CN1634032A - Andrographolide preparation and its production method - Google Patents
Andrographolide preparation and its production method Download PDFInfo
- Publication number
- CN1634032A CN1634032A CNA2004100407654A CN200410040765A CN1634032A CN 1634032 A CN1634032 A CN 1634032A CN A2004100407654 A CNA2004100407654 A CN A2004100407654A CN 200410040765 A CN200410040765 A CN 200410040765A CN 1634032 A CN1634032 A CN 1634032A
- Authority
- CN
- China
- Prior art keywords
- andrographolide
- preparation
- gel
- coating
- medicated powder
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Medicinal Preparation (AREA)
Abstract
The invention relates to the andrographolide preparation and its production method which comprises andrographolide and right amount of adjuvant, and is made into the form of dispersible tablet, micro-pellet, gelling agent, the medicament can be applied for treating common cold, throat gall, boil of the tongue, dysentery, snakebite, and cardiovascular and cerebrovascular diseases.
Description
Technical field: the present invention is a kind of andrographolide preparation and preparation method thereof, belongs to technical field of Chinese medicine.
Technical background: andrographolide is the extract of Chinese medicine Herba Andrographis; be used for cold, fever more; laryngopharynx swelling and pain, aphtha of the mouth and tongue, pertussis chronic cough; dysentery; the puckery pain of pyretic stranguria, carbuncle skin infection, the treatment of venom and cardiovascular and cerebrovascular disease; can activate and anti-fibrinolytic, antioxidation and protection vascular endothelial cell by antiplatelet, suppress vascular smooth muscle cell curing.A large amount of research has been done to it by many inventors and medicine enterprise, the product of some treatments also is provided: as: andrographolide sheet, andrographolide capsule or the like, but the problem that they exist is: dosage form is too backward, product quality is not ideal enough, the dosage form kind is abundant inadequately, is suitable for crowd's narrow range; Poorly soluble, the case of thermal instability of what is more important andrographolide makes product bioavailability, medicine stability undesirable; It is that " 03110092 ", name are called the patent application of " dripping pills of andrographolide and preparation method thereof " that the Chinese patent communique discloses number of patent application, and number of patent application is that " 03141925 ", name are called the patent application of " andrographolide soft capsule formulation and preparation method thereof "; These two applications try hard to solve the deficiency that prior art, product exist, but we find: rely on the drug loading of its drop pill that provides, soft capsule preparation smaller, taking dose is bigger; Its production technology can not satisfy production requirement fully in addition.
Summary of the invention: the objective of the invention is to: provide a kind of andrographolide preparation and preparation method thereof, to solve these problems that prior art exists; At prior art, among the present invention andrographolide is prepared into micropill, gel, dispersible tablet formulation, their disintegrative is good, solved poorly soluble composition bioavailability problem, be particularly suitable for the old people and swallow tablet or the inconvenient patient of capsule take, owing to adopt packaging technique, so help stable components; Simultaneously, the preparation technology's that the present invention finishes screening, make the preparation technology provide rationally, science, feasible, can directly instruct the production of enterprise, guarantee the product that obtains effectively.
The present invention constitutes like this: it is to be formed by the andrographolide processing and fabricating.Preparation of the present invention comprises: injection comprises: all acceptable dosage forms on injection, powder pin, freeze-dried powder, gel, tablet, dispersible tablet, capsule, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, gel, oral liquid, soft extract, extractum and the membrane pharmaceutics.Say that accurately preparation of the present invention is dispersible tablet, gel, micropill.The preparation method of andrographolide preparation of the present invention: get andrographolide 20～100g, add appropriate amount of auxiliary materials, make 1000, sheet, ball or the like different preparation again.
