CN1318059C - Chinese medicinal formulation for treating infant lung and stomach exuberance heat - Google Patents
Chinese medicinal formulation for treating infant lung and stomach exuberance heat Download PDFInfo
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- CN1318059C CN1318059C CNB2005101049406A CN200510104940A CN1318059C CN 1318059 C CN1318059 C CN 1318059C CN B2005101049406 A CNB2005101049406 A CN B2005101049406A CN 200510104940 A CN200510104940 A CN 200510104940A CN 1318059 C CN1318059 C CN 1318059C
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Landscapes
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a Chinese medicinal preparation for treating excessive heat of the lung and stomach of an infant, which is prepared from the following traditional Chinese medicines (raw materials): baical skullcap root, patchouli, periostracum cicadae, plaster stone, kudzuvine root, rhubarb, red peony root, isatis root, platycodon root, figwort root, vietnamese sophora root and liquorice. The special preferable preparation form is oral liquid.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation, be particularly related to the Chinese medicine preparation of treatment infant lung and stomach exuberance heat, said preparation is made by following raw material of Chinese medicine: Radix Scutellariae, Herba Pogostemonis, Periostracum Cicadae, Gypsum Fibrosum, Radix Puerariae, Radix Et Rhizoma Rhei, Radix Paeoniae Rubra, Radix Isatidis, Radix Platycodonis, Radix Scrophulariae, Radix Sophorae Tonkinensis, Radix Glycyrrhizae.
Background technology:
Infant lung and stomach exuberance heat is a common disease in children disease, symptoms such as heating, headache, thirsty, dry pharynx pain, agitation, cough, abdominal distention constipation, yellowish urine, red tongue with yellow fur, slippery and rapid pulse are arranged more, in recent years, along with going deep into of clinical research, the medicine that also occurs some treatment infant lung and stomach exuberance heats on the market, existing medicine belongs to a bit cures the symptoms, not the disease, and some uses expensive composition, and some is cut and interrupt using owing to uncertain therapeutic efficacy in application process.
In view of this, the inventor develop a kind of taking convenience, effect steadily, determined curative effect, dosage form is stable, quality controllable and the pure Chinese medicinal preparation of the treatment infant lung and stomach exuberance heat that has no side effect, to satisfy the demand of extensive patients.
Summary of the invention:
The invention provides a kind of pure Chinese medicinal preparation for the treatment of infant lung and stomach exuberance heat, said preparation is made by following Chinese medicine raw materials by weight proportion:
Radix Scutellariae 50-200g Herba Pogostemonis 40-160g Periostracum Cicadae 20-80g Gypsum Fibrosum 100-400g
Radix Puerariae 40-160g Radix Et Rhizoma Rhei 20-80g Radix Paeoniae Rubra 40-160g Radix Isatidis 40-160g
Radix Platycodonis 40-160g Radix Scrophulariae 40-160g Radix Sophorae Tonkinensis 40-160g Radix Glycyrrhizae 30-120g
Preferably:
Radix Scutellariae 75-133g Herba Pogostemonis 60-106g Periostracum Cicadae 30-53g Gypsum Fibrosum 150-266g
Radix Puerariae 60-106g Radix Et Rhizoma Rhei 30-53g Radix Paeoniae Rubra 60-106g Radix Isatidis 60-106g
Radix Platycodonis 60-106g Radix Scrophulariae 60-106g Radix Sophorae Tonkinensis 60-106g Radix Glycyrrhizae 45-80g
Most preferably:
Radix Scutellariae 100g Herba Pogostemonis 80g Periostracum Cicadae 40g Gypsum Fibrosum 200g
Radix Puerariae 80g Radix Et Rhizoma Rhei 40g Radix Paeoniae Rubra 80g Radix Isatidis 80g
Radix Platycodonis 80g Radix Scrophulariae 80g Radix Sophorae Tonkinensis 80g Radix Glycyrrhizae 60g
In more than forming, the weight of each medicine of distinguishing the flavor of is calculated with crude drug, and above-mentioned prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1 dose of finger, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, granule 1000 grams, oral liquid 1000ml etc.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, and as serious symptom or light disease, fat or modest patient, the proportioning of the amount of can corresponding adjustment forming increases or reduces being no more than 100%, and drug effect is constant.
Raw material of Chinese medicine, especially adjuvant drug in more than forming can be replaced with the suitable Chinese medicine with identical property of medicine with messenger drug, and its drug effect of the Chinese medicine preparation after the replacement is constant.
