CN100409837C - Shenkang freeze-dried powder injection for injection and its preparation technology - Google Patents
Shenkang freeze-dried powder injection for injection and its preparation technology Download PDFInfo
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- CN100409837C CN100409837C CNB2004100043592A CN200410004359A CN100409837C CN 100409837 C CN100409837 C CN 100409837C CN B2004100043592 A CNB2004100043592 A CN B2004100043592A CN 200410004359 A CN200410004359 A CN 200410004359A CN 100409837 C CN100409837 C CN 100409837C
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- 238000002347 injection Methods 0.000 title claims abstract description 94
- 239000007924 injection Substances 0.000 title claims abstract description 94
- 238000002360 preparation method Methods 0.000 title claims abstract description 27
- 238000005516 engineering process Methods 0.000 title claims abstract description 20
- 239000000843 powder Substances 0.000 title abstract description 10
- 239000009457 shenkang Substances 0.000 title description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 707
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 263
- 239000012153 distilled water Substances 0.000 claims abstract description 181
- 210000003734 kidney Anatomy 0.000 claims abstract description 14
- 238000001914 filtration Methods 0.000 claims abstract description 10
- 239000000706 filtrate Substances 0.000 claims description 234
- 239000003814 drug Substances 0.000 claims description 166
- 229940079593 drug Drugs 0.000 claims description 162
- 238000004321 preservation Methods 0.000 claims description 120
- 238000007865 diluting Methods 0.000 claims description 102
- 239000000796 flavoring agent Substances 0.000 claims description 102
- 235000019634 flavors Nutrition 0.000 claims description 102
- 238000004064 recycling Methods 0.000 claims description 102
- 239000000243 solution Substances 0.000 claims description 84
- 239000007788 liquid Substances 0.000 claims description 81
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 54
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 claims description 45
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical class CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 claims description 36
- 241000628997 Flos Species 0.000 claims description 33
- 238000000605 extraction Methods 0.000 claims description 33
- 108010010803 Gelatin Proteins 0.000 claims description 27
- 229920000159 gelatin Polymers 0.000 claims description 27
- 239000008273 gelatin Substances 0.000 claims description 27
- 235000019322 gelatine Nutrition 0.000 claims description 27
- 235000011852 gelatine desserts Nutrition 0.000 claims description 27
- 238000003756 stirring Methods 0.000 claims description 27
- 235000018553 tannin Nutrition 0.000 claims description 27
- 229920001864 tannin Polymers 0.000 claims description 27
- 239000001648 tannin Substances 0.000 claims description 27
- 238000012546 transfer Methods 0.000 claims description 27
- 239000009636 Huang Qi Substances 0.000 claims description 19
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 18
- 229910052799 carbon Inorganic materials 0.000 claims description 18
- 239000012528 membrane Substances 0.000 claims description 18
- 238000012856 packing Methods 0.000 claims description 18
- 238000003810 ethyl acetate extraction Methods 0.000 claims description 15
- 241000545442 Radix Species 0.000 claims description 14
- 238000000108 ultra-filtration Methods 0.000 claims description 12
- 208000020832 chronic kidney disease Diseases 0.000 claims description 3
- 208000022831 chronic renal failure syndrome Diseases 0.000 claims description 3
- 230000002879 macerating effect Effects 0.000 claims description 3
- 239000002994 raw material Substances 0.000 claims description 2
- 238000000034 method Methods 0.000 abstract description 2
- 241000219061 Rheum Species 0.000 abstract 1
- 235000009411 Rheum rhabarbarum Nutrition 0.000 abstract 1
- 235000017276 Salvia Nutrition 0.000 abstract 1
- 240000007164 Salvia officinalis Species 0.000 abstract 1
- 238000010790 dilution Methods 0.000 abstract 1
- 239000012895 dilution Substances 0.000 abstract 1
- 238000004108 freeze drying Methods 0.000 abstract 1
- 238000001556 precipitation Methods 0.000 abstract 1
- 238000011084 recovery Methods 0.000 abstract 1
- 230000029219 regulation of pH Effects 0.000 abstract 1
- 238000005406 washing Methods 0.000 abstract 1
- 230000000694 effects Effects 0.000 description 8
- 239000003795 chemical substances by application Substances 0.000 description 3
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 230000003907 kidney function Effects 0.000 description 2
- 238000003556 assay Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000000284 extract Substances 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 235000008216 herbs Nutrition 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 229940126701 oral medication Drugs 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
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- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to a kidney health frozen dry powder injection and preparation technology thereof. The preparation technology is characterized in that rhubarb, salvia, etc. are respectively sequentially processed through processes of washing by water, decoction, stewing, filtration, concentration, alcohol precipitation, filtration, recovery of alcohol, dilution with distilled water, pH regulation, filtration with a microporous filtering film and freeze drying, and thus, the kidney health frozen dry powder injection can be obtained. The kidney health frozen dry powder injection has the advantages of high stability, long effective period and convenient storage and transportation.
Description
The present invention relates to a kind of injection kidney health freeze-dried powder and preparation technology thereof who treats chronic renal failure.