Concretely, dispersible tablet of the present invention prepares like this: get andrographolide, adding and medicated powder ratio are 3: 1 amylum pregelatinisatum, with the medicated powder ratio be 3: 1 crospolyvinylpyrrolidone mix homogeneously, make soft material with 3% polyvinylpyrrolidone aqueous solution, by No. 2 sieve series grains, 50～60 ℃ of forced air dryings, dry granular is after No. 3 sieve granulate, adding and medicated powder ratio are 1: 1 carboxymethyl starch sodium, adding and medicated powder ratio are 1: 1 steviosin, mix tabletting, coating then, Opadry 2 is a coating material, and coating adopts top spray method: nozzle diameter 1mm, fluidisation air quantity 100m
3/ h, 50 ℃ of inlet temperature, 35 ℃ of bed body temperature degree, atomizing pressure 0.15MPa, hydrojet speed 5mL/min, promptly.
Pellet of the present invention prepares like this: get andrographolide, adding and medicated powder ratio are 1: 1 microcrystalline Cellulose, and the mixing that sieves adds suitable quantity of water and makes soft material, and through the extruder sieve plate, aperture 0.9mm is extruded into fine strip shape, extrudes rotating speed 300rmin
-1, put in the spheronizator, regulate rotating speed 1000rmin
-1And round as a ball time 4min, make granule round as a ball fully, take out micropill in 50 ℃ of drying 3～4h, after the screening, carry out coating with 18～24 purpose micropills, Opadry 2 is a coating material, coating adopts top spray method: nozzle diameter 1mm, fluidisation air quantity 100m
3/ h, 55 ℃ of inlet temperature, 35 ℃ of bed body temperature degree, atomizing pressure 0.2MPa, hydrojet speed 10mL/min, promptly.
Gel of the present invention prepares like this: getting andrographolide, is Cera Flava: andrographolide by weight: acetone=14: 10: 7, get the Cera Flava that andrographolide places fusing, stir, after adding acetone, place frozen water, continue to stir into microcapsule; Jelly powder with 6% is broken into the attritive powder shape, and the gelatin limit adds the waterside stirring then, and rising temperature for dissolving is made glue, adds the andrographolide microcapsule when glue drops to 65 ℃ of left and right sides, adds fashionable stirring, and then at 65 ℃ of 30min that sterilize down, cold putting promptly gets gel.
Compared with prior art, pharmaceutical preparation provided by the invention is used for cold, fever, laryngopharynx swelling and pain, aphtha of the mouth and tongue, the pertussis chronic cough, dysentery, the puckery pain of pyretic stranguria, carbuncle skin infection, the treatment of venom and cardiovascular and cerebrovascular disease, can activate and anti-fibrinolytic, antioxidation and protection vascular endothelial cell by antiplatelet, suppress vascular smooth muscle cell curing, its effect is remarkable; At prior art, the micropill that provides, dispersible tablet, gel, disintegrative is good, solved poorly soluble composition bioavailability problem, be particularly suitable for the old people and swallow tablet or the inconvenient patient of capsule take, adopted packaging technique, help stable components; Adopt the gel of microcapsule technique for packing preparation, good mouthfeel, all-ages, enlarged use crowd scope, have the vast market potentiality; Reached the purpose of invention.
The applicant has carried out a series of experiments, with the supplementary product kind of the preparation technology that selects pharmaceutical preparation provided by the invention, use and consumption, ratio etc.; Guarantee its science, reasonable, feasible; The preparation that obtains has effective therapeutic effect.
Experimental example 1: Study on Forming
(1) dispersible tablet Study on Forming
Dispersible tablet meet water rapidly disintegrate form the water dispersion tablet of uniform sticky suspension, it is poor to have solved former dosage form disintegrative, stripping is shortcoming slowly, and the dispersible tablet that the applicant makes is disintegrate fully in the 3min in 19 ℃～21 ℃ water, and suspension ability is good, bioavailability is high, dispersed homogeneous degree.Check disintegration: adopting changes the basket method, and the lift disintegration tester is got 6, observes the situation by screen cloth, and percent of pass height then disintegrative is good, more pleasant bulk absorption.
