CN105561275A - Preparation method of cough-relieving tablet - Google Patents
Preparation method of cough-relieving tablet Download PDFInfo
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Abstract
The invention provides a preparation method of a cough-relieving tablet and relates to the field of traditional Chinese medicine. The preparation method comprises the following steps: 1, preparation of first extract powder; 2, preparation of second extract powder; 3, preparation of the tablet. According to the preparation method of the cough-relieving tablet, the method for drying extract is staged drying, drying time can be greatly shortened, the influence on active ingredients in medicine is lowered, and the treatment effect is improved.
Description
Technical field
The present invention relates to a kind of preparation method of cough-relieving tablet.
Background technology
Along with atmospheric pollution is day by day serious, the incidence rate of haze is also in increase.The respiratory system injury of dirty air to human body is huge, and according to national health department's statistics, China is often close on 300000000 people and infects respiratory system disease, and wherein cough patients reaches more than 5,000 ten thousand.In every winter, air is cold, and haze is more serious, and cough patients's quantity increases further.Chronic cough patient also easily causes the complication such as hypertension, cerebral anoxia, pulmonary heart disease.
The precious sheet of cough-relieving is the Chinese patent medicine that Mr. that Taishan distinguished veteran doctors of TCM Liu obtains is formulated in 1915, include to some extent in 2010 editions pharmacopeia, its composition is Pericarpium Papaveris extractum, Radix Asteris, Radix Glycyrrhizae, Exocarpium Citri Rubrum, the Radix Stemonae, Fructus Schisandrae Chinensis, Radix Platycodonis, Fructus Aurantii, Pericarpium Citri Reticulatae, Herba Schizonepetae, Radix Peucedani, Rhizoma Zingiberis, ammonium chloride, peppermint wet goods.Full side's monarch coordinates appropriate, and complement each other, played the cold expelling that induces sweat, lung qi dispersing expectorant, lung benefiting gas supports the merit of lung yin, and a reason lung eliminates the phlegm, the function of relieving cough and asthma.
Chinese invention patent (Authorization Notice No. CN101862442B) disclose the invention discloses a kind of cough relief traditional Chinese medicine compositions and preparation method, adopt traditional prescription cough-relieving precious, extract processing technology such as hot reflux, double-effect evaporation, spraying dry etc. through the modern times and make extractum, and be mixed with corresponding dosage form.Wherein take spray-dired method in the preparation technology of extractum, it is higher to equipment requirements, can cause the increase of production cost.
Summary of the invention
For above-mentioned technical problem, the invention provides a kind of preparation method of cough-relieving tablet, comprise the following steps:
(1) preparation of .I extract powder: by the alcohol reflux 2 time of the Pericarpium Papaveris of 150 ~ 130kg with 1400 ~ 1800L, each 4h, merge extractive liquid, reclaim ethanol, concentrated after vacuum drying pulverizing stage by stage, obtain I extract powder flour;
(2) preparation of .II extract powder: take Exocarpium Citri Rubrum coarse powder 75 ~ 100kg, Radix Platycodonis coarse powder 100 ~ 150kg, Fructus Aurantii coarse powder 10 ~ 30kg, Radix Stemonae coarse powder 75 ~ 100kg, Fructus Schisandrae Chinensis coarse powder 10 ~ 30kg, Pericarpium Citri Reticulatae coarse powder 100 ~ 150kg, Rhizoma Zingiberis coarse powder 10 ~ 30kg, Herba Schizonepetae coarse powder 50 ~ 80kg, Radix Peucedani coarse powder 150 ~ 200kg, extract 2 times with at the ethanol 60 ± 5 DEG C of 8 times of weight, each 48h, merge extractive liquid, reclaims ethanol, concentrates to obtain II extractum A; Take Radix Asteris 100 ~ 150kg, the clean medical material of Radix Glycyrrhizae 350 ~ 400kg, put in multi-function extractor, extract 2 times with the water boil of 8 times of weight, each 2h, merge extractive liquid, concentrated to obtain II extractum B; Vacuum drying pulverizing stage by stage after described II extractum A being mixed homogeneously with II extractum B, obtains II extract powder flour;
(3). the preparation of tablet: described I extract powder flour 65 ~ 90kg, cough-relieving precious sheet II cream comminuted powder 161 ~ 231kg, ammonium chloride 150kg ~ 180kg are granulated after mixing with pharmaceutically acceptable adjuvant, add 1kg Oleum menthae and lubricant always mix 20min after tabletting, coating obtain described cough-relieving tablet.
Further, vacuum drying in described step (1) is also pulverized and is: I concentrated solution is pumped into material pot, and add dextrin 0.3kg, unlatching is uniformly mixed, and opens heating and make material 60 ~ 80 DEG C of insulations; First paragraph temperature 110 ~ 120 DEG C is set, second segment temperature 90 ~ 100 DEG C, 3rd section of temperature 10 ~ 30 DEG C, vacuum-0.1MPa, arranging feed pump charging rate is that 90 ~ 160kg/h, crawler track speeds 0.32 ~ 0.48m/min, described crawler belt are through the equal used time 18min of above-mentioned each section of temperature; Open vacuum, heating, after requirement to be achieved, open feed pump and carry out drying, open lock material and pulverizer when material to be dried enters the 3rd section of nearly discharging, pulverize through 80 order stainless steel meshs.
Further, in described step (2), vacuum drying is also pulverized and is: pump into material pot after described II extractum A being mixed homogeneously with II extractum B, add Pulvis Talci 30 ~ 50kg, unlatching is uniformly mixed, and opens heating and make material 60 ~ 80 DEG C of insulations; First paragraph temperature 120 ~ 130 DEG C is set, second segment temperature 100 ~ 110 DEG C, 3rd section of temperature 10 ~ 30 DEG C, vacuum-0.1MPa, arranging feed pump charging rate is 90 ~ 160kg/h, crawler track speeds 0.32 ~ 0.48m/min, described crawler belt through above-mentioned each section of temperature equal used time 18min, described crawler belt through the equal used time 18min of above-mentioned each section of temperature; Open vacuum, heating, after requirement to be achieved, open feed pump and carry out drying, open lock material and pulverizer when material to be dried enters the 3rd section of nearly discharging, pulverize through 80 order stainless steel meshs.
