CN101455778B - Traditional Chinese medicine preparation capable of reducing fever and relieving sore-throat and preparation method thereof - Google Patents
Traditional Chinese medicine preparation capable of reducing fever and relieving sore-throat and preparation method thereof Download PDFInfo
- Publication number
- CN101455778B CN101455778B CN2008102470133A CN200810247013A CN101455778B CN 101455778 B CN101455778 B CN 101455778B CN 2008102470133 A CN2008102470133 A CN 2008102470133A CN 200810247013 A CN200810247013 A CN 200810247013A CN 101455778 B CN101455778 B CN 101455778B
- Authority
- CN
- China
- Prior art keywords
- chinese medicine
- radix
- preparation
- medicine preparation
- bulbus fritillariae
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Abstract
The invention provides a traditional Chinese medicine preparation for clearing heat and relieving sore throat, and comprises a traditional Chinese medicine composition and pharmaceutic adjuvant. The traditional Chinese medicine composition consists of the following components: myrobalam, Chinese gall leaven, bulbus fritillariae cirrhosae, dark palm, radix puerariae, tuckahoe, liquorice, and trichosanthes root, wherein the bulbus fritillariae cirrhosae in the traditional Chinese medicine composition is bulbus fritillariae cirrhosae powder, and the myrobalam, the Chinese gall leaven, the dark palm, the radix puerariae, the tuckahoe, the liquorice, and the btrichosanthes root medicinal materials are extracts of the medicinal materials. The traditional Chinese medicine preparation can maintain the prior therapeutic effect of the prior preparation formulation, also has better dissolution rate and bioavailability than the prior preparation formulation, has steady quality, high automation degree, large yield, and low cost, and is convenient for modern production.
Description
Technical field
The invention provides a kind of Chinese medicine preparation, the improved formulations of the honeyed pill dosage form that it is used as medicine for a kind of former powder refers in particular to Chinese medicine preparation of a kind of relieving sore-throat by clearing away heat and preparation method thereof.
Background technology
The good for larynx pill kind still is traditional former powder big honeyed pills, water-honeyed pill dosage form in the field of circulation so far, the preparation method of medicine pill is still very backward at present, production automation level is lower, dose is big, taste is not good enough, absorb slow, reasons such as the diabetes patient can not take have limited the crowd of taking, and influence is sold.Therefore, be badly in need of this kind is carried out modified form, make it can keep it former effective in cure, dissolution rate and bioavailability are good than pill again, steady quality, and production mechanization, the automaticity height, output is big, and cost is low, and the medicament health is easily up to standard; Take, carry, storage etc. is more convenient, is convenient to the novel form of modern production.
Summary of the invention
Many disadvantages in view of present existing good for larynx pill existence, the present invention develops on the basis of existing kind, improved prior dosage form, made it can keep it former effective in cure, dissolution rate and bioavailability are good than pill again, steady quality, production mechanization, the automaticity height, output is big, cost is low, is convenient to modern production.
The purpose of this invention is to provide a kind of pharmaceutical preparation with sore throat relieving effect, this pharmaceutical preparation has kept the whole raw materials of original good for larynx pill and has formed and original prescription proportioning, it is become can keep effective ingredient to greatest extent, reduces dose and expansion use crowd's novel pharmaceutical formulation.
The present invention also aims to provide a kind of preparation method with pharmaceutical preparation of sore throat relieving effect, whole raw materials that can keep original pill by this method are formed and proportioning, and make a kind of novel pharmaceutical formulation that can keep effective ingredient to greatest extent, reduce dose and enlarge the use crowd.
The invention provides a kind of Chinese medicine preparation of relieving sore-throat by clearing away heat, said preparation comprises Chinese medicine composition and pharmaceutic adjuvant, and described Chinese medicine composition is made up of the component of following weight portion: 1 part of 1 part of terminalia flesh, 2 parts of Mass Galla chinesis et camelliae Fermentata, 2 parts of Bulbus Fritillariae Cirrhosaes, 1 part of Fructus Mume, 2 parts of Radix Puerariaes, 1 part in Poria, 2 parts in Radix Glycyrrhizae and Radix Trichosanthis; Wherein, Bulbus Fritillariae Cirrhosae is former powder (Bulbus Fritillariae Cirrhosae powder), and terminalia flesh and Mass Galla chinesis et camelliae Fermentata are ethanol extraction, and Fructus Mume, Radix Puerariae, Poria, Radix Glycyrrhizae and Radix Trichosanthis are water extract.
The present invention adopts the former powder of Bulbus Fritillariae Cirrhosae to substitute adjuvant Mel by extracting the functional component of Chinese medicine in the Chinese medicine composition, can enlarge the use crowd, accomplishes taking convenience, and is safe and reliable, increases the drug quality controllability.
Obtain the dry powder of extract after above-mentioned ethanol extract and water extract merge through spray drying, it is mixed with Bulbus Fritillariae Cirrhosae powder, make needed dosage form and get final product.
In Chinese medicine preparation of the present invention, described pharmaceutic adjuvant comprises starch, Icing Sugar, cellulose family, lactose, Mel etc. or its combination in any.
Preparation of the present invention can be different dosage forms, for example tablet, the watered pill, water-honeyed pill, capsule or the like.The different preparations shaping technologies of different dosage forms have determined it to add the kind and the weight of adjuvant, if make tablet, the present invention also preferably will carry out coating outside the tablet top layer.
The present invention has reduced the heated time of drug component by spray drying, thereby kept effective ingredient to greatest extent, again by extracting the functional component of Chinese medicine in the Chinese medicine composition, adopt the former powder of Bulbus Fritillariae Cirrhosae to substitute adjuvant Mel, the preparation that obtains is compared with former dosage form and has been reduced dose, and can enlarge the use crowd, increase the drug quality controllability.
