CN1160548A - Process for producing Qingkailing powder injection - Google Patents
Process for producing Qingkailing powder injection Download PDFInfo
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- CN1160548A CN1160548A CN96103347A CN96103347A CN1160548A CN 1160548 A CN1160548 A CN 1160548A CN 96103347 A CN96103347 A CN 96103347A CN 96103347 A CN96103347 A CN 96103347A CN 1160548 A CN1160548 A CN 1160548A
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Abstract
The materials including cholic acid, pig's deoxycholic acid, water buffalo horn, baicalin, anhydrous sodium sulfite, Concha margaritifeera, Cape jasmine, Radix isatidis and honey suckle are produced via extraction and refining into mixed medicine liquid, which is dewatered via freezing or spraying drying process to produce Qingkailing powder injection. The injection is suitable for curing hepatitis, serious cold, pulmonary high fever and other diseases.
Description
The present invention relates to the medicine of a kind of heat-clearing and toxic substances removing, tranquillizing and allaying excitement, particularly relating to a kind of is the heat-clearing and toxic substances removing made of raw material, the medicine of tranquillizing and allaying excitement with the Chinese herbal medicine.
QINGKAILING aqueous injection injection is the production history in existing several years at home.This product has the effect of heat-clearing and toxic substances removing, tranquillizing and allaying excitement, cures mainly that acute and chronic hepatitis, hepatitis B, reinfection are prosperous, lung hyperpyrexia etc. levies.Classified as essential drugs by health ministry in 9 years, and be designated as one of 20 kinds of first aid clinical medicines simultaneously.But there is the problem of a poor stability that can not be ignored in this product always, after storing a period of time, is prone to precipitation, and pH value reduces.Also there is the problem that is difficult for transportation in addition.In addition, the preparing process of the total mixed liquor of former liquid drugs injection production is cumbersome.
The purpose of this invention is to provide a kind of at steady quality storage period, the Qingkailing powder injection that is easy to transport; And shorten the preparing process of total mixed liquor.
Technical scheme of the present invention is: the composition of raw materials of Qingkailing powder injection is: (parts by weight)
Cholic acid 3.25 refining baicalin 4.25～5.25 hyodeoxycholic acids 3.75
Fructus Gardeniae 25 Cornu Bubalis 22.5～30 Concha Margaritiferas 45～60
Flos Lonicerae 1000 anhydrous sodium sulfite 10 Radix Isatidiss 200,
Water for injection is an amount of
Its concrete technology is as follows:
One, the extraction of Flos Lonicerae extract: claim Flos Lonicerae by prescription, put to boil and carry in the pot, add 15 times of amount distilled water, be heated to and boil, keep little boil to boil carry 1 hour, the leaching extracting solution; Medicinal residues add 10 times of water gagings, boil and carry half an hour, and the leaching medicinal liquid discards medicinal residues, merge filtrate twice, and reduction vaporization concentrates, and to 1/3～1/9 o'clock of the surplus original volume of concentrated solution volume, take out with 20% lime cream and regulate PH=12, the leaching precipitation.
Taking precipitate under agitation adds precipitate 2-3 and doubly measures 95% ethanol in container, makes its suspendible, transfer PH=3-4 with 50% sulphuric acid, after fully stirring, filter, filtrate neutralizes with 40% sodium hydroxide, transfer PH=6.5-7, filter, filtrate recycling ethanol, reconcentration is to proportion 1.2～1.3, airtight cold preservation, standby.
Two, the preparation of Radix Isatidis extracting solution:
Take by weighing selection Radix Isatidis decoction pieces by recipe quantity, wash, put and extract in the pot, add 6-7 and doubly measure distilled water, heated and boiled 1 hour, leaching extracting solution, medicinal residues add 4-5 again and doubly measure distilled water, heated and boiled 1 hour, leaching extracting solution, merging filtrate under agitation adds dense ethanol, reaches 6 0% to containing the alcohol amount, cold preservation 2-3 days, sucking filtration, decompression filtrate recycling ethanol, concentrated solution cold preservation was placed 24 hours, filtered, and must clarify concentrated solution.
