CN100364512C - Houjiling prepn for treating throat diseases and its use - Google Patents
Houjiling prepn for treating throat diseases and its use Download PDFInfo
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Abstract
The purpose of the present invention is to provide Houjiling preparations including novel preparations of sprays, dripping pills, etc., and the usage of the Houjiling preparations. The present invention has the advantages of high speed of drug release rate, high bioavailability, convenient operation of taking medicine, high speed of partial absorption, etc. The present invention overcomes the defects of low bioavailability, long disintegration time limit, etc. of the original tablets, the cure rate is increased, and the time of taking medicine is obviously shortened. The Houjiling preparations have the effects of preventing epidemic encephalitis and treating parotitis by the experiment of the extracorporeal action of pneumococcus, and the clinical observation of parotitis treatment.
Description
Technical field
The present invention relates to field of medicaments, be specifically related to a kind of Houjiling preparation for treating throat diseases and uses thereof.
Background technology
Throat is one of human body vitals, is the organ of swallowing food, breathe air, pronunciation, and the pharyngolaryngitis patient who suffers from various degree accounts for 40% among the crowd.Chronic pharyngolaryngitis such as obstinate easily become antibacterial and viral multiple abscess joint and internal organs such as streptococcus, streptomycete, staphylococcus, Diplococcus pneumoniae, obstinate diseases such as heart disease, pleuritis, rheumatoid arthritis, pulmonary tuberculosis, throat tumor, esophageal tumor occur, how to control wrong treatment relevant with the mistake of chronic pharyngolaryngitis.
Present western medicine is disease controlling temporarily, takes too many antibiotic medicine, and antibiotic or sulfonamides can cause immunologic hypofunction, and resistance goes down, and causes the state of an illness difficult repeatedly.
The various acute and chronic pharyngitis of Chinese patent medicine larynx disease spirit treatment, tonsillitis have unique curative effect that heat-clearing and toxic substances removing, nourishing YIN to lower pathogenic fire, preventing phlegm from forming and stopping coughing, anti-inflammation and sterilization, reducing swelling and alleviating pain, the Gui Yin that ignites, sore-throat relieving are opened sound, are first sides commonly used of treatment laryngopharyngeal diseases.Its tablet, capsule have been listed in the Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation ".
Relatively disclosed preparation method in HOUJILING PIAN and the larynx disease curing capsule standard with commercially available larynx disease spirit specification, does not all conform to, and illustrates that there are defective in the existing disclosed preparation method of pass standard of larynx disease spirit, quality control.Along with the continuous variation of environment and human to the adaptive variation of medicine, people have had higher requirement for the bioavailability and the drug effect of Chinese medicine, and need may be controlled to the method for quality control of product quality.
Spray, drop pill are owing to having the local absorption advantage, and be therefore, for throat class disease, especially suitable.
Meningococcus is the pathogenic bacterium of epidemic cerebrospinal meningitis (abbreviation epidemic encephalitis), and this disease is still a kind of common respiratory infectious disease of China's town and country winter-spring season so far.Mainly show as hyperpyrexia, headache, vomiting, skin petechia (speckle), the meningeal irritation sign positive and the suppurative change of cerebrospinal fluid clinically and have characteristics such as onset is anxious, variation is fast, fulminant type, case fatality rate height, the bacillicarrier is numerous in addition.Therefore bigger to the harm of healthy population.Although there have been classes such as sulfanilamide, penicillin, chloromycetin, cephalosporin meninges charcoal coccus to be had the Western medicine of strong antibacterial action at present, but because disorderly prolonged application and the abuse of antibiosis. many antibacterials produce drug resistance gradually to it, have in addition be multidrug resistant.Some Western medicine exist side effect big (as sulfanilamide, chloromycetin), the shortcomings such as (as cephalosporins) that costs an arm and a leg in addition, and in this case, seeking and developing has the Chinese medicine of antibacterial action to have realistic meaning to meningococcus.
Summary of the invention
The present invention is by with larynx disease spirit side: add appropriate amount of auxiliary materials in the medicinal substances extracts such as Calculus Bovis, Radix Isatidis, Fructus Chebulae, Radix Platycodonis, Fructus Gleditsiae Abnormalis, Fructus Forsythiae, Radix Trichosanthis, Margarita layer powder, Radix Eupatorii Chinensis, Borneolum Syntheticum, Radix Sophorae Tonkinensis, Radix Wikstroemae, make modern form of administration such as drop pill, spray, soft capsule, dispersible tablet, oral cavity disintegration tablet, effervescent tablet, micropill.
Drug regimen of the present invention is: the component weight proportion is preferably:
2～6 parts of Calculus Boviss, 27.5～82.5 parts of 33～99 parts of Fructus Chebulaes of Rhizoma Et Radix Baphicacanthis Cusiae, 5.5～16.5 parts of Fructus Gleditsiae Abnormalis, 33～99 parts of Radix Platycodoniss, 27.5～82.5 parts of Fructus Forsythiaes, 5.5～16.5 parts of Radix Trichosanthis, 33～99 parts of 2～6 parts of Radix Eupatorii Chinensiss of Margarita layer powder, 2～6 parts of Borneolum Syntheticums, 55～165 parts of Radix Sophorae Tonkinensiss, 55～165 parts of Radix Wikstroemae;
Make soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or oral cavity disintegration tablet or effervescent tablet or aerosol or micropill with pharmaceutically alleged adjuvant or substrate; Or more preferably:
4 parts of Calculus Boviss, 55 parts of 66 parts of Fructus Chebulaes of Rhizoma Et Radix Baphicacanthis Cusiae, 66 parts of Radix Platycodoniss,
11 parts of Fructus Gleditsiae Abnormalis, 55 parts of Fructus Forsythiaes, 11 parts of Radix Trichosanthis, 4 parts of Margarita layer powder,
66 parts of Radix Eupatorii Chinensiss, 4 parts of Borneolum Syntheticums, 110 parts of Radix Sophorae Tonkinensiss, 110 parts of Radix Wikstroemae.
Or more preferably:
Artificial Calculus Bovis 56g Borneolum Syntheticum 56g brother king 1541g Radix Sophorae Tonkinensis 1541g
Radix Eupatorii Chinensis 924g Fructus Gleditsiae Abnormalis 154g Fructus Chebulae 771g Margarita layer powder 56g
Rhizoma Et Radix Baphicacanthis Cusiae 924g Radix Trichosanthis 154g Fructus Forsythiae 771g Radix Platycodonis 924g
Make 500 or 1000 slice, or its integral multiple.
Radix Eupatorii Chinensis wherein: this product is the dry root of feverfew Herba Serissae Eupatorium chinense L..Calculus Bovis is artificial Calculus Bovis or natural Calculus Bovis.Rhizoma Et Radix Baphicacanthis Cusiae also can be by the use that feeds intake of Chinese Pharmacopoeia Radix Isatidis.
The present invention is achieved in that
The extraction of extract of the present invention:
Extracting method 1:
Get Borneolum Syntheticum and be ground into fine powder, with artificial Calculus Bovis and Margarita layer powder mixing; Fructus Chebulae powder is broken into fine powder; Radix Isatidis, Radix Platycodonis, Fructus Gleditsiae Abnormalis, Fructus Forsythiae, Radix Trichosanthis, Radix Eupatorii Chinensis, Radix Sophorae Tonkinensis, Radix Wikstroemae medical material decoct with water secondary, filter merging filtrate, be condensed into thick paste, put coldly, add certain density ethanol, stir evenly, leave standstill, filter or get supernatant, the certain density washing with alcohol of medicinal residues, washing liquid and filtrate or supernatant merge, reclaim ethanol, be condensed into thick paste, adding Fructus Chebulae fine powder, Borneolum Syntheticum, Margarita layer powder, artificial Calculus Bovis's mixing are medicinal substances extract; Or dry, be ground into fine powder, promptly get dry extract, also be medicinal substances extract;
The material extract of getting it filled is made soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or aerosol or oral cavity disintegration tablet or effervescent tablet or micropill or granule with pharmaceutically alleged adjuvant or substrate.
Extracting method 2:
Get Borneolum Syntheticum and be ground into fine powder, with artificial Calculus Bovis and Margarita layer powder mixing; The Fructus Chebulae partly is ground into fine powder; Residue Fructus Chebulae and Radix Isatidis, Radix Platycodonis, Fructus Gleditsiae Abnormalis, Fructus Forsythiae, Radix Trichosanthis, Radix Eupatorii Chinensis, Radix Sophorae Tonkinensis, Radix Wikstroemae medical material decoct with water secondary, filter merging filtrate, be condensed into thick paste, put coldly, add certain density ethanol, stir evenly, leave standstill, filter or get supernatant, the certain density washing with alcohol of medicinal residues, washing liquid and filtrate or supernatant merge, reclaim ethanol, be condensed into thick paste, adding Fructus Chebulae fine powder, Borneolum Syntheticum, Margarita layer powder, artificial Calculus Bovis's mixing are medicinal substances extract; Or dry, be ground into fine powder, promptly get dry extract, also be medicinal substances extract;
Get it filled the material extract with pharmaceutically alleged adjuvant or substrate or solvent are made soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or aerosol or oral cavity disintegration tablet or effervescent tablet or micropill or granule.