In Chinese medicine preparation of the present invention, the Chinese medicine composition in the described preparation is made up of following: terminalia flesh, Mass Galla chinesis et camelliae Fermentata, Bulbus Fritillariae Cirrhosae, Fructus Mume, Radix Puerariae, Poria, Radix Glycyrrhizae and Radix Trichosanthis, and wherein, Bulbus Fritillariae Cirrhosae is former powder, is preferably the fine powder of 80 mesh sieves; All the other compositions are the extract of terminalia flesh, Mass Galla chinesis et camelliae Fermentata, Fructus Mume, Radix Puerariae, Poria, Radix Glycyrrhizae and Radix Trichosanthis medical material.
Be that form of extract is used as medicine equally, the inventor finds that all medical materials except Bulbus Fritillariae Cirrhosae mix in principle and can implement, but method effect and the drug effect extracted are bad, having mass data to show, is the index composition with the puerarin, and the rate of transform of expectation puerarin is high more good more.The above-mentioned medical material mixture that needs extraction of the present invention, when not adding terminalia flesh, the puerarin rate of transform reaches 82.84%, when containing terminalia flesh, the puerarin rate of transform has only 39.52%, may be owing to contain generation interaction between a large amount of tannins and the flavonoid glycoside in the terminalia flesh.Therefore, the present invention preferably adopts Fructus Mume, Poria, Radix Glycyrrhizae, Radix Trichosanthis, Radix Puerariae to extract together; Mass Galla chinesis et camelliae Fermentata, terminalia flesh extract separately.
In the preferred embodiment of the present invention, the technical scheme of extract part is: Fructus Mume, Poria, Radix Glycyrrhizae, Radix Trichosanthis, Radix Puerariae can mix extraction by raw medicinal material, obtain the extract of above-mentioned Fructus Mume, Poria, Radix Glycyrrhizae, Radix Trichosanthis, Radix Puerariae; Mass Galla chinesis et camelliae Fermentata, terminalia flesh extract separately, obtain the extract of Mass Galla chinesis et camelliae Fermentata, terminalia flesh; Again described extract is mixed, obtain the mixing of form of extract of the present invention.Wherein preferred: terminalia flesh and Mass Galla chinesis et camelliae Fermentata are ethanol extraction, and Fructus Mume, Radix Puerariae, Poria, Radix Glycyrrhizae and Radix Trichosanthis are water extract.
Above-mentioned terminalia flesh ethanol extract and Mass Galla chinesis et camelliae Fermentata ethanol extract can obtain by following method:
Fructus Mume, Poria, Radix Glycyrrhizae, Radix Trichosanthis, Radix Puerariae extract together; Mass Galla chinesis et camelliae Fermentata, terminalia flesh extract separately.
Terminalia flesh, Mass Galla chinesis et camelliae Fermentata add the ethanol extraction of the 50-95%wt of at least 2 times of amounts (weight), reclaim ethanol to there not being the alcohol flavor, be concentrated into relative density 1.15～1.20 (50 ℃), the extract that obtains is terminalia flesh, Mass Galla chinesis et camelliae Fermentata ethanol extract, also is terminalia flesh, Mass Galla chinesis et camelliae Fermentata component in the Chinese medicine composition of the present invention.Preferred terminalia flesh, Mass Galla chinesis et camelliae Fermentata add the alcohol reflux 2 times of about 60%wt of about 10 times of amounts (weight), each 2 hours, filter, filtrate merges, decompression recycling ethanol is to there not being the alcohol flavor, be concentrated into relative density 1.15～1.20 (50 ℃), the extract that obtains is the ethanol extraction of terminalia flesh, Mass Galla chinesis et camelliae Fermentata.
Above-mentioned Fructus Mume, Radix Puerariae, Poria, Radix Glycyrrhizae and Radix Trichosanthis water extract can obtain by following method:
Get Fructus Mume, Radix Puerariae, Poria, Radix Glycyrrhizae, Radix Trichosanthis, the decocting that adds at least 5 times of amounts (quality) boils, and preferably the decocting of at least 10 times of amounts (weight) boils once or once, decocting liquid is the water extract of those medical materials; Perhaps decocting liquid obtains water extract through concentrated, dry.
In the preferred embodiments of the present invention, above-mentioned water extract adopts following method to obtain: amounting to 210g with Fructus Mume, Radix Puerariae, Poria, Radix Glycyrrhizae, Radix Trichosanthis is benchmark, get Fructus Mume 30g, Radix Puerariae 60g, Poria 30g, Radix Glycyrrhizae 60g, Radix Trichosanthis 30g, decoct with water 2 times, for the first time add water 2100ml, decocted 2 hours; For the second time add water 1680ml, decocted 1 hour, filter, collecting decoction, concentrate drying obtains these medical material water extract.
Former dosage form of the present invention is a honeyed pill, and constituent and proportioning thereof are: terminalia flesh 50g, Mass Galla chinesis et camelliae Fermentata 100g, Bulbus Fritillariae Cirrhosae 100g, Fructus Mume 50g, Radix Puerariae 100g, Poria 50g, Radix Glycyrrhizae 100g, Radix Trichosanthis 50g.
Method for making is: above eight flavors, be ground into fine powder, and sieve mixing.Every 100g powder adds refined honey 110～130g and makes big honeyed pills, promptly.The heavy 3g of the every ball of big honeyed pills.Every clothes crude drug amount is: 1.364g.
The present invention improves the novel formulation that obtains after original dosage form, comprises tablet, capsule, granule etc., and every clothes crude drug amount of dose and honeyed pill is suitable.With the tablet is example, and every clothes a slice is equivalent to the 1.364g crude drug, 1000 tablets of suitable 1364g crude drugs.
Tablet especially wraps the tablet of film-coat, and film-coat has been covered the bad smell of prescription flavour of a drug, has more increased the crowd's that uses compliance.