1. adjuvant screening
Adjuvant prescription 1 prescription 2 prescriptions 3 prescriptions 4
Consumption (medicine: adjuvant)
Lactose-1: 12: 13: 1
Amylum pregelatinisatum 3: 12: 11: 1-
Carboxymethyl starch sodium 1: 1-2: 13: 1
Crospolyvinylpyrrolidone 3: 12: 11: 1-
Cross-linking sodium carboxymethyl cellulose-1: 12: 13: 1
Polyvinylpyrrolidone--1: 12: 1
Steviosin 1: 12: 13: 1-
The result shows, optimum process condition for add with the medicated powder ratio be 3: 1 amylum pregelatinisatum, with the medicated powder ratio be 3: 1 crospolyvinylpyrrolidone, with the medicated powder ratio be that 1: 1 carboxymethyl starch sodium, adding and medicated powder ratio is 1: 1 steviosin.
2. art for coating
Group inlet temperature ℃ atomisation pressure Mpa hydrojet speed mL/min coating effect
1 45 0.15 5 is general, and many glutinous companies are arranged
2 45 0.15 10 is better, and micropill has seldom to be measured glutinous the company
3 45 0.20 5 is general, and many glutinous companies are arranged
4 45 0.20 10 is better, and micropill has seldom to be measured glutinous the company
5 50 0.15 5 is good, not glutinous company the between the micropill
6 50 0.15 10 is general, and many glutinous companies are arranged
7 50 0.20 5 is better, and micropill has seldom to be measured glutinous the company
8 50 0.20 10 is better, and micropill has seldom to be measured glutinous the company
The result shows that optimised process is 50 ℃ of inlet temperature, atomizing pressure 0.15Mpa, hydrojet speed 5mL/min.
(2) pellet Study on Forming
1. preparation technology: the plane critical angle of this measuring micropill, be about to a certain amount of micropill and put on the flat board, a dull and stereotyped side is lifted, to measure at micropill begin the to roll angle (φ) of top rake plane and horizontal plane, this angle is more little, and the roundness of micropill is good more.
Group is extruded rotating speed rmin
-1Round as a ball rotating speed rmin
-1Round as a ball time min 2 φ/°
1 100 500 2 36.7
2 100 800 4 34.4
3 100 1000 6 28.5
4 200 500 4 36.0
5 200 800 6 39.2
6 200 1000 2 36.6
7 300 500 6 37.8
8 300 800 2 31.8
9 300 1000 4 27.8
The result shows that optimised process is for extruding rotating speed 300rmin
-1, put in the spheronizator, regulate rotating speed 1000rmin
-1And round as a ball time 4min.
2. art for coating
Group inlet temperature ℃ atomisation pressure Mpa hydrojet speed mL/min coating effect
1 50 0.15 10 is general, and many glutinous companies are arranged
2 50 0.15 15 is better, and micropill has seldom to be measured glutinous the company
3 50 0.20 10 is general, and many glutinous companies are arranged
4 50 0.20 15 is better, and micropill has seldom to be measured glutinous the company
5 55 0.15 10 is general, and many glutinous companies are arranged
6 55 0.15 15 is general, and many glutinous companies are arranged
7 55 0.20 10 is good, not glutinous company the between the micropill
8 55 0.20 15 is better, and micropill has seldom to be measured glutinous the company
The result shows that optimised process is 55 ℃ of inlet temperature, atomizing pressure 0.2MPa, hydrojet speed 10mL/min.