Particularly, extract in step (1) and (2) with described ethanol to be percent by volume be 60% ethanol.
Particularly, the recovery ethanol in described step (1) and (2) is: the extracting solution after merging is proceeded to alcohol distillation column and reclaims ethanol, stop when distillation temperature in the kettle reaches 100 ~ 102 DEG C, obtains medicinal liquid and reclaims the ethanol of gained.
Particularly, simmer down in described step (1) and (2): control steam pressure≤0.2MPa, vacuum is effect-0.04 ~-0.08MPa, and two effect-0.06 ~-0.08MPa, being concentrated into extracting solution relative density at 50 DEG C ± 2 DEG C is 1.20 ~ 1.30.
Described pharmaceutically acceptable adjuvant can be excipient, binding agent, disintegrating agent, lubricant etc.Described excipient can comprise starch, Icing Sugar, dextrin, lactose, amylum pregelatinisatum, microcrystalline Cellulose, inorganic salt (as calcium sulfate, calcium hydrogen phosphate, medicinal calcium carbonate etc.), mannitol etc.Described binding agent can comprise distilled water, ethanol, starch slurry, sodium carboxymethyl cellulose, hydroxypropyl cellulose, methylcellulose, ethyl cellulose, hypromellose, PVP, gelatin solution etc.Disintegrating agent can comprise dried starch, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, cross linked polyvinyl pyrrolidone, cross-linking sodium carboxymethyl cellulose, gas-producing disintegrant etc.Lubricant can comprise magnesium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, Polyethylene Glycol, magnesium laurylsulfate etc.Described pharmaceutically acceptable adjuvant can also comprise some coloring agent, correctivess etc.As a specific embodiment of the present invention, described pharmaceutically acceptable adjuvant is specially carboxymethylstach sodium 22.0 ~ 44.0kg, dextrin 25.0 ~ 35.0kg, calcium hydrogen phosphate 70.0 ~ 100.0kg, microcrystalline Cellulose 70 ~ 160kg.
Particularly, described granulation comprises the following steps:
1. granulation binders preparation: first with ethanol, polyacrylic resin IV7.2kg is soaked dissolving, then add ethanol 208kg and purified water 25kg, stir, be made into granulation binders;
2. granulate: mixed powder flour is added in Wet mixed granulating machine, 180rpm stirs 5 minutes, after 1500rpm shreds 5 minutes, add the binding agent that 1. step obtains, 180rpm stirring 1 ~ 3 minute, 1500rpm shred discharging after 10 seconds, cross 16 mesh sieves make wet granular with oscillating granulator;
3. dry, granulate: put in HighefficientFluidbeddrier by gained wet granular, controlling inlet temperature is 80 ~ 100 DEG C, and leaving air temp is 55 ~ 65 DEG C, and being dried to moisture is 2.0 ~ 4.0%; Sieve granulate with multi-functional pelletizing machine 2.0mm, obtain dry granule.
Particularly, described coating comprises the following steps:
(S1) zein solution preparation: take zein 2 ~ 5kg and add in ethanol 30 ~ 50kg and soak, until completely dissolved, stir evenly, 120 orders filter, for subsequent use;
(S2) preparation of polyacrylic resin IV solution: take polyacrylic resin IV2 ~ 4kg, add ethanol 60 ~ 80kg, polyoxyethylene sorbitan monoleate 450 ~ 700ml, Pulvis Talci 2 ~ 5kg, Brown Ferric Oxide 2 ~ 4kg is added after polyacrylic resin IV dissolves completely, stir, cross colloid mill, 200 orders filter, for subsequent use;
(S3) preparation of polyacrylic resin IV hypromellose mixed solution: take hypromellose 0.5 ~ 2.0kg, add ethanol 30 ~ 50kg, after being uniformly dispersed, adding purified water 5 ~ 10kg, stirs evenly, obtain hypromellose cellulose solution; Taking polyacrylic resin IV0.3 ~ 2.0kg adds in ethanol 4 ~ 9kg, after polyacrylic resin IV dissolves completely, add described hypromellose cellulose solution, add polyoxyethylene sorbitan monoleate 200 ~ 600ml Oleum Ricini 200 ~ 600ml, Brown Ferric Oxide 1 ~ 4kg, simethicone 30 ~ 60g, stirs evenly, and crosses colloid mill, 200 orders filter, for subsequent use;
(S4) coating: plain sheet is put in seed-coating machine, open heating air intake and air draft, element sheet is heated to about 35 DEG C, get gained zein solution successively, polyacrylic resin IV solution, polyacrylic resin IV hypromellose mixed solution is whitewashed, setting drum rotation speed 4 ~ 15 revs/min, control inlet temperature 45 ~ 60 DEG C, leaving air temp 35 ~ 45 DEG C, regulate peristaltic pump rotating speed 3 ~ 15rpm, compressed air pressure 0.2 ~ 0.5MPa, in whitewashing process, constantly stir Coating Solution, wherein zein solution insulation 60 ± 5 DEG C;
(S5) polishing and cool: after the drying of step (S4) gained coated tablet, setting drum rotation speed 8 ~ 15 revs/min, after simethicone and the mixing of river wax, is evenly sprinkled in label, polishing 15 ~ 20 minutes; After by cool for polishing sheet more than 6 hours, pack to obtain finished product.
Compared with prior art, in the preparation method of cough-relieving tablet of the present invention, the drying means of extractum is dry stage by stage, can make greatly shorten drying time, reduce the impact of effective ingredient in medicine, improve therapeutic effect.Production process technology stability is improved, and process stabilizing, operation control easily.Production environment is improved, and reduces operation labor intensity.Production efficiency improves, and labour force reduces, and increases productivity.
In order to understand better and implement, the following detailed description of the present invention.
