CN1686240A - Coronary salvia micro pill agent and its preparation method - Google Patents
Coronary salvia micro pill agent and its preparation method Download PDFInfo
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- CN1686240A CN1686240A CN 200510020656 CN200510020656A CN1686240A CN 1686240 A CN1686240 A CN 1686240A CN 200510020656 CN200510020656 CN 200510020656 CN 200510020656 A CN200510020656 A CN 200510020656A CN 1686240 A CN1686240 A CN 1686240A
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Abstract
A Chinese medicine in the form of micrpill for treating coronary heart disease, cerebral thrombus, hypertension, cerebral infarction, etc is prepared from red sage root, notoginseng, dalbergia wood oil and excipient.
Description
Technical field: the present invention is a kind of coronary salvia micro pill agent and preparation method thereof, belongs to technical field of Chinese medicine.
Technical background: cardiovascular and cerebrovascular disease such as coronary heart disease, cerebral thrombosis, hypertension, cerebral infarction etc. all are one of the most common and diseases that harm is maximum in the world today, also can cause the damage of organs such as the heart, brain, kidney, cause as diseases such as apoplexy, heart failure, renal failures, serious threat human beings'health and life, it was reported, sickness rate in recent years has and increases trend year by year, and in, young patient constantly increases.Prevent and treat purpose in order to reach, number of research projects has been done by many inventors and medicine enterprise, and the product of some treatments also is provided; As: GUANXIN DANSHEN PIAN, GUANXIN DANSHEN KELI etc., but dosage form falls behind, product quality is not ideal enough, the dosage form kind is abundant inadequately, be suitable for crowd's narrow range, the more important thing is have blood vessel dilating, the tanshinone effective ingredient bioavailability of pharmacological action such as microcirculation improvement is low, and is particularly unfavorable for emergent treatment.And application number is 200410069114.8, name is called the patent of " a kind of coronary red sage root oral disintegration tablet and preparation method thereof ", adopted the dosage form of oral cavity disintegration tablet, though the disintegrate fast in the oral cavity of this product, be dispersed or dissolved in the tablet in the saliva, the patient does not need water or only needs little water medicine can be obeyed down smoothly, but for reaching quickly disintegrated purpose, need to add a large amount of disintegrating agents, general consumption surpasses 50%, if do not carry out purification expensive, very complicated, dose is very big, is unfavorable for taking of patient.
The advantage that micropill has many other oral formulations to compare: 1. can make sustained-release preparation by the controlled release micro pill coating; 2. big at the gastrointestinal tract distribution area, the bioavailability height, zest is little; 3. because particle diameter is little, be subjected to digestive tract to carry the food rhythm and pace of moving things to influence little (close as pylorus etc.); 4. controlled release micro pill can make blood drug level reach curative effect concentration rapidly, and keeps steady, long valid density, and the fluctuation of blood medicine is little; 5. the good fluidity of micropill is evenly big or small, is easy to handle (as coating, divided dose); 6. improve medicine stability, cover disagreeable taste; 7. the compatibility that is fit to compound preparation.In view of such circumstances, be necessary coronary heart disease is carried out form improvement, improve the preparation scientific and technological content, enrich the market kind.
Summary of the invention: the objective of the invention is to: a kind of coronary salvia micro pill agent and preparation method thereof is provided; The present invention is directed to prior art, pellet preparations is provided, solved the low problem of bioavailability, be particularly suitable for the old people and swallow tablet or the inconvenient patient of capsule take, adopted packaging technique, help stable components, can also cover poor taste, the abnormal smells from the patient of medicine, and play the effect that increases stability, improves bioavailability.