Chinese medicine preparation of the present invention is to process through extraction or other modes by the raw material of Chinese medicine that above-mentioned prescription is formed, and makes pharmaceutically active substance, subsequently, with this material is raw material, adds the medicine acceptable carrier when needing, and makes according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can obtain by the co-extracted raw material of Chinese medicine, also can obtain by other modes, as: by pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water are carried, alcohol extraction, ester are carried, methods such as ketone is carried, chromatography obtain, these active substances can be the material of extractum form, can be that dry extract also can be a fluid extract, make different concentration according to the different needs decision of preparation.
Pharmaceutical preparation of the present invention, the pharmaceutical dosage forms of unit dose preferably, can make any pharmaceutically useful dosage form when making pharmaceutical preparation, these dosage forms are selected from: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.Preferably oral liquid form, most preferably oral liquid.
Pharmaceutical preparation of the present invention, pharmaceutically active substance makes through extracting processing, and processing method is as follows: above 12 flavors, get Herba Pogostemonis and extract volatile oil, standby, carry the medicinal liquid behind the oil, in addition device is stored, medicinal residues with all the other ten simply medical material decoct with water adding when wherein Radix Scutellariae boils, merge decoction liquor, filter, merge with above-mentioned medicinal liquid, concentrating under reduced pressure, transfer pH, add ethanol, leave standstill, filter, filtrate recycling ethanol adds water, transfers pH, cold preservation, filter, get filtrate, this filtrate and volatile oil are pharmaceutically active substance of the present invention together.This active substance mixes with the medicine acceptable carrier, promptly can be made into pharmaceutical preparation of the present invention according to the galenic pharmacy routine techniques.
The preparation method of oral liquid can be:
More than 12 flavors, get Herba Pogostemonis and extract volatile oil, standby, carry the medicinal liquid behind the oil, device is stored in addition, medicinal residues with all the other ten simply medical material add 10 times of water gagings decoctions three times, add when wherein Radix Scutellariae boils, each 1 hour, merge decoction liquor, filter, merge, be evaporated to relative density 1.10 (40 ℃) with above-mentioned medicinal liquid, transfer pH5.5, add ethanol, make to contain the alcohol amount and reach 70%, leave standstill, filter, decompression filtrate recycling ethanol is to there not being the alcohol flavor, add water to about 900ml, transfer pH7.0, cold preservation, filter, filtrate adds sucrose 100g, boils, put when being chilled to about 40 ℃, stir the mixed liquor that adds Tween 80 3ml and volatile oil 0.5ml down, add water to be adjusted to 1000ml, transfer pH to 7.0, filter, fill, sterilization, promptly.
Pharmaceutical preparation of the present invention can add some medicine acceptable carriers as required, can adopt the galenic pharmacy routine techniques to prepare this pharmaceutical preparation, as pharmaceutically active substance is mixed with the medicine acceptable carrier.Described medicine acceptable carrier is selected from: mannitol, sorbitol, sorbic acid or potassium salt, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin A, vitamin C, vitamin E, vitamin D, azone, the EDTA disodium, EDTA calcium sodium, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, propylene glycol, ethanol, soil temperature 60-80, span-80, Cera Flava, lanoline, liquid paraffin, hexadecanol, gallate ester, agar, triethanolamine, basic amino acid, carbamide, allantoin, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, the phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Pharmaceutical preparation of the present invention is determined usage and dosage according to patient's situation in use.
Pharmaceutical composition of the present invention, when making medicament, the medicament of unit dose can contain pharmaceutically active substance 0.1-1000mg of the present invention, and all the other are pharmaceutically acceptable carrier.Pharmaceutically acceptable carrier can be the 0.1-99.9% of total formulation weight amount by weight.
The most preferred prescription of the present invention is listed in the embodiment of the invention.
Technology of the present invention obtains through screening, according to as follows:
Herba Pogostemonis contains volatile ingredient, extracts volatile oil with the way of distillation, its water soluble ingredient water boiling and extraction.
Contain the active component flavonoid in the Radix Scutellariae: baicalin, wogonoside etc., relevant extracting method report is more, and is better because of its water solublity, adopts water extraction.Monarch drug in the Radix Scutellariae side of being, baicalin has effects such as antibiotic, analgesic, is index so select the content with baicalin, and process conditions are carried out preferably.
