CN1301707C - Danhong freeze dried powder injection agent and its preparation method - Google Patents
Danhong freeze dried powder injection agent and its preparation method Download PDFInfo
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- CN1301707C CN1301707C CNB2005100384731A CN200510038473A CN1301707C CN 1301707 C CN1301707 C CN 1301707C CN B2005100384731 A CNB2005100384731 A CN B2005100384731A CN 200510038473 A CN200510038473 A CN 200510038473A CN 1301707 C CN1301707 C CN 1301707C
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Abstract
The present invention relates to a Danhong freeze-drying powder injection preparation used for injection and a preparation method thereof. The Danhong freeze-drying powder injection preparation is medicine which is composed of a red sage root phenolic acid effective part, a red ketone effective part and a safflower flavonoid effective part, and the red sage root phenolic acid effective part, the red sage root ketone effective part and the safflower flavonoid effective part are obtained by extracting red sage root medicinal material and safflower medicinal material. The present invention is characterized in that on the basis of the prior art, the concrete physicochemical property of prescription medicine of the Danhong freeze-drying powder injection preparation is combined; an organic extraction technique and a modern ultrafiltration purification technique are commendably combined, and the Danhong freeze-drying powder injection preparation is prepared into a freeze-drying preparation used for injection. The present invention has the advantages of fine and reasonable process line, high content of effective components, solid state existence of the medicine, less water content, strong stability and easy transportation and storage. The present invention can better satisfy the requirements of clinical application, and is used for treating a plurality of diseases of coronary disease, angina pectoris, cerebrovascular disease, etc.
Description
Technical field
What the present invention relates to is a kind of medicine that contains Radix Salviae Miltiorrhizae, safflower effective part---a kind of Danhong freeze dried powder injection agent.Belong to field of traditional Chinese medicine pharmacy.
Background technology
Radix Salviae Miltiorrhizae is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae Salvia miltiorrhiza Bge..Bitter in the mouth, cold nature.GUIXIN, Liver Channel.Have stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, effect such as the relieving restlessness that clears away heart-fire.Be used for that menoxenia, amenorrhea dysmenorrhea, lumps in the chest and abdomen, breast ventral spine pain, pyretic arthralgia pain, skin infection are swollen and ache, dysphoria and insomnia, hepatosplenomegaly, angina pectoris etc.
Flos Carthami is the dried floral of feverfew Flos Carthami Carthamus tinctorius L..Acrid in the mouth, warm in nature.GUIXIN, Liver Channel.The effect of tool promoting blood circulation to restore menstrual flow, eliminating stasis to stop pain is mainly used in that treatment amenorrhea, dysmenorrhea, lochia are not all right, injury from falling down, skin infection swell and ache etc.Modern study shows that Flos Carthami mainly contains chemical constituents such as safflower red pigment, Carthamus yellow.Safflower red pigment is a kind of dimeric chalcon; Carthamus yellow is the mixture of one kind of multiple water-soluble components, and the main effective ingredient for the Flos Carthami blood circulation invigorating efficacies has following multiple efficacies: coronary artery dilator, improve myocardial blood flow; Bring high blood pressure down, blood vessel dilating, improve the organ blood supply; Energy anticoagulation, inhibition thrombosis also have anoxia enduring, effect for reducing fat.
About DANHONG ZHUSHEYE, working standard adopting process standard is: after red rooted salvia is carried out rare alcohol extraction, be total to water with Flos Carthami again and carry, purification effect is bad, active constituent content is also not high, and dosage form is the injection water preparation, has problems such as transportation inconvenience, quality stability difference.
Summary of the invention
Purpose of the present invention is exactly the defective at above-mentioned existence, provides that a kind of preparation technology is more reasonable, active constituent content is higher, good stability, transportation store Danhong freeze dried powder injection agent easily.
The present invention is achieved through the following technical solutions: the active ingredient that it is characterized in that it is made up of through extraction gained salvianolic acid effective kind part, tanshinone, carthamone effective kind part red rooted salvia and flos carthami, and its preparation method divides extraction process and preparation sample processing step.
