CN104958403A - Yizhi osmotic pump preparation and preparing method thereof - Google Patents
Yizhi osmotic pump preparation and preparing method thereof Download PDFInfo
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- CN104958403A CN104958403A CN201510335237.XA CN201510335237A CN104958403A CN 104958403 A CN104958403 A CN 104958403A CN 201510335237 A CN201510335237 A CN 201510335237A CN 104958403 A CN104958403 A CN 104958403A
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Abstract
The invention discloses a Yizhi osmotic pump preparation and a preparing method thereof. The Yizhi osmotic pump preparation is prepared from jasmine extract and Sanchi extract with pharmaceutically effective aid. The preparing method includes: mixing well herbal materials and the aid; wetting mixture with 60% to 80% alcohol, performing granulating with a 10-mesh to 40-mesh screen, performing air-drying and size stabilizing, adding 0.2 to 0.4 %, by weight, of magnesium stearate, and performing mixing and tableting; performing coating, curing and laser punching. Compared with the prior art, the Yizhi osmotic pump preparation has the advantages that geniposide Cmax in the preparation is lowered, Tmax is prolonged, controlled release effect is good, bioequivalence of two preparations is judged by means of the typical confidence interval method, results show that ginsenoside Rb1 in them are bioequivalent.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine preparation, specifically, relate to a kind of Fructus Alpiniae Oxyphyllae osmotic pump preparation and preparation method thereof.
Background technology
Yizhi Decoction is the Empirical formula that the scorching academician of Wang Yong treats senile dementia, is made up of Fructus Gardeniae and Radix Notoginseng.Fructus Gardeniae bitter cold, rushes down the fire of three Jiao, clearing away heat and cooling blood, eliminating damp, detoxifying; The sweet temperature of Radix Notoginseng, removing stasis to stop bleeding, analgesic therapy of invigorating blood circulation.XINGNAOJING adopts unique theory of Chinese medical science heat clearing and blood circulation promoting rule for the treatment of, and for senile dementia prevention and early treatment etc., clinical efficacy is definite.Existing pharmacology also shows: XINGNAOJING at scavenging free radicals, reduce endogenous pyrogen in cerebrospinal fluid, suppress the cranial nerve cell apoptosis of ischemia-reperfusion induction, alleviate cerebral edema, improve cerebral circulation, protection brain cell, reduce apoplexy area, shorten the stupor time and have remarkable effect in bringing down a fever etc.; being used for the treatment of the total effective rates such as disturbance of consciousness that apoplexy, craniocerebral injury, central nervous system infection, drug intoxication etc. cause and high heat is 86.72%; the paralytic of unconscious obstacle applies this product in early days and significantly can alleviate nerve function lesion, has no toxicity.
Senile dementia belongs to chronic disease, and the course of disease is long, is suitable for oral administration.This disease take amnesia as typical characteristic, patient's many shortages self-care ability, need under the assistance of nursing staff drug administration, reduce take number of times, contribute to the burden alleviating nursing staff, effectively avoid medicine to miss problem, thus improve curative effect of medication.Have document to prove, by drug administration number of times by being kept to every day 2 times every day for 3 times, the rate of missing can significantly reduce, and the compliance of patient strengthens.XINGNAOJING, as the injection for the treatment of senile dementia, needs nursing staff's multiple dosing, there is the deficiencies such as medication trouble.Along with Chinese medicine preparation research deeply and people for the raising of formulation requirements, become sustained-release preparation to become development trend drug development.
Sustained-release preparation is one of direction of Chinese medicine preparation research in recent years, and the sustained release in TCM based on technological development such as film coating, framework sustained controlling, Entogastric lingering, bioadhesions has lot of documents report.But Chinese medicine preparation mostly is compound preparation, even if folk prescription is also often containing plurality of active ingredients, the physicochemical property of these compositions is different, can not ensure to discharge by proportioning in most sustained-release preparation.How to ensure that each effective ingredient is that sustained release in TCM meets Chinese medical theory by the release of prescription proportioning, embodying the key of TCM Features, is also the basis that sustained-release preparation ensures curative effect.The compound Chinese medicinal preparation heterogeneity that appears as of osmotic pumps technology discharges in proportion and provides solution.