The present invention constitutes like this: it is that Radix Salviae Miltiorrhizae 200g, Radix Notoginseng 200g, Lignum Dalbergiae Odoriferae oil 1.75ml add the ball shape preparation that diameter that an amount of excipient makes is less than or equal to 2.5mm.It can also be prepared into: soft capsule, dispersible tablet, oral liquid.Pellet in the described preparation adopts and extrudes-the spheronization pill, adopts top spray method coating.Pellet in the described preparation prepares like this: get Radix Notoginseng and pulverize; Get Radix Salviae Miltiorrhizae and pulverize, ethanol percolation, the liquid of filtering is concentrated into the thick paste shape, and medicinal residues decoct with water, and collecting decoction filters, and filtrate is concentrated in right amount, adds Radix Notoginseng fine powder and thick paste, stirs evenly, and spray adds Lignum Dalbergiae Odoriferae oil; Perhaps Radix Salviae Miltiorrhizae ethanol extraction, filtrate merges, and reclaims ethanol, is condensed into clear paste; Radix Notoginseng powder is broken into coarse powder, alcohol reflux, merge extractive liquid,, filter, filtrate recycling ethanol, and continue to be condensed into clear paste, mix a small amount of kieselguhr, drying under reduced pressure, and be ground into fine powder, with the fine powder alcohol reflux, put cold back and filter, filtrate recycling ethanol concentrates, merge clear paste, spray adds Lignum Dalbergiae Odoriferae oil; Make preparation again.
Say accurately: the pellet in the described preparation prepares like this: get Radix Notoginseng powder and be broken into fine powder; Get Radix Salviae Miltiorrhizae powder and be broken into middle powder, make solvent, carry out percolation with 90% ethanol, the liquid of filtering is concentrated into the thick paste shape, and medicinal residues decoct with water secondary, each 1 hour, collecting decoction filters, and filtrate is concentrated in right amount, add fine powder and thick paste, stir evenly, adding and medicated powder ratio are 1: 1.2 microcrystalline Cellulose, the mixing that sieves adds suitable quantity of water and makes soft material, through the extruder sieve plate, aperture 0.9mm is extruded into fine strip shape, extrudes rotating speed 100rmin
-1, put in the spheronizator, regulate rotating speed 1000rmin
-1And round as a ball time 8min, make granule round as a ball fully, take out micropill in 50 ℃ of drying 3～4h, spray adds Lignum Dalbergiae Odoriferae oil, after the screening, carries out coating with 18～24 purpose micropills, and Opadry 2 is a coating material, and 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 0.15MPa, hydrojet speed 15mL/min, promptly.
Pellet in the described in other words preparation prepares like this: Radix Salviae Miltiorrhizae ethanol extraction secondary, and each 70 minutes, filter, filtrate merges, and reclaims ethanol and continues to be condensed into clear paste; Radix Notoginseng powder is broken into coarse powder, 70% alcohol reflux secondary, each 1.5 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and continue to be concentrated into clear paste, mix a small amount of kieselguhr, drying under reduced pressure, and be ground into fine powder, with fine powder alcohol reflux secondary, each 1 hour, put cold back and filter, filtrate recycling ethanol also continues to be concentrated into clear paste, merges clear paste, adding and medicated powder ratio are 1: 1.2 microcrystalline Cellulose, the mixing that sieves adds suitable quantity of water and makes soft material, through the extruder sieve plate, aperture 0.9mm is extruded into fine strip shape, extrudes rotating speed 100rmin
-1, put in the spheronizator, regulate rotating speed 1000rmin
-1And round as a ball time 8min, make granule round as a ball fully, take out micropill in 50 ℃ of drying 3～4h, spray adds Lignum Dalbergiae Odoriferae oil, after the screening, carries out coating with 18～24 purpose micropills, and Opadry 2 is a coating material, and 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 0.15MPa, hydrojet speed 15mL/min, promptly.
