CN1872179B - Microspheres in use for injection of Chinese traditional medicine of containing astragalus root, and preparation method - Google Patents
Microspheres in use for injection of Chinese traditional medicine of containing astragalus root, and preparation method Download PDFInfo
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- 238000002360 preparation method Methods 0.000 title claims description 15
- 238000002347 injection Methods 0.000 title abstract description 4
- 239000007924 injection Substances 0.000 title abstract description 4
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- 239000000463 material Substances 0.000 claims abstract description 4
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- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
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Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
A microball for injection is prepared from 18 Chinese-medicinal materials including Chinese angelica root, astragalus root, red peony root, Chuan-xiong rhizome, etc and biodegradable high-molecular auxiliary. Its preparing process is also disclosed.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of Chinese medicine release injectable microsphere and preparation method thereof that contains the Radix Astragali.
Background technology
The Radix Astragali be leguminous plant Radix Astagali Astragalus membranaceus (Fisch) Bge, var, monghlicus (Bge.) Hsiao or Radix Astragali Astragalus membranaceus (Fisch.) Bge, dry root.Its Main Ingredients and Appearance is glycoside, polysaccharide, aminoacid and trace element.Have enhancing human body immunity power, diuresis, defying age, protect the liver, effect such as blood pressure lowering, heart tonifying, expansion coronary vasodilator and whole body peripheral vessel, anti-mattress, be one of clinical Chinese medicine commonly used.
Motherland's medical science thinks that the Radix Astragali both can be used as medicine separately, also can unite use with other medical material, to reach clinical required curative effect.Through exploration for many years, the inventor finds that drug combinations such as the Radix Astragali and Radix Salviae Miltiorrhizae, Radix Notoginseng are had benefiting QI for activating blood circulation, and angina pectoris has better curative effect and (sees Chinese patent, application number: 02100879.5) for coronary heart disease with qi deficiency and blood stasis clinically.
Wherein, this patent disclosure by the drop pill of said composition preparation and conventional tablet etc., but owing to the intravital half-life of water-soluble active ingredient in the Radix Astragali or the Radix Salviae Miltiorrhizae is shorter, make common oral formulations be faced with a series of problem, frequent as the clinical administration number of times, use inconvenience, patient's compliance (compliance) difference etc.
The inventor finds can reach non-lentamente constant release with making microsphere with suitable adjuvant after the medicinal material extract such as the Radix Astragali through years of researches, reduces and takes number of times, improves the purpose of patient's compliance.
Summary of the invention
The object of the invention has been to provide a kind of brand-new slow release, the injection Chinese medicine microsphere of high bioavailability.
Another object of the present invention is to provide the preparation method of this injectable microsphere.
The prescription of pharmaceutical composition of the present invention is (in a weight percentage):
Radix Angelicae Sinensis 10-100mg; Radix Astragali 50-100mg; Radix Paeoniae Rubra 10-50g; Rhizoma Chuanxiong 20-100g; Radix Salviae Miltiorrhizae 60-300g; Ramulus Cinnamomi 10-100g; Semen Persicae 10-100g; Flos Carthami 10-100g; Ramulus Mori 10-200g; Radix Achyranthis Bidentatae 10-200g; Olibanum 10-150g; Myrrha 10-150g; Ramulus Uncariae Cum Uncis 10-200g; Pheretima 10-500g; Scorpio 10-1000g; Scolopendra 1-100 bar; Caulis Spatholobi 10-500g; Hirudo 10-1000g.
Said medicine prescription proportioning is the weight proportion of institute's uses crude drug, need further process and suitable adjuvant be made microsphere described medical material if be made into preparation.
The extraction of above-mentioned medical material can adopt the method for prior art routine to extract, and must make microsphere again behind the extract.
