CN102579609A - Blood-clearing dropping pills and preparation method thereof - Google Patents
Blood-clearing dropping pills and preparation method thereof Download PDFInfo
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- CN102579609A CN102579609A CN2012100616739A CN201210061673A CN102579609A CN 102579609 A CN102579609 A CN 102579609A CN 2012100616739 A CN2012100616739 A CN 2012100616739A CN 201210061673 A CN201210061673 A CN 201210061673A CN 102579609 A CN102579609 A CN 102579609A
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Abstract
The invention belongs to the technical field of a medicinal preparation, in particular to blood-clearing dropping pills and a preparation method thereof. In the blood-clearing dropping pills with quick disintegration and high bioavailability, mixed substrate is adopted, and preferably mixed substrate consisting of polyethylene glycol and one of poloxamer, sodium stearate and gelatin glycerin at a weight ratio of 1-5:1, and the ratio of the medicinal active component to the substrate is preferably 1:(3-5).
Description
Technical field
The invention belongs to technical field of pharmaceuticals, be specifically related to a kind of XUEBIQING drop pill and preparation method thereof.
Background technology
The XUEBIQING injection is to be prepared into by Flos Carthami, Radix Paeoniae Rubra, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, has blood circulation promoting and blood stasis dispelling, dredging the meridian, the evil effect of defeated and dispersed poison, can anti-endotoxin and suppress endogenous inflammatory mediator (TNF α) release out of control.Cure mainly: because of respiratory system disease such as acute suppurative tonsillitis, pneumonia such as purulent bronchitis, bronchiolitis and Klebsiella bacillus, pseudomonas, bacillus pyocyaneus; Diseases of urinary system such as pyelonephritis, cystitis, urethritis etc.; IAI: the systemic inflammatory response syndrome that infection such as suppurative cholecystitis, cholangitis, purulent peritonitis cause, Chinese medical discrimination are stasis of blood poison knot card mutually, and clinical manifestation is heating, heating, aversion to cold, and tachypnea, thirsty, agitation, deep red tongue, rapid pulse etc.The impaired phase of organ dysfunction of the multiple organ dysfunction syndrome that causes because of infection, wound, burn etc. (stasis of blood poison is knot, evil malicious inward invasion syndrome mutually) and depleted early stage, clinical with hyperpyrexia, dyspnea with rapid and short breath, dysphoria; Or coma, or cardiopalmus, or hematemesis; Or have blood in stool, or abdominal distention, or oliguria or anuria; Or jaundice, crimson tongue without fur or purplish tongue secretly have ecchymosis, and rapid pulse or knot are on behalf of principal character.Research shows: these article have the effect of external anti-endotoxin; These article have protective effect to injection endotoxin mice, can reduce injection endotoxin mortality of mice; These article have the trend that suppresses the rat endotoxin shock, can improve the decline to arteriotony; These article have therapeutical effect to the damage that endotoxin causes the rat vital organ, can reduce organ injury rat blood serum GOT, CPK, LDH, MDA level, and it is active to improve its liver SOD; These article have therapeutical effect to the DIC rat, and the coagulation function that can improve the DIC rat is unusual, improve platelet count and fibrinogen content, and the platelet increasing PAR shortens TT and PT, reduces blood plasma TXB2; These article can reduce endotoxin and attack the serum TNF alpha levels rising that mice causes, and have TNF α antagonism; These article bring out delayed allergy to dinitrofluorobenzene does not have obvious influence; These article can improve the level of anti-sheep red blood cell antibody in the sensitized mice serum, show that this medical instrument has the effect that strengthens humoral immune function.These article have activation, strengthen the effect of mice reticuloendothelial system (RES) phagocytic function, can improve normal mouse and clean up index K value and phagocytic index value.
Because Chinese medicine is injected directly into human body or vein; Therefore its safety receives publicity day by day; And also have the XUEBIQING injection to cause some toxic and side effects or anaphylactoid report clinically; Exist bioavailability low and injection is prepared into some conventional oral formulations such as oral liquid, tablet, capsule etc., be difficult to reach the defective of the therapeutic effect of injection.
Summary of the invention
The present invention is directed to the problems referred to above that prior art exists, successfully develop a kind of fast XUEBIQING drop pill that looses that dissolves.And therefore dropping pill formulation has the characteristics rapid, that bioavailability is high that absorb owing to adopting the solid dispersion technology preparation.
XUEBIQING drop pill of the present invention is the basis with the preparation technology of injection, on the basis of the extraction process of injection, through its choice of base, successfully prepares a kind of respond well XUEBIQING drop pill.
The substrate of the application's drop pill is Polyethylene Glycol and the mixed-matrix that is selected from a kind of composition of poloxamer, sodium stearate, glycerin gelatine.
Wherein the composition weight ratio of mixed-matrix is 1-5: 1.
Wherein the part by weight of active constituents of medicine and mixed-matrix is 1: 3-5.
Wherein Polyethylene Glycol is a Macrogol 4000.
The unexpected under study for action discovery of applicant is when using mixed-matrix of the present invention, and drop pill is not only up-to-standard, and the molten time of loosing is short, bioavailability when helping improving the preparation use.
Wherein the method for distilling of active ingredient of Chinese herbs is:
Wherein the shared parts by weight of each component are following: Flos Carthami 100 weight portions, Radix Paeoniae Rubra 100 weight portions, Rhizoma Chuanxiong 100 weight portions, Radix Salviae Miltiorrhizae 100 weight portions, Radix Angelicae Sinensis 100 weight portions.
Its preparation process is:
The Flos Carthami extraction process: get Flos Carthami and put in the container, with 30% ethanol moistening 6 hours, in the percolator of packing into, press the Chinese Pharmacopoeia percolation and soak, percolation when the collection percolate is 4-5 times of volume of spice amount, stops to receive; In percolate, add 95% ethanol and make that to contain alcohol amount be 70%, after cold preservation is left standstill 48 hours, filter; Decompression filtrate recycling ethanol is concentrated into the equal-volume of spice amount to the greatest extent, adds 95% ethanol again and makes that to contain the alcohol amount be 80%; After cold preservation is left standstill 48 hours, the clear and bright medicinal liquid of leaching, decompression recycling ethanol is to most; Continue to be condensed into thick paste, vacuum drying gets the dried cream of Flos Carthami;
Radix Paeoniae Rubra extraction process: get Radix Paeoniae Rubra, add 10 times of water gagings and soaked 1 hour, decocted 2 hours; Leaching decoction liquor, medicinal residues add 8 times of water gagings, decoct 1 hour, filter, and merge decoction liquor twice, are evaporated to and spice amount equal-volume, and be anti-cold, adds 10% Ovum Gallus domesticus album, stirs and place half an hour; In placing liquid, add 95% ethanol and make that to contain the alcohol amount be 70%, after cold preservation is left standstill 24 hours, filter; Decompression filtrate recycling ethanol is to most, and residual liquid divides four extractions, combining extraction liquid with the water-saturated n-butanol of twice spice amount; Decompression and solvent recovery is extremely most, after residual liquid dissolves with the suitable quantity of water commentaries on classics, and cold preservation 48 hours; Filter, filtrating concentrates thick paste, and vacuum drying gets the dried cream of Radix Paeoniae Rubra;
Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis extraction process: get Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, add 10 times of water gagings and soaked 1 hour, decocted 2 hours; Leaching decoction liquor, medicinal residues add 8 times of water gagings, decoct 1 hour, filter, and merge decoction liquor twice, are evaporated to and spice amount equal-volume, and be anti-cold, adds 10% Ovum Gallus domesticus album, stirs and place half an hour; In placing liquid, add 95% ethanol and make that to contain the alcohol amount be 70%, after cold preservation is left standstill 24 hours, filter; Decompression filtrate recycling ethanol is to most, and residual liquid divides four extractions, combining extraction liquid with the water-saturated n-butanol of twice spice amount; Decompression and solvent recovery is extremely most, after residual liquid dissolves with the suitable quantity of water commentaries on classics, and cold preservation 48 hours; Filter, filtrating concentrates thick paste, and vacuum drying gets Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, the dried cream of Radix Angelicae Sinensis;
Merge above-mentioned dried cream, promptly get active constituents of medicine.
Those skilled in the art also can adjust above-mentioned concrete extraction process under the prerequisite of the character that does not change main component.
The method for preparing of drop pill is: according to the given ratio of prescription, accurately take by weighing active component and substrate, be placed on heating while stirring in the heating container, obtain containing the mixed liquor of active component and substrate;
The temperature control system of adjustment drop pill machine makes the water dropper temperature heating of drop pill machine and remains on 50-90 ℃, and the temperature cooling of condensing agent also remains on 40 ± 5 ℃;
When treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and being in above desired state of temperature, the mixed liquor that will contain active component and substrate places in the water dropper jar of drop pill machine, splashes in the condensing agent through water dropper; Condensing agent is selected from any one of liquid paraffin, methyl-silicone oil, vegetable oil: will shrink the drop pill taking-up of molding by the outlet of drop pill machine, and remove the surface condensation agent, and be drying to obtain.
Drop pill of the present invention is compared with the administering mode of traditional oral formulations, exists essential distinction.With the drop pill of solid dispersion technology preparation, can adopt oral, can also sublingual administration, effective ingredient is fully contacted with mucomembranous surface, through the mucomembranous epithelial cell absorption, directly get into blood circulation.Owing to directly get into blood circulation without gastrointestinal tract and liver, avoided first pass effect effectively, also avoided gastrointestinal irritation, thereby it is rapid to have an onset, bioavailability is high, and side effect is little, and medication such as makes things convenient at characteristics.
The applicant finds under study for action when using single substrate, and the application's drop pill dissolves and looses relatively slowly, and when using the specific mixed-matrix of the application, it dissolves diffusing time significantly accelerates, and helps improving its bioavailability more.
The present invention is owing to adopted the preparation technology of injection, and it is few therefore to extract the active ingredient of Chinese herbs purity height, the impurity content that obtain, more helps bringing into play its effect and be prepared into drop pill.
The specific embodiment
Embodiment 1
Extraction method of active ingredients:
Wherein the shared weight of each component is following: Flos Carthami 1000g weight portion, Radix Paeoniae Rubra 1000g, Rhizoma Chuanxiong 1000g, Radix Salviae Miltiorrhizae 1000g, Radix Angelicae Sinensis 1000g.
Its preparation process is:
With the Flos Carthami extraction process: get Flos Carthami and put in the container, with 30% ethanol moistening 6 hours, in the percolator of packing into, press the Chinese Pharmacopoeia percolation and soak, percolation when collecting percolate and being 4-5 times of volume of spice amount, stops to receive; In percolate, add 95% ethanol and make that to contain alcohol amount be 70%, after cold preservation is left standstill 48 hours, filter; Decompression filtrate recycling ethanol is concentrated into the equal-volume of spice amount to the greatest extent, adds 95% ethanol again and makes that to contain the alcohol amount be 80%; After cold preservation is left standstill 48 hours, the clear and bright medicinal liquid of leaching, decompression recycling ethanol is to most; Continue to be condensed into thick paste, vacuum drying gets the dried cream of Flos Carthami;
Radix Paeoniae Rubra extraction process: get Radix Paeoniae Rubra, add 10 times of water gagings and soaked 1 hour, decocted 2 hours; Leaching decoction liquor, medicinal residues add 8 times of water gagings, decoct 1 hour, filter, and merge decoction liquor twice, are evaporated to and spice amount equal-volume, and be anti-cold, adds 10% Ovum Gallus domesticus album, stirs and place half an hour; In placing liquid, add 95% ethanol and make that to contain the alcohol amount be 70%, after cold preservation is left standstill 24 hours, filter; Decompression filtrate recycling ethanol is to most, and residual liquid divides four extractions, combining extraction liquid with the water-saturated n-butanol of twice spice amount; Decompression and solvent recovery is extremely most, after residual liquid dissolves with the suitable quantity of water commentaries on classics, and cold preservation 48 hours; Filter, filtrating concentrates thick paste, and vacuum drying gets the dried cream of Radix Paeoniae Rubra;
Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis extraction process: get Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, add 10 times of water gagings and soaked 1 hour, decocted 2 hours; Leaching decoction liquor, medicinal residues add 8 times of water gagings, decoct 1 hour, filter, and merge decoction liquor twice, are evaporated to and spice amount equal-volume, and be anti-cold, adds 10% Ovum Gallus domesticus album, stirs and place half an hour; In placing liquid, add 95% ethanol and make that to contain the alcohol amount be 70%, after cold preservation is left standstill 24 hours, filter; Decompression filtrate recycling ethanol is to most, and residual liquid divides four extractions, combining extraction liquid with the water-saturated n-butanol of twice spice amount; Decompression and solvent recovery is extremely most, after residual liquid dissolves with the suitable quantity of water commentaries on classics, and cold preservation 48 hours; Filter, filtrating concentrates thick paste, and vacuum drying gets Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, the dried cream of Radix Angelicae Sinensis;
Merge above-mentioned dried cream, promptly get active constituents of medicine.
The screening experiment of substrate:
1. get the active component of the method preparation of embodiment 1;
2. substrate: see table 1-3, wherein the Polyethylene Glycol in the mixed-matrix is a Macrogol 4000
3. the method for preparing of drop pill is: according to the given ratio of prescription, accurately take by weighing active component and substrate, be placed on heating while stirring in the heating container, obtain containing the mixed liquor of active component and substrate;
The temperature control system of adjustment drop pill machine makes the water dropper temperature heating of drop pill machine and remains on 50-90 ℃, and the temperature cooling of condensing agent also remains on 40 ± 5 ℃;
When treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and being in above desired state of temperature, the mixed liquor that will contain active component and substrate places in the water dropper jar of drop pill machine, splashes in the condensing agent through water dropper; Condensing agent is selected from liquid paraffin (also can be methyl-silicone oil, vegetable oil any one): will shrink the drop pill taking-up of molding by the outlet of drop pill machine, and remove the surface condensation agent, and be drying to obtain, and promptly can make the XUEBIQING drop pill of various different sizes.
Result of the test
The group practices of table 1 active constituents of medicine and substrate (active constituents of medicine: substrate weight ratio=1: 1)
The experimental result of table 1 shows that when the weight ratio of active component and substrate is 1: 1 all substrate (comprising single-matrix and mixed-matrix) ball method of double differences is different all defective, part single-matrix amount collapse the prescription that the time of loosing does not meet drop pill yet.
The group practices of table 2 active constituents of medicine and substrate (active constituents of medicine: substrate weight ratio=1: 3)
Table 2 experimental result shows when the weight ratio of active component and substrate is 1: 3; The drop pill of the single substrate of Polyethylene Glycol and above-mentioned all mixed-matrixes (1: 1) all meets the prescription of drop pill; But the time of loosing of dissolving of mixed-matrix obviously accelerates; Help improving bioavailability of medicament, and the time still long (＞30 minutes) of dissolve loosing of part single-matrix and the ball method of double differences different＞10%.
The group practices of table 3 active constituents of medicine and substrate (active constituents of medicine: substrate weight ratio=1: 5)
Table 3 experimental result shows when the weight ratio of active component and substrate is 1: 5; The prescription that all meets drop pill of the single substrate of Polyethylene Glycol and all mixed-matrixes (1: 5); But the time of loosing of dissolving of mixed-matrix is compared obvious quickening, helps improving bioavailability of medicament.Take all factors into consideration the drug loading of drop pill, select to be limited to 1: 5 on the weight ratio of its property composition and substrate
Brief summary:
1, can find out by experimental result, when the ratio of active constituents of medicine and substrate is 1: 1, no matter be the prescription that single-matrix or mixed-matrix all do not meet drop pill.
2. when the ratio of active constituents of medicine and substrate was 1: 3, it is obviously faster that mixed-matrix and traditional single-matrix Polyethylene Glycol relatively dissolve the time of loosing, and shows that the mixed-matrix that the application selects has remarkable meaning.
3. when the ratio of active constituents of medicine and substrate was 1: 5, the molten time of loosing of single-matrix did not obviously improve, and the molten time of loosing of mixed-matrix is still significantly faster, and considered the drug loading of medicine, and its ratio is suitable to be continued to strengthen.
4. can be reached a conclusion by above-mentioned screening experiment, the general effect of the specific blend substrate that the application selects is superior to single-matrix, and above-mentioned effect can't be expected according to prior art.
5. the hardness method for expressing in the subordinate list adopts drop pill is placed on the glass plate, press...withes one's finger it, observes its metamorphosis."+" expression flicking promptly is out of shape, the distortion that " ++ " expression is firmly pressed, and " +++" expression is indeformable by it.
Claims (6)
1. XUEBIQING drop pill; Its active component is prepared into by crude drug Flos Carthami 100 weight portions, Radix Paeoniae Rubra 100 weight portions, Rhizoma Chuanxiong 100 weight portions, Radix Salviae Miltiorrhizae 100 weight portions, Radix Angelicae Sinensis 100 weight portions, and wherein the substrate of drop pill is Polyethylene Glycol and the mixed-matrix that is selected from a kind of composition of poloxamer, sodium stearate, glycerin gelatine.
2. according to the XUEBIQING drop pill of claim 1, wherein the composition weight ratio of mixed-matrix is 1-5: 1.
3. according to the XUEBIQING drop pill of claim 1, wherein the part by weight of active constituents of medicine and mixed-matrix is 1: 3-5.
4. according to the XUEBIQING drop pill of claim 1, wherein Polyethylene Glycol is a Macrogol 4000.
5. according to the XUEBIQING drop pill of claim 1, wherein the method for preparing of active component is:
The Flos Carthami extraction process: get Flos Carthami and put in the container, with 30% ethanol moistening 6 hours, in the percolator of packing into, press the Chinese Pharmacopoeia percolation and soak, percolation when the collection percolate is 4-5 times of volume of spice amount, stops to receive; In percolate, add 95% ethanol and make that to contain alcohol amount be 70%, after cold preservation is left standstill 48 hours, filter; Decompression filtrate recycling ethanol is concentrated into the equal-volume of spice amount to the greatest extent, adds 95% ethanol again and makes that to contain the alcohol amount be 80%; After cold preservation is left standstill 48 hours, the clear and bright medicinal liquid of leaching, decompression recycling ethanol is to most; Continue to be condensed into thick paste, vacuum drying gets the dried cream of Flos Carthami;
Radix Paeoniae Rubra extraction process: get Radix Paeoniae Rubra, add 10 times of water gagings and soaked 1 hour, decocted 2 hours; Leaching decoction liquor, medicinal residues add 8 times of water gagings, decoct 1 hour, filter, and merge decoction liquor twice, are evaporated to and spice amount equal-volume, and be anti-cold, adds 10% Ovum Gallus domesticus album, stirs and place half an hour; In placing liquid, add 95% ethanol and make that to contain the alcohol amount be 70%, after cold preservation is left standstill 24 hours, filter; Decompression filtrate recycling ethanol is to most, and residual liquid divides four extractions, combining extraction liquid with the water-saturated n-butanol of twice spice amount; Decompression and solvent recovery is extremely most, after residual liquid dissolves with the suitable quantity of water commentaries on classics, and cold preservation 48 hours; Filter, filtrating concentrates thick paste, and vacuum drying gets the dried cream of Radix Paeoniae Rubra;
Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis extraction process: get Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, add 10 times of water gagings and soaked 1 hour, decocted 2 hours; Leaching decoction liquor, medicinal residues add 8 times of water gagings, decoct 1 hour, filter, and merge decoction liquor twice, are evaporated to and spice amount equal-volume, and be anti-cold, adds 10% Ovum Gallus domesticus album, stirs and place half an hour; In placing liquid, add 95% ethanol and make that to contain the alcohol amount be 70%, after cold preservation is left standstill 24 hours, filter; Decompression filtrate recycling ethanol is to most, and residual liquid divides four extractions, combining extraction liquid with the water-saturated n-butanol of twice spice amount; Decompression and solvent recovery is extremely most, after residual liquid dissolves with the suitable quantity of water commentaries on classics, and cold preservation 48 hours; Filter, filtrating concentrates thick paste, and vacuum drying gets Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, the dried cream of Radix Angelicae Sinensis;
Merge above-mentioned dried cream, promptly get active constituents of medicine.
6. according to each XUEBIQING drop pill of claim 1-5, the method for preparing of its preparation is:
According to the given ratio of prescription, accurately take by weighing active component and substrate, be placed on heating while stirring in the heating container, obtain containing the mixed liquor of active component and substrate;
The temperature control system of adjustment drop pill machine makes the water dropper temperature heating of drop pill machine and remains on 50-90 ℃, and the temperature cooling of condensing agent also remains on 40 ± 5 ℃;
When treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and being in above desired state of temperature, the mixed liquor that will contain active component and substrate places in the water dropper jar of drop pill machine, splashes in the condensing agent through water dropper; Condensing agent is selected from any one of liquid paraffin, methyl-silicone oil, vegetable oil: will shrink the drop pill taking-up of molding by the outlet of drop pill machine, and remove the surface condensation agent, and be drying to obtain.
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| CN2012100616739A CN102579609A (en) | 2012-03-09 | 2012-03-09 | Blood-clearing dropping pills and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103784521A (en) * | 2014-01-21 | 2014-05-14 | 李桂霞 | Traditional Chinese medicinal composition for treating abdominal absdcess in combination with operative treatment and preparation method thereof |
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2012
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103784521A (en) * | 2014-01-21 | 2014-05-14 | 李桂霞 | Traditional Chinese medicinal composition for treating abdominal absdcess in combination with operative treatment and preparation method thereof |
| CN103784521B (en) * | 2014-01-21 | 2015-12-09 | 李桂霞 | A kind ofly coordinate Chinese medicine composition of operative treatment peritoneal abscess and preparation method thereof |
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Application publication date: 20120718 |