CN104224726A - Preparation method of traditional Chinese medicine pellet - Google Patents
Preparation method of traditional Chinese medicine pellet Download PDFInfo
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Abstract
The invention relates to a preparation method of a traditional Chinese medicine pellet. The method comprises the following steps of (1) taking a base pellet, and sucking the base pellet into a fluidized drying coating machine to completely fluidize the base pellet in a bed body; and (2) starting to spray a liquid traditional Chinese medicine at the speed of 120g/min when the temperature of the base pellet is raised to 45 DEG C, gradually increasing the infusion quantity along with the increment of the diameter of the pellet, however, controlling the highest speed not to exceed 400g/min, and coating by spraying a coating liquid as required after ending the operation of spraying the liquid traditional Chinese medicine.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation and preparation method thereof, described pharmaceutical preparation refers to medicinal granule, particularly the granule and preparation method thereof of Chinese medicine or plant amedica.
Background technology
The traditional preparation methods of Chinese medicine or plant amedica granule adopts dry method or wet method to make the particulate material of certain particle size Chinese medicine or plant amedica or its extract, for mixing in water for oral taking during patient or swallow.Due to Chinese medicine or plant amedica extractum viscosity higher, the preparation method of conventional particles exists that the drug loading of granule is low mostly, outward appearance unsightly, mouthfeel is poor, the easy problem such as the moisture absorption.
Blank Pellets is pharmaceutical carrier conventional in preparation industry, and much commercially available capsule preparations is all medicine carrying on Blank Pellets, then the target micropill of certain release request made by coating.The features such as it has good fluidity, easily loads capsule, and content uniformity is little, and release is stable.The application of micropill in art of pharmacy is very extensive, as the carrier of medicine, it both can be pressed into tablet further, again can filled capsules, not only increased medicine stability, and can regulating drug rate of release effectively, as drug delivery system, micropill also has advantage therapeutically, and it stimulates less to intestinal, decrease the burst effect of medicine, improve drug safety.
On Blank Pellets, drug delivery technologies uses for many years, but tcm product is few, a lot of Chinese medicine drug delivery technologies or drug loading is few, or unstable, or appearance poor.
The present invention on the basis of existing technology, through process modification, finds a kind of drug delivery technologies of applicable Chinese medicine extract, and is prepared into Chinese medicine pellet further.
Summary of the invention
The invention provides a kind of preparation method of pharmaceutical preparation, comprise the steps:
(1) getting weight ratio is Chinese medicine extract or Chinese medical concrete: 1:5-5:1 is for subsequent use for base ball;
(2) material loading fluidisation: be drawn in fluidized drying seed-coating machine by recipe quantity base ball, makes base ball complete fluidisation in bed body;
(3) in the medicine carrying stage at initial stage: treat temperature of charge 40-60 DEG C, start with speed 70-120g/min hydrojet, described hydrojet is premix Chinese medicine extract Chinese medicine extract or Chinese medical concrete thin up obtained;
(4) in drug incorporation: at temperature of charge 40-60 DEG C, along with the increase in ball footpath, spouting liquid progressively increases, and granule ball footpath and hydrojet speed improve in gradient, until spraying obtains the granule that particle diameter is 0.5-1.8mm
Preparation method of the present invention, after spray medicine, can also be as required, coating solution is sprayed into medicine carrying micropill and carries out coating steps (5), coating temperature of charge 40-60 DEG C, hydrojet speed 40-300g/ml, Coating times 1-4 hour, described coating solution concentration is 5-25%.
Preferably, preparation method of the present invention, comprises the steps:
(1) getting weight ratio is Chinese medicine extract or Chinese medical concrete: 1:3-3:1 is for subsequent use for base ball; Preferred 2:1-1:1.
(2) base ball material loading fluidisation: setting air quantity 600 ~ 1500m
3/ h, is drawn into base ball in fluidized drying seed-coating machine, makes base ball complete fluidisation in bed body; But can not vigorous fluidisation cause base ball to have worn and torn powder, spray gun atomized drop can be covered with base ball and be as the criterion;
(3) the medicine carrying stage at initial stage: debugging spray gun and atomizing pressure, medicinal liquid uniform-mist is enable to change into fine drop, traditional Chinese medicine liquid is transported to spray gun by dosing pump, respectively setting upper jet and lower jet be 2.0 ~ 3.0Bar and 2.5 ~ 3.5Bar, setting temperature of charge about 50 DEG C, hydrojet is started, hydrojet Speed Setting 120g/min after temperature of charge rises to 45 DEG C;
(4) in drug incorporation: temperature of charge 45 ~ 55 DEG C, with the increase in ball footpath, amount of infusion progressively increases, and the highest 400g/min that is no more than of transfusion speed, air quantity adjusts according to the fluidized state of micropill.
(5) coating: medicine carrying terminates rear direct spray coating solution and carries out coating, coating initial setting temperature of charge 50 DEG C, hydrojet speed 80g/min, hydrojet speed can be adjusted to 80 ~ 150g/min after 20 minutes by coating, temperature of charge controls at 40 ~ 55 DEG C, according to the adhesion situation adjustment transfusion speed of micropill, air quantity and temperature of charge;
Wherein, it is formulated that traditional Chinese medicine liquid is that Chinese medical concrete adds water, and the weight ratio of Chinese medical concrete and water is 100:60-100, preferred 100:70-90, more preferably 100:75-85.
Preparation method of the present invention, is suitable for any one Chinese medicine extract or Chinese medical concrete, comprises folk prescription or compound recipe, preferred Radix Salviae Miltiorrhizae extract, stilbene ginseng QI invigorating, Herba Pogostemonis extract etc., most preferably Radix Salviae Miltiorrhizae extract.
