CN1634479A - Medicine composition for treating cold and upper respiratory tract infection, preparation method and purpose thereof - Google Patents
Medicine composition for treating cold and upper respiratory tract infection, preparation method and purpose thereof Download PDFInfo
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- CN1634479A CN1634479A CNA2004100961749A CN200410096174A CN1634479A CN 1634479 A CN1634479 A CN 1634479A CN A2004100961749 A CNA2004100961749 A CN A2004100961749A CN 200410096174 A CN200410096174 A CN 200410096174A CN 1634479 A CN1634479 A CN 1634479A
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Abstract
The present invention discloses a pharmaceutical composition used for treating common cold and upper respiratory tract infection, which comprises the pharmaceutical product made according to the following components and proportions: 1-600 parts aspirin, 1-100 parts artificial ox gallstone, 1-300 parts amantadine hydrochloride, 1-80 parts caffeine, 1-10 parts chlorpheniramine maleate, 1-1000 parts flower of honeysuckle or/and 1-1000 parts folium isatidis. There is also discloses a process for preparation of said pharmaceutical composition. As Chineses and Western medicine compound recipe formulation, the pharmaceutical composition in accordance with the present invention exhibits effects such as refrigeration, ease pains, antivirus, antibiotic, antiinflammatory and the like, can be clinically used for removing or alleviating symptoms such as nasal, sternutation, rhinorrhea, fervescence, headache, neuralgia, thews aches, throat painful swelling and the like which are caused by common cold and upper respiratory tract infection.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, Its Preparation Method And Use; relate in particular to a kind of by aspirin, artificial Calculus Bovis, amantadine hydrochloride, caffeine, chlorphenamine maleate, Flos Lonicerae or/and the pharmaceutical composition that the Folium Isatidis drug regimen forms, its preparation method and removing or alleviating purposes aspect the diseases such as flu and the caused nasal obstruction of upper respiratory tract infection, sneeze, rhinorrhea, heating, headache, neuralgia, muscular soreness, laryngopharynx swelling and pain.
Background technology
Flu and upper respiratory tract infection are common frdquently encountered diseases, symptom shows as nasal obstruction, sneeze, rhinorrhea, heating, headache, neuralgia, muscular soreness, laryngopharynx swelling and pain etc., influence people's operate as normal and life, severe patient crisis people's life, clinical in the above-mentioned symptom of catching a cold and upper respiratory tract infection causes, usually adopt the compound Western medicine preparation symptomatic treatment, as aspirin, caffeine, the chlorphenamine maleate assembly, the above-mentioned ill symptoms that is used to catch a cold and causes, sometimes the flu that causes at epidemic virus is organized the complex salt symmetrel separately and is carried out the correspondence treatment at influenza virus; Certainly; clinical also use aspirin, caffeine, chlorphenamine maleate, amantadine hydrochloride one or more make the Chinese medicine and western medicine compound preparation with the Chinese medicine with heat-clearing and toxic substances removing such as artificial Calculus Bovis, Herba Andrographis, Radix Isatidis, YINQIAO, Rhizoma Dryopteris Crassirhizomatis etc.; be used to catch a cold and ill symptoms treatment that upper respiratory tract infection causes; has certain treating both the principal and secondary aspects of a disease effect, the clinical certain curative effect that obtains.Make compound recipe Rhizoma Osmundae aspirin tablet as aspirin, chlorphenamine maleate and Radix Isatidis, Flos Chrysanthemi Indici, Rhizoma Dryopteris Crassirhizomatis, Radix Sophorae Tonkinensis compatibility, the treatment of diseases such as the laryngopharynx swelling and pain that causes of can be used for catching a cold, heating clinically obtains better curative effect.
Application number 98100721, denomination of invention compound cold-preventing nasal drop and preparation method thereof discloses a kind of medicine for the treatment of flu, belong to compound preparation, it is characterized in that, Rhizoma Osmundae 200-300 gram, Radix Scutellariae 200-280 gram, Radix Isatidis 200-300 gram, Flos Lonicerae 100-150 gram, Fructus Forsythiae 100-150 gram, Radix Glycyrrhizae 50-60 gram, Folium Isatidis 200-300 gram, amantadine hydrochloride 25 grams, Mentholum 5 grams, vinegar 100 grams.
Application number 03108749, denomination of invention compound recipe Rhizoma Osmundae aspirin tablet, a kind of medicaments compound Rhizoma Osmundae aspirin tablet for the treatment of flu and influenza is disclosed, it is by the following raw materials by weight percent medicine: Rhizoma Dryopteris Crassirhizomatis 30-42%, Radix Isatidis 20-30%, Flos Chrysanthemi Indici 20-30%, Radix Sophorae Tonkinensis 8-16%, aspirin 1-4%, chlorphenamine maleate 0.01-0.1% make.This medicine is the product that Chinese medicine and western medicine organically combines, western medicine composition antipyretic-antalgic wherein, relief of symptoms; Chinese medicinal ingredients is at the cause of disease, kill virus.The Chinese medicine and western medicine synergism, treating both the principal and secondary aspects of a disease, treatment is significantly.