Clinically mostly be to adopt oral medication with the treatment by Chinese herbs chronic renal failure at present, its weak point is to absorb slowly, and bioavailability is low, the course of treatment is long, and weak curative effect is especially poorer to the above curative effect of renal function injury moderate, and gastrointestinal reaction is bigger, unsuitable prolonged application.The Chinese medicine injection effect is rapid, the bioavailability height, short treating period, good effect, especially the patient more than the renal function injury moderate there is better effects, patent " SHENKANG ZHUSHEYE and preparation technology thereof " (application number 96117626 notification numbers 1146358) as the applicant's application is to extract the Chinese medicine injection made from herbal mixture, and its weak point is poor stability, and effect duration is short.The present invention is that the dosage form to the patent " SHENKANG ZHUSHEYE and preparation technology thereof " of the applicant application changes agent.
The object of the present invention is to provide a kind of SHENKANG ZHUSHEYE to be changed the preparation technology that agent becomes injection kidney health freeze-dried powder, can improve stability, extend the expiration date, help storage and transport.
The present invention extracts the lyophilized injectable powder of making by Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, the Radix Astragali, Flos Carthami, and its raw material is made up of for 10～20 parts 10～20 parts of Radix Et Rhizoma Rhei, 10～20 parts of Radix Salviae Miltiorrhizaes, 40～70 parts of the Radixs Astragali, Flos Carthami.Can obtain by following 6 kinds of process routes during preparation:
Preparation technology 1:
With 10～20 parts of Radix Et Rhizoma Rhei, 10～20 parts of Radix Salviae Miltiorrhizaes are clean with distilled water, decoct three times with 6～12 times of distilled water respectively, and decocting time was respectively 1～2 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.001.15 that filtrate is concentrated into 60 ℃ of relative densities, merges concentrated solution, adds ethanol and makes that to contain the alcohol amount be 45～70%, cold preservation 12～48 hours filters filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, after fully stirring to there being the tannin reaction, placed 2～4 hours, add ethanol and make that to contain alcohol amount be 70～80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, add ethanol and make that to contain the alcohol amount be 70～80% with distilled water diluting, transfer PH7.5, one night of airtight placement filters, and filtrate recycling ethanol is to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, cold preservation 12～48 hours filters filtrate for later use; 40～70 parts of the Radixs Astragali, Flos Carthami is cleaned with distilled water respectively for 10～20 parts, decoct three times with 6～12 times of distilled water, decocting time was respectively 1 hour, merged three times decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, merges concentrated solution and adds ethanol and make that to contain the alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add ethanol again and make that to contain alcohol amount be 70～80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g, filtrate for later use to every 1ml with distilled water diluting; Merge above-mentioned reserve liquid, add the injection water and contain crude drug 1g, adding 0.2～0.5% active carbon heated and boiled 15～30 minutes to every 1ml, cold preservation 12 hours, filter, filtrate adds injection and is diluted with water to about 50% concentration, transfers PH7.5 with sodium hydroxide, add injection water to 1000ml, filter, the microporous filter membrane that filtrate is crossed 0.2 μ m filters filtrate packing 5～20ml, lyophilizing, promptly.
Preparation technology 2:
With 10～20 parts of Radix Et Rhizoma Rhei, 10～20 parts of Radix Salviae Miltiorrhizaes are clean with distilled water, decoct three times with 6～12 times of distilled water respectively, and decocting time was respectively 1～2 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and the Radix Salviae Miltiorrhizae concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain that alcohol measures be 70～80%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add ethanol and make that to contain alcohol amount be 70～80%, transfer PH7.5, one night of airtight placement, filter, filtrate recycling ethanol is not to there being the alcohol flavor, contains crude drug 2g, cold preservation 12～48 hours with distilled water diluting to every 1ml, filter filtrate for later use; The Radix Et Rhizoma Rhei concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, and cold preservation 12～48 hours filters, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there not being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain alcohol amount be 70～80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, add ethanol and make that to contain the alcohol amount be 70～80% with distilled water diluting, transfer PH7.5, one night of airtight placement filters, and filtrate recycling ethanol is to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, cold preservation 12～48 hours filters filtrate for later use; 40～70 parts of the Radixs Astragali, 10～20 parts on Flos Carthami is clean with distilled water, decoct three times with 6～12 times of distilled water respectively, decocting time was respectively 1 hour, merged three times decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and Radix Astragali concentrated solution adds ethanol makes that to contain the alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add ethanol again and make that to contain alcohol amount be 70～80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g, filtrate for later use to every 1ml with distilled water diluting; The Flos Carthami concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, and cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, add ethanol again and make that to contain the alcohol amount be 70～80% with distilled water diluting, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g, filtrate for later use with distilled water diluting to every 1ml; Merge above-mentioned all reserve liquids, add the injection water and contain crude drug 1g, adding 0.2～0.5% active carbon heated and boiled 15～30 minutes to every 1ml, cold preservation 12 hours, filter, filtrate adds injection and is diluted with water to about 50% concentration, transfers PH7.5 with sodium hydroxide, add injection water to 1000ml, filter, the microporous filter membrane that filtrate is crossed 0.2 μ m filters filtrate packing 5～20ml, lyophilizing, promptly.
Preparation technology 3:
With 10～20 parts of Radix Et Rhizoma Rhei, 10～20 parts of Radix Salviae Miltiorrhizaes are clean with distilled water, decoct three times with 6～12 times of distilled water respectively, and decocting time was respectively 1～2 hour, merge three times decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, the Radix Salviae Miltiorrhizae concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours filters filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, after fully stirring to there being the tannin reaction, placed 2～4 hours, add ethanol and make that to contain alcohol amount be 70～80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, waving most alcohol does not extremely have the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, filtration, filtrate is with the ultrafiltration of 1～20,000 fenestra, and ultrafiltrate is standby; The Radix Et Rhizoma Rhei concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain that alcohol measures be 70～80%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, filter, filtrate is with the ultrafiltration of 1～20,000 fenestra, and ultrafiltrate is standby; 10～20 parts of 40～70 parts of the Radixs Astragali, Flos Carthami are cleaned with distilled water, decoct three times with 6～12 times of distilled water respectively, decocting time was respectively 1 hour, merge three times decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.001.15 that filtrate is concentrated into 60 ℃ of relative densities, and Radix Astragali concentrated solution adds ethanol makes that to contain the alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, filter, filtrate is with the ultrafiltration of 1～40,000 fenestra, and ultrafiltrate is standby; The Flos Carthami concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, and cold preservation 12～48 hours filters, and filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, filters, and filtrate is with the ultrafiltration of 1～20,000 fenestra, and ultrafiltrate is standby; Merge above-mentioned all reserve liquids, add the injection water and contain crude drug 1g, adding 0.2～0.5% active carbon heated and boiled 15～30 minutes to every 1ml, cold preservation 12 hours, filter, filtrate adds injection and is diluted with water to about 50% concentration, transfers PH7.5 with sodium hydroxide, add injection water to 1000ml, filter, the microporous filter membrane that filtrate is crossed 0.2 μ m filters filtrate packing 5～20ml, lyophilizing, promptly.
Preparation technology 4:
With 10～20 parts of Radix Et Rhizoma Rhei, 10～20 parts of Radix Salviae Miltiorrhizaes are clean with distilled water, decoct three times with 6～12 times of distilled water respectively, decocting time was respectively 1～2 hour, merged three times decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and concentrated solution adds ethanol makes that to contain the alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there not being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain alcohol amount be 70～80%, cold preservation 12～48 hours filters filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, filtration, filtrate for later use; 10～20 parts on Flos Carthami is clean with distilled water, use 6～12 times 80 ℃ distilled water warm macerating secondaries respectively, decocting time was respectively 1 hour, merged the secondary decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and the Flos Carthami concentrated solution adds ethanol makes that to contain the alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, filter filtrate and Radix Salviae Miltiorrhizae, big yellow filtrate merges, and uses ethyl acetate extraction 2～6 times, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; 40～70 parts of the Radixs Astragali are clean with distilled water, decoct three times with 6～12 times of distilled water respectively, decocting time was respectively 1 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, Radix Astragali concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, and cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, with water saturated n-butanol extraction 2～6 times with distilled water diluting, combining extraction liquid, reclaim n-butyl alcohol, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; Merge above-mentioned reserve liquid, added 0.2～0.5% active carbon heated and boiled 15～30 minutes, cold preservation 12 hours filters, filtrate adds injection and is diluted with water to about 50% concentration, transfer PH7.5 with sodium hydroxide, add injection water, filter to 1000ml, the microporous filter membrane that filtrate is crossed 0.2 μ m filters, filtrate packing 5～20ml, lyophilizing, promptly.
Preparation technology 5:
With 10～20 parts of Radix Et Rhizoma Rhei, 10～20 parts of Radix Salviae Miltiorrhizaes are clean with distilled water, decoct three times with 6～12 times of distilled water, and decocting time was respectively 1～2 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain that alcohol measures be 70～80%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, with ethyl acetate extraction 2～6 times, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; 40～70 parts of the Radixs Astragali, 10～20 parts on Flos Carthami is clean with distilled water, decoct three times with 6～12 times of distilled water, decocting time was respectively 1 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, and cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, with water saturated n-butanol extraction 2～6 times with distilled water diluting, combining extraction liquid, reclaim n-butyl alcohol, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; Merge above-mentioned reserve liquid, added 0.2～0.5% active carbon heated and boiled 15～30 minutes, cold preservation 12 hours filters, filtrate adds injection and is diluted with water to about 50% concentration, transfer PH7.5 with sodium hydroxide, add injection water, filter to 1000ml, the microporous filter membrane that filtrate is crossed 0.2 μ m filters, filtrate packing 5～20ml, lyophilizing, promptly.
Preparation technology 6:
With 10～20 parts of Radix Et Rhizoma Rhei, 10～20 parts of Radix Salviae Miltiorrhizaes are clean with distilled water, decoct three times with 6～12 times of distilled water respectively, decocting time was respectively 1～2 hour, merged three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and the Radix Salviae Miltiorrhizae concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain that alcohol measures be 70～80%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, with ethyl acetate extraction 2～6 times, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; The Radix Et Rhizoma Rhei concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours filters filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, after fully stirring to there being the tannin reaction, placed 2～4 hours, add ethanol and make that to contain alcohol amount be 70～80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, with ethyl acetate extraction 2～6 times with distilled water diluting, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; 40～70 parts of the Radixs Astragali, 10～20 parts on Flos Carthami is clean with distilled water, decoct three times with 6～12 times of distilled water respectively, decocting time was respectively 1 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, Radix Astragali concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, and cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, with water saturated n-butanol extraction 2～6 times with distilled water diluting, combining extraction liquid, reclaim n-butyl alcohol, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; The Flos Carthami concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, with ethyl acetate extraction 2～6 times, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; Merge above-mentioned all reserve liquids, add the injection water and contain crude drug 1g, adding 0.2～0.5% active carbon heated and boiled 15～30 minutes to every 1ml, cold preservation 12 hours, filter, filtrate adds injection and is diluted with water to about 50% concentration, transfers PH7.5 with sodium hydroxide, add injection water to 1000ml, filter, the microporous filter membrane that filtrate is crossed 0.2 μ m filters filtrate packing 5～20ml, lyophilizing, promptly.
The invention has the advantages that better stability of preparation, effect duration is long, helps storage and transport.By " specification requirement of new Chinese medicine steady quality Journal of Sex Research ", test agent in 3 batches of the kidney health freeze-dried powders is investigated through 0-48 month preliminary stability test, SHENKANG ZHUSHEYE is placed observation under the room temperature condition, respectively at 0 month, January, February, March, June, December, 18 months, 24 months, 30 months, 36 months, 40 months, 48 months projects such as its character, discriminating, inspection, assay and health examination have been carried out check and measured, projects are all up to specification.The result shows, kidney health freeze-dried powder constant product quality prolongs more than 1 times than SHENKANG ZHUSHEYE effect duration (18 months).
With specific embodiment the present invention is elaborated below:
Embodiment 1:
With 15 parts of Radix Et Rhizoma Rhei, 15 parts of Radix Salviae Miltiorrhizaes are clean with distilled water, decoct three times with 8 times of distilled water respectively, and decocting time was respectively 1～2 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, merges concentrated solution, adds ethanol and makes that to contain the alcohol amount be 60%, cold preservation 12～48 hours filters filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, after fully stirring to there being the tannin reaction, placed 2～4 hours, add ethanol and make that to contain alcohol amount be 80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, add ethanol and make that to contain the alcohol amount be 80% with distilled water diluting, transfer PH7.5, one night of airtight placement filters, and filtrate recycling ethanol is to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, cold preservation 12～48 hours filters filtrate for later use; 55 parts of the Radixs Astragali, Flos Carthami is cleaned with distilled water respectively for 15 parts, decoct three times with 8 times of distilled water, decocting time was respectively 1 hour, merged three times decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, merges concentrated solution and adds ethanol and make that to contain the alcohol amount be 60%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add ethanol again and make that to contain alcohol amount be 80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g, filtrate for later use to every 1ml with distilled water diluting; Merge above-mentioned reserve liquid, add the injection water and contain crude drug 1g, adding 0.2～0.5% active carbon heated and boiled 15～30 minutes to every 1ml, cold preservation 12 hours, filter, filtrate adds injection and is diluted with water to about 50% concentration, transfers PH7.5 with sodium hydroxide, add injection water to 1000ml, filter, the microporous filter membrane that filtrate is crossed 0.2 μ m filters filtrate packing 5～20ml, lyophilizing, promptly.
Embodiment 2:
With 15 parts of Radix Et Rhizoma Rhei, 15 parts of Radix Salviae Miltiorrhizaes are clean with distilled water, decoct three times with 8 times of distilled water respectively, and decocting time was respectively 1～2 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and the Radix Salviae Miltiorrhizae concentrated solution adds ethanol makes that to contain alcohol amount be 60%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain that alcohol measures be 80%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add ethanol and make that to contain alcohol amount be 80%, transfer PH7.5, one night of airtight placement, filter, filtrate recycling ethanol is not to there being the alcohol flavor, contains crude drug 2g, cold preservation 12～48 hours with distilled water diluting to every 1ml, filter filtrate for later use; The Radix Et Rhizoma Rhei concentrated solution adds ethanol makes that to contain alcohol amount be 60%, and cold preservation 12～48 hours filters, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there not being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain alcohol amount be 80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, add ethanol and make that to contain the alcohol amount be 80% with distilled water diluting, transfer PH7.5, one night of airtight placement filters, and filtrate recycling ethanol is to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, cold preservation 12～48 hours filters filtrate for later use; 55 parts of the Radixs Astragali, 15 parts on Flos Carthami is clean with distilled water, decoct three times with 8 times of distilled water respectively, decocting time was respectively 1 hour, merged three times decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and Radix Astragali concentrated solution adds ethanol makes that to contain the alcohol amount be 60%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add ethanol again and make that to contain alcohol amount be 80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g, filtrate for later use to every 1ml with distilled water diluting; The Flos Carthami concentrated solution adds ethanol makes that to contain alcohol amount be 60%, and cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, add ethanol again and make that to contain the alcohol amount be 80% with distilled water diluting, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g, filtrate for later use with distilled water diluting to every 1ml; Merge above-mentioned all reserve liquids, add the injection water and contain crude drug 1g, adding 0.2～0.5% active carbon heated and boiled 15～30 minutes to every 1ml, cold preservation 12 hours, filter, filtrate adds injection and is diluted with water to about 50% concentration, transfers PH7.5 with sodium hydroxide, add injection water to 1000ml, filter, the microporous filter membrane that filtrate is crossed 0.2 μ m filters filtrate packing 5～20ml, lyophilizing, promptly.
Embodiment 3:
With 15 parts of Radix Et Rhizoma Rhei, 15 parts of Radix Salviae Miltiorrhizaes are clean with distilled water, decoct three times with 8 times of distilled water respectively, and decocting time was respectively 1～2 hour, merge three times decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, the Radix Salviae Miltiorrhizae concentrated solution adds ethanol makes that to contain alcohol amount be 60%, cold preservation 12～48 hours filters filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, after fully stirring to there being the tannin reaction, placed 2～4 hours, add ethanol and make that to contain alcohol amount be 80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, waving most alcohol does not extremely have the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, filtration, filtrate is with the ultrafiltration of 1～20,000 fenestra, and ultrafiltrate is standby; The Radix Et Rhizoma Rhei concentrated solution adds ethanol makes that to contain alcohol amount be 60%, and cold preservation 12～48 hours filters, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there not being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain alcohol amount be 80%, cold preservation 12～48 hours filters, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, filter, filtrate is with the ultrafiltration of 1～20,000 fenestra, and ultrafiltrate is standby; 15 parts of 55 parts of the Radixs Astragali, Flos Carthami are cleaned with distilled water, and with 8 times of distilled water decoctions three times, decocting time was respectively 1 hour respectively, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and Radix Astragali concentrated solution adds ethanol makes that to contain alcohol amount be 60%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, filter, filtrate is with the ultrafiltration of 1～40,000 fenestra, and ultrafiltrate is standby; The Flos Carthami concentrated solution adds ethanol makes that to contain alcohol amount be 60%, and cold preservation 12～48 hours filters, and filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, filters, and filtrate is with the ultrafiltration of 1～20,000 fenestra, and ultrafiltrate is standby; Merge above-mentioned all reserve liquids, add the injection water and contain crude drug 1g, adding 0.2～0.5% active carbon heated and boiled 15～30 minutes to every 1ml, cold preservation 12 hours, filter, filtrate adds injection and is diluted with water to about 50% concentration, transfers PH7.5 with sodium hydroxide, add injection water to 1000ml, filter, the microporous filter membrane that filtrate is crossed 0.2 μ m filters filtrate packing 5～20ml, lyophilizing, promptly.
Embodiment 4:
With 15 parts of Radix Et Rhizoma Rhei, 15 parts of Radix Salviae Miltiorrhizaes are clean with distilled water, decoct three times with 8 times of distilled water respectively, decocting time was respectively 1～2 hour, merged three times decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and concentrated solution adds ethanol makes that to contain the alcohol amount be 60%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there not being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain alcohol amount be 80%, cold preservation 12～48 hours filters filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, filtration, filtrate for later use; 15 parts on Flos Carthami is clean with distilled water, use 8 times 80 ℃ distilled water warm macerating secondaries respectively, decocting time was respectively 1 hour, merged the secondary decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and the Flos Carthami concentrated solution adds ethanol makes that to contain the alcohol amount be 60%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, filter filtrate and Radix Salviae Miltiorrhizae, big yellow filtrate merges, and uses ethyl acetate extraction 2～6 times, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; 55 parts of the Radixs Astragali are clean with distilled water, decoct three times with 8 times of distilled water respectively, decocting time was respectively 1 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, Radix Astragali concentrated solution adds ethanol makes that to contain alcohol amount be 60%, and cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, with water saturated n-butanol extraction 2～6 times with distilled water diluting, combining extraction liquid, reclaim n-butyl alcohol, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; Merge above-mentioned reserve liquid, added 0.2～0.5% active carbon heated and boiled 15～30 minutes, cold preservation 12 hours filters, filtrate adds injection and is diluted with water to about 50% concentration, transfer PH7.5 with sodium hydroxide, add injection water, filter to 1000ml, the microporous filter membrane that filtrate is crossed 0.2 μ m filters, filtrate packing 5～20ml, lyophilizing, promptly.
Embodiment 5:
With 15 parts of Radix Et Rhizoma Rhei, 15 parts of Radix Salviae Miltiorrhizaes are clean with distilled water, decoct three times with 8 times of distilled water, and decocting time was respectively 1～2 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and concentrated solution adds ethanol makes that to contain alcohol amount be 60%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain that alcohol measures be 80%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, with ethyl acetate extraction 2～6 times, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; 15 parts of 55 parts of the Radixs Astragali, Flos Carthami are cleaned with distilled water, decoct three times with 8 times of distilled water, decocting time was respectively 1 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, concentrated solution adds ethanol makes that to contain alcohol amount be 60%, and cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, with water saturated n-butanol extraction 2～6 times with distilled water diluting, combining extraction liquid, reclaim n-butyl alcohol, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; Merge above-mentioned reserve liquid, added 0.2～0.5% active carbon heated and boiled 15～30 minutes, cold preservation 12 hours filters, filtrate adds injection and is diluted with water to about 50% concentration, transfer PH7.5 with sodium hydroxide, add injection water, filter to 1000ml, the microporous filter membrane that filtrate is crossed 0.2 μ m filters, filtrate packing 5～20ml, lyophilizing, promptly.
Embodiment 6:
With 15 parts of Radix Et Rhizoma Rhei, 15 parts of Radix Salviae Miltiorrhizaes are clean with distilled water, decoct three times with 8 times of distilled water respectively, and decocting time was respectively 1～2 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and the Radix Salviae Miltiorrhizae concentrated solution adds ethanol makes that to contain alcohol amount be 60%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain that alcohol measures be 80%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, with ethyl acetate extraction 2～6 times, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; The Radix Et Rhizoma Rhei concentrated solution adds ethanol makes that to contain alcohol amount be 60%, cold preservation 12～48 hours filters filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, after fully stirring to there being the tannin reaction, placed 2～4 hours, add ethanol and make that to contain alcohol amount be 80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, with ethyl acetate extraction 2～6 times with distilled water diluting, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; 15 parts of 55 parts of the Radixs Astragali, Flos Carthami are cleaned with distilled water, decoct three times with 8 times of distilled water respectively, decocting time was respectively 1 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, Radix Astragali concentrated solution adds ethanol makes that to contain alcohol amount be 60%, and cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, with water saturated n-butanol extraction 2～6 times with distilled water diluting, combining extraction liquid, reclaim n-butyl alcohol, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; The Flos Carthami concentrated solution adds ethanol makes that to contain alcohol amount be 60%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, with ethyl acetate extraction 2～6 times, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; Merge above-mentioned all reserve liquids, add the injection water and contain crude drug 1g, adding 0.2～0.5% active carbon heated and boiled 15～30 minutes to every 1ml, cold preservation 12 hours, filter, filtrate adds injection and is diluted with water to about 50% concentration, transfers PH7.5 with sodium hydroxide, add injection water to 1000ml, filter, the microporous filter membrane that filtrate is crossed 0.2 μ m filters filtrate packing 5～20ml, lyophilizing, promptly.
Claims (6)
1. injection kidney caring freeze dried injection for the treatment of chronic renal failure, its raw material of Chinese medicine is made up of for 10～20 parts 10～20 parts of Radix Et Rhizoma Rhei, 10～20 parts of Radix Salviae Miltiorrhizaes, 40～70 parts of the Radixs Astragali, Flos Carthami, it is characterized in that making by following preparation technology:
With Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae is cleaned with distilled water, decocts three times with 6～12 times of distilled water respectively, and decocting time was respectively 1～2 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, merges concentrated solution, adds ethanol and makes that to contain the alcohol amount be 45～70%, cold preservation 12～48 hours filters filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, after fully stirring to there being the tannin reaction, placed 2～4 hours, add ethanol and make that to contain alcohol amount be 70～80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, add ethanol and make that to contain the alcohol amount be 70～80% with distilled water diluting, transfer PH7.5, one night of airtight placement filters, and filtrate recycling ethanol is to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, cold preservation 12～48 hours filters filtrate for later use;
The Radix Astragali, Flos Carthami is cleaned with distilled water respectively, decoct three times with 6～12 times of distilled water, decocting time was respectively 1 hour, merged three times decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, merges concentrated solution and adds ethanol and make that to contain the alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add ethanol again and make that to contain alcohol amount be 70～80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g, filtrate for later use to every 1ml with distilled water diluting;
Merge above-mentioned reserve liquid, add the injection water and contain crude drug 1g, adding 0.2～0.5% active carbon heated and boiled 15～30 minutes to every 1ml, cold preservation 12 hours, filter, filtrate adds injection and is diluted with water to about 50% concentration, transfers PH7.5 with sodium hydroxide, add injection water to 1000ml, filter, the microporous filter membrane that filtrate is crossed 0.2 μ m filters filtrate packing 5～20ml, lyophilizing, promptly.
2. the preparation technology of injection kidney caring freeze dried injection as claimed in claim 1 is characterized in that comprising following preparation process:
With Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae is cleaned with distilled water, decocts three times with 6～12 times of distilled water respectively, and decocting time was respectively 1～2 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and the Radix Salviae Miltiorrhizae concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain that alcohol measures be 70～80%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add ethanol and make that to contain alcohol amount be 70～80%, transfer PH7.5, one night of airtight placement, filter, filtrate recycling ethanol is not to there being the alcohol flavor, contains crude drug 2g, cold preservation 12～48 hours with distilled water diluting to every 1ml, filter filtrate for later use; The Radix Et Rhizoma Rhei concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, and cold preservation 12～48 hours filters, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there not being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain alcohol amount be 70～80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, add ethanol and make that to contain the alcohol amount be 70～80% with distilled water diluting, transfer PH7.5, one night of airtight placement filters, and filtrate recycling ethanol is to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, cold preservation 12～48 hours filters filtrate for later use;
The Radix Astragali, Flos Carthami is cleaned with distilled water, decoct three times with 6～12 times of distilled water respectively, decocting time was respectively 1 hour, merged three times decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and Radix Astragali concentrated solution adds ethanol makes that to contain the alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add ethanol again and make that to contain alcohol amount be 70～80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g, filtrate for later use to every 1ml with distilled water diluting; The Flos Carthami concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, and cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, add ethanol again and make that to contain the alcohol amount be 70～80% with distilled water diluting, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g, filtrate for later use with distilled water diluting to every 1ml;
Merge above-mentioned all reserve liquids, add the injection water and contain crude drug 1g, adding 0.2～0.5% active carbon heated and boiled 15～30 minutes to every 1ml, cold preservation 12 hours, filter, filtrate adds injection and is diluted with water to about 50% concentration, transfers PH7.5 with sodium hydroxide, add injection water to 1000ml, filter, the microporous filter membrane that filtrate is crossed 0.2 μ m filters filtrate packing 5～20ml, lyophilizing, promptly.
3. the preparation technology of injection kidney caring freeze dried injection as claimed in claim 1 is characterized in that comprising following preparation process:
With Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae is cleaned with distilled water, decocts three times with 6～12 times of distilled water respectively, and decocting time was respectively 1～2 hour, merge three times decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, the Radix Salviae Miltiorrhizae concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours filters filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, after fully stirring to there being the tannin reaction, placed 2～4 hours, add ethanol and make that to contain alcohol amount be 70～80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, waving most alcohol does not extremely have the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, filtration, filtrate is with the ultrafiltration of 1～20,000 fenestra, and ultrafiltrate is standby; The Radix Et Rhizoma Rhei concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain that alcohol measures be 70～80%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, filter, filtrate is with the ultrafiltration of 1～20,000 fenestra, and ultrafiltrate is standby;
The Radix Astragali, Flos Carthami are cleaned with distilled water, decoct three times with 6～12 times of distilled water respectively, and decocting time was respectively 1 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and Radix Astragali concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, filter, filtrate is with the ultrafiltration of 1～40,000 fenestra, and ultrafiltrate is standby; The Flos Carthami concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, and cold preservation 12～48 hours filters, and filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, filters, and filtrate is with the ultrafiltration of 1～20,000 fenestra, and ultrafiltrate is standby;
Merge above-mentioned all reserve liquids, add the injection water and contain crude drug 1g, adding 0.2～0.5% active carbon heated and boiled 15～30 minutes to every 1ml, cold preservation 12 hours, filter, filtrate adds injection and is diluted with water to about 50% concentration, transfers PH7.5 with sodium hydroxide, add injection water to 1000ml, filter, the microporous filter membrane that filtrate is crossed 0.2 μ m filters filtrate packing 5～20ml, lyophilizing, promptly.
4. the preparation technology of injection kidney caring freeze dried injection as claimed in claim 1 is characterized in that comprising following preparation process:
With Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae is cleaned with distilled water, decoct three times with 6～12 times of distilled water respectively, decocting time was respectively 1～2 hour, merged three times decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and concentrated solution adds ethanol makes that to contain the alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there not being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain alcohol amount be 70～80%, cold preservation 12～48 hours filters filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, filtration, filtrate for later use;
Flos Carthami is cleaned with distilled water, use 6～12 times 80 ℃ distilled water warm macerating secondaries respectively, decocting time was respectively 1 hour, merged the secondary decocting liquid, after leaving standstill 12～48 hours, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and the Flos Carthami concentrated solution adds ethanol makes that to contain the alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, filter filtrate and Radix Salviae Miltiorrhizae, big yellow filtrate merges, and uses ethyl acetate extraction 2～6 times, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby;
The Radix Astragali is cleaned with distilled water, decoct three times with 6～12 times of distilled water respectively, decocting time was respectively 1 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, Radix Astragali concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, and cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, with water saturated n-butanol extraction 2～6 times with distilled water diluting, combining extraction liquid, reclaim n-butyl alcohol, add the injection water and contain crude drug 1g crude drug to every 1ml, standby;
Merge above-mentioned reserve liquid, added 0.2～05% active carbon heated and boiled 15～30 minutes, cold preservation 12 hours filters, filtrate adds injection and is diluted with water to about 50% concentration, transfer PH7.5 with sodium hydroxide, add injection water, filter to 1000ml, the microporous filter membrane that filtrate is crossed 0.2 μ m filters, filtrate packing 5～20ml, lyophilizing, promptly.
5. the preparation technology of injection kidney caring freeze dried injection as claimed in claim 1 is characterized in that comprising following preparation process:
With Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae is cleaned with distilled water, decocts three times with 6～12 times of distilled water, and decocting time was respectively 1～2 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain that alcohol measures be 70～80%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, with ethyl acetate extraction 2～6 times, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby;
The Radix Astragali, Flos Carthami are cleaned with distilled water, decoct three times with 6～12 times of distilled water, decocting time was respectively 1 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, filtrate is concentrated into 60 ℃ of relative density 1.00-1.15, concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, and cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, with water saturated n-butanol extraction 2～6 times with distilled water diluting, combining extraction liquid, reclaim n-butyl alcohol, add the injection water and contain crude drug 1g crude drug to every 1ml, standby;
Merge above-mentioned reserve liquid, added 0.2～0.5% active carbon heated and boiled 15～30 minutes, cold preservation 12 hours filters, filtrate adds injection and is diluted with water to about 50% concentration, transfer PH7.5 with sodium hydroxide, add injection water, filter to 1000ml, the microporous filter membrane that filtrate is crossed 0.2 μ m filters, filtrate packing 5～20ml, lyophilizing, promptly.
6. the preparation technology of injection kidney caring freeze dried injection as claimed in claim 1 is characterized in that comprising following preparation process:
With Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae is cleaned with distilled water, decocts three times with 6～12 times of distilled water respectively, and decocting time was respectively 1～2 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, it is 1.00-1.15 that filtrate is concentrated into 60 ℃ of relative densities, and the Radix Salviae Miltiorrhizae concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contains crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, to there being the tannin reaction, placed 2～4 hours after fully stirring, add ethanol and make that to contain that alcohol measures be 70～80%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, with ethyl acetate extraction 2～6 times, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; The Radix Et Rhizoma Rhei concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours filters filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, add 3～5% gelatin solution, after fully stirring to there being the tannin reaction, placed 2～4 hours, add ethanol and make that to contain alcohol amount be 70～80%, cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, with ethyl acetate extraction 2～6 times with distilled water diluting, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby;
The Radix Astragali, Flos Carthami are cleaned with distilled water, decoct three times with 6～12 times of distilled water respectively, decocting time was respectively 1 hour, merge three times decocting liquid, leave standstill 12～48 hours after, filter, filtrate is concentrated into 60 ℃ of relative density 1.00-1.15, Radix Astragali concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, and cold preservation 12～48 hours filters, filtrate recycling ethanol, wave most alcohol to there not being the alcohol flavor, contain crude drug 2g to every 1ml, with water saturated n-butanol extraction 2～6 times with distilled water diluting, combining extraction liquid, reclaim n-butyl alcohol, add the injection water and contain crude drug 1g crude drug to every 1ml, standby; The Flos Carthami concentrated solution adds ethanol makes that to contain alcohol amount be 45～70%, cold preservation 12～48 hours, filter, filtrate recycling ethanol is waved most alcohol to there not being the alcohol flavor, contain crude drug 2g with distilled water diluting to every 1ml, with ethyl acetate extraction 2～6 times, combining extraction liquid, reclaim ethyl acetate, add the injection water and contain crude drug 1g crude drug to every 1ml, standby;
Merge above-mentioned all reserve liquids, add the injection water and contain crude drug 1g, adding 0.2～0.5% active carbon heated and boiled 15～30 minutes to every 1ml, cold preservation 12 hours, filter, filtrate adds injection and is diluted with water to about 50% concentration, transfers PH7.5 with sodium hydroxide, add injection water to 1000ml, filter, the microporous filter membrane that filtrate is crossed 0.2 μ m filters filtrate packing 5～20ml, lyophilizing, promptly.
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| CNB2004100043592A CN100409837C (en) | 2004-02-17 | 2004-02-17 | Shenkang freeze-dried powder injection for injection and its preparation technology |
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| CNB2004100043592A CN100409837C (en) | 2004-02-17 | 2004-02-17 | Shenkang freeze-dried powder injection for injection and its preparation technology |
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| CN100409837C true CN100409837C (en) | 2008-08-13 |
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| CN102475762B (en) * | 2010-11-30 | 2013-12-18 | 西安世纪盛康药业有限公司 | Shenkang oral liquid compound preparation for treating chronic renal failure and preparation method of Shenkang oral liquid compound preparation |
| CN102475760B (en) * | 2010-11-30 | 2014-04-02 | 西安世纪盛康药业有限公司 | Kidney-health compound preparation for treating chronic renal failure and preparation method thereof |
| CN102475758B (en) * | 2010-11-30 | 2013-12-18 | 西安世纪盛康药业有限公司 | Shenkang tablet for treating chronic renal failure and preparation method of Shenkang tablet |
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| CN102475754B (en) * | 2010-11-30 | 2013-12-18 | 西安世纪盛康药业有限公司 | Shenkang soft capsule for treating chronic renal failure and preparation method of Shenkang soft capsule |
| CN102475761B (en) * | 2010-11-30 | 2013-12-18 | 西安世纪盛康药业有限公司 | Shenkang oral solid compound preparation for treating chronic renal failure and preparation method of Shenkang oral solid compound preparation |
| CN102475764A (en) * | 2010-11-30 | 2012-05-30 | 西安世纪盛康药业有限公司 | Preparation method of Shenkang injection |
| CN102475756B (en) * | 2010-11-30 | 2014-03-19 | 西安世纪盛康药业有限公司 | Shenkang injection compound preparation for treating chronic renal failure and preparation method of Shenkang injection compound preparation |
| CN102475757B (en) * | 2010-11-30 | 2013-10-16 | 西安世纪盛康药业有限公司 | Kidney-strengthening externally applied compound preparation for treating chronic renal failure and preparation method of compound preparation |
| CN102475753B (en) * | 2010-11-30 | 2014-04-02 | 西安世纪盛康药业有限公司 | Kidney-health patch for treating chronic renal failure and preparation method thereof |
| CN102475759B (en) * | 2010-11-30 | 2013-10-16 | 西安世纪盛康药业有限公司 | Shenkang sodium chloride injection for treating chronic renal failure and preparation method of Shenkang sodium chloride injection |
| CN103893284B (en) * | 2012-12-28 | 2016-08-10 | 西安世纪盛康药业有限公司 | A kind of Chinese medicine composition treating chronic kidney disease and chronic renal failure and its production and use |
| CN103893285B (en) * | 2012-12-28 | 2016-08-03 | 西安世纪盛康药业有限公司 | A kind of Chinese medicine composition is the application in nephrotoxicity and cardiovascular and cerebrovascular diseases medicament after preparation treatment chemicotherapy |
| CN105012411A (en) * | 2014-04-25 | 2015-11-04 | 西安世纪盛康药业有限公司 | Medicinal composition for treating kidney diseases and pharmaceutical application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1146358A (en) * | 1996-07-16 | 1997-04-02 | 成都中医药大学附属医院 | Shengkang injection solution (for nephrosis) and preparation technology |
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- 2004-02-17 CN CNB2004100043592A patent/CN100409837C/en not_active Expired - Lifetime
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1146358A (en) * | 1996-07-16 | 1997-04-02 | 成都中医药大学附属医院 | Shengkang injection solution (for nephrosis) and preparation technology |
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