Injectable microsphere diameter of the present invention is 1～250 μ m, is made up of at 5000～1000000 daltonian biodegradable medical high-molecular additives the active component of microsphere gross weight 0.2%～50% (w/w) and the molecular weight of derivant and microsphere gross weight 50～99.8% (w/w) thereof.Wherein said biodegradable medical high-molecular additive is selected from polylactide, Acetic acid, hydroxy-, bimol. cyclic ester, polylactic acid, polyglycolic acid, poly--the 3-butyric ester, polylactic acid-polyglycolic acid, polylactic acid. glycolic, poly-adjacent ester, polylactone, polyanhydride, poly butyric ester-hydroxyl pentanoate copolymer, polyglycolic acid, polypropylene glucosan, hydroxyacetic acid, polylactic acid-polyglycol, polyglycolic acid. and wherein a kind of of Polyethylene Glycol; Preferred polylactide-co-glycolide, polylactic acid, polylactic acid. polyglycolic acid, polylactic acid. glycolic, poly butyric ester-hydroxyl pentanoate copolymer, the best is polylactide, Acetic acid, hydroxy-, bimol. cyclic ester, molecular weight is 12000～15000 dalton; The polymerization ratio of lactide-Acetic acid, hydroxy-, bimol. cyclic ester is 40: 60-60: 40.
Microsphere of the present invention can adopt the conventional preparation method of microsphere to make, as adopting emulsifying dispersion method, spray drying method and solvent evaporation method, preferably spray drying method.When preparing microsphere of the present invention with the emulsifying dispersion method, with dichloromethane, chloroform, ethyl acetate, dioxane, ether, acetone, oxolane, glacial acetic acid and by the mixed acid that they are formed medicinal substances extract and the dissolving of biodegradable pharmaceutic adjuvant are mixed with organic facies, wherein the bulking value percent of pharmaceutic adjuvant in organic solvent is 1～30%, the emulsifying agent that organic facies adopts is the nonionic emulsifier of HBL=4.5～6.0, and consumption is the 0.01-12% of organic facies; Prepare continuous water with polyvinyl alcohol, polyvinyl pyrrolidone, sodium polymethacrylate, sodium polyacrylate, sodium carboxymethyl cellulose solution in addition, wherein they are 0.01～10.0% in the percetage by weight of aqueous phase, the emulsifying agent of aqueous phase is the nonionic emulsifier of HLB=14.0～15.5, and consumption is 0.01～12% of a water; The volume ratio of organic facies and water is 1: 4～100; Organic facies slowly is injected in the continuous phase by tubule, fully emulsified after, the formed microsphere of sieving separating is drying to obtain.When adopting solvent evaporation method, be decentralized photo slowly be injected into by tubule in the continuous phase fully emulsified after, the decompression solvent flashing, centrifugalize obtains formed microsphere, is drying to obtain.
When adopting the spray drying method for preparation microsphere, to be the mixed acid formed with dichloromethane, chloroform, ethyl acetate, dioxane, ether, acetone, oxolane, glacial acetic acid and by them Chinese medicine extract and biodegradable pharmaceutic adjuvant fully dissolve is mixed with organic solution; Filter, spray drying is made microsphere.
Microsphere of the present invention be will make microsphere sterilized powder suspendible in aseptic 0.9% normal saline solvent earlier, evenly the back intramuscular injection comes administration.
In motherland's medical science to record that pill has " the ball person is slow also, releives and controls it ... " (Li Gao, 1180-1251).As seen Ancient Times in China medicine man early has recognized that and has used practice of pharmacy, reaches the purpose of steadily lasting curative effect.
Conventional dosage forms, most drug release process is all undertaken by first order kinetics, and the blood drug level of its medicine might be lower than minimum effective blood drug concentration and hold time short shortcoming in treatment concentration.For reaching therapeutic purposes and reducing side effect and often take repeatedly medicining mode, the compliance that makes the patient take medicine like this descends.Slow releasing preparation has overcome the deficiency of conventional formulation just, and steady, persistent blood drug level is provided.
Chinese medicine microsphere of the present invention has adopted the design principle of Western medicine slow releasing preparation to obtain achievement at aspects such as adjuvant selection, quality evaluations, for the research of Chinese medicine slow releasing preparation is used for reference.
Below beneficial effect by extracorporeal releasing test explanation microsphere
Laboratory sample: according to the microsphere of the embodiment of the invention 1,2,3 described method preparations.
Experiment reagent: the buffer solution (4.0,5.5) of certain pH value.
Experimental apparatus: constant temperature oscillator, centrifuge.
Experiment condition: temperature: 37 ± 10 ℃; Rotating speed: 30rp/ minute.
Experimental technique: precision takes by weighing the about 10mg of laboratory sample, and to place volume be the tool lid plastic centrifuge tube of 15ml, adds 5ml release medium (PH=4.0 and 5.5 phosphate buffer solutions) and place constant temperature oscillator, keeps certain temperature and rotating speed to take a sample on time.