Detailed description of the invention
prepared by embodiment 1:I extract powder
The preparation of I extract powder of the present invention comprises the following steps:
(1) extract
Get the clean medical material 100kg of Pericarpium Papaveris, first time adds 1800L60% (v/v) ethanol, circumfluence distillation 4 hours, obtain alcohol extract, second time adds 1400L60% (v/v) ethanol, circumfluence distillation 4 hours, obtain alcohol extract, merge alcohol extract;
(2) ethanol reclaims
Alcohol extract is proceeded to alcohol distillation column and reclaim ethanol, reach 100 ~ 102 DEG C of stoppings to distillation temperature in the kettle, obtain the ethanol of medicinal liquid and recovery gained;
(3) concentrated
Medicinal liquid is proceeded in double effect evaporator and carry out double-effect evaporation, control steam pressure≤0.2MPa, vacuum: effect-0.04 ~-0.08MPa, two effect-0.06 ~-0.08MPa, being concentrated into relative density is 1.20 ~ 1.30 (50 DEG C ± 2 DEG C), obtains cough-relieving precious sheet I extractum;
(4) vacuum dehydrating at lower temperature
Precious for cough-relieving sheet I extractum is pumped into material pot, and add dextrin 0.3kg, unlatching is uniformly mixed, and opens heating and make material 60 ~ 80 DEG C of insulations; First paragraph temperature 110 ~ 120 DEG C is set, second segment temperature 90 ~ 100 DEG C, 3rd section of temperature 10 ~ 30 DEG C, vacuum-0.1MPa, arranging feed pump charging rate is that 90 ~ 160kg/h, crawler track speeds 0.32 ~ 0.48m/min, described crawler belt are through the equal used time 18min of above-mentioned each section of temperature; Open vacuum, heating, after requirement to be achieved, open feed pump and carry out drying, open lock material and pulverizer when material to be dried enters the 3rd section of nearly discharging, pulverize cough precious sheet I extract powder flour through 80 order stainless steel meshs.
prepared by embodiment 2:I extract powder system
The preparation of I extract powder of the present invention comprises the following steps:
(1) extract
Get the clean medical material 130kg of Pericarpium Papaveris, first time adds 1800L60% (v/v) ethanol, circumfluence distillation 4 hours, obtain alcohol extract, second time adds 1400L60% (v/v) ethanol, circumfluence distillation 4 hours, obtain alcohol extract, merge alcohol extract;
(2) ethanol reclaims
Alcohol extract is proceeded to alcohol distillation column and reclaim ethanol, reach 100 ~ 102 DEG C of stoppings to distillation temperature in the kettle, obtain the ethanol of medicinal liquid and recovery gained;
(3) concentrated
Medicinal liquid is proceeded in double effect evaporator and carry out double-effect evaporation, control steam pressure≤0.2MPa, vacuum: effect-0.04 ~-0.08MPa, two effect-0.06 ~-0.08MPa, being concentrated into relative density is 1.20 ~ 1.30 (50 DEG C ± 2 DEG C), obtains cough-relieving precious sheet I extractum;
(4) vacuum dehydrating at lower temperature
Precious for cough-relieving sheet I extractum is pumped into material pot, and add dextrin 0.3kg, unlatching is uniformly mixed, and opens heating and make material 60 ~ 80 DEG C of insulations; First paragraph temperature 110 ~ 120 DEG C is set, second segment temperature 90 ~ 100 DEG C, 3rd section of temperature 10 ~ 30 DEG C, vacuum-0.1MPa, arranging feed pump charging rate is that 90 ~ 160kg/h, crawler track speeds 0.32 ~ 0.48m/min, described crawler belt are through the equal used time 18min of above-mentioned each section of temperature; Open vacuum, heating, after requirement to be achieved, open feed pump and carry out drying, open lock material and pulverizer when material to be dried enters the 3rd section of nearly discharging, pulverize cough precious sheet I extract powder flour through 80 order stainless steel meshs.
prepared by embodiment 3:I extract powder
The preparation of I extract powder of the present invention comprises the following steps:
(1) extract
Get the clean medical material 150kg of Pericarpium Papaveris, first time adds 1800L60% (v/v) ethanol, circumfluence distillation 4 hours, obtain alcohol extract, second time adds 1400L60% (v/v) ethanol, circumfluence distillation 4 hours, obtain alcohol extract, merge alcohol extract;
(2) ethanol reclaims
Alcohol extract is proceeded to alcohol distillation column and reclaim ethanol, reach 100 ~ 102 DEG C of stoppings to distillation temperature in the kettle, obtain the ethanol of medicinal liquid and recovery gained;
(3) concentrated
Medicinal liquid is proceeded in double effect evaporator and carry out double-effect evaporation, control steam pressure≤0.2MPa, vacuum: effect-0.04 ~-0.08MPa, two effect-0.06 ~-0.08MPa, being concentrated into relative density is 1.20 ~ 1.30 (50 DEG C ± 2 DEG C), obtains cough-relieving precious sheet I extractum;
(4) vacuum dehydrating at lower temperature
Precious for cough-relieving sheet I extractum is pumped into material pot, and add dextrin 0.3kg, unlatching is uniformly mixed, and opens heating and make material 60 ~ 80 DEG C of insulations; First paragraph temperature 110 ~ 120 DEG C is set, second segment temperature 90 ~ 100 DEG C, 3rd section of temperature 10 ~ 30 DEG C, vacuum-0.1MPa, arranging feed pump charging rate is that 90 ~ 160kg/h, crawler track speeds 0.32 ~ 0.48m/min, described crawler belt are through the equal used time 18min of above-mentioned each section of temperature; Open vacuum, heating, after requirement to be achieved, open feed pump and carry out drying, open lock material and pulverizer when material to be dried enters the 3rd section of nearly discharging, pulverize cough precious sheet I extract powder flour through 80 order stainless steel meshs.
prepared by embodiment 4:II extract powder
The preparation of II extract powder of the present invention comprises the following steps:
(1) alcohol extraction part
1, extract: take Exocarpium Citri Rubrum 75kg, Radix Platycodonis 100kg, Fructus Aurantii 10kg, Radix Stemonae 75kg, Fructus Schisandrae Chinensis 10kg, Pericarpium Citri Reticulatae 100kg, Rhizoma Zingiberis 10kg, Herba Schizonepetae 50kg, the clean medicinal material coarse powder of Radix Peucedani 150kg nine taste, put in multi-function extractor, first time adds 8 times amount 60% (v/v) ethanol, heating, be incubated 60 ± 5 DEG C of dippings 48 hours, obtain alcohol extract; Second time adds 8 times amount 60% (v/v) ethanol, heating, is incubated 60 ± 5 DEG C of dippings 48 hours, obtains alcohol extract, merge alcohol extract;
2, ethanol reclaims: alcohol extract is proceeded to alcohol distillation column recovery ethanol, stops, obtaining the ethanol of medicinal liquid and recovery gained when distillation temperature in the kettle reaches 100 ~ 102 DEG C;
3, concentrated: medicinal liquid to be proceeded in double effect evaporator concentrated, control steam pressure≤0.2MPa, vacuum: effect-0.04 ~-0.08MPa, two effect-0.06 ~-0.08MPa, being concentrated into relative density is 1.20 ~ 1.30 (50 DEG C ± 2 DEG C), obtains cough-relieving precious sheet II extractum A;
(2) water extraction part
1, extract: take Radix Asteris 100kg, the clean medical material of Radix Glycyrrhizae 350kg bis-taste, put in multi-function extractor, first time adds 8 times of water gagings, boils extraction 2 hours, obtains aqueous extract; Second time adds 8 times of water gagings, boils extraction 2 hours, obtains aqueous extract, merges aqueous extract;
2, concentrated: aqueous extract to be proceeded in double effect evaporator concentrated, control steam pressure≤0.2MPa, vacuum: effect-0.04 ~-0.08MPa, two effect-0.06 ~-0.08MPa, being concentrated into relative density is 1.20 ~ 1.30 (50 DEG C ± 2 DEG C), obtains cough-relieving precious sheet II extractum B;
(3) vacuum dehydrating at lower temperature
Will cough-relieving precious sheet II extractum A and cough-relieving precious sheet II extractum B mix homogeneously, pump into material pot, add Pulvis Talci 30 ~ 50kg, unlatching is uniformly mixed, and opens heating and make material 60 ~ 80 DEG C of insulations; First paragraph temperature 120 ~ 130 DEG C is set, second segment temperature 100 ~ 110 DEG C, 3rd section of temperature 10 ~ 30 DEG C, vacuum-0.1MPa, arranging feed pump charging rate is that 90 ~ 160kg/h, crawler track speeds 0.32 ~ 0.48m/min, described crawler belt are through the equal used time 18min of above-mentioned each section of temperature; Open vacuum, heating, after requirement to be achieved, open feed pump and carry out drying, when material to be dried enters the 3rd section of nearly discharging, open lock material and pulverizer, pulverize to obtain cough-relieving precious sheet II extract powder flour through 80 order stainless steel meshs.
Prepared by embodiment 5:II extract powder
The preparation of II extract powder of the present invention comprises the following steps:
(1) alcohol extraction part
1, extract: take Exocarpium Citri Rubrum 84kg, Radix Platycodonis 128kg, Fructus Aurantii 20kg, Radix Stemonae 84kg, Fructus Schisandrae Chinensis 20kg, Pericarpium Citri Reticulatae 128kg, Rhizoma Zingiberis 20kg, Herba Schizonepetae 64kg, the clean medicinal material coarse powder of Radix Peucedani 188kg nine taste, put in multi-function extractor, first time adds 8 times amount 60% (v/v) ethanol, heating, be incubated 60 ± 5 DEG C of dippings 48 hours, obtain alcohol extract; Second time adds 8 times amount 60% (v/v) ethanol, heating, is incubated 60 ± 5 DEG C of dippings 48 hours, obtains alcohol extract, merge alcohol extract;
2, ethanol reclaims: alcohol extract is proceeded to alcohol distillation column recovery ethanol, stops, obtaining the ethanol of medicinal liquid and recovery gained when distillation temperature in the kettle reaches 100 ~ 102 DEG C;
3, concentrated: medicinal liquid to be proceeded in double effect evaporator concentrated, control steam pressure≤0.2MPa, vacuum: effect-0.04 ~-0.08MPa, two effect-0.06 ~-0.08MPa, being concentrated into relative density is 1.20 ~ 1.30 (50 DEG C ± 2 DEG C), obtains cough-relieving precious sheet II extractum A;
(2) water extraction part
1, extract: take Radix Asteris 128kg, the clean medical material of Radix Glycyrrhizae 380kg bis-taste, put in multi-function extractor, first time adds 8 times of water gagings, boils extraction 2 hours, obtains aqueous extract; Second time adds 8 times of water gagings, boils extraction 2 hours, obtains aqueous extract, merges aqueous extract;
2, concentrated: aqueous extract to be proceeded in double effect evaporator concentrated, control steam pressure≤0.2MPa, vacuum: effect-0.04 ~-0.08MPa, two effect-0.06 ~-0.08MPa, being concentrated into relative density is 1.20 ~ 1.30 (50 DEG C ± 2 DEG C), obtains cough-relieving precious sheet II extractum B;
(3) vacuum dehydrating at lower temperature
Will cough-relieving precious sheet II extractum A and cough-relieving precious sheet II extractum B mix homogeneously, pump into material pot, add Pulvis Talci 30 ~ 50kg, unlatching is uniformly mixed, and opens heating and make material 60 ~ 80 DEG C of insulations; First paragraph temperature 120 ~ 130 DEG C is set, second segment temperature 100 ~ 110 DEG C, the 3rd section of temperature 10 ~ 30 DEG C, vacuum-0.1MPa, arranging feed pump charging rate is that 90 ~ 160kg/h, crawler track speeds 0.32 ~ 0.48m/min, described crawler belt are through the equal used time 18min of above-mentioned each section of temperature; Open vacuum, heating, after requirement to be achieved, open feed pump and carry out drying, when material to be dried enters the 3rd section of nearly discharging, open lock material and pulverizer, pulverize to obtain cough-relieving precious sheet II extract powder flour through 80 order stainless steel meshs.
prepared by embodiment 6:II extract powder
The preparation of II extract powder of the present invention comprises the following steps:
(1) alcohol extraction part
1, extract: take Exocarpium Citri Rubrum 100kg, Radix Platycodonis 150kg, Fructus Aurantii 30kg, Radix Stemonae 100kg, Fructus Schisandrae Chinensis 30kg, Pericarpium Citri Reticulatae 150kg, Rhizoma Zingiberis 30kg, Herba Schizonepetae 80kg, the clean medicinal material coarse powder of Radix Peucedani 200kg nine taste, put in multi-function extractor, first time adds 8 times amount 60% (v/v) ethanol, heating, be incubated 60 ± 5 DEG C of dippings 48 hours, obtain alcohol extract; Second time adds 8 times amount 60% (v/v) ethanol, heating, is incubated 60 ± 5 DEG C of dippings 48 hours, obtains alcohol extract, merge alcohol extract;
2, ethanol reclaims: alcohol extract is proceeded to alcohol distillation column recovery ethanol, stops, obtaining the ethanol of medicinal liquid and recovery gained when distillation temperature in the kettle reaches 100 ~ 102 DEG C;
3, concentrated: medicinal liquid to be proceeded in double effect evaporator concentrated, control steam pressure≤0.2MPa, vacuum: effect-0.04 ~-0.08MPa, two effect-0.06 ~-0.08MPa, being concentrated into relative density is 1.20 ~ 1.30 (50 DEG C ± 2 DEG C), obtains cough-relieving precious sheet II extractum A;
(2) water extraction part
1, extract: take Radix Asteris 150kg, the clean medical material of Radix Glycyrrhizae 400kg bis-taste, put in multi-function extractor, first time adds 8 times of water gagings, boils extraction 2 hours, obtains aqueous extract; Second time adds 8 times of water gagings, boils extraction 2 hours, obtains aqueous extract, merges aqueous extract;
2, concentrated: aqueous extract to be proceeded in double effect evaporator concentrated, control steam pressure≤0.2MPa, vacuum: effect-0.04 ~-0.08MPa, two effect-0.06 ~-0.08MPa, being concentrated into relative density is 1.20 ~ 1.30 (50 DEG C ± 2 DEG C), obtains cough-relieving precious sheet II extractum B;
(3) vacuum dehydrating at lower temperature
Will cough-relieving precious sheet II extractum A and cough-relieving precious sheet II extractum B mix homogeneously, pump into material pot, add Pulvis Talci 30 ~ 50kg, unlatching is uniformly mixed, and opens heating and make material 60 ~ 80 DEG C of insulations; First paragraph temperature 120 ~ 130 DEG C is set, second segment temperature 100 ~ 110 DEG C, the 3rd section of temperature 10 ~ 30 DEG C, vacuum-0.1MPa, arranging feed pump charging rate is that 90 ~ 160kg/h, crawler track speeds 0.32 ~ 0.48m/min, described crawler belt are through the equal used time 18min of above-mentioned each section of temperature; Open vacuum, heating, after requirement to be achieved, open feed pump and carry out drying, when material to be dried enters the 3rd section of nearly discharging, open lock material and pulverizer, pulverize to obtain cough-relieving precious sheet II extract powder flour through 80 order stainless steel meshs.
embodiment 7: the preparation of the precious sheet of cough-relieving
The preparation of the precious sheet of cough-relieving of the present invention comprises the following steps:
(1) mix
Take the I cream comminuted powder 90kg of embodiment 2 preparation, the II cream comminuted powder 231kg of embodiment 5 preparation, ammonium chloride 160.0kg, carboxymethylstach sodium 44.0kg, dextrin 35.0kg, calcium hydrogen phosphate 70.0kg, microcrystalline Cellulose 160kg, add in Wet mixed granulating machine, 180rpm stir 5 minutes, 1500rpm shreds 5 minutes, obtains mixed powder;
(2) pulverize
Mixed powder Universalpulverizer 60 mesh sieve is pulverized, and obtains mixed powder flour;
(3) granulate
1, granulation binders preparation: first with ethanol, polyacrylic resin IV7.2kg is soaked dissolving, add enough ethanol 208kg and purified water 25kg, stir, be made into granulation binders;
2, granulate: mixed powder flour is added in Wet mixed granulating machine, after unlatching 180rpm stirring, 1500rpm shred 5 minutes, add polyacrylic resin IV alcoholic solution, open 180rpm to stir 1 ~ 3 minute, I speed 1500rpm shreds 10 seconds, discharging, crosses 16 mesh sieves with oscillating granulator and makes granule;
3, dry, granulate: by dry for the wet granular HighefficientFluidbeddrier made, controlling inlet temperature is 80 ~ 100 DEG C, and leaving air temp is 55 ~ 65 DEG C, and being dried to moisture is 2.0 ~ 4.0%; Sieve granulate with multi-functional pelletizing machine 2.0mm, obtain the dry granule of the precious sheet of cough-relieving;
(4) always mix
Get that dry granule adds Oleum menthae 1kg, magnesium stearate 7kg adds in two-dimensional motion mixer and mix 20 minutes, obtain the precious sheet granule of cough-relieving;
(5) tabletting.
