CN100569265C - A kind of diabetes-treating tablet and preparation method thereof - Google Patents
A kind of diabetes-treating tablet and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to a kind of diabetes-treating tablet and preparation method thereof, belong to technical field of Chinese medicine.It is mainly by the Radix Astragali, the Radix Rehmanniae, Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Radix Achyranthis Bidentatae, Radix Ophiopogonis, 11 flavor medicines such as Radix Puerariae and suitably adjuvant be prepared from; Supplementary product kind of the present invention, consumption and principal agent reasonable mixture ratio, technology is rationally feasible, but the quality stable and controllable; Preparation dose of the present invention significantly reduces, and mouthfeel is good, and it is very convenient to preserve, carry, and stability greatly improves, and meets the modern requirement of Chinese medicine preparation.
Description
Technical field
The present invention be more particularly directed to a kind of diabetes-treating tablet and preparation method thereof, belong to technical field of Chinese medicine.
Technical background
Diabetes are a kind of common endocrine and metabolic disorders diseases, are one group of h and E factor interactions and the clinical syndrome that causes is its outstanding feature with hyperglycemia; Its basic pathology physiology is that a variety of causes causes insulin to lack relatively or definitely, and insulin resistant in various degree, causes water, the metabolic disturbance of electrolyte of sugar, protein, fat and secondary.Visible clinically excessive thirst, polyuria, polydipsia, tired, performance such as become thin.Its course of disease is tediously long; pathological changes is involved whole body: brain, cardiovascular, kidney, nerve, retina, skin and foot; ketoacidosis, non-ketosis hyperosmolar coma, cerebrovascular disease, myocardial infarction, chronic renal insufficiency etc. can take place when critical; normal easily concurrentization pyogenic infection, urinary tract infection, pulmonary tuberculosis etc., serious threat patient life.
Now, diabetes have become " No. three killer " who threatens the mankind after cardiovascular and cerebrovascular disease and tumor in the world.According to the popular scholar's prediction of internal authority diabetes, by 2010, global diabetes patient will reach 2.4 hundred million, 2025 then can be increased to 300,000,000 people.China is the big country of one 1,200,000,000 population, and the pace of population aging is fast and radix is big, and diabetes prevalence rises rapidly, will bring huge health care expenditures to China, shows according to the study, about 170,000,000,000 yuan of the annual at present expense that for this reason expends.So diabetes have become the significant problem that countries in the world are concerned about as a kind of serious chronic disease.Because the diabetes medication has chronicity, the long-term accumulation of toxic and side effects is very big to the influence of human body, and the Chinese medicine hypoglycemic activity relaxes and lasting, has dual regulation mostly, generally can not cause hypoglycemia, and Chinese medicine is improving symptom and treatment has a clear superiority in aspect the complication, and non-evident effect; The world today start natural drug heat and the trend that goes back to nature in, seek curative effect safety, blood sugar reducing component easy to use to developing the very big concern that new diabetes medicament just is subjected to many research and development units and pharmaceutical producing enterprise from nature.
TANGMAIKANG KELI is a pure Chinese medicinal preparation, and its Chinese medicinal ingredients Radix Astragali, the Radix Rehmanniae, Radix Puerariae, Rhizoma Polygonati etc. are the common drugs of treatment diabetes in the ancient prescription, and clinical efficacy is remarkable, right dose is big owing to former granule, and mouthfeel is not good, and be easy to deficiencies such as the moisture absorption, in clinical use, be subjected to very big restriction.For this reason, the inventor furthers investigate it, has developed diabetes-treating tablet, and by retrieval, said preparation still belongs to internal blank.