Contain flavones ingredient in the Radix Puerariae: puerarin, daidzein, daidzin etc., not only water-soluble but also be dissolved in alcohol.According to bibliographical information, Radix Glycyrrhizae contains glycyrrhizic acid, enoxolone, licoflavone etc.; Radix Platycodonis contains kikyosaponin, glycoside unit etc.; Radix Paeoniae Rubra contains paeoniflorin, oxypaeoniflorin; Radix Scrophulariae contains Radix Scrophulariae element, iridoids etc.; Radix Sophorae Tonkinensis contains matrine, oxymatrine etc.; Radix Et Rhizoma Rhei contains chrysophanic acid, chrysophanol, emodin etc.; Periostracum Cicadae contains aminoacid etc., and these compositions all have certain dissolubility in water and alcohol, so the method that adopts decocting to boil is extracted.The Gypsum Fibrosum main component is a calcium sulfate, and being decocted first to fry in shallow oil for a long time to increase content, closes to fry in shallow oil in compound recipe to be better than singly frying in shallow oil, so adopt the technology of frying in shallow oil altogether.
Radix Isatidis contains indirubin, composition such as indigo, and the extracting method report is more.We result of the test show, and are similar with the content of indirubin in the oral liquid that water extraction process is made with ethanol extraction technology, so adopt with water extraction.The present invention determines with the method that decocting boils its main effective ingredient to be extracted, but also extract water-solubility impurity in the time of with water boiling and extraction, remove with ethanol precipitation,, process conditions are carried out preferably by orthogonal test so the present invention is to be the basic technology route with the water extract-alcohol precipitation.
The present invention selects respective carrier when making oral liquid, selection as sweeting agent, solubilizing agent is as follows: for regulating mouthfeel, selected sucrose as sweeting agent, the solution that is made into variable concentrations compares, evidence, and sucrose concentration is 10% o'clock, sugariness is moderate, viscosity is suitable, and mouthfeel is better, the results are shown in Table 1.
The selection of sweeting agent consumption in table 1 oral liquid
| Sucrose % (g/ml) | 5 | 10 | 15 | 20 |
| The mouthfeel viscosity | The heavier variation of bitterness is not obvious | Bitterness is thickness more slightly | Bitterness is arranged slightly than thickness | The bitterness thickness is arranged slightly |
Herba Pogostemonis Volatile oil is insoluble in water in the prescription, selects for use Tween 80 to do solubilizing agent, gets not commensurability Tween 80, mixes the back with volatile oil and adds medicinal liquid, and result of the test shows: the consumption of Tween 80 is advisable with 0.3%, the results are shown in Table 2.
The Tween 80 consumption is selected in table 2 oral liquid
| Tween 80 % (ml/ml) | 0.1 | 0.2 | 0.3 | 0.4 | 0.5 | 0.6 |
| The clarity mouthfeel | Better muddy | Muddiness has abnormal flavour slightly | Clarification has abnormal flavour slightly | Clarification has abnormal flavour | The clarification abnormal flavour is dense | The clarification abnormal flavour is dense |
(3). the dosing prescription
According to above test, determine that oral liquid dosing prescription is:
Extracting solution 900ml sucrose 100g Herba Pogostemonis Volatile oil 0.5ml Tween 80 3ml makes 1000ml the present invention and also comprises preparation of the present invention, the method of quality control of oral liquid particularly, this method comprises: contents such as character, discriminating, inspection, assay, specifically:
[character] this oral liquid is the supernatant liquid of rufous, and postpone for a long time can have microprecipitation, sweet, little hardship of distinguishing the flavor of.
This oral liquid 20ml is got in [discriminating] (1), with petroleum ether (30-60 ℃) extraction 4 times, each 30ml, merge extractive liquid, reclaims petroleum ether, and residue adds petroleum ether (60-90 ℃) 2ml makes dissolving, as need testing solution, other gets Bai Qiuli alcohol reference substance, adds ethyl acetate and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw need testing solution 10 μ l, reference substance solution 2 μ l, putting respectively on same silica gel g thin-layer plate, is developing solvent with petroleum ether (30-60 ℃)-ethyl acetate-glacial acetic acid (95: 5: 0.2), launches, take out, dry, spray is with 5% ferric chloride alcoholic solution, and hot blast blows to clear spot.In the test sample chromatograph, with reference substance chromatograph relevant position on, show the same color speckle.
(2) get this oral liquid 20ml, be added in AB-8 type macroporous adsorptive resins (the internal diameter 1.5cm that has handled well, long 12cm) successively with water 100ml, 20% ethanol 100ml eluting, discard eluent, reuse 50% ethanol 100ml eluting, eluent evaporate to dryness, residue adds methanol 2ml dissolving, as need testing solution.Other gets the puerarin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw need testing solution 6 μ l, reference substance solution 4 μ l, putting respectively on same silica gel g thin-layer plate, is developing solvent with chloroform-methanol-water (14: 5: 0.5), launches, take out, dry, after the ammonia steam is smoked, to ultra-violet lamp (365nm), inspect.In the test sample chromatograph, with contrast chromatograph corresponding position on, show the fluorescence speckle of same color.
(3) get the paeoniflorin reference substance, add ethanol and make the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000) test, draw above-mentioned reference substance solution respectively and reach
Each 6 μ l of need testing solution under the item of [discriminating] (2), put respectively on same silica gel g thin-layer plate, (40: 5: 10: 0.2) be developing solvent, expansion was taken out with chloroform-ethyl acetate-methanol-formic acid, dry, spray is with 5% vanillin sulfuric acid solution, and hot blast blows to clear spot, in the test sample chromatograph, with reference substance chromatograph relevant position on, show identical bluish violet speckle.
(4) get this oral liquid 20ml, add hydrochloric acid 3ml, heated 30 minutes to water-bath, extracted with diethyl ether 3 times are used in cooling immediately, and each 30ml merges ether solution, and low temperature volatilizes ether, and residue adds chloroform 2ml and dissolves, as need testing solution.Other gets emodin reference substance and chrysophanol reference substance, add methanol respectively and make the solution that every 1ml contains 1mg, product solution according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000) test, is drawn each 6 μ l of above-mentioned three kinds of solution in contrast, put respectively on same silica gel g thin-layer plate, with petroleum ether (30-60 ℃)-Ethyl formate (15: 5) is developing solvent, launches, and takes out, dry, to ultra-violet lamp (365nm), inspect.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle.After the ammonia steam is smoked, to daylight, to inspect, speckle becomes redness.
(5) this oral liquid retention time in the gained chromatograph under the assay item should be consistent with the retention time of reference substance.
[inspection] relative density should be not less than 1.05 (appendix VIIA of Chinese Pharmacopoeia version in 2000).
PH value should be 4.5-7.0 (appendix VIIA of Chinese Pharmacopoeia version in 2000).
Other should meet every regulation relevant under the mixture item (appendix IJ of Chinese Pharmacopoeia version in 2000).
[assay] measured according to high performance liquid chromatography (appendix VID).
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Methanol-water-phosphoric acid (47: 53: 0.2) is mobile phase, and the detection wavelength is 280nm.Number of theoretical plate is pressed the baicalin peak and is calculated, and should be not less than 2500.
It is an amount of that the preparation precision of reference substance solution takes by weighing the baicalin reference substance, adds 70% ethanol and make the solution that every 1ml contains 18 μ g, in contrast product solution.
The accurate this product 5ml that draws of the preparation of need testing solution puts in the 100ml measuring bottle, adds 70% ethanol dilution to scale, shakes up.The accurate 1.0ml that draws puts in the 10ml measuring bottle, adds 70% ethanol dilution to scale, shakes up, as need testing solution.
Accurate respectively reference substance and each the 10 μ l injection chromatograph of liquid of need testing solution drawn of algoscopy measured promptly.
This oral liquid contains Radix Scutellariae must not be less than 3.0mg/ml in baicalin.
Pharmaceutical preparation of the present invention, its function are dispelling wind and heat pathogens, clearing interior heat, heat-clearing and toxic substances removing, relieving sore throat and pain with curing mainly.Be applicable to the card of infant lung and stomach exuberance heat.Cure mainly diseases such as heating, headache, thirsty, dry pharynx pain, agitation, cough, abdominal distention constipation, yellowish urine, red tongue with yellow fur, slippery and rapid pulse.
Chinese medicine preparation of the present invention, its prescription composition complements each other, and has synergism, and therapeutic effect is good, and few side effects is suitable for child administration.
Chinese medicine preparation of the present invention, particularly oral liquid, its usage and consumption are: oral 2-3 time on the 1st, 2 years old with interior 5ml, 2-4 year 5-10ml, 4-6 year 10-15ml, 15-20ml more than six years old, or follow the doctor's advice.
The specific embodiment:
Further specify the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1
Prescription:
Radix Scutellariae 1000g Herba Pogostemonis 800g Periostracum Cicadae 400g Gypsum Fibrosum 2000g
Radix Puerariae 800g Radix Et Rhizoma Rhei 400g Radix Paeoniae Rubra 800g Radix Isatidis 800g
Radix Platycodonis 800g Radix Scrophulariae 800g Radix Sophorae Tonkinensis 800g Radix Glycyrrhizae 600g
The dosing prescription:
Extracting solution 9000ml Herba Pogostemonis Volatile oil 5ml
Sucrose 1000g Tween 80 30ml
Make 10000ml
More than 12 flavors, get Herba Pogostemonis and extract volatile oil, standby, carry the medicinal liquid behind the oil, device is stored in addition, medicinal residues with all the other ten simply medical material add 10 times of water gagings decoctions three times, add when wherein Radix Scutellariae boils, each 1 hour, merge decoction liquor, filter, merge, be evaporated to relative density 1.10 (40 ℃) with above-mentioned medicinal liquid, transfer pH5.5, add ethanol, make to contain the alcohol amount and reach 70%, leave standstill, filter, decompression filtrate recycling ethanol is to there not being the alcohol flavor, add water to about 900ml, transfer pH7.0, cold preservation, filter, filtrate adds sucrose 100g, boils, put when being chilled to about 40 ℃, stir the mixed liquor that adds Tween 80 3ml and volatile oil 0.5ml down, add water to be adjusted to 1000ml, transfer pH to 7.0, filter, fill, sterilization, promptly.
10,000 milliliters every batch, totally three batches.The data result of each link and discriminating in the relevant preparation process, quality examination and assay (measuring with the HPLC method) the results are shown in Table 3.
The result shows that the content of the discriminating of three batches of oral liquids, clarity, content uniformity, pH value, relative density, limit test of microbe and baicalin (using high-performance liquid chromatogram determination) is all up to specification.
The fragrant removing summer-heat oral liquid of table 3 a kind of reed mentioned in ancient books pilot scale creation data table
| Lot number | 960518 | 960611 | 960627 |
| The content % decocting liquid of radix scutellariae medicinal materials baicalin concentrates relative density precipitate with ethanol pH value alcohol precipitation concentration, (%) baicalin content before the fill of medicinal liquid pH value, (mlg/ml) | 8.14 1.13 5.52 70 7.0 3.21 | 9.13 1.10 5.50 70 7.0 3.78 | 9.13 1.12 5.53 70 7.0 4.03 |
| Finished product number (propping up) yield rate (%) is differentiated clarity relative density loading amount (ml) pH value baicalin content (mg/ml) baicalin retention rate (%) microorganism checking | 908 95.35 are positive reaction clarifies 1.110 10 5.53 3.06 37.59 and up to specificationly sees attached list 4 | 916 96.18 are positive reaction clarifies 1.116 10 5.53 3.67 40.20 and up to specificationly sees attached list 5 | 919 96.53 are positive reaction clarifies 1.110 10 5.48 4.00 43.81 and up to specificationly sees attached list 6 |
Embodiment 2
Radix Scutellariae 50g Herba Pogostemonis 40g Periostracum Cicadae 20g Gypsum Fibrosum 100g
Radix Puerariae 40g Radix Et Rhizoma Rhei 20g Radix Paeoniae Rubra 40g Radix Isatidis 40g
Radix Platycodonis 40g Radix Scrophulariae 40g Radix Sophorae Tonkinensis 40g Radix Glycyrrhizae 30g
More than 12 flavors, get Herba Pogostemonis and extract volatile oil, standby, carry the medicinal liquid behind the oil, device is stored in addition, medicinal residues with all the other ten simply medical material add 10 times of water gagings decoctions three times, add when wherein Radix Scutellariae boils, each 1 hour, merge decoction liquor, filter, merge, be evaporated to relative density 1.10 (40 ℃) with above-mentioned medicinal liquid, transfer pH5.5, add ethanol, make to contain the alcohol amount and reach 70%, leave standstill, filter, decompression filtrate recycling ethanol is to there not being the alcohol flavor, add water to about 900ml, transfer pH7.0, cold preservation, filter, filtrate adds sucrose 100g, boils, put when being chilled to about 40 ℃, stir the mixed liquor that adds Tween 80 3ml and volatile oil 0.5ml down, add water to be adjusted to 1000ml, transfer pH to 7.0, filter, fill, sterilization, promptly.
Embodiment 3
Radix Scutellariae 200g Herba Pogostemonis 160g Periostracum Cicadae 80g Gypsum Fibrosum 400g
Radix Puerariae 160g Radix Et Rhizoma Rhei 80g Radix Paeoniae Rubra 160g Radix Isatidis 160g
Radix Platycodonis 160g Radix Scrophulariae 160g Radix Sophorae Tonkinensis 160g Radix Glycyrrhizae 120g
More than 12 flavors, get Herba Pogostemonis and extract volatile oil, standby, carry the medicinal liquid behind the oil, device is stored in addition, medicinal residues with all the other ten simply medical material add 10 times of water gagings decoctions three times, add when wherein Radix Scutellariae boils, each 1 hour, merge decoction liquor, filter, merge, be evaporated to relative density 1.10 (40 ℃) with above-mentioned medicinal liquid, transfer pH5.5, add ethanol, make to contain the alcohol amount and reach 70%, leave standstill, filter, decompression filtrate recycling ethanol is to there not being the alcohol flavor, add water to about 900ml, transfer pH7.0, cold preservation, filter, filtrate adds sucrose 100g, boils, put when being chilled to about 40 ℃, stir the mixed liquor that adds Tween 80 3ml and volatile oil 0.5ml down, add water to be adjusted to 1000ml, transfer pH to 7.0, filter, fill, sterilization, promptly.
Embodiment 4
Radix Scutellariae 100g Herba Pogostemonis 80g Periostracum Cicadae 40g Gypsum Fibrosum 200g
Radix Puerariae 80g Radix Et Rhizoma Rhei 40g Radix Paeoniae Rubra 80g Radix Isatidis 80g
Radix Platycodonis 80g Radix Scrophulariae 80g Radix Sophorae Tonkinensis 80g Radix Glycyrrhizae 60g
More than 12 flavors, get Herba Pogostemonis and extract volatile oil, standby, carry the medicinal liquid behind the oil, device is stored in addition, medicinal residues with all the other ten simply medical material add 10 times of water gagings decoctions three times, add when wherein Radix Scutellariae boils, each 1 hour, merge decoction liquor, filter, merge, be evaporated to relative density 1.10 (40 ℃) with above-mentioned medicinal liquid, transfer pH5.5, add ethanol, make to contain the alcohol amount and reach 70%, leave standstill, filter, decompression filtrate recycling ethanol is to there not being the alcohol flavor, add water to about 900ml, transfer pH7.0, cold preservation, filter, get filtrate, this filtrate and volatile oil are pharmaceutically active substance together, add an amount of dextrin therein, starch, alcohol granulation, Pulvis Talci is a lubricant, and tabletting gets tablet.
Embodiment 5
Radix Scutellariae 100g Herba Pogostemonis 80g Periostracum Cicadae 40g Gypsum Fibrosum 200g
Radix Puerariae 80g Radix Et Rhizoma Rhei 40g Radix Paeoniae Rubra 80g Radix Isatidis 80g
Radix Platycodonis 80g Radix Scrophulariae 80g Radix Sophorae Tonkinensis 80g Radix Glycyrrhizae 60g
More than 12 flavors, get Herba Pogostemonis and extract volatile oil, standby, carry the medicinal liquid behind the oil, device is stored in addition, medicinal residues with all the other ten simply medical material add 10 times of water gagings decoctions three times, add when wherein Radix Scutellariae boils, each 1 hour, merge decoction liquor, filter, merge, be evaporated to relative density 1.10 (40 ℃) with above-mentioned medicinal liquid, transfer pH5.5, add ethanol, make to contain the alcohol amount and reach 70%, leave standstill, filter, decompression filtrate recycling ethanol is to there not being the alcohol flavor, add water to about 900ml, transfer pH7.0, cold preservation, filter, get filtrate, this filtrate and volatile oil are pharmaceutically active substance together, add an amount of dextrin therein, starch, alcohol granulation, magnesium stearate is lubricant, and is encapsulated, obtains capsule.
Claims (10)
1, a kind of Chinese medicine preparation for the treatment of infant lung and stomach exuberance heat is characterized in that said preparation is made raw materials of effective components and consisted of:
Radix Scutellariae 50-200g Herba Pogostemonis 40-160g Periostracum Cicadae 20-80g Gypsum Fibrosum 100-400g
Radix Puerariae 40-160g Radix Et Rhizoma Rhei 20-80g Radix Paeoniae Rubra 40-160g Radix Isatidis 40-160g
Radix Platycodonis 40-160g Radix Scrophulariae 40-160g Radix Sophorae Tonkinensis 40-160g Radix Glycyrrhizae 30-120g.
2, the Chinese medicine preparation of claim 1 is characterized in that, said preparation is made raw materials of effective components and consisted of:
Radix Scutellariae 75-133g Herba Pogostemonis 60-106g Periostracum Cicadae 30-53g Gypsum Fibrosum 150-266g
Radix Puerariae 60-106g Radix Et Rhizoma Rhei 30-53g Radix Paeoniae Rubra 60-106g Radix Isatidis 60-106g
Radix Platycodonis 60-106g Radix Scrophulariae 60-106g Radix Sophorae Tonkinensis 60-106g Radix Glycyrrhizae 45-80g.
3, the Chinese medicine preparation of claim 1 is characterized in that, said preparation is made raw materials of effective components and consisted of:
Radix Scutellariae 100g Herba Pogostemonis 80g Periostracum Cicadae 40g Gypsum Fibrosum 200g
Radix Puerariae 80g Radix Et Rhizoma Rhei 40g Radix Paeoniae Rubra 80g Radix Isatidis 80g
Radix Platycodonis 80g Radix Scrophulariae 80g Radix Sophorae Tonkinensis 80g Radix Glycyrrhizae 60g.
4. any one Chinese medicine preparation of claim 1-3 is selected from: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.
5. the Chinese medicine preparation of claim 4 is oral liquids.
6. the Chinese medicine preparation of claim 1 wherein also comprises the medicine acceptable carrier.
7. the application of the Chinese medicine preparation of claim 1 in the medicine of preparation treatment infant lung and stomach exuberance heat card.
8, the preparation method of the Chinese medicine preparation of claim 1 is characterized in that, the process following steps: get Herba Pogostemonis and extract volatile oil, standby, carry the medicinal liquid behind the oil, device is stored in addition, medicinal residues and all the other ten medical material simply decoct with water, and add when wherein Radix Scutellariae boils, and merge decoction liquor, filter, merge concentrating under reduced pressure with above-mentioned medicinal liquid, transfer pH, add ethanol, leave standstill, filter, filtrate recycling ethanol adds water, transfers pH, cold preservation, filter, get filtrate, this filtrate and volatile oil are pharmaceutically active substance together, this active substance mixes with the medicine acceptable carrier, makes pharmaceutical preparation of the present invention according to the galenic pharmacy routine techniques.
9, preparation method according to Claim 8 is characterized in that, the process following steps of purchasing of oral liquid formulation wherein: get Herba Pogostemonis and extract volatile oil, standby, carry the medicinal liquid behind the oil, device is stored in addition, medicinal residues and all the other ten medical material simply add 10 times of water gagings and decoct three times, add each 1 hour when wherein Radix Scutellariae boils, merge decoction liquor, filter, merge with above-mentioned medicinal liquid, be evaporated to relative density 1.10, transfer pH5.5, add ethanol, make to contain alcohol amount and reach 70%, leave standstill, filter, decompression filtrate recycling ethanol adds water to about 900ml to there not being the alcohol flavor, transfers pH7.0, cold preservation filters, and filtrate adds sucrose 100g, boil, put when being chilled to about 40 ℃, stir the mixed liquor that adds Tween 80 3ml and volatile oil 0.5ml down, add water and be adjusted to 1000ml, transfer pH to 7.0, filter fill, sterilization, promptly.
10, the method for quality control of the pharmaceutical preparation of claim 5 is characterized in that, comprises following content, character, discriminating, inspection, assay, wherein
Theing contents are as follows of character
This oral liquid is the supernatant liquid of rufous, and postpone for a long time can have microprecipitation, sweet, little hardship of distinguishing the flavor of;
That differentiates thes contents are as follows:
(1) gets this oral liquid 20ml, use petroleum ether, extract 4 times, each 30ml, merge extractive liquid, reclaims petroleum ether, residue adds petroleum ether, and 2ml makes dissolving, as need testing solution, other gets Bai Qiuli alcohol reference substance, add ethyl acetate and make the solution that every 1ml contains 1mg, product solution is tested according to thin layer chromatography in contrast, draw need testing solution 10 μ l, reference substance solution 2 μ l put respectively on same silica gel g thin-layer plate, with petroleum ether-ethyl acetate-glacial acetic acid, be developing solvent, launch, take out, dry, spray is with 5% ferric chloride alcoholic solution, and hot blast blows to clear spot.In the test sample chromatograph, with reference substance chromatograph relevant position on, show the same color speckle;
(2) get this oral liquid 20ml, be added in the AB-8 type macroporous adsorptive resins handled well successively with water 100ml, 20% ethanol 100ml eluting, discard eluent, reuse 50% ethanol 100ml eluting, eluent evaporate to dryness, residue adds methanol 2ml dissolving, as need testing solution.Other gets the puerarin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.According to the thin layer chromatography test, draw need testing solution 6 μ l, reference substance solution 4 μ l put respectively on same silica gel g thin-layer plate, are developing solvent with chloroform-methanol-water, launch, and take out, and dry, and after the ammonia steam is smoked, inspect to ultra-violet lamp.In the test sample chromatograph, with contrast chromatograph corresponding position on, show the fluorescence speckle of same color;
(3) get the paeoniflorin reference substance, add ethanol and make the solution that every 1ml contains 1mg, product solution in contrast, test according to thin layer chromatography, draw each the 6 μ l of need testing solution under above-mentioned reference substance solution and discriminating (2) item respectively, put respectively on same silica gel g thin-layer plate, with chloroform-ethyl acetate-methanol-formic acid is developing solvent, launches, and takes out, dry, spray is with 5% vanillin sulfuric acid solution, and hot blast blows to clear spot, in the test sample chromatograph, with reference substance chromatograph relevant position on, show identical bluish violet speckle;
