digestive tract ulcer Disease, and acute digestive tract ulcer and gastritis sufferer are even more to reach 100,000,000 every year.
Sweet extra large Weikang capsule for curing gastric disease (Chinese medicines quasi-word Z20025708) component be radix glycyrrhizae, cuttlebone, sea-buckthorn, the dried immature fruit of citron orange, the bighead atractylodes rhizome, golden cypress,
Corydalis tuber, Gypenosides；For Reflux exophagitis, old stomach trouble, obstinate, the basic reason of recurrent exerbation, to repair
Gastric mucosa is core point, uses strengthening the spleen and replenishing qi, only sour sore, adjustment stomach and intestine work(, promoting blood circulation eliminating dampness method, for the principles of formulating prescriptions, pass through entirety
Adjust to realize the reparation to local pathological change, farthest transfer body disease-resistant eliminating evil, the ability of removing necrosis, promoting granulation, not only
The unbalance of digestive tract function can be effectively adjusted, suppresses stomach and the reverse creeping effect of duodenum, continues the contraction work for recovering sphincter
Energy.And esophagus gastric mucosa can be repaired, so as to improve Reflux exophagitis, the healing quality of ulcer.Sweet extra large Weikang capsule for curing gastric disease treatment
Reflux exophagitis, peptic ulcer, chronic gastritis have significant curative effect, few side effects.In clinical practice, sweet Hai Weikang is taken
Patient's cure rate of capsule is higher, and recurrence rate is low.
But the medicine uses simple, traditional extracting method in providing in a standard.It has been investigated that, this method can not be protected
The abundant extraction of active ingredient is demonstrate,proved, the rate of transform is relatively low, so as to cause the increase of medicinal material consumption, is also unfavorable for the reasonable profit of resource
With, therefore, each medicinal material in sweet extra large Weikang capsule for curing gastric disease prescription need to fully be studied, according to each property of medicinal material active ingredient visit
A kind of new preparation method of rope.
The content of the invention
It is an object of the present invention to provide a kind of preparation method of new sweet extra large Weikang capsule for curing gastric disease, and investigate its to effectively into
Divide the influence of content and drug effect.
In order to realize above-mentioned task, the present invention takes following technical solution：
A kind of preparation method of sweet extra large stomach health preparation, the component of the sweet extra large stomach health preparation includes：Radix glycyrrhizae, cuttlebone, sand
Spine, the dried immature fruit of citron orange, the bighead atractylodes rhizome, golden cypress, corydalis tuber and Gypenosides, it is characterised in that method includes：
(1) radix glycyrrhizae, sea-buckthorn, the dried immature fruit of citron orange, the bighead atractylodes rhizome, six kinds of components of golden cypress and corydalis tuber reclaim extract solution with alcohol steep, extract
Liquid obtains powder after drying；
(2) powder and cuttlebone powder and Gypenosides powder are mixed.
Further, method also includes：Addition starch, granulation, loading capsule in material after step (2) mixing.
Optionally, the concentration of the ethanol is 65%, and extraction time is twice.
The prescription of the sweet extra large Weikang capsule for curing gastric disease is：Radix glycyrrhizae 50-65 mass parts, cuttlebone 28-36 mass parts, sea-buckthorn 20-30
Mass parts, dried immature fruit of citron orange 50-65 mass parts, bighead atractylodes rhizome 70-85 mass parts, golden cypress 15-25 mass parts, corydalis tuber 215-25 mass parts are twisted
The stock total glycosides 0.5-1.5 mass parts of Lan.
Further, above-mentioned preparation method comprises the following steps：
(1) cuttlebone after processing is taken, after 80 ± 5 DEG C are dried, crushes, crosses 100 mesh sieves, it is mixed with Gypenosides
It is even；
(2) remaining six medicinal material, extract secondary with 65% alcohol reflux, and 8 times of amount ethanol of quality of medicinal material, second are added for the first time
Secondary plus 6 times of amount ethanol of quality of medicinal material, each extraction time is 2 hours, merges extract solution, filters, decompression filtrate recycling ethanol is extremely
Clear cream relative density is：At 60 DEG C, 1.05, put to room temperature, add 0.5 times of amount water of crude drug quality, stir evenly, stand 24h, filter
Cross, precipitation is dried under reduced pressure into fine powder；
(3) combining step (1) and powder obtained by (2), mix, are pelletized in right amount with 3%HPMC (m/v) in right amount with starch,
60 DEG C of dryings, are mixed, and are loaded capsule, are made 1000 and produce.Applicant is proved by pharmacological experiment, using point of the present invention
Sweet extra large Weikang capsule for curing gastric disease prepared by group extraction process, can improve active constituent content, reduce product dose, while lifting product
Curative effect.
Brief description of the drawings
Fig. 1 is the process chart of the present invention；
Below in conjunction with accompanying drawing and experiment, the present invention is described in further detail.
Embodiment
The current technology of sweet extra large Weikang capsule for curing gastric disease is as follows：Cuttlebone is ground into fine powder and is well mixed with Gypenosides, standby.
