CN100362983C - Chinese medicinal preparation for abating child fever and its preparation method - Google Patents
Chinese medicinal preparation for abating child fever and its preparation method Download PDFInfo
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Abstract
The present invention relates to a Chinese medical preparation for infantile defervescence and a preparation method thereof, particularly to oral medicinal liquor for infantile defervescence and a preparation method thereof, and the present invention belongs to the technical field of medicine. The preparation technology of the present invention uses water distillation extraction to determin parameters; the present invention has the advantages of little loss of paeonol, good mouth feel, high biologic utilization, feasible operation, easy control and convenient mass production. Compared with western medicine for defervescence, the oral administration liquor for infantile defervescence has the advantages of smaller side effect, moderate defervescence, endurance and stability, and performs the functions of expelling wind, relieving exterior syndromes, eliminating toxicity and relieving sore-throat; the oral medicinal liquor for infantile defervescence not only takes temporary solution, but also effects a permanent cure, and temperature rapidly drops without relapse; thus, the oral medicinal liquor for infantile defervescence is a preferred medicinal preparation for doctors, patriarches and sick infants.
Description
Technical field:
The present invention relates to Chinese medicine preparation of a kind of children's antipyretic and preparation method thereof, relate in particular to children's and move back oral liquid and preparation method thereof.The field that belongs to the medicine technology.
Technical background: children's's internal organs are tender and lovely, and skin is dredged thin, and weakened defensive QI is felt the heresy of wind heat again, or trembles with fear from transconversion into heat, so fever and aversion to wind; Hold together on the heresy of wind heat and the visitor in the lung pharyngeal swelling of then having a headache; Penting up as pyretic toxicity then has mumps swelling, diseases such as hyperpyrexia.So in a single day hyperpyrexia appears in infantile common cold, be badly in need of bringing down a fever, also need declare catharsis simultaneously, make heresy that outlet be arranged.The children's antipyretic preparation just is being based on above-mentioned pathology and is developing.
Children's antipyretic preparation such as children's antipyretic oral liquid and children's antipyretic granule agent, list " the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation " the 6th in, the technology features of these two kinds of dosage forms is with Cortex Moutan, Radix Bupleuri, Fructus Forsythiae steam distillation, collect distillate, medicinal residues and all the other medical materials decoct with water secondary, Flos Lonicerae, Fructus Forsythiae, Herba Lophatheri are declared expelling pathogenic factors from the exterior clearly in the side, the detoxifcation heat radiation; The Radix Bupleuri reducing fever by reconciliation, the heat of clear few sun is the eliminating evil key medicine of heat clearing away expelling pathogenic factors from the exterior.Radix Scutellariae, Folium Isatidis, Radix Isatidis heat-clearing and toxic substances removing, the detumescence sore-throat relieving; Fructus Gardeniae is rushed down the three warmers interior-heat clearly, and Radix Cynanchi Atrati, Cortex Moutan are joined the Fructus Gardeniae clearing away heat and cooling blood, and the heat of clearing heat in YING system blood is with clear interior-heat, two clear with the prodrug the exterior and the interior that matches; Rhizoma Paridis, Pheretima heat clearing away arresting convulsion can be prevented infantile hyperpyrexia convulsions, and each medicine share, and the merit of bringing down a fever is played in performance heat clearing away expelling pathogenic factors from the exterior, resolving toxin and disinhibiting the throat effect altogether, holds concurrently with the effect of detumescence arresting convulsion.
The traditional Chinese medical science and doctor trained in Western medicine antipyretic are all based on diaphoresis at present.But because the side-effect problem of Western medicine is particularly outstanding to the child.As the ibuprofen class gastric mucosa there are stimulation and damage.Aspirin also can bring out asthma, and in the febris acuta disease, may cause the Renyi syndrome when especially influenza and chickenpox infant are used this medicine.So world's health organization is advocated without this medicine the heating infant that acute respiratory infection causes.Even the acetaminophen that the side effect of world health organisation recommendations is less the influence of children's's hemocyte also be can't neglect, and Chinese medicine has certain advantage in this respect.Compare with the antipyretic Western medicine, the side effect of children's antipyretic oral liquid is less, and it is gentle, lasting, stable to bring down a fever.The effect of children's antipyretic oral liquid dispelling wind to relieve the exterior syndrome, resolving toxin and disinhibiting the throat not only can take stopgap measures but also can effect a permanent cure, and body temperature descends to such an extent that seldom rebound again soon, is all acceptable Therapeutic Method of doctor, the head of a family and infant.Therefore, carry out the research of children's antipyretic mechanism in a deep going way, prevent the Western medicine untoward reaction, develop the Chinese patent medicine preparation of new children's antipyretic medicine, the advantage of performance Chinese medicine fever of children is of great practical significance.
Existing children's antipyretic preparation such as oral liquid and granule, distil process laid down by imprecision causes paeonol to lose in a large number among the preparation technology.This be because, the effective ingredient paeonol in the Cortex Moutan has the low 49.5-50 of fusing point, poorly water-soluble, therefore characteristics such as highly volatile fail to detect paeonol at itself and group's medicine with in the finished product that boils.And this technology is wayward in process of production, is unfavorable for big production, and is unstable in storage period, easily produces sedimentation.Simultaneously, the infant that generates heat period is rather responsive to the sense of taste, especially the medicinal liquid that bitterness is arranged is refused clothes easily, even feed inlet, also can tell sometimes, and above-mentioned these all are the difficult points that overcomes not yet in the prior art.Therefore, be necessary to improve technology, improve the quality of the pharmaceutical preparations.
Summary of the invention:
The invention provides a kind of Chinese medicine preparation of children's antipyretic.
The Chinese medicine preparation of children's antipyretic of the present invention is made by following Chinese medicine raw materials by weight proportion: 50～450 parts of Folium Isatidiss, 30～270 parts of Radix Isatidis, 30～270 parts of Flos Loniceraes, 30～270 parts of Fructus Forsythiaes, 30～270 parts of Fructus Gardeniaes, 30～270 parts of Cortex Moutans, 30～270 parts of Radix Scutellariaes, 20～180 parts of Herba Lophatheris, 20～180 parts of Pheretimas, 15～135 parts of Rhizoma Paridis, 30～270 parts of Radix Bupleuri, 20～180 parts of Radix Cynanchi Atratis.
The present invention processes above-mentioned raw material of Chinese medicine through extracting, obtain pharmaceutically active substance, again by the galenic pharmacy routine techniques, as pharmaceutically active substance and appropriate amount of drug acceptable auxiliary are mixed with into any pharmaceutically useful dosage form.
As preferred Chinese medicine preparation be: Folium Isatidis 150g, Radix Isatidis 90g, Flos Lonicerae 90g, Fructus Forsythiae 90g, Fructus Gardeniae 90g, Cortex Moutan 90g, Radix Scutellariae 90g, Herba Lophatheri 60g, Pheretima 60g, Rhizoma Paridis 45g, Radix Bupleuri 90g, Radix Cynanchi Atrati 60g.
