CN1194700C - Globeflower powder for injection and its prepn - Google Patents
Globeflower powder for injection and its prepn Download PDFInfo
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- CN1194700C CN1194700C CN 03123767 CN03123767A CN1194700C CN 1194700 C CN1194700 C CN 1194700C CN 03123767 CN03123767 CN 03123767 CN 03123767 A CN03123767 A CN 03123767A CN 1194700 C CN1194700 C CN 1194700C
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- flos
- injectable powder
- globeflower
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- flos trollii
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- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention provides globeflower injectable powder and a preparation method thereof, which comprises the injectable powder prepared from four traditional Chinese medicines mainly including globeflower, a composition formula and a preparation method thereof. The globeflower injectable powder contains chlorogenic acid, vitexin, orientoside, crysanthemum indicum lctone, artoglasin and baicalin. The composition formula comprises (by weight) 3 to 5 parts of globeflower, 2 to 4 parts of honeysuckle flower, 1 to 3 parts of scutellaria roots and 1 to 3 parts of chrysanthemi indici. The preparation method comprises: preparing a globeflower extract with a water-alcohol method, preparing a scutellaria root extract with an acid-alkali method, mixing the two extracts to prepare a semi-finished solution of the globeflower injectable powder, filtering the solution, adding injection water, regulating pH to 7 with a 35 to 40% sodium hydroxide solution, treating the semi-finished solution with a freeze drying or spray drying method to obtain the globeflower injectable powder. The four traditional Chinese medicines jointly perform the functions of clearing heat and toxic material, leaking fire and relieving sore-throat. Thus, the globeflower injectable powder is used for swelling and sore throats, upper respiratory tract infections, tonsillitis, pestilence and influenza, and provides a new antiinflammation antiviral medicine for Chinese traditional treatment on emergency and severe cases.
Description
Technical field: the invention belongs to Chinese medicine powder injection and preparation method thereof, particularly Flos Trollii injectable powder and preparation method thereof.
Background technology: the Flos Trollii bitter in the mouth is cold in nature nontoxic, is good at heat-clearing and toxic substances removing, and normal and Flos Lonicerae, Flos Chrysanthemi Indici compatibility are used for the treatment of laryngopharynx swelling and pain, upper respiratory tract infection due to the lung sthenia gastropyrexia, and diseases such as tonsillitis, pestilence influenza have extraordinary curative effect.Single preparation based on Flos Trollii commonly used has Tabellae Trollii, capsule etc., but usage all is oral.As be made into injections of Chinese medicine, then can satisfy above-mentioned emergency and severe disease patient's treatment needs.
At present, Chinese medicine injection has two kinds with injection: a kind of is aqueous injection, and another kind is an injectable powder.Though the production equipment of aqueous injection is simple, medicine stability is poor, is unfavorable for preserving, and is not easy to transportation, and resting period length is prone to precipitate or color shoals, and pH value descends, and its curative effect also descends thereupon.Chinese medicine injection with the injectable powder great majority based on single medicinal material, herbal mixture injection (injectable powder) prescription drug is formed at most at three flavors, as Chinese patent 8910360.0,89106021.9 these two patents are respectively method and the preparation of injection of Chinese medicines of making dual coptis powder injection.And for based on Flos Trollii, in addition compatibility Flos Lonicerae, Radix Scutellariae, Flos Chrysanthemi Indici the injectable powder made of totally four flavor Chinese medicine compositions yet there are no report.
Summary of the invention: the object of the invention provides a kind of Flos Trollii injectable powder and makes each method, comprise with the Flos Trollii being the injectable powder made of main totally four flavor Chinese medicines, composite formula and preparation method thereof, its powder injection formulation and preparation method thereof can be in industrial application, serialization production, for the Chinese traditional treatment emergency and severe disease provides a kind of antiinflammatory, new antiviral drug.
Contain chlorogenic acid, apigenin-8-C-glucoside, orientin, yejuhua lactone, Flos Chrysanthemi element, baicalin in the Flos Trollii injectable powder.
The composite formula of Flos Trollii injectable powder: the compositions component is by Flos Trollii, Flos Lonicerae, Radix Scutellariae, Flos Chrysanthemi Indici, and totally four flavor Chinese medicines are formed, and its component content is counted with parts by weight:
Flos Trollii 3-5 part Flos Lonicerae 2-4 part Radix Scutellariae 1-3 part Flos Chrysanthemi Indici 1-3 part
Component optimum content in the compositions is counted with parts by weight:
3 parts of 3 parts of Flos Chrysanthemi Indicis of 3 parts of Radix Scutellariaes of 4 portions of Flos Loniceraes of Flos Trollii
Be monarch drug with the Flos Trollii in the above-mentioned composition, Flos Lonicerae, Radix Scutellariae are ministerial drug, and Flos Chrysanthemi Indici is assistant.The Flos Trollii bitter in the mouth is cold in nature in the side, is good at heat-clearing and toxic substances removing; Flos Lonicerae bitter but sweet flavor cold nature can heat-clearing and toxic substances removing, kind again infection; Radix Scutellariae is cold in nature because of its bitter in the mouth, the energy eliminating fire and detoxication, and two flavor medicine and the mutual compatibilities of Flos Trollii can be strengthened heat-clearing and toxic substances removing, the effect of the lung excess of the stomach fire of dispelling; Flos Chrysanthemi Indici bitter in the mouth suffering is cool in nature, energy wind and heat dispersing, subduing swelling and detoxicating.The effect that above four Chinese medicine share common performance heat-clearing and toxic substances removing, lets out fiery sore-throat relieving is applicable to laryngopharynx swelling and pain, upper respiratory tract infection that the lung sthenia gastropyrexia causes, tonsillitis, pestilence influenza.
The preparation method of Flos Trollii injectable powder is: water alcohol legal system is equipped with Flos Trollii extract, prepare Radix Scutellariae extract (baicalin) with acid-base method, two kinds of extract mixtures are lumped together make Flos Trollii injectable powder semi-finished product solution, Flos Trollii injectable powder semi-finished product solution adds the injection water after filtering, sodium hydroxide solution with 35-40% is transferred pH value 7.0, make the Flos Trollii injectable powder through freeze-drying or spray drying method, the ratio of Flos Trollii extract and Radix Scutellariae extract is 8-10 in the Flos Trollii injectable powder: 1, and main preparation process is divided into: the preparation of Flos Trollii extract, the preparation of Radix Scutellariae extract, the half-finished preparation of Flos Trollii injectable powder, the preparation of Flos Trollii injectable powder.
Concrete preparation process is as follows:
1, the preparation of Flos Trollii extract
Flos Trollii extract mainly is a chlorogenic acid, apigenin-8-C-glucoside, orientin, yejuhua lactone, the Flos Chrysanthemi element, earlier with Flos Trollii, Flos Chrysanthemi Indici, Flos Lonicerae takes by weighing by recipe quantity, be positioned over together after cleaning soak 30 minutes in the container after, decoct and extract twice, merge decoction liquor twice, filter, each decoction hourly water consumption is 8-10 a times of medicine, and decocting time is to boiling back 60-90 minute, and filtrate filtered is concentrated into proportion 1.05-1.15 70-80 ℃ of heating, after being cooled to room temperature, 95% ethanol precipitation that adds triplication is heated with stirring to and boils back static 48 hours, the clear liquid above the leaching, ethanol reclaims, when clear liquid heating is concentrated into proportion for 70-80 ℃ and is 1.15-1.25, be cooled to room temperature after, add 95% ethanol of 10 times of amounts of volume, stir in the temperature below 40 ℃, cooled off static 48 hours, brown clear liquid above the leaching reclaims ethanol to there not being the alcohol flavor, make Flos Trollii extract (liquid) 80000-100000 milliliter, 0-6 ℃ of cold preservation is standby.
2, the preparation of Radix Scutellariae extract
The extract of Radix Scutellariae mainly is a baicalin, takes by weighing Radix Scutellariae by recipe quantity, is positioned in the container and extracts, and extracts Radix Scutellariae extract 1.0-1.2 kilogram, and standby, its extracting method is known acid-base method.
3, the preparation of Flos Trollii injectable powder semi-finished product solution
In Flos Trollii extract, add refining Radix Scutellariae extract (baicalin), after two kinds of extract mixtures lump together, add 40% sodium hydroxide pH value is transferred to 7.0, purified baicalin is dissolved fully, add water recently distilled to full dose, stir, add 0.5% activated carbon, boiled 15-20 minute, be cooled to 30-40 ℃ after, remove activated carbon with paper pulp filtering, the filtrate embedding, sterilization is 45 minutes under 115 ℃ of temperature, is cooled to room temperature and is placed in the refrigerator under the temperature after cold preservation 72-120 hour (3-5 days), make Flos Trollii injectable powder semi-finished product, standby.
Radix Scutellariae extract also can directly use commercially available baicalin goods
4, the preparation of Flos Trollii injectable powder
With Flos Trollii injectable powder semi-finished product solution G
3The sintered glass funnel filtration under diminished pressure adds to the full amount of water for injection, and transferring to pH value with the 35-40% sodium hydroxide is 7.0, adds to the full amount of water for injection, and uses G once more
3The sintered glass funnel filtration under diminished pressure, the filtering with microporous membrane of reuse 0.2-0.65 micron adopts freeze-drying or spray drying method to make powder.
Freeze-drying is the known preparation method in the Chinese medicine powder injection formulation, filtrate is filled under aseptic condition in the sterilization cillin bottle, and every loading amount is the 3.85-4.10 milliliter, is equivalent to crude drug in whole 6 gram and is positioned in the fridge lyophilization and makes, product is the dark yellow porous solid.
Spray drying method is the known preparation method in the Chinese medicine powder injection formulation, and filtrate is positioned in the spray dryer spray drying and makes under aseptic condition, and every loading amount is the 0.885-1.100 gram, is equivalent to crude drug in whole 6 grams, and product is the dark yellow solid.
The quality of product of the present invention is to adopt Chinese medicine fingerprint that the quality of raw material and preparation thereof is controlled, from the finger printing of every flavor Chinese crude drug and the finger printing after making the finished product medicine control, promptly Flos Trollii injectable powder quality standard control method adopts finger printing---Chinese medicine extract---Chinese medicine preparation obtains reflecting this Chinese medicine feature from raw material of Chinese medicine, the collection of illustrative plates that indicates the total peak of this Chinese medicine characteristic controls.
Beneficial effect:
1, the Flos Trollii injectable powder is to be that main totally four flavor Chinese medicines are formed with the Flos Trollii, and the flavor number is maximum in present Chinese medicine compound injection, and reasonable recipe, and compatibility is accurate, particularly uses the invalid viral infection of antibiotics evident in efficacy to respiratory tract infection;
2, Flos Trollii injectable powder constant product quality height, higher more than 10 times than aqueous injection, constant product quality was placed 4 years, and pH value, color, clarity do not change, and are convenient to keeping, deposit and transport;
3, the preparation method of Flos Trollii injectable powder is easy to control to thermal source, microgranule, antibacterial, and every technical specification all meets the version Pharmacopoeia of the People's Republic of China in 2000 requirement.
4, Flos Trollii injectable powder target level of product quality control method adopts finger printing, obtains reflecting this Chinese medicine feature, indicates the total peak spectrogram of this Chinese medicine characteristic from Chinese crude drug (raw material)-Chinese medicine extract-Chinese medicine preparation semi-finished product-Chinese medicine preparation finished product.
The specific embodiment:
Embodiment 1:
1, the preparation of Flos Trollii extract
Taking by weighing is mixed to be positioned over after 4 parts of Flos Trolliis (40 kilograms), Flos Lonicerae 3 parts of (30 kilograms), Flos Chrysanthemi Indicis 3 parts (30 kilograms) are cleaned added 10 times of water loggings bubbles after 30 minutes in the container, heating decocts, boil 90 minutes after-filtration, the leaching medicinal liquid, the decocting that adds 8 times of amounts in medicinal residues boils to boiling back 60 minutes, filter, twice filtrate is merged, heating, being concentrated into proportion under 75 ℃ ± 5 ℃ temperature is 1.05-1.15, slowly adds 95% ethanol of medicine liquid volume triplication, be heated with stirring to boil after, static 48 hours of cold preservation, the clear liquid above the leaching, ethanol reclaims.It is 1.15-1.25 that clear liquid is concentrated into proportion, to be cooled to room temperature, slowly adds 95% ethanol of 10 times of amounts of volume this moment, stir at normal temperatures, cooled off clear liquid above the leaching static 48 hours, reclaim ethanol to there not being the alcohol flavor, make 100000 milliliters of Flos Trollii extracts (liquid), standby.
2, the preparation of Radix Scutellariae extract (baicalin)
Take by weighing 3 parts of Radix Scutellariaes (30 kilograms) by prescription, be positioned over immediately after cleaning and add 10 times of decoctings in the container and boil, decoct after boiled back 90 minutes, the leaching medicinal liquid, the water that adds 8 times of amounts in medicinal residues decocts after boiled back 90 minutes, filters, merge secondary filtrate, transfer pH value to 2.0 with concentrated hydrochloric acid, be heated to 80 ℃, be incubated 30 minutes, precipitate is separated out, leaching precipitation is washed, and adds water that 8-10 doubly measures and makes precipitate mixed and suspend in water, with concentration is that 40% sodium hydroxide solution transfers to 7.0 with pH value, 95% ethanol that adds equivalent stirs, dissolving is filtered, and again filtrate being transferred pH value with concentrated hydrochloric acid is 2.0, be heated with stirring to 50 ℃, be incubated 30 minutes, the Radix Scutellariae extract precipitation is separated out, after the filtration, reuse 95% washing with alcohol precipitate to pH value be 4.0,60 ℃ dry Radix Scutellariae extract crude product (baicalin).The pulverizing of Radix Scutellariae extract crude product is added 10 times of water gagings make its suspendible, transfer pH value to 6.0 with 40% sodium hydroxide solution, the activated carbon that adds Radix Scutellariae extract weight 3%, after the stirring, 50-55 ℃ of insulation 30 minutes, after 95% ethanol of one times of amount of adding stirs evenly, filter, filtrate is transferred pH value 3.0 with concentrated hydrochloric acid, and insulation is 30 minutes under 60 ℃ of conditions, Radix Scutellariae extract is separated out, after the centrifugal filtration, with a small amount of 95% washing with alcohol precipitate, centrifugal filtration is to doing, make loose shape solid after the pulverizing and be 1.0 kilograms of refining Radix Scutellariae extracts (baicalin), standby.
3, the preparation of Flos Trollii injectable powder semi-finished product solution
Take by weighing 100000 milliliters of Flos Trollii extract solution, add 1.0 kilograms of refining Radix Scutellariae extracts (baicalin) rapidly, Flos Trollii extract and Radix Scutellariae extract ratio are 10: 1.Add 40% sodium hydroxide and transfer pH value to 7.0, Radix Scutellariae extract is dissolved fully, add water recently distilled to 100000 milliliter, 0.5% activated carbon boiled 30 minutes, cooling back paper pulp filtering, remove activated carbon, in the filtrate embedding hermetic container, sterilization is 45 minutes under 115 ℃ of temperature, cooling is placed on cold preservation 5 days (120 hours) in the refrigerator, makes Flos Trollii injectable powder semi-finished product solution.
4, the preparation of Flos Trollii injectable powder
100000 milliliters of depletion Flos Nelumbinis injectable powder semi-finished product solutions are used G
3The sintered glass funnel filtration under diminished pressure adds injection water to 100000 milliliter, and transferring to pH value with 40% sodium hydroxide is 7.0, adds to inject water to 100000 milliliter, uses G once more
3The sintered glass funnel filtration under diminished pressure, the filtering with microporous membrane that reuse is 0.4 micron, filtrate is filled into cillin bottle under aseptic condition, every loading amount is the 3.885-4.100 milliliter, is positioned in the fridge, freezing four hours, make the plate temperature reach-17 ℃, products temperature reaches-23 ℃, and chilling temperature reaches-50～55 ℃, evacuation, the plate temperature slowly is increased to 20 ℃ subsequently, condensation temperature is constant, unpacks after 24 hours, makes dried frozen aquatic products, again with the cillin bottle gland, seal with wax, be the final products-Flos Trollii injectable powder of this method after labelled, product is the loose shape solid of dark yellow, and medicine weighs 600 milligrams in every injectable powder, is equivalent to crude drug in whole 6g.Every contains 100 milligrams of chlorogenic acids, 10 milligrams of apigenin-8-C-glucoside, 120 milligrams of orientin, 10 milligrams of yejuhua lactones, plain 25 milligrams of Flos Chrysanthemi, 80 milligrams of baicalins.
Embodiment 2:
Flos Trollii extract and Radix Scutellariae extract ratio are 8:1 in the Flos Trollii injectable powder semi-finished product solution, and other is with embodiment 1.
The preparation of Flos Trollii injectable powder is under aseptic condition Flos Trollii injectable powder semi-finished product solution to be made powder by spray drying.100000 milliliters of depletion Flos Nelumbinis semi-finished product solutions filter with sintered glass filter-bulb, add injection water to 100000 milliliter, transfer pH value to 7.0 with 40% sodium hydroxide, with the sintered glass filter-bulb filtration, behind the reuse filtering with microporous membrane.Before the spray drying, equipment, pipeline are sterilized, carry out evacuation then and handle, the whiff pressure of regulating spray dryer is at 2-5kg/cm
2, draft 6kg/cm
2, inlet temperature 180-300 ℃, outlet temperature 60-80 ℃, charging rate is that 30ml/min carries out spray drying.Medicinal liquid places sterilization container, pumps into nozzle, transfers the needle-valve chew pressure, is 1.0-1 at the proportion of admixing medical solutions, and 15G/ml sprays into hothouse with medicinal liquid.After the whirlwind platform separated, dry powder was collected in the catcher, and product is dark yellow brown ceramic powder, was sub-packed under aseptic condition in the sterilization injection bottle, and every bottled amount is the 0.885-1.100 gram, seals to get final product.
Claims (3)
1, a kind of Flos Trollii injectable powder is prepared from by following traditional Chinese medicine raw:
3～5 parts of Flos Trolliis, 1～3 part of Flos Chrysanthemi Indici, 1～3 part of 2～4 parts of Flos Loniceraes and Radix Scutellariae.
2, the preparation method of Flos Trollii injectable powder as claimed in claim 1 is characterized in that:
After a, elder generation merge Flos Trollii, Flos Chrysanthemi Indici, twice water boiling and extraction liquid of Flos Lonicerae, it is 1.05～1.15 that filtrate is concentrated into proportion, is cooled to 22～28 ℃ and adds 3 times of amount 95% ethanol, static 48 hours, the leaching supernatant, reconcentration to proportion is 1.15～1.25, is cooled to 22～28 ℃, adds 10 times of amount 95% ethanol, static 48 hours, the leaching supernatant reclaims ethanol to there not being the alcohol flavor, and making Flos Trollii extracting solution proportion is 1.15;
The preparation of b, lily feet pollen pin semi-finished product liquid
After two kinds of Flos Trollii extracting solution and Radix Scutellariae extracts (baicalin) are mixed, mixed by weight 8: 1, add 40% sodium hydroxide and transfer PH to 7.0, stirring is dissolved its baicalin fully, add water recently distilled to full dose, add 0.5% activated carbon, boiled 15～20 minutes, be cooled to 30～40 ℃ after, remove activated carbon with paper pulp filtering, the filtrate embedding, 115 ℃ of temperature sterilization 45 minutes, be cooled to 22～28 ℃ after, place refrigerator cold preservation after 72～120 hours (3～5 days), make lily feet pollen pin semi-finished product, solution proportion is 1.15;
The preparation of c, Flos Trollii injectable powder
With lily feet pollen pin semi-finished product solution G
3The sintered glass funnel filtration under diminished pressure adds to the full amount of water for injection, and transfers pH value to 7.0 to add to the full amount of water for injection reuse G with 35～40% sodium hydroxide
3The sintered glass funnel filtration under diminished pressure, the filtering with microporous membrane that reuse is 0.2～0.6 micron is packed solution in the sterilization cillin bottle under aseptic condition, and every loading amount is 3.885～4.100 milliliters, adopts freeze-drying to make the powder pin.
3, Flos Trollii injectable powder according to claim 1 is characterized in that being the dark yellow porous solid.
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| CN 03123767 CN1194700C (en) | 2003-05-20 | 2003-05-20 | Globeflower powder for injection and its prepn |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102188506A (en) * | 2011-05-12 | 2011-09-21 | 承德天原药业有限公司 | Trollius chinensis granule preparation and preparation method thereof |
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| CN101152202B (en) * | 2007-09-29 | 2010-11-24 | 中国药科大学 | Pharmaceutical composition for treating respiratory diseases and preparation method thereof |
| CN104189110B (en) * | 2014-08-20 | 2016-02-10 | 乔智 | A kind of Chinese medicine composition for the treatment of influenza and preparation method thereof |
| CN106038927A (en) * | 2016-06-03 | 2016-10-26 | 陈瑞 | Plaster for cold of children |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102188506A (en) * | 2011-05-12 | 2011-09-21 | 承德天原药业有限公司 | Trollius chinensis granule preparation and preparation method thereof |
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