The Six-elements such as remaining sea-buckthorn, radix glycyrrhizae, the dried immature fruit of citron orange, the bighead atractylodes rhizome, golden cypress, corydalis tuber are added water to cook three times, and 2 hours for the first time, 1.5 is small for the second time
When, third time 1 hour, collecting decoction, filtration, filtrate is concentrated into the thick paste that relative density is 1.38 (60 DEG C), adds above-mentioned thin
Powder, mixes, dry, pulverize into fine powder, particle is made, and dries, and sieving loads capsule, produced.
I.e. sweet extra large Weikang capsule for curing gastric disease current technology is under guidance of traditional Chinese medicine theory, using Chinese medicine as raw material, according to regulation
The preparation of prescription, production technology and quality standard production, is a traditional Chinese medicine capsule preparation process.It is a large amount of by consulting
Document, carries out analysis and research discovery, the active ingredient that can not be extracted completely in medicinal material is boiled in decocting to the drug ingedient of medicinal material,
Liposoluble constituent especially therein, and extracted the invalid components such as many protein, starch, chlorophyll.Therefore, Wo Menkao
Consider the Gypenosides kept in current technology, two kinds of components of cuttlebone constant, still added to beat powder；Pass through test of many times, hair
The extracting method that now traditional water decoction that Six-element medicinal material is used in current technology is boiled is changed to new ethanol extract from water precipitation, i.e., first with suitable
The ethanol of suitable concentration extracts medicinal ingredient, and extract solution is reclaimed after ethanol, plus suitable quantity of water is stirred evenly, and stands refrigeration certain time, precipitation
The method filtered out after completely.The active ingredient such as alkaloid and its salt, glucoside, volatile oil and organic acid had so both been can extract out,
The leaching of the compositions such as starch, protein, lymphatic temperament can be avoided simultaneously.Namely while curative effect of medication is increased, medicine is reduced
Dose.
According to technical scheme, applicant prepares sweet Hai Weikang to sweet extra large Weikang capsule for curing gastric disease using packet extraction process
Capsule, as shown in figure 1, specifically including the following steps：
1) prescription：Radix glycyrrhizae 570g, cuttlebone 316g, sea-buckthorn 252g, dried immature fruit of citron orange 570g, bighead atractylodes rhizome 758g, golden cypress 190g, corydalis tuber
200g, Gypenosides 9.4g；
2) the taste medicinal material of radix glycyrrhizae, sea-buckthorn etc. in prescription eight is cleaned, after net system, is divided into two groups of progress.
1. the cuttlebone after processing is taken, after 80 ± 5 DEG C are dried, crushes, crosses 100 mesh sieves, it is mixed with Gypenosides
It is even, put standby in clean container；
2. remaining six medicinal material, extracts secondary with 65% alcohol reflux, and 8 times of amount ethanol, second plus 6 times of amounts are added for the first time
Ethanol, each 2 hours every time, merges extract solution, filtration, filtrate decompression (- 0.04Mpa, 70 DEG C) reclaims ethanol to relative density
1.05 (60 DEG C) Zuo You, put to room temperature, add 0.5 times of amount water of crude drug weight, stir evenly, stand 24h, filtration, precipitation decompression
(- 0.04Mpa, 70 DEG C) is dried to fine powder；
3) merge above-mentioned fine powder, mixed in right amount with starch, pelletized, dried (60 DEG C) in right amount with 3%HPMC (m/v), mixed
It is even, load capsule, be made 1000, produce.
Extracted according to the property of effective ingredient in sweet extra large Weikang capsule for curing gastric disease prescription, and select in each group medicine to refer to
Mark composition and assay is carried out using high performance liquid chromatography, to ensure clinical efficacy, meanwhile, by pharmacological evaluation to the technique
The sweet extra large Weikang capsule for curing gastric disease prepared carries out evaluating drug effect.
First, sweet extra large Weikang capsule for curing gastric disease Study on extraction
1. drug ingedient
Radix glycyrrhizae：It is main to contain dipotassium glycyrrhizinate, calcium salt, it is the sweet ingredient of radix glycyrrhizae.Separately contain licorice root lactone, methyl glycyrrhetate.Also
It is new containing glycyrrhizin, liquiritin, Neoliquiritin, flavonols, glycycoumarin, licoricidin, isoglycyrol, isoflavones, radix glycyrrhizae
Lignanoid, formononetin, the composition such as licorice polysaccharide.
Cuttlebone：Calcium carbonate 80~85%, conchiolin 6~7%, mucilaginous substance 10~15%, and containing a small amount of sodium chloride, phosphorus
Sour calcium, magnesium salts etc..
Sea-buckthorn：Containing flavones ingredient, such as Isorhamnetin, isorhamnetin-3-O-β-D-glycopranoside, Isorhamnetin -3-O-
β-rutinoside, rutin sophorin, astragalin and Quercetin and the low sugar glycosides that Kaempferol is aglycon.Also contain vitamin A, B1、B2、
C, E, dehydroascorbic acid, folic acid, carrotene, carotenoid, cachou extract, anthocyanidin, amino acid, protein etc..