(3) gel forming technical study
(1) screening of coating material: the external stripping of andrographolide and andrographolide microcapsule is compared, and the vitamin C crystal is i.e. all dissolvings in 20s, and the dissolution rate of vitamin C microcapsule is compared and wanted slowly.And using different coating materials, its dissolution rate is also different.Get natural Cera Flava, gelatin and ethyl cellulose respectively as coating material, make microcapsule, unite dimension C crystal and do external stripping experiment, and after 6 hours, 8 hours and 12 hours, write down its stripping quantity according to standards of pharmacopoeia.Data see Table 1
The vitamin C microcapsule dissolution rate that the different lappings of table 1 are made compares:
Lapping 6 hours (%) 8 hours (%) 12 hours (%)
Andrographolide 100 100 100
Cera Flava 65.23 72.58 80.34
Gelatin 45.35 56.24 57.68
Ethyl cellulose 54.57 60.86 67.42
Experimental result shows, the microcapsule that uses natural Cera Flava to make as coating material, and its external dissolution rate is apparently higher than the microcapsule that uses other coating materials to make.
(2) microcapsule Study on Preparation: the Cera Flava that quantitative andrographolide is placed fusing, stir, after adding acetone and other adjuvants, place frozen water, continue to stir into microcapsule, make three groups of microcapsules that ratio is different, each group ratio is respectively (Cera Flava: andrographolide: acetone): group 1 (12: 10: 7), group 2 (14: 10: 5), group 3 (14: 10: 7).Three batches of microencapsulated sample and material sample are placed conical flask respectively, uncovered, and placed 9 days 50 ℃ of waters bath with thermostatic control respectively, every 24 hours, quantitative sampling, survey its content.Data see Table 2
The changes of contents of table 2 microcapsule different time under 50 ℃ of temperature: (being located at 0 o'clock is 100%)
Group 1 group 2 groups 3
Per 98.35 97.58 99.58
Every 97.84 97.21 99.45
24 96.22 96.98 98.56
Little by 94.58 96.28 98.35
The time 93.75 96.13 98.15
93.24 95.75 97.82
Vc 92.61 95.61 97.24
Contain 91.67 94.32 97.12
Measure 91.54 93.74 97.02
Experimental result shows: the encystation of microcapsule, the optimal proportion of good stability are Cera Flava: andrographolide c: acetone=14: 10: 7
(3) gel consumption: adopting gelatin in development is gel, gelatin has very strong jelly power, than using agar, the fruit jelly that starch is made, more high resilience, sustained when chewing, caloric value is little, be easy to digest and assimilate, and it is a kind of protein, except that lacking tryptophan, contains other whole essential amino acids, add in the fruit jelly and can improve its nutritive value, experiment shows, adopts gelatin as gel, and the product quality is even, transparency is good, mouthfeel is crisp tough, but rate of set is slow, need to add 6% gelatin, otherwise easily produces lamination or toughness is too strong, mouthfeel is bad.
Gelatin consumption % product
5% quality is even, and transparency is good, layering
6% quality is even, and transparency is good, and quality is crisp tough, and is not stratified
7% quality is even, and transparency is good, and quality is tough, and is not stratified
Experimental example 2: contrast experiment
(1) check disintegration: adopting changes the basket method, and the lift disintegration tester is got 6, observes the situation by screen cloth, and percent of pass height then disintegrative is good, more pleasant bulk absorption
The group disintegration time
Andrographolide capsule 25min
Micropill 2.40min of the present invention
(2) release experiment: simulated gastric fluid-95% ethanol (3: 2) is solvent, 37 ± 0.5 ℃ 100 rev/mins.Get andrographolide sheet, soft capsule of the present invention, drop pill of the present invention, put and get the 6ml solvent when changeing in the basket respectively at 5min, 10min, 20min, 30min, 40min, 50min, 60min, 90min, put immediately in the centrifuge tube with 4,000 rev/mins of centrifugal 5min, get supernatant 5ml, thin up is to 10ml, content with high-efficient liquid phase technique mensuration andrographolide lactone calculates the cumulative percentage rate that discharges.