Extracting method 3:
Get Borneolum Syntheticum and be ground into fine powder, with artificial Calculus Bovis and Margarita layer powder mixing; The Fructus Chebulae uses certain density alcohol reflux, and backflow reclaims ethanol, is condensed into thick paste, and is standby; Radix Isatidis, Radix Platycodonis, Fructus Gleditsiae Abnormalis, Fructus Forsythiae, Radix Trichosanthis, Radix Eupatorii Chinensis, Radix Sophorae Tonkinensis, Radix Wikstroemae medical material decoct with water secondary, filter merging filtrate, be condensed into thick paste, put coldly, add certain density ethanol, stir evenly, leave standstill, filter or get supernatant, the certain density washing with alcohol of medicinal residues, washing liquid and filtrate or supernatant merge, reclaim ethanol, be condensed into thick paste, adding Fructus Chebulae thick paste, Borneolum Syntheticum, Margarita layer powder, artificial Calculus Bovis's mixing are medicinal substances extract; Or dry, be ground into fine powder, promptly get dry extract, also be medicinal substances extract;
Get it filled the material extract with pharmaceutically alleged adjuvant or substrate or solvent are made soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or aerosol or oral cavity disintegration tablet or effervescent tablet or micropill or granule.
The preparation drop pill:
Get drop pill substrate heating and melting, other get it filled material extract and substrate mix homogeneously splashes into coolant, makes drop pill;
Substrate in its drop pill is polyethylene glycol 6000, can also be: molecular weight be by cured etc. one or more of 2000～12000 Polyethylene Glycol, polyoxyethylene monostearate, sodium stearate or glycerin gelatine, poloxamer, stearic acid, glyceryl monostearate, polyvinylpyrrolidone, carboxymethyl cellulose, worm, or the best is a polyethylene glycol 6000: the mixture of poloxamer (7: 0.5).Coolant in its drop pill preparation is one or more of dimethicone or liquid paraffin or Oleum Camelliae or vegetable oil etc.
Its adjuvant can preferably use by following proportioning:
Extract 100g, with consumption be that the drop pill substrate of 120～460g is used, the best 225g that uses.
The preparation spray:
With extracting the medicinal substances extract of gained, make certain density alcoholic solution or aqueous solution, divide to be filled in the spray bottle, promptly.
With the Borneolum Syntheticum porphyrize, add an amount of dissolve with ethanol, standby; Artificial Calculus Bovis and Margarita layer powder are added the ethanol grinding, mixing, standby; Fructus Chebulae powder is broken into fine powder, and with 85% alcohol reflux 60 minutes, backflow reclaims ethanol, and was standby; All the other Fructus Forsythiaes etc. eight flavor decocts with water secondary, filters, and merging filtrate is condensed into thick paste, puts coldly, adds 2 times of amount ethanol, stirs evenly, and standing over night is drawn supernatant, medicinal residues 75% washing with alcohol, and washing liquid and supernatant merging, recovery ethanol is condensed into thick paste; Above-mentioned thick paste and Borneolum Syntheticum ethanol liquid, Calculus Bovis, Margarita layer powder suspension, Fructus Chebulae's extracting solution mixing mixing are settled to 2000ml, divide to be filled in the spray bottle.
The preparation soft capsule:
1. modulate capsule liquid: medicinal substances extract is added disperse medium, add one or more of antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
2. get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, additives etc., stir, after the degassing, insulation is left standstill, and makes the capsule material;
3. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.
The disperse medium of making soft capsule is: olive oil or other crude vegetals; or triglyceride oils; or oleic acid sorbitol ester; or olein: propylene glycol is 90: 10 mixture by weight; or Oleum Cocois C8/C10 monoglyceride or dibasic acid esters; or Oleum Cocois C8/C10 propylene glycol ester; or Oleum Cocois triglyceride; or the acetylizad monoglyceride of purification; or olein; or glyceryl linoleate, or Polyethylene Glycol glyceryl laurate ester, or in the purification Oleum helianthi monoglyceride one or more.
The suspending agent of soft capsule is: can increase the solid matter of disperse medium viscosity, as Cera Flava, aluminum monostearate, ethyl cellulose, carbomer etc.
The antiseptic of soft capsule is: one or more in glycerol, propylene glycol, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, the P-hydroxybenzoic acid phenyl ester.
Its adjuvant can preferably use by following proportioning:
A kind of medicinal substances extract 100g of Houjiling preparation for treating throat diseases with disperse medium 30～360g, suspending agent 0～55g, antiseptic 0～5.5g, is modulated into stable capsule liquid and makes soft capsule.
Its capsule material is: weight ratio is 1: 0.24: 0.76: 0.12: 1.42 gelatin: arabic gum: glycerol: syrup: distilled water etc. are mixed and made into.
The preparation dispersible tablet:
Get above-mentioned medicinal substances extract, add adjuvant and granulate, drying adds adjuvants such as lubricant, mixing, and tabletting promptly gets dispersible tablet, or the coated coated dispersing tablet of making; Get 2 of this sheets, put jolting in the 100ml water, in 20 ℃ ± 1 ℃ water, the whole disintegrates of planted agent in 3 minutes are also passed through sieve No. 2.
Its The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, and low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.,
Binding agent in the dispersible tablet is: the alcoholic solution or the aqueous solution of 40% ethanol～95% alcoholic solution or starch slurry or polyvinylpyrrolidone;
Filler is in the dispersible tablet: starch, or lactose or microcrystalline Cellulose, or one or more of precoking starch etc.,
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or one or more of Pulvis Talci etc.
Its adjuvant can preferably use by following proportioning:
A kind of medicinal substances extract 100g of Houjiling preparation for treating throat diseases is with filler 0～150g, disintegrating agent 3～250g, lubricant 0～258 proportioning;
The preparation oral cavity disintegration tablet:
Get above-mentioned medicinal substances extract, with filler, disintegrating agent, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again; Or
Get above-mentioned medicinal substances extract,, make granule, add adjuvant mix homogeneously such as fluidizer with one or more of adjuvants such as filler, disintegrating agent, tabletting, that is, or coating is made coated tablet again.
A kind of medicinal substances extract 100g of Houjiling preparation for treating throat diseases, filler 0～120g, disintegrating agent 3～75g, correctives 0～25g, lubricant 0.01～20g;
Described disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.;
Described lubricant is: micropowder silica gel, or one or more of magnesium stearate etc.;
Described correctives is: A Basi is sweet, stevioside, sucrose, maltose alcohol, citric acid etc. are edible or one or more of medicinal correctives; Preferably use A Basi sweet with citric acid 1: 1.5.
The preparation effervescent tablet:
Get above-mentioned medicinal substances extract, with filler, disintegrating agent, effervescent acid-base pair, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again; Or
Get above-mentioned medicinal substances extract,, make granule, add adjuvant mix homogeneously such as effervescent acid-base pair, fluidizer with one or more of adjuvants such as filler, disintegrating agent, tabletting, that is, or coating is made coated tablet again.
The effervescent acid-base pair is formed for two kinds of materials of bronsted lowry acids and bases bronsted lowry of meeting water and can produce gas, as the citric acid of sodium bicarbonate and equivalent or tartaric acid etc.;
Filler is a lactose, or starch, or pregelatinized Starch, or one or more of microcrystalline Cellulose etc., and the best is preferably lactose: mannitol: precoking starch: microcrystalline Cellulose 3: 5: 1: 1 mixture;
Disintegrating agent is: crospolyvinylpyrrolidone, or carboxymethyl starch sodium, or low-substituted hydroxypropyl cellulose, or one or more of cross-linked carboxymethyl cellulose sodium etc.; Or the best crospolyvinylpyrrolidone that uses: low-substituted hydroxypropyl cellulose: the mixture of carboxymethyl starch sodium=4: 1: 0.5.
Its supplementary product consumption proportioning is: a kind of medicinal substances extract 100g of Houjiling preparation for treating throat diseases, filler 0～140g, disintegrating agent 3～150g, correctives 0～25g, effervescent acid-base pair 5～75g, lubricant 0～20g.
The preparation granule:
Get above-mentioned medicinal substances extract, add adjuvant, make granule, drying; Promptly.
The granule adjuvant be except that selecting for use the starch, can also be lactose, dextrin, starch, amylum pregelatinisatum, carboxymethyl starch, microcrystalline Cellulose, methylcellulose, hydroxy methocel, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, micropowder silica gel, xylitol, sucrose etc. one or more.