Above-mentioned preparation formulation of the present invention and preparation technology thereof (comprising the extraction process of composition and the preparation technology of preparation) grope the preferred embodiment that selected optimization process parameter obtains on the basis of numerous data through a large amount of experiments.With the tablet is example, and selected parts are as follows:
Prerun:
No. 1: take by weighing Fructus Mume 30g, Radix Puerariae 60g, Poria 30g, Radix Glycyrrhizae 60g, Radix Trichosanthis 30g amounts to 210g, decocts with water 2 times, adds water 2100ml for the first time, decocted 2 hours; For the second time add water 1680ml, decocted 1 hour, filter, collecting decoction concentrates, and drying is weighed, and measures puerarin content, and calculates the puerarin rate of transform.
No. 2: get terminalia flesh 30g, Fructus Mume 30g, Radix Puerariae 60g, Poria 30g, Radix Glycyrrhizae 60g, Radix Trichosanthis 30g amount to 240g, decoct with water 2 times, add water 2400ml for the first time, decocted 2 hours; For the second time add water 1920ml, decocted 1 hour, claim that all the other operations are the same.The results are shown in Table 1.
Table 1 Different Extraction Method is to the comparison of the puerarin rate of transform
Conclusion: when not adding terminalia flesh, the puerarin rate of transform reaches 82.84%, and when containing terminalia flesh, the puerarin rate of transform has only 39.52%, may be owing to contain generation interaction between a large amount of tannins and the flavonoid glycoside in the terminalia flesh.Therefore adopt Fructus Mume, Poria, Radix Glycyrrhizae, Radix Trichosanthis, Radix Puerariae to extract together; Mass Galla chinesis et camelliae Fermentata, terminalia flesh extract separately.
Mass Galla chinesis et camelliae Fermentata, terminalia flesh extraction conditions preferred:
Content of tannin is measured (the lucifuge operation is answered in this experiment) and is measured according to content of tannin algoscopy (appendix XB of Chinese Pharmacopoeia version in 2005).
Different Extraction Method is to the influence of the tannin rate of transform:
The a tree name bibliographical information according to the character of tannin, extracts the methods that adopt alcohol reflux and water temperature to soak at present, now two methods is compared.Because high concentration ethanol can make tannin produce precipitation, so concentration of alcohol is chosen as 60%, boiling water can make the tannin degeneration, so water temperature is chosen as 80 ℃.
Extracting method: 1. get Mass Galla chinesis et camelliae Fermentata 240g, terminalia flesh 120g, amount to 360g, add 10 times of amount 60% alcohol refluxs 3 times, each 1 hour; Filter, concentrating under reduced pressure, drying under reduced pressure gets dry extract.2. get Mass Galla chinesis et camelliae Fermentata 240g, terminalia flesh 120g, amount to 360g, add 10 times of water gagings, 80 ℃ of warm macerating 3 times, each 1 hour.Filter, reclaim under reduced pressure water, drying under reduced pressure gets dry extract.Survey content of tannin in the dried cream.Measure content of tannin in Mass Galla chinesis et camelliae Fermentata, the terminalia flesh simultaneously, and calculate the rate of transform.
Take by weighing Mass Galla chinesis et camelliae Fermentata, terminalia flesh powder and 1, No. 2 each 0.1g of dried cream powder end, method is the same.See Table 2.
Table 2 Mass Galla chinesis et camelliae Fermentata, terminalia flesh Different Extraction Method table
Conclusion: adopt alcohol reflux, filter easily, the tannin rate of transform is higher, and device requirement when considering big production is so the selective extraction method is an alcohol reflux.
Investigation factor and level: get Mass Galla chinesis et camelliae Fermentata, terminalia flesh,, adopt alcohol extraction, mainly consider the influence of concentration of alcohol, alcohol adding amount, decoction number of times, extraction time to effective ingredient according to the active component characteristics.See Table 3.
Table 3 Mass Galla chinesis et camelliae Fermentata, terminalia flesh alcohol extraction factor level table
The selection of orthogonal table and result: select L
9(3
4) orthogonal table tests 9 parts, undertaken by each test requirements document, be example with No. 1 test, see following operation for details.
Get Mass Galla chinesis et camelliae Fermentata 240g, terminalia flesh 120g, amount to 360g, add 40% ethanol and decoct once, add 40% ethanol 2880ml at every turn, extracted 1 hour.Filter, decompression recycling ethanol is put and is not had the alcohol flavor, and drying under reduced pressure gets dry extract.Survey content of tannin in the dried cream.
Get this product 0.10g, measure content of tannin, calculate the rate of transform of tannin by purgation.Owing to do not have the error row,, the results are shown in orthogonal table 4-1,4-2 so repeat to do 9 parts of tests.
Table 4-1 L
9(3
4) the alcohol extraction orthogonal experiments
Table 4-2 alcohol extraction analysis of variance table
F
1-0.10(2，9)＝3.01
* F
1-0.05(2，9)＝4.26
** F
1-0.01(2，9)＝8.02
***
ANOVA showed significant: factor A, B, D have appreciable impact to this kind alcohol extraction result, and the C factor is taken second place.To tannin rate of transform index, A factor selection level 2,3 is more or less the same, and considers energy savings, twice of selective extraction; B factor concentration of alcohol 50% to 60% is high slightly, but 50% filtration is difficult, considers actual big production equipment, so extraction solvent is chosen as 60% ethanol; Factor D selection level 2,3 is more or less the same, so select to add 10 times of amounts of water, factor C level 3 is higher, so 2 hours selective extraction time; That is: extraction time is 2 times, concentration of alcohol 60%, extracts 2 hours, 10 times of amounts of solvent consumption at every turn.
The checking of three batch datas:
Get Mass Galla chinesis et camelliae Fermentata 240g, terminalia flesh 120g, amount to 360g, add 60% ethanol 3600ml, decoct secondary, each 2 hours; Collecting decoction filters, and decompression recycling ethanol concentrates to there not being the alcohol flavor, and drying under reduced pressure gets dry extract.Survey dried cream amount, triplicate.And the mensuration content of tannin, calculate the tannin rate of transform.The results are shown in Table 5.