Therefore, adopt the bonded mode of Chinese medicine and western medicine, the treatment flu for the treatment of both the principal and secondary aspects of a disease and upper respiratory tract infection are very significant.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition for the treatment of flu and upper respiratory tract infection, this pharmaceutical composition is the Chinese medicine and western medicine compound preparation, have effects such as analgesic, analgesia, antiviral, antibiotic, antiinflammatory, clinically can be used for removing or alleviate symptoms such as flu and the caused nasal obstruction of upper respiratory tract, sneeze, rhinorrhea, heating, headache, neuralgia, muscular soreness, laryngopharynx swelling and pain, and this medicine has advantages such as treatment speed is fast, remission is fast, side effect is little.
Another object of the present invention is to provide a kind of preparation of drug combination method for the treatment of flu and upper respiratory tract infection.
A further object of the present invention is to provide a kind of pharmaceutical composition for the treatment of flu and upper respiratory tract infection, can be used for removing or alleviate the purposes of disease aspects such as flu and the caused nasal obstruction of upper respiratory tract, sneeze, rhinorrhea, heating, headache, neuralgia, muscular soreness, laryngopharynx swelling and pain.
A kind of pharmaceutical composition for the treatment of flu and upper respiratory tract infection of the present invention comprises the medicament that following component and proportioning are made:
1～600 part of aspirin, 1～100 part of artificial Calculus Bovis,
1～300 part of amantadine hydrochloride, 1～80 part of caffeine,
1～10 part of chlorphenamine maleate, 1～1000 part of Flos Lonicerae are or/and 1～1000 part of Folium Isatidis.
Preferred ingredients and proportioning:
30～400 parts of aspirin, 1～50 part of artificial Calculus Bovis,
10～200 parts of amantadine hydrochlorides, 3～50 parts of caffeine,
1～8 part of chlorphenamine maleate, 100～800 parts of Flos Loniceraes are or/and 100～800 parts of Folium Isatidiss.
More preferred ingredients and proportioning:
50～300 parts of aspirin, 5～30 parts of artificial Calculus Boviss,
20～150 parts of amantadine hydrochlorides, 10～40 parts of caffeine,
200～600 parts of 1～5 part of chlorphenamine maleate, 200～600 parts of Flos Loniceraes and Folium Isatidiss.
Most preferred component and proportioning:
250 parts of aspirin, 10 parts of artificial Calculus Boviss,
100 parts of amantadine hydrochlorides, 15 parts of caffeine,
500 parts of 2 parts of chlorphenamine maleate, 500 parts of Flos Loniceraes and Folium Isatidiss.
Weight portion of the present invention can be the known content units of field of medicaments such as μ g, mg, g, kg.
Pharmaceutical composition of the present invention is a kind of flu and compound preparation of upper respiratory tract infection for the treatment of, and has effects such as analgesic, analgesia, antiviral, antibiotic, antiinflammatory.
Aspirin (C wherein
9H
8O
4) by suppressing prostaglandin and act on the hypothalamus thermotaxic centre to play analgesia and refrigeration function.
The artificial Calculus Bovis is that bass element, cholic acid, Hyodeoxycholic Acid, bilirubin, cholesterol, inorganic salt etc. are formulated, has heat clearing away, detoxifies, eliminates the phlegm, antiinflammatory, arresting convulsion effect, is used for the heat-phlegm delirium, coma in silence, the anxious hot infantile convulsion of children's, laryngopharynx swelling and pain.
Amantadine hydrochloride (C
10H
17NHCl), have influenza A type virus function, can be used for the prevention and the treatment of influenza.
Chlorphenamine maleate (has another name called chlorphenamine, C
16H
19ClN
2C
4H
4O
4) be antihistaminic, can competitiveness block the H1 receptor and produce irritated effect, make the nasal mucosa drying by anti-M cholinoceptor simultaneously, can eliminate or alleviate nasal obstruction, sneeze, rhinorrhea and various allergic symptom, and have sedation.It also has central inhibitory action, produces sleepy and drowsiness.
Caffeine (C
8H
10N
4O
2H
2O) be central stimulants, low dose acts on the elevated maincenter of cerebral cortex, impels mental excitation, and relieving fatigue can increase analgesic effect, and it is caused sleepy to eliminate chlorphenamine maleate.