Osmotic pumps technology is using osmotic pressure as release power and in conjunction with semipermeable membrane Drug controlled release, take zero-order release kinetics as a kind of sustained-release preparation technology of preparing of feature.Osmotic pump preparation is generally made up of medicine, osmotic pressure active substance, push agent etc., and uses semipermeable membrane coating, and coating membrane has drug release hole.After taking, body fluid enters in sheet by semipermeable membrane, and after medicine dissolution, the permeable pressure head inside and outside dependence tablet and the effect of push agent, discharged by the even constant speed of drug release hole.Osmotic pump preparation has drug release rate and can realize Zero order release and be easy to regulation and control, do not affect by gastrointestinal physiological environment, in vivo and in vitro dependency is good, the advantages such as individual variation impact is less, simultaneously osmotic pump preparation can to realize in compound preparation heterogeneity in the release of prescription ratio, and therefore osmotic pumps technology becomes and prepares the optimal technology of sustained-release preparation.
Summary of the invention
For solving the problems of the technologies described above, the invention provides good Fructus Alpiniae Oxyphyllae osmotic pump preparation of a kind of slow controlled-release effect and preparation method thereof.
A kind of Fructus Alpiniae Oxyphyllae osmotic pump preparation of the present invention adds pharmaceutically effective adjuvant by crude drug Fructus Gardeniae extract and Radix Notoginseng extract and obtains.
The preparation method of described Fructus Gardeniae extract is: get Fructus Gardeniae 4-10 times amount soak by water 1-3 time, each 1-2 hour, merging filtrate, be concentrated into fluid extract, with the alcohol settling of 50%-70%, washing precipitation, collect cleaning mixture and filtrate, recovery ethanol without alcohol taste to medicinal liquid, adds water and makes liquor strength be wash remove impurity after 0.9-1.1g crude drug/ml, adsorbent 3-5 hour with water to molish reaction for negative, use ethanol elution again, eluent reclaims ethanol, and less than 60 DEG C drying under reduced pressure, obtain Fructus Gardeniae crude extract; Getting Fructus Gardeniae crude extract carries out secondarily purified, sample solution concentration is 0.04-0.06g/ml, and resin column blade diameter length ratio is 1/4-1/8, and loading volume is 1.5-3.5BV, adsorption flow rate is 1-3BV/h, elution flow rate is 0.3-0.7BV/h, washing volume 1-3BV, and 1-3BV volume washed by 5-9% ethanol, 20-40% ethanol 4-6BV eluting, wave to without alcohol taste, vacuum drying, obtains Fructus Gardeniae extract.
The preparation method of described Radix Notoginseng extract is: get pseudo-ginseng coarse powder, adds 4-8 times amount 60-80% ethanol, reflux, extract, 1-3 time, each 1-2 hour, filters, merges each filtrate, water bath method, drying under reduced pressure, obtain dry extract; Get dry extract dilute with water, HPD-300 type purification with macroreticular resin, upper column liquid concentration is 0.3-0.7g crude drug/ml, and applied sample amount is 0.3-0.5g crude drug/ml resin, blade diameter length ratio is 1/6-1/8, ion 3-5BV, 5-15% ethanol remove impurity eluting 2-4BV, 60-80% ethanol desorbing 4-6BV, adsorption flow rate is 2-4BV/h, remove impurity elution flow rate is 5-7BV/h, and desorbing flow velocity is 10-14BV/h, obtains Radix Notoginseng extract.
The proportion of composing of described crude drug is: Fructus Gardeniae extract 30-50 mass parts, Radix Notoginseng extract 80-120 mass parts.
The proportion of composing of described crude drug is preferred: Fructus Gardeniae extract 40 mass parts, Radix Notoginseng extract 100 mass parts.
Described adjuvant is one or more in microcrystalline Cellulose, pregelatinized Starch, lactose, dibutyl phthalate, Polyethylene Glycol and magnesium stearate.
The preparation method of a kind of Fructus Alpiniae Oxyphyllae osmotic pump preparation of the present invention, its concrete steps are: crude drug and the adjuvant mix homogeneously of getting 60-100 mesh sieve; Moistening with 60-80% ethanol, 10-40 mesh sieve is granulated, and dries, granulate, adds the mixing of 0.2-0.4wt% magnesium stearate, tabletting; Coating, coating weight gain 5-9%, 30-50 DEG C more than ripening 4h; Laser boring, every sheet 2-3 hole, aperture is 0.15-0.2mm.
The preparation method of a kind of Fructus Alpiniae Oxyphyllae osmotic pump preparation of the present invention, its preferred operations step is: crude drug and the adjuvant mix homogeneously of getting 80 mesh sieves; Moistening with 70% ethanol, 20 mesh sieves are granulated, and dry, granulate, add the mixing of 0.3wt% magnesium stearate, tabletting, coating, coating weight gain 7%, 40 DEG C of ripening 12h; Punching, every sheet 2 hole, aperture is 0.2mm.
Described coating operations condition is: coating pan diameter 10-30cm, coating pan rotating speed 40-60rmin
-1, vertical tilt angle 15-45 °, temperature is 30-50 DEG C, coating solution transporting velocity 1-3mLmin
-1, pressure 0.2-0.4MPa; The formula of described coating solution is: in Fructus Alpiniae Oxyphyllae osmotic pump preparation gross mass, 2.0-4.0% acetone, 1.0-1.2% dibutyl phthalate, 3.0-4.0% Polyethylene Glycol.
Described coating solution formula is: in Fructus Alpiniae Oxyphyllae osmotic pump preparation gross mass, 3.0% acetone, 1.1% dibutyl phthalate, 3.5% PEG400.
" times amount " statement adding water and ethanol of the present invention refers to the volume amount being doubly equivalent to medical material.
Compared with prior art, the jasminoidin C in Fructus Alpiniae Oxyphyllae osmotic pump preparation of the present invention
maxreduce, T
maxextend, there is good slow release effect; Adopt the bioequivalence of classical confidence interval method to two kinds of preparations to judge, result shows ginsenoside Rb
1bioequivalence.
Accompanying drawing explanation
Jasminoidin drug-time curve (n=6, Mean scholar SD) after the oral two kinds of intelligence-raising formulations of Figure 1B eagle dog.
R after the oral two kinds of intelligence-raising formulations of Fig. 2 Beagle dog
1drug-time curve (n=6, Mean scholar SD).
Rg after the oral two kinds of intelligence-raising formulations of Fig. 3 Beagle dog
1drug-time curve (n=6, Mean scholar SD).
Rb after the oral two kinds of intelligence-raising formulations of Fig. 4 Beagle dog
1drug-time curve (n=6, Mean ± SD).
Detailed description of the invention
Below in conjunction with specific embodiment, Fructus Alpiniae Oxyphyllae osmotic pump preparation of the present invention and preparation method thereof is described further, but protection scope of the present invention is not limited to this.
The preparation of Fructus Gardeniae extract: get Fructus Gardeniae 6 times amount soak by water 3 times, each 1.5 hours, merging filtrate, be concentrated into fluid extract, with the alcohol settling of 60%, washing precipitation, collect cleaning mixture and filtrate, reclaim ethanol to medicinal liquid without alcohol taste, add water and make liquor strength be 1g crude drug/ml, adsorbent washes remove impurity with water to molish reaction for negative after 4 hours, use ethanol elution again, eluent reclaims ethanol, 60 DEG C of drying under reduced pressure, obtain Fructus Gardeniae crude extract, getting Fructus Gardeniae crude extract carries out secondarily purified, sample solution concentration is 0.05g/ml, resin column blade diameter length ratio is 1/6, loading volume is 2.5BV, adsorption flow rate is 2BV/h, elution flow rate is 0.5BV/h, washing volume 2BV, 2BV volume washed by 7% ethanol, 30% ethanol 5BV eluting, wave to without alcohol taste, vacuum drying, obtain Fructus Gardeniae extract.
The preparation of Radix Notoginseng extract: get pseudo-ginseng coarse powder, add 6 times amount 70% ethanol, reflux, extract, 2 times, each 1.5 hours, filter, merge each filtrate, water bath method, drying under reduced pressure, obtain dry extract, get dry extract dilute with water, HPD-300 type purification with macroreticular resin, upper column liquid concentration is 0.5g crude drug/ml, applied sample amount is 0.4g crude drug/ml resin, blade diameter length ratio is 1/7, ion 4BV, 10% ethanol remove impurity eluting 3BV, 70% ethanol desorbing 5BV, adsorption flow rate is 3BV/h, remove impurity elution flow rate is 6BV/h, desorbing flow velocity is 12BV/h, obtain Radix Notoginseng extract.
Embodiment 1
Medicine: Fructus Gardeniae extract 40mg, Radix Notoginseng extract 100mg; Adjuvant: microcrystalline Cellulose 50mg, dibutyl phthalate, PEG400.
Preparation: principal agent and the microcrystalline Cellulose mix homogeneously of getting 80 mesh sieves, use 70% ethanol wet, 20 mesh sieves are granulated, dry, granulate, add the mixing of 0.3wt% magnesium stearate, tabletting, (coating solution formula is coating: 3.0% acetone, 1.1% dibutyl phthalate, 3.5% PEG400; Art for coating is: coating pan diameter 20cm, coating pan rotating speed 50rmin
-1, vertical tilt angle 30 °, temperature is 40 DEG C, coating solution transporting velocity 2mLmin
-1, pressure 0.3MPa), coating weight gain 7%, 40 DEG C of ripening 12h; Laser boring, every sheet 2 hole, aperture is 0.2mm.
Consumption: every day 2 times, each 0.6g.
Embodiment 2
Medicine: Fructus Gardeniae extract 40mg, Radix Notoginseng extract 100mg; Adjuvant: pregelatinized Starch 45mg, dibutyl phthalate, polyethylene glycol 1500.
Preparation: principal agent and the pregelatinized Starch mix homogeneously of getting 80 mesh sieves, by 70% amount of alcohol removing dampness profit, 20 mesh sieves are granulated, dry, granulate, add 0.3% magnesium stearate mixing, tabletting, (coating solution formula is coating: 3.0% acetone, 1.1% dibutyl phthalate, 3.5% polyethylene glycol 1500; Art for coating is: coating pan diameter 20cm, coating pan rotating speed 50rmin
-1, vertical tilt angle 30 °, temperature is 40 DEG C, coating solution transporting velocity 2mLmin
-1, pressure 0.3MPa), coating weight gain 7%, 40 DEG C of ripening 12h; Mechanical punching, every sheet 2 hole, aperture is 0.2mm.
Consumption: every day 2 times, each 0.6g.
Embodiment 3
Medicine: Fructus Gardeniae extract 40mg, Radix Notoginseng extract 100mg; Adjuvant: lactose 50mg, dibutyl phthalate, Macrogol 2000.
Preparation: principal agent and the lactose mix homogeneously of getting 80 mesh sieves, by 70% amount of alcohol removing dampness profit, 20 mesh sieves are granulated, and dry, granulate, add 0.3% magnesium stearate mixing, tabletting, (coating solution formula is coating: 3.0% acetone, 1.1% dibutyl phthalate, 3.5% Macrogol 2000, surplus is water; Art for coating is: coating pan diameter 20cm, coating pan rotating speed 50rmin
-1, vertical tilt angle 30 °, temperature is 40 DEG C, coating solution transporting velocity 2mLmin
-1, pressure 0.3MPa), coating weight gain 7%, 40 DEG C of ripening 12h; Laser boring, every sheet 2 hole, aperture is 0.2mm.
Consumption: every day 2 times, each 0.6g.
The dynamic (dynamical) research of blood medicine in Fructus Alpiniae Oxyphyllae osmotic pump preparation Beagle dog body
By 6 healthy Beagl dogs, body weight is 9.3 scholar 1.0kg, is divided into 2 groups at random, often organizes 3.Adopt the design of binary cycle cross-over experiment, own control, Fructus Alpiniae Oxyphyllae osmotic pump tablet prepared by the oral embodiment 1 of random intersection or Fructus Alpiniae Oxyphyllae ordinary tablet, dosing interval is two weeks.Fasting 12h before experiment, get blank blood before administration, the Fructus Alpiniae Oxyphyllae osmotic pump tablet then embodiment 1 prepared or Fructus Alpiniae Oxyphyllae ordinary tablet directly fill in epiglottis portion, domesticated dog are swallowed automatically and injects 100mL clear water to send down, unified water inlet after administration 2h, unified feed after 6h.
Ordinary tablet respectively at 0,0.25,0.5,0.75,1,1.25,1.5,2,2.5,3,4,5,6,8,10,12,14,16,24,36,48h is totally 21 time point foreleg vein blood 3mL, embodiment 1 prepare Fructus Alpiniae Oxyphyllae osmotic pump tablet respectively at 0,0.5,1,1.5,2,2.5,3,4,5,6,8,10,12,14,16,24,36,48h totally 18 time points gets foreleg vein blood and is about 3mL, moves into immediately and scribbles in the test tube of heparin, 3000rmin
-1centrifugal 10min, gets blood plasma 1mL, in-10 DEG C of Refrigerator stores, to be analyzed.
Blood plasma pharmacokinetic studies: the results are shown in accompanying drawing 1-4 and table 1-9.
Jasminoidin pharmacokinetic parameters (n=6) after the oral Fructus Alpiniae Oxyphyllae ordinary tablet of table 1 Beagle dog
Jasminoidin pharmacokinetic parameters (n=6) after the oral Fructus Alpiniae Oxyphyllae micro-porous osmotic pump tablet of table 2 Beagle dog
Panax Notoginseng saponin R after the oral Fructus Alpiniae Oxyphyllae ordinary tablet of table 3 Beagle dog
1pharmacokinetic parameters (n=6)
Ginsenoside R after the oral Fructus Alpiniae Oxyphyllae micro-porous osmotic pump tablet of table 4 Beagle dog
1pharmacokinetic parameters (n=6)
Panax Notoginseng saponin R g after the oral Fructus Alpiniae Oxyphyllae ordinary tablet of table 5 Beagle dog
1pharmacokinetic parameters (n=6)
Ginsenoside Rg after the oral Fructus Alpiniae Oxyphyllae micro-porous osmotic pump tablet of table 6 Beagle dog
1pharmacokinetic parameters (n=6)
Panax Notoginseng saponin R b after the oral Fructus Alpiniae Oxyphyllae ordinary tablet of table 7 Beagle dog
1pharmacokinetic parameters (n=6)
Ginsenoside Rb after the oral Fructus Alpiniae Oxyphyllae micro-porous osmotic pump tablet of table 8 Beagle dog
1pharmacokinetic parameters (n=6)
The oral two kinds of Yizhi Decoction preparation artifact equivalences of table 9 Beagle dog compare (n=6)
From Drug-time curve and pharmacokinetic parameters, Fructus Alpiniae Oxyphyllae osmotic pump tablet C compared with the jasminoidin in ordinary tablet
maxreduce, T
maxextend, there is good slow release effect.Adopt the bioequivalence of classical confidence interval method to two kinds of preparations to judge, result shows ginsenoside Rb
1bioequivalence.
Claims (10)
1. a Fructus Alpiniae Oxyphyllae osmotic pump preparation, is characterized in that, said preparation adds pharmaceutically effective adjuvant by crude drug Fructus Gardeniae extract and Radix Notoginseng extract and obtains.
2. Fructus Alpiniae Oxyphyllae osmotic pump preparation according to claim 1, it is characterized in that, the preparation method of described Fructus Gardeniae extract is: get Fructus Gardeniae 4-10 times amount soak by water 1-3 time, each 1-2 hour, merging filtrate, be concentrated into fluid extract, with the alcohol settling of 50%-70%, washing precipitation, collect cleaning mixture and filtrate, reclaim ethanol to medicinal liquid without alcohol taste, add water and make liquor strength be 0.9-1.1g crude drug/ml, remove impurity is washed with water to molish reaction for negative after adsorbent 3-5 hour, use ethanol elution again, eluent reclaims ethanol, less than 60 DEG C drying under reduced pressure, obtain Fructus Gardeniae crude extract, getting Fructus Gardeniae crude extract carries out secondarily purified, sample solution concentration is 0.04-0.06g/ml, and resin column blade diameter length ratio is 1/4-1/8, and loading volume is 1.5-3.5BV, adsorption flow rate is 1-3BV/h, elution flow rate is 0.3-0.7BV/h, washing volume 1-3BV, and 1-3BV volume washed by 5-9% ethanol, 20-40% ethanol 4-6BV eluting, wave to without alcohol taste, vacuum drying, obtains Fructus Gardeniae extract.
3. Fructus Alpiniae Oxyphyllae osmotic pump preparation according to claim 1, it is characterized in that, the preparation method of described Radix Notoginseng extract is: get pseudo-ginseng coarse powder, adds 4-8 times amount 60-80% ethanol, reflux, extract, 1-3 time, each 1-2 hour, filter, merge each filtrate, water bath method, drying under reduced pressure, obtains dry extract; Get dry extract dilute with water, HPD-300 type purification with macroreticular resin, upper column liquid concentration is 0.3-0.7g crude drug/ml, and applied sample amount is 0.3-0.5g crude drug/ml resin, blade diameter length ratio is 1/6-1/8, ion 3-5BV, 5-15% ethanol remove impurity eluting 2-4BV, 60-80% ethanol desorbing 4-6BV, adsorption flow rate is 2-4BV/h, remove impurity elution flow rate is 5-7BV/h, and desorbing flow velocity is 10-14BV/h, obtains Radix Notoginseng extract.
4. Fructus Alpiniae Oxyphyllae osmotic pump preparation according to claim 1, is characterized in that, the proportion of composing of described crude drug is: Fructus Gardeniae extract 30-50 mass parts, Radix Notoginseng extract 80-120 mass parts.
5. Fructus Alpiniae Oxyphyllae osmotic pump preparation according to claim 1, is characterized in that, the proportion of composing of described crude drug is: Fructus Gardeniae extract 40 mass parts, Radix Notoginseng extract 100 mass parts.
6. Fructus Alpiniae Oxyphyllae osmotic pump preparation according to claim 1, is characterized in that, described adjuvant is one or more in microcrystalline Cellulose, pregelatinized Starch, lactose, dibutyl phthalate, Polyethylene Glycol and magnesium stearate.
7. the preparation method of the Fructus Alpiniae Oxyphyllae osmotic pump preparation as described in as arbitrary in claim 1-6, it is characterized in that, its concrete steps are: crude drug and the adjuvant mix homogeneously of getting 60-100 mesh sieve; Moistening with 60-80% ethanol, 10-40 mesh sieve is granulated, and dries, granulate, adds the mixing of 0.2-0.4wt% magnesium stearate, tabletting; Coating, coating weight gain 5-9%, 30-50 DEG C more than ripening 4h; Laser boring, every sheet 2-3 hole, aperture is 0.15-0.2mm.
8. the preparation method of a kind of Fructus Alpiniae Oxyphyllae osmotic pump preparation as claimed in claim 7, it is characterized in that, its concrete steps are: crude drug and the adjuvant mix homogeneously of getting 80 mesh sieves; Moistening with 70% ethanol, 20 mesh sieves are granulated, and dry, granulate, add the mixing of 0.3wt% magnesium stearate, tabletting, coating, coating weight gain 7%, 40 DEG C of ripening 12h; Punching, every sheet 2 hole, aperture is 0.2mm.
9. the preparation method according to claim 7 or 8, is characterized in that, described coating operations condition is: coating pan diameter 10-30cm, coating pan rotating speed 40-60rmin
-1, vertical tilt angle 15-45 °, temperature is 30-50 DEG C, coating solution transporting velocity 1-3mLmin
-1, pressure 0.2-0.4MPa; The formula of described coating solution is: in Fructus Alpiniae Oxyphyllae osmotic pump preparation gross mass, 2.0-4.0% acetone, 1.0-1.2% dibutyl phthalate, 3.0-4.0% Polyethylene Glycol.
10. preparation method according to claim 9, is characterized in that, described coating solution formula is: in Fructus Alpiniae Oxyphyllae osmotic pump preparation gross mass, 3.0% acetone, 1.1% dibutyl phthalate, 3.5% PEG400.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114425029A (en) * | 2022-02-14 | 2022-05-03 | 西安绿天生物技术有限公司 | Plant extract composition with anti-inflammatory and allergy-relieving functions, preparation method and application thereof |
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| CN114425029A (en) * | 2022-02-14 | 2022-05-03 | 西安绿天生物技术有限公司 | Plant extract composition with anti-inflammatory and allergy-relieving functions, preparation method and application thereof |
| CN114425029B (en) * | 2022-02-14 | 2024-05-10 | 西安绿天生物技术有限公司 | Plant extract composition with anti-inflammatory and allergy relieving effects, preparation method and application thereof |
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Application publication date: 20151007 |