Use Φ 10mm dark arc punch die tabletting, obtain cough-relieving precious sheet element sheet
(6) coating
1, syrup is joined
(1) zein solution preparation:
Take zein 2kg to add in ethanol 30kg and soak, until completely dissolved, stir evenly, 120 orders filter, for subsequent use;
(2) preparation of polyacrylic resin IV solution:
Take polyacrylic resin IV2kg, add ethanol 60kg, add polyoxyethylene sorbitan monoleate 450ml, Pulvis Talci 2kg, Brown Ferric Oxide 2kg, stir after polyacrylic resin IV dissolves completely, cross colloid mill, 200 orders filter, for subsequent use;
(3) preparation of polyacrylic resin IV hypromellose mixed solution:
Take hypromellose 0.5kg, add ethanol 30kg, after being uniformly dispersed, add purified water 5kg, stir evenly, obtain hypromellose cellulose solution; Taking polyacrylic resin IV0.3kg adds in ethanol 4kg, after polyacrylic resin IV dissolves completely, adds described hypromellose cellulose solution, add polyoxyethylene sorbitan monoleate 200ml Oleum Ricini 200ml, Brown Ferric Oxide 1kg, simethicone 30g, stirs evenly, cross colloid mill, 200 orders filter, for subsequent use.
2, film coating
(1) take cough-relieving precious sheet element sheet to set high in effect sugar-coat-film coater, start high seed-coating machine, open heating air intake and air draft, plain sheet is heated to about 35 DEG C, controls suitable rotating speed, starts to enter coating procedure.
(2) film-coat is sprayed: get successively and prepare zein solution, polyacrylic resin IV solution, polyacrylic resin IV hypromellose mixed solution is whitewashed, setting drum rotation speed 4 ~ 15 revs/min, controls inlet temperature 45 ~ 60 DEG C, leaving air temp 35 ~ 45 DEG C, regulate peristaltic pump rotating speed 3 ~ 15rpm, compressed air pressure 0.2 ~ 0.5MPa, with the whitewashing of suitable speed, makes coat tablets moistening and adhesion.In whitewashing process, constantly stir Coating Solution, wherein zein solution insulation 60 ± 5 DEG C.
(3) polishing and cool: first allow sheet natural drying before polishing, after drying, setting drum rotation speed 8 ~ 15 revs/min, after simethicone and the mixing of river wax, is evenly sprinkled in label, polishing 15 ~ 20 minutes.After coating, polishing sheet is laid in the stainless steel disc on cool horse, cool more than 6 hours, collect the precious sheet product to be packaged of cool good polishing sheet and cough-relieving.
embodiment 8: the preparation of the precious sheet of cough-relieving
The preparation of the precious sheet of cough-relieving of the present invention comprises the following steps:
(1) mix
Take the I cream comminuted powder 65kg of embodiment 1 preparation, the II cream comminuted powder 161kg of embodiment 4 preparation, ammonium chloride 160.0kg, carboxymethylstach sodium 44.0kg, dextrin 35.0kg, calcium hydrogen phosphate 70.0kg, microcrystalline Cellulose 70kg, add in Wet mixed granulating machine, 180rpm stir 5 minutes, 1500rpm shreds 5 minutes, obtains mixed powder;
(2) pulverize
Mixed powder Universalpulverizer 60 mesh sieve is pulverized, and obtains mixed powder flour;
(3) granulate
1, granulation binders preparation: first with ethanol, polyacrylic resin IV7.2kg is soaked dissolving, add enough ethanol 208kg and purified water 25kg, stir, be made into granulation binders;
2, granulate: mixed powder flour is added in Wet mixed granulating machine, after unlatching 180rpm stirring, 1500rpm shred 5 minutes, add polyacrylic resin IV alcoholic solution, open 180rpm to stir 1 ~ 3 minute, I speed 1500rpm shreds 10 seconds, discharging, crosses 16 mesh sieves with oscillating granulator and makes granule;
3, dry, granulate: by dry for the wet granular HighefficientFluidbeddrier made, controlling inlet temperature is 80 ~ 100 DEG C, and leaving air temp is 55 ~ 65 DEG C, and being dried to moisture is 2.0 ~ 4.0%; Sieve granulate with multi-functional pelletizing machine 2.0mm, obtain the dry granule of the precious sheet of cough-relieving;
(4) always mix
Get that dry granule adds Oleum menthae 1kg, magnesium stearate 7kg adds in two-dimensional motion mixer and mix 20 minutes, obtain the precious sheet granule of cough-relieving;
(5) tabletting.
Use Φ 10mm dark arc punch die tabletting, obtain cough-relieving precious sheet element sheet
(6) coating
1, syrup is joined
(1) zein solution preparation:
Take zein 5kg to add in ethanol 50kg and soak, until completely dissolved, stir evenly, 120 orders filter, for subsequent use;
(2) preparation of polyacrylic resin IV solution:
Take polyacrylic resin IV4kg, add ethanol 80kg, add polyoxyethylene sorbitan monoleate 700ml, Pulvis Talci 5kg, Brown Ferric Oxide 4kg, stir after polyacrylic resin IV dissolves completely, cross colloid mill, 200 orders filter, for subsequent use;
(3) preparation of polyacrylic resin IV hypromellose mixed solution:
Take hypromellose 2.0kg, add ethanol 50kg, after being uniformly dispersed, add purified water 10kg, stir evenly, obtain hypromellose cellulose solution; Taking polyacrylic resin IV2.0kg adds in ethanol 9kg, after polyacrylic resin IV dissolves completely, adds described hypromellose cellulose solution, add polyoxyethylene sorbitan monoleate 600ml Oleum Ricini 600ml, Brown Ferric Oxide 4kg, simethicone 60g, stirs evenly, cross colloid mill, 200 orders filter, for subsequent use.
2, film coating
(1) take cough-relieving precious sheet element sheet to set high in effect sugar-coat-film coater, start high seed-coating machine, open heating air intake and air draft, plain sheet is heated to about 35 DEG C, controls suitable rotating speed, starts to enter coating procedure.
(2) film-coat is sprayed: get successively and prepare zein solution, polyacrylic resin IV solution, polyacrylic resin IV hypromellose mixed solution is whitewashed, setting drum rotation speed 4 ~ 15 revs/min, controls inlet temperature 45 ~ 60 DEG C, leaving air temp 35 ~ 45 DEG C, regulate peristaltic pump rotating speed 3 ~ 15rpm, compressed air pressure 0.2 ~ 0.5MPa, with the whitewashing of suitable speed, makes coat tablets moistening and adhesion.In whitewashing process, constantly stir Coating Solution, wherein zein solution insulation 60 ± 5 DEG C.
