CN104256590A - Composition with efficacies of clearing and smoothing laryngopharynx - Google Patents
Composition with efficacies of clearing and smoothing laryngopharynx Download PDFInfo
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- CN104256590A CN104256590A CN201410486694.4A CN201410486694A CN104256590A CN 104256590 A CN104256590 A CN 104256590A CN 201410486694 A CN201410486694 A CN 201410486694A CN 104256590 A CN104256590 A CN 104256590A
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- 239000008280 blood Substances 0.000 description 1
- 108010079058 casein hydrolysate Proteins 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000003153 chemical reaction reagent Substances 0.000 description 1
- MYSWGUAQZAJSOK-UHFFFAOYSA-N ciprofloxacin Chemical compound C12=CC(N3CCNCC3)=C(F)C=C2C(=O)C(C(=O)O)=CN1C1CC1 MYSWGUAQZAJSOK-UHFFFAOYSA-N 0.000 description 1
- 238000010835 comparative analysis Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 208000006111 contracture Diseases 0.000 description 1
- 230000002354 daily effect Effects 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 235000020188 drinking water Nutrition 0.000 description 1
- 208000017574 dry cough Diseases 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 239000000428 dust Substances 0.000 description 1
- 238000004043 dyeing Methods 0.000 description 1
- 210000005069 ears Anatomy 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000003912 environmental pollution Methods 0.000 description 1
- 210000001105 femoral artery Anatomy 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 235000012631 food intake Nutrition 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 229930182494 ginsenoside Natural products 0.000 description 1
- 229940089161 ginsenoside Drugs 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- 230000000762 glandular Effects 0.000 description 1
- 125000003147 glycosyl group Chemical group 0.000 description 1
- 229940094952 green tea extract Drugs 0.000 description 1
- 235000020688 green tea extract Nutrition 0.000 description 1
- 230000002962 histologic effect Effects 0.000 description 1
- 235000001050 hortel pimenta Nutrition 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 230000002390 hyperplastic effect Effects 0.000 description 1
- 230000001900 immune effect Effects 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 210000004969 inflammatory cell Anatomy 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 229940079322 interferon Drugs 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- DEMKZLAVQYISIA-ZRWXNEIDSA-N liquiritin Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=CC=C([C@H]2OC3=CC(O)=CC=C3C(=O)C2)C=C1 DEMKZLAVQYISIA-ZRWXNEIDSA-N 0.000 description 1
- 230000000527 lymphocytic effect Effects 0.000 description 1
- 210000002540 macrophage Anatomy 0.000 description 1
- 239000000845 maltitol Substances 0.000 description 1
- 235000010449 maltitol Nutrition 0.000 description 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 description 1
- 229940035436 maltitol Drugs 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 150000002729 menthone derivatives Chemical class 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 210000001616 monocyte Anatomy 0.000 description 1
- 210000000865 mononuclear phagocyte system Anatomy 0.000 description 1
- 210000002200 mouth mucosa Anatomy 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 231100000957 no side effect Toxicity 0.000 description 1
- LSQZJLSUYDQPKJ-UHFFFAOYSA-N p-Hydroxyampicillin Natural products O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)C(N)C1=CC=C(O)C=C1 LSQZJLSUYDQPKJ-UHFFFAOYSA-N 0.000 description 1
- 230000000242 pagocytic effect Effects 0.000 description 1
- 239000012188 paraffin wax Substances 0.000 description 1
- 230000008506 pathogenesis Effects 0.000 description 1
- 238000003359 percent control normalization Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229960003531 phenolsulfonphthalein Drugs 0.000 description 1