Summary of the invention
The object of the present invention is to provide a kind of new pharmaceutical preparation and preparation method thereof, said preparation mainly by the Radix Astragali, Radix Salviae Miltiorrhizae, Radix Puerariae, Radix Rehmanniae etc. ten simply Chinese medicine form, be used for diabetes due to the type of deficiency of both QI and YIN blood stasis; Disease is seen: thirst and liking drink, fatigue and weakness, the lazy speech of breathing hard, spontaneous perspiration, night sweat, dysphoria with feverish sensation in the chest palms and soles, vexed in the heart pain, numb limbs and tense tendons or twinge, constipation etc.Radix Astragali invigorating the spleen and replenishing QI in the side, lung benefiting promotes the production of body fluid, and the Radix Rehmanniae, Radix Ophiopogonis, Radix Puerariae YIN nourishing and the production of body fluid promoting, blood sugar lowering are aided with Radix Paeoniae Rubra, the Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling is promoted blood circulation.Full side plays the merit that nourishing kidney-YIN, supplementing QI for promoting the production of body fluid, blood stasis dispelling are promoted blood circulation altogether, effects a permanent cure with nourishing kidney yin, and blood circulation promoting and blood stasis dispelling takes stopgap measures, giving consideration to both the incidental and fundamental.Clinical demonstration, blood sugar lowering obvious effective rate are 59.33%, and effective percentage is 85.02%, the obvious effective rate of traditional Chinese medical science disease is 59.67%, and effective percentage is 88.67%, TANGMAIKANG treatment diabetics curative effect is described certainly, but because of former dosage form is a granule, exist dose big, mouthfeel is poor, the easy moisture absorption, the not high drawback of bioavailability, preparation dose of the present invention significantly reduces, and mouthfeel is good, and it is very convenient to preserve, carry, stability greatly improves, and meets the modern requirement of Chinese medicine preparation.
The present invention is achieved by the following technical solutions:
A kind of diabetes-treating tablet is counted by weight percentage, and it is mainly to be prepared from by TANGMAIKANG extract powder 50-70% and adjuvant 30-50%.Described TANGMAIKANG extract powder is mainly to be made up of following raw material medicaments in part by weight: 2 parts of the Radixs Astragali, 2.17 parts of Radix Rehmanniae, 2.17 parts of Radix Paeoniae Rubra, 2 parts of Radix Salviae Miltiorrhizaes, 1.25 parts of Radix Achyranthis Bidentataes, 1.25 parts of Radix Ophiopogonis, 1.25 parts of Radix Puerariaes, 1.25 parts on Folium Mori, 0.42 part of Rhizoma Coptidis, 1.25 parts of Rhizoma Polygonatis, 1.67 parts of Herba Epimedii.Adjuvant is meant filler, lubricant, counts by weight percentage, and filler accounts for 29-50%, and lubricant accounts for 0-1.0%.Filler comprises one or more in calcium sulfate, calcium carbonate, calcium bicarbonate, calcium bisulfate, pregelatinized Starch, mannitol, lactose, xylitol, the microcrystalline Cellulose etc.; Lubricant comprises one or more in micropowder silica gel, Pulvis Talci, the magnesium stearate.Preferred filler is calcium sulfate and dextrin, counts by weight percentage, and the consumption of calcium sulfate accounts for 20-30%; Lubricant is a magnesium stearate, counts by weight percentage, and the consumption of lubricant accounts for 0.4-0.6%.
Tablet of the present invention is preparation like this: above ten Herba indigoferae Pseudotinctoriae, and add water 15-25 and doubly measure, heat 70-120 ℃, constantly stir and extracted 1-3 hour, coarse filtration is separated medicinal residues, medicinal liquid is evaporated to the thick paste of relative density about 1.30 (60-65 ℃), and drying under reduced pressure is ground into fine powder, add adjuvant, mixing is used the 85%-99.5% alcohol granulation, dry, tabletting, coating, promptly.
