CN102218109A - Simotang chewable tablet and preparation method thereof - Google Patents
Simotang chewable tablet and preparation method thereof Download PDFInfo
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- CN102218109A CN102218109A CN201010619413XA CN201010619413A CN102218109A CN 102218109 A CN102218109 A CN 102218109A CN 201010619413X A CN201010619413X A CN 201010619413XA CN 201010619413 A CN201010619413 A CN 201010619413A CN 102218109 A CN102218109 A CN 102218109A
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Abstract
The invention discloses a simotang chewable tablet and a preparation method thereof. The formula of the simotang chewable tablet comprises a simotang volatile oil extractive, a simotang water extractive, a filling agent and a lubricating agent, wherein the mass ratio of the simotang volatile oil extractive to the using amount of the filling agent is 1:1 to 1:10; and the filling agent is one or more of mannitol, sorbitol, lactose and dextrin. The preparation method for the simotang chewable tablet comprises the following steps of: according to the formula, uniformly mixing the simotang water extractive and the filling agent, sieving, mixing with an ethanol aqueous solution with the volume percent of 50% to 95% for preparing soft materials, palletizing the soft materials, drying, then uniformly mixing with the simotang water extractive and the lubricating agent, and finally tabletting. The simotang chewable tablet prepared with the method has the advantage of good stability, high quality and better medicinal effect.
Description
Technical field
The present invention relates to a kind of Decoction of Four-Drug Juice chewable tablet and preparation method thereof.
Background technology
Decoction of Four-Drug Juice comes from recipes for Saving Lives, pleasant sending down the abnormal ascending QI, removing food stagnancy pain relieving.Decoction of Four-Drug Juice can be used for the card that stagnates in the infant breast food, and food stagnation card, disease are seen the gastral cavity abdomen, the uneasiness of crying, anorexia poor appetite, diarrhoea or constipation; Also can be used for person in middle and old age's stagnation of QI, food stagnation card, disease is seen distension and fullness in the abdomen, stomachache, constipation; And but abdominal postoperative promotes the recovery of gastrointestinal function.Modern medicine study shows that the Radix Aucklandiae can make enterokinesia amplitude and muscular tension obviously strengthen, and gastric emptying and intestinal propelling are all had facilitation, and the myenteron spasm due to acetylcholine and the histamine is had antagonism; Semen Arecae can excited M-cholinoceptor, causes that glandular secretion increases, and makes digestive juice secretion vigorous, and has excited smooth muscle effect; The Radix Linderae plays key effect in prescription, can not only strengthen the pharmacological action of other medicines in the prescription, and can make intestinal shrink enhancing by excited gastrointestinal smooth muscle.Therefore, the Simo Decoction Treatment Acute constipation often can be received good effect.
At present, Decoction of Four-Drug Juice product forms on market only has the Decoction of Four-Drug Juice Chinese medicine oral liquid, and this dosage form is the regular dosage form of Decoction of Four-Drug Juice.But all there is the loss easily in preparation process of poor stability, quality instability, active ingredient in Chinese medicine oral liquid as liquid preparation, transports, stores, carries limitation such as inconvenience.On the other hand, if attempt dosage formulation transformation of ownership one-tenth and the diverse another kind of preparation of regular dosage form with particular types Chinese medicine, need to experimentize, and if realize that simultaneously concrete equal the even better drug effect of novel form medicine and original dosage form is extremely difficult especially through a large amount of manpower and materials.This present situation needs to be resolved hurrily.
Summary of the invention
Technical problem to be solved by this invention is to have overcome that Decoction of Four-Drug Juice only has the Chinese medicine oral liquid dosage form single in the prior art, and it exists poor stability, quality instability as liquid preparation, transport, store, carry defectives such as inconvenience, a kind of good stability, quality quality height are provided and have had Decoction of Four-Drug Juice chewable tablet of better drug effect and preparation method thereof.
Decoction of Four-Drug Juice chewable tablet prescription of the present invention contains Decoction of Four-Drug Juice extractive of volatile oil, Decoction of Four-Drug Juice water extract, filler and lubricant, wherein, the consumption of described Decoction of Four-Drug Juice water extract and filler is mass ratio 1: 1～1: 10, and described filler is one or more in mannitol, sorbitol, lactose and the dextrin.
Among the present invention, described Decoction of Four-Drug Juice is the conventional described Decoction of Four-Drug Juice in this area, generally comprise the medicinal raw material Radix Aucklandiae, Fructus Aurantii, the Radix Linderae and Semen Arecae, each preferable medical material consumption is mass ratio (0.2～3): (0.2～3): (0.2～3): (0.2～3), better is mass ratio 1: 1: 1: 1.Wherein, the described Radix Aucklandiae, Fructus Aurantii, the Radix Linderae and Semen Arecae are the conventional medical material that uses in this area.