- GWBIYORWNUYYMZ-UHFFFAOYSA-N platycodin D Natural products CC1OC(OC2C(O)C(O)COC2OC(=O)C34CCC(C)(C)CC3C5=CCC6C7(C)CC(O)C(OC8CC(CO)C(O)C(O)C8O)C(CO)(CO)C7CCC6(C)C5(C)CC4O)C(O)C(O)C1OC9OCC(O)C(OC%10OCC(O)(CO)C%10O)C9O GWBIYORWNUYYMZ-UHFFFAOYSA-N 0.000 description 1
- CYBWUNOAQPMRBA-NDTOZIJESA-N platycodin D Chemical compound O([C@H]1[C@@H](O)C[C@]2(C)[C@H]3CC=C4[C@@H]5CC(C)(C)CC[C@@]5([C@@H](C[C@@]4(C)[C@]3(C)CC[C@H]2C1(CO)CO)O)C(=O)O[C@@H]1OC[C@H](O)[C@H](O)[C@H]1O[C@@H]1O[C@H]([C@@H]([C@@H](O)[C@H]1O)O[C@H]1[C@@H]([C@@H](O[C@H]2[C@@H]([C@@](O)(CO)CO2)O)[C@H](O)CO1)O)C)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O CYBWUNOAQPMRBA-NDTOZIJESA-N 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 239000001397 quillaja saponaria molina bark Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000000306 recurrent effect Effects 0.000 description 1
- 239000003507 refrigerant Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 206010039083 rhinitis Diseases 0.000 description 1
- 230000001835 salubrious effect Effects 0.000 description 1
- 229930182490 saponin Natural products 0.000 description 1
- 150000007949 saponins Chemical group 0.000 description 1
- 231100000241 scar Toxicity 0.000 description 1
- 238000006748 scratching Methods 0.000 description 1
- 230000002393 scratching effect Effects 0.000 description 1
- 239000000779 smoke Substances 0.000 description 1
- 235000011888 snacks Nutrition 0.000 description 1
- UAJTZZNRJCKXJN-UHFFFAOYSA-M sodium;2-dodecoxy-2-oxoethanesulfonate Chemical compound [Na+].CCCCCCCCCCCCOC(=O)CS([O-])(=O)=O UAJTZZNRJCKXJN-UHFFFAOYSA-M 0.000 description 1
- 239000008279 sol Substances 0.000 description 1
- GSZUGBAEBARHAW-UHFFFAOYSA-N sophoraflavone B Natural products OC1C(O)C(O)C(CO)OC1OC1=CC=C(C=2OC3=CC(O)=CC=C3C(=O)C=2)C=C1 GSZUGBAEBARHAW-UHFFFAOYSA-N 0.000 description 1
- 239000004334 sorbic acid Substances 0.000 description 1
- 235000014347 soups Nutrition 0.000 description 1
- 230000008925 spontaneous activity Effects 0.000 description 1
- 210000004876 tela submucosa Anatomy 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 206010044008 tonsillitis Diseases 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 230000009385 viral infection Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
- A23L2/38—Other non-alcoholic beverages
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
- A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
- A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
- A23G3/48—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing plants or parts thereof, e.g. fruits, seeds, extracts
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Health & Medical Sciences (AREA)
- Nutrition Science (AREA)
- Botany (AREA)
- Inorganic Chemistry (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to the fields of foods and health products, and particularly relates to a composition with efficacies of clearing and smoothing laryngopharynx. The composition disclosed by the invention contains a ginseng extract and an immunomodulator or an immunopotentiator, wherein the ginseng extract is a total extract of total ginseng prosapogenin or a ginseng prosapogenin monomer; and the ginseng prosapogenin monomer is selected from at least one out of Rg1, Rg2, Rg3, Rg5, Rk1, Rz1, Rh1, Rh2, Rb1, Rb2, Rb3, Re, Rc or Rd. The composition with efficacies of clearing and smoothing laryngopharynx, disclosed by the invention, can be prepared into a tablet or oral liquid, such as mouth lozenge, a sustained release tablet, an orally disintegrating tablet and a chewable tablet, and can also be prepared into foods, such as beverage, soft candies, hard candies and cakes.
Description
Technical field
The present invention relates to food, field of health care products, specifically, relate to a kind of composition with throat-clearing throat-moistening effect.
