CN1682926A - Ginseng-ophiopogon root freeze-dried powder injection and its preparing method - Google Patents
Ginseng-ophiopogon root freeze-dried powder injection and its preparing method Download PDFInfo
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Abstract
The present invention discloses a kind of freeze dried ginseng-ophiopogon root powder for injection and its preparation process. The present invention features that Chinese medicinal materials ginseng and ophiopogon root are extracted together with alcohol to obtain the alcohol extract and the alcohol extract is combined with optimized medicine supplementary material mannitol to prepare the freeze dried powder for injection. The freeze dried powder for injection contains ginsenoside content not less than 20 mg/ampoule and ophiopogonin content not less than 8 mg/ampoule. The freeze dried powder for injection of the present invention has excellent pharmacological effect.
Description
Affiliated technical field
The invention belongs to field of traditional Chinese medicine pharmacy, be specifically related to a kind of ginseng-ophiopogon root freeze-dried powder injection and preparation method thereof.
Technical background
Radix Ophiopogonis, be the dried root of liliaceous plant dwarf lilyturf, nature and flavor: sweet, little hardship is slightly cold GUIXIN, stomach, lung meridian, have YIN nourishing and the production of body fluid promoting, nourishing the lung to arrest cough, the effect that clears away heart-fire, the clinical dryness of the lung dry cough that is used for, Tianjin is few thirsty, vexed insomnia, constipation, diseases such as diphtheria, Radix Ophiopogonis, main effective ingredient was an ophiopogonin.
Radix Ginseng is one of genuine medicinal materials of abounding with of Changbaishan area, is used as medicine with its root, has good actions such as " strongly invigorating primordial QI promote the production of body fluid admittedly take off, the Fructus Alpiniae Oxyphyllae of calming the nerves ", is famous valuable ingredient of Chinese medicine.Radix Ginseng has better curative effect for diseases such as hemorrhage, shock, heart failure, can use the Radix Ginseng strongly invigorating primordial QI, saves collapse, reaches the effect that QI invigorating is held up arteries and veins.
With Radix Ginseng, Radix Ophiopogonis compatibility, derive from ancient prescription " SHENGMAI SAN ", according to modern Chinese medicine theory and modern means of science and technology the SHENGMAI SAN sanction is obtained, Radix Ginseng, Radix Ophiopogonis, prescription was prepared into SHENMAI ZHUSHEYE, very extensive in clinical practice, obtained extraordinary curative effect, obtain doctor and patient's approval, SHENMAI ZHUSHEYE has supplementing QI to prevent collapse, YIN nourishing and the production of body fluid promoting, give birth to the effect of arteries and veins, be used for the treatment of shock, coronary heart disease, viral myocarditis, chronic cardiopulmonary disease, the granulocytopenia of type of deficiency of both QI and YIN; Along with the expansion of clinical practice, the report of its untoward reaction is arranged, its untoward reaction mainly contains: bring out tachycardia, serious abdominal distention, hypotension, drug eruption, bring out angina pectoris, anaphylactic shock, contact allergy dermatitis.(" giving birth to the untoward reaction of arteries and veins (and Rhizoma Zingiberis Recens) injection ", Chinese patent medicine, 1999,21 (8), Nanfang Hospital of No.1 Military Medical Univ., Zhuan Zhiquan, Jinhua).
SHENMAI ZHUSHEYE contains Radix Ginseng, Radix Ophiopogonis effective site, the two has unstability in aqueous solution, use the unstable factor that the freeze-dried powder technology can fundamentally solve SHENMAI ZHUSHEYE, but low concentration solution is in freeze-drying process, occurs that medicine and steam disperse and the very fast dissipation of fine hair shape material and be phenomenon such as atrophing state behind the loosely organized fine hair shape material in dry back, outlet.Therefore, must in experiment, select a kind of good pharmaceutic adjuvant, as freeze dried support; Mannitol, Mannitolum, molecular formula C
6H
14O
6, character is a white crystalline powder, odorless, and distinguish the flavor of sweet, soluble in water, diluted acid or dilute alkaline soln are slightly soluble in ethanol; 5.07% aqueous solution is an isosmotic solution.Therefore, mannitol can be used as good lyophilizing pharmaceutic adjuvant.