(4) get this oral liquid 20ml, add hydrochloric acid 3ml, heated 30 minutes to water-bath, extracted with diethyl ether 3 times are used in cooling immediately, and each 30ml merges ether solution, and low temperature volatilizes ether, and residue adds chloroform 2ml and dissolves, as need testing solution.Other gets emodin reference substance and chrysophanol reference substance, add methanol respectively and make the solution that every 1ml contains 1mg, product solution in contrast, test according to thin layer chromatography, drawing each 6 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, is developing solvent with petroleum ether-Ethyl formate, launch, take out, dry, to ultra-violet lamp, inspect, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show identical orange-yellow fluorescence speckle, after the ammonia steam is smoked, inspect to daylight, speckle becomes redness;
(5) this oral liquid retention time in the gained chromatograph under the assay item should be consistent with the retention time of reference substance;
That checks thes contents are as follows:
Relative density should be not less than 1.05;
PH value should be 4.5-7.0;
Other should meet every regulation relevant under the mixture item;
Theing contents are as follows of assay:
According to high effective liquid chromatography for measuring;
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; Methanol-water-phosphoric acid is mobile phase, and the detection wavelength is 280nm.Number of theoretical plate is pressed the baicalin peak and is calculated, and should be not less than 2500; It is an amount of that the preparation precision of reference substance solution takes by weighing the baicalin reference substance, adds 70% ethanol and make the solution that every 1ml contains 18 μ g, in contrast product solution;
The accurate this product 5ml that draws of the preparation of need testing solution puts in the 100ml measuring bottle, adds 70% ethanol dilution to scale, shakes up.The accurate 1.0ml that draws puts in the 10ml measuring bottle, adds 70% ethanol dilution to scale, shakes up, as need testing solution;
Accurate respectively reference substance and each the 10 μ l injection chromatograph of liquid of need testing solution drawn of algoscopy measured promptly; This oral liquid contains Radix Scutellariae must not be less than 3.0mg/ml in baicalin.
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| CN101352534B (en) * | 2007-07-24 | 2011-07-27 | 郑秀萍 | Chinese medicinal composition, and preparation method and uses thereof |
| CN102366489B (en) * | 2011-10-26 | 2013-09-18 | 刘运波 | Chinese traditional medicine for treating acute tonsillitis |
| CN104800616A (en) * | 2015-04-07 | 2015-07-29 | 范永启 | Compound essential oil for preventing and curing stomatitis |
| CN105535136A (en) * | 2015-12-21 | 2016-05-04 | 北京同仁堂科技发展股份有限公司 | A traditional Chinese medicine composition having a bacteriostasis function, a preparing method thereof and uses of the composition |
| CN105456385B (en) * | 2015-12-21 | 2018-02-23 | 北京同仁堂科技发展股份有限公司 | A kind of Chinese medicine composition with refrigeration function and preparation method thereof and purposes |
| CN106198840A (en) * | 2016-08-12 | 2016-12-07 | 成都维恒医药科技有限公司 | Developing solvent and thin-layer identification method for Chinese crude drug Radix Et Rhizoma Rhei thin-layer identification method |
| CN106806710A (en) * | 2016-11-28 | 2017-06-09 | 李元英 | A kind of traditional Chinese powder medicine for treating cough due to wind-heat evil |
| CN107462658B (en) * | 2017-07-18 | 2019-07-30 | 厦门市健康医疗大数据管理中心 | A kind of thin-layer chromatography qualitative identification method of Pueraria lobota ' Yanming ' capsules for clearing |
| CN112402516A (en) * | 2020-11-19 | 2021-02-26 | 广州一品红制药有限公司 | Preparation method and application of Qinxiang Qingjie oral liquid |
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| CN1348795A (en) * | 2001-10-30 | 2002-05-15 | 刘汉超 | Chinese medicine mixture for treating infantile infection of upper respiratory tract and pulmonitis |
| CN1544070A (en) * | 2003-05-21 | 2004-11-10 | 西安碑林药业股份有限公司 | Chinese traditional medicine for treating chronic pharyngolaryngitis and its preparing process |
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| CN1348795A (en) * | 2001-10-30 | 2002-05-15 | 刘汉超 | Chinese medicine mixture for treating infantile infection of upper respiratory tract and pulmonitis |
| CN1544070A (en) * | 2003-05-21 | 2004-11-10 | 西安碑林药业股份有限公司 | Chinese traditional medicine for treating chronic pharyngolaryngitis and its preparing process |
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