Discharge cumulative percentage rate %
Andrographolide sheet dispersible tablet of the present invention
5min 5.34 83.05
10min 41.22 92.18
20min 62.50 95.62
30min 68.86 97.75
40min 78.53 98.52
50min 87.55 100.00
60min 89.56 100.10
90min 92.37 102.30
(3) stability experiment
Andrographolide lactone %
0 month 6 months March of group
Andrographolide sheet 0.84 0.77 0.74
Andrographolide capsule 0.83 0.79 0.76
Dispersible tablet 0.82 0.81 0.80 of the present invention
Micropill 0.83 0.82 0.81 of the present invention
The result shows that preparation of the present invention is functional.
Experimental example 3: pharmacodynamic experiment
(1) antibacterial anti-inflammatory effect experiment
1. antiinflammatory action: mice dimethylbenzene is brought out the influence of mice auricle swelling
Get body weight 20-26g mice, be divided into 4 groups at random, irritate stomach respectively and give different preparations, the administration capacity is the 0.25g/kg body weight, and 2 times/day, successive administration 6d, be coated with dimethylbenzene 0.1ml in the Mus auris dextra back of the body in 30 minutes after the last administration, mice is put to death in the cervical vertebra dislocation after 2 hours, lays round auricle with card punch in left and right sides ear same area, weighs.Experimental result shows that product xylol of the present invention brings out mice auricle swelling all the obvious suppression effect, sees the following form.
Group number of animals contrast swelling degree (g)
Capsule matched group 0.8g/kg 10 100.0 0.015 ± 0.001
Gel experimental group 0.8g/kg 10 100.0 0.013 ± 0.002
Dispersible tablet experimental group 0.8g/kg 10 100.0 0.011 ± 0.003
2. external bacteriostasis research
The preparation of ordinary culture medium: escherichia coli, staphylococcus aureus, bacillus pyocyaneus are inoculated into common Nutrient medium surface with getting the collarium densification respectively, the filter paper that will contain the diameter 0.4cm of formulation soln with the sterile working is attached on the culture medium, cultivates 24h for 37 ℃ and observes the measurement inhibition zone diameter.The preparation of blood plate culture medium: behind autoclave sterilization on the ordinary nutrient agar medium base, add 5%～10% aseptic defiber sheep blood mixing when being cooled to 56 ℃, pour in the culture dish standby.Bacteriostatic experiment: with alpha streptococcus, group B streptococcus with get collarium respectively densification be inoculated on the blood plate nutrition base, after the filter paper that will contain the diameter 0.4cm of formulation soln with the sterile working is attached on the culture medium, cultivates 24h for 37 ℃ and observe and measure inhibition zone diameters.
Group strain inhibition zone diameter meansigma methods d/cm
Tablet matched group escherichia coli 0.765
Staphylococcus aureus 0.816
Bacillus pyocyaneus 0.802
Alpha streptococcus 1.476
Group B streptococcus 1.418
Pellet experimental group escherichia coli 0.876
Staphylococcus aureus 0.910
Bacillus pyocyaneus 0.815
Alpha streptococcus 1.485
Group B streptococcus 1.426
Dispersible tablet experimental group escherichia coli 0.879
Staphylococcus aureus 0.920
Bacillus pyocyaneus 0.819
Alpha streptococcus 1.482
Group B streptococcus 1.423
The result shows that preparation antiinflammatory fungistatic effect of the present invention is good, and effect is not less than tablet, capsule.
(2) to the protective effect of rat experiment myocardial ischemia
20 of SD rats, wt, 175 ± 24g, the male and female dual-purpose is divided into treatment group (8) and matched group (8) at random, anesthesia is fixing, connect the electrocardiogram electrode, write down one section normal lead electrocardiogram, given the solution (4mg/kg of dispersible tablet of the present invention then respectively, iP) or normal saline (5ml/kg, iP).Behind the 15min, every the equal Sublingual of rat iV pituitrin (0.5U/kg) causes the rat heart muscle ischemia model, and disconnected neck is got blood after 6 hours, opens breast and cores, and uses for collecting serum and preparing myocardium homogenate.Measure MDA in serum and the myocardium homogenate supernatant, the result is expressed as nmol/ml and nmol/mg cardiac muscle weight in wet base respectively.The MDA level is starkly lower than matched group in treatment group cardiac muscle and the serum, shows that the present invention can resist the rat myocardium from injury due to the pituitrin.
