CN1839906A - Wild chrysanthemum flower injection and its preparing method - Google Patents
Wild chrysanthemum flower injection and its preparing method Download PDFInfo
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- CN1839906A CN1839906A CN 200610002823 CN200610002823A CN1839906A CN 1839906 A CN1839906 A CN 1839906A CN 200610002823 CN200610002823 CN 200610002823 CN 200610002823 A CN200610002823 A CN 200610002823A CN 1839906 A CN1839906 A CN 1839906A
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- injection
- flos chrysanthemi
- wild chrysanthemum
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- chrysanthemi indici
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Abstract
The invention provides an injection and its preparing method, wherein the injection comprises wild chrysanthemum flower volatile oil extract, aqueous extract, auxiliary solvent and water for injection, or isotonic conditioning agent if needed.
Description
Technical field
The present invention relates to a kind of Flos Chrysanthemi indici injection that can use for muscle and vein.
Background technology
Flos Chrysanthemi Indici is the dry capitulum of feverfew Herba Dendranthematis indici, claims valida limaciopsis, the bitter heart of a lotus seed, mountain Flos Chrysanthemi etc. again, and the name beginning of Herba Dendranthematis indici sees " Japan hanako materia medica ", and " book on Chinese herbal medicine converges and says " claims that it can " removing blood stasis be soothing the liver, separates and treats the poison that looses.Stagnated blood in housewife people's abdomen, the capable fire-toxin of Xie Tian is red to be treated, and washes the skin ulcer scabies, can remove the wind parasite killing again ".The Pharmacopoeia of the People's Republic of China one one of version in 2005 is recorded.Flos Chrysanthemi Indici is the class sphere, and yellow green is to pale brown color, gas fragrance, bitter in the mouth.With yellow skin do not have stalk, complete, gas is fragrant, the standard-sized sheet person is not for good for flower, and the standard-sized sheet of using up is put, the lobe that looses, bennet, the moisture absorption, dark, the gas person that looses of color are arranged, matter time.Have the effect of heat-clearing and toxic substances removing, dispelling wind suppressing the hyperactive liver, medicinal history among the people is long in China, and modern pharmacology proves: Flos Chrysanthemi Indici has effects such as broad-spectrum antiseptic, antiviral, blood pressure lowering, coronary blood flow increasing, removing oxygen-derived free radicals.Contained chlorogenic acid, volatile oil and total flavonoid chemical compound is the main effective ingredient of its performance drug effect in the Flos Chrysanthemi Indici.The Flos Chrysanthemi Indici biological activity is various, delicate fragrance is pleasant, safe and reliable, simultaneously the medicine source is extensive, cheap, has exploitation and is worth in that medicine, food, health product and cosmetics etc. are multi-field.The Flos Chrysanthemi indici injection that has gone on the market (WS-11041 (ZD-1041)-2002), it is mainly used in intramuscular dose, has heat-clearing toxin-expelling functions, is used for fever caused by exogenous pathogenic factors, conjunctival congestion and swelling pain, has sore throat, upper respiratory tract infection, acute tonsillitis belongs to merit person on the pyretic toxicity.Currently used Flos Chrysanthemi indici injection is intramuscular injection liquid, and the scope of application is narrow, is to use scope wide and rapid-action etc. its advantage that changes the injection that vein and intramuscular injection use simultaneously into.
Summary of the invention
The objective of the invention is on the basis of original intramuscular dose, to improve, provide a kind of steady quality, convenient use can be for the Flos Chrysanthemi indici injection of vein or muscle use.
The present invention is achieved through the following technical solutions.
One, preparation method
(1) prescription of crude drug is: Flos Chrysanthemi Indici.