Table 5 three batch data proof lists
Three batches of result of the tests show that paste volume, the tannin rate of transform are more or less the same, and show process stabilizing.
Water is carried the preferred of condition:
Investigation factor and level: according to Radix Puerariae, Poria, Radix Glycyrrhizae, Radix Trichosanthis, the contained active component characteristics of Fructus Mume five kinds of Chinese medicine in the side, adopt water to carry, mainly consider to add the water multiple, extraction time, decoct the influence of number of times to the puerarin rate of transform.See Table 6.
Table 6 water is carried the factor level table
The selection of orthogonal table and result: select L
9(3
4) orthogonal table tests, undertaken by each test requirements document, be example with No. 1 test, see following operation for details.
Take by weighing Radix Puerariae 140g, Fructus Mume 70g, Poria 70g, Radix Glycyrrhizae 140g, Radix Trichosanthis 70g in the prescription ratio, amount to 490g, decoct with water 1 time, add water 3920ml at every turn, extracted 1 hour.Filter, merging filtrate, concentrate thick paste, drying under reduced pressure gets dry extract, and surveys dried cream weight and puerarin content, and calculates the total rate of transform of puerarin.
Table 7-1 L
9(3
4) water puies forward orthogonal experiments
Table 7-2 water is carried analysis of variance table
F
1-0.10(2，2)＝9
* F
1-0.05(2，2)＝19
** F
1-0.01(2.2)＝99
***
The results of analysis of variance shows: factor A, C put forward the result to this kind water appreciable impact, and the B factor is taken second place, because each factor level 2,3 is more or less the same, considers energy savings, with A
2, B
2, C
2Be optimum extraction condition, that is: add 10 times of amounts of water, decocted 1.5 hours at every turn; Extract 2 times.
The checking of three batch datas:
Get Radix Puerariae 140g, Fructus Mume 70g, Poria 70g, Radix Glycyrrhizae 140g, Radix Trichosanthis 70g, amount to 490g,, add water 4900ml, decocted secondary each 1.5 hours; Collecting decoction filters, and concentrates, and drying under reduced pressure gets dry extract, triplicate.Claim dried cream amount, measure puerarin content and calculate the puerarin rate of transform.The results are shown in Table 8.
Table 8 three batch data proof lists (Radix Puerariae medical material content is 3.051%)
Three batches of result of the tests show that paste volume, puerarin content and the puerarin rate of transform are more or less the same, and show process stabilizing.
The spray drying parameter is selected:
Because forced air drying is long heat time heating time, temperature is wayward, easily makes tannin, the degeneration of polysaccharide composition, and spray drying is adopted in producing in the historical facts or anecdotes border.
Investigate feed liquor speed, relative density of medicine liquid to influencing degree of drying, the uniformity and the drying time of ejection material.Investigate through overtesting, it is preferred selecting the clear paste of relative density 1.15～1.20 (50 ℃).
Granule formation technology preferred:
Behind the former powder mix homogeneously of dried cream powder and medical material, sieve, granulate.
Usually adopting ethanol is binding agent, now consumption, concentration is investigated.
1, binding agent concentration of alcohol (mass concentration) influences grain forming.
Get 3 parts in 500g compound powder, add 90%, 85%, 80% ethanol 100ml respectively and granulate the result: concentration of alcohol 90%, make loose particles, frangible; Concentration of alcohol 85%, it is good to make grain forming, good fluidity.Concentration of alcohol 80% during granulation, has little grit, and it is inhomogeneous to make the granule color and luster.So preferred 85% ethanol of the present invention is binding agent, molding is better.
2, binding agent ethanol consumption influences grain forming.
Get 500g compound powder, add 85% ethanol 50,100,150ml granulation respectively, the results are shown in Table 9.
Table 9 ethanol scale
Because air humidity directly influences cream powder water content, the Various Seasonal relative air humidity changes greatly, so select cream grain weight 15～20% binder dosages suitable.
3, for guaranteeing end product quality, in the preparation process, need granule is carried out Quality Control, measured angle of repose, bulk density.The method of measuring angle of repose, bulk density is a known method, and therefore process is omited herein.
Conclusion: sample of the present invention has good mobility.
Tabletting and coating:
To remain the compound powder by best granulating process and granulate, and compacting in flakes.
During coating total augment weight 3%, smooth in appearance, color and luster is even.The preferred coating raw material of the present invention for example consumption of Opadry 80W66694 is controlled at sheet gross weight 5%, and weightening finish should be controlled at 3-4%, and the coated tablet aggregative indicator that obtains is best.
In sum: above eight flavors, Bulbus Fritillariae Cirrhosae powder is broken into fine powder, crosses 80 mesh sieves, and is standby.Terminalia flesh, Mass Galla chinesis et camelliae Fermentata add 10 times of amount 60% ethanol, reflux, extract, 2 times, and each 2 hours, filter, filtrate merges, and decompression recycling ethanol is concentrated into relative density 1.15～1.20 (50 ℃) to there not being the alcohol flavor; The five tastes such as all the other Radix Puerariaes add 10 times of water gagings, extract 2 times, and each 1.5 hours, filter, filtrate merges, and is evaporated to the clear paste of relative density 1.15～1.20 (50 ℃); After above-mentioned two kinds of clear paste merging, be spray dried to fine powder.With above-mentioned fine powder mixing, make granule, be pressed into 1000, the bag film-coat promptly gets Qingyin Pian of the present invention (coated tablet).
Pharmacodynamic test of active extract
The ICR mice is selected in test for use, observes the influence of Qingyin Pian to the mouse peritoneal capillary permeability; Select for use the SD rat to observe that Qingyin Pian causes the influence of rat paw edema to Ovum Gallus domesticus album and to implanting the effect of granuloma induced by implantation of cotton pellets in the rat body.