Background technology
Pharyngitis, especially chronic pharyngitis are one of common diseases being very difficult at present cure.Its morbidity mainly due to bacterium, virus infections, and environmental pollution, and tobacco and wine excessive etc. be the common inducement of chronic pharyngitis very.And at present for the treatment of pharyngitis, doctor trained in Western medicine is advocated with gargles such as mouth Thailand, Dobell's solutions, containing taking Dobell, Anji lozenge etc.These curative effect of medication are lower, and Long-Time Service easily produces drug resistance.For plump hyperplastic pharyngitis, laser, microwave, the method such as freezing can be adopted.These therapies can cause the serious hyperplasia of the pharyngeal scar of Post operation, contracture and aggravation.Chronic pharyngitis is equivalent to " hypopyretic laryngalgia " of the traditional Chinese medical science, its etiology and pathogenesis be lung-kidney deficiency cause easily get ecited, throat lose support.Control should nourishing the lung and kidney, clearing heat and eliminating phlegm, wet one's whistle relieve sore throat.Also disclose at present medicine or the health products of a lot of Chinese medicine, generally adopt heat-clearing, deciphering, nourishing Yin and moistening lung effect Chinese drug preparation form.And Chinese medicine has onset slowly, the defect that complicated component, uncertain therapeutic efficacy are cut.
ZL201110122329.1 discloses a kind of extract for the treatment of sphagitis, contains: schizonepeta 1 part, balloonflower root 4 parts, 2 parts, raw Radix Glycyrrhizae; And be prepared by supercritical preparation process.Glycyrrhizic acid >=2.8%, liquiritin >=0.7%, Platycodin D >=0.3%, menthones >=0.04% is equipped with in described extract.Patent application 201310087764.4 provides a kind of pharynx-clearing throat-benefiting preparation, containing herba houttuyniae powder 400 ~ 800 parts, dendrobe powder 150 ~ 250 parts, Astragalus Root P.E 200 ~ 400 parts and green-tea extract 40 ~ 80 parts.Patent application 200910017358.4 discloses a kind of Chinese medicine for the treatment of pharyngo-laryngitis chronica, is mixed by raw material levigations such as radix scrophulariae, ginseng, the fruit of Chinese wolfberry, the tuber of pinellia, Exocarpium Citri Rubrum, blackberry lily, Bulbus Fritillariae Cirrhosae, Ligusticum wallichii, courage star, edible tulip, willowweed, Long Liye, subprostrate sophora, Radix Glycyrrhizaes.Patent application 201010602027.X discloses a kind of medicine for the treatment of tracheitis rhinitis, sphagitis, swollen wind-puff, pulmonary heart disease, asthma, and it comprises glossy ganoderma, ginseng, HERBA EPIMEDII, the Radix Astragali, giant knotweed, rhizoma Gastrodiae, cordate houttuynia and Radix Glycyrrhizae.
In order to overcome defect of the prior art, special proposition the present invention.
Summary of the invention
Goal of the invention of the present invention is to propose a kind of composition with throat-clearing throat-moistening effect.
In order to realize object of the present invention, the technical scheme of employing is:
The present invention relates to a kind of composition with throat-clearing throat-moistening effect, containing ginseng extract and immunomodulator or immunopotentiator in described composition, wherein the weight ratio of ginseng extract and immunomodulator or immunopotentiator is 1:0.1 ~ 10, preferred 1:0.1 ~ 5; Ginseng extract content is 0.0001 ~ 0.05wt%, preferably 0.0005 ~ 0.01wt%; The content of immunomodulator is 0.001 ~ 0.1wt%, preferably 0.002 ~ 0.05wt%.
First optimal technical scheme of the present invention is: the ginseng prosapogenin monomer that described ginseng extract is total secondary ginseng glucoside's pharmaceutical composition or purifies out, and described ginseng prosapogenin monomer is selected from Rg
1, Rg
2, Rg
3, Rg
5, Rk
1, Rz
1, Rh
1, Rh
2, Rb
1, Rb
2, Rb
3, at least one in Re, Rc or Rd.
Second optimal technical scheme of the present invention is: described immunomodulator or immunopotentiator are selected from short corynebacteria preparation, pseudomonad preparation, BCG-polysaccharide, nucleic acid preparation, Nocardia rubra cell skeleton, A group streptococcus preparation, Pseudomonas aeruginosa preparation, Brucella sp preparation or thymopeptide-5; Or be selected from the cell-free preparation of short corynebacteria, the cell-free preparation of pseudomonad, the cell-free preparation of BCG-polysaccharide, nucleic acid, the cell-free preparation of Lyopgized Nocardia rubra-cell Wall Skeleton, the cell-free preparation of A group streptococcus, the cell-free preparation of Pseudomonas aeruginosa or the cell-free preparation of Brucella sp; Or be selected from the CpG DNA of described immunomodulator or immunopotentiator.