Radix Salviae Miltiorrhizae extract is commercial or is prepared by prior art, prepares Radix Salviae Miltiorrhizae extract to better test the limited following method of object of the present invention.
Radix Salviae Miltiorrhizae extract preparation method of the present invention is as follows:
(1) red rooted salvia alcohol extraction, filter and obtain alcohol extract, medicinal residues A is for subsequent use;
(2) medicinal residues A extracting in water, filter, obtain Aqueous extracts, medicinal residues B discards;
(3) alcohol extract, Aqueous extracts are lowered the temperature standing respectively, then Aspirate supernatant is alcohol extraction supernatant, water extraction supernatant respectively;
(4) water extraction supernatant concentration obtains water extracting liquid;
(5) water extracting liquid progressively adds alcohol extraction supernatant, merges concentrated, obtains mixed concentrated liquid;
(6) purified water is added in mixed concentrated liquid, concentrated after mix homogeneously, be drying to obtain Radix Salviae Miltiorrhizae extract.
Preferably, described Radix Salviae Miltiorrhizae extract preparation method is as follows:
(1) red rooted salvia adds medical material amount 2-7 times amount 50-100% ethanol, and reflux, extract, is about 0.5-4 hour, filters to obtain alcohol extract, and medicinal residues A is for subsequent use;
(2) above-mentioned medicinal residues 1 add medical material amount 2-7 times water gaging, decoct about 0.5-4 hour, and filter, obtain Aqueous extracts, medicinal residues B discards;
(3) alcohol extract in step (1) stirs 10-60 minute, in 4 hours, extracting solution temperature is down to less than 15 DEG C, leave standstill 6 ~ 24 hours Aspirate supernatant and obtain alcohol extraction supernatant, Aqueous extracts in step (2) stirs 10-60 minute, in 4 hours, extracting solution temperature is down to less than 15 DEG C, leave standstill 6 ~ 24 hours, Aspirate supernatant obtains water extraction supernatant;
(4) water extraction supernatant concentration is to relative density 1.10 ~ 1.35, obtains water extracting liquid;
(5) water extracting liquid progressively adds step (3) alcohol extraction supernatant, merges concentrated, is evaporated to relative density >=1.20, obtains mixed concentrated liquid;
(6) mixed concentrated liquid gradation adds 10L ~ 100L purified water, adds 5 ~ 50L purified water at every turn, and merge concentrated, being evaporated to 82.5 ± 2.5 DEG C of relative densities is 1.25 ~ 1.35, and filtered while hot, obtains Radix Salviae Miltiorrhizae extract.
Wherein, step (3) alcohol extraction supernatant is progressively added after condensed water extract to relative density 1.10 ~ 1.35 in preferred step (5).
Wherein, progressively add step (3) alcohol extraction supernatant after condensed water extract to relative density 1.10 ~ 1.35 in preferred step (5), being concentrated into relative density is 1.25 ~ 1.35(82.5 ± 2.5 DEG C) receive cream.
Most preferred, described Radix Salviae Miltiorrhizae extract preparation method is as follows:
Get cutting Radix Salviae Miltiorrhizae, add 90 ± 0.5% ethanol 400 ± 12L, decoct 90 ± 5min, 200 orders filter, and alcohol extract merges puts into standing tank; Medicinal residues carry out second time and extract, and add water 500 ± 15L, decoct 60 ± 3min, and 200 orders filter, and medicinal residues discard, and Aqueous extracts merging is put into difference and left standstill tank.Alcohol extraction mixed liquor and water mixing extract are placed in respectively and Bu Tong leave standstill tank, standing tank leads to chilled water cooling and leaves standstill, and after extracting solution stirs 30 minutes, in 4 hours, extracting solution temperature is down to less than 15 DEG C, leave standstill 6 ~ 24 hours, absorption alcohol extraction supernatant and water extraction supernatant are put in respective storage tank.First condensed water puts on clear liquid to water extracting liquid proportion 1.25 ~ 1.30(82.5 ± 2.5 DEG C) between; Progressively adding alcohol extraction supernatant merges concentrated further, and in concentration process, concentrated solution proportion must not lower than 1.15; Be concentrated into mixed concentrated liquid proportion >=1.34, add 10L purified water at twice, add 5L (45 ± 5 DEG C) at every turn, merge concentrated, be concentrated into proportion 1.33 ~ 1.35(82.5 ± 2.5 DEG C), filtered while hot (40 mesh sieve) obtains Radix Salviae Miltiorrhizae extract.
Base ball of the present invention, also celphere is claimed, or medicinal fine pellet core, it is prior art, and commercially can buy and obtain, the major product in medicinal fine pellet core has: medicinal fine pellet core (cane sugar type), microcrystalline Cellulose ball core, starch ball cores etc., base ball of the present invention is selected from starch base ball, polyethylene glycol 6000 base ball, sucrose base ball, the one in microcrystalline cellulose based ball.Preferred starch base ball or polyethylene glycol 6000 base ball, this base ball can drug loading high, easily, technique easily controls, and is easy to industrialization in spraying.
Preparation in accordance with the present invention, gained medicine carrying micropill can make salvia micro pill capsule through processing further.As by medicine carrying coating of pellets, sieve, obtain coated micropill, load in blank capsules and namely obtain Chinese medicine pellet capsule of the present invention.
In order to better realize compound Salviae Miltiorrhizae extract micropill of the present invention, prescription of the present invention is preferably Radix Salviae Miltiorrhizae extract 20-40 part, starch base ball 10-20 part, Opadry 1-2 part.Preferred Radix Salviae Miltiorrhizae extract 32 parts, 16 parts, starch base ball, Opadry 1.5 parts.