Micropill of the present invention or pellet capsule are made like this:
Get above-mentioned medicinal substances extract,, make the micropill of diameter less than 2.0mm with the adjuvant mix homogeneously; With gained micropill drying; Or the coating after drying, promptly.
100 parts of extracts of the present invention, 5～60 parts of carboxymethyl starch sodium, 2～40 parts of precoking starch, wetting agent are 60～95% alcoholic solution of 2～13% polyvinylpyrrolidones; Or be preferably: medicinal substances extract 100g, carboxymethyl starch sodium 45g, precoking starch 30g, wetting agent are 85% alcoholic solution of 11% polyvinylpyrrolidone.
The coating solution of making the various coated preparations of the present invention is a gastric solubility coating material, as Opadry, acrylic resin IV, hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl methylcellulose, polyvinyl alcohol, methylcellulose one or more, or the coating solution formula optimization is:
Polyvinylpyrrolidone 12g, hydroxypropyl methylcellulose 6g, 90% alcoholic solution 200ml, Pulvis Talci 6g, magnesium stearate 2g, titanium dioxide 5g, polyethylene glycol 6000 4g, pigment 1.5g.
Purposes of the present invention:, proved that HOUJILING ZHIJI has the prevention epidemic encephalitis, treats parotitic effect by to the interaction in vitro experiment of Diplococcus pneumoniae and to parotitic treatment clinical observation.
Effect of the present invention:
One, preparation of the present invention is used for the treatment of the observation of curative effect of throat active chronic inflammation:
Chinese medicine has saying of " all diseases of throat all belonging to fire ", and the spirit of larynx disease has heat clearing away, detoxifcation, the effect of the swollen pain relieving of loosing.According to the prescription characteristics, we use this medicine to treat acute and chronic pharyngolaryngitis patient's 180 examples in July, 2002～2005 year January. and obtain significant curative effect, now be described below.
1 clinical data:
1.1 diagnostic criteria: formulate with reference to " new Chinese medicine clinical research guideline ".All possess following person and classify the object of observation as:
1.1.1 Western medicine diagnose standard:
The acute pharyngitis diagnostic criteria
(1) medical history virus all can cause primary disease with bacterial infection.Often suffer from cold, be heated, wet, overwork, tobacco and wine be excessive, and various physical chemistry etc. stimulate inducement.
(2) symptom
Primary symptom pharyngalgia or odynophagia, pharyngeal drying, scorching hot.
The sense of inferior disease general malaise, heating, fear of cold, extremities aching pain, inappetence.
(3) check
A. pharyngeal mucosa hyperemia, color is scarlet.
B. swallow rear wall lymph follicle and lateral pharyngeal band redness or pharyngeal mucous membrane pus point is dispersed in distribution.
C. outstanding heap soil or fertilizer over and around the roots is hung down, soft palate is red and swollen.
D. throat swab is cultivated pathogenic bacterium or feminine gender.
During diagnosis, acute attack must be arranged, possess above part or all of symptom, and inspection finding positive sign more than 1 or 1 is arranged, promptly diagnosable.
1.1.2 tcm diagnosis standard: with reference to " tcm clinical practice diagnosis and treatment term ", " traditional Chinese medical science disease diagnosis criterion of therapeutical effect ", five editions teaching materials of the traditional Chinese medical science " otorhinolaryngology of Chinese medicine "
Syndrome
(1) wind-cold syndrome
The primary symptom pharyngalgia, dysphagia.
Inferior disease aversion to cold does not generate heat or slight fever, the general malaise sense, and mouth is not thirsty, and headache is lossless, rhinorrhea with clear discharge.
Check that pharyngeal mucous membrane is light red or not red, pharyngeal mucous membrane does not have edema.
The picture of the tongue body of the tongue is not red, white and thin fur.
Pulse condition is floating tight.
(2) wind-heat syndrome
The primary symptom pharyngalgia, pharyngeal dryness and heat, dysphagia.
Inferior disease heating, aversion to cold, thirsty.
Check that pharyngeal mucous membrane is red or scarlet, the outstanding redness of hanging down, the retropharyneal folliculosis stopped up.
Picture of the tongue body of the tongue red white and thin fur of point or BOHUANG.
The floating number of pulse condition.
(3) lung excess of the stomach heat syndrome
The primary symptom pharyngalgia is violent, and pain connects ear, dysphagia, pharyngeal drying, thirsty polydipsia.
Inferior disease heating, cough, thick sputum, headache, big dry stool, yellowish or reddish urine.
Check pharyngeal scarletly, under the jaw nuclear is arranged.
Picture of the tongue light red tongue yellow and thin fur.
The floating number of pulse condition is strong.
Chronic pharyngitis diagnosis: because due to acute pharyngitis shows effect repeatedly, also there is more people to cause or the chronic inflammatory disease of upper respiratory tract, anemia, dyspepsia, hepatopathy, nephropathy etc. because of long-term tobacco and wine stimulate, and some occupational factors (reaching the people who in unclean environment, works as teacher or chanteur), also normal relevant with primary disease.
Clinical manifestation: pharyngalgia, dry pharynx, itching throat, pharynx foreign body sensation, check visible pharyngeal mucosa chronic congestion, pharynx rear wall drying or lymph foilicie hyperplasia, lateral pharyngeal band plumpness etc.
1.2 include the case standard in
(1) meets the Western medicine diagnose standard.
(2) meet the tcm syndrome diagnostic criteria.
(3), note limiting and reasonably include the course of disease in according to each clinical trial phase purpose and primary disease characteristics.
(4) determine reasonably to be tried the age according to test objective.
(5) signature enters the research Informed Consent Form.
1.3 exclusion standard:
(1) food or drug allergy person are arranged.
(2) because of measles, scarlet fever, pharyngeal symptom or inflammation that influenza and agranulocytosis, infectious monocytosis, leukemia etc. cause.
(3) gestation and purpose gestation or women breast-feeding their children.
(4) merge to have the inclination, liver, kidney and the serious primary disease of hemopoietic system, the psychotic.
1.5 physical data 210 examples are the acute pharyngitis patient, male 115 examples, women 95 examples are divided into two groups at random.
Treatment group (preparation of the present invention) 180 examples, male 102 examples, 3～61 years old age; Woman's 78 examples, 4～63 years old age.
Matched group (HOUJILING PIAN) 30 examples, male 13 examples, 4～65 years old age; Woman's 17 examples, 3～62 years old age.Two groups of patients do not have significant difference (P＞0.05), and comparability is arranged.
2 Therapeutic Method:
2.1 treatment group: preparation of the present invention, each 2～3, every day 2～4 times.
Be divided into 6 groups at random, use soft capsule, spray, drop pill, dispersible tablet, pellet capsule, the oral cavity disintegration tablet of preparation of the present invention respectively.It is identical that the raw medicinal herbs a great deal of is taken by institute.
2.2 each 2～3 of matched group HOUJILING PIAN (Guangdong Fushan medicine company limited), every day 2～4 times.
It is 1 course of treatment that two groups of patients took medicine 5 days, judges curative effect after the course of treatment of all taking medicine.
3 observation of curative effect:
3.1 curative effect determinate standard is pressed clinical recovery, produce effects, effective, invalid 4 grades of evaluations with reference to relevant document:
3.1.1 acute pharyngitis curative effect determinate standard
(1) 5 days with interior clinical symptoms and sign disappearance with interior sx in 3 days in the clinical recovery medication.
(2) produce effects medication 5 days obviously improves with interior symptom, sign.
(3) the part sign disappeared with interior sx in 5 days in effective medication.
(4) invalid medication 5 days does not have obvious improvement with interior symptom and sign.
3.1.2 individual event symptom, sign efficacy assessment standard
(1) the independent Sx of clinical recovery disappears or basic the disappearance.
(2) the independent Sx of produce effects obviously improves.
(3) Sx take a favorable turn effectively separately.
(4) invalid independent Sx does not have obvious improvement.
3.2 therapeutic outcome
3.2.1 two groups of clinical efficacies see Table 1.
Table 1 treatment group and matched group curative effect are relatively
| Group | The example number | Clinical recovery | Produce effects | Effectively | Invalid | Total effective rate (%) | Total obvious effective rate (%) |
| Treatment group 1 | 30 examples | 10 | 11 | 8 | 1 | 96.7 | 70.0 |
| Treatment group 2 | 30 examples | 14 | 9 | 7 | 0 | 100.0 | 76.7 |
| Treatment group 3 | 30 examples | 11 | 10 | 7 | 2 | 93.3 | 70.0 |
| Treatment group 4 | 30 examples | 12 | 9 | 8 | 1 | 96.7 | 70.0 |
| Treatment group 5 | 30 examples | 10 | 12 | 6 | 2 | 93.3 | 73.3 |
| Treatment group 6 | 30 examples | 11 | 11 | 7 | 1 | 96.7 | 73.3 |
| Matched group | 30 examples | 8 | 10 | 8 | 4 | 86.7 | 60.0 |
Adopt the T check, the total obvious effective rate of treatment group and matched group is P＜0.05 relatively, has the significance meaning.