3rd optimal technical scheme of the present invention is: also containing Radix Glycyrrhizae or licorice in composition of the present invention, described licorice comprises glycyrrhizic acid, glycyrrhizin and enoxolone.
4th optimal technical scheme of the present invention is: the addition of Radix Glycyrrhizae or licorice is 0.01 ~ 0.5wt%, preferably 0.05 ~ 0.3wt%.
5th optimal technical scheme of the present invention is: also containing menthol in composition, the addition of described menthol is 0.01 ~ 0.5wt%, preferably 0.05 ~ 0.3wt%.
6th optimal technical scheme of the present invention is: also containing pH adjusting agent, sweetener and anticorrisive agent in described composition; Described pH adjusting agent is selected from least one in citric acid, lactic acid, malic acid or tartaric acid; Sweetener is selected from least one in mannose, fructose, sucrose or maltose, and anticorrisive agent is selected from Sodium Benzoate or potassium sorbate.
The invention still further relates to a kind of containing tablet or the oral liquid with the composition of throat-clearing throat-moistening effect of the present invention, described tablet is selected from buccal tablet, sustained release tablets, disintegrated tablet, chewable tablets.
The invention still further relates to a kind of containing the food with the composition of throat-clearing throat-moistening effect of the present invention, described food is beverage, soft sweets, hard candy.
Below technical scheme of the present invention is made further explanation.
Total secondary ginseng glucoside's pharmaceutical composition in composition of the present invention is by ginsenoside partial hydrolysis, and take off the mixture of the secondary saponin(e of catabolite of part glycosyl, its physiologically active strengthens greatly.
Immunomodulator has the ability of activated mononuclear mononuclear phagocyte system, immune effect is mainly manifested in: activated mononuclear macrophage, NK cytoactive is strengthened, promote that body produces IgG and IgM, inducement interferon, interleukins-2 etc. to plurality of antigens, therefore there is antitumor and anti-infectious function.And after immunopotentiator absorbed by oral mucosa epithelial cell, the immunocyte in epithelium can be activated, thus play the effect of anti-inflammatory.Total secondary ginseng glucoside extract in the present invention can increase the activity of the immunocyte be activated further, thus increases its phagocytic activity.The discovery that inventor is pleasantly surprised in research process, merge with total secondary ginseng glucoside and immunopotentiator and use, in the direct administration in position, chamber, determined curative effect, has no drug resistance, efficient height, and individual difference is little; Not only may be used for treating pharyngitis, sphagitis, canker sore, gingivitis, periodontitis and tonsillitis can also be used for the treatment of, and security is high, has no side effect.
The present invention, on the basis containing immunomodulator and total secondary ginseng glycoside composition, also with the addition of the extract of Radix Glycyrrhizae or Radix Glycyrrhizae further, thus increases curative effect further.Glycyrrhizic acid has good antiinflammation, and has the effect of certain develop immunitypty.After being added with glycyrrhizic acid, can further improve the effect of the anti-inflammatory in the oral cavity of the present composition, thus better reach and can treat pharyngitis, sphagitis, canker sore, gingivitis, periodontitis and tonsillitic effect.
The present invention, on the basis containing immunomodulator and total secondary ginseng glycoside composition, also with the addition of menthol further, from but product has more refrigerant pleasant mouthfeel.Thus after human body is taken, sensation throat is salubrious, comfortable, moistens.
