CN104224726B - A kind of preparation method of traditional Chinese medicine pellet - Google Patents

A kind of preparation method of traditional Chinese medicine pellet Download PDF

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CN104224726B
CN104224726B CN201310277101.9A CN201310277101A CN104224726B CN 104224726 B CN104224726 B CN 104224726B CN 201310277101 A CN201310277101 A CN 201310277101A CN 104224726 B CN104224726 B CN 104224726B
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temperature
charge
base ball
extract
water
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CN104224726A (en
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章顺楠
杨建会
孙艳
张洪坡
董海鸥
邵星云
董莉娜
马永强
姚风娟
陈聪
刘晓峰
周立红
李晨鸣
闫希军
叶正良
郑永锋
范立君
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Tasly Pharmaceutical Group Co Ltd
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Abstract

The present invention relates to a kind of preparation method of traditional Chinese medicine pellet, methods described comprises the following steps:(1)Base ball is taken, base ball is drawn into fluidized drying seed-coating machine, base ball is fluidized completely in bed body;(2)When base ball temperature rises to 45 DEG C, start to spray into traditional Chinese medicine liquid with 120g/min speed, with the increase in ball footpath, amount of infusion is stepped up, but speed not more than 400g/min, spray finish, and can be sprayed into coating solution as needed and is coated.

Description

A kind of preparation method of traditional Chinese medicine pellet
Technical field
The present invention relates to a kind of pharmaceutical preparation and preparation method thereof, described pharmaceutical preparation refers to medicinal granule, especially It is granule of Chinese medicine or autonomic drug and preparation method thereof.
Background technology
The traditional preparation methods of Chinese medicine or autonomic drug particle are that Chinese medicine or autonomic drug or its extract are used into dry method or wet The particulate material of certain particle size is made in method, for patient using when mixing in water for oral taking or swallow.Because Chinese medicine or autonomic drug medicinal extract glue Degree is higher, the drugloading rate that the preparation methods of conventional particles has particle mostly is low, outward appearance unsightly, poor taste, the easy moisture absorption etc. ask Topic.
Blank Pellets are the pharmaceutical carriers commonly used in preparation industry, and many commercially available capsule preparations are all on Blank Pellets Medicine is carried, then is coated the target micropill that certain release request is made.It has good fluidity, easily loads capsule, and content uniformity is small, releases The features such as drug stabilisation.Application of the micropill in art of pharmacy is quite varied, and as the carrier of medicine, it both can further be pressed Tablet is made, capsule can be filled again, not only increases medicine stability, and can effectively regulating drug rate of release, as Drug delivery system, micropill also have advantage therapeutically, and it is smaller to enteron aisle stimulation, reduces the burst effect of medicine, Improve drug safety.
Drug delivery technologies use for many years on Blank Pellets, but tcm product is few, otherwise many Chinese medicine drug delivery technologies Drugloading rate is few, otherwise it is unstable, otherwise poor appearance.
The present invention on the basis of existing technology, by process modification, finds a kind of load medicine skill of suitable Chinese medical extract Art, and it is further prepared into traditional Chinese medicine pellet.
The content of the invention
The present invention provides a kind of preparation method of pharmaceutical preparation, comprises the following steps:
(1)It is Chinese medical extract or Chinese medical concrete to take weight ratio:Base ball 1:5-5:1 is standby;
(2)Feeding fluidizes:Recipe quantity base ball is drawn into fluidized drying seed-coating machine, base ball is flowed completely in bed body Change;
(3)Initial stage carries the medicine stage:40-60 DEG C of temperature of charge is treated, is started with speed 70-120g/min hydrojets, the hydrojet It is that Chinese medical extract or Chinese medical concrete are diluted with water obtained premix Chinese medical extract;
(4)In drug incorporation:In 40-60 DEG C of temperature of charge, with the increase in ball footpath, spouting liquid is stepped up, particle ball Footpath is improved in gradient with hydrojet speed, until spraying obtains the particle that particle diameter is 0.5-1.8mm
The preparation method of the present invention, after spray, it can also be carried out as needed to carrying medicine micropill penetrating coating solution Coating steps(5), it is coated 40-60 DEG C of temperature of charge, hydrojet speed 40-300g/ml, Coating times 1-4 hours, the coating solution Concentration is 5-25%.
Preferably, preparation method of the invention, comprises the following steps:
(1)It is Chinese medical extract or Chinese medical concrete to take weight ratio:Base ball 1:3-3:1 is standby;It is preferred that 2:1-1:1.
(2)Base ball feeding fluidizes:Set 600 ~ 1500m of air quantity3/ h, base ball is drawn into fluidized drying seed-coating machine, made Base ball fluidizes completely in bed body;But being unable to vigorous fluidisation causes base ball to wear powder, spray gun atomized liquid can be covered with base ball Drop is defined;
(3)Initial stage carries the medicine stage:Spray gun and atomizing pressure are debugged, enables decoction uniform atomizing into fine drop, by Medicine decoction is pumped into spray gun by metering, sets jet and lower jet respectively as 2.0 ~ 3.0Bar and 2.5 ~ 3.5Bar, if Determine 50 DEG C or so of temperature of charge, start hydrojet, hydrojet speed setting 120g/min after temperature of charge rises to 45 DEG C;
(4)In drug incorporation:45 ~ 55 DEG C of temperature of charge, with the increase in ball footpath, amount of infusion is stepped up, and transfusion speed is most Height is no more than 400g/min, and air quantity is adjusted according to the fluidized state of micropill.
(5)Coating:Carry directly spray coating solution after medicine terminates to be coated, 50 DEG C of coating initial setting temperature of charge, hydrojet Hydrojet speed can be adjusted to 80 ~ 150g/min, temperature of charge and controlled at 40 ~ 55 DEG C by speed 80g/min, coating after 20 minutes, Transfusion speed, air quantity and temperature of charge are adjusted according to the adhesion situation of micropill;
Wherein, traditional Chinese medicine liquid is that Chinese medical concrete adds water to be formulated, and the weight ratio of Chinese medical concrete and water is 100:60-100, It is preferred that 100:70-90, more preferably 100:75-85.
