CN100370970C - Compound red-rooted salvia prepn., and its prepn. method - Google Patents
Compound red-rooted salvia prepn., and its prepn. method Download PDFInfo
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- CN100370970C CN100370970C CNB2005100360671A CN200510036067A CN100370970C CN 100370970 C CN100370970 C CN 100370970C CN B2005100360671 A CNB2005100360671 A CN B2005100360671A CN 200510036067 A CN200510036067 A CN 200510036067A CN 100370970 C CN100370970 C CN 100370970C
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Abstract
The present invention provides a compound red sage root preparation containing red sage root phenolic acid B with stable content and having the advantage of convenient use, and a preparation method thereof. Compound medical red sage root, borneol, notoginseng, etc. are prepared into an extract of a proper preparation through extraction, and the extract and proper auxiliary materials are prepared into new preparations, such as dispersible tablets, coated dispersible tablets, dripping pills, coated dripping pills, soft capsules, mini-pills, coated mini-pills, puffing tablets, effervescent tablets, etc.
Description
Technical field:
The invention belongs to field of medicaments, be specifically related to a kind of compound Salviae Miltiorrhizae novel formulation and preparation method thereof.
Background technology:
FUFANG DANSHEN PIAN is recorded respectively in " Chinese pharmacopoeia version in 2000, version in 2005.Form by three flavors such as Radix Salviae Miltiorrhizae, Radix Notoginseng, Borneolum Syntheticum.
Along with the deepen continuously research of people, quality control, the dosage form of said preparation are had higher requirement to compound red sage root preparation.
Salvianolic acid B is one of aqueous soluble active constituent in the Radix Salviae Miltiorrhizae, is one of important content's index of control compound red sage root preparation quality.But because the structure of salvianolic acid B, it is unstable under conventional state.
Summary of the invention:
The object of the invention provides a kind of salvianolic acid B of stablizing content, compound red sage root preparation that reaches convenient use and preparation method thereof of containing.
The invention provides Compositae Salviae Miltiorrhizae medicine Radix Salviae Miltiorrhizae/Borneolum Syntheticum/Radix Notoginseng etc. is made the extract of suitable formulations through extraction, and make dispersible tablet, coated dispersing tablet, drop pill, soft capsule, micropill, coated micropill or novel forms such as oral cavity disintegration tablet or effervescent tablet with suitable adjuvant.
The present invention is achieved in that
Used medical material proportioning is:
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
The treated medicinal substances extract of making of above-mentioned medical material is made soft capsule or peroral dosage forms such as dispersible tablet or drop pill or oral cavity disintegration tablet or effervescent tablet or micropill with pharmaceutically alleged adjuvant or substrate.
Or more can be preferably:
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g.
Extraction of the present invention is to make through following steps:
Radix Salviae Miltiorrhizae added alcohol reflux 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 50% alcohol reflux 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Get the mixture that above-mentioned Radix Salviae Miltiorrhizae extracts concentrated solution and Radix Notoginseng fine powder, add the Borneolum Syntheticum fine powder, be the extract of preparation compound red sage root preparation.
Or make through following steps:
Radix Salviae Miltiorrhizae added alcohol reflux 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 50% alcohol reflux 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Get the mixture that above-mentioned Radix Salviae Miltiorrhizae extracts concentrated solution and Radix Notoginseng fine powder, add Borneolum Syntheticum and doubly reach the cyclodextrin inclusion compound fine powder, be the extract of preparation compound red sage root preparation.
Soft capsule of the present invention is made like this:
I) modulation capsule liquid: get compound Salviae Miltiorrhizae extract, add one or more of vegetable oil, suspending agent, antiseptic, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Ii) get gelatin, water mixing,, add glycerol, antiseptic, additives, stir in heating in water bath dissolving down, the degassing, insulation is left standstill, and it is standby to make the capsule material;
Iii) suppress or drip and make soft capsule: with preparation soft capsule equipment capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water, makes soft capsule.
Used vegetable oil is one or more in soybean oil, salad oil, Oleum Sesami, Oleum Arachidis hypogaeae semen, Semen Maydis oil, almond oil, peach kernel oil, Oleum Gossypii semen, Oleum Helianthi, Oleum Ricini, the olive oil, and best use peach kernel oil and soybean oil weight ratio are 1: 3.5 mixture.