3.2.2 two groups of pharyngalgia or odynophagia, pharyngeal drying, scorching hot symptom curative effect are relatively:
180 examples are organized in treatment, clinical recovery (pharyngalgia or odynophagia, pharyngeal drying, scorching hot) 68 examples, produce effects 62 examples, effective 43 examples. invalid 7 examples, total effective rate 96.1%.
Matched group 30 examples, clinical recovery (pharyngalgia or odynophagia, pharyngeal drying, scorching hot) 8 examples, produce effects 10 examples, effective 8 examples, invalid 4 examples, total effective rate 86.7%.Two groups of total effective rates compare P＜0.01, have utmost point significance meaning.
Because chronic pharyngitis mostly is due to acute pharyngitis shows effect repeatedly, as long as well the treatment acute pharyngitis does not allow its development develop into chronic pharyngitis, just can better controlled pharyngolaryngitis disease.Moreover preparation of the present invention also is the good medicine of treatment chronic pharyngitis.
4 model cases:
Zhao, the man, 32 years old, married, the teacher.Main suit with " have sore throat and accompanied dysphagia 3 " came to go to a doctor on April 16th, 2003.Pharyngalgia, dry pharynx occur with symptoms such as heating, dysphagia after 3 days causes of patient's readme are suffered from cold, be diagnosed as " acute pharyngitis " on inspection.Once obeyed multiple Drug therapys such as " Amoxicillin Capsules ", " sulfanilamide ", " adrenocortical hormone ", poor effect.Look into: pharyngeal mucosa hyperemia, color is scarlet, the outstanding redness of hanging down of stopping up.Throat swab is cultivated pathogenic bacterium.
The spray of medicinal preparation of the present invention, the spray throat.Per hour 1 time, each 2～3 press.Do not make swallowing act in short time, make medicinal liquid rest on the part as far as possible, to keep drug effect.After 4 days, symptoms such as pharyngalgia, dry pharynx obviously alleviate through medication, do not have heating.Look into: pharyngeal mucosa is light red, and the outstanding nothing of hanging down of stopping up is red and swollen, and throat swab is cultivated negative.Show clinical recovery, outpatient service is followed up a case by regular visits to does not have recurrence so far.
Invention preparation prescription and HOUJILING PIAN are identical, through clinical observation relatively, can obviously shorten administration time, and therapeutic effect is better than HOUJILING PIAN through check, and cure rate is higher, so above-mentioned case also can be used preparation of the present invention, and can receive better curative effect.
Two, HOUJILING ZHIJI is to the effect of meningococcus
Meningococcus (meningocoecus) is the pathogenic bacterium of epidemic cerebrospinal meningitis.The research of relevant larynx disease miraculous cure reason does not relate to the meningococcus effect, so the solution of variable concentrations of HOUJILING ZHIJI that the inventor has selected different process now is reported as follows meningococcal external bacteriostatic experiment.
1 experiment material
1.1 strain meningococcal B group bacterial strain CM-C (B)-29021. is provided by Chengdu Biological Products Inst., Ministry of Public Health's Guangzhou terminal.
1.2 culture medium: 1. serum internal field culture medium; 2. CB agar flat board
1.3 the Chinese medicine experimental drug is mainly available from Guangdong LuoFoshan Medicine Co., Ltd.
Make 6 concentration such as containing crude drug 50g/ml, 35g/ml, 25g/ml, 15g/ml, 7.5g/ml, 5.0g 1.3.1 be dissolved in water with the dried cream of commercially available larynx disease spirit.
1.3.2 the dried cream that the Fructus Chebulae is obtained with the improved technology of ethanol extraction is dissolved in water and makes 5 concentration such as containing crude drug 30g/ml 25g/ml, 15g/ml, 9.0g/ml, 6.0g/ml
2. experimental technique
With meningococcus vaccination in the serum internal field, after placing 37 ℃ to cultivate 18h, be diluted to the physiological saline solution of pre-temperature and contain the bacterium liquid that the bacterium number is about 10cfu/ml, drawing 0.1ml injects on the blood agar plate. and coating is evenly, equidistantly on the bacterium flat board make a call to 4 holes with containing outward through the aseptic card punch of 9mm. every hole adds treats reagent liquid 0.1ml, and a kind of medicine is irritated and added 2 holes, builds ware and is placed on and takes out after cultivating 24h in 37 ℃ of calorstats, measure antibacterial circle diameter, with the average of each medicine.
Determine its antimicrbial power power with reference to related standards.
3 experimental results
3.1 antibacterial power strong (comparison of antibacterial circle diameter 〉=27mm):
Solution by the dried cream of commercially available HOUJILING PIAN is made demonstrates strong antibacterial power more than the 35g/ml concentration, the aqueous solution with the Fructus Chebulae makes with the dried cream of the improved technology acquisition of ethanol extraction demonstrates strong antibacterial power more than the 25g/ml concentration.
3.2 antibacterial power medium (comparison of inhibition zone footpath 17mm～26mm):
Solution by the dried cream of commercially available HOUJILING PIAN is made demonstrates medium antibacterial power more than the 15g/ml concentration, the aqueous solution with the Fructus Chebulae makes with the dried cream of the improved technology acquisition of ethanol extraction demonstrates strong antibacterial power more than the 9g/ml concentration.
The dried cream solution of larynx disease spirit variable concentrations, technology shows definite antibacterial activity in vitro, and demonstrates certain concentration dependent form.The Fructus Chebulae has the pharmacology advantage of antibacterial aspect with the improved technology of ethanol extraction.
Three: HOUJILING ZHIJI is to parotitic therapeutical effect
Larynx disease spirit treatment mumps observation of curative effect
Mumps is the acute infectious disease that is caused by mumps virus, the winter and spring pilosity, and child Yi Zhong is as no complication prognosis bona.Western medicine does not have specific drug.The author adopts HOUJILING ZHIJI treatment mumps 80 examples, satisfactory effect a year August in January, 2002 to 2004.
1 clinical data
165 routine infants are divided into treatment group and matched group all from outpatient service or inpatient.
80 examples are organized in treatment, 28 examples of being in hospital, outpatient service 52 examples; Man's 41 examples, women 39 examples; Year at age 1～15 (6.1 ± 2.0); The course of disease 0.5～4 (2.4 ± 0.7) sky; One-sided mumps 14 examples, be associated with submaxillary gland or (with) Sublingual adenoncus 5 examples, hot 62 examples occur together.
According to group 85 examples, 22 examples of being in hospital, outpatient service 63 examples; Man's 39 examples, women 46 examples; Year at age 1～15 (5.6 ± 2.1), the course of disease 0.5～5 (2.3 ± 0.9) sky; One-sided mumps 9 examples, be associated with neck down gland or (with) Sublingual adenoncus 4 examples, hot 56 examples occur together.Two groups of case data are learned comparison there was no significant difference (P＞0.05) by statistics, have comparability.
Diagnostic criteria is diagnosed with reference to " traditional Chinese medical science disease diagnosis and treatment standard and prescription are selected for use ".All cases are all done routine blood test and serum, examination of amylase in urine.
Two groups are not all had cases such as the orchitis of merging, meningitis, encephalitis or pancreatitis.
The treatment group adopts HOUJILING PIAN, and is oral, one time 2～3,2～4 times on the one, and use larynx disease spirit spray in the mouthspray administration, one day twice, each about 2～3ml.
Matched group: SHUANGHUANGLIAN ZHUSHEYE 40ml, ribavirin injection 0.1～0.4g adds 5% glucose injection 250ml iv drip; Oral Radix Isatidis granules, symptomatic treatment.
3 therapeutic outcomes
3.1 criterion of therapeutical effect is with reference to " traditional Chinese medical science disease diagnosis and treatment standard and prescription are selected for use " evaluation curative effect.
Cure: body temperature is normal, mumps complete obiteration, no complication.
Take a turn for the better: mumps and other sxs.
Invalid: mumps is not seen improvement, or deteriorated case occurs.
3.2 two groups of curative effects relatively see Table 1～3:
Table one: relatively through 4 days two groups of curative effects of treatment:
| Group | n | Cure | Take a turn for the better | Invalid |
| The treatment group | 80 | 52 | 26 | 2 |
| Matched group | 85 | 16 | 45 | 19 |
Table two: relatively through 7 days two groups of curative effects of treatment:
| Group | n | Cure | Take a turn for the better | Invalid |
| The treatment group | 80 | 71 | 8 | 1 |
| Matched group | 85 | 65 | 14 | 6 |
Table two: two groups bring down a fever, the complete regression time of mumps relatively:
| Group | Heating case n | Fever time | Mumps | The detumescence time |
| The treatment group | 60 | 2.0±0.8 | 72 | 2.6±0.5 |
| Matched group | 58 | 1.8±0.5 | 75 | 3.6±0.8 |
Two groups of curative effects are relatively analyzed through Ridit.Through controlling 4 days two groups of curative effects significant differences (P＜0.01) is arranged relatively.Through controlling for 1 week, two groups of curative effects still have significant difference (P＜0.05), and two groups of time ratios of bringing down a fever, subside a swelling respectively have superiority.Illustrate with HOUJILING PIAN agent and spray treatment mumps and shortening the course of treatment, be better than matched group aspect the detumescence.