The dried immature fruit of citron orange：Contain flavonoid glycoside composition, such as aurantiamarin, neohesperidin, aurantiin, synephrine；Also contain volatile oil,
Such as australene, nopinene, laurene, limonene, lauro lene, γ-terpinene, to P-cymene and cloves alkene.
The bighead atractylodes rhizome：Containing volatile oil, such as atractylone, atractylol, α-and β-Humuleno, β-elemol, α-curcumene, 3 β-acetyl
Epoxide atractylone, eucalyptol, palmitic acid, β-selinene etc.；Also constituents containing sesquiterpene lactone, such as atractyloide-I ,-II ,-III
And 8 β-ethyoxyl atractyloide-II；Contain polyacetylene compound again：The cis bighead atractylodes rhizomes three of 14- acetyl group -12- climbing groundsel acyl groups -8-
Alcohol, each inner smooth trans bighead atractylodes rhizome triols of acyl group -8- of 14- acetyl group, the cis bighead atractylodes rhizome triols of 12- climbing groundsel light acyl group -8-, 12- a thousand lis
The trans bighead atractylodes rhizome triols of light acyl group -8-, the 12 cis bighead atractylodes rhizome triols of Alpha-Methyl bytyry -14- acetyl group -8-, 12 Alpha-Methyl bytyries -
The trans bighead atractylodes rhizome triols of 14- acetyl group -8-, the 14 cis bighead atractylodes rhizome triols of Alpha-Methyl bytyry -8-, 14 Alpha-Methyl bytyry -8- are trans
Bighead atractylodes rhizome triol；Separately contain Scopoletin, fructose, synanthrin, amino acid etc..
Golden cypress：Containing jamaicin, phellodendrine, magnoflorine, jateorrhizine, palmatine, candicine, menispermum dauricum
A variety of alkaloids such as alkali.In addition, also containing obakulactone, obakunone, obacunonic acid and 7- dehydrogenations stigmasterol, cupreol, dish
Oily sterol, blue or green fluorescent acid, Dictamnolide, lymphatic temperament etc..
Corydalis tuber：It is main to contain Corydaline (corydaline), tetrahydropalmatine (dl- tetrahydropalmatines), corydalis tuber
C prime (Biflorine), corydalis tuber D prime (l- Tetrahydrocoptisines), corydalis tuber penta plain (dl- Tetrahydrocoptisines), the own element of corydalis tuber
(l- tetrahydrochysenes Gu human relations amine base), corydalis tuber heptan plain (corybulbine), the pungent element of corydalis tuber, corydalis tuber nonyl element, corydalis tuber Kui prime, prolong Hu
Large rope element, corydalis, the corydalis tuber third of the twelve Earthly Branches plain (α-allocryptopine), coptisine, dehydrogenation Corydaline (dehydrocory daline),
The alkaloid components such as corydalis tuber amine base, dehydrogenation corydalis tuber amine base, leonticine, dihydrosanguinarine, dehydronanteine.Separately contain
The compositions such as starch, mucilaginous substance, resin and trace element.Its promoting blood circulation, promoting the circulation of qi, the principle active component of analgesic are alkaloid.
Gypenosides：Gynostemma pentaphylla contain a variety of saponin(es, triterpenes, flavones, sterol, amino acid, organic acid, inorganic salts,
The chemical compositions such as carbohydrate, trace element.It is now recognized that the bioactive substance that maximum effect is played in gynostemma pentaphylla is Gypenosides
Separate and identified 80 Multiple components.Wherein there is several and ginsenoside Rb1、Rb2、Rb3、Rd、F2It is identical.
2. early-stage Study
Radix glycyrrhizae：Found by inspection target of glycyrrhizic acid, the extraction rate of transform of 50-75% ethanol is higher.Wherein 75% ethanol
The radix glycyrrhizae acid transfer rate highest of extraction, receives cream rate 22.7%.
Sea-buckthorn：Find that the extraction rate of transform of 50-80% ethanol is higher as inspection target using Isorhamnetin and general flavone.Its
In the general flavone rate of transform highest extracted of 50% ethanol, receive cream rate 29%；The Isorhamnetin rate of transform highest that 70% ethanol is extracted,
Receive cream rate 12%.
The dried immature fruit of citron orange：Found by inspection target of synephrine and general flavone, the extraction rate of transform of 50-80% ethanol and decocting compared with
It is high.The general flavone rate of transform highest that wherein 50% ethanol is extracted, receives cream rate 17%；The synephrine rate of transform that 70% ethanol is extracted is most
Height, receives cream rate 6%.
Golden cypress：Found by inspection target of jamaicin, the extraction rate of transform of 50-90% ethanol is higher.Wherein 70% ethanol
The jamaicin rate of transform highest of extraction, receives cream rate 15.5%.
Corydalis tuber：Found by inspection target of tetrahydropalmatine, the extraction rate of transform of 60-80% ethanol is higher.Wherein
The tetrahydropalmatine rate of transform highest that 75% ethanol is extracted, receives cream rate 17.5%.