Select for use intraperitoneal injection of cyclophosphamide to cause immunocompromised ICR mouse model, observe Qingyin Pian to the influence of mice reticuloendothelial system phagocytic function, to the influence of mouse humoral immune and the influence that DNCB is caused the mice delayed hypersensitivity by the experimental observation Qingyin Pian.
Select for use the ICR mice to observe the Qingyin Pian Dichlorodiphenyl Acetate and cause that mice produces the analgesic activity of writhing response.
Select for use the ICR mice to observe the resolve phlegm effect of Qingyin Pian to the phenol red mice of lumbar injection.
Select for use ammonia to spray the rabbit chronic pharyngitis model that the injection Oleum Terebinthinae causes under pharyngeal and the pharyngeal mucosa, observe the antiinflammatory action of Qingyin Pian.
Select the pharyngeal rat acute pharyngitis model that causes of ammonia spray for use, observe the antiinflammatory action of Qingyin Pian.
The result shows: Qingyin Pian has certain inhibitory action to the acute exudative inflammation that reflects in the test of mouse peritoneal capillary permeability; Ovum Gallus domesticus album is caused the inflammation early symptom that occurs in the rat paw edema test certain inhibitory action is arranged; Breed the propagation of phase for the inflammatory of granuloma induced by implantation of cotton pellets certain inhibitory action is also arranged.Qingyin Pian has the effect that strengthens mice reticuloendothelial system phagocytic function and strengthen humoral immune function.In writhing test, the analgesia percentage rate of two dosage groups of Qingyin Pian shows that all more than 50% it has analgesic activity.In expectorant test, Qingyin Pian has the phenol red effect of the trachea excretion of enhancing, has certain phlegm-dispelling functions.For rabbit chronic pharyngitis model, pathological replacement shows that Qingyin Pian is for being caused that by Oleum Terebinthinae the mucosa suppuration has good antiinflammatory action, essentially no suppuration kitchen range under the administration group rabbit mucosa.
In sum, Qingyin Pian has antiinflammatory, eases pain, eliminates the phlegm and strengthens the effect of humoral immunization and non-specific immunity, and rabbit chronic pharyngitis symptom is had certain inhibitory action, has verified its relieving sore-throat by clearing away heat, the effect of promoting the production of body fluid and moisturizing.
1 Qingyin Pian antiinflammatory action.
1.1 influence to the mouse peritoneal capillary permeability.
Mouse peritoneal injection dilute acetic acid solution is at H
+Stimulation under, the abdominal cavity capillary permeability increases, and liquid component oozes out to the abdominal cavity in blood vessel in the blood, and intravenous injection ivens orchid can combine with plasma protein and infiltrate the abdominal cavity with the body fluid composition, measure Intraabdominal amount of dye, inflammatory exudation what can be represented.Result of the test shows under 0.910g crude drug/kg, 0.455g crude drug/kg, 0.228g crude drug/kg dosage, Qingyin Pian is to the absorbance and the apparent in view reduction of blank group of the abdominal cavity capillary permeability of mice, difference has the significance meaning, this shows that Qingyin Pian has certain inhibitory action to inflammatory exudation.
1.2 Ovum Gallus domesticus album solution is caused rat paw edema influence test.
Fresh Ovum Gallus domesticus album is given rat foot plantar subcutaneous injection, cause inflammatory mediator release such as histamine, 5-HT, cause local capillary permeability hyperfunction, ooze out and edema early stage acute inflammation performances such as that the Mus pawl is is red, hot, swollen, pain, and similar to clinical some " heat syndrome ".Qingyin Pian is heat clearing away side's medicine, and acute inflammation is had better curative effect, can suppress early stage development of inflammation, promote it to disappear.Under 0.637g crude drug/kg, 0.318g crude drug/kg, 0.159g crude drug/kg dosage, 0.5,1 hour three dosage group after causing inflammation can both obviously suppress rat paw edema, and certain suppression ratio is arranged.And causing scorching back 2,4 hours, the various dose group still has certain inhibitory action to rat paw edema, compares with the blank group, and the difference of swelling difference has the significance meaning, illustrates that Qingyin Pian has tangible antiinflammatory action.
1.3 to the bullate influence test of rat granuloma.
Subcutaneous rat groin place implants drug sensitive test paper can produce the granulation hyperplasia similar to the pathological change of inflammation later stage.Under 0.637g crude drug/kg, 0.318g crude drug/kg, 0.159g crude drug/kg dosage, compare with the blank group, Qingyin Pian has the obvious suppression effect to the hypertrophy of granulation, and difference has the significance meaning.The result the shows Qingyin Pian effective accretion of inflammation-inhibiting propagation phase.
2 Qingyin Pians are to the influence of immunity.
2.1 Qingyin Pian medicated powder is to the influence (mice carbon clearance method) of mice reticuloendothelial system phagocytic function.
When microgranular foreign body enters in the body blood circulation, can be removed by the monokaryon macrophage phagocytic rapidly, so measure the phagocytic function that the removing speed of foreign body in the blood can reflect reticuloendothelial system.After intraperitoneal injection of cyclophosphamide being caused the mouse model intravenous injection india ink of immunocompromised, under 0.910g crude drug/kg dosage, Qingyin Pian can increase mice carbon clearance index, with model control group the significance meaning is arranged relatively.This shows that Qingyin Pian can strengthen the phagocytic function of mice reticuloendothelial system mononuclear phagocyte, can strengthen the mice non-specific immunity.And good for larynx pill is not seen obvious influence to mice carbon clearance index.
2.2 Qingyin Pian causes the influence test of mice delayed hypersensitivity to DNCB.
Dinitrochlorobenzene is the micromolecule hapten, and it is applied on the skin, can see through epithelium and be combined into holoantigen with keratoprotein and collagen protein, and stimulation T lymphocyte transformation is primed lymphocyte, is distributed in the whole skin.Attack with dinitrochlorobenzene again, promptly as seen attack the position and form DCHR.Mice is through taking Qingyin Pian medicated powder, and DNCB is caused the mice delayed hypersensitivity does not have obvious influence.