The specific embodiment:
Embodiment 1: a kind of medicinal substances extract preparation of Houjiling preparation for treating throat diseases:
Calculus Bovis 4 weight portions, Radix Isatidis 66 weight portions, Fructus Chebulae's 55 weight portions, Radix Platycodonis 66 weight portions,
Fructus Gleditsiae Abnormalis 11 weight portions, Fructus Forsythiae 55 weight portions, Radix Trichosanthis 11 weight portions, Margarita layer powder 4 weight portions,
Radix Eupatorii Chinensis 66 weight portions, Borneolum Syntheticum 4 weight portions, Radix Sophorae Tonkinensis 110 weight portions, Radix Wikstroemae 110 weight portions.
With the Borneolum Syntheticum porphyrize, with Calculus Bovis and Margarita layer powder mixing; Fructus Chebulae powder is broken into fine powder; Eight flavors such as all the other Fructus Forsythiaes decoct with water secondary, and 3 hours for the first time, 2 hours for the second time, filter, merging filtrate is condensed into thick paste 1.25～1.35 (50 ℃), put cold, add 2～4 times the amount ethanol, stir evenly, standing over night is drawn supernatant, and medicinal residues are with 60～90% washing with alcohol, washing liquid and supernatant merge, reclaim ethanol, be condensed into thick paste 1.25～1.35 (50 ℃), add the Fructus Chebulae, and mixings such as Borneolum Syntheticum, Margarita layer powder, artificial Calculus Bovis be medicinal substances extract; Or dry, be ground into fine powder, promptly get dry extract, also be medicinal substances extract; Maybe can continue drying, be ground into fine powder.
Embodiment 2: a kind of medicinal substances extract preparation of Houjiling preparation for treating throat diseases:
4 parts of artificial Calculus Boviss, 55 parts of 66 parts of Fructus Chebulaes of Rhizoma Et Radix Baphicacanthis Cusiae, 66 parts of Radix Platycodoniss,
11 parts of Fructus Gleditsiae Abnormalis, 55 parts of Fructus Forsythiaes, 11 parts of Radix Trichosanthis, 4 parts of Margarita layer powder,
66 parts of Radix Eupatorii Chinensiss, 4 parts of Borneolum Syntheticums, 110 parts of Radix Sophorae Tonkinensiss, 110 parts of Radix Wikstroemae.
Get Borneolum Syntheticum and be ground into fine powder, with artificial Calculus Bovis and Margarita layer powder mixing; The Fructus Chebulae of 1/5 weight portion partly is ground into fine powder; Remain 4/5 Fructus Chebulae and Radix Isatidis, Radix Platycodonis, Fructus Gleditsiae Abnormalis, Fructus Forsythiae, Radix Trichosanthis, Radix Eupatorii Chinensis, Radix Sophorae Tonkinensis, the Radix Wikstroemae medical material decocts with water secondary, 2 hours for the first time, 1.5 hours for the second time, filter, merging filtrate, be condensed into thick paste 1.30 (50 ℃), put cold, add 2 times the amount ethanol, stir evenly, standing over night is drawn supernatant, medicinal residues 75% washing with alcohol, washing liquid and supernatant merge, reclaim ethanol, be condensed into thick paste 1.20 (50 ℃), add the Fructus Chebulae, and mixings such as Borneolum Syntheticum, Margarita layer powder, artificial Calculus Bovis be medicinal substances extract; Or dry, be ground into fine powder, promptly get dry extract, also be medicinal substances extract; Maybe can continue drying, be ground into fine powder.
Embodiment 3: a kind of medicinal substances extract preparation of Houjiling preparation for treating throat diseases:
Artificial Calculus Bovis 56g Borneolum Syntheticum 56g Fructus Forsythiae 771g Radix Platycodonis 924g
Radix Sophorae Tonkinensis 1541g Fructus Gleditsiae Abnormalis 154g Fructus Chebulae 771g Margarita layer powder 56g
Radix Eupatorii Chinensis 924g Rhizoma Et Radix Baphicacanthis Cusiae 924g Radix Trichosanthis 154g Radix Wikstroemae 1541g
Get Borneolum Syntheticum and be ground into fine powder, with artificial Calculus Bovis and Margarita layer powder mixing; The Fructus Chebulae was with the alcohol reflux of 95% concentration 1.5 hours, and backflow reclaims ethanol, is condensed into thick paste, and is standby; Radix Isatidis, Radix Platycodonis, Fructus Gleditsiae Abnormalis, Fructus Forsythiae, Radix Trichosanthis, Radix Eupatorii Chinensis, Radix Sophorae Tonkinensis, Radix Wikstroemae medical material decoct with water secondary, 1.5 hours for the first time, 1.0 hours for the second time, filter, merging filtrate, be condensed into thick paste 1.30 (50 ℃), put cold, add 2 times the amount ethanol, stir evenly, standing over night is drawn supernatant, medicinal residues 75% washing with alcohol, washing liquid and supernatant merge, reclaim ethanol, be condensed into thick paste 1.20 (50 ℃), add the Fructus Chebulae, and mixings such as Borneolum Syntheticum, Margarita layer powder, artificial Calculus Bovis be medicinal substances extract; Or dry, be ground into fine powder, promptly get dry extract, also be medicinal substances extract; Maybe can continue drying, be ground into fine powder.
Get it filled the material extract with pharmaceutically alleged adjuvant or substrate or solvent are made soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or aerosol or oral cavity disintegration tablet or effervescent tablet or micropill or granule.
Embodiment 4: a kind of medicinal substances extract preparation of Houjiling preparation for treating throat diseases:
Artificial Calculus Bovis 56g Borneolum Syntheticum 56g Fructus Forsythiae 771g Radix Platycodonis 924g
Radix Sophorae Tonkinensis 1541g Fructus Gleditsiae Abnormalis 154g Fructus Chebulae 771g Margarita layer powder 56g
Radix Eupatorii Chinensis 924g Rhizoma Et Radix Baphicacanthis Cusiae 924g Radix Trichosanthis 154g Radix Wikstroemae 1541g
Get Borneolum Syntheticum 95% dissolve with ethanol, mix with the saturated solution of 350g beta-schardinger dextrin-, cold preservation is filtered and is made the Borneolum Syntheticum Benexate Hydrochloride, with artificial Calculus Bovis and Margarita layer powder mixing; The Fructus Chebulae was with the alcohol reflux of 95% concentration 1.5 hours, and backflow reclaims ethanol, is condensed into thick paste, and is standby; Radix Isatidis, Radix Platycodonis, Fructus Gleditsiae Abnormalis, Fructus Forsythiae, Radix Trichosanthis, Radix Eupatorii Chinensis, Radix Sophorae Tonkinensis, Radix Wikstroemae medical material decoct with water secondary, 1.5 hours for the first time, 1.0 hours for the second time, filter, merging filtrate, be condensed into thick paste 1.30 (50 ℃), put cold, add 2 times the amount ethanol, stir evenly, standing over night is drawn supernatant, medicinal residues 75% washing with alcohol, washing liquid and supernatant merge, reclaim ethanol, be condensed into thick paste 1.20 (50), add mixings such as Fructus Chebulae's thick paste, Borneolum Syntheticum, Margarita layer powder, artificial Calculus Bovis and be medicinal substances extract; Or dry, be ground into fine powder, promptly get dry extract, also be medicinal substances extract; Maybe can continue drying, be ground into fine powder.
Get it filled the material extract with pharmaceutically alleged adjuvant or substrate or solvent are made soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or aerosol or oral cavity disintegration tablet or effervescent tablet or micropill or granule.
Embodiment 5: a kind of medicinal substances extract preparation of Houjiling preparation for treating throat diseases:
Get Borneolum Syntheticum 95% dissolve with ethanol, mix with the saturated solution of 350g beta-schardinger dextrin-, cold preservation is filtered and is made the Borneolum Syntheticum Benexate Hydrochloride; The artificial Calculus Bovis makes Benexate Hydrochloride with method; Margarita layer powder is ground into impalpable powder; The Fructus Chebulae was with the alcohol reflux of 95% concentration 1.5 hours, and backflow reclaims ethanol, is condensed into thick paste, and is standby; Radix Isatidis, Radix Platycodonis, Fructus Gleditsiae Abnormalis, Fructus Forsythiae, Radix Trichosanthis, Radix Eupatorii Chinensis, Radix Sophorae Tonkinensis, Radix Wikstroemae medical material decoct with water secondary, 2.0 hours for the first time, 1.5 hours for the second time, filter, merging filtrate, be condensed into thick paste 1.25 (40 ℃), put cold, add 2 times the amount ethanol, stir evenly, standing over night is drawn supernatant, medicinal residues 75% washing with alcohol, washing liquid and supernatant merge, reclaim ethanol, be condensed into thick paste 1.20 (40 ℃), add mixings such as Fructus Chebulae's thick paste, Borneolum Syntheticum, artificial Calculus Bovis, Margarita layer powder and be medicinal substances extract; Or dry, be ground into fine powder, promptly get dry extract, also be medicinal substances extract; Maybe can continue drying, be ground into fine powder.