Summary of the invention
For these reasons, the present invention obtains ethanol extract with common ethanol extraction of Radix Ginseng, Radix Ophiopogonis, give according to its physics and chemical property,, select mannitol as pharmaceutic adjuvant through our experimentation, be prepared into lyophilized injectable powder, the ginsenoside is (with ginsenoside Rg, Rb in the control injectable powder
1, Re meter) be not less than the 20mg/ bottle, control ophiopogonin (in ophiopogonin B) is not less than the 8mg/ bottle; Pharmacological evaluation shows that lyophilized injectable powder of the present invention has better pharmacological action.
The present invention is achieved through the following technical solutions.
One. process recipes
(1) crude drug composition proportioning weight portion of the present invention is:
Radix Ginseng 0.8-1.2, Radix Ophiopogonis 0.8-1.2;
(2) get Radix Ginseng Rubra, add alcohol dipping Radix Ophiopogonis after, put in the continuous extractor continuous backflow and extract 5-8 time, 1-3 hour at every turn, filter, medicinal residues wash with 1 times of crude drug amount ethanol gradation, merge above-mentioned filtrate and extracting solution, and cold preservation was left standstill 10-15 hour, filter, drying obtains Radix Ginseng, Radix Ophiopogonis ethanol extract;
(3) preparation prescription of the present invention is:
Radix Ginseng, Radix Ophiopogonis, ethanol extract was the 160-240 weight portion, and pharmaceutic adjuvant is the 60-140 weight portion;
(4) get Radix Ginseng, Radix Ophiopogonis ethanol extract, add the dissolving of injection water fully, filter, in filtrate, add 1% active carbon, stirred 1 hour, and filtered, decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is refining, add the injection water, filter, in filtrate, add pharmaceutic adjuvant, regulate pH value to 6.0-8.0 with sodium hydroxide, cold preservation filtered more than 48 hours, filtrate adds the injection water, filters sterilization, aseptic subpackaged every bottle of 2ml, lyophilization, promptly.
Two. the check and analysis experiment
1. ginsenoside's check and analysis
According to high effective liquid chromatography for measuring.
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile 0.05% phosphoric acid solution (19: 81) is a mobile phase; The detection wavelength is 203nm.
The preparation of reference substance solution: precision takes by weighing panaxoside Rg, each 5mg of Rb1, Re that is dried to constant weight in phosphorus pentoxide desiccator, put in the 25ml measuring bottle, add acetonitrile: water (19: 81) is to scale, shake up, precision is measured 5ml, puts in the 10ml measuring bottle, adds acetonitrile: water (19: 81) is diluted to scale, shake up, promptly.
The preparation of need testing solution: get lyophilized injectable powder 300mg of the present invention and put in the 25ml measuring bottle, add acetonitrile: water (19: 81) shakes up to scale, precision is measured 5ml, puts in the 10ml measuring bottle, adds acetonitrile: water (19: 81) is diluted to scale, shake up, promptly get as need testing solution.
Algoscopy: accurate respectively reference substance solution and each 20 μ l of need testing solution of drawing, inject chromatograph of liquid respectively, measure, promptly.Result of calculation sees Table 1:
2. the check and analysis of ophiopogonin
Tlc scanning determination Saponin Radix Ophiopogonis constituents
Experimental drug: ophiopogonin B (ophioponinB) (Shenyang Pharmaceutical University's Chinese patent medicine is analyzed teaching and research room)
Ginseng-ophiopogon root freeze-dried powder injection of the present invention (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides)
Experimental apparatus: Tianjin, island CS-930 type thin-layer chromatogram scanner; Silica gel plate (German Merck company).
Chromatographic condition: developing solvent is ethyl acetate-methanol-water (15: 5: 1), and developer is 10% sulphuric acid, and scan mode is saw-tooth sweep, SX=6, slit: 1.2mm * 1.2mm.Through in the interscan of 370～700nm scope, determine that 570nm is the mensuration wavelength of ophiopogonin B.
The standard curve preparation: precision takes by weighing ophiopogonin B, with methanol constant volume, make that its concentration is respectively 0.9,1.0g/L, draw 2.0,4.0,6.0,8.0,10.0 μ L point samples respectively, launch, after the colour developing, measure the area integral value, concentration range is at 2～10 μ g, and the regression equation of ophiopogonin B (n=5) is respectively:
Y＝-1.675×104+1.426×104C??r＝0.992
Sample determination: get lyophilized injectable powder of the present invention and ophiopogonin B contrast liquid point sample 5.0 μ L respectively, measure by the chromatographic condition of Saponin analysis.Assay the results are shown in Table 1.
Table 1 lyophilized injectable powder assay of the present invention
| Group | The ginsenoside is (with ginsenoside Rg, Rb 1, Re meter) the mg/ bottle, | Ophiopogonin (in ophiopogonin B) mg/ bottle |
| Ginseng-ophiopogon root freeze-dried powder injection of the present invention | 38.76 | ??10.23 |
Conclusion: show that by above-mentioned check and analysis experiment technology of the present invention has practical significance.
Three. the selection of pharmaceutic adjuvant
Experimental technique: according to the present invention Radix Ginseng in the technology, Radix Ophiopogonis ethanol extract character, we select the mixture of sucrose, lactose, mannitol, glucose and mannitol and above-mentioned each adjuvant, carry out the lyophilizing experiment, observe appearance luster, mouldability, water solublity, indexs such as clarity, experimental result sees Table 2
The different pharmaceutic adjuvants of table 2 are to the influence of freeze-dried powder quality
| Group | Crude drug amount g/ bottle | Molding | Color and luster | Dissolubility | Clarity | ??pH |
| Glucose lactose sucrose mannitol and other mixture mannitol | ??2.0 ??2.0 ??2.0 ??2.0 ??2.0 | Difference difference difference is poor slightly good | Yellow little Huang | Broad instant | Clear and bright clear and bright | ??6.42 ??6.54 ??6.45 ??6.57 ??6.46 |
Conclusion: by above-mentioned experiment, we select mannitol is the pharmaceutic adjuvant of ginseng-ophiopogon root freeze-dried powder injection.
Four. pharmacology embodiment
Embodiment 1
Influence to ischemic brain injury rat hippocampus c-fos protein expression
Laboratory animal: male Wistar rat, body weight 200-250 gram.
Experiment medicine: the commercially available SHENMAI ZHUSHEYE of ginseng-ophiopogon root freeze-dried powder injection of the present invention (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides) (for Zhengda Qingchunbao Pharmaceutical Co., Ltd produces), 1% pentobarbital sodium, 1% heparin (2.5ml/kg, perfusion is fixedly injected in the front center), 0.9%Nacl (flushing was used before perfusion was fixing), 4% paraformaldehyde, 3% hydrogen peroxide, 0.01%MPBS (Ph7.4), the complete SABC test kit of c-fos, DAB developer (pale brown color).
Experimental technique: get rat, random packet, three groups of rats are all used 1% pentobarbital (40mg/kg) intraperitoneal anesthesia, administration group, the big mousetrap of ischemia group close bilateral common carotid arteries and poured into after 30 minutes 1 hour again, set up the ischemic brain injury model, the administration group is at ischemia lumbar injection injection containing ginseng extract preparation 2mg crude drug/kg before 30 minutes; Matched group does not press from both sides and closes common carotid artery, yet not administration.The rat routine is poured into 4% paraformaldehyde and is fixed, draws materials, the back is fixing, makes crown paraffin section (thick 8 μ m).Microscopic examination is through the painted section of c-fos protein immunization groupization.The Hippocampus position is determined in each section of every routine rat earlier, select the more section of hippocampal neuron to be this example rat representative then, with 10 hippocampal neurons of computer, carry out the sxemiquantitative statistics facing to pornographic condition, (1) color depth, the person that is the dark-brown is " +++", (2) painted darker, be brown person and be " ++ ", (3) are painted more shallow, be light brown person and be "+", (4) not tinter are "-".10 of every group of rats, 100 neuron karyons altogether count.Experimental result is seen
Table 3:
The table 3 fos protein immunization result of tissue reaction relatively
| Group | Number of animals only | Counting cells is individual | The painted situation of cell +++ | The painted situation of cell ++ | The painted situation of cell+ | The painted situation of cell- | Sum of ranks |
| The commercially available SHENMAI ZHUSHEYE of matched group ischemia group ginseng-ophiopogon root freeze-dried powder injection of the present invention | ??10 ??10 ??10 ? ? ??10 | ??100 ??100 ??100 ? ? ??100 | ??7 ??24 ??13 ? ? ??10 | ??14 ??34 ??25 ? ? ??18 | ??36 ??26 ??33 ? ? ??34 | ??43 ??16 ??29 ? ? ??38 | ??11839 **??18412 ??14899 *? ? ??12147 ** |
Embodiment 2
To the Acute Myocardial Ischemia in Rats protective effect
Laboratory animal: animal wister rat, male, body weight (300 ± 20) g.
The experiment medicine: the commercially available SHENMAI ZHUSHEYE of ginseng-ophiopogon root freeze-dried powder injection of the present invention (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides) (for Zhengda Qingchunbao Pharmaceutical Co., Ltd produces),
Experimental technique: the ramus descendens anterior arteriae coronariae sinistrae of ligation rat causes the acute myocardial ischemia model.Each group is carried out tail intravenously administrable (2g crude drug/kg administration), and 20% urethane (1g/kg, ip) anesthesia separates common carotid artery, and parallel trachea is inserted art, connects animal respirator.Left side the 4th intercostal is opened breast, cuts off pericardium, separates ramus descendens anterior arteriae coronariae sinistrae, and the ligation position is done in flat right auricle.The taking-up heart is weighed,-10 ℃ of freezing 30～50min, under the heart ligature, parallel coronary sulcus becomes 5 with the ventricle crosscut, behind the normal saline flushing, the concentration that places the preparation of pH value 8.0 phosphate buffers is 1% triphenyltetrazolium chloride (TTC) solution, 10min dyes in 38 ℃ of waters bath with thermostatic control, normal myocardium is coloured to kermesinus, infarcted myocardium is dyed lark, cuts off the part that myocardium sheet is colored, and the ischemic infarction district cardiac muscle that is not colored is weighed, (the ischemic infarction area accounts for heavy whole-heartedly percentage ratio, the results are shown in Table 4 to calculate the ischemia scope.
Table 4 group preparation is to the Acute Myocardial Ischemia in Rats protective effect
| Group | Heart heavy (g) | Heart infarction heavy (g) | Heart infarction percentage rate (%) |
| Normal saline SHENMAI ZHUSHEYE injectable powder of the present invention | ?0.938 ?0.909 ?0.961 | ?0.192 ?0.113 ?0.053 | ??20.40 ??12.40 **??5.50 **[ *] |
Compare with the normal saline group
*P＜0.01, compare with positive controls [
*] P＜0.05
Conclusion: show that by above-mentioned pharmacological evaluation ginseng-ophiopogon root freeze-dried powder injection of the present invention has better pharmacological action.
Four. preparation embodiment
Embodiment 1
(1) crude drug composition proportioning weight portion of the present invention is:
Radix Ginseng 800 grams, restrain Radix Ophiopogonis 800;
(2) get Radix Ginseng Rubra, add alcohol dipping Radix Ophiopogonis after, put in the continuous extractor continuous backflow and extract each 1 hour 5 times, filter, medicinal residues wash with 1 times of crude drug amount ethanol gradation, merge above-mentioned filtrate and extracting solution, and cold preservation was left standstill 10 hours, filter, drying obtains Radix Ginseng, Radix Ophiopogonis ethanol extract;
(3) preparation prescription of the present invention is:
Radix Ginseng, Radix Ophiopogonis, ethanol extract was 160 grams, and pharmaceutic adjuvant mannitol is 140 grams;
(4) get Radix Ginseng, Radix Ophiopogonis ethanol extract, add the dissolving of injection water fully, filter, in filtrate, add 1% active carbon, stirred 1 hour, and filtered, decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is refining, add the injection water, filter, in filtrate, add pharmaceutic adjuvant, regulate pH value to 6.0 with sodium hydroxide, cold preservation filtered more than 48 hours, filtrate adds the injection water, filters sterilization, aseptic subpackaged every bottle of 2ml, lyophilization promptly gets 1000 bottles.[the lyophilized injectable powder ginsenoside is (with ginsenoside Rg, Rb
1, Re meter)] the 20mg/ bottle, control ophiopogonin (in ophiopogonin B) 8mg/ bottle]
Embodiment 2
(1) crude drug composition proportioning weight portion of the present invention is:
Radix Ginseng 1200 grams, restrain Radix Ophiopogonis 1200;
(2) get Radix Ginseng Rubra, add alcohol dipping Radix Ophiopogonis after, put in the continuous extractor continuous backflow and extract each 3 hours 8 times, filter, medicinal residues wash with 1 times of crude drug amount ethanol gradation, merge above-mentioned filtrate and extracting solution, and cold preservation was left standstill 15 hours, filter, drying obtains Radix Ginseng, Radix Ophiopogonis ethanol extract;
(3) preparation prescription of the present invention is:
Radix Ginseng, Radix Ophiopogonis, ethanol extract was 240 grams, and pharmaceutic adjuvant mannitol is 60 grams;
(4) get Radix Ginseng, Radix Ophiopogonis ethanol extract, add the dissolving of injection water fully, filter, in filtrate, add 1% active carbon, stirred 1 hour, and filtered, decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is refining, add the injection water, filter, in filtrate, add pharmaceutic adjuvant, regulate pH value to 8.0 with sodium hydroxide, cold preservation filtered more than 48 hours, filtrate adds the injection water, filters sterilization, aseptic subpackaged every bottle of 2ml, lyophilization promptly gets 1000 bottles.[the lyophilized injectable powder ginsenoside is (with ginsenoside Rg, Rb
1, Re meter)] the 43.2mg/ bottle, control ophiopogonin (in ophiopogonin B) 11.9mg/ bottle]
Embodiment 3
(1) crude drug composition proportioning weight portion of the present invention is:
Radix Ginseng 1000 grams, restrain Radix Ophiopogonis 1000;
(2) get Radix Ginseng Rubra, add alcohol dipping Radix Ophiopogonis after, put in the continuous extractor continuous backflow and extract each 2 hours 6 times, filter, medicinal residues wash with 1 times of crude drug amount ethanol gradation, merge above-mentioned filtrate and extracting solution, and cold preservation was left standstill 12 hours, filter, drying obtains Radix Ginseng, Radix Ophiopogonis ethanol extract;
(3) preparation prescription of the present invention is:
Radix Ginseng, Radix Ophiopogonis, ethanol extract was 200 grams, and pharmaceutic adjuvant mannitol is 100 grams;
(4) get Radix Ginseng, Radix Ophiopogonis ethanol extract, add the dissolving of injection water fully, filter, in filtrate, add 1% active carbon, stirred 1 hour, and filtered, decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is refining, add the injection water, filter, in filtrate, add pharmaceutic adjuvant, regulate pH value to 7.0 with sodium hydroxide, cold preservation filtered more than 48 hours, filtrate adds the injection water, filters sterilization, aseptic subpackaged every bottle of 2ml, lyophilization, promptly.[the lyophilized injectable powder ginsenoside is (with ginsenoside Rg, Rb
1, Re meter)] the 38.3mg/ bottle, control ophiopogonin (in ophiopogonin B) 9.8mg/ bottle]
Embodiment 4
(1) crude drug composition proportioning weight portion of the present invention is:
Radix Ginseng 850 grams, restrain Radix Ophiopogonis 850;
(2) get Radix Ginseng Rubra, add alcohol dipping Radix Ophiopogonis after, put in the continuous extractor continuous backflow and extract each 1.5 hours 6 times, filter, medicinal residues wash with 1 times of crude drug amount ethanol gradation, merge above-mentioned filtrate and extracting solution, and cold preservation was left standstill 11 hours, filter, drying obtains Radix Ginseng, Radix Ophiopogonis ethanol extract;
(3) preparation prescription of the present invention is:
Radix Ginseng, Radix Ophiopogonis, ethanol extract was 170 grams, and pharmaceutic adjuvant mannitol is 130 grams;
(4) get Radix Ginseng, Radix Ophiopogonis ethanol extract, add the dissolving of injection water fully, filter, in filtrate, add 1% active carbon, stirred 1 hour, and filtered, decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is refining, add the injection water, filter, in filtrate, add pharmaceutic adjuvant, regulate pH value to 6.5 with sodium hydroxide, cold preservation filtered more than 48 hours, filtrate adds the injection water, filters sterilization, aseptic subpackaged every bottle of 2ml, lyophilization promptly gets 1000 bottles.[the lyophilized injectable powder ginsenoside is (with ginsenoside Rg, Rb
1, Re meter)] the 32.3mg/ bottle, control ophiopogonin (in ophiopogonin B) 8.4mg/ bottle]
Embodiment 5
(1) crude drug composition proportioning weight portion of the present invention is:
Radix Ginseng 1100 grams, restrain Radix Ophiopogonis 1100;
(2) get Radix Ginseng Rubra, add alcohol dipping Radix Ophiopogonis after, put in the continuous extractor continuous backflow and extract each 2.5 hours 7 times, filter, medicinal residues wash with 1 times of crude drug amount ethanol gradation, merge above-mentioned filtrate and extracting solution, and cold preservation was left standstill 14 hours, filter, drying obtains Radix Ginseng, Radix Ophiopogonis ethanol extract;
(3) preparation prescription of the present invention is:
Radix Ginseng, Radix Ophiopogonis, ethanol extract was 220 grams, and pharmaceutic adjuvant mannitol is 80 grams;
(4) get Radix Ginseng, Radix Ophiopogonis ethanol extract, add the dissolving of injection water fully, filter, in filtrate, add 1% active carbon, stirred 1 hour, and filtered, decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is refining, add the injection water, filter, in filtrate, add pharmaceutic adjuvant, regulate pH value to 7.5 with sodium hydroxide, cold preservation filtered more than 48 hours, filtrate adds the injection water, filters sterilization, aseptic subpackaged every bottle of 2ml, lyophilization promptly gets 1000 bottles.[the lyophilized injectable powder ginsenoside is (with ginsenoside Rg, Rb
1, Re meter)] the 41.8mg/ bottle, control ophiopogonin (in ophiopogonin B) 10.9mg/ bottle]
Embodiment 6
(1) crude drug composition proportioning weight portion of the present invention is:
Radix Ginseng 850 grams, restrain Radix Ophiopogonis 1100;
(2) get Radix Ginseng Rubra, add alcohol dipping Radix Ophiopogonis after, put in the continuous extractor continuous backflow and extract each 2 hours 6 times, filter, medicinal residues wash with 1 times of crude drug amount ethanol gradation, merge above-mentioned filtrate and extracting solution, and cold preservation was left standstill 13 hours, filter, drying obtains Radix Ginseng, Radix Ophiopogonis ethanol extract;
(3) preparation prescription of the present invention is:
Radix Ginseng, Radix Ophiopogonis, ethanol extract was 180 grams, and pharmaceutic adjuvant mannitol is 120 grams;
(4) get Radix Ginseng, Radix Ophiopogonis ethanol extract, add the dissolving of injection water fully, filter, in filtrate, add 1% active carbon, stirred 1 hour, and filtered, decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is refining, add the injection water, filter, in filtrate, add pharmaceutic adjuvant, regulate pH value to 7.0 with sodium hydroxide, cold preservation filtered more than 48 hours, filtrate adds the injection water, filters sterilization, aseptic subpackaged every bottle of 2ml, lyophilization promptly gets 1000 bottles.[the lyophilized injectable powder ginsenoside is (with ginsenoside Rg, Rb
1, Re meter)] the 32.3mg/ bottle, control ophiopogonin (in ophiopogonin B) 10.7mg/ bottle]
Embodiment 7
(1) crude drug composition proportioning weight portion of the present invention is:
Radix Ginseng 1150 grams, restrain Radix Ophiopogonis 850;
(2) get Radix Ginseng Rubra, add alcohol dipping Radix Ophiopogonis after, put in the continuous extractor continuous backflow and extract each 1 hour 5 times, filter, medicinal residues wash with 1 times of crude drug amount ethanol gradation, merge above-mentioned filtrate and extracting solution, and cold preservation was left standstill 10 hours, filter, drying obtains Radix Ginseng, Radix Ophiopogonis ethanol extract;
(3) preparation prescription of the present invention is:
Radix Ginseng, Radix Ophiopogonis, ethanol extract was 193 grams, and pharmaceutic adjuvant mannitol is 107 grams;
(4) get Radix Ginseng, Radix Ophiopogonis ethanol extract, add the dissolving of injection water fully, filter, in filtrate, add 1% active carbon, stirred 1 hour, and filtered, decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is refining, add the injection water, filter, in filtrate, add pharmaceutic adjuvant, regulate pH value to 7.0 with sodium hydroxide, cold preservation filtered more than 48 hours, filtrate adds the injection water, filters sterilization, aseptic subpackaged every bottle of 2ml, lyophilization promptly gets 1000 bottles.[the lyophilized injectable powder ginsenoside is (with ginsenoside Rg, Rb
1, Re meter)] the 43.7mg/ bottle, control ophiopogonin (in ophiopogonin B) 8.3mg/ bottle]
Embodiment 8
(1) crude drug composition proportioning weight portion of the present invention is:
Radix Ginseng 1000 grams, restrain Radix Ophiopogonis 1000;
(2) get Radix Ginseng Rubra, add alcohol dipping Radix Ophiopogonis after, put in the continuous extractor continuous backflow and extract each 1 hour 5 times, filter, medicinal residues wash with 1 times of crude drug amount ethanol gradation, merge above-mentioned filtrate and extracting solution, and cold preservation was left standstill 10 hours, filter, drying obtains Radix Ginseng, Radix Ophiopogonis ethanol extract;
(3) preparation prescription of the present invention is:
Radix Ginseng, Radix Ophiopogonis, ethanol extract was 197 grams, and pharmaceutic adjuvant mannitol is 103 grams;
(4) get Radix Ginseng, Radix Ophiopogonis ethanol extract, add the dissolving of injection water fully, filter, in filtrate, add 1% active carbon, stirred 1 hour, and filtered, decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is refining, add the injection water, filter, in filtrate, add pharmaceutic adjuvant, regulate pH value to 7.0 with sodium hydroxide, cold preservation filtered more than 48 hours, filtrate adds the injection water, filters sterilization, aseptic subpackaged every bottle of 2ml, lyophilization promptly gets 1000 bottles.[the lyophilized injectable powder ginsenoside is (with ginsenoside Rg, Rb
1, Re meter)] the 39.4mg/ bottle, control ophiopogonin (in ophiopogonin B) 10.2mg/ bottle]
Embodiment 9
(1) crude drug composition proportioning weight portion of the present invention is:
Radix Ginseng 1000 grams, restrain Radix Ophiopogonis 1000;
(2) get Radix Ginseng Rubra, add alcohol dipping Radix Ophiopogonis after, put in the continuous extractor continuous backflow and extract each 3 hours 8 times, filter, medicinal residues wash with 1 times of crude drug amount ethanol gradation, merge above-mentioned filtrate and extracting solution, and cold preservation was left standstill 15 hours, filter, drying obtains Radix Ginseng, Radix Ophiopogonis ethanol extract;
(3) preparation prescription of the present invention is:
Radix Ginseng, Radix Ophiopogonis, ethanol extract was 212 grams, and pharmaceutic adjuvant mannitol is 88 grams;
(4) get Radix Ginseng, Radix Ophiopogonis ethanol extract, add the dissolving of injection water fully, filter, in filtrate, add 1% active carbon, stirred 1 hour, and filtered, decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is refining, add the injection water, filter, in filtrate, add pharmaceutic adjuvant, regulate pH value to 7.0 with sodium hydroxide, cold preservation filtered more than 48 hours, filtrate adds the injection water, filters sterilization, aseptic subpackaged every bottle of 2ml, lyophilization promptly gets 1000 bottles.[the lyophilized injectable powder ginsenoside is (with ginsenoside Rg, Rb
1, Re meter)] the 39.7mg/ bottle, control ophiopogonin (in ophiopogonin B) 9.9mg/ bottle]
Embodiment 10
(1) crude drug composition proportioning weight portion of the present invention is:
Radix Ginseng 10000 grams, restrain Radix Ophiopogonis 10000;
(2) get Radix Ginseng Rubra, add alcohol dipping Radix Ophiopogonis after, put in the continuous extractor continuous backflow and extract each 2 hours 6 times, filter, medicinal residues wash with 1 times of crude drug amount ethanol gradation, merge above-mentioned filtrate and extracting solution, and cold preservation was left standstill 12 hours, filter, drying obtains Radix Ginseng, Radix Ophiopogonis ethanol extract;
(3) preparation prescription of the present invention is:
Radix Ginseng, Radix Ophiopogonis, ethanol extract was 2014 grams, and pharmaceutic adjuvant is mannitol 986 grams;
(4) get Radix Ginseng, Radix Ophiopogonis ethanol extract, add the dissolving of injection water fully, filter, in filtrate, add 1% active carbon, stirred 1 hour, and filtered, decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is refining, add the injection water, filter, in filtrate, add pharmaceutic adjuvant, regulate pH value to 7.0 with sodium hydroxide, cold preservation filtered more than 48 hours, filtrate adds the injection water, filters sterilization, aseptic subpackaged every bottle of 2ml, lyophilization promptly gets 10000 bottles.[the lyophilized injectable powder ginsenoside is (with ginsenoside Rg, Rb
1, Re meter)] the 40.2mg/ bottle, control ophiopogonin (in ophiopogonin B) 10.4mg/ bottle]
Claims (2)
1. ginseng-ophiopogon root freeze-dried powder injection is characterized in that it is that pharmaceutic adjuvant mannitol is formed for the 60-140 weight portion by Radix Ginseng, Radix Ophiopogonis ethanol extract 160-240 weight portion; Its feature also is to control this lyophilized injectable powder ginsenoside (with ginsenoside Rg, Rb
1, Re meter) be not less than the 20mg/ bottle, control ophiopogonin (in ophiopogonin B) is not less than the 8mg/ bottle.
2. according to the preparation method of the described a kind of ginseng-ophiopogon root freeze-dried powder injection of claim 1, its feature may further comprise the steps:
(1) crude drug composition proportioning weight portion of the present invention is:
Radix Ginseng 0.8-1.2, Radix Ophiopogonis 0.8-1.2;
(2) get Radix Ginseng Rubra, add alcohol dipping Radix Ophiopogonis after, put in the continuous extractor continuous backflow and extract 5-8 time, 1-3 hour at every turn, filter, medicinal residues wash with 1 times of crude drug amount ethanol gradation, merge above-mentioned filtrate and extracting solution, and cold preservation was left standstill 10-15 hour, filter, drying obtains Radix Ginseng, Radix Ophiopogonis ethanol extract;
(3) get Radix Ginseng, Radix Ophiopogonis ethanol extract, add the dissolving of injection water fully, filter, in filtrate, add 1% active carbon, stirred 1 hour, and filtered, decompression filtrate recycling ethanol is to there not being the alcohol flavor, and is refining, add the injection water, filter, in filtrate, add pharmaceutic adjuvant, regulate pH value to 6.0-8.0 with sodium hydroxide, cold preservation filtered more than 48 hours, filtrate adds the injection water, filters sterilization, aseptic subpackaged every bottle of 2ml, lyophilization, promptly.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510051520 CN1682926A (en) | 2005-03-04 | 2005-03-04 | Ginseng-ophiopogon root freeze-dried powder injection and its preparing method |
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| CN 200510051520 CN1682926A (en) | 2005-03-04 | 2005-03-04 | Ginseng-ophiopogon root freeze-dried powder injection and its preparing method |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103877112A (en) * | 2014-04-06 | 2014-06-25 | 吴静 | Pharmaceutical composition containing ginsenoside Rh2 and ophiopogonin B |
| CN103989925A (en) * | 2014-05-28 | 2014-08-20 | 王庚禹 | Extract for preparing pulse-activating preparation |
| CN105267619A (en) * | 2014-06-07 | 2016-01-27 | 兰州大学 | Antitumor traditional Chinese medicine compound extract for inhibiting ras proto-oncogene over-expression |
-
2005
- 2005-03-04 CN CN 200510051520 patent/CN1682926A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103877112A (en) * | 2014-04-06 | 2014-06-25 | 吴静 | Pharmaceutical composition containing ginsenoside Rh2 and ophiopogonin B |
| CN103877112B (en) * | 2014-04-06 | 2016-03-16 | 吴静 | A kind of pharmaceutical composition containing ginsenoside Rh2, ophiopogonin B |
| CN103989925A (en) * | 2014-05-28 | 2014-08-20 | 王庚禹 | Extract for preparing pulse-activating preparation |
| CN105267619A (en) * | 2014-06-07 | 2016-01-27 | 兰州大学 | Antitumor traditional Chinese medicine compound extract for inhibiting ras proto-oncogene over-expression |
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