Step 1, extraction process:
Get Radix Salviae Miltiorrhizae 1500 grams, be ground into coarse powder, with 40-95% ethanol warm macerating secondary, each 1-2 hour, filter, merging filtrate, decompression recycling ethanol gets Radix Salviae Miltiorrhizae extract A; Medicinal residues add 8-15 times of water gaging, decoct each 2 hours three times, filter, merging filtrate, being evaporated to relative density is 1.10 ~ 1.20 (50 ℃), adding ethanol is 65% to containing the alcohol amount, regulate pH to 8.5-10 with 20%NaOH, leave standstill 24h, filter decompression recycling ethanol, and to be concentrated into relative density be 1.10 ~ 1.20, measure 50 ℃ of temperature, regulate pH with dilute hydrochloric acid and be 1-2, centrifugal, supernatant is with equal volume of ethyl acetate 3 times, the combined ethyl acetate extract reclaims ethyl acetate, vacuum drying, pulverize, make Radix Salviae Miltiorrhizae extract B;
Get Flos Carthami 500 gram, add the water temperature that 8-20 doubly measures 20-90 ℃ and soak each 0.5-2.5 hour three times, filter, merging filtrate, being evaporated to relative density is 1.05 ~ 1.15, measure 50 ℃ of temperature, regulate pH to 7.0, add ethanol and make and contain the alcohol amount and be 60-80%, leave standstill 24h, filter decompression filtrate recycling ethanol, and to be concentrated into relative density be 1.05 ~ 1.15, measure 50 ℃ of temperature, regulate pH to 7.0, add ethanol and make and contain the alcohol amount and be 70-85%, leave standstill 24h, filter, decompression filtrate recycling ethanol, and to be concentrated into relative density be 1.30, measure 50 ℃ of temperature, or vacuum drying, pulverize, make Flos Carthami extract;
Get Radix Salviae Miltiorrhizae extract A, B and add an amount of water for injection, heating makes dissolving, cold preservation 24h, get supernatant and filter, filtrate is 3000 ultrafilter ultrafiltration with molecular cut off, collects ultrafiltrate, or, make tanshinone, salvianolic acid effective kind part with ultrafiltrate concentrating under reduced pressure and dry;
Get Flos Carthami extract, add 20-80 ℃ of water and stir and make dissolving, cold preservation 24h gets supernatant and filters, and filtrate is 3000 ultrafilter ultrafiltration with molecular cut off, collects ultrafiltrate, or with ultrafiltrate concentrating under reduced pressure and dry, makes the carthamone effective kind part; Also the Radix Salviae Miltiorrhizae extract ultrafiltrate can be mixed with the Flos Carthami ultrafiltrate, make and mix ultrafiltrate or ultrafiltrate concentrating under reduced pressure and drying are made effective site; The dilution that perhaps Radix Salviae Miltiorrhizae extract, Flos Carthami extract is dissolved in water in the lump, cold preservation 24 hours is got supernatant and is filtered, and filtrate is 3000 ultrafilter ultrafiltration with molecular cut off, collects ultrafiltrate, or with ultrafiltrate concentrating under reduced pressure and dry.
Step 2, sample preparation technology:
Get tanshinone effective site, salvianolic acid effective kind part, carthamone effective kind part, add injection freeze-dried excipient, isoosmotic adjusting agent etc., add 0.1%～1.0% (g/v) needle-use activated carbon, be incubated 15-20 minute, filter, filtrate is regulated pH value to 6.0-7.5 with 20%NaOH, is made into the solution of 400-2000ml, Entkeimung with water for injection, packing, partly fill in plug, the sabot inlet carries out lyophilizing by freeze-drying curve, after the lyophilizing, vacuum is put in tamponade, and outlet rolls aluminium-plastic cap, label, packing, check gets product; Perhaps directly freeze with pallet, pallet is taken out, be ground into fine powder under aseptic condition, the reuse aseptic manipulation is sub-packed in the antibiotic glass bottle, seal, and packing, check gets product.
The salvianolic acid effective kind part is characterized in that its preparation is to get it filled material behind the prior art water extract-alcohol precipitation, with the organic solvent ethyl acetate extraction, makes through ultrafiltration purification again.
The carthamone effective kind part is characterized in that its preparation is that the material of getting it filled carries out ultrafiltration purification again and makes after the prior art water extract-alcohol precipitation extracts.
Salvianolic acid effective kind part, tanshinone effective site, carthamone effective kind part can be medical material gained ultrafiltrates after extracting ultrafiltration, also can be drying solids.
Used freeze-dried excipient is a mannitol, glucose, lactose, the compositions of one or more in inositol and the dextran.
Used isoosmotic adjusting agent can be sodium chloride for injection or glucose.
Advantage of the present invention: with veriety DANHONG drip liquid relatively, have following characteristics:
This product is based on the DANHONG drip liquid, traditional Chinese medicine culture and advanced preparation process are combined, the utilization modern scientific method, Chinese medicine new product newly developed on the basis of summing up in conjunction with the experimentation of Chemistry for Chinese Traditional Medicine, analytical chemistry, pharmacology of Chinese materia medica and clinical efficacy thereof and amount of literature data.
1, about this product process route, we take water extract-alcohol precipitation, the organic solvent extraction ultrafiltration purification technique in conjunction with the modern times, in the technology leaching process, we use high-efficient liquid phase chromatogram technology, it is carried out the finger printing research of expecting preparation from former, as one of quality control index, improve process route is carried out rational science with finger printing, thereby realized better removal impurity, kept its effective ingredient efficiently, its process route is more consummate rationally; We actively develop the research of its effective site and the mechanism of action simultaneously, have formulated Danhong freeze dried powder injection agent of new generation
2, about the DANHONG product, existing DANHONG drip liquid on the market has problems such as transportation inconvenience, quality stability difference, and lyophilized formulations is solid-state existence among the present invention, and water content is few, have stability by force, be easy to the characteristics of transporting and preserving.
Show through experimentation: about the Danhong for injection lyophilized formulations, the improvement of this process route, the exploitation of this dosage form have stronger science, novelty, feasibility, and higher, the steady quality of the prepared sample purity of this technology meets the prescription of treatment.
The specific embodiment
Embodiment 1:
1, prescription: Radix Salviae Miltiorrhizae 1500g Flos Carthami 500g
2, extraction, preparation technology:
1), extract:
Get Radix Salviae Miltiorrhizae, be ground into coarse powder, with 50% ethanol warm macerating secondary, each 1.5 hours, filter, merging filtrate, decompression recycling ethanol gets Radix Salviae Miltiorrhizae extract A; Medicinal residues add 8 times of water gagings, decoct three times, each 2 hours, filter, merging filtrate, being evaporated to relative density is 1.17 (50 ℃), adding ethanol is 65% to containing the alcohol amount, regulates pH to 8.5 with 20%NaOH, leave standstill 24h, filter decompression recycling ethanol, and to be concentrated into relative density be 1.10 (50 ℃), regulates pH with dilute hydrochloric acid and be 1.7, centrifugal, supernatant is with equal volume of ethyl acetate 3 times, and the combined ethyl acetate extract reclaims ethyl acetate, vacuum drying is pulverized, and makes Radix Salviae Miltiorrhizae extract B.
Get Flos Carthami, the water temperature that adds 60 ℃ of 8 times of amounts is soaked three times, each 2h, filter, merging filtrate, being evaporated to relative density is 1.06 (50 ℃), regulates pH to 7.0, add ethanol and make that to contain alcohol amount be 70%, leave standstill 24h, filter decompression filtrate recycling ethanol, and to be concentrated into relative density be 1.08 (50 ℃), regulate pH to 7.0, add ethanol and make that to contain the alcohol amount be 80%, leave standstill 24h, filter, decompression filtrate recycling ethanol, and to be concentrated into relative density be 1.23 (50 ℃), vacuum drying, pulverize, make Flos Carthami extract.
Get Flos Carthami extract, add 60 ℃ of water and stir and make dissolving, cold preservation 24h gets supernatant and filters, and filtrate is 3000 ultrafilter ultrafiltration with molecular cut off, collects ultrafiltrate; Get Radix Salviae Miltiorrhizae extract A, B and add an amount of water for injection, heating makes dissolving, and cold preservation 24h gets supernatant and filters, and filtrate is 3000 ultrafilter ultrafiltration with molecular cut off, collects ultrafiltrate, and mixes with the Flos Carthami ultrafiltrate.
2), preparation:
Get above Radix Salviae Miltiorrhizae ultrafiltrate and Flos Carthami ultrafiltrate mixed liquor, add injection freeze-dried excipient mannitol 375g, isoosmotic adjusting agent glucose etc., add 0.5% (g/v) needle-use activated carbon, be incubated 15 minutes, filter, filtrate is regulated pH value to 6.0 with 20%NaOH, is made into the solution of 2000ml, Entkeimung with water for injection, packing whenever with 2ml, is partly filled in plug, the sabot inlet, carry out lyophilizing by freeze-drying curve, after the lyophilizing, vacuum is put in tamponade, outlet rolls aluminium-plastic cap, labels, packing, check gets product.
Embodiment 2:
1, prescription: Radix Salviae Miltiorrhizae 1500g Flos Carthami 500g
2, extraction, preparation technology:
1), extract:
Get Radix Salviae Miltiorrhizae, be ground into coarse powder, with 60% ethanol warm macerating secondary, each 2 hours, filter, merging filtrate, decompression recycling ethanol gets Radix Salviae Miltiorrhizae extract A; Medicinal residues add 10 times of water gagings, decoct three times, each 2 hours, filter, merging filtrate, being evaporated to relative density is 1.13 (50 ℃), adding ethanol is 65% to containing the alcohol amount, regulates pH to 9.2 with 20%NaOH, leave standstill 24h, filter decompression recycling ethanol, and to be concentrated into relative density be 1.11 (50 ℃), regulates pH with dilute hydrochloric acid and be 1-2, centrifugal, supernatant is with equal volume of ethyl acetate 3 times, and the combined ethyl acetate extract reclaims ethyl acetate, vacuum drying is pulverized, and makes Radix Salviae Miltiorrhizae extract B.
Get Flos Carthami, the water temperature that adds 50 ℃ of 10 times of amounts is soaked three times, and each 1.5h filters, merging filtrate, being evaporated to relative density is 1.09 (50 ℃), regulates pH to 7.0, add ethanol and make that to contain alcohol amount be 70%, leave standstill 24h, filter, decompression filtrate recycling ethanol, and to be concentrated into relative density be 1.12 (50 ℃), regulates pH to 7.0, add ethanol and make that to contain alcohol amount be 80%, leave standstill 24h, filter, decompression filtrate recycling ethanol, and to be concentrated into relative density be 1.31 (50 ℃), makes Flos Carthami extract.
Get Flos Carthami extract, add 50 ℃ of water and stir and make dissolving, cold preservation 24h gets supernatant and filters, and filtrate is 3000 ultrafilter ultrafiltration with molecular cut off, collects ultrafiltrate; Get Radix Salviae Miltiorrhizae extract A, B and add an amount of water for injection, heating makes dissolving, and cold preservation 24h gets supernatant and filters, and filtrate is 3000 ultrafilter ultrafiltration with molecular cut off, collects ultrafiltrate, and mixes with the Flos Carthami ultrafiltrate.
2), preparation:
Get above Radix Salviae Miltiorrhizae ultrafiltrate and Flos Carthami ultrafiltrate mixed liquor, add injection freeze-dried excipient mannitol 200g, isoosmotic adjusting agent sodium chloride, add 0.7% (g/v) needle-use activated carbon, be incubated 15 minutes, filter, filtrate is regulated pH value to 7.3 with 20%NaOH, is made into the solution of 1500ml, Entkeimung with water for injection, packing, every bottle of 1.5ml partly fills in plug, the sabot inlet, carry out lyophilizing by freeze-drying curve, after the lyophilizing, vacuum is put in tamponade, outlet rolls aluminium-plastic cap, labels, packing, check gets product.
Embodiment 3:
1, prescription: Radix Salviae Miltiorrhizae 1500g Flos Carthami 500g
2, extraction, preparation technology:
1), extract:
Get Radix Salviae Miltiorrhizae, be ground into coarse powder, with 80% ethanol warm macerating secondary, each 1.0 hours, filter, merging filtrate, decompression recycling ethanol gets Radix Salviae Miltiorrhizae extract A; Medicinal residues add 12 times of water gagings, decoct three times, each 2 hours, filter, merging filtrate, being evaporated to relative density is 1.13 (50 ℃), adding ethanol is 65% to containing the alcohol amount, regulates pH to 9.7 with 20%NaOH, leave standstill 24h, filter decompression recycling ethanol, and to be concentrated into relative density be 1.14 (50 ℃), regulates pH with dilute hydrochloric acid and be 1.8, centrifugal, supernatant is with equal volume of ethyl acetate 3 times, and the combined ethyl acetate extract reclaims ethyl acetate, vacuum drying is pulverized, and makes Radix Salviae Miltiorrhizae extract B.
Get Flos Carthami, the water temperature that adds 70 ℃ of 15 times of amounts is soaked three times, each 1.5h, filter, merging filtrate, being evaporated to relative density is 1.08 (50 ℃), regulates pH to 7.0, add ethanol and make that to contain alcohol amount be 70%, leave standstill 24h, filter decompression filtrate recycling ethanol, and to be concentrated into relative density be 1.12 (50 ℃), regulate pH to 7.0, add ethanol and make that to contain the alcohol amount be 80%, leave standstill 24h, filter, decompression filtrate recycling ethanol, and to be concentrated into relative density be 1.26 (50 ℃), vacuum drying, pulverize, make Flos Carthami extract.
Get Flos Carthami extract, add 70 ℃ of water and stir and make dissolving, cold preservation 24h gets supernatant and filters, and filtrate is 3000 ultrafilter ultrafiltration with molecular cut off, collects ultrafiltrate; Get Radix Salviae Miltiorrhizae extract A, B and add an amount of water for injection, heating makes dissolving, cold preservation 24h, getting supernatant filters, filtrate is 3000 ultrafilter ultrafiltration with molecular cut off, collect ultrafiltrate, and mix with the Flos Carthami ultrafiltrate, concentrating under reduced pressure is drying to obtain tanshinone, salvianolic acid and carthamone effective kind part mixture.
2), preparation:
Get above tanshinone, salvianolic acid and carthamone effective kind part mixture, add injection mannitol 200g, injection lactose 200g, add 1.0% (g/v) needle-use activated carbon, be incubated 15 minutes, mistake
Filter, filtrate is regulated pH value to 7.4 with 20%NaOH, is made into the solution of 2000ml with water for injection, Entkeimung, plug is partly filled in packing, the sabot inlet carries out lyophilizing by freeze-drying curve, and after the lyophilizing, vacuum is put in tamponade, outlet, roll aluminium-plastic cap, label, packing, check gets product.
Embodiment 4:
1, prescription: Radix Salviae Miltiorrhizae 1500g Flos Carthami 500g
2, extraction, preparation technology:
1), extract:
Get Radix Salviae Miltiorrhizae, be ground into coarse powder, with 75% ethanol warm macerating secondary, each 2 hours, filter, merging filtrate, decompression recycling ethanol gets Radix Salviae Miltiorrhizae extract A; Medicinal residues add 12 times of water gagings, decoct three times, each 2 hours, filter, merging filtrate, being evaporated to relative density is 1.17 (50 ℃), adding ethanol is 65% to containing the alcohol amount, regulates pH to 9.2 with 20%NaOH, leave standstill 24h, filter decompression recycling ethanol, and to be concentrated into relative density be 1.14 (50 ℃), regulates pH with dilute hydrochloric acid and be 1.2, centrifugal, supernatant is with equal volume of ethyl acetate 3 times, and the combined ethyl acetate extract reclaims ethyl acetate, vacuum drying is pulverized, and makes Radix Salviae Miltiorrhizae extract B.
Get Flos Carthami, the water temperature that adds 60 ℃ of 10 times of amounts is soaked three times, each 2h, filter, merging filtrate, being evaporated to relative density is 1.07 (50 ℃), regulates pH to 7.0, add ethanol and make that to contain alcohol amount be 70%, leave standstill 24h, filter decompression filtrate recycling ethanol, and to be concentrated into relative density be 1.09 (50 ℃), regulate pH to 7.0, add ethanol and make that to contain the alcohol amount be 80%, leave standstill 24h, filter, decompression filtrate recycling ethanol, and to be concentrated into relative density be about 1.28 (50 ℃), vacuum drying, pulverize, make Flos Carthami extract.
Get Flos Carthami extract, Radix Salviae Miltiorrhizae extract A, B add 60 ℃ of water and stir and make dissolved dilution, and cold preservation 24h gets supernatant and filters, and filtrate is 3000 ultrafilter ultrafiltration with molecular cut off, collects ultrafiltrate.
2), preparation:
Get above ultrafiltrate, add injection mannitol 300g, sodium chloride for injection is an amount of, add 0.5% (g/v) needle-use activated carbon, be incubated 20 minutes, filter, filtrate is regulated pH value to 7.0 with 20%NaOH, be made into the solution of 2000ml with water for injection, Entkeimung is directly freezed with pallet, pallet is taken out, be ground into fine powder under aseptic condition, the reuse aseptic manipulation is sub-packed in the antibiotic glass bottle, seal, packing, check gets product.
Claims (3)
1, a kind of Danhong freeze dried powder injection agent, the active ingredient that it is characterized in that it is made up of through extraction gained tanshinone effective site, salvianolic acid effective kind part, carthamone effective kind part red rooted salvia and flos carthami, its preparation method divides extraction process and two steps of preparation sample technology, wherein step 1, extraction process: get Radix Salviae Miltiorrhizae 1500 grams, be ground into coarse powder, with 40-95% ethanol warm macerating secondary, each 1-2 hour, filter, merging filtrate, decompression recycling ethanol gets Radix Salviae Miltiorrhizae extract A; Medicinal residues add 8-15 times of water gaging, decoct each 2 hours three times, filter, merging filtrate, being evaporated to relative density is 1.10 ~ 1.20, measure 50 ℃ of temperature, adding ethanol is 65% to containing the alcohol amount, regulates pH to 8.5-10 with 20%NaOH, leaves standstill 24h, filter, decompression recycling ethanol, and to be concentrated into relative density be 1.10 ~ 1.20, measures 50 ℃ of temperature, regulating pH with dilute hydrochloric acid is 1-2, centrifugal, supernatant is with equal volume of ethyl acetate 3 times, combined ethyl acetate extract, reclaim ethyl acetate, vacuum drying is pulverized, and makes Radix Salviae Miltiorrhizae extract B; Get Flos Carthami 500 gram, add the water temperature that 8-20 doubly measures 20-90 ℃ and soak each 0.5-2.5 hour three times, filter, merging filtrate, being evaporated to relative density is 1.05 ~ 1.15, measure 50 ℃ of temperature, regulate pH to 7.0, add ethanol and make and contain the alcohol amount and be 60-80%, leave standstill 24h, filter decompression filtrate recycling ethanol, and to be concentrated into relative density be 1.05 ~ 1.15, measure 50 ℃ of temperature, regulate pH to 7.0, add ethanol and make and contain the alcohol amount and be 70-85%, leave standstill 24h, filter, decompression filtrate recycling ethanol, and to be concentrated into relative density be 1.30, measure 50 ℃ of temperature, or vacuum drying, pulverize, make Flos Carthami extract;
Get Flos Carthami extract, add 20-80 ℃ of water and stir and make dissolving, cold preservation 24h gets supernatant and filters, and filtrate is 3000 ultrafilter ultrafiltration with molecular cut off, collects ultrafiltrate, or with ultrafiltrate concentrating under reduced pressure and dry, makes the carthamone effective kind part; Get Radix Salviae Miltiorrhizae extract A, B and add an amount of water for injection, heating makes dissolving, cold preservation 24h, get supernatant and filter, filtrate is 3000 ultrafilter ultrafiltration with molecular cut off, collects ultrafiltrate, or, make tanshinone, salvianolic acid effective kind part with ultrafiltrate concentrating under reduced pressure and dry; Also the Flos Carthami ultrafiltrate can be mixed with the Radix Salviae Miltiorrhizae extract ultrafiltrate, make and mix ultrafiltrate or ultrafiltrate concentrating under reduced pressure and drying are made effective site; The dilution that perhaps Flos Carthami extract, Radix Salviae Miltiorrhizae extract is dissolved in water in the lump, cold preservation 24 hours is got supernatant and is filtered, and filtrate is 3000 ultrafilter ultrafiltration with molecular cut off, collects ultrafiltrate, or with ultrafiltrate concentrating under reduced pressure and dry;
Step 2, sample preparation technology: get the salvianolic acid effective kind part, tanshinone effective site, the carthamone effective kind part, add the injection freeze-dried excipient, isoosmotic adjusting agent, the adding by weight/volume is 0.1%～1.0% needle-use activated carbon, is incubated 15-20 minute, filter, filtrate is regulated pH value to 6.0-7.5 with 20%NaOH, supplies volume to 1500ml-2000ml with water for injection, Entkeimung, packing, partly fill in plug, the sabot inlet carries out lyophilizing by freeze-drying curve, after the lyophilizing, vacuum is put in tamponade, and outlet rolls aluminium-plastic cap, label, packing, check gets product; Perhaps directly freeze with pallet, pallet is taken out, be ground into fine powder under aseptic condition, the reuse aseptic manipulation is sub-packed in the antibiotic glass bottle, seal, and packing, check gets product.
2, a kind of Danhong freeze dried powder injection agent according to claim 1 is characterized in that used freeze-dried excipient is a mannitol, glucose, lactose, inositol, and one or more the compositions in the dextran.
3, a kind of Danhong freeze dried powder injection agent according to claim 1 is characterized in that used isoosmotic adjusting agent can be sodium chloride for injection or glucose.
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| CN101002828B (en) * | 2007-01-10 | 2010-11-03 | 厦门国宇知识产权研究有限公司 | Method for preparing Danhong injection, and products thereof |
| CN103127197B (en) * | 2013-03-21 | 2015-02-18 | 悦康药业集团有限公司 | Preparation method of freeze-drying preparation for safflower yellow injection |
| CN113599358B (en) * | 2021-09-26 | 2023-01-17 | 天津红日药业股份有限公司 | Chinese medicinal powder for injection and its preparation method |
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| CN1460517A (en) * | 2003-07-02 | 2003-12-10 | 北京博尔达生物技术开发有限公司 | Compound danshen oral disintegrant tablet and its preparation method |
| CN1513848A (en) * | 2003-08-19 | 2004-07-21 | 江苏扬子江药业集团有限公司 | Method of extracting phenolic components from chinese medicine red sage root and its freeze dried powder injection agent |
| CN1554335A (en) * | 2003-12-26 | 2004-12-15 | 北京乾露春科技有限公司 | Freeze-dried Danhong powder injection for injection and its preparing method |
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| CN1686275A (en) | 2005-10-26 |
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Assignee: Jiangsu Kingsley Pharmaceutical Co., Ltd. Assignor: Zou Qiaogen Contract record no.: 2010320001189 Denomination of invention: Danhong freeze dried powder injection agent and its preparation method Granted publication date: 20070228 License type: Exclusive License Open date: 20051026 Record date: 20101117 |
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