Among the present invention, what the consumption of described Decoction of Four-Drug Juice water extract and filler was preferable is 1: 1.5～1: 4.
Among the present invention, the consumption of described lubricant is this area conventional amount used, and preferable is 1%～5%, and percentage ratio is the mass percent of lubricant material total amount when accounting for tabletting.Described lubricant is the conventional described lubricant in this area, and preferable is magnesium stearate and/or Pulvis Talci.
Among the present invention, described Decoction of Four-Drug Juice chewable tablet prescription is preferable also contains sweeting agent and/or correctives.
Wherein, described sweeting agent consumption is the conventional institute in a this area consumption, and preferable is 0.2%～10%, the mass percent of material total amount when percentage ratio accounts for tabletting for each composition.Described sweeting agent is preferable is in sucrose, erythritol, protein sugar, aspartame and the stevioside one or more.
Wherein, described correctives consumption is the conventional institute in a this area consumption, and preferable is 0.2%～5%, the mass percent of material total amount when percentage ratio accounts for tabletting for each composition.Described correctives is the conventional correctives in this area, and preferable is honey peach essence and/or Fructus Myricae rubrae essence.
Among the present invention, described Decoction of Four-Drug Juice extractive of volatile oil is the conventional described Decoction of Four-Drug Juice extractive of volatile oil in this area, and generally conventional way of distillation extraction obtains through this area with the Decoction of Four-Drug Juice medical material.
Wherein, it is the operation that the conventional way of distillation in this area is extracted volatile oil that the described way of distillation is extracted volatile oil, and preferable comprising the steps: extracted volatile oil with water with the way of distillation with the Decoction of Four-Drug Juice medical material Radix Aucklandiae, Fructus Aurantii, the Radix Linderae and Semen Arecae, and be standby after handling.
Wherein, the consumption of described water is this area conventional amount used, and preferable is 6～20 times of amounts of Decoction of Four-Drug Juice quality of medicinal material, and better is 6～12 times.
Wherein, described Decoction of Four-Drug Juice medical material and water preferable soaking before the way of distillation is extracted volatile oil by this area conventional method; What the time of described immersion was preferable is 1～3 hour, and better is 2 hours.
Wherein, what the distillation time of described way of distillation extraction volatile oil was preferable is 1～4 hour, and better is 3 hours.
Wherein, the described way of distillation is extracted volatile oil that volatile oil obtains and is generally handled the back according to this area conventional method and use, preferable be treated to through absorbent absorb volatile oil-absorber blend or get volatile oil-cyclodextrin clathrate through cyclodextrin inclusion compound.
Described absorbent is the conventional volatile oil absorbent that uses in this area, one or more that preferable is in calcium phosphate, calcium hydrogen phosphate, calcium sulfate, magnesium oxide and the calcium carbonate; Wherein, described calcium sulfate is generally calcium sulfate dihydrate.What the consumption of described absorbent was preferable is 5～20 times of amounts of volatile oil quality, and better is 8～12 times.
Described cyclodextrin is the conventional beta-schardinger dextrin-that uses in this area.What described cyclodextrin inclusion compound was preferable is with the beta-schardinger dextrin-saturated aqueous solution, with the alcohol mixeding liquid stirring enclose of volatile oil.What the consumption of described cyclodextrin was preferable is 6～15 times of amounts of volatile oil quality.What the time of described stirring enclose was preferable is 0.5～4 hour.Obtain solid clathrates by this area routine after the described enclose, be generally, get precipitation cold preservation after volatile oil-cyclodextrin clathrate aqueous solution cooling, the reuse petroleum ether, cold drying gets final product.
Among the present invention, described Decoction of Four-Drug Juice water extract is the conventional described Decoction of Four-Drug Juice water extract in this area, and generally conventional water extraction obtains through this area with the Decoction of Four-Drug Juice medical material, and preferable will extract the medicinal residues water extraction that the volatile oil after-filtration gets through the way of distillation.Preferably, comprise the steps: the Decoction of Four-Drug Juice medical material is carried out the precipitate with ethanol remove impurity after the extracting solution of water extraction concentrates, reconcentration promptly gets the Decoction of Four-Drug Juice water extract afterwards.
Wherein, the water consumption of described water extraction is this area conventional amount used, and preferable is 3～10 times of amounts of quality of medicinal material.