1. the influence that acute myocardial ischemia rat MDA is generated
Cardiac muscle (nmol/mg weight in wet base) serum (nmol/ml)
Matched group 4.46 ± 0.31 2.30 ± 0.45
Treatment group 3.01 ± 0.40 1.79 ± 0.20
And is to acute myocardial ischemia rat blood serum LDH and the active influence of 2-HBD, the rat injection of pituitrin after 6 hours disconnected neck get blood, preparation serum, use set time colorimetry and 2,4 respectively---LDH and 2-HBD in the dinitrophenylhydrazine determination of color serum.
2. to acute myocardial ischemia rat blood serum LDH and 2-HBD activity influence
LDH(u/100ml) D-HBD(nu/ml)
Matched group 230.15 ± 86.01 300.26 ± 50.12
Treatment group 127.35 ± 10.11 142.04 ± 30.60
The result shows that preparation of the present invention has good protective action to the rat experiment myocardial ischemia.
Concrete embodiment:
Embodiments of the invention 1: get andrographolide 20g, add with the medicated powder ratio be 3: 1 amylum pregelatinisatum, with the medicated powder ratio be 3: 1 crospolyvinylpyrrolidone mix homogeneously, make soft material with 3% polyvinylpyrrolidone aqueous solution, by No. 2 sieve series grains, 50～60 ℃ of forced air dryings, dry granular is after No. 3 sieve granulate, adding and medicated powder ratio are that 1: 1 carboxymethyl starch sodium, adding and medicated powder ratio is 1: 1 steviosin, mix, tabletting, coating then, Opadry 2 is a coating material, coating adopts top spray method: nozzle diameter 1mm, fluidisation air quantity 100m
3/ h, 50 ℃ of inlet temperature, 35 ℃ of bed body temperature degree, atomizing pressure 0.15MPa, hydrojet speed 5mL/min makes 1000, promptly gets dispersible tablet, and this product is oral, three times on the one, each 2.
Embodiments of the invention 2: get andrographolide 100g, adding and medicated powder ratio are 1: 1 microcrystalline Cellulose, and the mixing that sieves adds suitable quantity of water and makes soft material, and through the extruder sieve plate, aperture 0.9mm is extruded into fine strip shape, extrudes rotating speed 300rmin
-1, put in the spheronizator, regulate rotating speed 1000rmin
-1And round as a ball time 4min, make granule round as a ball fully, take out micropill in 50 ℃ of drying 3～4h, after the screening, carry out coating with 18～24 purpose micropills, Opadry 2 is a coating material, coating adopts top spray method: nozzle diameter 1mm, fluidisation air quantity 100m
3/ h, 55 ℃ of inlet temperature, 35 ℃ of bed body temperature degree, atomizing pressure 0.2MPa, hydrojet speed 10mL/min makes 1000, promptly gets micropill.
Embodiments of the invention 3: get andrographolide 30g, dry, pulverizing is granulated, and tabletting promptly gets tablet.
Embodiments of the invention 4: get andrographolide 40g, add alcohol granulation, promptly get granule.
Embodiments of the invention 5: get andrographolide 50g, add alcohol granulation, encapsulated, promptly get capsule.
Embodiments of the invention 6: get andrographolide 60g, add water for injection, syrup, promptly get oral liquid.
Embodiments of the invention 7: get andrographolide 70g, add carbomer, stir evenly, promptly get gel.
Embodiments of the invention 8: get andrographolide 80g, add microcrystalline Cellulose, granulate, tabletting promptly gets oral cavity disintegration tablet.