The preparation method of the present invention, is suitable for any Chinese medical extract or Chinese medical concrete, including folk prescription or compound, excellent Salvia root P.E, stilbene ginseng QI invigorating, agastache extract etc. are selected, most preferably Salvia root P.E.
Salvia root P.E is purchased in market or is prepared by prior art, limited in order to preferably test the purpose of the present invention Following methods prepare Salvia root P.E.
Salvia root P.E preparation method of the present invention is as follows:
(1)Red rooted salvia alcohol extracting, is filtrated to get alcohol extract, and dregs of a decoction A is standby;
(2)Dregs of a decoction A extracting in waters, filtering, obtain Aqueous extracts, dregs of a decoction B is discarded;
(3)Alcohol extract, Aqueous extracts cool standing respectively, then Aspirate supernatant is alcohol extracting supernatant, water extraction supernatant respectively;
(4)Water extraction supernatant concentration obtains water extracting liquid;
(5)Water extracting liquid is gradually added alcohol extracting supernatant, merges concentration, obtains mixed concentrated liquid;
(6)Purified water is added in mixed concentrated liquid, is concentrated after well mixed, is drying to obtain Salvia root P.E.
Preferably, the Salvia root P.E preparation method is as follows:
(1)2-7 times of red rooted salvia dosing material amount measures 50-100% ethanol, refluxing extraction about 0.5-4 hours, filters to obtain alcohol extracting Liquid, dregs of a decoction A are standby;
(2)Above-mentioned 2-7 times of the dosing material amount of the dregs of a decoction 1 measures water, decocts about 0.5-4 hours, filtering, obtains Aqueous extracts, dregs of a decoction B is abandoned Go;
(3)Step(1)In alcohol extract stirring 10-60 minutes, extract solution temperature is down to less than 15 DEG C in 4 hours, it is quiet Put 6 ~ 24 hours Aspirate supernatants and obtain alcohol extracting supernatant, step(2)In Aqueous extracts stirring 10-60 minutes, will extraction in 4 hours Liquid temperature degree is down to less than 15 DEG C, stands 6 ~ 24 hours, Aspirate supernatant obtains water extraction supernatant;
(4)Water extraction supernatant concentration obtains water extracting liquid to relative density 1.10 ~ 1.35;
(5)Water extracting liquid is gradually added step(3)Alcohol extracting supernatant, merge concentration, be concentrated under reduced pressure into relative density >= 1.20, obtain mixed concentrated liquid;
(6)Mixed concentrated liquid adds 10L ~ 100L purified waters by several times, adds 5 ~ 50L purified waters every time, merges concentration, decompression It is 1.25 ~ 1.35 to be concentrated into 82.5 ± 2.5 DEG C of relative densities, filters while hot, obtains Salvia root P.E.
Wherein, step preferably(5)Step is gradually added after middle concentration Aqueous extracts to relative density 1.10~1.35(3)Alcohol Put on clear liquid.
Wherein, preferred step(5)Step is gradually added after middle concentration Aqueous extracts to relative density 1.10~1.35(3) Alcohol extracting supernatant, relative density is concentrated into as 1.25~1.35(82.5±2.5℃)Receive cream.
Most preferably, the Salvia root P.E preparation method is as follows:
The cutting red sage root is taken, adds 90 ± 0.5% 400 ± 12L of ethanol, decocts 90 ± 5min, the filtering of 200 mesh, alcohol extract, which merges, to be put Enter to stand in tank;The dregs of a decoction carry out second and extracted, and add 500 ± 15L of water, decoct 60 ± 3min, the filtering of 200 mesh, and the dregs of a decoction discard, water Extract, which merges, to be put into different standing tanks.Alcohol extracting mixed liquor and water mixing extract are respectively placed in different standing tanks, are stood tank and are led to Chilled water cooling is stood, and after extract solution stirs 30 minutes, extract solution temperature is down into less than 15 DEG C in 4 hours, it is small to stand 6 ~ 24 When, draw alcohol extracting supernatant and water extraction supernatant is put into respective storage tank.First condensed water puts on clear liquid to water extracting liquid proportion 1.25~1.30(82.5±2.5℃)Between;It is gradually added alcohol extracting supernatant and further merges concentration, concentrate in concentration process Proportion must not be less than 1.15;Be concentrated into mixed concentrated liquid proportion >=1.34, at twice add 10L purified waters, every time plus 5L (45 ± 5 DEG C), merge concentration, be concentrated into proportion 1.33~1.35(82.5±2.5℃), filter while hot(40 mesh sieves)Obtain Salvia root P.E.
Base ball of the present invention, also referred to as blank capsule core, or medicinal fine pellet core, it is prior art, can be in market On be commercially available, the major product in terms of medicinal fine pellet core has:Medicinal fine pellet core(Cane sugar type), microcrystalline cellulose ball Core, starch capsule core etc., base ball of the present invention are selected from starch base ball, Macrogol 6000 base ball, sucrose base ball, microcrystalline cellulose One kind in plain base ball.Preferred starch base ball or Macrogol 6000 base ball, the base ball can drugloading rate it is high, spraying is easy, work Skill is easily controlled, and is easy to industrialization.
Preparation in accordance with the present invention, gained carry medicine micropill by being processed further that salvia micro pill capsule can be made. Medicine coating of pellets will be such as carried, sieving, obtains coating micro-pill, is fitted into blank capsules and produces the traditional Chinese medicine pellet capsule of the present invention.