Beneficial effect of the present invention
Micropill of the present invention, as microspheric granula, the consumption of carrier is few, single dose is little, is generally 0.1 ~ 4g each serving consumption; Profile rule, spherical in shape or class is spherical, smooth surface rounding; Physical characteristic is good, and such as good fluidity, particle size distribution are regular, the fine and close anti-extrusion of quality, and wear-resistant, density large (bulk density is 0.6 ~ 1.3g/ml), specific surface area is little (only has 0.01 ~ 0.03m
2/ g), dissolve scattered time limit is short; These characteristics can improve the compliance of patient, and makes actual the applying of packaging technique become possibility, thus improves the problem such as Chinese medicine or the easy moisture absorption of plant amedica, instability; In addition, micropill of the present invention, can also as intermediate or granule except using as common granule, and fill becomes the dosage forms such as capsule, can be prepared into various coated preparation, sustained-release preparation, positioning release medicine preparation etc. in addition.
The advantage of Radix Salviae Miltiorrhizae extract of the present invention and preparation method thereof is as follows:
The benefit that Chinese medicine extract condensing mode of the present invention brings to preparation is mainly: in extract, slightly solubility granule significantly improves, and stifled spray gun problem no longer appears in drug incorporation.Extract alcohol residue level is lower, and production process no longer increases containing alcohol operation, guarantees that product alcohol residue meets the requirements.Extract stability improves, and the production process index components rate of transform is stablized.
It is below the comparative experiments of different method for concentration
Precise red rooted salvia 450g, with 4 times amount 90% ethanol extraction 1.5h, medical filtration; Medicinal residues 5 times of water gaging reflux, extract, 1h, filter, obtain alcohol extract and Aqueous extracts.Each experiment parallel extraction twice.
Progressively adding condensed water extract after experimental program one, first concentrated alcohol extract merges concentrated, receives cream to pol 86 ± 2%.
After experimental program two, first condensed water extract to pol 84 ± 2%, progressively add alcohol extract and merge concentrated, receive cream to pol 86 ± 2%.
Sample source: 20120823 first concentrated alcohol extract add Aqueous extracts again and concentrate
20120829 first condensed water extracts add alcohol extract again and concentrate
1, the known 20120823 black mole bits granules of picture adhered to from flask after Radix Salviae Miltiorrhizae extract blowing are large and sticking ratio is more serious, 20120829 can see that precipitation black bits are more tiny and relatively more even, thus 20120829 condensing mode extract character are better.
2, clean respective batch of flask result picture with water and can find out that 20120823 flask black mole bits sticking ratios are serious, it is less that rear kind of condensing mode glues wall situation.Thus from 20120829 batches of condensing mode water cleaning performance to equipment cleaning better.
3, heavier from the known 20120823 cleaning solution colors of the picture of 95% ethanol purge, 20120829 solution colours are more clear.
In sum, after the first condensed water extracts of 20120829 batches of condensing mode Radix Salviae Miltiorrhizae extract Apparent character and follow-up equipment cleaning, progressively adding alcohol extract, to merge condensing mode optimum.
Different condensing mode is on the impact of Radix Salviae Miltiorrhizae extract particle size distribution
2 can find out in coating picture from the graph, and 20120823 have obvious oarse-grained black mole bits to separate out, and another kind condensing mode Radix Salviae Miltiorrhizae extract black bits distribute relatively evenly and granule is smaller, less on follow-up preparation impact on Radix Salviae Miltiorrhizae extract.
Particle size distribution is surveyed in pharmacopeia screening
Get each batch of Radix Salviae Miltiorrhizae extract extractum 50 respectively, add 5 times amount water dissolutioies, cross 1-8 pharmacopeia sieve (pharmacopeia sieve stacks successively), with about 500ml distilled water flushing, observe extract granule distribution situation in every layer of pharmacopeia sieve, then the particles with water in every layer is rinsed, collect, sucking filtration, dries together with filter paper and weighs.
As known in above-mentioned chart from extract particles size and bulky grain appearance order, the excellent slightly order of extract character is 20120829-J>20120823-J.Therefore 20120829 condensing mode are better.
Accompanying drawing explanation
Test picture in Fig. 1 experimentation, wherein, after first row Radix Salviae Miltiorrhizae extract blowing, flask adheres to picture, picture after the cleaning of second row flask of water, picture after the 3rd row's flask 95% ethanol purge
Fig. 2 Radix Salviae Miltiorrhizae extract coating photo
Detailed description of the invention
Further illustrate the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1
The preparation of Radix Salviae Miltiorrhizae extract, step is as follows:
Cutting Radix Salviae Miltiorrhizae: medical material visual examination, weighs, for subsequent use.
Medical material feeds intake requirement:
Cutting Radix Salviae Miltiorrhizae: can as required different batches cutting Radix Salviae Miltiorrhizae be used by proper proportion collocation.
Add material order: first throw E cutting Radix Salviae Miltiorrhizae when feeding intake, one decoct add 90 ± 0.5% ethanol, two decoct add one-level RO water as extraction solvent extract.
Extract:
One batch is made up of 2 tanks, and every tank all takes cutting Radix Salviae Miltiorrhizae 100kg respectively by batch prescription, adds 90 ± 0.5% ethanol 400 ± 12L, decocts 90 ± 5min, and 200 orders filter, and two tank alcohol extracts merge puts into standing tank; Medicinal residues carry out second time and extract, and add water 500 ± 15L, decoct 60 ± 3min, and 200 orders filter, and medicinal residues discard, and two tank Aqueous extracts merging are put into difference and left standstill tank.
Cooling leaves standstill:
Alcohol extraction mixed liquor and water mixing extract are placed in respectively and Bu Tong leave standstill tank, standing tank leads to chilled water cooling and leaves standstill, and after extracting solution stirs 30 minutes, in 4 hours, extracting solution temperature is down to less than 15 DEG C, leave standstill 6 ~ 24 hours, absorption alcohol extraction supernatant and water extraction supernatant are put in respective storage tank.