Studied and found by the above-mentioned extraction to single medicinal material, from ethanol for extract solvent can efficiently extract index into
Point, and reduce receipts cream rate, it is possible to achieve the target of reduction dose.
3rd, the research of extraction process is determined according to effective ingredient and pharmacological action in sweet extra large Weikang capsule for curing gastric disease
3.1. sweet extra large stomach health medicinal material orthogonal experiment
Shown according to technique Preliminary Results, the active ingredient in remaining Six-element medicinal material such as radix glycyrrhizae is dissolved mainly in ethanol
In, therefore, radix glycyrrhizae 14.25g, sea-buckthorn 6.30g, dried immature fruit of citron orange 14.25g, bighead atractylodes rhizome 18.95g, golden cypress 4.75g are weighed by 1/20 recipe quantity
Corydalis tuber 5.00g, the refluxing extraction of ethanol is carried out using orthogonal.From orthogonal arrage L9(34) experiment arrangement, factor with
Water-glass, the result analytical table and side
Poor analytical table 1,2,3.
The factor level table of table 1
The orthogonal of table 2 and interpretation of result
Remaining Six-element medicinal material alcohol extracting optimize technique analysis of variance table such as radix glycyrrhizae of table 3
F0.05(2,18)=3.55F0.01(2,18)=6.01
Experimental result is shown:Optimised process is that 65% alcohol reflux is extracted 2 times, and alcohol adding amount is respectively：8、
6 times, return time is respectively：2nd, 2 hours.
3.2 sweet extra large stomach health medicinal material extract confirmatory experiments
By testing the reasonability, feasibility and the stability that carry out verifying the sweet extra large orthogonal preferred parameter of stomach health medicinal material.By 0.2
Individual recipe quantity weighs radix glycyrrhizae 57.0g, sea-buckthorn 25.2g, dried immature fruit of citron orange 57.0g, bighead atractylodes rhizome 75.8g, golden cypress 19.0g, corydalis tuber 20.0g, each 6
Part, it is 1~3 prescription to compile at random, every group of medicinal material gross weight 254g, by the preferred parameter experiment arrangement of orthogonal test, and ethanol is extracted,
Merge extract solution, filtration collects filtrate, its quantities received (volume), dry cream content, synephrine, jamaicin, corydalis tuber second are surveyed respectively
Element, the content of glycyrrhizic acid composition, statistical result.The main alcohol extracting by repeating 3 batches of sweet extra large stomach health medicinal materials is tested, according to
The optimised process that orthogonal experiment is drawn is extracted.Experimental result such as table 4.
The experimental result of table 4
Experimental result is shown：Optimised process is that 65% alcohol reflux is extracted 2 times, and alcohol adding amount is respectively：8th, 6 times, during backflow
Between be respectively：2nd, 2 hours.
The heavy removal of impurities experiments of 3.3 sweet extra large stomach Kang Shui
In order to remove the water-soluble macromolecule inert matter in alcohol extracting thing, and make active ingredient jamaicin, glycyrrhizic acid, orange
Skin glycosides etc. is further enriched with, and experimental study is carried out using the method for the heavy removal of impurities of water to the Six-element medicinal material such as radix glycyrrhizae alcohol extract, with true
Determine amount of water when water sinks.Each 2000ml of the extract solution of above-mentioned " Six-element medicinal material extract confirmatory experiment " is mixed, then taken after mixing
9 groups of extract solution, every group of 400ml, random number is 1-1,1-2,1-3,2-1,2-2,2-3,3-1,3-2,3-3, reclaims ethanol simultaneously
It is the medicinal extract (no alcohol taste) between 1.05-1.10 (25 DEG C) to be concentrated into relative density.Add water crude drug 0.5 times of amount (1-1,1- respectively
2,1-3), 1 times of amount (2-1,2-2,2-3), 1.5 times of amount (3-1,3-2,3-3), stirs evenly, is stored at room temperature 24h, filter, and collects heavy
Form sediment, its dry cream content, jamaicin, glycyrrhizic acid, the content of aurantiamarin composition, statistical result are determined respectively.To receive cream amount, barberry
Alkali, glycyrrhizic acid, the rate of transform of aurantiamarin are performance assessment criteria.Glycyrrhizic acid, jamaicin, the aurantiamarin rate of transform are shown in Table 5-1,5-2,5-3.
Table 5-1 radix glycyrrhizae acid transfer rates
The table 5-2 jamaicin rates of transform
The table 5-3 aurantiamarin rates of transform
Experimental result is shown：1.5 times of amount water receipts dry cream rates are minimum, but loss of effective components is big；0.5 times of amount water is existing preferably
The rate of transform have relatively good impurity removal effect again, therefore the heavy optimum water of water is 0.5 times of amount.That is the heavy technique of water is determined
For：The alcohol extract of Six-element medicinal material reclaims ethanol to the medicinal extract (no alcohol taste) that relative density is 1.05 (25 DEG C), adds crude drug
0.5 times of amount water of weight, stirs evenly, stands 24 hours, filtration, precipitation decompression (- 0.04Mpa, 70 DEG C) is dried to fine powder, standby.