Sampling method: centrifugal 50min under the 3600 commentaries on classics conditions, essence is got 3ml solution, adds the release medium of 3ml again, takes out liquid and detects with HPLC.Concrete detection index is a paeoniflorin, detects wavelength: 281nm.
Sampling time point (my god): 0,1,2,4,6,8,10,12,14,16,18,20.
Result of the test: the external release test of control-release microsphere is table 1 as a result.
Ligustrazine release in vitro result in table 1, the microsphere
The specific embodiment
The present invention is further illustrated below in conjunction with embodiment, and following this embodiment only is used to the present invention is described and to the present invention without limits.
Embodiment 1
Get Radix Astragali 200g, Ramulus Mori 20g, Radix Angelicae Sinensis 40g, Radix Achyranthis Bidentatae 20g, Radix Paeoniae Rubra 20g, Olibanum 20g, Rhizoma Chuanxiong 40g, Myrrha 20g, Radix Salviae Miltiorrhizae 60g, Ramulus Uncariae Cum Uncis 20g, Ramulus Cinnamomi 20g, Pheretima 20g, Semen Persicae 20g, Scorpio 200g, Flos Carthami 20g, Caulis Spatholobi 20g, 30 of Scolopendras, Hirudo 100g.
With above-mentioned pulverizing medicinal materials, extracting in water gets extracting solution, is condensed into extractum.
The preparation of microsphere: above-mentioned 100mg extract, 200mg polylactide-co-glycolide are dissolved in the 3ml dichloromethane, with syringe under high degree of agitation with it to being equipped with in the three-necked bottle of 10%PVA that 300ml includes the 3.5Ghlb=14 emulsifying agent, after fully emulsified 1 hour, under the pressure of 30 ℃ of 0.03MPa, solvent flashing 1.5 hours, centrifugalize, wash reactant three times with distillation, in 30 ℃ of vacuum drying ovens, dry, sterilized 48 hours at 30 ℃ with oxirane, guarantee residual ethylene oxide content below 5ppm, fill.
Claims (1)
1. a sustained-release micro-spheres that contains the Radix Astragali is characterized in that, following preparation method obtains:
(1) gets Radix Astragali 200g, Ramulus Mori 20g, Radix Angelicae Sinensis 40g, Radix Achyranthis Bidentatae 20g, Radix Paeoniae Rubra 20g, Olibanum 20g, Rhizoma Chuanxiong 40g, Myrrha 20g, Radix Salviae Miltiorrhizae 60g, Ramulus Uncariae Cum Uncis 20g, Ramulus Cinnamomi 20g, Pheretima 20g, Semen Persicae 20g, Scorpio 200g, Flos Carthami 20g, Caulis Spatholobi 20g, 30 of Scolopendras, Hirudo 100g is with above-mentioned pulverizing medicinal materials, extracting in water gets extracting solution, is condensed into extractum;
(2) preparation of microsphere: above-mentioned 100mg extract, 200mg polylactide-co-glycolide are dissolved in the 3ml dichloromethane, with syringe under high degree of agitation with it to being equipped with in the three-necked bottle of 10%PVA that 300ml includes the 3.5Ghlb=14 emulsifying agent, after fully emulsified 1 hour, under the pressure of 30 ℃ of 0.03MPa, solvent flashing 1.5 hours, centrifugalize, wash reactant three times with distillation, in 30 ℃ of vacuum drying ovens, dry, sterilized 48 hours at 30 ℃ with oxirane, guarantee residual ethylene oxide content below 5ppm, fill.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2005100136962A CN1872179B (en) | 2005-06-03 | 2005-06-03 | Microspheres in use for injection of Chinese traditional medicine of containing astragalus root, and preparation method |
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| CN2005100136962A CN1872179B (en) | 2005-06-03 | 2005-06-03 | Microspheres in use for injection of Chinese traditional medicine of containing astragalus root, and preparation method |
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| CN1872179B true CN1872179B (en) | 2010-12-01 |
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| CN102836237B (en) * | 2012-01-18 | 2015-09-30 | 湖南中医药大学 | YANG invigorating also five controlled slow-release preparations and preparation method thereof of a kind of entirety release |
| CN110538290A (en) * | 2018-05-29 | 2019-12-06 | 李天生 | First-aid medicine liquid and its preparing method |
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