In more than forming, the weight of Chinese medicine is calculated with crude drug, and this prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, granule 1000 grams, oral liquid 1000ml etc., also can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1-2 time.
More than form, can be made into the preparation of 50-1000 taking dose, as patch, make 1000, make 1000 of capsules, determine usage and dosage according to the situation of infant in use, but obey 1-3 time every day, each 1-20 agent can be taken 50-1000 time altogether.As granule, make 125 bags, take the 1-2 bag at every turn, can take 62.5-125 time altogether.
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 ministerial drug and adjuvant drug in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.
Pharmaceutically active substance of the present invention can prepare by the following method: this preparation method constitutes key of the present invention.
More than 12 flavors, Cortex Moutan, Radix Bupleuri, Fructus Forsythiae pulverizing medicinal materials to all by 45 orders, but can not be crossed 30 orders, add water by medicated powder and water ratio 1/10, use steam distillation 2h, the collection distillate; Medicinal residues and all the other Folium Isatidis etc. nine flavor adds 4-20 times of decocting and boils 2-5 time, and each 0.5-2 hour, collecting decoction filtered, and filtrate is concentrated in right amount, adds ethanol and makes that to contain pure measuring be more than 70%, leaves standstill.Get supernatant and reclaim ethanol, be concentrated into more than the 200ml, add water and stir evenly, leave standstill, get supernatant, filter, filtrate is concentrated in right amount, and this concentrated solution and distillate lump together, and form pharmaceutically active substance of the present invention.
With this pharmaceutically active substance is that raw material adds the medicine acceptable auxiliary, can be made into any pharmaceutical dosage forms according to the galenic pharmacy routine techniques.
Chinese medicine preparation of the present invention can be any pharmaceutically useful dosage form, these dosage forms comprise: oral liquid, membrane, enema, patch, syrup, granule, tablet, capsule, pill, powder, unguentum, sublimed preparation, injection, suppository, cream, spray, drop pill, slow releasing preparation, controlled release preparation, preferably oral liquid.
Pharmaceutical preparation of the present invention, the preparation of its oral administration can contain excipient commonly used, such as sweeting agent, binding agent, filler, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, correctives and wetting agent, can carry out coating to tablet in case of necessity.
The form of oral liquid for example can be aqueous or oily suspensions, solution, Emulsion, syrup or elixir, perhaps can be a kind of available water before use or other suitable composite dry products of carrier.This liquid preparation can contain conventional additive, such as correctives, for example pulp, sucrose, aspartame, fruit Fructus Vitis viniferae slurry, fructose, maltose alcohol, stabilizing agent, for example carboxymethyl cellulose sodium, sorbitol, syrup, methylcellulose, gelatin, hydroxyethyl-cellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenation edible fat, emulsifying agent, for example lecithin, anhydro sorbitol monooleate or arabic gum; Non-aqueous carrier (they can comprise edible oil), for example almond oil, fractionated coconut oil, such as oily ester, propylene glycol or the ethanol of the ester of glycerol; Antiseptic, for example sodium benzoate or propylene glycol or para hydroxybenzene methyl ester or propyl p-hydroxybenzoate or sorbic acid, and if desired, can contain conventional flavouring agent or coloring agent.
The filler that is suitable for comprises cellulose, mannitol, lactose and other similar filler.Suitable disintegrating agent comprises starch, polyvinylpyrrolidone and starch derivatives, for example sodium starch glycollate.Suitable lubricant, for example magnesium stearate.The acceptable wetting agent of appropriate drug comprises sodium lauryl sulphate.
Can fill by mixing, the method that tabletting etc. are commonly used prepares solid oral composition.Mix repeatedly active substance is distributed in those compositionss of a large amount of filleies of whole use.
For injection, the liquid unit dosage forms of preparation contains active substance of the present invention and sterile carrier.According to carrier and concentration, this chemical compound can be suspended or dissolving.The preparation of solution is normally by being dissolved in active substance in a kind of carrier filter-sterilized before it is packed into a kind of suitable bottle or ampoule, sealing then.For example a kind of local anesthetic of adjuvant, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, can be after the bottle of packing into that this compositions is freezing, and under vacuum, water is removed.
Pharmaceutical preparation of the present invention, when being prepared into medicament, optionally add suitable medicine acceptable carrier, described medicine acceptable carrier preferably is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, 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, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, the phospholipid material, Kaolin, Pulvis Talci, micropowder silica gel, magnesium carbonate, calcium stearate, magnesium stearate etc.
According to the present invention, most preferred dosage form is an oral liquid, and its basic preparation method comprises, with said medicine active substance and correctives, stabilizing agent, antiseptic mixes, as: said medicine active substance with mix with the syrup of making more than the sucrose 400g, add stabilizing agent again, antiseptic is an amount of, water is adjusted total amount to ormal weight, stir evenly, filter fill, sterilization, promptly.
Concrete as: above 12 flavors, Cortex Moutan, Radix Bupleuri, Fructus Forsythiae pulverizing medicinal materials to all by 45 orders, but can not be crossed 30 orders, add water by medicated powder and water ratio 1/10, use steam distillation 2h, the collection distillate; Medicinal residues and all the other Folium Isatidis etc. nine flavor adds 10 times of decoctings and boils secondary, and each 1 hour, collecting decoction filtered, and filtrate is concentrated in right amount, adds ethanol and makes that to contain that alcohol measures be 70%, leaves standstill.Get supernatant and reclaim ethanol, be concentrated into about 200ml, add water and stir evenly, leave standstill, get supernatant, filter, filtrate is concentrated in right amount.Other gets sucrose 400g and makes syrup, merges with above-mentioned medicinal liquid and distillate, adds an amount of stabilizing agent, antiseptic again, adjusts total amount to 1000ml, stirs evenly, filter, and the fill sterilization, promptly.
The best preparation method of oral liquid of the present invention is: Folium Isatidis 150g, Radix Isatidis 90g, Flos Lonicerae 90g, Fructus Forsythiae 90g, Fructus Gardeniae 90g, Cortex Moutan 90g, Radix Scutellariae 90g, Herba Lophatheri 60g, Pheretima 60g, Rhizoma Paridis 45g, Radix Bupleuri 90g, Radix Cynanchi Atrati 60g, more than 12 the flavor, with Cortex Moutan, Radix Bupleuri, Fructus Forsythiae pulverizing medicinal materials to all by 45 orders, but can not cross 30 orders, add water by medicated powder and water ratio 1/10, be 2700ml, use steam distillation 2h, collect distillate; Medicinal residues and all the other Folium Isatidis etc. nine flavor adds the 7350ml decocting and boils secondary, and each 1 hour, collecting decoction filtered, and filtrate is concentrated in right amount, adds ethanol and makes that to contain that alcohol measures be 70%, leaves standstill.Get supernatant and reclaim ethanol, be concentrated into 200ml, add water and stir evenly, leave standstill, get supernatant, filter, filtrate is concentrated in right amount.Other gets sucrose 400g and makes syrup, merges with above-mentioned medicinal liquid and distillate, adds carboxymethyl cellulose sodium 8g, sodium benzoate 0.1% again, adjusts total amount to 1000ml, stirs evenly, filter, and fill, sterilization, promptly.
Said water distil process is characterised in that Cortex Moutan, Radix Bupleuri, Fructus Forsythiae pulverizing medicinal materials to all by 45 orders, but can not cross 30 orders, adds water by medicated powder and water ratio 1/10, uses steam distillation 2h; Said decocting boils technology characteristics and is finally to contain alcohol amount 70%, sucrose, and the ratio of the concentrated amount of carboxymethyl cellulose sodium and medicinal liquid is 50: 25: 1, best for finally containing alcohol amount 70%, sucrose 400g, carboxymethyl cellulose sodium 8g, medicinal liquid concentrate and measure 200ml.
The preparation of the preferred oral liquid of the present invention, it preferably fills a prescription composed as follows:
Pharmaceutically active substance of the present invention: Folium Isatidis 150g, Radix Isatidis 90g, Flos Lonicerae 90g, Fructus Forsythiae 90g, Fructus Gardeniae 90g, Cortex Moutan 90g, Radix Scutellariae 90g, Herba Lophatheri 60g, Pheretima 60g, Rhizoma Paridis 45g, Radix Bupleuri 90g, Radix Cynanchi Atrati 60g.
Correctives: sucrose, aspartame, fruit Fructus Vitis viniferae slurry, fructose and maltose alcohol.
Stabilizing agent: carboxymethyl cellulose sodium.
Antiseptic: ethylparaben, methyl parahydroxybenzoate, sodium benzoate, benzoic acid and sorbic acid.
Most preferred prescription is composed as follows:
Pharmaceutically active substance of the present invention: Folium Isatidis 150g, Radix Isatidis 90g, Flos Lonicerae 90g, Fructus Forsythiae 90g, Fructus Gardeniae 90g, Cortex Moutan 90g, Radix Scutellariae 90g, Herba Lophatheri 60g, Pheretima 60g, Rhizoma Paridis 45g, Radix Bupleuri 90g, Radix Cynanchi Atrati 60g.
Correctives: aspartame
Stabilizing agent: carboxymethyl cellulose sodium
Antiseptic: sodium benzoate
More than most preferred prescription form through screening and obtain, mouthfeel is improved greatly.
Children's antipyretic oral liquid of the present invention is compared with the contained prior art of Chinese traditional patent formulation preparation, its water distil process parameter is determined, guaranteed the proposition of paeonol effective ingredient, avoid former technology to cause paeonol to lose in a large number, detect paeonol easily, improved drug effect, stablized quality, mouthfeel is good, the bioavailability height; Operation feasible is controlled easily simultaneously, is convenient to big production.
Above-mentioned advantage is done further confirmation by following technological experiment:
1 the present invention extracts the optimised process experiment of volatile oil (comprising paeonol):
1.1 the present invention adopts common hydrodistillation to extract, and gets the pulverizing sample 30g of Cortex Moutan, Radix Bupleuri, Fructus Forsythiae, 3 distillation parameters is set: the A distillation time; Pulverize the ratio of sample and amount of water during the B distillation; C pulverizing medicinal materials degree is with these 3 factors as investigation.
1.1.1 each parameter is selected 3 class values, is respectively: A
1Distillation time 2h; A
2Distillation time is less than 2h; A
3Distillation time is greater than 2h; B
1Medicated powder and water ratio 1/20 promptly add water 900ml; B
2Medicated powder and water ratio 1/15 promptly add water 675ml; B
3Medicated powder and water ratio 1/10 promptly add water 450ml; C
1Pulverizing medicinal materials is extremely all by 30 orders; C
2Pulverizing medicinal materials is to all by 45 orders, but can not cross 30 orders; C
3Pulverizing medicinal materials is to all by 60 orders, but can not cross 45 orders.All parameter is combined as 9 processing mutually, and combination meets Latin square design, sees table 1. for details
1.2 ingredient analysis in the volatile oil:
1.2.1 GC condition: chromatographic column is the DB5 quartz capillary column, 30m * 0.25mm * 0.25 μ m; Carrier gas is high-pure helium (99.999%); Post flow 1ml Pmin does not shunt; Press before the post: 100kPa; 220 ℃ of injector temperatures; Sample size 1 μ l. temperature programming: column temperature keeps 1min for 40 ℃, is elevated to 200 ℃ with 10 ℃ of Pmin and keeps the 3min.DSQ condition: ionization mode EI, electron energy 70eV; 210 ℃ of interface temperature, 200 ℃ of ion source temperatures; Traffic scanning scope 50～350; Solvent delay 4.0min; Emission current 100 μ A.
Table 1 volatile matter distillation oil is used the variation square formation (Latin square design) of distillation parameter
| Sequence number | Combination | Sequence number | Combination | Sequence number | Combination |
| 1 2 3 | A 1B 1C 3 A 1B 2C 1 A 1B 3C 2 | 4 5 6 | A 2B 1C 3 A 2B 2C 3 A 2B 3C 1 | 7 8 9 | A 3B 1C 1 A 3B 2C 2 A 3B 3C 3 |
2 results and analysis
2.1 different distillation parameters are to the influence (seeing Table 2) of volatile oil productive rate
After the different distillation of table 2 parameter combinations to the productive rate of volatile oil
| Parameter combinations | Volatile oil productive rate % | Parameter combinations | Volatile oil productive rate % | Parameter combinations | Volatile oil productive rate % |
| A 1B 1C 3A 1B 2C 1A 1B 3C 2 | 1.767 1.633 2.417 | A 2B 1C 3 A 2B 2C 3 A 2B 3C 1 | 1.250 0.717 1.108 | A 3B 1C 1 A 3B 2C 2 A 3B 3C 3 | 0.367 0.483 0.417 |
As can be seen from Table 2: the distillation condition of 9 kinds of different parameters combinations has influenced the output capacity of volatile oil significantly, and wherein, A is made up in being combined as that output capacity is the highest
2B
2C
3, oil productivity is up to 3.54%; A is made up in being combined as that output capacity is minimum
1B
3C
2, oil productivity is 0.367%, both differ 6.6 times.
For comparing the sizes of 3 distillation conditions to the influence of volatile oil productive rate, variance analysis (table 3) has been carried out in this experiment, can find out from table 3: this experiment, the factor that the volatile oil productive rate is had the greatest impact is a distillation time, next is a ratio of pulverizing medicated powder and add water, and to its influence minimum is the pulverizing medicinal materials degree.