The suspending agent of making soft capsule is: any one or a few in glycerol, tween 80, Petiolus Trachycarpi oil, aluminum monostearate, soybean lecithin, the Cera Flava etc.
Its vegetable oil, and the suspending agent consumption be 100 parts of compound Salviae Miltiorrhizae extracts: 50～120 parts of vegetable oil, 15～45 parts of suspending agents; Its capsule material formula is weight ratio 1: 0.24: 0.74: 0.12: 1.42 gelatin: arabic gum: glycerol: syrup: distilled water etc. are mixed and made into.
Dispersible tablet of the present invention is made like this:
Get compound Salviae Miltiorrhizae extract, add filler and part disintegrating agent mix homogeneously, granulate with wetting agent or adhesive, drying, granulate adds adjuvants such as residue disintegrating agent, lubricant, mix homogeneously, tabletting promptly gets dispersible tablet; Or coating behind the tabletting, promptly get coated dispersing tablet.
Filler in the dispersible tablet is: starch, or lactose or microcrystalline Cellulose, or one or more of precoking starch etc.,
The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, and low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.,
Binding agent in the dispersible tablet is: the alcoholic solution of 40% ethanol～95% alcoholic solution or 4～11% polyvinylpyrrolidones.
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or Pulvis Talci, or cetyl sulfo-sodium succinate, or one or more of sodium lauryl sulphate etc.,
Its consumption is: 150 parts of compound Salviae Miltiorrhizae extracts cooperate 15～200 parts of filleies, 10～65 parts of disintegrating agents, 0.3～6 part of lubricant; Or being preferably 150 parts of 72.5 parts of filleies of compound Salviae Miltiorrhizae extracts cooperation, 25 parts of disintegrating agents, lubricant is 2.5 parts;
Or the best is preferably:
A lactose: 52.5%
B mannitol: 20%
C carboxymethyl starch sodium: 6%
D sodium carboxymethyl cellulose: 1%
The e hydroxypropyl emthylcellulose: 3%,
F microcrystalline Cellulose: 5%
G crospolyvinylpyrrolidone: 10%
H cetyl sulfo-sodium succinate: 0.25%
I sodium lauryl sulphate: 0.25%
J magnesium stearate: 2.0%.
Mix with compound Salviae Miltiorrhizae extract successively before above-mentioned adjuvant branch is granulated with before the tabletting, used adjuvant is before granulating: used adjuvant is before lactose, carboxymethyl starch sodium, the sodium carboxymethyl cellulose, tabletting: magnesium stearate, sodium lauryl sulphate, cetyl sulfo-sodium succinate, crospolyvinylpyrrolidone, microcrystalline Cellulose, sodium carboxymethyl cellulose.
Oral cavity disintegration tablet of the present invention is made like this:
Get compound Salviae Miltiorrhizae extract, with filler, disintegrating agent, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again;
Described disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.;
Described fluidizer is: micropowder silica gel, or one or more of magnesium stearate etc.;
Described correctives is: A Basi is sweet, stevioside, sucrose, maltose alcohol, citric acid etc. are edible or one or more of medicinal correctives; Preferably use A Basi sweet with citric acid 3: 1.
Mix with compound Salviae Miltiorrhizae extract successively before above-mentioned adjuvant branch is granulated with before the tabletting, the adjuvant of sneaking into is before granulating: filler, disintegrating agent: low-substituted hydroxypropyl cellulose; Used adjuvant is before the tabletting: fluidizer, correctives, disintegrating agent: crospolyvinylpyrrolidone.
Effervescent tablet of the present invention is made like this:
Get compound Salviae Miltiorrhizae extract,, add disintegrating agent, lubricant with filler, effervescent acid-base pair mixing granulation, mixing, tabletting promptly gets effervescent tablet, or the coated again coating effervescent tablet of making;
Effervescent is that sodium bicarbonate is formed with citric acid or tartaric acid;
Filler is a lactose: mannitol: 5: 3: 1.5 mixture of precoking starch;
Disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.; Or the best crospolyvinylpyrrolidone that uses: the mixture of low-substituted hydroxypropyl cellulose=1: 2;
Compound Salviae Miltiorrhizae extract 100g and 20～130g filler, 15～45g effervescent acid-base pair, 5～55g disintegrating agent are formed.