The Chinese crude drug Flos Lonicerae is the flower that the evergreen prehensile bejuco of Caprifoliaceae perennial half Radix Ophiopogonis, Flos Lonicerae, Flos Lonicerae or hair style Radix Ophiopogonis dry flower or band are just opened, and mainly contains active ingredients such as chlorogenic acid and isochlorogenic acid.Has heat-clearing and toxic substances removing, the dispelling wind and heat pathogens effect, Flos Lonicerae has certain inhibitory action to various pathogens as staphylococcus aureus, Hemolytic streptococcus, escherichia coli, vibrio cholera, Bacillus typhi, Salmonella paratyphi, streptococcus pneumoniae, bacillus pyocyaneus, tubercule bacillus in addition.Flos Lonicerae and Chinese patent medicine prepared therefrom are the conventional Chinese medicine of heat-clearing and toxic substances removing, anti-inflammation, are used for affection due to external wind and heat or epidemic febrile disease from the beginning of the headache of, fever of the body, and pharyngalgia is thirsty, clinically can be used for disease treatments such as upper respiratory tract infection, acute tonsillitis, pharyngitis, pneumonia.
The Chinese crude drug Folium Isatidis is the dried leaves of Cruciferae Isatis indigotica Fort., mainly contains active ingredients such as indirubin.Has heat-clearing and toxic substances removing, the effect of cooling blood for hemostasis.Motherland's medical science is thought, Folium Isatidis bitter in the mouth cold in nature, and energy heat clearing away, detoxifcation, cooling blood for hemostasis, commonly used with diseases such as treatment epidemic febrile disease intenseness of heat excessive thirst, erysipelas, haematemesis, epistaxis, sore throat, aphtha, swollen ulcer drugs.
Modern pharmacological research shows:
(1) Folium Isatidis has antivirus action, the Folium Isatidis of different germplasms has been carried out antiviral with chick embryo method studies show that Folium Isatidis has antivirus action to influenza A virus;
(2) Folium Isatidis has anti-endotoxin effect, in the body and in vitro tests show that all Folium Isatidis has anti-endotoxin effect;
(3) have antibacterial action, the Folium Isatidis leachate is to staphylococcus aureus, Staphylococcus albus, alpha streptococcus, and group B streptococcus all has obvious inhibitory action.
Folium Isatidis and Chinese patent medicine prepared therefrom are the conventional Chinese medicine of heat-clearing and toxic substances removing, clinically are mainly used in the disease that viral infections such as preventing and treating influenza, mumps, epidemic encephalitis type B causes.
Aspirin of the present invention, artificial Calculus Bovis, amantadine hydrochloride, caffeine, these several components of chlorphenamine maleate all can adopt the commercially available powder product that meets the national drug standards at present.
Flos Lonicerae of the present invention or/and Folium Isatidis can adopt method effective component extracting that water carries again the method on pharmacy of Chinese materia medica handle and pulverize that to obtain medicated powder standby.
The preparation of drug combination method of treatment flu of the present invention and upper respiratory tract infection is: Flos Lonicerae and/or the Folium Isatidis with said ratio decocts with water earlier, filter, be condensed into thick paste, oven dry is ground into Flos Lonicerae and/or Folium Isatidis extract powder, add other composition mix homogeneously by proportioning then, add pharmaceutically acceptable adjuvant again and make acceptable various dosage forms on the pharmaceutics.
Specifically, to put forward the medicated powder preparation process as follows for used Flos Lonicerae of the present invention and/or Folium Isatidis water:
Flos Lonicerae and/or Folium Isatidis decoct with water 2～3 times, each amount of water is 4～10 times of raw material dose, decocts 0.5～3 hour, merges decoction liquor, filter, be concentrated into relative density and be 1.10～1.20 thick paste, extractum is carried out vacuum drying, get dry extract, with the dried cream powder crushing screening, get Flos Lonicerae and/or Folium Isatidis extract powder, standby, the extract powder yield is 8～20%.
The various dosage forms of the pharmaceutical composition of treatment flu of the present invention and upper respiratory tract infection can be according to the conventional production method preparation of pharmaceutical field.Such as using said composition to mix, be made into required dosage form then with one or more carriers.
The pharmaceutical composition of treatment flu of the present invention and upper respiratory tract infection can be made into a kind of dosage forms wherein such as acceptable tablet on the pharmaceutics, capsule, granule, pill, powder, most preferably is capsule.