Concentrated:
First condensed water puts on clear liquid to water extracting liquid proportion 1.25 ~ 1.30(82.5 ± 2.5 DEG C) between; Progressively adding E01 alcohol extraction supernatant merges concentrated further, and in concentration process, concentrated solution proportion must not lower than 1.15; Be concentrated into E01 mixed concentrated liquid proportion >=1.34, add 10L purified water at twice, add 5L (45 ± 5 DEG C) at every turn, merge concentrated, be concentrated into proportion 1.33 ~ 1.35(82.5 ± 2.5 DEG C), filtered while hot (40 mesh sieve) obtains E01 Radix Salviae Miltiorrhizae extract.
Embodiment 2
Salvia micro pill capsule, can prepare according to following methods:
Raw material:
Radix Salviae Miltiorrhizae extract 32.5kg
Starch base ball 16.0kg
Opadry 85G66817 1.5kg
Preparation method is as follows:
The preparation of Radix Salviae Miltiorrhizae extract medicinal liquid: Radix Salviae Miltiorrhizae extract drops in premixing tank, adds the purified water of 0.7 ~ 0.9 times amount, stirs more than 30 minutes, obtain traditional Chinese medicine liquid;
Starch base ball medicine carrying: debugging spray gun and atomizing pressure, enable medicinal liquid uniform atomizing be fine drop;
Material loading fluidisation: starch base ball is sucked in fluidisation dry coationg machine, setting air quantity 600 ~ 1500m
3/ h, makes base ball complete fluidisation in bed body, but can not vigorous fluidisation cause base ball to have worn and torn powder, can cover spray gun atomized drop be as the criterion with base ball;
Premix extract is transported to spray gun by dosing pump, respectively setting upper jet and lower jet be 2.0 ~ 3.0Bar and 2.5 ~ 3.5Bar; In the medicine carrying stage at initial stage, setting temperature of charge about 50 DEG C, starts hydrojet, hydrojet Speed Setting 70 ~ 120g/min after temperature of charge rises to 45 DEG C; In drug incorporation, temperature of charge 45 ~ 55 DEG C, with the increase in ball footpath, amount of infusion progressively increases, the highest 400g/min that is no more than of transfusion speed, and air quantity adjusts according to the fluidized state of micropill; In drug incorporation, if desired from sample tap sampling observe micropill adhesion and powder situation, and according to the adhesion of micropill with play a powder situation adjustment transfusion speed, air quantity and temperature of charge;
Coating: get Opadry 85G66817 and purified water, stirring and evenly mixing, stir be no less than 45 minutes, obtain 18% coating solution for subsequent use; Medicine carrying terminates rear direct spray coating solution and carries out coating, coating initial setting temperature of charge 50 DEG C, hydrojet speed 40 ~ 80g/min, hydrojet speed can be adjusted to 80 ~ 150g/min after 20 minutes by coating, and temperature of charge controls at 40 ~ 55 DEG C, according to the adhesion situation adjustment transfusion speed of micropill, air quantity and temperature of charge, after coating terminates, be cooled to 35 DEG C, discharging;
Coated pill is screened: intermediate coated pill screened, screen cloth net footpath is 1.8mm, and siftage is salvia micro pill; Screening gained salvia micro pill accounting example is not less than 90%;
Capsule-filling: by the salvia micro pill screened, uses capsule filling machine filled capsules, to obtain final product.
Embodiment 3
The preparation of medicine carrying micropill
Base ball material loading fluidisation: setting air quantity 600m
3/ h, is drawn into base ball in fluidized drying seed-coating machine, makes base ball complete fluidisation in bed body; But can not vigorous fluidisation cause base ball to have worn and torn powder;
In the medicine carrying stage at initial stage: debugging spray gun, allow to atomization well, traditional Chinese medicine liquid is transported to spray gun by dosing pump; respectively setting upper jet and lower jet be 2.0Bar and 2.5Bar; setting temperature of charge about 50 DEG C, starts hydrojet, hydrojet Speed Setting 70g/min after temperature of charge rises to 45 DEG C;
In drug incorporation: temperature of charge 50 DEG C, with the increase in ball footpath, amount of infusion progressively increases, and the highest 400g/min that is no more than of transfusion speed, air quantity adjusts according to the fluidized state of micropill.
Coating: medicine carrying terminates rear direct spray coating solution and carries out coating, coating initial setting temperature of charge 50 DEG C, hydrojet speed 40g/min, hydrojet speed can be adjusted to 80g/min after 20 minutes by coating, temperature of charge controls at 40 DEG C, according to the adhesion situation adjustment transfusion speed of micropill, air quantity and temperature of charge;
Wherein, it is formulated that traditional Chinese medicine liquid is that Chinese medical concrete adds water, and the weight ratio of Chinese medical concrete and water is 100:90.Embodiment 4
The preparation of medicine carrying micropill
Base ball material loading fluidisation: setting air quantity 1500m
3/ h, is drawn into base ball in fluidized drying seed-coating machine, makes base ball complete fluidisation in bed body;
In the medicine carrying stage at initial stage: debugging spray gun, allow to atomization well, traditional Chinese medicine liquid is transported to spray gun by dosing pump; respectively setting upper jet and lower jet be 3.0Bar and 3.5Bar; setting temperature of charge about 50 DEG C, starts hydrojet, hydrojet Speed Setting 120g/min after temperature of charge rises to 45 DEG C;
In drug incorporation: temperature of charge 55 DEG C, with the increase in ball footpath, amount of infusion progressively increases, and the highest 400g/min that is no more than of transfusion speed, air quantity adjusts according to the fluidized state of micropill.
Coating: medicine carrying terminates rear direct spray coating solution and carries out coating, coating initial setting temperature of charge 50 DEG C, hydrojet speed 80g/min, hydrojet speed can be adjusted to 150g/min after 20 minutes by coating, temperature of charge controls at 55 DEG C, according to the adhesion situation adjustment transfusion speed of micropill, air quantity and temperature of charge;
Wherein, it is formulated that traditional Chinese medicine liquid is that Chinese medical concrete adds water, and the weight ratio of Chinese medical concrete and water is 100:70.Embodiment 5
The preparation of medicine carrying micropill
Base ball material loading fluidisation: setting air quantity 1500m
3/ h, is drawn into base ball in fluidized drying seed-coating machine, makes base ball complete fluidisation in bed body;
In the medicine carrying stage at initial stage: debugging spray gun, allow to atomization well, traditional Chinese medicine liquid is transported to spray gun by dosing pump; respectively setting upper jet and lower jet be 3.0Bar and 3.5Bar; setting temperature of charge about 50 DEG C, starts hydrojet, hydrojet Speed Setting 120g/min after temperature of charge rises to 45 DEG C;
In drug incorporation: temperature of charge 55 DEG C, with the increase in ball footpath, amount of infusion progressively increases, and the highest 400g/min that is no more than of transfusion speed, air quantity adjusts according to the fluidized state of micropill.
Coating: medicine carrying terminates rear direct spray coating solution and carries out coating, coating initial setting temperature of charge 50 DEG C, hydrojet speed 80g/min, hydrojet speed can be adjusted to 150g/min after 20 minutes by coating, temperature of charge controls at 55 DEG C, according to the adhesion situation adjustment transfusion speed of micropill, air quantity and temperature of charge;
Wherein, Chinese medicine extract is Radix Salviae Miltiorrhizae extract, and base ball is starch base ball, and both part by weight are 2:1, and it is formulated that traditional Chinese medicine liquid is that Chinese medical concrete adds water, and the weight ratio of Chinese medical concrete and water is 100:82.
Embodiment 6
The preparation of medicine carrying micropill
Base ball material loading fluidisation: setting air quantity 1500m
3/ h, is drawn into base ball in fluidized drying seed-coating machine, makes base ball complete fluidisation in bed body; But can not vigorous fluidisation cause base ball to have worn and torn powder;
The medicine carrying stage at initial stage: spray gun uses the pad of 0.2mm; debugging spray gun; allow to atomization good; traditional Chinese medicine liquid is transported to spray gun by dosing pump; respectively setting upper jet and lower jet be 3.0Bar and 3.5Bar; setting temperature of charge about 50 DEG C, starts hydrojet, hydrojet Speed Setting 120g/min after temperature of charge rises to 45 DEG C; In drug incorporation: temperature of charge 55 DEG C, with the increase in ball footpath, amount of infusion progressively increases, and the highest 400g/min that is no more than of transfusion speed, air quantity adjusts according to the fluidized state of micropill.
Coating: medicine carrying terminates rear direct spray coating solution and carries out coating, coating initial setting temperature of charge 50 DEG C, hydrojet speed 80g/min, hydrojet speed can be adjusted to 150g/min after 30 minutes by coating, temperature of charge controls at 55 DEG C, according to the adhesion situation adjustment transfusion speed of micropill, air quantity and temperature of charge;
Wherein, Chinese medicine extract is Radix Salviae Miltiorrhizae extract, and base ball is sucrose base ball, and both part by weight are 1:1, and it is formulated that traditional Chinese medicine liquid is that Chinese medical concrete adds water, and the weight ratio of Chinese medical concrete and water is 100:90.
Embodiment 7
Salvia micro pill capsule, can prepare according to following methods:
Raw material:
Radix Salviae Miltiorrhizae extract 32.5kg
Starch base ball 16.0kg
Opadry 85G66817 1.5kg
Preparation method is as follows:
The preparation of Radix Salviae Miltiorrhizae extract medicinal liquid: Radix Salviae Miltiorrhizae extract drops in premixing tank, adds the purified water of 0.82 times of weight, stirs more than 30 minutes, obtain traditional Chinese medicine liquid;
Starch base ball medicine carrying: debugging spray gun, allows to atomization well; Material loading fluidisation: starch base ball is sucked in fluidisation dry coationg machine, setting air quantity 1000m
3/ h, makes base ball complete fluidisation in bed body, but can not vigorous fluidisation cause base ball to have worn and torn powder; Premix extract is transported to spray gun by dosing pump, respectively setting upper jet and lower jet be 2.5Bar and 3Bar; In the medicine carrying stage at initial stage, setting temperature of charge about 50 DEG C, starts hydrojet, hydrojet Speed Setting 120g/min after temperature of charge rises to 45 DEG C; In drug incorporation, temperature of charge 50 DEG C, with the increase in ball footpath, amount of infusion progressively increases, the highest 400g/min that is no more than of transfusion speed, and air quantity adjusts according to the fluidized state of micropill; In drug incorporation, if desired from sample tap sampling observe micropill adhesion and powder situation, and according to the adhesion of micropill with play a powder situation adjustment transfusion speed, air quantity and temperature of charge;
Coating: get Opadry 85G66817 and purified water, stirring and evenly mixing, stir be no less than 45 minutes, obtain 18% coating solution for subsequent use; Medicine carrying terminates rear direct spray coating solution and carries out coating, coating initial setting temperature of charge 50 DEG C, hydrojet speed 80g/min, hydrojet speed can be adjusted to 100g/min after 20 minutes by coating, and temperature of charge controls at 50 DEG C, according to the adhesion situation adjustment transfusion speed of micropill, air quantity and temperature of charge, after coating terminates, be cooled to 35 DEG C, discharging;
Coated pill is screened: intermediate coated pill screened, screen cloth net footpath is 1.8mm, and siftage is salvia micro pill; Screening gained salvia micro pill accounting example is not less than 90%;
Capsule-filling: by the salvia micro pill screened, uses capsule filling machine filled capsules, to obtain final product.
Embodiment 8 Radix Bupleuri extract pellet capsule,
Prescription:
Radix Bupleuri extract 1.40kg
Microcrystalline cellulose based ball 1.60kg
Opadry 85G66817 0.10kg
Preparation method is as follows:
The preparation of Radix Bupleuri extract medicinal liquid: Radix Bupleuri extract drops in premixing tank, adds the purified water of 0.9 times of weight, stirs more than 30 minutes, obtain traditional Chinese medicine liquid;
Microcrystalline cellulose based ball medicine carrying: debugging spray gun, allows to atomization well; Material loading fluidisation: microcrystalline cellulose based ball is sucked in fluidisation dry coationg machine, setting air quantity 1200m
3/ h, makes base ball complete fluidisation in bed body, but can not vigorous fluidisation cause base ball to have worn and torn powder; Premix extract is transported to spray gun by dosing pump, respectively setting upper jet and lower jet be 2.2Bar and 3.2Bar; In the medicine carrying stage at initial stage, setting temperature of charge about 50 DEG C, starts hydrojet, hydrojet Speed Setting 100g/min after temperature of charge rises to 45 DEG C; In drug incorporation, temperature of charge 50 DEG C, with the increase in ball footpath, amount of infusion progressively increases, the highest 400g/min that is no more than of transfusion speed, and air quantity adjusts according to the fluidized state of micropill; In drug incorporation, if desired from sample tap sampling observe micropill adhesion and powder situation, and according to the adhesion of micropill with play a powder situation adjustment transfusion speed, air quantity and temperature of charge;
Coating: get Opadry 85G66817 and purified water, stirring and evenly mixing, stir be no less than 45 minutes, obtain 18% coating solution for subsequent use; Medicine carrying terminates rear direct spray coating solution and carries out coating, coating initial setting temperature of charge 50 DEG C, hydrojet speed 80g/min, hydrojet speed can be adjusted to 100g/min after 20 minutes by coating, and temperature of charge controls at 50 DEG C, according to the adhesion situation adjustment transfusion speed of micropill, air quantity and temperature of charge, after coating terminates, be cooled to 35 DEG C, discharging;
Coated pill is screened: intermediate coated pill screened, screen cloth net footpath is 1.8mm, and siftage is Radix Bupleuri micropill; Screening gained Radix Bupleuri micropill accounting example is not less than 90%;
Capsule-filling: by the Radix Bupleuri micropill screened, use capsule filling machine filled capsules, to obtain final product.
Embodiment 9 stilbene ginseng QI invigorating pellet capsule,
Prescription:
Stilbene ginseng QI invigorating mixed extract 1.25kg
Polyethylene glycol 6000 base ball 3.75kg
Opadry 85G66817 0.20kg
Preparation method is as follows:
The preparation of stilbene ginseng QI invigorating extract medicinal liquid: stilbene ginseng QI invigorating extract drops in premixing tank, adds the purified water of 0.7 times of weight, stirs more than 30 minutes, obtain traditional Chinese medicine liquid;
Polyethylene glycol 6000 base ball medicine carrying: debugging spray gun, allows to atomization well; Material loading fluidisation: polyethylene glycol 6000 base ball is sucked in fluidisation dry coationg machine, setting air quantity 900m
3/ h, makes base ball complete fluidisation in bed body, but can not vigorous fluidisation cause base ball to have worn and torn powder; Premix extract is transported to spray gun by dosing pump, respectively setting upper jet and lower jet be 2.2Bar and 3.2Bar; In the medicine carrying stage at initial stage, setting temperature of charge about 50 DEG C, starts hydrojet, hydrojet Speed Setting 80g/min after temperature of charge rises to 40 DEG C; In drug incorporation, temperature of charge 50 DEG C, with the increase in ball footpath, amount of infusion progressively increases, the highest 400g/min that is no more than of transfusion speed, and air quantity adjusts according to the fluidized state of micropill; In drug incorporation, if desired from sample tap sampling observe micropill adhesion and powder situation, and according to the adhesion of micropill with play a powder situation adjustment transfusion speed, air quantity and temperature of charge;
Coating: get Opadry 85G66817 and purified water, stirring and evenly mixing, stir be no less than 45 minutes, obtain 18% coating solution for subsequent use; Medicine carrying terminates rear direct spray coating solution and carries out coating, coating initial setting temperature of charge 50 DEG C, hydrojet speed 80g/min, hydrojet speed can be adjusted to 100g/min after 20 minutes by coating, and temperature of charge controls at 50 DEG C, according to the adhesion situation adjustment transfusion speed of micropill, air quantity and temperature of charge, after coating terminates, be cooled to 35 DEG C, discharging;
Coated pill is screened: intermediate coated pill screened, screen cloth net footpath is 1.8mm, and siftage is stilbene ginseng QI invigorating micropill; Screening gained stilbene ginseng QI invigorating micropill accounting example is not less than 90%;
Capsule-filling: by the stilbene ginseng QI invigorating micropill screened, use capsule filling machine filled capsules, to obtain final product.
Embodiment 10
Ageratum pellet capsule,
Prescription:
Ageratum mixed extract 6.25kg
Polyethylene glycol 6000 base ball 6.25kg
Opadry 85G66817 0.40kg
Preparation method is as follows:
The preparation of ageratum extract medicinal liquid: ageratum extract drops in premixing tank, adds the purified water of 0.8 times of weight, stirs more than 30 minutes, obtain traditional Chinese medicine liquid;
Polyethylene glycol 6000 base ball medicine carrying: debugging spray gun, allows to atomization well; Material loading fluidisation: polyethylene glycol 6000 base ball is sucked in fluidisation dry coationg machine, setting air quantity 900m
3/ h, makes base ball complete fluidisation in bed body, but can not vigorous fluidisation cause base ball to have worn and torn powder; Premix extract is transported to spray gun by dosing pump, respectively setting upper jet and lower jet be 2.2Bar and 3.2Bar; In the medicine carrying stage at initial stage, setting temperature of charge about 50 DEG C, starts hydrojet, hydrojet Speed Setting 80g/min after temperature of charge rises to 40 DEG C; In drug incorporation, temperature of charge 50 DEG C, with the increase in ball footpath, amount of infusion progressively increases, the highest 400g/min that is no more than of transfusion speed, and air quantity adjusts according to the fluidized state of micropill; In drug incorporation, if desired from sample tap sampling observe micropill adhesion and powder situation, and according to the adhesion of micropill with play a powder situation adjustment transfusion speed, air quantity and temperature of charge;
Coating: get Opadry 85G66817 and purified water, stirring and evenly mixing, stir be no less than 45 minutes, obtain 18% coating solution for subsequent use; Medicine carrying terminates rear direct spray coating solution and carries out coating, coating initial setting temperature of charge 50 DEG C, hydrojet speed 80g/min, hydrojet speed can be adjusted to 100g/min after 20 minutes by coating, and temperature of charge controls at 50 DEG C, according to the adhesion situation adjustment transfusion speed of micropill, air quantity and temperature of charge, after coating terminates, be cooled to 35 DEG C, discharging;
Coated pill is screened: intermediate coated pill screened, screen cloth net footpath is 1.8mm, and siftage is ageratum micropill; Screening gained ageratum micropill accounting example is not less than 90%;
Capsule-filling: by the ageratum micropill screened, use capsule filling machine filled capsules, to obtain final product.Ageratum described in above-described embodiment, Radix Bupleuri extract, stilbene ginseng QI invigorating extract is all conventionally prepared.
Claims (10)
1. a preparation method for pharmaceutical preparation, is characterized in that: comprise the steps:
(1) getting weight ratio is Chinese medicine extract or Chinese medical concrete: 1:5-5:1 is for subsequent use for base ball;
(2) material loading fluidisation: be drawn in fluidized drying seed-coating machine by recipe quantity base ball, makes base ball complete fluidisation in bed body;
(3) in the medicine carrying stage at initial stage: treat temperature of charge 40-60 DEG C, start with speed 70-120g/min hydrojet, described hydrojet is that the premix Chinese medicine extract that Chinese medicine extract or Chinese medical concrete thin up obtain is atomized into fine drop, coats base ball surface;
(4) in drug incorporation: at temperature of charge 40-60 DEG C, along with the increase in ball footpath, spouting liquid progressively increases, and granule ball footpath and hydrojet speed improve in gradient, until spraying obtains the granule that particle diameter is 0.5-1.8mm.
2. preparation method as claimed in claim 1, is characterised in that: also comprise (5) packaging technique, after step (4) medicine carrying terminates, direct spray coating solution spraying, coating temperature of charge 30-60 DEG C, hydrojet speed 40-300g/min, Coating times 1-4 hour, described coating solution concentration is 5-25%.
3. preparation method as claimed in claim 1 or 2, is characterized in that: comprise the steps:
(1) getting weight ratio is Chinese medicine extract or Chinese medical concrete: base ball 1:5-5:1;
(2) material loading fluidisation: recipe quantity base ball is sucked in fluidisation dry coationg machine, setting air quantity 600-1500m
3/ h, makes base ball complete fluidisation in bed body, but can not vigorous fluidisation, can cover spray gun atomized drop be as the criterion with base ball;
(3) the medicine carrying stage at initial stage: premix extract is transported to spray gun by dosing pump; debugging spray gun and atomizing pressure; the uniform atomizing of premix extract is enable to be tiny drop; respectively setting upper jet and lower jet be 2.0-3.0Bar and 2.5-3.5Bar; setting temperature of charge about 50 DEG C; hydrojet is started, hydrojet Speed Setting 60-120g/min after temperature of charge rises to 45 DEG C;
(4) in drug incorporation: temperature of charge 45-55 DEG C, with the increase in ball footpath, amount of infusion progressively increases, the highest 400g/min that is no more than of transfusion speed, and air quantity adjusts according to the fluidized state of micropill;
(5) coating: medicine carrying terminates rear direct spray coating solution and carries out coating, coating initial setting temperature of charge 50 DEG C, hydrojet speed 40-80g/min, hydrojet speed can be adjusted to 80-150g/min after 20 minutes by coating, temperature of charge controls at 40-55 DEG C, according to the adjustment of adhesion situation transfusion speed, air quantity and the temperature of charge of micropill.
4. preparation method as claimed in claim 1 or 2, wherein said Chinese medicine extract is Radix Salviae Miltiorrhizae extract.
5. preparation method as claimed in claim 4, is characterized in that: described Radix Salviae Miltiorrhizae extract has following method to prepare:
(1) red rooted salvia lower alcohol extraction, filter and obtain alcohol extract, medicinal residues A is for subsequent use;
(2) medicinal residues A extracting in water, filter, obtain Aqueous extracts, medicinal residues B discards;
(3) alcohol extract, Aqueous extracts are lowered the temperature standing respectively, then Aspirate supernatant is alcohol extraction supernatant, water extraction supernatant respectively;
(4) water extraction supernatant concentration obtains water extracting liquid;
(5) water extracting liquid progressively adds alcohol extraction supernatant, merges concentrated, obtains mixed concentrated liquid;
(6) mixed concentrated liquid adds purified water, concentrated after mix homogeneously, obtains Radix Salviae Miltiorrhizae extract.
6. preparation method as claimed in claim 5, is characterized in that: described Radix Salviae Miltiorrhizae extract is prepared by following method:
(1) red rooted salvia adds medical material amount 2-7 times amount 50-100% ethanol, and reflux, extract, is about 0.5-4 hour, filters to obtain alcohol extract, and medicinal residues A is for subsequent use;
(2) above-mentioned medicinal residues A adds medical material amount 2-7 times water gaging, decocts about 0.5-4 hour, and filter, obtain Aqueous extracts, medicinal residues B discards;
(3) in step (1), alcohol extract cooling leaves standstill, extracting solution mixing time 10-60 minute, in 4 hours, extracting solution temperature is down to less than 15 DEG C, leave standstill 6 ~ 24 hours Aspirate supernatant and obtain alcohol extraction supernatant, the cooling of step (2) Aqueous extracts leaves standstill, and extracting solution mixing time 10-60 minute, was down to less than 15 DEG C by extracting solution temperature in 4 hours, leave standstill 6 ~ 24 hours, Aspirate supernatant obtains water extraction supernatant;
(4) water extraction supernatant concentration is to relative density 1.10 ~ 1.35, obtains water extracting liquid;
(5) water extracting liquid progressively adds step (3) alcohol extraction supernatant, merges concentrated, is evaporated to relative density >=1.20, obtains mixed concentrated liquid;
(6) mixed concentrated liquid gradation adds 10L ~ 100L purified water, adds 5 ~ 50L purified water at every turn, and merge concentrated, being evaporated to 82.5 ± 2.5 DEG C of relative densities is 1.25 ~ 1.35, and filtered while hot, obtains Radix Salviae Miltiorrhizae extract.
7. as the preparation method of claim 5 or 6 as described in any one, it is characterized in that: in step (5), after condensed water extract to relative density 1.10 ~ 1.35, progressively add step (3) alcohol extraction supernatant.
8. preparation method as claimed in claim 7, is characterized in that: progressively add step (3) alcohol extraction supernatant after condensed water extract to relative density 1.10 ~ 1.35 in step (5), being concentrated into relative density is 1.25 ~ 1.35(82.5 ± 2.5 DEG C) receive cream.
9. preparation method as claimed in claim 1, is characterized in that: described base ball is selected from starch base ball, polyethylene glycol 6000 base ball, sucrose base ball, the one in microcrystalline cellulose based ball.
10. preparation method as claimed in claim 1, gained micropill through being processed into salvia micro pill capsule further, described salvia micro pill capsule, formula is as follows:
Radix Salviae Miltiorrhizae extract 20-40 part
Starch base ball 10-20 part
Opadry 85G66817 1-2 part
Preparation method is as follows:
The preparation of Radix Salviae Miltiorrhizae extract medicinal liquid: Radix Salviae Miltiorrhizae extract drops in premixing tank, adds the purified water of 0.2 ~ 2 times amount, stirs more than 30 minutes, obtain traditional Chinese medicine liquid;
Starch base ball medicine carrying: debugging spray gun and atomizing pressure, enable medicinal liquid uniform-mist change into fine drop;
Material loading fluidisation: starch base ball is sucked in fluidisation dry coationg machine, setting air quantity 600 ~ 1500m
3/ h, makes base ball complete fluidisation in bed body, can cover spray gun atomized drop be as the criterion with base ball;
Premixed drug solutions is transported to spray gun by dosing pump, respectively setting upper jet and lower jet be 2.0 ~ 3.0Bar and 2.5 ~ 3.5Bar; In the medicine carrying stage at initial stage, setting temperature of charge about 50 DEG C, starts hydrojet, hydrojet Speed Setting 70 ~ 120g/min after temperature of charge rises to 45 DEG C; In drug incorporation, temperature of charge 45 ~ 55 DEG C, with the increase in ball footpath, amount of infusion progressively increases, the highest 400g/min that is no more than of transfusion speed, and air quantity adjusts according to the fluidized state of micropill; In drug incorporation, if desired from sample tap sampling observe micropill adhesion and powder situation, and according to the adhesion of micropill with play a powder situation adjustment transfusion speed, air quantity and temperature of charge;
Coating: get Opadry 85G66817 and purified water, stirring and evenly mixing, stir be no less than 45 minutes, obtain 18% coating solution for subsequent use; Medicine carrying terminates rear direct spray coating solution and carries out coating, coating initial setting temperature of charge 50 DEG C, hydrojet speed 40 ~ 80g/min, hydrojet speed can be adjusted to 80 ~ 150g/min after 20 minutes by coating, and temperature of charge controls at 40 ~ 55 DEG C, according to the adhesion situation adjustment transfusion speed of micropill, air quantity and temperature of charge, after coating terminates, be cooled to 35 DEG C, discharging;
Coated pill is screened: intermediate coated pill screened, screen cloth net footpath is 1.8mm, and siftage is salvia micro pill; Screening gained salvia micro pill accounting example is not less than 90%;
Capsule-filling: by the salvia micro pill screened, uses capsule filling machine filled capsules, to obtain final product.
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| CN109925296A (en) * | 2017-12-19 | 2019-06-25 | 四川济生堂药业有限公司 | A kind of coating method of traditional Chinese medicine pellet |
| CN110420194A (en) * | 2019-07-09 | 2019-11-08 | 上海真仁堂药业有限公司 | A kind of condensed pill preparation process |
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| CN107823180B8 (en) * | 2017-11-21 | 2021-07-16 | 河南泓医药业有限公司 | Preparation method of single-medicine micro-pill containing volatile oil |
| CN107823155B (en) * | 2017-11-21 | 2021-06-11 | 河南泓医药业有限公司 | Preparation method of single-medicine micro-pills |
| CN111617088A (en) * | 2020-07-13 | 2020-09-04 | 中国人民解放军北部战区总医院 | Pharmaceutical composition for treating myocardial injury caused by Kawasaki disease and application thereof |
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