(3) polishing and cool: first allow sheet natural drying before polishing, after drying, setting drum rotation speed 8 ~ 15 revs/min, after simethicone and the mixing of river wax, is evenly sprinkled in label, polishing 15 ~ 20 minutes.After coating, polishing sheet is laid in the stainless steel disc on cool horse, cool more than 6 hours, collect the precious sheet product to be packaged of cool good polishing sheet and cough-relieving.
The tablet that embodiment 7 and the tablet obtained by embodiment 8 and existing technique obtain shows through entirely examining data, quality indifference.
The present invention is not limited to above-mentioned embodiment, if do not depart from the spirit and scope of the present invention to various change of the present invention or distortion, if these are changed and distortion belongs within claim of the present invention and equivalent technologies scope, then the present invention is also intended to comprise these changes and distortion.
Claims (9)
1. a preparation method for cough-relieving tablet, is characterized in that comprising the following steps:
(1) preparation of .I extract powder: by the alcohol reflux 2 time of the Pericarpium Papaveris of 100 ~ 150kg with 1400 ~ 1800L, each 4h, merge extractive liquid, reclaim ethanol, concentrated after vacuum drying pulverizing stage by stage, obtain I extract powder flour;
(2) preparation of .II extract powder: take Exocarpium Citri Rubrum coarse powder 75 ~ 100kg, Radix Platycodonis coarse powder 100 ~ 150kg, Fructus Aurantii coarse powder 10 ~ 30kg, Radix Stemonae coarse powder 75 ~ 100kg, Fructus Schisandrae Chinensis coarse powder 10 ~ 30kg, Pericarpium Citri Reticulatae coarse powder 100 ~ 150kg, Rhizoma Zingiberis coarse powder 10 ~ 30kg, Herba Schizonepetae coarse powder 50 ~ 80kg, Radix Peucedani coarse powder 150 ~ 200kg, extract 2 times with at the ethanol 60 ± 5 DEG C of 8 times of weight, each 48h, merge extractive liquid, reclaims ethanol, concentrates to obtain II extractum A; Take Radix Asteris 100 ~ 150kg, the clean medical material of Radix Glycyrrhizae 350 ~ 400kg, put in multi-function extractor, extract 2 times with the water boil of 8 times of weight, each 2h, merge extractive liquid, concentrated to obtain II extractum B; Vacuum drying pulverizing stage by stage after described II extractum A being mixed homogeneously with II extractum B, obtains II extract powder flour;
(3). the preparation of tablet: described I extract powder flour 65 ~ 90kg, cough-relieving precious sheet II cream comminuted powder 161 ~ 231kg, ammonium chloride 150kg ~ 180kg are granulated after mixing with pharmaceutically acceptable adjuvant, add 1kg Oleum menthae and lubricant always mix 20min after tabletting, coating obtain described cough-relieving tablet.
2. the preparation method of cough-relieving tablet according to claim 1, it is characterized in that the middle vacuum drying of described step (1) is also pulverized is: I concentrated solution is pumped into material pot, add dextrin 0.3kg, unlatching is uniformly mixed, and opens heating and make material 60 ~ 80 DEG C of insulations; First paragraph temperature 110 ~ 120 DEG C is set, second segment temperature 90 ~ 100 DEG C, 3rd section of temperature 10 ~ 30 DEG C, vacuum-0.1MPa, arranging feed pump charging rate is that 90 ~ 160kg/h, crawler track speeds 0.32 ~ 0.48m/min, described crawler belt are through the equal used time 18min of above-mentioned each section of temperature; Open vacuum, heating, after requirement to be achieved, open feed pump and carry out drying, open lock material and pulverizer when material to be dried enters the 3rd section of nearly discharging, pulverize through 80 order stainless steel meshs.
3. the preparation method of cough-relieving tablet according to claim 1, it is characterized in that the middle vacuum drying of described step (2) is also pulverized is: pump into material pot after described II extractum A being mixed homogeneously with II extractum B, add Pulvis Talci 30 ~ 50kg, unlatching is uniformly mixed, and opens heating and make material 60 ~ 80 DEG C of insulations; First paragraph temperature 120 ~ 130 DEG C is set, second segment temperature 100 ~ 110 DEG C, 3rd section of temperature 10 ~ 30 DEG C, vacuum-0.1MPa, arranging feed pump charging rate is that 90 ~ 160kg/h, crawler track speeds 0.32 ~ 0.48m/min, described crawler belt are through the equal used time 18min of above-mentioned each section of temperature; Open vacuum, heating, after requirement to be achieved, open feed pump and carry out drying, open lock material and pulverizer when material to be dried enters the 3rd section of nearly discharging, pulverize through 80 order stainless steel meshs.
4. the preparation method of the cough-relieving tablet according to Claims 2 or 3, it is characterized in that extracting in step (1) and (2) with described ethanol to be percent by volume be 60% ethanol.
5. the preparation method of the cough-relieving tablet according to Claims 2 or 3, it is characterized in that the recovery ethanol in described step (1) and (2) is: the extracting solution after merging is proceeded to alcohol distillation column recovery ethanol, stop when distillation temperature in the kettle reaches 100 ~ 102 DEG C, obtain the ethanol of medicinal liquid and recovery gained.
6. the preparation method of the cough-relieving tablet according to Claims 2 or 3, it is characterized in that the simmer down in described step (1) and (2): control steam pressure≤0.2MPa, vacuum is effect-0.04 ~-0.08MPa, two effect-0.06 ~-0.08MPa, being concentrated into extracting solution relative density at 50 DEG C ± 2 DEG C is 1.20 ~ 1.30.
7. the preparation method of the cough-relieving tablet according to Claims 2 or 3, is characterized in that described pharmaceutically acceptable adjuvant is: carboxymethylstach sodium 22.0 ~ 44.0kg, dextrin 25.0 ~ 35.0kg, calcium hydrogen phosphate 70.0 ~ 100.0kg, microcrystalline Cellulose 70 ~ 160kg.
8. the preparation method of the cough-relieving tablet according to Claims 2 or 3, is characterized in that described granulation comprises the following steps:
1. granulation binders preparation: first with ethanol, polyacrylic resin IV7.2kg is soaked dissolving, then add ethanol 208kg and purified water 25kg, stir, be made into granulation binders;
2. granulate: mixed powder flour is added in Wet mixed granulating machine, 180rpm stirs 5 minutes, after 1500rpm shreds 5 minutes, add the binding agent that 1. step obtains, 180rpm stirring 1 ~ 3 minute, 1500rpm shred discharging after 10 seconds, cross 16 mesh sieves make wet granular with oscillating granulator;
3. dry, granulate: put in HighefficientFluidbeddrier by gained wet granular, controlling inlet temperature is 80 ~ 100 DEG C, and leaving air temp is 55 ~ 65 DEG C, and being dried to moisture is 2.0 ~ 4.0%; Sieve granulate with multi-functional pelletizing machine 2.0mm, obtain dry granule.
9. the preparation method of the cough-relieving tablet according to Claims 2 or 3, is characterized in that described coating comprises the following steps:
(S1) zein solution preparation: take zein 2 ~ 5kg and add in ethanol 30 ~ 50kg and soak, until completely dissolved, stir evenly, 120 orders filter, for subsequent use;
(S2) preparation of polyacrylic resin IV solution: take polyacrylic resin IV2 ~ 4kg, add ethanol 60 ~ 80kg, polyoxyethylene sorbitan monoleate 450 ~ 700ml, Pulvis Talci 2 ~ 5kg, Brown Ferric Oxide 2 ~ 4kg is added after polyacrylic resin IV dissolves completely, stir, cross colloid mill, 200 orders filter, for subsequent use;
(S3) preparation of polyacrylic resin IV hypromellose mixed solution: take hypromellose 0.5 ~ 2.0kg, add ethanol 30 ~ 50kg, after being uniformly dispersed, adding purified water 5 ~ 10kg, stirs evenly, obtain hypromellose cellulose solution; Taking polyacrylic resin IV0.3 ~ 2.0kg adds in ethanol 4 ~ 9kg, after polyacrylic resin IV dissolves completely, add described hypromellose cellulose solution, add polyoxyethylene sorbitan monoleate 200 ~ 600ml Oleum Ricini 200 ~ 600ml, Brown Ferric Oxide 1 ~ 4kg, simethicone 30 ~ 60g, stirs evenly, and crosses colloid mill, 200 orders filter, for subsequent use;
(S4) coating: plain sheet is put in seed-coating machine, open heating air intake and air draft, element sheet is heated to about 35 DEG C, get gained zein solution successively, polyacrylic resin IV solution, polyacrylic resin IV hypromellose mixed solution is whitewashed, setting drum rotation speed 4 ~ 15 revs/min, control inlet temperature 45 ~ 60 DEG C, leaving air temp 35 ~ 45 DEG C, regulate peristaltic pump rotating speed 3 ~ 15rpm, compressed air pressure 0.2 ~ 0.5MPa, in whitewashing process, constantly stir Coating Solution, wherein zein solution insulation 60 ± 5 DEG C;
(S5) polishing and cool: after the drying of step (S4) gained coated tablet, setting drum rotation speed 8 ~ 15 revs/min, after simethicone and the mixing of river wax, is evenly sprinkled in label, polishing 15 ~ 20 minutes; After by cool for polishing sheet more than 6 hours, pack to obtain finished product.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108420807A (en) * | 2018-06-08 | 2018-08-21 | 重庆希尔安药业有限公司 | A kind of metformin hydrochloride medicinal composition preparation and preparation method thereof |
| CN109621463A (en) * | 2018-12-25 | 2019-04-16 | 特药业集团股份有限公司 | A kind of preparation of cough-relieving tablet evaporation equipment and cough stopping tablet agent producing process |
| CN112494629A (en) * | 2020-11-23 | 2021-03-16 | 海南海力制药有限公司 | Preparation method of cough-relieving tablet |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101862442A (en) * | 2010-05-25 | 2010-10-20 | 广东台城制药股份有限公司 | Cough-relieving Chinese medicinal composition and preparation method thereof |
| CN102379927A (en) * | 2011-10-25 | 2012-03-21 | 海南海力制药有限公司 | Preparation methods of poppy shell extract and cough tablet |
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2016
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101862442A (en) * | 2010-05-25 | 2010-10-20 | 广东台城制药股份有限公司 | Cough-relieving Chinese medicinal composition and preparation method thereof |
| CN102379927A (en) * | 2011-10-25 | 2012-03-21 | 海南海力制药有限公司 | Preparation methods of poppy shell extract and cough tablet |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108420807A (en) * | 2018-06-08 | 2018-08-21 | 重庆希尔安药业有限公司 | A kind of metformin hydrochloride medicinal composition preparation and preparation method thereof |
| CN109621463A (en) * | 2018-12-25 | 2019-04-16 | 特药业集团股份有限公司 | A kind of preparation of cough-relieving tablet evaporation equipment and cough stopping tablet agent producing process |
| CN112494629A (en) * | 2020-11-23 | 2021-03-16 | 海南海力制药有限公司 | Preparation method of cough-relieving tablet |
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Address after: 529200 Taishan, Guangdong, North pit Industrial Park Applicant after: Special pharmaceutical group Limited by Share Ltd Address before: 529200 Guangdong city of Jiangmen province Taishan City Industrial Park, Changxin Road No. 9 pit Applicant before: Guangdong Taicheng Pharmaceutical Co., Ltd. |
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| COR | Change of bibliographic data | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| CP02 | Change in the address of a patent holder | ||
| CP02 | Change in the address of a patent holder |
Address after: 529200 9 and 11 Changxin Road, Taicheng, Jiangmen, Guangdong, Taishan Patentee after: Special pharmaceutical group Limited by Share Ltd Address before: 529200 Taishan North pit Industrial Park, Jiangmen, Guangdong Patentee before: Special pharmaceutical group Limited by Share Ltd |