Wherein, described with the time of water extraction preferable be 0.3～1 hour.
Wherein, described with the number of times of water extraction preferable be 1～3 time, better is 2 times.Described number of times with water extraction merge extractive liquid, during more than 1 time.
What wherein, the extracting solution of described water extraction was preferable also extracts the medicinal liquid merging that volatile oil obtains simultaneously with the way of distillation.
The concentrated concentrating under reduced pressure that is preferably when wherein, carrying out the precipitate with ethanol remove impurity after described the concentrating.What described striking point was preferable is 1.05～1.15 clear paste for being concentrated into 60 ℃～70 ℃ relative densities.Described clear paste refers to that Chinese medicine extraction liquid is through being concentrated into and the roughly suitable Chinese medicine extraction liquid of medical material amount that extracts.
Wherein, described precipitate with ethanol remove impurity is this area routine operation, and preferable is to add ethanol to containing pure percent by volume 70%～80%, and cold preservation, filtration remove ethanol, add water again and stir cold preservation, filtration.
Described contain alcohol amount preferable be percent by volume 75%.
What the temperature of described cold preservation was preferable is 0 ℃～10 ℃.
What described cold preservation time was preferable is 10～24 hours, and better is 12 hours.
Described add water consumption that water stirs preferable be 3～6 times of medical material amounts.
Wherein, the described concentrated concentrating under reduced pressure that is preferably that concentrates when promptly getting the Decoction of Four-Drug Juice water extract.What described striking point was preferable is 1.25～1.30 thick paste for being concentrated into 60 ℃ of relative densities.Described thick paste be Chinese medicine extraction liquid through be concentrated into medicine liquid volume with the Chinese medicine extract of about 1: 2 o'clock formed semi-solid of the medical material amount of extracting.
A kind of Decoction of Four-Drug Juice chewable tablet prescription that also relates to that the present invention is preferable is made up of Decoction of Four-Drug Juice extractive of volatile oil, Decoction of Four-Drug Juice water extract, filler and lubricant, wherein, the consumption of described Decoction of Four-Drug Juice water extract and filler is mass ratio 1: 1～1: 10, and described filler is one or more in mannitol, sorbitol, lactose and the dextrin.
Wherein, the kind of described Decoction of Four-Drug Juice extractive of volatile oil, Decoction of Four-Drug Juice water extract, filler and lubricant and content and optimum condition are all as previously mentioned.
The invention still further relates to the preparation method of Decoction of Four-Drug Juice chewable tablet of the present invention, it comprises the steps: by described prescription, behind Decoction of Four-Drug Juice water extract and filler uniform mixing, sieve, with the mixed soft material of the ethanol water of percent by volume 50%～95%, with soft material granulation, oven dry, again with Decoction of Four-Drug Juice extractive of volatile oil and lubricant (wherein, if also contain the material except that aforementioned preparation method is mentioned in the prescription, then add with lubricant this moment) uniform mixing, tabletting gets final product.
It is wherein, described that to sieve preferable be 80 mesh sieves.
Wherein, described granulation is this area routine operation, and preferable is that 18 mesh sieves are granulated.
Wherein, described oven dry is this area routine operation, and preferable is 60 ℃～100 ℃ oven dry.
Wherein, described tabletting is this area routine operation, uses equipment as this area routine, as tablet machine.Wherein, described tablet machine can be one-shot or many stampings, and punch die can be circle or abnormity.
Wherein, described tabletting sheet heavily is generally 0.2g～1.5g.
Wherein, the preparation method of described Decoction of Four-Drug Juice extractive of volatile oil, Decoction of Four-Drug Juice water extract all as previously mentioned.
Among the present invention, on the basis that meets this area general knowledge, each above-mentioned technical characterictic optimum condition can combination in any obtain preferred embodiments.
Agents useful for same of the present invention and raw material are all commercially available to be got.
Positive progressive effect of the present invention is: the Decoction of Four-Drug Juice chewable tablet good stability of the preparation method gained of Decoction of Four-Drug Juice chewable tablet of the present invention, quality quality height, medicine good dispersing state, absorb fast, bioavailability is high, taking convenience, and compare with existing Chinese medicine oral liquid and to have better drug effect, the stagnation of QI, the food stagnation card that are particularly useful for the patient of infant, middle-aged and elderly people, paralytic, the difficulty of swallowing and gastrointestinal function difference, disease is seen diseases such as distension and fullness in the abdomen, stomachache, constipation, its transportation simultaneously as solid preparation, store and carry also very convenient.