4th, the sweet extra large Weikang capsule for curing gastric disease content balance research of new old technology
4.1 sweet extra large Weikang capsule for curing gastric disease content assaying methods
Determined according to high performance liquid chromatography (one annex VI D of Chinese Pharmacopoeia version in 2000).
Chromatographic condition is filler with octadecylsilane chemically bonded silica with system suitability；The 0.1mol/L of acetonitrile one
The glacial acetic acid (28 of ammonium acetate solution one:72:0.3) it is mobile phase；Detection wavelength is 250mn；Number of theoretical plate is calculated by glycyrrhizic acid peak
2000 should be not less than.
The preparation precision of reference substance solution weighs mono-ammonium glycyrrhizinate reference substance in right amount, plus Diluted Alcohol is made in every lml and contained
0.1mg solution, is produced.(equivalent glycyrrhizic acid is 0.09795mg).
The preparation of need testing solution takes the lower content of this product content uniformity, finely ground, mixes, takes 0.6g, accurately weighed, puts
In conical flask with cover, precision plus Diluted Alcohol 20ml, close plug, weighed weight ultrasonically treated 30 minutes, is let cool, then weighed weight, is used
Diluted Alcohol supplies the weight of less loss, shakes up, and centrifuges, and filtration takes subsequent filtrate, produced.
Determination method is accurate respectively to draw reference substance solution and each 20ul of need testing solution, injects liquid chromatograph, determines, i.e.,
.
4.2 sweet extra large Weikang capsule for curing gastric disease assays
Assay is carried out to three batches of new sweet extra large Weikang capsule for curing gastric disease of old technology respectively, 6 are the results are shown in Table.
The sweet extra large Weikang capsule for curing gastric disease result of the new old technology of table 6
Experimental result is shown：The content of the index glycyrrhizic acid containing survey of the sweet extra large Weikang capsule for curing gastric disease of new technology is sweet apparently higher than old technology
Extra large Weikang capsule for curing gastric disease, has reached raising content, reduces the purpose of dose.
2nd, sweet extra large Weikang capsule for curing gastric disease test of pesticide effectiveness research
(1) gastritis effect experiment is studied
1 materials and methods
1.1 material
1.1.1 animal
Cleaning grade Wister adult rats 80, first quality standard, the 230 ± 20g of body weight of male and female half and half.
1.1.2 medicine and reagent
Medicine：Sweet extra large Weikang capsule for curing gastric disease glue is by corydalis tuber, cuttlebone, sea-buckthorn, the 6 taste Chinese medicines composition such as radix glycyrrhizae, by the eastern sections of Yang Ling
Mildison is provided.
Reagent：NOS determines kit；AchE determines kit；Coomassie brilliant blue protein determination kit.
1.1.3 laboratory apparatus
Automatic biochemistry analyzer；Pathologic section slicer；BX60 type microscopes；Electric heating constant-temperature water-bath tank；Low-temperature and high-speed centrifuge.
1.2 experimental method
1.2.1 animal model and packet and administration
80 rats, randomly select 10 (male and female half and half) as normal control (normal) group, daily with distilled water gavage,
2ml/ is only；70 rats remaining with 5% sodium salicylate solution gavage, water 1h, continuous 8 are prohibited in 2ml/ (.d), fasting before and after gavage
Week, wherein, preceding 4 weeks normal diets are fed, quantity-unlimiting, are freely intake；4 weeks afterwards, odd-numbered day fasting, even-numbered days enough feedings.Modeling
10 progress gastric mucosa pathological histology inspections are randomly selected in dead female mice 4 in journey, modeling in remaining 66 rats before terminating
Look into, confirm to randomly select the principle of 25 male mouse and 25 female mices according to male and female half and half after model success in remaining 56 rats
It is grouped.
50 rats are randomly divided into 5 groups again:Sodium salicylate (model) group, sweet extra large Weikang capsule for curing gastric disease are big, in, low dose treatment
(large, medium and small dosage) group, ranitidine group.Large, medium and small dosage group gives sweet extra large Weikang capsule for curing gastric disease 28,14,7g/ (kg.d) respectively
(equivalent to 20,10,5 times of adult human dose's dosage), ranitidine group gives ranitidine 0.06g/ (kg.d) (equivalent to adult's agent
10 times of amount), gavage preceding Extemporaneous to add medicine to.Successive administration 7d, carries out indices detection.
1.2.2 Testing index and method
The fresh pyloric part gastric tissue 0.5g of rat, plus 9 times of 0.9% sodium chloride 4.5ml are taken, homogenate, is made 10% manually
Tissue homogenate, after with 3000r/min centrifugations 10min, takes 3ml tissue homogenates to be put into -80 DEG C of refrigerators, to be measured to refer to below
Mark：
1. the measure of pyloric sphincter NOS vigor：Sample and reagent are taken out from refrigerator, and 37 DEG C of water-bath 3min are carried out following
Operation, blank tube distilled water a* (50 μ l)；Total NOS determines pipe sample size a* (50 μ l), the substrate buffer solution of 2 pipe reagent one, 200
μ l, the accelerator of reagent two, 10 μ l, the developer of reagent three, 100 μ l are mixed, and 37 DEG C of water-bath accurate response 15min, reagent four is transparent
The μ l of agent 100, the μ l of five terminator of reagent 2000, are mixed, at 530nm, 1cm optical paths, distilled water zeroing, survey absorbance.