Specifically, the preparation method of tablet of the present invention is: above ten Herba indigoferae Pseudotinctoriae are cut into 10-12mm, add 20 times of amounts of water, heat 90 ± 5 ℃, constantly stir and extracted coarse filtration 2 hours, separate medicinal residues, medicinal liquid is evaporated to the thick paste of relative density about 1.30 (60～65 ℃), drying under reduced pressure, be ground into fine powder, add filler, lubricant, mixing is used the 90%-95% alcohol granulation, drying, tabletting, coating, art for coating is: Opadry-Y-1-7000 is dissolved in 80% alcoholic solution, soaked 10 minutes, stir, ground 20 minutes through colloidal film, cross 200 mesh sieves and filter, remove coarse granule, with the blockage resisting spray gun, it is standby to make film liquid; Going fine powder to place the sheet sieve of suppressing is preheated in the coating pan about 45 ℃, start air compressor machine, open air cock, and the flow of regulating both makes carefully and uniformly vaporific, spray velocity do not cause powder to fly upward with control and in time drying be advisable, continue stirring at coating process film liquid; The coating parameter is: spray gun diameter: 1.4mm, nozzle and sheet bed spacing: 150mm, intake: 7m
2/ min, inlet temperature: 55 ℃, the gate temperature: preheating 5rpm/ changes, and coating: 12rpm/ changes, and drying: 5rpm/ changes, whiff pressure: 0.15mpa, hydrojet speed: 49g/min, drying: be placed on tray, placed the silica dehydrator chamber 3 hours; Promptly.
At prior art, former granule dose is big, the easy moisture absorption, mouthfeel is poor, and stability is bad, disintegration time is longer, deficiencies such as bioavailability difference, the present invention furthers investigate, and it is little to have developed dose, mouthfeel is good, good stability, the tablet that bioavailability is good has carried out a large amount of tests to its supplementary product kind and consumption, the adjuvant and the principal agent reasonable mixture ratio of screening, technology is rationally feasible through lab scale, pilot scale, and is stable and controllable for quality, and suitable the amplification produces, and drug effect improves a lot, and meets the modern requirement of Chinese medicine preparation.
The inventor finds that in development process kind, the consumption of adjuvant have considerable influence to it, and for this reason, the applicant has carried out a series of experiments, and is rationally feasible, quality controllable with proof technology of the present invention, to guarantee the beneficial effect of medicine.
The research of experimental example 1 moulding process
1.1 the examination of filler kind:
Because the filler that Chinese medicine preparation is commonly used is starch, dextrin, lactose, so the present invention is a filler with starch, dextrin, lactose earlier, carry out pressure testing, the result is as follows.
The screening of table filler kind
Join principal agent amylodextrin lactose calcium sulfate mannitol microcrystalline Cellulose compressibility
Side (g) is (g) (g) (g) (g) (g) (g)
1 32 18-----general
2 32-18----general
3 32--18---general
4 32---18--general
5 32----18-general
6 32-----18 is general
7 32 6--12--better
8 32-6-12--better
9 32--6 12--better
10 32 9 9----better
11 32--9-9-better
12 32 9----9 is better
13 32-9--9-good
14 32--9--9 is better
15 32 66 6---better
16 32-6-6 6-better
The result shows, no matter above most of adjuvant uses separately or is used and can satisfy the preparation requirement substantially, but with starch be filler then because of its have certain draw moist, may cause sticking and sliver, with dextrin and lactose be filler then compressibility fail to improve preferably, and when finding with two or more adjuvant, compressibility be improved significantly, be used to good with other any adjuvants with dextrin or lactose, especially be used to good with calcium sulfate; But because of the lactose price higher, so preferred dextrin and calcium sulfate are used to good.Below the ratio of the two use is examined or check, the result is as follows.
Table filler ratio is preferred
Prescription principal agent (g) calcium sulfate (g) dextrin (g) compressibility
1 32.0 13.5 4.5 is better, the minority sliver
2 32.0 12.0 6.0 is good
3 32.0 9.0 9.0 is better, slightly sticking
Above result shows, when calcium sulfate and dextrin were used, the ratio of calcium sulfate and dextrin was can both satisfy the preparation requirement at 1: 1～3: 1 o'clock, but is good with 2: 1 especially.
1.2 the examination of filler loading
According to the paste volume of extract, design sheet respectively and heavily carry out pressure testing, examine or check filler loading, the result is as follows.