In order to preferably realize the compound Salviae Miltiorrhizae extract micropill of the present invention, prescription of the present invention is preferably Salvia root P.E 20-40 parts, starch base ball 10-20 parts, Opadry 1-2 parts.It is preferred that 32 parts of Salvia root P.E, 16 parts of starch base ball, Opadry 1.5 Part.
Beneficial effects of the present invention
The micropill of the present invention, as microspheric granula, the dosage of carrier is few, single dose is small, typically each taking dosage be 0.1~ 4g;Profile rule, spherical in shape or spherical, the smooth rounding in surface;Physical characteristic is good, such as good fluidity, grain graininess point Cloth is regular, the fine and close anti-extrusion of quality, wear-resistant, density is big(Heap density is 0.6~1.3g/ml), specific surface area it is small(Only 0.01 ~0.03m2/g), it is short to leach the time limit;These characteristics can improve the compliance of patient, and make the actual popularization of packaging technique should With being possibly realized, so as to improve Chinese medicine or the easy moisture absorption of autonomic drug, it is unstable the problems such as;In addition, the micropill of the present invention is except can To be used as common granule, intermediate or granule are also used as, it is filling into formulations such as capsules, additionally may be used To be prepared into various coated preparations, sustained-release preparation, positioning release medicine preparation etc..
The advantages of Salvia root P.E of the present invention and preparation method thereof, is as follows:
The present invention Chinese medical extract condensing mode be mainly to the benefit that preparation is brought:Slightly solubility particle shows in extract Writing improves, and stifled spray gun problem no longer occurs in drug incorporation.Extract ethanol residual level is relatively low, and production process is not further added by containing alcohol Operation, it is ensured that product ethanol residual meets the requirements.Extract stability improves, and the production process index components rate of transform is stable.
It is the comparative experiments of different method for concentration below
Precise red rooted salvia 450g, with 4 times of amount 90% ethanol extraction 1.5h, medical filtration;The dregs of a decoction are returned with 5 times of amount water Stream extraction 1h, filtering, obtains alcohol extract and Aqueous extracts.Each experiment parallel extraction is twice.
Experimental program one, concentration Aqueous extracts merging concentration is gradually added after first concentrating alcohol extract, cream is received to pol 86 ± 2%.
Experimental program two, after first concentrating Aqueous extracts to pol 84 ± 2%, it is gradually added alcohol extract and merges concentration, to pol 86 ± 2% receives cream.
Sample source:20120823, which first concentrate alcohol extract, adds water extract concentration
20120829 first concentrate Aqueous extracts adds alcohol extract to concentrate again
1st, and sticking ratio big from 20120823 black mole bits particles knowable to the picture of flask adhesion after Salvia root P.E blowing More serious, 20120829 it can be seen that precipitation black bits are relatively fine and than more uniform, so as to 20120829 condensing modes Extract character is preferable.
2nd, clean respective batch flask result picture with water and can be seen that 20120823 flask black mole bits sticking ratios are serious, It is less that the viscous wall situation of condensing mode is planted afterwards.So as to from 20120829 batch condensing modes for water cleaning performance to equipment clean compared with It is good.
3rd, understand that 20120823 cleaning solution colors are heavier from the picture of 95% ethanol cleaning, 20120829 solution colours It is more clear.
In summary, it is first from 20120829 batch condensing modes for Salvia root P.E Apparent character and follow-up equipment cleaning It is optimal that alcohol extract merging condensing mode is gradually added after concentration Aqueous extracts.
Influence of the different condensing modes to Salvia root P.E size distribution
2 it can be seen that in coating picture from the graph, and the 20120823 black mole bits for having obvious bulky grain separate out, another kind concentration Mode Salvia root P.E black bits distribution it is smaller than more uniform and particle, on Salvia root P.E on follow-up preparation influence compared with It is small.
Size distribution is surveyed in pharmacopeia screening
Each batch Salvia root P.E medicinal extract 50 is taken respectively, is added 5 times of amount water dissolvings, is crossed 1-8 pharmacopeia sieve(Pharmacopeia sieve is folded successively Put), with about 500ml distilled water flushing, extract granule distribution situation in every layer of pharmacopeia sieve is observed, then uses the particle in every layer Water rinses, and collects, and filters, and is weighed together with filter paper drying.
As above-mentioned chart understands that it was found from extract particles size and bulky grain appearance order extract character is excellent slightly suitable Sequence is 20120829-J>20120823-J.Therefore 20120829 condensing modes are preferable.
Brief description of the drawings
Picture is tested in Fig. 1 experimentations, wherein, flask adheres to picture, second row after first row Salvia root P.E blowing Picture after flask of water cleaning, picture after the cleaning of the ethanol of the 3rd row's flask 95%
Fig. 2 Salvia root P.Es are coated with photo
Embodiment
The present invention is further illustrated by the following examples, but not as limitation of the present invention.
Embodiment 1
The preparation of Salvia root P.E, step are as follows:
The cutting red sage root:Medicinal material visual examination, weigh, it is standby.
Medicinal material feeds intake requirement:
The cutting red sage root:The different batches cutting red sage root can be used by proper proportion collocation as needed.
Add material order:The E cutting reds sage root are first thrown when feeding intake, one decocts 90 ± 0.5% ethanol of addition, two pan-fried addition one-level RO Water is extracted as extraction solvent.
Extraction:
One batch is made up of 2 tanks, is weighed cutting red sage root 100kg respectively by batch prescription per tank, is added 90 ± 0.5% ethanol 400 ± 12L, 90 ± 5min, the filtering of 200 mesh are decocted, two tank alcohol extracts, which merge to be put into, to be stood in tank;The dregs of a decoction carry out second and extracted, and add 500 ± 15L of water, 60 ± 3min, the filtering of 200 mesh are decocted, the dregs of a decoction are discarded, and two tank Aqueous extracts, which merge, to be put into different standing tanks.
Cooling is stood:
Alcohol extracting mixed liquor and water mixing extract are respectively placed in different standing tanks, are stood tank and are led to chilled water cooling standing, carry After taking liquid to stir 30 minutes, extract solution temperature is down to less than 15 DEG C in 4 hours, stands 6 ~ 24 hours, draws alcohol extracting supernatant Put with water extraction supernatant into respective storage tank.
Concentration:
First condensed water puts on clear liquid to water extracting liquid proportion 1.25~1.30(82.5±2.5℃)Between;It is gradually added E01 alcohol extractings supernatant further merges concentration, and concentrate proportion must not be less than 1.15 in concentration process;It is dense to be concentrated into E01 mixing Contracting liquor ratio weight >=1.34,10L purified waters are added at twice, every time plus 5L (45 ± 5 DEG C), merging concentrate, and are concentrated into proportion 1.33 ~1.35(82.5±2.5℃), filter while hot(40 mesh sieves)Obtain E01 Salvia root P.Es.
Embodiment 2
Salvia micro pill capsule, it can be prepared according to following methods:
Raw material:
Salvia root P.E 32.5kg
Starch base ball 16.0kg
Opadry 85G66817 1.5kg
Preparation method is as follows:
The preparation of Salvia root P.E decoction:In Salvia root P.E input premixing tank, the purified water of 0.7 ~ 0.9 times of amount is added, Stirring more than 30 minutes, obtains traditional Chinese medicine liquid;
Starch base ball carries medicine:Spray gun and atomizing pressure are debugged, it is fine drop to enable decoction uniform atomizing;
Feeding fluidizes:Starch base ball is sucked in fluidisation dry coationg machine, sets 600 ~ 1500m of air quantity3/ h, base ball is set to exist Fluidized completely in bed body, but be unable to vigorous fluidisation and cause base ball to wear powder, can cover spray gun atomized drop by base ball is defined;
Will premix extract by metering be pumped into spray gun, set respectively jet and lower jet as 2.0 ~ 3.0Bar with 2.5~3.5Bar;Initial stage carries the medicine stage, sets 50 DEG C or so of temperature of charge, starts hydrojet after temperature of charge rises to 45 DEG C, sprays Liquid speed degree sets 70 ~ 120g/min;In drug incorporation, 45 ~ 55 DEG C of temperature of charge, with the increase in ball footpath, amount of infusion is stepped up, Transfusion speed not more than 400g/min, air quantity are adjusted according to the fluidized state of micropill;In drug incorporation, if necessary from Sample tap sampling observes the adhesion of micropill and plays a powder situation, and adjusts transfusion speed, wind with powder situation is played according to the adhesion of micropill Amount and temperature of charge;
Coating:Opadry 85G66817 and purified water are taken, is stirred and evenly mixed, stirring is no less than 45 minutes, obtains 18% coating Liquid is standby;Carry directly spray coating solution after medicine terminates to be coated, 50 DEG C of coating initial setting temperature of charge, hydrojet speed 40 ~ Hydrojet speed can be adjusted to 80 ~ 150g/min, temperature of charge and controlled at 40 ~ 55 DEG C by 80g/min, coating after 20 minutes, according to The adhesion situation adjustment transfusion speed of micropill, air quantity and temperature of charge, after coating terminates, are cooled to 35 DEG C, discharging;
Coated pellet is screened:Intermediate coated pellet is screened, screen cloth net footpath is 1.8mm, and screenings is salvia micro pill;Screening institute Obtain salvia micro pill accounting example and be not less than 90%;
Capsule is filled:The salvia micro pill that will be screened, capsule is filled with capsule filling machine, is produced.
Embodiment 3
Carry the preparation of medicine micropill
Base ball feeding fluidizes:Set air quantity 600m3/ h, base ball is drawn into fluidized drying seed-coating machine, makes base ball in bed Fluidize completely in vivo;But being unable to vigorous fluidisation causes base ball to wear powder;
Initial stage carries the medicine stage:Spray gun is debugged, allows to atomization well, traditional Chinese medicine liquid is pumped into spray gun by metering, Jet and lower jet are set respectively as 2.0Bar and 2.5Bar, are set 50 DEG C or so of temperature of charge, are treated that temperature of charge rises to 45 Start hydrojet, hydrojet speed setting 70g/min after DEG C;
In drug incorporation:50 DEG C of temperature of charge, with the increase in ball footpath, amount of infusion is stepped up, and transfusion speed is not more than 400g/min is crossed, air quantity is adjusted according to the fluidized state of micropill.
Coating:Carry directly spray coating solution after medicine terminates to be coated, 50 DEG C of coating initial setting temperature of charge, hydrojet speed 40g/min, hydrojet speed can be adjusted to 80g/min, temperature of charge and controlled at 40 DEG C by coating after 20 minutes, according to the viscous of micropill Even situation adjustment transfusion speed, air quantity and temperature of charge;
Wherein, traditional Chinese medicine liquid is that Chinese medical concrete adds water to be formulated, and the weight ratio of Chinese medical concrete and water is 100:90.Implement Example 4
Carry the preparation of medicine micropill
Base ball feeding fluidizes:Set air quantity 1500m3/ h, base ball is drawn into fluidized drying seed-coating machine, makes base ball in bed Fluidize completely in vivo;
Initial stage carries the medicine stage:Spray gun is debugged, allows to atomization well, traditional Chinese medicine liquid is pumped into spray gun by metering, Jet and lower jet are set respectively as 3.0Bar and 3.5Bar, are set 50 DEG C or so of temperature of charge, are treated that temperature of charge rises to 45 Start hydrojet, hydrojet speed setting 120g/min after DEG C;
In drug incorporation:55 DEG C of temperature of charge, with the increase in ball footpath, amount of infusion is stepped up, and transfusion speed is not more than 400g/min is crossed, air quantity is adjusted according to the fluidized state of micropill.
Coating:Carry directly spray coating solution after medicine terminates to be coated, 50 DEG C of coating initial setting temperature of charge, hydrojet speed 80g/min, coating can adjust hydrojet speed after 20 minutes to 150g/min, and temperature of charge is controlled at 55 DEG C, according to micropill Adhesion situation adjusts transfusion speed, air quantity and temperature of charge;
Wherein, traditional Chinese medicine liquid is that Chinese medical concrete adds water to be formulated, and the weight ratio of Chinese medical concrete and water is 100:70.Implement Example 5
Carry the preparation of medicine micropill
Base ball feeding fluidizes:Set air quantity 1500m3/ h, base ball is drawn into fluidized drying seed-coating machine, makes base ball in bed Fluidize completely in vivo;
Initial stage carries the medicine stage:Spray gun is debugged, allows to atomization well, traditional Chinese medicine liquid is pumped into spray gun by metering, Jet and lower jet are set respectively as 3.0Bar and 3.5Bar, are set 50 DEG C or so of temperature of charge, are treated that temperature of charge rises to 45 Start hydrojet, hydrojet speed setting 120g/min after DEG C;
In drug incorporation:55 DEG C of temperature of charge, with the increase in ball footpath, amount of infusion is stepped up, and transfusion speed is not more than 400g/min is crossed, air quantity is adjusted according to the fluidized state of micropill.
Coating:Carry directly spray coating solution after medicine terminates to be coated, 50 DEG C of coating initial setting temperature of charge, hydrojet speed 80g/min, coating can adjust hydrojet speed after 20 minutes to 150g/min, and temperature of charge is controlled at 55 DEG C, according to micropill Adhesion situation adjusts transfusion speed, air quantity and temperature of charge;
Wherein, Chinese medical extract is Salvia root P.E, and base ball is starch base ball, and both part by weight are 2:1, traditional Chinese medicine liquid It is that Chinese medical concrete adds water to be formulated, the weight ratio of Chinese medical concrete and water is 100:82.
Embodiment 6
Carry the preparation of medicine micropill
Base ball feeding fluidizes:Set air quantity 1500m3/ h, base ball is drawn into fluidized drying seed-coating machine, makes base ball in bed Fluidize completely in vivo;But being unable to vigorous fluidisation causes base ball to wear powder;
Initial stage carries the medicine stage:Spray gun uses 0.2mm pad, debugs spray gun, allows to atomization well, traditional Chinese medicine liquid is led to Cross metering and be pumped into spray gun, set jet and lower jet respectively as 3.0Bar and 3.5Bar, 50 DEG C of left sides of setting temperature of charge The right side, start hydrojet, hydrojet speed setting 120g/min after temperature of charge rises to 45 DEG C;In drug incorporation:55 DEG C of temperature of charge, With the increase in ball footpath, amount of infusion is stepped up, transfusion speed not more than 400g/min, and air quantity is according to the fluidized state of micropill It is adjusted.
Coating:Carry directly spray coating solution after medicine terminates to be coated, 50 DEG C of coating initial setting temperature of charge, hydrojet speed 80g/min, coating can adjust hydrojet speed after 30 minutes to 150g/min, and temperature of charge is controlled at 55 DEG C, according to micropill Adhesion situation adjusts transfusion speed, air quantity and temperature of charge;
Wherein, Chinese medical extract is Salvia root P.E, and base ball is sucrose base ball, and both part by weight are 1:1, traditional Chinese medicine liquid It is that Chinese medical concrete adds water to be formulated, the weight ratio of Chinese medical concrete and water is 100:90.
Embodiment 7
Salvia micro pill capsule, it can be prepared according to following methods:
Raw material:
Salvia root P.E 32.5kg
Starch base ball 16.0kg
Opadry 85G66817 1.5kg
Preparation method is as follows:
The preparation of Salvia root P.E decoction:In Salvia root P.E input premixing tank, the purified water of 0.82 times of weight is added, is stirred Mix more than 30 minutes, obtain traditional Chinese medicine liquid;
Starch base ball carries medicine:Spray gun is debugged, it is good to allow to atomization;Feeding fluidizes:Starch base ball is sucked into fluidized drying In seed-coating machine, air quantity 1000m is set3/ h, base ball is fluidized completely in bed body, but be unable to vigorous fluidisation and cause base ball to wear Powder;Premix extract is pumped into spray gun by metering, sets jet and lower jet respectively as 2.5Bar and 3Bar;Initial stage The medicine stage is carried, sets 50 DEG C or so of temperature of charge, starts hydrojet, hydrojet speed setting 120g/ after temperature of charge rises to 45 DEG C min;In drug incorporation, 50 DEG C of temperature of charge, with the increase in ball footpath, amount of infusion is stepped up, and transfusion speed is not more than 400g/min, air quantity are adjusted according to the fluidized state of micropill;In drug incorporation, micropill from being sampled if necessary from sample tap Adhesion and play a powder situation, and according to the adhesion of micropill and play powder situation adjustment transfusion speed, air quantity and a temperature of charge;
Coating:Opadry 85G66817 and purified water are taken, is stirred and evenly mixed, stirring is no less than 45 minutes, obtains 18% coating Liquid is standby;Carry directly spray coating solution after medicine terminates to be coated, 50 DEG C of coating initial setting temperature of charge, hydrojet speed 80g/ Min, coating can adjust hydrojet speed after 20 minutes to 100g/min, and temperature of charge is controlled at 50 DEG C, according to the adhesion of micropill Situation adjusts transfusion speed, air quantity and temperature of charge, after coating terminates, is cooled to 35 DEG C, discharging;
Coated pellet is screened:Intermediate coated pellet is screened, screen cloth net footpath is 1.8mm, and screenings is salvia micro pill;Screening institute Obtain salvia micro pill accounting example and be not less than 90%;
Capsule is filled:The salvia micro pill that will be screened, capsule is filled with capsule filling machine, is produced.
The bupleurum extract micro pill capsule of embodiment 8,
Prescription:
Bupleurum extract 1.40kg
Microcrystalline cellulose base ball 1.60kg
Opadry 85G66817 0.10kg
Preparation method is as follows:
The preparation of bupleurum extract decoction:In bupleurum extract input premixing tank, the purified water of 0.9 times of weight is added, is stirred Mix more than 30 minutes, obtain traditional Chinese medicine liquid;
Microcrystalline cellulose base ball carries medicine:Spray gun is debugged, it is good to allow to atomization;Feeding fluidizes:By microcrystalline cellulose base ball In suction fluidisation dry coationg machine, air quantity 1200m is set3/ h, base ball is fluidized completely in bed body, but be unable to vigorous fluidisation and make Powder has been worn into base ball;Will premix extract by metering be pumped into spray gun, set respectively jet and lower jet as 2.2Bar and 3.2Bar;Initial stage carries the medicine stage, sets 50 DEG C or so of temperature of charge, starts to spray after temperature of charge rises to 45 DEG C Liquid, hydrojet speed setting 100g/min;In drug incorporation, 50 DEG C of temperature of charge, with the increase in ball footpath, amount of infusion is stepped up, Transfusion speed not more than 400g/min, air quantity are adjusted according to the fluidized state of micropill;In drug incorporation, if necessary from Sample tap sampling observes the adhesion of micropill and plays a powder situation, and adjusts transfusion speed, wind with powder situation is played according to the adhesion of micropill Amount and temperature of charge;
Coating:Opadry 85G66817 and purified water are taken, is stirred and evenly mixed, stirring is no less than 45 minutes, obtains 18% coating Liquid is standby;Carry directly spray coating solution after medicine terminates to be coated, 50 DEG C of coating initial setting temperature of charge, hydrojet speed 80g/ Min, coating can adjust hydrojet speed after 20 minutes to 100g/min, and temperature of charge is controlled at 50 DEG C, according to the adhesion of micropill Situation adjusts transfusion speed, air quantity and temperature of charge, after coating terminates, is cooled to 35 DEG C, discharging;
Coated pellet is screened:Intermediate coated pellet is screened, screen cloth net footpath is 1.8mm, and screenings is radix bupleuri micropill;Screening institute Obtain radix bupleuri micropill accounting example and be not less than 90%;
Capsule is filled:The radix bupleuri micropill that will be screened, capsule is filled with capsule filling machine, is produced.
The stilbene of embodiment 9 joins QI invigorating micro pill capsule,
Prescription:
Stilbene ginseng QI invigorating mixed extract 1.25kg
Macrogol 6000 base ball 3.75kg
Opadry 85G66817 0.20kg
Preparation method is as follows:
Stilbene joins the preparation of QI invigorating extract decoction:In stilbene ginseng QI invigorating extract input premixing tank, the pure of 0.7 times of weight is added Change water, stir more than 30 minutes, obtain traditional Chinese medicine liquid;
Macrogol 6000 base ball carries medicine:Spray gun is debugged, it is good to allow to atomization;Feeding fluidizes:By Macrogol 6000 In base ball suction fluidisation dry coationg machine, air quantity 900m is set3/ h, base ball is fluidized completely in bed body, but can not acutely flow Change causes base ball to wear powder;Will premix extract by metering be pumped into spray gun, set respectively jet and lower jet as 2.2Bar and 3.2Bar;Initial stage carries the medicine stage, sets 50 DEG C or so of temperature of charge, starts to spray after temperature of charge rises to 40 DEG C Liquid, hydrojet speed setting 80g/min;In drug incorporation, 50 DEG C of temperature of charge, with the increase in ball footpath, amount of infusion is stepped up, defeated Liquid speed degree not more than 400g/min, air quantity are adjusted according to the fluidized state of micropill;In drug incorporation, if necessary from taking The sampling of sample mouth observes the adhesion of micropill and plays a powder situation, and adjusts transfusion speed, air quantity with powder situation is played according to the adhesion of micropill And temperature of charge;
Coating:Opadry 85G66817 and purified water are taken, is stirred and evenly mixed, stirring is no less than 45 minutes, obtains 18% coating Liquid is standby;Carry directly spray coating solution after medicine terminates to be coated, 50 DEG C of coating initial setting temperature of charge, hydrojet speed 80g/ Min, coating can adjust hydrojet speed after 20 minutes to 100g/min, and temperature of charge is controlled at 50 DEG C, according to the adhesion of micropill Situation adjusts transfusion speed, air quantity and temperature of charge, after coating terminates, is cooled to 35 DEG C, discharging;
Coated pellet is screened:Intermediate coated pellet is screened, screen cloth net footpath is 1.8mm, and screenings is that stilbene joins QI invigorating micropill;Sieve Choosing gained stilbene ginseng QI invigorating micropill accounting example is not less than 90%;
Capsule is filled:The stilbene screened is joined into QI invigorating micropill, capsule is filled with capsule filling machine, produces.
Embodiment 10
Ageratum micro pill capsule,
Prescription:
Ageratum mixed extract 6.25kg
Macrogol 6000 base ball 6.25kg
Opadry 85G66817 0.40kg
Preparation method is as follows:
The preparation of ageratum extract decoction:In ageratum extract input premixing tank, the pure of 0.8 times of weight is added Change water, stir more than 30 minutes, obtain traditional Chinese medicine liquid;
Macrogol 6000 base ball carries medicine:Spray gun is debugged, it is good to allow to atomization;Feeding fluidizes:By Macrogol 6000 In base ball suction fluidisation dry coationg machine, air quantity 900m is set3/ h, base ball is fluidized completely in bed body, but can not acutely flow Change causes base ball to wear powder;Will premix extract by metering be pumped into spray gun, set respectively jet and lower jet as 2.2Bar and 3.2Bar;Initial stage carries the medicine stage, sets 50 DEG C or so of temperature of charge, starts to spray after temperature of charge rises to 40 DEG C Liquid, hydrojet speed setting 80g/min;In drug incorporation, 50 DEG C of temperature of charge, with the increase in ball footpath, amount of infusion is stepped up, defeated Liquid speed degree not more than 400g/min, air quantity are adjusted according to the fluidized state of micropill;In drug incorporation, if necessary from taking The sampling of sample mouth observes the adhesion of micropill and plays a powder situation, and adjusts transfusion speed, air quantity with powder situation is played according to the adhesion of micropill And temperature of charge;
Coating:Opadry 85G66817 and purified water are taken, is stirred and evenly mixed, stirring is no less than 45 minutes, obtains 18% coating Liquid is standby;Carry directly spray coating solution after medicine terminates to be coated, 50 DEG C of coating initial setting temperature of charge, hydrojet speed 80g/ Min, coating can adjust hydrojet speed after 20 minutes to 100g/min, and temperature of charge is controlled at 50 DEG C, according to the adhesion of micropill Situation adjusts transfusion speed, air quantity and temperature of charge, after coating terminates, is cooled to 35 DEG C, discharging;
Coated pellet is screened:Intermediate coated pellet is screened, screen cloth net footpath is 1.8mm, and screenings is ageratum micropill;Sieve Choosing gained ageratum micropill accounting example is not less than 90%;
Capsule is filled:The ageratum micropill that will be screened, capsule is filled with capsule filling machine, is produced.Above-described embodiment Described in ageratum, bupleurum extract, stilbene ginseng QI invigorating extract prepared according to prior art.

Claims (9)

  1. A kind of 1. preparation method of pharmaceutical preparation, it is characterised in that:Comprise the following steps:
    (1) it is Chinese medical extract or Chinese medical concrete to take weight ratio:Base ball 1:3-3:1 is standby;
    (2) feeding fluidizes:Recipe quantity base ball is drawn into fluidized drying seed-coating machine, base ball is fluidized completely in bed body;
    (3) initial stage carries the medicine stage:Treat 40-60 DEG C of temperature of charge, start with speed 70-120g/min hydrojets, the hydrojet be by The premix Chinese medical extract that Chinese medical extract or Chinese medical concrete are diluted with water to obtain is atomized into fine drop, is coated on base ball table Face;The weight of Chinese medical concrete and water ratio is 100:60-100;
    (4) in drug incorporation:In 40-60 DEG C of temperature of charge, with the increase in ball footpath, spouting liquid is stepped up, particle ball footpath with Hydrojet speed improves in gradient, until spraying obtains the particle that particle diameter is 0.5-1.8mm;
    Described Chinese medical extract is Salvia root P.E;Described Salvia root P.E has following methods to be prepared:
    (1) the rudimentary alcohol extracting of red rooted salvia, is filtrated to get alcohol extract, and dregs of a decoction A is standby;
    (2) dregs of a decoction A extracting in waters, filtering, obtain Aqueous extracts, dregs of a decoction B is discarded;
    (3) alcohol extract, Aqueous extracts cool standing respectively, then Aspirate supernatant is alcohol extracting supernatant, water extraction supernatant respectively;
    (4) water extraction supernatant concentration obtains water extracting liquid;
    (5) water extracting liquid is gradually added alcohol extracting supernatant, merges concentration, obtains mixed concentrated liquid;
    (6) mixed concentrated liquid adds purified water, is concentrated after well mixed, produces Salvia root P.E.
  2. 2. preparation method as claimed in claim 1, is characterised by:Also include (5) packaging technique, after step (4) load medicine terminates, Coating solution spraying is directly sprayed, is coated 30-60 DEG C of temperature of charge, hydrojet speed 40-300g/min is Coating times 1-4 hours, described Coating solution concentration is 5-25%.
  3. 3. preparation method as claimed in claim 1 or 2, it is characterised in that:Comprise the following steps:
    (1) it is Chinese medical extract or Chinese medical concrete to take weight ratio:Base ball 1:3-3:1;
    (2) feeding fluidizes:Recipe quantity base ball is sucked in fluidisation dry coationg machine, sets air quantity 600-1500m3/ h, base ball is set to exist Fluidized completely in bed body, but be unable to vigorous fluidisation, can cover spray gun atomized drop by base ball is defined;
    (3) initial stage carries the medicine stage:Premix extract is pumped into spray gun by metering, spray gun and atomizing pressure is debugged, makes pre- Mixed extract can uniform atomizing be tiny drop, set jet and lower jet respectively as 2.0-3.0Bar and 2.5- 3.5Bar, 50 DEG C of temperature of charge is set, start hydrojet, hydrojet speed setting 60-120g/min after temperature of charge rises to 45 DEG C;
    (4) in drug incorporation:45-55 DEG C of temperature of charge, with the increase in ball footpath, amount of infusion is stepped up, and transfusion speed highest is not More than 400g/min, air quantity is adjusted according to the fluidized state of micropill;
    (5) it is coated:Carry directly spray coating solution after medicine terminates to be coated, 50 DEG C of coating initial setting temperature of charge, hydrojet speed 40-80g/min, coating can adjust hydrojet speed to 80-150g/min after 20 minutes, and temperature of charge control is at 40-55 DEG C, root Transfusion speed, air quantity and temperature of charge are adjusted according to the adhesion situation of micropill.
  4. 4. preparation method as claimed in claim 1, it is characterised in that:Described Salvia root P.E is prepared into by following methods Arrive:
    (1) 2-7 times of red rooted salvia dosing material amount measures 50-100% ethanol, refluxing extraction 0.5-4 hours, filters to obtain alcohol extract, medicine Slag A is standby;
    (2) above-mentioned 2-7 times of dregs of a decoction A dosing materials amount measures water, decocts 0.5-4 hours, filtering, obtains Aqueous extracts, dregs of a decoction B is discarded;
    (3) alcohol extract cooling is stood in step (1), extract solution mixing time 10-60 minutes, drops extract solution temperature in 4 hours To less than 15 DEG C, stand 6~24 hours Aspirate supernatants and obtain alcohol extracting supernatant, the cooling of step (2) Aqueous extracts is stood, and extract solution stirs Mix minute time 10-60, extract solution temperature is down to less than 15 DEG C in 4 hours, stand 6~24 hours, Aspirate supernatant obtains water Put on clear liquid;
    (4) water extraction supernatant concentration obtains water extracting liquid to relative density 1.10~1.35;
    (5) water extracting liquid is gradually added step (3) alcohol extracting supernatant, merges concentration, is concentrated under reduced pressure into relative density >=1.20, Obtain mixed concentrated liquid;
    (6) mixed concentrated liquid adds 10L~100L purified waters by several times, adds 5~50L purified waters every time, merges concentration, and decompression is dense It is 1.25~1.35 to be reduced to 82.5 ± 2.5 DEG C of relative densities, filters while hot, obtains Salvia root P.E.
  5. 5. preparation method as claimed in claim 3, it is characterised in that:Aqueous extracts are concentrated in step (5) to relative density 1.10 Step (3) alcohol extracting supernatant is gradually added after~1.35.
  6. 6. preparation method as claimed in claim 5, it is characterised in that:Aqueous extracts are concentrated in step (5) to relative density 1.10 Be gradually added step (3) alcohol extracting supernatant after~1.35, determine at 82.5 ± 2.5 DEG C, be concentrated into relative density for 1.25~ 1.35 receive cream.
  7. 7. preparation method as claimed in claim 1, it is characterised in that:Described base ball is selected from starch base ball, polyethylene glycol 6000 base balls, sucrose base ball, one kind in microcrystalline cellulose base ball.
  8. 8. preparation method as claimed in claim 1, it is characterised in that described Salvia root P.E is obtained by following methods 's:The cutting red sage root is taken, adds 90 ± 0.5% 400 ± 12L of ethanol, decocts 90 ± 5min, the filtering of 200 mesh, alcohol extract merging is put into quiet Put in tank;The dregs of a decoction carry out second and extracted, and add 500 ± 15L of water, decoct 60 ± 3min, the filtering of 200 mesh, and the dregs of a decoction discard, Aqueous extracts Merging is put into different standing tanks;Alcohol extracting mixed liquor and water mixing extract are respectively placed in different standing tanks, stand the logical freezing of tank Water cooling is stood, and after extract solution stirs 30 minutes, extract solution temperature is down into less than 15 DEG C in 4 hours, stands 6~24 hours, Draw alcohol extracting supernatant and water extraction supernatant to put into respective storage tank, determine at 82.5 ± 2.5 DEG C, first condensed water puts on clear liquid extremely Between water extracting liquid proportion 1.25~1.30;It is gradually added alcohol extracting supernatant and further merges concentration, is concentrated in concentration process Liquor ratio weight must not be less than 1.15;Mixed concentrated liquid proportion >=1.34 are concentrated into, add 10L purified waters at twice, at 45 ± 5 DEG C, Every time plus water 5L, merge concentration, determine at 82.5 ± 2.5 DEG C, be concentrated into proportion 1.33~1.35, filter while hot, cross 40 mesh sieves Obtain Salvia root P.E.
  9. 9. preparation method as claimed in claim 8, gained micropill is by being processed further that salvia micro pill capsule, the pellet is made Join micro pill capsule, formula is as follows:
    Salvia root P.E 20-40 parts
    Starch base ball 10-20 parts
    Opadry 85G66817 1-2 parts
    Preparation method is as follows:
    The preparation of Salvia root P.E decoction:In Salvia root P.E input premixing tank, the purified water of 0.2~2 times of amount, stirring 30 are added More than minute, traditional Chinese medicine liquid is obtained;
    Starch base ball carries medicine:Spray gun and atomizing pressure are debugged, enables decoction uniform atomizing into fine drop;
    Feeding fluidizes:Starch base ball is sucked in fluidisation dry coationg machine, sets 600~1500m of air quantity3/ h, make base ball in bed body Interior fluidisation completely, can cover spray gun atomized drop by base ball and be defined;
    By premixed drug solutions by metering be pumped into spray gun, set respectively jet and lower jet as 2.0~3.0Bar and 2.5~ 3.5Bar;Initial stage carries the medicine stage, sets 50 DEG C of temperature of charge, starts hydrojet after temperature of charge rises to 45 DEG C, hydrojet speed is set Fixed 70~120g/min;In drug incorporation, 45~55 DEG C of temperature of charge, with the increase in ball footpath, amount of infusion is stepped up, transfusion speed Not more than 400g/min is spent, air quantity is adjusted according to the fluidized state of micropill;In drug incorporation, if necessary from sample tap Sampling observes the adhesion of micropill and plays a powder situation, and adjusts transfusion speed, air quantity and thing with powder situation is played according to the adhesion of micropill Material temperature degree;
    Coating:Opadry 85G66817 and purified water are taken, is stirred and evenly mixed, stirring is no less than 45 minutes, obtains 18% coating solution It is standby;Carry directly spray coating solution after medicine terminates to be coated, 50 DEG C of coating initial setting temperature of charge, 40~80g/ of hydrojet speed Min, coating can adjust hydrojet speed after 20 minutes to 80~150g/min, and temperature of charge is controlled at 40~55 DEG C, according to micro- The adhesion situation adjustment transfusion speed of ball, air quantity and temperature of charge, after coating terminates, are cooled to 35 DEG C, discharging;
    Coated pellet is screened:Intermediate coated pellet is screened, screen cloth net footpath is 1.8mm, and screenings is salvia micro pill;Screening gained is red Join micropill accounting example and be not less than 90%;
    Capsule is filled:The salvia micro pill that will be screened, capsule is filled with capsule filling machine, is produced.
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