The pharmaceutical composition of treatment flu of the present invention and upper respiratory tract infection passes through aspirin; the artificial Calculus Bovis; amantadine hydrochloride; caffeine; chlorphenamine maleate; Flos Lonicerae or/and Folium Isatidis totally six kinds or seven kinds of medicine components with the specified weight ratio and by the different mechanism of action or the additional mutually synergism of action pathway; Chinese and Western is in conjunction with treating both the principal and secondary aspects of a disease; as aspirin; caffeine; chlorphenamine maleate mainly cooperatively interacts to remove or alleviate by the different mechanism of action or action pathway and catches a cold and the caused nasal obstruction of upper respiratory tract; sneeze; rhinorrhea; heating; headache; neuralgia; muscular soreness; symptoms such as laryngopharynx swelling and pain; and amantadine hydrochloride has influenza A type virus function; Flos Lonicerae; Folium Isatidis; three kinds of clinical heat-clearing and toxic substances removing commonly used of artificial Calculus Bovis; anti-inflammation Chinese medicine replenishes the collaborative effect of necessarily taking stopgap measures that has mutually; bring into play the little characteristics of herbal toxic effect simultaneously; it is fast to have treatment speed; remission is fast; advantages such as toxic and side effects is little can be used for removing or alleviating flu and the caused nasal obstruction of upper respiratory tract; sneeze; rhinorrhea; heating; headache; neuralgia; muscular soreness; symptoms such as laryngopharynx swelling and pain.
Research worker of the present invention is tested discovery in a large number, and seven kinds of components are with aspirin (C in pharmaceutical composition
9H
8O
4) 250 parts, 10 parts of artificial Calculus Boviss, amantadine hydrochloride (C
10H
17NHCl) 100 parts, caffeine (C
8H
10N
4O
2H
2O) 15 parts, chlorphenamine maleate (C
8H
10N
4O
2H
2Synergism is best when O) 2 parts, 500 parts of Flos Loniceraes and 500 parts of part by weight proportionings of Folium Isatidis, curative effect is best.
The present invention is the specification of medicament composition capsule agent most preferably: every contains aspirin (C
9H
8O
4) 0.25g, artificial Calculus Bovis 0.01g, amantadine hydrochloride (C
10H
17NHCl) 0.1g, caffeine (C
8H
10N
4O
2H
2O) 0.015g, chlorphenamine maleate (C
8H
10N
4O
2H
2O) 0.002g, Flos Lonicerae (crude drug) 0.5g and Folium Isatidis (crude drug) 0.5g.
Usage is as follows: oral, one time 1,2 times on the one, or follow the doctor's advice.
The pharmaceutical composition of treatment flu of the present invention and upper respiratory tract infection is the compound preparation of Chinese medicine and western medicine, effects such as, analgesia analgesic as preparation treatment, antiviral, antibiotic, antiinflammatory clinically can be used for removing or alleviate application in the medicine of diseases such as flu and the caused nasal obstruction of upper respiratory tract, sneeze, rhinorrhea, heating, headache, neuralgia, muscular soreness, laryngopharynx swelling and pain.
The specific embodiment
Further describe the present invention with embodiment below, help understanding, but described embodiment only is used to illustrate the present invention rather than restriction the present invention the present invention and advantage thereof, better effects if.
Embodiment 1
Flos Lonicerae (crude drug) 500g and Folium Isatidis 500g add water boil and decoct 2 times, add 10 times of amounts of water for the first time, decoct 2 hours, for the second time add 8 times of amounts of water, decocted 1 hour, collect decoction liquor, twice decoction liquor merged, filter, be concentrated into relative density and be 1.15 thick paste, extractum is carried out vacuum drying, get dry extract,, get Flos Lonicerae and Folium Isatidis extract powder the dried cream powder crushing screening, standby, the extract powder yield is 12%.
Take by weighing aspirin 250g, artificial Calculus Bovis 10g, amantadine hydrochloride 100g, caffeine 15g, chlorphenamine maleate 2g; above component and Flos Lonicerae and Folium Isatidis extract powder mix (above component is used to prepare 1000 of capsules); add the 30g Pulvis Talci; 80 mesh sieves; mixing; encapsulated, promptly get capsule.
Embodiment 2
Flos Lonicerae (crude drug) 800g and Folium Isatidis 600g add water boil and decoct 3 times, add 8 times of amounts of water for the first time, decoct 2 hours, for the second time add 6 times of amounts of water, decocted 1 hour, add 4 times of amounts of water for the third time, decoct and collected decoction liquor in 0.5 hour, three decoction liquor are merged, filter, be concentrated into relative density and be 1.18 thick paste, extractum is carried out vacuum drying, get dry extract, with the dried cream powder crushing screening, get Flos Lonicerae and Folium Isatidis extract powder, standby, yield is 15%.
Take by weighing aspirin 150g, artificial Calculus Bovis 20g, amantadine hydrochloride 50g, caffeine 20g, chlorphenamine maleate 3g; above component and Flos Lonicerae and Folium Isatidis extract powder mix (above component is used to prepare 1000 bags of granules); the sucrose, 100g starch and the 100g dextrin that add 1420g; make wetting agent with 75% ethanol; granulate with 16 mesh sieves, baking temperature is 60 ℃, and the time is 2 hours; dry back gets granule with oscillating granulator 14 mesh sieve granulate, pack packing.