The principle of the present composition is the immunity increasing oral cavity, bottleneck throat mucous membrane, thus reaches the effect of anti-inflammation, overcomes the shortcoming taking drug resistance that antibiotic causes or flora imbalance.And oral traditional Chinese medicine preparation, due to complicated component in Chinese medicine compound prescription, and need oral administration, need through renal metabolism, and the traditional Chinese medicine ingredients of complexity can increase the weight of the burden of kidney, kidney is caused damage.And composition of the present invention in oral cavity, the direct administration of bottleneck throat, directly absorbed by the epithelial cell of oral cavity, bottleneck throat, do not need the metabolism through health just can directly onset, it is not only rapid-action, and without other toxic and side effects, and dosage is little, and can make an addition in candy or beverage, cured the disease in Chi Tang limit, patient limit, greatly reduce the misery of medication.
Composition of the present invention confirms through zoopery and clinical testing, and have very strong anti-inflammatory activity, clinical effectiveness cure rate is high, determined curative effect.
The present invention can be prepared into pharmaceutical preparation, and various formulation of the present invention can adopt formula of the prior art and preparation scheme to be prepared.Owing to not containing drug ingedient in composition of the present invention, can also make and can supply daily edible pot foods, candy, snacks etc., thus when people can be utilized to eat a piece, good health-care effect is played to the chronic disease such as throat, canker sore, there is obvious pharynx-clearing throat-benefiting health care.
The specific embodiment of the present invention is only limitted to explain further and the present invention is described, does not limit Composition of contents of the present invention.
Detailed description of the invention
Embodiment 1: buccal tablet
Formula is: total secondary ginseng glucoside's pharmaceutical composition 0.05g, short corynebacteria cell-free preparation 0.1g, licorice 0.3g, menthol 0.3g, low-substituted hydroxypropyl cellulose 62.75g, hydroxypropyl cellulose 14g, dolomol 1g, superfine silica gel powder 5g, xylitol 15g, citric acid 1g, potassium sorbate 0.5g.And make 200, every sheet contains total secondary ginseng glucoside's pharmaceutical composition 0.25mg.
Embodiment 2: buccal tablet
Formula is: ginseng prosapogenin Rh
11mg, Rh
21mg, Rg
21mg and Rg
31mg, the cell-free preparation 1mg of BCG-polysaccharide, nucleic acid preparation, licorice 2g, menthol 1g, hydroxypropyl cellulose 18g, dolomol 1g, superfine silica gel powder 5g, fructose 2g, xylitol 5g, citric acid 0.5g, potassium sorbate 0.5g, it is 100g that low-substituted hydroxypropyl cellulose complements to gross mass.And make 200, every sheet contains ginseng prosapogenin 0.02mg.
Embodiment 3: disintegrated tablet
Formula is: ginseng prosapogenin Rb
11mg, Rg
31mg, short corynebacteria cell-free preparation 1mg, licorice 2g, menthol 1g, xylitol 5g, citric acid 0.5g, potassium sorbate 0.5g, pregelatinized starch 19g, superfine silica gel powder 3g, Ac-Di-Sol 5g, it is 100g that dolomol 1g, low-substituted hydroxypropyl cellulose complement to gross mass; And make 200, every sheet contains ginseng prosapogenin 0.01mg.
Embodiment 4: soft sweets
Formula is: ginseng prosapogenin Rb
11mg, Rg
31mg, Rb
31mg, Rg
11mg, Rg
2it is 100g that the cell-free preparation 2mg of 1mg, pseudomonad, licorice 0.01g, menthol 0.01g, citric acid 1g, gelatin 5g, maltitol 16g, maltose complement to gross mass.And make 50, every sheet contains ginseng prosapogenin 0.1mg.
Embodiment 5: beverage
Formula is: total secondary ginseng glucoside's monomer Rb
10.5g, Rg
30.5g, A group streptococcus cell-free preparation 1g, licorice 5g, menthol 1g, citric acid 2g, potassium sorbate 0.5g, sucrose 50g, adding distil water, to 5L, is distributed into 100 bottles.
Embodiment 6: hard candy
Formula is: it is 100g that total secondary ginseng glucoside's pharmaceutical composition 5mg, short corynebacteria cell-free preparation 0.05g, licorice 0.1g, menthol 0.5g, citric acid 2g, white granulated sugar 83g, maltose complement to gross mass.And make 50.Every sheet contains ginseng prosapogenin 0.1mg.