The preferred result table of table supplementary product consumption
Heavy principal agent amount (g) calcium sulfate amount (g) dextrin amount (g) result of the test of tested number sheet
1 0.4 0.32 0.053 0.027 stickings
2 0.5 0.32 0.12 0.06 compressibility are good
3 0.6 0.32 0.19 0.09 compressibility are good
Above result shows, certain draws moistly because of medicated powder has, and supplementary product consumption is the granule moisture absorption at least, make the 0.40g sheet and have any problem, and the compressibility of 0.5g sheet and 0.6g sheet is all better, considers from the cost angle, determines that sheet heavily is 0.5g.The consumption of preferably calcium sulfate is best with 25% wherein for the 20-30% of prescription total amount; Dextrin dosage must be measured according to each medicated powder,, adds to full dose and gets final product heavily for 0.5g calculates according to sheet.
1.3 selection of lubricants
Lubricant commonly used has magnesium stearate, micropowder silica gel, Pulvis Talci, according to trial test, above-mentioned any adjuvant or any and all the other one or more can both satisfy the preparation requirement when being used, but especially with magnesium stearate for well, so preferred magnesium stearate is a lubricant; Consumption examination shows, finds that the consumption of magnesium stearate can both satisfy the preparation requirement 1.0% with interior, during with 0.4-0.6% for well, especially with 0.5% for well.
Experimental example 2: the determining of method of granulating
Take by weighing medical material, extract, obtain dried cream powder.Its dried cream powder is divided into 4 parts, carries out the comparison of Different concentrations of alcohol granulating efficiency.Because of water in the dried cream powder is carried the large percentage of medicated powder, the moisture absorption easily is so the ethanol of the following concentration of selection is tested (23 ℃ of room temperatures; Humidity 50%), its result is as follows.
Table granulating efficiency comparison sheet
Sequence number concentration of alcohol (%) granulating efficiency
1 85 made soft materials are hard slightly; Grain forming is general
2 90 made soft material soft durometer are moderate; The grain forming effect is better
3 95 made soft material soft durometer are moderate; Grain forming is effective
The made soft material of 4 dehydrated alcohol is looser; Grain forming is general
As seen from the above table, this granule used concentration of alcohol of granulating can both satisfy the granulation requirement at 85%-99.5% ethanol, but especially with between the 90-95% for well.
Experimental example 3: the mensuration of practical physical characteristics
3.1 mobile mensuration
Get dried granule (water content is 3.5%) 50g, from funnel, flow in the culture dish, treat the height of granule circular cone on the mensuration culture dish of static back, measure the diameter (2R) of granule conical base by graph paper, (tg α=H/R), the result is as follows to calculate angle of repose.
Show particulate angle of repose
Experiment angle of repose (α °)
1 27.5
2 28.3
3 28.6
4 27.7
5 28.9
Meansigma methods 28.5
As seen from the above table, α＜40 ° illustrate that particulate flowability is fine, meet the needs of producing tabletting.
3.2 the mensuration of granule critical relative humidity
For whether easily the granule moisture absorption is described, we have carried out the mensuration of critical relative humidity, concrete grammar is as follows: it is an amount of to get granule, be ground into fine powder, be dried to constant weight after, put into the fine powder of thick about 2mm in the weighing botle bottom of constant weight, accurately weighing is placed on the exsiccator interior (the weighing bottle cap is opened) of the listed supersaturated aqueous solution that fills 7 kinds of variable concentrations sulphuric acid or different salt respectively of following table, in 25 constant incubators, keep weighing after 72 hours, calculate the moisture absorption percentage rate.The result is as follows.
Show the moisture absorption counting rate meter under the different relative humiditys
Solution 54%H
2SO
448%H
2SO
444%H
2SO
4NaBr NaCL KCL KNO
3
RH(25℃) 29.55 40.52 48.52 57.70 75.28 84.26 92.48
Hydroscopicity (%) 5.52 5.78 6.25 6.86 8.19 9.97 11.69
Figure sees Figure of description 1.
Accompanying drawing 1 explanation: the hydroscopicity in the above table is a vertical coordinate, and relative humidity (RH%) is mapped for abscissa, and accompanying drawing 1 shows, envionmental humidity is 70% when following, and particulate hydroscopicity is lower; And greater than 70%, hydroscopicity sharply increases.Envionmental humidity should be below 70% when tabletting was described.