Embodiment 3
Flos Lonicerae (crude drug) 200g and Folium Isatidis 100g add water boil and decoct 2 times, add 8 times of amounts of water for the first time, decoct 3 hours, for the second time add 6 times of amounts of water, decocted 1 hour, collect decoction liquor, twice decoction liquor merged, filter, be concentrated into relative density and be 1.16 thick paste, extractum is carried out vacuum drying, get dry extract,, get Flos Lonicerae and Folium Isatidis extract powder the dried cream powder crushing screening, standby, yield is 14%.
Take by weighing aspirin 150g, artificial Calculus Bovis 5g, amantadine hydrochloride 80g, caffeine 10g, chlorphenamine maleate 1g; above component and Flos Lonicerae and Folium Isatidis extract powder mix (above component is used to prepare 1000 in tablet); with add water behind the 25 gram starch mixings; granulate; cross 20 mesh sieve granulate; drying adds 3 gram magnesium stearate compactings in flakes, promptly gets the pharmaceutical composition tablet.
Embodiment 4
With embodiment 1, different is that the set of dispense ratio is: take by weighing aspirin 400g, artificial Calculus Bovis 20g, amantadine hydrochloride 150g, caffeine 20g, chlorphenamine maleate 2g, the pharmaceutical composition of treatment gastropathy is crossed 100 mesh sieves, and mixing, subpackage promptly gets powder.
Embodiment 5-8
The pharmaceutical composition component and the proportioning of treatment flu and upper respiratory tract infection see Table 1:
Table 1 unit: gram
| Sequence number | Aspirin | Amantadine hydrochloride | Caffeine | Chlorphenamine maleate | The artificial Calculus Bovis | Flos Lonicerae |
| Embodiment 5 | ????200 | ????100 | ????30 | ????3 | ????20 | 600 (yields 8%) |
| Embodiment 6 | ????300 | ????60 | ????15 | ????2 | ????30 | 800 (yields 10%) |
| Embodiment 7 | ????350 | ????50 | ????10 | ????1 | ????60 | 100 (yields 20%) |
| Embodiment 8 | ????100 | ????200 | ????20 | ????4 | ????10 | 400 (yields 15%) |
| Embodiment 9 | ????600 | ????300 | ????3 | ????8 | ????5 | 200 (yields 18%) |
Embodiment 10-14
The pharmaceutical composition component and the proportioning table 2 of treatment flu and upper respiratory tract infection:
Table 2 unit: gram
| Sequence number | Aspirin | Amantadine hydrochloride | Caffeine | Chlorphenamine maleate | The artificial Calculus Bovis | Folium Isatidis |
| Embodiment 10 | ??250 | ????80 | ????10 | ????3 | ????15 | 800 (yields 8%) |
| Embodiment 11 | ??500 | ????50 | ????20 | ????2 | ????30 | 700 (yields 16%) |
| Embodiment 12 | ??100 | ????100 | ????30 | ????4 | ????20 | 300 (yields 12%) |
| Embodiment 13 | ??300 | ????150 | ????20 | ????3 | ????10 | 100 (yields 18%) |
| Embodiment 14 | ??50 | ????20 | ????1 | ????1 | ????1 | 1 (yield 20%) |
Experimental example 1
This experimental example is the detection of optimal drug composition capsule of the present invention (every contains aspirin 0.25g, artificial Calculus Bovis 0.01g, amantadine hydrochloride 0.1g, caffeine 0.015g, chlorphenamine maleate 0.002g, Flos Lonicerae (crude drug) 0.5g and Folium Isatidis (crude drug) 0.5g) appearance character, molten out-degree and other project.
Medicament composition capsule agent of the present invention is faint yellow to brown powder.
Get 1 of this product, according to dissolution method (two appendix XC first methods of Chinese Pharmacopoeia version in 2000), 1000ml is a solvent with hydrochloric acid solution (9 → 1000), 100 rev/mins of rotating speeds, operation in accordance with the law is in the time of 15 minutes, get the about 5ml of solution, filter, precision is measured subsequent filtrate 1ml, puts in the 50ml measuring bottle, add the 0.1mol/L sodium hydroxide to scale, according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2000 A), measure trap at 257nm wavelength place, press aspirin (C
8H
9NO
2) absorptance (E
1cm 1%) 715 calculating, every stripping quantity must not be less than 80% of labelled amount.
Other should meet every regulation relevant under the capsule (two appendix IE of Chinese Pharmacopoeia version in 2000).
Experimental example 2
This experimental example is the qualitative determination of component in the optimal drug composition capsule of the present invention (every contains aspirin 0.25g, artificial Calculus Bovis 0.01g, amantadine hydrochloride 0.1g, caffeine 0.015g, chlorphenamine maleate 0.002g, Flos Lonicerae (crude drug) 0.5g and Folium Isatidis (crude drug) 0.5g).
Get 1 of this product, porphyrize adds chloroform 5ml and makes dissolving, filters, and filtrate is as need testing solution.Other gets aspirin 100mg, chlorphenamine maleate 10mg, caffeine 15mg, amantadine hydrochloride 100mg mixing, adds chloroform 10ml and makes dissolving, filters, and filtrate is product solution in contrast.Test according to thin layer chromatography (two appendix VB of Chinese Pharmacopoeia version in 2000), draw each 20 μ l of reference substance solution and need testing solution, put respectively on same silica GF254 lamellae, with chloroform-methanol-acetone (9: 1.5: 1) is developing solvent, and it is saturated to put a cuvette ammonia in chroma jar, dry after the expansion, put under the ultra-violet lamp (254nm) and inspect.Need testing solution apparent speckle should be identical with the speckle that reference substance solution is shown; [bismuth subnitrate 0.85g adds glacial acetic acid 10ml and makes dissolving, and adding water 40ml is A liquid to spray developer again; Get potassium iodide 8g, adding water 20ml is B liquid; Get each 4ml of A, B liquid and mix, add glacial acetic acid solution (1 → 6) 20ml, shake up], inspect immediately, need testing solution apparent speckle should be corresponding with the speckle that reference substance solution is shown.
Get 1 of this product, porphyrize adds chloroform 5ml and makes dissolving, filter, filtrate is put evaporate to dryness in the water-bath, and residue adds acetum and (gets glacial acetic acid 6ml, add water to 10ml) 2ml, stir, make the cholic acid dissolving, filter, get filtrate and put in the test tube, add furfural solution (1 → 100) 100ml of new preparation, sulfuric acid solution (5 → 12) 5ml, heating is about 10 minutes in 70 ℃ of water-baths, and solution shows aeruginous.
Experimental example 3
This experimental example is the detection by quantitative of main component in the optimal drug composition capsule of the present invention (every contains aspirin 0.25g, artificial Calculus Bovis 0.01g, amantadine hydrochloride 0.1g, caffeine 0.015g, chlorphenamine maleate 0.002g, Flos Lonicerae (crude drug) 0.5g and Folium Isatidis (crude drug) 0.5g), contains aspirin (C
9H
8O
4) and amantadine hydrochloride (C
10H
17NHCl) all should be 90.0%～110.0% of labelled amount.
Aspirin is got 20 of this product, the accurate title, decide, porphyrize, precision weigh up in right amount (being equivalent to aspirin 0.3g approximately) and put in the conical flask, add dilute hydrochloric acid 50ml, water 50ml, reflux 1 hour is chilled to room temperature, adds water 50ml and potassium bromide 3g, about 2/3 place under the liquid level is inserted at the tip of burette, with rapidly titration of sodium nitrite volumetric solution (0.1mol/L), with dripping, during to nearly terminal point with stirring, the tip of burette is proposed liquid level, most advanced and sophisticated with the low amounts of water washing, washing liquid is incorporated in the solution, continues slowly titration and streaks on the white plaque that scribbles the potassium iodide and starch indicator solution to dipping in the solution that takes a morsel with fine glass rod, when promptly showing blue streak, stop titration, after 5 minutes, dip in again and get a little and streak 1 time, as still showing blue streak, be terminal point.The sodium nitrite volumetric solution (0.1mol/L) of every 1ml is equivalent to the C of 15.12mg
9H
8O
4
The amantadine hydrochloride precision takes by weighing above-mentioned fine powder an amount of (being equivalent to amantadine hydrochloride 0.4g approximately), and in the 100ml measuring bottle, it is an amount of to add water, jolting makes dissolving, adds water to scale, shakes up, filter, precision is measured subsequent filtrate 50ml, puts in the conical flask, adds 2 of bromophenol blue indicator solutions, add 36% acetic acid regulator solution to yellow green, add 6 of bromophenol blue indicator solutions, be gray purple with silver nitrate titration liquid (0.1mol/L) titration to precipitation, every 1ml silver nitrate titration liquid (0.1mol/L) is equivalent to the C of 18.77mg
10H
17NHCl.
By three batches of mensuration, every content results sees the following form 3:
Table 3
| Lot number | Aspirin | Amantadine hydrochloride |
| ????20031201 | ????0.262 | ????0.105 |
| ????20031202 | ????0.244 | ????0.0984 |
| ????20031203 | ????0.282 | ????0.0964 |
Experimental example 4
This experimental example is that the infant upper respiratory tract infection clinical effectiveness is being treated in most preferably medicament composition capsule of the present invention agent (every contains aspirin 0.25g, artificial Calculus Bovis 0.01g, amantadine hydrochloride 0.1g, caffeine 0.015g, chlorphenamine maleate 0.002g, Flos Lonicerae (crude drug) 0.5g and Folium Isatidis (crude drug) 0.5g), and the good efficacy of medicament composition capsule agent of the present invention is described.
1, clinical settings:
Children with upper respiratory infections, 60 examples: male 38 examples, women 22 examples; Age 1-4 year 25 examples, 5-8 year 27 examples, 9-15 year 8 examples; Clinical manifestation is light disease 34 examples, and serious symptom 26 examples all meet the acute upper respiratory tract infection diagnostic criteria.
The observation item of table 4 infant
| Heating | Nasal obstruction | Watery nasal discharge | Cough | Pharyngeal hyperemia | WBC＜10.0，109/L |
| ??n(％) | ??n(％) | ??n(％) | ??n(％) | ??n(％) | ????n(％) |
| ??45(75.0) | ??52(86.7) | ??55(91.7) | ??39(65.0) | ??38(63.3) | ????57(95.0) |
2, Therapeutic Method:
Take most preferably medicament composition capsule of the present invention agent, 1/4 of 1-4 year, 1/3 of 4-8 year, 1/2 of 9-15 year, every day 2 times.Medication observing time is 3 days, no longer takes other drug in the observation period.
3, efficacy determination:
Curative effect judging standard: 1. produce effects: body temperature recovered in 24-48 hour normally, and other symptom and signs are most of to disappear; 2. take a turn for the better: body temperature recovered in 48-72 hour normally, and other symptoms, sign partly disappear or take a turn for the better; 3. invalid: still have heating, other symptoms, sign do not have obvious improvement.
4, therapeutic outcome:
Produce effects 43 examples, effective 14 examples, invalid 3 examples, total effective rate 95.0%.
5, conclusion:
Acute upper respiratory tract infection is the modal disease of children's, mainly invades nose, nasopharynx and pharyngeal, and various viruses and antibacterial all can cause upper respiratory tract infection, is common with virus especially, accounts for more than 90% of primary infection.Every of most preferably medicament composition capsule of the present invention agent contains aspirin 0.25g, artificial Calculus Bovis 0.01g, amantadine hydrochloride 0.1g, caffeine 0.015g, chlorphenamine maleate 0.002g, Flos Lonicerae (crude drug) 0.5g and Folium Isatidis (crude drug) 0.5g; pharmaceutical composition of the present invention organically combines amantadine hydrochloride, aspirin, artificial Calculus Bovis, caffeine, chlorphenamine maleate, Flos Lonicerae, Folium Isatidis, makes it to bring into play speciality separately.This medical instrument have significantly bring down a fever, analgesia, antiviral, antibiotic, antiinflammatory, anti-allergic effects, take stopgap measures and also effect a permanent cure, can also treat and can prevent.
Experimental example 5
This experimental example is that (every contains aspirin 0.25g in most preferably medicament composition capsule of the present invention agent; artificial Calculus Bovis 0.01g; amantadine hydrochloride 0.1g; caffeine 0.015g; chlorphenamine maleate 0.002g; Flos Lonicerae (crude drug) 0.5g and Folium Isatidis (crude drug) 0.5g) (every contains acetaminophen 0.25g with kelike capsule; amantadine hydrochloride 0.1g; artificial Calculus Bovis 0.01g; caffeine 0.015g; chlorphenamine maleate 0.03g) at treatment infantile acute upper respiratory infection clinical effectiveness relatively, the good efficacy of medicament composition capsule agent of the present invention is described.
1, clinical settings:
Children with upper respiratory infections, 120 examples are divided into 2 groups at random: male's 33 examples, women's 27 examples; 4.3 years old mean age (June～13 years old), 38～38.9 ℃ of 32 example of body temperature, 〉=39 ℃ of 28 example, average course of disease 1.5 ± 0.5d; The kelike capsule matched group: male's 31 examples, women's 29 examples, 5.4 years old mean age (June～12a); 38～38.9 ℃ of 35 example of body temperature, 〉=39 ℃ of 25 example; Average course of disease 1.6 ± 0.5d.
120 examples all possess following condition: (1) Acute onset, in the course of disease 3d; (2) body temperature 〉=38 ℃, and with symptoms such as cough, watery nasal discharge, nasal obstruction, sneeze, hoarseness, older youngster also can be with headache, pharyngalgia and systemic pain, the rarely seen pharyngeal congestion of physical examination, antiadoncus; (3) surrounding hemogram numeration of leukocyte and classification all meet the acute upper respiratory tract infection diagnostic criteria all in normal range.
2, Therapeutic Method:
Medicine composite for curing group of the present invention: take most preferably medicament composition capsule of the present invention agent, in 1/4 of 0.5-4 year, in 1/3 of 4-8 year, in 1/2 of 9-13 year, every day 2 times, be 3～5 days the course of treatment.
The kelike capsule matched group: take kelike capsule, in 1/4 of 0.5-4 year, in 1/3 of 4-8 year, in 1/2 of 9-13 year, every day 2 times, be 3～5 days the course of treatment.
3, efficacy determination:
Take medicine the back every 4h take temperature and record, and 4 days～institute's further consultation over 6 days, inquiry fever time and other clinical symptoms were improved situation, and make physical examination.Produce effects: the back body temperature 24～48h that takes medicine recovers normal, and clinical symptoms such as cough, watery nasal discharge are clearly better or disappear; Effectively: recover normal in body temperature 48～72h, clinical symptoms such as cough, watery nasal discharge take a turn for the better; Invalid: body temperature 72h does not recover normally yet, and clinical symptoms such as cough, watery nasal discharge do not have improvement.
4, therapeutic outcome:
Medicine composite for curing group produce effects 21 examples of the present invention (35%), effective 34 examples (57%), invalid 5 examples (8%), kelike capsule matched group produce effects 7 examples (12%), effective 38 examples (63%), invalid 15 examples (25%).Treatment group total effective rate (92%) is higher than matched group (75%), 2 groups of difference highly significants (P＜0.01).
Although the present invention has been done detailed explanation and has quoted some instantiations as proof, for a person skilled in the art, only otherwise leave that the spirit and scope of the present invention can be done various variations or correction is obvious.
Claims (9)
1. a pharmaceutical composition for the treatment of flu and upper respiratory tract infection is characterized in that, comprises the medicament that following component and proportioning are made:
1～600 part of aspirin, 1～100 part of artificial Calculus Bovis,
1～300 part of amantadine hydrochloride, 1～80 part of caffeine,
1～10 part of chlorphenamine maleate, 1～1000 part of Flos Lonicerae are or/and 1～1000 part of Folium Isatidis.
2. pharmaceutical composition according to claim 1 is characterized in that, comprises following component and proportioning:
30～400 parts of aspirin, 1～50 part of artificial Calculus Bovis,
10～200 parts of amantadine hydrochlorides, 3～50 parts of caffeine,
1～8 part of chlorphenamine maleate, 100～800 parts of Flos Loniceraes are or/and 100～800 parts of Folium Isatidiss.
3. pharmaceutical composition according to claim 1 and 2 is characterized in that, comprises following component and proportioning:
50～300 parts of aspirin, 5～30 parts of artificial Calculus Boviss,
20～150 parts of amantadine hydrochlorides, 10～40 parts of caffeine,
200～600 parts of 1～5 part of chlorphenamine maleate, 200～600 parts of Flos Loniceraes and Folium Isatidiss.
4. according to any one described pharmaceutical composition of claim 1-3, it is characterized in that, comprise following component and proportioning:
250 parts of aspirin, 10 parts of artificial Calculus Boviss,
100 parts of amantadine hydrochlorides, 15 parts of caffeine,
500 parts of 2 parts of chlorphenamine maleate, 500 parts of Flos Loniceraes and Folium Isatidiss.
5. method for preparing the pharmaceutical composition of any one described treatment flu of claim 1-4 and upper respiratory tract infection, it is characterized in that, comprise the steps: that elder generation decocts with water the Flos Lonicerae and/or the Folium Isatidis of said ratio, filter, be condensed into thick paste, oven dry is ground into Flos Lonicerae and/or Folium Isatidis extract powder, adds other composition mix homogeneously by proportioning then, adds pharmaceutically acceptable adjuvant again and makes acceptable various dosage forms on the pharmaceutics.
6. the preparation of pharmaceutical compositions method of treatment flu according to claim 5 and upper respiratory tract infection is characterized in that, described Flos Lonicerae and/or the concrete preparation process of Folium Isatidis extract powder are:
Flos Lonicerae and/or Folium Isatidis decoct with water 2～3 times, each amount of water is 4～10 times of raw material dose, decocted 0.5～3 hour, and merged decoction liquor, filter, be concentrated into relative density and be 1.10～1.20 thick paste, extractum is carried out vacuum drying, get dry extract, with the dried cream powder crushing screening, get Flos Lonicerae and/or Folium Isatidis extract powder, standby.
7. the pharmaceutical composition of treatment flu according to claim 1 or 5 and upper respiratory tract infection is characterized in that described medicament is acceptable tablet, capsule, granule, pill, powder a kind of dosage form wherein on the pharmaceutics.
8. medicine compositions according to claim 7 is characterized in that described medicament is a capsule.
9. remove as preparation treatment according to any one described pharmaceutical composition of claim 1-8 or alleviate application in the medicine of flu and the caused nasal obstruction of upper respiratory tract infection, sneeze, rhinorrhea, heating, headache, neuralgia, muscular soreness, laryngopharynx swelling and pain symptom.
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| KR20200014489A (en) * | 2018-08-01 | 2020-02-11 | 주식회사대성미생물연구소 | Antibiotics complex composition for veterinary treatment of multiple respiratory diseases |
| KR102086462B1 (en) | 2018-08-01 | 2020-03-09 | 주식회사대성미생물연구소 | Antibiotics complex composition for veterinary treatment of multiple respiratory diseases |
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