Embodiment 7: hard candy
Formula is: it is 100g that total secondary ginseng glucoside's pharmaceutical composition 5mg, thymopeptide-5 0.1g, licorice 0.1g, menthol 0.5g, citric acid 2g, white granulated sugar 83g, maltose complement to gross mass.And make 50.Every sheet contains ginseng prosapogenin 0.1mg.
Experimental example 1
1 experiment material
1.1 Experimental agents
Group 1: the buccal tablet that the formula of embodiment 1 prepares;
Group 2: the buccal tablet prepared according to the formula of embodiment 1; But only add total secondary ginseng glucoside, do not add immunopotentiator;
Group 3: the buccal tablet prepared according to the formula of embodiment 1; But only add immunopotentiator, do not add total secondary ginseng glucoside;
Above-mentioned Experimental agents is prepared solution for standby.
The selection of 1.2 positive drug and dosage are arranged
Amoxil capsule: astute water pharmaceutcal corporation, Ltd of Harbin Pharmaceutical Group three produces, and people's consumption per day is 500mg; By the conversion of body surface area ratio, animal used as test dosage 30mg/kg, is equivalent to 10.8 times of clinical day for human beings dosing, is mixed with 1% concentration for experiment with distilled water.
1.3 animal used as test
Kunming mouse, Wistar rat, Japan large ear rabbit.
1.4 major experimental instrument and reagent
721 spectrophotometers, centrifugal precipitation mechanism, Olympus light microscope, plum Teller-Tuo benefit GB303 basic model balance, laryngeal spray, turpentine oil, concentrated ammonia liquor, dimethylbenzene (content >99.0%), methyl alcohol (analyzing pure), phenol red, sodium acid carbonate (analyzing pure), casein hydrolysate, agar.
1.5 statistical method
Enumeration data adopts X
2inspection, measurement data adopts t inspection, uses SPSS12.0 statistical package to complete.
2 experimental techniques and result
2.1 chronic pharyngitis animal model comparitive study
Select body weight 2 ~ 2.5kg Japan large ear rabbit, male and female dual-purpose.Be divided into normal group, model control group, experimental group 1, experimental group 2, experimental group 3 at random, often organize 10.
Set up chronic pharyngitis animal model, except normal group, other 4 groups of every days, with 2.5% ammoniacal liquor spray pharyngeal twice, spray 3 times with sprayer at every turn, within the 8th day, in pharyngeal submucosal injection turpentine oil 0.5ml, and continue spray ammoniacal liquor to the 15th day.16th ~ 25 days, modeling group gavage every day equal-volume physiological saline, the experimental group gavage every day Experimental agents aqueous solution 1 slice/day, 1 time/d, continuous 10 days.
5 treated animals got pharyngeal on 26th after femoral artery sacrificed by exsanguination, and fixing in the neutral formalin of 10%, routine paraffin wax embeds, section, dyeing, om observation, and carries out statistics comparative analysis in table 1 to the histologic lesion of each group of throat swab:
Table 1: each treated animal pharyngeal pathomorphism compares
Note: with group 2 than #P<0.05, ##P<0.01; With group 2 than * P<0.05, * * P<0.01.
Result: observe on rabbit chronic pharyngitis model, modeling plays most of rabbit on 3rd and engenders that spontaneous activity reduces, oral area of scratching, frequently drinking-water, amount is few, and oral secretion increases, food-intake slightly reduces, body weight slightly declines, congestion of throat, Mild edema etc., injection turpentine oil after 1 ~ 2 day, feed subtracts greatly, and occur individually panting, pharyngeal oedema is obvious.There is not above-mentioned situation in normal group, experimental group 1 symptom alleviates, and recovers very fast.Pharyngeal pathomorphism shows: model group animal is chronic congestion state, kermesinus, and glossiness is not good enough, and secretion increases.Mucous epithelium is prominent shape hyperplasia in nail, tunica propria is swelling in various degree, blood vessel hyperplasia, increasing number, visible obviously cell infiltration, based on lymphocyte and monocyte, submucosa lymphocyte, histocyte and proliferation of fibroblast, the changes such as serous gland mucous modification, comparing with normal group has significant difference (P<0.05, P<0.01), modeling success is shown.And as seen from the data in Table 1, group 1 obviously can improve the tired blood state of the pharyngeal blood vessel dilatation of Japan large ear rabbit, suppress or alleviate the infiltration of inflammatory cell, suppress fibroblast proliferation and glandular secretion, with group 2 with organize 3 and compared significant differences (P<0.01, P<0.05).
2.2 anti-mice caused by dimethylbenzene xylene ear swelling tests
Select body weight 23 ~ 30g mouse, male and female dual-purpose, is divided into 5 groups at random, is respectively saline control group, experimental group 1, experimental group 2, experimental group 3, Western medicine group; Saline control group gavage every day equal-volume physiological saline, the experimental group gavage every day Experimental agents aqueous solution 0.5 slice/day, Western medicine group gives Amoxicillin 1mg/ days; Every day gavage once, 1 time/d, continuous 7 days.And after last administration in the 7th day 1h, smear dimethylbenzene 0.lml at the wide positive and negative of mouse right ear, left ear makes blank.After 30 minutes, mouse is put to death in dislocation of cervical vertebra, cuts two ears, lay round auricle (diameter 9mm) weigh at same position card punch along auricle baseline.Represent inflammatory swelling degree with the difference of two auricle weight, t inspection between organizing, and obtain the inhibitory rate of intumesce of each group as follows.Experimental result is in table 2.
Average swelling × 100% of the average swelling/control group of inhibitory rate of intumesce (%)=control group average swelling-administration group
Table 2: the experimental result (X ± s, %) of anti-mice caused by dimethylbenzene xylene auricle edema
P is for compared with experimental group 1.
Result shows, and the auricle edema (P<0.01) that composition of the present invention can significantly suppress dimethylbenzene to cause, inhibiting rate can reach 49.39%, and effect is better than Western medicine group.
Experimental example 2: clinical trial
1 data and method
1.1 physical data
During selecting year November in May, 2012 to 2012, outpatient service chronic pharyngitis case 78 example is divided into two groups at random, often organizes 39 routine treatment group man 19 examples, female 20 example; Year at age 15 ~ 65 (35.150 ± 4.696); The course of disease (52.870 ± 6.027) d control group man 17 example, female 22 example; Year at age 15 ~ 65 (36.200 ± 4.903); The course of disease (53.840 ± 5.769) d two groups of cases are through statistical analysis in sex, age etc., and no significant difference (P > 0.05), has comparativity.
Diagnostic criteria: all case diagnosis are all diagnosed with reference to " modern internal medicine diagnosis handbook ".Cardinal symptom and sign: pharyngeal discomfort, pharyngeal drying or itch, hypodynia foreign body sensation, burn feeling, the few phlegm of dry cough or without phlegm etc.; Check and find the swelling of pharyngeal mucous membrane chronic congestion, or lateral pharyngeal band enlargement, pharynx rear wall lymphocytic hyperplasia is red and swollen, has infiltration of more lymphocytes around its blood vessel.Often have acpuei pharyngitis recurrent exerbation medical history, or because of tobacco and wine excessively, with sound excessively, dust oil smoke stimulates and brings out.
1.2 methods for the treatment of
Control group gives the treatment of relieve sore throat soup, square medicine composition: honeysuckle 24g, capsule of weeping forsythia 15g, root of large-flowered skullcap 15g, Radix Isatidis 21g, blackberry lily 12g, great burdock achene 15g, subprostrate sophora 9g, radix scrophulariae 20g, cicada slough 12g, peppermint 10g, wintercherry fruit or calyx 6g, Radix Glycyrrhizae 6g is decocted in water for oral dose, day potion, sooner or later twice sub-service
Treatment group: give embodiment 1 lozenge, every day 5 is sucked and takes.
All treat 14d for two groups.
1.3 curative effect determinate standard
Criterion of therapeutical effect is drafted according to " disease of tcm Standardization of diagnosis and curative effect ":
Cure: clinical symptoms disappear completely, and pharyngeal mucous membrane hyperemia is disappeared, pharynx rear wall lymph follicle disappears;
Effective: clinical symptoms are significantly improved, pharyngeal mucous membrane hyperemia alleviates, and pharynx rear wall lymph follicle obviously reduces;
Invalid: clinical symptoms, sign is unchanged.
1.4 statistical methods adopt SPSS 16.0 statistics software process measurement data to represent with mean ± standard (x ± s), and ranked data adopt rank test, and measurement data adopts t inspection, and enumeration data adopts X
2inspection P < 0.05 has statistical significance for difference.
2 results
Table 3:
Group | Number of cases | Cure | Effective | Invalid | Efficient |
Treatment group | 39 | 19 | 17 | 3 | 92.3% |
Control group | 39 | 11 | 16 | 12 | 69.2% |
Adopt the formula of other embodiments of the invention also can obtain the experiment effect similar to this experimental example with composition.
Claims (9)
1. one kind has the composition of throat-clearing throat-moistening effect, it is characterized in that, containing ginseng extract and immunomodulator or immunopotentiator in described composition, wherein the weight ratio of ginseng extract and immunomodulator or immunopotentiator is 1:0.1 ~ 10, preferred 1:0.1 ~ 5; Ginseng extract content is 0.0001 ~ 0.05wt%, preferably 0.0005 ~ 0.01wt%; The content of immunomodulator or immunopotentiator is 0.001 ~ 0.1wt%, preferably 0.002 ~ 0.05wt%.
2. the composition with throat-clearing throat-moistening effect according to claim 1, is characterized in that, the ginseng prosapogenin monomer that described ginseng extract is total secondary ginseng glucoside's pharmaceutical composition or purifies out, and described ginseng prosapogenin monomer is selected from Rg
1, Rg
2, Rg
3, Rg
5, Rk
1, Rz
1, Rh
1, Rh
2, Rb
1, Rb
2, Rb
3, at least one in Re, Rc or Rd.
3. the composition with throat-clearing throat-moistening effect according to claim 1, it is characterized in that, described immunomodulator or immunopotentiator are selected from short corynebacteria preparation, pseudomonad preparation, BCG-polysaccharide, nucleic acid preparation, Nocardia rubra cell skeleton, A group streptococcus preparation, Pseudomonas aeruginosa preparation, Brucella sp preparation or thymopeptide-5; Or be selected from the cell-free preparation of short corynebacteria, the cell-free preparation of pseudomonad, the cell-free preparation of BCG-polysaccharide, nucleic acid, the cell-free preparation of Lyopgized Nocardia rubra-cell Wall Skeleton, the cell-free preparation of A group streptococcus, the cell-free preparation of Pseudomonas aeruginosa or the cell-free preparation of Brucella sp; Or be selected from the CpG DNA of described immunomodulator or immunopotentiator.
4. the composition with throat-clearing throat-moistening effect according to claim 1, is characterized in that, also containing Radix Glycyrrhizae or licorice in described composition, described licorice comprises glycyrrhizic acid, glycyrrhizin and enoxolone.
5. the composition with throat-clearing throat-moistening effect according to claim 1, is characterized in that, the addition of described Radix Glycyrrhizae or licorice is 0.01 ~ 0.5wt%, preferably 0.05 ~ 0.3wt%.
6. the composition with throat-clearing throat-moistening effect according to claim 1, is characterized in that, also containing menthol in described composition, the addition of described menthol is 0.01 ~ 0.5wt%, preferably 0.05 ~ 0.3wt%.
7. the composition with throat-clearing throat-moistening effect according to claim 1, is characterized in that, also containing pH adjusting agent, sweetener and anticorrisive agent in described composition; Described pH adjusting agent is selected from least one in citric acid, lactic acid, malic acid or tartaric acid; Sweetener is selected from least one in mannose, fructose, sucrose or maltose, and anticorrisive agent is selected from Sodium Benzoate or potassium sorbate.
8., containing the tablet with the composition of throat-clearing throat-moistening effect described in the arbitrary claim of claim 1 ~ 7 or an oral liquid, described tablet is selected from buccal tablet, sustained release tablets, disintegrated tablet, chewable tablets.
9., containing the food with the composition of throat-clearing throat-moistening effect described in the arbitrary claim of claim 1 ~ 7, described food is beverage, soft sweets, hard candy.
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