Get concentrated solution dropping ammonia under agitation, fully stir, make pH value transfer to 8.5～9.0, the airtight placement of cold preservation 24 hours (it is diffusing not allow ammonia wave), sucking filtration, filtrate is heated in water-bath, remove ammonia to flavor and disappear under constantly stirring, some cold preservation is placed for dosing and is used to PH5.5～6.0.
Three, gardenia extract preparation: take by weighing Fructus Gardeniae by the recipe quantity selection, add 6 times of amount distilled water and boiled 1 hour, juice is fried in shallow oil in leaching; Medicinal residues add 4 times of amount distilled water again, boil and carry partly 2 hours, and filtrate is fried in shallow oil juice, with first fry in shallow oil juice and merge, reduction vaporization is concentrated into the suitable volume of raw material weight, puts under agitation to add dense ethanol after cold, make to contain alcohol amount and reach 60%, cold preservation 2-3 days, sucking filtration, get clear filtrate, precipitation merges washing liquid and filtrate with 60% cold washing with alcohol, decompression recycling ethanol, cold preservation 24 hours, leaching clarification gardenia extract, cold preservation is placed, and uses for dosing.
Four, the dissolving of cholic acid and hyodeoxycholic acid:
Regulate 95% the alcoholic acid PH to 8.5-9 that weight is 50 times of cholic acid weight with 1 molar concentration NaoH.Under agitation add the cholic acid fine powder gradually, transfer PH=8.5-9, make its whole dissolvings.Merge two sodium cholate solution, sucking filtration, standby.
Five, the preparation of Cornu Bubali and Concha Margaritifera Usta hydrolysate:
Take by weighing Cornu Bubali powder by prescription, put in the hydrolytic decomposition pot (alkaline-resisting container), add 8 times of amount 4N barium hydroxide hot solution, be heated to and boil, constantly stir and note preventing bumping, be hydrolyzed 8 hours, treat that Cornu Bubali powder all is hydrolyzed till.40～50 ℃ of laying temperatures incline and get supernatant, refilter, and filtering residue is collected all solution with small amount of thermal distilled water flushing 1-2 time, place that standby (having a large amount of canescence flaky crystals to separate out after cold is Ba (OH)
2Precipitation produces harmless, needn't remove).
In addition take by weighing Concha Margaritifera, put in the hydrolytic decomposition pot in (acid-resistant container), add 6-8 and doubly measure 4N sulfuric acid solution, heating hydrolysis by recipe quantity.Begin to note, because of a large amount of CO are arranged
2Gas is emitted, and produces a large amount of bubbles, and the messenger drug hydrorrhea does not go out, and continues heating hydrolysis then 8 hours, treats that Concha Margaritifera powder transfers yellow mercury oxide (caso to by Lycoperdon polymorphum Vitt
4) stop heating, put temperature to the 40-50 degree, filter, filtering residue is with small amount of thermal distilled water wash 3 times, washing liquid merges with filtrate, put cold after again adularescent acicular crystal separate out, refilter and remove, get light yellow transparent solution.
Barium sulfate (Baso is removed in neutralization
4) waiting impurity: the warm Ba of making of horn powder hydrolyzed solution (OH) fetches water
2After dissolving, under agitation add in the Concha Margaritifera Usta hydrolysate, a large amount of white Baso are arranged
4Precipitation produces, and after whole Cornu Bubali hydrolysate are added, as the mixed liquor peracid, adds an amount of Ba (OH) again
2Solid, it is 4 that stirring and dissolving is transferred pH value, (as crude drug in whole weight is 10g to filter, be evaporated to the volume of 2 times of suitable crude drug in whole weight, the concentrated solution volume should be 20ML) accent PH=6-7, under agitation add dense ethanol, make to contain alcohol amount and reach 60%, cold preservation 24 hours, filter, decompression recycling ethanol to nearly nothing alcohol flavor ends.Enriching ethanol makes and contains alcohol amount and reach 70% again, and cold preservation 24 hours is filtered, and decompression recycling ethanol does not have the alcohol flavor and ends near.Filter, survey content, cold preservation is used for dosing.
Six, the dissolving of baicalin: get the dissolving of 20 times of amount water for injection.Transfer about PH to 7 with 10%NaOH, be heated to and boil, filter, treat dosing.
Seven, the mixing of medicinal liquid: Radix Isatidis extracting solution and gardenia extract are under agitation mixed, join in the cholic acid solution again, add 95% ethanol to containing alcohol amount 70%, cold preservation 24 hours is filtered, and is concentrated into the 1/6-1/7 of original volume, adds Flos Lonicerae extractive solution again.
Above-mentioned mixed liquor, Cornu Bubali and Concha Margaritifera mixed extract, baicalin solution are merged, get total admixing medical solutions.
Eight, the processing of total admixing medical solutions: above-mentioned admixing medical solutions, add anhydrous sodium sulfite solution and (take by weighing anhydrous sodium sulfite by the side, add a small amount of water for injection dissolving), benefit adds to the full amount of water for injection, regulate PH=6.5-7.0, add 0.02% active carbon, water-bath was boiled 1 hour, put warm after-filtration, filtrate cold preservation is placed and is spent the night, sucking filtration (using the paper pulp cake in case of necessity), filtrate heating in water bath is again boiled half an hour, and cold preservation is spent the night again, through the microporous filter membrane sucking filtration, get clear and bright salmon pink medicinal liquid, pH value should be 6.8-7.5, the sample presentation inspection.
Nine, lyophilization or spray drying:
Lyophilization: above-mentioned total mixed liquor is evaporated to 1/5 of original volume, pass through the G3 sintered glass filter-bulb with the filter press pressurization, microporous filter membrane (0.65), filtrate is sub-packed in the cillin bottle, every 2.5ml, and be placed in the freeze dryer, cool off after 4 hours, make the plate temperature reach-15 ℃～-17.5 ℃, products temperature reaches-20 ℃～-23 ℃, and condensation temperature reaches-35 ℃～-40 ℃, evacuation, the plate temperature slowly is increased to 20 ℃ subsequently, and products temperature increases to 20 ℃, and condensation temperature is constant, unpack after 24 hours, make dried frozen aquatic products, gland, labeling gets Qingkailing powder injection.
Spray drying: air after filtration, the heating, go into by the spray drying tower jacking.Total admixing medical solutions forms droplet by the nozzle of cat head, contacts with hot-air, and exsiccant powder enters in the finished container, and waste gas is discharged after cyclone separator, bag filter.Collect powder, bottling, (every bottled powder 0.5 gram in XiLin) gland, labeling, get Qingkailing powder injection.
During spray drying, main points of processes control is: inlet temperature: 115-120 ℃, and leaving air temp 85-90 ℃, air mass flow: 360m
3/ hour, rate of drying: 4-5L/ hour, sprinkler pressure: 2.3-2.5kg/cm
2Cloth bag powder pressure: 400mm water column.
Use the prepared Qingkailing powder injection of the inventive method, effect duration prolongs than aqueous injection, is easy to storing, and every technical specification meets Pharmacopoeia of the People's Republic of China requirement.
Embodiment 1: raw material weight umber prescription:
Cholic acid 3.25g makes with extra care baicalin 5g hyodeoxycholic acid 3.75g
Fructus Gardeniae 25.0g Cornu Bubali 25.0g Concha Margaritifera 50g
Flos Lonicerae 1000g anhydrous sodium sulfite 10.0g Radix Isatidis 200.0g
Water for injection is an amount of
Be mixed with 1000 total mixed liquors, make 80 Qingkailing powder injections.
One, the extraction of Flos Lonicerae extract: claim Flos Lonicerae by prescription, put to boil and carry in the pot, add 15 times of amount distilled water, be heated to and boil, keep little boil to boil carry 1 hour, the leaching extracting solution; Medicinal residues add 10 times of water gagings, boil and carry half an hour, and the leaching medicinal liquid discards medicinal residues, merge filtrate twice, and reduction vaporization concentrates, and to 1/3～1/9 o'clock of the surplus original volume of concentrated solution volume, take out with 20% lime cream and regulate PH=12, the leaching precipitation.
Taking precipitate under agitation adds precipitate 2-3 and doubly measures 95% ethanol in container, makes its suspendible, transfer PH=3-4 with 50% sulphuric acid, after fully stirring, filter, filtrate neutralizes with 40% sodium hydroxide, transfer PH=6.5-7, filter, filtrate recycling ethanol, reconcentration is to proportion 1.2～1.3, airtight cold preservation, standby.
Two, the preparation of Radix Isatidis extracting solution:
Take by weighing selection Radix Isatidis decoction pieces by recipe quantity, wash, put and extract in the pot, add 6-7 and doubly measure distilled water, heated and boiled 1 hour, leaching extracting solution, medicinal residues add 4-5 again and doubly measure distilled water, heated and boiled 1 hour, leaching extracting solution, merging filtrate under agitation adds dense ethanol, reaches 60% to containing the alcohol amount, cold preservation 2-3 days, sucking filtration, decompression filtrate recycling ethanol, concentrated solution cold preservation was placed 24 hours, filtered, and must clarify concentrated solution.
Get concentrated solution dropping ammonia under agitation, fully stir, make pH value transfer to 8.5～9.0, the airtight placement of cold preservation 24 hours (it is diffusing not allow ammonia wave), sucking filtration, filtrate is heated in water-bath, remove ammonia to flavor and disappear under constantly stirring, some cold preservation is placed for dosing and is used to PH5.5～6.0.
Three, gardenia extract preparation: take by weighing Fructus Gardeniae by the recipe quantity selection, add 6 times of amount distilled water and boiled 1 hour, juice is fried in shallow oil in leaching; Medicinal residues add 4 times of amount distilled water again, boil and carry partly 2 hours, and filtrate is fried in shallow oil juice, with first fry in shallow oil juice and merge, reduction vaporization is concentrated into the suitable volume of raw material weight, puts under agitation to add dense ethanol after cold, make to contain alcohol amount and reach 60%, cold preservation 2-3 days, sucking filtration, get clear filtrate, precipitation merges washing liquid and filtrate with 60% cold washing with alcohol, decompression recycling ethanol, cold preservation 24 hours, leaching clarification gardenia extract, cold preservation is placed, and uses for dosing.
Four, the dissolving of cholic acid and hyodeoxycholic acid:
Regulate 95% the alcoholic acid PH to 8.5-9 that weight is 50 times of cholic acid weight with 1 molar concentration ZaoH.Under agitation add the cholic acid fine powder gradually, transfer PH=8.5-9, make its whole dissolvings.Merge two sodium cholate solution, sucking filtration, standby.
Five, the preparation of Cornu Bubali and Concha Margaritifera Usta hydrolysate:
Take by weighing Cornu Bubali powder by prescription, put in the hydrolytic decomposition pot (alkaline-resisting container), add 8 times of amount 4N barium hydroxide hot solution, be heated to and boil, constantly stir and note preventing bumping, be hydrolyzed 8 hours, treat that Cornu Bubali powder all is hydrolyzed till.40～50 ℃ of laying temperatures incline and get supernatant, refilter, and filtering residue is collected all solution with small amount of thermal distilled water flushing 1-2 time, place that standby (having a large amount of canescence flaky crystals to separate out after cold is Ba (OH)
2Precipitation produces harmless, needn't remove).
In addition take by weighing Concha Margaritifera, put in the hydrolytic decomposition pot in (acid-resistant container), add 6-8 and doubly measure 4N sulfuric acid solution, heating hydrolysis by recipe quantity.Begin to note, because of a large amount of CO are arranged
2Gas is emitted, and produces a large amount of bubbles, and the messenger drug hydrorrhea does not go out, and continues heating hydrolysis then 8 hours, treats that the Concha Margaritifera powder transfers yellow mercury oxide (caso to by Lycoperdon polymorphum Vitt
4) stop heating, put temperature to the 40-50 degree, filter, filtering residue is with small amount of thermal distilled water wash 3 times, washing liquid merges with filtrate, put cold after again adularescent acicular crystal separate out, refilter and remove, get light yellow transparent solution.
Barium sulfate (Baso is removed in neutralization
4) waiting impurity: the warm Ba of making of horn powder hydrolyzed solution (OH) fetches water
2After dissolving, under agitation add in the Concha Margaritifera Usta hydrolysate, a large amount of white Baso are arranged
4Precipitation produces, and after whole Cornu Bubali hydrolysate are added, as the mixed liquor peracid, adds an amount of Ba (OH) again
2Solid, it is 4 that stirring and dissolving is transferred pH value, (as crude drug in whole weight is 10g to filter, be evaporated to the volume of 2 times of suitable crude drug in whole weight, the concentrated solution volume should be 20ML) accent PH=6-7, under agitation add dense ethanol, make to contain alcohol amount and reach 60%, cold preservation 24 hours, filter, decompression recycling ethanol to nearly nothing alcohol flavor ends.Enriching ethanol makes and contains alcohol amount and reach 70% again, and cold preservation 24 hours is filtered, and decompression recycling ethanol does not have the alcohol flavor and ends near.Filter, survey content, cold preservation is used for dosing.
Six, the dissolving of baicalin: get the dissolving of 20 times of amount water for injection.Transfer about PH to 7 with 10%NaOH, be heated to and boil, filter, treat dosing.
Seven, the mixing of medicinal liquid: Radix Isatidis extracting solution and gardenia extract are under agitation mixed, join in the cholic acid solution again, add 95% ethanol to containing alcohol amount 70%, cold preservation 24 hours is filtered, and is concentrated into the 1/6-1/7 of original volume, adds Flos Lonicerae extractive solution again.
Above-mentioned mixed liquor, Cornu Bubali and Concha Margaritifera mixed extract, baicalin solution are merged, get total admixing medical solutions.
Eight, the processing of total admixing medical solutions: above-mentioned admixing medical solutions, add anhydrous sodium sulfite solution and (take by weighing anhydrous sodium sulfite by the side, add a small amount of water for injection dissolving), benefit adds to the full amount of water for injection, regulate PH=6.5-7.0, add 0.02% active carbon, water-bath was boiled 1 hour, put warm after-filtration, filtrate cold preservation is placed and is spent the night, sucking filtration (using the paper pulp cake in case of necessity), filtrate heating in water bath is again boiled half an hour, and cold preservation is spent the night again, through the microporous filter membrane sucking filtration, get clear and bright salmon pink medicinal liquid, pH value should be 6.8-7.5, the sample presentation inspection.
Nine, lyophilization or spray drying:
Lyophilization: above-mentioned total mixed liquor is evaporated to 1/5 of original volume, pass through the G3 sintered glass filter-bulb with the filter press pressurization, microporous filter membrane (0.65), filtrate is sub-packed in the cillin bottle, every 2.5ml, and be placed in the freeze dryer, cool off after 4 hours, make the plate temperature reach-15 ℃～-17.5 ℃, products temperature reaches-20 ℃～-23 ℃, and condensation temperature reaches-35 ℃～-40 ℃, evacuation, the plate temperature slowly is increased to 20 ℃ subsequently, and products temperature increases to 20 ℃, and condensation temperature is constant, unpack after 24 hours, make dried frozen aquatic products, gland, labeling gets Qingkailing powder injection.
Spray drying: air after filtration, the heating, go into by the spray drying tower jacking.Total admixing medical solutions forms droplet by the nozzle of cat head, contacts with hot-air, and exsiccant powder enters in the finished container, and waste gas is discharged after cyclone separator, bag filter.Collect powder, bottling, (every bottled powder 0.5 gram in XiLin) gland, labeling, get Qingkailing powder injection.
During spray drying, main points of processes control is: inlet temperature: 115-120 ℃, and leaving air temp 85-90 ℃, air mass flow: 360m
3/ hour, rate of drying: 4-5L/ hour, sprinkler pressure: 2.3-2.5kg/cm
2Cloth bag powder pressure: 400mm water column.
Claims (3)
1, a kind of preparation technology of Qingkailing powder injection, its parts by weight prescription is: cholic acid 3.25, hyodeoxycholic acid 3.75, Cornu Bubali 22.5～30, Concha Margaritifera 45～60, anhydrous sodium sulfite 10, refining baicalin 4.25～5.25, Fructus Gardeniae 25, Radix Isatidis 200, Flos Lonicerae 1000, it is characterized by: the cillin bottle that total mixed liquor is housed places freeze dryer, cool off after 4 hours, make the plate temperature reach-15 ℃～17.5 ℃, products temperature reaches-20 ℃～23 ℃, condensation temperature reaches-35 ℃～-40 ℃, evacuation, the plate temperature slowly is increased to 20 ℃ subsequently, and products temperature increases to 20 ℃, and condensation temperature is constant, unpack after 24 hours, make Qingkailing powder injection.
2, a kind of preparation technology of Qingkailing powder injection, its parts by weight prescription is: cholic acid 3.25, hyodeoxycholic acid 3.75, Cornu Bubali 22.5～30, Concha Margaritifera 45～60, anhydrous sodium sulfite 10, refining baicalin 4.25～5.25, Fructus Gardeniae 25, Radix Isatidis 200, Flos Lonicerae 1000, it is characterized by: total mixed liquor forms droplet by the nozzle of spray drying cat head, contact with hot-air, make Qingkailing powder injection; During spray drying, main points of processes control is: 115～120 ℃ of inlet temperature, 85～90 ℃ of leaving air temps, air mass flow 360m8/ hour, rate of drying 4～5L/ hour, sprinkler pressure 2.3～2.5kg/cm
2, cloth bag powder pressure: 400mm water column.
3, the preparation technology of a kind of Qingkailing powder injection as claimed in claim 1 or 2, it is characterized by, the preparing process of total admixing medical solutions is: Radix Isatidis extracting solution and gardenia extract are under agitation mixed, join again in the cholic acid solution, add 95% ethanol to containing alcohol amount 70%, cold preservation 24 hours is filtered, be concentrated into 1/6～1/7 of original volume, add Flos Lonicerae extractive solution again; Above-mentioned mixed liquor, Cornu Bubali and Concha Margaritifera mixed extract, baicalin solution are merged, get total admixing medical solutions.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96103347A CN1052650C (en) | 1996-03-29 | 1996-03-29 | Process for producing Qingkailing powder injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96103347A CN1052650C (en) | 1996-03-29 | 1996-03-29 | Process for producing Qingkailing powder injection |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1160548A true CN1160548A (en) | 1997-10-01 |
| CN1052650C CN1052650C (en) | 2000-05-24 |
Family
ID=5118007
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN96103347A Expired - Fee Related CN1052650C (en) | 1996-03-29 | 1996-03-29 | Process for producing Qingkailing powder injection |
Country Status (1)
| Country | Link |
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| CN (1) | CN1052650C (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1101184C (en) * | 1999-04-12 | 2003-02-12 | 远达药业集团哈尔滨一洲制药有限公司 | Process for preparing medical particles Qingkailing by wrapping chololic acid and animal extract with cyclodextrin |
| CN1317025C (en) * | 2003-12-17 | 2007-05-23 | 段维和 | Chinese medicine for treating high fever and its preparation |
| CN100370252C (en) * | 2003-04-10 | 2008-02-20 | 贵州益佰制药股份有限公司 | Method for controlling quality of injection liquid or powder of |
| CN1899430B (en) * | 2006-06-30 | 2010-08-11 | 曲韵智 | Large size Qingkailing dripping pill and its preparing method |
-
1996
- 1996-03-29 CN CN96103347A patent/CN1052650C/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1101184C (en) * | 1999-04-12 | 2003-02-12 | 远达药业集团哈尔滨一洲制药有限公司 | Process for preparing medical particles Qingkailing by wrapping chololic acid and animal extract with cyclodextrin |
| CN100370252C (en) * | 2003-04-10 | 2008-02-20 | 贵州益佰制药股份有限公司 | Method for controlling quality of injection liquid or powder of |
| CN1317025C (en) * | 2003-12-17 | 2007-05-23 | 段维和 | Chinese medicine for treating high fever and its preparation |
| CN1899430B (en) * | 2006-06-30 | 2010-08-11 | 曲韵智 | Large size Qingkailing dripping pill and its preparing method |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1052650C (en) | 2000-05-24 |
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