CN103735904A - Pain-alleviating and bacterium-resisting Chinese medicinal composition and preparation method thereof - Google Patents
Pain-alleviating and bacterium-resisting Chinese medicinal composition and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a pain-alleviating and bacterium-resisting Chinese medicinal composition and a preparation method thereof. The method for preparing the Chinese medicinal composition mainly comprises the steps of preparing eight types of medicinal materials, namely snowbell-leaf tickclover herb, corn stigma, pyrrosia leaf, chickenbone herb, Indian buead, plantain herb, Japanese climbing fern spore and cogongrass rhizome; extracting the corn stigma, snowbell-leaf tickclover herb, pyrrosia leaf and chickenbone herb with an alkaline aqueous solution; extracting the cogongrass rhizome, Indian buead, Japanese climbing fern spore and plantain herb with water; finally combining liquid extracts obtained by using the two extraction methods. As proved by the results of animal pharmacological experiments and clinical tests, the Chinese medicinal composition provided by the invention has better pain-alleviating and bacterium-resisting effects than the prior art in the treatment of urinary systematic calculi.
Description
Technical field
The present invention relates to treat the Chinese medicine composition of urinary system calculus, be specifically related to a kind of analgesia antibacterial Chinese medicine composition and method of making the same.
Background technology
Urinary system calculus belongs to " sand Stranguria ", " stranguria caused by urinary stone " and " stranguria with blood " scope in traditional Chinese medical science gonorrhea, mainly comprises 4 kinds of pattern of syndrome:
(1) qi stagnation and blood stasis type: disease is seen waist dull pain, dull pain, the normal or stringy and tense pulse of arteries and veins, tongue is normal; Or urine is interrupted suddenly when excessive, sharp ache, the upper waist abdomen that connects, sandstone discharge after pain slow; Or waist, flank portion tugging pain be as strand, pain extending to the lower abdomen, outbreak again and again, pale complexion, cold sweat, vomiting and nausea during pain, companion's hematuria or urine yellow skin are red, dimly red tongue or have petechia, ecchymosis, stringy and tense pulse or slow puckery.
(2) damp heat downward flowing type: card is shown in fever with aversion to cold, lumbago, few abdomen is anxious full, and frequent micturition is short red, and while drowning, puckery pain unbearably, is drenched drop not well.Yellow and greasy fur, stringy and rolling pulse or sliding number.
(3) deficiency of the kidney yin type: calculus is stopped for a long time, pathogenic heat are strongly fragrant for a long time.Kidney-Yin loss, dizzy tinnitus, pain in the low back and legs, dribbling urination or not well, insomnia and dreamful sleep, time have low grade fever, shortness of breath and palpitation, dysphoria with feverish sensation in the chest palms and soles, night sweat, eye is dry or puckery, abdominal distention constipation, poor appetite, thready and rapid pulse, red tongue or few tongue.
(4) kidney yang deficiency syndrome: calculus is stayed for a long time, kidney yang deficiency, the acid of waist lower limb is heavy, lassitude, whole body is timid cold, and extremities being not warm or the lower part of the body often have creeping chill, frequent micturition or dysuria, frequent urination at night, complexion is white, a little less than deep-thready pulse, the white pale tongue of tongue.
The 13rd disclosed JIESHITONG PIAN of < < the Sanitation Ministry medicine standard > > discloses following information:
1) form: Herba Desmodii Styracifolii, Stigma Maydis, Folium Pyrrosiae, Herba Abri, Poria, Herba Plantaginis, Herba lygodii, Rhizoma Imperatae.
2) method for making: above eight tastes, to get Poria 96g and be ground into fine powder, seven tastes such as residue Poria and all the other Stigma Maydis decoct with water secondary, each 3 hours, collecting decoction, filtered, filtrate is condensed into the clear paste that relative density is 1.19-1.20 (90 ℃), adds Poria fine powder, mixes, dry, pulverize into fine powder, sieve, add appropriate amount of auxiliary materials, granule processed, mixes, be pressed into 1000, sugar coating, obtains.
3) function with cure mainly: clearing away heat-damp and promoting diuresis, Tonglin Paishi, pain easing and hemostasis.For urinary system infection, cystitis, oedema due to nephritis, lithangiuria, hematuria, drenches drop muddy, urethra causalgia etc.
But the proportional quantity that there is no clear and definite each composition in described ministry standard.
About the logical extracting method of calculus, there is following report:
Chinese patent application 01100318.9 is clear and definite, and the logical preparation method of calculus is: all pulverizing medicinal materials are nanoscale, microwave extracting, and concentrating under reduced pressure, dry.
Chinese patent application 200510032580.3 discloses the preparations such as the logical ball of calculus, drop pill, micropill, dispersible tablet, pellet capsule.The disclosed preparation method of this patent adopts part Poria to pulverize, residue Poria and all the other 7 taste medical material water extractions, or whole medical material water extraction.
Chinese patent application 200510047400.9 discloses a kind of Chinese medicine sugar free granule that is used for the treatment of lithangiuria and preparation method thereof.This patent raw material is JIESHITONG PIAN raw material, and disclosed preparation method is that part Poria is pulverized, and residue Poria and all the other 7 taste medical material water extractions, adopt low temperature drying method.
Chinese patent application 200910224023.x discloses the treatment pharmaceutical composition of diseases of urinary system and the detection method of component thereof.The raw material that this patent is used is JIESHITONG PIAN raw material, and disclosed preparation method is that part Poria is pulverized, residue Poria and all the other 7 taste medical material water extractions.The detection method of Herba Abri, chlorogenic acid in preparation is disclosed.
Chinese patent application 200910249899.x discloses the preparation method of pharmaceutical composition and the detection method of component thereof for the treatment of diseases of urinary system.The raw material that this patent is used is JIESHITONG PIAN raw material, and disclosed preparation method is that part Poria is pulverized, residue Poria and all the other 7 taste medical material water extractions.The detection method of Folium Pyrrosiae in preparation is disclosed.