The variance analysis of table 3 volatile oil output
| The variation source | Quadratic sum | Degree of freedom | Variance | The F value | F0.05 | F0.01 |
| A factor B factor | 0.205 3.499 | 2 2 | 0.103 1.750 | 34.167 5833.167 |
| C factor error amounts to | 0.299 0.006 4.009 | 2 2 8 | 0.150 0.003 | 49.833 |
2.2 different distillation parameters see Table 4 to the influence of ingredient paeonol in the volatile oil
The volatile oil main component percentage change that table 4 obtains with the distillation of different parameters combination carrying out water
| Composition | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 |
| Myrcene phenol Forsythia volatile oil forsythol glycoside Radix Bupleuri long-chain aldehyde paeonol | 0.05 0.16 1.00 0.49 1.16 62.68 | 0.07 0.14 0.89 0.39 1.02 69.64 | 0.05 0.13 0.72 0.39 1.11 93.11 | 0.04 0.18 1.04 0.46 1.00 65.43 | 0.05 0.17 0.76 0.44 0.96 60.09 | 0.07 0.21 1.20 0.51 1.07 67.51 | 0.12 0.25 1.52 0.61 1.51 55.59 | 0.14 0.27 1.63 0.66 1.50 58.47 | 0.17 0.31 1.97 0.70 1.63 57.52 |
Analyze by the difference distillation volatile oil that parameter distilled out is carried out GC-DSQ, draw the relative percentage composition (table 4) of 6 kinds of main components.From experimental result as can be seen: at distillation time is that the relative amount of paeonol 2 hours the combination is higher, wherein makes up 3 (A
1B
3C
2) the content of paeonol reach 93.11%, show that distillation time directly influences the steam rate of paeonol. except that paeonol, the higher relative percentage composition of other compositions appears in other the distillation time combination.
3 conclusions
In the prior art, though extract volatile oil a variety of methods are arranged, but what often use mainly is the way of distillation. this just requires us to select to distill parameter value in earnest, determine the optimal parameter combination, to improve the quality of distillation output and oil. from experimental result of the present invention as can be seen: the distillation parameter is bigger to the influence of the output of volatile oil and composition, wherein distillation time has remarkable influence to volatile oil output, and distillation time is 2h, and the output of oil is high more.In addition, with regard to paeonol, be that the relative amount of paeonol in 2 hours the combination is the highest at distillation time.Therefore among the present invention, the best distillation condition of setting is distillation time 2h, adds water 450ml, and pulverizing medicinal materials is to all by 45 orders, but can not cross 30 orders.
For stabilised quality, make good mouthfeel, we the adjuvant that added carried out a series of screening experiment:
Experiment one: by orthogonal experiment amount of liquid medicine and the best proportioning of adjuvant are selected, investigated stability of formulation:
1 experiment material
1.1 make the water drug-decocting concentrating liquids that decoct with nine flavors such as mixed all the other Folium Isatidis of medicinal residues after Cortex Moutan, Radix Bupleuri, the distillation of Fructus Forsythiae steam distillation by method for making of the present invention, precipitate with ethanol, distillate is with sucrose, carboxymethyl cellulose sodium mixing, promptly.
1.2 it is medicinal that sucrose, carboxymethyl cellulose sodium are.
2 experimental techniques and result
Select L for use
9(3
4) the orthogonal array experiment arrangement.
Table 1 factor level
| Level | A precipitate with ethanol degree % | B sucrose g | C carboxymethyl cellulose sodium g | D concentrated medicament amount ml |
| 1 2 3 | 50 60 70 | 400 600 800 | 6 7 8 | 400 300 200 |
Table 2 L
9(3
4) Orthogonal experiment results
| Tested number | A | B | C | D | Storage period, clarity was observed |
| 1 2 3 4 5 6 7 8 9 | 1 1 1 2 2 2 3 3 3 | 1 2 3 1 2 3 1 2 3 | 1 2 3 2 3 1 3 1 2 | 1 2 3 3 1 2 2 3 1 | Almost there is not the later half amount sedimentation of sedimentation 3min behind the sedimentation 4min behind the micro-sedimentation 20min behind the micro-sedimentation 5min behind the micro-sedimentation 25min behind the sedimentation 30min behind the later half amount sedimentation of the later half amount sedimentation of the 5min 25min 25min |
Conclusion: by data in the table as can be known, technology A
1B
3C
2D
2And A
1B
3C
2D
2What make has good stability, and standard was deposited in the phase, and mixing is even, but A
1B
3C
2D
2Technology sucrose consumption is big, and dose is big, so select A
1B
3C
2D
2Be precipitate with ethanol degree 70%, sucrose, the ratio that carboxymethyl cellulose sodium and medicinal liquid concentrate amount is 50: 25: 1; The best is a precipitate with ethanol degree 70%, sucrose 400g, and carboxymethyl cellulose sodium 8g, medicinal liquid concentrate amount 200ml.With 70% ethanol precipitate with ethanol, processing compound prepares each batch oral liquid according to this, and room temperature was observed 1 year, stablized; Carboxymethyl cellulose sodium is a stabilizing agent, and it is even almost not have the sedimentation medicinal liquid behind the 30min, and outward appearance is good.
Experiment two:, investigate the mouthfeel of preparation with this to the selection of correctives.
Test as follows: test sucrose consumption in by the present invention, we replace sucrose with aspartame, fruit Fructus Vitis viniferae slurry, fructose, maltose alcohol respectively, are divided into 5 groups, are prepared into oral liquid according to the technology of the present invention, compare its mouthfeel successively, and the result is as follows:
Table 1 correctives is investigated influence of the present invention
| Group | Infant acceptance level (taking compliance) | Mouthfeel | Scoring |
| 1 aspartame group | Children's very easily takes | Pure and fresh, sweet taste is better | 98 |
| 2 fruit Fructus Vitis viniferae slurries are organized 3 fructose groups, 4 maltose alcohol groups, 5 sucrose groups | Children's is ready to take children's and is ready to take children's's many clothes of being unwilling, and easily tells children's's many clothes of being unwilling, and feeds difficulty | Delicate fragrance, good mouthfeel are pure and fresh, and good mouthfeel is pure and fresh, the good little hardship of mouthfeel | 95 93 91 90 |
More than investigate and show: after adding correctives, can strengthen the compliance that infant is taken medicine, its effect is arranged in order and is aspartame＞fruit Fructus Vitis viniferae slurry＞fructose＞maltose alcohol＞sucrose.
Experiment three: to choice of preservatives:
Owing to contain a large amount of sugar part in the soft extract of the present invention, in storage process, grow microorganism easily, go mouldy, thereby influence the quality of medicine.So can add an amount of antiseptic in the soft extract of the present invention, if but the antiseptic improper use also can influence the quality of medicament.Below be to the choice of preservatives experimental result:
| Project | Cosmetic variation | Mouthfeel | ||||
| 30 days | 60 days | 90 days | 120 days | 180 days | ||
| 0.1% sodium benzoate | - | - | - | - | - | No change |
| 0.2% sodium benzoate | - | - | - | - | - | No change |
| 0.1% benzoic acid | - | - | - | - | - | Numb feeling in the tongue slightly |
| 0.2% benzoic acid | - | - | - | - | - | Numb feeling in the tongue slightly |
| 0.03% ethylparaben | - | + | ++ | ++ | ++ | Abnormal flavour is arranged |
| 0.05% methyl parahydroxybenzoate | - | - | - | - | - | Abnormal flavour is arranged |
| 0.05% potassium sorbate | - | - | 0 | 0 | 0 | Become sour |
| 0.2% potassium sorbate | - | - | - | 0 | 0 | Become sour |
Annotate :-expression no change; + expression has a small amount of mycete; ++ expression has mycete; 0 expression fermentation is become sour.
According to experimental result in the table relatively, we select sodium benzoate as antiseptic.
Since sodium benzoate during as antiseptic consumption big more, drug quality is not had obvious variation, but can cause damage human body, the consumption of sodium benzoate is advisable to be no more than 0.2% in this preparation, the selection experimental result of its minimum use amount is:
| Project | Cosmetic variation | Mouthfeel | ||
| 30 days | 60 days | 90 days | 120 days | 180 days |
| 0.05% sodium benzoate | - | - | + | ++ | +++ | Abnormal flavour is arranged |
| 0.10% sodium benzoate | - | - | - | + | + | Abnormal flavour is arranged |
| 0.15% sodium benzoate | - | - | - | - | - | No change |
| 0.20% sodium benzoate | - | - | - | - | - | No change |
| 0.25% sodium benzoate | - | - | - | - | - | No change |
| 0.3% sodium benzoate | - | - | - | - | - | Numb feeling in the tongue slightly |
According to experimental result in the table, effective use amount of sodium benzoate is 0.10%-0.20% in this preparation.
Beneficial effect: Pharmacodynamic test of active extract result shows: children's antipyretic oral liquid of the present invention have significantly bring down a fever, antiinflammatory action, these pharmacological actions be confirmed by following test example, and result of the test provide foundation for clinical application.Following test example is used to further specify the present invention.
Test example 1 children's antipyretic oral liquid of the present invention is to the effect of bringing down a fever of rabbit infective fever.
1 materials and methods
1.1 animal: 56 of New Zealand's large ear rabbits (the Guiyang Medical College Animal Lab. provides), body weight 2.0 ± 0.2kg, male and female half and half.
1.2 medicine:
According to " the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation " the 6th children's antipyretic granule that contained prepared forms, hereinafter to be referred as medicine A;
The children's antipyretic oral liquid of making by technology of the present invention is hereinafter to be referred as medicine B.
1.3 method: get 56 of New Zealand's large ear rabbits, the male and female dual-purpose is divided into 7 groups at random, 8 every group.Water 12h is can't help in fasting.Under 20 ± 1 ℃ of room temperatures, fixing rabbit, treat peace and quiet after, survey the anus temperature continuously 2 times with PD-U type digital thermometer (Germany produces), all proofread and correct before the experiment through normal thermometer (the medical instrucment and meter plant in Chongqing produces).Every 30min, average as normal body temperature at every turn.After normal body temperature was determined, each treated animal was pressed the quiet notes typhoid fever of 1.0mlPkg paratyphoid fever the first and second three bacterium liquid.During 60min, measure as stated above that body temperature changes after the pyrogenicity.Then, one group gavages ordinary water as negative control group, three groups of children's antipyretic granule agent that gavage various dose respectively, and the excess-three group gavages the children's antipyretic oral liquid of various dose respectively.Body temperature after the administration when sequentially determining 30,60,120,180,240 and 300min, and the body temperature before the administration after the normal body temperature of each treated animal and this treated animal pyrogenicity carried out paired t-test is asked the statistical significance of body temperature after its normal body temperature and the pyrogenicity.Simultaneously administration animal groups body temperature and matched group are organized a t check, calculate respectively and relatively the body temperature after the pyrogenicity change.Result of the test such as following table:
Subordinate list children's antipyretic oral liquid to pyrogenicity after the influence of rabbit
| Group | Dosage (g/kg) | Normal body temperature (℃) | 1h body temperature after the pyrogenicity (℃) | Body temperature after the administration (℃) | |||||
| 0.5h | 1h | 2h | 3h | 4h | 5h | ||||
| Matched group medicine A medicine B | - 0.2 0.4 0.8 0.2 0.4 0.8 | 38.3±0.7 38.3±0.2 38.3±0.6 38.3±0.6 38.2±0.4 38.33±0.1 38.1±0.4 | 40.4±0.5 #40.3±0.3 #40.5±0.6 #40.5±0.6 #40.3±0.3 #40.5±0.2 #40.4±0.4 # | 40.6±0.6 40.2±0.3 40.6±0.5 40.6±0.5 40.5±0.4 40.2±0.2 40.6±0.5 | 40.8±0.7 40.4±0.6 40.4±0.5 39.6±0.2 △*40.1±0.6 △39.6±0.2 △*39.5±0.3 △* | 40.6±0.4 40.3±0.1 40.2±0.1 39.8±0.3 39.4±0.5 39.5±0.6 39.4±0.5 | 40.5±0.3 40.2±0.1 40.2±0.1 39.5±0.2 39.6±0.4 39.5±0.3 39.3±0.5 | 40.3±0.5 39.7±0.4 39.5±0.4 39.3±0.5 39.8±0.5 39.2±0.6 39.4±0.3 | 39.8±0.2 39.6±0.3 39±0.4 39±0.4 39.6±0.5 39±0.4 39.1±0.3 |
1h and normal body temperature are relatively after the preceding pyrogenicity of #P＜0.01 administration.
* body temperature comparison after the pyrogenicity before 1h and the administration after P＜0.01 administration.
The body temperature of 1h and matched group respective point relatively after each administration group administration of △ P＜0.01.
2 results
Rabbit by quiet notes three bacterium liquid 1h after, produce thermal effect, body temperature obviously increases.With comparison before the pyrogenicity, difference has significance (P＜0.01).After rabbit after the pyrogenicity was irritated respectively and feeds children's antipyretic granule agent (medicine A) and children's antipyretic oral liquid (medicine B), medicine B group body temperature obviously reduced, and compares with body temperature before the administration after the pyrogenicity, and difference has highly significant (P＜0.01); And the reduction of medicine A body temperature is not obvious.1h body temperature and the body temperature of corresponding time of matched group compare after each administration group administration, and medicine B group difference has highly significant (P＜0.01), and medicine A group difference is significance not, sees attached list.
The result shows that children's antipyretic oral liquid of the present invention can reduce the infective fever of rabbit.
Test example 2 children's antipyretic oral liquid antiphlogistic effects of the present invention
1 materials and methods
1.1 animal: 40 of Male Kunming strain mice (the Guiyang Medical College Animal Lab. provides), body weight 27 ± 0.5g.
1.2 medicine:
Medicine A: aspirin (commercially available)
Medicine B: the children's antipyretic oral liquid of making by technology of the present invention;
The blank group.
1.3 method: get 40 of male mices, be divided into the heavy dose of group of children's antipyretic oral liquid 40mlkg at random
-1, children's antipyretic oral liquid small dose group 10mlkg
-1, children's antipyretic oral liquid small dose group 30mlkg
-1And the blank group, 10 every group, be disposable gastric infusion (40mlkg
-1), matched group is given the equivalent distilled water.Behind the administration 1.5h, every Mus left side ear is coated with dimethylbenzene 30ul and causes inflammation, and auris dextra is put to death mice after causing scorching 30min in contrast, lays auricle at same position respectively with diameter 9mm card punch, weighs, and heavily subtracting the auris dextra recast with left ear is the swelling degree.Administration group and matched group compare, and calculate the swelling rate.See Table 1.
The influence of decimal auricle edema due to the table 1 oral liquid xylol of the present invention
The result shows, the decimal auricle edema has the obvious suppression effect due to the oral liquid xylol of the present invention.
The specific embodiment
The present invention is further illustrated below in conjunction with fact Example, and following each fact Example only is used to illustrate the present invention, to the present invention and unrestricted.
Embodiment 1
Folium Isatidis 150g, Radix Isatidis 90g, Flos Lonicerae 90g, Fructus Gardeniae 90g, Cortex Moutan 90g, Radix Bupleuri 90g, Fructus Forsythiae 90g, Radix Scutellariae 90g, Herba Lophatheri 60g, Pheretima 60g, Rhizoma Paridis 45g, Radix Cynanchi Atrati 60g, sucrose 400g, carboxymethyl cellulose sodium 8g and sodium benzoate 1g
More than 12 flavors, Cortex Moutan, Radix Bupleuri, Fructus Forsythiae pulverizing medicinal materials to all by 45 orders, but can not be crossed 30 orders, add water by medicated powder and water ratio 1/10, promptly add water 2700ml, use steam distillation 2h, the collection distillate; Medicinal residues and all the other Folium Isatidis etc. nine flavor adds water 7350ml and decocts secondary, and each 1 hour, collecting decoction filtered, and filtrate is concentrated in right amount, adds ethanol and makes that to contain that alcohol measures be 70%, leaves standstill.Get supernatant and reclaim ethanol, be concentrated into 200ml, add water and stir evenly, leave standstill, get supernatant, filter, filtrate is concentrated in right amount.Other gets sucrose 400g and makes syrup, merges with above-mentioned medicinal liquid and distillate, adds carboxymethyl cellulose sodium, sodium benzoate again, adjusts total amount to 1000ml, stirs evenly filtration, fill, and sterilization, promptly.
Embodiment 2
Folium Isatidis 150g, Radix Isatidis 90g, Flos Lonicerae 90g, Fructus Gardeniae 90g, Cortex Moutan 90g, Radix Bupleuri 90g, Fructus Forsythiae 90g, Radix Scutellariae 90g, Herba Lophatheri 60g, Pheretima 60g, Rhizoma Paridis 45g, Radix Cynanchi Atrati 60g, aspartame 400g, carboxymethyl cellulose sodium 8g and sodium benzoate 1g
More than 12 flavors, Cortex Moutan, Radix Bupleuri, Fructus Forsythiae pulverizing medicinal materials to all by 45 orders, but can not be crossed 30 orders, add water by medicated powder and water ratio 1/10, promptly add water 2700ml, steam distillation 2h, collection distillate; Medicinal residues and all the other Folium Isatidis etc. nine flavor adds water 7350ml and decocts secondary, and each 1 hour, collecting decoction filtered, and filtrate is concentrated in right amount, adds ethanol and makes that to contain that alcohol measures be 70%, leaves standstill.Get supernatant and reclaim ethanol, be concentrated into 200ml, add water and stir evenly, leave standstill, get supernatant, filter, filtrate is concentrated in right amount.Other gets aspartame and makes syrup, merges with above-mentioned medicinal liquid and distillate, adds carboxymethyl cellulose sodium, sodium benzoate again, adjusts total amount to 1000ml, stirs evenly, filter, and fill, sterilization, promptly.
Embodiment 3 Folium Isatidis 50g, Radix Isatidis 30g, Flos Lonicerae 30g, Fructus Forsythiae 30g, Fructus Gardeniae 30g, Cortex Moutan 30g, Radix Scutellariae 30g, Herba Lophatheri 20g, Pheretima 20g, Rhizoma Paridis 15g, Radix Bupleuri 30g, Radix Cynanchi Atrati 20g, fruit Fructus Vitis viniferae slurry 400g, carboxymethyl cellulose sodium 8g and sodium benzoate 0.34g
More than 12 flavors, Cortex Moutan, Radix Bupleuri, Fructus Forsythiae pulverizing medicinal materials to all by 45 orders, but can not be crossed 30 orders, add water by medicated powder and water ratio 1/10, promptly add water 900ml, steam distillation 2h, collection distillate; Medicinal residues and all the other Folium Isatidis etc. nine flavor adds water 2450ml and decocts secondary, and each 1 hour, collecting decoction filtered, and filtrate is concentrated in right amount, adds ethanol and makes that to contain that alcohol measures be 70%, leaves standstill.Get supernatant and reclaim ethanol, be concentrated into 200ml, add water and stir evenly, leave standstill, get supernatant, filter, filtrate is concentrated in right amount.Other gets fruit Fructus Vitis viniferae slurry and makes syrup, merges with above-mentioned medicinal liquid and distillate, adds carboxymethyl cellulose sodium, sodium benzoate again, transfers total amount to 1000ml, stirs evenly filtration, fill, and sterilization, promptly.
Embodiment 4
Folium Isatidis 450g, Radix Isatidis 270g, Flos Lonicerae 270g, Fructus Forsythiae 270g, Fructus Gardeniae 270g, Cortex Moutan 270g, Radix Scutellariae 270g, Herba Lophatheri 180g, Pheretima 180g, Rhizoma Paridis 135g, Radix Bupleuri 270g, Radix Cynanchi Atrati 180g, sucrose 800g, carboxymethyl cellulose sodium 8g and sodium benzoate 3g
More than 12 flavors, Cortex Moutan, Radix Bupleuri, Fructus Forsythiae pulverizing medicinal materials to all by 45 orders, but can not be crossed 30 orders, add water by medicated powder and water ratio 1/10, promptly add water 8100ml, steam distillation 2h, collection distillate; Medicinal residues and all the other Folium Isatidis etc. nine flavor adds water 22050ml and decocts secondary, and each 1 hour, collecting decoction filtered, and filtrate is concentrated in right amount, adds ethanol and makes that to contain that alcohol measures be 70%, leaves standstill.Get supernatant and reclaim ethanol, be concentrated into 600ml, add water and stir evenly, leave standstill, get supernatant, filter, filtrate is concentrated in right amount.Other gets sucrose 800g and makes syrup, merges with above-mentioned medicinal liquid and distillate, adds carboxymethyl cellulose sodium, sodium benzoate again, adjusts 1000 doses of total amounts, stirs evenly, filter, and fill, sterilization, promptly.
Embodiment 5
Folium Isatidis 50g, Radix Isatidis 270g, Flos Lonicerae 30g, Cortex Moutan 270g, Fructus Forsythiae 270g, Radix Bupleuri 30g, Fructus Gardeniae 30g, Radix Scutellariae 30g, Herba Lophatheri 180g, Pheretima 20g, Rhizoma Paridis 135g, Radix Cynanchi Atrati 180g, sucrose 600g, carboxymethyl cellulose sodium 8g and sodium benzoate 1.5g
More than 12 flavors, Cortex Moutan, Radix Bupleuri, Fructus Forsythiae pulverizing medicinal materials to all by 45 orders, but can not be crossed 30 orders, add water by medicated powder and water ratio 1/10, promptly add water 5700ml, steam distillation 2h, collection distillate; Medicinal residues and all the other Folium Isatidis etc. nine flavor adds water 9250ml and decocts secondary, and each 1 hour, collecting decoction filtered, and filtrate is concentrated in right amount, adds ethanol and makes and contain alcohol and measure 70%, leaves standstill.Get supernatant and reclaim ethanol, be concentrated into 298ml, add water and stir evenly, leave standstill, get supernatant, filter, filtrate is concentrated in right amount.Other gets sucrose 600g and makes syrup, merges with above-mentioned medicinal liquid and distillate, adds carboxymethyl cellulose sodium, sodium benzoate again, adjusts total amount to 1000ml, stirs evenly, filter, and fill, sterilization, promptly.
Embodiment 6 Folium Isatidis 450g, Radix Isatidis 30g, Flos Lonicerae 270g, Cortex Moutan 30g, Fructus Forsythiae 30g, Radix Bupleuri 270g, Fructus Gardeniae 270g, Radix Scutellariae 270g, Herba Lophatheri 20g, Pheretima 180g, Rhizoma Paridis 15g, Radix Cynanchi Atrati 20g, aspartame 400g, carboxymethyl cellulose sodium 8g and sodium benzoate 1.86g
More than 12 flavors, Cortex Moutan, Radix Bupleuri, Fructus Forsythiae pulverizing medicinal materials to all by 45 orders, but can not be crossed 30 orders, add water by medicated powder and water ratio l/10, promptly add water 3300ml, steam distillation 2h, collection distillate; Medicinal residues and all the other Folium Isatidis etc. nine flavor adds water 15250ml and decocts secondary, and each 1 hour, collecting decoction filtered, and filtrate is concentrated in right amount, adds ethanol and makes and contain alcohol and measure 70%, leaves standstill.Get supernatant and reclaim ethanol, be concentrated into 369ml, add water and stir evenly, leave standstill, get supernatant, filter, filtrate is concentrated in right amount.Other gets sucrose 600g and makes syrup, merges with above-mentioned medicinal liquid and distillate, adds carboxymethyl cellulose sodium, sodium benzoate again, adjusts total amount to 1000 dose, stirs evenly, filter, and fill, sterilization, promptly.
Embodiment 7 membrane
Folium Isatidis 150g, Radix Isatidis 90g, Flos Lonicerae 90g, Fructus Gardeniae 90g, Cortex Moutan 90g, Radix Bupleuri 90g, Fructus Forsythiae 90g, Radix Scutellariae 90g, Herba Lophatheri 60g, Pheretima 60g, Rhizoma Paridis 45g, Radix Cynanchi Atrati 60g, filmogen carboxymethyl cellulose sodium solution (1: 10) 800g and propylene glycol 30g
More than 12 flavors, Cortex Moutan, Radix Bupleuri, Fructus Forsythiae pulverizing medicinal materials to all by 45 orders, but can not be crossed 30 orders, add water by medicated powder and water ratio 1/10, promptly add water 2700ml, use steam distillation 2h, the collection distillate; Medicinal residues and all the other Folium Isatidis etc. nine flavor adds water 7350ml and decocts secondary, and each 1 hour, collecting decoction filtered, and filtrate is concentrated in right amount, adds ethanol and makes that to contain that alcohol measures be 70%, leaves standstill.Get supernatant and reclaim ethanol, be concentrated into 200ml, add water and stir evenly, leave standstill, get supernatant, be concentrated into an amount of.Other gets the carboxymethyl cellulose sodium solution, merges with above-mentioned medicinal liquid and distillate, adds propylene glycol and grinds well, and places and removes bubble, and coat and make film on the plate glass, drying, demoulding is cut into suitable size, in encapsulation and the packaging material, promptly gets membrane.
Embodiment 8 granules
Folium Isatidis 150g, Radix Isatidis 90g, Flos Lonicerae 90g, Fructus Gardeniae 90g, Cortex Moutan 90g, Radix Bupleuri 90g, Fructus Forsythiae 90g, Radix Scutellariae 90g, Herba Lophatheri 60g, Pheretima 60g, Rhizoma Paridis 45g, Radix Cynanchi Atrati 60g, sucrose 1000g
Press embodiment 1, gained medical material concentrated solution and distillate are merged, add sucrose, can make granule according to the granule method for making.
Embodiment 9 tablets
Folium Isatidis 150g, Radix Isatidis 90g, Flos Lonicerae 90g, Fructus Gardeniae 90g, Cortex Moutan 90g, Radix Bupleuri 90g, Fructus Forsythiae 90g, Radix Scutellariae 90g, Herba Lophatheri 60g, Pheretima 60g, Rhizoma Paridis 45g, Radix Cynanchi Atrati 60g, carboxymethyl starch sodium 30g, dextrin 30g, magnesium stearate 10g
Press embodiment 1, gained medical material concentrated solution and distillate are merged, spray drying is pulverized, and adds adjuvant, and compression molding promptly gets tablet.
Embodiment 10 capsules
Folium Isatidis 150g, Radix Isatidis 90g, Flos Lonicerae 90g, Fructus Gardeniae 90g, Cortex Moutan 90g, Radix Bupleuri 90g, Fructus Forsythiae 90g, Radix Scutellariae 90g, Herba Lophatheri 60g, Pheretima 60g, Rhizoma Paridis 45g, Radix Cynanchi Atrati 60g, starch 30g, Talcum 10g
Press embodiment 1, gained medical material concentrated solution and distillate are merged, spray drying is pulverized, and adds adjuvant, incapsulates, and promptly gets capsule.
Claims (6)
1. the Chinese medicine preparation of a children's antipyretic, it is characterized in that, by 50～450 parts of Folium Isatidiss, 30～270 parts of Radix Isatidis, 30～270 parts of Flos Loniceraes, 30～270 parts of Fructus Forsythiaes, 30～270 parts of Fructus Gardeniaes, 30～270 parts of Cortex Moutans, 30～270 parts of Radix Scutellariaes, 20～180 parts of Herba Lophatheris, 20～180 parts of Pheretimas, 15～135 parts of Rhizoma Paridis, 30～270 parts of Radix Bupleuri, 20～180 parts of Radix Cynanchi Atratis and pharmaceutic adjuvant are prepared from, described preparation is that the Chinese medicine with described proportioning extracts processing and obtains pharmaceutically active substance, with this pharmaceutically active substance is that raw material mixes with pharmaceutic adjuvant, it is characterized in that, pharmaceutically active substance prepares in order to the below method, with Cortex Moutan, Radix Bupleuri, the Fructus Forsythiae pulverizing medicinal materials is extremely all by 45 orders, add water by medicated powder and water ratio 1/10, with steam distillation 2 hours, collect distillate; Medicinal residues and all the other Folium Isatidis etc. nine flavor adds 4-20 times of decocting and boils 2-5 time, and each 0.5-2 hour, collecting decoction filtered, and filtrate is concentrated in right amount, adds ethanol and makes that to contain pure measuring be more than 70%, leaves standstill; Get supernatant and reclaim ethanol, be concentrated into more than the 200ml, add water and stir evenly, leave standstill, get supernatant, filter, filtrate is concentrated in right amount, and this concentrated solution and distillate lump together, and form pharmaceutically active substance of the present invention.
2. the Chinese medicine preparation of claim 1, it is characterized in that, be oral liquid, membrane, enema, patch, granule, tablet, capsule, pill, powder, unguentum, sublimed preparation, injection, suppository, cream, spray, drop pill, slow releasing preparation or controlled release preparation.
3. the Chinese medicine preparation of claim 2 is characterized in that, is oral liquid.
4. the Chinese medicine preparation of claim 3 is characterized in that, its prescription is composed as follows:
Pharmaceutically active substance of the present invention: Folium Isatidis 150g, Radix Isatidis 90g, Flos Lonicerae 90g, Fructus Forsythiae 90g, Fructus Gardeniae 90g, Cortex Moutan 90g, Radix Scutellariae 90g, Herba Lophatheri 60g, Pheretima 60g, Rhizoma Paridis 45g, Radix Bupleuri 90g, Radix Cynanchi Atrati 60g
Correctives: sucrose, aspartame, fruit Fructus Vitis viniferae slurry, fructose, maltose alcohol
Stabilizing agent: carboxymethyl cellulose sodium
Antiseptic: ethylparaben, methyl parahydroxybenzoate, sodium benzoate, benzoic acid, sorbic acid.
5. the Chinese medicine preparation of claim 4 is characterized in that, its prescription is composed as follows:
Pharmaceutically active substance of the present invention: Folium Isatidis 150g, Radix Isatidis 90g, Flos Lonicerae 90g, Fructus Forsythiae 90g, Fructus Gardeniae 90g, Cortex Moutan 90g, Radix Scutellariae 90g, Herba Lophatheri 60g, Pheretima 60g, Rhizoma Paridis 45g, Radix Bupleuri 90g, Radix Cynanchi Atrati 60g
Correctives: aspartame
Stabilizing agent: carboxymethyl cellulose sodium
Antiseptic: sodium benzoate.
6. the preparation method of the Chinese medicine preparation of claim 1, it is characterized in that, through following steps, Folium Isatidis 150g, Radix Isatidis 90g, Flos Lonicerae 90g, Fructus Forsythiae 90g, Fructus Gardeniae 90g, Cortex Moutan 90g, Radix Scutellariae 90g, Herba Lophatheri 60g, Pheretima 60g, Rhizoma Paridis 45g, Radix Bupleuri 90g, Radix Cynanchi Atrati 60g, more than 12 the flavor, with Cortex Moutan, Radix Bupleuri, Fructus Forsythiae pulverizing medicinal materials to all by 45 orders, but can not cross 30 orders, add water by medicated powder and water ratio 1/10, be 2700ml, use steam distillation 2h, collect distillate; Medicinal residues and all the other Folium Isatidis etc. nine flavor adds the 7350ml decocting and boils secondary, and each 1 hour, collecting decoction filtered, and filtrate is concentrated in right amount, adds ethanol and makes that to contain that alcohol measures be 70%, leaves standstill; Get supernatant and reclaim ethanol, be concentrated into 200ml, add water and stir evenly, leave standstill, get supernatant, filter, filtrate is concentrated in right amount; Other gets sucrose 400g and makes syrup, merges with above-mentioned medicinal liquid and distillate, adds carboxymethyl cellulose sodium 8g, sodium benzoate 0.1% again, adjusts total amount to 1000ml, stirs evenly, filter, and fill, sterilization, promptly.
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| CN102145134B (en) * | 2007-03-23 | 2012-10-31 | 北京亚东生物制药有限公司 | Detection methods of pharmaceutical composition for treatment of wind-heat cold of children |
| CN101822779B (en) * | 2010-05-14 | 2012-05-02 | 江西中成中药原料有限公司 | Antipyretic powder containing honeysuckle and indigowoad leaf and preparation method thereof |
| CN104547680B (en) * | 2014-12-25 | 2018-03-09 | 北京亚东生物制药有限公司 | A kind of plastics for being used for children's antipyretic and paediatric acute tonsillitis |
| CN104688882A (en) * | 2015-03-21 | 2015-06-10 | 王雪雁 | TCM (Traditional Chinese Medicine) composition for treating fever in children |
| CN106267046A (en) * | 2015-05-15 | 2017-01-04 | 王世祥 | The Chinese medicine formula that a kind of juvenile for the treatment of brings down a fever |
| CN105327179A (en) * | 2015-11-30 | 2016-02-17 | 四川美大康药业股份有限公司 | Preparation method of infantile febrifugal oral liquid preparation |
| CN105963558A (en) * | 2016-06-12 | 2016-09-28 | 佛山市腾瑞医药科技有限公司 | Plant extract for treating fever of children and application thereof |
| CN106265912A (en) * | 2016-08-22 | 2017-01-04 | 齐齐哈尔医学院 | A kind of Chinese medicine compound cream treating fever of children and preparation method thereof |
| CN115531492A (en) * | 2022-09-21 | 2022-12-30 | 青岛权道管理咨询有限公司 | Preparation method of heat dissipation gel |
| CN117660111B (en) * | 2024-01-31 | 2024-04-16 | 山东义才和锐生物技术有限公司 | Extraction method of camellia essential oil |
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| CN101279056B (en) * | 2008-05-28 | 2012-03-07 | 山东沃华医药科技股份有限公司 | Children's antipyretic granule |
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