Total NOS vigor (U/mg prot)=total NOS determines pipe OD values-blank tube OD values/is in look for nanomole delustring system
Number × reaction solution cumulative volume/sampling amount × 1/ (colorimetric optical path × reaction time)/protein content (mg prot/L).According to the above
Formula show that total NOS vigor=total NOS determines pipe OD values-blank tube OD value/(3.83 × 10-6) × (2.41+a*)/a*x1/
(1 × 15)/protein content (mg prot/L).
2. the measure of AchE vigor is organized：Supernatant 25ul is taken to determine AchE vigor, operating procedure is shown in Table 7.
The organizational vitality AchE vitality test operating procedures of table 7
Calculation formula：AchE vigor (U/ml)=measure pipe OD values-control tube OD values/standard pipe OD in tissue homogenate
Extension rate before value-blank tube OD values × standard pipe concentration × test sample.
1.3 statistical procedures methods
It is analyzed using SPSS 11.5for Windows statistical softwares, measurement data withRepresent, using t
Examine.
2. result
The comparison of each group rat pyloric sphincter NOS, AchE activity.
The comparison U/mg prot of table 8 each group rat pyloric sphincter NOS, AchE activity,
1)Compared with normal group；2)Compared with model group；3)Compared with ranitidine group, equal P ＜ 0.01
3. discuss
On the one hand NO has double action in inflammatory process in treatment CSG, and endothelium-derived NO, which has, suppresses inflammation mistake
The effect of journey；On the other hand, the inflammatory process later stage synthesizes a large amount of NO and may participate in inflammatory reaction again, with CDCC, can be with
This CDCC for causing mucosal lesion NO is considered as one of mechanism of injury of gastrointestinal tract caused by endotoxin.
Gastrointestinal peristalsis and sphincters contract rely primarily on excitatory neurotransmitter such as Ach motilins and Arg-Pro-Lys-Pro-Gln-Gln-Phe-Phe-Gly-Leu-Met-NH2 etc..Wherein
Ach plays a major role, and Ach levels can react vagal tone in stomach, be gastroenteritic power excitatory transmitter, with stimulation stomach
Myenteron shrink and promote stomach-enterocinesia effect, it is also relevant with stomach and intestine glandular secretion, pyloric sphincter be regulation and control stomach-
The critical point of duodenal digestion physiology of exercise function, has more rich endogenous neural dominating system ENS directly to dominate Koch
Deng, research find vagal tone lose and sympathetic activity increase causes Gastric neoplasm, this is probably that CSG causes stomach
One of mechanism of mucosa injury.
This test result indicates that, experimental CSG rats pyloric sphincter tissue i NOS expression is significantly higher than normal group, respectively
Treatment group i NOS expression is significantly lower than model group, wherein sweet extra large Weikang capsule for curing gastric disease middle dose group is substantially close to normal group.This is probably
Due to：1. chronic inflammation stimulates i NOS induction synthesis, and then synthesizes a large amount of NO participation stomach lining local damages and inflammatory reaction；
2. sweet extra large Weikang capsule for curing gastric disease plays the role of directly to suppress i NOS generations, or may be mitigated by number of ways the damage of stomach lining with
Inflammation, reduces the cell factor that mediation promotes i NOS generations, i NOS synthesis is inhibited indirectly.Meanwhile, there is data to show：
NOS plays the role of antagonism Ach, but does not influence Ach release.This experimental studies results points out experimental CSG rats both to there is NOS
Level is raised, and there is also increasing for AchE activity；Ach release reductions cause peristole to slow down, emptied lowly, and NOS level liters
Height not only reduces neural malnutrition and synthesis Ach, and gastric emptying can be caused disorderly.This is probably that sweet extra large Weikang capsule for curing gastric disease is controlled
Treat one of CSG mechanism.
(2) gastric ulcer effect experiment is studied
1 materials and methods
1.1 material
1.1.1 animal
Animal KM kind mouse, male, 18-22g；Wistar rats, male, 200 scholar 20g.
1.1.2 medicine and reagent
Cimetidine (CIM) piece；Reserpine parenteral solution；Sweet extra large Weikang capsule for curing gastric disease；Formalin.
2 experimental methods
The influence of 2.1 pairs of Animal ulcer models
2.1.1 to the influence of mouse irritability acute gastric ulcer
KM kind mouse are taken to be randomly divided into 6 groups, fasting 24h before each group zoopery is disposably orally given during experiment by table 1
It is administered once again after medicine, fasting 24h, faces upward position and four limbs are fixed on iron plate with holes, be dipped in tank, water temperature (20 ± 1) DEG C, water
It is deep at mouse xiphoid-process, leaching 24h takes off, and execution takes stomach, is splitted along greater curvature, slowly washes down gastric content, is put on slide
Flattening, in dissection Microscopic observation measurement.The Area of ulcer that observation numeration glandular stomach portion occurs.As a result show, sweet extra large Weikang capsule for curing gastric disease height,
Low dosage (600,300mg/kg) group gastric ulcer points significantly reduce (P compared with NS groups<0.01).It is shown in Table 1
2.1.2 to the influence of the impatient gastric ulcer of mouse reserpine
Take KM kind mouse to be randomly divided into 6 groups, 1h subcutaneous injection of reserpine 10mg/kg after administration, medicine once gavaged by table 1,
Animal is put to death after 6h, in observing glandular stomach portion Area of ulcer under disecting microscope, is as a result shown, sweet extra large Weikang capsule for curing gastric disease high and low dose
(600,300mg/kg) group gastric ulcer points significantly reduce (P compared with NS groups<0.O1).It is shown in Table 9.
2.1.3 to the influence of rats acetic acid chronic gastric ulcer
Wistar rats are taken, the glacial acetic acid 20ul of people 20% is noted in (0.5mm) under glandular stomach serous coat.It is postoperative to be randomly divided into animal
6 groups, postoperative next day gavages administration by table 2, and one time a day, continuous 12d, and 24h is fasted 24h. after last medicine
Method：First 1% formaldehyde 0.5mL is injected in stomach, after 15min, stomach is taken, is splitted along greater curvature, slowly wash down stomach
Content, is put on slide and flattens, in dissection Microscopic observation measurement：Glandular stomach portion ulcer index is (with ulcer surface length and width
Product be index).As a result show, sweet extra large Weikang capsule for curing gastric disease high and low dose (600,300mg/kg) organizes the ulcer index of animal
(P is significantly reduced compared with NS groups<0.O1).It is shown in Table 10.
Influence (n=10) of the sweet extra large Weikang capsule for curing gastric disease of table 9 to mouse stress ulcer (SU) and reserpine ulcer (RU)
The * p compared with NS groups<0.01
Influence (n=10) of the sweet extra large Weikang capsule for curing gastric disease of table 10 to rats acetic acid chronic gastric ulcer (RU)
| Dosage (m/mg.kg-1) | Ulcer index (s/mm2) | Inhibiting rate (%) | |
| NS | 17.36±3.39 | - | |
| CIM | 300 | 3.55±1.44* | 79.2 |
| Sweet extra large Weikang capsule for curing gastric disease | 600 | 4.88±1.79* | 71.5 |
| Sweet extra large Weikang capsule for curing gastric disease | 300 | 7.55±1.34* | 56.3 |
The * p compared with NS groups<0.01
The influence of 2.2 pairs of rat tolerance secretions and pepsin activity
Wistar rats are taken, 6 groups are randomly divided into, fasting 24h after administration are once gavaged by table 3, free water will with ether
Animal Anesthesia, opens abdominal cavity, ligatures and is put to death after pylorus, 5h, ligature orifice of the stomach, takes gastric juice to carry out gastric acid output and proteinase activity
Determine.As a result show, sweet extra large Weikang capsule for curing gastric disease high and low dose (600,300mg/kg) group gastric secretion is with NS without marked difference (P
>0.05), and free acid and total acidity substantially reduce (P compared with NS<0.05), sweet extra large Weikang capsule for curing gastric disease high dose group Gastric pH compared with
NS groups substantially increase, and illustrate that this product can neutralize hydrochloric acid in gastric juice, reduce gastric acid secretion.Experimental group stomach acid activity substantially reduces (P compared with NS groups
<0.05).It is shown in Table 11.
3 discuss
Test result indicates that, sweet extra large Weikang capsule for curing gastric disease can suppress the formation of irritability and acetic acid acute and chronic gastritis ulcer, also can
Suppress the generation of the impatient gastric ulcer of reserpine.Being capable of gastric acid secretion inhibiting, reduction gastric activity.
The peptic ulcer traditional Chinese medical science belongs to the dirty pain of stomach, noisy, acid regurgitation category, more by weakness of the spleen and the stomach, stagnation of the circulation of vital energy blood is tired, the damage of stomach network is drawn
Rise, conventional benefit stomach invigorating the spleen, activate blood circulation and disperse blood clots, the treatment of regulating qi-flowing for relieving pain method.
Hydrochloric acid in gastric juice can be neutralized in sweet extra large Weikang capsule for curing gastric disease, mitigates the stimulation to ulcer.Extract of licorice root is to many animals Ulcer Models
There is preferable preventive and therapeutic effect.This product curative effect is better than Cimetidine, and adverse reaction and toxicity substantially less and are lighter than sago and replaced
Fourth.Said preparation is used for canker and treats the principle for meeting and treating both principal and secondary aspect of disease.
(3) analgesia effect experimental study
1 experiment material
1 medicine and reagent
Sweet extra large Weikang capsule for curing gastric disease, Jianweiyuyang Tablets, aspirin.
Glacial acetic acid is that domestic analysis is pure.
1.2 laboratory apparatus
BS210S types electronic balance, 721 spectrophotometers, GJ-4O2 type hot plate pain threshold detectors.
1.3 experimental animal
ICR kind mouse, male and female half and half, 18~22g of body weight.
2 experimental methods and result
The influence of 2.1 pairs of mouse acetic acid twisting reactions
ICR mouse male and female half and half, are randomly divided into 6 groups, gavage relative medicine and distilled water, are shown in Table 12 respectively.Each group is continuous
0.6% glacial acetic acid (HAC) 0.2ml/20g is injected intraperitoneally after 1 hour in gavage 15 days, last gastric infusion, and record is moved in 15 minutes
Thing writhing number of times.Statistical procedures carry out variance analysis (similarly hereinafter) using SPSS8.0for Windows software kits.It the results are shown in Table
12。
The influence of 2.2 pairs of mouse hot-plate threshold of pains
Packet and administration are with 2.1, and each group animal continuous gavage is administered 15 days, before last dose and 15,30,60 after administration
Animal is placed on the hot plate of (55 ± 0.5) DEG C by minute respectively, determines mouse pain threshold.Such as 60 seconds mouse are still reactionless, its
The threshold of pain was calculated with 60 seconds, the results are shown in Table 12.
3 discuss
Epigastric pain refers to below xiphoid-process, the regular pain or the gastral cavilty portion illness of mutability pain more than navel occurred.It is sweet
Extra large Weikang capsule for curing gastric disease is main by radix glycyrrhizae, sea Piao sheath, sea-buckthorn, the dried immature fruit of citron orange, the bighead atractylodes rhizome, golden cypress, corydalis tuber, the 8 taste Chinese medicine groups such as Gypenosides
Into, disappear ruffian, regulating the qi flowing in the channels and middle effect with analgesic, cure mainly the gastral cavity pain caused by the insufficiency of the spleen stagnation of the circulation of vital energy, swollen ruffian and do not relax, belch nausea,
Poor appetite etc., sea Piao sheath astringing to arrest bleeding, relieving haperacidity analgesic；The several formulations of corydalis tuber have obvious analgesic activity, especially with alcohol system
The effect of medicinal extract, pulvis and fluid-acet-extract is obvious.
Reacted the study show that sweet extra large Weikang capsule for curing gastric disease can substantially suppress mouse writhing caused by acetic acid, improve mouse to heat
Pain value；In acetic acid twisting experiment, compared with model group, the writhing number of times of the high, medium and low dosage group mouse of sweet extra large Weikang capsule for curing gastric disease
Significantly reduce, and high, medium and low dosage group is respectively provided with significant inhibitory action (P<0.01).
As a result show, sweet extra large Weikang capsule for curing gastric disease has obvious analgesic activity.
Claims (1)
1. a kind of preparation method of sweet extra large stomach health preparation, the sweet extra large stomach health preparation is made up of following components：The mass parts of radix glycyrrhizae 57,
The mass parts of cuttlebone 31.6, the mass parts of sea-buckthorn 25.2, the mass parts of the dried immature fruit of citron orange 57, the mass parts of the bighead atractylodes rhizome 75.8, the mass parts of golden cypress 19 are prolonged recklessly
The mass parts of rope 20, the mass parts of Gypenosides 0.94, it is characterised in that method includes：
(1) cuttlebone after processing is taken, after 80 ± 5 DEG C are dried, crushes, crosses 100 mesh sieves, mixed with Gypenosides；
(2) remaining six medicinal material, it is secondary with the extraction of 65% alcohol reflux, 8 times of amount ethanol of quality of medicinal material are added for the first time, are added for the second time
6 times of amount ethanol of quality of medicinal material, each extraction time is 2 hours, merges extract solution, filtration, decompression filtrate recycling ethanol to clear cream
Relative density is：At 60 DEG C, 1.05, put to room temperature, add 0.5 times of amount water of crude drug quality, stir evenly, stand 24h, filter,
Precipitation is dried under reduced pressure into fine powder；
(3) combining step (1) and powder obtained by (2), mix, are pelletized in right amount with 3%HPMC (m/v), 60 DEG C are done in right amount with starch
It is dry, mix, load capsule, be made 1000 and produce.
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| CN1698818A (en) * | 2005-06-09 | 2005-11-23 | 赵东科 | Medicine for treating chronic gastropathy and its preparation method |
| CN102940835A (en) * | 2012-11-08 | 2013-02-27 | 西安福安创意咨询有限责任公司 | Traditional Chinese medicine for treating peptic ulcer |
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| CN1698818A (en) * | 2005-06-09 | 2005-11-23 | 赵东科 | Medicine for treating chronic gastropathy and its preparation method |
| CN102940835A (en) * | 2012-11-08 | 2013-02-27 | 西安福安创意咨询有限责任公司 | Traditional Chinese medicine for treating peptic ulcer |
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| Title |
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| 甘海胃康胶囊联合兰索拉唑治疗慢性浅表性胃炎和胃脘痛64例;张鑫;《中国药业》;20141120;第23卷(第22期);第100-102页 * |
| 甘海胃康胶囊联合西药治疗胃食管反流病56例;许永攀等;《陕西中医》;20131231;第34卷(第1期);第22-23页 * |
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