CN101024034A - Ginseng, astragalus diabetes dropping pills - Google Patents
Ginseng, astragalus diabetes dropping pills Download PDFInfo
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- CN101024034A CN101024034A CN 200610059952 CN200610059952A CN101024034A CN 101024034 A CN101024034 A CN 101024034A CN 200610059952 CN200610059952 CN 200610059952 CN 200610059952 A CN200610059952 A CN 200610059952A CN 101024034 A CN101024034 A CN 101024034A
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Abstract
The present invention discloses an oral Chinese medicine preparation-Shenqi Xiaoke dripping pills with the functions of supplementing qi and nourishing yin for effectively curing diabetes with obvious therapeutic effect. It is made up by using 13 Chinese medicinal materials of ginseng, astragalus root and others through a certain preparation process.
Description
Technical field
The present invention relates to a kind of ginseng, astragalus diabetes dropping pills preparation of supplementing QI and nourishing YIN, mainly form, be used for thirsty, polydipsia, the polyuria of diabetes, lassitude, dizzy (type ii diabetes) with 13 flavor feedstock production such as the Radix Ginseng Radix Astragali.This preparation is a raw material with Radix Ginseng, the Radix Astragali, Rhizoma Dioscoreae, the Rhizoma Atractylodis Macrocephalae, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Rhizoma Polygonati Odorati, Radix Rehmanniae Preparata, Radix Achyranthis Bidentatae, Poria, Rhizoma Alismatis, Fructus Arctii, Bombyx Batryticatus 13 flavor Chinese medicines, changes a social system a kind of oral drop pills that forms through dosage form by the ginseng, astragalus diabetes granule.
Background technology
Diabetes mainly are because hypoinsulinism (absolute not enough) or to the Requirement Increases (relative deficiency) of insulin in the body, then blood sugar increasing, glucose in urine occurs, cause polyuria, polydipsia, polyphagia and symptoms such as muscle power, weight loss, fat, protein, mineral, water and acid-base unbalance take place when serious.If diabetes can not get good control for a long time, the complication of vitals such as brain, heart, nerve, eye and kidney be can also cause, even maimed person or death caused, belong to the category of the traditional Chinese medical science " diabetes ".China's diabetes have risen to the Chronic Non-Communicable Diseases of the 3rd serious harm residents ' health.And the type ii diabetes patient accounts for 90% of China diabetes patient sum, have in the diabetics 87% 40 years old with sequela, onset relatively relaxes hidden, is not easy to take place ketoacidosis, not necessarily insulinize.The rapid increase of diabetics sum mainly is the result that the type ii diabetes patient increases rapidly at present.Chinese medicine prevention diabetes (diabetes) have accumulated a large amount of invaluable experiences through practice in several thousand, and constantly develop innovation through successive dynasties medicine expert, form the Chinese medical theory of system and the Scientific systems of original creation gradually, have made huge contribution for guaranteeing people ' s health.Ginseng, astragalus diabetes granule prescription is made up of Radix Ginseng, the Radix Astragali, Rhizoma Dioscoreae, the Rhizoma Atractylodis Macrocephalae, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Rhizoma Polygonati Odorati, Radix Rehmanniae Preparata, Poria 13 flavor medical materials.We's supplementing QI and nourishing YIN is grown the spleen the kidney invigorating, and the type ii diabetes of deficiency of both QI and YIN is had obvious blood sugar reducing function.Confirm through clinical experiment, ginseng, astragalus diabetes granule therapy deficiency of both QI and YIN, thirsty, polydipsia, polyuria, lassitude, giddies etc. all take an evident turn for the better, and the patient feels good, no hypoglycemia generation, and in the medication process, do not observe significant side effects.And the patient is in the selection of medicine for treatment, and the side effect in the chemicals is more obvious, develops therefore that preparation stabilization, drug safety, dosage are accurate, quality controllable, the reliable Chinese medicine preparation of curative effect has great importance.
According to the prescription that provides among the national drug standards WS3-B-3232-98 and preparation technology's ginseng, astragalus diabetes granule is a kind of ginseng, astragalus diabetes dropping pills preparation of supplementing QI and nourishing YIN, mainly form with 13 flavor feedstock production such as the Radix Ginseng Radixs Astragali, thirsty, the polydipsia, the polyuria that are used for diabetes, lassitude, dizzy (type ii diabetes).
Standard numbering: WS3-B-3232-98
Prescription Radix Ginseng 56g Radix Astragali 390g Rhizoma Dioscoreae 278g
Rhizoma Atractylodis Macrocephalae 166g Fructus Schisandrae Chinensis 84g 278g Radix Ophiopogonis
Rhizoma Polygonati Odorati 278g Radix Rehmanniae Preparata 140g Radix Achyranthis Bidentatae 166g
Poria 166g Rhizoma Alismatis 166g Fructus Arctii 166g
Bombyx Batryticatus 166g
Method for making: above 13 flavors, the Radix Ginseng powder is broken into coarse powder, according to the percolation (appendix I O) under fluid extract and the extractum item, makes solvent with 60% ethanol, soaks to drill after 24 hours and carries out percolation, and it is standby to collect the liquid 200ml that filters; 12 flavors such as all the other Radixs Astragali decoct with water secondary, and each 2 hours, collecting decoction, filter, filtrate leaving standstill makes precipitation, and getting supernatant concentration to relative density is 1.38～1.40, add dextrin 500g, mixing, drying, be ground into fine powder, add Mel 100g, mixing, with above-mentioned percolate and alcohol granulation, drying is made 1000g, promptly.
Character: this product is tan granule; Gas perfume (or spice), bitter in the mouth, little sweet.
Differentiate: get this product 12g, porphyrize adds ethanol 30ml, soaked overnight, incline and get supernatant, filter, precipitation adds ethanol 20ml jolting again, floods 30 minutes, filter, merging filtrate, evaporate to dryness, residue add water 10ml makes dissolving, and in the dislocation separatory funnel, the n-butyl alcohol liquid that the sodium hydroxide with 0.4% is saturated extracts 2 times, and each 15ml merges n-butyl alcohol liquid, wash with water 2 times, each 15ml discards water liquid, merges n-butyl alcohol liquid, evaporate to dryness, residue add ethanol 0.5ml makes dissolving, as need testing solution.Other gets ginsenoside Rb1, Re, Rg1 and astragaloside reference substance, adds ethanol and makes the mixed solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (appendix VI B), draw reference substance solution 5 μ l, need testing solution 10 μ l, putting respectively on same silica gel g thin-layer plate, is developing solvent with lower floor's solution of chloroform-methanol-water (13: 7: 2), launches, take out, dry, spray ethanol solution of sulfuric acid, about 10 minutes of 105 ℃ of bakings with 10%.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
Check: should meet every regulation relevant under the granule item (appendix I C).
Extractum: get the about 2g of this product, claim to decide weight, make solvent with 60% ethanol, measure according to the cold-maceration (appendix X A) under the ethanol-soluble extractives algoscopy item, extractum must not be less than 45.0%.
Function with cure mainly: supplementing QI and nourishing YIN.Thirsty, the polydipsia, the polyuria that are used for diabetes, lassitude, dizzy (type ii diabetes).
Usage and consumption: boiled water is taken after mixing it with water, one time 1～2 bag, 3 times on the one.
Specification: every packed 12g
Storage: sealing.
Prescription also has capsule, tablet or the like for basic other preparations of making according to this, owing to reasons such as technologies of preparing, the oral formulations of most of Chinese medicines exists all after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, bioavailability is lower and defective such as liver sausage first pass effect.These factors all affect the performance of the various dosage form drug effects of ginseng, astragalus diabetes, directly the effect of influence treatment.The selection of condensing agent also is difficult to satisfy the forming requirements of big specification drop pill in the existing drop pill technology of preparing simultaneously, so can't prepare the above big specification drop pill of 100mg.The single dose of many Chinese medicine dripping pills preparations is all more than 20, and this takes to the patient and brings very big inconvenience.Especially gerontal patient, greatly inconvenience especially.
Summary of the invention
The objective of the invention is to remedy the deficiencies in the prior art, provide a kind of bioavailability height to extensive patients and medical personnel, release fast, quick produce effects, toxic and side effects is littler, and the ginseng, astragalus diabetes dropping pills dosage form of taking convenience (comprising common specification ginseng, astragalus diabetes dropping pills and big specification ginseng, astragalus diabetes dropping pills) and preparation method thereof.Take following preparation method can make common specification ginseng, astragalus diabetes dropping pills involved in the present invention and big specification ginseng, astragalus diabetes dropping pills.
Preparation method
The prescription: Radix Ginseng 5.6g, Radix Astragali 39.0g, Rhizoma Dioscoreae 27.8g, Rhizoma Atractylodis Macrocephalae 16.6g, Fructus Schisandrae Chinensis 8.4g, Radix Ophiopogonis 27.8g, Rhizoma Polygonati Odorati 27.8g, Radix Rehmanniae Preparata 14.0g, Radix Achyranthis Bidentatae 16.6g, Poria 16.6g, Rhizoma Alismatis 16.6g, Fructus Arctii 16.6g, Bombyx Batryticatus 16.6g;
2. the extraction of raw material and preparation: the Radix Ginseng powder is broken into coarse powder, with percolation, makes solvent with 60% ethanol, soaks and carries out percolation after 24 hours, collects percolate, reclaims ethanol, and is standby; All the other Radixs Astragali, Rhizoma Dioscoreae, the Rhizoma Atractylodis Macrocephalae, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Rhizoma Polygonati Odorati, Radix Rehmanniae Preparata, Radix Achyranthis Bidentatae, Poria, Rhizoma Alismatis, Fructus Arctii, Bombyx Batryticatus 12 flavor medical materials decoct with water secondary, each 2 hours, collecting decoction, filter, filtrate leaving standstill makes precipitation, get supernatant and above-mentioned ginseng liquid percolation and merge concentrating under reduced pressure, spray drying;
3. substrate: polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, stearic acid hydroxyl oxygen 40 esters, betacyclodextrin, poloxamer, hydroxymethyl starch are received, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, and one or more in above-mentioned pharmaceutically suitable carrier mix;
4. proportioning: with g or kg is unit, by weight, and drug extract dry powder: substrate=1: 0.5～1: 20;
5. adopt water-bath, oil bath or other mode of heatings, with the mixed material heating, until the fused solution and/or emulsion and/or the suspension that obtain containing drug extract dry powder and substrate, mixing;
6. adopt the special drilling pill machine, the specification of pre-set required drop pill, and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on 50 ℃～90 ℃, the temperature cooling of condensing agent also forms the thermograde that decays gradually from top to bottom, upper temp is 15 ℃～35 ℃, and bottom temp is-5 ℃～10 ℃;
7. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, to contain the fused solution of extract drugs and substrate and/or emulsion and/or suspension places in the water dropper jar of drop pill machine, splash in the condensing agent, shrink molding.Condensing agent is selected methyl-silicone oil for use;
8. will shrink the drop pill taking-up of molding by the outlet of drop pill machine, remove the surface condensation agent, be drying to obtain.
Beneficial effect
Ginseng, astragalus diabetes dropping pills is that ginseng, astragalus diabetes granule dosage changing form comes, and belongs to the dosage changing form kind that production technology does not have the change of matter.Form by 13 flavor medical materials such as Radix Ginseng, the Radix Astragali, Rhizoma Dioscoreae, the Rhizoma Atractylodis Macrocephalae, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Rhizoma Polygonati Odorati, Radix Rehmanniae Preparata, Poria.But we have supplementing QI and nourishing YIN, grow the spleen the kidney invigorating, and the type ii diabetes of deficiency of both QI and YIN is had obvious blood sugar reducing function.Confirm through clinical experiment, behind the ginseng, astragalus diabetes granule therapy syndrome of deficiency of both qi and yin, thirsty, polydipsia, polyuria, lassitude, giddies etc. all take an evident turn for the better, and the patient feels good, no hypoglycemia generation, and in the medication process, do not observe significant side effects.And the patient is in the selection of medicine for treatment, and the side effect in the chemicals is more obvious, develops therefore that preparation stabilization, drug safety, dosage are accurate, quality controllable, the reliable Chinese medicine preparation of curative effect has great importance.
The ginseng, astragalus diabetes preparation that utilizes prior art to obtain, reasons such as characteristics owing to technology of preparing and dosage form itself, also exist some defectives in actual use, be not enough to satisfy fully the needs of clinical treatment, as ginseng, astragalus diabetes granule, tablet and capsule, exist after taking that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, liver sausage first pass effect and the lower problem of bioavailability.Ginseng, astragalus diabetes dropping pills involved in the present invention and adopt the drops of solid dispersion technology of preparing has thoroughly changed the existing defective of conventional drug composition oral preparation from the frame mode of medicine.Utilize surfactant to make solid dispersion with Radix Notoginseng extractum for substrate; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases; and substrate is hydrophilic; medicine is had wetting action, can make that medicine is rapidly molten to loose into microgranule or solution, thereby make the dissolving of medicine and absorb and accelerate; thereby improved bioavailability, brought into play efficient, quick-acting effects.Ginseng, astragalus diabetes dropping pills involved in the present invention is to be mixed mutually with molten matrix by the extract that contains active constituents of medicine, splashes in the not miscible condensation and makes.Therefore, the medicine stability height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
Existing drop pill technology of preparing, its system principle are to rely on medicine and the formed medicine of substrate mixed liquor self gravitation to splash into to meet in the condensed fluid quenching to shrink to form, and the size that formed medicine drips relies on the characteristic of medicine itself to a great extent; The selection of condensing agent also is difficult to satisfy the forming requirements of big specification drop pill in the existing drop pill technology of preparing simultaneously, so can't prepare the above big specification drop pill of 100mg.The single dose of many Chinese medicine dripping pills preparations is all more than 20, and this takes to the patient and brings very big inconvenience.Especially gerontal patient, greatly inconvenience especially.Big specification ginseng, astragalus diabetes dropping pills involved in the present invention, utilize the special drilling pill machine, the traditional handicraft that overcome of success is only dripped the disadvantage of making by medicinal liquid gravity, simultaneously again the process conditions of the kind temperature of condensing agent are carried out rational experiment screening, successfully prepare the above big specification ginseng, astragalus diabetes dropping pills of 100mg, make that utilizing the drop pill technology of preparing that the Chinese medicine dosage form is improved becomes possibility, brought more convenience also for taking of extensive patients, especially make things convenient for the gerontal patient, conveniently take and carry.
Do not have dust when ginseng, astragalus diabetes dropping pills is produced in addition, help labor protection, equipment is simple, and is easy to operate, and production process is few, and the cycle is short, automaticity height, so productivity ratio height, and the relatively low working condition of cost is easy to control, and the ball method of double differences is different little, and content is more accurate.
The specific embodiment
Now with several groups of specific embodiments, be described further with regard to the preparation method of ginseng, astragalus diabetes dropping pills of the present invention and big specification ginseng, astragalus diabetes dropping pills:
The prescription: Radix Ginseng 5.6g, Radix Astragali 39.0g, Rhizoma Dioscoreae 27.8g, Rhizoma Atractylodis Macrocephalae 16.6g, Fructus Schisandrae Chinensis 8.4g, Radix Ophiopogonis 27.8g, Rhizoma Polygonati Odorati 27.8g, Radix Rehmanniae Preparata 14.0g, Radix Achyranthis Bidentatae 16.6g, Poria 16.6g, Rhizoma Alismatis 16.6g, Fructus Arctii 16.6g, Bombyx Batryticatus 16.6g;
2. the extraction of raw material and preparation: the Radix Ginseng powder is broken into coarse powder, according to percolation, makes solvent with 60% ethanol, soaks and carries out percolation after 24 hours, collects the liquid 20ml that filters, and reclaims ethanol, and is standby; All the other Radix Astragali Radixs Astragali, Rhizoma Dioscoreae, the Rhizoma Atractylodis Macrocephalae, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Rhizoma Polygonati Odorati, Radix Rehmanniae Preparata, Radix Achyranthis Bidentatae, Poria, Rhizoma Alismatis, Fructus Arctii, Bombyx Batryticatus 12 flavors decoct with water secondary, each 2 hours, collecting decoction, filter, filtrate leaving standstill makes precipitation, get supernatant and above-mentioned ginseng liquid percolation and merge, being evaporated to relative density is 1.05～1.10, spray drying.
3. substrate: Macrogol 4000, polyethylene glycol 6000, Macrogol 4000+polyethylene glycol 6000.
4. proportioning: with g or kg is unit, by weight, and drug extract dry powder: substrate=1: 1～1: 3.
5. adopt water-bath, oil bath or other mode of heatings, with the mixed material heating, until the fused solution and/or emulsion and/or the suspension that obtain containing drug extract dry powder and substrate, mixing.
6. adopt the special drilling pill machine, the specification of pre-set required drop pill, and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on 50 ℃～90 ℃, the temperature cooling of condensing agent also forms the thermograde that decays gradually from top to bottom, upper temp is 15 ℃～35 ℃, and bottom temp is-5 ℃～10 ℃.
7. condensing agent: liquid paraffin, soybean oil, methyl-silicone oil.
8. when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, to contain the fused solution of extract drugs and substrate and/or emulsion and/or suspension places in the water dropper jar of drop pill machine, splash in the condensing agent, shrink molding.The drop pill that will be shunk molding by the outlet of drop pill machine takes out, and removes the surface condensation agent, is drying to obtain.
Result of the test
Example one is selected different substrates, different proportionings with substrate of drug extract dry powder and select different water dropper temperature to carry out the test of prescription.
EXPERIMENTAL DESIGN: in order to observe under the following condition: 1. select different substrates, 2. same matrix is selected different proportionings, 3. same matrix proportioning of the same race selects the different temperature of bowing to carry out the influence of prescription to product involved in the present invention, respectively with Polyethylene Glycol-4000, polyethylene glycol 6000, substrate such as Macrogol 4000+polyethylene glycol 6000 are mixed mutually with raw material powder, respectively according to drug extract dry powder: substrate=1: 1/1: 1.5/1: 2 proportioning, other are all according to the given condition in [specific embodiment], adopt electrically heated mode that the former secondary material that each assembly makes is heated to molten condition respectively, adopt special-purpose drop pill machine, regulate the water dropper temperature respectively and make and remain on 70 ± 2 ℃ and 80 ± 2 ℃; With the methyl-silicone oil is condensing agent, the refrigeration control system of regulating the drop pill machine makes the temperature of condensing agent remain on 20 →-5 ℃, be prepared respectively by the given technology in front [specific embodiment] again, can obtain 3 raw materials respectively with the test of the prescription of different substrates, and obtain 18 groups of different experimental results and see attached list one;
Select the test of different condensing agents in example two preparation process
EXPERIMENTAL DESIGN: select of the influence of different condensing agents in the preparation process to product involved in the present invention in order to observe, respectively with liquid paraffin, soybean oil, methyl-silicone oil as condensing agent, other are all according to the given condition in [specific embodiment], substrate selects for use Macrogol 4000 to mix mutually with 1.5: 1 ratio with dry powder, adopt electrically heated mode that the former secondary material that each assembly makes is heated to molten condition respectively, adopt special-purpose drop pill machine, regulate the water dropper temperature respectively and make and remain on 70 ± 2 ℃; The refrigeration control system of regulating the drop pill machine makes the temperature of condensing agent remain on 20 →-5 ℃, be prepared respectively by the given technology in front [specific embodiment] again, can obtain 3 raw materials and divide prescription test with different substrates, and obtain 3 groups of different experimental results and see attached list two.
Result of the test such as table one, matrix species
| Polyethylene Glycol-4000 | Polyethylene Glycol-4000+6000 | Polyethylene Glycol-6000 | ||||||
| Substrate and medicine ratio | Drip system temperature ℃ | Smooth rounding rate (%) | Substrate and medicine ratio | Drip system temperature ℃ | Smooth rounding rate (%) | Substrate and medicine ratio | Drip system temperature ℃ | Smooth rounding rate (%) |
| 1.0∶1 | 70±2 | 0.0 | 1.0∶1 | 70±2 | 0.0 | 1.0∶1 | 70±2 | 0.0 |
| 1.0∶1 | 80±2 | 40.5 | 1.0∶1 | 80±2 | 0.0 | 1.01 | 80±2 | 0.0 |
| 1.5∶1 | 70±2 | 95.5 | 1.5∶1 | 70±2 | 30.4 | 1.5∶1 | 70±2 | 0.0 |
| 1.5∶1 | 80±2 | 96.6 | 1.5∶1 | 85±2 | 35.6 | 1.5∶1 | 80±2 | 46.2 |
| 2.0∶1 | 70±2 | 98.2 | 2.0∶1 | 70±2 | 75.5 | 2.0∶1 | 70±2 | 25.6 |
| 2.0∶1 | 80±2 | 97.6. | 2.0∶1 | 80±2 | 78.2 | 2.0∶1 | 80±2 | 65.4 |
By table one as seen, adopting Macrogol 4000 (1.5: 1) is substrate, and substrate and medicament mixed ratio 1.5: 1 are dripped 70 ± 2 ℃ or 80 ± 2 ℃ combination conditions of system temperature, and the smooth rounding rate of drop pill is higher.
The screening of table two condensing agent
By table one as seen, soybean oil is because density is little, and the sedimentation velocity of drop pill is fast, and hangover is serious, causes mouldability bad.Liquid paraffin density is bigger slightly than soybean oil density, and sedimentation velocity is slower, no conditions of streaking, but this product ball heavy big, in the infall process total condensation of failing, cause mouldability bad.Methyl-silicone oil density maximum, the sedimentation velocity minimum does not have hangover, good moldability.
Claims (8)
1. the ginseng, astragalus diabetes dropping pills preparation of a supplementing QI and nourishing YIN mainly forms with 13 flavor feedstock production such as the Radix Ginseng Radixs Astragali, is used for thirsty, polydipsia, the polyuria of diabetes, lassitude, dizzy (type ii diabetes):
1.1 raw material: the extract dry powder that contains Radix Ginseng, the Radix Astragali, Rhizoma Dioscoreae, the Rhizoma Atractylodis Macrocephalae, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Rhizoma Polygonati Odorati, Radix Rehmanniae Preparata, Radix Achyranthis Bidentatae, Poria, Rhizoma Alismatis, Fructus Arctii, Bombyx Batryticatus 13 flavor active ingredient of Chinese herbs;
1.2 the prescription: Radix Ginseng 5.6g, Radix Astragali 39.0g, Rhizoma Dioscoreae 27.8g, Rhizoma Atractylodis Macrocephalae 16.6g, Fructus Schisandrae Chinensis 8.4g, Radix Ophiopogonis 27.8g, Rhizoma Polygonati Odorati 27.8g, Radix Rehmanniae Preparata 14.0g, Radix Achyranthis Bidentatae 16.6g, Poria 16.6g, Rhizoma Alismatis 16.6g, Fructus Arctii 16.6g, Bombyx Batryticatus 16.6g;
1.3 substrate: polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, stearic acid hydroxyl oxygen 40 esters, betacyclodextrin, poloxamer, hydroxymethyl starch are received, sodium lauryl sulphate, stearic acid, sodium stearate, glycerin gelatine, Lac, the mixture of one or more in above-mentioned pharmaceutically suitable carrier;
1.4 proportioning: with g or kg is unit, by weight, and drug extract dry powder: substrate=1: 0.5～1: 10.
2. ginseng, astragalus diabetes dropping pills preparation as claimed in claim 1 comprises common specification and big specification ginseng, astragalus diabetes dropping pills, and the every ball of common specification ginseng, astragalus diabetes dropping pills weighs 5～50mg, and the big every ball of specification ginseng, astragalus diabetes dropping pills is great in equaling 100mg.
3. ginseng, astragalus diabetes dropping pills preparation as claimed in claim 1 is characterized in that the proportioning of addressing is a drug extract dry powder: substrate=1: 1～1: 3.
4. ginseng, astragalus diabetes dropping pills preparation as claimed in claim 1 is characterized in that the substrate of being addressed is Macrogol 4000-6000.
5. the preparation method that is used for the described ginseng, astragalus diabetes dropping pills preparation of claim 1 the steps include: that the Radix Ginseng powder is broken into coarse powder, uses percolation to carry out percolation, collects the liquid of filtering, and reclaims ethanol, and is standby; All the other Radixs Astragali, Rhizoma Dioscoreae, the Rhizoma Atractylodis Macrocephalae, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Rhizoma Polygonati Odorati, Radix Rehmanniae Preparata, Radix Achyranthis Bidentatae, Poria, Rhizoma Alismatis, Fructus Arctii, Bombyx Batryticatus 12 flavor medical materials decoct with water, filter, filtrate leaving standstill makes precipitation, gets supernatant and above-mentioned ginseng liquid percolation and merges, be evaporated to spray drying; Adopt water-bath, oil bath or other mode of heatings, with the mixed material heating, until the fused solution and/or emulsion and/or the suspension that obtain containing drug extract and substrate, mixing, last drop pill machine drips and makes ball.
6. the preparation method that is used for the described ginseng, astragalus diabetes dropping pills preparation of claim 5 is characterized in that enough being become by following step:
6.1 the extraction of raw material and preparation: the Radix Ginseng powder is broken into coarse powder, with percolation, makes solvent with 60% ethanol, soaks and carries out percolation after 24 hours, collects percolate, reclaims ethanol, and is standby; All the other Radixs Astragali, Rhizoma Dioscoreae, the Rhizoma Atractylodis Macrocephalae, Fructus Schisandrae Chinensis, Radix Ophiopogonis, Rhizoma Polygonati Odorati, Radix Rehmanniae Preparata, Radix Achyranthis Bidentatae, Poria, Rhizoma Alismatis, Fructus Arctii, Bombyx Batryticatus 12 flavor medical materials decoct with water secondary, each 2 hours, collecting decoction, filter, filtrate leaving standstill makes precipitation, get supernatant and above-mentioned ginseng liquid percolation and merge concentrating under reduced pressure, spray drying;
6.2 will make dry powder with 1: 1～5 ratio by previous step, mix with the matrix phase as adjuvant: substrate can be for polyethylene glycols, sorbitol anhydride class, polyoxyethylene sorbitol acid anhydride class, stearic acid hydroxyl oxygen 40 esters, betacyclodextrin, poloxamer, hydroxymethyl starch be received, sodium lauryl sulphate, sodium stearate, glycerin gelatine, Lac, and one or more in above-mentioned pharmaceutically suitable carrier mix;
6.3 adopt water-bath, oil bath or other mode of heatings, with the mixed material heating, until the fused solution and/or emulsion and/or the suspension that obtain containing drug extract dry powder and substrate, mixing;
6.4 adopt the special drilling pill machine, the specification of pre-set required drop pill, and the temperature control system of adjustment drop pill machine, make the water dropper temperature heating of drop pill machine and remain on 50 ℃～90 ℃, the temperature cooling of condensing agent also forms the thermograde that decays gradually from top to bottom, upper temp is 15 ℃～35 ℃, and bottom temp is-5 ℃～10 ℃;
6.5 when treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and reaching desired state of temperature, to contain the fused solution of extract drugs and substrate and/or emulsion and/or suspension places in the water dropper jar of drop pill machine, splash in the condensing agent, shrink molding, promptly.
7 preparation methoies as claimed in claim 5 is characterized in that: described condensing agent be liquid paraffin, soybean oil, methyl-silicone oil one or more mix.
8 preparation methoies as claimed in claim 6 is characterized in that condensing agent is a methyl-silicone oil.
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| JP2012528144A (en) * | 2009-05-26 | 2012-11-12 | 株式会社アモーレパシフィック | Saponin bioavailability enhancing composition |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2012528144A (en) * | 2009-05-26 | 2012-11-12 | 株式会社アモーレパシフィック | Saponin bioavailability enhancing composition |
| US10172900B2 (en) | 2009-05-26 | 2019-01-08 | Amorepacific Corporation | Composition with improved bioavailabilty of saponin and method for improving the bioavailability of saponin |
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