Concrete embodiment
Embodiment 1: press the shared umber of each raw material in the diabetes-treating tablet, get following recipe quantity raw material:
Radix Astragali 200g Radix Rehmanniae 217g Radix Paeoniae Rubra 217g Radix Salviae Miltiorrhizae 200g Radix Achyranthis Bidentatae 125g
Radix Ophiopogonis 125g Radix Puerariae 125g Folium Mori 125g Rhizoma Coptidis 42g Rhizoma Polygonati 125g Herba Epimedii 167g
More than ten Herba indigoferae Pseudotinctoriae be cut into 10～12mm, add 20 times of amounts of water, heat 90 ± 5 ℃, constantly stir and extracted 2 hours, coarse filtration is separated medicinal residues, medicinal liquid is evaporated to the thick paste of relative density about 1.30 (60～65 ℃), and drying under reduced pressure is ground into fine powder, heavily about 315g adds calcium sulfate 125g, magnesium stearate 2.5g and dextrin 57.5g, mixing is used 95% alcohol granulation, drying, tabletting, coating, promptly.
Embodiment 2: press the shared umber of each raw material in the diabetes-treating tablet, get following recipe quantity raw material:
Radix Astragali 200g Radix Rehmanniae 217g Radix Paeoniae Rubra 217g Radix Salviae Miltiorrhizae 200g Radix Achyranthis Bidentatae 125g
Radix Ophiopogonis 125g Radix Puerariae 125g Folium Mori 125g Rhizoma Coptidis 42g Rhizoma Polygonati 125g Herba Epimedii 167g
More than ten Herba indigoferae Pseudotinctoriae be cut into 10～12mm, add 15 times of amounts of water, heat 80 ± 5 ℃, constantly stir and extracted 1 hour, coarse filtration is separated medicinal residues, medicinal liquid is evaporated to the thick paste of relative density about 1.30 (60～65 ℃), and drying under reduced pressure is ground into fine powder, heavily about 250g adds calcium bicarbonate 150g, micropowder silica gel 2.0g and starch 98g, mixing is used 90% alcohol granulation, drying, tabletting, coating, promptly.
Embodiment 3: press the shared umber of each raw material in the diabetes-treating tablet, get following recipe quantity raw material:
Radix Astragali 200g Radix Rehmanniae 217g Radix Paeoniae Rubra 217g Radix Salviae Miltiorrhizae 200g Radix Achyranthis Bidentatae 125g
Radix Ophiopogonis 125g Radix Puerariae 125g Folium Mori 125g Rhizoma Coptidis 42g Rhizoma Polygonati 125g Herba Epimedii 167g
More than ten Herba indigoferae Pseudotinctoriae be cut into 10～12mm, add 25 times of amounts of water, heat 100 ± 5 ℃, constantly stir and extracted 3 hours, coarse filtration is separated medicinal residues, medicinal liquid is evaporated to the thick paste of relative density about 1.30 (60～65 ℃), and drying under reduced pressure is ground into fine powder, heavily about 350g adds calcium carbonate 100g, Pulvis Talci 3.0g and lactose 47g, mixing is used 85% alcohol granulation, drying, tabletting, coating, promptly.
Embodiment 4: press the shared umber of each raw material in the diabetes-treating tablet, get following recipe quantity raw material:
Radix Astragali 200g Radix Rehmanniae 217g Radix Paeoniae Rubra 217g Radix Salviae Miltiorrhizae 200g Radix Achyranthis Bidentatae 125g
Radix Ophiopogonis 125g Radix Puerariae 125g Folium Mori 125g Rhizoma Coptidis 42g Rhizoma Polygonati 125g Herba Epimedii 167g
More than ten Herba indigoferae Pseudotinctoriae be cut into 10～12mm, add 18 times of amounts of water, heat 95 ± 5 ℃, constantly stir and extracted 2.5 hours, coarse filtration is separated medicinal residues, medicinal liquid is evaporated to the thick paste of relative density about 1.30 (60～65 ℃), and drying under reduced pressure is ground into fine powder, heavily about 298g adds calcium bisulfate 125g, Pulvis Talci 5g and mannitol 72g, mixing is used alcohol granulation, drying, tabletting, coating, promptly.
Embodiment 5: press the shared umber of each raw material in the diabetes-treating tablet, get following recipe quantity raw material:
Radix Astragali 200g Radix Rehmanniae 217g Radix Paeoniae Rubra 217g Radix Salviae Miltiorrhizae 200g Radix Achyranthis Bidentatae 125g
Radix Ophiopogonis 125g Radix Puerariae 125g Folium Mori 125g Rhizoma Coptidis 42g Rhizoma Polygonati 125g Herba Epimedii 167g
More than ten Herba indigoferae Pseudotinctoriae be cut into 10～12mm, add 22 times of amounts of water, heat 90 ± 5 ℃, constantly stir and extracted 2 hours, coarse filtration is separated medicinal residues, and medicinal liquid is evaporated to the thick paste of relative density about 1.30 (60～65 ℃), drying under reduced pressure is ground into fine powder, heavily about 300g, add microcrystalline Cellulose 130g, magnesium stearate 2g, Pulvis Talci 1g and xylitol 67g, mixing is used 95% alcohol granulation, drying, tabletting, coating, promptly.
Embodiment 6: press the shared umber of each raw material in the diabetes-treating tablet, get following recipe quantity raw material:
Radix Astragali 200g Radix Rehmanniae 217g Radix Paeoniae Rubra 217g Radix Salviae Miltiorrhizae 200g Radix Achyranthis Bidentatae 125g
Radix Ophiopogonis 125g Radix Puerariae 125g Folium Mori 125g Rhizoma Coptidis 42g Rhizoma Polygonati 125g Herba Epimedii 167g
More than ten Herba indigoferae Pseudotinctoriae be cut into 10～12mm, add 20 times of amounts of water, heat 90 ± 5 ℃, constantly stir and extracted 2 hours, coarse filtration is separated medicinal residues, medicinal liquid is evaporated to the thick paste of relative density about 1.30 (60～65 ℃), and drying under reduced pressure is ground into fine powder, heavily about 350g adds calcium sulfate 100g, magnesium stearate 2g, Pulvis Talci 1g, micropowder silica gel 2g and xylitol 45g, mixing is used 85% alcohol granulation, drying, tabletting, coating, promptly.
Embodiment 7: press the shared umber of each raw material in the diabetes-treating tablet, get following recipe quantity raw material:
Radix Astragali 200g Radix Rehmanniae 217g Radix Paeoniae Rubra 217g Radix Salviae Miltiorrhizae 200g Radix Achyranthis Bidentatae 125g
Radix Ophiopogonis 125g Radix Puerariae 125g Folium Mori 125g Rhizoma Coptidis 42g Rhizoma Polygonati 125g Herba Epimedii 167g
More than ten Herba indigoferae Pseudotinctoriae be cut into 10～12mm, add 16 times of amounts of water, heat 90 ± 5 ℃, constantly stir and extracted 2 hours, coarse filtration is separated medicinal residues, medicinal liquid is evaporated to the thick paste of relative density about 1.30 (60～65 ℃), and drying under reduced pressure is ground into fine powder, heavily about 295g adds calcium sulfate 150g, magnesium stearate 5.0g and dextrin 50g, mixing is used 90% alcohol granulation, drying, tabletting, coating, promptly.
Embodiment 8: press the shared umber of each raw material in the diabetes-treating tablet, get following recipe quantity raw material:
Radix Astragali 200g Radix Rehmanniae 217g Radix Paeoniae Rubra 217g Radix Salviae Miltiorrhizae 200g Radix Achyranthis Bidentatae 125g
Radix Ophiopogonis 125g Radix Puerariae 125g Folium Mori 125g Rhizoma Coptidis 42g Rhizoma Polygonati 125g Herba Epimedii 167g
More than ten Herba indigoferae Pseudotinctoriae be cut into 10～12mm, add 24 times of amounts of water, heat 85 ± 5 ℃, constantly stir and extracted 2 hours, coarse filtration is separated medicinal residues, medicinal liquid is evaporated to the thick paste of relative density about 1.30 (60～65 ℃), and drying under reduced pressure is ground into fine powder, heavily about 300g adds calcium sulfate 100g and dextrin 100g, mixing, granulate drying, tabletting with dehydrated alcohol, coating, promptly.
Art for coating can adopt method in the foregoing description, but is not limited to this method:
Art for coating is: Opadry-Y-1-7000 is dissolved in 80% alcoholic solution, soaked 10 minutes, stir, ground 20 minutes through colloidal film, cross 200 mesh sieves and filter, remove coarse granule, with the blockage resisting spray gun, it is standby to make film liquid; Going fine powder to place the sheet sieve of suppressing is preheated in the coating pan about 45 ℃, start air compressor machine, open air cock, and the flow of regulating both makes carefully and uniformly vaporific, spray velocity do not cause powder to fly upward with control and in time drying be advisable, continue stirring at coating process film liquid; The coating parameter is: spray gun diameter: 1.4mm, nozzle and sheet bed spacing: 150mm, intake: 7m
2/ min, inlet temperature: 55 ℃, the gate temperature: preheating 5rpm/ changes, and coating: 12rpm/ changes, and drying: 5rpm/ changes, whiff pressure: 0.15mpa, hydrojet speed: 49g/min, drying: be placed on tray, placed the silica dehydrator chamber 3 hours.
Claims (1)
1, a kind of preparation method of diabetes-treating tablet is characterized in that, counts by weight percentage, and it is to be prepared from by TANGMAIKANG extract powder 50-70% and adjuvant 30-50%;
Wherein, described TANGMAIKANG extract powder is made up of following raw material medicaments in part by weight: 2.0 parts of the Radixs Astragali, 2.17 parts of Radix Rehmanniae, 2.17 parts of Radix Paeoniae Rubra, 2.0 parts of Radix Salviae Miltiorrhizaes, 1.25 parts of Radix Achyranthis Bidentataes, 1.25 parts of Radix Ophiopogonis, 1.25 parts of Radix Puerariaes, 1.25 parts on Folium Mori, 0.42 part of Rhizoma Coptidis, 1.25 parts of Rhizoma Polygonatis, 1.67 parts of Herba Epimedii;
Preparation method is: above ten Herba indigoferae Pseudotinctoriae, be cut into 10-12mm, and add 20 times of amounts of water, heat 90 ± 5 ℃ and constantly stir extraction 2 hours, coarse filtration is separated medicinal residues, relative density was 1.30 thick paste when medicinal liquid was evaporated to 60-65 ℃, and drying under reduced pressure is ground into fine powder, add filler, lubricant, mixing, use the 90-95% alcohol granulation, drying, tabletting, coating;
Filler is meant calcium sulfate and dextrin, and the consumption of calcium sulfate accounts for 20-30%, and lubricant is meant magnesium stearate, and consumption accounts for 0.4-0.6%;
Art for coating is: Opadry-Y-1-7000 is dissolved in 80% alcoholic solution, soaked 10 minutes, stir, ground 20 minutes through colloidal film, cross 200 mesh sieves and filter, remove coarse granule, with the blockage resisting spray gun, it is standby to make film liquid; Going fine powder to place the sheet sieve that is pressed into is preheated in the coating pan about 45 ℃, start air compressor machine, open air cock, and the flow of regulating both makes carefully and uniformly vaporific, spray velocity do not cause powder to fly upward with control and in time drying be advisable, continue stirring at coating process film liquid; The coating parameter is: spray gun diameter: 1.4mm, nozzle and sheet bed spacing: 150mm, intake: 7m
2/ min, inlet temperature: 55 ℃, the gate temperature: preheating 5rpm/ changes, and coating: 12rpm/ changes, and drying: 5rpm/ changes, whiff pressure: 0.15mpa, hydrojet speed: 49g/min, drying: be placed on tray, placed the silica dehydrator chamber 3 hours; Promptly.
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Non-Patent Citations (2)
| Title |
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| 国家药品标准 新药转正标准. 1028. 2000 |
| 国家药品标准 新药转正标准. 1028. 2000 * |
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