2.3 the influence that Qingyin Pian forms the mice serum hemolysin.
The chicken red blood cell immune mouse can make its lymphocyte produce specific antibody, and is released into peripheral blood.With chicken cell, complement incubation, can make the chicken red blood cell dissolving external, discharge hemoglobin.And erythrocyte hemolysis is relevant with antibody content in the serum.Result of the test shows: administration was compared with model control group after 14 days, and the absorbance of Qingyin Pian under 0.455 crude drug g/kg dosage obviously increases than model control group, and difference has the significance meaning.This shows, cause the immunocompromised model mice to irritate the stomach Qingyin Pian to intraperitoneal injection of cyclophosphamide after, chicken red blood cell induced mice specific antibody generated obvious facilitation, the reflection Qingyin Pian has the effect that strengthens humoral immunization.
3 Qingyin Pians cause the influence of mouse writhing reaction to lumbar injection acetic acid.
Lumbar injection acetic acid causes the abdominal cavity large tracts of land and produces persistent pain stimulation, and mice produces writhing response.Administration 5 days, under 0.910 crude drug g/kg, 0.455 crude drug g/kg, 0.228g crude drug/kg dosage, compare with the blank group, three dosage groups of Qingyin Pian can both reduce the mouse writhing number of times that glacial acetic acid causes, wherein have the analgesia percentage rate of two dosage groups to reach more than 50%.This shows that Qingyin Pian has certain analgesic activity.
4 Qingyin Pians are to the phlegm-dispelling functions of mice.
Mice is after the abdominal cavity injection is phenol red, and is phenol red by the respiratory mucosa discharge, and under the effect of apophlegmatisant, along with the excretory increase of trachea, the phenol red amount of being discharged by respiratory mucosa also increases, and measures phenol red excretion amount with spectrophotometric, can reflect its expectorant effect.Continuous irrigation stomach Qingyin Pian 14 days, under 0.910g crude drug/kg, 0.455g crude drug/kg, 0.228g crude drug/kg dosage, Qingyin Pian has the phenol red effect of the trachea excretion of enhancing, with blank group comparing difference the significance meaning is arranged, and shows that this product has certain resolve phlegm effect.
5 Qingyin Pians influence rabbit chronic pharyngitis model.
Inject the chronic pharyngitis Rabbit Model that terebinthine method causes in pharyngeal spraying with under pharyngeal mucosa with 4% ammonia, observe rabbit pharyngeal mucosa lower floor from the histopathology aspect and suppurative inflammation occurs, simultaneously similar to chronic pharyngitis with pathological changes such as matter hyperemia between the tela submucosa acinus, matter connective tissue proliferations.Result of the test shows: the suppurative inflammation pathological changes is compared alleviating to a certain degree under the Qingyin Pian group rabbit mucosa with model control group, and the specimen that has is not seen suppurative inflammation, is the tela submucosa cell infiltration.Pathological changes such as congested hemorrhage and interstitial proliferation are also light than model group, and learn by statistics relatively, and difference has the significance meaning.Show that these product have the effect of treatment chronic pharyngitis.
6 Qingyin Pians influence rat acute pharyngitis model.
With 15% ammonia the method for rat pharyngeal mucosa spraying is carried out the modeling of acute pharyngitis to rat, the result of total white blood cells from rat blood, Qingyin Pian does not have obviously influence to it.Pathological study result: the size of animal of model control group generation pathological changes is few, and degree is slight.All the other each groups relatively do not have significant difference with model control group, are difficult to according to this result the curative effect of medicine be estimated.
In addition, contrast through overtesting, a plurality of achievement datas show that Qingyin Pian effect in some aspects obviously is better than good for larynx pill, the beneficial effect that this advantage embodied is due to the dosage form judged according to conventional experience and technology of those skilled in the art changes no thanks to, therefore, the present invention compared with prior art, it is pleasantly surprised and attract attention that advantage is made us, and also is significant.
In sum, Qingyin Pian has antiinflammatory, enhance immunity, analgesia, phlegm-dispelling functions, and acute and chronic pharyngitis is had the obvious treatment effect.The result proves Qingyin Pian to the lung-heat body fluid deficiency, discomfort in the throat, and dry mouth and parching tongue, the therapeutical effect effect and the good for larynx pill of the acute and chronic pharyngitis of diseases such as hoarseness and aphonia are suitable.
The specific embodiment
Describe the present invention in detail below in conjunction with embodiment, but do not limit practical range of the present invention.
Right amount of auxiliary materials of the present invention is meant that the addition of adjuvant and the dried cream powder weight sum of effective ingredient are equal to the weight that preplans the product that obtains in theory, consider the agricultural product characteristic of raw material of Chinese medicine, paste volume, component content change with different year, the place of production, and produce and go up all multifactor inevitable losses that causes, those skilled in the art comprise that according to general knowledge and experience and practical situation equipment, production scale etc. take the circumstances into consideration to adjust, should not be limited with fixed numeric values, this is known in this field, need not to give unnecessary details.
Embodiment 1. tablets
Form (weight portion):
Terminalia flesh 1 Mass Galla chinesis et camelliae Fermentata 2 Bulbus Fritillariae Cirrhosaes 2 Fructus Mume 1
Radix Puerariae 2 Poria 1 Radix Glycyrrhizae 2 Radix Trichosanthis 1.
Method for making:
More than eight the flavor, Bulbus Fritillariae Cirrhosae powder is broken into fine powder, sieves, and is standby.Terminalia flesh, Mass Galla chinesis et camelliae Fermentata add 10 times of amount 60% alcohol reflux 2 times, and each 2 hours, filter, filtrate merges, and decompression recycling ethanol is concentrated into relative density 1.15～1.20 (50 ℃) to there not being the alcohol flavor, and is standby; The five tastes such as all the other Radix Puerariaes add 10 times of water extraction 2 times, and each 1.5 hours, filter, filtrate merges, and concentrating under reduced pressure becomes the clear paste of relative density 1.15～1.20 (50 ℃); After above-mentioned two kinds of clear paste merging, be spray dried to fine powder.With above-mentioned fine powder mixing, add appropriate amount of starch or microcrystalline Cellulose, make granule, be pressed into 1000.Every heavy 0.5～0.6g.