The specific embodiment
Mode below by embodiment further specifies the present invention, but does not therefore limit the present invention among the described scope of embodiments.
Embodiment 1
Get the Radix Aucklandiae, Fructus Aurantii, the Radix Linderae, four kinds of each 37.5g of medical material of Semen Arecae, add 10 times of water gagings, soaked 2 hours, extracted volatile oil 3 hours with the way of distillation, collect volatile oil, add the calcium sulfate dihydrate absorbent of 8 times of amounts of volatile oil, it is standby to be prepared into volatile oil-calcium sulfate dihydrate mixture; The medicinal liquid of said extracted volatile oil is filtered, and medicinal liquid is standby, and medicinal residues add 6 times of water gagings of medical material amount and decoct secondary, and each 0.5 hour, filter, collecting decoction is with the medicinal liquid merging behind the extraction volatile oil; Medicinal liquid is evaporated to the clear paste that relative density is 1.10 (60～70 ℃), adding ethanol makes and contains alcohol amount and reach 75%, cold preservation 12 hours, filter, filtrate recycling ethanol adds 5 times of water gagings of medical material amount and stirs to there not being the alcohol flavor, cold preservation 12 hours, filter, filtrate decompression is concentrated into the thick paste that relative density is 1.25～1.30 (60 ℃), and is standby; In medicinal substances extract: adjuvant is 1: 2.5 a ratio, gets each 37.5g of mannitol and dextrin, crosses 80 mesh sieves, mix, add mix homogeneously in the above-mentioned thick paste, be mixed with soft material, granulate with 18 mesh sieves with the ethanol water of percent by volume 75%, 60 ℃ of oven dry down, with 18 mesh sieve granulate, add above-mentioned volatile oil-calcium sulfate dihydrate mixture, sweeting agent 0.45g, correctives 0.45g, magnesium stearate 1g, mix homogeneously, put tabletting in the tablet machine, promptly get the Decoction of Four-Drug Juice chewable tablet.
Embodiment 2
Get the Radix Aucklandiae, Fructus Aurantii, the Radix Linderae, four kinds of each 37.5g of medical material of Semen Arecae, add 10 times of water gagings, soaked 2 hours, and extracted volatile oil 3 hours, collect volatile oil with the way of distillation, take by weighing 3.6g β-CD, the distilled water that adds 43ml, heating makes its dissolving, makes saturated solution, be cooled to 40 ℃, constant temperature stirs on the magnetic force heating stirrer, above-mentioned volatile oil is added in 1: 1 by volume slowly be added drop-wise in β-CD solution after dehydrated alcohol dilutes, and is stirred to the stipulated time postcooling to room temperature, put into refrigerator cold-storage (4 ℃) 24h, sucking filtration, precipitation is used 30ml petroleum ether 3 times, put cold drying in 40 ℃ of environment, promptly get the white powder clathrate and be volatile oil-beta-CD inclusion; The medicinal liquid of said extracted volatile oil is filtered, and medicinal liquid is standby, and medicinal residues add 6 times of water gagings of medical material amount and decoct 2 times, and each 0.5 hour, filter, collecting decoction is with the medicinal liquid merging behind the extraction volatile oil; Medicinal liquid is evaporated to the clear paste that relative density is 1.10 (60～70 ℃), adding ethanol makes and contains alcohol amount and reach 75%, cold preservation 12 hours, filter, filtrate recycling ethanol adds 5 times of water gagings of medical material amount and stirs to there not being the alcohol flavor, cold preservation 12 hours, filter, filtrate decompression is concentrated into the thick paste that relative density is 1.25～1.30 (60 ℃), and is standby; In medicinal substances extract: adjuvant is 1: 2.5 a ratio, gets each 37.5g of mannitol and dextrin, crosses 80 mesh sieves, mix, add mix homogeneously in the above-mentioned thick paste, be mixed with soft material, granulate with 18 mesh sieves with the ethanol water of percent by volume 75%, 60 ℃ of oven dry down, with 18 mesh sieve granulate, add above-mentioned volatile oil-beta-CD inclusion, sweeting agent 0.45g, correctives 0.45g, magnesium stearate 1g, mix homogeneously, put tabletting in the tablet machine, promptly get the Decoction of Four-Drug Juice chewable tablet.