Because the character of active component in eight taste medical materials is different, as preparation method in above-mentioned patent all adopts water extraction, can cause some active component to propose, or extraction ratio is low, affect the performance of drug effect.
Therefore, need searching that a kind of preparation method that can improve medicine analgesia antibacterial action is provided.
Summary of the invention
The analgesia antibacterial Chinese medicine compositions that the object of this invention is to provide a kind of determined curative effect.
A kind of analgesia antibacterial Chinese medicine compositions provided by the invention, the preparation method of its active component comprises the following steps:
1) get the medical material of following weight portion: 456 parts of Herba Desmodii Styracifolii, 302 parts of Stigma Maydis, 228 parts of Folium Pyrrosiaes, 228 parts of Herba Abris, 228 parts, Poria, 165 parts of Herba Plantaginiss, 165 parts of Herba lygodiis, 228 parts of Rhizoma Imperataes;
2) Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri are used alkaline aqueous solution to extract for extracting solvent, and extract is made fluid extract;
3) Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water, extract is made fluid extract;
4) by step 2), 3) two kinds of fluid extracts of gained mix, obtain.
Above in described preparation analgesia antibacterial Chinese medicine compositions step:
Described step 2) neutral and alkali aqueous solution is preferably: the sodium bicarbonate solution that quality-percent by volume is 0.1-5%.
Described step 2) alkaline aqueous solution more preferably: the sodium bicarbonate solution that quality-percent by volume is 0.5-1%.
Described step 2) extracting method is preferably:
Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri add alkaline aqueous solution and extract 2-3 time, add the alkaline aqueous solution that medical material gross weight 10-20 doubly measures at every turn, each extraction time is 1-4 hour, merge extractive liquid,, filter, the clear paste that when filtrate is concentrated into 70-80 ℃, relative density is 1.10-1.20, is dried to fluid extract.
Described step 3) is preferably:
Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water 2-3 time add the water that four taste Chinese medicine gross weight 6-12 doubly measure at every turn, decoct 1-3 hour at every turn, and collecting decoction filters, and filtrate is condensed into fluid extract.
Described step 3) is more preferably:
Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water 2-3 time add the water that four taste Chinese medicine gross weight 8-10 doubly measure at every turn, decoct 2-3 hour at every turn, and collecting decoction filters, and filtrate is condensed into fluid extract.
Described step 3) is further preferably:
Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water 2 times add the water that four taste Chinese medicine gross weight 8-10 doubly measure at every turn, decoct 2-3 hour at every turn, and collecting decoction filters, and filtrate is condensed into fluid extract.
The present invention also provides the preparation containing above-mentioned Chinese medicine composition, and said preparation is made separately by Chinese medicine composition or is comprised of Chinese medicine composition and pharmaceutically acceptable carrier.
Described preparation is solid preparation or liquid preparation, and solid preparation is tablet, capsule or granule; Liquid preparation is mixture or oral liquid.
Described pharmaceutically acceptable carrier is one or more in lactose, starch, dextrin, mannitol, sucrose, hydroxypropyl methylcellulose, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, micropowder silica gel, pregelatinized Starch, sorbitol, magnesium stearate, Pulvis Talci, hydroxypropyl methylcellulose, low-substituted hydroxypropyl cellulose, sodium benzoate, potassium sorbate, sucrose or aspartame, monosodium glutamate, Mel, orange flavor.
The preparation method of Chinese medicinal composition preparation of the present invention, the method can adopt conventional formulation technique to be prepared as various common dosage forms.
For example:
Method 1: Chinese medicinal composition capsules agent of the present invention
Get Chinese medicine composition preparation process 4) middle gained Chinese medicine composition, be dried to dried cream powder, add capsule to commonly use adjuvant, production method is prepared into the capsule of Chinese medicine composition of the present invention routinely.
Method 2: Chinese medicine composition tablet of the present invention
Get Chinese medicine composition preparation process 4) middle gained Chinese medicine composition, be dried to dried cream powder, add tablet to commonly use adjuvant, production method is prepared into the tablet of Chinese medicine composition of the present invention routinely.
Method 3: Chinese medicinal composition granules of the present invention
Get Chinese medicine composition preparation process 4) middle gained Chinese medicine composition, be dried to dried cream powder, add granule to commonly use adjuvant, production method is prepared into the granule of Chinese medicine composition of the present invention routinely.
Method 4: Chinese medicine composition mixture of the present invention
Get Chinese medicine composition preparation process 4) middle gained Chinese medicine composition, add mixture to commonly use adjuvant, production method is prepared into the mixture of Chinese medicine composition of the present invention routinely.
Method 5: Chinese medicine composition oral liquid of the present invention
Get Chinese medicine composition preparation process 4) middle gained Chinese medicine composition, add oral liquid to commonly use adjuvant, production method is prepared into the oral liquid of Chinese medicine composition of the present invention routinely.
Method 6: Chinese medicine composition syrup of the present invention
Get Chinese medicine composition preparation process 4) middle gained Chinese medicine composition, add syrup to commonly use adjuvant, production method is prepared into the syrup of Chinese medicine composition of the present invention routinely.
The application that the present invention also provides above-mentioned Chinese medicine composition or preparation to improve analgesia antibacterial effect when preparation treatment urinary system calculus disease.
Urinary system calculus belongs to stranguria caused by urinary stone, sand Stranguria in traditional Chinese medical science gonorrhea, due to damp invasion of lower energizer, changes the scorching the moon that burns, and decocts urine, becomes sandstone, alluvial water channel, and be stranguria caused by urinary stone.Amass in next bladder qi dysfunction, it is unfavorable to urinate, very want can not, poverty-strickenly feel bad, pain extending to the lower abdomen; Be stranded in, affect the duty of kidney department urine, pent-up must not be let out down, and QI and blood is unsmooth, and stagnation of QI and blood may bring about pain is involved bladder, pudendum by kidney; It is hematuria that sandstone is hindered network.Therefore, treatment stranguria caused by urinary stone should be when washing away sandstone, diuresis promoting, and the infection symptoms that urinary system is occurred is treated in time, prevents that inflammation from further expanding, and has influence on other normal organs, and the having an intense pain of appearance when alleviating calculus and do not eliminate for patient.
Chinese medicine composition effective ingredient disclosed in this invention is to be prepared from by raw materials such as Herba Desmodii Styracifolii, Stigma Maydis, Folium Pyrrosiae, Herba Abri, Poria, Herba Plantaginis, Herba lygodii, Rhizoma Imperataes.Inventor finds in preparation research process for many years, identical drug dose, different extraction processes are prepared the active component of gained, also can there is larger difference and emphasis in its pharmacological action, for this reason, applicant has carried out a series of technical study to Chinese medicine composition of the present invention in conjunction with pharmacological evaluation, sum up process for extracting of the present invention, and through the such improvement of experimental verification, brought drug effect potentiation: work as Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri is used alkaline aqueous solution to extract for extracting solvent, Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis medical material water extraction, above two kinds of extracts merge gained Chinese medicine composition, while being used for the treatment of urinary system calculus, its analgesia antibacterial effect is far superior to the existing extractive technique of identical prescription, clinical efficacy shows, extract of the present invention compared with prior art, easing pain, there were significant differences for antibacterial curative effect, there is significance progress.
Inventor detects Chinese medicine composition of the present invention, find: Chinese medicine composition general flavone content of the present invention is very high, compare with existing extraction process products obtained therefrom, both have notable difference, may be because flavone component in Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri is soluble in alkaline aqueous solution, so extract more complete in alkaline aqueous solution.
Above-mentioned testing result has shown that in each component, the extraction of some effective ingredient is better than prior art from the side.Because every taste Chinese crude drug all contains many active component, at least not yet there is any a herb purely and simply to be analyzed and know all the components, different Chinese medicine combines while extracting with different extracting modes, due to influencing each other and acting between solvent, temperature and heterogeneity, can produce very complicated chemical reaction.Therefore, above-mentioned effective ingredient is a part for Chinese medicine extract active component, for the drug action impact of whole medicine, is still not clear.We can only contrast different extracting modes in the quality aspect certain therapeutic use by effect experiment at present, and the method that there is no judges that from the change indicator of part effective ingredient the curative effect of compound Chinese patent medicine changes.
We contrast different extracting modes in the curative effect of ease pain by " impact of mice hot water contracting end reaction " zoopery; By " test tube method extracorporeal bacteria inhibitor test ", contrast different extracting modes in the curative effect of antibiosis.
Inventor has carried out a large amount of systematic research experiments to extracting method and the excellent effect of medicine of each logical medical material of calculus, by medical material is split as to many groups, with diverse ways, extract, finally obtained extractive technique scheme of the present invention, make the medical material of same recipe, given play to that therapeutic purposes are clearer and more definite, the effect of more remarkable treatment effect.
A kind of analgesia antibacterial Chinese medicine compositions provided by the invention has the following advantages:
1, Chinese medicine composition analgesic activity of the present invention is obvious, gives after the present invention, and the mice hot water contracting tail pain threshold utmost point significantly improves (P < 0.01); And, there is significant difference (P < 0.01 or P < 0.05) in the present invention and the comparison of comparative example group.
2, the present invention is remarkable to staphylococcus aureus, bacillus pyocyaneus, Bacillus proteus, streptococcus inhibition.Minimal inhibitory concentration of the present invention is all lower than comparative example, and result shows, Chinese medicine composition antibacterial action provided by the invention is better than prior art.
3, clinical test results shows: pain and urinary system infection therapeutic effect that the present invention causes urinary system calculus are remarkable.And the present invention compares with matched group, analgesic effect and antibacterial effect have significant difference (P<0.05), and prompting the technology of the present invention is better than prior art JIESHITONG PIAN.
The specific embodiment
Following examples are used for illustrating the present invention, but are not used for limiting the scope of the invention.
If no special instructions, the concentration of alcohol in the present invention is percent by volume.
Embodiment 1:
1) get the medical material of following weight portion: Herba Desmodii Styracifolii 456g, Stigma Maydis 302g, Folium Pyrrosiae 228g, Herba Abri 228g, Poria 228g, Herba Plantaginis 165g, Herba lygodii 165g, Rhizoma Imperatae 228g;
2) Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri to add quality-percent by volume be that 0.1% sodium bicarbonate solution extracts 2 times, each sodium bicarbonate solution that adds respectively 20 times, 15 times amounts of medical material gross weight, each extraction time is respectively 4 hours, 2 hours, merge extractive liquid,, filter, filtrate is condensed into fluid extract;
3) Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water are 2 times, add respectively the water of 12 times, 10 times amounts of four taste Chinese medicine gross weights at every turn, decoct respectively 3 hours, 2 hours at every turn, and collecting decoction, filters, and filtrate is condensed into fluid extract;
4) by step 2), 3) two kinds of fluid extracts of gained mix, and obtain Chinese medicine composition.
Embodiment 2:
1) get the medical material of following weight portion: Herba Desmodii Styracifolii 456g, Stigma Maydis 302g, Folium Pyrrosiae 228g, Herba Abri 228g, Poria 228g, Herba Plantaginis 165g, Herba lygodii 165g, Rhizoma Imperatae 228g;
2) Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri to add quality-percent by volume be that 1% sodium bicarbonate solution extracts 3 times, each sodium bicarbonate solution that adds respectively 20 times, 15 times, 10 times amounts of medical material gross weight, each extraction time is respectively 4 hours, 2 hours, 1 hour, merge extractive liquid,, filter, filtrate is condensed into fluid extract;
3) Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water are 3 times, add respectively the water of 12 times, 10 times, 6 times amounts of four taste Chinese medicine gross weights at every turn, decoct respectively 3 hours, 2 hours, 1 hour at every turn, and collecting decoction, filters, and filtrate is condensed into fluid extract;
4) by step 2), 3) two kinds of fluid extracts of gained mix, and obtain Chinese medicine composition.
Embodiment 3:
1) get the medical material of following weight portion: Herba Desmodii Styracifolii 456g, Stigma Maydis 302g, Folium Pyrrosiae 228g, Herba Abri 228g, Poria 228g, Herba Plantaginis 165g, Herba lygodii 165g, Rhizoma Imperatae 228g;
2) Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri to add quality-percent by volume be that 0.5% sodium bicarbonate solution extracts 3 times, each sodium bicarbonate solution that adds respectively 20 times, 15 times, 10 times amounts of medical material gross weight, each extraction time is respectively 3 hours, 2 hours, 1 hour, merge extractive liquid,, filter, filtrate is condensed into fluid extract;
3) Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water are 3 times, add respectively the water of 10 times, 8 times, 8 times amounts of four taste Chinese medicine gross weights at every turn, decoct respectively 3 hours, 2 hours, 2 hours at every turn, and collecting decoction, filters, and filtrate is condensed into fluid extract;
4) by step 2), 3) two kinds of fluid extracts of gained mix, and obtain Chinese medicine composition.
Embodiment 4:
1) get the medical material of following weight portion: Herba Desmodii Styracifolii 456g, Stigma Maydis 302g, Folium Pyrrosiae 228g, Herba Abri 228g, Poria 228g, Herba Plantaginis 165g, Herba lygodii 165g, Rhizoma Imperatae 228g;
2) Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri to add quality-percent by volume be that 5% sodium bicarbonate solution extracts 2 times, each sodium bicarbonate solution that adds respectively 20 times, 10 times amounts of medical material gross weight, each extraction time is respectively 2 hours, 1 hour, merge extractive liquid,, filter, filtrate is condensed into fluid extract;
3) Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water are 2 times, add respectively the water of 10 times, 10 times amounts of four taste Chinese medicine gross weights at every turn, decoct respectively 3 hours, 2 hours at every turn, and collecting decoction, filters, and filtrate is condensed into fluid extract;
4) by step 2), 3) two kinds of fluid extracts of gained mix, and obtain Chinese medicine composition.
Embodiment 5:
1) get the medical material of following weight portion: Herba Desmodii Styracifolii 456g, Stigma Maydis 302g, Folium Pyrrosiae 228g, Herba Abri 228g, Poria 228g, Herba Plantaginis 165g, Herba lygodii 165g, Rhizoma Imperatae 228g;
2) Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri to add quality-percent by volume be that 2% sodium bicarbonate solution extracts 3 times, each sodium bicarbonate solution that adds respectively 20 times, 15 times, 15 times amounts of medical material gross weight, each extraction time is respectively 2 hours, 2 hours, 1 hour, merge extractive liquid,, filter, filtrate is condensed into fluid extract;
3) Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water are 2 times, add respectively the water of 10 times, 8 times amounts of four taste Chinese medicine gross weights at every turn, decoct respectively 3 hours, 2 hours at every turn, and collecting decoction, filters, and filtrate is condensed into fluid extract;
4) by step 2), 3) two kinds of fluid extracts of gained mix, and obtain Chinese medicine composition.
Embodiment 6:
1) get the medical material of following weight portion: Herba Desmodii Styracifolii 456g, Stigma Maydis 302g, Folium Pyrrosiae 228g, Herba Abri 228g, Poria 228g, Herba Plantaginis 165g, Herba lygodii 165g, Rhizoma Imperatae 228g;
2) Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri to add quality-percent by volume be that 0.1% sodium carbonate liquor extracts 3 times, each sodium carbonate liquor that adds respectively 20 times, 15 times, 15 times amounts of medical material gross weight, each extraction time is respectively 2 hours, 2 hours, 1 hour, merge extractive liquid,, filter, filtrate is condensed into fluid extract;
3) Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water are 2 times, add respectively the water of 10 times, 8 times amounts of four taste Chinese medicine gross weights at every turn, decoct respectively 3 hours, 2 hours at every turn, and collecting decoction, filters, and filtrate is condensed into fluid extract;
4) by step 2), 3) two kinds of fluid extracts of gained mix, and obtain Chinese medicine composition.
Embodiment 7:
1) get the medical material of following weight portion: Herba Desmodii Styracifolii 456g, Stigma Maydis 302g, Folium Pyrrosiae 228g, Herba Abri 228g, Poria 228g, Herba Plantaginis 165g, Herba lygodii 165g, Rhizoma Imperatae 228g;
2) Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri to add quality-percent by volume be 0.05% sodium hydroxide solution extraction 2 times, each sodium hydroxide solution that adds respectively 15 times, 8 times amounts of medical material gross weight, each extraction time is respectively 2 hours, 1 hour, merge extractive liquid,, filter, filtrate is condensed into fluid extract;
3) Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water are 2 times, add respectively the water of 10 times, 10 times amounts of four taste Chinese medicine gross weights at every turn, decoct respectively 3 hours, 2 hours at every turn, and collecting decoction, filters, and filtrate is condensed into fluid extract;
4) by step 2), 3) two kinds of fluid extracts of gained mix, and obtain Chinese medicine composition.
Embodiment 8: capsule
1, form: the fluid extract of embodiment 1 gained, be dried to dried cream powder, obtain 310g, add pregelatinized Starch 68g, magnesium stearate 6.4g, micropowder silica gel 6.4g.
2, preparation method: the method with reference to conventional Chinese medicine preparation is made capsule.
Embodiment 9: tablet
1, form: the fluid extract of embodiment 2 gained, be dried to dried cream powder, obtain 310g, add pregelatinized Starch 68g, magnesium stearate 6.4g, micropowder silica gel 6.4g.
2, preparation method: the method with reference to conventional Chinese medicine preparation is made tablet.
Embodiment 10: granule
1, form: the fluid extract of embodiment 3 gained, be dried to dried cream powder, obtain 315g, add sucrose 1310g, pregelatinized Starch 156g.
2, preparation method: with reference to the method granulation agent of conventional Chinese medicine preparation.
Embodiment 11: oral liquid
1, form: embodiment 4 gained fluid extract 4.6L (1.050～1.065/30 ℃ of relative densities), sucrose 550g, monosodium glutamate 8.7g, sodium benzoate 5.4g.
2, preparation method: fluid extract is heated to more than 80 ℃, then add sucrose and antiseptic, embedding, sterilizing, makes oral liquid.
Embodiment 12: syrup
1, form: embodiment 5 gained fluid extract 9.0L (1.015～1.035/30 ℃ of relative densities), sucrose 8.2kg, Mel 1.0kg, sodium benzoate 22g.
2, preparation method: the method with reference to conventional Chinese medicine preparation is made syrup.
Comparative example 1:
With reference to the 13rd disclosed JIESHITONG PIAN methods of extraction and preparation of < < the Sanitation Ministry medicine standard > >, specific as follows:
Take Herba Desmodii Styracifolii 456g, Stigma Maydis 302g, Folium Pyrrosiae 228g, Herba Abri 228g, Poria 228g, Herba Plantaginis 165g, Herba lygodii 165g, Rhizoma Imperatae 228g;
Above eight tastes, get Poria 96g and are ground into fine powder, and seven tastes such as residue Poria and all the other Stigma Maydis decoct with water secondary, and each 3 hours, collecting decoction, filter, filtrate is condensed into the clear paste that relative density is 1.19 (90 ℃), adds Poria fine powder, mixes, dry, pulverize into fine powder, sieve, obtain.
Comparative example 2: full water extraction
Take Herba Desmodii Styracifolii 456g, Stigma Maydis 302g, Folium Pyrrosiae 228g, Herba Abri 228g, Poria 228g, Herba Plantaginis 165g, Herba lygodii 165g, Rhizoma Imperatae 228g;
Above eight tastes, extracting in water 3 times adds the water of 10 times of amounts of medical material gross weight at every turn, each decoction 3 hours, collecting decoction, filters the clear paste that when filtrate is concentrated into 70 ℃, relative density is 1.10, adding concentration and be 95% ethanol makes to reach 60% containing alcohol amount, standing 12 hours, filter the clear paste that when filtrate is concentrated into 70 ℃, relative density is 1.15, be dried to dried cream powder, obtain.
Comparative example 3: full alcohol extraction
Take Herba Desmodii Styracifolii 456g, Stigma Maydis 302g, Folium Pyrrosiae 228g, Herba Abri 228g, Poria 228g, Herba Plantaginis 165g, Herba lygodii 165g, Rhizoma Imperatae 228g;
Above eight tastes, use ethanol extraction 3 times, add 10 times of amount 80% ethanol of medical material gross weight at every turn, extract 2 hours at every turn, and merge extractive liquid,, filters, and the clear paste that when filtrate is concentrated into 60 ℃, relative density is 1.15, is dried to dried cream powder, obtains.
Experimental example 1: Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, the comparison of Herba Abri extracting method
With different extracting method, Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri are extracted, by the analgesic activity of the more different extracts of animal effect experiment.
1 extracts solvent: 0.5% sodium bicarbonate solution, 30% alcoholic solution, water.
2 extracting method: take Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri by recipe quantity, adding above-mentioned Different solution extracts respectively 3 times, each solvent that adds respectively 12 times, 10 times, 10 times amounts of medical material gross weight, each extraction time is respectively 5 hours, 4 hours, 3 hours, merge extractive liquid,, filter, reclaim medicinal residues, filtrate is condensed into fluid extract.
3 analgesic effect test methods: the impact on mice hot water contracting end reaction
4 analysis results are in Table 1
The impact of table 1 Different Extraction Method on mice hot water contracting end reaction pain threshold
| Group | Extract solvent | The time (s) is improved in the threshold of pain | Percentage rate (%) is improved in the threshold of pain |
| 1 | Blank group | 0.30±0.75 | 3.95 |
| 2 | 0.5% sodium bicarbonate solution | 2.60±0.81** | 37.68 |
| 3 | 30% ethanol | 1.25±0.68**## | 16.45 |
| 4 | Water | 1.75±0.82**# | 22.15 |
Note: with the comparison of blank group, * P<0.05, * * P<0.01; With 0.5% sodium bicarbonate solution experimental group comparison, #P<0.05, ##P < 0.01.
Table 1 result shows: 0.5% the sodium bicarbonate solution of take is the extract that solvent extracts gained, and the mice hot water contracting tail pain threshold utmost point significantly improves (P < 0.05, P < 0.01), and analgesic effect is best.0.5% sodium bicarbonate solution is compared with 30% ethanol experimental group, water experimental group, and analgesic effect has significant difference.
Experimental example 2: Rhizoma Imperatae, Poria, Herba lygodii, the comparison of Herba Plantaginis four Chinese medicine material extracting method
With different extracting method, Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis four Chinese medicine material are extracted, by experiment the antibacterial effect of more different extracts.
1 extracts solvent: 30% alcoholic solution, 70% alcoholic solution, water, 0.1% sodium bicarbonate solution.
2 extracting method: take Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis by recipe quantity, adding Different solution extracts 3 times, each 12 times of medical material gross weights, solvent of 10 times, 8 times of adding respectively, each extraction time is respectively 5 hours, 4 hours, 3 hours, merge extractive liquid,, filter, reclaim medicinal residues, filtrate is condensed into fluid extract.
3 antibacterial tests: test tube method extracorporeal bacteria inhibitor test.
4 analysis results are in Table 2
Table 2 Different Extraction Method In Vitro Bacteriostasis
Table 2 result shows: the water of take extracts the extract of gained as solvent, the minimal inhibitory concentration of staphylococcus aureus, escherichia coli, bacillus pyocyaneus, Bacillus proteus is minimum, with 30% ethanol experimental group, 70% ethanol experimental group, that 0.1% sodium bicarbonate solution experimental group is compared antibacterial effect is better.
Experimental example 3: the comparison of Chinese medicine composition extracting method
1 sample grouping
Embodiment 1-7, comparative example 1-3 make respectively dried cream powder, grouping.
2 contrast projects
General flavone content: use colorimetric method for determining general flavone content.
3 experimental results, in Table 3
The extraction effect of table 3 Different Extraction Method to medical material
| Group | Total flavones (mgg-1) |
| Embodiment 1 | 76.392±1.84 |
| Embodiment 2 | 74.363±1.86 |
| Embodiment 3 | 76.682±1.83 |
| Embodiment 4 | 75.207±1.78 |
| Embodiment 5 | 73.042±1.76 |
| Embodiment 6 | 73.980±1.75 |
| Embodiment 7 | 73.121±1.87 |
| Comparative example 1 | 56.019±1.83 |
| Comparative example 2 | 58.954±1.79 |
| Comparative example 3 | 57561±182 |
Table 3 result shows: the general flavone content of embodiment of the present invention 1-7 is better than comparative example 1-3.Experimental result prompting the technology of the present invention is extracted gained Chinese medicine composition total flavones compared with prior art, extracts more complete.
Antibacterial effect experiment eases pain
One, the impact on pain model-mice hot water contracting end reaction
1, experiment material
(1) animal
Healthy SPF level kunming mice, 18～22g, male and female dual-purpose, buys from Guangxi Medical University's Experimental Animal Center (production licence number: SCXK osmanthus 2009-0002).
(2) medicine
Embodiment of the present invention 1-7, comparative example 1-3,0.9% normal saline (Guizhou Kelun Pharmaceutical Co., Ltd.), aspirin (AstraZeneca pharmaceutical Co. Ltd)
(3) instrument
Thermostat water bath (Shanghai Ke Sheng Instrument Ltd.), mouse fixing device, AE100 type 1/10000 electronic analytical balance (prunus mume (sieb.) sieb.et zucc. Teller-Tuo benefit instrument Shanghai company limited)
2, experimental technique
(1) get the fixing rear afterbody of mice and naturally droop, with marker pen, according to mousetail end 3cm place, doing a labelling, water bath with thermostatic control is heated to (48 ± 0.5) ℃, the following part of labelling is immersed in the water, record contracting tail incubation period (s), as pain territory index.By incubation period, the mice of < 5s or > 30s is rejected.
(2) get 120 of the qualified mices of preliminary election, divide at random 12 groups to be: blank group (normal saline), aspirin group (0.15g/kg), embodiment 1-7 group and comparative example 1-3 group (4.5g/kg), 10 every group.Before administration, measure twice (interval 5min), using its average as Basic Pain Threshold.Each organizes the latency change of measuring mice contracting tail after gastric infusion 1h, surpasses 60s unresponsive, in 60s.According to following formula, calculate the threshold of pain and improve percentage rate:
Percentage rate (%)=(average pain threshold after medication-average Basic Pain Threshold value)/average Basic Pain Threshold value * 100% is improved in the threshold of pain.
3, experimental result
The impact of each trial drug of table 4 on mice hot water contracting end reaction pain threshold
Note: with the comparison of blank group, * P < 0.05, * * P < 0.01; With 1 group of comparison of comparative example,
△p < 0.05,
△ △p < 0.01; With 2 groups of comparisons of comparative example,
▲p < 0.05,
▲ ▲p < 0.01; With 3 groups of comparisons of comparative example,
◆p < 0.05,
◆ ◆p < 0.01.
Table 4 result shows, with the comparison of blank group, and embodiment 1-7 group and comparative example 1-3 group pain threshold be significantly increased (P < 0.01, P < 0.05); And, there is significant difference (P < 0.01, P < 0.05) in embodiment 1-7 group and comparative example group 1-3 comparison.
Result shows, Chinese medicine composition analgesic activity provided by the invention is better than prior art.
Two, test tube method extracorporeal bacteria inhibitor test
1, experiment material
(1) bacterial strain
Staphylococcus aureus (CICC23656), bacillus pyocyaneus, common degeneration bacillus (CMCC (B) 49027), streptococcus (ATCC32210).
(2) medicine and reagent
Embodiment of the present invention 1-7, comparative example 1-3 medicine (being mixed with the medicinal liquid containing crude drug amount 2.5g/mL); Carnis Bovis seu Bubali cream, peptone, sodium chloride, distilled water are mixed with nutrient broth, and sterilizing is standby.
(3) instrument
High-pressure sterilizing pot (three Shens, Shanghai), biochemical cultivation case (Shanghai Yao Shi instrument), CJ-840 aseptic working platform (Purifying Equipment Co., Ltd., Suzhou), test tube (autoclaving)
2, experimental technique
Each bacterial strain is 37 ℃ of cultivation 18-24h of constant temperature in suitable culture medium, rear with normal saline dilution standby (approximately 10
6/ mL).Get 10 sterilizing test tubes for every group, the 1st test tube adds nutrient broth 1.8ml, and all the other each test tubes add culture medium 1mL, after every group of the 1st test tube adds the tested medicinal liquid 0.2mL preparing to mix, with 9 test tubes of continuous 2 times of dilution methods to the, the 10th test tube is blank.In each pipe, liquor capacity is 1mL, and then each Guan Jun adds bacterium liquid 0.1mL to cultivate after 24-48h in 37 ℃, the observed result muddiness of indicator discoloration situation and solution (take be index).The highest drug level of asepsis growth of take is minimal inhibitory concentration (MIC).
3, experimental result
The In Vitro Bacteriostasis of each test group medicine of table 5
The demonstration of table 5 result, embodiment 1-7 and comparative example 1-3Dui Jin Portugal bacterium, bacillus pyocyaneus, Bacillus proteus, streptococcus all have certain inhibitory action; Embodiment 1 Dui Jin Portugal bacterium, Bacillus proteus, streptococcus m IC are all less than comparative example 1-3,2 pairs of escherichia coli of embodiment, bacillus pyocyaneus MIC are all less than comparative example 1-3, embodiment 3 Dui Jin Portugal bacterium, Bacillus proteus MIC are all less than comparative example 1-3, the embodiment 4 bacterium MIC of Dui Jin Portugal are all less than equal comparative example 1-3,5 couples of streptococcus m IC of embodiment are all less than comparative example 1-3, the embodiment 6 bacterium MIC of Dui Jin Portugal are all less than comparative example 1-3, and 7 couples of streptococcus m IC of embodiment are all less than comparative example 1-3.
Result shows, Chinese medicine composition antibacterial action provided by the invention is better than prior art.
Clinical trial:
The present invention's antibacterial curative effect of easing pain is carried out to clinical observation, by contrast take medicine Patients Before And After urinary system calculus pain relief situation and urinary tract pathogenic infection situation, investigate and analyze analgesia antibacterial effect of the present invention.
1 diagnosis basis
1.1 urinary system calculus pain
Pain is according to WHO pain degree classification (VRS): 0 grade is painless, and 1～3 grade is mild pain, and 4～7 grades is moderate pain, and 8～10 grades is severe pain.This evaluation form is issued to each patient, before receiving treatment, by patient, according to the pain situation of oneself, at table centre circle, go out own residing rank.
1.2 urinary system infection
1.2.1 the urinary tract infection symptom such as frequent micturition, urgent micturition, dysurea, or have that lower abdomen is touched a tender spot, kidney district kowtows pain, companion or the heat that do not occur together, and there is the one of following situations:
1. urine examination male leukocyte >=5/high power field, female WBC >=10/high power field, plugs in catheter patient and should cultivate in conjunction with urine.
2. clinicist is diagnosed as urinary tract infection, or antibacterial therapy effectively and the urinary tract infection of assert.
1.2.2 etiological diagnosis
On clinical diagnosis basis, meet the one of following situations:
1. CCMS or urethral catheterization are left and taken urine (non-indwelling catheter) and are cultivated gram-positive cocci bacterium number >=104cfu/ml, gram negative bacilli bacterium number >=105cfu/ml.
2. on pubic symphysis, punctio vesicae is left and taken urine culture of bacteria bacterium number >=103cfu/ml.
3. freshly voided urine specimen is through centrifugal, and application phase-contrast microscopy (1X400) has the half visual field to see antibacterial in 30 visuals field.
4. ABU disease: although patient is asymptomatic, but there are endoscopy or indwelling catheter history in recent (1 week), urine is cultivated gram-positive cocci concentration >=104city/ml, gram negative bacilli concentration >=105cfu/ml, should be considered as urinary system infection.
2 case selections
20～70 years old age, be ready to accept 2 weeks therapists, signature enters clinical research Informed Consent Form person.
3 medicines
Experimental group: embodiment 3
Matched group: JIESHITONG PIAN, Guangxi Wuzhou Pharmaceutical (group) limited company
4 curative effect index
4.1 pain therapy effects
The medication of pain efficacy evaluation reevaluated according to VRS classification after 2 weeks.
Effective: more than pain relief secondary;
Effective: pain relief one-level;
Invalid: though pain do not alleviate or have in the course for the treatment of of alleviating, get back to again original degree and more than.Total effective rate calculates with effective and effective sum.
4.2 bacteriology's curative effects check
Remove: treatment finishes rear original pathogenic bacterium and disappears;
Part is removed: in original various pathogens, have to be severally eliminated;
Do not remove: treatment finishes rear original pathogenic bacterium and still exists.
5 clinical grouping and Therapeutic Method
Enter to organize the routine patient of case 378, male 196 examples, female's 182 examples; Average approximately 45 years old; All patients are all diagnosed as urinary system calculus companion urinary system infection after diagnosing, and case is by being divided at random two groups.
Therapeutic Method:
Experimental group: the embodiment of the present invention 5, is equivalent to crude drug 10g each serving consumption, three times on the one.
Matched group: JIESHITONG PIAN, each 1.5g, three times on the one.
Experimental group and matched group, taking medicine simultaneously, strengthen amount of drinking water every day, and average daily drink amount is 3000～5000ml, takes exercises more, take jumping exercise or going upstairs motion as main, and both hands are in dorsal part intersection knocking back lumbar part.
6 results
In experimental example group case, most of patient takes after the embodiment of the present invention 3, and the pain phenomenons such as paroxysmal lumbago reduce or disappear, and through etiological examination, pathogenic bacterium reduce, remove.
Table 6: bacteriology checking result after treatment
Note: experimental group and matched group comparison, * P < 0.05.
Table 7: pain degree result after treatment
Note: experimental group and matched group comparison, * P < 0.05.
Interpretation of result: the above results shows, experimental group and matched group are all effectively alleviated the pain that urinary system calculus causes, and antibacterial action is good.But the antibacterial analgesic of experimental group curative effect is especially good, compares have significant difference (P<0.05) with matched group.Pain and urinary system infection effect that medicine of the present invention causes urinary system calculus are remarkable, are better than the effect of JIESHITONG PIAN.
Model case:
1. Liu, man, 42 years old, waist abdomen severe pain, time heavy when light, it is 38.6 ℃ (may have urinary system infection) that hospital observes and learns patient temperature by experience, further check that getting interrupted urinary does antibacterial culturing and show that escherichia coli is positive, B ultrasonic abdominal part is detected right hydronephrosis, shows right side ureteral calculus, red tongue with yellow fur is micro-greasy, and pulse condition stringy and tense pulse is number slightly.Give the embodiment of the present invention 9 tablets, 3 times on the 1st, each 5.Take after 5 days pain relief, the calculus of 3 diameter 02-0.3cm of discharge.Then pain disappears, and following the service checks after 2 days that tongue fur is light red, and thin white, routine blood test is normal, and ultrasound diagnosis bladder, ureter have no calculus, and urine antibacterial culturing shows that escherichia coli is negative.
2. Lin, Ms, 26 years old, before 2 hours, without inducement, there is right side waist and belly pain, pain is angor, and paroxysm increases the weight of, and companion feels sick, vomiting, and vomitus is gastric content, to hypogastric region radiation, companion's gross hematuria, without clot, without heating, without frequent micturition, urgent micturition, dysurea.Routine urinalysis: occult blood 2+, albumen+-, the full visual field of R-RBC, leukocyte: 4-5/HP, B ultrasonic is detected 2 pieces of the right renal calculuss of prompting.Give the embodiment of the present invention 10 granules, 3 times on the 1st, each 1 bag, taking medicine one day is that pain is significantly alleviated, and after 3 days, pain disappears.Within 10 days, all rear check routine urinalysis are normal, and urine antibacterial culturing shows that former pathogenic bacterium are negative, and B ultrasonic is detected and pointed out pair kidneys, ureter, bladder to be showed no calculus.
Although, above used general explanation, the specific embodiment and test, the present invention is described in detail, on basis of the present invention, can make some modifications or improvements it, and this will be apparent to those skilled in the art.Therefore, these modifications or improvements, all belong to the scope of protection of present invention without departing from theon the basis of the spirit of the present invention.
Claims (7)
1. an analgesia antibacterial Chinese medicine compositions, is characterized in that the preparation method of its active component comprises the following steps:
1) get the medical material of following weight portion: 456 parts of Herba Desmodii Styracifolii, 302 parts of Stigma Maydis, 228 parts of Folium Pyrrosiaes, 228 parts of Herba Abris, 228 parts, Poria, 165 parts of Herba Plantaginiss, 165 parts of Herba lygodiis, 228 parts of Rhizoma Imperataes;
2) Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri are used alkaline aqueous solution to extract for extracting solvent, and extract is made fluid extract;
3) Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water, extract is made fluid extract;
4) by step 2), 3) two kinds of fluid extracts of gained mix, obtain.
2. Chinese medicine composition according to claim 1, is characterized in that step 2) described in alkaline aqueous solution be: the sodium bicarbonate solution that quality-percent by volume is 0.1-5%.
3. Chinese medicine composition according to claim 2, is characterized in that, described alkaline aqueous solution is: the sodium bicarbonate solution that quality-percent by volume is 0.5-1%.
4. Chinese medicine composition according to claim 1, is characterized in that step 2) described in the extracting method of Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri be:
Stigma Maydis, Herba Desmodii Styracifolii, Folium Pyrrosiae, Herba Abri add alkaline aqueous solution extracts 2-3 time, adds the alkaline aqueous solution that medical material gross weight 10-20 doubly measures at every turn, and each extraction time is 1-4 hour, and merge extractive liquid, filters, and filtrate is condensed into fluid extract.
5. Chinese medicine composition according to claim 1, it is characterized in that, water extraction method described in step 3) is: Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water 2-3 time, add the water that four taste Chinese medicine gross weight 6-12 doubly measure at every turn, each 1-3 hour that decocts, collecting decoction, filters, and filtrate is condensed into fluid extract.
6. according to the Chinese medicine composition described in claim 1 or 5 any one, it is characterized in that, described in step 3), water extraction method is: Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water 2-3 time, add the water that four taste Chinese medicine gross weight 8-10 doubly measure at every turn, each 2-3 hour that decocts, collecting decoction, filters, and filtrate is condensed into fluid extract.
7. Chinese medicine composition according to claim 6, it is characterized in that, described in step 4), water extraction method is: Rhizoma Imperatae, Poria, Herba lygodii, Herba Plantaginis extracting in water 2 times, add the water that four taste Chinese medicine gross weight 8-10 doubly measure at every turn, each decoction 3 hours, collecting decoction, filters, and filtrate is condensed into fluid extract.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1824178A (en) * | 2005-12-20 | 2006-08-30 | 王衡新 | Chinese medicinal preparation for treating urinary system disease, its preparation method and quality control method |
| CN1947781A (en) * | 2005-10-14 | 2007-04-18 | 王玫 | Sugar-free traditional Chinese medicine granules for treating lithangiuria and its prepn. method |
| CN102266501A (en) * | 2011-07-25 | 2011-12-07 | 王疆宏 | Jieshitong tea composition and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1947781A (en) * | 2005-10-14 | 2007-04-18 | 王玫 | Sugar-free traditional Chinese medicine granules for treating lithangiuria and its prepn. method |
| CN1824178A (en) * | 2005-12-20 | 2006-08-30 | 王衡新 | Chinese medicinal preparation for treating urinary system disease, its preparation method and quality control method |
| CN102266501A (en) * | 2011-07-25 | 2011-12-07 | 王疆宏 | Jieshitong tea composition and preparation method thereof |
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Application publication date: 20140423 |