Function cures mainly: relieving sore-throat by clearing away heat, and promote the production of body fluid and moisturize.Be used for the lung-heat body fluid deficiency, discomfort in the throat, dry mouth and parching tongue, hoarseness and aphonia.
Embodiment 2. coated tablet
Form: same with embodiment 1.
Method for making: same with embodiment 1, after the compacting in flakes, wrap film-coat, promptly get the coated tablet of present embodiment.Every heavy 0.57g.
The tablet of present embodiment is a Film coated tablets, removes to show light brown behind the coating, sweet in the mouth, little sour and astringent.
Embodiment 3. capsules
Form: same with embodiment 1.
Method for making: make preceding step of granule and embodiment 1 together, after the granulation, add appropriate amount of auxiliary materials starch, incapsulate, promptly get the capsule of present embodiment.The great about 0.5g of every capsular content.
Embodiment 4. capsules
Form: same with embodiment 1.
Method for making: make preceding step of granule and embodiment 1 together, after the granulation, granule is encapsulated, promptly gets the capsule of present embodiment.About 0.45～the 0.55g of every capsular content.
Embodiment 5. granules
Form: same with embodiment 1.
Method for making: make preceding step of granule and embodiment 1 together, after the granulation, granule packs, and promptly gets the granule of present embodiment, and it is a sugar free granule.
Also can granulate with Icing Sugar before granulation, pack can obtain sacchariferous granule.
About 0.45～the 0.55g of every bag content.
Claims (10)
1. the Chinese medicine preparation of a relieving sore-throat by clearing away heat, said preparation comprises Chinese medicine composition and pharmaceutic adjuvant, and described traditional Chinese medicinal composition raw materials is made up of the component of following weight portion: 1 part of 1 part of terminalia flesh, 2 parts of Mass Galla chinesis et camelliae Fermentata, 2 parts of Bulbus Fritillariae Cirrhosaes, 1 part of Fructus Mume, 2 parts of Radix Puerariaes, 1 part in Poria, 2 parts in Radix Glycyrrhizae and Radix Trichosanthis; Wherein, the Bulbus Fritillariae Cirrhosae in this Chinese medicine composition is a Bulbus Fritillariae Cirrhosae powder, and terminalia flesh, Mass Galla chinesis et camelliae Fermentata, Fructus Mume, Radix Puerariae, Poria, Radix Glycyrrhizae and Radix Trichosanthis medical material are the extract of this medical material.
2. Chinese medicine preparation as claimed in claim 1, wherein, described terminalia flesh and Mass Galla chinesis et camelliae Fermentata are its ethanol extraction, described Fructus Mume, Radix Puerariae, Poria, Radix Glycyrrhizae and Radix Trichosanthis are its water extract.
3. Chinese medicine preparation as claimed in claim 1, wherein, described terminalia flesh and Mass Galla chinesis et camelliae Fermentata are ethanol extraction, this ethanol extraction obtains by following method:
Terminalia flesh, Mass Galla chinesis et camelliae Fermentata add the ethanol extraction of the 50-95%wt of at least 2 times of weight, reclaim ethanol, are concentrated into 50 ℃ of following relative densities 1.15～1.20, obtain the ethanol extraction of terminalia flesh, Mass Galla chinesis et camelliae Fermentata.
4. Chinese medicine preparation as claimed in claim 1, wherein, described Fructus Mume, Radix Puerariae, Poria, Radix Glycyrrhizae and Radix Trichosanthis are water extract; This water extract obtains by following method:
Get Fructus Mume, Radix Puerariae, Poria, Radix Glycyrrhizae, Radix Trichosanthis, the decocting that adds at least 5 times of weight boils, and decocting liquid or this decocting liquid obtain the water extract of described medical material through concentrating.
5. Chinese medicine preparation as claimed in claim 1, wherein, this Chinese medicine preparation is an oral dosage form; Described pharmaceutic adjuvant comprises starch, Icing Sugar, cellulose family, lactose, Mel or its combination in any.
6. Chinese medicine preparation as claimed in claim 1, wherein, this Chinese medicine preparation makes by the following method:
Get Fructus Mume, Radix Puerariae, Poria, Radix Glycyrrhizae, Radix Trichosanthis, the decocting that adds at least 5 times of weight boils, and decocting liquid or this decocting liquid obtain the water extract of described medical material through concentrating;
Terminalia flesh, Mass Galla chinesis et camelliae Fermentata add the ethanol extraction of the 50-95%wt of at least 2 times of weight, reclaim ethanol, are concentrated into 50 ℃ of following relative densities 1.15～1.20, obtain the ethanol extraction of terminalia flesh, Mass Galla chinesis et camelliae Fermentata;
Above-mentioned ethanol extract and water extract merge, and drying obtains the dry powder of extract;
Bulbus Fritillariae Cirrhosae powder is broken into Bulbus Fritillariae Cirrhosae powder;
The dry powder of said extracted thing is mixed with Bulbus Fritillariae Cirrhosae powder, add the pharmacy adjuvant, make described pharmaceutical preparation.
7. Chinese medicine preparation as claimed in claim 1, wherein, this Chinese medicine preparation is tablet, the watered pill, water-honeyed pill or capsule.