Embodiments of the invention 9: getting andrographolide 80g, is Cera Flava: andrographolide by weight: acetone=14: 10: 7, get the Cera Flava that andrographolide places fusing, and stir, behind the adding acetone, place frozen water, continue to stir into microcapsule; Jelly powder with 6% is broken into the attritive powder shape, and the gelatin limit adds the waterside stirring then, and rising temperature for dissolving is made glue, adds the andrographolide microcapsule when glue drops to 65 ℃ of left and right sides, adds fashionable stirring, and then at 65 ℃ of 30min that sterilize down, cold putting promptly gets gel.
Claims (7)
1, a kind of andrographolide preparation is characterized in that: it mainly is to be made by andrographolide.
2, according to the described andrographolide preparation of claim 1, it is characterized in that: be made into injection with andrographolide, comprise: all acceptable dosage forms on injection, powder pin, freeze-dried powder, gel and dispersible tablet, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, gel, oral liquid, soft extract, extractum and the membrane pharmaceutics.
3, according to claim 1 or 2 described andrographolide preparations, it is characterized in that: be made into dispersible tablet, gel preparation or pellet preparations with andrographolide.
4, as the preparation method of any described andrographolide preparation in the claim 1～3, it is characterized in that: get andrographolide 20～100g, add appropriate amount of auxiliary materials, make 1000 as grain, sheet or the different preparation of ball.
5, preparation method according to the described andrographolide preparation of claim 4, it is characterized in that: the dispersible tablet in the described preparation prepares like this: get andrographolide, adding and medicated powder ratio are 3: 1 amylum pregelatinisatum, with the medicated powder ratio be 3: 1 crospolyvinylpyrrolidone mix homogeneously, make soft material with 3% polyvinylpyrrolidone aqueous solution, by No. 2 sieve series grains, 50～60 ℃ of forced air dryings, dry granular is after No. 3 sieve granulate, adding and medicated powder ratio are 1: 1 carboxymethyl starch sodium, adding and medicated powder ratio are 1: 1 steviosin, mix, tabletting, coating then, Opadry 2 is a coating material, and coating adopts top spray method: nozzle diameter 1mm, fluidisation air quantity 100m
3/ h, 50 ℃ of inlet temperature, 35 ℃ of bed body temperature degree, atomizing pressure 0.15MPa, hydrojet speed 5mL/min, promptly.
6, according to the preparation method of the described andrographolide preparation of claim 4, it is characterized in that: the pellet in the described preparation prepares like this: get andrographolide, adding and medicated powder ratio are 1: 1 microcrystalline Cellulose, mixing sieves, add suitable quantity of water and make soft material, through the extruder sieve plate, aperture 0.9mm is extruded into fine strip shape, extrudes rotating speed 300rmin
-1, put in the spheronizator, regulate rotating speed 1000rmin
-1And round as a ball time 4min, make granule round as a ball fully, take out micropill in 50 ℃ of drying 3～4h, after the screening, carry out coating with 18～24 purpose micropills, Opadry 2 is a coating material, coating adopts top spray method: nozzle diameter 1mm, fluidisation air quantity 100m
3/ h, 55 ℃ of inlet temperature, 35 ℃ of bed body temperature degree, atomizing pressure 0.2MPa, hydrojet speed 10mL/min, promptly.