Compared with prior art, the present invention is directed to prior art, micropill is provided, 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.Water solublity of the effective ingredient-TANSHINONES of Radix Salviae Miltiorrhizae is not good in this, makes micropill and can improve medicine and gastrointestinal contact area, is beneficial to the stripping and the absorption of effective ingredient.But find in preparation process: after this product was made micropill, because the surface area increase, hygroscopicity had also increased, and easily bonding is rotten to cause product, influenced the stability and the use of product greatly.In order to increase the moisture resistance of pellet preparations of the present invention, adopted packaging technique, its inlet temperature, atomisation pressure are to the effect of coating, and for example surface roughness influences very big.And the roundness of micropill not only influences the outward appearance of product, and is also closely bound up with the curative effect of product, and the roundness difference is contact area instability, the difficult control of coating stripping inhomogeneous, medicine then; To found through experiments the principal element that influences roundness be round as a ball rotating speed, round as a ball time, extrude rotating speed.In view of selection of process parameters will influence end product quality, for improving the quality of product itself, the applicant has carried out the science screening and has adopted best packaging technique micropill technology, effectively raises the moisture resistance of micropill, and the pill making craft that obtains after the screening (is extruded rotating speed 100rmin by experiment
-1, rotating speed 1000rmin
-1, round as a ball time 8min) and coating conditions (50 ℃ of inlet temperature, atomizing pressure 0.15MPa, hydrojet speed 15mL/min), make micropill of the present invention have superperformance and diseases such as cardiovascular and cerebrovascular disease such as coronary heart disease, cerebral thrombosis, hypertension, cerebral infarction are had reliable curative effect.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
(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 4 32.5
2 100 800 6 37.6
3 100 1000 8 25.3
4 200 500 6 36.2
5 200 800 8 39.8
6 200 1000 4 34.1
7 300 500 8 37.9
8 300 800 4 31.5
9 300 1000 6 29.0
Round as a ball rotating speed is the most important to micropill, because along with the raising of round as a ball rotating speed, shearing force increases, and makes strip-shaped materials quicken to be cut off and by round as a ball.It is comparatively less important to extrude rotating speed, because after extrusion pressure reaches certain limit, increase pressure is to becoming the ball influence not too obvious again.The result shows that optimised process is for extruding rotating speed 100rmin
-1, put in the spheronizator, regulate rotating speed 1000rmin
-1And round as a ball time 8min.
2. art for coating
Group inlet temperature ℃ atomisation pressure Mpa hydrojet speed mL/min coating effect
1 55 0.15 10 is poor, and a large amount of glutinous companies are arranged
2 55 0.15 15 is good, not glutinous company the between the micropill
3 55 0.20 10 is general, and many glutinous companies are arranged
4 55 0.20 15 is general, and many glutinous companies are arranged
5 60 0.15 10 is better, and micropill has seldom to be measured glutinous the company
6 60 0.15 15 is general, and many glutinous companies are arranged
7 60 0.20 10 is better, and micropill has seldom to be measured glutinous the company
8 60 0.20 15 is poor, and micropill has a large amount of glutinous companies
When inlet temperature is too high, the dry too fast film-coat rough surface that makes of droplet; Suitable atomization air pressure, may command droplet speed reduces the droplet drying, increases droplet and sprawls in the mandatory of substrate surface, improves coarse.The result shows that optimised process is 50 ℃ of inlet temperature, atomizing pressure 0.15MPa, hydrojet speed 15mL/min.
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
Capsule 23min
Tablet 26min
Micropill 2.20min of the present invention
(2) release experiment: simulated gastric fluid-95% ethanol (3: 2) is solvent, 37 ± 0.5 ℃ 100 rev/mins.Get not ball of oral cavity disintegration tablet, 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, with the content of high-efficient liquid phase technique mensuration tanshinone, calculate the cumulative percentage rate that discharges.
Discharge cumulative percentage rate %
Oral cavity disintegration tablet micropill of the present invention
5min 75.34 83.12
10min 82.28 92.15
20min 85.51 95.42
30min 88.87 96.95
40min 94.48 98.53
50min 97.30 100.00
60min 89.66 100.10
90min 100.50 102.10
The result shows that preparation of the present invention is functional.
(3) hygroscopicity experiment: get test sample, about 2g puts in the weighing botle, and accurate the title decides, the weighing bottle cap is opened, put into relative humidity respectively and be 92% environment, in 25 ℃ of constant incubators, placed 84 hours, take out weighing botle, add a cover the accurate title in back and decide, calculate the moisture absorption percentage rate.
Moisture absorption percentage rate %
123 meansigma methodss
Plain particles 22 21 21 20.7
Coated micropill 28 30 32 30.0
Coated micropill 19 18 19 18.7
The result shows that after this product was made micropill, because surface area increases, hygroscopicity had also increased, and can effectively improve hygroscopicity by packaging technique of the present invention.
Experimental example 3: pharmacodynamic experiment
(1) to the research of acute myocardial ischemia effect
Get 70 of SD rats, male and female half and half, body weight (241.5 soil 12.4) g.Be divided into normal control group, model group, tween group, GUANXIN DANSHEN JIAONANG group, GUANXIN DANSHEN DIWAN group and micropill group of the present invention at random.Above-mentioned being subjected to all is formulated as 1ml/kg with normal saline before the use of reagent thing, and tween dosage is equal to the used tween dosage of dissolving GUANXIN DANSHEN DIWAN.Before experiment, at first carry out animal to pituitrin sensitivity screening experiment flatly.Method is: rat sublingual vein injection of pituitrin 0.35U/kg (concentration is 0.5U/ml), observe II lead electrocardiogram situation of change, and choose the responsive rat of pituitrin is used for experiment (the T ripple is obviously raised, and the ST section is raised above 0.1mV).Be used for experiment behind 60 selected rat 24h.Shift to an earlier date 1h gastric infusion respectively by the random packet principle before the experiment, it with mass fraction 3% pentobarbital sodium (30mg/kg) intraperitoneal injection of anesthesia, the animal dorsal position is fixed on the Mus platform, and join with polygraph, trace the II lead electrocardiogram, with electrocardiogram normal rat sublingual vein injection of pituitrin 0.35U/kg, and in 5s, annotated, trace II lead electrocardiogram 5min, heart extracting blood behind the observation 3h detects every biochemical indicator
1. each group changes percentile influence to II lead electrocardiogram T ripple behind the rat injection of pituitrin
At once the II lead electrocardiogram T ripple height that significantly begins behind model group and the tween group rat injection of pituitrin, reach the highest during 30s, Electrocardiographic variation of the first phase promptly appears, behind injection of pituitrin 30s electrocardiogram occur that the T ripple is low flat, two-phase or inversion, decreased heart rate, the second phase such as P-R and Q-T interval prolongation electrocardiogram changes, and tween group and model group comparison do not have significant difference between the two.And GUANXIN DANSHEN JIAONANG group, GUANXIN DANSHEN DIWAN group and micropill group of the present invention all can significantly be resisted rat electrocardiogram first phase that pituitrin causes and the variation of the second phase, with model group relatively, the difference highly significant.
Each organizes the comparison that II lead electrocardiogram T ripple changes
The experiment back time (min)
Group 0 0.25 0.5 13
Model group 29.32 ± 11.27 35.16 ± 20.72 43.62 ± 24.08 41.38 ± 21.43 37.67 ± 15.34
Tween group 26.12 ± 12.07 37.51 ± 18.24 49.27 ± 25.74 47.81 ± 23.95 40.25 ± 16.12
Capsules group 14.18 ± 8.57 15.85 ± 10.93 14.76 ± 10.76 15.24 ± 11.72 12.05 ± 7.38
Micropill group 10.34 ± 5.84 11.18 ± 8.49 11.73 ± 6.83 13.46 ± 5.34 10.72 ± 3.53
2. each group is to the influence of rat blood serum LDH and CPK
CPK and LDH when myocardial damage because of ischemia after membrane damage be released in the blood, so can be used as the index of observing myocardial ischemia.Experimental result shows: Serum LDH and CPK all raise to some extent behind model group and the tween group rat injection of pituitrin, GUANXIN DANSHEN DIWAN group, GUANXIN DANSHEN JIAONANG group and micropill group of the present invention then have the trend that reduces Serum LDH and CPK, and there was no significant difference between micropill group of the present invention and GUANXIN DANSHEN KELI, the Capsules group.