Micropill of the present invention or pellet capsule are made like this:
(1) gets compound Salviae Miltiorrhizae extract,, make the micropill of diameter less than 2.0mm with mix homogeneously such as carboxymethyl starch sodium, precoking starch;
(2) with gained micropill drying, or the coating after drying, promptly.Or the micropill filled capsules made pellet capsule.
(3) 100 parts of the extracts of compound Salviae Miltiorrhizae, 5～60 parts of carboxymethyl starch sodium, 2～40 parts of precoking starch, wetting agent are 60～95% alcoholic solution of 2～13% polyvinylpyrrolidones.
Or be preferably: 100 parts of the extracts of compound Salviae Miltiorrhizae, 25 parts of carboxymethyl starch sodium, 30 parts of precoking starch, wetting agent are 85% alcoholic solution of 11% polyvinylpyrrolidone.
The coating solution of making the various coated preparations of the present invention is a gastric solubility coating material, as Opadry, acrylic resin IV, hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl methylcellulose, polyvinyl alcohol, methylcellulose one or more, or the coating solution formula optimization is:
Polyvinylpyrrolidone 12g
Hydroxypropyl methylcellulose 4～8g
90% alcoholic solution 200ml
Pulvis Talci 4～8g
Magnesium stearate 2g
Titanium dioxide 4～6g
Polyethylene glycol 6000 4g
Pigment 1～2g
Effect of the present invention:
Salvianolic acid B is one of aqueous soluble active constituent in the Radix Salviae Miltiorrhizae, is one of important content's index of control compound red sage root preparation quality.But because the structure of salvianolic acid B, its chemical composition is that the four poly-caffeic acid compounds catabolic processes that two molecule danshensus and the condensation of a part prolithospermic acid form remain in many uncertain factors, make the homogeneity of the quality of the pharmaceutical preparations be difficult to be guaranteed, the present invention doubly reaches cyclodextrin clathrate by using antioxidant or Radix Salviae Miltiorrhizae extract being formed, and makes the stable raising greatly of salvianolic acid B.
Use the dispersion tablet of red sage root salvianolic acid B stable content test of different antioxidant with batch dried cream:
| Antioxidant uses | 3 months | 6 months | 12 months |
| 0.5% ascorbic acid, | 10.3mg | 6.4mg | 5.2mg |
| 1.0% ascorbic acid, | 10.2mg | 7.2mg | 7.0mg |
| 1.2% ascorbic acid+L-cysteine hydrochlorate | 9.8mg | 7.4mg | 7.2mg |
| 1.35% sodium metabisulfite, | 9.65mg | 7.32mg | 7.24mg |
| 2% sodium sulfite | 10.4mg | 8.0mg | 7.8mg |
The present invention makes coated dispersing tablet with compound red sage root preparation, the adjuvant prescription design of its dispersible tablet, and helping reaching is the purpose of the rapid disintegrate of medicine.When coating can make tablet more attractive in appearance,, slow down oxidation deterioration, the moisture absorption process of medicine, make medicine more stable drug blockage.
The coating weightening finish too much can influence medicine and collapse the boundary.Coatings is thin excessively, can not reach the purpose of stablizing medicine, and the present invention has determined appropriate coating weightening finish percent.
Use the effect of different coating material, coating weightening finish percent:
| The coating solution prescription | Weightening finish percent | Salvianolic acid B content | ||
| 3 months | 6 months | 12 months | ||
| HPMC：7.5％+PEG400：1.2％、 | 1.5％ | 10.4mg | 8.2mg | 6.4mg |
| HPMC：7.2％+PEG400：0.8％、 | 2.4％ | 10.1mg | 7.4mg | 7.1mg |
| Opadry | 2.2％ | 9.8mg | 8.6mg | 8.4mg |
| The Europe crust is treated | 3.1％ | 10.6mg | 8.8mg | 8.4mg |
Specific embodiment:
Embodiment 1: the preparation of compound Salviae Miltiorrhizae extract:
Radix Salviae Miltiorrhizae adds 6 times of amounts of ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount: Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Get the mixture that above-mentioned Radix Salviae Miltiorrhizae extracts concentrated solution and Radix Notoginseng fine powder, add the Borneolum Syntheticum fine powder, be the extract of preparation compound red sage root preparation.
Embodiment 2: the preparation of compound Salviae Miltiorrhizae extract:
Radix Salviae Miltiorrhizae adds 10 times of amounts of ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 10 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 10 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Get the mixture that above-mentioned Radix Salviae Miltiorrhizae extracts concentrated solution and Radix Notoginseng fine powder, add the Borneolum Syntheticum fine powder, be the extract of preparation compound red sage root preparation.
Embodiment 3: the preparation of compound Salviae Miltiorrhizae extract:
Radix Salviae Miltiorrhizae adds 8 times of amounts of ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 8 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Get the mixture that above-mentioned Radix Salviae Miltiorrhizae extracts concentrated solution and Radix Notoginseng fine powder, add the Borneolum Syntheticum fine powder, be the extract of preparation compound red sage root preparation.
Embodiment 4: the preparation of compound Salviae Miltiorrhizae extract:
Radix Salviae Miltiorrhizae adds 8 times of amounts of alcohol reflux 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 8 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Get the mixture that above-mentioned Radix Salviae Miltiorrhizae extracts concentrated solution and Radix Notoginseng fine powder, add Borneolum Syntheticum and doubly reach the cyclodextrin inclusion compound fine powder, be the extract of preparation compound red sage root preparation.
Embodiment 5: the compound Salviae Miltiorrhizae preparation of soft capsule
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Cera Flava 15g
Olive oil 220g
Propylene glycol 2g
Soybean lecithin 8g
Make 1000
I) modulation capsule liquid: medical material is made extract by embodiment 1～4, add vegetable oil, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Ii) get gelatin, water, in heating in water bath dissolving down, mix homogeneously adds glycerol, antiseptic, additives, stirs, and after the vacuumize degassing, insulation is left standstill, and makes capsule material glue;
Iii) suppress or drip and make soft capsule: capsule liquid is encapsulated in the capsule material glue with soft capsule system of dripping or press; Control capsule grain is heavy, makes and makes 1000, promptly.
Embodiment 6: the compound Salviae Miltiorrhizae preparation of soft capsule
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Medical material is made extract 200g by embodiment 1～4.
Peach kernel oil 25g
Soybean oil 175g:
Cera Flava: ethyl cellulose weight ratio 1.5: 3.5 30
Ethylparaben 1.0g
Make 1000
I) modulation capsule liquid: medical material is made extract by embodiment 1～4, add disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
Ii) its capsule material formula is weight ratio 1: 0.24: 0.74: 0.12: 1.42 gelatin: arabic gum: glycerol: syrup: distilled water etc. are mixed and made into.Get gelatin, water in heating in water bath dissolving down, mix homogeneously adds glycerol, antiseptic, additives, stirs, and after the vacuumize degassing, insulation is left standstill, and makes capsule material glue;
Iii) suppress or drip and make soft capsule: capsule liquid is encapsulated in the capsule material glue with soft capsule system of dripping or press; Promptly get soft capsule.
Embodiment 7: the preparation of compound salvia dispersion tablet:
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Lactose: 40g
Microcrystalline Cellulose: 25g
Mannitol: 15g
Carboxymethyl starch sodium: 10g
Polyvinylpyrrolidone: 45g
Sodium lauryl sulphate: 2.5g
Magnesium stearate: 3.0g
Make extract by embodiment 1～4, use 75% alcohol granulation with lactose, carboxymethyl starch sodium, microcrystalline Cellulose, mannitol etc., drying adds polyvinylpyrrolidone, sodium lauryl sulphate, and the magnesium stearate mix homogeneously is pressed into 1000, promptly.
Embodiment 8: the preparation of compound salvia dispersion tablet:
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Lactose: 35g
Hydroxypropyl emthylcellulose: 25g
Microcrystalline Cellulose: 25g
Crospolyvinylpyrrolidone: 35g
Cetyl sulfo-sodium succinate: 2.0g
Differential silica gel: 3.0g
Make extract by embodiment 1～4, with lactose, hydroxypropyl emthylcellulose, microcrystalline Cellulose, etc. granulate with the alcoholic solution moistening of 11% poly-second ketopyrrolidine, dry, add polyvinylpyrrolidone, cetyl sulfo-sodium succinate, differential silica gel mix homogeneously, tabletting, coating are made 1000, and coating solution is:
Polyvinylpyrrolidone 12g
Hydroxypropyl methylcellulose 4～8g
90% alcoholic solution 200ml
Pulvis Talci 4～8g
Magnesium stearate 2g
Titanium dioxide 4～6g
Polyethylene glycol 6000 4g
Pigment 1～2g.
Embodiment 9: the preparation of compound red sage root effervescent tablet agent
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Lactose: 100g
Mannitol: 60g
Precoking starch: 20g
Crospolyvinylpyrrolidone: 15g
Low-substituted hydroxypropyl cellulose 30g
Sodium bicarbonate 30g
Citric acid 20g
Tartaric acid 15g
Sodium lauryl sulphate: 2.5g
Magnesium stearate: 3.0g
Make extract by embodiment 4, use 75% alcohol granulation with lactose, mannitol, precoking starch, sodium bicarbonate etc., drying adds all the other adjuvant mix homogeneously of magnesium stearate such as citric acid, tartaric acid, sodium lauryl sulphate, is pressed into 1000, promptly.Or coating makes Film coated tablets, and coating solution is by following preparation: HPMC:7.1%, PEG400:0.8%, red iron oxide powder: 4.1, distilled water: 88%.
Embodiment 10: the preparation of compound Salviae Miltiorrhizae micropill
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Carboxymethyl starch sodium 120g
Precoking starch 55g
8% polyvinylpyrrolidone, 85% alcoholic solution 100ml
(1) gets compound Salviae Miltiorrhizae extract,, make the micropill of diameter less than 2.0mm with agitation procedure with mix homogeneously such as carboxymethyl starch sodium, precoking starch;
(2) with gained micropill drying, or the coating after drying, promptly.Or the micropill filled capsules made pellet capsule.
Embodiment 11: the preparation of compound Salviae Miltiorrhizae oral cavity disintegration tablet
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Lactose: 100g
Mannitol: 60g
Crospolyvinylpyrrolidone: 15g
Hydroxypropyl methylcellulose: 30g
Magnesium stearate: 3.0g
The sweet 5.0g of A Basi
Citric acid 12g
Embodiment 1～4 makes extract, and with starch, lactose, hydroxypropyl methylcellulose 75% alcohol granulation, drying, tabletting, coating is made 1000.
Coating solution is pressed following preparation:
HPMC:7.2%, PEG400:0.8%, red iron oxide powder: 4.1, distilled water: 88%.
Embodiment 12: the preparation of compound salvia dispersion tablet:
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Lactose: 35g
Hydroxypropyl emthylcellulose: 25g
Microcrystalline Cellulose: 25g
Crospolyvinylpyrrolidone: 35g
Cetyl sulfo-sodium succinate: 2.0g
Differential silica gel: 3.0g
Make extract by embodiment 4, with lactose, hydroxypropyl emthylcellulose, microcrystalline Cellulose, etc. granulate with the alcoholic solution moistening of 11% poly-second ketopyrrolidine, dry, add polyvinylpyrrolidone, cetyl sulfo-sodium succinate, differential silica gel mix homogeneously, tabletting, coating are made 1000, coating solution is: Opadry coating solution, coating weightening finish 1.8%.
Embodiment 13: the preparation of compound salvia dispersion tablet:
Radix Salviae Miltiorrhizae 450g Radix Notoginseng 141g Borneolum Syntheticum 8g
Lactose: 75g
Hydroxypropyl emthylcellulose: 258
Microcrystalline Cellulose: 25g
Mannitol 30g
Crospolyvinylpyrrolidone: 35g
Cetyl sulfo-sodium succinate: 2.0g
Magnesium stearate: 2.5g
Method for making: Radix Salviae Miltiorrhizae adds 8 times of amounts of ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 8 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into micropowder, mixes with above-mentioned concentrated solution; Drying is crushed to 100 orders, and is standby;
Get Borneolum Syntheticum, make powder-beta-dextrin clathrate compound, with the mixing fine powders of above-mentioned Radix Salviae Miltiorrhizae extract and Radix Notoginseng, lactose, hydroxypropyl emthylcellulose, microcrystalline Cellulose, etc. granulate with the alcoholic solution moistening of 11% poly-second ketopyrrolidine, drying adds polyvinylpyrrolidone, cetyl sulfo-sodium succinate, differential silica gel mix homogeneously, tabletting, coating is made 1000, and coating solution is: Opadry coating solution, coating weightening finish 2.2%.
Claims (1)
1. compound Salviae Miltiorrhizae novel formulation is characterized in that:
(1) used medical material weight proportion is: 225～675 parts of Radix Salviae Miltiorrhizaes, 70.5～211.5 parts of Radix Notoginseng, 4～12 parts of Borneolum Syntheticums;
(2) its dispersible tablet preparation method is: Radix Salviae Miltiorrhizae adds 6～10 times of amounts of ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6～10 times of amounts of 50% ethanol and refluxed 1.5 hours, and extracting solution filters, and filtrate recycling ethanol also is concentrated into an amount of, standby; Medicinal residues add 6～10 times of amounts of water and refluxed 2 hours, and decocting liquid filters, and filtrate is concentrated in right amount; Radix Notoginseng powder is broken into fine powder, mixes with above-mentioned concentrated solution; Add the Borneolum Syntheticum fine powder, add adjuvant and granulate, drying adds adjuvants such as lubricant, mixing, and tabletting promptly gets dispersible tablet, or the coated coated dispersing tablet of making;
Its adjuvant is: 150 parts of compound Salviae Miltiorrhizae extracts cooperate 15～200 parts of filleies, 10～65 parts of disintegrating agents, 0.3～6 part of lubricant;
Filler is: microcrystalline Cellulose, pregelatinized Starch;
Disintegrating agent is: crospolyvinylpyrrolidone, or carboxymethyl starch sodium, or one or more of cross-linking sodium carboxymethyl cellulose;
Lubricant is a magnesium stearate;
Antioxidant is: ascorbic acid, sodium metabisulfite, sodium sulfite, one or more of L-cysteine hydrochlorate;
Its coating material formula is:
Polyvinylpyrrolidone 12g
Hydroxypropyl methylcellulose 4～8g
90% alcoholic solution 200ml
Pulvis Talci 4～8g
Magnesium stearate 2g
Titanium dioxide 4～6g
Polyethylene glycol 6000 4g
Pigment 1～2g.
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| CN102160872A (en) | 2010-02-23 | 2011-08-24 | 天津天士力制药股份有限公司 | Compound salvia dropping pill capsules |
| CN102247434A (en) * | 2010-05-20 | 2011-11-23 | 云南楚雄天利药业有限公司 | Przewalsk sage root blood activating medicine and preparation method thereof |
| TWI571257B (en) * | 2011-02-23 | 2017-02-21 | Tasly Pharmaceutical Group Co | Capsule preparation |
| CN102138970A (en) * | 2011-03-24 | 2011-08-03 | 江苏苏南药业实业有限公司 | Method for preparing compound salvia tablet |
| CN106333931B (en) * | 2016-11-02 | 2019-10-01 | 山东省中医药研究院 | A kind of compound Danshen Root liquid-solid compression tablet and preparation method thereof |
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| CN1348815A (en) * | 2001-11-09 | 2002-05-15 | 天津天士力制药股份有限公司 | Medicine for preventing and treating coronary heart disease and angina pectoris and its prepn and other use |
| CN1559587A (en) * | 2004-03-09 | 2005-01-05 | 济南康众医药科技开发有限公司 | Compound red sage dispersing tablet and its preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1348815A (en) * | 2001-11-09 | 2002-05-15 | 天津天士力制药股份有限公司 | Medicine for preventing and treating coronary heart disease and angina pectoris and its prepn and other use |
| CN1559587A (en) * | 2004-03-09 | 2005-01-05 | 济南康众医药科技开发有限公司 | Compound red sage dispersing tablet and its preparation method |
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