Get it filled the material extract with pharmaceutically alleged adjuvant or substrate or solvent are made soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or aerosol or oral cavity disintegration tablet or effervescent tablet or micropill or granule.
Embodiment 6: a kind of preparation of medicinal soft capsule of Houjiling preparation for treating throat diseases:
Artificial Calculus Bovis 56g Borneolum Syntheticum 56g Fructus Forsythiae 771g Radix Platycodonis 924g Radix Sophorae Tonkinensis 1541g
Fructus Gleditsiae Abnormalis 154g Fructus Chebulae 771g Margarita layer powder 56g Radix Eupatorii Chinensis 924g
Rhizoma Et Radix Baphicacanthis Cusiae 924g Radix Trichosanthis 154g Radix Wikstroemae 1541g
Cera Flava 20g
Olive oil 215g
Propylene glycol 2g
Soybean lecithin 8g
Make 1000
1. above-mentioned medical material is made extract, the material extract of getting it filled, one or more of adding disperse medium, antiseptic, suspending agent, emulsifying agent etc. stir, and grind homogenizing, promptly get soft capsule liquid;
2. get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, antiseptic, additives, stir, after the vacuumize degassing, insulation is left standstill, and it is standby to make the capsule material;
3. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.Embodiment 7: a kind of preparation of medicinal soft capsule of Houjiling preparation for treating throat diseases:
Medicinal substances extract 200g
Peach kernel oil 15g
Soybean oil 150g
Cera Flava: 1.5: 3.5 12g of ethyl cellulose weight ratio
Ethylparaben 0.7g
Make 500
1. with the Borneolum Syntheticum porphyrize, with artificial Calculus Bovis and Margarita layer powder mixing; The Fructus Chebulae reclaims ethanol to there not being the alcohol flavor with 5 times of amount 95% alcohol reflux, extracting solution, and is standby; Eight flavors such as all the other Fructus Forsythiaes decoct with water secondary, filter merging filtrate, be condensed into thick paste, put cold, add 2 times the amount ethanol, stir evenly, standing over night is drawn supernatant, and medicinal residues are with 60～90% washing with alcohol, washing liquid and supernatant merge, reclaim ethanol, be condensed into thick paste, add mixings such as Fructus Chebulae's thick paste, Borneolum Syntheticum, Margarita layer powder, artificial Calculus Bovis and be medicinal substances extract; Or dry, be ground into fine powder, promptly get dry extract, also be medicinal substances extract;
2. modulate capsule liquid: get above-mentioned medicinal substances extract, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
3. its capsule material formula is weight ratio 1: 0.23: 0.76: 0.12: 1.42 gelatin: arabic gum: glycerol: syrup: distilled water etc. are mixed and made into.Get gelatin, water in heating in water bath dissolving down, mix homogeneously adds glycerol, antiseptic, additives, stirs, and after the vacuumize degassing, insulation is left standstill, and makes capsule material glue;
4. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.Embodiment 8: a kind of preparation of medicinal soft capsule of Houjiling preparation for treating throat diseases:
Calculus Bovis 56g Borneolum Syntheticum 56g Fructus Forsythiae 771g Radix Platycodonis 924g
Radix Sophorae Tonkinensis 1541g Fructus Gleditsiae Abnormalis 154g Fructus Chebulae 771g Margarita layer powder 56g
Radix Eupatorii Chinensis 924g Radix Isatidis 924g Radix Trichosanthis 154g Radix Wikstroemae 1541g
The material of getting it filled is made extract by embodiment 1～5, gets extract 200g, with
Peach kernel oil 25g
Soybean oil 100g
Make 1000
Embodiment 9: a kind of preparation of medicament spraying agent of Houjiling preparation for treating throat diseases:
Artificial Calculus Bovis 56g Borneolum Syntheticum 56g Fructus Forsythiae 771g Radix Platycodonis 924g
Radix Sophorae Tonkinensis 1541g Fructus Gleditsiae Abnormalis 154g Fructus Chebulae 771g Margarita layer powder 56g
Radix Eupatorii Chinensis 924g Rhizoma Et Radix Baphicacanthis Cusiae 924g Radix Trichosanthis 154g Radix Wikstroemae 1541g
With the Borneolum Syntheticum porphyrize, add an amount of dissolve with ethanol, standby; Artificial Calculus Bovis and Margarita layer powder are added the ethanol grinding, mixing, standby; Fructus Chebulae powder is broken into fine powder, and with 85% alcohol reflux 60 minutes, backflow reclaims ethanol, and was standby; All the other Fructus Forsythiaes etc. eight flavor decocts with water secondary, filters, and merging filtrate is condensed into thick paste, puts coldly, adds 2 times of amount ethanol, stirs evenly, and standing over night is drawn supernatant, medicinal residues 75% washing with alcohol, and washing liquid and supernatant merging, recovery ethanol is condensed into thick paste; Above-mentioned thick paste and Borneolum Syntheticum ethanol liquid, Calculus Bovis, Margarita layer powder suspension, Fructus Chebulae's extracting solution mixing mixing are settled to 5000ml with 70% ethanol, divide to be filled in the spray bottle, promptly.
Embodiment 10: a kind of preparation of medicine dispersible tablet of Houjiling preparation for treating throat diseases:
Artificial Calculus Bovis 56g Borneolum Syntheticum 56g Fructus Forsythiae 771g Radix Platycodonis 924g
Radix Sophorae Tonkinensis 1541g Fructus Gleditsiae Abnormalis 154g Fructus Chebulae 771g Margarita layer powder 56g
Radix Eupatorii Chinensis 924g Rhizoma Et Radix Baphicacanthis Cusiae 924g Radix Trichosanthis 154g Radix Wikstroemae 1541g
The material of getting it filled is made extract by embodiment 1～5, gets extract 200g, with
Lactose: 100g
Microcrystalline Cellulose: 65g
Mannitol: 45g
Carboxymethyl starch sodium: 10g
Polyvinylpyrrolidone: 75g
Sodium lauryl sulphate: 2.5g
Magnesium stearate: 3.0g
Make extract by embodiment 1～3, use 75% alcohol granulation with lactose, carboxymethyl starch sodium, microcrystalline Cellulose, mannitol etc., drying adds polyvinylpyrrolidone, sodium lauryl sulphate, and the magnesium stearate mix homogeneously is pressed into 1000, promptly.
Embodiment 10: a kind of preparation of medicine dispersible tablet of Houjiling preparation for treating throat diseases:
Medicinal substances extract (dried cream powder) 200g
Lactose: 30g
Hydroxypropyl emthylcellulose: 8g
Microcrystalline Cellulose: 25g
Crospolyvinylpyrrolidone: 12g
Micropowder silica gel: 2.3g
Make the extract thick paste by embodiment 1～3, with lactose, hydroxypropyl emthylcellulose, microcrystalline Cellulose, etc. granulate with 85% alcoholic solution moistening of 11% poly-second ketopyrrolidine, add volatile oil, dry, add polyvinylpyrrolidone, differential silica gel mix homogeneously, tabletting, coating is made 1000, and coating solution is:
Polyvinylpyrrolidone 12g
Hydroxypropyl methylcellulose 4～8g
90% alcoholic solution 200ml
Pulvis Talci 4～8g
Magnesium stearate 2g
Titanium dioxide 4～6g
Polyethylene glycol 6000 4g
Pigment 1～2g.
Embodiment 11: a kind of preparation of medicinal dropping ball of Houjiling preparation for treating throat diseases:
Artificial Calculus Bovis 56g Borneolum Syntheticum 56g Fructus Forsythiae 771g Radix Platycodonis 924g Radix Sophorae Tonkinensis 1541g
Fructus Gleditsiae Abnormalis 154g Fructus Chebulae 771g Margarita layer powder 56g Radix Eupatorii Chinensis 924g
Rhizoma Et Radix Baphicacanthis Cusiae 924g Radix Trichosanthis 154g Radix Wikstroemae 1541g
The material of getting it filled is made extract by embodiment 1～5, gets extract 200g, with
Polyethylene glycol 6000 235g
Macrogol 4000 15g
Poloxamer 10g
Make 5000.