Each organizes the comparison of Serum LDH and CPK
Group animal number of elements LDH (U/L) CPK (U/L)
Normal control group 10 875.1 ± 215.9 593.4 ± 261.5
Model group 10 1046.5 ± 248.6 1105.1 ± 342.8
Tween group 10 1093.2 ± 318.4 1034.6 ± 315.4
GUANXIN DANSHEN KELI group 10 856.8 ± 192.3 785.6 ± 212.7
GUANXIN DANSHEN JIAONANG group 10 882.4 ± 154.7 798.1 ± 234.8
Micropill group 10 863.0 of the present invention ± 176.5 724.3 ± 251.5
3. each group is to the influence of rat blood serum SOD and MDA
SOD is as the index of reflection oxygen radical removing ability; can remove superoxide anion; the protection cell is avoided damage; its active height has often reflected the ability of body removing free radical indirectly; when cardiac muscle is impaired; can cause the active reduction of SOD, and the intermediate product MDA of lipid peroxidation often is used as the index of observing the oxygen-derived free radicals generation and causing cell membrane damage, reflects the weight of body inner cell damage and the degree of lipid peroxidation indirectly.Show according to experimental result: GUANXIN DANSHEN JIAONANG, GUANXIN DANSHEN DIWAN group and micropill group of the present invention be the obvious activity of enhancement of SOD all, reduces the content of MDA, thereby to cardiac muscle performance protective effect.And the effect of micropill of the present invention will be better than GUANXIN DANSHEN DIWAN and GUANXIN DANSHEN JIAONANG group slightly, but difference is little.
Table 3 is respectively organized the comparison of SOD in serum and MDA
Group animal number of elements SOD (kNU/L) MDA (μ mol/L)
Normal control group 10 213.28 ± 10.86 11.08 ± 1.47
Model group 10 151.24 ± 16.42 14.35 ± 1.39
Tween group 10 153.51 ± 13.76 13.84 ± 2.15
GUANXIN DANSHEN PIANJI group 10 186.92 ± 9.48 12.07 ± 1.84
GUANXIN DANSHEN JIAONANG group 10 180.75 ± 10.85 12.53 ± 1.28
Micropill group 10 198.27 of the present invention ± 11.94 11.62 ± 1.51
Comprehensive above experimental result illustrates that micropill of the present invention can significantly improve the acute myocardial ischemia that is brought out by pituitrin.Prompting explanation micropill of the present invention is the active drug of treatment acute myocardial ischemia.
(2) to the influence of mice normal pressure anoxia enduring
Get 40 of healthy mices, male and female half and half.Be divided into model control group, GUANXIN DANSHEN JIAONANG group, GUANXIN DANSHEN DIWAN group and micropill group of the present invention at random.Each group is administered once in advance by table 4 dosage, test the back 30min that was administered once again the same day, each organizes the equal subcutaneous injection isoprenaline of mice 20mg/kg, gets a white mice for every group at every turn and puts into the 125ml grournd glass respectively (bottle is put into 25gNaOH and 25gCaCl in advance
2, to absorb moisture and CO
2, be encased inside filter paper above it, draw urine), use the vaseline seal cover tight after putting into immediately, the mice time-to-live in the opening entry bottle.
To the influence of anoxia enduring time-to-live of mice normal pressure
Group dosage (g/kg) animal number of elements mean survival time (min)
Model control group-10 10.47 ± 2.48
GUANXIN DANSHEN JIAONANG group 1.00 10 14.35 ± 1.67
GUANXIN DANSHEN KELI group 1.00 10 13.78 ± 2.36
Micropill group 1.00 10 13.28 ± 1.95 of the present invention
Result according to table 4 can find, the mean survival time of GUANXIN DANSHEN JIAONANG group, drop pill group and micropill treated animal of the present invention has tangible prolongation effect than model control group, and the prolongation effect of micropill of the present invention is not worse than GUANXIN DANSHEN JIAONANG and GUANXIN DANSHEN DIWAN.Illustrate that micropill of the present invention has tangible anti-resisting oxygen lack.
Concrete embodiment:
Embodiments of the invention 1: Radix Salviae Miltiorrhizae 200g, Radix Notoginseng 200g, Lignum Dalbergiae Odoriferae oil 1.75ml
Get Radix Notoginseng powder and be broken into fine powder; Get Radix Salviae Miltiorrhizae powder and be broken into middle powder, make solvent, carry out percolation with 90% ethanol, the liquid of filtering is concentrated into the thick paste shape, and medicinal residues decoct with water secondary, each 1 hour, collecting decoction filters, and filtrate is concentrated in right amount, add fine powder and thick paste, stir evenly, adding and medicated powder ratio are 1: 1.2 microcrystalline Cellulose, the mixing that sieves adds suitable quantity of water and makes soft material, through the extruder sieve plate, aperture 0.9mm is extruded into fine strip shape, extrudes rotating speed 100rmin
-1, put in the spheronizator, regulate rotating speed 1000rmin
-1And round as a ball time 8min, make granule round as a ball fully, take out micropill in 50 ℃ of drying 3～4h, spray adds Lignum Dalbergiae Odoriferae oil, after the screening, carries out coating with 18～24 purpose micropills, and Opadry 2 is a coating material, and 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 0.15MPa, hydrojet speed 15mL/min, diameter be the micropill of 2.5mm, this product oral, three times on the one, each 10.
Embodiments of the invention 2: Radix Salviae Miltiorrhizae 200g, Radix Notoginseng 200g, Lignum Dalbergiae Odoriferae oil 1.75ml
Radix Salviae Miltiorrhizae ethanol extraction secondary, each 70 minutes, filter, filtrate merges, and reclaims ethanol and continues to be condensed into clear paste; Radix Notoginseng powder is broken into coarse powder, 70% alcohol reflux secondary, each 1.5 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and continue to be concentrated into clear paste, mix a small amount of kieselguhr, drying under reduced pressure, and be ground into fine powder, with fine powder alcohol reflux secondary, each 1 hour, put cold back and filter, filtrate recycling ethanol also continues to be concentrated into clear paste, merges clear paste, adding and medicated powder ratio are 1: 1.2 microcrystalline Cellulose, the mixing that sieves adds suitable quantity of water and makes soft material, through the extruder sieve plate, aperture 0.9mm is extruded into fine strip shape, extrudes rotating speed 100rmin
-1, put in the spheronizator, regulate rotating speed 1000rmin
-1And round as a ball time 8min, make granule round as a ball fully, take out micropill in 50 ℃ of drying 3～4h, spray adds Lignum Dalbergiae Odoriferae oil, after the screening, carries out coating with 18～24 purpose micropills, and Opadry 2 is a coating material, and 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 0.15MPa, hydrojet speed 15mL/min, getting diameter is the micropill of 2.0mm.
Embodiments of the invention 3: Radix Salviae Miltiorrhizae 200g, Radix Notoginseng 200g, Lignum Dalbergiae Odoriferae oil 1.75ml
Getting Radix Notoginseng pulverizes; Get Radix Salviae Miltiorrhizae and pulverize, ethanol percolation, the liquid of filtering is concentrated into the thick paste shape, medicinal residues decoct with water, and collecting decoction filters, filtrate is concentrated in right amount, adds fine powder and thick paste, stirs evenly, spray adds Lignum Dalbergiae Odoriferae oil, and adding and medicated powder ratio are that 1: 2 carboxymethyl starch sodium, adding and medicated powder ratio is 1: 2 steviosin, mix, tabletting, coating then, Opadry 2 is a coating material, coating adopts top spray method, promptly gets dispersible tablet, this product oral, three times on the one, each 2.
Embodiments of the invention 4: Radix Salviae Miltiorrhizae 200g, Radix Notoginseng 200g, Lignum Dalbergiae Odoriferae oil 1.75ml
Getting Radix Notoginseng pulverizes; Get Radix Salviae Miltiorrhizae and pulverize, ethanol percolation, the liquid of filtering is concentrated into the thick paste shape, medicinal residues decoct with water, and collecting decoction filters, filtrate is concentrated in right amount, adds fine powder and thick paste, stirs evenly, spray adds Lignum Dalbergiae Odoriferae oil, press extractum again: substrate=1: 1.2, the mixed-matrix of adding soybean oil, soybean lecithin, heating and melting, mixing gets soft capsule content; The preparation of glue: with gelatin: glycerol: water=1: 0.5: 0.7, getting gelatin adds an amount of distilled water and makes its imbibition, in addition the water of glycerol and remainder is put and be heated to 70～80 ℃ in the glue pot, mix homogeneously, add expansible gelatin and stir, make it to dissolve into uniform glue, in 70 ℃ of insulations 1～2 hour, leave standstill, remove the come-up foam, filter, in encapsulating machine, be pressed into soft capsule with cloth bag, be pressed into soft capsule, put in the drum drying machine and finalize the design, whole ball, drying, make 1000, promptly get soft capsule.
Embodiments of the invention 5: Radix Salviae Miltiorrhizae 200g, Radix Notoginseng 200g, Lignum Dalbergiae Odoriferae oil 1.75ml
Getting Radix Notoginseng pulverizes; Get Radix Salviae Miltiorrhizae and pulverize, ethanol percolation, the liquid of filtering is concentrated into the thick paste shape, and medicinal residues decoct with water, and collecting decoction filters, and filtrate is concentrated in right amount, adds fine powder and thick paste, stirs evenly, and spray adds Lignum Dalbergiae Odoriferae oil, adds distilled water, promptly gets oral liquid.
Claims (5)
1, a kind of coronary salvia micro pill agent is characterized in that: it is that Radix Salviae Miltiorrhizae 200g, Radix Notoginseng 200g, Lignum Dalbergiae Odoriferae oil 1.75ml add the ball shape preparation that diameter that an amount of excipient makes is less than or equal to 2.5mm.
2, according to the described coronary salvia micro pill agent of claim 1, it is characterized in that: it can also be prepared into: soft capsule, dispersible tablet, oral liquid.
3, the preparation method of coronary salvia micro pill agent as claimed in claim 1 or 2 is characterized in that: the pellet in the described preparation prepares like this: get Radix Notoginseng powder and be broken into fine powder; Get Radix Salviae Miltiorrhizae and pulverize, ethanol percolation, the liquid of filtering is concentrated into the thick paste shape, and medicinal residues decoct with water, and collecting decoction filters, and filtrate is concentrated in right amount, adds Radix Notoginseng fine powder and thick paste, stirs evenly, and spray adds Lignum Dalbergiae Odoriferae oil; Perhaps Radix Salviae Miltiorrhizae ethanol extraction, filtrate merges, and reclaims ethanol, is condensed into clear paste; Radix Notoginseng powder is broken into coarse powder, alcohol reflux, merge extractive liquid,, filter, filtrate recycling ethanol, and continue to be condensed into clear paste, mix a small amount of kieselguhr, drying under reduced pressure, and be ground into fine powder, with the fine powder alcohol reflux, put cold back and filter, filtrate recycling ethanol concentrates, merge clear paste, spray adds Lignum Dalbergiae Odoriferae oil; Make preparation again.
4, according to the preparation method of the described coronary salvia micro pill agent of claim 3, it is characterized in that: the pellet in the described preparation prepares like this: get Radix Notoginseng powder and be broken into fine powder; Get Radix Salviae Miltiorrhizae powder and be broken into middle powder, make solvent, carry out percolation with 90% ethanol, the liquid of filtering is concentrated into the thick paste shape, and medicinal residues decoct with water secondary, each 1 hour, collecting decoction filters, and filtrate is concentrated in right amount, add fine powder and thick paste, stir evenly, adding and medicated powder ratio are 1: 1.2 microcrystalline Cellulose, the mixing that sieves adds suitable quantity of water and makes soft material, through the extruder sieve plate, aperture 0.9mm is extruded into fine strip shape, extrudes rotating speed 100rmin
-1, put in the spheronizator, regulate rotating speed 1000rmin
-1And round as a ball time 8min, make granule round as a ball fully, take out micropill in 50 ℃ of drying 3～4h, spray adds Lignum Dalbergiae Odoriferae oil, after the screening, carries out coating with 18～24 purpose micropills, and Opadry 2 is a coating material, and 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 0.15MPa, hydrojet speed 15mL/min, promptly.
5, according to the preparation method of the described coronary salvia micro pill agent of claim 3, it is characterized in that: the pellet in the described preparation prepares like this: Radix Salviae Miltiorrhizae ethanol extraction secondary, and each 70 minutes, filter, filtrate merges, and reclaims ethanol and continues to be condensed into clear paste; Radix Notoginseng powder is broken into coarse powder, 70% alcohol reflux secondary, each 1.5 hours, merge extractive liquid,, filter, filtrate recycling ethanol, and continue to be concentrated into clear paste, mix on a small amount of diatom, drying under reduced pressure, and be ground into fine powder, with fine powder alcohol reflux secondary, each 1 hour, put cold back and filter, filtrate recycling ethanol also continues to be concentrated into clear paste, merges clear paste, adding and medicated powder ratio are 1: 1.2 microcrystalline Cellulose, the mixing that sieves adds suitable quantity of water and makes soft material, through the extruder sieve plate, aperture 0.9mm is extruded into fine strip shape, extrudes rotating speed 100rmin
-1, put in the spheronizator, regulate rotating speed 1000rmin
-1And round as a ball time 8min, make granule round as a ball fully, take out micropill in 50 ℃ of drying 3～4h, spray adds Lignum Dalbergiae Odoriferae oil, after the screening, carries out coating with 18～24 purpose micropills, and Opadry 2 is a coating material, and 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 0.15MPa, hydrojet speed 15mL/min, promptly.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510020656 CN1686240A (en) | 2005-03-29 | 2005-03-29 | Coronary salvia micro pill agent and its preparation method |
| CN2006102002774A CN1853670B (en) | 2005-03-29 | 2006-03-27 | Coronary heart Danshen root micropellets and preparation thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510020656 CN1686240A (en) | 2005-03-29 | 2005-03-29 | Coronary salvia micro pill agent and its preparation method |
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| Publication Number | Publication Date |
|---|---|
| CN1686240A true CN1686240A (en) | 2005-10-26 |
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ID=35304282
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510020656 Pending CN1686240A (en) | 2005-03-29 | 2005-03-29 | Coronary salvia micro pill agent and its preparation method |
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| Country | Link |
|---|---|
| CN (1) | CN1686240A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106511462A (en) * | 2016-07-15 | 2017-03-22 | 中国医学科学院药用植物研究所 | Application of Guanxin salvia miltiorrhiza compound preparation in preparing medicine for improving ventricular remodeling |
| CN107184646A (en) * | 2017-05-23 | 2017-09-22 | 吉林省中药制剂工程研究中心有限公司 | Coronary heart disease drop pill is used for the new application for preventing and treating cranial vascular disease |
-
2005
- 2005-03-29 CN CN 200510020656 patent/CN1686240A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106511462A (en) * | 2016-07-15 | 2017-03-22 | 中国医学科学院药用植物研究所 | Application of Guanxin salvia miltiorrhiza compound preparation in preparing medicine for improving ventricular remodeling |
| CN106511462B (en) * | 2016-07-15 | 2019-10-22 | 中国医学科学院药用植物研究所 | Application of the coronary heart disease compound preparation in the drug that preparation improves remodeling ventricle |
| CN107184646A (en) * | 2017-05-23 | 2017-09-22 | 吉林省中药制剂工程研究中心有限公司 | Coronary heart disease drop pill is used for the new application for preventing and treating cranial vascular disease |
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