7, according to the preparation method of the described andrographolide preparation of claim 4, it is characterized in that: the gel in the described preparation prepares like this: get andrographolide, it is Cera Flava by weight: andrographolide: acetone=14: 10: 7, get the Cera Flava that andrographolide places fusing, stir, after adding acetone, place frozen water, continue to stir into microcapsule; Jelly powder with 6% is broken into the attritive powder shape, and the gelatin limit adds the waterside stirring then, and rising temperature for dissolving is made glue, adds the andrographolide microcapsule when glue drops to 65 ℃ of left and right sides, adds fashionable stirring, and then at 65 ℃ of 30min that sterilize down, cold putting promptly gets gel.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2004100407654A CN1634032A (en) | 2004-09-24 | 2004-09-24 | Andrographolide preparation and its production method |
| CNA2005102005477A CN1762347A (en) | 2004-09-24 | 2005-09-22 | Andrographolide preparation and its production method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2004100407654A CN1634032A (en) | 2004-09-24 | 2004-09-24 | Andrographolide preparation and its production method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1634032A true CN1634032A (en) | 2005-07-06 |
Family
ID=34845858
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2004100407654A Pending CN1634032A (en) | 2004-09-24 | 2004-09-24 | Andrographolide preparation and its production method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1634032A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102670515A (en) * | 2012-05-30 | 2012-09-19 | 陆荣政 | Andrographolide inclusion compound and preparation process thereof |
| CN103622951A (en) * | 2012-08-27 | 2014-03-12 | 康阳润和（北京）医药科技有限公司 | Preparation method of Andrographolidi Natrii Bisulfis oral liquid |
-
2004
- 2004-09-24 CN CNA2004100407654A patent/CN1634032A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102670515A (en) * | 2012-05-30 | 2012-09-19 | 陆荣政 | Andrographolide inclusion compound and preparation process thereof |
| CN103622951A (en) * | 2012-08-27 | 2014-03-12 | 康阳润和（北京）医药科技有限公司 | Preparation method of Andrographolidi Natrii Bisulfis oral liquid |
| CN103622951B (en) * | 2012-08-27 | 2015-09-30 | 黑龙江佰彤儿童药物研究有限公司 | Lian Bizhi oral liquid its preparation method |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1296052C (en) | Non-injection preparation containing medium and/or low molecular weight chondroitin sulfate | |
| CN1628764A (en) | Creat formulation and its preparation process | |
| CN1634032A (en) | Andrographolide preparation and its production method | |
| CN1443535A (en) | Tegasevod maleate oral preparation and its preparation process-for curing intestinal irritability syndrome | |
| CN1615844A (en) | Development of micro particle silybum marianum preparation | |
| CN1739609A (en) | Common lamiophlomis root prepn and its prepn process | |
| CN1742957A (en) | Sangju effervescent tablet for treating common cold | |
| CN1303990C (en) | Sodium ferulate oral disintegrating tablet and its preparation process | |
| CN101032472A (en) | Ibuprofen rapidly disintegrating tablet in oral cavity for pain treatment and preparing method thereof | |
| CN101066267A (en) | Solid oral medicine composition containing aripiprazole microcrystal | |
| CN1762347A (en) | Andrographolide preparation and its production method | |
| CN1634061A (en) | Pharmaceutical formulation of pseudoephenrine hydrochloride and its preparing process | |
| CN1762400A (en) | 'Xuesaitong' formulation and its preparation method | |
| CN1768800A (en) | Chinese medicinal formulation for treating blennorrhagia and urinary system infection, and preparation method thereof | |
| CN1895535A (en) | Chinese-medicinal preparation for treating gutture disease and it making method | |
| CN1911251A (en) | Traditional Chinese medicine enteric oral liquor using fresh earthworm extractive as active component, and its prepn. method | |
| CN1785188A (en) | Compounding metformin glipidide prepn. for treating diabetes type II, and its prepn. method | |
| CN1513439A (en) | Slow release medicine of pseudo-ephedrine hydrochloride | |
| CN1634096A (en) | Notoginseng total saponin orally disintegrating tablet | |
| CN1626207A (en) | Preparation including unique ingredient and fabricating method | |
| CN1698664A (en) | Isatic root effervescence tablet and preparation method thereof | |
| CN1628654A (en) | Liver benefiting effective agent prepared from hepadestal and preparation method thereof | |
| CN1267094C (en) | Orally disintegrating tablet of safflor yellow and its preparation process | |
| CN1429618A (en) | Erigeron breviscapus oral caving fast disintegration tablet and its preparation method | |
| CN1660250A (en) | Chinese materia medica preparation for treating dysmenorrhea of women |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |