CN1872242A - Injection preparation of leaf of nakedflower beautyberry, and preparation method - Google Patents
Injection preparation of leaf of nakedflower beautyberry, and preparation method Download PDFInfo
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- CN1872242A CN1872242A CN 200610020617 CN200610020617A CN1872242A CN 1872242 A CN1872242 A CN 1872242A CN 200610020617 CN200610020617 CN 200610020617 CN 200610020617 A CN200610020617 A CN 200610020617A CN 1872242 A CN1872242 A CN 1872242A
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Abstract
A nakedflower beautyberry injection is prepared from naked flower beautyberry through pulverizing, sieving, decocting 1-3 times, collecting decoction, filtering, concentrating, laying aside, concentrating again, and preparing injection, powder injection, perfusion, or eyedrops.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation and preparation method thereof with antiinflammatory, detoxifcation, convergence, hemostasia effect, particularly, the present invention relates to Callicarpa nudiflora injectable powder, injection with small volume and high-capacity injection, the eye drop and preparation method thereof of injection.
Background technology:
Callicarpa nudiflora (Callicarpa nudiflora Hook.et Arn), be the Verenaceae medicinal plants, mildly bitter flavor, puckery, property is put down, contain flavone compound, phenolic compound and saccharide compound, have antibacterial anti hemorrhagic, eliminating inflammation and expelling toxin, the effect of dissipating blood stasis for subsidence of swelling has therapeutical effect to diseases such as inflammation caused by bacterial infection, acute infectious hepatitis, respiratory tract and digestive tract hemorrhage, cervicitis, vaginitis, burn, scald, traumatic hemorrhage.
Motherland's traditional medicine is in detoxifcation, and the hemostasis aspect has significant curative effect, and at present clinical middle eliminating inflammation and expelling toxin, the astringing to arrest bleeding Chinese patent medicine preparation that uses is various in style, but because the limitation of dosage form or prescription, more Chinese patent medicine only plays the auxiliary treatment effect.
Confirm through clinical practice at present: dosage forms such as Callicarpa nudiflora tablet, mixture, suppository, granule, capsule, soft capsule, diseases such as, traumatic hemorrhage hemorrhage to treatment viral hepatitis, acute catarrhal tonsillitis, suppurative tonsillitis, pulmonary tuberculosis, urinary tract infection, cervical erosion, acne, radiation enteritis, vaginitis, rhinitis, epistaxis, postoperative hemorrhage, miscarriage, hemorrhoid hemorrhage, early stage hemorrhagic fever with renal syndrome all have good eliminating inflammation and expelling toxin, the astringing to arrest bleeding curative effect.Period in a medicine is not seen apparent side effect.
For promoting the well-being of mankind; excavate the rarity of motherland's Chinese medicine; therefore the injection preparation effect of Callicarpa nudiflora developmental research one-tenth is rapid, evident in efficacy, that bioavailability is high, the clinical practice safety is good; to produce very positive effect to entire society and economics aspect, satisfy different patients' medication demand.
Summary of the invention:
The object of the present invention is to provide Callicarpa nudiflora preparation of a kind of effect with eliminating inflammation and expelling toxin, astringing to arrest bleeding and preparation method thereof.The said preparation effect is rapid, evident in efficacy, bioavailability is high.And not only be easy to preserve by the medicine that the inventive method obtains, and steady quality controls easily, effective ingredient is easy to detect, thereby it has safety preferably in clinical practice.
For achieving the above object, the concrete technical scheme of the present invention's employing is as follows:
The Callicarpa nudiflora preparation is characterized in that: contain the Callicarpa nudiflora total flavones 0.001g～1.0g that makes by following processing step among the every 1ml of said preparation or the every 1g:
A, get the Callicarpa nudiflora medical material, pulverize, cross 40 mesh sieves, add the water of 5～12 times of weight, decocts 1～3 time, each 0.5～3 hour, collecting decoction, filtration, filtrate is concentrated into the extracting solution A that relative density is 1.05～1.30 (50～90 ℃);
B, extracting solution A was left standstill 6～72 hours, perhaps in extracting solution A, add the ethanol of 20%～80% weight ratio after, leave standstill again and promptly got extracting solution B in 6～72 hours;
C, get extracting solution B, it is the extracting solution C of 1.05～1.25 (50～90 ℃) that routine or concentrating under reduced pressure become relative density;
D, get extracting solution C, the preparation method of injection preparation directly is prepared into injectable powder, injection with small volume or high-capacity injection, eye drop routinely.
Described Callicarpa nudiflora medical material is the dried leaves of Verenaceae plant Callicarpa nudiflora Callicarpa nudiflora Hook.etArn..
The preparation method of described injectable powder is: get extracting solution C, the adjuvant that adds 0～0.1 grams per milliliter, it is an amount of to add the injection water again, the need activated carbon decolorizing, add needle-use activated carbon 0.01～0.5 gram by per 100 ml solns, stirring the back filters, gained filtrate is 4.0～8.0 with the pH value that acid-base modifier is adjusted to solution, add to the full amount of water for injection again, selecting the aperture then for use is that the microporous filter membrane of 0.2～0.8 μ m filters 1～3 time continuously or discontinuously, is that 1～10ml is sub-packed in the cillin bottle with gained filtrate by every volume, places freeze drying box again and temperature is reduced to below-30 ℃, again to the freeze drying box evacuation, make vacuum reach 10 simultaneously
-1～10
-3MmHg, pre-freeze slowly is warming up to 30 ℃ after 2～10 hours again, reaches standard-required to the moisture of dried frozen aquatic products, promptly gets the Callicarpa nudiflora injectable powder.
The preparation method of described injection with small volume is: get extracting solution C, the adjuvant that adds 0～0.1 grams per milliliter, it is an amount of to add the injection water again, the need activated carbon decolorizing, add needle-use activated carbon 0.01～0.5 gram by per 100 ml solns, stir, filter, again with filtrate heated and boiled 5～20 minutes, put coldly, cold preservation 6～24 hours is 4.0～8.0 with the pH value that acid-base modifier is adjusted to solution then, add to the full amount of water for injection, it is that the microporous filter membrane of 0.2～0.8 μ m filters 1～3 time continuously or discontinuously that gained solution is selected the aperture for use, and at last with the embedding of gained filtrate, the packing volume is 1～10ml, sterilization, quality inspection promptly gets the Callicarpa nudiflora injection with small volume.
The preparation method of described high-capacity injection is: get extracting solution C, the adjuvant that adds 0～0.1 grams per milliliter, it is an amount of to add the injection water, the need activated carbon decolorizing, add needle-use activated carbon 0.001～0.5 gram by per 100 ml solns, stir, filter, filtrate heated and boiled 5～20 minutes, put coldly, cold preservation 6～24 hours is 4.0～8.0 with the pH value that acid-base modifier is adjusted to solution then, add to the full amount of water for injection, it is that the microporous filter membrane of 0.2～0.8 μ m filters 1～3 time continuously or discontinuously that gained solution is selected the aperture for use, and at last with the embedding of gained filtrate, the packing volume is 100～500ml, sterilization, quality inspection promptly gets the Callicarpa nudiflora high-capacity injection.
The preparation method of described eye drop is: get extracting solution C, the adjuvant that adds 0～0.1 grams per milliliter, it is an amount of to add the injection water again, the need activated carbon decolorizing, add needle-use activated carbon 0.01～0.5 gram by per 100 ml solns, stir, filter, again with filtrate heated and boiled 5～20 minutes, put coldly, cold preservation 6～24 hours is 4.0～8.0 with the pH value that acid-base modifier is adjusted to solution then, add to the full amount of water for injection, it is that the microporous filter membrane of 0.2～0.8 μ m filters 1～3 time continuously or discontinuously that gained solution is selected the aperture for use, and at last with the embedding of gained filtrate, the packing volume is 5～10ml, sterilization, quality inspection promptly gets the Callicarpa nudiflora eye drop.
Described adjuvant is selected one or more in sodium chloride, glucose, sodium sulfite, sodium sulfite or the sodium thiosulfate for use.
Described acid-base modifier comprises sodium hydroxide, hydrochloric acid, sodium carbonate, sodium bicarbonate, sodium citrate, citric acid, sodium dihydrogen phosphate, sodium hydrogen phosphate and/or sodium phosphate.
Using method: Callicarpa nudiflora injection with small volume of the present invention and high-capacity injection can be directly used in patient and carry out intravenous drip, intravenous injection or intramuscular injection; Injectable powder with preceding adding 5% glucose injection or 0.9% sodium chloride injection or water for injection with medicine dissolution after, carry out intravenous drip, intravenous injection or intramuscular injection; Eye drop can directly drip in patient's eyes and use.
The invention has the advantages that:
1, medicine of the present invention carries out administration by intravenous drip, intravenous injection, intramuscular injection path or ophthalmic, and drug effect is rapid, and is evident in efficacy, the bioavailability height;
2, containing the Callicarpa nudiflora total flavones among the every 1ml of Callicarpa nudiflora preparation of the present invention or the every 1g is 0.001g～1.0g, and its eliminating inflammation and expelling toxin, astringing to arrest bleeding effect are remarkable, has satisfied different patients' medication demand.
3, preparation of the present invention is sub-packed in cillin bottle, ampoule bottle, infusion bottle or the polyester bottles through aseptic process, and its drug quality is stable, and is safe.
4, process equipment of the present invention is simple, easy operating, and production cost is low, and constant product quality is used other organic solvent hardly, has reduced environmental pollution.
5, the present invention passes through the research of prescription Chinese medicine medical material, extraction, separation, purification, concentrates, process test research such as preparations shaping, the quality control standard and the method for inspection that meet industrialization of Chinese medicine modernization standard have been set up, also study the stability of pilot sample under 24 months room temperature is placed simultaneously, guaranteed the effectiveness and the safety of medicine.Every experimental study all meets the every technological guidance principle of State Food and Drug Administration about the new drug registration.
The specific embodiment
Embodiment 1
A kind of Callicarpa nudiflora powder ampoule agent for injection is characterized in that: contain the Callicarpa nudiflora total flavones 0.1g～1.0g that makes by following processing step among the every 1g of said preparation:
A, get the Callicarpa nudiflora medical material, pulverize, cross 40 mesh sieves, add the water of 5-12 times of weight, decocts 3 times, each 0.5～3 hour, collecting decoction, filtration, filtrate is concentrated into the extracting solution A that relative density is 1.05～1.30 (50～90 ℃);
B, extracting solution A was left standstill 6-72 hour, promptly get extracting solution B;
C, get extracting solution B, it is the extracting solution C of 1.05～1.25 (50～90 ℃) that routine or concentrating under reduced pressure become relative density;
D, get extracting solution C, the sodium chloride, the glucose that add the 0-0.1 grams per milliliter, it is an amount of to add the injection water again, add needle-use activated carbon 0.01～0.5 gram decolouring by per 100 ml solns, stirring the back filters, gained filtrate is 4.0～8.0 with the pH value that sodium carbonate is adjusted to solution, add to the full amount of water for injection again, selecting the aperture then for use is the microporous filter membrane continuous filtration 3 times of 0.2～0.8 μ m, is that 1-10ml is sub-packed in the cillin bottle with gained filtrate by every volume, place freeze drying box again and temperature is reduced to below-30 ℃,, make vacuum reach 10 simultaneously again to the freeze drying box evacuation
-1～10
-3MmHg, pre-freeze slowly is warming up to 30 ℃ after 2～10 hours again, reaches standard-required to the moisture of dried frozen aquatic products, promptly gets the Callicarpa nudiflora injectable powder.
Embodiment 2
A kind of Callicarpa nudiflora injection with small volume is characterized in that: contain the Callicarpa nudiflora total flavones 0.1g～1.0g that makes by following processing step among the every 1ml of said preparation:
A, get the Callicarpa nudiflora medical material, pulverize, cross 40 mesh sieves, add the water of 5～12 times of weight, decocts 3 times, each 0.5～3 hour, collecting decoction, filtration, filtrate is concentrated into the extracting solution A that relative density is 1.05～1.30 (50～90 ℃);
B, in extracting solution A, add the ethanol of 20%～80% weight ratio after, leave standstill again and promptly got extracting solution B in 6～72 hours;
C, get extracting solution B, it is the extracting solution C of 1.05～1.25 (50～90 ℃) that routine or concentrating under reduced pressure become relative density;
D, get extracting solution C, add 0～0.1 grams per milliliter sodium chloride, it is an amount of to add the injection water, stir, filter, again with filtrate heated and boiled 5～20 minutes, put coldly, cold preservation 6～24 hours is 4.0～8.0 with the pH value that sodium citrate is adjusted to solution then, add to the full amount of water for injection, it is that the microporous filter membrane of 0.2～0.8 μ m filters 2 times discontinuously that gained solution is selected the aperture for use, and at last with the embedding of gained filtrate, the packing volume is 1～10ml, sterilization, quality inspection promptly get the Callicarpa nudiflora injection with small volume.
Embodiment 3
A kind of Callicarpa nudiflora high-capacity injection is characterized in that: contain the Callicarpa nudiflora total flavones 0.001g～0.01g that makes by following processing step among the every 1ml of said preparation:
A, get the Callicarpa nudiflora medical material, pulverize, cross 40 mesh sieves, add the water of 5～12 times of weight, decocts 3 times, each 0.5～3 hour, collecting decoction, filtration, filtrate is concentrated into the extracting solution A that relative density is 1.05～1.30 (50～90 ℃);
B, extracting solution A was left standstill 6～72 hours, promptly get extracting solution B;
C, get extracting solution B, it is the extracting solution C of 1.05～1.25 (50～90 ℃) that routine or concentrating under reduced pressure become relative density;
D, get extracting solution C, add 0～0.1 grams per milliliter sodium chloride, it is an amount of to add the injection water, adding needle-use activated carbon 0.001～0.5 gram by per 100 ml solns decolours, stir, filter, filtrate heated and boiled 5～20 minutes is put cold, cold preservation 6～24 hours, use sodium dihydrogen phosphate then, sodium hydrogen phosphate and sodium phosphate acid-alkali accommodation to the pH value of solution is 4.0～8.0, adds to the full amount of water for injection, and it is the microporous filter membrane continuous filtration 3 times of 0.2～0.8 μ m that gained solution is selected the aperture for use, at last with the embedding of gained filtrate, the packing volume is 100～500ml, sterilization, quality inspection promptly gets the Callicarpa nudiflora high-capacity injection.
Embodiment 4
A kind of Callicarpa nudiflora eye drop is characterized in that: contain the Callicarpa nudiflora total flavones 0.1g～1.0g that makes by following processing step among the every 1ml of said preparation:
A, get the Callicarpa nudiflora medical material, pulverize, cross 40 mesh sieves, add the water of 5～12 times of weight, decocts 3 times, each 0.5～3 hour, collecting decoction, filtration, filtrate is concentrated into the extracting solution A that relative density is 1.05～1.30 (50～90 ℃);
B, in extracting solution A, add the ethanol of 20%～80% weight ratio after, leave standstill again and promptly got extracting solution B in 6～72 hours;
C, get extracting solution B, it is the extracting solution C of 1.05～1.25 (50～90 ℃) that routine or concentrating under reduced pressure become relative density;
D, get extracting solution C, add 0～0.1 grams per milliliter sodium chloride, it is an amount of to add the injection water, stir, filter, again with filtrate heated and boiled 5～20 minutes, put coldly, cold preservation 6～24 hours is 4.0～8.0 with the pH value that sodium citrate is adjusted to solution then, add to the full amount of water for injection, it is that the microporous filter membrane of 0.2～0.8 μ m filters 2 times discontinuously that gained solution is selected the aperture for use, and at last with the embedding of gained filtrate, the packing volume is 5～10ml, sterilization, quality inspection promptly get the Callicarpa nudiflora eye drop.
Claims (7)
1, Callicarpa nudiflora preparation is characterized in that: contain the Callicarpa nudiflora total flavones 0.001g～1.0g that makes by following processing step among the every 1ml of said preparation or the every 1g;
A, get the Callicarpa nudiflora medical material, pulverize, cross 40 mesh sieves, add the water of 5～12 times of weight, decocts 1～3 time, each 0.5～3 hour, collecting decoction, filtration, it is 1.05～1.30 extracting solution A that filtrate is concentrated into relative density;
B, extracting solution A was left standstill 6～72 hours, perhaps in extracting solution A, add the ethanol of 20%～80% weight ratio after, leave standstill again and promptly got extracting solution B in 6～72 hours;
C, get extracting solution B, it is 1.05～1.25 extracting solution C that routine or concentrating under reduced pressure become relative density;
D, get extracting solution C, the preparation method of injection preparation directly is prepared into injectable powder, injection with small volume or high-capacity injection routinely.
2, Callicarpa nudiflora preparation according to claim 1, it is characterized in that: the preparation method of described injectable powder is: get extracting solution C, the adjuvant that adds 0～0.1 grams per milliliter, it is an amount of to add the injection water again, the need activated carbon decolorizing, add needle-use activated carbon 0.01～0.5 gram by per 100 ml solns, stirring the back filters, gained filtrate is 4.0～8.0 with the pH value that acid-base modifier is adjusted to solution, add to the full amount of water for injection again, selecting the aperture then for use is that the microporous filter membrane of 0.2～0.8 μ m filters 1～3 time continuously or discontinuously, is that 1～10ml is sub-packed in the cillin bottle with gained filtrate by every volume, place freeze drying box again and temperature is reduced to below-30 ℃,, make vacuum reach 10 simultaneously again to the freeze drying box evacuation
-1～10
-3MmHg, pre-freeze slowly is warming up to 30 ℃ after 2～10 hours again, reaches standard-required to the moisture of dried frozen aquatic products, promptly gets the Callicarpa nudiflora injectable powder.
3, Callicarpa nudiflora preparation according to claim 1, it is characterized in that: the preparation method of described injection with small volume is: get extracting solution C, the adjuvant that adds 0～0.1 grams per milliliter, it is an amount of to add the injection water, the need activated carbon decolorizing, add needle-use activated carbon 0.01～0.5 gram by per 100 ml solns, stir, filter, with filtrate heated and boiled 5～20 minutes, put cold again, cold preservation 6～24 hours, the pH value that is adjusted to solution with acid-base modifier is 4.0～8.0 then, adds to the full amount of water for injection, and it is that the microporous filter membrane of 0.2～0.8 μ m filters 1～3 time continuously or discontinuously that gained solution is selected the aperture for use, at last with the embedding of gained filtrate, the packing volume is 1～10ml, sterilization, quality inspection promptly gets the Callicarpa nudiflora injection with small volume.
4, Callicarpa nudiflora preparation according to claim 1, it is characterized in that: the preparation method of described high-capacity injection is: get extracting solution C, add 0～0.1 grams per milliliter adjuvant, it is an amount of to add the injection water, the need activated carbon decolorizing, add needle-use activated carbon 0.001～0.5 gram by per 100 ml solns, stir, filter, filtrate heated and boiled 5～20 minutes is put cold, cold preservation 6～24 hours, the pH value that is adjusted to solution with acid-base modifier is 4.0～8.0 then, adds to the full amount of water for injection, and it is that the microporous filter membrane of 0.2～0.8 μ m filters 1～3 time continuously or discontinuously that gained solution is selected the aperture for use, at last with the embedding of gained filtrate, the packing volume is 100～500ml, sterilization, quality inspection promptly gets the Callicarpa nudiflora high-capacity injection.
5, Callicarpa nudiflora preparation according to claim 1, it is characterized in that: the preparation method of described eye drop is: get extracting solution C, the adjuvant that adds 0～0.1 grams per milliliter, it is an amount of to add the injection water, the need activated carbon decolorizing, add needle-use activated carbon 0.01～0.5 gram by per 100 ml solns, stir, filter, with filtrate heated and boiled 5～20 minutes, put cold again, cold preservation 6～24 hours, the pH value that is adjusted to solution with acid-base modifier is 4.0～8.0 then, adds to the full amount of water for injection, and it is that the microporous filter membrane of 0.2～0.8 μ m filters 1～3 time continuously or discontinuously that gained solution is selected the aperture for use, at last with the embedding of gained filtrate, the packing volume is 5～10ml, sterilization, quality inspection promptly gets the Callicarpa nudiflora eye drop.
6, according to claim 2,3,4 or 5 described Callicarpa nudiflora preparations, it is characterized in that: described adjuvant is selected one or more in sodium chloride, glucose, sodium sulfite, sodium sulfite or the sodium thiosulfate for use.
7, according to claim 2,3,4 or 5 described Callicarpa nudiflora preparations, it is characterized in that: described acid-base modifier comprises sodium hydroxide, hydrochloric acid, sodium carbonate, sodium bicarbonate, sodium citrate, citric acid, sodium dihydrogen phosphate, sodium hydrogen phosphate and/or sodium phosphate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610020617 CN1872242A (en) | 2006-03-30 | 2006-03-30 | Injection preparation of leaf of nakedflower beautyberry, and preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610020617 CN1872242A (en) | 2006-03-30 | 2006-03-30 | Injection preparation of leaf of nakedflower beautyberry, and preparation method |
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| CN1872242A true CN1872242A (en) | 2006-12-06 |
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| CN 200610020617 Pending CN1872242A (en) | 2006-03-30 | 2006-03-30 | Injection preparation of leaf of nakedflower beautyberry, and preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102048909A (en) * | 2009-10-28 | 2011-05-11 | 江西省药物研究所 | Callicarpa nudiflora effective part with hemostatic effect and pharmaceutical preparation thereof |
| CN105194108A (en) * | 2014-06-18 | 2015-12-30 | 海南国瑞堂中药制药有限公司 | Preparation method of callicarpa nudiflora extract |
-
2006
- 2006-03-30 CN CN 200610020617 patent/CN1872242A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102048909A (en) * | 2009-10-28 | 2011-05-11 | 江西省药物研究所 | Callicarpa nudiflora effective part with hemostatic effect and pharmaceutical preparation thereof |
| CN105194108A (en) * | 2014-06-18 | 2015-12-30 | 海南国瑞堂中药制药有限公司 | Preparation method of callicarpa nudiflora extract |
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Open date: 20061206 |