Wherein, the inclusion rate mensuration mode of prepared clathrate is:
The clathrate precision is weighed, place the 500ml round-bottomed flask, add distilled water 300ml, measure actual oil content in the clathrate; Carry out the blank determination of recovery rates of volatile oil simultaneously, precision is measured volatile oil 1.00ml, and parallel test is 3 times as stated above, is calculated as follows:
The blank response rate (%) of volatile oil=collection volatilization oil mass (ml)/adding volatilization oil mass (ml) * 100%
Actual oil content (ml) in inclusion essential oil rate (%)=clathrate/[throwing oil mass (ml) * blank response rate] * 100%
Testing result is that the inclusion rate of Decoction of Four-Drug Juice volatile oil-Benexate Hydrochloride is 86%.
Embodiment 3
Prepare to thick paste by embodiment 1, standby; In medicinal substances extract: adjuvant is 1: 2.5 a ratio, get each 37.5g of mannitol and dextrin, cross 80 mesh sieves, mix, add mix homogeneously in the above-mentioned thick paste, 80 ℃ of oven dry down, pulverized 80 mesh sieves, prepared soft material, granulated with 18 mesh sieves with the alcoholic solution of percent by volume 75%, 60 ℃ of oven dry down, with 18 mesh sieve granulate, add above-mentioned volatile oil-calcium sulfate dihydrate mixture, sweeting agent 0.45g, correctives 0.45g, magnesium stearate 1g, mix homogeneously, put tabletting in the tablet machine, promptly get the Decoction of Four-Drug Juice chewable tablet.
Embodiment 4
Prepare to thick paste by embodiment 2, standby; In medicinal substances extract: adjuvant is 1: 2.5 a ratio, get each 37.5g of mannitol and dextrin, cross 80 mesh sieves, mix, add mix homogeneously in the above-mentioned thick paste, 80 ℃ of oven dry down, pulverized 80 mesh sieves, prepared soft material, granulated with 18 mesh sieves with the alcoholic solution of percent by volume 75%, 60 ℃ of oven dry down, with 18 mesh sieve granulate, add above-mentioned volatile oil-calcium sulfate dihydrate mixture, sweeting agent 0.45g, correctives 0.45g, magnesium stearate 1g, mix homogeneously, put tabletting in the tablet machine, promptly get the Decoction of Four-Drug Juice chewable tablet.
Embodiment 5
Prepare to thick paste by embodiment 1, standby; In medicinal substances extract: adjuvant is 1: 2.5 a ratio, gets dextrin 75g, crosses 80 mesh sieves, mixes, and all the other are with embodiment 3.
Embodiment 6～9
Except that following listed condition, all the other steps are with embodiment 1 preparation Decoction of Four-Drug Juice chewable tablet.
Also add aspartame 0.45% in the adjuvant, Fructus Myricae rubrae essence 0.45% among this effect embodiment, mix homogeneously, be divided into 4 parts, add magnesium stearate shown in the following table or Pulvis Talci respectively, mix homogeneously, adopting the single punch tablet machine tab is 0.5g heavily, is pressed into tablet, respectively get 10 and weigh, calculate tablet weight variation.The results are shown in following table:
Embodiment 10～22
Among the following embodiment, the listed condition, all the other steps operations and conditional parameter all prepare the concrete operations condition and the step of Decoction of Four-Drug Juice chewable tablet with embodiment 1 in following table.
Embodiment 23～24
Among the following embodiment, the listed condition, all the other steps operations and conditional parameter all prepare the concrete operations condition and the step of Decoction of Four-Drug Juice chewable tablet with embodiment 2 in following table.
Effect embodiment 1 volatile oil absorbent kind and consumption are to the influence of Decoction of Four-Drug Juice chewable tablet
Except that following listed condition, all the other steps are with embodiment 1 preparation Decoction of Four-Drug Juice chewable tablet.
With kind and the consumption of Decoction of Four-Drug Juice volatile oil by the listed absorbent of amount adding following table of every 0.5ml, mix homogeneously, and preparation Decoction of Four-Drug Juice chewable tablet.Wherein, with volatile oil can be scattered in the absorbent equably, to be Powdered, adhesion serve as to absorb complete optimality criterion to formed mixture, the results are shown in shown in the following table.
Annotate: "-" is for absorbing not exclusively; "+" is for absorbing fully
As seen from the above table, although the conventional absorbent in this area all can use, preferred absorbent consumption of the present invention and scope have better good effect.
Effect embodiment 2 system soft materials use the influence of the selection of concentration of alcohol and consumption to the Decoction of Four-Drug Juice chewable tablet
Except that following listed condition, all the other steps are with embodiment 1 preparation Decoction of Four-Drug Juice chewable tablet.
Wherein, system is during soft material, prepares soft material with the alcoholic solution of percent by volume 30%～90%, the results are shown in following table:
| Different concentrations of alcohol solution | The situation of preparation soft material |
| 30％ | Cross stickingly, can not be prepared into suitable soft material |
| 45％ | Sticking slightly, can not be prepared into suitable soft material |
| 60％ | The soft material of preparation is easily held agglomerating, but not too easily scatters, and it is sticking slightly to granulate |
| 75％ | The soft material of preparation is easily held agglomerating, easily scatters, and easily is prepared into suitable granule |
| 90％ | The soft material of preparation is easily held agglomerating, too easily scatters, and makes granule |
As seen from the above table, preparation Decoction of Four-Drug Juice chewable tablet has only that the scope of the invention of use ethanol water prepares the Decoction of Four-Drug Juice soft material, granule is more suitable.
The kind of effect embodiment 3 sweeting agents and correctives and consumption are selected the influence to the Decoction of Four-Drug Juice chewable tablet
Except that following listed condition, all the other steps are with embodiment 1 preparation Decoction of Four-Drug Juice chewable tablet.
Get Decoction of Four-Drug Juice medical material 900g, be prepared into granule by embodiment 1 method, volatile oil-calcium sulfate dihydrate the mixture, the 3g magnesium stearate that add 9g, mix homogeneously, be divided into 24 parts, according to the form below adds sweeting agent and correctives, mix homogeneously, adopting the single punch tablet machine tab is 0.5g heavily, is pressed into tablet.Every kind of tablet carries out mouth feel score by 3 people respectively, is divided into full marks with 10, the results are shown in following table:
| Kind and consumption | Honey peach essence 0.3% | Fructus Myricae rubrae essence 0.3% | Honey peach essence 0.45% | Fructus Myricae rubrae essence 0.45% |
| Protein sugar 0.3% | 4 | 5.7 | 6 | 6.7 |
| Aspartame 0.3% | 6 | 6.7 | 7 | 7.3 |
| Stevioside 0.3% | 5 | 6 | 7 | 7 |
| Protein sugar 0.45% | 5 | 5.7 | 6.7 | 7.3 |
| Aspartame 0.45% | 6 | 7.3 | 7.7 | 8 |
| Stevioside 0.45% | 6 | 7 | 7 | 7.7 |
Annotate: the score value in the form is the average mark of 3 people scoring
As seen from the above table, in sweeting agent of the present invention and correctives scope, Decoction of Four-Drug Juice chewable tablet mouthfeel is all suitable.
Effect embodiment 4
Decoction of Four-Drug Juice chewable tablet of the present invention and oral mushroom liquor naringin content of the prior art stability are relatively
(producer: HuNan HanSen Pharmacy Co., Ltd), placed 10 days under 60 ℃, the condition of relative humidity 75%, precision is measured 3 parts of 10ml to oral mushroom liquor, places D respectively
101Type macroporous adsorptive resins (the about 2cm of internal diameter, packed height 10cm) on, with the flow velocity of per minute 2.5ml, water 200ml eluting, discard water liquid, continue with 70% ethanol 150ml eluting, collect eluent, put and fling to part ethanol in the water-bath, be transferred in the 50ml measuring bottle, add water to scale, shake up, as the oral mushroom liquor need testing solution; Get 1 new preparation Decoction of Four-Drug Juice chewable tablet in addition by embodiment, placed 10 days under 60 ℃, the condition of relative humidity 75%, get 5 pulverizes, precision takes by weighing 3 parts in the chewable tablet powder that is equivalent to 0.15g Decoction of Four-Drug Juice raw medicinal herbs amount, add water 10ml dissolving respectively or be ground into suspension, place D
101The same operation is prepared into Decoction of Four-Drug Juice chewable tablet need testing solution on the type macroporous adsorptive resins.It is an amount of that precision takes by weighing the naringin reference substance in addition, adds methanol and make the solution that every 1ml contains 0.15mg, is prepared into the naringin reference substance solution.(with octadecylsilane chemically bonded silica is filler under following chromatographic condition; Methanol-1% acetic acid (38: 62) is mobile phase; The detection wavelength is 283nm), accurate respectively above-mentioned reference substance solution and each 5 μ l of need testing solution of drawing inject chromatograph of liquid, measure, and calculate the content of each sample naringin by external standard method.
As a result, the oral liquid that is equivalent to Decoction of Four-Drug Juice raw medicinal herbs amount 0.15g on average contains naringin 3.11mg, and the chewable tablet that is equivalent to 0.15g Decoction of Four-Drug Juice raw medicinal herbs amount on average contains naringin 5.35mg.
Show that thus the Decoction of Four-Drug Juice chewable tablet has better stability than oral mushroom liquor.
The kind of effect embodiment 5 filleies is to the influence of Decoction of Four-Drug Juice chewable tablet
Get the Radix Aucklandiae, Fructus Aurantii, the Radix Linderae, four kinds of each 37.5g of medical material of Semen Arecae, get 6 parts, prepare to thick paste by embodiment 1 respectively, standby; In medicinal substances extract: adjuvant is 1: 2.5 a ratio, get mannitol 75g respectively, each 37.5g of mannitol and dextrin, starch 75g, each 37.5g of starch and mannitol, microcrystalline Cellulose 75g, each 37.5g of microcrystalline Cellulose and mannitol, cross 80 mesh sieves respectively, mix, add mix homogeneously in the above-mentioned thick paste, 80 ℃ of oven dry down, pulverized 80 mesh sieves, alcoholic solution with percent by volume 75% prepares soft material, granulate with 18 mesh sieves, 60 ℃ of oven dry down, with 18 mesh sieve granulate, add above-mentioned volatile oil-calcium sulfate dihydrate mixture respectively, sweeting agent 0.45g, correctives 0.45g, magnesium stearate 1g, mix homogeneously, put tabletting in the tablet machine, promptly get the Decoction of Four-Drug Juice chewable tablet that six kinds of different auxiliary material are made.Get six kinds of Decoction of Four-Drug Juice chewable tablet, allow three volunteers chew 3 respectively, feel to have or not grains of sand sense, the marking of mouthfeel satisfaction according to chewing, full marks are 10 minutes.The results are shown in following table:
By last table result as can be known, except that filler of the present invention, not only mouthfeel is relatively poor to use the filler of other kinds, and can't prepare the Decoction of Four-Drug Juice chewable tablet.
Claims (10)
1. Decoction of Four-Drug Juice chewable tablet, it is characterized in that: its prescription contains Decoction of Four-Drug Juice extractive of volatile oil, Decoction of Four-Drug Juice water extract, filler and lubricant, wherein, the consumption of described Decoction of Four-Drug Juice water extract and filler is mass ratio 1: 1～1: 10, and described filler is one or more in mannitol, sorbitol, lactose and the dextrin.
2. Decoction of Four-Drug Juice chewable tablet as claimed in claim 1 is characterized in that: described Decoction of Four-Drug Juice chewable tablet prescription is made up of Decoction of Four-Drug Juice extractive of volatile oil, Decoction of Four-Drug Juice water extract, filler and lubricant.
3. Decoction of Four-Drug Juice chewable tablet as claimed in claim 1 or 2, it is characterized in that: the consumption mass ratio of the described Decoction of Four-Drug Juice medicinal raw material Radix Aucklandiae, Fructus Aurantii, the Radix Linderae and Semen Arecae is (0.2～3): (0.2～3): (0.2～3): (0.2～3), and preferable is mass ratio 1: 1: 1: 1; And/or the consumption of described Decoction of Four-Drug Juice water extract and filler is 1: 1.5～1: 4; And/or the consumption of described lubricant is 1%～5%, and percentage ratio is the mass percent of lubricant material total amount when accounting for tabletting; And/or described lubricant is magnesium stearate and/or Pulvis Talci.
4. Decoction of Four-Drug Juice chewable tablet as claimed in claim 1 is characterized in that: described Decoction of Four-Drug Juice chewable tablet prescription also contains sweeting agent and/or correctives; Described sweeting agent consumption is 0.2%～10%, and described correctives is 0.2%～5%, the mass percent of material total amount when percentage ratio accounts for tabletting for each composition; Described sweeting agent is one or more in sucrose, erythritol, protein sugar, aspartame and the stevioside; Described correctives is honey peach essence and/or Fructus Myricae rubrae essence.
5. Decoction of Four-Drug Juice chewable tablet as claimed in claim 1 or 2 is characterized in that: described Decoction of Four-Drug Juice extractive of volatile oil extracts through the way of distillation with the Decoction of Four-Drug Juice medicinal raw material and obtains; The described way of distillation is extracted volatile oil and comprised the steps: the Decoction of Four-Drug Juice medical material Radix Aucklandiae, Fructus Aurantii, the Radix Linderae and Semen Arecae are extracted volatile oil with water with the way of distillation, and is standby after handling;
Wherein, described water is 6～20 times of amounts of Decoction of Four-Drug Juice quality of medicinal material, and preferable is 6～12 times;
Described Decoction of Four-Drug Juice medical material and water also soaked before the way of distillation is extracted volatile oil; The time of described immersion is 1～3 hour, and preferable is 2 hours;
The distillation time that the described way of distillation is extracted volatile oil is 1～4 hour, and preferable is 3 hours;
The described way of distillation extract volatilization oil handling that volatile oil obtains through absorbent absorb volatile oil-absorber blend or get volatile oil-cyclodextrin clathrate through cyclodextrin inclusion compound.
6. Decoction of Four-Drug Juice chewable tablet as claimed in claim 5 is characterized in that: described absorbent is one or more in calcium phosphate, calcium hydrogen phosphate, calcium sulfate, magnesium oxide and the calcium carbonate; The consumption of described absorbent is 5～20 times of amounts of volatile oil quality, and preferable is 8～12 times; Described cyclodextrin inclusion compound is with the beta-schardinger dextrin-saturated aqueous solution, and with the alcohol mixeding liquid stirring enclose of volatile oil, wherein, the time of described stirring enclose is 0.5～4 hour; The consumption of described cyclodextrin is 6～15 times of amounts of volatile oil quality.
7. Decoction of Four-Drug Juice chewable tablet as claimed in claim 1 or 2 is characterized in that: described Decoction of Four-Drug Juice water extract is that the Decoction of Four-Drug Juice medicinal raw material obtains through water extraction, preferable will extract the medicinal residues that the volatile oil after-filtration gets through the way of distillation and obtain through water extraction; Described water extraction obtains the Decoction of Four-Drug Juice water extract and comprises the steps: the Decoction of Four-Drug Juice medical material is carried out the precipitate with ethanol remove impurity after the extracting solution of water extraction concentrates, and reconcentration promptly gets the Decoction of Four-Drug Juice water extract afterwards;
Wherein, the water consumption of described water extraction is 3～10 times of amounts of quality of medicinal material;
The described time with water extraction is 0.3～1 hour;
Described number of times with water extraction is 1～3 time, and preferable is 2 times, described number of times with water extraction merge extractive liquid, during more than 1 time; What the extracting solution of described water extraction was preferable also extracts the medicinal liquid merging that volatile oil obtains simultaneously with the way of distillation;
Simmer down to concentrating under reduced pressure when carrying out the precipitate with ethanol remove impurity after described the concentrating; Described striking point is that to be concentrated into 60 ℃～70 ℃ relative densities be 1.05～1.15 clear paste;
Described precipitate with ethanol remove impurity is for adding ethanol to containing pure percent by volume 70%～80%, and cold preservation, filtration remove ethanol, add water again and stir cold preservation, filtration; Described contain alcohol amount preferable be percent by volume 75%; The temperature of described cold preservation is 0 ℃～10 ℃; Described cold preservation time is 10～24 hours, and preferable is 12 hours; The described water consumption that adds the water stirring is 3～6 times of medical material amounts;
The described simmer down to concentrating under reduced pressure that promptly gets the Decoction of Four-Drug Juice water extract that concentrates; Described striking point; For being concentrated into 60 ℃ of relative densities is 1.25～1.30 thick paste.
8. as the preparation method of each described Decoction of Four-Drug Juice chewable tablet of claim 1～7, it is characterized in that: it comprises the steps: by described prescription, behind Decoction of Four-Drug Juice water extract and filler uniform mixing, sieve, with the mixed soft material of the ethanol water of percent by volume 50%～95%, with soft material granulation, oven dry, with Decoction of Four-Drug Juice extractive of volatile oil and lubricant uniform mixing, tabletting gets final product again.
9. preparation method as claimed in claim 8 is characterized in that: described sieving to crossing 80 mesh sieves; Described granulation is that 18 mesh sieves are granulated; Described oven dry is 60 ℃～100 ℃ oven dry; Described tabletting sheet heavily is 0.2g～1.5g.
10. preparation method as claimed in claim 8 is characterized in that: the preparation method of described Decoction of Four-Drug Juice water extract water extraction as claimed in claim 7 obtains Decoction of Four-Drug Juice water extract method; The preparation method of the described Decoction of Four-Drug Juice extractive of volatile oil way of distillation as claimed in claim 5 is extracted volatile oil.
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| CN105866279A (en) * | 2016-04-20 | 2016-08-17 | 广西壮族自治区梧州食品药品检验所 | Method for determining content of naringin in Qinghouliyan granules by high performance liquid chromatography (HPLC) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105929100A (en) * | 2016-04-20 | 2016-09-07 | 广西壮族自治区梧州食品药品检验所 | Method for identifying naringin in throat-clearing granule by using combination of macroporous resin and thin-layer chromatography |
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Application publication date: 20111019 |