CN1223364C - Liquid preparation of gingko leaves and its preparing method - Google Patents
Liquid preparation of gingko leaves and its preparing method Download PDFInfo
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- CN1223364C CN1223364C CN 03103622 CN03103622A CN1223364C CN 1223364 C CN1223364 C CN 1223364C CN 03103622 CN03103622 CN 03103622 CN 03103622 A CN03103622 A CN 03103622A CN 1223364 C CN1223364 C CN 1223364C
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Abstract
The present invention relates to a liquid preparation of ginkgo leaf and sodium chloride and a preparing method thereof. The liquid preparation has the raw materials of ginkgo leaf, sodium chloride, propanediol, L-cysteine, sodium metabisulfite and disodium ethylene diamine tetraacetate. The preparing method comprises: adding alcohol to the ginkgo leaf, heating for reflux extraction, reducing pressure, recovering the alcohol and adding a flocculating agent for precipitation to remove impurities; regulating the ph value of the supernatant with an alkaline or acidic solution, processing the solution with a mixed resin column of macroporous resin and polyamide, washing the column with water at first, eluting the column with alcohol, and collecting the portion eluted by alcohol; carrying out fine filtration twice, adding the propanediol, the L-cysteine and the disodium ethylene diamine tetraacetate to the filtrate, regulating the ph value of the filtrate, diluting the filtrate with water and adding active carbon to obtain a concentrated solution on standby; adding water for injection into the sodium chloride to obtain a concentrated solution of the sodium chloride on standby; adding the concentrated solution of the sodium chloride into the concentrated solution of the ginkgo leaf, regulating the ph value of the concentrated solution, and metering the volume of the concentrated solution with water. The clarity of the preparation is improved, and the use of the L-cysteine can stabilize the preparation.
Description
(1) technical field
The present invention relates to the Folium Ginkgo is intravenous transfusion preparation of primary raw material and preparation method thereof, especially a kind of Folium Ginkgo sodium chloride (NaCl) injection and preparation method thereof.
(2) background technology
China's gingko resource is abundant, accounts for 70% of world's total amount, nearly 600 years of the medicinal history of Semen Ginkgo.Main component in the Folium Ginkgo is flavonoid and terpenes lactone compound, have the expansion coronary vasodilator, improve cerebral circulation, eliminate oxygen-derived free radicals, suppress effect such as platelet activating factor, be used for the treatment of diseases such as coronary heart disease, cerebral thrombosis, cerebral ischemia, clinical efficacy is definite.Along with the change of people's dietary habit, the number of suffering from diseases such as cerebral thrombosis, coronary heart disease increases, and directly threatens the people's orthobiosis.The preparation of Folium Ginkgo such as tablet, oral liquid etc. are in wide clinical application, the shortcoming that oral formulations exists such as ampoule is little, absorption is unhappy, bioavailability is not high, influences treatment of diseases, and little pin then treatment cycle is long, makes troubles to the patient.The CN1048724 patent disclosure a kind of method of from Folium Ginkgo, extracting total flavones.This method comprises: will clean, chopping, air dried Folium Ginkgo low amounts of water soaked overnight, alkaline water in order to saturated limewater, small amount of antioxidant preparation carries out three extractions then, filter and merge three filtrates, vacuum concentration, cooling, under agitation add a certain amount of absorptive clarificant, the insulation regular hour, centrifugal filtration adds a certain amount of ethanol in filtrate, stir, add a certain amount of 5% Na again
2CO
3Making pH is 9-10, staticly settle, centrifugal filtration, adding 10% hydrochloric acid in supernatant, to pull back to pH be about 6, with D101 macroporous resin column, ethanol elution to there being the flavone reaction, after eluent reclaims ethanol, vacuum concentration at vacuum drying below 60 ℃, obtains certain density yellow extract to syrupy shape.
(3) summary of the invention
The object of the present invention is to provide and a kind ofly be used for heavy dose of that use, good stability, can replenish Folium Ginkgo intravenous transfusion preparation of body body fluid and energy and preparation method thereof.
The said Folium Ginkgo infusion preparation of the present invention is the Folium Ginkgo sodium chloride injection, its primary raw material is a Folium Ginkgo, contain Folium Ginkgo 5～15g in every 100ml transfusion, sodium chloride 0.9g, propylene glycol 0.2～0.5ml, L-cysteine 25～45mg, sodium pyrosulfite 30～50mg, disodiumedetate (EDTA-2Na) 15～30mg.
The preparation method of the said Folium Ginkgo infusion preparation of the present invention is:
1. be that heating and refluxing extraction 3～6h extracts 2 times altogether at least in 40%～70% the alcoholic solution with adding concentration after the Folium Ginkgo fragmentation.Merge extractive liquid,, decompression recycling ethanol, add the flocculating agent precipitation again and remove impurity, in supernatant, regulate pH to 8.5～9.0 with alkaline solution, elimination post precipitation filtrate is regulated pH to 6～7 backs with acid solution and is gone up the hybrid resin of macroporous adsorbent resin and polyamide, and the ratio of macroporous adsorbent resin and polyamide is 1: (0.3～3).With 4～5 times washing post, behind the ethanol elution with low concentration (15%～25%), use the ethanol elution of high concentration (65%～80%) earlier.Collect high concentration ethanol eluting part.
2. with rare NaOH and HCl hybrid resin is handled respectively, extremely neutral with the water flushing again.Concentrating under reduced pressure high concentration ethanol part is not to there being the alcohol flavor, and fine straining at least twice adds propylene glycol and L-cysteine in the filtrate again, add EDTA-2Na again, regulate between pH to 4.5～6.5, behind the dilute with water, add 0.08%～0.12% active carbon, 60～80 ℃ are incubated 20min at least, filtering decarbonization.It is standby to be prepared into concentrated solution.
3. get in the water for injection that sodium chloride adds to 60～80 ℃, add 0.08%～0.12% active carbon, be incubated 20min at least, filter, for the sodium chloride concentrated solution, standby.
4. the Folium Ginkgo concentrated solution is joined in the sodium chloride concentrated solution, regulating pH is 4.5～6.5, reuse water standardize solution, fine straining, fill after the passed examination, again blooming, jump a queue, roll lid, sterilize promptly.
The present invention has adopted hybrid resin that the Folium Ginkgo ethanol extract is adsorbed, and resin is in order to reduce the pollution of extracting solution to resin, to prolong the life-span of resin, extracting solution being carried out the pretreatment purification.Earlier come sedimentation protein with flocculating agent (synthetic high molecular polymer), an amount of flocculating agent consumption has reduced the loss of flavone.Regulate pH value 8.5～9.0 with diluted alkaline (as NaOH) in the supernatant of post precipitation, purpose is that sedimentation has certain toxic proanthocyanidin to human body, suitably controls its content.In preparation process, also add kieselguhr, at this moment further remove impurity, solution is played good Stabilization.
The quality of used resin regeneration directly influences its absorbability, and the present invention selects for use NaOH solution and HCl solution respectively hybrid resin to be carried out acid-alkali treatment for this reason, and is extremely neutral with the water flushing at last.The preparation of transfusion is adopted NaCl and ginkgo biloba succi is made into earlier concentrated solution respectively, the method for remix dilution.Used propylene glycol in the preparation, it can improve the clarity of preparation well; The use of L-cysteine then can be played the effect that makes preparation stabilization.
(4) specific embodiment
Embodiment 1:
The Folium Ginkgo infusion preparation is a raw material with following formulation by weight:
Folium Ginkgo 10kg
Sodium chloride 0.9kg
Propylene glycol 300ml
L-cysteine 30g
Sodium pyrosulfite 35g
EDTA-2Na 15g
Water for injection adds to 100L.
The method for preparing the transfusion of Folium Ginkgo sodium chloride is as follows:
The 10kg ginkgo leaf powder is broken into little bulk, adds in 45% the alcoholic solution of 7 times of volumes heating extraction 4h, leach extracting solution, 45% the alcohol heating reflux that medicinal residues add 7 times of volumes again extracts 4h, merges twice extracting solution, and decompression recycling ethanol is to small size.Add the 500ml flocculating agent and stir, produce precipitation in a large number.Centrifugal filtration, filtrate are clear liquid.Regulate the pH to 8.5 of clear liquor with the NaOH solution of 0.5ml/L, produce flocculent deposit, centrifugal filtration, filtrate is regulated pH to 6 with 0.5ml/L HCl solution.Resin bed is made up of 1: 1 AB-8 macroporous adsorbent resin and polyamide, and pH adsorbs 1h after 6 filtrate is gone up sample, and towards post, 15% ethanol liquid of 3 times of volumes of reuse is removed pigment, 65% alcohol desorption, collection eluent with the deionized water of 4 times of bed volumes.Being evaporated to does not have the alcohol flavor substantially, adds an amount of kieselguhr fine straining twice.With the 0.4mol/LNaOH process resin bed of 10 times of volumes, the HCl that carries out the transition to 0.4mol/L again handles earlier, at last with a large amount of deionized water rinsings, is neutral until effluent.
Accurately take by weighing the EDTA-2Na of recipe quantity, add in the suitable quantity of water, make its whole dissolvings, join in the filtrate behind the fine straining, fully stir, add the propylene glycol of recipe quantity, the L-cysteine that stirs and add recipe quantity is again regulated pH to 9.2, regulates pH5.0 with glacial acetic acid, the sodium pyrosulfite that adds recipe quantity, it is an amount of to add water, adds 0.1% active carbon, 70 ℃ of insulation 30min, filter, be stand-by concentrated solution; The sodium chloride of getting recipe quantity adds in 90L, 70 ℃ the water for injection and dissolves, and the Folium Ginkgo concentrated solution that will prepare constantly stirs down and joins in the sodium chloride concentrated solution, and mensuration pH is 5, adds water to scale.Fine straining, after the passed examination, lid is jumped a queue, rolled to fill, at blooming, and 115 ℃, sterilization 30min are promptly.
Embodiment 2:
The Folium Ginkgo infusion preparation is a raw material with following formulation by weight:
Folium Ginkgo 12kg
Sodium chloride 0.9kg
Propylene glycol 400ml
L-cysteine 40g
Sodium pyrosulfite 50g
EDTA-2Na 20g
Water for injection adds to 100L.
The method for preparing the transfusion of Folium Ginkgo sodium chloride is as follows:
The 12kg ginkgo leaf powder is broken into little bulk, adds in 50% the alcoholic solution of 8 times of volumes, heating extraction 6h leaches extracting solution, and 45% the alcohol heating reflux that medicinal residues add 8 times of volumes again extracts 4h, merges 3 times extracting solution, and decompression recycling ethanol is to small size.Add the 600ml flocculating agent and stir, produce precipitation in a large number.Centrifugal filtration, filtrate are clear liquid.Regulate the pH to 9 of clear liquor with the NaOH solution of 0.2ml/L, produce flocculent deposit, centrifugal filtration, filtrate is regulated pH to 7 with 0.2ml/L HCl solution.Resin bed is made up of 1: 3 D101 macroporous adsorbent resin and polyamide, pH adsorbs 0.5h after 7 filtrate is gone up sample, with the deionized water of 3 times of bed volumes towards post, 20% ethanol liquid of 4 times of volumes of reuse removal pigment, 70% alcohol desorption is collected eluent.Being evaporated to does not have the alcohol flavor substantially, adds an amount of kieselguhr fine straining 3 times.With the 0.6mol/L NaOH process resin bed of 10 times of volumes, the HCl that carries out the transition to 0.6mol/L again handles earlier, at last with a large amount of deionized water rinsings, is neutral until effluent.
Accurately take by weighing the EDTA-2Na of 20g, add in the entry, make its whole dissolvings, join in the filtrate behind the fine straining, fully stir, add the propylene glycol of 400mL, the L-cysteine that stirs and add 40g is again regulated pH to 9.35, regulates pH6.5 with glacial acetic acid, the sodium pyrosulfite that adds 50g, it is an amount of to add water, adds 0.1% active carbon, 80 ℃ of insulation 20min, filter, be stand-by concentrated solution; The sodium chloride of getting recipe quantity adds in 80L, 80 ℃ the water for injection and dissolves, and the Folium Ginkgo concentrated solution for preparing is joined in the sodium chloride concentrated solution, and measuring pH is 6.5, adds water to scale.Lid is jumped a queue, rolled to fine straining, at fill, blooming after the passed examination, and sterilization 35min are promptly down at 110 ℃.
Embodiment 3:
The proportioning raw materials of Folium Ginkgo infusion preparation sees Table 1, and water for injection adds to 100L.
Table 1
| Embodiment | Folium Ginkgo (Kg) | Sodium chloride (Kg) | Propylene glycol (mL) | L-cysteine (g) | Sodium pyrosulfite (g) | EDTA-2Na (g) |
| 3 | 5 | 0.2 | 25 | 30 | 25 | |
| 4 | 8 | 0.5 | 45 | 40 | 30 | |
| 5 | 15 | 0.3 | 35 | 45 | 20 |
The technical process of its preparation and embodiment 1,2 are similar.
Ginkgo leaf powder is broken into little bulk, adds in 40% the alcoholic solution of 7 times of volumes, heating extraction 3h leaches extracting solution, and 45% the alcohol heating reflux that medicinal residues add 7 times of volumes again extracts 4h, merges twice extracting solution, and decompression recycling ethanol is to small size.Add the 1000ml flocculating agent and stir, produce precipitation in a large number.Centrifugal filtration, filtrate are clear liquid.Regulate the pH to 8.8 of clear liquor with the NaOH solution of 0.5ml/L, produce flocculent deposit, centrifugal filtration, filtrate is regulated pH to 6.8 with 0.5ml/L HCl solution.Resin bed is made up of 1: 0.3 AB-8 macroporous adsorbent resin and polyamide, pH adsorbs 1h after 6 filtrate is gone up sample, with the deionized water of 4 times of bed volumes towards post, 25% ethanol liquid of 3 times of volumes of reuse removal pigment, 80% alcohol desorption is collected eluent.Being evaporated to does not have the alcohol flavor substantially, adds an amount of kieselguhr fine straining twice.With the 0.4mol/L NaOH process resin bed of 10 times of volumes, the HCl that carries out the transition to 0.4mol/L again handles earlier, at last with a large amount of deionized water rinsings, is neutral until effluent.
Accurately take by weighing the EDTA-2Na of recipe quantity, add in the suitable quantity of water, make its whole dissolvings, join in the filtrate behind the fine straining, fully stir, add the propylene glycol of recipe quantity, the L-cysteine that stirs and add recipe quantity is again regulated pH to 9.2, regulates pH5.0 with glacial acetic acid, the sodium pyrosulfite that adds recipe quantity, it is an amount of to add water, adds 0.1% active carbon, 70 ℃ of insulation 30min, filter, be stand-by concentrated solution; The sodium chloride of getting recipe quantity adds in 90L, 70 ℃ the water for injection and dissolves, and the Folium Ginkgo concentrated solution that will prepare constantly stirs down and joins in the sodium chloride concentrated solution, and mensuration pH is 5, adds water to scale.Fine straining, after the passed examination, lid is jumped a queue, rolled to fill, at blooming, and 120 ℃, sterilization 20min are promptly.
Embodiment 4:
The component prescription of Folium Ginkgo infusion preparation sees Table 1.
The method for preparing the transfusion of Folium Ginkgo sodium chloride is as follows:
Ginkgo leaf powder is broken into little bulk, adds in 70% the alcoholic solution of 8 times of volumes, heating extraction 5h leaches extracting solution, and 45% the alcohol heating reflux that medicinal residues add 8 times of volumes again extracts 4h, merges 5 times extracting solution, and decompression recycling ethanol is to small size.Add the 700ml flocculating agent and stir, produce precipitation in a large number.Centrifugal filtration, filtrate are clear liquid.Regulate the pH to 8.5 of clear liquor with the NaOH solution of 0.2ml/L, produce flocculent deposit, centrifugal filtration, filtrate is regulated pH to 6.5 with 0.2ml/L HCl solution.Resin bed is made up of 1: 1.5 D101 macroporous adsorbent resin and polyamide, pH adsorbs 0.5h after 7 filtrate is gone up sample, with the deionized water of 3 times of bed volumes towards post, 20% ethanol liquid of 4 times of volumes of reuse removal pigment, 70% alcohol desorption is collected eluent.Being evaporated to does not have the alcohol flavor substantially, adds an amount of kieselguhr fine straining 3 times.With the 0.6mol/LNaOH process resin bed of 10 times of volumes, the HCl that carries out the transition to 0.6mol/L again handles earlier, at last with a large amount of deionized water rinsings, is neutral until effluent.
Accurately take by weighing EDTA-2Na, add in the entry, make its whole dissolvings, join in the filtrate behind the fine straining, fully stir, add propylene glycol, stirring adds the L-cysteine again, regulates pH to 9.35, regulates pH6.5 with glacial acetic acid, add sodium pyrosulfite, it is an amount of to add water, adds 0.1% active carbon, 80 ℃ of insulation 20min, filter, be stand-by concentrated solution; The sodium chloride of getting recipe quantity adds in 80L, 80 ℃ the water for injection and dissolves, and the Folium Ginkgo concentrated solution for preparing is joined in the sodium chloride concentrated solution, and measuring pH is 6.5, adds water to scale.Lid is jumped a queue, rolled to fine straining, at fill, blooming after the passed examination, and sterilization 30min are promptly down at 115 ℃.
Embodiment 5:
The proportioning raw materials of Folium Ginkgo infusion preparation sees Table 1, and water for injection adds to 100L.
The method for preparing the transfusion of Folium Ginkgo sodium chloride is as follows:
Ginkgo leaf powder is broken into little bulk, adds in 70% the alcoholic solution of 8 times of volumes, heating extraction 4h leaches extracting solution, and 20% the alcohol heating reflux that medicinal residues add 8 times of volumes again extracts 4h, merges 3 times extracting solution, and decompression recycling ethanol is to small size.Add the 800ml flocculating agent and stir, produce precipitation in a large number.Centrifugal filtration, filtrate are clear liquid.Regulate the pH to 9 of clear liquor with the NaOH solution of 0.2ml/L, produce flocculent deposit, centrifugal filtration, filtrate is regulated pH to 7 with 0.2ml/LHCl solution.Resin bed is made up of 1: 2 D101 macroporous adsorbent resin and polyamide, pH adsorbs 0.5h after 7 filtrate is gone up sample, with the deionized water of 3 times of bed volumes towards post, 20% ethanol liquid of 4 times of volumes of reuse removal pigment, 70% alcohol desorption is collected eluent.Being evaporated to does not have the alcohol flavor substantially, adds an amount of kieselguhr fine straining 2 times.With the 0.6mol/L NaOH process resin bed of 10 times of volumes, the HCl that carries out the transition to 0.6mol/L again handles earlier, at last with a large amount of deionized water rinsings, is neutral until effluent.
Accurately take by weighing EDTA-2Na, add in the entry, make its whole dissolvings, join in the filtrate behind the fine straining, fully stir, add propylene glycol, stirring adds the L-cysteine again, regulates pH to 9.35, regulates pH6.5 with glacial acetic acid, add sodium pyrosulfite, it is an amount of to add water, adds 0.1% active carbon, 80 ℃ of insulation 20min, filter, be stand-by concentrated solution; The sodium chloride of getting recipe quantity adds in 80L, 80 ℃ the water for injection and dissolves, and the Folium Ginkgo concentrated solution for preparing is joined in the sodium chloride concentrated solution, and measuring pH is 6.5, adds water to scale.Lid is jumped a queue, rolled to fine straining, at fill, blooming after the passed examination, and sterilization 35min are promptly down at 116 ℃.
Claims (4)
1, a kind of Folium Ginkgo infusion preparation is characterized in that its raw material and content thereof are Folium Ginkgo 5～15g in every 100ml transfusion, sodium chloride 0.9g, propylene glycol 0.2～0.5ml, L-cysteine 25～45mg, sodium pyrosulfite 30～50mg, disodiumedetate 15～30mg.
2, the preparation method of Folium Ginkgo infusion preparation is characterized in that its raw material and content thereof are Folium Ginkgo 5～15g in every 100ml transfusion, sodium chloride 0.9g, propylene glycol 0.2～0.5ml, L-cysteine 25～45mg, sodium pyrosulfite 30～50mg, disodiumedetate 15～30mg; Its processing step is as follows:
1. be in 40%～70% the alcoholic solution with adding concentration after the Folium Ginkgo fragmentation, heating and refluxing extraction 3～6h, extract at least 2 times altogether, merge extractive liquid,, decompression recycling ethanol, add the flocculating agent precipitation again and remove impurity, in supernatant, regulate pH to 8.5～9.0 with alkaline solution, elimination post precipitation filtrate is regulated pH to 6～7 backs with acid solution and is gone up the hybrid resin of macroporous adsorbent resin and polyamide, the ratio of macroporous adsorbent resin and polyamide is 1: 0.3～3, earlier with 4～5 times washing post, with behind the ethanol elution of low concentration 15%～25%, with the ethanol elution of high concentration 65%～80%, collect high concentration ethanol eluting part;
2. with rare NaOH and HCl hybrid resin is handled respectively, extremely neutral with the water flushing again, concentrating under reduced pressure high concentration ethanol part is to not having pure flavor, fine straining at least twice again, add propylene glycol and L-cysteine in the filtrate, add disodiumedetate again, regulate between pH to 4.5～6.5, behind the dilute with water, add 0.08%～0.12% active carbon, 60～80 ℃ are incubated 20min at least, filtering decarbonization, and it is standby to be prepared into concentrated solution;
3. get in the water for injection that sodium chloride adds to 60～80 ℃, add 0.08%～0.12% active carbon, be incubated 20min at least, filter, for the sodium chloride concentrated solution, standby;
4. the Folium Ginkgo concentrated solution is joined in the sodium chloride concentrated solution, regulating pH is 4.5～6.5, reuse water standardize solution, fine straining, fill after the passed examination, again blooming, jump a queue, roll lid, sterilize promptly.
3, the preparation method of Folium Ginkgo infusion preparation as claimed in claim 2, the content that it is characterized in that said flocculating agent is 0.5%～1%.
4, the preparation method of Folium Ginkgo infusion preparation as claimed in claim 2, the ratio that it is characterized in that said macroporous adsorbent resin and polyamide is 1: 1.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102133244A (en) * | 2011-03-22 | 2011-07-27 | 江苏神龙药业有限公司 | Preparation method of low-acid and high-quality ginkgo leaf extractive |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105267267A (en) * | 2014-06-05 | 2016-01-27 | 樊伟 | Applications of L-cysteine composition in prevention, removal (or elimination) of carcinogenic factor acetaldehyde generated during smoking and drinking |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102133244A (en) * | 2011-03-22 | 2011-07-27 | 江苏神龙药业有限公司 | Preparation method of low-acid and high-quality ginkgo leaf extractive |
| CN102133244B (en) * | 2011-03-22 | 2013-03-27 | 江苏神龙药业有限公司 | Preparation method of low-acid and high-quality ginkgo leaf extractive |
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