Get drop pill substrate heating and melting, add medicinal substances extract dried cream powder, poloxamer mix homogeneously with it, be incubated under 95 ℃ of conditions, mix homogeneously splashes in the coolant and is shaped, and remove liquid coolant and promptly get drop pill, or coated again technology is made coated drop pill.
Keep 90 centimetres of cooling column effective column lengths when dripping system, 5 ℃ of liquid coolants are dripped 55 on every part of clock of speed, dropper mouth external diameter 2.4mm, and internal diameter 2.2mm, then dripping the drop pill of making does not have the tail of taking off, and outward appearance is bright and clean shaped.
Coating solution can be made by following proportioning:
Polyvinylpyrrolidone 30g
Hydroxypropyl methylcellulose 8g
95% alcoholic solution 200ml
Magnesium stearate 2g
Titanium dioxide 6g
Polyethylene glycol 6000 2g
Pigment 3g
Embodiment 12: a kind of preparation of medicinal dropping ball of Houjiling preparation for treating throat diseases:
Artificial Calculus Bovis 56g Borneolum Syntheticum 56g Fructus Forsythiae 771g Radix Platycodonis 924g Radix Sophorae Tonkinensis 1541g
Fructus Gleditsiae Abnormalis 154g Fructus Chebulae 771g Margarita layer powder 56g Radix Eupatorii Chinensis 924g
Rhizoma Et Radix Baphicacanthis Cusiae 924g Radix Trichosanthis 154g Radix Wikstroemae 1541g
β-CD 40g
Low-substituted hydroxypropyl cellulose 10g
Medical material and enclose adjuvant are made extract-thick paste by embodiment 4, and described thick paste relative density is 1.32 (25 ℃), gets this thick paste 2 50g, continues to make drop pill with following adjuvant.
Polyethylene glycol 6000 260g
Poloxamer 10g
Make 5000.
Embodiment 13: a kind of preparation of drug port disintegrating tablet of Houjiling preparation for treating throat diseases:
Artificial Calculus Bovis 56g Borneolum Syntheticum 56g Fructus Forsythiae 771g Radix Platycodonis 924g Radix Sophorae Tonkinensis 1541g
Fructus Gleditsiae Abnormalis 154g Fructus Chebulae 771g Margarita layer powder 56g Radix Eupatorii Chinensis 924g
Rhizoma Et Radix Baphicacanthis Cusiae 924g Radix Trichosanthis 154g Radix Wikstroemae 1541g
The material of getting it filled is made extract by embodiment 1～5, gets extract 250g, with
Lactose: 120g
Microcrystalline Cellulose: 20g
Mannitol: 75g
Carboxymethyl starch sodium: 12g
Polyvinylpyrrolidone: 55g
The sweet 3.5g of A Basi
Citric acid 7.0g
Magnesium stearate: 7.0g
With the Borneolum Syntheticum porphyrize, with artificial Calculus Bovis and Margarita layer powder mixing; Fructus Chebulae powder is broken into fine powder; Eight flavors such as all the other Fructus Forsythiaes decoct with water secondary, filter merging filtrate, be condensed into thick paste, put cold, add 2 times the amount ethanol, stir evenly, standing over night is drawn supernatant, and medicinal residues are with 60～90% washing with alcohol, washing liquid and supernatant merge, reclaim ethanol, be condensed into thick paste, add mixings such as Fructus Chebulae's fine powder, Borneolum Syntheticum, Margarita layer powder, artificial Calculus Bovis and be medicinal substances extract; Or dry, be ground into fine powder, promptly get dry extract, also be medicinal substances extract;
Get above-mentioned medicinal substances extract, with 75% alcohol granulation, drying such as lactose, carboxymethyl starch sodium, microcrystalline Cellulose, mannitol, add volatile oil polyvinylpyrrolidone, sodium lauryl sulphate, A Basi is sweet, the magnesium stearate mix homogeneously, is pressed into 1000, promptly.
Embodiment 14: a kind of preparation of drug port disintegrating tablet of Houjiling preparation for treating throat diseases:
The material extract 200g that gets it filled,
Carboxymethyl starch sodium: 17g
Polyvinylpyrrolidone: 22g
Magnesium stearate: 0.03g
Get said extracted thing and carboxymethyl starch sodium 75% alcohol granulation, drying adds polyvinylpyrrolidone, magnesium stearate mix homogeneously, is pressed into 1000, promptly.
Embodiment 15: a kind of preparation of drug port disintegrating tablet of Houjiling preparation for treating throat diseases:
Artificial Calculus Bovis 56g Borneolum Syntheticum 56g Fructus Forsythiae 771g Radix Platycodonis 924g Radix Sophorae Tonkinensis 1541g
Fructus Gleditsiae Abnormalis 154g Fructus Chebulae 771g Margarita layer powder 56g Radix Eupatorii Chinensis 924g
Rhizoma Et Radix Baphicacanthis Cusiae 924g Radix Trichosanthis 154g Radix Wikstroemae 1541g
β-CD 60g
Low-substituted hydroxypropyl cellulose 15g
Medical material and enclose adjuvant are made extract (thick paste) 250g by embodiment 4, continue to make effervescent tablet with following adjuvant.
Lactose 90g
Mannitol 150g
Precoking starch 30g
Microcrystalline Cellulose 30g
Polyvinylpyrrolidone: 40g
Low-substituted hydroxypropyl cellulose 10g
Carboxymethyl starch sodium 5g
Sodium bicarbonate 45g
Citric acid 20g
Magnesium stearate: 0.03g
Embodiment 16: a kind of preparation of medicament pellet of Houjiling preparation for treating throat diseases
The material extract 200g that gets it filled,
Carboxymethyl starch sodium 40g
Precoking starch 12g
85% alcoholic solution, the 25～35ml of 11% polyvinylpyrrolidone
(1) gets above-mentioned medicinal substances extract,, make the micropill of diameter less than 2.0mm with extruding the pill method with mix homogeneously such as carboxymethyl starch sodium, precoking starch;
(2) with gained micropill drying, or the coating after drying, promptly.Or the micropill filled capsules made pellet capsule.
Embodiment 17: the spray of a kind of treatment and prevention epidemic encephalitis
Artificial Calculus Bovis 56g Borneolum Syntheticum 56g Fructus Forsythiae 771g
Radix Platycodonis 924g Radix Sophorae Tonkinensis 1541g Radix Eupatorii Chinensis 924g
Fructus Gleditsiae Abnormalis 154g Fructus Chebulae 771g Margarita layer powder 56g
Rhizoma Et Radix Baphicacanthis Cusiae 924g Radix Trichosanthis 154g Radix Wikstroemae 1541g
Carbomer 2.0g
Fructus Citri Limoniae essence 2.0g
Make 5000ml
Method for making: above 12 flavors, with the Borneolum Syntheticum porphyrize, add an amount of dissolve with ethanol, standby; Artificial Calculus Bovis and Margarita layer powder are added ethanol grinding suspendible, mixing, standby; Fructus Chebulae powder is broken into fine powder, and with 95% alcohol reflux 60 minutes, backflow reclaims ethanol to there not being the alcohol flavor, and was standby; All the other Fructus Forsythiaes etc. eight flavor decocts with water secondary, filters, and merging filtrate is condensed into thick paste, puts coldly, adds 2 times of amount ethanol, stirs evenly, and standing over night is drawn supernatant, medicinal residues 75% washing with alcohol, and washing liquid and supernatant merging, recovery ethanol is condensed into thick paste; Above-mentioned thick paste and Borneolum Syntheticum ethanol liquid, Calculus Bovis, Margarita layer powder suspension, Fructus Chebulae's extracting solution mixing mixing add carbomer and Fructus Citri Limoniae essence, are settled to 5000ml with 55% ethanol, divide to be filled in the spray bottle, and every bottle of 20ml, promptly.
Usage: do air disinfection and epidemic encephalitis susceptible person's epidemic prevention when epidemic encephalitis is popular, each 2～3ml is sprayed on the oral cavity.
Embodiment 18: the parotitic drop pill of a kind of treatment
Calculus Bovis 56g Borneolum Syntheticum 56g Fructus Forsythiae 771g
Radix Platycodonis 924g Radix Sophorae Tonkinensis 1541g Radix Eupatorii Chinensis 924g
Fructus Gleditsiae Abnormalis 154g Fructus Chebulae 771g Margarita layer powder 56g
Radix Isatidis 924g Radix Trichosanthis 154g Radix Wikstroemae 1541g
Polyethylene glycol 6000 400g
Poloxamer 10g
Make 5000
Method for making: above 12 flavors, with the Borneolum Syntheticum porphyrize, add an amount of dissolve with ethanol, standby; Artificial Calculus Bovis and Margarita layer powder are added ethanol grinding suspendible, mixing, standby; Fructus Chebulae powder is broken into fine powder, and with 95% alcohol reflux 60 minutes, backflow reclaims ethanol to there not being the alcohol flavor, and was standby; All the other Fructus Forsythiaes etc. eight flavor decocts with water secondary, filters, and merging filtrate is condensed into thick paste, puts coldly, adds 2 times of amount ethanol, stirs evenly, and standing over night is drawn supernatant, medicinal residues 75% washing with alcohol, and washing liquid and supernatant merging, recovery ethanol is condensed into thick paste; Above-mentioned thick paste and Borneolum Syntheticum ethanol liquid, Calculus Bovis, Margarita layer powder suspension, Fructus Chebulae's extracting solution mixing mixing join in the melt and dissolved polyethylene glycol 6000, add poloxamer, and mix homogeneously drips and makes shape, promptly.
Usage: take 10～20,2～3 times on the one, the child is cut down according to the circumstance at every turn.
Embodiment 19: the parotitic ointment of a kind of treatment
Calculus Bovis 56g Borneolum Syntheticum 56g Fructus Forsythiae 771g
Radix Platycodonis 924g Radix Sophorae Tonkinensis 1541g Radix Eupatorii Chinensis 924g
Fructus Gleditsiae Abnormalis 154g Fructus Chebulae 771g Margarita layer powder 56g
Radix Isatidis 924g Radix Trichosanthis 154g Radix Wikstroemae 1541g
Make 1000ml
Method for making: above 12 flavors, with the Borneolum Syntheticum porphyrize, add an amount of dissolve with ethanol, standby; Artificial Calculus Bovis and Margarita layer powder are added ethanol grinding suspendible, mixing, standby; Fructus Chebulae powder is broken into fine powder, and with 95% alcohol reflux 60 minutes, backflow reclaims ethanol to there not being the alcohol flavor, and was standby; All the other Fructus Forsythiaes etc. eight flavor decocts with water secondary, filters, and merging filtrate is condensed into thick paste, puts coldly, adds 2 times of amount ethanol, stirs evenly, and standing over night is drawn supernatant, medicinal residues 75% washing with alcohol, and washing liquid and supernatant merging, recovery ethanol is condensed into thick paste; Above-mentioned thick paste and Borneolum Syntheticum ethanol liquid, Calculus Bovis, Margarita layer powder suspension, Fructus Chebulae's extracting solution mixing mixing join in the emulsion-type emulsifiable paste matrix, packing, and every 10g is promptly.
Claims (1)
1. Houjiling preparation for treating throat diseases is characterized in that:
(1) used medical material weight proportion is: 4 parts of Calculus Boviss, 55 parts of 66 parts of Fructus Chebulaes of Radix Isatidis, 66 parts of Radix Platycodoniss, 11 parts of Fructus Gleditsiae Abnormalis, 55 parts of Fructus Forsythiaes, 11 parts of Radix Trichosanthis, 4 parts of Margarita layer powder, 66 parts of Radix Eupatorii Chinensiss, 4 parts of Borneolum Syntheticums, 110 parts of Radix Sophorae Tonkinensiss, 110 parts of Radix Wikstroemae;
(2) preparation of medicinal substances extract; Get Borneolum Syntheticum and be ground into fine powder, with Calculus Bovis and Margarita layer powder mixing; Fructus Chebulae powder is broken into fine powder; Radix Isatidis, Radix Platycodonis, Fructus Gleditsiae Abnormalis, Fructus Forsythiae, Radix Trichosanthis, Radix Eupatorii Chinensis, Radix Sophorae Tonkinensis, Radix Wikstroemae medical material decoct with water secondary, filter merging filtrate, be condensed into thick paste, put coldly, add certain density ethanol, stir evenly, leave standstill, filter or get supernatant, the certain density washing with alcohol of medicinal residues, washing liquid and filtrate or supernatant merge, reclaim ethanol, be condensed into thick paste, adding Fructus Chebulae fine powder, Borneolum Syntheticum, Margarita layer powder, artificial Calculus Bovis's mixing are medicinal substances extract; Or dry, be ground into fine powder, promptly get dry extract, also be medicinal substances extract; Or
Get Borneolum Syntheticum and be ground into fine powder, with Calculus Bovis and Margarita layer powder mixing; The Fructus Chebulae partly is ground into fine powder; Residue Fructus Chebulae and Radix Isatidis, Radix Platycodonis, Fructus Gleditsiae Abnormalis, Fructus Forsythiae, Radix Trichosanthis, Radix Eupatorii Chinensis, Radix Sophorae Tonkinensis, Radix Wikstroemae medical material decoct with water secondary, filter merging filtrate, be condensed into thick paste, put coldly, add certain density ethanol, stir evenly, leave standstill, filter or get supernatant, the certain density washing with alcohol of medicinal residues, washing liquid and filtrate or supernatant merge, reclaim ethanol, be condensed into thick paste, adding Fructus Chebulae fine powder, Borneolum Syntheticum, Margarita layer powder, artificial Calculus Bovis's mixing are medicinal substances extract; Or dry, be ground into fine powder, promptly get dry extract, also be medicinal substances extract; Or
Get Borneolum Syntheticum and be ground into fine powder, with Calculus Bovis and Margarita layer powder mixing; The Fructus Chebulae uses certain density alcohol reflux, and backflow reclaims ethanol, is condensed into thick paste, and is standby; Radix Isatidis, Radix Platycodonis, Fructus Gleditsiae Abnormalis, Fructus Forsythiae, Radix Trichosanthis, Radix Eupatorii Chinensis, Radix Sophorae Tonkinensis, Radix Wikstroemae medical material decoct with water secondary, filter merging filtrate, be condensed into thick paste, put coldly, add certain density ethanol, stir evenly, leave standstill, filter or get supernatant, the certain density washing with alcohol of medicinal residues, washing liquid and filtrate or supernatant merge, reclaim ethanol, be condensed into thick paste, adding Fructus Chebulae thick paste, Borneolum Syntheticum, Margarita layer powder, artificial Calculus Bovis's mixing are medicinal substances extract; Or dry, be ground into fine powder, promptly get dry extract, also be medicinal substances extract;
(3) preparation method of its oral cavity disintegration tablet: get above-mentioned medicinal substances extract, with filler, disintegrating agent, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again; Or
Get above-mentioned dried cream or thick paste,, make granule, add the fluidizer mix homogeneously with one or both of filler, disintegrating agent, tabletting, that is, or coating is made coated tablet again.
Medicinal substances extract 100g, filler 0～120g, disintegrating agent 3～175g, correctives 0～25g, lubricant 0.01～20g;
Described disintegrating agent is: one or more of crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross-linked carboxymethyl cellulose sodium;
Described lubricant is: one or both of micropowder silica gel or magnesium stearate;
Described correctives is: edible or medicinal correctives: A Basi is sweet, stevioside, sucrose, maltose alcohol, citric acid, or the sweet ratio with citric acid of A Basi is 1 to 1.5.
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| CNB2005100368353A CN100364512C (en) | 2005-08-25 | 2005-08-25 | Houjiling prepn for treating throat diseases and its use |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102657778B (en) * | 2012-05-15 | 2014-12-10 | 中国人民解放军总医院 | Honeysuckle throat clearing tablets and preparation method thereof |
| CN109260321B (en) * | 2018-11-26 | 2021-08-13 | 广东新峰药业股份有限公司 | Houjiling film-coated tablet and preparation method thereof |
| CN110934928A (en) * | 2019-12-31 | 2020-03-31 | 广东罗浮山国药股份有限公司 | Application of Houjiling preparation in preparation of medicine for treating pharyngitis and herpangina |
| CN110946929B (en) * | 2019-12-31 | 2023-04-07 | 广东罗浮山国药股份有限公司 | Application of Houjiling preparation in preparing medicament for treating furunculosis |
| CN110917269A (en) * | 2019-12-31 | 2020-03-27 | 广东罗浮山国药股份有限公司 | Application of Houjiling preparation in preparing medicine for treating angular stomatitis |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1365728A (en) * | 2001-01-15 | 2002-08-28 | 杨孟君 | Nano medicine for treating throat disease and its preparing process |
| CN1429571A (en) * | 2001-12-30 | 2003-07-16 | 湖南省衡阳卫生材料有限公司 | Notoginseng pain relieving plaster and its preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1365728A (en) * | 2001-01-15 | 2002-08-28 | 杨孟君 | Nano medicine for treating throat disease and its preparing process |
| CN1429571A (en) * | 2001-12-30 | 2003-07-16 | 湖南省衡阳卫生材料有限公司 | Notoginseng pain relieving plaster and its preparation method |
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Assignee: GUANGDONG LUOFUSHAN SINOPHARM Co.,Ltd. Assignor: Ye Yaoliang Contract record no.: 2010440000859 Denomination of invention: Houjiling prepn for treating throat diseases and its use Granted publication date: 20080130 License type: Exclusive License Open date: 20060301 Record date: 20100625 |
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