8. the preparation method of the described Chinese medicine preparation of claim 1, this method comprises:
Get Fructus Mume, Radix Puerariae, Poria, Radix Glycyrrhizae, Radix Trichosanthis, the decocting that adds at least 5 times of weight boils, and decocting liquid or this decocting liquid obtain the water extract of described medical material through concentrated, dry;
Terminalia flesh, Mass Galla chinesis et camelliae Fermentata add the ethanol extraction of the 50-95%wt of at least 2 times of weight, reclaim ethanol, are concentrated into 50 ℃ of following relative densities 1.15～1.20, obtain the ethanol extraction of terminalia flesh, Mass Galla chinesis et camelliae Fermentata;
Above-mentioned ethanol extract and water extract merge, and drying obtains the dry powder of extract;
Bulbus Fritillariae Cirrhosae powder is broken into Bulbus Fritillariae Cirrhosae powder;
The dry powder of said extracted thing is mixed with Bulbus Fritillariae Cirrhosae powder, add the pharmacy adjuvant, make described Chinese medicine preparation.
9. preparation method as claimed in claim 8, wherein, this method comprises: with the dry powder of described extract with after Bulbus Fritillariae Cirrhosae powder mixes, add the pharmacy adjuvant, this pharmacy adjuvant comprises starch, Icing Sugar, cellulose family, lactose, Mel or its combination in any.
10. preparation method as claimed in claim 8, wherein, this preparation method comprises: with the dry powder of described extract with after Bulbus Fritillariae Cirrhosae powder mixes, add the pharmacy adjuvant, this pharmacy adjuvant is starch, Icing Sugar, cellulose family, lactose or its combination in any, tabletting obtains described Chinese medicine preparation, and this Chinese medicine preparation is a tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008102470133A CN101455778B (en) | 2008-12-29 | 2008-12-29 | Traditional Chinese medicine preparation capable of reducing fever and relieving sore-throat and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2008102470133A CN101455778B (en) | 2008-12-29 | 2008-12-29 | Traditional Chinese medicine preparation capable of reducing fever and relieving sore-throat and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101455778A CN101455778A (en) | 2009-06-17 |
| CN101455778B true CN101455778B (en) | 2011-08-17 |
Family
ID=40767077
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2008102470133A Active CN101455778B (en) | 2008-12-29 | 2008-12-29 | Traditional Chinese medicine preparation capable of reducing fever and relieving sore-throat and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101455778B (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102755585A (en) * | 2012-06-20 | 2012-10-31 | 陆健 | Traditional Chinese medicine for treating chronic pharyngitis |
| CN105148098A (en) * | 2015-10-27 | 2015-12-16 | 烟台瑞智生物医药科技有限公司 | Traditional Chinese medicine for treating exuberant lung and stomach heat syndrome type wind-heat pharyngitis |
| CN109481497B (en) * | 2018-12-21 | 2021-07-20 | 广东一方制药有限公司 | Buccal tablet for relieving discomfort of oral cavity and throat and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1895535A (en) * | 2005-07-14 | 2007-01-17 | 黄开智 | Chinese-medicinal preparation for treating gutture disease and it making method |
-
2008
- 2008-12-29 CN CN2008102470133A patent/CN101455778B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1895535A (en) * | 2005-07-14 | 2007-01-17 | 黄开智 | Chinese-medicinal preparation for treating gutture disease and it making method |
Non-Patent Citations (1)
| Title |
|---|
| 药典委员会.清音丸.《中华人民共和国药典2005年版一部》.2005,618. * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101455778A (en) | 2009-06-17 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN109674958B (en) | Traditional Chinese medicine composition with effect of reducing uric acid and preparation method and application thereof | |
| CN102085257B (en) | Preparation method of micro-pills prepared from cassia twig and tuckahoe | |
| CN101455778B (en) | Traditional Chinese medicine preparation capable of reducing fever and relieving sore-throat and preparation method thereof | |
| CN103690582B (en) | A kind of compositions and application thereof containing dendrobium polysaccharide and atractylis concrete | |
| CN103845607A (en) | Compound traditional Chinese medicinal preparation for preventing and treating diabetes mellitus and preparation method thereof | |
| CN101224283A (en) | Chinese traditional medicine compounds for treating diabetes and preparing method thereof | |
| CN114272295A (en) | Traditional Chinese medicine composition for treating diabetic acromelic gangrene | |
| CN102188522A (en) | Traditional Chinese medicine composition for treating constipation | |
| CN101229329A (en) | Indigestion tablet and preparing process thereof | |
| CN101524447A (en) | Pharmaceutical composition for treating constipation and preparation process thereof | |
| CN104288527A (en) | Traditional Chinese medicinal composition for treating diabetes and preparation method and application thereof | |
| CN104983759A (en) | Traditional Chinese medicine composition treating diabetic nephropathy and preparing method thereof | |
| CN103877513A (en) | Chinese herbal compound composition with blood fat reduction effect, and applications thereof | |
| CN108704036A (en) | A kind of Chinese traditional compound medicine and preparation method thereof for treating gout | |
| CN103610975A (en) | Preparation method of cattle medicine for promoting digestion | |
| CN110448622B (en) | Medicine for treating heat type cold and preparation method and application thereof | |
| CN102579601A (en) | Medicinal composition for treating rheumatoid arthritis, and preparation method and application thereof | |
| CN111803559B (en) | Eggplant peel composition with blood sugar reducing effect and preparation method and application thereof | |
| CN102935129B (en) | Pharmaceutical composition for cleaning and removing acne and preparation method of pharmaceutical composition | |
| CN107469014A (en) | A kind of pharmaceutical composition for treating female mammary gland proliferation disease and preparation method thereof | |
| CN107596065B (en) | A kind of pharmaceutical composition treated the hypertension of pregnancy and merge preeclampsia | |
| CN101491580A (en) | Combination with blood sugar reducing function and preparation method thereof | |
| CN104352974A (en) | Ciliatenerve knotweed root-containing traditional Chinese medicine composition for treating diabetes | |
| CN103611046A (en) | Manufacturing method of composition for treating rumen indigestion | |
| CN104027450A (en) | Traditional Chinese medicine composition for treating diabetes |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant |