CN100408059C - Heat-clearing effervescence tablet for infants and its preparing method - Google Patents
Heat-clearing effervescence tablet for infants and its preparing method Download PDFInfo
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Abstract
The present invention provides a fever fast clearing effervescence tablet for an infant and a preparation method. The fever fast clearing effervescence tablet is made by 625g of bupleurum roots, 312.5g of scutellaria, 625g of radix isatidis, 312.5g of pueraria root, 343.75g of honeysuckle, 156.25g of buffalo horn, 375g of forsythia fruit, 156.25g of rhubarb, 125g of lactose, 660g of sodium bicarbonate, 540g of citric acid, 100g of aspartame, 6000 100g of polyethylene glycol and 4g of magnesium stearate. Compared with the prior art, the effervescent tablet of the present invention has the advantages of high medicine dissolvability, fast effect taking, good taste and mouth feel, definite curative effect, portability, etc. The effervescent tablet of the present invention is especially suitable for child patients to take.
Description
Technical field:
The present invention relates to a kind of effervescence tablet for quickly allaying infantile fever and preparation method thereof, belong to technical field of Chinese medicine.
Background technology:
Acute upper respiratory tract infection is a usual diseases of childhood, and sickness rate accounts for the 65.5-70% of whole pediatric disease, and not only sickness rate height, and change of illness state is fast, is controlled as untimely, and inflammation is easy to spread to lower respiratory tract, and the serious threat children's is healthy.The last sense of children's etiological examination is based on viral infection, but the chemicals that can effectively treat viral infection at present seldom, then usually can obtain effect preferably with treatment by Chinese herbs.At present, quickly allaying infantile fever granule and oral liquid are treatment infantile fever caused by exogenous pathogens medicines preferably, but along with the raising of Chinese medicine research level, the dosage form that exploitation constantly makes new advances.Effervescent tablet is one of selectable dosage form of form of Chinese drug modernization, has advantages such as carrying and store conveniently, be beneficial to child administration.
Summary of the invention:
The objective of the invention is to: a kind of effervescence tablet for quickly allaying infantile fever and preparation method thereof is provided, the present invention is directed to prior art, change the quickly allaying infantile fever granule into effervescent tablet, determined curative effect not only, and also it carries, stores conveniently, is specially adapted to child patient.
The present invention is achieved in that according to weight and calculates that it is made with Radix Bupleuri 625g, Radix Scutellariae 312.5g, Radix Isatidis 625g, Radix Puerariae 312.5g, Flos Lonicerae 343.75g, Cornu Bubali 156.25g, Fructus Forsythiae 375g, Radix Et Rhizoma Rhei 156.25g and lactose 125g, sodium bicarbonate 660g, citric acid 540g, aspartame 100g, polyethylene glycol 6000 100g, magnesium stearate 4g.
The preparation method of effervescence tablet for quickly allaying infantile fever is: with lactose, sodium bicarbonate, citric acid, aspartame, polyethylene glycol 6000 pulverize separately, cross 80 mesh sieves, drying for standby; Radix Bupleuri, Flos Lonicerae, Fructus Forsythiae add 10 times of water gagings, and distillating extracting oil 3 hours, the aqueous solution after the distillation device are in addition collected; Cornu Bubali adds 8 times of water gagings and decocts after 3 hours, adds the medicinal residues after Radix Scutellariae, Radix Isatidis, Radix Puerariae, Radix Et Rhizoma Rhei four flavors and the distillation again, adds 10 times of water gagings and decocts secondaries, each 1 hour, collecting decoction filtered, filtrate and above-mentioned aqueous solution merge, and are concentrated into the thick paste shape, are chilled to room temperature, add ethanol and make that to contain alcohol amount be 65%, stir evenly static 24 hours, getting that supernatant reclaims ethanol and be concentrated into 80 ℃ of relative densities is 1.03～1.35 clear paste, and drying is pulverized, cross 80 mesh sieves, get dry extract; The lactose of adding 3/5 in dry extract, mix homogeneously adds sodium bicarbonate, citric acid, aspartame wherein again, and mix homogeneously obtains mixture; Get an amount of ethanol solution again, add moistening in the mixture, the system soft material, soft material is crossed 16 mesh sieves, granulates, and gets wet granular; 60 ℃ of forced air dryings of wet granular 2 hours must be done granule, and dried granule 20 mesh sieve granulate get granule I; Other gets 2/5 lactose and granulates with dehydrated alcohol, drying, and 20 mesh sieve granulate dissolve in volatile oil in the dehydrated alcohol, slowly stir down to spray in the granule, and are airtight, place and soak into, and get granule II; With granule I and granule II mix homogeneously, take by weighing polyethylene glycol 6000, magnesium stearate, add in the granule, mixing, tabletting, promptly.
Pharmaceutical formulation of the present invention is scientific and reasonable, has tangible antiviral, antiinflammatory, refrigeration function, and can improve the function of body defending system, strengthens function immunity.Radix Bupleuri, Radix Puerariae are principal agent in the side, and the suffering table that cools completely is brought down a fever and promoted the production of body fluid; The hold concurrently heat of removing heat from blood branch of Flos Lonicerae, heat-clearing and toxic substances removing such as Radix Isatidis is auxilliary; The analgesic removing the relative excess heat of Radix Et Rhizoma Rhei is assistant; Full side can declare and induce sweat based on the cool bitter cold of suffering, and the merit of clearing away interior-heat is arranged again, and expelling pathogen from the exterior and clearing up internal heat is laid equal stress on, and the infantile hyperpyrexia caused by exogenous pathogenic factor's pathological characteristic that hits is the ideal medicament of treatment infantile fever caused by exogenous pathogens.
Compared with prior art, effervescent tablet of the present invention have the drug solubility height, rapid-action, delicious, mouthfeel is good, determined curative effect, carry and store advantages such as convenient, be particularly suitable for child patient and take.
Experimental example: Study on Preparation
(1) medicinal material extract technical study
1. extraction process foundation
The extraction process of this product is with reference to the particulate method for making of quickly allaying infantile fever, and former method for making is " above eight flavors, the device collection in addition of Radix Bupleuri, Flos Lonicerae, Fructus Forsythiae distillating extracting oil, the aqueous solution after the distillation; After Cornu Bubali decocts with water 3 hours, add the medicinal residues after four flavors such as all the other Radix Scutellariaes and the distillation again, decoct with water secondary, each 1 hour, collecting decoction filtered, filtrate and above-mentioned aqueous solution merge, and are concentrated into the thick paste shape, are chilled to room temperature, add ethanol and make that to contain alcohol amount be 65%, stir evenly, left standstill 24 hours, get supernatant and reclaim ethanol and be concentrated into the clear paste that relative density is 1.03～1.35 (80 ℃), dry, pulverize, add right amount of auxiliary materials, mixing, make granule, drying sprays into above-mentioned volatile oil, mixing, make 1000g, promptly." in the former method for making, extraction process lacks the amount of water and the distillation time of three flavor medicinal material extract volatile oil such as Radix Bupleuri, the decoction amount of water of Cornu Bubali decocts the amount of water of four Chinese medicine materials such as back Cornu Bubali, distillation back medicinal residues and Radix Scutellariae.Therefore we have carried out the research of refinement to the extraction process of these parts
2. the investigation of volatile oil extraction process
Radix Bupleuri, Flos Lonicerae, this three flavors medicine of Fructus Forsythiae contain volatile oil, and do not describe in detail extracting the water yield and extraction time in the former prescription.So with the oil pump capacity is that index has been investigated above two parameters.
In the prescription ratio, take by weighing the above three flavor medical materials of 1/10 recipe quantity, add 8,10,12 times of water gagings respectively, soak saturating, extract volatile oil with steam distillation, by " an appendix XD of Chinese pharmacopoeia version in 2000 determination of volatile oil method is measured volatile oil contents, collects volatile oil, read oil mass respectively at 0.5,1,1.5,2,2.5,3,4,6,8 hour, calculate extraction ratio.The results are shown in following table.
Table 1 volatile oil extracts the water yield and the time is investigated the result
By last table intuitive analysis, add 8,10,12 times of water yields and carry out vapor distillation extraction volatile oil, 8 times of amounts of volatile oil extraction ratio will be starkly lower than 10 times of amounts and 12 times of amounts, and 10 times of amounts are close with 12 times of amounts, therefore consider industrial saving production cost, should select 10 water yields extraordinarily for use; Along with the prolongation of extraction time, the oil mass after 3 hours does not have big change.Take all factors into consideration production time and energy consumption cost, we select 10 times of water yields to extract volatile oil 3 hours.
In the three flavor medical materials that take by weighing 1/10 recipe quantity of prescription ratio, pressed 10 times of water yield distillating extracting oils 3 hours, the results are shown in following table.
Table 2 repeated authentication result of the test
| Tested number | 1 | 2 | 3 |
| Volatilization oil mass (ml) | 0.26 | 0.25 | 0.26 |
| Volatile oil yield (%) | 0.193 | 0.186 | 0.193 |
Conclusion: extract volatile oil by above definite technology, repeatability is good, and average yield is 0.191%.
3. Cornu Bubali decocts the technical study of amount of water
The decocting time of the existing Cornu Bubali of former decocting process, but lack the technological parameter that decocts the water yield.In order better to control the quality of the pharmaceutical preparations, we have investigated the amount of water that Cornu Bubali decocts by the situation of paste-forming rate.
Take by weighing three parts of the Cornu Bubali decoction pieces of 1/10 recipe quantity, add 6,8,10 times of water gagings respectively and decocted 3 hours, filter, the filtrate evaporate to dryness obtains dry extract, weighs.And the paste-forming rate of calculating dry extract, the results are shown in following table.
Table 3 Cornu Bubali decocts amount of water and investigates the result
Result of the test shows, the dry extract yield of 6 times of water gagings is littler by 3.1% respectively than 8 times, 10 times water gagings, 3.3%; And 8 times of water gagings only lack 0.2% than 10 times of water gagings.Take all factors into consideration factors such as energy consumption, paste-forming rate, select 8 times of water gagings decoct 3 hours more suitable.
Take by weighing the Cornu Bubali of 1/10 recipe quantity,, get dry extract by above technology extracting in water, drying.The results are shown in following table.
Table 4 repeated authentication result of the test
| Tested number | 1 | 2 | 3 |
| Dry extract amount (g) | 3.206 | 3.274 | 3.129 |
| Paste-forming rate (%) | 20.5 | 21.0 | 20.0 |
Conclusion: by above definite explained hereafter, repeatability is good.
4. decoct the technical study of the amount of water of four Chinese medicine materials such as back Cornu Bubali, distillation back medicinal residues and Radix Scutellariae
Former decocting process is existing to decoct the decoction number of times of four Chinese medicine materials such as back Cornu Bubali, distillation back medicinal residues and Radix Scutellariae and each decocting time, but lacks the technological parameter that decocts amount of water.We are screening index with effective ingredient content of baicalin in the yield of dry extract and the dry extract mainly, investigate decocting technology and decoct water consumption.Process of the test: take by weighing three parts of the medical materials of 1/10 recipe quantity in the prescription ratio, Radix Bupleuri, Flos Lonicerae, Fructus Forsythiae add 10 times of water gagings, distillating extracting oil 3 hours; Cornu Bubali adds 8 times of water gagings and decocts after 3 hours earlier, adds the medicinal residues after four flavors such as all the other Radix Scutellariaes and the distillation again, adds 8,10,12 times of water gagings respectively to decoct secondaries, and each 1 hour, collecting decoction filtered, and the filtrate evaporate to dryness obtains dry extract, weighs.Get dry extract then respectively and grind to form fine powder, precision takes by weighing 0.05g and puts in the 10ml volumetric flask respectively, adds 70% ethanol 8ml, and ultrasonic dissolution 30 minutes is put coldly, and standardize solution promptly gets need testing solution.Measure content of baicalin in the test sample according to the method under the assay item in the quality standard draft.Result of the test sees the following form.
Table 5 extraction process is investigated result of the test
| Test number | Amount of water (doubly) | Dried cream amount g | Receive cream rate % | Content of baicalin % in the dried cream powder |
| 1 | 8 | 41.037 | 14.1 | 0.88 |
| 2 | 10 | 47.809 | 16.5 | 1.00 |
| 3 | 12 | 48.274 | 16.6 | 1.04 |
The extractum yield of 8 times of water gagings is littler by 2.4% respectively than 10 times, 12 times water gagings, 2.5%, content of baicalin low 0.12%, 0.16% in the dried cream; And 10 times of water gagings lack 0.1% and 0.04% than 12 times of water gagings respectively on these two indexs.Above data show, 10 times and 12 extraordinarily the water yield carry out extraction effect and obviously be better than 8 times of water gagings; And when 10 times and 12 extraordinarily the water yield was extracted, the effect difference was little, took all factors into consideration factors such as extraction effect in the actual production, energy consumption, select 10 extraordinarily the water yield extract more reasonable.
Take by weighing the medical material of 1/10 recipe quantity in the prescription ratio, extract by above technology, drying, dry extract.The results are shown in following table.
Table 6 repeated authentication result of the test
| Tested number | 1 | 2 | 3 |
| Dry extract amount (g) | 47.954 | 49.262 | 46.559 |
| Paste-forming rate (%) | 16.5 | 17.0 | 16.0 |
Conclusion: by above definite explained hereafter, repeatability is good.
5. precipitate with ethanol
According to former technology, add ethanol and make that to contain alcohol amount be 65%, stir evenly, left standstill 24 hours.
6. concentrate
According to former technology, the supernatant concentration behind the precipitate with ethanol to relative density is the clear paste of 1.03 ~ 1.35 (80 ℃).The condition of concentrating: adopt normal pressure to concentrate earlier, adopt vacuum concentration again, condition is vacuum 0.06Kpa, temperature 70-80 ℃.
7. dry
Adopt drying under reduced pressure, condition is vacuum-0.1Kpa, 60 ~ 70 ℃ of temperature.
8. spray volatile oil
Consider that the volatilization oil mass of extracting medical materials such as Radix Bupleuri is few, can evenly add, so earlier volatile oil is dissolved in the dehydrated alcohol in order to make volatile oil, slowly spray in the lactose granule under the stirring state, airtight, place and soak into, obtain granule II, again with granule II and granule I mixing.
(2) research of preparations shaping prescription and technology
1. the selection of preparations shaping prescription
It is effervescent tablet that the present invention develops dosage form, and we have done corresponding research to the kind, consumption and the moulding process that add adjuvant.Complexity, effervescent effect with granulation and tabletting process serve as that the main index of investigating is screened.Process of the test: take by weighing medical material by 1/2 recipe quantity, make the dried cream powder of medicinal material extract by the extraction process of determining, the dried cream powder that obtains is divided into five parts, and design prescription respectively is to granulate and complexity, the effervescent effect of tabletting process serve as that mainly the investigation index is screened each prescription.Test recipe sees the following form.
Table 7 experiment sieving prescription is formed
In the preparations shaping prescription, lactose is a diluent, and sodium bicarbonate and citric acid are effervescent, and aspartame is a correctives, and polyethylene glycol 6000 and magnesium stearate are lubricant, and dehydrated alcohol is a wetting agent.Above-mentioned main materials and auxiliary materials is crossed 80 mesh sieves, intensive drying, standby, the material extract of getting it filled, filler, effervescent, correctives mixing add absolute ethyl alcohol and stirring system soft material, soft material is crossed 16 mesh sieves and is granulated, 60 ℃ of dryings, dried granule 20 mesh sieve granulate add the lubricant mixing, tabletting (temperature is below 20 ℃, and relative humidity is below 30%).Result of the test sees the following form.