(2) get the Flos Chrysanthemi Indici medical material, soaked 2 hours, use steam distillation, collect the about 1000ml of distillate just, redistillation collection re-distilled liquid is about 500ml again, and is standby.The water liquid that extracts volatile oil is filtered, medicinal residues decoct with water secondary again, each 1 hour, filter, merging filtrate, being concentrated into relative density is the extractum of 1.20～1.24 (40～70 ℃), adding ethanol makes the alcohol amount of containing reach 65-70%, cold preservation was left standstill 18 hours, filtered, filtrate recycling ethanol is to there not being the alcohol flavor, thin up is to solution: medical material is 1: 1, and medicinal liquid is crossed the macroporous adsorptive resins of having handled well, behind the water elution with 5 times of amount column volumes, earlier with behind 5 times of amount column volume 30% ethanol elutions, 5 times of amounts of reuse column volume, 40%～50% ethanol water eluting, 5 times of amounts of last reuse column volume, 65%～80% ethanol water eluting merges ethanol elution, be evaporated to and do not have the alcohol flavor, thin up is to 500ml (containing crude drug 2g/ml), and cold preservation 18 hours is standby.Get Flos Chrysanthemi Indici extracting solution 500ml and re-distilled liquid 500ml mix homogeneously, filter, add Polyethylene Glycol 5g or Tween 80 5ml, 95% ethanol 5ml and sodium chloride 7g, reflux 30 minutes is put and is chilled to room temperature, regulates pH value to 7.4～7.6 with 20% sodium hydroxide solution.Add the injection water to 1000ml, filter, embedding, sterilization, promptly.
Two, assay analysis
1, content of total flavone is measured in the wild chrysanthemum preparation
1.1 instrument and reagent day island proper Tianjin UV-3000A ultraviolet spectrophotometer; Flos Chrysanthemi indici injection of the present invention (our company's laboratory provides); Control substance of Rutin (Nat'l Pharmaceutical ﹠ Biological Products Control Institute); Methanol, sodium nitrite, aluminum nitrate, sodium hydroxide reagent are analytical pure; Water is tri-distilled water (self-control).
1.2 the preparation precision of reference substance solution takes by weighing exsiccant control substance of Rutin 22mg, puts in the 100ml measuring bottle, it is an amount of to add 60% ethanol, and the dissolving back, shakes up, promptly to scale with 60% ethanol dilution.
1.3 accurate above-mentioned reference substance solution 0,1.00,2.00,3.00,4.00,5.00, the 6.00ml of drawing of standard curve preparation, put respectively in the 25ml measuring bottle, each adds 60% ethanol to 6.0ml, add each 1ml of 5% sodium nitrite solution again, mixing is placed 6min, adds 10% aluminum nitrate solution 1ml, shake up, place 6min, add 4%NaOH test solution 10ml, add water to scale, shake up, after placing 15min, measuring absorbance at 500nm wavelength place, is vertical coordinate with the absorbance, concentration is abscissa, the drawing standard curve.Regression equation is: Y=0.458X+0.0028, r=0.9993 has good linear relationship at the amount and the absorbance of 0.216～1.301 scope internal reference product.
1.4 this product content (Flos Chrysanthemi Indici water extract of the present invention) is got in the preparation of need testing solution, the accurate title, decide, and gets about 0.25g, put in the tool plug conical flask, the accurate 60% ethanol 100ml that adds claims to decide weight, supersound process 40min is put coldly, claims to decide weight again, supply the weight that subtracts mistake with 60% ethanol, shake up, centrifugal (12000rpm) 10min gets supernatant liquid filtering, get subsequent filtrate, promptly.
Get one of injection of the present invention (three batches), cold doing, the accurate title, decide, put in the tool plug conical flask, the accurate 60% ethanol 100ml that adds claims to decide weight, supersound process 40min is put coldly, claims to decide weight again, supply the weight that subtracts mistake with 60% ethanol, shake up, centrifugal (12000rpm) 10min gets supernatant liquid filtering, get subsequent filtrate, promptly.
1.5 the mensuration of total flavones precision is respectively measured need testing solution 5ml and is put in the 25ml volumetric flask, sighting target directrix curve method is measured, colour developing, measure A value at 500nm wavelength place, other precision is measured need testing solution 5ml and is put in the 25ml volumetric flask, and adding distil water is to scale, shake up, measure the A value at 500nm wavelength place, get the trap difference twice, by the regression equation calculation general flavone content.
1.6 the results are shown in Table
Total flavones in table 1 preparation (in anhydrous rutin) assay
| Batch | Flos Chrysanthemi Indici water extract of the present invention (content %) | Flos Chrysanthemi indici injection of the present invention (mg/ props up) |
| 1 2 3 | 57.0 55.3 58.7 | 45.7 46.1 45.3 |
2, the assay of chlorogenic acid in the wild chrysanthemum preparation
2.1 chromatographic condition
Chromatographic column: YMC-Pack ODS-A (250mm * 4.6mm, 5 μ m); Column temperature: room temperature; Mobile phase: methanol-0.2% acetic acid (60: 40); Flow velocity: 1.0ml/min; Detect wavelength: 326nm.
2.2 standard curve preparation
Precision takes by weighing chlorogenic acid reference substance 20mg, puts in the 25ml measuring bottle, adds methanol solution and is diluted to scale, shakes up, and gets reference substance stock solution 0.477mg/ml.Accurately draw this solution 0.5ml again and put in the 10ml measuring bottle, add methanol, shake up and promptly get the reference substance solution that concentration is 0.0239mg/ml to scale.Accurately draw this solution 2,4,6,8,10ul, injecting chromatograph, the regression equation of peak area and sample size: A=35106X-175.77.The result shows that the amount of chlorogenic acid and the score value of chromatographic peak area have good linear relationship between 0.0475～0.3815.
2.3 get three batch samples (Flos Chrysanthemi Indici water extract of the present invention), the accurate title, decide, and measures respectively by above-mentioned HPLC method, the results are shown in Table 2.
Get one of injection of the present invention (three batches), cold doing, the accurate title, decide, and measures respectively by above-mentioned HPLC method, the results are shown in Table 2.
Determination of chlorogenic acid in table 2 preparation
| Batch | Flos Chrysanthemi Indici water extract of the present invention (content %) | Flos Chrysanthemi indici injection of the present invention (mg/ props up) |
| 1 2 3 | 0.67 0.70 0.68 | 0.58 0.51 0.55 |
The specific embodiment
Embodiment 1:
Flos Chrysanthemi Indici 100g
NaCl 0.7g
Polyethylene Glycol (PEG400) 0.5g
Water for injection is to 100mL
According to above-mentioned recipe quantity, get the Flos Chrysanthemi Indici medical material, soaked 2 hours, use steam distillation, collect the about 100ml of distillate just, redistillation collection re-distilled liquid is about 50ml again, and is standby.The water liquid that extracts volatile oil is filtered, medicinal residues decoct with water secondary again, each 1 hour, filter, merging filtrate, being concentrated into relative density is the extractum of 1.20～1.24 (40～70 ℃), adding ethanol makes and contains alcohol amount and reach 65%, cold preservation was left standstill 18 hours, filtered, filtrate recycling ethanol is to there not being the alcohol flavor, thin up is to solution: medical material is 1: 1, and medicinal liquid is crossed the AB-8 macroporous adsorptive resins of having handled well, behind the water elution with 5 times of amount column volumes, earlier with behind 5 times of amount column volume 30% ethanol elutions, 5 times of amounts of reuse column volume, 45% ethanol water eluting, 5 times of amounts of last reuse column volume, 70% ethanol water eluting merges ethanol elution, be evaporated to and do not have the alcohol flavor, thin up is to 50ml (containing crude drug 2g/ml), and cold preservation 18 hours is standby.Get Flos Chrysanthemi Indici extracting solution 50ml and re-distilled liquid 50ml mix homogeneously, filter, add Polyethylene Glycol (PEG400) 0.5g, 95% ethanol 0.5ml and sodium chloride 0.7g, reflux 30 minutes is put and is chilled to room temperature, regulates pH value to 7.4～7.6 with 20% sodium hydroxide solution.Add the injection water to 100ml, filter, embedding, sterilization is distributed into 50.
Embodiment 2:
Flos Chrysanthemi Indici 1000g
NaCl 7g
Polyethylene Glycol (PEG1000) 5g
Water for injection is to 1000mL
According to above-mentioned recipe quantity, get the Flos Chrysanthemi Indici medical material, soaked 2 hours, use steam distillation, collect the about 1000ml of distillate just, redistillation collection re-distilled liquid is about 500ml again, and is standby.The water liquid that extracts volatile oil is filtered, medicinal residues decoct with water secondary again, each 1 hour, filter, merging filtrate, being concentrated into relative density is the extractum of 1.20～1.24 (40～70 ℃), adding ethanol makes and contains alcohol amount and reach 70%, cold preservation was left standstill 18 hours, filtered, filtrate recycling ethanol is to there not being the alcohol flavor, thin up is to solution: medical material is 1: 1, and medicinal liquid is crossed the AB-8 macroporous adsorptive resins of having handled well, behind the water elution with 5 times of amount column volumes, earlier with behind 5 times of amount column volume 30% ethanol elutions, 5 times of amounts of reuse column volume, 50% ethanol water eluting, 5 times of amounts of last reuse column volume, 80% ethanol water eluting merges ethanol elution, be evaporated to and do not have the alcohol flavor, thin up is to 500ml (containing crude drug 2g/ml), and cold preservation 18 hours is standby.Get Flos Chrysanthemi Indici extracting solution 500ml and re-distilled liquid 500ml mix homogeneously, filter, add Polyethylene Glycol (PEG1000) 5g, 95% ethanol 5ml and sodium chloride 7g, reflux 30 minutes is put and is chilled to room temperature, regulates pH value to 7.4～7.6 with 20% sodium hydroxide solution.Add the injection water to 1000ml, filter, embedding, sterilization is distributed into 500.
Embodiment 3:
Flos Chrysanthemi Indici 100g
NaCl 0.7g
Polyethylene Glycol (PEG4000) 0.5g
Water for injection is to 100mL
According to above-mentioned recipe quantity, get the Flos Chrysanthemi Indici medical material, soaked 2 hours, use steam distillation, collect the about 100ml of distillate just, redistillation collection re-distilled liquid is about 50ml again, and is standby.The water liquid that extracts volatile oil is filtered, medicinal residues decoct with water secondary again, each one hour, filter, merging filtrate, being concentrated into relative density is the extractum of 1.20～1.24 (40～70 ℃), adding ethanol makes and contains alcohol amount and reach 65%, cold preservation was left standstill 18 hours, filtered, filtrate recycling ethanol is to there not being the alcohol flavor, thin up is to solution: medical material is 1: 1, and medicinal liquid is crossed the AB-8 macroporous adsorptive resins of having handled well, behind the water elution with 5 times of amount column volumes, earlier with behind 5 times of amount column volume 30% ethanol elutions, 5 times of amounts of reuse column volume, 45% ethanol water eluting, 5 times of amounts of last reuse column volume, 70% ethanol water eluting merges ethanol elution, be evaporated to and do not have the alcohol flavor, thin up is to 50ml (containing crude drug 2g/ml), and cold preservation 18 hours is standby.Get Flos Chrysanthemi Indici extracting solution 50ml and re-distilled liquid 50ml mix homogeneously, filter, add Polyethylene Glycol (PEG4000) 0.5g, 95% ethanol 0.5ml and sodium chloride 0.7g, reflux 30 minutes is put and is chilled to room temperature, regulates pH value to 7.4～7.6 with 20% sodium hydroxide solution.Add the injection water to 100ml, filter, embedding, sterilization is distributed into 50.
Embodiment 4:
Flos Chrysanthemi Indici 100g
NaCl 0.7g
Tween 80 0.5ml
Water for injection is to 100mL
According to above-mentioned recipe quantity, get the Flos Chrysanthemi Indici medical material, soaked 2 hours, use steam distillation, collect the about 100ml of distillate just, redistillation collection re-distilled liquid is about 50ml again, and is standby.The water liquid that extracts volatile oil is filtered, medicinal residues decoct with water secondary again, each 1 hour, filter, merging filtrate, being concentrated into relative density is the extractum of 1.20～1.24 (40～70 ℃), adding ethanol makes and contains alcohol amount and reach 70%, cold preservation was left standstill 18 hours, filtered, filtrate recycling ethanol is to there not being the alcohol flavor, thin up is to solution: medical material is 1: 1, and medicinal liquid is crossed the AB-8 macroporous adsorptive resins of having handled well, behind the water elution with 5 times of amount column volumes, earlier with behind 5 times of amount column volume 30% ethanol elutions, 5 times of amounts of reuse column volume, 50% ethanol water eluting, 5 times of amounts of last reuse column volume, 75% ethanol water eluting merges ethanol elution, be evaporated to and do not have the alcohol flavor, thin up is to 50ml (containing crude drug 2g/ml), and cold preservation 18 hours is standby.Get Flos Chrysanthemi Indici extracting solution 50ml and re-distilled liquid 50ml mix homogeneously, filter, add Tween 80 0.5ml, 95% ethanol 0.5ml and sodium chloride 0.7g, reflux 30 minutes is put and is chilled to room temperature, regulates pH value to 7.4～7.6 with 20% sodium hydroxide solution.Add the injection water to 100ml, filter, embedding, sterilization is distributed into 50.
Claims (6)
1. Wild chrysanthemum flower injection and preparation method thereof is characterized in that, wherein contains Flos Chrysanthemi Indici volatile oil extract, water extract, cosolvent and water for injection, also can add isoosmotic adjusting agent as required.
2. Wild chrysanthemum flower injection according to claim 1 is characterized in that, this injection can be for human muscle and intravenous administration.
3. Wild chrysanthemum flower injection according to claim 1 is characterized in that chlorogenic acid is one of main component in the Flos Chrysanthemi Indici water extract, and content is more than or equal to 0.65%.
4. Wild chrysanthemum flower injection according to claim 1 is characterized in that total flavonoid is one of main component in the Flos Chrysanthemi Indici water extract, and content of total flavone is more than or equal to 55%.
5. Wild chrysanthemum flower injection according to claim 1 is characterized in that, the flux of intravenous fluid is Polyethylene Glycol PEG 400, Polyethylene Glycol PEG 1000, Polyethylene Glycol PEG4000, Tween 80 and poloxamer.
6. Wild chrysanthemum flower injection according to claim 1 is characterized in that, isoosmotic adjusting agent is sodium chloride or glucose.
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| CN 200610002823 CN1839906A (en) | 2006-02-06 | 2006-02-06 | Wild chrysanthemum flower injection and its preparing method |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102731309A (en) * | 2012-06-25 | 2012-10-17 | 浙江农林大学 | Method for extracting and separating chlorogenic acid from chrysanthemum indicum |
| CN104490973A (en) * | 2014-12-02 | 2015-04-08 | 江西钟山药业有限责任公司 | Method for preparing tradtional Chinese medicine wild chrysanthemum injection |
| CN105106270B (en) * | 2015-10-10 | 2018-11-30 | 江西天施康中药股份有限公司 | A kind of preparation method of Flos Chrysanthemi indici injection |
| CN109601559A (en) * | 2019-01-07 | 2019-04-12 | 贵州省烟草公司遵义市公司 | It is a kind of prevent and treat phytophthora mother chrysanthemum essential oil and its application |
-
2006
- 2006-02-06 CN CN 200610002823 patent/CN1839906A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102731309A (en) * | 2012-06-25 | 2012-10-17 | 浙江农林大学 | Method for extracting and separating chlorogenic acid from chrysanthemum indicum |
| CN102731309B (en) * | 2012-06-25 | 2016-12-21 | 浙江农林大学 | A kind of method extracting separating chlorogenic acid from Herba Dendranthematis indici |
| CN104490973A (en) * | 2014-12-02 | 2015-04-08 | 江西钟山药业有限责任公司 | Method for preparing tradtional Chinese medicine wild chrysanthemum injection |
| CN105106270B (en) * | 2015-10-10 | 2018-11-30 | 江西天施康中药股份有限公司 | A kind of preparation method of Flos Chrysanthemi indici injection |
| CN109601559A (en) * | 2019-01-07 | 2019-04-12 | 贵州省烟草公司遵义市公司 | It is a kind of prevent and treat phytophthora mother chrysanthemum essential oil and its application |
| CN109601559B (en) * | 2019-01-07 | 2021-01-15 | 贵州省烟草公司遵义市公司 | Wild chrysanthemum essential oil for preventing and treating phytophthora and application thereof |
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