Table 8 prescription screening result of the test (one)
| Prescription | Pelletization | The tabletting process |
| 1 | Soft material is easy to get, and it is easier to sieve, granulate | The granule compressibility is good, does not see obvious sticking, and is unilateral smooth |
| 2 | Soft material is easy to get, and it is easier to sieve, granulate | The granule compressibility is good, and slightly sticking is unilateral smooth |
| 3 | Soft material is easy to get, and it is easier to sieve, granulate | The granule compressibility is good, does not see obvious sticking, and is unilateral smooth |
| 4 | Soft material is easy to get, and it is easier to sieve, granulate | The granule compressibility is good, does not see obvious sticking, and is unilateral smooth |
| 5 | Soft material is easy to get, and it is easier to sieve, granulate | The granule compressibility is good, does not see obvious sticking, and is unilateral smooth |
Table 9 prescription screening result of the test (two)
| Prescription | Disintegration phenomenon | Disintegration (minute) |
| 1 | Produce bubble, after effervescent stopped, solution was clarified substantially, and the surface flotation white powder is more | 10～15 |
| 2 | Produce bubble, after effervescent stopped, solution was clarified substantially, and the no white powder in surface is floating | 9～11 |
| 3 | Produce bubble, after effervescent stopped, solution was clarified substantially, and surface slightly white powder is floating | 8～10 |
| 4 | Bubbles volume is bigger, and after effervescent stopped, solution was clarified substantially, and surface slightly white powder is floating | 6～8 |
| 5 | Bubbles volume is bigger, and after effervescent stopped, solution was clarified substantially, and surface slightly white powder is floating | 3～5 |
Test result analysis:
(1) this product main component is a Chinese medicine extract, has certain moisture, and this product exploitation dosage form is an effervescent tablet, this dosage form to tabletting before moisture requirement higher, the ratio of extract is unsuitable excessive in the prescription.We calculate according to the yield and the amount of making in the former dosage form of extract dried cream powder, and the dosage that former granule is once taken is divided into four parts, thereby reduces the ratio of extract dried cream powder in prescription, reduces particulate hygroscopicity, improves the effervescent effect.
(2) prescription 1, prescription 2 and the 3 effervescent consumptions of writing out a prescription are 40% of prescription total amount, and wherein acid, alkali ratio have different the adjustment in the side throughout, investigate acid, the alkali ratio influence to the effervescent effect with this.Result of the test shows that adopting acid, alkali ratio is, the effervescent best results of tablet at 0.8: 1 o'clock.
(3) prescription 1 adopts magnesium stearate as lubricant, plays lubricant effect preferably when tabletting, but magnesium stearate can't dissolve in water, flies at liquid level, influences the outward appearance of solution; Prescription 2 adopts polyethylene glycol 6000 as lubricant, and lubricant effect is worse than magnesium stearate, and slightly the sticking phenomenon takes place; Prescription 3 makes the ratio of magnesium stearate in prescription that bigger reduction be arranged with using polyethylene glycol 6000 and magnesium stearate as lubricant constantly, when obtaining better lubricant effect, can obviously improve the solution appearance that prescription 1 forms.
(4) requirement of failing to reach effervescent disintegration of prescription 1～prescription 3, therefore in prescription 4 and prescription 5 with the corresponding raising of ratio of effervescent, result of the test shows, increase along with the effervescent consumption, also corresponding reduction disintegration of prescription, the sample that the effervescent consumption that prescription 5 adopts makes, therefore the requirement in the disintegration time mensuration pharmacopeia up to specification determines that prescription 5 is the final prescription of this product.
2. the selection of preparations shaping technology
This product dosage form is higher to moisture requirement, because the moisture in the granule can make and have an effect between the effervescent and lost efficacy, influences the effervescent effect.In addition, in the tabletting process, the relative humidity of environment is too high also can to influence forming process, therefore in the preparation process of this product, should strictly control moisture, and the temperature and humidity to environment also should strictly be controlled, the production process ambient temperature of conventional effervescent tablet should be controlled at below 20 ℃, and ambient humidity should be controlled at below 30%.
We adopt two kinds of preparation technologies with 5 the main materials and auxiliary materials proportioning of writing out a prescription, and investigate the influence of different process to prescription effervescent effect.Result of the test sees the following form.
Preparation technology 1: after soda acid mixed, dehydrated alcohol was granulated, drying.
Preparation technology 2: acid, alkali are granulated with dehydrated alcohol respectively, and dry respectively, dried granule mixes.
Table 10 moulding process is selected result of the test
| Technology | Disintegration phenomenon | Disintegration (minute) |
| Preparation technology 1 | Bubbles volume is bigger, and after effervescent stopped, solution was clarified substantially, and surface slightly white powder is floating. | 3～5 |
| Preparation technology 2 | Bubbles volume is bigger, and after effervescent stopped, solution was clarified substantially, and surface slightly white powder is floating. | 3～5 |
Conclusion (of pressure testing): investigate by above test, adopt two kinds of samples that preparation technology makes, do not see obvious difference at gas release with on disintegration, preparation technology's 1 production process is easy relatively, production efficiency is higher, therefore, finally select soda acid to mix the final molding technology of the technology of back granulation as this product.
(3) amplify product technical data and result
With three batches of pilot products researchs that the production technology determined and molding prescription carry out 10 times of recipe quantities, correlation technique parameter and the results are shown in following table.
Three batches of pilot scale technological production norms of table 11 and result
| Lot number | 04072001 | 04072202 | 04072403 |
| Medical material inventory (kg) | 29.063 | 29.063 | 29.063 |
| Dried cream heavy (kg) | 4.766 | 4.824 | 4.886 |
| Dried cream yield (%) | 16.4 | 16.6 | 16.8 |
| Lactose consumption (kg) | 0.734 | 0.676 | 0.614 |
| Sodium bicarbonate consumption (kg) | 6.6 | 6.6 | 6.6 |
| Citric acid consumption (kg) | 5.4 | 5.4 | 5.4 |
| Aspartame consumption (kg) | 1.0 | 1.0 | 1.0 |
| The amount of volatile oil (ml) | 27.1 | 25.8 | 26.3 |
| Volatile oil yield (%) | 0.202 | 0.192 | 0.196 |
| The lactose yield (kg) that adds volatile oil | 0.5 | 0.5 | 0.5 |
| Polyethylene glycol 6000 consumption (kg) | 1.0 | 1.0 | 1.0 |
| Magnesium stearate consumption (kg) | 0.04 | 0.04 | 0.04 |
| Dehydrated alcohol consumption (L) | 0.6 | 0.6 | 0.6 |
| Tabletting is with dried particles amount (kg) | 19.6 | 19.7 | 19.6 |
| Finished product sheet number (sheet, 2.0g/ sheet) | 9334 | 9467 | 9371 |
| Yield rate (%) | 93.34 | 94.67 | 93.71 |
As seen from the experiment, test agent in be prepared according to the process conditions of determining three batches, every index basically identical has repeatability preferably, so feasible process.
The specific embodiment:
Embodiments of the invention: Radix Bupleuri 625g, Radix Scutellariae 312.5g, Radix Isatidis 625g, Radix Puerariae 312.5g, Flos Lonicerae 343.75g, Cornu Bubali 156.25g, Fructus Forsythiae 375g, Radix Et Rhizoma Rhei 156.25g, lactose 125g, sodium bicarbonate 660g, citric acid 540g, aspartame 100g, polyethylene glycol 6000 100g, magnesium stearate 4g
With lactose, sodium bicarbonate, citric acid, aspartame, polyethylene glycol 6000 pulverize separately, cross 80 mesh sieves, drying for standby; Radix Bupleuri, Flos Lonicerae, Fructus Forsythiae add 10 times of water gagings, and distillating extracting oil 3 hours, the aqueous solution after the distillation device are in addition collected; Cornu Bubali adds 8 times of water gagings and decocts after 3 hours, adds the medicinal residues after Radix Scutellariae, Radix Isatidis, Radix Puerariae, Radix Et Rhizoma Rhei four flavors and the distillation again, adds 10 times of water gagings and decocts secondaries, each 1 hour, collecting decoction filtered, filtrate and above-mentioned aqueous solution merge, and are concentrated into the thick paste shape, are chilled to room temperature, add ethanol and make that to contain alcohol amount be 65%, stir evenly static 24 hours, getting that supernatant reclaims ethanol and be concentrated into 80 ℃ of relative densities is 1.03～1.35 clear paste, and drying is pulverized, cross 80 mesh sieves, get dry extract; The lactose of adding 3/5 in dry extract, mix homogeneously adds sodium bicarbonate, citric acid, aspartame wherein again, and mix homogeneously obtains mixture; Get an amount of ethanol solution again, add moistening in the mixture, the system soft material, soft material is crossed 16 mesh sieves, granulates, and gets wet granular; 60 ℃ of forced air dryings of wet granular 2 hours must be done granule, and dried granule 20 mesh sieve granulate get granule I; Other gets 2/5 lactose and granulates with dehydrated alcohol, drying, and 20 mesh sieve granulate dissolve in volatile oil in the dehydrated alcohol, slowly stir down to spray in the granule, and are airtight, place and soak into, and get granule II; With granule I and granule II mix homogeneously, take by weighing polyethylene glycol 6000, magnesium stearate, add in the granule, mixing, tabletting is made 1000, promptly.
Claims (1)
1. effervescence tablet for quickly allaying infantile fever, it is characterized in that: calculate according to weight, it is made according to following method with Radix Bupleuri 625g, Radix Scutellariae 312.5g, Radix Isatidis 625g, Radix Puerariae 312.5g, Flos Lonicerae 343.75g, Cornu Bubali 156.25g, Fructus Forsythiae 375g, Radix Et Rhizoma Rhei 156.25g and lactose 125g, sodium bicarbonate 660g, citric acid 540g, aspartame 100g, polyethylene glycol 6000 100g, magnesium stearate 4g:
With lactose, sodium bicarbonate, citric acid, aspartame, polyethylene glycol 6000 pulverize separately, cross 80 mesh sieves, drying for standby; Radix Bupleuri, Flos Lonicerae, Fructus Forsythiae add 10 times of water gagings, and distillating extracting oil 3 hours, the aqueous solution after the distillation device are in addition collected; Cornu Bubali adds 8 times of water gagings and decocts after 3 hours, adds the medicinal residues after Radix Scutellariae, Radix Isatidis, Radix Puerariae, Radix Et Rhizoma Rhei four flavors and the distillation again, adds 10 times of water gagings and decocts secondaries, each 1 hour, collecting decoction filtered, filtrate and above-mentioned aqueous solution merge, and are concentrated into the thick paste shape, are chilled to room temperature, add ethanol and make that to contain alcohol amount be 65%, stir evenly static 24 hours, getting that supernatant reclaims ethanol and be concentrated into 80 ℃ of relative densities is 1.03～1.35 clear paste, and drying is pulverized, cross 80 mesh sieves, get dry extract; The lactose of adding 3/5 in dry extract, mix homogeneously adds sodium bicarbonate, citric acid, aspartame wherein again, and mix homogeneously obtains mixture; Get an amount of ethanol solution again, add moistening in the mixture, the system soft material, soft material is crossed 16 mesh sieves, granulates, and gets wet granular; 60 ℃ of forced air dryings of wet granular 2 hours must be done granule, and dried granule 20 mesh sieve granulate get granule I; Other gets 2/5 lactose and granulates with dehydrated alcohol, drying, and 20 mesh sieve granulate dissolve in volatile oil in the dehydrated alcohol, slowly stir down to spray in the granule, and are airtight, place and soak into, and get granule II; With granule I and granule II mix homogeneously, take by weighing polyethylene glycol 6000, magnesium stearate, add in the granule, mixing, tabletting, promptly.
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| CN101085055B (en) * | 2007-06-26 | 2010-06-02 | 黑龙江省珍宝岛制药有限公司 | Traditional Chinese medicinal composition syrup for heat-clearing and toxin-removing, fire-draining and throat-moistening and its preparation method |
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| CN114767533A (en) * | 2022-04-08 | 2022-07-22 | 江西倍肯药业有限公司 | Alcohol precipitation process control method based on children's fever-relieving granules |
| CN115181609A (en) * | 2022-08-23 | 2022-10-14 | 江西倍肯药业有限公司 | Extraction method of volatile oil for children's antipyretic granules |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1364581A (en) * | 2001-01-16 | 2002-08-21 | 杨孟君 | Nano Children heat fast clearing away medicine and its preparing method |
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2005
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1364581A (en) * | 2001-01-16 | 2002-08-21 | 杨孟君 | Nano Children heat fast clearing away medicine and its preparing method |
Non-Patent Citations (2)
| Title |
|---|
| 中华人民共和国药典. 国家药典委员会，371，化学工业出版社. 2000 |
| 中华人民共和国药典. 国家药典委员会，371，化学工业出版社. 2000 * |
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| CN1813936A (en) | 2006-08-09 |
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